Accepted for/Published in: JMIR Research Protocols
Date Submitted: Feb 25, 2023
Date Accepted: May 25, 2023
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Developing a core outcome set for assessing clinical safety outcomes of prostate cancer in clinical trials of Traditional Chinese medicine: study protocol
ABSTRACT
Background:
Among the common malignant tumors in men worldwide, the incidence of prostate cancer (PCa) ranks second only to lung cancer, which will bring an economic burden to patients and their families and reduce the quality of life of patients. Researchers have conducted numerous clinical trials on the efficacy and safety of different interventions in the treatment of prostate cancer with traditional Chinese medicine combined with standard treatment regimens. However, published clinical trials currently suffer from inconsistent and irregular reporting of outcome measures.
Objective:
To facilitate future research in prostate cancer, a core outcome set (COS) is needed, which helps the trials into high-quality evidence.
Methods:
This mixed-method project has three phases instrument: 1. A scoping review of the literature to identify outcomes that have been reported in clinical trials and systematic reviews of clinical trials of interventions for PCa in the treatment of TCM. And a ualitative component using interviews to obtain the views of PCa patients, families, and their caregivers (with the history of TCM treatment). 2. Delphi survey among stakeholders to prioritize the core outcomes. Participants will include Traditional Chinese and Western medicine clinicians in prostate cancer-related directions, nurses, and methodology experts participated in two rounds of Delphi method expert consultation to score each outcome in the list of outcome indicators. 3. A face-to-face consensus meeting to discuss and agree on the final PCa in the treatment of TCM COS.
Results:
We will publish our research findings of the final COS through TCM-related associations and the COMET platform to promote the recognition and application of the core indicator set in a wider range.
Conclusions:
The development of a core outcome set for assessing clinical safety outcomes of prostate cancer in clinical trials of Traditional Chinese medicine will provide a significant first step to assist the Chinese doctors, researchers and policy makers. Clinical Trial: Trial registration: Core Outcome Measures in Effectiveness Trials (COMET) Initiative database registration: https://www.comet-initiative.org/Studies/Details/2012. PROSPERO registation number This study protocol was registered in the PROSPERO database before the start of the review process (CRD42022356184). Ethical registration: Ethical approval of this study has been granted by the First Teaching Hospital of Tianjin University of Traditional Chinese Medicine Research Ethics Committee (TYLL2022[K]-21).
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