Abstract
Objective
This randomized controlled trial (RCT) aimed to test the efficacy of enhanced access to Cochrane Handbook (Handbook) recommendations for judging the 2011 Cochrane risk of bias (RoB) domains for improving the adequacy of RoB judgments.
Study Design and Setting
Parallel-group RCT with a 1:1 allocation ratio (N = 2271 per group) was conducted. Eligible participants were corresponding authors of all published Cochrane reviews and protocols. After allocation by a random number generator, participants received 20 scenarios for assessing RoB. The intervention group was shown tables from the Handbook with instructions for assessing 2011 RoB tool together with scenarios they were supposed to assess – enhanced access to the Handbook. The control group was shown only a general link to the Handbook. The primary outcome was the proportion of participants that made an adequate judgment of RoB scenarios for analyzed domains.
Results
There were 240 responses out of 2020 delivered e-mail invitations in the intervention and 197/2254 in the control group. Only 5 participants from the intervention group judged RoB adequately in all the 20 scenarios and no one in the control group. The proportion of participants who adequately assessed all the scenarios within a domain was significantly higher in the intervention than in the control group. The prevalence of adequate RoB judgments was 7.1% (95%CI: 5.0% to 9.3%, P<0.001) higher in the intervention group (76.2%) than in the control group (69.0%).
Conclusion
The enhanced yields more adequate RoB assessments and could be incorporated in software supporting the RoB tool.
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