| Methods | Cluster RCT, with the primary care physician as the unit of randomisation | |
| Participants | 480 adults with coronary heart disease from 252 practices in Edmonton and Calgary; Opinion leader statement: n= 165; Unsigned statement:n=158 and Control: n=157 Country: Canada Type of targeted behaviour: General management of a problem (secondary care for CHD statin management |
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| Interventions |
Method of OL identification: Sociometric Proportion of Social Network that nominated OL: UNCLEAR Single OL or OL teams identified: single OL OL disseminated information: Formal (Faxed evidence summaries) OL frequency of involvement:action taken at one time-point Control: No intervention (physicians only received a coronary chart for their patients, which is considered somewhat more than standard care in this region) |
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| Outcomes | Improvement in statin management (new start or dose increase) 6 months post-catheterisation | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors’ judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | p.898/Col 2/Para 1 “Randomizationtookplace 1:1:1 following the completion of the patients angiogram using a computer-generated central randomization system with concealment of the randomization list.” |
| Allocation concealment (selection bias) | Low risk | p.898/Col 2/Para 1 Although primary care physicians were not blinded to allocation status, both allocation concealment and blinding were achieved for investigators, patients, outcome assessors, and analysts |
| Blinding (performance bias and detection bias) All outcomes |
Low risk | Although primary care physicians were not blinded to allocation status, both allocation concealment and blinding were achieved for investigators, patients, outcome assessors, and analysts p.900/Col 2/Para 2 Follow-up data was collected by independent and blinded outcome assessors, clinical events were independently adjudicated by two blinded investigators (FAM and SRM) who then met to resolve discrepancies, and statistical analyses were conducted by a statistician blinded to allocation status |
| Incomplete outcome data (attrition bias) All outcomes |
Low risk | p.901/Col 2/Para 1 We evaluated the status of 466 patients (97%) after six months (2 patients were lost to follow up, 6 withdrew consent, 3 died and 3 were excluded due to protocol violations |
| Selective reporting (reporting bias) | Low risk | All outcomes mentioned in the methods section were also presented in the results |
| Other bias | Low risk | |
| Similar baseline outcome measures? | Low risk | p.28 /Table 1
At baseline, there were no statistically significant differences between groups (Table 1) |
| Similar baseline characteristics? | Low risk | p.28/Table 1. At baseline, there were no statistically significant differences between groups |
| Protection against contamination? | Low risk | This was a randomized clinical trial clustered at the level of the primary care physician to avoid contamination |