Jarab 2012.
Study characteristics | ||
Methods |
Design: RCT Duration: 26 weeks Location: Jordan Setting: 1 outpatient COPD Clinic at the Royal Medical Services Hospital |
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Participants |
Population: 133 participants with COPD randomly assigned to structured patient education (n = 66) or a control group (n = 67) Baseline characteristics COPD severity: moderate to severe Age (median): structured patient education 61 (IQR 14) years; control 64 (IQR 15) years % male: structured patient education 39.4%; control 41.8% FEV1 (mean) each group 1.1 (SD 0.5) L Inclusion criteria: people attending the outpatient COPD clinic at the Royal Medical Services, confirmed diagnosis of COPD by the hospital consultant for ≥ 1 year, aged > 35 years, FEV1 30–80% of the predicted normal value and hospital consultant agreement that the person was suitable for entering the trial Exclusion criteria: moderate‐to‐severe learning difficulties, mobility problems, confusion, disorientation or terminal illness, congestive heart failure or if patients attended a pulmonary rehabilitation programme or had consulted a pulmonary nurse or clinical pharmacist in the last 6 months |
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Interventions |
Treatment arms
Allowed co‐medications: median 8 (IQR 5) in each group |
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Outcomes |
Primary outcome: HRQoL improvement (SGRQ) Secondary outcomes: healthcare utilisation, COPD knowledge, medication adherence (self‐report) |
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Notes |
Funding: Alzaytoonah University of Jordan Identifiers: DOI: 10.1007/s11096‐011‐9585‐z |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Participants were randomly assigned to intervention and control groups via minimisation technique using MINIM software." |
Allocation concealment (selection bias) | Unclear risk | Not reported. |
Blinding of participants and personnel (performance bias) all outcomes | Unclear risk | Not reported. |
Blinding of outcome assessment (detection bias) all outcomes | Unclear risk | Not reported. |
Incomplete outcome data (attrition bias) all outcomes | Unclear risk | Attrition rate similar in both groups; however, there was no explanation of the people who withdrew, and the analysis was not ITT. |
Selective reporting (reporting bias) | Unclear risk | Trial protocol was not found, unclear if outcomes were reported as planned. |
Other bias | Low risk | None identified. |