| Methods | Cluster RCT, the community was the unit of randomisation. | |
| Participants | Physicians (73% - primary care specialists, 22% surgeons, 5% medical sub-specialists) and nurses (75% hospital setting) from 6 communities Intervention: n=3 and Control:n=3 Country: US Type of targeted behaviour: general management of a problem (cancer care) |
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| Interventions | Intervention Local Opinion Leaders + community outreach meetings + local TV program (2/3 communities) Method of OL identification: Sociometric Proportion of Social Network that nominated OL: NOT CLEAR Single OL or OL teams: teams of clinicians, unclear number OL disseminated information: Informal & Formal (Conferences, Educational material) OL frequency of involvement: UNCLEAR Control Standard dissemination |
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| Outcomes | Health professional outcomes: physicians & nurses knowledge and attitudes scores about cancer pain management (CPM). Patient outcome: pain intensity score, pain prevalence. |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors’ judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | p.193/Col 1/Para 2 “Three pairs of communities were matched according to the selection criteria. Within each pair, one was randomly assigned to the intervention condition and the other to the control condition.” |
| Allocation concealment (selection bias) | Low risk | It was a cluster RCT, with the community as the unit of randomisation |
| Blinding (performance bias and detection bias) All outcomes |
Unclear risk | Not mentioned in the paper. |
| 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 result section |
| Other bias | Low risk | |
| Similar baseline outcome measures? | Low risk | |
| Similar baseline characteristics? | Low risk | Pg.197/ Col1/Par 1 The six communities recruited into the study were similar in several key characteristics as follows: population (mean 32,000) , number of practicing physicians (mean, 56), and miles distant from Minneapolis -St. Paul (mean, 129).There were no significant differences in variables of interest between the six communities at baseline |
| Protection against contamination? | Low risk | Randomisation was done at the community level. |