Sanchez‐Nieto 2016.
Study characteristics | ||
Methods | RCT; multi‐centre (n = 2); follow‐up: 12 months; control: usual care | |
Participants | Eligible: 124 Randomised: 96, I: 54, C: 45 Completed: 85, I: 47, C: 38 Mean age: I: 69 years, C: 68 years Sex (% male): I: 6, C: 11 Inclusion criteria: clinical stability (at least in the 3 months before randomisation, with no change in medication or usual symptoms); active smoker or prior history of smoking of ≥ 10 pack‐years; post‐bronchodilator FEV₁/FVC ratio 70%; normal cognitive status to read and understand written texts and receive training in inhalation techniques or self‐care education sessions; physical status that allows for regular walking or exercise; no diagnosis of asthma, advanced heart failure, unstable ischaemic heart disease, terminal disease, dementia, or uncontrolled psychiatric disorders; ability to read texts; no participation in any pulmonary rehabilitation programme in previous year Major exclusion criteria: none reported (included in inclusion criteria) |
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Interventions | Self‐management programme consisting of several components ‐ Education: group education session on main characteristics COPD, specially designed for the SMP‐COPD programme ‐ Individual training session on inhalation techniques ‐ Written action plan with colour‐coded treatment instructions including recommendations for physical exercise, exacerbations ‐ Visit by respiratory nurse to check correct use of treatment instructions and inhalation techniques. Duration intervention: 12 weeks Disciplines involved: nurse, physiotherapist, medical specialist in respiratory medicine |
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Outcomes | Hospitalisation for COPD exacerbation (primary outcome), days at risk (primary outcome), A&E visits for COPD exacerbation, length of stay, antibiotic or glucocorticoid treatment, all‐cause mortality | |
Notes | Dominant component: self‐management | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: “simple randomisation was carried out separately at each site by means of a list of computer‐generated random numbers, assigning the patients to two groups” |
Allocation concealment (selection bias) | Low risk | Quote: “simple randomisation was carried out separately at each site by means of a list of computer‐generated random numbers, assigning the patients to two groups” |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: due to the nature of the intervention, blinding of personnel and participants was not possible |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: “because double‐blinding was not possible, an independent evaluator, who did not know the patients’ group assignments, was responsible for evaluating the outcome variables” |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: missing data on outcomes and reasons for loss to follow‐up are balanced between groups |
Selective reporting (reporting bias) | Low risk | Comment: study protocol in not available; published reports include all expected outcomes that were pre‐specified |