Abstract
Background
Asthma remains a significant cause of avoidable morbidity and mortality. Regular check‐ups with a healthcare professional are essential to monitor symptoms and adjust medication.
Health services worldwide are considering telephone and internet technologies as a way to manage the rising number of people with asthma and other long‐term health conditions. This may serve to improve health and reduce the burden on emergency and inpatient services. Remote check‐ups may represent an unobtrusive and efficient way of maintaining contact with patients, but it is uncertain whether conducting check‐ups in this way is effective or whether it may have unexpected negative consequences.
Objectives
To assess the safety and efficacy of conducting asthma check‐ups remotely versus usual face‐to‐face consultations.
Search methods
We identified trials from the Cochrane Airways Review Group Specialised Register (CAGR) up to 24 November 2015. We also searched www.clinicaltrials.gov, the World Health Organization (WHO) trials portal, reference lists of other reviews and contacted trial authors for additional information.
Selection criteria
We included parallel randomised controlled trials (RCTs) of adults or children with asthma that compared remote check‐ups conducted using any form of technology versus standard face‐to‐face consultations. We excluded studies that used automated telehealth interventions that did not include personalised contact with a health professional. We included studies reported as full‐text articles, as abstracts only and unpublished data.
Data collection and analysis
Two review authors screened the literature search results and independently extracted risk of bias and numerical data. We resolved any disagreements by consensus, and we contacted study authors for missing information.
We analysed dichotomous data as odds ratios (ORs) using study participants as the unit of analysis, and continuous data as mean differences using the random‐effects models. We rated all outcomes using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.
Main results
Six studies including a total of 2100 participants met the inclusion criteria: we pooled four studies including 792 people in the main efficacy analyses, and presented the results of a cluster implementation study (n = 1213) and an oral steroid tapering study (n = 95) separately. Baseline characteristics relating to asthma severity were variable, but studies generally recruited people with asthma taking regular medications and excluded those with COPD or severe asthma. One study compared the two types of check‐up for oral steroid tapering in severe refractory asthma and we assessed it as a separate question. The studies could not be blinded and dropout was high in four of the six studies, which may have biased the results.
We could not say whether more people who had a remote check‐up needed oral corticosteroids for an asthma exacerbation than those who were seen face‐to‐face because the confidence intervals (CIs) were very wide (OR 1.74, 95% CI 0.41 to 7.44; 278 participants; one study; low quality evidence). In the face‐to‐face check‐up groups, 21 participants out of 1000 had exacerbations that required oral steroids over three months, compared to 36 (95% CI nine to 139) out of 1000 for the remote check‐up group. Exacerbations that needed treatment in the Emergency Department (ED), hospital admission or an unscheduled healthcare visit all happened too infrequently to detect whether remote check‐ups are a safe alternative to face‐to‐face consultations. Serious adverse events were not reported separately from the exacerbation outcomes.
There was no difference in asthma control measured by the Asthma Control Questionnaire (ACQ) or in quality of life measured on the Asthma Quality of Life Questionnaire (AQLQ) between remote and face‐to‐face check‐ups. We could rule out significant harm of remote check‐ups for these outcomes but we were less confident because these outcomes are more prone to bias from lack of blinding.
The larger implementation study that compared two general practice populations demonstrated that offering telephone check‐ups and proactively phoning participants increased the number of people with asthma who received a review. However, we do not know whether the additional participants who had a telephone check‐up subsequently benefited in asthma outcomes.
Authors' conclusions
Current randomised evidence does not demonstrate any important differences between face‐to‐face and remote asthma check‐ups in terms of exacerbations, asthma control or quality of life. There is insufficient information to rule out differences in efficacy, or to say whether or not remote asthma check‐ups are a safe alternative to being seen face‐to‐face.
Plain language summary
Are telephone or internet check‐ups a safe alternative to being seen face‐to‐face?
Take‐home message Studies that tried to answer this research question did not show important differences between the two types of check‐up. However, there is not enough information to rule out differences in their harms or benefits. At this stage, we cannot say whether or not asthma check‐ups conducted over the phone or internet are a safe alternative to usual face‐to‐face consultations.
Background Regular contact with a doctor or asthma nurse is essential to keep track of symptoms and use of inhalers. Telephone and internet technologies may be a way to manage the rising number of people with asthma and other long‐term health conditions. This has been referred to as 'remote reviews' or e‐consultations, and may be a way of more easily keeping contact between patients and doctors, but we don't know whether it's as good as meeting face‐to‐face.
Study characteristics We found a total of six studies including 2100 participants: four studies including 792 people could be pooled for the main results, and two other studies were looked at separately because their designs were very different (n = 1213 and n = 95). People in the four pooled studies in general took regular medications and we excluded those with severe asthma or other lung diseases. We looked at two other studies with very different designs to the main four separately: one compared a practice where people with asthma were given the option of a telephone check‐up or a practice visit where they came to the clinic as usual, and one looked specifically at using technology to monitor people while cutting down their oral steroids dose. We last looked for studies on 24 November 2015.
Key results We cannot say whether or not people who had a check‐up over the phone or internet were more or less likely to need oral corticosteroids for an asthma attack than those seen face‐to‐face, and we were uncertain of the result for several reasons. Too few people had asthma attacks that needed treatment in the Emergency Department or hospital, or an unscheduled visit to see their doctor to tell if remote check‐ups were as good as face‐to‐face consultations. There didn't appear to be a difference in asthma control or quality of life, but we were able to rule out the possibility that remote check‐ups are not as good as face‐to‐face consultations on these measures. The evidence was all considered to be of low or moderate quality. The study that tested the possible benefit of giving people the option of a telephone check‐up showed that this increased the number of people reviewed, but did not show an overall benefit on asthma outcomes.
Summary of findings
Summary of findings for the main comparison. Summary of findings table.
Remote versus face‐to‐face check‐ups for asthma | ||||||
Patient or population: adults or children with asthma Setting: outpatient Intervention: remote check‐ups conducted using technology (e.g. telephone, email) Comparison: face‐to‐face asthma check‐ups | ||||||
Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | Number of participants (studies) | Quality of the evidence (GRADE) | Comments | |
Risk with face‐to‐face check‐ups | Risk with remote check‐ups | |||||
Exacerbations requiring oral corticosteroids 3 months | 21 per 1000 | 36 per 1000 (9 to 139) | OR 1.74 (0.41 to 7.44) | 278 (1 RCT) | ⊕⊕⊝⊝ low1,2 | Very imprecise. Data from the implementation study** were consistent. |
Exacerbations requiring hospital admission 6 months |
5 per 1000 | 3 per 1000 (0 to 33) | Peto OR 0.63 (0.06 to 6.32) | 651 (3 RCTs) | ⊕⊕⊝⊝ low1,3 | Very few events ‐ no conclusion could be drawn. The implementation study was more in favour of face‐to‐face check‐ups. |
Asthma control (ACQ) Scale 0 to 6; lower is better 12 months |
The mean ACQ score with face‐to‐face check‐ups improved by 0.11 | The mean ACQ score with remote check‐ups improved by 0.07 more (0.35 more to 0.21 less) |
― | 146 (1 RCT) | ⊕⊕⊕⊝ moderate 4,5 | No difference and CIs ruled out significant harm of remote check‐ups (MCID for the ACQ is 0.5). The implementation study results were consistent. |
Serious adverse events (including mortality) | ― | ― | ― | 0 RCTs | ― | No efficacy studies reported all‐cause SAEs. The implementation study recorded 12/554 and 8/659 in the remote and face‐to‐face groups respectively (OR 1.80, 95% CI 0.73 to 4.44) |
Asthma‐related quality of life (AQLQ) Scale 1 to 7; higher is better 8 months |
The mean AQLQ score with face‐to‐face check‐ups was 5.49 | The mean AQLQ score with remote check‐ups was 0.08 better (0.14 worse to 0.30 better) |
― | 544 (3 RCTs) | ⊕⊕⊕⊝ moderate 4,5 | No difference and CIs ruled out significant harm of remote check‐ups (MCID for the AQLQ is 0.5). The implementation study results were consistent. |
Unscheduled healthcare visits 5 months |
120 per 1000 | 110 per 1000 (58 to 201) | OR 0.91 (0.45 to 1.85) | 531 (2 RCTs) | ⊕⊕⊝⊝ low1,3 | Very few events ‐ we could not draw any conclusions. The implementation study was more precise and did not show a difference. |
Lung function (trough FEV1) 6 months |
The mean trough FEV1 with face‐to‐face check‐ups was 20 mL | The mean trough FEV1 with remote check‐ups was 166.76 mL better (78.03 more to 255.5 more) |
― | 253 (1 RCT) | ⊕⊕⊕⊝ moderate 1,6 | People having remote check‐ups had better lung function than those seen face‐to‐face in the one study that measured it. |
*The risk in the intervention group (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). The risk with face‐to‐face check‐ups for continuous outcomes was calculated as a weighted mean of the face‐to‐face values.
Abbreviations: CI = confidence interval; RR = risk ratio; OR = odds ratio; ED = emergency department; ACQ = Asthma Control Questionnaire; AQLQ = Asthma Quality of Life Questionnaire; FEV1 = forced expiratory volume in one second; RCT = randomised controlled trial. **The 'Implementation study', Pinnock 2007a, had a two‐cluster pragmatic design and was not pooled with the rest of the included studies (efficacy studies). Durations were calculated as a weighted mean duration of the studies contributing data to the analysis. | ||||||
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. |
1Studies were at high risk of bias for one or more blinding domains but it is unlikely that this had an effect on the objective outcomes (no downgrade). 2Evidence from 1 study with 7 events. There were very wide CIs (downgrade by 2 for imprecision). 3The effect was based on very few events. The 95% confidence intervals included significant harm and significant benefit of remote check‐ups (downgraded by 2 for imprecision). 4The upper limit of the CI crossed the line of no effect but both limits were well within the 0.5 unit minimal clinically important difference for the scale (no downgrade). 5Studies were at high risk of bias for blinding which may have affected this subjective outcome, and there was evidence of possible attrition bias (downgraded by 1 for risk of bias). 6The CIs excluded benefit of face‐to‐face check‐ups but they were wide and based on only one study of 253 people (downgraded by 1 for imprecision).
Background
Description of the condition
Asthma is a chronic disease of the airways, which causes reversible inflammation and narrowing of the airways and mucus production (GINA 2014). It commonly causes symptoms of wheezing, breathlessness, chest tightness and cough, although these vary between people and over time in their presence, frequency and severity (GINA 2014).
Despite the emergence and update of several national and international management guidelines which recommend a range of cost‐effective treatments based on frequency and severity of symptoms and exacerbations (e.g. BTS/SIGN 2014; GINA 2014), the disease remains a significant cause of avoidable morbidity and mortality worldwide (BTS/SIGN 2014; Global Asthma Report 2014; NRAD 2014). A national review of the 195 asthma deaths that occurred between February 2012 and January 2013 in the UK revealed that, in the year preceding their death, nearly one‐third had no record of seeing a general practitioner (GP) and nearly two‐thirds had not had an asthma check‐up in secondary care (NRAD 2014). The importance of self‐monitoring and regular check‐ups with a healthcare professional to monitor symptoms, and encourage adherence to preventer inhalers, is now well accepted (Gibson 2002; NRAD 2014), especially for people at high risk of severe asthma attacks.
