LAUSR

BackgroundSynthesizing outcomes of underreported primary studies can pose a serious threat to the validity of outcomes and conclusions of systematic reviews. To address this problem, the Cochrane Collaboration recommends reviewers to contact authors of eligible primary studies to obtain additional information on poorly reported items. In this protocol, we present a cross-sectional study and a survey to assess (1) how reviewers of new Cochrane intervention reviews report on procedures and outcomes of contacting of authors of primary studies to obtain additional data, (2) how authors reply, and (3) the consequences of these additional data on the outcomes and quality scores in the review. All research questions and methods were pilot tested on 2 months of Cochrane reviews and were subsequently fine-tuned.Methods for the cross-sectional studyEligibility criteria are (1) all new (not-updates) Cochrane intervention reviews published in 2016, (2) reviews that included one or more primary studies, and (3) eligible interventions refer to contacting of authors of the eligible primary studies included in the review to obtain additional research data (e.g., information on unreported or missing data, individual patient data, research methods, and bias issues). Searching for eligible reviews and data extraction will be conducted by two authors independently. The cross-sectional study will primarily focus on how contacting of authors is conducted and reported, how contacted authors reply, and how reviewers report on obtained additional data and their consequences for the review.Methods for the surveyThe same eligible reviews for the cross-sectional study will also be eligible for the survey. Surveys will be sent to the contact addresses of these reviews according to a pre-defined protocol. We will use Google Forms as our survey platform. Surveyees are asked to answer eight questions. The survey will primarily focus on the consequences of contacting authors of eligible primary studies for the risk of bias and Grading of Recommendations, Assessment, Development and Evaluation scores and the primary and secondary outcomes of the review.DiscussionThe findings of this study could help improve methods of contacting authors and reporting of these procedures and their outcomes. Patients, clinicians, researchers, guideline developers, research sponsors, and the general public will all be beneficiaries.