关键词: 指南, 临床问题构建, 结局指标, 中西医结合, 德尔菲法, 痔

Abstract: Objective To collect and determine the clinical questions and outcome indicators of "Guidelines for the diagnosis and treatment of Hemorrhoids with Integrated Traditional Chinese and Western Medicine", so as to provide a basis for the follow-up evidence-based evidence retrieval and writing of the guideline.Methods Through literature review, expert interviews and clinical investigation, a preliminary list of clinical questions and outcome indicators was drawn up. Then, a Delphi expert questionnaire was designed and two rounds of expert surveys were conducted on this basis. SPSS Statistics 26 and Excel 2021 software were used to analyze the questionnaire results, and the importance evaluation criteria such as positive coefficient, mean value, full score frequency, coefficient of variation and Cronbach's α coefficient of each clinical question and outcome indicator were calculated. The items with an average score of clinical questions ≥3, an average score of outcome indicators ≥7, a full score frequency ≥50%, and a coefficient of variation < 30% were included in the guidelines. The expert positive coefficient ≥75%, harmony coefficient > 0.7, and Gronbach α coefficient ≥0.7 were taken as the quality control standards of the Delphi method questionnaire. Results After preliminary investigation, 27 clinical questions (9 basic questions and 18 PICO clinical questions) and 9 outcome indicators were formulated. After two rounds of Delphi survey, 28 clinical questions (9 basic questions and 19 PICO clinical questions) and 9 key outcome indicators were formed. The positive coefficients of experts in the two rounds of questionnaires were 85% and 97%, the Kendall harmony coefficients were 0.837 and 0.826, and the Cronbach's α coefficients of each item of clinical questions and outcome indicators were 0.929 and 0.866 and 0.923 and 0.803, respectively. It showed that experts paid high attention to this study, with little disagreement and high degree of coordination. The reliability of the questionnaire was good and the reliability of the results was high. Finally, 28 clinical questions (9 basic questions and 19 PICO clinical questions) were selected and included in the guidelines. The clinical problems covered the characteristics of hemorrhoids in traditional Chinese medicine (TCM), preoperative evaluation, diagnosis and treatment of TCM and western medicine, and perioperative management. Conclusions Through literature review, expert interviews, clinical investigation and Delphi expert survey, the clinical problems and outcome indicators of the guideline for the diagnosis and treatment of Hemorrhoids with Integrated Traditional Chinese and Western Medicine were determined, which laid the foundation for the follow-up compilation of the guideline, and also provided methodological reference for the construction of clinical problems in anorectal field guidelines. It is suggested that multi-field expert consensus meeting and effective transformation of clinical problems are of great significance in the development of evidence-based diagnosis and treatment guidelines of integrated traditional Chinese and western medicine.

Key words: Guidelines, Construction of clinical problems, Outcome indicators, Integrated traditional Chinese and western medicine, Delphi method, hemorrhoid