Description of the intervention
Communication technologies, such as telephones and video conferencing, have been proposed as a way to conduct asthma check‐ups remotely. Conducting check‐ups in this way is a form of 'telehealth', otherwise referred to as 'telecare', 'digital health', 'telemedicine' or 'e‐health'. McLean 2013 described this field as "the use of information and communication technologies to deliver healthcare at a distance and to support patient self‐management through remote monitoring and personalised feedback". It may also be conceptualised as "an emerging field in the intersection of medical informatics, public health and business, referring to health services and information delivered or enhanced through the internet and related technologies (Eysenback 2001). Health services around the world are considering remote check‐ups as a way to manage the rising number of people with long‐term health conditions, to improve health outcomes and reduce the burden on emergency and inpatient services (Department of Health 2012; Steventon 2012).
The UK government outlined its aims for the widespread use of technology in health in their 2013 mandate, including wide availability of 'e‐consultations' by GPs, and significant progress towards home 'telemonitoring' of three million people with long‐term conditions by 2017 (Department of Health 2013). Researchers have studied the role of a range of technology‐based check‐ups and monitoring in asthma and other health conditions, including the use of telephone calls, email contact, text‐messaging and video‐conferencing (Laver 2013; McLean 2010; McLean 2011).
How the intervention might work
In the context of asthma, a condition that affects around 334 million people worldwide (Global Asthma Report 2014) and places a significant burden on healthcare systems, remote check‐ups may represent an unobtrusive and efficient way of maintaining contact with patients. Regular monitoring with communication technologies that does not disrupt a patient's life in the way that regular clinic visits might, may serve to enhance self management behaviours that have known benefits on morbidity and mortality, such as keeping personalised action plans up‐to‐date, and adherence to maintenance medications (NRAD 2014).
However, while governments and health services have highlighted the potential for cost savings and improved clinical outcomes of using remote check‐ups instead of face‐to‐face consultations, its use to monitor patients with potentially serious or life‐threatening conditions may not be without hazard. Focus groups have suggested that telehealth may be acceptable to patients and clinicians, but they have also raised concerns that it could actually discourage self management, or increase the likelihood of serious outcomes, by instilling a false sense of security (Pinnock 2007b).
The feasibility of using communication technologies in different situations and populations may be hampered by barriers, including insufficient healthcare infrastructure and funding (Lustig 2012). However, it may be a way to reduce inequality in health care related to socioeconomic status and rural living by improving access to services (Jannett 2003; Lustig 2012).
Why it is important to do this review
The release of the UK National Health Service (NHS) mandate in 2013 has seen a push to advance the use of telehealth for economic and clinical benefit. A recent overview of systematic reviews suggested that these benefits should not be assumed and that people at highest risk of serious health outcomes are likely to show the biggest gains (McLean 2013). For asthma, existing reviews have noted a large degree of variation in the way telehealth is defined and delivered in studies, to whom and to what it is compared (Jaana 2009; McLean 2010), and have been limited for this reason in the conclusions that could be drawn. This Cochrane review will focus on conducting asthma check‐ups remotely as a form of telehealth compared with usual face‐to‐face consultations in a hospital or clinic. A related Cochrane review will consider the evidence for remote monitoring of asthma control between visits with ongoing personalised feedback from a health professional (Kew 2015a).
Objectives
To assess the safety and efficacy of conducting asthma check‐ups remotely versus usual face‐to‐face consultations.
Methods
Criteria for considering studies for this review
Types of studies
We included parallel randomised controlled trials (RCTs) of any duration. We included studies reported as full‐text articles, those published as an abstract only and unpublished data.
Types of participants
We included studies of adults or children with a diagnosis of asthma. We excluded studies that recruited participants with other long‐term health conditions, unless they presented data for people with asthma separately.
Types of interventions
We included trials that compared remote check‐ups conducted with any form of technology (e.g. telephone calls, video‐conferencing) versus standard face‐to‐face check‐ups. We included trials which compared the two types of check‐up on top of education or another co‐intervention. We excluded trials that used automated telehealth interventions and did not include personalised contact with a health professional.
Types of outcome measures
Primary outcomes
Exacerbations that required oral corticosteroidsa.
Asthma control (measured on a validated scale, e.g. the Asthma Control Questionnaire (ACQ)).
Serious adverse events (including mortality).
aIf trials reported exacerbations in a different way (e.g. required hospital emergency department (ED) visit), we analysed these separately.
Secondary outcomes
Asthma‐related quality of life (measured on a validated scale, e.g. the Asthma Quality of Life Questionnaire (AQLQ)).
Unscheduled healthcare visits.
Lung function (trough forced expiratory volume in one second (FEV1) preferred).
Adverse events/side effects.
Reporting of one or more of the outcomes listed here in the trial was not an inclusion criterion for this Cochrane review.
Search methods for identification of studies
Electronic searches
We identified trials from the Cochrane Airways Review Group's Specialised Register (CAGR), which is maintained by the Information Specialist for the Cochrane Airways Review Group. The CAGR contains trial reports identified through systematic searches of bibliographic databases including the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, CINAHL, AMED, and PsycINFO, and handsearches of respiratory journals and meeting abstracts (please see Appendix 1 for further details). We used the search strategy in Appendix 2 to search for all records in the CAGR.
We also conducted a search of ClinicalTrials.gov (www.ClinicalTrials.gov) and the World Health Organization (WHO) International Clinical Trials Registry Portal (www.who.int/ictrp/en/) limited to interventional studies, using the condition term 'asthma', intervention terms 'remote OR telehealth OR telemedicine OR internet OR web', and title terms 'NOT education'. We searched all databases from their inception to 24 November 2015, and did not impose any restriction on language of publication.
Searching other resources
We checked reference lists of all primary studies and review articles for additional references.
We searched for errata or retractions from included studies published in full‐text on PubMed (www.ncbi.nlm.nih.gov/pubmed) on 20 July 2015.
Data collection and analysis
Selection of studies
Two review authors (KK and CJC) independently screened titles and abstracts for inclusion of all the potential studies identified from the literature searches and coded them as either 'retrieve' (eligible or potentially eligible/unclear) or 'do not retrieve'. We retrieved the full‐text study reports/publication and two review authors (KK and CJC) independently screened the full‐text and identified studies for inclusion, and identified and recorded reasons for exclusion of the ineligible studies. We resolved any disagreement through discussion. We identified and excluded duplicates and collated multiple reports of the same study so that each study, rather than each report, was the unit of interest in the review. We recorded the selection process in sufficient detail to complete a PRISMA flow diagram and 'Characteristics of excluded studies' table (Moher 2009).
Data extraction and management
We used a data collection form for study characteristics and outcome data, which we piloted on at least one study included in the review. One review author (KK) extracted the following study characteristics from included studies.
Methods: study design, total duration of study, details of any 'run in' period, number of study centres and location, study setting, withdrawals and date of study.
Participants: number of participants, mean age, age range, gender, severity of condition, diagnostic criteria, baseline lung function, smoking history, inclusion criteria and exclusion criteria.
Interventions: intervention, comparison, concomitant medications and excluded medications.
Outcomes: primary and secondary outcomes specified and collected, and time points reported.
Notes: trial funding and notable conflicts of interest of the trial authors.
Two review authors (KK and CJC) independently extracted outcome data from the included studies. We noted in the 'Characteristics of included studies' table if the study authors did not report outcome data in a usable way. We resolved any disagreements by consensus. One review author (KK) transferred data into the Review Manager (RevMan) (RevMan 2014) file. We double‐checked that KK entered data correctly by comparing the data presented in the systematic review with the study reports. A second review author (CJC) spot‐checked study characteristics for accuracy against the trial report.
Assessment of risk of bias in included studies
Two review authors (KK and CJC) independently assessed the risk of bias for each included study using the criteria outlined in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011). We resolved any disagreements by discussion. We assessed the risk of bias according to the following domains.
Random sequence generation.
Allocation concealment.
Blinding of participants and personnel.
Blinding of outcome assessment.
Incomplete outcome data.
Selective outcome reporting.
Other bias.
We graded each potential source of bias as either 'high', 'low' or 'unclear', and provided a quote from the study report together with a justification for our judgment in the 'Risk of bias' table. We summarised the 'Risk of bias' judgements across different studies for each domain listed. We considered blinding separately for different key outcomes where necessary (e.g. for unblinded outcome assessment, risk of bias for all‐cause mortality may be very different than for a patient‐reported pain scale). Where information on risk of bias related to unpublished data or correspondence with a trial author, we noted this in the 'Risk of bias' table.
When we considered treatment effects, we took into account the risk of bias for the studies that contributed to that outcome.
Assessment of risk of bias in conducting the systematic review
We conducted the review according to the published Cochrane protocol, Kew 2015b, and reported any deviations from it in the 'Differences between protocol and review' section.
Measures of treatment effect
We analysed dichotomous data as odds ratios (ORs) and continuous data as either mean difference or standardised mean difference values. We entered data presented as a scale with a consistent direction of effect.
We undertook meta‐analyses only where this was meaningful, i.e. if the treatments, participants and the underlying clinical question were similar enough for pooling to make sense.
We narratively described skewed data reported as medians and interquartile ranges.
Where a single trial reported multiple trial arms, we only included the relevant trial arms. If the trial combined two comparisons (e.g. drug A versus placebo and drug B versus placebo) in the same meta‐analysis, we halved the control group to avoid double‐counting.
Unit of analysis issues
For dichotomous outcomes we used participants, rather than events, as the unit of analysis (i.e. number of adults admitted to hospital, rather than number of admissions per adult). However, if studies reported exacerbations as rate ratios, we analysed them on this basis. We did not anticipate the inclusion of cluster RCTs and hence presented a large two‐cluster implementation study, Pinnock 2007a, separately from the other studies. For the purposes of display in the analyses, we have referred to Pinnock 2007a as the 'cluster implementation study' and Chan 2007, Gruffydd‐Jones 2005, Pinnock 2003 and Rasmussen 2005 as the 'efficacy RCTs'. There were only two clusters so we included the data with participants as the unit of analysis. Although we presented the results of the cluster RCT on forest plots with the other studies, we did not pool the effects so weighting of the cluster trial within the analysis was not an issue. We presented Hashimoto 2011 in a separate comparison as the study focused on tapering OCS dose.
Dealing with missing data
We contacted the study authors or study sponsors in order to verify key study characteristics and obtain missing numerical outcome data where possible (e.g. when we identified a study as an abstract only). Where this was not possible, and we thought the missing data introduced serious bias, we explored the impact of including such studies in the overall assessment of results by a sensitivity analysis.
Assessment of heterogeneity
We used the I² statistic to measure heterogeneity among the trials in each analysis. If we identified substantial heterogeneity we reported it and explored possible causes by prespecified subgroup analysis.
Assessment of reporting biases
If we were able to pool more than 10 trials, we created and examine a funnel plot to explore possible small study and publication biases.
Data synthesis
We used a random‐effects model for all analyses, as we expected variation in effects due to differences in study populations and interventions. We performed sensitivity analyses with a fixed‐effect model when heterogeneity was statistically significant.
