Risk of bias for analysis 1.5 Healthcare utilisation: respiratory‐related hospital admissions (number of participants with at least one admission) (primary analysis).
| Study | Bias | |||||||||||
| Randomisation process | Deviations from intended interventions | Missing outcome data | Measurement of the outcome | Selection of the reported results | Overall | |||||||
| Authors' judgement | Support for judgement | Authors' judgement | Support for judgement | Authors' judgement | Support for judgement | Authors' judgement | Support for judgement | Authors' judgement | Support for judgement | Authors' judgement | Support for judgement | |
| Gallefoss 1999 | Low risk of bias | Comment: At inclusion they signed a written consent and were then randomised to an intervention group or a control group. | High risk of bias |
Effect of assignment:
Comment: No information reported about blinding, but it is almost impossible to blind these patients because of the nature of the intervention. Furthermore, no information was reported whether deviations arose from the intended intervention because of the trial context. Effect of adhering: "Forty‐six percent of those educated (12 of 26) received a standard treatment plan. Non‐standard treatment plans, incorporating the use of oral steroids as the first line of action in the yellow zone, were followed in some cases, for example, if the patient already used high dosages of inhaled steroids as maintenance therapy, or could report that a double or triple increase in inhaled steroids previously had shown marginal effect on the course of attacks/exacerbations. Among those 14 patients receiving non‐standard treatment plans, eight patients did not want to or were not able to use peak flow monitoring as a basis for change in medication. For those patients, symptom‐only based treatment plans were issued." Gallefoss 2002, p. 425. "In the intervention group, four patients failed to complete the educational program (social problems (n = 1), unannounced emigration (n = 1), failure to meet at educational group sessions for unknown reasons (n = 1) and serious myocardial infarction (n = 1))." Gallefoss 2002, p. 427. Comment: No information reported about adherence to the programme of the other patients (who completed the programme). |
High risk of bias | “In the intervention group, four patients failed to complete the educational programme (social problems (n = 1), unannounced emigration (n = 1), failure to meet at educational group sessions for unknown reasons (n = 1) and serious myocardial infarction (n = 1)). Another patient was withdrawn from the study during the follow‐up due to lymphoma (n = 1). This left us with 26 patients (81%) for a 1‐year follow‐up. The patients who were withdrawn from the intervention group did not, to our knowledge, have any serious deterioration in their obstructive lung disease, and none were hospitalised. In the control group four patients were withdrawn (lack of co‐operation (n = 2), diagnosis of rectal cancer (n = 1) and emigration (n = 1)). Two of the withdrawn control group patients were hospitalised for exacerbations of their COPD. This left us with 27 patients (84%) for the 1‐year follow‐up” Gallefoss 2002, p. 427. Comment: The number of dropouts was relatively low, and reasons for dropout were comparable over groups |
High risk of bias | "Prebronchodilator spirometry was performed before randomization and at 12 mo follow‐up by standard methods using a Jaeger MasterLab Body Box (Würzburg, Germany). The technical staff did not know whether the patients belonged to the control or intervention groups." Gallefoss 1999, p. 2003. Comment: No information reported regarding the assessors of the primary outcome. Number of prednisolone courses was retrospectively self‐reported at 12 months of follow‐up. |
Some concerns | "We defined a priori the patient as compliant when dispensed regular medication was greater than 75% of prescribed regular medication during the study period." Gallefoss 1999, p. 2002. | High risk of bias | Unpredictable direction of the outcome. |
| Bourbeau 2003 | Low risk of bias | “… central computergenerated list of random numbers. Randomization was stratified per center and in blocks of 6, and patients were assigned to the self‐management program (intervention group) or to usual care.” p. 586. “The blocking factor was not known by the investigators or their staff in each participating center." p. 586. “The use of respiratory medications was similar between study groups, except that oral steroids were used less commonly in the intervention group (7%) than in the usual care group (13%). None of the disease severity characteristics were otherwise different between the study groups.” p. 586. Comment: Random sequence allocation was adequately performed. |
High risk of bias |
Effect of assignment:
"Since a double‐blind design was impossible..." p. 586.
