Öztürk 2020.
| Study characteristics | ||
| Methods | RCT; follow‐up: 3 months; control group: usual care | |
| Participants | Eligible: 80 (consecutive inclusion) Randomised: 80, I: 40, C: 40 Completed: 63, I: 31, C: 30 Mean age: I: 65 years, C: 61 years Sex (% male): I: 94, C: 83 Inclusion criteria: aged 45 to 75 years with moderate and/or severe COPD Major exclusion criteria for patients: psychiatric, neurological, muscular, or decompensated chronic disease (congestive heart failure, chronic renal insufficiency, diabetes mellitus), mild COPD, respiratory disease other than COPD, acute exacerbation of COPD, exacerbation of COPD in the last 1 month |
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| Interventions | Structure d self‐management educational programme provided by specified education team Intervention components ‐ 1 group educational session on activity and nutrition training (5 or fewer patients) ‐ Structural follow‐up by a chest disease specialist every 2 weeks, using motivational sentences and action plans ‐ Psychological assessment by a psychologist, on coping with chronic illness, leisure time, redirect to mental health support unit Duration intervention: 12 weeks Disciplines involved: chest disease specialist, physiotherapist, psychologist, dietician |
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| Outcomes | CAT, SGRQ, SF‐36, HADS, mMRC | |
| Notes | Dominant component: self‐management | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "by using the random number table, 40 patients each were assigned to the self‐management training (case) and standard care (control) groups" |
| Allocation concealment (selection bias) | Unclear risk | Comment: not enough detail provided |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: no details provided; considering the nature of the study, unlikely that participants and personnel were blinded |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: "a chest physician interviewed all included patients, and pulmonary function test, short form‐36 (SF‐36), St George’s respiratory questionnaire (SGRQ), and modified British Medical Research Council (mMRC) dyspnea scale were performed" Comment: no details provided; outcome assessors were the same personnel as those delivering the intervention |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "9 from the case and 10 from the control groups did not participate in the post‐training evaluation; therefore, 31 case and 30 control patients were included in the study" Comment: loss to follow‐up was balanced between groups; reason for loss to follow‐up was unclear but occurred prior to intervention period; therefore unlikely to be related to the intervention |
| Selective reporting (reporting bias) | Unclear risk | Quote: "in our study, we also found no significant differences between the two groups in terms of mortality and hospital readmission rates after one year" Comment: n o trial registration or protocol paper available; mortality and hospital admission rates not defined as outcomes in methods section of the paper. Reported only in the discussion |