This research presents a project to develop a Core Outcome Set (COS) for varicocele (VC), a common male reproductive system disease. The study is essential due to the lack of standardized outcome indicators in current clinical trials, which hinders research progress. The research follows a structured approach, including registration on the Core Outcome Measures in Effectiveness Trials (COMET) Initiative website and obtaining ethical approval. A research team and expert advisory committee are established to ensure scientific rigor and multidisciplinary support. The study involves analyzing outcome indicators from VC clinical research, clinical trial registration protocols, and patient-reported outcomes through semi-structured interviews. The collected indicators are standardized and integrated into a comprehensive pool. Delphi surveys and consensus meetings with experts and stakeholders are conducted to finalize the COS. This study will standardize outcome indicators for VC, enhancing the quality and comparability of clinical research, and provide a foundation for future large-scale, multi-center studies, ultimately improving the clinical evidence base for VC treatment and its application in male reproductive health.
ContributorsXiyuan Hospital of China Academy of Chinese Medical Sciences, Anmin Wang is the principal investigator.
Disease Category: Urology
Disease Name: Varicocele
Age Range: 18 - 60
Sex: Male
Nature of Intervention: Any
- Clinical experts
- Conference participants
- Consumers (patients)
- Epidemiologists
- Ethicists
- Methodologists
- Patient/ support group representatives
- Researchers
- Statisticians
- COS for clinical trials or clinical research
- Consensus conference
- Consensus meeting
- Delphi process
- Focus group(s)
- Interview
- Literature review
- Semi structured discussion
- Survey
- Systematic review
This research project aims to develop a Core Outcome Set (COS) for varicocele (VC) through a comprehensive and systematic approach. The methods employed in this study are designed to ensure the rigor, validity, and applicability of the COS. The key steps involved in this process are as follows:
1. Literature Review and Data Extraction
A comprehensive literature search will be conducted across multiple databases to identify relevant clinical studies on VC. The search will be performed using a combination of keywords and subject headings related to VC. Studies will be included if they are clinical research on VC, including randomized controlled trials, cohort studies, case-control studies, case series reports, and non-randomized controlled trials. Relevant information will then be extracted into an Excel information extraction table, which includes basic paper information, study characteristics, and outcome indicators.
2.Standardization of Outcome Indicators
The extracted outcome indicators will be organized and standardized using the "Commonly Used Clinical Medical Terminology (2023 Edition)" issued by the National Health Commission to avoid misunderstandings caused by inconsistent expressions.
3.Patient Interviews
Semi-structured interviews will be conducted with patients diagnosed with VC to collect patient-reported outcomes. The interviews will focus on patients' perceptions of the impact of VC on their quality of life and treatment outcomes.
4.Delphi Survey and Consensus Meeting
A two-round Delphi survey will be conducted using a questionnaire distributed via the "Questionnaire Star" platform. The expert panel will include clinicians experienced in TCM, Western medicine, and integrated TCM-Western medicine treatment for male and urinary diseases, as well as other relevant stakeholders. The experts will be asked to rate the importance of each outcome indicator on a 9-point Likert scale. A consensus meeting will be held after the Delphi survey to finalize the COS. Consensus will be reached if an indicator receives a score of 7 - 9 from over 70% of the experts.
5.Development of the Core Outcome Set
The final COS will be developed based on the results of the literature review, patient interviews, Delphi survey, and consensus meeting. The COS will include a minimum set of standardized outcome indicators that should be measured and reported in all clinical trials on VC.