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. Author manuscript; available in PMC: 2014 Sep 23.
Published in final edited form as: Cochrane Database Syst Rev. 2011 Aug 10;(8):CD000125. doi: 10.1002/14651858.CD000125.pub4
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)
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.