Analysis of Current Guidance on the Use of Randomized Controlled Trial Study Protocols in Systematic Reviews

Abstract Objective Use of trial registry records and randomized controlled trial (RCT) study protocols can assist systematic reviewers in evaluating and, possibly, minimizing publication and selective reporting biases. This study examined current guidance on the use of registry records and RCT study protocols from key systematic review organizations, institutes and collaborations. Study Design and Setting Handbooks, guidelines and standards documents from key systematic review organizations and the EQUATOR network database were identified. Textual excerpts providing guidance on the use of trial registry records, RCT protocols and ongoing/unpublished studies were extracted independently by two reviewers and coded into a systematic review framework. Results Eleven documents published in English between 2009 and 2016 were included. Guidance for using RCT protocols and trial registry records was provided for 7 of the 16 framework categories, and guidance for using unpublished and ongoing studies was available for 8 of the 16 categories. Conclusion This study identified gaps and ambiguities in language in guidance on the use of RCT protocols and trial registry records. To encourage and assist reviewers to employ trial registry records and RCT study protocols in systematic reviews current guidance should be expanded and clarified.