Comment: Participants and personnel were not blinded. ITT analysis was performed. Effect of adhering: "Since a double‐blind design was impossible..." p. 586. Comment: Participants and personnel were not blinded. Comment: There might be some imbalance in non‐protocol interventions such as exercise evaluation (not mandatory). However, no information available. |
Low risk of bias | ‐ | Low risk of bias | "...an independent evaluator unaware of the patient assignment was responsible for the evaluation process in each center. The evaluator was cautioned not to ask about the workbook modules and types of contact.” p. 586. Comment: Outcome assessment was blinded. |
Some concerns | Comment: No protocol or prespecified analysis plan available. | High risk of bias | Unpredictable direction of the outcome. |
| Coultas 2005 | Low risk of bias | “Patients were randomly assigned to one of three intervention groups (usual care (UC), nurse‐assisted medical management (MM), or nurse‐assisted collaborative management (CM)) using a computer‐generated random list.” p. 2018. “Although the distribution of most of the baseline characteristics of the three groups was similar (Tables 2 and 3), only the distribution of gender and the tangible domain of social support were significantly different among the intervention groups.” p. 2020. Comment: It is unclear how allocation concealment was guaranteed. Observed imbalances are probably compatible with chance. Random sequence generation was adequately performed. |
High risk of bias |
Effect of assignment:
“Of the 217 patients enrolled in the study, 151 (69.6%) completed the 6‐month intervention and follow‐up data collection.” p. 2020.
“The reasons for the failure to complete the study were patient was unavailable for follow‐up (26.7%) and death (3.7%) [Fig 1]. The frequency of patients being unavailable for follow‐up was equally distributed among the three intervention groups (Fig 1). Overall, the demographic characteristics of the patients who dropped out of the study were similar to those who completed the study (data not shown). However, patients who dropped out of the study had more severe airflow obstruction, higher levels of distress, and lower quality of life, as measured with the SGRQ, compared with the patients who had completed the study (data not shown).” p. 2020.
Comment: Not reported whether deviations arose because of the trial context. Only patients who completed the 6‐month intervention and follow‐up data collection were analysed (per‐protocol analyses). Effect of adhering: Comment: Patients and personnnel were probably aware of assignment to the intervention during the trial. |
High risk of bias | “The reasons for the failure to complete the study were patient was unavailable for follow‐up (26.7%) and death (3.7%).” p. 2020. “However, patients who dropped out of the study had more severe airflow obstruction, higher levels of distress, and lower quality of life, as measured with the SGRQ, compared with the patients who had completed the study (data not shown).” p. 2020. Comment: Only patients who completed the 6‐month intervention and follow‐up data collection were analysed. |
Low risk of bias | “To limit interviewer bias, each interviewer who obtained the baseline and 6‐month outcome data was blinded to the patient’s treatment group.” p. 2023. "Although self‐reported health‐care utilization may be subject to recall bias, it has been shown to be an acceptable method of measurement and may actually result in an underestimation of utilization with more frequent use.” p. 2023. |
Some concerns | Comment: No protocol available. Measures and analysis intentions were only reported in the method section of the paper. | High risk of bias | Unpredictable direction of the outcome. |
| Coultas 2005 | Low risk of bias | “Patients were randomly assigned to one of three intervention groups (usual care (UC), nurse‐assisted medical management (MM), or nurse‐assisted collaborative management (CM)) using a computer‐generated random list.” p. 2018. “Although the distribution of most of the baseline characteristics of the three groups was similar (Tables 2 and 3), only the distribution of gender and the tangible domain of social support were significantly different among the intervention groups.” p. 2020. Comment: It is unclear how allocation concealment was guaranteed. Observed imbalances are probably compatible with chance. Random sequence generation was adequately performed. |
High risk of bias |
Effect of assignment:
“Of the 217 patients enrolled in the study, 151 (69.6%) completed the 6‐month intervention and follow‐up data collection.” p. 2020.
