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      Core Outcome Set–STAndards for Reporting: The COS-STAR Statement

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          Abstract

          Background

          Core outcome sets (COS) can enhance the relevance of research by ensuring that outcomes of importance to health service users and other people making choices about health care in a particular topic area are measured routinely. Over 200 COS to date have been developed, but the clarity of these reports is suboptimal. COS studies will not achieve their goal if reports of COS are not complete and transparent.

          Methods and Findings

          In recognition of these issues, an international group that included experienced COS developers, methodologists, journal editors, potential users of COS (clinical trialists, systematic reviewers, and clinical guideline developers), and patient representatives developed the Core Outcome Set–STAndards for Reporting (COS-STAR) Statement as a reporting guideline for COS studies. The developmental process consisted of an initial reporting item generation stage and a two-round Delphi survey involving nearly 200 participants representing key stakeholder groups, followed by a consensus meeting. The COS-STAR Statement consists of a checklist of 18 items considered essential for transparent and complete reporting in all COS studies. The checklist items focus on the introduction, methods, results, and discussion section of a manuscript describing the development of a particular COS. A limitation of the COS-STAR Statement is that it was developed without representative views of low- and middle-income countries. COS have equal relevance to studies conducted in these areas, and, subsequently, this guideline may need to evolve over time to encompass any additional challenges from developing COS in these areas.

          Conclusions

          With many ongoing COS studies underway, the COS-STAR Statement should be a helpful resource to improve the reporting of COS studies for the benefit of all COS users.

          Abstract

          Paula Williamson and colleagues present reporting standards for studies that report core outcome sets for health research.

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          Most cited references 7

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          Choosing Important Health Outcomes for Comparative Effectiveness Research: A Systematic Review

          Background A core outcome set (COS) is a standardised set of outcomes which should be measured and reported, as a minimum, in all effectiveness trials for a specific health area. This will allow results of studies to be compared, contrasted and combined as appropriate, as well as ensuring that all trials contribute usable information. The COMET (Core Outcome Measures for Effectiveness Trials) Initiative aims to support the development, reporting and adoption of COS. Central to this is a publically accessible online resource, populated with all available COS. The aim of the review we report here was to identify studies that sought to determine which outcomes or domains to measure in all clinical trials in a specific condition and to describe the methodological techniques used in these studies. Methods We developed a multi-faceted search strategy for electronic databases (MEDLINE, SCOPUS, and Cochrane Methodology Register). We included studies that sought to determine which outcomes/domains to measure in all clinical trials in a specific condition. Results A total of 250 reports relating to 198 studies were judged eligible for inclusion in the review. Studies covered various areas of health, most commonly cancer, rheumatology, neurology, heart and circulation, and dentistry and oral health. A variety of methods have been used to develop COS, including semi-structured discussion, unstructured group discussion, the Delphi Technique, Consensus Development Conference, surveys and Nominal Group Technique. The most common groups involved were clinical experts and non-clinical research experts. Thirty-one (16%) studies reported that the public had been involved in the process. The geographic locations of participants were predominantly North America (n = 164; 83%) and Europe (n = 150; 76%). Conclusions This systematic review identified many health areas where a COS has been developed, but also highlights important gaps. It is a further step towards a comprehensive, up-to-date database of COS. In addition, it shows the need for methodological guidance, including how to engage key stakeholder groups, particularly members of the public.
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            The Harmonising Outcome Measures for Eczema (HOME) statement to assess clinical signs of atopic eczema in trials.

            The lack of core outcome sets for atopic eczema (AE) is a major obstacle for advancing evidence-based treatment. The global Harmonising Outcome Measures for Eczema (HOME) initiative has already defined clinical signs, symptoms, quality of life, and long-term control of flares as core outcome domains for AE trials. This article deals with the standardization of measurement instruments to assess clinical signs of AE. To resolve the current lack of standardization of the assessment of clinical signs of AE, we followed a structured process of systematic reviews and international consensus sessions to identify 1 core outcome measurement instrument for assessment of clinical signs in all future AE trials. Systematic reviews indicated that from 16 different instruments identified to assess clinical signs of AE, only the Eczema Area and Severity Index (EASI) and the objective Scoring Atopic Dermatitis (SCORAD) index were identified as extensively validated. The EASI has adequate validity, responsiveness, internal consistency, and intraobserver reliability. The objective SCORAD index has adequate validity, responsiveness, and interobserver reliability but unclear intraobserver reliability to measure clinical signs of AE. In an international consensus study, patients, physicians, nurses, methodologists, and pharmaceutical industry representatives agreed that the EASI is the preferred core instrument to measure clinical signs in all future AE trials. All stakeholders involved in designing, reporting, and using clinical trials on AE are asked to comply with this consensus to enable better evidence-based decision making, clearer scientific communication, and improved patient care. Copyright © 2014 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.
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              Choosing Important Health Outcomes for Comparative Effectiveness Research: An Updated Review and User Survey

