Self‐management interventions including action plans for exacerbations versus usual care in patients with chronic obstructive pulmonary disease

Abstract

Background

Chronic Obstructive Pulmonary Disease (COPD) self‐management interventions should be structured but personalised and often multi‐component, with goals of motivating, engaging and supporting the patients to positively adapt their behaviour(s) and develop skills to better manage disease. Exacerbation action plans are considered to be a key component of COPD self‐management interventions. Studies assessing these interventions show contradictory results. In this Cochrane Review, we compared the effectiveness of COPD self‐management interventions that include action plans for acute exacerbations of COPD (AECOPD) with usual care.

Objectives

To evaluate the efficacy of COPD‐specific self‐management interventions that include an action plan for exacerbations of COPD compared with usual care in terms of health‐related quality of life, respiratory‐related hospital admissions and other health outcomes.

Search methods

We searched the Cochrane Airways Group Specialised Register of trials, trials registries, and the reference lists of included studies to May 2016.

Selection criteria

We included randomised controlled trials evaluating a self‐management intervention for people with COPD published since 1995. To be eligible for inclusion, the self‐management intervention included a written action plan for AECOPD and an iterative process between participant and healthcare provider(s) in which feedback was provided. We excluded disease management programmes classified as pulmonary rehabilitation or exercise classes offered in a hospital, at a rehabilitation centre, or in a community‐based setting to avoid overlap with pulmonary rehabilitation as much as possible.

Data collection and analysis

Two review authors independently assessed trial quality and extracted data. We resolved disagreements by reaching consensus or by involving a third review author. Study authors were contacted to obtain additional information and missing outcome data where possible. When appropriate, study results were pooled using a random‐effects modelling meta‐analysis. The primary outcomes of the review were health‐related quality of life (HRQoL) and number of respiratory‐related hospital admissions.

Main results

We included 22 studies that involved 3,854 participants with COPD. The studies compared the effectiveness of COPD self‐management interventions that included an action plan for AECOPD with usual care. The follow‐up time ranged from two to 24 months and the content of the interventions was diverse.

Over 12 months, there was a statistically significant beneficial effect of self‐management interventions with action plans on HRQoL, as measured by the St. George's Respiratory Questionnaire (SGRQ) total score, where a lower score represents better HRQoL. We found a mean difference from usual care of ‐2.69 points (95% CI ‐4.49 to ‐0.90; 1,582 participants; 10 studies; high‐quality evidence). Intervention participants were at a statistically significant lower risk for at least one respiratory‐related hospital admission compared with participants who received usual care (OR 0.69, 95% CI 0.51 to 0.94; 3,157 participants; 14 studies; moderate‐quality evidence). The number needed to treat to prevent one respiratory‐related hospital admission over one year was 12 (95% CI 7 to 69) for participants with high baseline risk and 17 (95% CI 11 to 93) for participants with low baseline risk (based on the seven studies with the highest and lowest baseline risk respectively).

There was no statistically significant difference in the probability of at least one all‐cause hospital admission in the self‐management intervention group compared to the usual care group (OR 0.74, 95% CI 0.54 to 1.03; 2467 participants; 14 studies; moderate‐quality evidence). Furthermore, we observed no statistically significant difference in the number of all‐cause hospitalisation days, emergency department visits, General Practitioner visits, and dyspnoea scores as measured by the (modified) Medical Research Council questionnaire for self‐management intervention participants compared to usual care participants. There was no statistically significant effect observed from self‐management on the number of COPD exacerbations and no difference in all‐cause mortality observed (RD 0.0019, 95% CI ‐0.0225 to 0.0263; 3296 participants; 16 studies; moderate‐quality evidence). Exploratory analysis showed a very small, but significantly higher respiratory‐related mortality rate in the self‐management intervention group compared to the usual care group (RD 0.028, 95% CI 0.0049 to 0.0511; 1219 participants; 7 studies; very low‐quality evidence).

Subgroup analyses showed significant improvements in HRQoL in self‐management interventions with a smoking cessation programme (MD ‐4.98, 95% CI ‐7.17 to ‐2.78) compared to studies without a smoking cessation programme (MD ‐1.33, 95% CI ‐2.94 to 0.27, test for subgroup differences: Chi² = 6.89, df = 1, P = 0.009, I² = 85.5%). The number of behavioural change techniques clusters integrated in the self‐management intervention, the duration of the intervention and adaptation of maintenance medication as part of the action plan did not affect HRQoL. Subgroup analyses did not detect any potential variables to explain differences in respiratory‐related hospital admissions among studies.

Authors' conclusions

Self‐management interventions that include a COPD exacerbation action plan are associated with improvements in HRQoL, as measured with the SGRQ, and lower probability of respiratory‐related hospital admissions. No excess all‐cause mortality risk was observed, but exploratory analysis showed a small, but significantly higher respiratory‐related mortality rate for self‐management compared to usual care.

For future studies, we would like to urge only using action plans together with self‐management interventions that meet the requirements of the most recent COPD self‐management intervention definition. To increase transparency, future study authors should provide more detailed information regarding interventions provided. This would help inform further subgroup analyses and increase the ability to provide stronger recommendations regarding effective self‐management interventions that include action plans for AECOPD. For safety reasons, COPD self‐management action plans should take into account comorbidities when used in the wider population of people with COPD who have comorbidities. Although we were unable to evaluate this strategy in this review, it can be expected to further increase the safety of self‐management interventions. We also advise to involve Data and Safety Monitoring Boards for future COPD self‐management studies.

Plain language summary

Self‐management interventions including action plans for patients with Chronic Obstructive Pulmonary Disease (COPD)

Review question

We looked at the evidence on the effects of self‐management interventions that include action plans for when COPD symptoms get worse. In particular, we looked at the effects on health‐related quality of life and hospital admissions related to lung diseases in people with COPD.

Background

People with COPD, a chronic lung disease, have symptoms that get worse over time leading to loss of well‐being (also known as reduction in health‐related quality of life, HRQoL). In self‐management interventions people with COPD learn what to do in different disease situations, such as when symptoms get worse and to develop skills and change health behaviour to successfully manage their disease. Action plans describe what can be done by people with COPD when symptoms get worse.

The effectiveness of action plans for when COPD gets worse is not completely clear. Action plans have become a central part of COPD management and are very often included in COPD self‐management programmes.

Search date

We searched up to May 2016.

Study characteristics

We included 22 studies, involving a total of 3,854 participants, that evaluated the effects of self‐management interventions that include an action plan. All studies had control groups who received usual care. Follow‐up was from two to 24 months.

Key results

Self‐management interventions including an action plan for worsening COPD symptoms improved health‐related quality of life compared with usual care (high‐quality evidence). The number of people who had at least one hospital admission related to lung disease was reduced among those who participated in a self‐management intervention (moderate‐quality evidence). There was a very small but significant increase in respiratory‐related deaths for self‐management interventions (very low‐quality evidence).

The included studies looked at different content of self‐management interventions and action plans. Study populations also differed.

Although we were unable to identify the most effective components, we found that including a smoking cessation programme seemed to be effective to further improve health‐related quality of life.

Quality of the evidence

The evidence in this review is reliable, and the evidence for the main findings is moderate to high.

Summary of findings

Summary of findings for the main comparison. Self‐management interventions including action plans for exacerbations compared to usual care for patients with COPD.

Self‐management interventions including action plans for exacerbations compared to usual care for patients with COPD
Patient or population: patients with chronic obstructive pulmonary disease (COPD) Setting: hospital, outpatient clinic, primary care, home‐based Intervention: self‐management interventions including action plans for COPD exacerbations Comparison: usual care
Outcomes	Anticipated absolute effects* (95% CI)		Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
	Risk with usual care	Risk with self‐management interventions including action plans for exacerbations
Health‐related quality of life (HRQoL) assessed with: St. George's Respiratory Questionnaire adjusted total score Scale from: 0 to 100 follow up: 12 months	The mean HRQoL ranged from 37.7 to 70.4 points	MD 2.69 points lower (4.49 lower to 0.9 lower)	‐	1582 (10 RCTs)	⊕⊕⊕⊕ HIGH	Lower score indicates better health‐related quality of life.
Respiratory‐related hospital admissions assessed with: number of patients with at least one respiratory‐related hospital admission follow up: range 6 months to 24 months	312 per 1,000	238 per 1,000 (188 to 298)	OR 0.69 (0.51 to 0.94)	3,157 (14 RCTs)	⊕⊕⊕⊝ MODERATE 1
All‐cause hospital admissions assessed with: number of patients with at least one all‐cause hospital admission follow up: range 6 months to 12 months	427 per 1000	356 per 1,000 (287 to 434)	OR 0.74 (0.54 to 1.03)	2,467 (10 RCTs)	⊕⊕⊕⊝ MODERATE 2
All‐cause mortality assessed with: number of all‐cause deaths follow up: range 3 months to 24 months	102 per 1000	107 per 1,000 (74 to 153)	OR 1.06 (0.71 to 1.59)	3,296 (16 RCTs)	⊕⊕⊕⊝ MODERATE3	Pooled risk difference of 0.0019 (95% CI ‐0.0225 to 0.0263).
Respiratory‐related mortality assessed with: number of respiratory‐related deaths follow up: range 3 months to 24 months	48 per 1000	89 per 1,000 (57 to 136)	OR 1.94 (1.20 to 3.13)	1,219 (7 RCTs)	⊕⊝⊝⊝ VERY LOW 4	Pooled risk difference of 0.028 (95% CI 0.0049 to 0.0511).
Dyspnoea assessed with: (modified) Medical Research Council Dyspnoea Scale Scale from: 0 to 4 follow up: 12 months	The mean dyspnoea ranged from 2.4 to 2.6	MD 0.63 lower (1.44 lower to 0.18 higher)	‐	217 (3 RCTs)	⊕⊕⊝⊝ LOW 5	Lower score indicates improvement in dyspnoea.
COPD exacerbations assessed with: number of COPD exacerbations per patient follow up: range 3 months to 24 months 7	The mean COPD exacerbations ranged from 1.13 to 4.3	MD 0.01 higher (0.28 lower to 0.29 higher)	‐	740 (4 RCTs)	⊕⊕⊕⊝ MODERATE 6
Courses of oral steroids assessed with: number of patients who used at least one course of oral steroids follow up: 12 months	497 per 1000	812 per 1000 (352 to 972)	OR 4.38 (0.55 to 34.91)	963 (4 RCTs)	⊕⊕⊝⊝ LOW 8
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; MD: mean difference; OR: Odds ratio; RCT: randomised controlled trial
GRADE Working Group grades of evidence High quality: We are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect

¹ Heterogeneity was substantial (I² = 57%) (inconsistency ‐1).

² Heterogeneity was substantial (I² = 62%) (inconsistency ‐1).

³ Imprecision of pooled effect size (imprecision ‐1).

⁴ Explorative meta‐analysis. Four studies (Gallefoss 1999; Kheirabadi 2008; Ninot 2011; Tabak 2014) with no events and a high risk of bias for three studies (Bucknall 2012; Tabak 2014; Titova 2015) for incomplete outcome data and selective reporting. Two studies (Bucknall 2012; Fan 2012) dominated the overall effect and heavily influenced the OR (risk of bias ‐1, inconsistency ‐1, imprecision ‐1).

⁵ Heterogeneity was high (I² =86%). Only three studies were included in this meta‐analysis (inconsistency ‐1, imprecision ‐1).

⁶ Only four studies were included in this meta‐analysis (imprecision ‐1).

⁷ COPD exacerbations were defined as worsening of respiratory symptoms beyond normal day‐to‐day variations that required treatment with bronchodilators, oral steroids and/or antibiotics

⁸ Heterogeneity was high (I² = 94%). Only four studies were included in this meta‐analysis (inconsistency ‐1, imprecision ‐1).

Background

Description of the condition

Chronic obstructive pulmonary disease (COPD) is characterised by respiratory symptoms that are caused predominantly by persistent airflow limitation, which is usually progressive. COPD is associated with an enhanced chronic inflammatory response in the lung to noxious particles or gases (GOLD 2017). Many people with COPD experience increasing functional impairment and progressive loss of quality of life over many years (Carrasco Garrido 2006; Celli 2007; Heyworth 2009). Acute exacerbations of COPD (AECOPD), defined as acute deterioration in respiratory health, contribute to functional impairment and risk of mortality in individual people with the disease (Celli 2007; Seemungal 1998).

COPD leads to more than six million deaths annually and has been predicted to be the third leading cause of death worldwide (GOLD 2017; Lozano 2012). Increased mortality is driven mainly by the expanding global epidemic of smoking, reduced mortality from other common causes of death (e.g., ischaemic heart disease, infectious disease) and increasing age of the world population (GOLD 2017). COPD is also a leading cause of morbidity. In 2010, COPD was the fifth largest cause of years of life lived with disability (Vos 2012). Apart from personal distress, COPD confers a substantial and increasing economic and social burden on society (GOLD 2017), with its exacerbations accounting for most direct costs (Toy 2010).

Description of the intervention

Wagner's Chronic Care model (Wagner 1998) suggested improvement of chronic illness care through health systems that: 1) have well‐developed processes and incentives for making change in the care delivery system; 2) assure behaviourally sophisticated self‐management support that gives priority to increasing a person's confidence and skills so they can be the ultimate manager of their illness; 3) re‐organise team function and practice systems (e.g., appointments and follow‐up) to meet the needs of people who are chronically ill; 4) develop and implement evidence‐based guidelines that are supported through provider education, reminders, and increased interaction between generalists and specialists; 5) enhance information systems to facilitate the development of disease registries, tracking systems, and reminders and to give feedback on performance. Patient education, written management plans, access to 24/7 healthcare, and a case manager are required to reduce healthcare utilisation (Wagner 1998).

Self‐management interventions are defined as structured interventions for individuals aimed at improvement in self‐health behaviours and self‐management skills (Lorig 2003). Lorig 2003 indicated that a self‐management programme should ideally include training with feedback to improve the following patient skills: problem solving, decision making, resource utilisation, formating patient‐provider partnerships, action planning and self‐tailoring. Mastery, modelling, interpretation of symptoms and social persuasion skills are believed to contribute to enhanced self‐efficacy (Lorig 2003). People progressively achieve greater confidence in (self) managing their health, and this is a powerful factor in inducing new and sustaining behaviours that provide perceived benefit (Bourbeau 2004; Lorig 2003).

Self‐management has been proposed as an essential part of disease management targeted to helping people develop skills to manage disease more effectively. This is especially important in people with chronic disease (e.g., COPD, for which the individual is responsible for day‐to‐day care for the duration of the illness) (Lorig 2003). COPD self‐management interventions are associated with reduced duration of exacerbations and hospitalisations and decreased healthcare costs, as well as improved health‐related quality of life (HRQoL) (Effing 2009a; Rice 2010; Zwerink 2014). COPD self‐management training aims to help people acquire and improve skills needed to carry out disease‐specific medical regimens (Bourbeau 2009; Effing 2012). Self‐management training also guides changes in health behaviour and provides emotional support for optimal function of people with COPD and control of their disease (Bourbeau 2009; Effing 2012). Self‐management training is considered to be an increasingly important component of treatment and management of COPD. Training should occur as an interactive and iterative process aimed at sustained behavioural change and to instil confidence to recognise when an exacerbation is starting and to self manage it effectively and safely (Bourbeau 2009). Self‐management will not be successful without effective co‐operation between patient and healthcare providers (Bodenheimer 2002). Ongoing case manager support is recognised as an additional component required to achieve effective and safe self‐management (Effing 2012).

Recently, an international expert group reached consensus regarding a conceptual definition for a COPD self‐management intervention (Effing 2016). Self‐management interventions should be structured but personalised and often multi‐component, with goals of motivating, engaging and supporting the patients to positively adapt their behaviour(s) and develop skills to better manage their disease. Our review inclusion criteria were developed in line with this definition.

Action planning is a frequently applied planning technique in generic self‐management programmes and adopted to change behaviour (Hagger 2014; Webb 2010). COPD exacerbation action plans are disease‐specific and considered to be an intrinsic part of COPD self‐management interventions (Effing 2012; Zwerink 2014). People with COPD are trained to use exacerbation action plans if they experience worsening of respiratory symptoms. Appropriate actions can include contacting a healthcare provider for support or initiating self‐treatment (Wood‐Baker 2006). Furthermore, written action plans can include instructions regarding, for example, maintenance treatment.

How the intervention might work

Using action plans for exacerbations of COPD within a self‐management intervention provides training for people with COPD to recognise symptoms earlier, accelerate the initiation of appropriate treatment and lead to better control of deteriorating symptoms. This may lead to improved HRQoL, reduced exacerbation duration and hospitalisations, and decreased healthcare costs for people with COPD.

Why it is important to do this review

A Cochrane Review on COPD self‐management concluded that self‐management is associated with improved HRQoL, reduced respiratory‐related and all‐cause hospitalisations and improved dyspnoea (Zwerink 2014). Subgroup analyses indicate that a standardised exercise component in self‐management interventions did not change the effects of self‐management interventions on HRQoL and respiratory‐related hospital admissions. However, the review could not reveal the effective components within self‐management interventions, not least because of heterogeneity among interventions, study populations, follow‐up time and outcome measures (Zwerink 2014). In recently published individual patient data (IPD) meta‐analyses on the effectiveness of COPD self‐management the included self‐management interventions also differed from each other in terms of dose, mode and content (Jonkman 2016b). Because of the very frequent use of action plans for exacerbations in the included studies, subanalyses on the use of action plans could not be performed by Zwerink 2014. As COPD action plans are currently considered as an intrinsic part of COPD self‐management interventions, in the current new review written action plans for AECOPD were included as part of the self‐management intervention.

Since the publication of Zwerink 2014, several studies have been published and new opinions have been raised regarding the limitations and content of COPD self‐management interventions with exacerbation action plans for people with COPD. So far, the evidence regarding COPD action plans is somewhat contradictory. After two years of follow‐up, a self‐management programme including action plans for the self‐treatment of exacerbations in people with COPD without significant comorbidities resulted in reduced exacerbation duration, exacerbation severity and healthcare utilisation (Zwerink 2016). Furthermore, a review showed that the use of action plans with a single short educational component along with ongoing support, but without a comprehensive self‐management programme, reduces in‐hospital healthcare utilisation and increases treatment of COPD exacerbations (Howcroft 2016). This review showed a small improvement in HRQoL from action plans compared to usual care but it was unlikely to increase or decrease mortality (Howcroft 2016). As a result of using individualised action plans and ongoing support, the impact of exacerbations on health status decreased and the recovery of an exacerbation might be accelerated (Trappenburg 2011). A study evaluating the efficacy of a comprehensive care management programme in reducing the risk for COPD hospitalisations with COPD‐specific action plans was prematurely terminated (Fan 2012) because of significantly higher mortality rates in the intervention group. No definitive explanation for these study outcomes has emerged, and they conflict with the positive study outcomes of another highly comparable self‐management study by Rice 2010. The significantly higher mortality rates in the intervention group reported by Fan 2012 may be partly explained by the use of COPD‐specific action plans for people with COPD and comorbidities. A single‐centre RCT that included nurse support identified only 42% of the intervention group as successful self‐managers. This group of successful self‐managers had a significantly reduced risk of hospital re‐admissions (Bucknall 2012). This study implied that not all people with COPD derive benefit from a COPD self‐management intervention. All COPD self‐management interventions discussed above have included a COPD exacerbation action plan as a key intervention component, underlining that these action plans are currently seen as an intrinsic part of COPD self‐management interventions. Nevertheless, these studies show contradictory results. We assessed the effectiveness of COPD self‐management interventions that include action plans for AECOPD compared with usual care for this review.

Objectives

To evaluate the efficacy of COPD‐specific self‐management interventions that include an action plan for exacerbations of COPD compared with usual care in terms of health‐related quality of life, respiratory‐related hospital admissions and other health outcomes.

Methods

Criteria for considering studies for this review

Types of studies

We considered randomised controlled trials (RCTs) reported in full text, those published as abstracts only and unpublished data from RCTs.

Types of participants

We included studies that included participants diagnosed with Chronic Obstructive Pulmonary Disease (COPD) according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) classification criteria (GOLD 2017); people with a post‐bronchodilator forced expiratory volume in one second (FEV₁)‐to‐forced vital capacity (FVC) ratio < 0.70. Participants with primary diagnoses of asthma were excluded.

Types of interventions

We included trials comparing COPD self‐management interventions that included a written action plan for acute exacerbations of COPD (AECOPD) versus usual care. For this review, an action plan refers to specific behaviour to be initiated when respiratory symptoms deteriorate; the plan needed to describe when, where and how one should act. An action plan is an agreed strategy by which people act appropriately when symptoms deteriorate (indicating the start of a COPD exacerbation), for example, by contacting a healthcare provider for support or initiating self‐treatment. It may also include maintenance treatment and advice to avoid situations in which viral infection might be prevalent.

The self‐management intervention needed to include formal training on how and when to use an action plan for AECOPD. To be eligible for inclusion, the formal training programme had to be an iterative process between participants and healthcare provider(s) in which feedback was provided to develop participants’ self‐management skills (e.g., how and when to use an action plan for AECOPD). Training should ideally include techniques directed to achieving behavioural change (Michie 2013). The intervention could also include other components that were directed to achieving behaviour change (e.g., smoking behaviour, exercise or physical activity, diet, use of maintenance medication and correct device use, coping with breathlessness). The intervention content could be delivered to participants verbally, in writing (hard copy or digital) or via audiovisual media.

Disease management programmes classified as pulmonary rehabilitation or exercise classes offered in a hospital, at a rehabilitation centre or in a community‐based setting were excluded to avoid possible overlap with pulmonary rehabilitation as much as possible. The study was considered if the participants were randomised and allocated to self‐management or usual care after pulmonary rehabilitation. The study was excluded if randomisation was performed before pulmonary rehabilitation. Home‐based (unsupervised) exercise programmes that included action plans for AECOPD were included, as these studies asked a more active role of participants and were more clearly aimed at development of self‐management skills compared to supervised exercise programmes.

As the definition, content and focus of COPD self‐management training in particular, and of COPD treatment in general, have dramatically changed over the past 20 years, we excluded studies published before 1995. We included studies that were published in full‐text and excluded abstracts if there was no additional information available from the study authors.

Usual care differs significantly among countries and healthcare systems, and sometimes elements of self‐management interventions were included as part of usual care. We defined usual care as de facto routine clinical care.

Types of outcome measures

Primary outcomes

• Health‐related quality of life (HRQoL).

• Respiratory‐related hospital admissions.

Secondary outcomes

• Number of all‐cause hospital admissions.

• Use of (other) healthcare facilities (e.g., number of emergency department (ED) visits, number of all‐cause and respiratory‐related hospitalisation days in total and per patient, general practitioner (GP), number of nurse and specialist visits).

• Rescue medication use.

• Health status.

• Number of COPD exacerbations.

• All‐cause mortality.

• Self‐efficacy.

• Days lost from work.

Reporting one or more of the listed outcomes was not an inclusion criterion for our review. We intended to divide COPD exacerbations into those based on COPD symptom scores (e.g., symptom diary), courses of oral corticosteroids and courses of antibiotics.

Search methods for identification of studies

Electronic searches

We identified studies from the Cochrane Airways Trials Register, which is maintained by the Information Specialist for the Group.

The Cochrane Airways Trials Register contains studies identified from several sources:

1. Monthly searches of the Cochrane Central Register of Controlled Trials (CENTRAL), through the Cochrane Register of Studies Online (crso.cochrane.org);

2. Weekly searches of MEDLINE Ovid SP 1946 to date;

3. Weekly searches of Embase Ovid SP 1974 to date;

4. Monthly searches of PsycINFO Ovid SP 1967 to date;

5. Monthly searches of CINAHL EBSCO (Cumulative Index to Nursing and Allied Health Literature) 1937 to date;

6. Monthly searches of AMED EBSCO (Allied and Complementary Medicine); and

7. Handsearches of the proceedings of major respiratory conferences.

Studies contained in the Trials Register are identified through search strategies based on the scope of Cochrane Airways. Details of these strategies, as well as a list of handsearched conference proceedings are in Appendix 1. See Appendix 2 for search terms used to identify studies for this review.

We searched the Cochrane Airways Trials Register from 1995 to May 2016, with no restriction on language of publication.

We contacted the authors of included studies to ask for further information, if needed.

Searching other resources

We checked reference lists of all primary studies and reviewed articles for additional references. We searched for additional trials using ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform (WHO ICTRP, www.who.int/ictrp/en/ databases).

Data collection and analysis

Selection of studies

Two review authors (AL and TE) independently assessed titles and abstracts of all references retrieved. Subsequently, two review authors (AL and TE or MB) independently reviewed full‐text versions of potentially relevant reports, assessed eligibility for inclusion and resolved disagreements by discussion with the third review author (TE or MB).

Data extraction and management

Two review authors (AL and TE or MB) independently assessed trial quality and extracted the following data from included studies: relevant outcome measures; sample size; demographics of included participants; disease severity; setting, duration and content of the intervention and potential effect modifiers. We used standard data extraction forms and spreadsheets. We completed a data extraction form for study characteristics and outcome data that was piloted on two studies in the review.

We noted in Characteristics of included studies tables whether outcome data were reported in a useable way. We resolved disagreements by reaching consensus or by involving a third (TE or MB) or fourth review author (JP or PV). Data were transferred into the Review Manager (RevMan) 5.3 (Review Manager 2014) file (AL) and double‐checked for accuracy by comparing data presented in the systematic review versus data in the study reports (TE).

Assessment of risk of bias in included studies

Two review authors (AL and TE or MB) independently assessed the risk of bias according to recommendations outlined in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011) for the following items.

• Random sequence generation.

• Allocation concealment.

• Blinding of participants and personnel.

• Blinding of outcome assessment.

• Incomplete outcome data.

• Selective reporting.

• Other potential sources of bias.

For each included study we graded all listed domains to whether high, low or unclear risk of bias was present (AL and TE or MB). An unclear risk indicated that there was insufficient detail of what happened in the study; that what happened in the study was known but the risk of bias was unknown; or that an entry was not relevant to the study at hand. Each judgement of risk of bias is supported by a short description of what was reported to have happened in the specific study. The grade of each potential bias from the included study together with a quote from the study report and justification for our judgement is reported in 'Risk of bias' tables. In the case of cluster‐RCTs, we assessed the risk of recruitment bias, risk of bias for baseline imbalance, risk of bias due to loss of clusters, risk of bias due to incorrect analysis and publication bias. We resolved disagreements by discussion or with involvement of another review author (JP or PV).

Assessment of bias in conducting the systematic review

We conducted the review according to the published protocol and reported deviations from it in the 'Differences between protocol and review' section of the systematic review.

Measures of treatment effect

We analysed the results of studies using random‐effects modelling in RevMan (Review Manager 2014). We used forest plots to compare results across trials. We expressed the results of each RCT as odds ratios (ORs) with corresponding 95% confidence intervals (95% CIs) for dichotomous outcomes, and as mean differences (MDs) or standardised mean differences (SMDs) for continuous outcomes. For primary analyses, we used the calculator tool in RevMan along with information from adjusted scores (analysis of co‐variance (ANCOVA)), change from baseline scores or final scores to create a single forest plot. We used the calculator tool with the generic inverse variance method for dichotomous or continuous data to allow transformation from data on effect sizes, CIs and standard errors (SE) to data required by RevMan to create forest plots with relative risks (RRs) or mean differences (MDs). We determined the clinical relevance of treatment effects by using the minimal clinically important difference (MCID), when available. If possible, numbers needed to treat for an additional beneficial outcome (NNTB) were calculated for both respiratory‐related and all‐cause hospital admissions using pooled ORs and control group data from individual studies within the meta‐analysis to obtain study‐specific NNTB, with Visual Rx 3 (Cates).

Unit of analysis issues

The participant was the unit of analysis for included RCTs. We intended to include cluster‐RCTs with the cluster as the unit of analysis. We had envisaged that for more recent studies, clusters would have been taken into account in the analyses. However, if this was not the case, we intended to adjust for the clusters.

Dealing with missing data

We contacted the study authors to obtain missing or incomplete outcome data where possible. If study authors did not respond, we made two further attempts to request missing data. If study authors did not respond after a third attempt, we analysed and described the available data and indicated that data were missing.

Assessment of heterogeneity

Variability among studies was explored by performing visual inspection and using the I² statistic (Higgins 2011). If we identified substantial heterogeneity (I² > 50%), we discussed possible explanations and critically reconsidered the appropriateness of a meta‐analysis. We used a random‐effects model, rather than a fixed‐effect model in meta‐analyses to account for heterogeneity.

Assessment of reporting biases

We explored possible reporting bias by assessing asymmetry in funnel plots to determine whether studies were selectively reported (see Assessment of risk of bias in included studies). We constructed a funnel plot when at least ten studies could be included.

Data synthesis

When appropriate, we performed meta‐analysis using RevMan. We considered a meta‐analysis when at least three studies reported sufficient data for the outcome. Because of the nature of the intervention, we expected to see clinical heterogeneity among studies. If pooling was possible, we performed meta‐analyses using the random‐effects model.

Summary of findings Table

Using the criteria outlined in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011), we created a 'Summary of findings' (SoF) table that includes key information concerning the quality of evidence, the magnitude of effect of the self‐management intervention and the sum of available data on the main outcomes. We used the five GRADE (Grades of Recommendation, Assessment, Development and Evaluation) considerations regarding: 1) study limitations; 2) consistency of effect; 3) imprecision; 4) indirectness; and 5) publication bias, to assess the quality of a body of evidence as it relates to studies that contribute data to the meta‐analyses for pre‐specified outcomes. We used methods and recommendations described in Section 8.5 and Chapter 12 of the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011) by using GRADEpro (GRADEpro GDT) software. We justified all decisions to downgrade or upgrade the quality of studies by using footnotes, and we provided comments to aid the reader's understanding of the review when necessary.

Subgroup analysis and investigation of heterogeneity

We considered subgroup analyses when at least three studies could be included in each subgroup. We intended to perform the following subgroup analyses to detect potential explanatory variables and determine whether outcomes differed in terms of the following:

• Duration of follow‐up: fewer than 12 months of follow‐up after the start of the study versus 12 or more months of follow‐up after the start of the study. Shorter‐term and longer‐term effects of self‐management interventions including action plans might be different. In addition, we will perform explorative analyses by using different cut‐off points for follow‐up times (e.g., six months, 18 months).

• Inclusion of participants in the acute phase: inclusion of participants with COPD in the acute unstable phase (with an acute exacerbation of COPD) versus inclusion of participants in the non‐acute stable phase (at least four weeks post exacerbation and six weeks post hospitalisation). Acute exacerbations may threaten self‐management improvements. Awareness of the clinical sequelae of acute exacerbations of COPD enables approaches such as early post‐exacerbation rehabilitation to mitigate its negative effects (Goldstein 2014).

• Use of a standardised exercise programme as part of the intervention: use of an exercise component in self‐management versus no exercise component. Increased exercise capacity may result in better HRQoL and potentially fewer hospital admissions (McCarthy 2015).

• Use of a smoking cessation programme in the intervention: smoking cessation component in self‐management versus no smoking cessation component. Smoking cessation may result in improved HRQoL (Cheruvu 2016; van Eerd 2016).

• Self‐management as part of usual care: low‐level usual care versus high‐level usual care. Usual care differs significantly among countries and healthcare systems, and sometimes self‐management will already be included as part of usual care. We classified according to whether self‐management was likely to be part of usual care.

We used the formal test for subgroup interactions in RevMan (Review Manager 2014).

In addition, we have assessed the integration of 16 clusters of behavioural change techniques (BCTs) in an explorative subgroup analysis to promote uptake and optimal use of COPD‐specific self‐management behaviour patterns in the intervention:

• Goals and planning

• Feedback and monitoring

• Social support

• Shaping of knowledge

• Natural consequences

• Comparison of behaviours

• Associations

• Repetition and substitution

• Comparison of outcomes

• Reward and threat

• Regulation

• Antecedents

• Identity

• Scheduled consequences

• Self‐belief; and

• Covert learning.

The BCT taxonomy is a methodological tool for specifying intervention content (Michie 2013). The BCT taxonomy (version 1) published by Michie et al. (Michie 2013) describes 93 hierarchically clustered techniques in 16 clusters. The BCT must be an observable, replicable and irreducible component of an intervention designed to alter or redirect causal processes that regulate behaviour; that is, a technique that is proposed to be an "active ingredient" (Michie 2011). In this subgroup analysis, we classified interventions by their number of BCT taxonomy clusters ('lower or equal' versus 'higher' than the median of BCT clusters found in all included interventions) (Michie 2013).

In exploratory analyses, we assessed potential effect modifiers by participant and self‐management intervention levels (e.g., case manager support). We also aimed to collect information about the intention of the self‐management intervention and how it was delivered to participants.

Sensitivity analysis

We planned to carry out sensitivity analyses under different assumptions to investigate the robustness of effect sizes found in this review. Sensitivity analyses were performed to identify whether review findings were dependent on study characteristics, using random‐effects versus fixed‐effect modelling.

Results

Description of studies

See Characteristics of included studies.

Results of the search

Searches identified 1,811 titles and abstracts (Figure 1). In total, 255 potentially eligible articles about self‐management interventions including an action plan for acute exacerbations of chronic obstructive pulmonary disease (AECOPD) were identified, of which 22 studies (described in 30 articles) were included. One study (Österlund Efraimsson 2008) could not be included in the quantitative synthesis (meta‐analysis) because insufficient data were provided.

1.

Study flow diagram

This review fully incorporates the results of searches conducted up to May 2016. A further nine reports were identified by a search update conducted in May 2017. However, these have not yet been incorporated into the results and will be addressed in the next update. See Characteristics of studies awaiting classification.

Included studies

All 22 included studies compared a self‐management intervention using an action plan for AECOPD with a usual care control group (Bischoff 2012; Bösch 2007; Bourbeau 2003; Bucknall 2012; Casas 2006; Garcia‐Aymerich 2007; Fan 2012; Gallefoss 1999; Hernández 2015; Jennings 2015; Khdour 2009; Kheirabadi 2008; Martin 2004; Mitchell 2014; Monninkhof 2003; Ninot 2011; Österlund Efraimsson 2008; Rea 2004; Rice 2010; Song 2014; Tabak 2014; Titova 2015). Twenty‐one included studies were parallel randomised controlled trials (RCTs) and one was a cluster‐RCT (Rea 2004). Details of participant and intervention characteristics (Table 2 and Table 3, respectively) were tabulated. We structured both tables according to potential effect modifiers on participant and self‐management intervention levels (e.g., lost to follow‐up, duration and delivery of intervention).

