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

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          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.

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          Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials.

          K Schulz, I. Chalmers, R Hayes … (1995)
          To determine if inadequate approaches to randomized controlled trial design and execution are associated with evidence of bias in estimating treatment effects. An observational study in which we assessed the methodological quality of 250 controlled trials from 33 meta-analyses and then analyzed, using multiple logistic regression models, the associations between those assessments and estimated treatment effects. Meta-analyses from the Cochrane Pregnancy and Childbirth Database. The associations between estimates of treatment effects and inadequate allocation concealment, exclusions after randomization, and lack of double-blinding. Compared with trials in which authors reported adequately concealed treatment allocation, trials in which concealment was either inadequate or unclear (did not report or incompletely reported a concealment approach) yielded larger estimates of treatment effects (P < .001). Odds ratios were exaggerated by 41% for inadequately concealed trials and by 30% for unclearly concealed trials (adjusted for other aspects of quality). Trials in which participants had been excluded after randomization did not yield larger estimates of effects, but that lack of association may be due to incomplete reporting. Trials that were not double-blind also yielded larger estimates of effects (P = .01), with odds ratios being exaggerated by 17%. This study provides empirical evidence that inadequate methodological approaches in controlled trials, particularly those representing poor allocation concealment, are associated with bias. Readers of trial reports should be wary of these pitfalls, and investigators must improve their design, execution, and reporting of trials.
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            Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide.

            Tammy C Hoffmann, Paul P Glasziou, David Moher … (2014)
            Without a complete published description of interventions, clinicians and patients cannot reliably implement interventions that are shown to be useful, and other researchers cannot replicate or build on research findings. The quality of description of interventions in publications, however, is remarkably poor. To improve the completeness of reporting, and ultimately the replicability, of interventions, an international group of experts and stakeholders developed the Template for Intervention Description and Replication (TIDieR) checklist and guide. The process involved a literature review for relevant checklists and research, a Delphi survey of an international panel of experts to guide item selection, and a face to face panel meeting. The resultant 12 item TIDieR checklist (brief name, why, what (materials), what (procedure), who provided, how, where, when and how much, tailoring, modifications, how well (planned), how well (actual)) is an extension of the CONSORT 2010 statement (item 5) and the SPIRIT 2013 statement (item 11). While the emphasis of the checklist is on trials, the guidance is intended to apply across all evaluative study designs. This paper presents the TIDieR checklist and guide, with an explanation and elaboration for each item, and examples of good reporting. The TIDieR checklist and guide should improve the reporting of interventions and make it easier for authors to structure accounts of their interventions, reviewers and editors to assess the descriptions, and readers to use the information.
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              Consort 2010 statement: extension to cluster randomised trials.

              , K. Campbell, Doug G. Altman … (2011)
              Article 0 comments Cited 273 times – based on 0 reviews     Review now
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                Author and article information

                Contributors
                Nikolaos Pandis: Role: senior lecturer
                Bryan Chung: Role: clinical instructor
                Roberta W Scherer: Role: senior scientist
                Diana Elbourne: Role: professor of healthcare evaluation
                Douglas G Altman: Role: professor of statistics in medicine
                Journal
                Journal ID (nlm-ta): BMJ
                Journal ID (iso-abbrev): BMJ
                Journal ID (publisher-id): bmj
                Title: The BMJ
                Publisher: BMJ Publishing Group Ltd.
                ISSN (Print): 0959-8138
                ISSN (Electronic): 1756-1833
                Publication date Collection: 2017
                Publication date (Electronic): 30 June 2017
                Volume: 357
                Electronic Location Identifier: j2835
                Affiliations
                [1 ]University of Bern, Medical Faculty, School of Dental Medicine, Department of Orthodontics and Dentofacial Orthopedics, Bern, Switzerland
                [2 ]Division of Plastic Surgery, University of British Columbia, Victoria, BC, Canada
                [3 ]Johns Hopkins Bloomberg School of Public Health, Epidemiology Mailroom E6138 Baltimore, MD, USA
                [4 ]London School of Hygiene and Tropical Medicine, Department of Medical Statistics, London, UK
                [5 ]Centre 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@ 123456yahoo.com
                Article
                Publisher ID: pann035936
                DOI: 10.1136/bmj.j2835
                PMC ID: 5492474
                PubMed ID: 28667088
                SO-VID: eab88735-1fea-4eb5-9a2a-4ee80a86464e
                Copyright © Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions
                License:

                This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

                History
                Date accepted : 13 May 2017
                Categories
                Subject: Research Methods & Reporting

                ScienceOpen disciplines: Medicine
                Data availability:
                ScienceOpen disciplines: Medicine

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