Skip to main content
. 2021 Sep 8;2021(9):CD009437. doi: 10.1002/14651858.CD009437.pub3

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
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
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