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. 2021 Sep 8;2021(9):CD009437. doi: 10.1002/14651858.CD009437.pub3

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)
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
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