| Methods | Cluster RCT, with the patient as the unit of randomisation. | |
| Participants | Physicians from 2 emergency departments and two fracture clinics (four hospitals); Patients;Intervention: n=137 and Control: n=135 Country: Canada Type of targeted behaviour: General management of a problem (osteoporosis) |
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| Interventions | Local opinion endorsed guidelines sent to physicians + telephone based patient education (performed by nurses) + reminders sent to physicians Method of OL identification: Sociometric method Proportion of Social Network that nominated OL: UNCLEAR Single OL or OL teams identified: teams of five physicians OL disseminated information: Formal (dissemination of guidelines) OL frequency of involvement: at one time-point sending a signed guideline on osteoporosis care to physician Control: Usual care (provision of printed materials to patients) |
|
| Outcomes | Starting biophosphonate treatment within 6 months of the fracture. Bone mineral testing, “appropriate care” (consisting ofbone mineral density testing with treatment ifbone mass was low), and osteoporosis related quality of life | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors’ judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | p.570/Col 1/Para 3 “In this randomized controlled trial, patients were assigned to either the intervention group or the control group. Allocation was concealed by application of variable block sizes and by use of a secure, centralized, Internet-based, computer-generated randomization system housed within the Epidemiology Coordinating and Research Centre at the University of Alberta in Edmonton.” |
| Allocation concealment (selection bias) | Low risk | p.570/Col 1/Para 3 “Allocation was concealed by application of variable block sizes and by use of a secure, centralized, Internet-based, computer-generated randomization system ” |
| Blinding (performance bias and detection bias) All outcomes |
Low risk | p.570/Col 1/Para “Patients could not be blinded to the fact that they were part of an osteoporosis quality improvement study. However, physicians were not informed that their patients were part of a study, and neither physicians nor patients were aware of the study outcomes. Research nurses collected outcomes data without knowledge of allocation status. Investigators were blinded at all times. |
| Incomplete outcome data (attrition bias) All outcomes |
Low risk | p.571/Figure 1 |
| 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.572/Table 1 |
| Similar baseline characteristics? | High risk | p.572/Table 1 |
| Protection against contamination? | Low risk | The study was a cluster RCT. |