'Summary of findings' table
We created a 'Summary of findings' table using the seven outcomes listed above. We used the five GRADE considerations (study limitations, consistency of effect, imprecision, indirectness and publication bias) to assess the quality of a body of evidence as it relates to the studies which contribute data to the meta‐analyses for the prespecified 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, and used GRADEpro Guidelines Development Tool (GDT) software (GRADEpro GDT 2015). We justified all decisions to downgrade or upgrade the quality of the evidence in footnotes, and we made comments to aid the reader's understanding of the Cochrane review, where necessary.
Subgroup analysis and investigation of heterogeneity
We performed the following subgroup analyses for the primary outcomes, where there was a sufficient number of included studies.
Mean age (less than 16 years, 17 to 65 years, and greater than 65 years).
Type of technology (telephone calls, text‐messages, emails).
We used the formal test for subgroup interactions in Review Manager (RevMan) (RevMan 2014).
Sensitivity analysis
We carried out the following sensitivity analyses by exclusion of the following from the primary analyses.
Studies that recruited people with severe or life‐threatening asthma.
Unpublished data (obtained from trial authors or from conference abstracts).
Studies at high risk of selection biasa.
aInadequate selection procedures may result in unbalanced baseline characteristics between groups which could skew the data. Due to the nature of the studies, we anticipated that all or most included studies would be at high risk of performance or detection bias, so we discussed the possible effect of lack of blinding, in particular for subjective outcomes.
Results
Description of studies
Results of the search
We performed searches up to 24 November 2015. We identified 591 records from the Cochrane Airways Review Group's Specialised Register (CAGR). We also examined a total of 750 additional records, comprised of an older database search (n = 710), clinicaltrials.gov records (n = 29) and the World Health Organization (WHO) International Clinical Trials Registry Portal (ICTRP) (n = 11). After we removed duplicates, we screened the remaining 823 records and excluded 673 by looking at titles and abstracts alone. We retrieved full texts for the remaining 150 records and excluded 126 (collated into 95 studies). The other 25 records met all the inclusion criteria and we collated them as six included studies. We have presented a study flow diagram and the reasons for exclusion in Figure 1.
Included studies
Six studies including a total of 2100 participants met the inclusion criteria: we pooled four studies including 792 people in the main efficacy analyses, and presented the results of a cluster implementation study (n = 1213) and an oral steroid tapering study (n = 95) separately. We have presented a summary of study, participant and intervention characteristics in Table 2, and more details for each individual study are in the 'Characteristics of included studies' tables.
1. Summary of study and intervention characteristics.
Study ID | Total N | Country | Duration | Mean age | % male | % FEV1 | Intervention | Control |
Chan 2007 | 120 | Hawaii, USA | 12 months | 9.6 | 62.5 | 100.5 | In‐home, website‐based case management and education. | In‐person education and case management. |
Gruffydd‐Jones 2005 | 194 | UK | 12 months | 50.2 | 45.4 | NR | 6‐monthly phone calls from trained asthma nurses. Formulation of individual AAP. | 6‐monthly usual face‐to‐face appointment with an asthma nurse. Symptoms, peak flow and inhaler technique checked, and participants were issued with an AAP. |
Hashimoto 2011 | 95 | The Netherlands | 6 months | 50.1 | 45.3 | 73.9 | OCS dose adjustment guided by an internet‐based diary, decision support and monitoring with support from a study nurse. | OCS dose adjustment according to GINA by the specialist. |
Pinnock 2003 | 278 | UK | 3 months | 55.5 | 41.4 | NR | Telephone check‐up with the asthma nurse. | Face‐to‐face check‐ups in the surgery with the asthma nurse. |
Pinnock 2007a | 1728 | UK | 12 months | 42.6 | 44.6 | NR | Three invitations to book either a telephone or face‐to‐face check‐up. Non‐attenders were phoned and reviewed opportunistically. | Three invitations to book a face‐to‐face check‐up. Non‐attenders were not phoned opportunistically. |
Rasmussen 2005 | 300 | Denmark | 6 months | 29 | 34.5 | 92.0 | Participants were given an AAP, online electronic diary and peak flow meter. Physicians gave participants instructions via e‐mail or telephone aided by computer decision support. | The specialists taught the participants how to adjust their medication on the basis of a peak flow meter and AAP. |
Total N: the total number of participants randomised in the study, included to groups not analysed in this Cochrane review % FEV1: the baseline mean of the predicted normal values Abbreviations: AAP = asthma action plan; NR = not reported; OCS = oral corticosteroids
Design, setting and duration
Three included studies were conducted in the UK (Gruffydd‐Jones 2005; Pinnock 2003; Pinnock 2007a), one in Hawaii, USA (Chan 2007), one in the Netherlands (Hashimoto 2011) and one in Denmark (Rasmussen 2005). Five studies were randomised controlled trials (RCTs) that lasted six or 12 months, and Pinnock 2007a was a before‐and‐after implementation study which randomised three practices rather than individual participants.
The design of Pinnock 2007a differed from the other studies in several respects. Firstly, it was cluster randomised which had an effect on the unit used for analysis and could not completely control for potential group differences between the practices. Secondly, it was a before‐and‐after design which meant the number and type of people on the practice lists was different at the two time points. Thirdly, the intervention offered a telephone check‐up as an option for asthma review so the study did not make a clean comparison between remote and face‐to‐face check‐ups, especially since most people in the telephone group did not choose that option. Fourthly, the primary aim of the study was to increase the number of people having a check‐up at all and so people in the intervention group were phoned opportunistically on top of being offered a phone check‐up, and this additional effort to contact participants may have been a confounding factor on the other study outcomes. We considered the study to be important so did not exclude it, and instead presented the study results separately from the main comparison for each outcome.
Population characteristics and inclusion criteria
The number of participants in each trial ranged from 95 in Hashimoto 2011 to 1728 in Pinnock 2007a; the median number of participants recruited was 236 and the total who received phone or face‐to‐face check‐ups was 2100. This was complicated by the design of Pinnock 2007a which assigned three GP practices rather than individual participants, although we will discuss the number of people for the descriptive purposes. Five studies recruited adults with a lower age limit of 17 or 18 and an upper age limits of between 45 (Rasmussen 2005) and 75 (Hashimoto 2011). Mean age of participants in the adult trials ranged from 29 to 55.5 years (median 50.1). One study recruited children between the ages of six and 17 years, and had a mean age of 9.6 years (Chan 2007). Studies included slightly more females than males (range 34.5% to 62.5% male, median 45%). Baseline characteristics related to the asthma severity were patchy and variable across studies. Hashimoto 2011 recruited people with more severe asthma than the other included studies; the mean percentage predicted FEV1 at baseline was 73.9%. Two other studies reported this measure of baseline severity at 92% (Rasmussen 2005) and 100.5% (Chan 2007).
In general the included studies did not describe the inclusion and exclusion criteria in great detail, and had varying requirements for the diagnosis and classification of asthma in their participants. With the exception of Hashimoto 2011, the studies recruited from the practice or clinic lists of their participating centres. Pinnock 2003 and Pinnock 2007a required participants to have received a prescription for asthma medications within the previous six and 12 months respectively, and both excluded participants with chronic obstructive disease. Pinnock 2003 further required participants to have been diagnosed with asthma for at least a year. Other inclusion criteria were related to computer or telephone access, and exclusion criteria were related to social, communication or medical difficulties that might preclude involvement in the intervention. Hashimoto 2011 only recruited participants on daily oral corticosteroids, and its inclusion criteria differed from the other studies. This study required participants to have a diagnosis of severe refractory asthma according to the major and minor criteria recommended by the American Thoracic Society (ATS 2000), and for their asthma to be uncontrolled despite intensive follow‐up by an asthma specialist for at least a year, chronic treatment with oral corticosteroids and high doses of inhaled steroids and long‐acting bronchodilators.
Interventions and comparisons
The interventions received in the active and comparison groups varied in several respects across studies, in particular regarding the length of observation, amount of professional contact and method of communication.
Four studies were designed to test remote check‐ups with standard face‐to‐face care. Chan 2007 was the only child study, and tested an in‐home website case management and education programme against an in‐person equivalent for 12 months. Participants in the active group of Gruffydd‐Jones 2005 received phone calls every six months from trained asthma nurses and those in the intervention group had equivalent face‐to‐face check‐ups with the asthma nurse. Both groups were given a personalised asthma action plan and discussed symptoms, peak flow and inhaler technique. Pinnock 2003 was described as a pragmatic RCT where participants were offered a telephone check‐up or a face‐to‐face consultation in the surgery, both with an asthma nurse. One of the study's main aims was the uptake of check‐ups with either method within three months of randomisation. Rasmussen 2005 was a six‐month study where physicians gave participants instructions via email or over the phone based on an agreed asthma action plan, an online diary and peak flow measurements uploaded by the participant. The comparison group received face‐to‐face instruction from an asthma specialist on how to adjust medication based on their asthma action plan and peak flow measurements.
As described above, Pinnock 2007a was a 12‐month implementation study where participants were given a structured recall with a choice of telephone or face‐to‐face for their asthma check‐up or a structured recall with no choice of a telephone check‐up (i.e. face‐to‐face only). We did not include a usual‐care group not subject to the methods to control for bias in the main comparison in this review. We chose to present the results of this study alongside the results of the four studies above, but in a separate subgroup so we did not pool the data with the main comparison. In addition to the choice of a telephone check‐up, people in the intervention group were called opportunistically if they did not respond or attend, which did not happen in the control group.
Hashimoto 2011 compared face‐to‐face check‐ups with internet‐delivered check‐ups for the specific purpose of tapering long‐term oral corticosteroid therapy (OCS), and for this reason we analysed the study as a separate comparison. The study was designed to test the effectiveness of a six‐month programme of OCS adjustment either via an internet diary and associated monitoring from an asthma nurse or via face‐to‐face check‐ups with a specialist according to Global Initiative for Asthma (GINA) guidelines.
Excluded studies
We excluded 125 records after viewing full texts, which we collated to represent 94 unique studies. The most common reason for exclusion was that the intervention did not meet the inclusion criteria (82 studies). Within this explanation, we explored the reasons and found that we often excluded studies because they used technology to facilitate self‐monitoring between usual face‐to‐face check‐ups (n = 22), and these studies meet the inclusion for another Cochrane review (Kew 2015a). Other excluded studies with interventions that did not meet the inclusion criteria used technology as education rather than for asthma check‐ups (n = 14), as automated monitoring systems without involvement from a health professional (n = 8), to validate an asthma questionnaire (n = 7), to improve or monitor adherence (n = 7), or to deliver a range of other interventions that did not match the remit of this review (including technology delivered counselling or behavioural interventions, parenting advice and monitoring interventions delivered without technology). We excluded eight studies as they were not RCTs (n = 8), and four because they made the wrong comparison (n = 4).
Risk of bias in included studies
We have shown a summary of the 'Risk of bias' judgements in Figure 2.
Allocation
We rated all the included studies at low risk of bias for random sequence generation as they described the randomisation methods, such as centralised systems, random numbers tables or coin toss. We judged two studies at low risk of bias for allocation concealment after the study authors responded to our request to clarify the study methods. Also we considered one study at unclear risk of bias because it did not adequately describe the methods. Regarding Pinnock 2007a, the cluster implementation study, we rated it at high risk of bias for allocation concealment because of its two‐cluster design.