“The reasons for the failure to complete the study were patient was unavailable for follow‐up (26.7%) and death (3.7%) [Fig 1]. The frequency of patients being unavailable for follow‐up was equally distributed among the three intervention groups (Fig 1). Overall, the demographic characteristics of the patients who dropped out of the study were similar to those who completed the study (data not shown). However, patients who dropped out of the study had more severe airflow obstruction, higher levels of distress, and lower quality of life, as measured with the SGRQ, compared with the patients who had completed the study (data not shown).” p. 2020.
Comment: Not reported whether deviations arose because of the trial context. Only patients who completed the 6‐month intervention and follow‐up data collection were analysed (per‐protocol analyses). Effect of adhering: Comment: Patients and personnnel were probably aware of assignment to the intervention during the trial. |
High risk of bias | “The reasons for the failure to complete the study were patient was unavailable for follow‐up (26.7%) and death (3.7%).” p. 2020. “However, patients who dropped out of the study had more severe airflow obstruction, higher levels of distress, and lower quality of life, as measured with the SGRQ, compared with the patients who had completed the study (data not shown).” p. 2020. Comment: Only patients who completed the 6‐month intervention and follow‐up data collection were analysed. |
Low risk of bias | “To limit interviewer bias, each interviewer who obtained the baseline and 6‐month outcome data was blinded to the patient’s treatment group.” p. 2023. "Although self‐reported health‐care utilization may be subject to recall bias, it has been shown to be an acceptable method of measurement and may actually result in an underestimation of utilization with more frequent use.” p. 2023. |
Some concerns | Comment: No protocol available. Measures and analysis intentions were only reported in the method section of the paper. | High risk of bias | Unpredictable direction of the outcome. |
| Rice 2010 | Some concerns | "We assigned subjects in equal proportions to each of the two treatment arms by permuted‐block randomisation." Appendix 1, p. 3. "The baseline characteristics of the two treatment groups were generally well matched, with differences in age, lung function, and ED visits (not significant)." p. 891. Comment: Information on the method of allocation concealment was not reported. |
High risk of bias |
Effect of assignment:
"We performed a randomized, adjudicator‐blinded, controlled, 1‐year trial." p. 890.
"The status of all 743 patients was determined after 1 year. Electronic medical records were available for all hospitalizations and ED visits that occurred within the VA medical system. The success rate for obtaining discharge summaries and ED records for self‐reported events that occurred outside the VA was 99% in the usual care group and 98% in the disease management group." p. 891. Effect of adhering: Comment: 336 out of 372 (90.3%) patients completed disease management 323 out of 371 (87%) completed usual care. |
Low risk of bias | "55% of patients in the usual care group and 60% of patients in the disease management group returned a completed the Saint George’s Respiratory Questionnaire in response to a single mailing at the end of the study. low response rates on SGRQ leading to a high risk of bias. However, data on healthcare utilisation seem complete with no risk of bias." p. 892. | Low risk of bias | "Blinded pulmonologists independently reviewed all discharge summaries and ED reports and assigned a primary cause for each." p. 891. | High risk of bias | Comment: Primary outcome in the paper is reported as a combined outcome measure, whereas it was planned to analyse the two outcomes separately. | High risk of bias | Unpredictable direction of the outcome. |
| Bucknall 2012 | Low risk of bias | “We used a minimisation technique to stratify randomisation of participants by demographic factors (deprivation category of area of residence,11 age and sex, FEV1 per cent predicted at the time of randomisation, smoking status, participation in pulmonary rehabilitation within two years, and number of previous admissions) to control for key aspects of disease severity and predictors of readmission. We constructed a computer generated sequence by using the method of randomised permuted blocks of length four, with two allocations being made at random and two by minimisation. Treatment group allocations were obtained by telephone, after baseline assessments had been made.” p 2. Comment: Random sequence allocation was adequately performed. |
