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Research Methods & Reporting

CONSORT 2010 statement: extension checklist for reporting within person randomised trials

BMJ 2017; 357 doi: https://doi.org/10.1136/bmj.j2835 (Published 30 June 2017) Cite this as: BMJ 2017;357:j2835
  1. Nikolaos Pandis, senior lecturer1,
  2. Bryan Chung, clinical instructor2,
  3. Roberta W Scherer, senior scientist3,
  4. Diana Elbourne, professor of healthcare evaluation4,
  5. Douglas G Altman, professor of statistics in medicine5
  1. 1University of Bern, Medical Faculty, School of Dental Medicine, Department of Orthodontics and Dentofacial Orthopedics, Bern, Switzerland
  2. 2Division of Plastic Surgery, University of British Columbia, Victoria, BC, Canada
  3. 3Johns Hopkins Bloomberg School of Public Health, Epidemiology Mailroom E6138 Baltimore, MD, USA
  4. 4London School of Hygiene and Tropical Medicine, Department of Medical Statistics, London, UK
  5. 5Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK OX3 7LD
  6. Correspondence to: N Pandis npandis@yahoo.com
  • Accepted 13 May 2017

Evidence shows that the quality of reporting of randomised controlled trials (RCTs) is not optimal. The lack of transparent reporting impedes readers from judging the reliability and validity of trial findings and researchers from extracting information for systematic reviews and results in research waste. The Consolidated Standards of Reporting Trials (CONSORT) statement was developed to improve the reporting of RCTs. Within person trials are used for conditions that can affect two or more body sites, and are a useful and efficient tool because the comparisons between interventions are within people. Such trials are most commonly conducted in ophthalmology, dentistry, and dermatology. The reporting of within person trials has, however, been variable and incomplete, hindering their use in clinical decision making and by future researchers. This document presents the CONSORT extension to within person trials. It aims to facilitate the reporting of these trials. It extends 16 items of the CONSORT 2010 checklist and introduces a modified flowchart and baseline table to enhance transparency. Examples of good reporting and evidence based rationale for CONSORT within person checklist items are provided.

Introduction

Many journals now require that reports of randomised controlled trials (RCTs) conform to the recommendations in the Consolidated Standards of Reporting Trials (CONSORT) statement.1 The CONSORT statement includes a checklist of items that should be included in the trial report. The most recent version of the checklist was published in 2010.1 These items are based on evidence whenever possible. The statement also recommends including a flow diagram to show the flow of participants from before enrolment to final analysis. Explanation and elaboration of the rationale for checklist items is provided elsewhere.2

The primary focus of the CONSORT statement is the most common type of RCT, with two treatment groups using an individually randomised parallel group design.2 Almost …

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