1. Participant characteristics, included studies.

Study	Included participants (N)		Lost to follow‐up (%)		Age (years; mean (SD))		Gender (% male)		FEV₁ (% predicted unless stated otherwise (SD))
	Self‐management	Usual care	Self‐management	Usual care	Self‐management	Usual care	Self‐management	Usual care	Self‐management	Usual care
Bischoff 2012	55	55	10.9	20.0	65.5 (11.5)	63.5 (10.3)	67.0	51.0	66.3 (16.5)	67.0 (18.0)
Bösch 2007	38	12	21.1	8.3	63.8 (8.4)	64.6 (6.8)	63.0% of completers		45.9 (17.5)	47.8 (16.9)
Bourbeau 2003	96	95	10.4	16.8	69.4 (6.5)	69.6 (7.4)	52.0	59.0	1.0 L (0.33)	0.98 (0.31)
Bucknall 2012	232	232	9.1	13.8	70.0 (9.3)	68.3 (9.2)	38.0	35.0	41.2 (13.4)	39.8 (13.8)
Casas 2006	65	90	26.2	20.0	70 (9.0)	72 (9.0)	77.0	88.0	43 (20)	41 (15)
Garcia‐Aymerich 2007	44	69	52.3	40.6	72 (10.0)	73 (9.0)	75.0	93.0	1.2 L (IQR 0.8 to 1.4)	1.0 L (IQR 0.8‐1.5)
Fan 2012	209	217	3.8a; 51.7b	4.6a; 50.2b	66.2 (8.4)	65.8 (8.2)	97.6	96.3	38.2 (14.3)	37.8 (14.5)
Gallefoss 1999	31	31	16.0	13.0	57 (9.0)	58 (10.0)	48.0	52.0	59 (9)	56 (11)
Hernández 2015	71	84	23.9	34.5	73 (8.0)	75 (9.0)	83.0	86.0	41 (19)	44 (20)
Jennings 2015	93	79	0	0	64.9 (10.9)	64.4 (10.5)	43.1	46.8	44.1 (23.1)	48.3 (22.2)
Khdour 2009	86	87	17.4	17.2	65.6 (10.1)	67.3 (9.2)	44.2	43.7	52.0 (15.9)	52 (17.8)
Kheirabadi 2008	21	21	0	0	56.6 (5.7)	56.2 (4.1)	61.9	76.2	N/A	N/A
Martin 2004	44	49	20.5	8.2	71.1 (95% CI 68.7 to 73.5)	69.1 (95% CI 63.5 to 74.7)	34.1	65.3	35.4 (95% CI 31.6 to 39.2)	34.3 (95% CI 31.2 to 37.4)
Mitchell 2014	89	95	26.9	16.8	69 (8.0)	69 (10.1)	60.7	49.5	56.0 (16.8)	59.6 (17.4)
Monninkhof 2003	127	121	3.9	5.8	65 (7.0)	65 (7.0)	85.0	84.0	56.1 (15.4)	58.4 (14.5)
Ninot 2011	23	22	13.0	18.2	65 (range 59 to 74)	61 (range 56 to 65)	90.0	77.8	56 (range 42 to 67)	54 (range 42 to 57)
Österlund Efraimsson 2008	26	26	0	0	66 (9.4)	67 (10.4)	50.0	50.0	N/A	N/A
Rea 2004	83	52	14.5	11.5	68 (range 44 to 84) for the total group		41.5% for the total group		51.8 (18.1)	50.0 (20.3)
Rice 2010	372	371	9.7	12.9	69.1 (9.4)	70.7 (9.7)	97.6	94.8	36.1 (14.5)	38.2 (14.4)
Song 2014	20	20	15.0	15.0	66.6 (7.1)	68.1 (6.5)	55.0	75.0	57.0 (10.0)	60.4 (24.9)
Tabak 2014	15	14	33.3	85.7	64.1 (9.0)	62.8 (7.4)	50.0	50.0	50.0 (IQR 33.3 to 61.5)	36.0 (IQR 26.0 to 53.5)
Titova 2015	91	81	44.0	39.5	74.1 (9.3)	72.6 (9.3)	42.9	43.2	33.6 (9.9)	33.0 (9.7)

^adiscontinued; ^bincomplete baseline and 1‐year study visits; CI: confidence interval; IQR: interquartile range; L: liters; N/A: not applicable.

2. Characteristics of interventions in included studies.

Study	Follow‐up (months)	Setting; provision intervention	Duration intervention	Content intervention	Content action plan
Bischoff 2012	24	General practice; trained practice nurse	2 to 4 FTF individual sessions (60 min each) scheduled in 4‐6 consecutive weeks, 6 phone calls	Iterative process, self‐recognition of COPD exacerbations, education regarding COPD	Self‐recognition and self‐treatment of exacerbations, use of maintenance treatment, contact healthcare providers for support
Bösch 2007	12	Outpatient clinic; trained respiratory nurse under supervision of a respiratory specialist	4 FTF group sessions (120 min each) and final session scheduled 6 weeks later	Self‐recognition of COPD exacerbations, education regarding COPD, smoking cessation, other: travelling, daily live	Self‐recognition and self‐treatment of exacerbations, use of maintenance treatment, avoid situations in which viral infection might be prevalent, contact healthcare providers for support
Bourbeau 2003	24	Hospital (outpatient); trained professionals (nurses, respiratory therapists, a physiotherapist)	7 FTF individual sessions (60 min each) scheduled in 7‐8 consecutive weeks, 18 phone calls	Iterative process, self‐recognition of COPD exacerbations, education regarding COPD, exercise or physical activity component	Self‐recognition and self‐treatment of exacerbations, use of maintenance treatment, contact healthcare providers for support, other: symptom monitoring list linked to appropriate therapeutic actions
Bucknall 2012	12	Hospital (inpatient); trained study nurse	4 FTF individual sessions (40 min each) in 2 months, at least 6 subsequent home visits, 828 phone calls intervention group	Iterative process, self‐recognition of COPD exacerbations, education regarding COPD	Self‐recognition and self‐treatment of exacerbations, use of maintenance treatment, contact healthcare providers for support
Casas 2006	12	Hospital (inpatient); trained respiratory nurse and GP, physician, nurse, social worker	3 to 13 FTF individual sessions, 1 x group (40 min), 6 phone calls; Barcelona: 1 joint visit at home. Leuven: GP regularly visited patients at home	Iterative process, self‐recognition of COPD exacerbations, education regarding COPD, other: reinforcement of the logistics for treatment of comorbidities and social support	Self‐recognition and self‐treatment of exacerbations, use of maintenance treatment, contact healthcare providers for support, other: reinforcement of the logistics for treatment of comorbidities
Garcia‐Aymerich 2007	12	Hospital (inpatient); trained specialised respiratory nurse and physician, nurse, social worker	3 to 13 FTF individual sessions at the hospital (40 min each) or at home (20 min), 6 phone calls	Iterative process, self‐recognition of COPD exacerbations, education regarding COPD, other: reinforcement of the logistics for treatment of comorbidities and social support	Self‐recognition and self‐treatment of exacerbations, use of maintenance treatment, contact healthcare providers for support, other: reinforcement of the logistics for treatment of comorbidities
Fan 2012	12	Outpatient clinic; trained case manager (various health‐related professionals)	4 FTF individual sessions (90 min each) scheduled weekly, 1x group, 6 phone calls	Iterative process, self‐recognition of COPD exacerbations, education regarding COPD	Self‐recognition and self‐treatment of exacerbations, contact healthcare providers for support
Gallefoss 1999	12	Hospital (outpatient); trained nurse, physiotherapist, pharmacist, medical doctor	1 to 2 FTF individual sessions by a nurse and 1 to 2 by physiotherapist (40 min each), 2 x group (120 min each)	Iterative process, self‐recognition of COPD exacerbations, education regarding COPD, other: compliance, self‐care	Self‐recognition and self‐treatment of exacerbations, use of maintenance treatment, contact healthcare providers for support
Hernández 2015	12	Hospital (outpatient); trained specialised respiratory nurse, physician, nurse, social worker	Participants with no mobility problems: 1 FTF individual session (40 min) at home by primary care team, 3 x group at outpatient clinic (2 x 90 min, 1x 120 min) Participants with mobility problems: 4 FTF individual sessions (15 min each), 1 x individual (120 min) or 1 x group (40 min), all at home by primary care team	Self‐recognition of COPD exacerbations, education regarding COPD, smoking cessation, exercise or physical activity component, other: instructions on non‐pharmacological treatment	Self‐recognition and self‐treatment of exacerbations, use of maintenance treatment, avoid situations in which viral infection might be prevalent, contact healthcare providers for support, self‐treatment of comorbidities
Jennings 2015	3	Hospital (inpatient); research team and research nurse	1 FTF individual session (60 min) at the hospital by research team member 24 hours prior to discharge, phone call 48 hours after discharge	Iterative process, education regarding COPD, smoking cessation, other: primary team was notified if patient was identified as having anxiety or depressive symptoms	Contact healthcare providers for support
Khdour 2009	12	Hospital (outpatient); clinical pharmacist, respiratory specialist, respiratory nurse	1 FTF individual session of 45 min (60 min for smokers) and 2 phone calls	Iterative process, self‐recognition of COPD exacerbations, education regarding COPD, smoking cessation	Self‐recognition and self‐treatment of exacerbations, contact healthcare providers for support
Kheirabadi 2008	3	Hospital (outpatient); psychologist, trained psychiatric residents	8 FTF group sessions (60 to 90 minutes each) with 1 week interval and follow‐up by phone	Self‐recognition of COPD exacerbations, education regarding COPD, exercise or physical activity component	Avoid situations in which viral infection might be prevalent
Martin 2004	12	General practice; respiratory physician and nurse, GP, ED consultant, medical staff hospital	4 FTF individual sessions and respiratory nurse visits at 3, 6 and 12 months	Iterative process, self‐recognition of COPD exacerbations	Self‐recognition and self‐treatment of exacerbations, use of maintenance treatment, self‐treatment of comorbidities, other: when to use oxygen therapy and diuretics
Mitchell 2014	6	General practice; physiotherapist, trainee health psychologist	1 FTF individual session (30‐45 min) by a physiotherapist and 2 phone calls	Iterative process, self‐recognition of COPD exacerbations, education regarding COPD, exercise or physical activity component	Self‐recognition and self‐treatment of exacerbations, avoid situations in which viral infection might be prevalent, contact healthcare providers for support, other: self‐administration, requesting rescue medication
Monninkhof 2003	12	Hospital (outpatient); trained respiratory nurse, respiratory physiotherapist	5 FTF group sessions (120 min each) by a respiratory nurse (4 x with a 1‐week interval and 3 months later) and 1 to 2 x groups (30 to 45 min) by a physiotherapist	Iterative process, self‐recognition of COPD exacerbations, education regarding COPD, exercise or physical activity component	Self‐recognition and self‐treatment of exacerbations, contact healthcare providers for support
Ninot 2011	12	Hospital (outpatient); health professional and qualified exercise trainer	8 FTF group sessions (120 min each) by a health professional for 4 weeks, 8 exercise sessions (30 to 45 min each) by a qualified exercise trainer, 3 phone calls	Self‐recognition of COPD exacerbations, education regarding COPD, exercise or physical activity component	Self‐recognition and self‐treatment of exacerbations, use of maintenance treatment, avoid situations in which viral infection might be prevalent
Österlund Efraimsson 2008	3 to 5	Primary healthcare clinic; COPD nurse, physician, if needed: dietician, medical social worker, physical and occupational therapist	2 FTF individual sessions for self‐care education during 3 to 5 months (60 min each) by the nurse	Iterative process, self‐recognition of COPD exacerbations, education regarding COPD, smoking cessation, exercise or physical activity component	Self‐recognition and self‐treatment of exacerbations, contact healthcare providers for support
Rea 2004	12	General practice; respiratory physician, respiratory nurse specialist, GP	At least 17 individual FTF sessions (monthly visits to practice nurse (N = 12), 3‐monthly to GP (N = 4), 1 x home visit by the respiratory nurse specialist, 1 x after admission)	Iterative process, self‐recognition of COPD exacerbations, other: annual influenza vaccination and PR programme attendance	Self‐recognition and self‐treatment of exacerbations, contact healthcare providers for support
Rice 2010	12	Hospital (Veterans Affairs medical centres); trained respiratory therapist case manager	1 group session (60 to 90 min) by a respiratory therapist case manager, 12 monthly phone calls (10 to 15 min each)	Iterative process, self‐recognition of COPD exacerbations; education regarding COPD, smoking cessation	Self‐recognition and self‐treatment of exacerbations, contact healthcare providers for support
Song 2014	2	Hospital (inpatient); trained nurse interventionists	3 FTF individual sessions (2 x inpatient (90 + 45 min each) on the day before and on the day of discharge, 1 x outpatient (90 min) on the first follow‐up day) by 2 nurse interventionists, 2 phone calls with a 2‐week interval	Iterative process, self‐recognition of COPD exacerbations, education regarding COPD, exercise or physical activity component	Self‐recognition and self‐treatment of exacerbations
Tabak 2014	9	Hospital (outpatient); primary care physiotherapy practices; respiratory nurse practitioner, respiratory physiotherapist	2 group sessions (90 min each) by a nurse practitioner, 1 FTF individual session and 1 x intake by the physiotherapist, additional meetings after 1, 3, 6 and 9 months	Iterative process, self‐recognition of COPD exacerbations, education regarding COPD, exercise or physical activity component	Self‐recognition and self‐treatment of exacerbations, contact healthcare providers for support
Titova 2015	24	Hospital (inpatient); trained specialist nurse	6 FTF individual sessions (1 x at discharge, 5 x home visits at 3 and 14 days, and at 6, 12, 24 months) by the specialist nurse, 1 e‐learning programme (15 min), at least 24 phone calls	Iterative process, self‐recognition of COPD exacerbations, education regarding COPD	Self‐recognition and self‐treatment of exacerbations, avoid situations in which viral infection might be prevalent, contact healthcare providers for support

COPD: Chronic Obstructive Pulmonary Disease; FTF: face‐to‐face; PR: pulmonary rehabilitation

Participants and recruitment

A total of 3,854 participants (self‐management intervention N = 1,931, usual care control N = 1,923) were assessed in the 22 included studies (Table 2). Dropout rates in the studies ranged from 0% to 59%, and in total 3,293 (85%) participants completed the study follow‐up. Seventeen studies recruited participants from hospitals; 12 studies from outpatient clinics (Bösch 2007; Bourbeau 2003; Bucknall 2012; Fan 2012; Gallefoss 1999; Hernández 2015; Khdour 2009; Kheirabadi 2008; Monninkhof 2003; Ninot 2011; Rice 2010; Tabak 2014) and five from inpatient populations (Casas 2006; Garcia‐Aymerich 2007; Jennings 2015; Song 2014; Titova 2015). Tabak 2014 reported recruitment from both outpatient clinic and primary care physiotherapy practices. Five studies (Bischoff 2012; Martin 2004; Mitchell 2014; Österlund Efraimsson 2008; Rea 2004) recruited participants from general practices or primary healthcare clinics.

Interventions

Content of the interventions assessed by the 22 included studies were diverse (Table 3). The median follow‐up duration was 12 months (interquartile range (IQR) 5.3 to 12.0). The duration of follow‐up was three months or less in three (14%) studies (Jennings 2015; Kheirabadi 2008; Song 2014), three to five months in one (4%) study (Österlund Efraimsson 2008), six months in one (4%) study (Mitchell 2014), nine months in one (4%) study (Tabak 2014), 12 months in 13 (59%) studies (Bösch 2007; Bucknall 2012; Casas 2006; Garcia‐Aymerich 2007; Fan 2012; Gallefoss 1999; Hernández 2015; Khdour 2009; Martin 2004; Monninkhof 2003; Ninot 2011; Rea 2004; Rice 2010) and 24 months in three (14%) studies (Bischoff 2012; Bourbeau 2003; Titova 2015).

Self‐management interventions were delivered individually in ten (45%) studies (Bischoff 2012; Bucknall 2012; Jennings 2015; Khdour 2009; Martin 2004; Mitchell 2014; Österlund Efraimsson 2008; Rea 2004; Song 2014; Titova 2015) and in small groups in three (14%) studies (Bösch 2007; Bourbeau 2003; Monninkhof 2003), and included both individual and group sessions in nine (41%) studies (Casas 2006; Garcia‐Aymerich 2007; Fan 2012; Gallefoss 1999; Hernández 2015; Kheirabadi 2008; Ninot 2011; Rice 2010; Tabak 2014).

The median duration of the intervention including self‐management reinforcement was nine months (IQR 1.0 to 12.0). The intervention duration was less than one month in two (9%) studies (Gallefoss 1999; Jennings 2015) and one month in four (18%) studies (Casas 2006; Mitchell 2014; Ninot 2011; Song 2014). In four (18%) studies (Bösch 2007; Kheirabadi 2008; Monninkhof 2003; Österlund Efraimsson 2008), the intervention duration was over one month up to six months. The intervention duration was nine months in two (9%) studies (Garcia‐Aymerich 2007; Tabak 2014), 12 months in eight (36%) studies (Bourbeau 2003; Bucknall 2012; Fan 2012; Hernández 2015; Khdour 2009; Martin 2004; Rea 2004; Rice 2010) and 24 months in two (9%) studies (Bischoff 2012; Titova 2015).

In nine (41%) studies (Bourbeau 2003; Hernández 2015; Kheirabadi 2008; Mitchell 2014; Monninkhof 2003; Ninot 2011; Österlund Efraimsson 2008; Song 2014; Tabak 2014) a standardised exercise programme was part of the intervention. A smoking cessation programme was part of the intervention in six (27%) studies (Bösch 2007; Hernández 2015; Jennings 2015; Khdour 2009; Österlund Efraimsson 2008; Rice 2010).

Self‐management topics about (maintenance) medication were discussed in all but one study (Jennings 2015), while coping with breathlessness or breathing techniques was discussed in all but two studies (Martin 2004; Rea 2004).

Other major topics addressed were diet or nutrition or both (n = 17; 77%) (Bischoff 2012; Bösch 2007; Bourbeau 2003; Bucknall 2012; Casas 2006; Garcia‐Aymerich 2007; Gallefoss 1999; Hernández 2015; Jennings 2015; Khdour 2009; Kheirabadi 2008; Mitchell 2014; Monninkhof 2003; Ninot 2011; Österlund Efraimsson 2008; Tabak 2014; Titova 2015), and correct device use (n = 13; 59%) (Bucknall 2012; Casas 2006; Garcia‐Aymerich 2007; Hernández 2015; Jennings 2015; Khdour 2009; Mitchell 2014; Monninkhof 2003; Ninot 2011; Österlund Efraimsson 2008; Rea 2004; Rice 2010; Titova 2015).

The AECOPD action plan components discussed in the interventions were self‐recognition of COPD exacerbations (n = 20) (Bischoff 2012; Bösch 2007; Bourbeau 2003; Bucknall 2012; Casas 2006; Garcia‐Aymerich 2007; Fan 2012; Gallefoss 1999; Hernández 2015; Khdour 2009; Martin 2004; Mitchell 2014; Monninkhof 2003; Ninot 2011; Österlund Efraimsson 2008; Rea 2004; Rice 2010; Song 2014; Tabak 2014; Titova 2015), self‐treatment of COPD exacerbations (n = 20) (Bischoff 2012; Bösch 2007; Bourbeau 2003; Bucknall 2012; Casas 2006; Garcia‐Aymerich 2007; Fan 2012; Gallefoss 1999; Hernández 2015; Khdour 2009; Martin 2004; Mitchell 2014; Monninkhof 2003; Ninot 2011; Österlund Efraimsson 2008; Rea 2004; Rice 2010; Song 2014; Tabak 2014; Titova 2015), contact healthcare providers for support (n = 18) (Bischoff 2012; Bösch 2007; Bourbeau 2003; Bucknall 2012; Casas 2006; Garcia‐Aymerich 2007; Fan 2012; Gallefoss 1999; Hernández 2015; Jennings 2015; Khdour 2009; Mitchell 2014; Monninkhof 2003; Österlund Efraimsson 2008; Rea 2004; Rice 2010; Tabak 2014; Titova 2015), use of maintenance treatment (n = 10) (Bischoff 2012; Bösch 2007; Bourbeau 2003; Bucknall 2012; Casas 2006; Garcia‐Aymerich 2007; Gallefoss 1999; Hernández 2015; Martin 2004; Ninot 2011), avoid situations in which viral infection might be prevalent (n = 6) (Bösch 2007; Hernández 2015; Kheirabadi 2008; Mitchell 2014; Ninot 2011; Titova 2015), and self‐treatment of comorbidities (n = 2) (Hernández 2015; Martin 2004).

A total of 204 behavioural change techniques (BCT) clusters (Michie 2013) were integrated in the interventions with a median of 9.5 (IQR 8.0 to 10.0) clusters per study (minimum 6 BCT clusters (Kheirabadi 2008), maximum 12 BCT clusters (Bucknall 2012)). The behaviour change clusters that were integrated to promote the uptake and optimal use of COPD‐specific self‐management behaviour patterns in the intervention were: goals and planning (n = 22); feedback and monitoring (n = 22); shaping knowledge (n = 22); associations (n = 22); regulation (n = 21; all but one study (Jennings 2015)); antecedents (n = 20; all but two studies (Kheirabadi 2008; Song 2014)); social support (n = 19; all but three studies (Gallefoss 1999; Kheirabadi 2008Rea 2004)); comparison of behaviour (n = 18; all but four studies (Fan 2012; Kheirabadi 2008; Song 2014; Titova 2015)); repetition and substitution (n = 16; all but six studies (Bösch 2007; Hernández 2015; Kheirabadi 2008; Martin 2004; Österlund Efraimsson 2008; Rea 2004)); natural consequences (n = 15; all but seven studies (Bösch 2007; Hernández 2015; Jennings 2015; Martin 2004; Ninot 2011; Song 2014; Titova 2015)); identity (n = 3) (Mitchell 2014; Österlund Efraimsson 2008; Song 2014); self‐belief (n = 3) (Bucknall 2012; Song 2014; Tabak 2014) and comparison of outcomes (n = 1) (Bucknall 2012). There were no rewards and threats, scheduled consequences or covert learning integrated in any of the self‐management interventions.

Adherence

Half of the studies reported details regarding participants' adherence to the intervention. Of these, six studies reported adherence as the number or percentage of sessions attended by participants. In Bischoff 2012 the number of sessions that were offered depended on the participant's needs, but was at least two sessions. Participants in Bischoff 2012 received a mean of 3.4 (SD 1.5) sessions; 13% did not attend any sessions or received telephone contact. The self‐management education course in Monninkhof 2003 consisted of five group sessions; of these, four were scheduled at one‐week intervals and the final session three months later. Mean attendance frequency was 0.77 (SD 0.22) sessions per week, and five (4%) participants randomised to the intervention group refused to attend the self‐management education course (Monninkhof 2003). Fan 2012 reported that during the entire follow‐up period, eight of 209 participants in the intervention group and 10 of 217 participants in the usual care group either did not attend scheduled visits or formally withdrew from the study. The study authors also reported that in the intervention group 87% completed all four individual educational visits and 57% completed the scheduled group visit (Fan 2012). Early termination after the intervention was enforced by the Data and Safety Monitoring Committee and the apparently low attendance rate of the group visit may well be a consequence (Fan 2012).

Tabak 2014 reported that the self‐management module on the web portal, including the self‐treatment of COPD exacerbations, was used on 86% of treatment days per participant. Ninot 2011 found that one of 23 participants from the intervention group did not fulfil adherence criteria to the four‐week self‐management programme, defined as completing at least seven of the eight sessions. In Gallefoss 1999, the intervention group participants who did not attend the individual or group sessions were withdrawn (N = 5, 16%). Three studies reported adherence according to different definitions. Self‐reported scales in Casas 2006 and Garcia‐Aymerich 2007 showed better adherence to recommended oral treatment in the intervention group than in the control group (90% versus 85%, respectively) and inhaled treatment regimens (71% versus 37%). Khdour 2009 reported that 78% of participants in the intervention group versus 60% of control group participants reported high adherence to maintenance medication after the 12‐month follow‐up, reflecting a lower number of medication omissions in the intervention group compared to the control group.

Comparisons

As per inclusion criteria, self‐management interventions that included an action plan for AECOPD were compared with usual care in 22 studies. Bischoff 2012 reported two intervention groups (one with and one without an action plan for AECOPD) and one usual care group. We used only data from the intervention group that included an action plan for AECOPD and the usual care group for this review.

Outcomes

See Table 4 for details on the number of included studies reporting outcomes of interest.

3. Number of included studies reporting outcomes of interest.

Outcome of interest	Number of studies
Primary outcomes
Health‐related quality of life	16
Respiratory‐related hospital admissions	16
Secondary outcomes
All‐cause hospital admissions	11
All‐cause hospitalisation days	8
Respiratory‐related hospitalisation days	5
Emergency department visits	9
General practitioner visits	7
Specialist visits	4
Rescue medication use	2
Health status	3
COPD exacerbations	6
Use of courses of oral corticosteroids or antibiotics	9
All‐cause mortality	16
Respiratory‐related mortality	7
Self‐efficacy	2
Days lost from work	2

COPD: Chronic Obstructive Pulmonary Disease

Missing data

We listed the study authors from whom we received responses to requests for additional data in Acknowledgements. However, not all study authors were able to provide the requested additional information. If the requested data were not provided for meta‐analyses, we described data that were available.

Excluded studies

We excluded 225 studies following assessment of the full‐text (Figure 1). The most frequent reasons for exclusion were: no COPD self‐management intervention (n = 56); no written action plan for AECOPD (n = 48); no usual care control group (n = 30). See Characteristics of excluded studies.

Studies awaiting classification

A total of 12 studies await classification. Koff 2009, Leiva‐Fernández 2014 and Lou 2015 await classification because we could not reach the authors to verify whether the studies met our eligibility criteria. From a search in May 2017, we identified nine studies (Benzo 2016; Chien 2016; Davis 2016; Imanalieva 2016; Licskai 2016; Sánchez‐Nieto 2016; Sano 2016; Silver 2017; Zwar 2016) that could be included in a future update of the review. Thesehave been added to Characteristics of studies awaiting classification and have not been fully incorporated into the review.

Ongoing studies

We identified two ongoing studies (Bourbeau 2016; Lenferink 2013).

Risk of bias in included studies

A summary of our risk of bias assessment is presented in Figure 2. Assessments were performed based on the content of study articles and no extra information was requested from the study authors. Further details and the rationale for judgments can be found in Characteristics of included studies.

2.

Risk of bias summary for each study according to authors' judgements

Allocation

Computer‐generated random number lists or other computerised methods were most frequently used to generate allocation sequences in studies (n = 13) (Bischoff 2012; Bourbeau 2003; Bucknall 2012; Casas 2006; Garcia‐Aymerich 2007; Fan 2012; Hernández 2015; Jennings 2015; Khdour 2009; Mitchell 2014; Ninot 2011; Rea 2004; Tabak 2014). Two of these studies used stratification or minimisation to balance for potential confounders (Bucknall 2012; Khdour 2009). All these 13 studies had a well‐defined rule for allocating the intervention to participants and were judged as having a low risk of selection bias. Two studies used random number tables or lists in sealed envelopes (Gallefoss 1999; Monninkhof 2003) or an independent person drew lots for allocation (Österlund Efraimsson 2008) and were assessed at low risk of bias. Six studies (Bösch 2007; Kheirabadi 2008; Martin 2004; Rice 2010; Song 2014; Titova 2015) did not report how the allocation sequence was generated and were judged as having an unclear risk of bias.

In most studies (n = 12) (Bourbeau 2003; Bucknall 2012; Casas 2006; Garcia‐Aymerich 2007; Fan 2012; Gallefoss 1999; Hernández 2015; Khdour 2009; Monninkhof 2003; Ninot 2011; Österlund Efraimsson 2008; Tabak 2014) the investigators or staff were not able to influence the allocation concealment, or the randomisation was performed by an independent person who was not involved in the study; risk of bias was considered to be low. The risk of bias was judged to be unclear in nine studies (Bischoff 2012; Bösch 2007; Jennings 2015; Kheirabadi 2008; Martin 2004; Mitchell 2014; Rice 2010; Song 2014; Titova 2015) which did not report who performed the allocation or methods used for the allocation concealment. One study was cluster‐randomised and no allocation concealment was provided; therefore, the risk of bias was considered to be high (Rea 2004).

Blinding

Because of the nature of the self‐management intervention, blinding of participants and personnel to group assignment is complicated. None of the included studies reported blinding of participants and personnel; performance bias risk was considered to be high in all included studies.

The detection bias was considered to be low in ten studies (Bischoff 2012; Bourbeau 2003; Garcia‐Aymerich 2007; Fan 2012; Hernández 2015; Jennings 2015; Mitchell 2014; Monninkhof 2003; Ninot 2011; Rice 2010), because these studies were investigator blinded, the outcome assessment was performed by an independent assessor, the evaluator was unaware of participant assignment or only objective outcome measures were used. In 11 studies (Bösch 2007; Bucknall 2012; Casas 2006; Gallefoss 1999; Khdour 2009; Kheirabadi 2008; Martin 2004; Rea 2004; Song 2014; Tabak 2014; Titova 2015) the detection bias was judged to be unclear, since the outcome assessment was not reported or the outcome assessment was only partly blinded. In one study the outcome assessments were performed or supervised by the same person who provided the intervention (Österlund Efraimsson 2008) and was considered to have a high risk of detection bias.

Incomplete outcome data

In 12 studies (Bischoff 2012; Bourbeau 2003; Casas 2006; Gallefoss 1999; Khdour 2009; Kheirabadi 2008; Mitchell 2014; Monninkhof 2003; Ninot 2011; Österlund Efraimsson 2008; Rea 2004; Song 2014), outcome data were complete and there were no systematic differences detected between the intervention and usual care groups in withdrawals. In these 12 studies the risk of attrition bias was considered to be low. There were incomplete data in two studies due to early termination; one as a result of significantly higher mortality rates in the intervention group (Fan 2012), and one because interim analysis at three years did not demonstrate the desired 10% between‐group differences in emergency department visits or rehospitalisations (Jennings 2015). The risk of attrition bias in these two studies was judged to be unclear (Fan 2012; Jennings 2015). The risk of attrition bias was also considered to be unclear in three studies, because there was insufficient information to permit judgment (Hernández 2015), there was no information provided regarding differences in dropout rates (Martin 2004), or only a part of the outcome data were missing (Rice 2010). In five studies (Bösch 2007; Bucknall 2012; Garcia‐Aymerich 2007; Tabak 2014; Titova 2015) the quantities of missing outcome data were high and the risk of attrition bias was considered to be high.

Selective reporting

Five studies (Bischoff 2012; Fan 2012; Gallefoss 1999; Mitchell 2014; Rice 2010) were judged to have low risk for reporting bias; there were no signs of selective outcome reporting when the reported outcomes and study findings were compared with information provided in the study protocols. In 13 studies (Bösch 2007; Bourbeau 2003; Casas 2006; Garcia‐Aymerich 2007; Hernández 2015; Khdour 2009; Kheirabadi 2008; Martin 2004; Monninkhof 2003; Ninot 2011; Österlund Efraimsson 2008; Rea 2004; Song 2014) there were no signs of selective reporting. However, for these studies there were no study protocols available and the reporting bias was considered to be unclear. One study reported a slightly different primary outcome in the paper compared to primary outcome as defined in the study protocol; this study was therefore judged as unclear risk of reporting bias (Jennings 2015). Three studies were considered to have a high risk of reporting bias, because not all relevant outcome measures were completely reported (Bucknall 2012; Tabak 2014; Titova 2015).

Other potential sources of bias

We assessed Rea 2004 for biases which are important in cluster‐RCTs. Rea 2004 reported that general practices were randomly assigned before the participants were included. For reasons unknown, the number of participants screened and included was higher in the intervention group than in the usual care group. Rea 2004 reported there were no significantly between‐group differences for baseline characteristics. We considered the risk of recruitment bias to be unclear and the risk of bias for baseline imbalance to be low. The risk of bias due to loss of clusters was judged as low, because no clusters were lost after participant enrolment. Rea 2004 did not correct for clustering in analyses. The risk of bias due to incorrect analysis was considered to be high. No other potential sources of bias were observed in this study.

We judged three studies in which per protocol analyses were performed as having an unclear risk of other bias (Bösch 2007; Tabak 2014; Ninot 2011). In these studies the baseline characteristics were not reported for all randomised participants. However, in Bösch 2007 and Ninot 2011 no differences were reported for baseline characteristics among withdrawals after randomisation and the participants who completed the study. In Tabak 2014 no differences were reported for baseline characteristics between withdrawals after randomisation and participants who completed the questionnaires at inclusion.

In addition, we explored possible reporting bias by assessing asymmetry in funnel plots for health‐related quality of life (HRQoL) (Figure 3) and respiratory‐related hospital admissions (Figure 4). A negative mean difference (MD) of the St. George's Respiratory Questionnaire (SGRQ) total score indicates better HRQoL in the self‐management group compared to usual care. The SGRQ funnel plot, with MD in SGRQ total score plotted against the standard error (SE) of the MD, seems to show a gap on the lower right side of the graph (Figure 3). This could indicate that smaller studies with effects in favour of the usual care group (positive MD in SGRQ scores) are published less frequently. On the contrary, the funnel plot of the odds ratio (OR) per study plotted against the SE (log OR) in respiratory‐related hospital admissions seems to show a gap on the left side of the graph (Figure 4), indicating that smaller studies and studies of moderate size with effects in favour of the self‐management group are published less frequently. We could not rule out the contribution of other study factors to funnel plot asymmetry.

3.

Funnel plot of comparison: Self‐management versus usual care, outcome: 1.1 HRQoL: adjusted SGRQ total score

4.

Funnel plot of comparison: Self‐management versus usual care, outcome: 1.2 Healthcare utilisation: respiratory‐related hospital admissions (number of patients with at least one admission)

Effects of interventions

See: Table 1

We included a 'Summary of Findings' table of the 22 included studies that compared self‐management with usual care. Table 1 reflects the endpoints related to health‐related quality of life (HRQoL), hospital admissions, mortality, dyspnoea, number of Chronic Obstructive Pulmonary Disease (COPD) exacerbations, and courses of oral steroids.

Health‐related quality of life (HRQoL)

COPD‐specific HRQoL was measured by the St. George's Respiratory Questionnaire (SGRQ) in ten studies (Bourbeau 2003; Bucknall 2012; Garcia‐Aymerich 2007; Fan 2012; Gallefoss 1999; Hernández 2015; Khdour 2009; Monninkhof 2003; Ninot 2011; Rice 2010; N = 1582). We used adjusted mean difference (MD) scores when available. If not available, we included the change from baseline scores and otherwise the mean total scores of these studies on a single forest plot to perform a meta‐analysis on SGRQ total score. Over 12 months of follow‐up, the included studies showed lower mean SGRQ total scores (meaning better HRQoL) in the self‐management intervention compared with the usual care group. The MD of ‐2.69 (95% CI ‐4.49 to ‐0.90), indicating better HRQoL in the intervention group compared to the control group, was statistically significant at the 5% level (Analysis 1.1; Figure 5; I² = 46%). The pooled MD of ‐2.69 did not reach the minimal clinically important difference (MCID) of four points (Jones 2005). However, four studies (Bucknall 2012; Hernández 2015; Ninot 2011; Rice 2010) reached MCID = 4 for SGRQ total score. Only Fan 2012 reported a statistically non‐significant positive MD of 0.31 for the change from baseline SGRQ total score among participants who completed 12 months follow‐up, indicating that the self‐management intervention group decreased by 0.31 points from baseline compared with the usual care group. Three studies (Österlund Efraimsson 2008; Martin 2004; Song 2014) provided insufficient data for inclusion in the meta‐analysis. Österlund Efraimsson 2008 reported significant and clinically relevant lower total SGRQ total scores in the self‐management intervention group (HRQoL was improved by 8.2 points) compared with the usual care group (no change noted). Martin 2004 found no significant difference in SGRQ total score after 12 months of follow‐up. The SGRQ total score in Song 2014 was significantly lower in the intervention group after two months, which meant better HRQoL. Sensitivity analysis using fixed‐effect modelling resulted in a lower effect size of the SGRQ total score (MD ‐2.08, 95% CI ‐3.21 to ‐0.95) compared to the random‐effects model.

