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

Smith 1999.

Study characteristics
Methods RCT; follow‐up: 12 months; control: usual care
Participants Eligible: 105
Randomised: 96, I: 48, I: 48
Completed: 36 (data completed only for intervention group)
Mean age: I: 70 years, C: 70 years
Major inclusion criteria: COPD diagnosis according to guidelines, age > 40 years, FEV₁/FVC < 60%, stable state, carer involved in management, able to speak and read English and give written consent
Major exclusion criterion: no other active illness
Interventions Intervention of 12 months including
‐ Follow‐up planning for inpatients and outpatients with a nurse in shared care approach with GP and medical staff. Nurses discussed with GP goals for discharge and needs and facilitated involvement of domiciliary service. Goals were inserted into patient notes
‐ During 12 months every 2 to 4 weeks, there was a home visit including education, spirometry, optimal medication, exacerbation management, smoking cessation, and fitness advice
Included HCPs: nurse, GP, social worker, hospital medical officer
Outcomes COOP (HRQoL), mortality, hospital admissions, lung function
Notes Dominant component: structured follow‐up with nurse/GP
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "patients were randomised as they were enrolled, following discharge from hospital (..), into the HBNI or control groups from two lists of randomly computer generated numbers"
Allocation concealment (selection bias) Low risk Quote: "patients were randomised as they were enrolled, following discharge from hospital"
Blinding of participants and personnel (performance bias)
All outcomes High risk Quote: "this study was unblinded"
Blinding of outcome assessment (detection bias)
All outcomes High risk Quote: "this study was unblinded"
Incomplete outcome data (attrition bias)
All outcomes High risk Quote: "attempts to perform questionnaires in the control subjects were unsuccessful due to a combination of (I) these subjects perceived no immediate benefit of the trial; and (ii) the burden of participating in a study"
Comment: no outcomes reported in control group
Selective reporting (reporting bias) High risk Comment: 1 or more primary outcomes in the review (COOP, spirometry) are reported incompletely, so they cannot be entered into a meta‐analysis