Blinding
Due to the nature of the interventions, none of the included studies were able to blind participants and personnel to group allocation (performance bias). For this reason, we chose to assess blinding of participants and personnel separately for the subjective and objective outcomes. In each study, we rated the subjective outcomes (Asthma Control Questionnaire (ACQ) and Asthma Quality of Life Questionnaire (AQLQ)) at high risk of bias and the objective outcomes (exacerbations, adverse events, FEV1) at low risk of bias.
While it was possible for studies to blind outcome assessors (detection bias), no included study described the procedures to do so. Gruffydd‐Jones 2005, Hashimoto 2011 (through personal communication) and Rasmussen 2005 explicitly stated that the outcomes assessors were not blinded to allocation so we rated them at high risk of bias, and the remaining studies as unclear.
Incomplete outcome data
We considered two included studies at low risk of bias (Pinnock 2003; Pinnock 2007a). The former had low and even dropout, and the latter was a real‐world implementation study where uptake rate was an integral part of the study. We rated four studies at high risk of bias due to incomplete outcome data, either because dropout was high or unbalanced between groups or missing data had not been sufficiently imputed to account for those not in the study at the end (or both) (Chan 2007; Gruffydd‐Jones 2005; Hashimoto 2011; Rasmussen 2005). Due to the nature of the question being posed in the studies, several were run in a real‐world context which made it more difficult to control for participants dropping out.
Selective reporting
There was no evidence of selective reporting in the six included studies so we rated them at low risk of bias. Where outcomes were unavailable in the published reports, the trial authors were able to provide the additional data or confirm they had not been measured.
Other potential sources of bias
We rated Pinnock 2007a at high risk of bias for several reasons related to its cluster before‐and‐after study design. It randomised two practices to the interventions which would not have controlled for baseline imbalances in the same way as individual randomisation, and this meant the participant population in each group was not static. The intervention was a telephone option and many in that practice opted for a usual face‐to‐face check‐up, which meant the study did not make a direct comparison of remote and face‐to‐face check‐ups. Additionally, people in the telephone option group were phoned opportunistically to increase uptake of check‐ups, which did not happen in the face‐to‐face group. These factors mean we cannot be certain that the mode of check‐up, and not the increased likelihood of being seen, was the variable measured and we considered this study as having a high risk of bias. For these reasons, we chose to present the study alongside the others but not to pool its results in the main analyses.
We did not identify any other sources of bias in the five other included studies, which we rated as having a low risk of bias.
Effects of interventions
See: Table 1
We have presented data from studies that made a direct comparison between remote and face‐to‐face check‐ups as the main results (referred herein as the 'efficacy studies', and supplemented these by the results from the large two‐cluster implementation study, Pinnock 2007a. We have described data from the OCS tapering study, Hashimoto 2011, as a separate comparison below.
Primary outcomes
Exacerbations that required oral corticosteroids
One efficacy study reported the number of people who needed a course of oral corticosteroids for an exacerbation of asthma (Pinnock 2003). The confidence intervals (CIs) were very wide due to the small number of events in the analysis (odds ratio (OR) 1.74, 95% CI 0.41 to 7.44; 278 participants). In the face‐to‐face check‐up group, 21 people out of 1000 had exacerbations requiring oral steroids over three months, compared to 36 (95% CI nine to 139) out of 1000 in the remote group. We downgraded the evidence to low quality due to imprecision. The effect from the cluster implementation study was much more precise and favoured face‐to‐face check‐ups (OR 1.43, 95% CI 1.04 to 1.97); we have shown the two effects together in Analysis 1.1.
Exacerbations that required emergency department (ED) visit and hospital admission
The effect for exacerbations that required treatment in the ED also favoured face‐to‐face check‐ups over those conducted remotely, but this was uncertain due to the wide CIs from a small number of events (OR 2.60, 95% CI 0.63 to 10.64; 651 participants; three studies; Analysis 1.2). The result of the cluster implementation study was much smaller but also very imprecise (OR 1.19, 95% CI 0.38 to 3.71; 1212 participants; one study). Too few people in the efficacy studies had exacerbations that required a hospital admission to detect any difference between the two types of check‐up (Peto OR 0.63, 95% CI 0.06 to 6.32; 651 participants; three studies; Analysis 1.3), and the cluster implementation study showed a possible but not statistically significant benefit of face‐to‐face check‐up (Peto OR 2.18, 95% CI 0.83 to 5.69; 1213 participants; one study).
Asthma control
There was no difference in scores on the Asthma Control Questionnaire (ACQ) between participants in the remote and face‐to‐face groups (mean difference (MD) −0.07, 95% CI −0.35 to 0.21; 146 participants; one study; Analysis 1.4). Both CIs were within the minimal clinically important difference (MCID) for the scale (MCID = 0.5). We downgraded the quality of the evidence to moderate quality due to risk of bias because the outcome was a subjective rating scale that may have been affected by the inability to blind participants and personnel to group allocation. While the effect from the cluster implementation study was more in favour of remote check‐ups than the efficacy studies, the estimate and its CIs were still within the MCID for the scale so the difference was unimportant.
Serious adverse events (including mortality)
Only the cluster implementation study reported serious adverse events (SAEs) and showed a higher number in participants in the remote groups, although the CIs did not exclude the possibility that they were more common with face‐to‐face check‐ups (OR 1.80, 95% CI 0.73 to 4.44; 1213 participants; one study; Analysis 1.5). Given that SAEs are usually defined as those requiring hospital admission, it is likely that most of these events were the exacerbations requiring hospital admission described above.
Subgroup analyses
We were unable to conduct meaningful subgroup analyses on the basis of age and type of technology as planned, as there was an insufficient number of included studies to do this.
Sensitivity analyses
Severe or life‐threatening asthma
It was not necessary to conduct this sensitivity analysis because only Hashimoto 2011 specifically recruited people with severe or life‐threatening asthma and we analysed this study on its own due to the nature of the intervention.
Unpublished data
The trial author of Pinnock 2007a provided additional data for exacerbations requiring oral steroids, but we did not pool the study effect with the other study in the analysis so there was no basis for a sensitivity analysis.
High risk of selection bias
None of the included studies were at high risk of selection biases so we did not perform the planned sensitivity analysis.
Secondary outcomes
Asthma‐related quality of life
There was no difference between remote and face‐to‐face check‐ups on the Asthma Quality of Life Questionnaire (AQLQ) (MD 0.08, 95% CI −0.14 to 0.30; 544 participants; three studies; Analysis 1.6). While the effect was marginally in favour of remote check‐ups, both CIs were within the 0.5 minimal clinically important difference on the scale. As with the ACQ, we downgraded the evidence to moderate quality for risk of bias because the outcome was subjective and may have been affected by lack of blinding. The point estimate in the implementation study lay marginally in the opposite direction but the result was not inconsistent given the MCID (−0.02, 95% CI −0.23 to 0.19; 536 participants; one study).
Rasmussen 2005 also reported the AQLQ but the data were skewed and analysed non‐parametrically so we could not combine it with the other studies in the meta‐analysis (internet group median 6.42, range 4.11 to 7.00; specialist group median 6.17, range 3.98 to 7.00; GP group median 6.31, range 1.41 to 7.00). Chan 2007 also reported the parent version of the AQLQ with the following scores (remote group: mean 6.4, SD = 1, N = 60; face‐to‐face group: mean 6.2, SD = 0.8, N = 60). We considered the child version to be more similar to the way the scores were taken in the other studies which is why we included the child and not the parent scores in the meta‐analysis.
Unscheduled healthcare visits
The pooled estimate from two efficacy studies was based on very few events and was too imprecise to draw a conclusion (OR 0.91, 95% CI 0.45 to 1.85; 531 participants; two studies; Analysis 1.7). The direction and magnitude of the effect from the implementation study were consistent but the estimate was more precise (OR 0.95, 95% CI 0.75 to 1.21; 1213 participants; one study).
Lung function (trough FEV1 preferred)
Only one efficacy study reported trough FEV1 (mL), and showed a bigger improvement in the remote check‐up group (MD 166.76, 95% CI 78.03 to 255.50; 253 participants; one study; Analysis 1.8). We downgraded the evidence for imprecision to moderate quality because it was based on only 253 people, even though the confidence intervals excluded the possibility that face‐to‐face check‐ups were better. The implementation study was not designed to measure lung function.
Adverse events/side effects
Studies generally did not report adverse events separately from the asthma exacerbation and resource use outcomes. One study author confirmed that no participants in either group experienced adverse events, which did not allow us to display an effect estimate.
Remote versus face‐to‐face check‐up for oral corticosteroid tapering ‐ analysis of Hashimoto 2011
We chose to assess Hashimoto 2011 separately from the other studies as it was specifically aimed at assessing remote versus face‐to‐face check‐ups to guide dose reduction for people with asthma taking long‐term oral corticosteroids.
Mostly the CIs were too wide to tell whether one type of check‐up was better than the other at reducing harmful outcomes that might occur as a result of withdrawing oral steroids, or to say that they were equivalent. This was true for exacerbations requiring hospital admission (OR 0.88, 95% CI 0.25 to 3.13; Analysis 2.1), unscheduled healthcare visits (OR 2.31, 95% CI 0.23 to 23.14; Analysis 2.4) and adverse events (OR 1.51, 95% CI 0.13 to 17.29; Analysis 2.5). Scores on the ACQ (MD 0.14, 95% CI −0.15 to 0.43; Analysis 2.2) and AQLQ (MD −0.17, 95% CI −0.49 to 0.15; Analysis 2.3) were slightly better in the face‐to‐face group than those who were managed remotely, but the difference was below the minimal clinically important difference on both scales and the CIs did not exclude the possibility that remote check‐ups were better.
Discussion
Summary of main results
Six studies met the inclusion criteria (including a total of 2100 participants): we pooled four studies in the main efficacy analyses, which randomised 792 people to remote or face‐to‐face check‐up. In addition we also presented the results of a cluster implementation study (n = 1213) alongside the main results but did not pool them with the other included studies, and assessed one study that compared the two types of check‐up for oral steroid tapering in severe refractory asthma as a separate comparison (n = 95). Baseline characteristics relating to asthma severity were variable, but studies generally recruited people with asthma who took regular medications and excluded those with chronic obstructive pulmonary disease (COPD) or severe asthma. The studies could not be blinded and dropout was high in four of the six included studies, which may have biased the results.
We cannot say whether more people in the remote groups needed oral corticosteroids for an asthma exacerbation than those seen face‐to‐face because the confidence intervals (CIs) were very wide (OR 1.74, 95% CI 0.41 to 7.44; 278 participants; one study; low quality evidence). In the face‐to‐face check‐up groups, 21 people out of 1000 had exacerbations that required oral steroids over three months, compared to 36 (95% CI nine to 139) out of 1000 for the remote check‐up group. Exacerbations that needed treatment in the hospital emergency department (ED), hospital admission or an unscheduled healthcare visit happened too infrequently to detect whether remote check‐ups are a safe alternative to face‐to‐face consultations. Serious adverse events were not reported separately from the exacerbation outcomes.
There was no difference in asthma control measured by the Asthma Control Questionnaire (ACQ) or in quality of life measured on the Asthma Quality of Life Questionnaire (AQLQ) between remote and face‐to‐face check‐ups. We ruled out the significant harm of remote check‐ups for these outcomes but we were less confident because these outcomes are more prone to bias from lack of blinding.
