A core outcome set for clinical trials of Chinese medicine for hyperlipidemia: a study protocol for a systematic review and a Delphi survey

IntroductionMyocardial 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 analysisWe 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 disseminationThis 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 numberThis 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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Development of a core outcome set (COS) and selecting outcome measurement instruments (OMIs) for non-valvular atrial fibrillation in traditional Chinese medicine clinical trials: study protocol

Trials ◽

10.1186/s13063-018-2904-0 ◽

2018 ◽

Vol 19 (1) ◽

Cited By ~ 7

Author(s):

Ruijin Qiu ◽

Min Li ◽

Xiaoyu Zhang ◽

Shiqi Chen ◽

Chengyu Li ◽

...

Keyword(s):

Atrial Fibrillation ◽

Clinical Trials ◽

Chinese Medicine ◽

Traditional Chinese Medicine ◽

Study Protocol ◽

Outcome Measurement ◽

Core Outcome Set ◽

Core Outcome ◽

Measurement Instruments ◽

Outcome Set

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Development of a core outcome set for clinical trials in basal cell carcinoma: study protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey

Trials ◽

10.1186/s13063-017-2244-5 ◽

2017 ◽

Vol 18 (1) ◽

Cited By ~ 16

Author(s):

Daniel I. Schlessinger ◽

Sanjana Iyengar ◽

Arianna F. Yanes ◽

Jake M. Lazaroff ◽

Victoria Godinez-Puig ◽

...

Keyword(s):

Systematic Review ◽

Clinical Trials ◽

Basal Cell Carcinoma ◽

Cell Carcinoma ◽

Study Protocol ◽

Basal Cell ◽

Core Outcome Set ◽

Core Outcome ◽

Review Of The Literature ◽

Outcome Set

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A core outcome set for neonatal abstinence syndrome: study protocol for a systematic review, parent interviews and a Delphi survey

Trials ◽

10.1186/s13063-016-1666-9 ◽

2016 ◽

Vol 17 (1) ◽

Cited By ~ 17

Author(s):

Lauren E. Kelly ◽

Lauren M. Jansson ◽

Wendy Moulsdale ◽

Jodi Pereira ◽

Sarah Simpson ◽

...

Keyword(s):

Systematic Review ◽

Study Protocol ◽

Core Outcome Set ◽

Delphi Survey ◽

Neonatal Abstinence Syndrome ◽

Core Outcome ◽

Abstinence Syndrome ◽

Outcome Set

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A Core Outcome Set for Clinical Trials of First- and Second-Segree Perineal Tears Prevention and Treatment: A Study Protocol for a Systematic Review and a Delphi Survey

10.21203/rs.3.rs-625834/v1 ◽

2021 ◽

Author(s):

Lin Xiao ◽

Lei Shi ◽

Suting Liu ◽

yuan yuan Luo ◽

Jin hui Tian ◽

...

Keyword(s):

Systematic Review ◽

Clinical Trials ◽

Vaginal Delivery ◽

Core Outcome Set ◽

Delphi Survey ◽

Core Outcome ◽

Perineal Tears ◽

Key Stakeholders ◽

Outcome Set ◽

Prevention And Treatment

Abstract Background Perineal tear is a common consequence of vaginal births affecting females globally. Even mild perineal tears could cause short- and long-term complications for females. Though many studies of interventions to prevent or treat perineal tears to minimize the consequences have been conducted, however, there is significant heterogeneity in the outcomes measured and reported in existing studies, which makes meaningful comparison difficult and makes the generalizability to clinical practice challenging. Developing a core outcome set (COS) could solve these methodological concerns. In this paper, we report a protocol to develop a COS for clinical trials of mild perineal tears, which shall assist in establishing the evidence base and implementation of effective measures to reduce the incidence and minimize the consequences of mild perineal tears. Methods /Design: The development of this COS will be guided by a study advisory group composed of obstetricians, midwives, nursing managers, service users and methodologists. This study will include four stages: (1) a systematic review of the literature to identify outcomes reported in prior studies; (2) a semi-structured interview with key stakeholders to collect their opinions on important outcomes; (3) a panel of experts will be invited to conduct a three-round Delphi survey to prioritize these outcomes; (4) a consensus meeting with key stakeholders to determine the list of outcomes included in the final COS. Discussion The development of this COS will provide an international standards for the outcomes to be collected and reported in all clinical trials and audits of practice, that involve prevention and treatment of first- and second-degree perineal tears for women with vaginal delivery. This will facilitate comparing and contrasting of studies and allow for combining of appropriate studies with the ultimate goal of improved perineal care for women choosing vaginal delivery.