1.1. Analysis.

Comparison 1 Self‐management versus usual care, Outcome 1 HRQoL: adjusted SGRQ total score.

5.

Forest plot of comparison: Self‐management versus usual care, outcome: 1.1 HRQoL: adjusted SGRQ total score after 12 months of follow‐up

Three studies (Bischoff 2012; Mitchell 2014; Rea 2004) measured COPD‐specific HRQoL using the Chronic Respiratory Questionnaire (CRQ) for a total of 394 participants. The CRQ consists of four domain scores: dyspnoea, fatigue, emotional function, and mastery (sense of control over the disease) (Guyatt 1987). A higher CRQ domain score indicates better HRQoL and the MCID is reflected by a change in a CRQ domain score of at least 0.5 on a 7‐point scale (Jaeschke 1989; Redelmeier 1996). Rea 2004 reported the CRQ domains on a different scale and did not provide SDs. Rea 2004 could not be included in a meta‐analysis, leaving an insufficient number of two studies to perform a meta‐analysis. In Rea 2004, two of the four CRQ domains, fatigue and mastery, showed statistically significant higher scores, indicating better HRQoL, for the self‐management intervention group (17.7 and 21.4, respectively) compared to usual care (15.7 and 20.7, respectively) after 12‐months follow‐up. Mitchell 2014 reported that both groups improved CRQ dyspnoea over time and only the self‐management group maintained within‐group changes that exceeded the MCID of 0.5. The between‐group differences were non‐significant at six months of follow‐up (Mitchell 2014). A non‐comprehensive approach with a lack of group support, supervised exercise training and healthcare professional‐led education might have limited the effectiveness of the intervention (Mitchell 2014). Bischoff 2012 reported no statistically significant mean treatment difference between the self‐management intervention and usual care group for the CRQ total score at 24 months of follow‐up. Although more participants in the intervention group showed a clinically important improvement compared to the usual care group, this difference was not statistically significant.

Only Rea 2004 used the Short Form‐36 (SF‐36) to measure the generic HRQoL. There were no differences noted between the intervention and usual care group after 12 months of follow‐up for any dimension of the SF‐36.

Bucknall 2012 and Tabak 2014 reported the generic HRQoL using EuroQol‐5 Dimensions (EQ‐5D). Bucknall 2012 reported no significant differences in the EQ‐5D areas under the curve between the groups after 12 months of follow‐up. The study findings reported by Tabak 2014 showed a trend toward a higher EQ‐5D index, indicating better HRQoL in the intervention group compared to the control group after three months follow‐up (mean 0.78 ± SE 0.08 versus mean 0.61 ± SE 0.09). However, these data were reported only descriptively.

In Tabak 2014 the individual participant's HRQoL state was also reported using a vertical Visual Analogue Scale (VAS). There was a trend toward a higher VAS score, indicating better HRQoL reported for self‐management (72.3 ± SE 3.1) compared to usual care (62.4 ± SE 3.5). Again, these data were only reported descriptively. Garcia‐Aymerich 2007 reported slight, non‐significant improvements in quality of life scores in both groups according to the VAS in the follow‐up year (intervention 1.56 ± SD 1.77, control 0.93 ± SD 2.11).

Generic HRQoL and health status were further measured using the short version of the questionnaire validated by the Nottingham Health Profile (NHP) in Ninot 2011. Ninot 2011 reported statistically significant beneficial effects of the self‐management intervention on the energy (between‐group difference ‐19.8, 95% CI ‐38 to ‐1) and emotional reaction (between‐group difference ‐10.4, 95% CI ‐20 to 0) dimensions of the NHP, after adjustment for baseline values.

Respiratory‐related hospital admissions

Respiratory‐related hospital admissions were reported in 14 studies (Bourbeau 2003; Bucknall 2012; Fan 2012; Gallefoss 1999; Hernández 2015; Jennings 2015; Khdour 2009; Mitchell 2014; Monninkhof 2003; Ninot 2011; Rea 2004; Rice 2010; Tabak 2014; Titova 2015; N = 3157). A statistically significant lower probability of at least one respiratory‐related hospital admission was noted among participants who received the self‐management intervention that included an action plan compared with those who received usual care (OR 0.69, 95% CI 0.51 to 0.94, Analysis 1.2; Figure 6). Heterogeneity was high (I² = 57%). Sensitivity analysis using the fixed‐effect model resulted in a similar effect size (OR 0.71, 95% CI 0.60 to 0.85) compared to random‐effects modelling.

1.2. Analysis.

Comparison 1 Self‐management versus usual care, Outcome 2 Healthcare utilisation: respiratory‐related hospital admissions (number of patients with at least one admission).

6.

Forest plot of comparison: Self‐management versus usual care, outcome: 1.2 Healthcare utilisation: respiratory‐related hospital admissions (number of patients with at least one admission)

Two studies (Bösch 2007; Martin 2004) could not be included in the meta‐analysis due to a lack of required data. In Martin 2004 more respiratory‐related hospitalisations were reported in the intervention group (1.1 per participant per year) compared to usual care (0.7 per participant per year). Due to a lack of SDs, this study could not be included in the meta‐analysis. There were six studies (Bischoff 2012; Casas 2006; Garcia‐Aymerich 2007; Kheirabadi 2008; Österlund Efraimsson 2008; Song 2014) that did not report any data on respiratory‐related hospital admissions and could not be included in the meta‐analysis.

The study‐specific number needed to treat for an additional beneficial outcome (NNTB) for respiratory‐related hospital admissions ranged from 11 (95% CI 7 to 65) to 71 (95% CI 44 to 367). To calculate NNTB, the pooled effect on respiratory‐related hospital admissions (OR 0.69, 95% CI 0.51 to 0.94) was used and applied to the mean control event risks of the studies with the highest and lowest baseline risks. The seven studies (Bourbeau 2003; Bucknall 2012; Jennings 2015; Khdour 2009; Rea 2004; Rice 2010; Tabak 2014) with the highest baseline risks for respiratory‐related hospital admissions had a mean control event risk (mean observed risk of the respiratory‐related hospital admissions in the usual care group) of 38.99 (Figure 7). Over 12 months of follow‐up, 12 participants (95% CI 7 to 69) with high baseline risk of respiratory‐related hospital admissions needed to be treated to prevent one participant with at least one respiratory‐related hospital admission. The seven studies (Fan 2012; Gallefoss 1999; Hernández 2015; Mitchell 2014; Monninkhof 2003; Ninot 2011; Titova 2015) with the lowest baseline risks for respiratory‐related hospital admissions had a mean control event risk of 23.10 (Figure 8). Over 12 months of follow‐up, 17 participants (95% CI 11 to 93) with low baseline risk of respiratory‐related hospital admissions needed to be treated to prevent one participant with at least one respiratory‐related hospital admission.

7.

Cates plot of COPD participants with high baseline risk of respiratory‐related hospital admissions in self‐management interventions including action plans for AECOPD compared to usual care. In the usual care group, 39 of 100 participants had at least one respiratory‐related hospital admission over 52 weeks, compared with 31 (95% CI 25 to 38) of 100 participants in the self‐management intervention group with the highest baseline risks for respiratory‐related hospital admissions

8.

Cates plot of COPD participants with low baseline risk of respiratory‐related hospital admissions in self‐management interventions with action plans for AECOPD compared to usual care. In the usual care group, 23 of 100 participants had at least one respiratory‐related hospital admission over 52 weeks, compared with 17 (95% CI 13 to 22) of 100 participants in the self‐management intervention group

Five studies (Bösch 2007; Bucknall 2012; Jennings 2015; Tabak 2014; Titova 2015) were included in a meta‐analysis on the mean number of respiratory‐related hospital admissions. No difference was found (MD ‐0.15, 95% CI ‐0.36 to 0.05, Analysis 1.3). Using fixed‐effect modelling in the sensitivity analysis produced similar effects.

1.3. Analysis.

Comparison 1 Self‐management versus usual care, Outcome 3 Healthcare utilisation: respiratory‐related hospital admissions (mean number per patient).

All‐cause hospital admissions

All‐cause hospital admissions were reported in 10 studies (Bucknall 2012; Casas 2006; Fan 2012; Hernández 2015; Khdour 2009; Mitchell 2014; Ninot 2011; Rea 2004; Rice 2010; Tabak 2014; N = 2467). There was no statistically significant difference in all‐cause hospital admissions (OR 0.74, 95% CI 0.54 to 1.03; Analysis 1.4). Heterogeneity was high (I² = 62%). Sensitivity analysis using fixed‐effect modelling resulted in statistically significant fewer all‐cause hospital admissions in the self‐management group compared to usual care (OR 0.74, 95% CI 0.63 to 0.88). Since the beneficial effect of the self‐management intervention on all‐cause hospital admissions observed was the same when analysing using random‐effects and fixed‐effect models, the presence of small study effects was considered unlikely.

1.4. Analysis.

Comparison 1 Self‐management versus usual care, Outcome 4 Healthcare utilisation: all‐cause hospital admissions (number of patients with at least one admission).

Twelve studies could not be meta‐analysed due to a lack of required information (Bischoff 2012; Bösch 2007; Bourbeau 2003; Garcia‐Aymerich 2007; Gallefoss 1999; Jennings 2015; Kheirabadi 2008; Martin 2004; Monninkhof 2003; Österlund Efraimsson 2008; Song 2014; Titova 2015). It was not possible to calculate the NNTB for all‐cause hospital admissions, because the 95% CI of the pooled OR for at least one all‐cause hospital admission included the possibilities of both benefit and harm.

Four (Bucknall 2012; Casas 2006; Martin 2004; Tabak 2014) of the six studies that reported on the mean number of all‐cause hospital admissions were included in a meta‐analysis. No difference was found (MD ‐0.04, 95% CI ‐0.38 to 0.29, Analysis 1.5). Heterogeneity was non‐significant (I²⁼ 35%). Two studies (Bourbeau 2003; Ninot 2011) could not be included in the meta‐analysis because SDs were not reported. A sensitivity analysis using fixed‐effect modelling resulted in an effect size (MD ‐0.07, 95% CI ‐0.33 to 0.19) similar to the random‐effects model.

1.5. Analysis.

Comparison 1 Self‐management versus usual care, Outcome 5 Healthcare utilisation: all‐cause hospital admissions (mean number per patient).

Healthcare utilisation

All‐cause hospitalisation days

The total number of all‐cause hospitalisation days was reported in three studies (Bourbeau 2003; Khdour 2009; Rea 2004; N = 469). The data reported in these studies were heavily skewed and unsuitable for meta‐analysis. All three studies (Bourbeau 2003; Khdour 2009; Rea 2004) reported a lower number of all‐cause hospitalisation days in the intervention group (n = 688, n = 164, and n = 263, respectively) compared to the usual care group (n = 1,190, n = 466, n = 352, respectively). This difference was reported to be statistically significant in Khdour 2009, but the other studies did not report significance of the differences.

The number of all‐cause hospitalisation days per patient was assessed in eight studies. Seven studies (Bourbeau 2003; Bucknall 2012; Hernández 2015; Khdour 2009; Monninkhof 2003; Ninot 2011; Rice 2010) with 1982 participants were meta‐analysed and no statistically significant between‐group differences were found (MD ‐0.65, 95% CI ‐2.01 to 0.71; Analysis 1.6). Heterogeneity was high (I² = 60%). Sensitivity analysis using a fixed‐effect model resulted in statistically significantly lower all‐cause hospitalisation days per participant (MD ‐0.69, 95% CI ‐1.36 to ‐0.02). Rea 2004 could not be included in the meta‐analysis because no SD was reported. The mean number of all‐cause bed days in this study was lower in the intervention group than the usual care group (3.2 versus 6.8); however, this difference did not reach statistical significance.

1.6. Analysis.

Comparison 1 Self‐management versus usual care, Outcome 6 Healthcare utilisation: all‐cause hospitalisation days (per patient).

Respiratory‐related hospitalisation days

The total number of respiratory‐related hospitalisation days was reported in three studies (Rea 2004; Tabak 2014; Titova 2015; N = 333). Reported data were unsuitable for meta‐analysis. All three studies (Rea 2004; Tabak 2014; Titova 2015) reported a lower number of respiratory‐related hospitalisation days in the intervention group (n = 90, n = 22, and n = 486, respectively) compared to the usual care group (n = 210, n = 36, n = 954, respectively). The studies did not report on significance of these differences. However, Titova 2015 reported that in the intervention group the number of respiratory‐related hospitalisation days was statistically significantly reduced during the first year of follow‐up and remained low during the second year of follow‐up.

The number of respiratory‐related hospitalisation days per participant was reported in three studies (Gallefoss 1999; Ninot 2011; Rea 2004; N = 226). However, Rea 2004 did not provide SD so the study could not be included in the meta‐analysis. There were an insufficient number of studies to perform a meta‐analysis, and the data provided were heavily skewed. Although Gallefoss 1999 reported a non‐significant lower mean number of respiratory‐related hospitalisation days in the intervention group (0.7 ± SD 2) compared to the usual care group (2.5 ± SD 11), Ninot 2011 reported a non‐significant higher mean number of respiratory‐related hospitalisation days in the intervention group (1.9 ± SD 3.7) compared to usual care (0.3 ± SD 0.7). Rea 2004 reported significantly fewer respiratory‐related hospitalisation days per participant per year in the intervention group (from 2.8 to 1.1) compared to a significant increase for the usual care group (from 3.5 to 4.0 days). Tabak 2014 could not be included in this meta‐analysis because the median length of stay was reported (intervention 5.5 (IQR 4.8 to 6.3), usual care 7.0 (IQR 6.0 to 7.0)).

Emergency department (ED) visits

Nine studies (Bourbeau 2003; Bucknall 2012; Fan 2012; Hernández 2015; Jennings 2015; Khdour 2009; Rea 2004; Rice 2010; Tabak 2014) reported ED visits. Three studies (Bourbeau 2003; Bucknall 2012; Jennings 2015) were included in a meta‐analysis; ED visit data were reported for 827 participants. There was no statistically significant difference between intervention and usual care (MD ‐0.31, 95% CI ‐0.74 to 0.12, Analysis 1.7). Sensitivity analysis using a fixed‐effect model resulted in a statistically significant lower number of ED visits in the intervention group compared to the control group (MD ‐0.35, 95% CI ‐0.43 to ‐0.27). The observed effect sizes in the fixed‐effect (MD ‐0.35) and random‐effects (‐0.31) models were comparable. The presence of small study effects was considered to be unlikely.

1.7. Analysis.

Comparison 1 Self‐management versus usual care, Outcome 7 Healthcare utilisation: emergency department visits (mean number per patient).

Six studies (Fan 2012; Hernández 2015; Khdour 2009; Rea 2004; Rice 2010; Tabak 2014) could not be meta‐analysed because different methods were used to report the outcome. Fan 2012 reported fewer participants who had at least one ED visit in the intervention group (N = 99, 47%) compared to the usual care group (N = 119, 55%) and a lower total number of ED visits in the intervention group (intervention N = 173 versus usual care N = 203) at 12 months follow‐up. It was not reported whether these differences were statistically significant or if numbers were adjusted for incomplete follow‐up. Hernández 2015 reported a lower mean number of respiratory‐related ED visits in the intervention group (10 ± SD 12.11) compared to the usual care group (23 ± SD 27.4). After adjusting for baseline differences, the intervention significantly reduced the risk of ED visits (OR 0.33, 95% CI 0.13 to 0.84). However, these data, could not be meta‐analysed because there was a different process reported for co‐ordination of hospital admissions in both groups; 80% of admissions in the intervention group were co‐ordinated between primary care and the hospital team, thus bypassing the ED (Hernández 2015). By contrast, all admissions in the usual care group were processed as unplanned admissions through the ED (Hernández 2015). The number of ED visits was dependent on group allocation. Khdour 2009 reported a statistically significant lower number of COPD‐related ED visits in the intervention group compared to the usual care group (40 versus 80) after 12 months of follow‐up. Rea 2004 observed five (6%) all‐cause ED visits in the intervention group and seven (13.5%) visits in the usual care group after 12 months of follow‐up. Rice 2010 found significantly fewer all‐cause ED visits in the intervention group than the usual care group (67.0 versus 91.2 per 100 person‐years) after 12 months of follow‐up. Tabak 2014 reported five (42%) participants with at least one COPD‐related ED visit in both groups.

General practitioner (GP) visits

General practitioner (GP) visits were reported in seven studies (Bourbeau 2003; Bucknall 2012; Casas 2006; Gallefoss 1999; Khdour 2009; Martin 2004; Monninkhof 2003). Three studies (Bucknall 2012; Gallefoss 1999; Martin 2004; N = 605) were included in a meta‐analysis. There was no statistically significant difference noted between the intervention and usual care (MD ‐0.36, 95% CI ‐2.64 to 1.93; Analysis 1.8). Sensitivity analysis using a fixed‐effect model resulted in a non‐significant lower effect on GP visits (MD ‐0.09, 95% CI ‐0.24 to 0.06). Four studies (Bourbeau 2003; Casas 2006; Khdour 2009; Monninkhof 2003) could not be included in the meta‐analysis because different methods were used to report the outcome (Casas 2006; Khdour 2009) and because of missing SDs (Bourbeau 2003; Monninkhof 2003). Bourbeau 2003 reported significantly fewer unscheduled GP visits in the intervention group (n = 46) compared to usual care (n = 112) after 12 months of follow‐up. However, the scheduled GP visits were comparable between groups. Monninkhof 2003 showed a reduction in unscheduled doctor and nurse visits per person per year between the intervention and control groups (difference ‐0.4). Casas 2006 reported no statistically significant differences in the number of GP home visits between the intervention (median 10, IQR 7 to 18) and control groups (median 13, IQR 9 to 27). Khdour 2009 reported a similar number of GP visits in both groups; a lower total number of scheduled GP visits in the intervention group (145 versus 183), although the total number of unscheduled visits in this study was somewhat higher in the intervention group (119 versus 75).

1.8. Analysis.

Comparison 1 Self‐management versus usual care, Outcome 8 Healthcare utilisation: GP visits (mean number per patient).

Specialist visits

Four studies reported data on specialist visits (Bourbeau 2003; Casas 2006; Jennings 2015; Martin 2004). These studies could not be included in a meta‐analysis, since different methods and definitions were used to report visits. Bourbeau 2003 reported comparable unscheduled (intervention N = 24, control N = 26) and scheduled specialist visits (intervention N = 347, control N = 316) in both groups. Casas 2006 reported a non‐significantly higher number of doctor and nurse visits (defined as unplanned visits to the GP, specialist outside the hospital, chest physician from the hospital, private doctors, domiciliary visits from the primary care team and visits to the day clinic) in the intervention group compared to the usual care group (14 ± SD 24 versus 10 ± SD 23). However, these data were heavily skewed. Martin 2004 reported a non‐significantly higher number of all‐cause doctor and nurse visits in the intervention group compared to the control group (15.6 ± SD 12.68 versus 11.6 ± SD 8.02). Jennings 2015 reported a non‐significantly lower number of primary care provider visits or pulmonary outpatient visits in the intervention group (0.46 ± SD 0.5) compared to the control group (0.53 ± SD 0.5) after three months of follow‐up.

Rescue medication use

Two studies included rescue medication use as an outcome (Gallefoss 1999; Rice 2010), but used different definitions. Gallefoss 1999 reported the use of dispensed short‐acting beta₂‐agonists as rescue medication. This was coded as defined daily dosages (DDDs) for comparison of medications within the same chemical therapeutic group. In this study, participants receiving self‐management used statistically significantly less rescue medication (median DDD 125, IQR 100 to 344) than the control group (median DDD 290, IQR 150 to 550) after 12 months of follow‐up. Rice 2010 reported the use of short‐acting beta₂‐agonists as the mean number of metered‐dose inhalers and found no statistically significant differences between intervention and control groups (6.4 ± 8.3 versus 5.6 ± 8.0).

Health status

In only two studies (Kheirabadi 2008; Tabak 2014) the change in severity of COPD was measured by means of the Clinical COPD Questionnaire (CCQ), so meta‐analysis could not be performed. A lower CCQ score indicates better HRQoL and the MCID of the CCQ total score is reflected by a change in score of 0.4 or more on a 6‐point scale. Kheirabadi 2008 reported that the intervention did not have a significant effect on the severity of COPD in the CCQ total score (mean 1.99 for both groups), but it did significantly decrease (meaning better HRQoL) three domain scores of the CCQ (symptoms, functional and mental). This improvement in HRQoL was clinically relevant for the self‐management group as the three domain scores reached the MCID of 0.4 points (Kheirabadi 2008). Tabak 2014 reported the CCQ total score for both groups after one and three months of follow‐up. These data were descriptive only, but showed trends toward a lower CCQ total score for the intervention group after three months of follow‐up (mean 1.8 ± SE 0.24) compared to usual care (mean 2.3 ± SE 0.26).

Dyspnoea symptoms

The effect of a self‐management intervention on dyspnoea as measured by the modified Medical Research Council questionnaire (mMRC) was assessed in three studies (Bösch 2007; Garcia‐Aymerich 2007; Hernández 2015). Garcia‐Aymerich 2007 assessed dyspnoea using the MRC and the other two studies used the mMRC. The outcomes of the three studies were combined in a meta‐analysis representing 217 participants. A non‐significant difference in dyspnoea scores was noted (MD ‐0.63, 95% CI ‐1.44 to 0.18; Analysis 1.9). Sensitivity analysis using a fixed‐effect model resulted in statistically significant lower dyspnoea scores in the intervention group compared with the control group (MD ‐0.59, 95% CI ‐0.89 to ‐0.29). The observed effect sizes in the fixed‐ (MD ‐0.59) and random‐ (‐0.63) effects models were comparable. The presence of small‐study effects was considered to be unlikely.

1.9. Analysis.

Comparison 1 Self‐management versus usual care, Outcome 9 Health status: (modified) Medical Research Council Dyspnoea Scale ((m)MRC).

Bourbeau 2003 reported a non‐significant difference of participant‐recorded dyspnoea deterioration in 90% of acute exacerbations in the intervention group versus 88% in the control group. Monninkhof 2003 used breathlessness extracted from two‐week diary data and reported non‐significant between‐group differences. Song 2014 reported a non‐significant difference in the degree of dyspnoea by using the BORG scale (range 0 to 10) after walking between the intervention (7.4 ± 2.0) and control groups (4.8 ± 2.1) after two months of follow‐up.

Other COPD symptoms

Bourbeau 2003 reported non‐significant increases in sputum volume (intervention 54%; control 57%) and purulent sputum was present in 48% of the intervention group and 53% of the control group. Monninkhof 2003 reported non‐significant differences in sputum production over a two‐week period. Whereas borderline beneficial significant differences in mean cough and sputum colour scores were reported for the self‐management intervention group, the study authors stated that these differences probably were not clinically relevant.

Number of COPD exacerbations

Data from four studies (Bösch 2007; Bischoff 2012; Fan 2012; Jennings 2015) on the mean number of exacerbations per participant were not statistically significant (MD 0.01, 95% CI ‐0.28 to 0.29, N = 740; Analysis 1.10). The same effect was found when a fixed‐effect rather than a random‐effects model was used in a sensitivity analysis. Monninkhof 2003 reported an average of 2.8 exacerbations in the intervention group and 1.5 in the control group. This study could not be included in the meta‐analysis because SDs were not reported.

1.10. Analysis.

Comparison 1 Self‐management versus usual care, Outcome 10 COPD exacerbations (mean number per patient).

Similar definitions were used for COPD exacerbations among studies. Bischoff 2012 defined exacerbations as a change for at least two consecutive days in either two or more major symptoms (dyspnoea, sputum purulence, sputum amount) or any one major symptom plus at least one minor symptom (colds, wheeze, sore throat, cough). Fan 2012 defined AECOPD as an increase in or new onset of one or more respiratory symptoms (cough, sputum, wheezing, dyspnoea or chest tightness) persisting for at least two days. Jennings 2015 defined an exacerbation as an acute event characterised by a worsening of the participant’s respiratory symptoms beyond normal day‐to‐day variations, leading to a change in medication. Bösch 2007 did not provide a definition of exacerbations, but indicated that exacerbations were treated with antibiotics. Monninkhof 2003 defined exacerbations as worsening of respiratory symptoms that required treatment with a short course of oral corticosteroids or antibiotics.

The total number of exacerbations were reported in five studies (Bischoff 2012; Bourbeau 2003; Fan 2012; Monninkhof 2003; Tabak 2014). Bischoff 2012 reported 280 exacerbations in the intervention group (N=55) and 235 in the control group (N=55) after 24 months of follow‐up. Bourbeau 2003 reported 299 exacerbations in the intervention group (N = 96) and 362 exacerbations in the control group (N = 95) after 12 months of follow‐up. Fan 2012 reported 600 self‐reported exacerbations in the intervention group (N = 209) and 610 in the control group (N = 217) during the first 12 months of follow‐up. Monninkhof 2003 reported 360 exacerbations in the intervention group (N = 127) and 177 exacerbations in the control group (N = 121) after 12 months of follow‐up.

Use of oral steroids and antibiotics

Thirteen studies (Casas 2006; Bourbeau 2003; Bucknall 2012; Hernández 2015; Jennings 2015; Khdour 2009; Kheirabadi 2008; Monninkhof 2003; Ninot 2011; Österlund Efraimsson 2008; Song 2014; Tabak 2014; Titova 2015) did not report any data on the use of oral steroids or antibiotics or both and could not be included in meta‐analyses. Two studies (Bischoff 2012; Khdour 2009) reported data on combined use of oral steroids and antibiotics. Bischoff 2012 reported a similar number of participants who started prednisolone, antibiotics or both to manage exacerbations in the self‐management group (N = 16, 11%) compared to the usual care group (N = 13, 10%) in the first year of follow‐up. In the second year of follow‐up, a higher number of exacerbations in the self‐management group were managed by starting prednisolone, antibiotics or both (OR 3.98, 95% CI 1.10 to 15.58). Khdour 2009 observed a significant difference with less oral steroids and antibiotic courses used in the intervention group compared with the control group (mean use 3.08, 95% CI 2.57 to 3.59 versus mean use 4.03, 95% CI 3.37 to 4.69).

Courses of oral steroids

The use of oral steroids for respiratory problems was reported by six studies (Garcia‐Aymerich 2007; Fan 2012; Gallefoss 1999; Martin 2004; Rea 2004; Rice 2010). However, the number of participants who used at least one course of steroids was available for four studies (Garcia‐Aymerich 2007; Gallefoss 1999; Rea 2004; Rice 2010); data from these studies were included in a meta‐analysis. A non‐significant higher probability of using at least one course of oral steroids in the self‐management group compared with the control group was observed (OR 4.38, 95% CI 0.55 to 34.91, Analysis 1.11), with high heterogeneity (I² = 94%). In this meta‐analysis the probability of using at least one course of oral steroids was reported to be in favour of the usual care group. However, it could also be argued that the higher probability of using at least one course of oral steroids is in favour of the self‐management group; it might lead to earlier appropriate treatment of AECOPD and may prevent hospital admissions. Rice 2010 was an outlier in our meta‐analysis (Analysis 1.11); it included many more participants than the other three studies. In addition, the proportion of participants who received at least one course of oral steroids in the self‐management group reported by Rice 2010 was relatively high (97.6%) compared with the other studies (Garcia‐Aymerich 2007 = 9.5%, Gallefoss 1999 = 69.2%, Rea 2004 = 47.6%). Rice 2010 reported that the much higher rates of oral steroid use in the intervention group suggested that participants were recognising and self‐(over)treating respiratory events that otherwise might have resulted in ED visits or hospital admissions. The OR in Rice 2010 was 32.7 which is probably an overestimation of the risk ratio due to the fact that the event is common. This meta‐analysis should therefore be interpreted with caution.

1.11. Analysis.

Comparison 1 Self‐management versus usual care, Outcome 11 Courses of oral steroids (number of patients used at least one course).

Fan 2012 reported a significantly higher mean of 2.5 exacerbations per patient‐year treated with prednisolone in the self‐management group compared with 2.1 in the control group (rate ratio 1.25, 95% CI 1.05 to 1.48). In Martin 2004, the frequency of oral prednisolone courses per 12 months was not statistically significant higher in the intervention group (2.3 courses, 95% CI 1.4 to 3.2) compared to the control group (1.3 courses, 95% CI 0.8 to 1.8).

Courses of antibiotics

The use of antibiotics for respiratory problems was reported by six studies (Bösch 2007; Fan 2012; Martin 2004; Mitchell 2014; Rea 2004; Rice 2010). However, the number of participants who used at least one course of antibiotics was available for only two studies (Rea 2004; Rice 2010). A meta‐analysis was not justified. Rea 2004 reported fewer participants receiving at least one course of antibiotics in the intervention group than in the control group (59% versus 69%), whereas Rice 2010 reported the opposite (92% versus 56%). Again, Rice 2010 reported that the much higher rates of antibiotic use in the intervention group suggested that participants were recognising and self‐(over)treating respiratory events that otherwise might have resulted in ED visits or hospital admissions. Bösch 2007 reported a statistically significant reduction in the mean number of exacerbations (2.0 ± SD 1.4 to 1.4 ± SD 1.6) that were treated with antibiotics in the intervention group, with no changes observed in the control group. Fan 2012 reported a non‐significantly higher mean of 2.7 exacerbations per patient‐year treated with an antibiotic in the self‐management group compared with 2.5 in the control group (rate ratio 1.11, 95% CI 0.97 to 1.27). In Martin 2004, there was no significant difference in the use of antibiotics between the groups (intervention 3.6, 95% CI 2.5 to 4.7 versus control 2.5, 95% CI 1.7 to 3.3) after 12 months of follow‐up. Mitchell 2014 also reported no statistically significant difference between groups in the number of antibiotic courses (intervention N = 82 versus control N = 70, OR 1.20, 95% CI 0.77 to 1.86) six months post‐randomisation.

Mortality

Mortality was reported as an outcome measure in five studies (Bucknall 2012; Casas 2006; Fan 2012; Rice 2010; Titova 2015). We extracted mortality data from sections describing the participant flow and reasons for losses to follow‐up from 11 studies (Bourbeau 2003; Gallefoss 1999; Hernández 2015; Khdour 2009; Kheirabadi 2008; Martin 2004; Mitchell 2014; Monninkhof 2003; Ninot 2011; Rea 2004; Tabak 2014). Mortality data reported by Garcia‐Aymerich 2007 could not be included in the meta‐analysis, since the same data were already incorporated in Casas 2006. Five studies provided no information on mortality (Bischoff 2012, N = 110 participants; Bösch 2007, N = 50 participants; Jennings 2015, N = 172 participants; Österlund Efraimsson 2008, N = 52 participants; Song 2014, N = 40 participants) and could not be included in the meta‐analysis.

All‐cause mortality

We included data from 16 studies (3,296 participants) in a meta‐analysis of all‐cause mortality (Bourbeau 2003; Bucknall 2012; Casas 2006; Fan 2012; Gallefoss 1999; Hernández 2015; Khdour 2009; Kheirabadi 2008; Martin 2004; Mitchell 2014; Monninkhof 2003; Ninot 2011; Rea 2004; Rice 2010; Tabak 2014; Titova 2015). No statistically significant differences in mortality were found between intervention and control group participants (RD 0.00, 95% CI ‐0.02 to 0.03, I² = 48%, Analysis 1.12; Figure 9). Four studies (Gallefoss 1999; Kheirabadi 2008; Ninot 2011; Tabak 2014) reported no deaths in the self‐management and control groups. Sensitivity analysis using a fixed‐effect model resulted in a similar non‐significant effect for all‐cause mortality (RD 0.01, 95% CI ‐0.01 to 0.03).

1.12. Analysis.

Comparison 1 Self‐management versus usual care, Outcome 12 Mortality: all‐cause mortality.

9.

Forest plot of comparison: Self‐management versus usual care, outcome: 1.13 All‐cause mortality

We included data from 12 studies (2,620 participants) in a subgroup analysis of one‐year all‐cause mortality (Bourbeau 2003; Bucknall 2012; Casas 2006; Gallefoss 1999; Hernández 2015; Khdour 2009; Martin 2004; Monninkhof 2003; Ninot 2011; Rea 2004; Rice 2010; Titova 2015). No statistically significant differences in mortality were found between intervention and control (RD ‐0.0070, 95% CI ‐0.0326 to 0.0186, I² = 33%, Analysis 1.12; Figure 9). Sensitivity analysis using a fixed‐effect model resulted in a similar non‐significant effect for one‐year all‐cause mortality (RD 0.0078, 95% CI ‐0.0128 to 0.0283).

Only two studies (Bourbeau 2003; Titova 2015) provided data on two‐year all‐cause mortality, so meta‐analysis could not be performed. Bourbeau 2003 reported a non‐significant lower two‐year all‐cause mortality rate in the intervention group compared to the usual care group (MD ‐0.05, 95% CI ‐0.16 to 0.05). Titova 2015 reported a non‐significant higher two‐year all‐cause mortality rate in the intervention group compared to the usual care group (MD 0.13, 95% CI ‐0.01 to 0.26).

Respiratory‐related mortality

We included data from seven studies in a meta‐analysis of respiratory‐related mortality (Bucknall 2012; Fan 2012; Gallefoss 1999; Kheirabadi 2008; Ninot 2011Tabak 2014; Titova 2015). A small, but statistically significant higher, respiratory‐related mortality rate was found for the intervention group compared to the control group (RD 0.028, 95% CI 0.0049 to 0.0511, 1219 participants, I² = 0%, Analysis 1.13; Figure 10). Four studies (Gallefoss 1999; Kheirabadi 2008; Ninot 2011; Tabak 2014) reported no deaths in the self‐management and control groups after 12, 3, 12 and 9 months of follow‐up, respectively. Two studies (Bucknall 2012; Fan 2012) dominated the overall effect after 12 months of follow‐up. A similar small, but significant higher one‐year respiratory‐related mortality rate was found for self‐management compared to usual care (RD 0.03, 95% CI 0.00 to 0.05, four studies, 981 participants, I² = 0%, Analysis 1.13; Figure 10). Sensitivity analysis using a fixed‐effect model resulted in a similar statistically significantly higher respiratory‐related mortality in the intervention group compared to the control group (RD 0.04, 95% CI 0.01 to 0.07).

1.13. Analysis.

Comparison 1 Self‐management versus usual care, Outcome 13 Mortality: respiratory‐related mortality.

10.

Forest plot of comparison: Self‐management versus usual care, outcome: 1.14 Respiratory‐related mortality

Self‐efficacy

Only two studies (Bischoff 2012; Bucknall 2012) reported on self‐efficacy, so it was not possible to perform a meta‐analysis. Both studies measured self‐efficacy using the COPD Self‐Efficacy Scale (CSES). Bischoff 2012 reported no statistically significant changes or difference in participants' self‐efficacy between the intervention and control groups according to the CSES total (MD ‐0.17, 95% CI ‐0.64 to 0.30) and domain scores after 24 months of follow‐up. Bucknall 2012 also reported a non‐significant difference in CSES total scores between the intervention and control groups (MD 2.65, 95% CI ‐5.85 to 11.14).

