Bourbeau 2003.
Study characteristics | ||
Methods | RCT; follow‐up: 12 months; control group: usual care | |
Participants | Eligible: 469 Randomised: 191, I: 95, C: 95 Completed: 165, I: 79, C: 86 Mean age: I: 69 years, C: 70 years Sex (% male): I: 52, C: 59 Inclusion criteria: stable COPD with ≥ 1 hospitalisation for an exacerbation in preceding year, age ≥ 50 years, pack‐years ≥ 10 years, FEV₁% predicted (post‐bronchodilator): 25% to 70%, FEV₁/FVC < 70% Major exclusions: no previous diagnosis of asthma or left congestive heart failure, terminal disease, dementia, uncontrolled psychiatric disease, no pulmonary rehab < 1 years ago, no long‐term facility stays |
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Interventions | Disease‐specific self‐management programme (Living Well With COPD) of 7 to 8 weeks' follow‐up including ‐ Individual sessions of education by an experienced health professional at the patient's home ‐ Content of education: COPD knowledge, breathing and coughing techniques, energy conservation during day‐by‐day activities, relaxation exercises; preventing and controlling symptoms through inhalation techniques, understanding and using a plan of action for acute exacerbation, adopting a healthy lifestyle, leisure activities and travelling, a simple home exercise programme. and long‐term home oxygen therapy ‐ An action plan for acute exacerbations was customised for each patient Intensity: education 1 hour per week during 7 to 8 weeks, follow‐up first 2 months' weekly telephone calls, then once‐a‐month telephone call. Exercise evaluation (not mandatory): 3 times per week, 30‐ to 45‐minutes/session + exercise teaching Intervention duration: 8 weeks followed by 10 months maintenance Involved disciplines: nurse, physiotherapist, physician, pulmonologist |
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Outcomes | SGRQ, exacerbations, spirometry, FEV₁ (L), forced vital capacity, hospital admissions, symptoms, emergency room visits, outpatients visits, 6MWD, walking distance | |
Notes | Dominant component: self‐management (including action plan) | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "patients underwent randomisation with the use of a central computer‐generated list of random numbers. Randomization was stratified per centre and in blocks of 6, and patients were assigned to the self management program (intervention group) or to usual care" |
Allocation concealment (selection bias) | Low risk | Quote: "the blocking factor was not known by the investigators or their staff in each participating centre" |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "since a double‐blind design was impossible ..." |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: ".. an independent evaluator unaware of the patient assignment was responsible for the evaluation process in each centre. The evaluator was cautioned not to ask about the workbook modules and types of contact" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "an intention to treat analysis included all available study patients" |
Selective reporting (reporting bias) | High risk | Comment: data on the 6MWD not presented but stated only as "not statistically significant"; study authors cannot provide us with additional data |