Bucher 2010.
Study characteristics | ||
Methods | Cluster‐randomised trial, parallel group (1:1) | |
Participants | Physicians in the Swiss HIV Cohort Study (SHCS) in Switzerland caring for HIV‐infected participants Unit of randomisation: physician Inclusion criteria: all physicians who were part of the SCHS were eligible. Eligible patients were those registered with the SHCS, not pregnant, aged ≥ 18 years, continuous ART for 90 days prior to baseline and with complete data on CHD risk factors at baseline Exclusion criteria: no additional criteria from above 165 physicians randomised at baseline (n = 80 intervention, n = 85 comparison) 117 physicians included (n = 57 intervention, n = 60 comparison) ‐ 45 physicians were excluded because they did not have any participants with risk factor assessment and 3 physicians did not have any eligible participants 4097 participants eligible at baseline (n = 2097 intervention, n = 2000 comparison) Mean age (IQR): 44 (39‐51) , 30% women, 5% diabetes mellitus, 26% with Framingham risk score (FRS) ≥ 10% |
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Interventions | Intervention group: risk profile generated by the data centre for each participant randomised to the intervention group; profile consisted of 10‐year CHD risk as calculated by FRS. Study nurses added the FRS risk profile to the patient chart. Each risk profile also included individualised targets for LDL cholesterol, systolic/diastolic blood pressure. Comparison group: booklet of evidence‐based guidelines for management of CHD risk factors. Guidelines also gave directions on how to approach and motivate lifestyle modifications and how to calculate CHD risk from a website |
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Outcomes | Primary outcome: total cholesterol Secondary outcomes: systolic and diastolic blood pressure, Framingham risk score Follow‐up: 12‐18 months 3362 participants analysed at follow‐up (n = 1680 intervention, n = 1682 comparison) |
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Study funding sources | Public and private sources. "This trial was funded by a grant from the Swiss National Science Foundation for nested cohort projects. . . and an unrestricted educational grant from Bristol‐Myers Squibb, Baar, Switzerland." | |
Notes | Primary and secondary outcomes analysed using generalised estimating equations to account for clustering Analyses reporting the effect of the intervention on medication prescribing and CVD events (not mentioned in methods, or in trial registration) |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Randomized groups were assigned according to a computerized list for each strata generated by a biostatistician not otherwise involved in the trial." |
Allocation concealment (selection bias) | Low risk | See above |
Blinding of participants and personnel (performance bias) All outcomes | High risk | "This was an open intervention trial, that is, physicians knew whether they received the intervention or not but were not told what outcomes would be measured." |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Method used for outcome assessment not provided |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 80% of participants had a final assessment with data recorded for the primary outcome; ITT analysis performed |
Selective reporting (reporting bias) | High risk | Trial prospectively registered (NCT00264394). Primary and secondary outcomes reported but medication prescribing outcome not prespecified |
Other bias | Unclear risk | Analyses for primary and secondary outcomes accounted for clustering but unclear if medication prescribing outcome accounted for clustering |