High risk of bias |
Effect of assignment:
Comment: No blinding of patients and personnel. Data for the primary outcome (time to first acute COPD hospital admission or death) were available for all patients and analysed with a Cox proportional hazards model adjusting for the stratification variables. Effect of adhering: Comment: No blinding of patients and personnel. Seventy‐five (42%) of 180 intervention group participants who completed 12 months of follow‐up were judged to have become successful self managers. |
Low risk of bias | Comment: Only for secondary outcome measures (e.g. SGRQ, HADS, CSES) not all data were available for all patients randomised (Table 3). | Low risk of bias | ‐ | Some concerns | ‐ | High risk of bias | Unpredictable direction of the outcome. |
| Fan 2012 | Low risk of bias | “Randomization lists were generated on the basis of random, permuted blocks of variable size to ensure approximate balance over time.” p. 674. “The CSP Coordinating Center in Boston, Massachusetts, randomly assigned eligible patients in equal numbers to 2 groups, stratifying patients per site to allow for possible regional differences in patient characteristics and clinical practice patterns.” p. 674. Comment: Random sequence generation was adequately performed. The allocation was adequately concealed. Authors didn’t report whether there were any significant differences. Most characteristics are equally balanced, but there is a bit larger difference in the following characteristics (>5%):
|
High risk of bias |
Effect of assignment:
“The 2 groups differed on the basis of a complex behavioral intervention that made blinding impossible.” p. 674.
Comment: No blinding of participants and personnel.
"For the primary intention‐to‐treat analysis, the null hypothesis was that the COPD hospitalization hazard rate for intervention did not differ from that for standardized care."p. 675.
"Also, with respect to time to first COPD hospitalization, we conducted a futility analysis to assess what might have resulted if the trial had continued." p. 676.
"When the study was stopped, the 1‐year cumulative incidence of COPD‐related hospitalization was 27% in the intervention group and 24% in the usual care group (hazard ratio, 1.13 [95% CI, 0.70 to 1.80]; P 0.62)." p. 677. Effect of adhering: "During the entire follow‐up period extending to September 2009, a total of 8 patients in the intervention group and 10 in the usual care group either did not attend scheduled study visits or formally withdrew from the study. Among patients in the intervention group, 87% completed all 4 individual educational visits and 57% completed the group visit. A review of the recorded sessions found that case managers covered 77% to 89% of the educational items in each session. The ranges of average scores across sites that provided audio recordings for each session were 18.3 to 31 for session 1 (13 sites), 12 to 19 for session 2 (12 sites), 12.7 to 23 for session 3 (10 sites), and 6 to 18 for session 4 (10 sites)." p. 677. |
High risk of bias | “This multisite, randomized, controlled trial of an educational and acute care management program was stopped early when a safety monitoring board noted more deaths in the intervention group.” p. 674 Comment: There is incomplete outcome data due to early termination of the study. |
Low risk of bias | “Telephone‐based ascertainment of study outcomes (COPD hospitalizations and exacerbations) was performed by centralized research staff blinded to assignment. All outcomes were collected by centralized staff blinded to study group, and all hospitalizations were adjudicated by a committee that was also blinded to study group.” p. 674. Comment: Research staff blinded to study group contacted patients every 2 months to determine whether they developed symptoms of a COPD exacerbation, along with details of treatment and health care use. Deaths were ascertained by staff at the study sites, by review of VA electronic medical and administrative records and by a search of the Social Security Death Index. Extensive multivariate analyses failed to identify any factors alone or combined that could plausibly explain the difference in mortality. Two of the authors who were blinded to study group reviewed all available medical information and did not find anything in the deaths that would not be expected in frail patients with COPD. |
Some concerns | Comment: The primary and secondary outcomes were reported, only healthcare costs as (secondary objective) were not reported. | High risk of bias | Predicted directon: Favours comparator, because more deaths in the intervention group were observed. There is still a chance that this was because of chance. |
