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.

《肛瘘中西医结合诊疗指南》对完善肛瘘中西医结合诊疗行业指南和标准有重要意义，其中临床问题与结局指标的构建是决定指南质量的关键点。

对《肛瘘中西医结合诊疗指南》的临床问题和结局指标的形成过程进行详细阐述。

通过对文献的深入研究、与专家的座谈交流以及广泛的临床调查，初步搜集各类临床问题和结局指标。在此基础上，设计德尔菲法专家调查问卷并开展两轮专家调查。运用Excel 2021和SPSS 26.0软件对问卷结果进行统计分析，通过各临床问题与结局指标的专家积极系数、均值、满分比以及变异系数等数据进行对比和分析。纳入临床问题的平均分数≥3分、结局指标的平均分数≥7分、满分比率≥50%以及变异系数<30%的条目。同时以专家积极系数≥75%、肯德尔和谐系数>0.7、Cronbach's α系数≥0.7进行德尔菲问卷质量控制。

经过初步研究，制定了26个临床问题（7个基础问题和19个PICO化临床问题）与9个结局指标。专家组由34位相关学科的专家组成，经过2次德尔菲法的调查与分析后，形成24个临床问题（7个基础问题和17个PICO化临床问题）和8个关键结局指标。两轮问卷专家的积极系数为100.0%和91.2%，肯德尔和谐系数为0.722、0.852，临床问题与结局指标各条目的Cronbach's α系数为0.919、0.809和0.935、0.746。表明专家对本研究的关注度高，分歧小，协调程度高，这份问卷的信度表现出色，结果具有很高的可靠性。经研究组内专家讨论后最终确定24个临床问题（7个基础问题和17个PICO化临床问题）纳入指南形成推荐意见。

通过文献调研、专家访谈、广泛的临床调研以及德尔菲法专家调查，确保《肛瘘中西医结合诊疗指南》中的临床问题和结果指标是清晰的，同时对于肛肠领域内的指南确定核心临床问题和结局指标方法学有一定的借鉴意义，并且为制定中医药循证指南提供相关参考。