Dataset Information

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

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.

SUBMITTER: Kirkham JJ

PROVIDER: S-EPMC5068732 | biostudies-literature | 2016 Oct

REPOSITORIES: biostudies-literature

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Publications

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

Kirkham Jamie J JJ Gorst Sarah S Altman Douglas G DG Blazeby Jane M JM Clarke Mike M Devane Declan D Gargon Elizabeth E Moher David D Schmitt Jochen J Tugwell Peter P Tunis Sean S Williamson Paula R PR

PLoS medicine 20161018 10

<h4>Background</h4>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.<h4>Methods and findings</h4>In recognition of these issues, an internati ...[more]

PMID: 27755541

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Project description: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]).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.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.

Project description:BackgroundBronchiectasis is a chronic respiratory disease characterised by airways widening and recurrent infections, resulting in episodes of chronic cough, sputum expectoration, and dyspnoea. This leads to deterioration in daily function, repeated hospital admissions and poor quality of life. The prevalence and mortality related to bronchiectasis is increasing worldwide with growing economic burden on healthcare systems. Physiotherapy for bronchiectasis aims to decrease accumulation of sputum, dyspnoea, and improve exercise capacity and daily function. A robust evidence base to support physiotherapy in bronchiectasis is currently lacking. This is partly because of inconsistency and poor reporting of outcomes in available studies. A core outcome set is the minimum acceptable group of outcomes that should be used in clinical trials for a specific condition. This decreases research waste by improving consistency and reporting of key outcomes and facilitates the synthesis of study outcomes in systematic reviews and guidelines. The aim of the study is therefore to develop a core outcome set and outcome measurement set for physiotherapy research in adults with bronchiectasis. This will ensure outcomes important to key stakeholders are consistently used and reported in future research.Methods and analysisThis project will use the COMET Initiative and COSMIN guidelines of core outcome set development and will include three phases. In the first phase, a comprehensive list of outcomes will be developed using systematic review of reported outcomes and qualitative interviews with patients and physiotherapists. Then consensus on key outcomes will be established in phase two using a Delphi survey and a consensus meeting. Finally, in phase three, we will identify appropriate instruments to measure the core outcomes by evaluating the psychometric properties of available instruments and a stakeholders' meeting to establish consensus.EthicsThe study was reviewed and has received ethical approval from the health-related Research Ethics Committee- Edge Hill University (ETH2021-0217).RegistrationThis study is registered with the COMET database. https://www.comet-initiative.org/Studies/Details/1931. The full systematic review protocol is registered in PROSPERO under the number CRD42021266247.

Project description:BackgroundInconsistent reporting of outcomes in clinical trials of women with Pelvic Girdle Pain (PGP) hinders comparison of findings and the reliability of evidence synthesis. A core outcome set (COS) can address this issue as it defines a minimum set of outcomes that should be reported in all clinical trials on the condition. The aim of this study was to develop a consensus-based COS for evaluating the effectiveness of interventions in PGP during pregnancy and postpartum for use in research and clinical practice.MethodsA systematic review of previous studies on PGP and semi-structured interviews with women were undertaken to identify all outcomes that were reported in prior studies and that are relevant to those experiencing the condition. Key stakeholders (clinicians, researchers, service providers/policy makers and individuals with PGP) then rated the importance of these outcomes for including in a preliminary PGP-COS using a 3-round Delphi study. The final COS was agreed at a face-to-face consensus meeting.ResultsConsensus was achieved on five outcomes for inclusion in the final PGP-COS. All outcomes are grouped under the "life impact" domain and include: pain frequency, pain intensity/severity, function/disability/activity limitation, health-related quality of life and fear avoidance.ConclusionThis study identified a COS for evaluating the effectiveness of interventions in pregnancy-related and postpartum-related PGP in research and clinical settings. It is advocated that all trials, other non-randomised studies and clinicians in this area use this COS by reporting these outcomes as a minimum. This will ensure the reporting of meaningful outcomes and will enable the findings of future studies to be compared and combined. Future work will determine how to measure the outcomes of the PGP-COS.Core outcome set registrationThis PGP-COS was registered with COMET (Core Outcome Measures for Effectiveness Trials) in January 2017 (http://www.comet-initiative.org/studies/details/958).

Project description:BackgroundAs the development of core outcome sets (COS) increases, guidance for developing and reporting high-quality COS continues to evolve; however, a number of methodological uncertainties still remain. The objectives of this study were: (1) to explore the impact of including patient interviews in developing a COS, (2) to examine the impact of using a 5-point versus a 9-point rating scale during Delphi consensus methods on outcome selection and (3) to inform and contribute to COS development methodology by advancing the evidence base on COS development techniques.MethodsSemi-structured patient interviews and a nested randomised controlled parallel group trial as part of the Pelvic Girdle Pain Core Outcome Set project (PGP-COS). Patient interviews, as an adjunct to a systematic review of outcomes reported in previous studies, were undertaken to identify preliminary outcomes for including in a Delphi consensus survey. In the Delphi survey, participants were randomised (1:1) to a 5-point or 9-point rating scale for rating the importance of the list of preliminary outcomes.ResultsFour of the eight patient interview derived outcomes were included in the preliminary COS, however, none of these outcomes were included in the final PGP-COS. The 5-point rating scale resulted in twice as many outcomes reaching consensus after the 3-round Delphi survey compared to the 9-point scale. Consensus on all five outcomes included in the final PGP-COS was achieved by participants allocated the 5-point rating scale, whereas consensus on four of these was achieved by those using the 9-point scale.ConclusionsUsing patient interviews to identify preliminary outcomes as an adjunct to conducting a systematic review of outcomes measured in the literature did not appear to influence outcome selection in developing the COS in this study. The use of different rating scales in a Delphi survey, however, did appear to impact on outcome selection. The 5-point scale demonstrated greater congruency than the 9-point scale with the outcomes included in the final PGP-COS. Future research to substantiate our findings and to explore the impact of other rating scales on outcome selection during COS development, however, is warranted.

Dataset Information

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

Background

Methods and findings

Conclusions

Publications

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

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