| Walters 2013 | High risk of bias |
Randomisation process:
"After recruitment, practices were randomised using a code generated by investigators from a random numbers table stratified in blocks of four by Rural, Remote and Metropolitan Areas (RRMA) classifications in Tasmania. Allocation occurred independently using sequentially numbered, opaque and sealed envelopes." p. 2. Timing of identification or recruitment of participants: GPs identified patients with COPD aged over 45 years seen within the previous 12 months through database searches, based on a diagnostic code for COPD or prescription of tiotropium. Comment: Most variables are equally distributed, but more smokers (not statistically significant, p=0.102) and more previous admissions in the intervention group (statistically significant, p=0.028), so potentially more room for improvement. Although, this small number of differences identified as ‘statistically significant’ at the conventional 0.05 threshold should usually be considered to be compatible with chance. |
High risk of bias |
Effect of assignment:
‐ Effect of adhering: "The limitations of the study were the high rate of misclassification of COPD in general practices, which impacted on enrolment, and higher than expected withdrawal rates, especially in the HM group, which reduced the intended statistical power." p. 6. Comment: Nine patients discontinued and 8 patients withdrew in the intervention group. |
Low risk of bias | Comment: Figure 1: 9 intervention patients discontinued, but they attended follow‐up. In Table 3, no patient numbers are mentioned. | Low risk of bias | Comment: Blinding of participants or research officers was not possible given the nature of the study. | Low risk of bias | Comment: Data that produced this result analysed in accordance with a pre‐specified analysis plan. | High risk of bias | Unpredictable direction of the outcome. |
| Mitchell 2014 | Low risk of bias | “Patients were assigned to either usual care or SPACE FOR COPD via a web‐based, concealed allocation programme, using simple randomisation codes prepared by the trial statistician (J. Bankart).” p. 1539.
"Randomisation was conducted by the trial investigator responsible for administering the intervention (K.E. Mitchell).” p. 1539. Comment: Random sequence allocation was adequately performed. The method of allocation concealment was not reported, but they say it is concealed. The only significant baseline difference between treatment groups was the CRQ‐SR dyspnoea score; therefore, this was corrected for in subsequent analyses. |
High risk of bias |
Effect of assignment:
“Lack of participant blinding may have increased motivation when receiving the treatment and attempts to satisfy the researchers might have increased the observed treatment effects in the intervention arm. We cannot, therefore, rule out the possible impact of attention.” p. 1546.
Comment: No blinding of participants. Analysis was carried out on an intention‐to‐treat basis. Effect of adhering: Comment: Withdrawal around intervention group: 27% and UC: 17%. The adherence of using the manual in by the intervention patients was not reported. |
Low risk of bias | Comment: Data were not available for all randomised patients (withdrawal intervention: 27%, usual care: 17%). However, they found no significant differences in demographics or baseline variables between those who completed and those who did not complete the study. | Low risk of bias | “The assessments at week 6 and 6 months were conducted by a member of the research team who was blind to randomisation allocation (V. Johnson‐Warrington)." p. 1540 Comment: The outcome assessment was blinded. |
Low risk of bias | Comment: No signs for selective outcome reporting. The primary outcome measure and most of the secondary outcome measures were reported. | High risk of bias | Unpredictable direction of the outcome. |
| Tabak 2014 | Low risk of bias | "Patients were randomized using a computer‐generated randomization list (Blocked Stratified Randomization version 5; Steven Piantadosi), where randomization was applied in blocks of two and four.” p. 936. “Participants were allocated by a data manager in order of inclusion following the randomization list, placed in a sealed envelope.” p. 936. Comment: There was a significant difference in dyspnea (MRC scale) but this seems by chance. All other parameters seem evenly distributed. |
Some concerns |
Effect of assignment:
"To present the outcome measures over time in both groups, a mixed‐model analysis for repeated measures was performed (intention to treat)." p. 938.
