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

Dheda 2004.

Study characteristics
Methods RCT; follow‐up: 6 months; control group: primary care follow‐up
Participants Eligible: 33
Completed: 25, I: 10; C: 15
Mean age: I: 68 years, C: 71 years
Sex (% male) both groups: unknown
Inclusion criteria: diagnosis of COPD according to B TS guidelines, first admission to hospital with progressive symptoms, smoking history > 20 pack‐years
Major exclusions: another dominant medical condition, mandatory reason for hospital follow‐up
Interventions Intensive outpatient follow‐up program me following BTS guidelines
Respiratory nurse and/or chest physician reviewed the intervention group ≥ 4 times in the 6‐month period (at 6, 8, 12, or 16 weeks). The following interventions were provided at some or all of these visits: spirometry with reversibility, review of inhaler technique and peak flow diary, ambulatory oxygen assessment, smoking cessation advice, steroid trial, nebuliser assessments, review of medication, advice about nutrition and exercise, and introduction to a patient support group
Intervention duration: 6 months
Involved disciplines: nurse, chest physician
Outcomes SGRQ, SF‐36
Notes Dominant component: structured follow‐up with nurse/GP
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Comment: sequence generation not reported
Allocation concealment (selection bias) Unclear risk Comment: methods used to conceal the sequence of treatment group allocation were not available
Blinding of participants and personnel (performance bias)
All outcomes High risk Comment: participants and treating therapists not likely to have been blind to group allocation
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Comment: not reported; therefore unclear who scored outcome assessments (patients, caregivers, or outcome assessors)
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Comment: not clear whether results in SGRQ were described in the total population, as well as in patients who withdrew (n = 8) from the study
Selective reporting (reporting bias) High risk Comment: not all outcome measurements are given in measures; some are reported only as "there was no significant difference at 6 months in FEV1"