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      Reporting randomised trials of social and psychological interventions: the CONSORT-SPI 2018 Extension

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          Abstract

          Background

          Randomised controlled trials (RCTs) are used to evaluate social and psychological interventions and inform policy decisions about them. Accurate, complete, and transparent reports of social and psychological intervention RCTs are essential for understanding their design, conduct, results, and the implications of the findings. However, the reporting of RCTs of social and psychological interventions remains suboptimal. The CONSORT Statement has improved the reporting of RCTs in biomedicine. A similar high-quality guideline is needed for the behavioural and social sciences. Our objective was to develop an official extension of the Consolidated Standards of Reporting Trials 2010 Statement (CONSORT 2010) for reporting RCTs of social and psychological interventions: CONSORT-SPI 2018.

          Methods

          We followed best practices in developing the reporting guideline extension. First, we conducted a systematic review of existing reporting guidelines. We then conducted an online Delphi process including 384 international participants. In March 2014, we held a 3-day consensus meeting of 31 experts to determine the content of a checklist specifically targeting social and psychological intervention RCTs. Experts discussed previous research and methodological issues of particular relevance to social and psychological intervention RCTs. They then voted on proposed modifications or extensions of items from CONSORT 2010.

          Results

          The CONSORT-SPI 2018 checklist extends 9 of the 25 items from CONSORT 2010: background and objectives, trial design, participants, interventions, statistical methods, participant flow, baseline data, outcomes and estimation, and funding. In addition, participants added a new item related to stakeholder involvement, and they modified aspects of the flow diagram related to participant recruitment and retention.

          Conclusions

          Authors should use CONSORT-SPI 2018 to improve reporting of their social and psychological intervention RCTs. Journals should revise editorial policies and procedures to require use of reporting guidelines by authors and peer reviewers to produce manuscripts that allow readers to appraise study quality, evaluate the applicability of findings to their contexts, and replicate effective interventions.

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          Most cited references90

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          Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015: elaboration and explanation

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            Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide

            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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              Developing and evaluating complex interventions: the new Medical Research Council guidance

              Evaluating complex interventions is complicated. The Medical Research Council's evaluation framework (2000) brought welcome clarity to the task. Now the council has updated its guidance
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                Author and article information

                Contributors
                p.x.montgomery@bham.ac.uk
                sgrant@rand.org
                evan.mayo-wilson@jhu.edu
                geraldine.macdonald@bristol.ac.uk
                s.michie@ucl.ac.uk
                sally.hopewell@csm.ox.ac.uk
                dmoher@ohri.ca
                Journal
                Trials
                Trials
                Trials
                BioMed Central (London )
                1745-6215
                31 July 2018
                31 July 2018
                2018
                : 19
                : 407
                Affiliations
                [1 ]ISNI 0000 0004 1936 7486, GRID grid.6572.6, School of Social Policy, , University of Birmingham, ; Edgbaston, Birmingham, B15 2TT UK
                [2 ]ISNI 0000 0004 0370 7685, GRID grid.34474.30, Behavioral & Policy Sciences, , RAND Corporation, ; 1776 Main Street, Santa Monica, 90407-2138 CA USA
                [3 ]ISNI 0000 0001 2175 4264, GRID grid.411024.2, Department of Epidemiology, ; 615 North Wolfe Street, E6036, Baltimore, 21205 MD USA
                [4 ]School for Policy Studies, 8 Priory Road, Bristol, BS8 1TZ UK
                [5 ]Department of Clinical, Educational and Health Psychology, Centre for Behaviour Change, London, WC1E 7HB UK
                [6 ]ISNI 0000 0004 1936 8948, GRID grid.4991.5, Oxford Clinical Trials Research Unit, Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences, , University of Oxford, Botnar Research Centre, ; Windmill Road, Oxford, OX3 7LD UK
                [7 ]Centre for Journalology, Clinical Epidemiology Program, Ottawa, K1H 8L6 ON Canada
                Author information
                http://orcid.org/0000-0001-8008-1370
                Article
                2733
                10.1186/s13063-018-2733-1
                6066921
                30060754
                1ec472ec-9e0c-4a07-92e4-9a14bd961ada
                © The Author(s). 2018

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 17 January 2018
                : 8 June 2018
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/501100000269, Economic and Social Research Council;
                Award ID: ES/K00087X/1
                Award Recipient :
                Categories
                Methodology
                Custom metadata
                © The Author(s) 2018

                Medicine
                consort,randomised controlled trial,reporting guideline,reporting standards,transparency
                Medicine
                consort, randomised controlled trial, reporting guideline, reporting standards, transparency

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