Trappenburg 2011.
| Study characteristics | ||
| Methods | RCT; follow‐up 6 months; control group: usual care | |
| Participants | Eligible: 391 Randomised: 233, I: 111, C: 122 Completed: 193, I: 91, C: 102 Mean age: I: 66 years, C: 65 years Sex (% male): I: 65, C: 69 Inclusion criteria: COPD diagnosed by spirometry, age > 40 years, smoking history > 20 years or 15 pack‐years, diagnosis of COPD as a major functionally limiting disease, current use of bronchodilator therapy Major exclusions: primary diagnosis of asthma, primary diagnosis of cardiac disease, presence of disease that could affect mortality or participation in the study |
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| Interventions | 6‐month self‐management/action plan programme ‐ Individualised action plan with treatment prescriptions related to color‐coded symptom status to enhance adequate response to periods of symptom deterioration ‐ Action plan included ongoing support of case manager, in concordance with GP/respiratory physician. 2 reinforcement sessions provided by telephone at 1 and 4 months Intervention duration: 6 months Disciplines involved: GP, nurse, pulmonologist |
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| Outcomes | Exacerbation rate and recovery time; SGRQ; HADS; courses of antibiotics, corticosteroids; ED visits for exacerbation; CCQ score during exacerbation | |
| Notes | Dominant component: self‐management/action plan | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "randomisation was carried out using the minimization technique to balance the control and intervention groups for centre and gender" |
| Allocation concealment (selection bias) | Low risk | Quote: "to conceal the assignment sequence, a central web‐based service was used" |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "an informed consent to postponed information procedure is used, keeping the patient unaware of the AP being the major study aim. This implies that all patients are informed about the fact that, besides the outcome assessment aiming at gaining more insight in daily symptom variations, the study has another purpose. Patients are told that they will be informed about this additional research question only after follow up because informing during recruitment would affect study results" |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "investigators were blinded to allocation" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "monthly discontinuation rates and reasons for withdrawal are comparable in both study arms" |
| 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 |