Rice 2010.
Study characteristics | ||
Methods | RCT; follow‐up: 12 months; control: single intervention (1 page of information and telephone number) | |
Participants | Eligible: 743 Randomised: 743, I: 372, C: 371 Completed: 743, I: 323, C: 336 Mean age: I: 69 years, C: 71 years Sex (% male): I: 98, C: 98 Inclusion criteria: COPD diagnosed by spirometry; high risk for hospitalisation as predicted by 1 or more of the following during previous year; hospital admission or ED visit for COPD; long‐term home oxygen use or course of systemic corticosteroids for COPD Major exclusion criteria: any condition that might preclude effective participation in the study or that would reduce life expectancy to less than a year; no access to a telephone |
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Interventions | Chronic disease management programme of 12 months, including ‐ Group session (1‐1, 5‐hour): general information about COPD, medication, smoking cessation, vaccinations, and exercise ‐ All patients received an individualised written action plan including prescriptions for prednisone and antibiotics with contact information for a case manager. Participants were in possession of action plan medications at all times and were to refill prescriptions immediately upon initiating the action plan ‐ Case manager made monthly telephone calls Intervention duration: 12 months Disciplines involved: case manager, pharmacist |
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Outcomes | ED and hospital admissions related to COPD, SGRQ, mortality, number of telephone contacts | |
Notes | Dominant component: self‐management/action plan | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "we assigned subjects in equal proportions to each of the two treatment arms by permuted Block randomisation" |
Allocation concealment (selection bias) | Unclear risk | Comment: information not available |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: participants and treating therapists not likely to have been blinded to group allocation |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "blinded pulmonologists independently reviewed all discharge summaries and ED reports and assigned a primary cause for each" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: all outcome data reported; concordance between outcome observers was tested in subsets and was 96.5% |
Selective reporting (reporting bias) | Low risk | Comment: no missing outcome data |