Wakabayashi 2011.
| Study characteristics | ||
| Methods | RCT; follow‐up 12 months; control group: single intervention (education) | |
| Participants | Eligible: 102 Randomised: 102; I: 52, C: 50 Completed: 85; I: 42, C: 43 Inclusion criteria: clinical diagnosis of COPD, > 65 years, exclusively visited clinic with monthly scheduled appointments, history of cigarette smoking Exclusion criteria: history of atopy or any apparent asthmatic features, illiterate or with cognitive impairment score < 26 on MMSE, lived in a residential care facility or nursing home, exacerbations during preceding 3 months, other respiratory disease such as bronchiectasis, any type of pulmonary fibrosis or congestive heart failure |
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| Interventions | Patients underwent a programme of educational sessions for 6 months, individually tailored according to their domain scores on the LINQ questionnaire, which was designed to assess the need for information from the patient's perspective. Programme was given by respiratory nurses and pulmonary physicians. There were six domains: (1) understanding of COPD, (2) pharmacological treatments, (3) exercise, (4) avoidance of exacerbations, including action plan with instructions in the event of exacerbation, (5) smoking cessation, (6) nutrition. All patients were provided with a booklet that was used during each session. After intensive education period, each patient was followed up for 6 months in the same way as patients in the usual care group Intervention duration: 6 months Disciplines involved: nurse, pulmonologist |
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| Outcomes | FEV₁, MRC, SGRQ, 6MWD, Lung Information Needs Questionnaire (LINQ), BMI, BODE Index (body mass index, dyspnoea, airflow obstruction, exercise capacity), activities of daily living (ADL), comorbidities, hospitalisations | |
| Notes | Dominant component: self‐management/action plan | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "a case manager independent of the study randomly assigned patients to either group I or group U using a computer‐generated list" |
| Allocation concealment (selection bias) | Low risk | Quote: "patients' allocations were sealed in numbered envelopes by an independent evaluator, not involved in the interventions" |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: p articipants and treating therapists not likely to have been blinded to group allocation |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "an independent evaluator, who assessed outcomes at the beginning of the study, after initial integrated education (6 months), and after follow‐up period (6 months)" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: c omparable dropout rates between groups |
| 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 |