Days lost from work

Two studies reported days lost from work (Gallefoss 1999; Monninkhof 2003), so it was not possible to perform a meta‐analysis. Gallefoss 1999 reported no significant differences between groups. Almost 50% of participants with COPD in this study were employed. Three of 14 (21%) participants in the intervention group and two of 13 (15%) in the control group reported absences from work. Monninkhof 2003 used the term 'restrictive activity days', defined as days on which work was missed or days when activities were significantly reduced because of health problems. A reduction in the average number of restricted activity days during exacerbation recovery was seen in the intervention compared with the control group (4.1 ± 4.2 versus 5.3 ± 5.3), but no significant between‐group differences were detected.

Subgroup analyses

We performed subgroup analysis for two outcomes; HRQoL and respiratory‐related hospital admissions.

Duration of follow‐up

We performed a subgroup analysis for duration of follow‐up to assess the short‐ and long‐term effects of self‐management compared to usual care. Six studies (Jennings 2015; Kheirabadi 2008; Mitchell 2014; Österlund Efraimsson 2008; Song 2014; Tabak 2014) reported follow‐up periods shorter than 12 months after the start of the study. Sixteen studies (Bischoff 2012; Bösch 2007; Bourbeau 2003; Bucknall 2012; Casas 2006; Garcia‐Aymerich 2007; Fan 2012; Gallefoss 1999; Hernández 2015; Khdour 2009; Martin 2004; Monninkhof 2003; Ninot 2011; Rea 2004; Rice 2010; Titova 2015) reported long‐term follow‐up (12 or more months of follow‐up after the start of the study).

It was not possible to perform follow‐up subgroup analysis for the effects on HRQoL, because follow‐up inf the 10 included studies were all long‐term (≥ 12 months). In addition, a subgroup analysis based on a follow‐up duration with a cut‐off point of 18 months was not possible to perform, since the criterion of at least three studies per subgroup was not met.

There was no statistically significant difference in respiratory‐related hospital admissions among studies with long‐term (n = 11) or short‐term follow‐up (n = 3) (test for subgroup differences: Chi² = 0.02, df = 1 (P = 0.90), I² = 0 %, Analysis 2.1). It was not possible to perform a subgroup analysis with six months as cut‐off point for the effects on respiratory‐related hospitalisations, since this resulted in an insufficient number of studies for the subgroup analysis. A cut‐off point of 18 months for the duration of follow‐up resulted in a subgroup with only two studies (Bourbeau 2003; Titova 2015) and therefore we could not perform a subgroup analysis.

2.1. Analysis.

Comparison 2 Subgroup analysis self‐management versus usual care, Outcome 1 Healthcare utilisation: respiratory‐related hospital admissions (subgroup by follow‐up duration).

COPD stability at time of inclusion

Five studies (Casas 2006; Garcia‐Aymerich 2007; Jennings 2015; Song 2014; Titova 2015) reported inclusion of participants with COPD who were in the unstable phase; eight studies (Bourbeau 2003; Fan 2012; Hernández 2015; Martin 2004; Mitchell 2014; Monninkhof 2003; Ninot 2011; Tabak 2014) reported inclusion of participants in the stable phase; and nine studies (Bischoff 2012; Bösch 2007; Bucknall 2012; Gallefoss 1999; Khdour 2009; Kheirabadi 2008; Österlund Efraimsson 2008; Rea 2004; Rice 2010) did not report if participants were in stable or unstable phases. It was not possible to perform a subgroup analysis on the inclusion of participants in the unstable phase versus the stable phase for effects on HRQoL or on the number of participants with at least one respiratory‐related hospital admission, because of the relatively small number of studies that reported inclusion of participants in the unstable phase.

Use of a standardised exercise programme

We performed subgroup analyses on the use of a standardised exercise programme as part of the self‐management intervention. No statistically significant difference was observed for the effects on HRQoL observed among studies (n = 4) with an exercise programme and studies (n = 6) without an exercise programme (test for subgroup differences: Chi² = 0.10, df = 1 (P = 0.76), I² = 0%, Analysis 2.2). The difference in effects on respiratory‐related hospital admissions among studies with (n = 6) and without (n = 8) an exercise programme was not statistically significantly different between subgroups (test for subgroup differences: Chi² = 0.79, df = 1 P = 0.37, I² = 0% Analysis 2.3).

2.2. Analysis.

Comparison 2 Subgroup analysis self‐management versus usual care, Outcome 2 HRQoL: adjusted SGRQ total score (subgroup by exercise programme).

2.3. Analysis.

Comparison 2 Subgroup analysis self‐management versus usual care, Outcome 3 Healthcare utilisation: respiratory‐related hospital admissions (subgroup by exercise programme).

Use of a smoking cessation programme

Studies included for subgroup analyses on use of a smoking cessation programme reported no statistically significant between‐group baseline differences in smoking status. There were two studies (Khdour 2009; Hernández 2015) with a smoking cessation programme and one study (Titova 2015) without, in which changes in smoking rates over time were observed. Khdour 2009 observed 22.2% self‐reported abstinence in the self‐management group at six‐ and 12‐months follow‐up compared with 5.3% and 10.5% in the usual care group smokers, respectively. However, the differences in stage of change status in relation to smoking did not reach statistical significance (Khdour 2009). After 12 months of follow‐up, Hernández 2015 reported a statistically significantly lower percentage of current smokers (self‐management 3% versus usual care 16%). Titova 2015 reported a non‐significant trend toward reduction in the percentage of current smokers in the self‐management group from 35.3% at baseline to 31.4% after 12 months and 27.5% after 24 months. In the usual care group these percentages were 30.6% at baseline and after 12 months, and 26.5% after 24 months.

Subgroup analyses on the use of a smoking cessation programme as part of the self‐management intervention showed a statistically significantly larger improvement in HRQoL in the three studies (Hernández 2015; Khdour 2009; Rice 2010) with a smoking cessation programme (MD ‐4.98, 95% CI ‐7.17 to ‐2.78, Analysis 2.4) compared to the seven studies (Bourbeau 2003; Bucknall 2012; Garcia‐Aymerich 2007; Fan 2012; Gallefoss 1999; Monninkhof 2003; Ninot 2011) without a smoking cessation programme (MD ‐1.33, 95% CI ‐2.94 to 0.27, test for subgroup differences: Chi² = 6.89, df = 1 (P = 0.009), I² = 85.5%).

2.4. Analysis.

Comparison 2 Subgroup analysis self‐management versus usual care, Outcome 4 HRQoL: adjusted SGRQ total score (subgroup by smoking cessation programme).

No statistically significant effect was observed in a subgroup analysis of four studies with and ten studies without a smoking cessation programme on the probability of respiratory‐related hospital admissions in the self‐management group compared to usual care (test for subgroup differences: Chi² = 0.00, df = 1 (P = 0.98), I² = 0%, Analysis 2.5).

2.5. Analysis.

Comparison 2 Subgroup analysis self‐management versus usual care, Outcome 5 Healthcare utilisation: respiratory‐related hospital admissions (subgroup by smoking cessation programme).

Self‐management as part of usual care

In Song 2014, self‐management was likely to be part of usual care, so it was not possible to perform a subgroup analysis on the level of self‐management as part of usual care. Song 2014 reported that the control group received usual care consisting of education on COPD management, proven benefits of exercise, and maintaining daily activities.

Integration of behavioural change techniques (BCT) clusters

No statistically significant difference was observed for the effects on HRQoL among studies (n = 6) with a high number of BCT clusters (higher than the median number of 9.5) and studies (n = 4) with few BCT clusters (test for subgroup differences: Chi² = 0.01, df = 1 (P = 0.94), I² = 0%, Analysis 2.6).

2.6. Analysis.

Comparison 2 Subgroup analysis self‐management versus usual care, Outcome 6 HRQoL: adjusted SGRQ total score (subgroup by median number of BCT clusters).

There were no statistically significant differences observed in respiratory‐related hospital admissions among studies (n = 7) with a high number of BCT clusters versus studies (n = 7) with few BCT clusters (test for subgroup differences: Chi² = 0.82, df = 1 (P = 0.37), I² = 0%, Analysis 2.7). An additional subgroup analysis using a lower cut‐off point for BCT clusters (> 8 BCT clusters (n = 10) versus ≤ 8 BCT clusters (n = 4) integrated) showed no statistically significant differences in respiratory‐related hospital admissions (test for subgroup differences: Chi² = 0.00, df = 1 (P = 0.97), I² = 0%, Analysis 2.8).

2.7. Analysis.

Comparison 2 Subgroup analysis self‐management versus usual care, Outcome 7 Healthcare utilisation: respiratory‐related hospital admissions (subgroup by median number of BCT clusters).

2.8. Analysis.

Comparison 2 Subgroup analysis self‐management versus usual care, Outcome 8 Healthcare utilisation: respiratory‐related hospital admissions (subgroup by number of BCT clusters).

Case manager support

In this review, case manager support was defined as unscheduled ongoing support from a case manager based on individual needs and capabilities in which reinforcement is directed to the patient’s self‐management skills, and delivered face‐to‐face, by telephone or by telemedicine. We included ten studies that reported case manager support (Bischoff 2012; Bourbeau 2003; Bucknall 2012; Casas 2006; Garcia‐Aymerich 2007; Fan 2012; Monninkhof 2003; Rice 2010; Tabak 2014; Titova 2015). No statistically significant difference was observed of effects on HRQoL among studies with case manager support (n = 6) and those without case manager support (n = 4) (test for subgroup differences: Chi² = 1.86, df = 1 (P = 0.17), I² = 46.1%, Analysis 2.9).

2.9. Analysis.

Comparison 2 Subgroup analysis self‐management versus usual care, Outcome 9 HRQoL: adjusted SGRQ total score (subgroup by case manager support).

No statistically significant differences were observed for effects on respiratory‐related hospital admissions among the eight studies with case manager support and the six studies without case manager support (test for subgroup differences: Chi² = 0.13, df = 1 (P = 0.72), I² = 0%, Analysis 2.10).

2.10. Analysis.

Comparison 2 Subgroup analysis self‐management versus usual care, Outcome 10 Healthcare utilisation: respiratory‐related hospital admissions (subgroup by case manager support).

Duration of intervention

Subgroup analyses on duration of the self‐management intervention showed no statistically significant differences in HRQoL in studies of at least six months of intervention duration (MD ‐2.96, 95% CI ‐5.20 to ‐0.72) compared to studies with less than six months intervention duration (MD ‐2.57, 95% CI ‐6.96 to 1.82, test for subgroup differences: Chi² = 0.02, df = 1 (P = 0.88), I² = 0%, Analysis 2.11).

2.11. Analysis.

Comparison 2 Subgroup analysis self‐management versus usual care, Outcome 11 HRQoL: adjusted SGRQ total score (subgroup by intervention duration).

There was no statistically significant difference in respiratory‐related hospital admissions among studies with longer intervention durations (OR 0.65, 95% CI 0.43 to 0.96) compared to studies of less than six months intervention duration (OR 0.84, 95% CI 0.53 to 1.32, test for subgroup differences: Chi² = 0.68, df = 1 (P = 0.41), I² = 0%, Analysis 2.12).

2.12. Analysis.

Comparison 2 Subgroup analysis self‐management versus usual care, Outcome 12 Healthcare utilisation: respiratory‐related hospital admissions (subgroup by intervention duration).

Action plan components

We performed subgroup analyses on the different components of the action plans for COPD exacerbations. There was no statistically significant difference in HRQoL effect among studies that defined an action for adaptation of maintenance medication (MD ‐3.75, 95% CI ‐6.16 to ‐1.33) and studies that had not defined this action in their action plans for COPD exacerbations (MD ‐2.02, 95% CI ‐4.77 to 0.72, test for subgroup differences: Chi² = 0.85, df = 1 (P = 0.36), I² = 0%, Analysis 2.13). Nor was there a statistically significant difference in effect on respiratory‐related hospital admissions in studies that included an action for adaptation of maintenance medication (OR 1.01, 95% CI 0.54 to 1.88) compared to studies that did not include this action (OR 0.59, 95% CI 0.42 to 0.83, test for subgroup differences: Chi² = 2.16, df = 1 (P = 0.14), I² = 53.7%, Analysis 2.14). Two studies (Hernández 2015; Ninot 2011) defined an action 'when to avoid situations in which viral infections might be prevalent' and reported data on the HRQoL. It was not possible to perform a subgroup analysis on the action plan component of 'avoiding situations in which viral infections might be prevalent'. There was no statistically significant difference observed in respiratory‐related hospital admissions in studies that defined an action 'when to avoid situations in which viral infections might be prevalent' (OR 0.88, 95% CI 0.25 to 3.13) compared to studies that did not include this action (OR 0.68, 95% CI 0.50 to 0.91, test for subgroup differences: Chi² = 0.16, df = 1 (P = 0.69), I² = 0%, Analysis 2.15). Four studies (Kheirabadi 2008; Martin 2004; Ninot 2011; Song 2014) did not define an action 'when to contact healthcare providers for support'. Only one study (Ninot 2011) did not define an action 'when to contact healthcare providers for support' and reported data on HRQoL or respiratory‐related hospital admissions, so we could not perform subgroup analyses. Two studies (Jennings 2015; Kheirabadi 2008) did not include self‐recognition of COPD exacerbations in their action plans and these studies did not define an action of 'when to self‐initiate treatment of a COPD exacerbation'. We were unable to perform subgroup analyses on these action plan components. Two studies (Hernández 2015; Martin 2004) reported an action 'when to initiate self‐treatment of comorbidities'. There were too few studies for subgroup analysis on the self‐initiation of comorbidities as a COPD exacerbation action plan component.

2.13. Analysis.

Comparison 2 Subgroup analysis self‐management versus usual care, Outcome 13 HRQoL: adjusted SGRQ total score (subgroup by action plan component 'adaptation of maintenance medication').

2.14. Analysis.

Comparison 2 Subgroup analysis self‐management versus usual care, Outcome 14 Healthcare utilisation: respiratory‐related hospital admissions (subgroup by action plan component 'adaptation of maintenance medication'.

2.15. Analysis.

Comparison 2 Subgroup analysis self‐management versus usual care, Outcome 15 Healthcare utilisation: respiratory‐related hospital admissions (subgroup by action plan component 'when to avoid situations in which viral infections might be prevalent').

Discussion

Summary of main results

We systematically evaluated 22 randomised controlled trials (RCTs) (described in 30 articles) on the effectiveness of Chronic Obstructive Pulmonary Disease (COPD) self‐management interventions that included an action plan for acute exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD) in comparison with usual care. An action plan was defined as an agreed strategy including actions to be initiated by people with COPD when symptoms deteriorate.

We observed a statistically significant beneficial effect of self‐management on health‐related quality of life (HRQoL) over 12 months, measured by the St. George's Respiratory Questionnaire (SGRQ) adjusted total score (MD ‐2.69, 95% CI ‐4.49 to ‐0.90; 10 studies; N = 1,582). The pooled mean difference (MD) of SGRQ total score did not reach the minimal clinically important difference (MCID) of four points and therefore could not be considered as clinically relevant (Jones 2005).

A beneficial self‐management effect was also observed for respiratory‐related hospital admissions as reported in 14 studies with 3157 participants. Participants in self‐management intervention study arms that included an action plan for AECOPD were at statistically significantly lower risk for at least one respiratory‐related hospital admission compared with participants who received usual care (OR 0.69, 95% CI 0.51 to 0.94). The number needed to treat to prevent one respiratory‐related hospital admission over one year was 12 (95% CI 7 to 69) for participants with high baseline risk and 17 (95% CI 11 to 93) for participants with low baseline risk.

We observed no statistically significant difference in the probability of at least one all‐cause hospital admission in the self‐management intervention group compared to the usual care group (OR 0.74, 95% CI 0.54 to 1.03; 14 studies; N = 2,467). Furthermore, we observed no statistically significant difference in the number of all‐cause hospitalisation days (MD ‐0.65, 95% CI ‐2.01 to 0.71), emergency department (ED) visits (MD ‐0.31, 95% CI ‐0.74 to 0.12), General practitioner (GP) visits (MD ‐0.36, 95% CI ‐2.64 to 1.93) and modified Medical Research Council questionnaire ((m)MRC) dyspnoea scores (MD ‐0.63, 95% CI ‐1.44 to 0.18). There was no statistically significant effect observed for self‐management on the number of COPD exacerbations (MD 0.01, 95% CI ‐0.28 to 0.29) and no excess all‐cause mortality risk was observed (RD 0.0019, 95% CI ‐0.0225 to 0.0263) in 16 studies (N = 3,296). However, a small, but statistically significant higher respiratory‐related mortality rate was observed in the self‐management intervention group compared to the usual care group (RD 0.028, 95% CI 0.0049 to 0.0511) in seven studies (N = 1,219).

Subgroup analyses

Subgroup analyses showed significantly more improvement in health‐related quality of life (HRQoL) in studies that included a smoking cessation programme as part of the self‐management intervention (MD ‐4.98, 95% CI ‐7.17 to ‐2.78) compared to studies with no smoking cessation programme (MD ‐1.33, 95% CI ‐2.94 to 0.27). The number of behavioural change technique (BCT) clusters integrated in the self‐management intervention, intervention duration, and adaptation of maintenance medication as part of an action plan did not affect HRQoL. Subgroup analyses did not detect potential explanatory variables for differences in respiratory‐related hospital admissions among studies.

Overall completeness and applicability of evidence

Our review showed a beneficial effect on HRQoL and respiratory‐related hospital admissions in a group of studies that differed considerably with regard to follow‐up duration, intervention duration, and self‐management and action plan components. The results were based on a total of 3,854 participants with COPD, verified with a post‐bronchodilator FEV₁ to FVC ratio < 0.70. We included studies performed in 14 countries on four continents (14 in Europe, 4 in North America, 2 in Asia and 2 in Oceania).

In our review, self‐management interventions including AECOPD action plans were associated with improvement in HRQoL (measured by the SGRQ) and lower probability of respiratory‐related hospital admissions. Although the improvement in HRQoL did not reach the MCID, self‐management interventions are part of COPD management and should be based on individualised assessment of COPD to reduce: 1) current symptoms to decrease personal burden and improve HRQoL; and 2) future risks of exacerbations, hospitalisations, mortality and costs (GOLD 2017). We observed no statistically significant difference in the probability of all‐cause hospital admissions, the number of all‐cause hospitalisation days, ED visits, GP visits, and dyspnoea scores as measured by the (m)MRC questionnaire for participants in self‐management interventions compared to usual care. No excess all‐cause mortality risk was observed, but exploratory analysis indicated a small significant higher respiratory‐related mortality rate for self‐management compared to usual care. Subgroup analyses indicated significant improvements in HRQoL from self‐management interventions with a smoking cessation programme. The number of BCT clusters integrated in the self‐management intervention, intervention duration, inclusion of a standardised exercise programme, and adaptation of maintenance medication as part of an action plan did not affect HRQoL.

There are some limitations for the generalisability of our results. We had difficulties with information collection from three studies (Koff 2009; Leiva‐Fernández 2014; Lou 2015). We made five attempts to request information from the authors of these studies on whether an action plan for AECOPD was used. No responses were received so we could not verify if these studies met our inclusion criteria. In addition, one included study (Österlund Efraimsson 2008) could not be included in the meta‐analyses because insufficient data were provided.

Three studies (14%) had follow‐up durations of three months or less (Jennings 2015; Kheirabadi 2008; Song 2014). Depending on the time of participant enrolment (e.g., during summer) in these three studies, seasonal variation may have influenced outcomes (e.g., the number of exacerbations) and may have resulted in under‐ or overestimation of the actual effect. It was also difficult to interpret behavioural change effects for studies with short follow‐up durations. Since the study by Fan 2012 was prematurely stopped with a mean follow‐up of 250 days, it is uncertain if a true effect was observed. The results of this study need to be interpreted with caution.

In addition, some hospitalisations may have been triggered by the COPD self‐management intervention because AECOPD action plans encouraged people to seek help when they may not have otherwise and therefore increased healthcare utilisation. However, the reduction in hospitalisations found in this review strengthens our hypothesis that self‐recognition and self‐treatment of symptoms prevent some of the severe exacerbations that otherwise would have needed hospitalisation. The definition of an exacerbation is also a factor that can influence the number of exacerbations found (Effing 2009b). For example, in Monninkhof 2003 an exacerbation was not based on an increase of symptoms, but on the number of courses of prednisolone and an additional course of antibiotics in the case of increased purulent sputum. This number of courses was driven by the self‐management intervention, which was based on symptoms, and the corresponding action plan stated to initiate self‐treatment with prednisolone and antibiotics if needed. For each individual it is important to recognise what constitutes an exacerbation and to identify what the usual symptoms are in a person's stable health state for COPD and comorbidities (Lenferink 2013; Zwerink 2016). Because of heterogeneity in exacerbations and other individual characteristics, tailoring of (standardised) action plans should always be considered.

Furthermore, usual care is diverse among countries, healthcare systems and populations. Although we excluded studies that did not include a usual care group, it was likely that in one study (Song 2014) self‐management was integrated as part of usual care. The study authors indicated that usual care management was directed toward COPD management education, exercise, and maintaining daily activities (Song 2014). Moreover, effects may be the result of optimised COPD management (e.g., medication treatment) during the self‐management intervention or results may reflect better compliance and concordance with medication treatment in the intervention group(Khdour 2009).

Data were skewed for continuous outcomes (number and duration of hospital admissions, number of exacerbations). In the analyses of mean differences these skews may have led to reduced power to detect a treatment difference for these continuous outcomes. The analyses of Incident Rate Ratios using regression models would have been more appropriate to use to reduce the impact of the skew. However, we could not perform these analyses, because we individual study data were not available.

Differences in study design and characteristics of included participants were not taken into account in the analyses of this review. An analysis of individual participant data, such as Jonkman 2016a and Jonkman 2016b, could contribute to the knowledge of factors influencing proper self‐management. The additional results of the recently published studies and the review with individual participant data do not automatically fit with the results reported in the current review. Future review updates should demonstrate how gained knowledge from recent studies influences and fits the results of the current meta‐analyses.

Quality of the evidence

We graded the quality of evidence for HRQoL as high. However, the significant improvement in HRQoL did not reach the MCID, and may therefore only have been clinically relevant for part of the population. We graded the quality of evidence for all‐cause mortality as high; and moderate for respiratory‐related hospital admissions because substantial heterogeneity resulted in inconsistency. We graded the quality of evidence for all other secondary outcomes as moderate to very low; assessments were based on fewer studies or smaller sample sizes, or both. The quality of evidence for respiratory‐related mortality was downgraded to very low because, as well as few studies and small sample sizes, the overall effect was driven by two of the seven studies (Bucknall 2012; Fan 2012); four studies (Gallefoss 1999; Kheirabadi 2008; Ninot 2011; Tabak 2014) had no events, and there was a high risk of bias for incomplete outcome data and selective reporting for three studies (Bucknall 2012; Tabak 2014; Titova 2015).

Potential biases in the review process

Debate about the definition and most effective content of COPD self‐management interventions is ongoing (Effing 2012). Although we included only studies that aligned with the most recent published conceptual definition of COPD self‐management interventions (Effing 2016), the self‐management interventions were diverse in duration (2 to 24 months of follow‐up), self‐management intervention components (one to six self‐management components), and action plan components (one to six actions defined). Furthermore, a large variety of topics were included in the educational sessions. Operationalisation of the conceptual definition of a COPD self‐management intervention would be helpful to refine future eligibility criteria and thus reduce heterogeneity in interventions.

The inclusion of studies in this review was not based on reported outcome measures. Hence, the included studies used a broad spectrum of outcome measures with different methods for assessment (e.g., different questionnaires) and different calculations (e.g., mean number versus the percentage of participants). This added to heterogeneity among studies. Furthermore, there were insufficient data available for some outcome measures, even after contact with study authors. Moreover, some meta‐analyses could not be performed due to insufficient (< 3 studies) reported outcome data.

Because of the nature of the self‐management intervention, we expected a priori to see clinical heterogeneity among studies so we decided to use random‐effects modelling for the meta‐analyses. The random‐effects model weighs by study rather than number of participants when heterogeneity is present. When only a few large studies and many small studies are included, this may result in bias introduced by small‐study effects. We therefore checked the fixed weights in sensitivity analyses. The beneficial effects of the self‐management intervention on all‐cause hospital admissions and all‐cause hospitalisation days became statistically significant when the fixed‐effect model was used instead of random‐effects modelling. Since the observed effect sizes in fixed‐effect and random‐effects modelling were comparable, the bias introduced by small‐study effects was considered to be unlikely.

Agreements and disagreements with other studies or reviews

Action plans for AECOPD

A written action plan for AECOPD was a requisite for inclusion of studies reporting self‐management interventions in this review. Multi‐component self‐management action plans with iterative processes aimed at sustained behavioural change, providing support and instilling confidence for self‐recognition of AECOPD are recognised as important factors to self‐manage symptoms effectively and safely (Bourbeau 2009; Effing 2012). The actions defined for AECOPD differed among studies (e.g., take direct action when symptoms get worse versus start action 48 hours after onset of symptoms if AECOPD symptoms persist or do not improve), and were not always very detailed (e.g., participants could call a team if they think they have an infection and the team would “maybe” advise to take antibiotics (Hernández 2015)). Because AECOPD self‐recognition, self‐treatment, and contacting healthcare providers for support were included in the AECOPD action plans in almost all included studies, we could not perform subgroup analyses. As a result, we were unable to determine the effectiveness of these action plan components and the most effective component of action plans.

Many people with COPD have comorbidities (Annecchino 2007; Vanfleteren 2013), which has an impact on disease severity, hospital admissions and survival (Divo 2012; Vestbo 2013). Tailored approaches with individualised care plans are needed to reduce the treatment burden and optimise care for people with COPD and comorbid conditions (Vanfleteren 2017). Using COPD‐specific action plans for people with COPD and comorbidities may lead to delayed or incorrect treatment due to symptom overlap (e.g., breathlessness may be caused by COPD, but also by heart failure or anxiety). Future COPD self‐management action plans should account for comorbidities. This would not only increase the safety of COPD self‐management interventions by appropriate and timely treatment actions, but would likely also increase benefits for all‐cause hospital admissions. Unfortunately, only two (Hernández 2015; Martin 2004) of the 11 studies that included participants with the added complexity of major comorbidities defined an action for the self‐treatment of comorbidities. Therefore, we were unable to evaluate the effects of tailoring action plans for people with comorbidities in this review.

Health‐related quality of life (HRQoL)

Previously reported COPD self‐management review data on HRQoL showed similar mean differences in SGRQ total scores. In the most recent Cochrane Review evaluating the effects of self‐management interventions in people with COPD, not focusing on action plan use, a MD of ‐3.51 (95% CI ‐5.37 to ‐1.65) was observed for the SGRQ total score and a MD of ‐2.68 (95% CI ‐4.16 to ‐1.20) for the change from baseline SGRQ total score (Zwerink 2014). These results are very comparable to our findings (MD ‐2.69, 95% CI ‐4.49 to ‐0.90). In Zwerink 2014, action plans were part of most study interventions. The review authors could not perform subgroup analyses and were unable to confirm whether action plans were an essential component of self‐management (Zwerink 2014). The main HRQoL effects reported by the current review are also in line with recently published individual participant data (IPD) meta‐analyses on the effectiveness of self‐management (Jonkman 2016a; Jonkman 2016b). Although we were unable to perform a subgroup analysis on follow‐up duration, Jonkman 2016b showed improved HRQoL at 12 months with a standardised mean difference (SMD) of 0.08, but not at six months (SMD 0.05). Subgroup analyses did not show a consistent pattern across health outcomes for participants benefiting most from the self‐management interventions (Jonkman 2016b).

Self‐management interventions aim to change health behaviours (Bourbeau 2004; Lorig 2003), one of which in many people is smoking. Smoking cessation programmes are currently considered by all evidence‐based and society guidelines as an essential component of care to help quit smoking and stay abstinent (GOLD 2017) and should be offered at the earliest possible stage. This implies ensuring that smoking cessation could be routinely offered in primary care. We observed a clinically relevant and significantly better HRQoL resulting from COPD self‐management interventions including smoking cessation programmes (MD ‐4.98) compared to interventions without smoking cessation programmes (MD ‐1.33). Although we could not compare our findings with other reviews, our results indicate that a smoking cessation programme seems to be an essential part of self‐management interventions to achieve a clinically relevantly improved HRQoL. Smoking cessation could also be offered and delivered to people as part of self‐management interventions to achieve optimal improvement in HRQoL.

Hospital admissions

Participants in self‐management interventions that included AECOPD action plans were at a significantly lower risk for at least one respiratory‐related hospital admission compared with those who received usual care (OR 0.69). Earlier reviews show similar beneficial effects of self‐management on respiratory‐related hospital admissions. A lower risk for at least one respiratory‐related hospital admission was observed in the review on self‐management interventions (OR 0.57) (Zwerink 2014). Recent IPD meta‐analysis showed a significant risk reduction at 12 months of follow‐up (RR 0.77) and interventions improved the time to the first respiratory‐related hospital admission (HR 0.79) (Jonkman 2016b). Whether these lower risks are clinically relevant is unclear, because there is no MCID for hospital admissions. However, a lower number of hospital admissions would potentially result in better HRQoL, reduced mortality, and a reduction in healthcare costs (Effing 2009a). Our subgroup analyses did not identify any specific components of self‐management interventions that were linked to the risk reduction of respiratory‐related hospital admissions.

We observed no significant difference in all‐cause hospital admissions. Based on the observed effect size (OR 0.74, 95% CI 0.54 to 1.03), its 95% CI and low power, we could not rule out there is no actual difference. Significant effects on all‐cause hospital admissions were found in previously published COPD self‐management reviews in which self‐management interventions led to a somewhat lower OR for at least one all‐cause hospital admission (OR 0.60) (Zwerink 2014), reduced relative risk for all‐cause hospital admission within 12 months (RR 0.84), and a longer time to the first all‐cause hospital admission (HR 0.80) (Jonkman 2016b). Because all AECOPD action plans were COPD‐specific in our review, it was perhaps unlikely that the interventions would lead to a reduced risk of all‐cause hospital admissions. This could probably only be expected for two studies (Hernández 2015; Martin 2004) that also defined an action for self‐treatment of comorbidities. This was not reflected in the study results; Hernández 2015 showed an unexplained opposite beneficial effect for usual care, and Martin 2004 provided insufficient data to enable meta‐analysis. A trend toward lower probability of respiratory‐related hospital admissions was present when case manager support was included in COPD self‐management interventions.

Mortality

Like this review, the authors of a previous Cochrane Review on COPD self‐management interventions did not observe an effect from self‐management on all‐cause mortality. Zwerink 2014 observed a trend toward lower all‐cause mortality for self‐management compared to usual care (OR 0.79, 95% CI 0.58 to 1.07). However, this current review includes some more recently conducted large studies, including Fan 2012 which was prematurely terminated because of significantly higher mortality rates in the intervention group. No effects were observed on all‐cause mortality (RD 0.00, 95% CI ‐0.02 to 0.03). Nevertheless, we observed a small, but statistically significantly higher respiratory‐related mortality rate in the self‐management intervention group compared to the usual care group (RD 0.04, 95% CI 0.01 to 0.07). However, these respiratory mortality data should be interpreted with caution because: 1) differentiating between ‘mortality with respiratory problems as a contributing factor’ and ‘respiratory‐specific mortality’ is challenging and misclassification is common (Vestbo 2004), future studies should ensure that classification of death is performed in the same way in all study groups to avoid any bias; 2) the overall effect on respiratory‐related mortality was dominated by two studies (Bucknall 2012; Fan 2012); and, most importantly, 3) the robust analyses for all‐cause mortality did not show any effect (nor trend) toward higher mortality due to self‐management. Since none of the seven included studies where respiratory‐related mortality was an a priori defined outcome, there may be a risk that the cause of mortality was defined differently in the study groups (misclassification). Preliminary findings from a recent large home‐based multi‐component COPD self‐management intervention with 319 participants showed unambiguously higher mortality rates in the usual care group (N = 23 (14.2%)) compared to self‐management (N = 3 (1.9%)) that were mainly respiratory‐related (Bourbeau 2016).

Other secondary outcomes

All‐cause hospitalisation days, ED visits, GP visits and (m)MRC dyspnoea scores showed no difference in healthcare utilisation where self‐management with action plans for AECOPD were used. Trappenburg 2011 observed that beneficial effects for self‐management resulted from improved skills for self‐recognition of AECOPD, quicker start of appropriate self‐initiated treatment, and decreased impact of exacerbations on health status and accelerated recovery. A reduction in dyspnoea score was observed in a Cochrane Review on self‐management interventions for COPD (Zwerink 2014). The review authors reasoned that the reduction may be related to components of self‐management interventions directed to learning strategies to cope with breathlessness (Norweg 2013; Zwerink 2014). In this review, coping with breathlessness or breathing techniques was discussed in all but two included studies.

Although we used an established taxonomy (Michie 2013) to assess the integration of behavioural change techniques (BCTs) into self‐management interventions, we observed no differences in HRQoL and respiratory‐related hospital admissions among studies with high and low integration levels of BCT clusters. The additional value of integrating BCT clusters was difficult to determine. Our inclusion criteria required that studies contained at least four BCTs (goals and (action) planning, feedback and monitoring, shaping knowledge, and associations). The lowest number of BCTs that we extracted from the included studies in our review was six. We expect the actual number of applied BCTs to be higher since we only extracted data that what was explicitly reported. To increase the meaningfulness of the BCT subgroup analysis, future studies should provide more detailed information regarding the behavioural techniques that were integrated.

Recently published studies

We searched up to May 2016 and fully incorporated the results of these trials into this review. An update search conducted in 2017 identified several new studies published on the effectiveness of self‐management interventions (Benzo 2016; Chien 2016; Davis 2016; Imanalieva 2016; Koff 2009; Leiva‐Fernández 2014; Licskai 2016; Lou 2015; Sánchez‐Nieto 2016; Sano 2016; Silver 2017; Zwar 2016). These will be fully incorporated in a future update of this review.

Authors' conclusions

Implications for practice.

Chronic Obstructive Pulmonary Disease (COPD) management should be based on individualised assessment of COPD to reduce both current symptoms (which reduce personal burden and improve health‐related quality of life (HRQoL)) and future risks (e.g., risk reduction of exacerbations, which reduces mortality and costs) (GOLD 2017). In this review, self‐management interventions including acute exacerbations of COPD (AECOPD) action plans were associated with improvement in HRQoL (measured by the St. George's Respiratory Questionnaire (SGRQ)) and lower probability of respiratory‐related hospital admissions. Improvement in HRQoL did not reach the minimal clinically important difference. We observed a non‐significant lower probability of all‐cause hospital admissions associated with self‐management interventions. We found no statistically significant difference in the number of all‐cause hospitalisation days, emergency department visits, general practitioner visits, and dyspnoea scores as measured by the modified MRC questionnaire for participants in self‐management interventions compared to usual care. No excess all‐cause mortality risk was observed, but exploratory analysis indicated a small significantly higher respiratory‐related mortality rate for self‐management compared to usual care (very low‐quality level evidence). Subgroup analyses indicated significant improvements in HRQoL from self‐management interventions with a smoking cessation programme. The number of behavioural change technique (BCT) clusters integrated in the self‐management intervention, the intervention duration, including a standardised exercise programme, and adaptation of maintenance medication as part of an action plan did not affect HRQoL.

Future clinical practice may focus on the following strategies:

• Ensuring that offered interventions meet the criteria of the most recent definition of COPD self‐management interventions (e.g., include patient‐centred iterative interactions with a healthcare provider) (Effing 2016).