Comment: Patients and personnel were not blinded. No information was reported regarding deviations from the intervention that arose because of the trial context. Effect of adhering: "Participants in the control group received only usual care. Patients in the control group were allowed to attend regular physiotherapy sessions if this was prescribed as part of usual care." p. 937. “Although some patients in the intervention group quit the physiotherapy modules ( exercising and activity coach) due to weak (n=l, < T l ) or unstable condition (n=l, <T2) and personal circumstances (n=2, <T4), they persisted in using the web portal and triage diary til! T4.” p. 939. Comment: Most outcome measures are reported for 3 months follow‐up, whereas there was a total of 9 months follow‐up. There was a high number of withdrawals for the 9 months follow‐up. However, there were more drop‐outs in the usual care control group than in the intervention group. |
High risk of bias | “A large number of patients were not able or willing to continue study participation: 33% in the intervention group and 86% in the control group.” p. 939. Comment: Most outcome measures are reported for 3 months follow‐up, whereas there was a total of 9 months follow‐up. There was a high number of withdrawals for the 9 months follow‐up (more dropouts in the control group). Reasons reported for patients from the control group: too much effort (n=2), exacerbation (n‐1), hospitalisation (n‐2), kidney problems (n‐1), exacerbation, and cancer (n‐1). |
Low risk of bias | ‐ | Low risk of bias | Comment: Not all outcome measures were reported for the 9 months follow‐up. Exacerbations (duration) were not reported. Also, no information or results provided for the use of diaries in the usual care control group. | High risk of bias | Unpredictable direction of the outcome. |
| Hernández 2015 | Low risk of bias | "A computer‐generated list of random numbers with no restrictions and administered by personnel who were not involved in the study ensured blinded randomisation." p. 2. "(…) and administered by personnel who were not involved in the study." p. 2. Comment: Random sequence generation was adequately performed. No blinding of participants or personnel. The patients of the two groups showed similar characteristics, except that influenza and pneumococcal vaccination were more prevalent in the IC group (P<0.01). |
High risk of bias |
Effect of assignment:
Comment: It was not possible to blind the treatment for patients and people delivering the treatment. Intention‐to‐treat analysis performed. Effect of adhering: "As a sensitivity analysis, we repeated all analyses after excluding patients who had a previous contact with any IC programme (n = 15)." p. 2. "25 patients (22%) died and 16 (14%) were lost during the 1‐year follow‐up, and the remaining 114 patients (IC, n = 59 and UC, n = 55) completed the 12‐month assessment visit. Patients lost to follow‐up exhibited a higher affectation of activities of daily living and health‐related quality of life at baseline than those who were followed up, without differences in other sociodemographic, clinical, functional and medical care‐related variables." p. 3. Comment: It is not mentioned in which way these patients were distributed over the two groups, nor are the results of the sensitivity analysis reported. Although the approach was not adequately adopted at the community level and thus the intervention was not continued after the 1 year of follow‐up, this was not a failure of implementing the intervention, since the intervention stopped at 1 year according to the protocol. |
Low risk of bias | ‐ | Low risk of bias | "A blind evaluation of the study group carried out before randomisation and after the 12‐month follow‐up consisted of a patient interview and analysis of medical records, self‐administered questionnaires and lung function testing." p. 2. | Some concerns | "Although the study was officially registered as part of the EU Grant (CIP‐ICT‐PSP‐2007.225025), the RCT was not included in the clinicaltrials.gov registry because at that time it was not compulsory." p. 5. Comment: No protocol available. |
High risk of bias | Unpredicted direction of outcome. |
| Titova 2015 | High risk of bias |
Randomisation process:
“They were randomly allocated to either integrated care (IC) or usual care (UC) based on their address of permanent residence. In order to create two pairs of districts with approximately equal numbers of citizens, a pair‐wise matching of districts was carried out. It was decided by lottery that participants from District Pair 1 were assigned to the UC group, and participants from District Pair 2 were assigned to the IC group.” Titova 2015, p. 2.
