An assessment of the compliance of Randomised controlled trials published in craniofacial surgery journals with the CONSORT statement: A systematic review protocol

INTRODUCTION: The role of clinical trials in medicine is expanding, particularly in surgery. Randomised controlled trials (RCTs) represent the gold standard evidence for high-quality assessment of healthcare interventions. The Consolidated Standards of Reporting Trials (CONSORT) guidance has been published to maximise RCT reporting transparency. This paper outlines the study protocol for a systematic review that will assess the current compliance of RCTs published within craniofacial surgery with the CONSORT criteria. The aims are to identify areas where reporting can be improved to ensure craniofacial surgery is guided by high-quality evidence. METHODS AND ANALYSIS: This protocol is compliant with the Preferred Reporting Items for Systematic Review and meta-Analysis protocols (PRISMA-P) guidelines. Craniofacial surgery RCTs will be identified by searching within craniofacial surgery journals. Five journals from the Thomson Reuters Impact Factor Report 2016 included ‘cranio’ in their title and were included. MEDLINE PubMed will be used to search all RCTs published in these journals. The search strategy is described within this protocol. It will be limited to articles written in English, conducted on humans, and published in the last five years. Two independent researchers will assess each study for inclusion and will perform the data extraction. The researchers will assess compliance of each RCT with the 25-item CONSORT Statement checklist as the primary outcome. Discrepancies will be resolved through consensus or third author arbitration. Secondary outcomes to be extracted include the pathology and interventions examined, and indices of RCT quality. The systematic review will be compliant with PRISMA guidelines. The review has been registered a priori with the Registry of Systematic Reviews/meta-analyses (UIN: reviewregistry219). ETHICS AND DISSEMINATION: This systematic review will be conducted in line with the Cochrane Handbook for Systematic Reviews and Interventions. The intent is to publish in a peer-reviewed journal and present the data at relevant conferences.