• Smoking cessation strategies could also be included in self‐management interventions for smokers to achieve clinically relevant HRQoL improvements.

• For safety reasons, COPD self‐management interventions may consider taking comorbidities into account in action plans, avoid offering action plans as a sole component, take literacy into account, and evaluate peoples’ adherence to action plans over time.

Implications for research.

Future studies should focus on the following suggestions to ensure clear information for optimal content of self‐management interventions including AECOPD action plans:

• Future studies should consider focusing on different populations (e.g., COPD severity, comorbid conditions, continent) to facilitate population subgroup analyses in future reviews and provide useful information for data that can be generalised for different healthcare systems. This would lead to higher likelihood of detecting potential explanatory variables for hospital admissions and identify components that might influence HRQoL.

• Study authors should aim to provide more detailed, uniformly reported data on the self‐management intervention and AECOPD action plan components, and behavioural change techniques used. This will permit stronger recommendations regarding effective self‐management interventions including AECOPD action plans in a future review.

• Investigators should aim to ensure blinding for classification of deaths to prevent misclassification for respiratory‐related mortality and ensure that classification is applied consistently for all study groups to avoid bias. For safety reasons, we also advise to involve Data and Safety Monitoring Boards.

• Future studies should endeavour to report assessment of economic evaluation (benefits and costs) of the implementation of self‐management interventions.

Since COPD is defined as a systemic disease with comorbidities (Vanfleteren 2017), we strongly feel that COPD self‐management action plans should take comorbidities into account. We were unable to evaluate this strategy because people with complex disease were excluded from half of the included studies and only two studies tailored action plans for comorbidities. Benefits from using tailored action plans are expected to further increase the effectiveness and safety of self‐management interventions by accounting for overlap in COPD and comorbid symptoms, and initiating appropriate actions for exacerbations of COPD and comorbidities that are very common in this population. An international multicentre RCT (Lenferink 2013) showed that exacerbation action plans for people with COPD and comorbidities are effective in reducing COPD exacerbation duration and respiratory‐related hospitalisations without excess all‐cause mortality. These action plans were embedded in an individualised, multi‐faceted self‐management intervention (Lenferink 2013).

Appendices

Appendix 1. Sources and search methods for the Cochrane Airways Group Specialised Register (CAGR)

Electronic searches: core databases

Database	Frequency of search
MEDLINE (Ovid)	Weekly
Embase (Ovid)	Weekly
CENTRAL	Monthly
PsycINFO (Ovid)	Monthly
CINAHL (EBSCO)	Monthly
AMED (EBSCO)	Monthly

 

Handsearches: core respiratory conference abstracts

Conference	Years searched
American Academy of Allergy, Asthma and Immunology (AAAAI)	2001 onwards
American Thoracic Society (ATS)	2001 onwards
Asia Pacific Society of Respirology (APSR)	2004 onwards
British Thoracic Society Winter Meeting (BTS)	2000 onwards
Chest Meeting	2003 onwards
European Respiratory Society (ERS)	1992, 1994, 2000 onwards
International Primary Care Respiratory Group Congress (IPCRG)	2002 onwards
Thoracic Society of Australia and New Zealand (TSANZ)	1999 onwards

 

MEDLINE search strategy used to identify trials for the CAGR

COPD search

1. Lung Diseases, Obstructive/

2. exp Pulmonary Disease, Chronic Obstructive/

3. emphysema$.mp.

4. (chronic$ adj3 bronchiti$).mp.

5. (obstruct$ adj3 (pulmonary or lung$ or airway$ or airflow$ or bronch$ or respirat$)).mp.

6. COPD.mp.

7. COAD.mp.

8. COBD.mp.

9. AECB.mp.

10. or/1‐9

Filter to identify RCTs

1. exp “clinical trial [publication type]”/

2. (randomised or randomised).ab,ti.

3. placebo.ab,ti.

4. dt.fs.

5. randomly.ab,ti.

6. trial.ab,ti.

7. groups.ab,ti.

8. or/1‐7

9. Animals/

10. Humans/

11. 9 not (9 and 10)

12. 8 not 11

The MEDLINE strategy and RCT filter are adapted to identify trials in other electronic databases.

Appendix 2. Search strategy to identify relevant trials from the CAGR

#1 MeSH DESCRIPTOR Pulmonary Disease, Chronic Obstructive Explode All

#2 MeSH DESCRIPTOR Bronchitis, Chronic

#3 (obstruct*) near3 (pulmonary or lung* or airway* or airflow* or bronch* or respirat*)

#4 COPD:MISC1

#5 (COPD OR COAD OR COBD):TI,AB,KW

#6 #1 OR #2 OR #3 OR #4 OR #5

#7 MeSH DESCRIPTOR Self Care Explode All

#8 MeSH DESCRIPTOR Education

#9 MeSH DESCRIPTOR Patient Education as Topic

#10 educat*

#11 self‐manag*

#12 "self manag*"

#13 self‐car* or "self car*"

#14 train* or instruct*

#15 "patient cent*" or patient‐cent*

#16 patient‐focus* or "patient focus*"

#17 patient‐education or "patient education"

#18 "management plan" or management‐plan

#19 management* NEAR1 program*

#20 behavior* or behaviour*

#21 disease* NEAR2 management*

#22 self‐efficac*

#23 empower*

#24 action‐plan*

#25 action NEXT plan*

#26 #7 or #8 or #9 or #10 or #11 or #12 or #13 or #14 or #15 or #16 or #17 or #18 or #19 or #20 or #21 or #22 or #23 or #24 or #25

#27 #6 AND #26

#28 (#27) AND (INREGISTER)

[Note: in search line #4, MISC2 denotes the field in which the reference has been coded for condition, in this case, COPD]

Data and analyses

Comparison 1. Self‐management versus usual care.

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 HRQoL: adjusted SGRQ total score	10	1582	Mean Difference (Random, 95% CI)	‐2.69 [‐4.49, ‐0.90]
2 Healthcare utilisation: respiratory‐related hospital admissions (number of patients with at least one admission)	14	3157	Odds Ratio (M‐H, Random, 95% CI)	0.69 [0.51, 0.94]
3 Healthcare utilisation: respiratory‐related hospital admissions (mean number per patient)	5	873	Mean Difference (IV, Random, 95% CI)	‐0.15 [‐0.36, 0.05]
4 Healthcare utilisation: all‐cause hospital admissions (number of patients with at least one admission)	10	2467	Odds Ratio (M‐H, Random, 95% CI)	0.74 [0.54, 1.03]
5 Healthcare utilisation: all‐cause hospital admissions (mean number per patient)	4	736	Mean Difference (IV, Random, 95% CI)	‐0.04 [‐0.38, 0.29]
6 Healthcare utilisation: all‐cause hospitalisation days (per patient)	7	1982	Mean Difference (IV, Random, 95% CI)	‐0.65 [‐2.01, 0.71]
7 Healthcare utilisation: emergency department visits (mean number per patient)	3	827	Mean Difference (IV, Random, 95% CI)	‐0.31 [‐0.74, 0.12]
8 Healthcare utilisation: GP visits (mean number per patient)	3	605	Mean Difference (IV, Random, 95% CI)	‐0.36 [‐2.64, 1.93]
9 Health status: (modified) Medical Research Council Dyspnoea Scale ((m)MRC)	3	217	Mean Difference (IV, Random, 95% CI)	‐0.63 [‐1.44, 0.18]
10 COPD exacerbations (mean number per patient)	4	740	Mean Difference (IV, Random, 95% CI)	0.01 [‐0.28, 0.29]
11 Courses of oral steroids (number of patients used at least one course)	4	963	Odds Ratio (M‐H, Random, 95% CI)	4.38 [0.55, 34.91]
12 Mortality: all‐cause mortality	16		Risk Difference (M‐H, Random, 95% CI)	Subtotals only
12.1 All‐cause mortality	16	3296	Risk Difference (M‐H, Random, 95% CI)	0.00 [‐0.02, 0.03]
12.2 All‐cause 1‐year mortality	12	2620	Risk Difference (M‐H, Random, 95% CI)	‐0.01 [‐0.03, 0.02]
13 Mortality: respiratory‐related mortality	7		Risk Difference (M‐H, Random, 95% CI)	Subtotals only
13.1 Respiratory‐related mortality	7	1219	Risk Difference (M‐H, Random, 95% CI)	0.03 [0.00, 0.05]
13.2 Respiratory‐related 1‐year mortality	4	981	Risk Difference (M‐H, Random, 95% CI)	0.03 [0.00, 0.05]

Comparison 2. Subgroup analysis self‐management versus usual care.

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Healthcare utilisation: respiratory‐related hospital admissions (subgroup by follow‐up duration)	14	3157	Odds Ratio (M‐H, Random, 95% CI)	0.69 [0.51, 0.94]
1.1 Long‐term follow up (≥ 12 months)	11	2777	Odds Ratio (M‐H, Random, 95% CI)	0.69 [0.49, 0.99]
1.2 Short‐term follow‐up (< 12 months)	3	380	Odds Ratio (M‐H, Random, 95% CI)	0.72 [0.39, 1.35]
2 HRQoL: adjusted SGRQ total score (subgroup by exercise programme)	10		Mean Difference (Random, 95% CI)	‐2.69 [‐4.49, ‐0.90]
2.1 Exercise programme	4		Mean Difference (Random, 95% CI)	‐2.34 [‐5.09, 0.40]
2.2 No exercise programme	6		Mean Difference (Random, 95% CI)	‐2.95 [‐5.63, ‐0.27]
3 Healthcare utilisation: respiratory‐related hospital admissions (subgroup by exercise programme)	14	3157	Odds Ratio (M‐H, Random, 95% CI)	0.69 [0.51, 0.94]
3.1 Exercise programme	6	840	Odds Ratio (M‐H, Random, 95% CI)	0.88 [0.47, 1.65]
3.2 No exercise programme	8	2317	Odds Ratio (M‐H, Random, 95% CI)	0.63 [0.43, 0.91]
4 HRQoL: adjusted SGRQ total score (subgroup by smoking cessation programme)	10		Mean Difference (Random, 95% CI)	‐2.69 [‐4.49, ‐0.90]
4.1 Smoking cessation programme	3		Mean Difference (Random, 95% CI)	‐4.98 [‐7.17, ‐2.78]
4.2 No smoking cessation programme	7		Mean Difference (Random, 95% CI)	‐1.33 [‐2.94, 0.27]
5 Healthcare utilisation: respiratory‐related hospital admissions (subgroup by smoking cessation programme)	14	3157	Odds Ratio (M‐H, Random, 95% CI)	0.69 [0.51, 0.94]
5.1 Smoking cessation programme	4	1213	Odds Ratio (M‐H, Random, 95% CI)	0.71 [0.34, 1.45]
5.2 No smoking cessation programme	10	1944	Odds Ratio (M‐H, Random, 95% CI)	0.71 [0.51, 1.00]
6 HRQoL: adjusted SGRQ total score (subgroup by median number of BCT clusters)	10		Mean Difference (Random, 95% CI)	‐2.69 [‐4.49, ‐0.90]
6.1 High number of BCT clusters (> median of 9.5)	6		Mean Difference (Random, 95% CI)	‐2.93 [‐4.85, ‐1.00]
6.2 Low number of BCT clusters (≤ median of 9.5)	4		Mean Difference (Random, 95% CI)	‐3.11 [‐7.65, 1.43]
7 Healthcare utilisation: respiratory‐related hospital admissions (subgroup by median number of BCT clusters)	14	3157	Odds Ratio (M‐H, Random, 95% CI)	0.69 [0.51, 0.94]
7.1 High number of BCT clusters (> median of 9.5)	7	1997	Odds Ratio (M‐H, Random, 95% CI)	0.61 [0.42, 0.89]
7.2 Low number of BCT clusters (≤ median of 9.5)	7	1160	Odds Ratio (M‐H, Random, 95% CI)	0.83 [0.48, 1.43]
8 Healthcare utilisation: respiratory‐related hospital admissions (subgroup by number of BCT clusters)	14	3157	Odds Ratio (M‐H, Random, 95% CI)	0.69 [0.51, 0.94]
8.1 High number of BCT clusters (> 8)	10	2523	Odds Ratio (M‐H, Random, 95% CI)	0.70 [0.51, 0.97]
8.2 Low number of BCT clusters (≤ 8)	4	634	Odds Ratio (M‐H, Random, 95% CI)	0.71 [0.30, 1.68]
9 HRQoL: adjusted SGRQ total score (subgroup by case manager support)	10		Mean Difference (Random, 95% CI)	‐2.69 [‐4.49, ‐0.90]
9.1 Case manager support	6		Mean Difference (Random, 95% CI)	‐2.15 [‐4.25, ‐0.04]
9.2 No case manager support	4		Mean Difference (Random, 95% CI)	‐5.11 [‐8.81, ‐1.41]
10 Healthcare utilisation: respiratory‐related hospital admissions (subgroup by case manager support)	14	3157	Odds Ratio (M‐H, Random, 95% CI)	0.69 [0.51, 0.94]
10.1 Case manager support	8	2403	Odds Ratio (M‐H, Random, 95% CI)	0.68 [0.49, 0.93]
10.2 No case manager support	6	754	Odds Ratio (M‐H, Random, 95% CI)	0.80 [0.36, 1.77]
11 HRQoL: adjusted SGRQ total score (subgroup by intervention duration)	10		Mean Difference (Random, 95% CI)	‐2.69 [‐4.49, ‐0.90]
11.1 Intervention duration ≥ 6 months	7		Mean Difference (Random, 95% CI)	‐2.96 [‐5.20, ‐0.72]
11.2 Intervention duration < 6 months	3		Mean Difference (Random, 95% CI)	‐2.57 [‐6.96, 1.82]
12 Healthcare utilisation: respiratory‐related hospital admissions (subgroup by intervention duration)	14	3157	Odds Ratio (M‐H, Random, 95% CI)	0.69 [0.51, 0.94]
12.1 Intervention duration ≥ 6 months	9	2453	Odds Ratio (M‐H, Random, 95% CI)	0.65 [0.43, 0.96]
12.2 Intervention duration < 6 months	5	704	Odds Ratio (M‐H, Random, 95% CI)	0.84 [0.53, 1.32]
13 HRQoL: adjusted SGRQ total score (subgroup by action plan component 'adaptation of maintenance medication')	10		Mean Difference (Random, 95% CI)	‐2.69 [‐4.49, ‐0.90]
13.1 Action defined for adaptation of maintenance medication	6		Mean Difference (Random, 95% CI)	‐3.75 [‐6.16, ‐1.33]
13.2 No action defined for adaptation of maintenance medication	4		Mean Difference (Random, 95% CI)	‐2.02 [‐4.77, 0.72]
14 Healthcare utilisation: respiratory‐related hospital admissions (subgroup by action plan component 'adaptation of maintenance medication'	14	3157	Odds Ratio (M‐H, Random, 95% CI)	0.69 [0.51, 0.94]
14.1 Action defined for adaptation of maintenance medication	5	910	Odds Ratio (M‐H, Random, 95% CI)	1.01 [0.54, 1.88]
14.2 No action defined for adaptation of maintenance medication	9	2247	Odds Ratio (M‐H, Random, 95% CI)	0.59 [0.42, 0.83]
15 Healthcare utilisation: respiratory‐related hospital admissions (subgroup by action plan component 'when to avoid situations in which viral infections might be prevalent')	14	3157	Odds Ratio (M‐H, Random, 95% CI)	0.69 [0.51, 0.94]
15.1 Action defined 'when to avoid situations in which viral infections might be prevalent'	4	549	Odds Ratio (M‐H, Random, 95% CI)	0.88 [0.25, 3.13]
15.2 No action defined 'when to avoid situations in which viral infections might be prevalent'	10	2608	Odds Ratio (M‐H, Random, 95% CI)	0.68 [0.50, 0.91]

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Bischoff 2012.

Methods	Design: RCT Follow‐up: 24 months Control group: usual care
Participants	Recruitment: general practice Assessed for eligibility: 748 Randomly assigned: Intervention (I): 55; Control (C): 55 Completed: I: 49; C: 44 Mean age: I: 65.5 ± 11.5 years; C: 63.5 ± 10.3 years Gender (% male): I: 67; C: 51 COPD diagnosis: GOLD, mild, moderate, severe airflow obstruction Inclusion of participants in the acute phase: not reported Major inclusion criteria: aged at least 35 years, post‐bronchodilator ratio of FEV₁/FVC < 0.70 Major exclusion criteria: post‐bronchodilator FEV₁ < 30% predicted, treatment by a respiratory physician, severe comorbid conditions with a reduced life expectancy, inability to communicate in the Dutch language, and objections to one or more of the modes of disease management used in the study
Interventions	Mode: individual sessions at the general practice, paper modules "Living well with COPD", telephone calls Duration: 2 to 4 individual face‐to‐face sessions of one hour each scheduled over 4 to 6 consecutive weeks, 6 telephone calls to reinforce self‐management skills Professional: practice nurse of each participating practice Training of case managers: before the study, all nurses were trained in how to apply the self‐management programme Self‐management components: action plan COPD exacerbations, iterative process with feedback on actions, self‐recognition of COPD exacerbations, education regarding COPD Self‐management topics: (home) exercise, (maintenance) medication, coping with breathlessness/breathing techniques, maintaining a healthy lifestyle, managing stress and anxiety. Exercise programme: no Smoking cessation programme: no Behavioural change techniques: 10 clusters: goals and planning, feedback and monitoring, social support, shaping knowledge, natural consequences, comparison of behaviour, associations, repetition and substitution, regulation, antecedents. Action plan components: self‐recognition of exacerbations, self‐treatment of exacerbations, use of maintenance treatment, contact healthcare providers for support
Outcomes	1. change from baseline in health‐related quality of life (CRQ) 2. change in CRQ domain scores 3. exacerbation frequency and management 4. total and five domain scores for self‐efficacy (CSES)
Notes	A third group of participants (N = 55) were assigned to routine monitoring through scheduled periodic monitoring visits as an adjunct to usual care. However, this group does not include an action plan
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"We randomised participants by using a computer generated two block randomisation procedure with stratification on severity of COPD (mild or moderate v severe airflow obstruction), smoking status (current v former smoker), and frequency of exacerbations in the previous 24 months (< 2 v ≥ 2 exacerbations)." p. 2 Comment: Random sequence generation was adequately performed
Allocation concealment (selection bias)	Unclear risk	"We randomly allocated patients to usual care, self management or routine monitoring." p. 2. "To ensure that the investigators were blinded to individual treatment allocation, practice nurses informed the patients of their allocation." p. 2 Comment: No information on who performed the allocation
Blinding of participants and personnel (performance bias) All outcomes	High risk	"This was a 24 month, multicentre, investigator blinded, three arm, parallel group, randomised controlled trial." p. 2 Comment: No blinding of participants and personnel
Blinding of outcome assessment (detection bias) All outcomes	Low risk	"Investigator blinded study." p. 2 "Outcome assessment with standardised questionnaires and a telephonic exacerbation assessment system (TEXAS)." Comment: Outcome assessment was blinded
Incomplete outcome data (attrition bias) All outcomes	Low risk	Baseline characteristics did not differ between dropouts and participants who completed follow‐up (p. 3). The dropout rate was lowest in the self management group, which may suggest that participants in this group were more motivated to adhere to COPD treatment because they were more “involved” in the long term management of their disease. p. 4 Our primary analysis was based on intention to treat principle and included all available data for all participants. We did not impute any missing data. p. 3 Comment: Almost 16% of the participants dropped out during follow‐up (intervention 11%; usual care 20%). However, baseline characteristics did not differ between dropouts and participants who finished follow‐up. Exclusion is well described in flow chart. Intention‐to‐treat analyses were used
Selective reporting (reporting bias)	Low risk	"Data sharing: Technical appendix, statistical code, and dataset are available from the corresponding author." p. 5 Comment: Not all secondary outcome measures were assessed. However, no signs for selective outcome reporting
Other bias	Low risk	None noted.

Bourbeau 2003.

Methods	Design: RCT Follow‐up: 12 and 24 months Control group: usual care
Participants	Recruitment: hospital (outpatient) Assessed for eligibility: not reported Randomly assigned: I: 96; C: 95 Completed: I: 86; C: 79 Mean age: I: 69.4 ± 6.5 years; C: 69.6 ± 7.4 years Gender (% male): I: 52; C: 59 COPD diagnosis: FEV₁ after the use of a bronchodilator between 25% and 70% of the predicted normal value and FEV₁–FVC ratio less than 70% Inclusion of participants in the acute phase: no Major inclusion criteria: hospitalised at least once in the preceding year for an exacerbation, stable COPD (respiratory symptoms and medication unchanged for at least 4 weeks before enrolment), at least 50 years of age, current or previous smoker (at least 10 pack‐years), FEV₁ after the use of a bronchodilator between 25% and 70% of the predicted normal value 14 and FEV₁–FVC ratio less than 70%, no previous diagnosis of asthma, left congestive heart failure, terminal disease, dementia, or uncontrolled psychiatric illness, no participation in a respiratory rehabilitation programme in the past year, and no long term‐care facility stays. Major exclusion criteria: participants with asthma as a primary diagnosis and those with major comorbidities (documented left ventricular failure and any terminal disease), dementia or uncontrolled psychiatric illness
Interventions	Mode: individual sessions at the participant's home, "Living well with COPD" programme with patient workbook, telephone calls Duration: seven face‐to‐face individual sessions of one hour each scheduled in seven to eight consecutive weeks, 18 telephone calls (weekly calls for eight weeks educational period, after eight weeks monthly phone calls for 12 months) Professional: experienced health professionals (nurses, respiratory therapists, a physiotherapist) who acted as case managers with the supervision and collaboration of the treating physician Training of case managers: "The programme was supervised by experienced and trained health professionals..." p. 586 “Half‐day training sessions were dedicated to interactive lecturing sessions on each aspect of COPD given by different members of the multidisciplinary team. The rest of the training days included workshops oriented toward how to assess patient needs and the acquisition of motivational and teaching skills using group discussion, demonstration and practice of techniques, case scenarios, and role modeling." Bourbeau 2006, p. 1705 Self‐management components: action plan COPD exacerbations, iterative process with feedback on actions, self‐recognition of COPD exacerbations, education regarding COPD, exercise or physical activity component Self‐management topics: smoking cessation, exercise, diet, (maintenance) medication, coping with breathlessness/breathing techniques, other: energy conservation during day‐by‐day activities, relaxation exercises, adopting a healthy lifestyle, leisure activities and travelling, long‐term oxygen when appropriate Exercise programme: yes, home‐based exercise program. The exercise teaching began at about the 7th week, and the training program was initiated with a supervised session at home. The exercise program included warm‐up and stretching exercises, muscle exercises, and cardiovascular exercises (stationary bicycle, walking, or climbing stairs). Participants were encouraged to follow the exercise program at least 3 times per week for 30 to 45 minutes per session. Smoking cessation programme: no Behavioural change techniques: 10 clusters: goals and planning, feedback and monitoring, social support, shaping knowledge, natural consequences, comparison of behaviour, associations, repetition and substitution, regulation, antecedents Action plan components: self‐recognition of exacerbations, self‐treatment of exacerbations, use of maintenance treatment, contact healthcare providers for support, other: symptom monitoring list for different situations (stress, environmental change, and respiratory tract infection) linked to appropriate therapeutic actions
Outcomes	1. hospital admissions 2. scheduled and unscheduled physician visits 3. emergency department visits 4. health‐related quality of life (SGRQ) 5. pulmonary function 6. functional exercise capacity 7. exacerbations
Notes	Completed first year of follow‐up: N = 165 (based on hospital registry database) Completed second year of follow‐up: N = 175 (based on provincial health insurance and hospitalisation database records)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	“… central computer generated list of random numbers. Randomisation was stratified per center and in blocks of 6, and patients were assigned to the self‐management programme (intervention group) or to usual care.” p. 586 Comment: Random sequence generation was adequately performed.
Allocation concealment (selection bias)	Low risk	“The blocking factor was not known by the investigators or their staff in each participating center." p. 586 Comment: Allocation was adequately concealed.
Blinding of participants and personnel (performance bias) All outcomes	High risk	"Since a double‐blind design was impossible..." p. 586 Comment: Participants and personnel were not blinded.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	"... an independent evaluator unaware of the patient assignment was responsible for the evaluation process in each center. The evaluator was cautioned not to ask about the workbook modules and types of contact.” p. 586 Comment: Outcome assessment was blinded.
Incomplete outcome data (attrition bias) All outcomes	Low risk	“At the end of the 2nd year of follow‐up, data were available for 75 patients in the standard‐care group (two subjects were lost to follow‐up, nine patients died in the 1st year and nine in the 2nd year) and 83 patients following the self‐management programme (five patients died in the 1st year and eight in the 2nd year).” Gadoury 2005, p. 855 Comment: Drop out in the usual care group was somewhat higher than in the self‐management group; however, an intention‐to‐treat analysis was used.
Selective reporting (reporting bias)	Unclear risk	Comment: No signs of selective reporting, however no protocol available.
Other bias	Low risk	None noted.

Bucknall 2012.

Methods	Design: RCT Follow‐up: 12 months Control group: usual care
Participants	Recruitment: hospital (inpatient) Assessed for eligibility: 1405 Randomly assigned: I: 232; C: 232 Completed: I: 211; C: 200 Mean age: I: 70.0 ± 9.3 years; C: 68.3 ± 9.2 years Gender (% male): I: 38; C: 35 COPD diagnosis: chronic irreversible airflow limitation with FEV₁ less than 70% predicted and a FEV₁ /FVC ratio of less than 70%. FVC is defined as the total amount of air that can be expelled from the chest by a forced expiratory manoeuvre Inclusion of participants in the acute phase: not reported Major inclusion criteria: admitted to hospital with an acute exacerbation of COPD Major exclusion criteria: a history of asthma or left ventricular failure, evidence of active malignant disease or any evidence of confusion/poor memory, assessed with the abbreviated mental test (scores of 9/10 or 10/10 required).
Interventions	Mode: individual sessions at the participant's home, adapted "Living well with COPD" booklets, telephone calls Duration: four face‐to‐face individual sessions of 40 minutes each scheduled fortnightly over a two month period. There were also 828 phone calls to the intervention group participants (mean 4.6 phone calls per intervention patient). There were at least six subsequent home visits (but more frequently on request) thereafter for a total of 12 months Professional: study nurse Training of case managers: "Study nurses’ training was based on self regulation theory ." (p. 2). "Nurses were trained to deliver a structured self management programme in four fortnightly home visits (…). Nurses without previous respiratory training completed three half day training sessions." (p. 3) Self‐management components: action plan COPD exacerbations, iterative process with feedback on actions, self‐recognition of COPD exacerbations, education regarding COPD Self‐management topics: smoking cessation, exercise, diet, (maintenance) medication, correct device use, coping with breathlessness/breathing techniques Exercise programme: no Smoking cessation programme: no Behavioural change techniques: 12 clusters: goals and planning, feedback and monitoring, social support, shaping knowledge, natural consequences, comparison of behaviour, associations, repetition and substitution, comparison of outcomes, regulation, antecedents, self‐belief Action plan components: self‐recognition of exacerbations, self‐treatment of exacerbations, use of maintenance treatment, contact healthcare providers for support
Outcomes	1. time to first acute hospital admission with a COPD exacerbation 2. death due to COPD within 12 months of randomisation 3. morbidity (change from baseline at six and 12 months in SGRQ) 4. likelihood of anxiety or depression (HADS) 5. sense of self efficacy (CSES) 6. quality of life (EuroQol 5D)
Notes	Self management materials based on the Living Well with COPD programme and previously adapted for the UK population and healthcare setting by an iterative process, were used (p. 2). Extra information author: "We used adapted “Living with COPD” booklets and daily diary cards (Stockley et al. – originally developed for use in Bronchiecistasis, piloted these and adapted them for this study, to include a line for recording steroid and antibiotic usage."
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	“We used a minimisation technique to stratify randomisation of participants by demographic factors (deprivation category of area of residence,11 age and sex, FEV1 per cent predicted at the time of randomisation, smoking status, participation in pulmonary rehabilitation within two years, and number of previous admissions) to control for key aspects of disease severity and predictors of readmission. We constructed a computer generated sequence by using the method of randomised permuted blocks of length four, with allocations being made at random and two by minimisation.” p. 2 Comment: Random sequence generation was adequately performed.
Allocation concealment (selection bias)	Low risk	“Treatment group allocations were obtained by telephone, after baseline assessment had been made. This registered the participant on the system, and a researcher entered the characteristics necessary for the minimisation algorithm by using an interactive voice response system. The researcher did not know whether a participant was being allocated at random or by minimisation and could therefore not determine the next treatment allocation before enrolling each participant” p. 2 Comment: Allocation was adequately concealed.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Comment: No blinding of participants and personnel.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	“Participants received monthly telephone calls from an independent researcher, blinded to the patients’ randomisation status, to collect information on health service usage and exacerbations.” p. 2 Comment: Outcome assessor partly blinded (researcher was blinded, participants were not blinded).
Incomplete outcome data (attrition bias) All outcomes	High risk	“The number of questionnaires available for analysis varied between outcomes and time points owing to the number of questionnaires returned and the completeness of the returned questionnaires.” p. 4 “Completion rates for study questionnaires were also disappointing and were lower in the control arm of the study. Consequently, the apparent improvements in the intervention arm (impacts subscale of St George’s Respiratory Questionnaire, hospital anxiety and depression scale anxiety) could be biased, and these results cannot be taken as convincing evidence in favour of the intervention.” p. 5 Comment: A lot of missing data for study questionnaires.
Selective reporting (reporting bias)	High risk	“Participants received monthly telephone calls from an independent researcher, blinded to the patients’ randomisation status, to collect information on health service usage and exacerbations.” Comment: Healthcare usage and number of exacerbations during follow‐up were not reported. Difference in length of hospital stay (all causes and sub classified by principle diagnosis) not reported.
Other bias	Low risk	None noted.

Bösch 2007.

Methods	Design: RCT Follow‐up: 12 months Control group: usual care
Participants	Recruitment: outpatient clinic Assessed for eligibility: not reported Randomly assigned: I: 38; C: 12 Completed: I: 30; C: 11 Mean age: I: 63.8 ± 8.4 years; C: 64.6 ± 6.8 years Gender (% male): 63% of 41 participants who completed the study; the distribution of males per group is not reported COPD diagnosis: GOLD, COPD with obstruction confirmed by spirometry and FEV₁ / FVC < 70% Inclusion of participants in the acute phase: not reported Major inclusion criteria: diagnosis of COPD with obstruction proven by spirometry and a FEV1/FVC < 70% Major exclusion criteria: comorbidities which significantly influences symptoms, capacity or spirometry (symptomatic cardiopulmonary disease)
Interventions	Mode: group sessions (six to eight participants) at the participant's home Duration: four face‐to‐face group sessions of two hours each with the final session scheduled six weeks later Professional: respiratory nurse under supervision of a respiratory specialist Training of case managers: nurses were trained for 10 hours Self‐management components: action plan COPD exacerbations, self‐recognition of COPD exacerbations, education regarding COPD, smoking cessation, other: travelling, daily live (life style modification) Self‐management topics: smoking cessation, exercise, diet, (maintenance) medication, coping with breathlessness/breathing techniques Exercise programme: no Smoking cessation programme: yes, motivation and guidance by the smoking cessation program Behavioural change techniques: eight clusters: goals and planning, feedback and monitoring, social support, shaping knowledge, comparison of behaviour, associations, comparison of outcomes, regulation, antecedents Action plan components: self‐recognition of exacerbations, self‐treatment of exacerbations, use of maintenance treatment, avoid situations in which viral infection might be prevalent, contact healthcare providers for support
Outcomes	1. mMRC 2. courses of antibiotics 3. FEV₁ (L) 4. hospital admissions 5. 6MWT
Notes	‐
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Comment: The method used to generate the random sequence generation was not clearly reported.
Allocation concealment (selection bias)	Unclear risk	Information from the author: ‘Pick of envelope. Enrolment and selection were right before the start of the study – a selection bias cannot be fully excluded.’ Comment: This information is too concise to assess the risk of bias for allocation concealment.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Comment: Blinding of participants and personnel was not reported.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Comment: Blinding of outcome assessment was not reported.
Incomplete outcome data (attrition bias) All outcomes	High risk	Comment: Eight participants in the intervention group and one participant in the control group dropped out. Reasons for dropout were not clearly reported, and only participants who completed follow‐up were included in the baseline characteristics and analysis.
Selective reporting (reporting bias)	Unclear risk	Comment: No signs for selective outcome reporting, results were reported extensively; however, no protocol was available.
Other bias	Unclear risk	Comment: Per protocol analysis, baseline characteristics only assessed for the participants who completed the study. No differences reported for baseline characteristics between the withdrawals after randomisation (N = 9) and the participants who completed the study

Casas 2006.

Methods	Design: RCT Follow‐up: 12 months Control group: usual care
Participants	Recruitment: hospital (inpatient) Assessed for eligibility: 850 Randomly assigned: I: 65; C: 90 Completed: I: 48; C: 72 Mean age: I: 70 ± 9 years; C: 72 ± 9 years Gender (% male): I: 77; C: 88 COPD diagnosis: 21 (14%) of participants had an FEV₁/FVC > 70%. However, these participants cannot be identified from the article. Inclusion of participants in the acute phase: yes, during hospitalisation Major inclusion criteria: admitted because of a previous episode of exacerbation requiring hospitalisation for > 48 hours Major exclusion criteria: not living in the healthcare area, severe comorbid conditions, logistical limitations due to extremely poor social conditions and being admitted to a nursing home
Interventions	Mode: individual and group sessions at the hospital and the participant's home, telephone calls, ICT platform Duration: 3‐13 face‐to‐face individual sessions, one group session of 40 minutes and six phone calls; three individual sessions at the hospital of 40 minutes each and one to 10 (depending on the patient's needs) of 20 minutes each at the participant's home. Barcelona: one joint visit at home. Leuven: GP regularly visited participants at home. Weekly phone calls during the first month and phone calls after three and nine months Professional: respiratory nurse, GP, primary care team (physician, nurse, social worker) Training of case managers: GP's in Leuven were trained, also by the specialized respiratory nurse specifically trained for the study intervention Self‐management components: action plan COPD exacerbations, iterative process with feedback on actions, self‐recognition of COPD exacerbations, education regarding COPD, other: reinforcement of the logistics for treatment of comorbidities and social support was carried out accordingly Self‐management topics: smoking cessation, exercise, diet, (maintenance) medication, correct device use, coping with breathlessness/breathing techniques, other: travelling, end‐of‐life decision making, interpretation of medical testing, irritant avoidance, anxiety and panic control Exercise programme: no Smoking cessation programme: no Behavioural change techniques: 10 clusters: goals and planning, feedback and monitoring, social support, shaping knowledge, natural consequences, comparison of behaviour, associations, repetition and substitution, regulation, antecedents Action plan components: self‐recognition of exacerbations, self‐treatment of exacerbations, use of maintenance treatment, contact healthcare providers for support, other: reinforcement of the logistics for treatment of comorbidities and social support was carried out accordingly
Outcomes	1. all‐cause (re‐)hospitalisations 2. all‐cause mortality 3. use of healthcare resources
Notes	This study was conducted in two cities, Barcelona (Spain) and Leuven (Belgium), with marked differences in the primary care settings. Consequently, the intervention required customisation to country specificities, particularly regarding the interactions between hospital and primary care teams. The subgroup from Barcelona (Spain) was also reported in Garcia‐Aymerich 2007. However, in the current study other outcome measures and different numbers of participants were reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"All 155 patients included in the study were blindly assigned (1:1 ratio) using computer generated random numbers to either IC or usual care (UC)." p. 124  Comment: Random sequence generation was adequately performed
Allocation concealment (selection bias)	Low risk	"Adequacy of the assignment process to either IC or UC was ensured by both the generation of the allocation sequence by a random process and preventing foreknowledge of the treatment assignments in the specialised team that implemented the allocation sequence." p. 128 Comment: Allocation was adequately concealed
Blinding of participants and personnel (performance bias) All outcomes	High risk	Comment: Blinding of participants and personnel was not reported
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	"Early assessment of patients at study admission was identical for both groups. Assessment included a blind administration of a questionnaire, described in detail elsewhere. (…) Assessment of the use of healthcare resources by phone or personal interview was carried out at 1, 3, 6, 9 and 12 months in both arms of the study. Data regarding admissions during follow‐up were obtained from hospital records. Data regarding mortality were obtained from hospital records and direct family interviews.” p. 125 Comment: Only part of the baseline assessment was blinded; the other assessments were not blinded, and it is unclear who performed the phone, personal or family interviews.
Incomplete outcome data (attrition bias) All outcomes	Low risk	“A strength of the present analysis was that there were no subjects lost to follow‐up, since all drop‐outs were due to appearance of exclusion criteria or death (fig. 1) and, in any case, valid information about re‐hospitalisations was available from the national health services.” p. 128 Comment: Data on healthcare utilization were presented for all included participants, leading to a low risk of bias.
Selective reporting (reporting bias)	Unclear risk	Comment: No signs of selective reporting; however, no protocol available
Other bias	Low risk	None noted.