The larger implementation study that compared two general practice populations demonstrated that offering telephone check‐ups and proactively phoning participants increased the number of people with asthma who received a review. However, we do not know whether the additional participants who had a telephone check‐up subsequently benefited in asthma outcomes.
Overall completeness and applicability of evidence
The design of this Cochrane review allowed us to focus on the specific question of whether regular asthma check‐ups can effectively be conducted remotely as opposed to face‐to‐face. By honing in on this form of telehealth, we were able to assess the evidence for a clearly defined application of technology‐based care that was more likely to lead to evidence that could be readily applied to real world settings. However, it did limit our assessments of possible effect moderators, such as age and type of technology, due to the small number of studies that met the inclusion criteria and reported the primary outcomes.
As described in the 'Included studies' section, Pinnock 2007a was a real‐word implementation study that differed from the other included studies in several respects. We chose to include this study because it addressed the feasibility of remote check‐ups in a real‐world setting, despite its design being dissimilar to the other included studies. By not pooling it with the other studies but presenting the results alongside them, we hoped to highlight the possible differences in a controlled comparison of remote and face‐to‐face check‐ups and what might actually happen in practice. While Pinnock 2007a's results do not lead to the cause and effect inferences that can be made from the efficacy RCTs, it does give an important insight into the relative merits of a possible incorporation of remote check‐ups into practice, and we consider the review to be more complete as a result. We did not set out to assess the possible benefit of improving access by offering remote check‐ups, especially for patients who are less likely to attend their annual check‐up. This is an important factor that can be addressed by implementation studies, such as Pinnock 2007a, better than classic randomised controlled trials (RCTs). Unfortunately, because there were only two clusters, the study results must be interpreted with caution and with the caveats both in this Cochrane review and in the study itself.
One efficacy study contributed data to the exacerbations requiring oral steroids analysis and this was provided by the study author (Pinnock 2003). It was not always possible to distinguish between courses of oral steroids for immediate treatment or future use (as part of an action plan). This highlights the importance of contacting study authors for additional data, as their own primary outcomes may differ from those of the review. This increased the completeness of the evidence base and our confidence in the results.
Quality of the evidence
We rated the evidence in this Cochrane review as low or moderate quality, mostly due to imprecision or risk of bias. We chose to assess blinding for the subjective outcomes separately from the objective outcomes. By differentiating the outcomes in this way, we were able to assess the effect lack of blinding was likely to have had on the confidence we have in the results. For the objective outcomes, we noted that the study designs did not allow for blinding of participants and personnel, but judged that this lack of blinding is unlikely to have made a difference to the number of people who had exacerbations, adverse events and lung function. There is a possibility that the lack of blinding may have still affected the way these outcomes were recorded but we did not consider this to sufficient to downgrade the evidence. For the subjective outcomes, it is more likely that the participant or investigators' knowledge of group allocation could have affected the way they responded to the asthma control and quality of life questionnaires, so we downgraded these outcomes for risk of bias.
We downgraded five outcomes for imprecision, including the primary outcome. We were fairly certain in the direction of the effect for the primary outcome, exacerbations requiring oral steroids, but there was only one efficacy study in the analysis and seven events, which reduced our confidence in the size and precision of the estimate significantly. Exacerbations that required an ED visit or a hospital admission, and unscheduled healthcare visits were all based on a very small number of events, which crucially meant we could not rule out significant harm of conducting remote check‐ups for people with asthma. Finally, we downgraded trough FEV1 for imprecision for a similar reason to the primary outcome: the effect was in favour of remote check‐ups, but the estimate was based on just one study of 253 people, so we weren't confident in the result. Visually, there was imprecision in the estimates for asthma control and quality of life, but the CIs for both were well with the established minimal clinically important differences for the scales (Juniper 1994; Juniper 1999).
We did not downgrade any of the outcomes for publication bias, inconsistency in the results or indirectness of the evidence. While not all studies reported the outcomes we were interested in, this was more likely to reflect the individual practices and designs of the studies (e.g. unable to measure lung function remotely) rather than selective reporting of outcome data. There was minimal statistical inconsistency in the analyses, and while there was a fair amount of variation in the aims and designs of the studies, we considered them all to match the PICO set out in the protocol for this review (Kew 2015b).
Potential biases in the review process
We made every effort to adhere to Cochrane methods during the review process. Both review authors extracted numerical data, performed 'Risk of bias' ratings in duplicate, and cross checked for accuracy and consistency. Throughout the process, we resolved any discrepancies through discussion. Neither review author has any conflicts of interest relating to this Cochrane review.
We performed broad literature searches that we independently screened in duplicate, and included studies regardless of language of publication or the existence of a full‐text paper. We also conducted comprehensive additional searches to identify unpublished studies that were not listed in the main electronic databases. It is unlikely that we missed studies during the study selection process, except for those not listed in non‐English language databases. We made every effort to contact study authors, although in some cases this was difficult due to when the studies were conducted and the effect this had both on the availability of contact details and the likelihood we could obtain data. We received detailed replies from two study authors which affected several analyses and the completeness of the 'Risk of bias' information.
Agreements and disagreements with other studies or reviews
Systematic reviews of the evidence for remote asthma check‐ups have generally had much broader inclusion criteria, assessing the use of any kind of telehealthcare for monitoring or educating people with asthma. As such, it is difficult to compare the results of this Cochrane review with their results because we designed this systematic review to assess specifically the use of technology systems to conduct asthma check‐ups remotely. For example, McLean 2010 included 21 studies that assessed a range of telehealth interventions against a range of control groups, and as such it was difficult to meta‐analyse the data in a way that led to conclusions with real‐world implications.
Systematic reviews that examined telehealth more broadly for asthma have generally approached the question from a different standpoint from our own. Other reviews have focused on possible benefits of remote healthcare over usual face‐to‐face care, whereas we were more concerned with highlighting the potential dangers of removing face‐to‐face contact with a healthcare professional. Conclusions made by McLean 2010 regarding the lack of benefit for relatively mild asthma and Zhao 2014 regarding the lack of improvements on asthma function scores do not disagree with our own, but are framed from the former standpoint. This is at least partly because these two reviews did not set out to compare remote or 'telehealthcare' against a consistent alternative form of monitoring. For most outcomes we looked at, we cannot conclude that remote check‐ups definitely lead to worse outcomes than face‐to‐face care, but neither can we conclude that remote check‐ups are a safe alternative to face‐to‐face care for either mild or severe asthma.
In their conclusions, Jaana 2009 focused on the attitudes and receptiveness of home telemonitoring for patients with respiratory illness, which we did not set out to assess, and commented on the "variations in study approaches and an absence of robust study designs and formal evaluations". We agree that the inherent differences in health systems and study designs continue to limit conclusions in this field, even when review questions are refined to one part of 'telehealthcare'.
Authors' conclusions
Implications for practice.
Current randomised evidence does not demonstrate any important differences between face‐to‐face and remote asthma check‐ups in terms of exacerbations, asthma control or quality of life. There is insufficient information to rule out differences in efficacy, or to say whether or not remote asthma check‐ups are a safe alternative to usual face‐to‐face consultations.
Implications for research.
It would be helpful to find out whether remote check‐ups for people with asthma who do not attend for a face‐to‐face consultation can achieve a reduction in the risk of serious asthma attacks that result in hospital admissions. To do this, further studies are required in high‐risk people with frequent asthma admissions who do not attend for regular face‐to‐face check‐up. It might be sensible to include remote monitoring and remote check‐ups in the intervention as it seems unlikely that remote check‐ups alone would be sufficient to reduce admissions to hospital.
Acknowledgements
We are grateful to the Cochrane Airways Group (CAG) staff for comments and support. We thank Simone Hashimoto, Hilary Pinnock and Linda Makowska Rasmussen who provided additional data and clarified the methods for three of the included studies.
Rebecca Normansell was the Editor for this review and commented critically on this review.
The Background and Methods sections of this review are based on a standard template used by Cochrane Airways.
The Background section shares similarities with another Cochrane review we co‐developed (Kew 2015a).
The National Clinical Guideline Centre (NCGC) and the CAG undertook collaborative work pertaining to a systematic review of published evidence on tele‐healthcare for monitoring asthma control. The CAG reviews are restricted to interventions that involve a healthcare professional only. This is different from the larger question addressed by the NCGC (as part of the National Institute for Health and Care Excellence (NICE) asthma guideline commission). The NCGC review of evidence is published in the NICE clinical guideline on asthma diagnosis and monitoring and received funding from NICE.
Appendices
Appendix 1. Sources and search methods for the Cochrane Airways Review Group's Specialised Register (CAGR)
Electronic searches: core databases
Database | Search frequency |
CENTRAL (the Cochrane Library) | Monthly |
MEDLINE (Ovid) | Weekly |
Embase (Ovid) | Weekly |
PsycINFO (Ovid) | Monthly |
CINAHL (EBSCO) | Monthly |
AMED (EBSCO) | Monthly |
Hand‐searches: 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
Asthma search
1. exp Asthma/
2. asthma$.mp.
3. (antiasthma$ or anti‐asthma$).mp.
4. Respiratory Sounds/
5. wheez$.mp.
6. Bronchial Spasm/
7. bronchospas$.mp.
8. (bronch$ adj3 spasm$).mp.
9. bronchoconstrict$.mp.
10. exp Bronchoconstriction/
11. (bronch$ adj3 constrict$).mp.
12. Bronchial Hyperreactivity/
13. Respiratory Hypersensitivity/
14. ((bronchial$ or respiratory or airway$ or lung$) adj3 (hypersensitiv$ or hyperreactiv$ or allerg$ or insufficiency)).mp.
15. ((dust or mite$) adj3 (allerg$ or hypersensitiv$)).mp.
16. or/1‐15
Filter to identify randomised controlled trials (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 AST:MISC1
#2 MeSH DESCRIPTOR Asthma Explode All
#3 asthma*:ti,ab
#4 #1 or #2 or #3
#5 MeSH DESCRIPTOR Telemedicine Explode All
#6 telehealth* or tele‐health*
#7 telemedicine* or tele‐medicine*
#8 (internet* or computer* or web*):ti,ab,kw
#9 interactive* or telecommunication*
#10 (telephone or phone or SMS):ti,ab,kw
#11 tele‐monitor* or telemonitor*
#12 telemanagement or tele‐management
#13 teleconsultation or tele‐consultation
#14 telecare* or tele‐care*
#15 telematic*
#16 telepharmacy or tele‐pharmacy
#17 telenurs* or tele‐nurs*
#18 (video or email or e‐mail):ti,ab,kw
#19 remote NEXT consult*
#20 wireless or bluetooth
#21 tele‐homecare or telehomecare
#22 "remote care"
#23 tele‐support or telesupport
#24 mobile NEXT health*
#25 "computer mediated therapy"
#26 ehealth or e‐health
#27 mhealth or m‐health
#28 #5 or #6 or #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 or #26 or #27
#29 #4 and #28
[Note: in search line #1, MISC1 denotes the field in which the reference has been coded for condition, in this case, asthma]
Data and analyses
Comparison 1. Remote versus face‐to‐face asthma reviews.
Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
---|---|---|---|---|
1 Exacerbations requiring oral corticosteroids | 2 | Odds Ratio (M‐H, Random, 95% CI) | Totals not selected | |
1.1 Efficacy randomised controlled trials (RCTs) | 1 | Odds Ratio (M‐H, Random, 95% CI) | 0.0 [0.0, 0.0] | |
1.2 Cluster implementation study | 1 | Odds Ratio (M‐H, Random, 95% CI) | 0.0 [0.0, 0.0] | |
2 Exacerbations requiring hospital emergency department (ED) treatment | 4 | Odds Ratio (M‐H, Random, 95% CI) | Subtotals only | |
2.1 Efficacy RCTs | 3 | 651 | Odds Ratio (M‐H, Random, 95% CI) | 2.60 [0.63, 10.64] |
2.2 Cluster implementation study | 1 | 1212 | Odds Ratio (M‐H, Random, 95% CI) | 1.19 [0.38, 3.71] |
3 Exacerbations requiring hospital admission | 4 | Peto Odds Ratio (Peto, Fixed, 95% CI) | Subtotals only | |
3.1 Efficacy RCTs | 3 | 651 | Peto Odds Ratio (Peto, Fixed, 95% CI) | 0.63 [0.06, 6.32] |
3.2 Cluster implementation study | 1 | 1213 | Peto Odds Ratio (Peto, Fixed, 95% CI) | 2.18 [0.83, 5.69] |
4 Asthma control (Asthma Control Questionnaire (ACQ)) | 2 | Mean Difference (IV, Random, 95% CI) | Totals not selected | |
4.1 Efficacy RCTs | 1 | Mean Difference (IV, Random, 95% CI) | 0.0 [0.0, 0.0] | |
4.2 Cluster implementation study | 1 | Mean Difference (IV, Random, 95% CI) | 0.0 [0.0, 0.0] | |
5 Serious adverse events (including mortality) | 1 | Odds Ratio (M‐H, Random, 95% CI) | Totals not selected | |
5.1 Cluster implementation study | 1 | Odds Ratio (M‐H, Random, 95% CI) | 0.0 [0.0, 0.0] | |
6 Asthma‐related quality of life (Asthma Quality of Life Questionnaire (AQLQ) | 4 | Mean Difference (IV, Random, 95% CI) | Subtotals only | |
6.1 Efficacy RCTs | 3 | 544 | Mean Difference (IV, Random, 95% CI) | 0.08 [‐0.14, 0.30] |
6.2 Cluster implementation study | 1 | 536 | Mean Difference (IV, Random, 95% CI) | ‐0.02 [‐0.23, 0.19] |
7 Unscheduled healthcare visits | 3 | Odds Ratio (M‐H, Random, 95% CI) | Subtotals only | |
7.1 Efficacy RCTs | 2 | 531 | Odds Ratio (M‐H, Random, 95% CI) | 0.91 [0.45, 1.85] |
7.2 Cluster implementation study | 1 | 1213 | Odds Ratio (M‐H, Random, 95% CI) | 0.95 [0.75, 1.21] |
8 Change in lung function (trough FEV1) | 1 | Mean Difference (IV, Random, 95% CI) | Totals not selected | |
9 Adverse events | 1 | 278 | Odds Ratio (M‐H, Random, 95% CI) | 0.0 [0.0, 0.0] |
Comparison 2. Remote versus face‐to‐face for OCS tapering.
Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
---|---|---|---|---|
1 Exacerbations requiring hospital admission | 1 | Odds Ratio (M‐H, Random, 95% CI) | Totals not selected | |
2 Asthma control (ACQ) | 1 | Mean Difference (IV, Random, 95% CI) | Totals not selected | |
3 Asthma‐related quality of life (AQLQ) | 1 | Mean Difference (IV, Random, 95% CI) | Totals not selected | |
4 Unscheduled healthcare visits | 1 | Odds Ratio (M‐H, Random, 95% CI) | Totals not selected | |
5 Adverse events | 1 | Odds Ratio (M‐H, Random, 95% CI) | Totals not selected |
Characteristics of studies
Characteristics of included studies [ordered by study ID]
Chan 2007.
Methods |
Study design: 12 month parallel RCT Setting: paediatric clinic at Tripler Army Medical Center, Hawaii Enrolment began in March 2003 and ended in December 2003. Participant data collection ended with the last participant’s final visit in February 2005 |
|
Participants |
Population: 120 children were randomised to the virtual group (60) or the office‐based group (60) Baseline characteristics: mean age, years (SD): remote 10.2 (3.1); face‐to‐face 9.0 (3.0) % male: remote 61.7; face‐to‐face 63.3 % predicted FEV1 (SD): remote 104.1 (19.9); face‐to‐face 96.8 (13.0) Inclusion criteria: children aged 6 to 17 years with persistent asthma, dependent of active duty or retired USA military personnel, not moving from Oahu for 12 months after entry into the study, ability to receive cable modem connections in the home, willingness to complete questionnaires and monitoring Exclusion criteria: none stated |
|
Interventions |
Intervention: virtual group participants received computers, internet connections and in‐home internet‐based case management and received education through the study website. Control: office‐based group patients received traditional in‐person education and case management. |
|
Outcomes | Control medication use, daily symptom diary, peak flow, patient and caregiver AQLQ, service utilisation, asthma knowledge retention Measured at 2 weeks, 6 weeks, 3 months, 6 months and 12 months |
|
Notes | Funding: grant from the US Army Medical Research Acquisition Activity ID number(s): N/A | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "patients underwent block randomisation with a table of random numbers". |
Allocation concealment (selection bias) | Unclear risk | The study did not provide any details. |
Blinding of participants and personnel Objective outcomes | Low risk | It would not have been possible to blind participants and personnel to allocation due to the nature of the intervention. However, participants and personnel being aware of group allocation is unlikely to have affected the results for the objective outcomes (exacerbations and adverse events). |
Blinding of participants and personnel Subjective outcomes | High risk | Participants and personnel being aware of group allocation could have affected their scores on subjective outcomes such as those measured on self‐report scales (Asthma Control Questionnaire (ACQ) and AQLQ). |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | It is possible to blind outcome assessment but the study did not provide any specific details of whether this was done. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Dropout was much higher in the virtual group (23%) than the office group (8%). The study authors did not account for non‐adherent participants and other dropouts in the analysis. |
Selective reporting (reporting bias) | Low risk | Outcomes were well reported. There was no protocol registration available to check all pre‐specified measures were included but there was no evidence of selective reporting. |
Other bias | Low risk | We did not note any other possible sources of bias. |
Gruffydd‐Jones 2005.
Methods |
Study design: 12 month parallel RCT Setting: 1 practice in England, UK Participants were recruited between December 2002 and March 2003 |
|
Participants |
Population: 194 people were randomised to the telephone group (97) or the clinic group (97) Baseline characteristics: mean age, years (standard deviation (SD)): remote 50.8 (15.4); face‐to‐face 49.6 (16.1) % male: remote 51.5; face‐to‐face 39.2 % predicted forced expiratory volume in one second (FEV1) (SD): not reported Inclusion criteria: adults with asthma aged 17 to 70 years and on the practice asthma list Exclusion criteria: housebound, did not possess a telephone or were unwilling to give informed consent |
|
Interventions |
Intervention: participants were contacted by telephone at 6‐monthly intervals by 1 of 2 trained asthma nurses. The participant was then asked the RCPs ‘three questions’ plus two extra questions related to a high risk of asthma death. The nurse formulated an individualised asthma action plan with the participant, with advice on what to do if asthma control deteriorated. Control: participants received usual care by 6‐monthly check up via a dedicated asthma appointment with a diploma‐level asthma nurse. Symptom scores, inhaler technique and peak flow measurements were checked and all participants issued with an asthma action plan. |
|
Outcomes | ACQ, mini‐AQLQ, mild and severe exacerbations, healthcare costs, clinical time, inhaler use, unscheduled healthcare visits all given per patient year. Measured at baseline, 6 months and 12 months |
|
Notes | Funding: grant from Asthma UK ID number(s): N/A | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | The study randomised participants using a random number tables on a 1 to 1 basis and stratified according to severity. |
Allocation concealment (selection bias) | Unclear risk | The study did not provide any details. |
Blinding of participants and personnel Objective outcomes | Low risk | It would not have been possible to blind participants and personnel to allocation due to the nature of the intervention. However, participants and personnel being aware of group allocation is unlikely to have affected the results for the objective outcomes (exacerbations and adverse events). |
Blinding of participants and personnel Subjective outcomes | High risk | Participants and personnel being aware of group allocation could have affected their scores on subjective outcomes such as those measured on self‐report scales (ACQ and AQLQ). |
Blinding of outcome assessment (detection bias) All outcomes | High risk | "assessors were not blinded to the interventions due to limited resources". |
Incomplete outcome data (attrition bias) All outcomes | High risk | "There were 20 withdrawals in the control group after the first visit, mainly due to non‐attendance and 6 in the telephone group, one of which was due to non‐attendance. As this trial is as real‐world as possible the fact that there was a high non‐attendance rate was taken account of in analysing the costs." |
Selective reporting (reporting bias) | Low risk | Outcomes were well reported. There was no protocol registration available to check all pre‐specified measures were included but there was no evidence of selective reporting. |
Other bias | Low risk | We did not note any other possible sources of bias. |
Hashimoto 2011.
Methods |
Study design: pragmatic 6 month parallel RCT Setting: 2 academic tertiary care hospitals and 4 large community hospitals in The Netherlands. Participants were randomised between November 2007 and October 2008 |
|
Participants |
Population: 95 people were randomised to the internet group (52) or the conventional face‐to‐face management group (38) Baseline characteristics: mean age, years (SD): remote 48.5 (12.4); face‐to‐face 52.4 (11.7) % male: remote 45; face‐to‐face 47 % predicted FEV1 (SD): remote 76.3 (24.7); face‐to‐face 71.3 (21.0) Inclusion criteria: adults (18 to 75 years) with a diagnosis of severe refractory asthma according to the major and minor criteria recommended by the American Thoracic Society. They had uncontrolled asthma despite intensive follow‐up by an asthma specialist for at least 1 year, chronic treatment with oral corticosteroids and high doses of ICS plus long‐acting bronchodilators. All were non‐smokers with a maximum smoking history of 15 pack‐years and had access to internet or mobile telephone Exclusion criteria: none stated |
|
Interventions |
Intervention: dose adjustment of oral corticosteroids guided by an internet‐based management tool (internet group). Included electronic diary, decision support and monitoring support by a study nurse Control: dose adjustment of oral corticosteroids according to conventional asthma treatment by the pulmonologist, according to GINA (conventional management group) |
|
Outcomes | Cumulative sparing of oral corticosteroid therapy (OCS), ACQ, AQLQ, global satisfaction scale, FEV1, number of exacerbations and days of hospitalisation The authors defined an exacerbation as a decrease in morning FEV1 of at least 10% compared with the mean FEV1 from the week before, or a respiratory event requiring an increase in prednisone equivalent to at least 10 mg/day, or a course of antibiotics, with or without hospitalisation |
|
Notes | Funding: The Netherlands Organization for Health Research and Development (ZonMw) ID number(s): 1146 (Netherlands Trial Reg No.) | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | The study randomised participants by a computer random number generator and remained on the same allocation throughout the study. Communication: "The random codes were stratified for study center and initial dose of corticosteroid dose (lower or higher than 10 mg prednisone per day)". |
Allocation concealment (selection bias) | Unclear risk | "unblinded after randomisation", implies it was concealed, but the study did not provide any further details. |
Blinding of participants and personnel Objective outcomes | Low risk | The treatment assignments were unblinded after randomisation to allow monthly corticosteroid dose adjustments according to conventional treatment by the physician or weekly adjustments according to the internet algorithm. While it was not possible to blind participants and personnel to allocation due to the nature of the intervention, participants and personnel being aware of group allocation is unlikely to have affected the results for the objective outcomes (exacerbations and adverse events). |
Blinding of participants and personnel Subjective outcomes | High risk | Participants and personnel being aware of group allocation could have affected their scores on subjective outcomes such as those measured on self‐report scales (ACQ and AQLQ). |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Communication: "This was a pragmatic study so the outcome assessors were not blind to the group allocation in order to allow monthly corticosteroid dose adjustments (according to conventional treatment by the physician) or weekly adjustments (according to the internet algorithm)". |
Incomplete outcome data (attrition bias) All outcomes | High risk | Five participants in the conventional management group withdrew consent before the study had started and the study excluded one participant because of poor adherence to the trial protocol. The study included 89 participants out of 95 in the intention‐to‐treat (ITT) analysis; 51 and 38. Dropout was higher in the conventional treatment group (16% versus 8%). |
Selective reporting (reporting bias) | Low risk | The study was prospectively registered, and outcomes were well reported. |
Other bias | Low risk | We did not note any other possible sources of bias. |
Pinnock 2003.
