Littlejohns 1991.
| Study characteristics | ||
| Methods | RCT; follow‐up: 12 months; control group: usual care | |
| Participants | Eligible: 166 Randomised: 152; I: 73, C: 79 Completed (12 months): 133, I: 68, C: 65 Mean age: I: 63 years, C: 63 years Sex (% male): I: 67, C: 63 Inclusion criteria: COPD diagnosed by spirometry, according to guidelines; age 30 to 75 years; pre‐bronchial FEV₁% < 60%; stable state; no change in medication for ≥ 6 weeks before recruitment; no other major disease |
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| Interventions | Intervention group received care from the respiratory health worker while continuing with routine outpatient appointments during 12 months. Health worker provided ‐ Health education directed at the patient and the primary care team ‐ Monitoring of treatment compliance and optimising treatment by ensuring correct inhalation techniques and supervision of domiciliary oxygen ‐ Monitoring of the results of spirometry and of patients' symptoms to enable acute exacerbations and worsening heart failure to be detected and treated early ‐ Liaison between GP and hospital‐based services (including domiciliary physiotherapy services and social services) Intervention duration: 12 months Disciplines involved: GP, respiratory health worker |
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| Outcomes | Mortality, spirometry, 6MWD, step test, MRC chronic bronchitis questionnaire, HADS, SIP, hospital admissions, drug prescriptions, visits to GP or clinic, satisfaction | |
| Notes | Dominant component: structured follow‐up with respiratory health worker | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "random numbers were generated by tables in permuted blocks of four, stratified by age and sex" |
| Allocation concealment (selection bias) | Low risk | Quote: "the groups to which successive patients were to be allocated were noted in sealed, numbered envelopes, which were kept centrally" |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "the physician was aware which group the patient was in" |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: no information provided |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: dropout rates comparable between groups |
| Selective reporting (reporting bias) | High risk | Comment: outcomes on MRC chronic bronchitis questionnaire not reported |