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Development of a core outcome set for clinical trials in squamous cell carcinoma: study protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey

Trials ◽

10.1186/s13063-017-2069-2 ◽

2017 ◽

Vol 18 (1) ◽

Cited By ~ 8

Author(s):

Daniel I. Schlessinger ◽

Sanjana Iyengar ◽

Arianna F. Yanes ◽

Sarah G. Chiren ◽

Victoria Godinez-Puig ◽

...

Keyword(s):

Systematic Review ◽

Squamous Cell Carcinoma ◽

Clinical Trials ◽

Cell Carcinoma ◽

Squamous Cell ◽

Study Protocol ◽

Core Outcome Set ◽

Core Outcome ◽

Review Of The Literature ◽

Outcome Set

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Faculty Opinions recommendation of Heterogeneity in definitions of endpoints for clinical trials of ulcerative colitis: A systematic review for development of a core outcome set.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.729280962.793569711 ◽

2020 ◽

Author(s):

Jack Satsangi

Keyword(s):

Systematic Review ◽

Ulcerative Colitis ◽

Clinical Trials ◽

Core Outcome Set ◽

Core Outcome ◽

Outcome Set

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The development of a faecal incontinence core outcome set: an international Delphi study protocol

International Journal of Colorectal Disease ◽

10.1007/s00384-021-03865-2 ◽

2021 ◽

Vol 36 (3) ◽

pp. 617-622

Author(s):

Sadé Assmann ◽

Daniel Keszthelyi ◽

Jos Kleijnen ◽

Merel Kimman ◽

Foteini Anastasiou ◽

...

Keyword(s):

Systematic Review ◽

Study Protocol ◽

Faecal Incontinence ◽

Delphi Study ◽

Evidence Synthesis ◽

Core Outcome Set ◽

Core Outcome ◽

Delphi Consensus ◽

Link Type ◽

Outcome Set

Abstract Purpose Faecal incontinence (FI) is estimated to affect around 7.7% of people. There is a lack of uniformity in outcome definitions, measurement and reporting in FI studies. Until now, there is no general consensus on which outcomes should be assessed and reported in FI research. This complicates comparison between studies and evidence synthesis, potentially leading to recommendations not evidence-based enough to guide physicians in selecting an FI therapy. A solution for this lack of uniformity in reporting of outcomes is the development of a Core Outcome Set (COS) for FI. This paper describes the protocol for the development of a European COS for FI. Methods Patient interviews and a systematic review of the literature will be performed to identify patient-, physician- and researcher-oriented outcomes. The outcomes will be categorised using the COMET taxonomy and put forward to a group of patients, physicians (i.e. colorectal surgeons, gastroenterologists and general practitioners) and researchers in a Delphi consensus exercise. This exercise will consist of up to three web-based rounds in which participants will prioritise and condense the list of outcomes, which is expected to result in consensus. A consensus meeting with participants from all stakeholder groups will take place to reach a final agreement on the COS. Discussion This study protocol describes the development of a European COS to improve reliability and consistency of outcome reporting in FI studies, thereby improving evidence synthesis and patient care. Trial registration This project has been registered in the COMET database on the 1st of April 2020, available at http://www.comet-initiative.org/Studies/Details/1554. The systematic review has been registered on the PROSPERO database on the 31st of August 2020, available at https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=202020&VersionID=1381336.

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