REporting quality of PilOt randomised controlled trials in surgery (REPORTS): a methodological survey protocol.

INTRODUCTION: The aim of this methodological review is to evaluate the completeness of reporting of surgical pilot and feasibility randomised trials as per the Consolidated Standards of Reporting Trials (CONSORT) extension to randomised pilot and feasibility trials. Moreover, we aim to assess for the presence of spin reporting and inconsistency between abstract and main text reporting in surgical pilot and feasibility randomised trials. METHODS AND ANALYSIS: A comprehensive, electronic search strategy will be used to identify studies indexed in Medline, Embase and Cochrane Central Register of Controlled Trials (CENTRAL) databases. Studies will be included if they are pilot or feasibility randomised trials of surgical interventions. The primary outcome will be overall CONSORT statement extension to randomised pilot and feasibility trials checklist completeness. This will be defined as trials reporting each of the 40 items in the CONSORT statement extension to randomised pilot and feasibility trials checklist. Secondary outcomes will include the reporting of individual studies as per the CONSORT extension to randomised pilot and feasibility trials, the use of spin reporting strategies, trial factors associated with reporting quality and spin strategy use, and consistency between abstract and main text reporting. Poisson and logistic regressions will be performed to explore the association between trial factors and completeness of reporting as measured by the number of reported CONSORT items. ETHICS AND DISSEMINATION: This is a methodological survey that has been registered a priori on the International Prospective Register for Systematic Reviews (PROSPERO) (CRD42023475512). Local ethics approval is not required. We plan to disseminate study results through peer-reviewed publication and conference presentations.

Pilot and feasibility trials in surgery are incompletely reported according to the CONSORT checklist: a meta-research study.

OBJECTIVES: Given the key role that pilot and feasibility (PAF) trials play in addressing the challenges of surgical trials, adequate reporting completeness is essential. Our aim was to assess completeness of reporting and evaluate if the items of the Consolidated Standards of Reporting Trials (CONSORT) extension for PAF trials have been reported in surgical PAF trials. STUDY DESIGN: This is a metaresearch study reported according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Studies were included if they were pilot or feasibility randomized trials evaluating a surgical intervention. The primary outcome was overall adherence to the CONSORT statement extension to randomized PAF trials checklist. A Poisson regression was performed to explore the association between research factors and reporting completeness. SETTING: MEDLINE, Embase, and Cochrane Central Register of Controlled Trials were searched from January 1-December 31, 2011 and 2021. RESULTS: After screening 1991 citations, 38 studies from 2011 to 34 studies from 2021 were included. The mean CONSORT reporting score across all included studies was 21.5 (standard deviation 6.3). After excluding items that were not applicable to all studies, a mean of 20.1 (standard deviation 6.1) of 34 items (0.59) were reported. Studies published in 2021 (vs 2011) did not have a greater number of CONSORT items reported (incidence rate ratio [IRR] 1.01, 95% confidence interval [CI] 0.89-1.15). Studies registered in a clinical trial registry (IRR 1.29, 95% CI 1.12-1.48) and randomizing more than 50 patients (IRR 1.16, 95% CI 1.04-1.30) were associated with more CONSORT items reported. CONCLUSION: The reporting completeness of surgical PAF trials is poor and has not improved after the publication of the CONSORT extension.

Development of the McMaster Embalming Scale (MES) to assess embalming solutions for surgical skills training.

Human cadavers used for surgical training are embalmed using various methods to facilitate tissue storage and longevity while preserving the natural characteristics required to achieve high fidelity functional task alignment. However, there are no standardized means to evaluate the suitability of embalming solutions for this purpose. The McMaster Embalming Scale (MES) was developed to assess the extent to which embalming solutions allow tissues to achieve physical and functional correspondence to clinical contexts. The MES follows a five-point Likert scale format and evaluates the effect of embalming solutions on tissue utility in seven domains. This study aims to determine the reliability and validity of the MES by presenting it to users after performing surgical skills on tissues embalmed using various solutions. A pilot study of the MES was conducted using porcine material. Surgical residents of all levels and faculty were recruited via the Surgical Foundations program at McMaster University. Porcine tissue was unembalmed (fresh- frozen) or embalmed using one of seven solutions identified in the literature. Participants were blinded to the embalming method as they completed four surgical skills on the tissue. After each performance, participants evaluated their experience using the MES. Internal consistency was evaluated using Cronbach's alpha. Domain to total correlations and a g-study were also conducted. Formalin-fixed tissue achieved the lowest average scores, while fresh frozen tissue achieved the highest. Tissues preserved using Surgical Reality Fluid (Trinity Fluids, LLC, Harsens Island, MI) achieved the highest scores among embalmed tissues. The Cronbach's alpha scores varied between 0.85 and 0.92, indicating a random sample of new raters would offer similar ratings using the MES. All domains except odor were positively correlated. The g-study indicated that the MES is able to differentiate between embalming solutions, but an individual rater's preference for certain tissue qualities also contributes to the variance in scores captured. This study evaluated the psychometric characteristics of the MES. Future steps to this investigation include validating the MES on human cadavers.