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

Farrero 2001.

Study characteristics
Methods RCT; follow‐up: 12 months; control group: usual care
Participants Randomised: 122, I: 60, C: 62
Completed: 94, I: 46, C: 48
Mean age: I: 69 years, C: 69 years
Clinical diagnosis of COPD, requiring oxygen for ≥ 6 months, with willingness to participate in a hospital‐based home care programme, and with residence within easy reach of the hospital
Interventions Hospital‐based home care programme of 12 months with the aim of combining home care management and easy access to hospital resources. Programme included
‐ Monthly telephone calls and 3‐monthly home visits from a nurse, working closely with a physician. Patients could also request an immediate response, which varied according to a home visit, a hospital visit, telephone advice, or a control visit
Intervention duration: 12 months
Involved disciplines: nurse and physician
Outcomes CRQ, spirometry, mortality, hospital admissions, hospital days, ED visits
Notes Dominant component: structured follow‐up with nurses
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "after this initial evaluation, informed consent was obtained and patients were allocated randomly to the HCP treatment group or to the control group"
Comment: unclear if patients were randomised by sequence generated or based on, for example, date of admission
Allocation concealment (selection bias) Low risk Quote: "codes of randomisation were kept in sealed envelopes"
Blinding of participants and personnel (performance bias)
All outcomes High risk Comment: participants and treating therapists not likely to have been blinded to group allocation
Blinding of outcome assessment (detection bias)
All outcomes High risk Quote: "patients in the control group were evaluated by the HCP team at the outpatient department in the initial visit, and after 1 year"
Comment: as the HCP team was the intervention team and was not blinded to which group a patient was randomised, it is likely that assessment can be influenced by no blinding of the outcome assessor
Incomplete outcome data (attrition bias)
All outcomes High risk Quote: "quality of life was investigated in the first 40 consecutive patients included in the study (..) applied before the study and after 3 months and 12 months"
Comment: reason for missing outcome data likely to be related to true outcome, with imbalance in numbers
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