Abstract
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.
Highlights
Many journals require that reports of randomised controlled trials (RCTs) conform to the recommendations in the Consolidated Standards of Reporting Trials (CONSORT) statement.[1 ]
A more recent review of published RCTs (1992-2012) in the eight oral health specialty journals with the highest impact factors found that only seven of 43 (16%) trials with a split mouth design identified the trial as split mouth in the title.[20]
Nine eyes randomised to posterior chamber intraocular lens (PC intraocular lenses (IOLs)) were converted to AC IOL; one eye randomised to AC IOL inadvertently received PC IOL
Summary
Many journals 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. Extensions of CONSORT 2010 to different trial designs have been published for cluster randomised trials,[10 ] non-inferiority and equivalence trials,[11 ] and N-of-1 trials.[12] As part of that series, in this paper we extend the CONSORT 2010 recommendations to RCTs in which participants receive two or more treatments to different body sites. Extracapsular cataract extraction (ECCE) with a posterior chamber intraocular lens (PC IOL) is the preferred method of cataract surgery in developed countries. A randomised controlled trial was carried out to compare these surgical strategies
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