“There were no significant differences in baseline characteristics between the IC and the UC groups, but when comparing those who died during follow‐up with those who were still alive after two years, those who died had a significantly higher PaCO2 and lower BMI at baseline (Table 1). Those who died during follow‐up also had significantly more HA and HD during the year prior to study start.” Titova 2015, p. 4.
Comment: No information provided about the allocation concealment. Timing of identification or recruitment of participants: "They were randomly allocated to either IC or UC group based on their address of permanent residence. Patient data were registered at discharge and 6, 12, and 24 months after discharge from the TUH." Titova 2017, p 3. Comment: If allocation was known before study inclusion, suitable patients could be selected for the intervention. |
High risk of bias |
Effect of assignment:
“The study was a prospective, open, single‐centre intervention study.” Titova 2015, p. 2.
"The principal comparisons of changes were performed on an intention‐to treat basis." Titova 2017, p. 4.
Comment: No blinding of participants and personnel. Effect of adhering: ‐ |
High risk of bias | “172 patients were randomly allocated to the IC group (n = 91) or the UC group (n = 81), respectively. After two years of follow‐up, a total of 100 patients (58% of the included patients), 51 patients in the IC group and 49 patients in the UC group, were available for evaluation (Figure 1).” Titova 2017, p. 5. "Those who died had a significantly higher PaCO2 and lower BMI at baseline (Table 2). Those who died during follow‐up also had significantly more HA and HD during the year prior to study start." Titova 2015, p. 4. Comment: No mortality reported; however, Figure 1 shows higher mortality for the IC group, n=35 (38.4%), compared to the UC group, n=21 (25.9%). |
High risk of bias | “Information concerning the number and duration of the COPD exacerbations, as well as the time from onset of symptoms until the start of self‐initiated treatment is insufficient due to many incomplete registrations in “My COPD book.” Titova 2015, p. 9. "“Data concerning HA (hospital admissions) and HD (hospital days) were collected from the hospital registry database’s medical charts.” Titova 2015, p. 3. Comment: Unclear who was the outcome assessor. |
Some concerns | Trial register reported number of hospitalisations as the primary outcome. Secondary outcomes were quality of life, lung function, use of medication, cost‐effectiveness. However, the article reported not all secondary outcomes (e.g. cost‐effectiveness). | High risk of bias | Unpredictable direction of the outcome. |
| Sanchez‐Nieto 2016 | Some concerns | "Controlled, randomized, parallel‐group, single‐blind study with follow‐up of 1 year. After consenting to take part in the study, simple randomization was carried out separately at each site by means of a list of computer‐generated random numbers, assigning the patients to two groups." p. 1940. Comment: No information reported regarding concealed allocation sequence. |
High risk of bias |
Effect of assignment:
Comment: Patients and personnel were not blinded. No proper intention‐to‐treat analysis used, as the baseline characteristics of the people that have dropped out haven’t been included in the analyses. Patients lost to follow‐up were evaluated until the time of the last contact with them by the research staff. Effect of adhering: Comment: No information reported regarding adherence. |
High risk of bias | "In the end, 85 patients (88.5%) completed the study: 38 patients in the CG (18 (47.4%) in area VI and 20 (52.6%) in area I); and 47 patients in the IG (25 (53.2%) in area VI and 22 (46.8%) in area I; P=0.593). In the CG, seven patients were lost to follow‐up (one protocol violation and six dropouts), and in the IG, four were lost (one protocol violation and three dropouts)." p. 1942. Comment: Data were not available for all randomised patients. |
Low risk of bias | "Because double‐blinding was not possible, an independent evaluator, who did not know the patients’ group assignments, was responsible for evaluating the outcome variables." p. 1940. | High risk of bias | Comment: No trial register number and study protocol were available. | High risk of bias | Unpredictable direction of the outcome. |
| Benzo 2016 | Low risk of bias | Comment: Patients were randomly assigned, using an online, computer‐generated, simple binomial randomization program to one of the two groups, stratified by center. | High risk of bias |
Effect of assignment:
"85% of the individuals in the intervention group received the intervention as intended, defined as 15 (.70%) of 21 calls completed. Reasons for not completing the intervention were death during the study period (n = 3), unable to contact (n = 6), and refusal to complete the scheduled calls (n = 7)." p. 674.
