| Methods | Cluster RCT, with the institution as the unit of randomisation | |
| Participants | Obstetricians from 27 tertiary care hospitals. (One hospital withdrew post randomization); Intervention: n=13 and Control: n=14 Country: US Type of targeted behaviour: general management of a problem (foetal maturation) |
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| Interventions | Intervention Local Opinion Leaders + audit & feedback + chart reminder + clinical guideline + grand round. Method of OL identification: Informant Proportion of social network that nominated OL: N/A Single OL or OL teams identified: teams of two persons (one nurse + one physician) OL disseminated information: Informal OL frequency of involvement: UNCLEAR Control Standard dissemination of clinical guideline |
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| Outcomes | Appropriate use of antenatal corticosteroids for foetal maturation | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors’ judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Pg. 47/Col 3/Para 2 We assigned hospitals by random number table either to the active dissemination (n= 13) or usual dissemination control (n=14) group |
| Allocation concealment (selection bias) | Low risk | It was a cluster RCT, with the institution as the unit of randomisation |
| Blinding (performance bias and detection bias) All outcomes |
Unclear risk | p.47/Col 3/para 2 and p.48/Col 1/Para 1 “The study was not blinded because physicians in the active dissemination condition were aware of the situation, and the leadership of all hospitals were aware of the condition of assignment” |
| 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.50/Table 1 |
| Similar baseline characteristics? | Low risk | Pg, 49/Col 3/ Para 2 There were no baseline differences between intervention and control hospitals for the following characteristics: geographic region, median number of Active obstetricians, births per hospital, NICU beds, percentage Medicaid patients, race, PROM diagnosis, GA, and indicated deliveries. Hospital characteristics were generally the same in both the NPIC and AECOM hospitals. A difference between intervention and control cases in the frequency of abnormal fetal conditions or fetal distress was significant at the patient level due to the large sample size |
| Protection against contamination? | Low risk | Pg. 47/Col 2/ Para 1 “To avoid diffusion of the active dissemination treatment to the control group, the unit of randomisation was the hospital.” |