Guidelines for the Diagnosis and Treatment of Anal Fistula with Integrated Traditional Chinese and Western Medicine is of great significance to complete industry guidelines and standards for the diagnosis and treatment of anal fistula, in which the construction of clinical problems and outcome indicators is the key point to determine the quality of the guidelines.

To elaborate in detail on the formation process of clinical questions and outcome indicators in the Guidelines for the Diagnosis and Treatment of Anal Fistula with Integrated Chinese and Western Medicine.

First, through literature research, expert interviews and extensive clinical research, preliminary sorting out clinical problems and outcome indicators. Then, on this basis, the Delphi method expert questionnaire was designed and two rounds of expert surveys were carried out. Excel 2021 and SPSS 26.0 software were used to statistically process the questionnaire results, and the expert positive coefficient, mean, full score ratio and coefficient of variation of each clinical problem and outcome index were calculated for importance evaluation. Entries with average score ≥3 for clinical problems, average score ≥7 for outcome indicators, full score ratio ≥50%, and coefficient of variation <30% were included in the guidelines. At the same time, the expert positive coefficient ≥75%, harmony coefficient >0.7, Cronbach's α coefficients ≥0.7 were used for the quality control of Delphi questionnaire.

After preliminary investigation, 26 clinical questions (7 basic questions and 19 PICO clinical questions) and 9 outcome indicators were formulated. After two rounds of Delphi method survey of 34 experts in related fields, 24 clinical questions (7 basic questions and 17 PICO clinical questions) and 8 key outcome indicators were formed. The positive coefficients of experts in the two rounds of questionnaires were 100.0% and 91.2%, the Kendall harmony coefficients were 0.722 and 0.852, and the Cronbach's α coefficients of clinical questions and outcome indicators were 0.919, 0.809 and 0.935, 0.746, respectively, indicating that experts paid high attention to this study, small disagreement, high degree of coordination, good questionnaire reliability and high reliability of results. Finally, after discussion among experts in the study group, 24 clinical questions (7 basic questions and 17 PICO clinical questions) were identified as included in the guidelines to form recommendations.

Through literature research, expert interviews, extensive clinical research and expert investigation of Delphi method, the clinical problems and outcome indicators of the Guidelines for the Diagnosis and Treatment of Anal Fistula with Integrated Chinese and Western Medicine were determined, and also provided a methodological reference for the construction of the core clinical problems and outcome indicators of the guidelines in the anorectal field, and had certain reference significance for the formulation of evidence-based guidelines for traditional Chinese medicine.