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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 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)
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
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.”