| Methods | Cluster RCT, with the hospital as the unit of randomisation. | |
| Participants | 37 hospitals. 2938 patients.Intervention:n=20 and Control: n=16 Country: US Type of targeted behaviour: general management of a problem myocardial infarction) |
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| Interventions | Intervention Local Opinion Leaders + distribution of educational materials. Method of OL identification: Sociometric Proportion of social network that nominated OL: 38% Single OL or OL teams identified: one single OL per hospital OL disseminated information: Informal & Formal (conferences, clinical practice guide-lines, audit & feedback) t:nc="2"OL frequency of involvement:UNCLEAR Control Audit & feedback |
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| Outcomes | Eligible patients receiving drugs for treatment of acute myocardial infarction | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors’ judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | P.1369/ “..hospitals were stratified and randomised by size from within each of the nine strata to experimental or control condition (standard care) |
| Allocation concealment (selection bias) | Low risk | it was a cluster RCT, with the hospitals as the unit of randomisation |
| Blinding (performance bias and detection bias) All outcomes |
Low risk | P.1359/ Col 2/ Para 2 Hospital administrators, physicians, AMI patients and nurse abstractors were all blinded with respect to study hypothesis and experimental assignment at each hospital |
| Incomplete outcome data (attrition bias) All outcomes |
Unclear risk | Not mentioned in the paper |
| 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 | Pg. 1361/Col 2/Para1 There were no significant differences in baseline rates of use of study drugs between experimental and control hospitals Pg 1362/Table 2 |
| Similar baseline characteristics? | Low risk | PG.1361/Col 1/Para 3 “Table 1 presents demographic and clinical characteristics of experimental and control patients before and after the intervention. Both groups were comparable overall and with respect to several characteristics that predicted use of study drugs at baseline, namely old age.(>75 years), female sex; severe co-morbidity, recent symptom-onset (6 hours) and heart failure Pg.1361/Col 3/Table 1 |
| Protection against contamination? | Low risk | Pg. 1359/Col 1/Para 3 To minimise contamination of control hospitals, large cities (i.e. St. Paul-7 hospitals and 2536 patients) and Minneapolis (11 hospitals and 2536) were randomised as clusters, resulting in a state-wide sample of 20 experimental and 17 control hospitals |