Hemorrhoids are the most common diseases in the anorectal department. Guidelines for Integrated Traditional Chinese and Western Medicine Diagnosis and Treatment of Hemorrhoids (2025 Edition) is of great significance to standardize the integrated diagnosis and treatment of hemorrhoids with traditional Chinese and western medicine.

To elaborate in detail on the process of screening core clinical questions and outcome indicators for the Guidelines for Integrated Traditional Chinese and Western Medicine Diagnosis and Treatment of Hemorrhoids (2025 Edition) .

A preliminary list of questions was formed through literature analysis, expert interviews, and clinical research. Two rounds of expert consultation were conducted using the Delphi method. Data analysis was performed using SPSS Statistics 26.0 and Excel 2021. Positive coefficients, mean values, full score rates, coefficient of variation, and Cronbach's αvalues were calculated. Inclusion criteria were: clinical issue mean score ≥3 points, outcome indicator mean score≥7 points, full score rate ≥50%, and coefficient of variation <30%. Quality control standards were: expert positive coefficient≥75%, Kendall's harmony coefficient >0.7, and Cronbach's α coefficient≥0.7 as the quality control standard for the Delphi questionnaire.

After preliminary investigation, 27 clinical issues (9 basic issues and 18 PICO-based clinical issues) and 9 outcome indicators were formulated. After two rounds of Delphi method surveys among 34 experts in related fields, 28 clinical issues (9 basic issues and 19 PICO-based clinical issues) and 9 key outcome indicators were formed. The positive coefficients of the two rounds of questionnaires were 85.3% and 97.0%, respectively. The Kendall's harmony coefficients were 0.837 and 0.826, respectively. The Cronbach's α coefficients of each item of clinical issues and outcome indicators were 0.929, 0.866, 0.923, and 0.803, respectively. This indicated that experts had high attention to this study, small differences, high coordination, good questionnaire reliability, and high result reliability. Finally, after discussion among the experts in the research group, 28 clinical issues (9 basic issues and 19 PICO-based clinical issues) were determined to be included in the guideline. The clinical issues cover the characteristics of traditional Chinese medicine in hemorrhoids, preoperative assessment, integrated diagnosis and treatment methods of Western medicine and traditional Chinese medicine, and perioperative management, etc.

The system of clinical questions and outcome indicators established based on multi-dimensional research and the Delphi method has a complete scientific framework, which can provide references for the formulation of relevant evidence-based guidelines for traditional Chinese medicine.