Fan 2012.

Methods	Design: RCT Follow‐up: 12 months Control group: guideline‐based usual care
Participants	Recruitment: outpatient clinic Assessed for eligibility: 467 Randomly assigned: I: 209; C: 217 Completed: I: 201 continued, 101 completed baseline and 1‐year study visits; C: 207 continued, 108 completed baseline and 1‐year study visits Mean age: I: 66.2 ± 8.4 years; C: 65.8 ± 8.2 years Gender (% male): I: 97.6; C: 96.3 COPD diagnosis: GOLD, a post‐bronchodilator ratio of FEV₁/FVC < 0.70 with an FEV₁ < 80% predicted. At baseline and 1‐year study visits, post‐bronchodilator spirometry performed according to ATS criteria Inclusion of participants in the acute phase: no Major inclusion criteria: hospitalised for COPD in the 12 months before enrolment, post‐bronchodilator ratio of FEV₁ to FVC < 0.70 with an FEV₁ < 80% predicted, age older than 40 years, current or past history of cigarette smoking (> 10 pack‐years), at least 1 visit in the past year to either a primary care or pulmonary clinic at a Veterans Affairs medical centre, no COPD exacerbation in the past 4 weeks, ability to speak English, and access to a telephone. Major exclusion criteria: primary diagnosis of asthma or any medical conditions that would impair ability to participate in the study or to provide informed consent.
Interventions	Mode: individual and group sessions at hospital outpatient clinics, telephone calls, educational booklet Duration: four face‐to‐face individual sessions of 90 minutes each scheduled weekly. The individual lessons were reinforced during a group session and by six phone calls, one per month for three months and every three months thereafter. Professional: case manager (various health‐related professionals) Training of case managers: before starting the study, all case managers received a three‐day training course with workshops covering detailed aspects of the self‐management programme, and all were supervised by the site investigator Self‐management components: action plan COPD exacerbations, iterative process with feedback on actions, self‐recognition of COPD exacerbations, education regarding COPD Self‐management topics: smoking cessation, exercise, (maintenance) medication, coping with breathlessness/breathing techniques Exercise programme: no Smoking cessation programme: no Behavioural change techniques: nine clusters: goals and planning, feedback and monitoring, social support, shaping knowledge, natural consequences, associations, repetition and substitution, regulation, antecedents Action plan components: self‐recognition of exacerbations, self‐treatment of exacerbations, contact healthcare providers for support
Outcomes	1. time from randomisation to first COPD hospitalisation 2. all‐cause mortality 3. number of exacerbations 4. health‐related quality of life 5. patient satisfaction 6. medication adherence 7. COPD‐related knowledge, skill acquisition and self‐efficacy
Notes	This multi site RCT of an educational and acute care management programme was stopped early when a safety monitoring board noted excess mortality in the intervention group. The mean follow‐up time was 250 days.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	“Randomisation lists were generated on the basis of random, permuted blocks of variable size to ensure approximate balance over time.” p. 674 Comment: Random sequence generation was adequately performed.
Allocation concealment (selection bias)	Low risk	“The CSP Coordinating Center in Boston, Massachusetts, randomly assigned eligible patients in equal numbers to 2 groups, stratifying patients per site to allow for possible regional differences in patient characteristics and clinical practice patterns.” p. 674 Comment: The allocation was adequately concealed.
Blinding of participants and personnel (performance bias) All outcomes	High risk	“The 2 groups differed on the basis of a complex behavioral intervention that made blinding impossible.” p. 674 Comment: No blinding of participants and personnel.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	“Telephone‐based ascertainment of study outcomes (COPD hospitalizations and exacerbations) was performed by centralized research staff blinded to assignment. All outcomes were collected by centralized staff blinded to study group, and all hospitalizations were adjudicated by a committee that was also blinded to study group.” p. 674 Comment: Outcome assessment was blinded.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	“This multi‐site, randomised, controlled trial of an educational and acute care management programme was stopped early when a safety monitoring board noted more deaths in the intervention group.” p. 674 Comment: There is incomplete outcome data due to early termination of the study.
Selective reporting (reporting bias)	Low risk	Comment: The primary and secondary outcomes were reported, only healthcare costs as (secondary objective) were not reported.
Other bias	Low risk	None noted.

Gallefoss 1999.

Methods	Design: RCT Follow‐up: 12 months Control group: usual care
Participants	Recruitment: hospital (outpatient) Assessed for eligibility: not reported Randomly assigned: I: 31; C: 31 Completed: I: 26; C: 27 Mean age: I: 57 ± 9 years; C: 58 ± 10 years Gender (% male): I: 48; C: 52 COPD diagnosis: FEV₁ equal to or higher than 40% and lower than 80% of predicted Inclusion of participants in the acute phase: not reported Major inclusion criteria: participants with COPD, <70 years of age, a FEV₁ equal to or higher than 40% and lower than 80% of predicted Major exclusion criteria: not suffering from any serious disease such as unstable coronary heart disease, heart failure, serious hypertension, diabetes mellitus, kidney or liver failure
Interventions	Mode: individual and group sessions at an outpatient clinic Duration: one to two face‐to‐face individual sessions by a nurse and one to two face‐to‐face individual sessions by a physiotherapist of 40 minutes each. Two two‐hour group education sessions (five to eight persons) were scheduled on two separate days. Professional: nurse, physiotherapist, pharmacist, medical doctor Training of case managers: specially trained nurse Self‐management components: action plan COPD exacerbations, iterative process with feedback on actions, self‐recognition of COPD exacerbations, education regarding COPD, other: compliance, self‐care Self‐management topics: smoking cessation, exercise, diet, (maintenance) medication, coping with breathlessness/breathing techniques Exercise programme: no Smoking cessation programme: no Behavioural change techniques: nine clusters: goals and planning, social support, feedback and monitoring, shaping knowledge, natural consequences, comparison of behaviour, associations, repetition and substitution, regulation, antecedents Action plan components: self‐recognition of exacerbations, self‐treatment of exacerbations, use of maintenance treatment, contact healthcare providers for support
Outcomes	1. health‐related quality of life (SGRQ and four simple questions) 2. hospital admissions 3. days lost from work 4. GP consultation 5. FEV₁ % predicted
Notes	‐
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"The patients signed a written consent and were then randomly assigned using random number tables supplied by an external statistician in sealed envelopes" Gallefoss 2002, p. 425 Comment: Random sequence generation was adequately performed
Allocation concealment (selection bias)	Low risk	"The patients signed a written consent and were then randomly assigned using random number tables supplied by an external statistician in sealed envelopes" Gallefoss 2002, p. 425 Comment: Allocation was adequately concealed
Blinding of participants and personnel (performance bias) All outcomes	High risk	Comment: Blinding of participants and personnel was not reported.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Comment: Blinding of outcome assessment was not reported; not clear who performed the measurements.
Incomplete outcome data (attrition bias) All outcomes	Low risk	“In the intervention group, four patients failed to complete the educational programme (social problems (n = 1), unannounced emigration (n = 1), failure to meet at educational group sessions for unknown reasons (n = 1) and serious myocardial infarction (n = 1)). Another patient was withdrawn from the study during the follow‐up due to lymphoma (n = 1). This left us with 26 patients (81%) for a 1‐year follow‐up. The patients who were withdrawn from the intervention group did not, to our knowledge, have any serious deterioration in their obstructive lung disease, and none were hospitalised. In the control group four patients were withdrawn (lack of co‐operation (n = 2), diagnosis of rectal cancer (n = 1) and emigration (n = 1)). Two of the withdrawn control group patients were hospitalised for exacerbations of their COPD. This left us with 27 patients (84%) for the 1‐year follow‐up” Gallefoss 2002, p. 427 Comment: The number of dropouts was relatively low, and reasons for dropout were comparable over groups.
Selective reporting (reporting bias)	Low risk	Comment: No signs of selective outcome reporting; study extensively described in various articles.
Other bias	Low risk	None noted.

Garcia‐Aymerich 2007.

Methods	Design: RCT Follow‐up: 12 months Control group: usual care
Participants	Recruitment: hospital (inpatient) Eligible: not reported Randomly assigned: I: 44; C: 69 Completed: I: 21; C: 41 Mean age: I (follow‐up): 72 ± 10 years, I (no follow‐up): 73 ± 6 years; C (follow‐up): 73 ± 9 years, C (no follow‐up): 74 ± 8 years Gender (% male): I: 75; C: 93 COPD diagnosis: some of the participants had an FEV₁/FVC > 70%. However, these participants cannot be identified from the article. Inclusion of participants in the acute phase: yes, during hospitalisation Major inclusion criteria: admitted because of a previous episode of exacerbation requiring hospitalisation for > 48 hours Major exclusion criteria: not living in the healthcare area or living in a nursing home, lung cancer or other advanced malignancies, logistical limitations due to extremely poor social conditions and extremely severe neurological or cardiovascular comorbidities
Interventions	Mode: individual sessions at the hospital and the participant's home, telephone calls, ICT platform Duration: 3‐13 face‐to‐face individual sessions at the hospital of 40 minutes each and one to 10 (depending on the patient's needs) of 20 minutes each at the participant's home. six phone calls, weekly during the first month and phone calls after three and nine months. Professional: specialised respiratory nurse and primary care team (physician, nurse, social worker) Training of case managers: an educational session of approximately two hours duration on self‐management of the disease was administered at discharge, also by the specialized respiratory nurse specifically trained for the study Self‐management components: action plan COPD exacerbations, iterative process with feedback on actions, self‐recognition of COPD exacerbations, education regarding COPD, other: reinforcement of the logistics for treatment of comorbidities and social support was carried out accordingly Self‐management topics: smoking cessation, exercise, diet, (maintenance) medication, correct device use, coping with breathlessness/breathing techniques, other: travelling, end‐of‐life decision making, interpretation of medical testing, irritant avoidance, anxiety and panic control Exercise programme: no Smoking cessation programme: no Behavioural change techniques: 10 clusters: goals and planning, feedback and monitoring, social support, shaping knowledge, natural consequences, comparison of behaviour, associations, repetition and substitution, regulation, antecedents Action plan components: self‐recognition of exacerbations, self‐treatment of exacerbations, use of maintenance treatment, contact healthcare providers for support, other: reinforcement of the logistics for treatment of comorbidities and social support was carried out accordingly
Outcomes	1. health‐related quality of life (SGRQ and EQ‐5D) 2. FEV₁ (L) 3. FEV₁/FVC 4. clinical factors (comorbidities, MRC dyspnoea, BMI) 5. lifestyle (smoking, alcohol, physical activity) 6. self‐management (knowledge, identification and early treatment, adherence 7. satisfaction with health services
Notes	The current study was conducted in Barcelona (Spain) only. This subgroup was also reported in Casas 2006. However, in the current study other outcome measures and different number of participants were reported.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	“and were blindly assigned (1:2 ratio) using computer generated random numbers either to integrated care (IC) or to usual care (UC).” p. 1463 Comment: Random sequence generation was adequately performed.
Allocation concealment (selection bias)	Low risk	“and were blindly assigned (1:2 ratio) using computer generated random numbers either to integrated care (IC) or to usual care (UC).” p. 1463 Comment: No information on allocation concealment. The allocation was adequately concealed.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Comment: Blinding of participants and personnel was not reported.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	“Early assessment of patients at their admission to the study was identical for both groups. It included a blind administration of a questionnaire, described in detail elsewhere.” p. 1464 Comment: The administration of a questionnaire was blinded.
Incomplete outcome data (attrition bias) All outcomes	High risk	“During follow‐up, a priori defined exclusion criteria, such as lung cancer, appeared in 9 subjects. Twente‐one subjects died, and 16 were lost to follow‐up. Only 57% of subjects finished the study at 12 months. (…) Since date about outcome variables was not available in the lost subjects (whether due to exclusion, loss to follow‐up or death), an intention‐to‐treat principle was not possible.” p. 1464 Comment: More than 40% of the data on functional status and HRQoL reported was missing, leading to a high risk of bias.
Selective reporting (reporting bias)	Unclear risk	Comment: VAS was reported, but the Euroqol (EQ‐5D) was not reported. No signs of selective reporting; however, no protocol available.
Other bias	Low risk	None noted.

Hernández 2015.

Methods	Design: RCT Follow‐up: 12 (and 72 months passive follow‐up thereafter) Control group: usual care
Participants	Recruitment: hospital (outpatient) Assessed for eligibility: 860 Randomly assigned: I: 71; C: 84 Completed: I: 54; C: 55 Mean age: I: 73 ± 8 years; C: 75 ± 9 years Gender (% male): I: 83; C: 86 COPD diagnosis: a person not involved in the study identified the cases with COPD (ICD9‐CM 491, 492, 493 or 496) as the primary diagnosis for admission. However, lung function testing was also assessed before randomisation Inclusion of participants in the acute phase: no Major inclusion criteria: clinically stable COPD participants with a history of at least two hospital admissions owing to severe respiratory exacerbations during two consecutive years, we considered a broad spectrum of COPD diagnostic terms that include chronic obstructive inflammatory diseases namely, emphysema, asthma, tuberculosis, chronic bronchitis and COPD, aged above 45 years and living at home within the healthcare area of the hospital (Barcelona‐Esquerra) Major exclusion criteria: nursing home or not living in the area, participants in another randomised controlled trial, exitus prior to contact
Interventions	Mode: individual and group sessions at an outpatient clinic and at the participant's home Duration: at least one face‐to‐face individual session of 40 minutes at the patient's home within 72 hours after entry into the study by the primary care team (participants without mobility problems), four face‐to‐face individual sessions of 15 minutes education each at the patient's home by the primary care team (participants with mobility problems), one two‐hour individual or group educational programme of 40 minutes. Three group sessions for participants without mobility problems (two comprehensive assessments of 90 minutes each at the outpatient clinic and one two‐hour educational programme) and for participants with mobility problems, the programme was done at home. In all visits, the nurses dedicated 15 minutes for education. Professional: specialised respiratory nurse, primary care team (physician, nurse and social worker) Training of case managers: the community care teams received training: a two‐hour face‐to‐face educational training and one‐day stay at the hospital ward, aiming at enhancing home‐based management of frail COPD participants. Self‐management components: action plan COPD exacerbations, self‐recognition of COPD exacerbations, education regarding COPD, smoking cessation, exercise or physical activity component, other: instructions on non‐pharmacological treatment Self‐management topics: smoking cessation, exercise, diet, (maintenance) medication, correct device use, coping with breathlessness/breathing techniques, other: vaccination Exercise programme: yes, no extra information available Smoking cessation programme: yes, no extra information available Behavioural change techniques: eight clusters: goals and planning, feedback and monitoring, social support, shaping knowledge, comparison of behaviour, associations, regulation, antecedents Action plan components: self‐recognition of exacerbations, self‐treatment of exacerbations, use of maintenance treatment, avoid situations in which viral infection might be prevalent, contact healthcare providers for support, self‐treatment of comorbidities
Outcomes	1. mental status 2. activities of daily living (Lawton index) 3. anxiety and depression (HADS) 4. health‐related quality of life (SGRQ) 5. sleepiness (Epworth sleepiness scale) 6. 6MWT 7. nocturnal pulse oximetry and body mass distribution 8. exacerbations
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	“A computer‐generated list of random numbers with no restrictions and administered by personnel who were not involved in the study ensured blinded randomisation (1:1 ratio).” p. 2 Comment: Random sequence generation was adequately performed.
Allocation concealment (selection bias)	Low risk	“(…) and administered by personnel who were not involved in the study” p. 2 Comment: The allocation was adequately concealed.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Comment: No blinding of participants or personnel
Blinding of outcome assessment (detection bias) All outcomes	Low risk	“A blind evaluation of the study group carried out before randomisation and after the 12‐month follow‐up consisted of a patient interview and analysis of medical records, self‐administered questionnaires and lung function testing.” p. 2 Comment: Outcome assessment was blinded.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Comment: Insufficient information to permit judgement.
Selective reporting (reporting bias)	Unclear risk	“The RCT was not included in the clinicaltrials.gov registry because at that time it was not compulsory.” p. 5 Comment: Not all outcome measures are reported (e.g., Epworth sleepiness scale, lung function, 6‐MWT). However, no protocol available.
Other bias	Low risk	None noted.

Jennings 2015.

Methods	Design: RCT Follow‐up: 3 months Control group: usual care
Participants	Recruitment: hospital (inpatient) Assessed for eligibility: 1225 Randomly assigned: I: 93; C: 79 Completed: I: 93; C: 79 Mean age: I: 64.88 ± 10.86 years; C: 64.43 ± 10.47 years Gender (% male): I: 43.4; C: 46.8 COPD diagnosis: based on spirometric testing in the prior year that demonstrated airflow obstruction (FEV₁/FVC , 70% and FEV₁ < 80%) based on GOLD criteria. If spirometric data were not available, a previously validated questionnaire was used in the diagnosis of COPD for purposes of study inclusion. The presence of airflow obstruction was then confirmed by spirometry prior to discharge. Inclusion of participants in the acute phase: yes, during hospitalisation Major inclusion criteria: diagnosis of COPD with the presence of an acute exacerbation, age > 40 years, and current or ex‐smoker with a history equivalent to at least 20 pack‐years. The diagnosis of AECOPD was made by the primary team but was confirmed by the research team prior to assessing eligibility for inclusion. AECOPD was defined as an acute event characterized by a worsening of the patient’s respiratory symptoms beyond normal day‐to‐day variations, leading to a change in medication. If there was a question about a true diagnosis of AECOPD, a pulmonologist on the research team evaluated the patient. Major exclusion criteria: a medical history of asthma, interstitial lung disease, bronchiectasis, presence of airway hardware (e.g., tracheal stents), lung cancer, any other cancer with an associated life expectancy of < 1 year, any cancer where the patient was receiving active chemotherapy or radiation treatment, active substance abuse, or neuromuscular disorders affecting the respiratory system, language barriers, residence in a nursing home, ICU stay during the current admission, and significant delirium or dementia.
Interventions	Mode: individual sessions at a hospital and at the participant's home, telephone calls Duration: one face‐to‐face individual session of one hour at the hospital by a member of the research team 24 hours prior to the anticipated discharge day. 48 hours after discharge, participants were contacted by telephone to reinforce the items in the bundle. Professional: research team and research nurse Training of case managers: not reported Self‐management components: action plan COPD exacerbations, iterative process with feedback on actions, education regarding COPD, smoking cessation, other: the primary team was notified if a patient was identified as having anxiety or depressive symptoms, and referral to outpatient behavioral health services or pharmacologic treatment was deferred to the primary team Self‐management topics: smoking cessation, diet, correct device use, coping with breathlessness/breathing techniques, other: assess current behaviours to manage COPD Exercise programme: no Smoking cessation programme: yes, active smokers received smoking cessation counselling and, with patient agreement, were enrolled in the Henry Ford Health System Smoking Cessation Program Behavioural change techniques: eight clusters: goals and planning, feedback and monitoring, social support, shaping knowledge, comparison of behaviour, associations, repetition and substitution, antecedents Action plan components: contact healthcare providers for support
Outcomes	1. 30‐day risk of readmission or ED visits for AECOPDs 2. 90‐day rate of COPD readmission
Notes	The trial was stopped early after an interim analysis at 3 years did not demonstrate that further accrual could achieve the desired 10% difference in the primary composite end point of ED visit or rehospitalisation between the two groups.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	“A computer‐generated list was used to randomise patients in a 1:1 ratio, stratified by age and sex, to either the bundle or the control group.” Comment: Random sequence generation was adequately performed.
Allocation concealment (selection bias)	Unclear risk	Comment: No information provided regarding allocation concealment.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Comment: No information provided regarding blinding of participants and personnel. However, the participants and personnel could not be blinded as all participants assigned to the bundle group received a 60‐min visit by a member of the research team.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Comment: No information provided regarding blinding of outcome assessment; however, objective outcome measures are used.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	“The trial was stopped early after an interim analysis at 3 years did not demonstrate that further accrual could achieve the desired 10% difference in the primary composite end point of ED visit or rehospitalization between the two groups.” p. 1229 Comment: it seems that there were no dropouts after randomisation.
Selective reporting (reporting bias)	Unclear risk	“The primary end point was the difference in the composite risk of hospitalizations or ED visits for AECOPDs between the two groups in the 30 days following discharge.” p. 1229 Comment: According to the protocol available in the Clinical Trials register the primary outcomes were the 30 day readmission rate and the time until readmission or ER visit, 30 days.
Other bias	Low risk	None noted.

Khdour 2009.

Methods	Design: RCT Follow‐up: 12 months Control group: usual hospital outpatient care
Participants	Recruitment: hospital (outpatient clinic) Assessed for eligibility: not reported Randomly assigned: I: 86; C: 87 Completed: I: 71; C: 72 Mean age: I: 65.63 ± 10.1 years; C: 67.3 ± 9.2 years Gender (% male): I: 44.2; C: 43.7 COPD diagnosis: confirmed diagnosis of COPD (by the hospital consultant) for at least 1 year, having a FEV₁ of 30–80% of the predicted normal value Inclusion of participants in the acute phase: not reported Major inclusion criteria: confirmed diagnosis of COPD for at least 1 year, having a FEV₁ of 30–80% of the predicted normal value and >45 years old Major exclusion criteria: having congestive heart failure, moderate to severe learning difficulties (as judged by hospital consultant), attended a pulmonary rehabilitation programme in the last 6 months, and severe mobility problems or terminal illness
Interventions	Mode: individual sessions at an outpatient clinic, telephone calls, booklet on techniques for expectoration Duration: one face‐to‐face individual session of 45 minutes (one hour for smokers) and two telephone calls at three and nine months Professional: clinical pharmacist, respiratory specialist, respiratory nurse Training of case managers: not reported Self‐management components: action plan COPD exacerbations, iterative process with feedback on actions, self‐recognition of COPD exacerbations, education regarding COPD, smoking cessation Self‐management topics: smoking cessation, exercise, diet, (maintenance) medication, correct device use, coping with breathlessness/breathing techniques Exercise programme: no Smoking cessation programme: yes, advice, using the motivational interviewing technique, was provided to the participants who still smoked and referral to a special smoking cessation programme run within the hospital was made Behavioural change techniques: ten clusters: goals and planning, feedback and monitoring, social support, shaping knowledge, natural consequences, comparison of behaviour, associations, repetition and substitution, regulation, antecedents Action plan components: self‐recognition of exacerbations, self‐treatment of exacerbations, contact healthcare providers for support
Outcomes	1. health‐related quality of life (SGRQ) 2. FEV₁ 3. hospital admissions for acute exacerbations 4. ED visits for acute exacerbations 5. GP visits, scheduled and unscheduled 6. knowledge of medication and disease management (COPD knowledge questionnaire) 7. adherence to prescribed medication
Notes	‐
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	“Recruited patients were randomly assigned to one of two groups: the intervention group and the usual care (control group). Both groups were matched as closely as possible for the following parameters: severity of COPD (measured by FEV1), age, gender and other concomitant illness. The randomisation was carried out using the minimization method described by Gore.” p. 589 Comment: Random sequence generation was performed adequately.
Allocation concealment (selection bias)	Low risk	“Recruited patients were randomly assigned to one of two groups: the intervention group and the usual care (control group). Both groups were matched as closely as possible for the following parameters: severity of COPD (measured by FEV1), age, gender and other concomitant illness. The randomisation was carried out using the minimization method described by Gore.” p. 589 Comment: Allocation was adequately concealed.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Comment: Blinding of participants and personnel was not reported.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	“Baseline measurements were performed by the research pharmacist (…) for operational reasons, the researcher could not be blinded to the group to which the patient belonged.” p. 590 Comment: Outcome assessment was not blinded; it was not clearly reported how the research pharmacist was related to the study.
Incomplete outcome data (attrition bias) All outcomes	Low risk	“A per‐protocol analysis was used. (…) During the study period, three patients from the intervention group and five from the control group died and a total of 22 patients withdrew from the study; 12 patients from the intervention group and 10 from the control group.” p. 590 Comment: In both groups, 15 participants (17%) dropped out during the 12‐month follow‐up. Reasons for dropout were comparable across groups.
Selective reporting (reporting bias)	Unclear risk	Comment: No signs of selective reporting; however, no protocol available.
Other bias	Low risk	None noted.

Kheirabadi 2008.

Methods	Design: RCT Follow‐up: 3 months Control group: usual care
Participants	Recruitment: hospital (outpatient clinic) Assessed for eligibility: not reported Randomly assigned: I: 21; C: 21 Completed: I: 21; C: 21 Mean age: I: 56.6 ± 5.7 years; C: 56.2 ± 4.1 years Gender (% male): I: 61.9; C: 76.2 COPD diagnosis: diagnosed by a pulmonologist according to ATS criteria Inclusion of participants in the acute phase: not reported Major inclusion criteria: diagnosed by a pulmonologist according to ATS criteria, consent for participation in the study, being literate and having sufficient knowledge (at least to understand and fill out the questionnaires), having physical and mental ability to tolerate the interventions, absence of disease that limit the function and other medical conditions affecting the mortality Major exclusion criteria: primary diagnosis of asthma, hospitalisation during the intervention, main treatment with oxygen and occurrence of serious unexpected stresses during the study.
Interventions	Mode: group sessions at a hospital (outpatient clinic), telephone calls Duration: eight face‐to‐face educational group sessions of 60‐90 minutes each (3‐4 member groups) with one week interval and during this 8‐week programme, participants of the intervention group were followed up by phone Professional: psychologist, trained psychiatric residents Training of case managers: the psychiatric residents are trained, but no further information is provided Self‐management components: action plan COPD exacerbations, self‐recognition of COPD exacerbations, education regarding COPD, exercise or physical activity component Self‐management topics: smoking cessation, exercise, diet, (maintenance) medication, coping with breathlessness/breathing techniques, other: healthy lifestyle, avoid places with air pollution, healthy sleep, sexual habits, stress management, free time activities, travelling, and behavioral interventions focusing on common issues like independence, decreased self‐esteem, feeling insecure, limited relation with family and friends Exercise programme: yes, simple regular exercise programme at home Smoking cessation programme: no Behavioural change techniques: six clusters: goals and planning, feedback and monitoring, shaping knowledge, natural consequences, associations, regulation Action plan components: avoid situations in which viral infection might be prevalent
Outcomes	1. severity of disease (CCQ questionnaire)
Notes	‐
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Comment: The method of random sequence generation was not reported.
Allocation concealment (selection bias)	Unclear risk	Comment: The method of allocation concealment was not reported.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Comment: Blinding of participants and personnel was not reported.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Comment: Blinding of outcome assessment was not reported. Not clear who performed the measurements.
Incomplete outcome data (attrition bias) All outcomes	Low risk	“We also encouraged and followed up the patients by phone and even when someone was absent, we teached [sic] him/her over the phone. In this way, all patients accompanied us till the end of the course and no patient was excluded from the study." p. 28 Comment: All participants completed follow‐up.
Selective reporting (reporting bias)	Unclear risk	Comment: No signs of selective reporting, although only one outcome measure was reported. No protocol available.
Other bias	Low risk	None noted.

Martin 2004.

Methods	Design: RCT Follow‐up: 12 months Control group: usual care
Participants	Recruitment: general practice Assessed for eligibility: not reported Randomly assigned: I: 44; C: 49 Completed: I: 35; C: 45 Mean age: I: 71.1 (95% CI 68.7‐73.5) years; C: 69.1 (95% CI 63.5‐74.7) years Gender (% male): I: 34.1; C: 65.3 COPD diagnosis: GOLD, a diagnosis of moderate or severe COPD Inclusion of participants in the acute phase: no (use of the plan was commenced at a time when each patient was in a stable condition) Major inclusion criteria: diagnosis of COPD, aged 55 years or over, at least one hospital admission or two acute exacerbations of COPD requiring GP care during the previous 12 months, a Mini Mental State Examination score > 22 Major exclusion criteria: terminally ill, coexisting lung cancer, admission to hospital with cardiac disease within previous 12 months, receiving home oxygen therapy.
Interventions	Mode: individual sessions at a GP, hospital, ambulance service, emergency department or home‐based Duration: four face‐to‐face individual sessions, during the 12‐months period all participants were visited by a respiratory nurse at three, six and 12 months to provide routine support and further education regarding use of the plan Professional: respiratory physician, respiratory nurse, GP, ED consultant, medical staff hospital Training of case managers: not reported Self‐management components: action plan COPD exacerbations, iterative process with feedback on actions, self‐recognition of COPD exacerbations Self‐management topics: (maintenance) medication Exercise programme: no Smoking cessation programme: no Behavioural change techniques: eight clusters: goals and planning, feedback and monitoring, social support, shaping knowledge, comparison of behaviour, associations, regulation, antecedents Action plan components: self‐recognition of exacerbations, self‐treatment of exacerbations, use of maintenance treatment, self‐treatment of comorbidities, other: when/how to use oxygen therapy and when to use diuretics
Outcomes	1. health care utilisation (GP visits, hospital admissions, ambulance calls) 2. quality of life (SGRQ) 3. medication use (courses of oral steroids and antibiotics)
Notes	Three participants subsequently withdrew for personal reasons. However, it was not reported in what group. A further 13 died during the follow‐up period (nine in the intervention group and four in the control group).
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	"Patients were randomly assigned to the intervention (care plan) or control (usual care) groups." p. 192 Comment: The method of random sequence generation was not reported.
Allocation concealment (selection bias)	Unclear risk	"Patients were randomly assigned to the intervention (care plan) or control (usual care) groups." p. 192 Comment: The method of allocation concealment was not reported.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Comment: Blinding of participants and personnel was not reported.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	“Quality of life was measured by the St George’s Respiratory Questionnaire (SGRQ). The questionnaire was administered by the research nurse (DMcN) at each visit.” Comment: The blinding of outcome assessment was not reported.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	“Three subsequently withdrew for personal reasons. A further 13 died during the follow‐up period (…) [nine in the intervention group and four in the control group (NS)]” p. 192 Comment: The number of withdrawals was higher in the intervention group compared to the control group. However, no information provided regarding the differences in dropout rates.
Selective reporting (reporting bias)	Unclear risk	Comment: No signs of selective reporting, however no protocol available.
Other bias	Low risk	None noted.

Mitchell 2014.

Methods	Design: RCT Follow‐up: 6 months Control group: usual care
Participants	Recruitment: general practice Assessed for eligibility: 326 Randomly assigned: I: 89; C: 95 Completed: I: 65; C: 79 Mean age: I: 69 ± 8 years; C: 69 ± 10.1 years Gender (% male): I: 60.7; C: 49.5 COPD diagnosis: a diagnosis of COPD confirmed by spirometry, with a FEV₁/FVC ratio < 0.7 Inclusion of participants in the acute phase: no Major inclusion criteria: have a diagnosis of COPD confirmed by spirometry, with a FEV₁/FVC ratio < 0.7, grade 2‐5 MRC dyspnoea scale, clinically stable for 4 weeks Major exclusion criteria: unable to undertake an exercise regime due to neurological, musculoskeletal or cognitive comorbidities, unable to read English to the reading age of an 8‐year‐old, completed pulmonary rehabilitation within the previous 12 months
Interventions	Mode: individual sessions at a GP or home‐based, telephone calls, workbook Duration: one face‐to‐face individual session for 30‐45 minutes by a physiotherapist and two telephone calls at two and four weeks into the programme to reinforce skills and providing encouragement to progress Professional: physiotherapist, trainee health psychologist Training of case managers: not reported Self‐management components: action plan COPD exacerbations, iterative process with feedback on actions, self‐recognition of COPD exacerbations, education regarding COPD, exercise or physical activity component Self‐management topics: smoking cessation, exercise, diet, (maintenance) medication, correct device use, coping with breathlessness/breathing techniques Exercise programme: yes, home exercise programme consisting of a daily walking programme, and resistance training of the upper and lower limbs using free weights three times per week. Smoking cessation programme: no Behavioural change techniques: 11 clusters: goals and planning, feedback and monitoring, social support, shaping knowledge, natural consequences, comparison of behaviour, associations, repetition and substitution, regulation, antecedents, identity Action plan components: self‐recognition of exacerbations, self‐treatment of exacerbations, avoid situations in which viral infection might be prevalent, contact healthcare providers for support, other: discussion with participants about self‐administration and requesting rescue medication from their primary care physician
Outcomes	1. health status (CRQ dyspnoea domain) 2. fatigue, emotion and mastery domains of the CRQ 3. disease knowledge (Bristol COPD Knowledge Questiionnaire) 4. anxiety and depression (HADS) 5. exercise capacity (ISWT, ESWT) 6. self‐efficacy (Pulmonary Rehabilitation Adapted Index of Self‐Efficacy) 7. healthcare utilisation (admissions, GP visits, ED visits, nurse home visits) 8. medication use (courses of antibiotics) 8. self‐reported smoking status
Notes	‐
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	“Patients were assigned to either usual care or SPACE FOR COPD via a web‐based, concealed allocation programme, using simple randomisation codes prepared by the trial statistician (J. Bankart).” p. 1539 Comment: Random sequence generation was adequately performed.
Allocation concealment (selection bias)	Unclear risk	“Randomisation was conducted by the trial investigator responsible for administering the intervention (K.E. Mitchell).” p. 1539 Comment: The method of allocation concealment was not reported.
Blinding of participants and personnel (performance bias) All outcomes	High risk	“Lack of participant blinding may have increased motivation when receiving the treatment and attempts to satisfy the researchers might have increased the observed treatment effects in the intervention arm. We cannot, therefore, rule out the possible impact of attention.” p. 1546 Comment: No blinding of participants.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	“The assessments at week 6 and 6 months were conducted by a member of the research team who was blind to randomisation allocation (V. Johnson‐Warrington).” p. 1540 Comment: The outcome assessment was blinded.
Incomplete outcome data (attrition bias) All outcomes	Low risk	“There were no significant differences in demographics or baseline variables between those who completed and those who did not complete the study. Analysis was carried out on an intention‐to‐treat basis. Missing data were imputed in Stata using multiple imputed chained equations. Analysis on imputed data sets were carried out using the micombine command in Stata, which analyses each dataset separately and combines the results.” p. 1540 Comment: No signs of incomplete outcome data. A bit more missing data in control group, maximum around 20%.
Selective reporting (reporting bias)	Low risk	Comment: No signs for selective outcome reporting. The primary outcome measure and most of the secondary outcome measures were reported.
Other bias	Low risk	None noted.

