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

Pandis, Nikolaos; Chung, B; Scherer, RW; Elbourne, D; Altman, DG (2017). CONSORT 2010 statement: extension checklist for reporting within person randomised trials. BMJ, 357, j2835. BMJ Publishing Group 10.1136/bmj.j2835

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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.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > School of Dental Medicine > Department of Orthodontics

UniBE Contributor:

Pandis, Nikolaos

Subjects:

600 Technology > 610 Medicine & health

ISSN:

1756-1833

Publisher:

BMJ Publishing Group

Language:

English

Submitter:

Renate Imhof-Etter

Date Deposited:

27 Mar 2018 12:46

Last Modified:

01 Apr 2018 02:25

Publisher DOI:

10.1136/bmj.j2835

PubMed ID:

28667088

BORIS DOI:

10.7892/boris.112317

URI:

https://boris.unibe.ch/id/eprint/112317

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