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 |
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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 |
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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 |