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      Reporting Quality of Social and Psychological Intervention Trials: A Systematic Review of Reporting Guidelines and Trial Publications

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          Abstract

          Background

          Previous reviews show that reporting guidelines have improved the quality of trial reports in medicine, yet existing guidelines may not be fully suited for social and psychological intervention trials.

          Objective/Design

          We conducted a two-part study that reviewed (1) reporting guidelines for and (2) the reporting quality of social and psychological intervention trials.

          Data Sources

          (1) To identify reporting guidelines, we systematically searched multiple electronic databases and reporting guideline registries. (2) To identify trials, we hand-searched 40 journals with the 10 highest impact factors in clinical psychology, criminology, education, and social work.

          Eligibility

          (1) Reporting guidelines consisted of articles introducing a checklist of reporting standards relevant to social and psychological intervention trials. (2) Trials reported randomised experiments of complex interventions with psychological, social, or health outcomes.

          Results

          (1) We identified 19 reporting guidelines that yielded 147 reporting standards relevant to social and psychological interventions. Social and behavioural science guidelines included 89 standards not found in CONSORT guidelines. However, CONSORT guidelines used more recommended techniques for development and dissemination compared to other guidelines. (2) Our review of trials (n = 239) revealed that many standards were poorly reported, such as identification as a randomised trial in titles (20% reported the information) and abstracts (55%); information about blinding (15%), sequence generation (23%), and allocation concealment (17%); and details about actual delivery of experimental (43%) and control interventions (34%), participant uptake (25%), and service environment (28%). Only 11 of 40 journals referenced reporting guidelines in “Instructions to Authors.”

          Conclusion

          Existing reporting guidelines have important limitations in content, development, and/or dissemination. Important details are routinely missing from trial publications; most leading journals in social and behavioural sciences do not ask authors to follow reporting standards. Findings demonstrate a need to develop a CONSORT extension with updated standards for social and psychological intervention trials.

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          Most cited references49

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          CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials

          The CONSORT statement is used worldwide to improve the reporting of randomised controlled trials. Kenneth Schulz and colleagues describe the latest version, CONSORT 2010, which updates the reporting guideline based on new methodological evidence and accumulating experience
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            Assessing the quality of reports of randomized clinical trials: is blinding necessary?

            It has been suggested that the quality of clinical trials should be assessed by blinded raters to limit the risk of introducing bias into meta-analyses and systematic reviews, and into the peer-review process. There is very little evidence in the literature to substantiate this. This study describes the development of an instrument to assess the quality of reports of randomized clinical trials (RCTs) in pain research and its use to determine the effect of rater blinding on the assessments of quality. A multidisciplinary panel of six judges produced an initial version of the instrument. Fourteen raters from three different backgrounds assessed the quality of 36 research reports in pain research, selected from three different samples. Seven were allocated randomly to perform the assessments under blind conditions. The final version of the instrument included three items. These items were scored consistently by all the raters regardless of background and could discriminate between reports from the different samples. Blind assessments produced significantly lower and more consistent scores than open assessments. The implications of this finding for systematic reviews, meta-analytic research and the peer-review process are discussed.
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              Understanding interobserver agreement: the kappa statistic.

              Items such as physical exam findings, radiographic interpretations, or other diagnostic tests often rely on some degree of subjective interpretation by observers. Studies that measure the agreement between two or more observers should include a statistic that takes into account the fact that observers will sometimes agree or disagree simply by chance. The kappa statistic (or kappa coefficient) is the most commonly used statistic for this purpose. A kappa of 1 indicates perfect agreement, whereas a kappa of 0 indicates agreement equivalent to chance. A limitation of kappa is that it is affected by the prevalence of the finding under observation. Methods to overcome this limitation have been described.
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                Author and article information

                Contributors
                Role: Editor
                Journal
                PLoS One
                PLoS ONE
                plos
                plosone
                PLoS ONE
                Public Library of Science (San Francisco, USA )
                1932-6203
                2013
                29 May 2013
                : 8
                : 5
                : e65442
                Affiliations
                [1 ]Centre for Evidence-Based Intervention, University of Oxford, Oxford, United Kingdom
                [2 ]Centre for Outcomes Research and Effectiveness, Research Department of Clinical, Educational & Health Psychology, University College London, London, United Kingdom
                University of Oxford, United Kingdom
                Author notes

                Competing Interests: SG, EMW, and PM are currently involved in the development of a CONSORT extension for social and psychological interventions ( http://www.tinyurl.com/CONSORT-study). This does not alter the authors' adherence to all the PLOS ONE policies on sharing data and materials.

                Conceived and designed the experiments: SG EMW PM. Performed the experiments: SG GJMT. Analyzed the data: SG EMW PM. Wrote the paper: SG EMW GJMT PM.

                Article
                PONE-D-13-04009
                10.1371/journal.pone.0065442
                3666983
                23734256
                4c1a7bc0-b71d-49a8-900d-cac202470cca
                Copyright @ 2013

                This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

                History
                : 29 January 2013
                : 24 April 2013
                Page count
                Pages: 11
                Funding
                SG holds a linked Clarendon Fund-Green Templeton College Annual Fund Scholarship to support his studies and research. EMW and PM have accepted a grant (no reference number assigned at time of submission) from the Economic and Social Research Council (ESRC; http://www.esrc.ac.uk/) to develop a CONSORT extension for complex psychological and social interventions. GJMT holds a Marshall Scholarship to support his studies and research. The authors thank the Centre for Evidence Based Intervention (Oxford), the Centre for Outcomes Research and Effectiveness (UCL), and the National Collaborating Centre for Mental Health (NCCMH) for internal support. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
                Categories
                Research Article
                Medicine
                Clinical Research Design
                Reporting Guidelines
                Mental Health
                Psychology
                Clinical Psychology
                Experimental Psychology
                Therapies
                Public Health
                Social and Behavioral Sciences
                Psychology
                Clinical Psychology
                Experimental Psychology
                Therapies
                Sociology
                Crime and Criminology
                Social Research

                Uncategorized
                Uncategorized

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