Wood‐Baker 2006.
| Study characteristics | ||
| Methods | Cluster‐RCT; follow‐up 12 months, control group: education + usual care | |
| Participants | Eligible: 218
Randomised: 138; I: 67, C: 72
Completed (12 months): 112; I: 54, C: 58
Mean age: I: 69 years, C: 71 years
Sex (% male): I: 49, C: 71 Inclusion criteria: COPD diagnosed by spirometry, age > 50 years, tobacco smoking history > 10 pack‐years, FEV₁ < 65% predicted Major e xclusion criterion: nursing home residents |
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| Interventions | Control + intervention group: COPD information booklet, individual educational session with nurse Intervention group: written self‐management plan, which was developed in consultation with the treating GP. Patients were encouraged to make early contact with GP during an exacerbation Intervention duration: 12 months Disciplines involved: GP, nurse |
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| Outcomes | SGRQ, exacerbations (courses of antibiotics/prednisone), ED visits, hospital admissions, GP consultations, spirometry, mortality, physical exercise (pedometer) | |
| Notes | Before commencement of the randomisation process, only 50% of included GPs attended 1 of a series of educational workshops on management of COPD Dominant component: self‐management/action plan | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "practices were randomised to the intervention or control group using a computer generated randomisation software package“ |
| Allocation concealment (selection bias) | Unclear risk | Comment: n o information provided |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: it is not likely that participants and personnel have been blinded |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "baseline, 6‐ and 12‐month assessments involved face to face contact with a research nurse at the GP’s surgery or at patient's home“ |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: 13 intervention patients vs 14 control patients missing at 6 months; reasons similar |
| Selective reporting (reporting bias) | Low risk | Comment: study protocol is not available, but it is clear that published reports include all expected outcomes, including those that were pre‐specified |
| Recruitment bias | Low risk | Comment: no information provided |
| Baseline imbalance between groups | High risk | Comment: baseline imbalance between groups |
| Loss to follow‐up of clusters | Low risk | Comment: no missing clusters |
| Adequate analysis methods for CRT | High risk | Comment: no adjustments for cluster‐randomised trials |