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      Development of a core outcome set for myocardial infarction in clinical trials of traditional Chinese medicine: a study protocol

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          Abstract

          Introduction

          Myocardial infarction (MI) is the most dangerous complication in patients with coronary heart disease. In China, there is an increasing number of randomised controlled trials (RCTs) of traditional Chinese medicine (TCM) for treating MI. However, the inconsistency of outcome reporting means that a large number of clinical trials cannot be included in systematic reviews to provide the best evidence for clinical practice. The aim of this study is to develop a core outcome set (COS) for future TCM clinical trials of MI, which may improve the consistency of outcome reporting and facilitate the synthesis of data across studies in systematic reviews.

          Methods and analysis

          We will conduct a systematic review of MI clinical trials with any intervention. Semistructured interviews will be conducted to obtain the perspectives of patients with MI. The outcomes from the systematic review and semistructured interviews will be grouped and used to develop a questionnaire. The questionnaire will be developed as a supplement for the TCM syndromes of MI and will be constructed from the results of a systematic review, existing medical records and a cross-sectional study. Then two rounds of the Delphi survey will be conducted with different stakeholders (TCM experts and Western medicine experts in cardiovascular disease, methodologists, magazine editors and patients) to determine the importance of the outcomes. Only the TCM experts will need to response to the questionnaire for core TCM syndromes. A face-to-face consensus meeting will be conducted to create a final COS and recommend measurement time for each outcome.

          Ethics and dissemination

          This project has been approved by the Ethics Committee of Dongzhimen Hospital, Beijing University of Chinese Medicine. The final COS will be published and freely available.

          Trial registration number

          This study is registered with the Core Outcome Measures in Effectiveness Trials database as study 1243 (available at: http://www.comet-initiative.org/studies/details/1243).

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          Most cited references14

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          A taxonomy has been developed for outcomes in medical research to help improve knowledge discovery

          Objectives There is increasing recognition that insufficient attention has been paid to the choice of outcomes measured in clinical trials. The lack of a standardized outcome classification system results in inconsistencies due to ambiguity and variation in how outcomes are described across different studies. Being able to classify by outcome would increase efficiency in searching sources such as clinical trial registries, patient registries, the Cochrane Database of Systematic Reviews, and the Core Outcome Measures in Effectiveness Trials (COMET) database of core outcome sets (COS), thus aiding knowledge discovery. Study Design and Setting A literature review was carried out to determine existing outcome classification systems, none of which were sufficiently comprehensive or granular for classification of all potential outcomes from clinical trials. A new taxonomy for outcome classification was developed, and as proof of principle, outcomes extracted from all published COS in the COMET database, selected Cochrane reviews, and clinical trial registry entries were classified using this new system. Results Application of this new taxonomy to COS in the COMET database revealed that 274/299 (92%) COS include at least one physiological outcome, whereas only 177 (59%) include at least one measure of impact (global quality of life or some measure of functioning) and only 105 (35%) made reference to adverse events. Conclusions This outcome taxonomy will be used to annotate outcomes included in COS within the COMET database and is currently being piloted for use in Cochrane Reviews within the Cochrane Linked Data Project. Wider implementation of this standard taxonomy in trial and systematic review databases and registries will further promote efficient searching, reporting, and classification of trial outcomes.
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            Improved outcomes in patients with ST-elevation myocardial infarction during the last 20 years are related to implementation of evidence-based treatments: experiences from the SWEDEHEART registry 1995–2014

            Abstract Aims Impact of changes of treatments on outcomes in ST-elevation myocardial infarction (STEMI) patients in real-life health care has not been documented. Methods and results All STEMI cases (n = 105.674) registered in the nation-wide SWEDEHEART registry between 1995 and 2014 were included and followed for fatal and non-fatal outcomes for up to 20 years. Most changes in treatment and outcomes occurred from 1994 to 2008. Evidence-based treatments increased: reperfusion from 66.2 to 81.7%; primary percutaneous coronary intervention: 4.5 to 78.0%; dual antiplatelet therapy from 0 to 89.6%; statin: 14.1 to 93.6%; beta-blocker: 78.2 to 91.0%, and angiotensin-converting-enzyme/angiotensin-2-receptor inhibitors: 40.8 to 85.2% (P-value for-trend <0.001 for all). One-year mortality decreased from 22.1 to 14.1%. Standardized incidence ratio compared with the general population decreased from 5.54 to 3.74 (P < 0.001). Cardiovascular (CV) death decreased from 20.1 to 11.1%, myocardial infarction (MI) from 11.5 to 5.8%; stroke from 2.9 to 2.1%; heart failure from 7.1 to 6.2%. After standardization for differences in demography and baseline characteristics, the change of 1-year CV-death or MI corresponded to a linear trend of 0.915 (95% confidence interval: 0.906–0.923) per 2-year period which no longer was significant, 0.997 (0.984–1.009), after adjustment for changes in treatment. The changes in treatment and outcomes were most pronounced from 1994 to 2008. Conclusion Gradual implementation of new and established evidence-based treatments in STEMI patients during the last 20 years has been associated with prolonged survival and lower risk of recurrent ischaemic events, although a plateauing is seen since around 2008.
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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

                Journal
                BMJ Open
                BMJ Open
                bmjopen
                bmjopen
                BMJ Open
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                2044-6055
                2019
                3 December 2019
                : 9
                : 12
                : e032256
                Affiliations
                [1 ] Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing, Dongzhimen Hospital, Beijing University of Chinese Medicine , Beijing, China
                [2 ] Tianjin University of Traditional Chinese Medicine , Tianjin, China
                Author notes
                [Correspondence to ] Hongcai Shang; shanghongcai@ 123456foxmail.com
                Author information
                http://orcid.org/0000-0003-3615-4960
                Article
                bmjopen-2019-032256
                10.1136/bmjopen-2019-032256
                6924774
                31796484
                10009641-a510-48a8-90fe-5f7c3cc58e6b
                © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

                This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See:  http://creativecommons.org/licenses/by-nc/4.0/.

                History
                : 10 June 2019
                : 03 October 2019
                : 07 November 2019
                Funding
                Funded by: National Key R&D Program of China;
                Award ID: 2017YFC1700400
                Award ID: 2017YFC1700402
                Funded by: Fundamental Research Funds for the Central University;
                Award ID: 2019-JYB-JS-033
                Categories
                Complementary Medicine
                Protocol
                1506
                1685
                Custom metadata
                unlocked

                Medicine
                myocardial infarction,protocols and guidelines,change management
                Medicine
                myocardial infarction, protocols and guidelines, change management

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