Methods |
Study design: pragmatic parallel RCT (duration of study participation varied across participants) Setting: 4 general practices in the UK |
|
Participants |
Population: 278 people were randomised to remote telephone check‐up (137) or face‐to‐face check‐up (141) Baseline characteristics: mean age, years (SD): remote 54.6 (17.5); face‐to‐face 56.4 (17.5) % male: remote 41; face‐to‐face 42 % predicted FEV1 (SD): not reported Inclusion criteria: adults with asthma who had requested a prescription for a bronchodilator inhaler in the last 6 months Exclusion criteria: if diagnosis of asthma had been made within the previous year, if they had chronic obstructive pulmonary disease, if communication difficulties made a telephone check‐up impossible, or (at the general practitioner's (GP's) request) for major social or medical reasons. |
|
Interventions |
Intervention: telephone check‐up with the asthma nurse. The nurse tried up to 4 times to contact the participants. Control: face‐to‐face check‐ups in the surgery also with the asthma nurse, one invitation was sent in the usual manner. Content of the check‐up was as the nurse deemed appropriate. |
|
Outcomes | Medical reviews, time taken to review participants in each arm, asthma morbidity on the short Q, asthma related quality of life on the mini AQLQ, participant satisfaction, costs | |
Notes | Funding: originally developed at a General Practice Airways Group research meeting, which was organised by Mark Levy and funded by an educational grant from AstraZeneca. The trial was funded by British Lung Foundation (Grant No P00/9). Additionally, one study author was supported by an NHS R&D national primary care fellowship. ID number(s): N/A | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Participants were centrally randomised in blocks of 10 to ensure that approximately equal numbers of participants were allocated to each study arm. |
Allocation concealment (selection bias) | Low risk | "Centrally randomised" implies that allocation was undertaken independently and concealed. |
Blinding of participants and personnel Objective outcomes | Low risk | It would not have been possible to blind participants and personnel to allocation due to the nature of the intervention. However, participants and personnel being aware of group allocation is unlikely to have affected the results for the objective outcomes (exacerbations and adverse events). |
Blinding of participants and personnel Subjective outcomes | High risk | Participants and personnel being aware of group allocation could have affected their scores on subjective outcomes such as those measured on self‐report scales (ACQ and AQLQ). |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | “a researcher, blinded to allocation visited each of the practices and validated a random 20% sample of consultation data and data retrieved from records”. However, the participants and investigators could not be blinded to the interventions and, in most cases, the outcome assessors were not blinded to group allocation either. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | The percentage of withdrawals was low and even between groups (5.1 and 4.3% in the remote and face‐to‐face groups respectively). |
Selective reporting (reporting bias) | Low risk | There was no evidence of selective reporting. |
Other bias | Low risk | We did not note any other possible sources of bias. |
Pinnock 2007a.
Methods |
Study design: 12 month before‐and‐after implementation study Setting: 1 large English general practice on 3 sites |
|
Participants |
Population: 3 practices were randomised to: 1. a choice of remote phone check‐ups or face‐to‐face check‐ups (554 on list), 2. face‐to‐face only check‐ups (659 on list), or 3. a usual care control group which was not included in this systematic review (515 on list) Baseline characteristics: mean age, years (SD): remote 43 (24.8); face‐to‐face 42.3 (24.4) % male: remote 44.2; face‐to‐face 44.9 % predicted FEV1 (SD): not reported Inclusion criteria: adults and adolescents with a diagnosis of asthma and prescribed asthma medication in the previous year Exclusion criteria: children under 12 years of age, diagnosis of COPD |
|
Interventions |
Intervention: participants were identified from the practice computer database and sent 3 invitations over the study period. They could book either a telephone or face‐to‐face check‐up both at a pre‐arranged time. Participants who did not respond to the 3 invitations were phoned and reviewed opportunistically Control: participants were recalled to face‐to‐face only asthma check‐ups using invitations by post or as memos with repeat prescriptions. There was no option of telephone check‐ups and no systematic attempt was made to phone non‐attenders opportunistically. Group excluded: the usual‐care control group maintained their well established asthma clinic, and existing procedures (for example, invitations are issued in response to clinical need), but no systematic recall was undertaken |
|
Outcomes | Proportion reviewed, asthma morbidity and enablement on the mini AQLQ, ACQ, modified patient enablement instrument and Asthma Bother Profile, adverse events, costs | |
Notes | Funding: Scientific Foundation Board of the Royal College of General Practitioners (SFB/2003/45) ID number(s): N/A | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | The study decided allocation to the telephone option by the public toss of a coin. |
Allocation concealment (selection bias) | High risk | The study allocated individuals to treatment after the two clusters had been decided by the toss of a coin. |
Blinding of participants and personnel Objective outcomes | Low risk | It would not have been possible to blind participants and personnel to allocation due to the nature of the intervention. However, participants and personnel being aware of group allocation is unlikely to have affected the results for the objective outcomes (exacerbations and adverse events). |
Blinding of participants and personnel Subjective outcomes | High risk | Participants and personnel being aware of group allocation could have affected their scores on subjective outcomes such as those measured on self‐report scales (ACQ and AQLQ). |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | The nurses were aware of allocation but it was unclear whether it was the nurses measuring outcomes, or if it was someone independent from the study who could remain blind to allocation. The study did not describe this. The study stated that there were quality control checks blinded to allocation which confirmed accuracy of data transfer. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Real‐world implementation study, therefore the uptake rate by participants is part of the study, routine asthma check‐up was provided for 66.3% of participants in the telephone only group and 53.8% in the face‐to‐face only group. |
Selective reporting (reporting bias) | Low risk | There was no evidence of selective reporting. |
Other bias | High risk | This study was a cluster implementation study with a before‐and‐after design. It randomised 2 practices to the interventions which would not have controlled for baseline imbalances in the same way as individual randomisation, and this meant the participant population in each group was not static. The intervention was a telephone option and many in that practice opted for a usual face‐to‐face check‐up, which meant the study was not making a direct comparison of remote and face‐to‐face check‐ups. Additionally, people in the telephone option group were phoned opportunistically to increase uptake of check‐ups which did not happen in the face‐to‐face group. These factors mean we cannot be certain that mode of check‐up, and not the increased likelihood of check‐up, was the variable being measured. |
Rasmussen 2005.
Methods |
Study design: 6 month pragmatic parallel RCT Setting: general practices and specialist clinics in Copenhagen, Denmark |
|
Participants |
Population: 300 people were randomised to remote check‐ups (100), face‐to‐face check‐ups with a specialist (100), and a usual care group not included in this review (100) Baseline characteristics: mean age, years (SD): remote 28 (NR); face‐to‐face 30 (NR) % male: remote 31.8; face‐to‐face 34.1 % predicted FEV1 (SD): remote 91 (NR); face‐to‐face 93 (NR) Inclusion criteria: 18 to 45 years with definite asthma, living in the catchment area of H:S Bispebjerg University Hospital of Copenhagen, Denmark Exclusion criteria: none stated |
|
Interventions |
Intervention: participants were given a Peak Flow Meter and taught how to fill in a daily diary and respond to the computer’s advice. Physicians gave instructions via e‐mail or telephone to the participant. The intervention included an electronic diary, an asthma action plan and a decision support system for the physician. Control: the specialists taught the participants how to adjust their medication on the basis of a peak flow meter and written action plan Group not included: the GP group was asked to contact their GP and pass on a letter describing the study and giving the test results. GPs in Copenhagen had been sent a circular about asthma and GINA guidelines in the past. |
|
Outcomes | AQLQ, asthma self‐care, smoking, education, salary, sick leave, hospitalisations, medication compliance, adverse events, lung function Measured at baseline and 6 months |
|
Notes | Funding: Grants from H:S Corporation of University Hospital of Copenhagen, AstraZeneca, and private funds ID number(s): N/A | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Communication: "The allocation sequences were computer‐generated by a senior respiratory physician. These sequences consisted of randomised blocks of 30 asthmatics". |
Allocation concealment (selection bias) | Low risk | Communication: "The envelopes were packed by two medical students one month before the start of the study and the randomisation lists were stored in a separate, sealed envelope. The consecutively numbered and sealed envelopes contained the randomisation code. All envelopes were opened sequentially after the asthma diagnosis had been verified". |
Blinding of participants and personnel Objective outcomes | Low risk | It would not have been possible to blind participants and personnel to allocation due to the nature of the intervention. However, participants and personnel being aware of group allocation is unlikely to have affected the results for the objective outcomes (exacerbations and adverse events). |
Blinding of participants and personnel Subjective outcomes | High risk | Participants and personnel being aware of group allocation could have affected their scores on subjective outcomes such as those measured on self‐report scales (ACQ and AQLQ). |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Communication: "It was not possible to blind outcome assessors to group allocation". |
Incomplete outcome data (attrition bias) All outcomes | High risk | Of the 300 participants randomised, 253 participants completed both the screening and follow‐up visits. Dropout was unbalanced across groups (12%, 15% and 20%), and the study does not appear to have imputed data for missing values. |
Selective reporting (reporting bias) | Low risk | The paper did not report all of the results from the questionnaires but the lead study author provided them on request. |
Other bias | Low risk | We did not note any other possible sources of bias. |
Abbreviations: ACQ = Asthma Control Questionnaire; AQLQ = Asthma Quality of Life Questionnaire; COPD = chronic obstructive pulmonary disease; FEV1 = forced expiratory volume in one second; GINA = Global Initiative for Asthma; GP = general practitioner; ICS = inhaled corticosteroids; ITT = intention‐to‐treat analysis; NR = not reported; OCS = oral corticosteroids; RCP = respiratory care practitioner; RCT = randomised controlled trial; SD = standard deviation.
