Background: Searching for clinical trial registry records and published study protocols (hereafter ‘protocols’) is mandatory according to most systematic review conduct and reporting guidelines. Additionally, the new Cochrane risk-of-bias tool recommends use of a protocol to evaluate reporting biases. However, there is no comprehensive guidance about how protocols should be used in systematic reviews. We have evaluated how protocols are used in a sample of Cochrane reviews(a), and we recognise some important challenges.
Objectives:The aim of this study is to: 1) synthesise the literature on using protocols when conducting systematic reviews of interventions; and, 2) formulate ‘good-practice’ recommendations to guide authors towards a more methodical use of protocols in systematic reviews.
Methods:A systematic search for published and unpublished literature describing procedures for using protocols in evidence synthesis will be conducted in bibliographic databases (Medline, EMBASE and CINAHL) and the websites of key systematic review collaborations (JBI, Cochrane, Campbell). The literature review findings, combined with previous work by this team (1), will be integrated develop ‘good-practice’ examples as concrete illustrations of those procedures for each step (as described in the Cochrane Handbook) of a systematic review.
Results:The results of this study are expected by August 2017.
Conclusions: We will provide practical examples of using protocols through all stages of a systematic review. This will help reviewers to know how to include protocols, particularly for evaluating and minimising bias, and to facilitate transparent reporting. We are aware that there are many forms of evidence synthesis (systematic reviews, rapid reviews, diagnostic review, overviews of reviews). Some, but not all, of the suggested examples may be applicable to other types of synthesis reviews.
1. Boden, Bidonde, Busch & Meneses (2016) Utilization of trial registry
records and randomized controlled trial study protocols in Cochrane systematic reviews
of interventions: a content analysis. 24th Cochrane Colloquium, Seoul, Korea, October 23-27, 2016