Fan 2012.
| Study characteristics | ||
| Methods | RCT; intended follow‐up: 12 months (terminated early, mean follow‐up 250 days); control: usual care (general information booklet COPD) | |
| Participants | Eligible: 426 Randomised: 426, I: 209, C: 217 Completed: 126, I: 197, C: 193 Mean age: I: 66.2 years, C: 65.8 years Sex (% male): I: 97.6, C: 96.3 Inclusion criteria: hospitalised for COPD in the 12 months before enrolment, post‐bronchodilator ratio of FEV₁ to FVC < 0.70 with FEV₁ < 80% predicted, older than 40 years, current or past history of cigarette smoking (> 10 pack‐years), ≥ 1 visit in the past year to a primary care or pulmonary clinic at a Veterans Affairs (VA) medical centre, no COPD exacerbation in the past 4 weeks, ability to speak English, access to a telephone Major exclusions: primary diagnosis of asthma or any medical condition that would impair ability to participate in the study or to provide informed consent |
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| Interventions | Comprehensive care management programme ‐ COPD education during 4 individual 90‐minute weekly sessions and 1 group session ‐ Action plan for identification and treatment of exacerbations and scheduled proactive telephone calls for case management Patients in both intervention and usual care groups received a COPD informational booklet specially designed for the study; primary care providers received a copy of COPD guidelines and were advised to manage patients according to these guidelines Intervention duration: 4 week s followed by 11 months ' structural follow‐up Disciplines involved: primary care physician, case manager (nurse) |
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| Outcomes | Time to first COPD hospitalisation (primary outcome); all‐cause hospitalisations; self‐reported COPD exacerbations; number of COPD exacerbations treated with prednisone/antibiotic; delay to prednisone/antibiotic treatment; all‐cause mortality; COPD‐related mortality; SGRQ; Veterans Medical Outcomes Study Short Form‐12; Patient Health Questionnaire (depressive symptoms); COPD‐related knowledge; self‐efficacy questionnaire | |
| Notes | Dominant component: self‐management Trial was stopped early when a safety monitoring board noted more deaths in the intervention group. Deaths due to COPD accounted for the largest difference: 10 in the intervention group vs 3 in the usual care group |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "the Cooperative Studies Program Coordinating Center in Boston, Massachusetts, randomly assigned eligible patients in equal numbers to 2 groups, stratifying patients by site to allow for possible regional differences in patient characteristics and clinical practice patterns" |
| Allocation concealment (selection bias) | Unclear risk | Comment: unclear whether investigators had access to randomisation lists |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "the 2 groups differed on the basis of a complex behavioral intervention that made blinding impossible" Comment: majority of outcomes are self‐reported and may be affected by performance bias. However, not all outcomes (hospitalisation, mortality) are likely to be affected by performance bias |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "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”; "3 blinded pulmonologists reviewed discharge summaries and other available information to determine the primary cause of all hospitalisations and classified them as COPD‐related (exacerbation or pneumonia), cardiovascular, or other” |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Quote: "citing serious safety concerns, the data monitoring committee terminated the intervention before the trial’s planned completion after 426 (44%) of the planned total of 960 patients were enrolled"; "available data could not fully explain the excess mortality in the intervention group. Ability to assess the quality of the educational sessions provided by the case managers was limited" Comment: study was terminated before planned 12‐month follow‐up period. However, based on computed data, results are likely to be the same if the study would have been continued |
| Selective reporting (reporting bias) | Low risk | Comment: health care‐related costs, health service use, and medication adherence were not reported in the paper. Selective reporting probably due to early termination of the study. Given negative findings that were reported, it appears unlikely that selective reporting influences the conclusions reached. Full protocol requested from investigators but not received |
| Adequate analysis methods for CRT | Unclear risk | , |