Reporting of planned statistical methods in published surgical randomised trial protocols: a protocol for a methodological systematic review.
Poor reporting can lead to inadequate presentation of data, confusion regarding research methodology used, selective reporting of results, and other misinformation regarding health research. One of the most recent attempts to improve quality of reporting comes from the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Group, which makes recommendations for the reporting of protocols. In this report, we present a protocol for a systematic review of published surgical randomised controlled trial (RCT) protocols, with the purpose of assessing the reporting quality and completeness of the statistical aspects.



We will include all published protocols of randomised trials that investigate surgical interventions. We will search MEDLINE, EMBASE, and CENTRAL for relevant studies. Author pairs will independently review all titles, abstracts, and full texts identified by the literature search, and extract data using a structured data extraction form. We will extract the following: year of publication, country, sample size, description of study population, description of intervention and control, primary outcome, important methodological qualities, and quality of reporting of planned statistical methods based on the SPIRIT guidelines.



The results of this review will demonstrate the quality of statistical reporting of published surgical RCT protocols. This knowledge will inform recommendations to surgeons, researchers, journal editors and peer reviewers, and other knowledge users that focus on common deficiencies in reporting and how to rectify them. Ethics approval for this study is not required. We will disseminate the results of this review in peer-reviewed publications and conference presentations, and at a doctoral independent study of oral defence.
Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada.
Kim
K
Madden
Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada.
Erika
E
Arseneau
Division of Orthopaedic Surgery, McMaster University, Hamilton, Ontario, Canada.
Nathan
N
Evaniew
OrthoEvidence Inc., Burlington, Ontario, Canada.
Christopher S
CS
Smith
Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada.
Lehana
L
Thabane
D035843:Biomedical Research; D002985:Clinical Protocols; D017408:Guidelines as Topic; D006801:Humans; D011642:Publications / Q000592:standards; D011643:Publishing / Q000592:standards; D016032:Randomized Controlled Trials as Topic; D012107:Research Design / Q000592:standards*; D012108:Research Personnel; D015983:Selection Bias; D000078202:Systematic Reviews as Topic
EPIDEMIOLOGY; STATISTICS & RESEARCH METHODS; SURGERY