editorialPilot and Feasibility StudiesOct 20, 2016GOLD OA

CONSORT 2010 statement: extension to randomised pilot and feasibility trials

OBon behalf of the PAFS consensus groupSESandra EldridgeCCClaire ChanMJMichael J. CampbellCBChristine Bond

Queen Mary University of London · University of Sheffield · +5 more institutions

PubMed
Indexed incrossrefdoajpubmed

Abstract

The Consolidated Standards of Reporting Trials (CONSORT) statement is a guideline designed to improve the transparency and quality of the reporting of randomised controlled trials (RCTs). In this article we present an extension to that statement for randomised pilot and feasibility trials conducted in advance of a future definitive RCT. The checklist applies to any randomised study in which a future definitive RCT, or part of it, is conducted on a smaller scale, regardless of its design (eg, cluster, factorial, crossover) or the terms used by authors to describe the study (eg, pilot, feasibility, trial, study). The extension does not directly apply to internal pilot studies built into the design of a main…

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Topics & keywords

Keywords
  • Consolidated Standards of Reporting Trials
  • Statement (logic)
  • Extension (predicate logic)
  • Medicine
  • Psychology
  • Randomized controlled trial
  • Computer science
  • Political science
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