              Background A COS represents an agreed minimum set of outcomes that should be measured and reported in all trials of a specific condition. The COMET (Core Outcome Measures in Effectiveness Trials) initiative aims to collate and stimulate the development and application of COS, by including data on relevant studies within a publically available internet-based resource. In recent years, there has been an interest in increasing the development of COS. Therefore, this study aimed to provide an update of a previous review, and examine the quality of development of COS. A further aim was to understand the reasons why individuals are searching the COMET database. Methods A multi-faceted search strategy was followed, in order to identify studies that sought to determine which outcomes/domains to measure in clinical trials of a specific condition. Additionally, a pop up survey was added to the COMET website, to ascertain why people were searching the COMET database. Results Thirty-two reports relating to 29 studies were eligible for inclusion in the review. There has been an improvement in the description of the scope of a COS and an increase in the proportion of studies using literature/systematic reviews and the Delphi technique. Clinical experts continue to be the most common group involved in developing COS, however patient and public involvement has increased. The pop-up survey revealed the most common reasons for visiting the COMET website to be thinking about developing a COS and planning a clinical trial. Conclusions This update demonstrates that recent studies appear to have adopted a more structured approach towards COS development and public representation has increased. However, there remains a need for developers to adequately describe details about the scope of COS, and for greater public engagement. The COMET database appears to be a useful resource for both COS developers and users of COS.
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                Author and article information

                Journal
                PLoS Med
                PLoS Med
                plos
                plosmed
                PLoS Medicine
                Public Library of Science (San Francisco, CA USA )
                1549-1277
                1549-1676
                18 October 2016
                October 2016
                : 13
                : 10
                Affiliations
                [1 ]MRC North West Hub for Trials Methodology Research, Department of Biostatistics, University of Liverpool, Liverpool, United Kingdom
                [2 ]Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, United Kingdom
                [3 ]MRC ConDuCT II Hub for Trials Methodology Research, School of Social and Community Medicine, University of Bristol, Bristol, United Kingdom
                [4 ]Northern Ireland Hub for Trials Methodology Research, Centre for Public Health, Queen's University Belfast, Belfast, United Kingdom
                [5 ]National University of Ireland Galway and HRB Trials Methodology Research Network, Ireland
                [6 ]Ottawa Methods Centre, Ottawa Hospital Research Institute, Ottawa, Canada
                [7 ]Center for Evidence-Based Healthcare, Medizinische Fakultät, Technische Universität Dresden, Dresden, Germany
                [8 ]Institute of Population Health, University of Ottawa, Ottawa, Canada
                [9 ]Center for Medical Technology Policy, Baltimore, Maryland, United States of America
                Author notes

                I have read the journal's policy and have the following conflicts: DGA, JMB, MC, EG, PRW, and ST are members of the COMET Management Group. DM is a member of the Editorial Board of PLOS Medicine. DD, SG, JJK, JS, and PT declare no competing interests.

                • Conceptualization: PRW.

                • Formal analysis: JJK PRW.

                • Funding acquisition: JJK DGA JMB MC EG PRW.

                • Investigation: JJK SG DGA JMB MC DD EG DM JS PT ST PRW.

                • Methodology: JJK MC PRW.

                • Project administration: JJK SG PRW.

                • Software: PRW.

                • Validation: JJK PRW.

                • Writing – original draft: JJK.

                • Writing – review & editing: JJK SG DGA JMB MC DD EG DM JS PT ST PRW.

                Article
                PMEDICINE-D-16-01576
                10.1371/journal.pmed.1002148
                5068732
                27755541
                © 2016 Kirkham et al

                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.

                Page count
                Figures: 0, Tables: 1, Pages: 11
                Product
                Funding
                Financial support for the COS-STAR consensus meeting was provided by the MRC Network of Hubs for Trials Methodology Research (MR/L004933/1-R55). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
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