Monninkhof 2003.

Methods	Design: RCT Follow‐up: 12 months Control group: usual care
Participants	Recruitment: hospital (outpatient clinic) Assessed for eligibility: 615 Randomly assigned: I: 127; C: 121 Completed: I: 122; C: 114 Mean age: I: 65 ± 7 years; C: 65 ± 7 years Gender (% male): I: 85; C: 84 COPD diagnosis: clinical diagnosis of stable COPD, as defined by ATS criteria; FEV₁% predicted (pre): 25% to 80%; FEV₁/VC (pre): < 60% Inclusion of participants in the acute phase: no Major inclusion criteria: clinical diagnosis of stable COPD, no history of asthma, no exacerbation in the month prior to enrolment, current or former smoker, aged 40 to 75 years, baseline pre‐bronchodilator (FEV₁) 25–80% predicted, pre‐bronchodilator ratio FEV₁/VC < 60% Major exclusion criteria: maintenance treatment of oral steroids or antibiotics, medical condition with low survival or serious psychiatric morbidity, any other active lung disease
Interventions	Mode: group sessions (approximately eight participants) at the outpatient clinic and community‐based, educational booklet Duration: five face‐to‐face group sessions for two hours each by a respiratory nurse (four sessions with a one‐week interval and the last (feedback) session was given three months after the fourth session) and one or two small group training sessions per week for 30‐45 minutes by a physiotherapist trained in COPD care Professional: respiratory nurse, respiratory physiotherapist Training of case managers: physiotherapists trained in COPD care Self‐management components: action plan COPD exacerbations, iterative process with feedback on actions, self‐recognition of COPD exacerbations, education regarding COPD, exercise or physical activity component Self‐management topics: smoking cessation, exercise, diet, (maintenance) medication, correct device use, coping with breathlessness/breathing techniques, other: ergonomic posture and energy conservation during daily activities or work, communication and social relationships, coping with disease, recognising participants’ individual capacity, social interactions and behavioural changes Exercise programme: yes, one or two 1 h small group training sessions per week under guidance of a physiotherapist trained in COPD care. In the first few months, inactive participants were offered two sessions per week to get started. Incorporation of exercise in daily life above the fitness training was the participants' own responsibility. The programme included strength training, breathing and cardiovascular exercises (stationary bicycling, walking etc.). Smoking cessation programme: no Behavioural change techniques: ten clusters: goals and planning, feedback and monitoring, social support, shaping knowledge, natural consequences, comparison of behaviour, associations, repetition and substitution, regulation, antecedents Action plan components: self‐recognition of exacerbations, self‐treatment of exacerbations, contact healthcare providers for support
Outcomes	1. health‐related quality of life (SGRQ) 2. self‐confidence 3. walking distance (6MWT) 4. exacerbations 5. COPD symptoms 6. healthcare utilisation (doctor consultations, hospital admissions) 7. healthcare costs (days lost from work) 8. preference‐based utilities (EuroQol, QALYs)
Notes	‐
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"Randomisation was performed in blocks of four, stratified by sex and smoking status, using sealed envelopes. ” p. 816 Comment: Random sequence generation was adequately performed.
Allocation concealment (selection bias)	Low risk	"Randomisation was performed in blocks of four, stratified by sex and smoking status, using sealed envelopes. ” p. 816 Comment: The allocation was adequately concealed.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Comment: Participants and personnel were not blinded.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Comment: Outcome assessment was not blinded. However, measurements were performed by an assessor who was independent of the study.
Incomplete outcome data (attrition bias) All outcomes	Low risk	"In the intervention group five patients (three deaths, two other) dropped out, as did seven patients (three deaths, two carcinoma, two other) in the control group." page 818 Comment: The number of withdrawals and reasons for withdrawal in both groups were comparable. Moreover, an intention‐to‐treat analysis was used and drop out was low.
Selective reporting (reporting bias)	Unclear risk	Comment: No signs of selective reporting; however, no protocol available
Other bias	Low risk	None noted.

Ninot 2011.

Methods	Design: RCT Follow‐up: 12 months Control group: usual care
Participants	Recruitment: hospital (outpatient, university‐based centre) Assessed for eligibility: 101 Randomly assigned: I: 23; C: 22 Completed: I: 20; C: 18 Mean age: I: 65 (range 59‐74) years; C: 61 (range 56‐65) years Gender (% male): I: 90; C: 77.8 COPD diagnosis: a FEV₁/FVC ratio of less than 0.70 Inclusion of participants in the acute phase: no Major inclusion criteria: stable COPD, 40 years of age or older, FEV₁/FVC ratio of less than 0.70, not previously been involved in pulmonary rehabilitation or had lived in a long‐term care facility, understood, read, and wrote French. Major exclusion criteria: previous diagnosis of asthma, oxygen dependence, unstable and/or uncontrolled cardiac disease, musculoskeletal problems precluding exercise training, a terminal disease, dementia or an uncontrolled psychiatric illness
Interventions	Mode: individual and group sessions (four‐eight participants) at the hospital, telephone calls Duration: eight face‐to‐face group sessions (two per week) for two hours each by a health professional for four weeks, eight exercise sessions for 30‐45 min each under the supervision of a qualified exercise trainer, three telephone calls to encourage personalised endurance training and on reporting symptoms Professional: health professional and qualified exercise trainer Training of case managers: not reported Self‐management components: action plan COPD exacerbations, self‐recognition of COPD exacerbations, education regarding COPD, exercise or physical activity component Self‐management topics: smoking cessation, exercise, diet, (maintenance) medication, correct device use, coping with breathlessness/breathing techniques Exercise programme: yes, after each educational session (8 in total) within the same group, participants performed the usual exercise program used in our laboratory (i.e. cycling at the level of the ventilatory threshold for 30‐45 min under the supervision of a qualified exercise trainer). Smoking cessation programme: no Behavioural change techniques: nine clusters: goals and planning, feedback and monitoring, social support, shaping knowledge, comparison of behaviour, associations, repetition and substitution, regulation, antecedents Action plan components: self‐recognition of exacerbations, self‐treatment of exacerbations, use of maintenance treatment, avoid situations in which viral infection might be prevalent
Outcomes	1. exercise training (change in 6MWD) 2. 6MWT 3. COPD‐specific health status (SGRQ) 4. perceived health status (Nottingham Health Profile) 5. maximal exercise capacity (peak work rate) 6. daily physical activity (Voorrips questionnaire) 7. healthcare utilisation (hospital admissions) 8. healthcare costs (cost of medication, hospitalisations)
Notes	‐
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	“Participants were randomly assigned either to the self‐management programme or usual care group. The trial statistician, MCP, generated the random allocation sequence using the random procedure in SAS (SAS v.9.1 e SAS Institute, Cary NC), with a 1:1 allocation using block size of 5 (…)” p. 379 Comment: Random sequence generation was adequately performed.
Allocation concealment (selection bias)	Low risk	“(…) After the physician had obtained the patient’s consent, he sent by fax the randomisation form to the Clinical Research Unit (AJ) for allocation consignment re‐addressed by fax” p. 379 Comment: Alllocation was adequately concealed.
Blinding of participants and personnel (performance bias) All outcomes	High risk	“Due to the nature of the intervention conditions, it is not possible to blind research participants or assessors. Several stratagems were adopted in an effort to ensure that objectivity was maintained as rigorously as possible. Participants were unaware of their group allocation until they had completed all of their pre‐intervention assessment” p. 379 Comment: participants and personnel were not blinded.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	“(…) The individuals carrying out the assessment were not part of the intervention team. Research participants were asked not to divulge information regarding their group allocation in conversation during assessment at 12 month.” p. 379 Comment: Outcome assessment was not blinded; however, assessors were not part of the intervention team.
Incomplete outcome data (attrition bias) All outcomes	Low risk	“One patient from the intervention group did not fulfil our adherence criteria to the 4‐week programme, and also did not complete the 1‐year evaluation. Six more patients were not available for follow‐up evaluation; four in the usual care group, and two in the intervention group. The withdrawals were due to miscellaneous medical conditions (n = 3), and COPD exacerbation (n = 3). Due to the missing data, we did not retain these patients in our 1‐year analyses” p. 380 “Baseline characteristics of the patients who withdrew from the study were similar to those of patients who completed the trial” p. 380 Comment: The number of withdrawal was relatively low and equally distributed over groups. Also, reasons for withdrawal in the two groups were comparable.
Selective reporting (reporting bias)	Unclear risk	Comment: No signs of selectively reporting; however, no protocol available.
Other bias	Unclear risk	Comment: Per protocol analysis, baseline characteristics were not reported for all randomised participants.

Rea 2004.

Methods	Design: cluster‐RCT Follow‐up: 12 months Control group: conventional care
Participants	Recruitment: general practice Assessed for eligibility: 700 Randomly assigned: I: 83; C: 52 Completed: I: 71; C: 46 Mean age: 68 (range 44‐84) years for total group Gender (% male): 41.5% for total group COPD diagnosis: diagnosis of COPD by ICD‐9‐CM codes and GP records for a clinical diagnosis of moderate to severe COPD Inclusion of participants in the acute phase: not reported Major inclusion criteria: clinical diagnosis of moderate to severe COPD Major exclusion criteria: chronic asthma, bronchiectasis, comorbidity more significant than COPD, unable to give informed consent; prognosis < 12 months, LTOT or too unwell, deceased, no longer enrolled with participating GP or moved out of area, unable to contact patient; insufficient practice nurse resource
Interventions	Mode: individual sessions at the outpatient clinic, GP and at the participant's home Duration: at least 17 individual face‐to‐face sessions (monthly visits to practice nurse to review their progress (N = 12), at least three monthly visits to GP (n = 4), at least one home visit by the respiratory nurse specialist and one following hospital admissions) Professional: respiratory physician, respiratory nurse specialist, GP Training of case managers: not reported Self‐management components: action plan COPD exacerbations, iterative process with feedback on actions, self‐recognition of COPD exacerbations, other: annual influenza vaccination and attendance at a PR programme were recommended Self‐management topics: smoking cessation, exercise, (maintenance) medication, correct device use Exercise programme: no Smoking cessation programme: no Behavioural change techniques: eight clusters: goals and planning, feedback and monitoring, shaping knowledge, natural consequences, comparison of behaviour, associations, regulation, antecedents Action plan components: self‐recognition of exacerbations, self‐treatment of exacerbations, contact healthcare providers for support
Outcomes	1. quality of life (SF‐36) 2. CRQ 3. distance walked (Shuttle Walk Test) 4. hospital admissions 5. spirometry (FEV₁ (L), FEV₁ % predicted) 6. medication use (courses of oral steroids and antibiotics)
Notes	Randomisation is done at the level of GP practice; 26 practices were randomised to intervention and 25 were randomised to usual care. Analysis is performed at the level of participants
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	“Fifty‐one eligible practices with 116 GPs were randomised, using a set of computer‐generated random numbers (…)” p. 609 Comment: Random sequence generation was adequately performed.
Allocation concealment (selection bias)	High risk	Comment: The study was cluster‐randomised. Therefore, there was no allocation concealment provided.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Comment: Blinding of participants and personnel was not reported.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	“For all patients, an initial assessment with the GP and practice nurse included clinical history and the Short Form (SF)‐36. Spirometry, the Shuttle Walk Test and the Chronic Respiratory Questionnaire (CRQ) were administered at the hospital outpatient clinic by a respiratory physician, respiratory nurses and experienced interviewers, respectively. At the completion of a 12‐month trial period, an identical reassessment was undertaken.” p. 609 Comment: Blinding of outcome assessment was not reported, measurements were predominantly performed by study personnel at the outpatient clinic.
Incomplete outcome data (attrition bias) All outcomes	Low risk	“During the trial period, six patients died, six patients withdrew from the study, four patients developed cancer and two patients moved from the area. The 12 month follow‐up assessment was completed by 117 patients (71 INT, 46 CON), although hospital admission data were available for all 135 patients.” p. 609 Comment: 12 participants dropped out in the intervention group (14%), six in the control group (12%). Reasons were comparable. Intention‐to‐treat analysis was performed on the primary outcome.
Selective reporting (reporting bias)	Unclear risk	Comment: No signs of selective reporting; however, no protocol available.
Other bias	Low risk	“GP practices were randomised rather than patients to try to avoid contamination of treatment groups within practices.” p. 609 “The characteristics of non‐participating and participating practices were similar, so a selection bias between INT and CON practices seems unlikely.” p. 613 Comment: We additionally assessed this study on bias specifically important in cluster‐randomised trials. In Rea’s study, the general practises were randomly assigned before the participants were included. For reasons unknown, the number of participants screened and included was lower in the control group than in the intervention group. The study authors state that baseline characteristics were not significantly different between groups. Therefore, the risk of recruitment bias is unclear, and risk of bias for baseline imbalance is low. The risk of bias due to loss of clusters is low because no clusters were lost after participant enrolment. Rea et al. did not correct for clustering in their analyses, so risk of bias due to incorrect analysis is high.

Rice 2010.

Methods	Design: RCT Follow‐up: 12 months Control group: usual care
Participants	Recruitment: hospital (Veterans Affairs medical centres) Assessed for eligibility: 1739 Randomly assigned: I: 372; C: 371 Completed: I: 336; C: 323 Mean age: I: 69.1 ± 9.4 years; C: 70.7 ± 9.7 years Gender (% male): I: 97.6%; C: 98.4% COPD diagnosis: clinical diagnosis of COPD with post‐bronchodilator spirometry showing an FEV₁ < 70% predicted and a FEV₁/FVC < 0.70 Inclusion of participants in the acute phase: not reported Major inclusion criteria: a diagnosis of COPD at high risk of hospitalisation as predicted by one or more of the following during the previous year: hospital admission or ED visit for COPD, chronic home oxygen use or course of systemic corticosteroids for COPD Major exclusion criteria: inability to have access to a home telephone line or sign a consent form, any condition that would preclude effective participation in the study or likely to reduce life expectancy to less than a year
Interventions	Mode: group sessions at an outpatient clinic, one‐page handout summary and number for help line, telephone calls Duration: one group session of 1‐1.5 hours by a respiratory therapist case manager, 12 monthly phone calls of 10‐15 minutes each Professional: respiratory therapist case manager Training of case managers: "case managers were respiratory therapists who had completed a one‐day training session.” Appendix 1, p. 2 Self‐management components: action plan COPD exacerbations, iterative process with feedback on actions, self‐recognition of COPD exacerbations; education regarding COPD, smoking cessation Self‐management topics: smoking cessation, exercise, (maintenance) medication, correct device use, coping with breathlessness/breathing techniques, other: oximetry, recommendation concerning influenza and pneumococcal vaccinations, instruction in hand hygiene Exercise programme: no Smoking cessation programme: yes (optional), smoking cessation counselling Behavioural change techniques: 10 clusters: goals and planning, feedback and monitoring, social support, shaping knowledge, natural consequences; comparison of behaviour, associations, repetition and substitution, regulation, antecedents Action plan components: self‐recognition of exacerbations, self‐treatment of exacerbations, contact healthcare providers for support
Outcomes	1. hospital admissions and ED visits for COPD 2. all‐cause hospitalisations and all‐cause ED visits 3. hospital and intensive care unit lengths of stay 4. respiratory medication use 5. change in respiratory quality of life (SGRQ) 6. all‐cause mortality
Notes	‐
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	“We assigned subjects in equal proportions to each of the two treatment arms by permuted‐block randomisation.” Appendix 1, p. 3 Comment: Information on the method of random sequence allocation was not reported.
Allocation concealment (selection bias)	Unclear risk	Comment: Information on the method of allocation concealment was not reported.
Blinding of participants and personnel (performance bias) All outcomes	High risk	“We performed a randomised, adjudicator‐blinded, controlled, 1‐year trial (…).” p. 890 Comment: Blinding of participants and personnel was not reported.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	“Blinded pulmonologists independently reviewed all discharge summaries and ED reports and assigned a primary cause for each.” p. 891 Comment: Outcome assessment was blinded.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	“All patients were followed for 12 months or until the time of death if it occurred before 12 months.” p. 981 “Fifty‐five percent of patients in the usual care group and 60% of patients in the disease management group returned a completed the Saint George’s Respiratory Questionnaire in response to a single mailing at the end of the study.” p. 982 Comment: Low response rates on SGRQ leading to a high risk of bias. However, data on healthcare utilisation seem complete with no risk of bias.
Selective reporting (reporting bias)	Low risk	Comment: All primary and secondary outcome measures were reported; no signs of selective reporting.
Other bias	Low risk	None noted.

Song 2014.

Methods	Design: RCT Follow‐up: 2 months Control group: usual care
Participants	Recruitment: hospital (inpatient) Assessed for eligibility: 62 Randomly assigned: I: 20; C: 20 Completed: I: 17, C: 17 Mean age: I: 66.6 ± 7.12 years; C: 68.1 ± 6.46 years Gender (% male): I: 55.0, C: 75.0 COPD diagnosis: a diagnosis of moderate COPD, based on the GOLD staging system Inclusion of participantsin the acute phase: yes, during hospitalisation Major inclusion criteria: diagnosis of moderate COPD, based on the GOLD staging system, confirmed discharge date at the discretion of the responsible medical doctors, age 65‐75 years, independent mobility Major exclusion criteria: history of other lung diseases, any concomitant diseases that could interfere with the general condition, neuromuscular impairment that would interfere with the patient’s mobility
Interventions	Mode: individual sessions at the hospital and at the outpatient clinic, telephone calls, written instruction Duration: three face‐to‐face individual sessions (two inpatient sessions for 90+45 minutes each on the day before discharge and on the day of discharge, one outpatient session for 90 minutes on the first follow‐up day which is usually planned one week after discharge) by two nurse interventionists, booster sessions were delivered through two phone calls with a two‐week interval Professional: nurse interventionists Training of case managers: "intervention sessions were delivered by two nurse interventionists selected on the basis of their previous experience in COPD care. They also received 6 hours of training sessions to ensure their consistency." p. 152 Self‐management components: action plan COPD exacerbations, iterative process with feedback on actions, self‐recognition of COPD exacerbations, education regarding COPD, exercise or physical activity component Self‐management topics: exercise, (maintenance) medication, coping with breathlessness/breathing techniques, other: identifying barriers to self‐care adherence Exercise programme: yes, each face‐to‐face session consisted of the education accompanied by practicing exercise. Participants learned 10 sets of upper and lower extremities stretching with pursed lip breathing. They also performed a 10‐minute‐per‐toleration walk on a course 30‐m corridor in the unit. The written instruction, plus illustrations, was given to the participants as a reminder for instructional support and practice at home. At the end of the outpatient session, participants were reminded and advised to continue and expand the exercises according to their own goals at home over a period of 2 months. Smoking cessation programme: no Behavioural change techniques: nine clusters: goals and planning, feedback and monitoring, social support, shaping knowledge, associations, repetition and substitution, regulation, identity, self‐belief Action plan components: self‐recognition of exacerbations, self‐treatment of exacerbations
Outcomes	1. exercise capacity (PEFR and 6MWD) 2. health‐related quality of life (SGRQ) 3. self‐care adherence (medication and exercise compliance)
Notes	Randomisation after matching for lung function, age and gender. Not all participants fulfilled the inclusion criterion 'a diagnosis of moderate COPD, based on the GOLD staging systems’, because the mean FEV1/FVC % predicted was > 0.70
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	“After being matched for lung function, age, and gender, participants were randomly allocated to either an experimental or a control group.” p. 149 Comment: There is no method described that was used to generate the allocation sequence.
Allocation concealment (selection bias)	Unclear risk	“After being matched for lung function, age, and gender, participants were randomly allocated to either an experimental or a control group.” p. 149 Comment: There is no method described that was used to conceal the allocation.
Blinding of participants and personnel (performance bias) All outcomes	High risk	“This single‐blinded, randomised control group, pre‐/posttest study (…)” p. 148 Comment: No blinding of participants and personnel.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Comment: Most of the outcome measures were self‐reported. There is insufficient information to permit judgement.
Incomplete outcome data (attrition bias) All outcomes	Low risk	“There were no significant differences in the aforementioned baseline characteristics between the final sample and those who withdrew.” p. 149 Comment: Whereas Table 3 states that data of 20 participants have been analysed, this cannot be the case, because t‐tests have been used and not all participants had complete data (15% non‐complete data in each group).
Selective reporting (reporting bias)	Unclear risk	Comment: No signs for selective outcome reporting, results were reported extensively; however, no protocol available.
Other bias	Low risk	None noted.

Tabak 2014.

Methods	Design: RCT Follow‐up: 9 months Control group: usual care
Participants	Recruitment: hospital, primary care physiotherapy practices Assessed for eligibility: not reported (101 participants eligible) Randomly assigned: I: 15; C: 14 Completed: I: 10; C: 2 Mean age: I: 64.1 ± 9.0 years; C: 62.8 ± 7.4 years Gender (% male): I: 50.0; C: 50.0 COPD diagnosis: GOLD II‐IV, a clinical diagnosis of COPD according to the GOLD criteria Inclusion of participants in the acute phase: no Major inclusion criteria: fulfil COPE‐II study (effects of self‐treatment and an exercise programme within a self‐management programme in outpatients with COPD) criteria: no exacerbation in the month prior to enrolment, three or more exacerbations or one hospitalisation for respiratory problems in the 2 years preceding study entry, a computer with Internet access at home Major exclusion criteria: serious other disease with a low survival rate, other diseases influencing bronchial symptoms and/or lung function, severe psychiatric illness, uncontrolled diabetes mellitus or a hospitalisation for diabetes mellitus in the 2 years preceding the study, need for regular oxygen therapy, maintenance therapy with antibiotics, known a1‐ antitrypsin deficiency, disorders or progressive disease seriously influencing walking ability
Interventions	Mode: individual and group sessions at the outpatient clinic, primary care physiotherapy practices and at the participant's home, web‐based teleconsultation module Duration: at least one face‐to‐face individual session by the primary care physiotherapist (no protocol for education, offered as blended care, depending on physiotherapist and patient) and a teleconsultation module. For research purposes there was one intake by a physiotherapist for baseline measure activity coach and explanations. Furthermore, there were additional meetings after one, three, six and nine months. Before the start of the programme, participants had to attend two group sessions of 90 minutes each by a nurse practitioner Professional: respiratory nurse practitioner, respiratory physiotherapist Training of case managers: not reported Self‐management components: action plan COPD exacerbations, iterative process with feedback on actions, self‐recognition of COPD exacerbations, education regarding COPD, exercise or physical activity component Self‐management topics: smoking cessation, exercise, diet, (maintenance) medication, coping with breathlessness/breathing techniques Exercise programme: yes, a web‐based exercise program on the web portal. For every individual patient, exercise schemes were created by the patient’s physiotherapist via the web portal. A scheme represents which exercises should be performed by the patient for which day, and which part of the day. Every exercise consists of a text description and movie. The patient is able to log in at home, follow the exercise scheme, execute the exercises, and provide feedback to the physiotherapist. There was no standardized exercise protocol: the physiotherapist could freely select the exercises for each patient for the online exercise program. This exercise program could be adapted during the intervention period following the progress of the patient at the discretion of the therapist. Both primary and secondary care professionals could supervise the patient at a distance by checking progress on the web portal. Smoking cessation programme: no Behavioural change techniques: 11 clusters: goals and planning, feedback and monitoring, social support, shaping knowledge, natural consequences, comparison of behaviour, associations, repetition and substitution, regulation, antecedents, self‐belief Action plan components: self‐recognition of exacerbations, self‐treatment of exacerbations, contact healthcare providers for support
Outcomes	1. use of application 2. adherence (online diary, exercise scheme) 3. satisfaction (Client Satisfaction Questionnaire) 4. hospitalisations (number and length of stay) 5. emergency department visits 6. exacerbations 7. level of activity (activity coach, accelerometer) 8. self‐perceived activity levels (Baecke Phsycial Activity Questionnaire) 9. exercise tolerance (6MWT) 10. fatigue (Multidimensional Fatigue Inventory 20) 11. health status (CCQ) 12. dyspnoea (MRC) 13. quality of life (EuroQol‐5D)
Notes	‐
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	“Patients were randomised using a computer‐generated randomisation list (Blocked Stratified Randomisation version 5; Steven Piantadosi), where randomisation was applied in blocks of two and four.” p. 936 Comment: Random sequence generation was adequately performed.
Allocation concealment (selection bias)	Low risk	“Participants were allocated by a data manager in order of inclusion following the randomisation list, placed in a sealed envelope.” p. 936 Comment: The allocation was adequately concealed.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Comment: Participants and personnel were not blinded.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	“The decision‐support diary automatically identified exacerbations following previously described criteria for the intervention group, while the control group filled in a paper version of the diary” p. 938 Comment: Unclear whether outcome assessors were blinded. Questionnaires used are validated questionnaires.
Incomplete outcome data (attrition bias) All outcomes	High risk	“A large number of patients were not able or willing to continue study participation: 33% in the intervention group and 86% in the control group.” p. 939 Comment: Most outcome measures are reported for 3 months follow‐up, whereas there was a total of 9 months follow‐up. There was a high number of withdrawals for the 9 months follow‐up (more dropouts in the control group).
Selective reporting (reporting bias)	High risk	Comment: Not all outcome measures were reported for the 9 month follow‐up. Exacerbations (duration) was not reported. Also, no information or results provided for the use of diaries in the control group.
Other bias	Unclear risk	Comment: Per protocol analysis, baseline characteristics only assessed for the participants who completed the study. No differences reported for baseline characteristics among the withdrawals after randomisation (N = 6) and the participants who completed the questionnaires at T0 (inclusion).

Titova 2015.

Methods	Design: RCT Follow‐up: 24 months Control group: usual care
Participants	Recruitment: hospital (inpatient) Assessed for eligibility: 199 Randomly assigned: I: 91; C: 81 Completed: I: 51; C: 49 Mean age: I: 74.1 ± 9.26 years; C: 72.6 ± 9.33 years Gender (% male): I: 42.9; C: 43.2 COPD diagnosis: GOLD stage III or IV Inclusion of participants in the acute phase: yes, during hospitalisation Major inclusion criteria: admission due to AECOPD, COPD (GOLD stage III or IV, 2007), living in the Trondheim municipality, ability to communicate in Norwegian, ability to sign the informed consent form Major exclusion criteria: any serious diseases that might cause a very short lifespan (expected survival time less than six months)
Interventions	Mode: individual sessions at the participant's home, telephone calls, e‐learning programme, "My COPD book" Duration: six face‐to‐face individual sessions (one at discharge, five joint visits at home at approximately three days, 14 days, six months, 12 months, and 24 months post‐discharge) by the specialist nurse, one interactive 15‐minute e‐learning programme, at least 24 telephone calls (routinely phone calls at least once a month and during COPD exacerbations) Professional: specialist nurse Training of case managers: "an education session for home‐care nurses: a three‐hour theoretical session covering several aspects of COPD and two days of practice at the DTM (Department of Thoracic Medicine)" p. 3 Self‐management components: action plan COPD exacerbations, iterative process with feedback on actions, self‐recognition of COPD exacerbations, education regarding COPD Self‐management topics: smoking cessation, exercise, diet, (maintenance) medication, correct device use, coping with breathlessness/breathing techniques Exercise programme: no Smoking cessation programme: no Behavioural change techniques: eight clusters: goals and planning, feedback and monitoring, social support, shaping knowledge, associations, repetition and substitution, regulation, antecedents Action plan components: self‐recognition of exacerbations, self‐treatment of exacerbations, avoid situations in which viral infection might be prevalent, contact healthcare providers for support
Outcomes	1. hospital utilisation (admissions caused by AECOPD, in‐hospital days due to AECOPD) 2. mortality 3. inhaled medication use (LAMA, LABA)
Notes	‐
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	“They were randomly allocated to either integrated care (IC) or usual care (UC) based on their address of permanent residence. In order to create two pairs of districts with approximately equal numbers of citizens, a pair‐wise matching of districts was carried out. It was decided by lottery that participants from District Pair 1 were assigned to the UC group, and participants from District Pair 2 were assigned to the IC group.” p. 2 Comment: It was unclear whether random sequence allocation was performed on patient or health centre level.
Allocation concealment (selection bias)	Unclear risk	Comment: No information provided about the allocation concealment
Blinding of participants and personnel (performance bias) All outcomes	High risk	“The study was a prospective, open, single‐centre intervention study.” p. 2 Comment: No blinding of participants and personnel.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	“Data concerning HA (hospital admissions) and HD (hospital days) were collected from the hospital registry database’s medical charts.” p. 3 Comment: Unclear who was the outcome assessor.
Incomplete outcome data (attrition bias) All outcomes	High risk	“Data from patients who completed a minimum of two years of follow‐up were included in the analysis.” p. 3 Comment: A lot of missing data; after two years of follow‐up 58% of the included participants were available for evaluation.
Selective reporting (reporting bias)	High risk	“Information concerning the number and duration of the COPD exacerbations, as well as the time from onset of symptoms until the start of self‐initiated treatment is insufficient due to many incomplete registrations in “My COPD book” p. 9 Comment: No mortality reported; however, Figure 1 shows higher mortality for the IC group, N = 35 (38.4%), compared to the UC group, N = 21 (25.9%)
Other bias	Low risk	None noted.

Österlund Efraimsson 2008.

Methods	Design: RCT Follow‐up: 3 to 5 months Control group: usual care
Participants	Recruitment: nurse‐led primary healthcare clinic Assessed for eligibility: 110 Randomly assigned: I: 26, C: 26 Completed: I: 26, C: 26 Mean age: I: 66 ± 9.4 years; C: 67 ± 10.4 years Gender (% male): I: 50.0, C: 50.0 COPD diagnosis: mild, moderate, severe or very severe COPD based on spirometry, lung capacity after bronchodilator use, based on GOLD criteria Inclusion of participants in the acute phase: not reported Major inclusion criteria: diagnosed with mild, moderate, severe or very severe COPD based on spirometry, lung capacity after bronchodilator use, based on GOLD criteria Major exclusion criteria: diagnosed severe mental disorders such as schizophrenia, dementia or alcohol or drug abuse
Interventions	Mode: individual sessions at the outpatient and nurse‐led primary healthcare clinic Duration: two face‐to‐face individual sessions for self‐care education during 3‐5 months for one hour each by the nurse Professional: COPD nurse, physician, if needed: dietician, medical social worker, physical therapist, occupational therapist Training of case managers: not reported Self‐management components: action plan COPD exacerbations, iterative process with feedback on actions, self‐recognition of COPD exacerbations, education regarding COPD, smoking cessation, exercise or physical activity component Self‐management topics: smoking cessation, exercise, diet, (maintenance) medication, correct device use, coping with breathlessness/breathing techniques, other: instructions on the coughing technique to prevent infections and exacerbations, measurement on oxygen saturation before and after exertion, psycho‐social counselling and support, counselling on infection prevention Exercise programme: yes (optional), dialogue on physical activity and exercise. When needed, a dietician, a medical social worker, a physical therapist and an occupational therapist were consulted. Smoking cessation programme: yes (optional), motivational dialogue on smoking cessation based on Prochaska and DiClementes’ transtheoretical model of the stages of change. The model is based on open questions to help patients reflect on their smoking habits and empower patients to quit smoking. Behavioural change techniques: ten clusters: goals and planning, feedback and monitoring, social support, shaping knowledge, natural consequences, comparison of behaviour, associations, repetition and substitution, comparison of outcomes, reward and threat, regulation, antecedents, identity, scheduled consequences, self‐belief, covert learning. Action plan components: self‐recognition of exacerbations, self‐treatment of exacerbations, contact healthcare providers for support
Outcomes	1. health‐related quality of life (SGRQ) 2. smoking 3. COPD knowledge
Notes	‐
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"The randomisation was performed when two patients with the same variables agreed to participate in the study by assigning each individual an identity number. An independent person drew lots for allocation to either intervention or control group." p. 2‐3 Comment: The random sequence generation was performed adequately.
Allocation concealment (selection bias)	Low risk	"The randomisation was performed when two patients with the same variables agreed to participate in the study by assigning each individual an identity number. An independent person drew lots for allocation to either intervention or control group." p. 2‐3 Comment: Allocation was adequately concealed.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Comment: Blinding of participants and personnel was not reported.
Blinding of outcome assessment (detection bias) All outcomes	High risk	“Each visit lasted for about 1 hour and the same nurse (Eva Österlund Efraimsson) was responsible for all consultations. At the first and last visits, all patients responded to the two questionnaires, which were completed by each participant in an undisturbed area. The nurse in charge was available to answer questions and to check that the patients responded to all the items.” p. 180 Comment: Outcome assessment was not blinded, and measurements were performed/supervised by the same person who provided the intervention (who was also the principal investigator)
Incomplete outcome data (attrition bias) All outcomes	Low risk	“The drop‐out rate was 10 patients (five women and five men) (…) The severity of the illness was evenly distributed between men and women: three women and three men had moderate COPD, one woman and one man had severe COPD and one woman and one man had very severe COPD. The drop‐out group did not differ from the sample in any of these aspects.” p. 180 Comment: The dropout group did not differ from the sample. However, it was unclear when the participants did dropout and in which group
Selective reporting (reporting bias)	Unclear risk	Comment: All subscales of the two questionnaires used were reported; no signs of selective reporting were noted. However, no protocol available.
Other bias	Low risk	None noted.

6MWD: 6 Minute Walking Distance; 6MWT: 6 Minute Walking Test; CCQ: Clinical COPD Questionnaire; COPD: Chronic Obstructive Pulmonary Disease; CRQ: Chronic Respiratory Questionnaire; CSES: COPD Self‐Efficacy Scale; ED: emergency department; ESWT: endurance shuttle walk test; EQ‐5D: EuroQol‐5 Dimensions; FEV₁: forced expiratory volume in one second; FVC: forced vital capacity; GOLD: Global Initiative for Chronic Obstructive Lung Disease; GP: general practitioner; HADS: Hospital Anxiety and Depression Scale; ICD‐9‐CM: International Statistical Classification of Diseases and Related Health Problems, Ninth Revision, Clinical Modification; ISWT: incremental shuttle walk test; LABA: long‐acting beta agonists; LAMA: long‐acting muscarinic antagonists; (m)MRC: modified Medical Research Council dyspnoea score; PEFR: peak expiratory flow rate; RCT: Randomised Controlled Trial; SF‐36: 36‐item Short Form quality of life; SGRQ: St. George's Respiratory Questionnaire; QALY: Quality‐Adjusted Life Year.

