A protocol for the development of the STROCSS guideline: Strengthening the Reporting of Cohort Studies in Surgery

INTRODUCTION: Strengthening the reporting of observational studies in epidemiology (STROBE) coined in 2007, highlighted the importance of improving the quality of observational research by providing an item checklist in order to avoid inadequate reporting of research. However, currently there are no reporting guidelines specific to surgical cohort studies, which have an extremely important role within the surgical literature. The recent development of surgery specific guidelines has underscored how surgical and procedural interventions require additional detail for readers to have a complete, clear, transparent and reproducible understanding. The objective of this research is to conduct a Delphi consensus exercise to develop the STROCSS guideline (Strengthening the Reporting of Cohort Studies in Surgery). METHODS AND ANALYSIS: Current guidelines for case series (PROCESS), Cohort Studies (STROBE) and randomised controlled trials (CONSORT) will be analysed to compile items to form baseline material for developing cohort guidelines in the Delphi consensus exercise. The Delphi questionnaire will be administered via Google Forms and conducted using standard Delphi Methodology. Surgeons and individuals with significant experience of reviewing cohort studies as well as those with experience in developing reporting guidelines will be invited to participate. In the first round, existing items from PROCESS and STROBE will be put forward and participants will be invited to augment them or contribute further items for consideration. The provisional guidelines will then be updated in successive rounds using the nine-point Likert scale as proposed by the Grading Recommendations, Assessment, Development, and Evaluations (GRADE) working group. This process will be used to agree Standard definitions for the outcomes. DISSEMINATION: The work will be published in a peer-reviewed journal and presented at national and international meetings. Findings will be disseminated to interested parties, and journals will be encouraged to endorse the reporting guidelines.