Comment: It was possible to blind the treatment for patients and people delivering the treatment. Intention‐to‐treat analysis was used. Effect of adhering: "Attendance at pulmonary rehabilitation visits anytime in the first 12 months after discharge tended to be higher in the intervention group (53% vs. 43%; P = 0.056)." p. 675. "In the intervention group, 85% of the individuals received a complete intervention, defined as 15 (.70%) of 21 calls completed." p. 674. |
Low risk of bias | ‐ | Low risk of bias | Comment: Outcome assessors were blinded. | High risk of bias | Comment: No analysis plan available in the trial register. Furthermore, the trial register mentions that the outcomes will be assessed in the 12 months time frame, but not mentioned how and when they were assessed. Although 12 months analyses show no differences, the additional time points that were reported (not prespecified) are in favour of experimental. | High risk of bias | Predicted direction: Favours experimental. |
| Johnson‐Warrington 2016 | Low risk of bias | "Participants were randomized to receive usual care or SPACE for COPD via a web‐based, concealed allocation program (www.sealedenvelope.com) using simple random permuted block 1:1 randomization by VJ‐W. Randomization was performed after the participants completed the baseline assessment, with treatment allocation prior to hospital discharge." p. 1162. | Some concerns |
Effect of assignment:
"Analysis was conducted on an intention‐to‐treat basis." p. 1163. Effect of adhering: Patients and personnel were not blinded. No information regarding adherence reported. |
High risk of bias | Some patients were missing: n= 78 were randomized (n= 39 to each arm). Included in the analysis: Intervention: n= 35 and usual care: n= 36. | Low risk of bias | "All outcomes were measured at baseline (during admission but as close to discharge as possible) and 3 months after randomization, by a clinician blinded to treatment allocation." p. 1163. | Some concerns | No protocol including a pre‐specified analysis plan was available. | High risk of bias | Unpredictable direction of the outcome. |
| Lenferink 2019 | Low risk of bias | Comment: Allocation was stratified on potential confounders. Only a baseline difference in 6MWD was reported. | High risk of bias |
Effect of assignment:
Comment: It was not possible to blind the treatment for patients and people delivering the treatment. Intention‐to‐treat analyses were performed. Effect of adhering: "The 12‐month follow‐up was completed by 83.3% of the individuals in the self‐management group and 84.8% in the UC group (figure 1). Patients completed 81.3% (self‐management: 82.3%; UC: 80.2%) of the diary data." p. 6. Comment: The effect of adherence to the intervention was not analysed. However, it was observed that a high number of patients in completed follow‐up and their symptom diaries. Adherence to action plans was measured, but not yet reported in the current publication. |
Low risk of bias | Comment: Relatively low number of drop‐outs. The imputated data analyses showed similar results as the observed data analyses. | Low risk of bias | "Wherever possible, though, assessors of outcomes were blinded to the treatment group." p. 3. | Low risk of bias | Comment: Some small changes in final analyses compared to analysis plan that was published with the study protocol. | High risk of bias |
Additional bias:
"Based on the exacerbation rates/patient/day from the COPE‐II study (intervention: 0.116; control: 0.176, both with an estimated standard deviation of 0.17) and allowing for overdispersion and an attrition rate of 10%, 105 patients per group provided 80% power to detect an effect of this size, with a two‐tailed p<0.05." p. 4.
Comment: The study included less patients (intervention: n= 102; usual care: n= 99) than aimed by power calculation (both groups n= 105). Unpredicted direction of the outcome. |