Characteristics of excluded studies [ordered by study ID]

Study	Reason for exclusion
Aiken 2006	No verification COPD
Akinci 2011	No RCT
Ashmore 2013	No usual care control group
Behnke 1999	No self‐management
Behnke 2000	No self‐management
Behnke 2003	No self‐management
Bentley 2014	No self‐management
Berkhof 2014	No written action plan AECOPD
Berkhof 2015	No self‐management
Bernocchi 2016	No written action plan AECOPD
Billington 2014	No usual care control group
Bischoff 2011	No RCT
Blumenthal 2009	No usual care control group
Bosma 2011	No self‐management
Bottle 2008	No RCT
Boxall 2005	No COPD
Cabedo García 2010	No self‐management
Cafarella 2002	No self‐management
Cai 2006	No written action plan AECOPD
Cameron‐Tucker 2011	No peer‐reviewed full‐text available
Carone 2002	No written action plan AECOPD
Carrieri‐Kohlman 1996	No usual care control group
Carrieri‐Kohlman 2001	No usual care control group
Carré 2008	No stratification for COPD
Casey 2013	No self‐management
Charlson 2014	No COPD
Chavannes 2009	No RCT
Chen 2005	No written action plan AECOPD
Cheng 2001	No written action plan AECOPD
Chuang 2011	No RCT
Cordova 2007	No peer‐reviewed full‐text available
Coultas 2005	No written action plan AECOPD
Coultas 2014	No peer‐reviewed full‐text available
Coultas 2016	No written action plan AECOPD
De San Miguel 2013	No usual care control group
de Sousa Pinto 2014	No usual care control group
Deenen 1996	No peer‐reviewed full‐text available
Demeyer 2017	No written action plan AECOPD
Deneckere 2012	No self‐management
Deneckere 2013	No self‐management
Deng 2013	No written action plan AECOPD
Dheda 2004	No self‐management
Dias 2013	No usual care control group
Dinesen 2013	No RCT
Doheny 2013	No peer‐reviewed full‐text available
Donesky 2014	No usual care control group
Donesky‐Cuenco 2009	No self‐management
du Moulin 2009	No self‐management
Dwinger 2013	No stratification COPD
Effing 2009a	No usual care control group
Elliott 2004	No usual care control group
Emery 1998	No written action plan AECOPD
Eng 2013	No peer‐reviewed full‐text
Farmer 2014	No usual care control group
Farrero 2001	No self‐management
Farris 2014	No stratification for COPD
Faulkner 2010	No self‐management
Fernández 2009	No written action plan AECOPD
Field 2009	No COPD
Finkelstein 2004	No self‐management
Finkelstein 2006	No stratification for COPD
Fish 2012	No RCT
Fitzsimmons 2011	No self‐management
Folz 2016	No written action plan AECOPD
Fortin 2013	No stratification for COPD
Gellis 2012	No stratification for COPD
Ghanem 2010	No written action plan AECOPD
Giangreco 2006	No self‐management
Gilmore 2010	No iterative process
Godycki‐Cwirko 2014	No verification COPD
Grabenhorst 2013	No peer‐reviewed full‐text available
Greulich 2012	No self‐management
Griffiths 1996	No self‐management
Gu 2011	No self‐management
Gómez 2006	No self‐management
Hamir 2010	No peer‐reviewed full‐text
Harris 2006	No RCT
Hermiz 2002	No COPD
Hernandez 2003	No self‐management
Hernández 2000	No self‐management
Hesselink 2004	No stratification for COPD
Hill 2010	No written action plan AECOPD
Horn 2007	No verification COPD
Houben 2014	No written action plan AECOPD
Huniche 2010	No self‐management
Hynninen 2010	No self‐management
James 2012	No peer‐reviewed full‐text available
Jarab 2012	No iterative process
Jerant 2008	No stratification for COPD
Jokar 2012	No written action plan AECOPD
Jonkers 2012	No verification COPD
Jonsdottir 2013	No peer‐reviewed full‐text available
Kara 2004	No written action plan AECOPD
Kara 2007	No self‐management
Kennedy 2013	No stratification for COPD
Kim 2012	No usual care control group
Kiser 2012	No iterative process
Knottnerus 2015	No RCT
Ko 2015	No written action plan AECOPD
Kocks 2013	No self‐management
Kruis 2014	No written action plan AECOPD
Kunik 2001	No usual care control group
Kuo 2009	No usual care control group
Lainscak 2013	No self‐management
Lamers 2006	No verification COPD
Lamers 2010	No verification COPD
Lange 2005	No self‐management
Lathlean 2008	No peer‐reviewed full‐text available
Lavesen 2016	No written action plan AECOPD
Lee 2007	No peer‐reviewed full‐text available
Lee 2014	No written action plan AECOPD
Li 2014	No written action plan AECOPD
Liu 2008	No usual care control group
Lorig 2003	No written action plan AECOPD
Mackay 1995	No self‐management
Maltais 2005	No self‐management
Mangovski‐Alzmora 2008	No peer‐reviewed full‐text available
Marchioro 2011	No peer‐reviewed full‐text available
Martinez 2008	No self‐management
Mateo 1997	No self‐management
McGeoch 2006	No iterative process
Mendes de Oliveira 2010	No usual care control group
Mendoza 2015	No self‐management
Meulepas 2007	No RCT
Morganroth 2014	No peer‐reviewed full‐text available
Moullec 2008	No RCT
Mularski 2009	No usual care control group
Mulder 1998	No self‐management
Na 2005	No RCT
NCT00251420	No self‐management
Newman 1995	No peer‐reviewed full‐text available
Nguyen 2003	No usual care control group
Nguyen 2008	No usual care control group
Nguyen 2013	No usual care control group
Oh 2003	No usual care control group
Pangilinan 1996	No peer‐reviewed full‐text available
Parker 2013	No self‐management
Paré 2013	No iterative process
Pascual 2011	No COPD
Petty 2006	No written action plan AECOPD
Pinnock 2013	No usual care control group
Pison 2004	No self‐management
Pommer 2012	No written action plan AECOPD
Postolache 2008	No self‐management
Puente Maestu 1996	No self‐management
Resqueti 2007	No usual care control group
Ringbaek 2010	No self‐management
Roberts 2010	No self‐management
Roberts 2011	No peer‐reviewed full‐text available
Roberts 2011a	No peer‐reviewed full‐text available
Rojas‐Gomez 2014	No peer‐reviewed full‐text available
Rootmensen 2005	No iterative process
Rosiello 2010	No peer‐reviewed full‐text available
Russo 2015	No usual care control group
Schacher 2006	No peer‐reviewed full‐text available
Schlosser 1995	No RCT
Semenyuk 2007	No peer‐reviewed full‐text available
Shao 2003	No peer‐reviewed full‐text available
Shin 2007	No peer‐reviewed full‐text available
Siddique 2012	No written action plan AECOPD
Sidhu 2015	No written action plan AECOPD
Slok 2014	No written action plan AECOPD
Smeele 1999	No COPD
Smidth 2013	No verification COPD
Soler 2006	No written action plan AECOPD
Sridhar 2008	No self‐management
Steiner 2003	No self‐management
Stulbarg 2002	No usual care control group
Sørensen 2015	No written action plan AECOPD
Taylor 2012	No written action plan AECOPD
Tommelein 2014	No verification COPD
Tong 2012	No peer‐reviewed full‐text available
Trappenburg 2009	No usual care control group
Trappenburg 2011	No usual care control group
Tregonning 2000	No peer‐reviewed full‐text available
Tsai 2016	No written action plan AECOPD
Udsen 2014	No written action plan AECOPD
van den Bemt 2009	No self‐management
van Wetering 2010	No written action plan AECOPD
Vanhaecht 2010	No self‐management
Verwey 2014	No written action plan AECOPD
Vianello 2016	No written action plan AECOPD
Voncken‐Brewster 2013	No stratification for COPD
Wakabayashi 2011	No usual care control group
Walters 2013	No written action plan AECOPD
Wang 2014	No written action plan AECOPD
Wang 2017	No usual care control group
Wardini 2012	No self‐management
Warlies 2006	No COPD
Watson 1997	No iterative process
Weekes 2009	No self‐management
Wei 2014	No written action plan AECOPD
Weinberger 2002	No self‐management
Weischen 2005	No COPD
Wilson 2015	No written action plan AECOPD
Wittmann 2001	No self‐management
Wong 2005	No self‐management
Wong 2014	No self‐management
Wood‐Baker 2006	No iterative process
Wood‐Baker 2012	No RCT
Wootton 2014	No self‐management
Worth 2002	No RCT
Worth 2003	No RCT
Xie 2003	No written action plan AECOPD
Yamanaka 2009	No self‐management
Young 2003	No COPD
Yu 2014	No written action plan AECOPD
Zanaboni 2016	No written action plan AECOPD
Zhang 2013	No written action plan AECOPD
Zhou 2010	No stratification for COPD
Zwar 2012	No COPD

Characteristics of studies awaiting assessment [ordered by study ID]

Benzo 2016.

Methods	Design: RCT Follow‐up: 12 months Control group: usual care
Participants	Recruitment: hospital (inpatient) Randomly assigned: I: 108; C: 107 Mean age: I: 67.9 ± 9.8 years; C: 68.1 ± 9.2 years Gender (% male): I: 43; C: 48 COPD diagnosis: participants admitted for a COPD exacerbation Inclusion of participants in the acute phase: yes, during hospitalisation Major inclusion criteria: admitted for a COPD exacerbation, age older than 40 years, current or past cigarette smoking history of more than 10 pack‐years, ability to speak English, and access to a telephone Major exclusion criteria: any medical conditions that would impair their ability to participate in the study or to provide informed consent or if they were receiving hospice care
Interventions	Mode: individual sessions at the hospital and after discharge, telephone follow‐up calls Duration: one visit at the hospital of 2 hours, and at least one in person after discharge, with subsequent sessions conducted by telephone. Professional: the Mayo Clinic: registered nurse, Health Partners Regions Hospital: respiratory therapist Training of case managers: both interventionists (registered nurse and respiratory therapist) received the same training, which included 1) face‐to‐face training on theory and strategies associated with self‐management education and motivational interviewing; 2) reading materials that detailed skills and strategies associated with self‐management education and motivational interviewing; 3) role play‐based experiential learning of intervention strategies with patient vignettes; and 4) recorded intervention sessions were reviewed and interventionists were provided tailored training. Self‐management components: action plan COPD exacerbations, iterative process with feedback on actions, self‐recognition of COPD exacerbations, education regarding COPD, exercise or physical activity component Self‐management topics: smoking cessation, exercise, diet, (maintenance) medication, correct device use, coping with breathlessness/breathing techniques, other: introduction of the concept of self‐management by providing copy of the book 'Living a Health Life with Chronic Conditions' Exercise programme: yes Smoking cessation programme: no Action plan components: self‐recognition of exacerbations, self‐treatment of exacerbations, use of maintenance treatment, contact healthcare providers for support
Outcomes	1. rate of COPD‐related rehospitalisations 2. disease‐specific quality of life (CRQ) 3. measured physical activity at 6 and 12 months (average number of steps and minutes per day spent in daily physical activities of at least moderate intensity)
Notes	Awaiting assessment: further information is needed before inclusion when the review is next updated.

Chien 2016.

Methods	Design: RCT Follow‐up: 2 months Control group: usual care
Participants	Recruitment: not reported Assessed for eligibility: not reported Randomly assigned: I: 20; C: 20 Completed: not reported Mean age: I: 71.6 ± 7.1 years; C: 67.4 ± 9.3 years Gender (% male): I: 93.8; C: 87.5 COPD diagnosis: FEV₁/FVC < 70 % Inclusion of participants in the acute phase: not reported Major inclusion criteria: not reported Major exclusion criteria: not reported
Interventions	Mode: one‐on‐one interviews, telephone follow‐up, or home visits Duration: 2 months multidisciplinary self‐management education program Professional: not reported (multidisciplinary) Training of case managers: not reported Self‐management components: education regarding COPD Self‐management topics: not reported Exercise programme: not reported Smoking cessation programme: not reported Action plan components: no information was reported whether an action plan for COPD exacerbations was used
Outcomes	1. self‐efficacy 2. exercise tolerance (6‐minute walking test) 3. quality of life (Taiwan Mandarin Chinese version of the SGRQ)
Notes	Awaiting assessment: further information is needed before inclusion when the review is next updated.

Davis 2016.

Methods	Design: cluster‐RCT Follow‐up: 6 months Control group: usual care
Participants	Recruitment: pharmacies Assessed for eligibility: not reported Randomly assigned: not reported Completed: not reported Mean age: not reported Gender (% male): not reported COPD diagnosis: physician‐diagnosed COPD, the use of inhaled medication or a known diagnosis of COPD Inclusion of participants in the acute phase: no Major inclusion criteria: physician‐diagnosed COPD, age 40 years or older, the ability to answer questionnaires in English Major exclusion criteria: severe disease, defined as a known FEV₁/FVC < 30 %, a diagnosis of dementia or a prescription for cholinesterase inhibitors, a terminal illness, physician‐diagnosed asthma, participation in another clinical trial, no consent provided
Interventions	Mode: not reported Duration: not reported Professional: pharmacist, family physician Training of case managers: staff pharmacists working at all participating pharmacies from both arms of the study will be offered training on the design of the study, including how to administer questionnaires, proper patient recruitment, and consenting of participants Self‐management components: action plan COPD exacerbations, iterative process with feedback on actions, self‐recognition of COPD exacerbations, education regarding COPD, smoking cessation, other: medication review, pulmonary rehabilitation Self‐management topics: smoking cessation, (maintenance) medication, correct device use, coping with breathlessness/breathing techniques Exercise programme: no Smoking cessation programme: provision of, or referral to, smoking cessation counselling (where applicable) Action plan components: self‐recognition of exacerbations, self‐treatment of exacerbations, use of maintenance treatment. The form is divided into two sections, each section having three subcategories. These include: (1) “My Symptoms” (I feel well, I feel worse, I feel much worse) and (2) “My Actions” (stay well, take action, call for help). This action plan is easy to read and simple to follow. A copy of this will be provided to the patient and to the patient’s physician (faxed). When needed, a prescription suggestion for antibiotics and oral steroids will be provided to the physician for signature and fax back to the pharmacy, to facilitate the action plan
Outcomes	1. medication adherence, difference in the change in the Medication Possession Ratio from baseline to 6 months between the intervention and control groups 2. quality of life (SGRQ) 3. medication inhalation technique (pharmacist‐scored scale) 4. healthcare resource utilisation (frequency of physician visits, hospitalisations, ED visits, and pharmacy visits) 5. antibiotic and orally administered corticosteroid use for acute exacerbations of COPD as reported by the patient at 6 months
Notes	Awaiting assessment: further information is needed before inclusion when the review is next updated. There is patient referral to pulmonary rehabilitation in collaboration with their family physician.

Imanalieva 2016.

Methods	Design: RCT Follow‐up: 6 months Control group: usual care
Participants	Recruitment: Assessed for eligibility: not reported Randomly assigned: I: 25; C: 25 Completed: not reported Mean age: total group: 59.3 ± 1.2 years Gender (% male): not reported COPD diagnosis: not reported Inclusion of participants in the acute phase: not reported Major inclusion criteria: COPD combined with essential hypertension Major exclusion criteria: not reported
Interventions	Mode: mobile telephone counselling Duration: monthly mobile telephone counselling for 6 months Professional: not reported Training of case managers: not reported Self‐management components: education regarding COPD Self‐management topics: not reported Exercise programme: not reported Smoking cessation programme: not reported Action plan components: no information was reported whether an action plan for COPD exacerbations was used
Outcomes	1. Primary outcomes: self‐reported exacerbation and hospitalisation, 6‐minute walking distance test, CAT score, mMRC and SF‐36 quality of life
Notes	Awaiting assessment: further information is needed before inclusion when the review is next updated.

Koff 2009.

Methods	Design: RCT Follow‐up: 3 months Control group: usual care
Participants	Recruitment: hospital (outpatient) Assessed for eligibility: not reported Randomly assigned: I: 20, C: 20 Completed: I: 19, C: 19 Mean age: I: 66.6 ± 9.1 years; C: 65.0 ± 8.2 years Gender (% male): I: 45, C: 50 COPD diagnosis: GOLD stage 3 or 4 COPD Inclusion of participants in the acute phase: Not reported Major inclusion criteria: GOLD stage 3 or 4 COPD, and a telephone land line Major exclusion criteria: active treatment for lung cancer, illiteracy, non‐English speaking, and inability to complete a 6‐min walk test
Interventions	Mode: individual face‐to‐face session, telecommunication device, home‐based Duration: one face‐to‐face session, 60 health buddy sessions (telecommunication) for 20 minutes each weekday morning during 3 months Professional: registered respiratory therapist Training of case managers: not reported Self‐management components: self‐recognition of COPD exacerbations, education regarding COPD, exercise or physical activity component. Self‐management topics: smoking cessation, exercise, diet, (maintenance) medication, coping with breathlessness/breathing techniques, other: oxygen therapy Exercise programme: yes Smoking cessation programme: no Action plan components: no information was provided whether an action plan for COPD exacerbations was used
Outcomes	1. quality of life (SGRQ) 2. COPD hospitalisations 3. COPD ER visits 4. healthcare costs
Notes	We could not verify with the authors whether this study did meet our eligibility criteria.

Leiva‐Fernández 2014.

Methods	Design: RCT Follow‐up: 12 months Control group: usual care
Participants	Recruitment: health centre (primary care setting) Assessed for eligibility: 1553 Randomly assigned: I: 72; C: 74 Completed: I: 47; C: 57 Mean age: I: 69.6 (95% CI 67.7‐71.4) years; C: 68.6 (95% CI 66.4‐70.8) years Gender (% male): I: 91.7; C: 91.9 COPD diagnosis: confirmed COPD diagnosis registered in the patient's clinical record Inclusion of participants in the acute phase: no Major inclusion criteria: confirmed COPD diagnosis registered in the patient’s clinical record, clinical assistance at primary care centres in the Malaga area, prescription of scheduled inhalation therapy and written informed consent Major exclusion criteria: other respiratory conditions that are not included in the COPD definition (bronchiectasis, asthma or cystic fibrosis) or cognitive impairment problems registered in their clinical record (dementia, Alzheimer’s, Parkinson’s or cognitive decline)
Interventions	Mode: group session at the beginning of the study and individual sessions during the follow‐up visits Duration: one group session of 2 hours and three individual sessions Professional: two professionals with special training in motivational techniques and in the use of inhaler devices Training of case managers: two professionals with special training in motivational techniques and in the use of inhaler devices Self‐management components: education regarding COPD, other: treatment adherence, motivational and cognitive aspects Self‐management topics: (maintenance) medication, correct device use, coping with breathlessness/breathing techniques, other: social and family support Exercise programme: no Smoking cessation programme: no Action plan components: no information was provided whether an action plan for COPD exacerbations was used
Outcomes	1. adherence to a medication regimen 2. functional status (forces spirometry) 3. health‐related quality of life (SGRQ and EuroQoL‐5D)
Notes	We could not verify with the authors whether this study did meet our eligibility criteria.

Licskai 2016.

Methods	Design: RCT Follow‐up: 12 months Control group: usual care
Participants	Recruitment: four primary care practices Assessed for eligibility: not reported Randomly assigned: I: 77; C: 74 Completed: total group: 145 (80%) completed 12 months Mean age: I: total group: 67.7 ± 10.2 years Gender (% male): total group: 45.5 COPD diagnosis: not reported Inclusion of participants in the acute phase: not reported Major inclusion criteria: not reported Major exclusion criteria: not reported
Interventions	Mode: not reported Duration: case management and comprehensive education at baseline and 3 months, telephone contacts at 6 and 9 months Professional: respiratory educator, physician Training of case managers: certified respiratory educator and physician Self‐management components: education regarding COPD Self‐management topics: not reported Exercise programme: not reported Smoking cessation programme: not reported Action plan components: no information was reported whether an action plan for COPD exacerbations was used
Outcomes	1. quality of life (COPD Assessment Test) at 12 months 2. health service utilisation (urgent/emergent visit for COPD, outpatient visit, emergency room visit, hospitalisation)
Notes	Awaiting assessment: further information is needed before inclusion when the review is next updated.

Lou 2015.

Methods	Design: RCT Follow‐up: 48 months Control group: usual care
Participants	Recruitment: healthcare units/centres in rural areas Assessed for eligibility: 8,217 Randomly assigned: I: 4,197; C: 4,020 Completed: I: 3,418; C: 2,803 Mean age: I: 71.2 ± 7.4 years; C: 71.5 ± 7.8 years Gender (% male): I: 47.8; C: 47.9 COPD diagnosis: the subjects had to have a diagnosis of COPD according to the criteria proposed by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Inclusion of participants in the acute phase: no Major inclusion criteria: at baseline, the subjects had to have a diagnosis of COPD according to the criteria proposed by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Major exclusion criteria: presence of fever, active tuberculosis, changes in radiographic images or medication in the 4 weeks immediately preceding recruitment, primary diagnosis of asthma or obvious bronchiectasis, cystic fibrosis, interstitial lung disease, previous lung‐volume‐reduction surgery, lung transplantation, pneumonectomy, uncontrolled or serious conditions that could potentially affect spirometry tests, and refusal to fill out psychological questionnaires
Interventions	Mode: group and individual face‐to‐face sessions Duration: 104 group sessions of 40‐60 minutes lecture each every 2 weeks, 104 individual follow‐up sessions at least once every two weeks. Every 2 months, the professionals examined the subjects collectively at the health‐care units Professional: respiratory specialist, nurse psychologist, (respiratory) physiotherapist, peer led dietician, GPs, psychiatrists, rehabilitation specialists, other experts Training of case managers: GPs took 2 days of training for health management in the intervention Self‐management components: education regarding COPD, smoking cessation, exercise or physical activity component, other: psychological counselling, review and adjustment of outpatient COPD medication Self‐management topics: smoking cessation, exercise, diet, (maintenance) medication, correct device use, other: recommendations concerning influenza and pneumococcal vaccinations, instruction on hand hygiene Exercise programme: yes Smoking cessation programme: yes Action plan components: no information was provided whether an action plan for COPD exacerbations was used
Outcomes	1. health status (BODE index) 2. changes in COPD knowledge, awareness and risk factors (survey) 3. changes in anxiety and depression symptoms (HADS) 4. changes in hospital admissions and ED visits 5. changes in medication regimens
Notes	We could not verify with the authors whether this study did meet our eligibility criteria.

Sano 2016.

Methods	Design: RCT Follow‐up: 4 months Control group: usual care
Participants	Recruitment: not reported Assessed for eligibility: not reported Randomly assigned: total: 29 participants Completed: I: 14; C: 11 Mean age: total group: 70.3 ± 7.5 years Gender (% male): total group: 86.2 COPD diagnosis: moderate to very severe COPD Inclusion of participants in the acute phase: not reported Major inclusion criteria: not reported Major exclusion criteria: not reported
Interventions	Mode: 40 educational contents on iPad interactive app Duration: not reported Professional: not reported Training of case managers: not reported Self‐management components: action plan COPD exacerbations, education regarding COPD Self‐management topics: exercise, coping with breathlessness/breathing techniques Exercise programme: no (motion pictures of stretching training) Smoking cessation programme: no Action plan components: no information was reported whether an action plan for COPD exacerbations was used
Outcomes	1. quality of life (SGRQ) 2. exercise capacity (6‐minute walking distance) 3. patient’s need for information about their disease (LINQ)
Notes	Awaiting assessment: further information is needed before inclusion when the review is next updated.

Silver 2017.

Methods	Design: RCT Follow‐up: 6 months Control group: usual care
Participants	Recruitment: hospital (inpatient) Assessed for eligibility: 2,689 Randomly assigned: I: 214; C: 214 Completed: I: 211, C: 212 Mean age: I: 56 (50‐60.25) years; C: 56.5 (51‐61) years Gender (% male): I: 43.5, C: 49.5 COPD diagnosis: spirometry‐confirmed: an FEV₁/FVC 0.7 or an FEV₁ 80% predicted (pre‐bronchodilator) Inclusion of participants in the acute phase: yes Major inclusion criteria: > 18 and < 65 years of age, spirometry‐confirmed COPD, at high risk for hospitalisation or ED visits as predicted by a hospital admission or ED visit in the previous 12 months for a COPD exacerbation, chronic home use of oxygen, or treatment with a course of systemic corticosteroids in the preceding 12 months Major exclusion criteria: not being expected to survive the hospitalisation, the presence of metastatic cancer, bed‐bound individuals, non‐English speaking, and inability to provide informed consent
Interventions	Mode: in‐patient care coordinated by respiratory therapists, scheduled telephone calls Duration: 1‐h education in‐service Professional: respiratory therapist Training of case managers: respiratory therapist case managers conducting the education in‐services all took the COPD Educator Certification Preparation Course. Self‐management components: action plan COPD exacerbations, iterative process with feedback on actions, education regarding COPD, smoking cessation Self‐management topics: smoking cessation, exercise, diet, (maintenance) medication, correct device use, coping with breathlessness/breathing techniques, other: recommendations concerning influenza and pneumococcal vaccinations, instruction in hand hygiene Exercise programme: no Smoking cessation programme: yes Action plan components: self‐treatment of exacerbations, contact healthcare providers for support
Outcomes	1. combined non‐hospitalised emergency department visits and hospital readmissions for a COPD exacerbation during the 6‐month follow‐up 2. hospital readmissions 3. non‐hospitalised emergency department visits for causes other than COPD exacerbations 4. hospital and ICU lengths of stay for readmission 5. all‐cause mortality
Notes	Awaiting assessment: further information is needed before inclusion when the review is next updated.

Sánchez‐Nieto 2016.

Methods	Design: RCT Follow‐up: 12 months Control group: usual care
Participants	Recruitment: hospital (outpatient) Randomly assigned: I: 51; C: 45 Mean age: I: 68.2 ± 7.2 years; C: 67.1 ± 6.8 years Gender (% male): I: 88.9; C: 92.2 COPD diagnosis: post‐bronchodilator FEV₁/FVC ratio < 70% (GOLD 2007) Inclusion of participants in the acute phase: no Major inclusion criteria: clinical stability (at least in the 3 months prior to randomisation, with no change in medication or usual symptoms), active smoker or prior history of smoking of at least 10 pack‐years; post‐bronchodilator FEV₁/FVC ratio < 70%, normal cognitive status to read and understand written texts, and receive training in inhalation techniques or self‐care education sessions, physical status that allows for regular walking or exercise Major exclusion criteria: diagnoses of asthma, advanced heart failure, unstable ischaemic heart disease, terminal disease, dementia, or uncontrolled psychiatric disorders, no ability to read texts, participation in any pulmonary rehabilitation program in the previous year
Interventions	Mode: group education and individual training sessions Duration: group education session (6 to 8 participants) and individual training session at the start, two extra visits with a respiratory nurse at 1 and 3 months of follow‐up. Professional: nurses, physiotherapists, medical specialists in respiratory medicine Training of case managers: professionals previously trained in the intervention's features Self‐management components: action plan COPD exacerbations, iterative process with feedback on actions, self‐recognition of COPD exacerbations, education regarding COPD, exercise or physical activity component Self‐management topics: exercise, (maintenance) medication, correct device use, coping with breathlessness/breathing techniques Exercise programme: yes Smoking cessation programme: no Action plan components: self‐recognition of exacerbations, self‐treatment of exacerbations, use of maintenance treatment, other: sheets with instructions on physical exercises for stable periods
Outcomes	1. combined number of hospital admissions and accident and emergency visits for COPD 2. hospitalisations and ED visits for COPD exacerbations 3. lengths of hospital stay 4. use of antibiotics and corticosteroids 5. all‐cause mortality
Notes	Awaiting assessment: further information is needed before inclusion when the review is next updated.

Zwar 2016.

Methods	Design: cluster‐RCT Follow‐up: 12 months Control group: usual care
Participants	Recruitment: general practices in Sydney Randomly assigned: I: 144; C: 110 Mean age: not reported Gender (% male): not reported COPD diagnosis: COPD on post‐bronchodilator spirometry Inclusion of participants in the acute phase: no Major inclusion criteria: participants newly identified as having COPD on post‐bronchodilator spirometry Major exclusion criteria: not reported
Interventions	Mode: not reported Duration: not reported Professional: practice nurse, GP teams Training of case managers: Self‐management components: not reported Self‐management topics: not reported Exercise programme: not reported Smoking cessation programme: not reported Action plan components: no information was reported whether an action plan for COPD exacerbations was used
Outcomes	1. quality of life (SGRQ) 2. other quality of life measures 3. lung function 4. disease knowledge 5. smoking and immunization status 6. inhaler technique 7. health service use
Notes	Awaiting assessment: further information is needed before inclusion when the review is next updated.

Characteristics of ongoing studies [ordered by study ID]

Bourbeau 2016.

Trial name or title	An international randomised study of a home‐based self‐management program for severe COPD: the COMET
Methods	Design: RCT Follow‐up: 24 months Control group: usual care
Participants	Recruitment: hospital (outpatient) Randomly assigned: I: 172; C: 173 Mean age: not reported Gender (% male): not reported COPD diagnosis: COPD GOLD III or IV, post‐bronchodilator FEV₁ < 60% Inclusion of participants in the acute phase: no Major inclusion criteria: post‐bronchodilator FEV₁ < 60%, smoking history of ≥ 10 pack‐years, ≥ 1 moderate to severe exacerbation in the prior 12 months Major exclusion criteria: probability of survival < 6 months, be uninsured, or permanently living in a nursing home
Interventions	Mode: individual home sessions during the run‐in period, and group or telephone individual sessions during follow‐up Duration: 3‐ to 5‐week run‐in period with four individual home sessions, during follow‐up every 3 months seen by hospital physician, and monthly group or telephone individual sessions Professional: healthcare professionals (case‐managers) Training of case managers: case‐managers undergo a standardised initial 4‐day training with specific focus on motivational communication Self‐management components: action plan COPD exacerbations, iterative process with feedback on actions, self‐recognition of COPD exacerbations, education regarding COPD Self‐management topics: smoking cessation, exercise, diet, (maintenance) medication, coping with breathlessness/breathing techniques, other: all participants on oxygen therapy are monitored with a wearable device that records time of oxygen use and respiration rate. Exercise programme: no Smoking cessation programme: no Action plan components: self‐recognition of exacerbations, self‐treatment of exacerbations, use of maintenance treatment, contact healthcare providers for support, other: self‐measurements of pulse oximetry, spirometry, and body temperature
Outcomes	1. number of unscheduled all‐causes hospital days 2. hospital days due to COPD exacerbations 3. moderate‐to‐severe COPD exacerbations 4. all‐cause and COPD‐related healthcare use 5. anxiety and depression levels (HADS) 6. health status (SGRQ, 15D HRQoL questionnaire) 7. compliance to oxygen therapy 8. cost‐effectiveness
Starting date	2010
Contact information	Jean Bourbeau, Center for Innovative Medicine, McGill University Health Centre, e‐mail: jean.bourbeau@mcgill.ca
Notes

Lenferink 2013.

Trial name or title	A self‐management approach using self‐initiated action plans for symptoms with ongoing nurse support in patients with chronic obstructive pulmonary disease (COPD) and comorbidities: the COPE‐III study
Methods	Design: RCT Follow‐up: 12 months Control group: usual care
Participants	Recruitment: hospital (outpatient) Randomly assigned: I: 102; C: 99 Mean age: I: 68.8 ± 9.0 years; C: 68.2 ± 8.9 years Gender (% male): I: 64.7; C: 63.6 COPD diagnosis: a clinical diagnosis of COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2011 criteria (GOLD II‐IV) Inclusion of participants in the acute phase: no Major inclusion criteria: aged at least 40 years, a clinical diagnosis of COPD according to the GOLD criteria (FEV₁ < 80% of the predicted value and FEV₁/FVC < 0.70), clinically stable at the time of inclusion, at least one clinically relevant comorbidity (ischaemic heart disease, chronic heart failure, diabetes mellitus, anxiety, depression), and at least three COPD exacerbations or one hospitalisation for respiratory problems in the two years preceding study entry. Major exclusion criteria: terminal cancer, end stage of COPD or another serious disease with low survival rate, other serious lung disease, participants with cognitive impairment
Interventions	Mode: group and individual sessions at the hospital, telephone follow‐up calls Duration: two or three face‐to‐face group sessions of 1.5 hours each and two individual sessions of one hour each scheduled in four consecutive weeks, three telephone calls to reinforce self‐management skills Professional: respiratory, cardiac, mental health and diabetes nurses Training of case managers: sessions were guided by a trained case‐manager (experienced respiratory nurses) and supported by cardiac, mental health and/or diabetes nurses Self‐management components: action plan COPD exacerbations, iterative process with feedback on actions, self‐recognition of COPD exacerbations, education regarding COPD Self‐management topics: exercise, diet, (maintenance) medication, correct device use, coping with breathlessness/breathing techniques, Exercise programme: no Smoking cessation programme: no Action plan components: self‐recognition of exacerbations, self‐treatment of exacerbations, use of maintenance treatment, contact healthcare providers for support, self‐treatment of comorbidities
Outcomes	number of COPD exacerbation days per patient per year number of chronic heart failure exacerbation days severity of symptom scores for COPD and comorbidities dyspnoea modified Medical Research Council (mMRC) health‐related quality of life (CRQ) subjective fatigue (Identity‐Consequence Fatigue Score (ICFS)) anxiety and depression symptoms (HADS) patient's self‐management behaviour and knowledge (Partners in Health scale (PiH)) confidence and competence (COPD Self‐Efficacy Scale (CSES)) adherence with self‐treatment protocol satisfaction and confidence of patients and healthcare providers regarding self‐treatment cost and healthcare utilisation
Starting date	2012
Contact information	Anke Lenferink, Department of Pulmonary Medicine, Medisch Spectrum Twente, Enschede, the Netherlands. E‐mail: a.lenferink@mst.nl
Notes

Differences between protocol and review

We included only studies that were published in full‐text, and excluded abstracts if there was no additional information available from the authors.

For the included cluster‐RCT (Rea 2004) we planned to use the cluster as the unit of analysis. However, Rea 2004 provided insufficient data at the cluster level and did not correct for clustering in the analyses. We could only use the individual participant as the unit of analysis.

We planned to divide the COPD exacerbations into exacerbations based on COPD symptom scores (e.g., symptom diary), based on courses of oral corticosteroids or based on courses of antibiotics. There were insufficient data available to divide the COPD exacerbations and to perform a meta‐analysis with the data provided.

We have performed exploratory analysis on the respiratory‐related mortality rate as during the extracting process it became clear that these data were available and we felt that this would be an important additional outcome for evaluation of safety of self‐management interventions.

Contributions of authors

Anke Lenferink co‐ordinated the review, independently assessed the eligibility of titles, abstracts and full‐text versions of potentially relevant reports, independently extracted data from the included studies, independently assessed the integration of behavioural change techniques in the included studies, generated the 'Summary of findings' table and wrote the review. Tanja Effing independently assessed the eligibility of titles and abstracts, assessed the eligibility of half of the full‐text versions of potentially relevant reports, independently extracted data from half of the included studies, double‐checked data entry and helped to write the review. Marjolein Brusse‐Keizer assessed the eligibility of half of the full‐text versions of potentially relevant reports, independently extracted data from half of the included studies, and helped to write the review. All other review authors provided critical comments on the review.

Sources of support

Internal sources

• The authors declare that no such funding was received for this systematic review, Other.

External sources

• Anke Lenferink, Australia.

  Lung Foundation Australia / Cochrane Airways Australia Scholarship 2016

Declarations of interest

Anke Lenferink declares that she received the Lung Foundation Australia/Cochrane Airways Australia Scholarship 2016. The other review authors declare they received no funding for this systematic review. There were no other potential sources of conflicts of interest.

New