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

Pandis, Nikolaos; Chung, B; Scherer, R W; Elbourne, D; Altman, D G (2019). CONSORT 2010 statement: extension checklist for reporting within person randomised trials. The British journal of dermatology, 180(3), pp. 534-552. Wiley 10.1111/bjd.17239

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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:

1365-2133

Publisher:

Wiley

Language:

English

Submitter:

Renate Imhof-Etter

Date Deposited:

20 May 2019 13:47

Last Modified:

20 May 2019 13:47

Publisher DOI:

10.1111/bjd.17239

PubMed ID:

30609010

BORIS DOI:

10.7892/boris.127911

URI:

https://boris.unibe.ch/id/eprint/127911

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