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      Development of a core outcome set for cardiovascular diabetology: a methodological framework

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          Abstract

          Background

          Cardiovascular diabetology is an emergent field focusing on all aspects of diabetes/cardiovascular interrelationship and metabolic syndrome. High-quality evidence needs to be provided to determine the efficacy and safety of interventions in cardiovascular diabetology. The heterogeneity of outcomes among trials limits the comparison of results, and some outcomes are not always meaningful to end-users. The cardiovascular diabetology core outcome set (COS) study aims to develop a COS of interventions for cardiovascular diabetology. In this paper, we introduce the methodological framework for developing the COS.

          Methods

          The COS development will include the following steps: (a) establish the COS groups of stakeholders, including international steering committee, Delphi survey group, and consensus meeting group; (b) systematic reviews of outcomes used in trials of cardiovascular diabetology; (c) semistructured interview of stakeholders for outcomes of cardiovascular diabetology; (d) generate a list of candidate outcomes and determine the original outcome pool; (e) Delphi survey with stakeholders of cardiovascular diabetology to select potential core outcomes; and (f) review and endorse the cardiovascular diabetology COS by expert consensus meeting.

          Conclusions

          This current study reports the methodological framework to develop a COS in cardiovascular diabetology and will provide evidence for the future development of COS in cardiovascular diabetology.

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          Most cited references32

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          What kind of systematic review should I conduct? A proposed typology and guidance for systematic reviewers in the medical and health sciences

          Background Systematic reviews have been considered as the pillar on which evidence-based healthcare rests. Systematic review methodology has evolved and been modified over the years to accommodate the range of questions that may arise in the health and medical sciences. This paper explores a concept still rarely considered by novice authors and in the literature: determining the type of systematic review to undertake based on a research question or priority. Results Within the framework of the evidence-based healthcare paradigm, defining the question and type of systematic review to conduct is a pivotal first step that will guide the rest of the process and has the potential to impact on other aspects of the evidence-based healthcare cycle (evidence generation, transfer and implementation). It is something that novice reviewers (and others not familiar with the range of review types available) need to take account of but frequently overlook. Our aim is to provide a typology of review types and describe key elements that need to be addressed during question development for each type. Conclusions In this paper a typology is proposed of various systematic review methodologies. The review types are defined and situated with regard to establishing corresponding questions and inclusion criteria. The ultimate objective is to provide clarified guidance for both novice and experienced reviewers and a unified typology with respect to review types.
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            Core Outcome Set–STAndards for Reporting: The COS-STAR Statement

            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.
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              Core Outcome Set-STAndardised Protocol Items: the COS-STAP Statement

              Background Several hundred core outcome set (COS) projects have been systematically identified to date which, if adopted, ensure that researchers measure and report those outcomes that are most likely to be relevant to users of their research. The uptake of a COS by COS users will depend in part on the transparency and robustness of the methods used in the COS development study, which would be increased by the use of a standardised protocol. This article describes the development of the COS-STAP (Core Outcome Set-STAndardised Protocol Items) Statement for the content of a COS development study protocol. Methods The COS-STAP Statement was developed following the Enhancing the Quality and Transparency Of Health Research (EQUATOR) Network’s methodological framework for guideline development. This included an initial item generation stage, a two-round Delphi survey involving more than 150 participants representing three stakeholder groups (COS developers, journal editors and patient and public involvement researchers interested in COS development), followed by a consensus meeting with eight voting participants. Results The COS-STAP Statement consists of a checklist of 13 items considered essential documentation in a protocol, outlining the scope of the COS, stakeholder involvement, COS development plans and consensus processes. Conclusions Journal editors and peer reviewers can use the guidance to assess the completeness of a COS development study protocol submitted for publication. By providing guidance for key content, the COS-STAP Statement will enhance the drafting of high-quality protocols and determine how the COS development study will be carried out. Electronic supplementary material The online version of this article (10.1186/s13063-019-3230-x) contains supplementary material, which is available to authorized users.
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                Author and article information

                Contributors
                URI : https://loop.frontiersin.org/people/2395350Role:
                URI : https://loop.frontiersin.org/people/1739739Role:
                URI : https://loop.frontiersin.org/people/911169Role: Role:
                URI : https://loop.frontiersin.org/people/1893463Role: Role: Role:
                URI : https://loop.frontiersin.org/people/1371491Role: Role:
                URI : https://loop.frontiersin.org/people/591110Role:
                URI : https://loop.frontiersin.org/people/1239444Role: Role: Role:
                Journal
                Front Endocrinol (Lausanne)
                Front Endocrinol (Lausanne)
                Front. Endocrinol.
                Frontiers in Endocrinology
                Frontiers Media S.A.
                1664-2392
                06 December 2023
                2023
                : 14
                : 1271891
                Affiliations
                [1] 1 Department of Anesthesiology and National Clinical Research Center for Geriatrics, West China Hospital, Sichuan University and The Research Units of West China, Chinese Academy of Medical Sciences , Chengdu, China
                [2] 2 Department of Cardiology, West China Hospital, Sichuan University , Chengdu, China
                [3] 3 Department of Endocrinology and Metabolism, West China Hospital, Sichuan University , Chengdu, China
                [4] 4 Department of Integrated Traditional and Western Medicine, West China Hospital, Sichuan University , Chengdu, China
                [5] 5 Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University , Chengdu, China
                [6] 6 Department of Periodical Press and National Clinical Research Center for Geriatrics, West China Hospital, Sichuan University , Chengdu, China
                [7] 7 Nursing Key Laboratory of Sichuan Province, West China Hospital of Sichuan University , Chengdu, China
                [8] 8 Department of Medical Administration, West China Hospital, Sichuan University , Chengdu, China
                Author notes

                Edited by: Xiaoqiang Tang, Sichuan University, China

                Reviewed by: Azadeh Anna Nikouee, Loyola University Chicago, United States; Chen Zhao, China Academy of Chinese Medical Sciences, China

                *Correspondence: Nian Li, linian@ 123456wchscu.cn

                †These authors have contributed equally to this work

                Article
                10.3389/fendo.2023.1271891
                10731247
                38125792
                4d2090ac-1b87-4a09-b720-85d3f15b2ce7
                Copyright © 2023 Jiao, Chen, Peng, Jia, He, Zhang and Li

                This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

                History
                : 03 August 2023
                : 15 November 2023
                Page count
                Figures: 1, Tables: 1, Equations: 0, References: 32, Pages: 7, Words: 3017
                Funding
                The author(s) declare that no financial support was received for the research, authorship, and/or publication of this article.
                Categories
                Endocrinology
                Methods
                Custom metadata
                Cardiovascular Endocrinology

                Endocrinology & Diabetes
                cardiovascular diabetology,consensus,core outcome set,efficacy,safety
                Endocrinology & Diabetes
                cardiovascular diabetology, consensus, core outcome set, efficacy, safety

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