Characteristics of excluded studies [ordered by study ID]
Study | Reason for exclusion |
---|---|
ACTRN12606000400561 | Wrong intervention ‐ technology‐based self management between reviews. |
Ahmed 2011 | Wrong intervention ‐ technology‐based self management between reviews |
Andersen 2007 | Wrong intervention ‐ minimal or no provider involvement |
Apter 2000 | Wrong design ‐ not a trial report |
Apter 2015 | Wrong comparison ‐ telemedicine portal used with or without home visits (both groups used the portal) |
Araujo 2012 | Wrong design ‐ crossover RCT |
Baptist 2013 | Wrong comparison ‐ phone calls for asthma education versus non‐asthma phone calls |
Barbanel 2003 | Wrong intervention ‐ asthma education intervention led by a pharmacist |
Bateman 2000 | Wrong intervention ‐ technology‐based self management between reviews |
Bender 2001 | Wrong intervention ‐ study assessing validity of self‐reports |
Bender 2007 | Wrong intervention ‐ study assessing validity of self‐reports |
Bender 2010 | Wrong intervention ‐ minimal or no provider involvement |
Boyd 2014 | Wrong intervention ‐ pharmacist led intervention about adherence |
Burbank 2012 | Wrong intervention ‐ focus on asthma education, not monitoring with remote reviews |
Burkhart 2002 | Wrong intervention ‐ intervention to improve adherence to home PEF measurements |
Bynum 2001 | Wrong intervention ‐ pharmacy led technology intervention to improve adherence |
Chandler 1990 | Wrong intervention ‐ monitoring theophylline levels |
Chatkin 2006 | Wrong intervention ‐ phone calls to promote adherence, not remote reviews |
Chen 2013 | Wrong intervention ‐ asthma behavioural intervention using technology, not remote reviews |
Cicutto 2009 | Wrong intervention ‐ not remote reviews |
Clark 2007 | Wrong intervention ‐ counselling intervention not remote reviews |
Clarke 2014 | Wrong intervention ‐ parenting intervention, not remote reviews |
Claus 2004 | Wrong design ‐ not a randomised controlled trial (RCT) |
Cruz‐Correia 2007 | Wrong design ‐ crossover RCT |
de Jongste 2008 | Wrong comparison ‐ comparing 2 types of electronic monitoring (FeNo versus symptoms) |
De Vera 2014 | Wrong intervention ‐ asthma education and adherence monitoring by a pharmacist |
Deschildre 2012 | Wrong intervention ‐ technology‐based self management between reviews |
Donald 2008 | Wrong intervention ‐ technology‐based self management between reviews |
Dwinger 2013 | Wrong intervention ‐ coaching/education intervention using technology for multiple chronic conditions |
Eakin 2012 | Wrong intervention ‐ not remote asthma reviews |
Finkelstein 2005 | Wrong intervention ‐ technology‐based self management between reviews |
Fonseca 2006 | Wrong design ‐ survey of RCT participants |
Foster 2014 | Wrong intervention ‐ adherence intervention |
Friedman 1999 | Wrong intervention ‐ mostly automated home monitoring, not remote reviews |
Garbutt 2010 | Wrong intervention ‐ asthma coaching/education intervention over the phone, not remote reviews |
Guendelman 2002 | Wrong intervention ‐ technology‐based self management between reviews |
Gustafson 2012 | Wrong intervention ‐ self‐determination theory intervention, not remote reviews |
Halterman 2012 | Wrong intervention ‐ technology‐based self management between reviews |
Huang 2013 | Wrong intervention ‐ support intervention, not remote reviews |
Jan 2007 | Wrong intervention ‐ technology‐based self management between reviews |
Janevic 2012 | Wrong intervention ‐ management intervention for African American women, not remote reviews |
Jerant 2003 | Wrong intervention ‐ mixed diagnosis study comparing models of delivering home care |
Kattan 2006 | Wrong intervention ‐ minimal or no provider involvement |
Khan 2003 | Wrong intervention ‐ one phone call at discharge, not remote reviews |
Kojima 2005 | Wrong intervention ‐ not technology‐based |
Kokubu 1999 | Wrong intervention ‐ technology‐based self management between reviews |
Lam 2011 | Wrong design ‐ cross‐sectional analysis of an ongoing RCT, and mixed diagnosis |
Liu 2011 | Wrong intervention ‐ technology‐based self management between reviews |
Lobach 2013 | Wrong intervention ‐ not about remote reviews |
McCowan 2001 | Wrong intervention ‐ computer‐aided decision support during consultation |
McPherson 2006 | Wrong intervention ‐ asthma education delivered via CD‐ROM and book versus book alone |
Merchant 2013 | Wrong intervention ‐ remote monitoring of inhaler adherence |
Morrison 2014 | Wrong intervention ‐ minimal or no provider involvement |
Murphy 2001 | Wrong design ‐ comment on a RCT |
NCT00149474 | Wrong comparison ‐ remote monitoring using PEF or symptoms |
NCT00232557 | Wrong comparison ‐ phone monitoring plus asthma education versus phone education |
NCT00411346 | Wrong intervention ‐ technology‐based self management between reviews |
NCT00562081 | Wrong intervention ‐ focus on asthma education not remote reviews |
NCT00910585 | Wrong intervention ‐ focus on asthma education not remote reviews |
NCT00964301 | Wrong intervention ‐ focus on asthma education not remote reviews |
NCT01117805 | Wrong intervention ‐ counselling not remote reviews |
Neville 1996 | Wrong intervention ‐ computer‐aided decision support during consultation |
Osman 1997 | Wrong intervention ‐ post admission follow‐up |
Ostojic 2005 | Wrong intervention ‐ technology‐based self management between reviews |
Pedram 2012 | Wrong intervention ‐ main focus of the study was to educate participants on how to use a peak flow meter |
Peruccio 2005 | Wrong intervention ‐ treatment awareness education delivered over the phone |
Petrie 2012 | Wrong intervention ‐ minimal or no provider involvement |
Prabhakaran 2009 | Wrong intervention ‐ technology‐based self management between reviews |
Price 2007 | Wrong intervention ‐ validating the Asthma Control Test for internet use |
Raat 2007 | Wrong design ‐ questionnaire not a RCT |
Rand 2005 | Wrong intervention ‐ study measuring validity of self‐report |
Ricci 2001 | Wrong intervention ‐ technology‐based self management between reviews |
Rikkers‐Mutsaerts 2012 | Wrong intervention ‐ minimal or no provider involvement |
Rosenzweig 2008 | Wrong intervention ‐ validation study |
Ryan 2012 | Wrong intervention ‐ technology‐based self management between reviews |
Schatz 2003 | Wrong comparison ‐ phone calls on top of face‐to‐face review, not instead of |
Schatz 2010 | Wrong intervention ‐ letter regarding validation of telephone delivery of the Asthma Control Questionnaire (ACQ) |
Searing 2012 | Wrong intervention ‐ minimal or no provider involvement |
Seid 2012 | Wrong intervention ‐ asthma education and motivational interviewing, not remote reviews |
Shanovich 2009 | Wrong intervention ‐ focus on asthma education not remote reviews |
Taitel 2014 | Wrong intervention ‐ pharmacy‐led compliance intervention, not remote reviews |
Uysal 2013 | Wrong intervention ‐ validating the Asthma Control Test via text messaging |
van den Berg 2002 | Wrong intervention ‐ general practitioner (GP) telephone access to paediatricians |
van der Meer 2009 | Wrong intervention ‐ technology‐based self management between reviews |
van Gaalen 2012 | Wrong intervention ‐ multifaceted intervention, not just remote reviews |
van Reisen 2010 | Wrong intervention ‐ multifaceted intervention, not just remote reviews |
Vasbinder 2013 | Wrong intervention ‐ minimal or no provider involvement. Medication reminder system |
Vollmer 2006 | Wrong intervention ‐ technology‐based self management between reviews |
Voorend‐van Bergen 2013 | Wrong intervention ‐ FeNO and Internet‐based monitoring |
Wiecha 2007 | Wrong intervention ‐ multi‐faceted intervention, not just about remote monitoring |
Willems 2008 | Wrong intervention ‐ technology‐based self management between reviews |
Young 2012 | Wrong intervention ‐ technology‐based self management between reviews |
Yun 2013 | Wrong intervention ‐ asthma education via text, not remote reviews |
Zachgo 2002 | Wrong intervention ‐ computer works out best inhaler type for patient |
Abbreviations: RCT = randomised controlled trial; PEF = peak expiratory flow.
Differences between protocol and review
We assessed participant and personnel blinding separately for the objective and subjective outcomes, which we had not planned in the protocol (Kew 2015b). We were unable to conduct the subgroup analyses for age and type of technology due to an insufficient number of included studies.
We included exacerbations that required hospital admission rather than adverse events in the 'Summary of findings' table. We could not include both as we had to keep to seven outcomes to adhere to guidelines, and we considered the hospital admission data to be more important than all adverse events which tended to be reported as part of the exacerbation and resource us data in the studies.
We removed a sentence about searching manufacturer websites from the methods as it came from a template and is irrelevant to this research question.
As discussed in the 'Unit of analysis issues' section, we did not anticipate the inclusion of a cluster randomised controlled trial (RCT) so we had not outlined how we would deal with Pinnock 2007a, a large two‐cluster implementation study that we identified. We included it because it met the other inclusion criteria, but we presented it separately from the other studies due to the differences in the study's design and analyses. For clarity in the analyses and write‐up, we referred to Pinnock 2007a as the 'cluster implementation study' and Chan 2007, Gruffydd‐Jones 2005, Pinnock 2003 and Rasmussen 2005 as the 'efficacy RCTs'. There were only two clusters so we included the data with participants as the unit of analysis.
Contributions of authors
Kayleigh Kew (KK) wrote the text of the Background and Methods, with significant comments and clinical input from Christopher Cates (CJC). Both review authors extracted and checked the data. KK contacted study authors for additional data, entered data into the analyses and wrote up the results. Both review authors contributed to the results interpretation, grading of the evidence and preparation of the final manuscript.
Sources of support
Internal sources
-
Kayleigh Kew, UK.
Supported by St George's, University of London
External sources
-
National Institute for Health Research, UK.
Evidence to guide care in adults and children with asthma, 13/89/14
Declarations of interest
Kayleigh Kew has no known conflicts of interest.
Christopher Cates has no known conflicts of interest.
New
References
References to studies included in this review
Chan 2007 {published and unpublished data}
- Callahan CW. Asthma in‐home monitoring (AIM) trial. http://www.clinicaltrials.gov/ct/show/NCT00282516 (accessed 14 August 2015).
- Callahan CW, Chan DS, Hatch‐Pigott G, Manning N, Proffitt L, Lawless A, et al. One year randomized controlled trial of home telemonitoring of children with persistent asthma using store‐and‐forward technology vs office‐based care [Abstract]. American Thoracic Society 2005 International Conference; May 20‐25; San Diego, California. 2005:[C47] [Poster: A21].
- Chan DS, Callahan CW, Hatch‐Pigott VB, Lawless A, Proffitt HL, Manning NE, et al. Internet‐based home monitoring and education of children with asthma is comparable to ideal office‐based care: results of a 1‐year asthma in‐home monitoring trial. Pediatrics 2007;119(3):569‐78. [DOI] [PubMed] [Google Scholar]
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Gruffydd‐Jones 2005 {published and unpublished data}
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Pinnock 2007a {published and unpublished data}
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Cruz‐Correia 2007 {published data only}
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Deschildre 2012 {published data only}
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