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

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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A core outcome set for localised prostate cancer effectiveness trials: protocol for a systematic review of the literature and stakeholder involvement through interviews and a Delphi survey

Trials ◽

10.1186/s13063-015-0598-0 ◽

2015 ◽

Vol 16 (1) ◽

Cited By ~ 33

Author(s):

Steven MacLennan ◽

Hendrika J Bekema ◽

Paula R Williamson ◽

Marion K Campbell ◽

Fiona Stewart ◽

...

Keyword(s):

Prostate Cancer ◽

Systematic Review ◽

Core Outcome Set ◽

Stakeholder Involvement ◽

Delphi Survey ◽

Core Outcome ◽

Review Of The Literature ◽

Outcome Set ◽

Effectiveness Trials

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

BMJ Open ◽

10.1136/bmjopen-2019-032256 ◽

2019 ◽

Vol 9 (12) ◽

pp. e032256 ◽

Cited By ~ 3

Author(s):

Ruijin Qiu ◽

Changming Zhong ◽

Songjie Han ◽

Tianmai He ◽

Ya Huang ◽

...

Keyword(s):

Myocardial Infarction ◽

Systematic Review ◽

Clinical Trials ◽

Chinese Medicine ◽

Traditional Chinese Medicine ◽

Core Outcome Set ◽

Core Outcome ◽

Outcome Reporting ◽

Outcome Set ◽

Semistructured Interviews

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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