Blog
About

10
views
0
recommends
+1 Recommend
0 collections
    0
    shares
      • Record: found
      • Abstract: found
      • Article: found
      Is Open Access

      Core Outcome Set-STAndards for Development: The COS-STAD recommendations

      Read this article at

      Bookmark
          There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

          Abstract

          Background

          The use of core outcome sets (COS) ensures that researchers measure and report those outcomes that are most likely to be relevant to users of their research. Several hundred COS projects have been systematically identified to date, but there has been no formal quality assessment of these studies. The Core Outcome Set-STAndards for Development (COS-STAD) project aimed to identify minimum standards for the design of a COS study agreed upon by an international group, while other specific guidance exists for the final reporting of COS development studies (Core Outcome Set-STAndards for Reporting [COS-STAR]).

          Methods and findings

          An international group of experienced COS developers, methodologists, journal editors, potential users of COS (clinical trialists, systematic reviewers, and clinical guideline developers), and patient representatives produced the COS-STAD recommendations to help improve the quality of COS development and support the assessment of whether a COS had been developed using a reasonable approach. An open survey of experts generated an initial list of items, which was refined by a 2-round Delphi survey involving nearly 250 participants representing key stakeholder groups. Participants assigned importance ratings for each item using a 1–9 scale. Consensus that an item should be included in the set of minimum standards was defined as at least 70% of the voting participants from each stakeholder group providing a score between 7 and 9. The Delphi survey was followed by a consensus discussion with the study management group representing multiple stakeholder groups. COS-STAD contains 11 minimum standards that are the minimum design recommendations for all COS development projects. The recommendations focus on 3 key domains: the scope, the stakeholders, and the consensus process.

          Conclusions

          The COS-STAD project has established 11 minimum standards to be followed by COS developers when planning their projects and by users when deciding whether a COS has been developed using reasonable methods.

          Abstract

          Paula Williamson and colleagues report on the core outcome set standards for development that researchers should use for improving reporting of their research.

          Related collections

          Most cited references 12

          • Record: found
          • Abstract: found
          • Article: not found

          An official American Thoracic Society/European Respiratory Society statement: asthma control and exacerbations: standardizing endpoints for clinical asthma trials and clinical practice.

          The assessment of asthma control is pivotal to the evaluation of treatment response in individuals and in clinical trials. Previously, asthma control, severity, and exacerbations were defined and assessed in many different ways. The Task Force was established to provide recommendations about standardization of outcomes relating to asthma control, severity, and exacerbations in clinical trials and clinical practice, for adults and children aged 6 years or older. A narrative literature review was conducted to evaluate the measurement properties and strengths/weaknesses of outcome measures relevant to asthma control and exacerbations. The review focused on diary variables, physiologic measurements, composite scores, biomarkers, quality of life questionnaires, and indirect measures. The Task Force developed new definitions for asthma control, severity, and exacerbations, based on current treatment principles and clinical and research relevance. In view of current knowledge about the multiple domains of asthma and asthma control, no single outcome measure can adequately assess asthma control. Its assessment in clinical trials and in clinical practice should include components relevant to both of the goals of asthma treatment, namely achievement of best possible clinical control and reduction of future risk of adverse outcomes. Recommendations are provided for the assessment of asthma control in clinical trials and clinical practice, both at baseline and in the assessment of treatment response. The Task Force recommendations provide a basis for a multicomponent assessment of asthma by clinicians, researchers, and other relevant groups in the design, conduct, and evaluation of clinical trials, and in clinical practice.
            Bookmark
            • Record: found
            • Abstract: found
            • Article: found
            Is Open Access

            Developing core outcome sets for clinical trials: issues to consider

            The selection of appropriate outcomes or domains is crucial when designing clinical trials in order to compare directly the effects of different interventions in ways that minimize bias. If the findings are to influence policy and practice then the chosen outcomes need to be relevant and important to key stakeholders including patients and the public, health care professionals and others making decisions about health care. There is a growing recognition that insufficient attention has been paid to the outcomes measured in clinical trials. These issues could be addressed through the development and use of an agreed standardized collection of outcomes, known as a core outcome set, which should be measured and reported, as a minimum, in all trials for a specific clinical area. Accumulating work in this area has identified the need for general guidance on the development of core outcome sets. Key issues to consider in the development of a core outcome set include its scope, the stakeholder groups to involve, choice of consensus method and the achievement of a consensus.
              Bookmark
              • Record: found
              • Abstract: found
              • Article: found
              Is Open Access

              The COMET Handbook: version 1.0

              The selection of appropriate outcomes is crucial when designing clinical trials in order to compare the effects of different interventions directly. For the findings to influence policy and practice, the outcomes need to be relevant and important to key stakeholders including patients and the public, health care professionals and others making decisions about health care. It is now widely acknowledged that insufficient attention has been paid to the choice of outcomes measured in clinical trials. Researchers are increasingly addressing this issue through the development and use of a core outcome set, an agreed standardised collection of outcomes which should be measured and reported, as a minimum, in all trials for a specific clinical area. Accumulating work in this area has identified the need for guidance on the development, implementation, evaluation and updating of core outcome sets. This Handbook, developed by the COMET Initiative, brings together current thinking and methodological research regarding those issues. We recommend a four-step process to develop a core outcome set. The aim is to update the contents of the Handbook as further research is identified. Electronic supplementary material The online version of this article (doi:10.1186/s13063-017-1978-4) contains supplementary material, which is available to authorized users.
                Bookmark

                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
                16 November 2017
                November 2017
                : 14
                : 11
                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 & Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom
                [3 ] MRC ConDuCT II Hub for Trials Methodology Research, School of Social & 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 ] 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, ST, and PRW are members of the COMET Management Group. KD and JJK declare no competing interests.

                Article
                PMEDICINE-D-17-02254
                10.1371/journal.pmed.1002447
                5689835
                29145404
                © 2017 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.

                Counts
                Figures: 0, Tables: 2, Pages: 10
                Product
                Funding
                Financial support for the dissemination of COS-STAD 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.
                Categories
                Guidelines and Guidance
                Research and Analysis Methods
                Research Assessment
                Systematic Reviews
                Research and Analysis Methods
                Research Design
                Survey Research
                Surveys
                Research and Analysis Methods
                Research Assessment
                Research Reporting Guidelines
                Biology and Life Sciences
                Neuroscience
                Cognitive Science
                Cognitive Psychology
                Language
                Biology and Life Sciences
                Psychology
                Cognitive Psychology
                Language
                Social Sciences
                Psychology
                Cognitive Psychology
                Language
                Medicine and Health Sciences
                Pharmacology
                Drug Research and Development
                Medicine and Health Sciences
                Clinical Medicine
                Clinical Trials
                Medicine and Health Sciences
                Pharmacology
                Drug Research and Development
                Clinical Trials
                Research and Analysis Methods
                Clinical Trials
                Research and Analysis Methods
                Database and Informatics Methods
                Database Searching
                Medicine and Health Sciences
                Health Care
                Patient Advocacy

                Medicine

                Comments

                Comment on this article

                Similar content 86

                Cited by 55

                Most referenced authors 152