Table 1

Summary of all the objectives, corresponding outcomes, explanatory variables and corresponding hypotheses, and methods of analysis

Protocol summary
Objective(s)Outcome(s)Explanatory variablesHypothesisMethods of analysis
Primary: to assess the completeness of reporting and evaluate if the items of the CONSORT extension for pilot and feasibility trials have been reported in surgical pilot and feasibility trials
Secondary: identify aspects of the CONSORT checklist consistently reported in pilot and feasibility trials; identify factors associated with complete reporting of pilot and feasibility trials as per the CONSORT checklist; assess the presence and level of spin reporting in surgical pilot and feasibility trials; identify factors associated with spin reporting in surgical pilot and feasibility trials; assess the presence of inconsistent reporting between abstracts and full texts in surgical pilot and feasibility trials; identify factors associated with inconsistent reporting in surgical pilot and feasibility trials
Overall completeness of the reporting of pilot and feasibility trials as per the CONSORT checklist.
Completeness of reporting of the individual trials according to the CONSORT checklist.
Completeness of reporting of the individual items in the CONSORT checklist.
The presence of spin reporting.
The level of spin reporting (ie, high, moderate and low).
The presence of inconsistent reporting between abstracts and main texts
  • Year of publication

  • Industry funding

  • Registration in a clinical trial database

  • Multisite study

  • Journal endorsement of CONSORT

  • Published a pilot RCT protocol

  • Number of patients randomised

*Publications between 1 January 2011 and 31 December 2011 and 1 January 2021 and 31 December 31 2021
Pilot and feasibility randomised trials in surgery will be poorly reported as per the CONSORT extension for pilot trials.
We hypothesise that the following trial factors will be associated with improved reporting: publication after creation of the CONSORT extension to randomised pilot and feasibility trials, industry funding, multicentre studies, journal endorsement of CONSORT and a larger sample size will be associated with an increased number of reported CONSORT items
The completeness of reporting will be summarised with descriptive statistics.
We will conduct a Poisson regression to explore the association between the explanatory variables and completeness of reporting as measured by the number of reported CONSORT items
  • *Note

  • CONSORT, Consolidated Standards of Reporting Trials; RCT, randomised controlled trial.