Chinese General Practice ›› 2025, Vol. 28 ›› Issue (32): 4089-4094.DOI: 10.12114/j.issn.1007-9572.2025.0058

• Original Research·Clinical Tools and Methods • Previous Articles     Next Articles

Collection and Determination of Clinical Questions and Outcome Indicators Based on the Guidelines for Integrated Traditional Chinese and Western Medicine Diagnosis and Treatment of Hemorrhoids (2025 Edition)

  

  1. 1. China-Japan Friendship Hospital, Beijing 100029, China
    2. Graduate School, Beijing University of Chinese Medicine, Beijing 100029, China
  • Received:2025-02-13 Revised:2025-05-16 Published:2025-11-15 Online:2025-09-23
  • Contact: ZHENG Lihua

《痔中西医结合诊疗指南(2025版)》临床问题与结局指标的收集与确定

  

  1. 1.100029 北京市,中日友好医院
    2.100029 北京市,北京中医药大学研究生院
  • 通讯作者: 郑丽华
  • 作者简介:

    作者贡献:

    智从从负责撰写论文初稿;智从从、程一乘、黄子宸、王孝龙、李雪负责发放、回收问卷以及整理与分析回收问卷;郑丽华负责临床问题的构思;智从从、郑丽华负责临床问题构建过程中问卷制作、文章的审校与质量控制,对文章负责。

  • 基金资助:
    中日友好医院临床研究与转化跃升项目(2022-NHLHCRF-LX-02-0121); 中央高水平医院临床业务费专项揭榜挂帅类项目(2024-NHLHCRF-JBGS-ZN-05)

Abstract:

Background

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.

Objective

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) .

Methods

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.

Results

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.

Conclusion

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.

Key words: Hemorrhoids, Clinical practice guidelines, Problem construction, Efficacy evaluation, Integrated traditional Chinese and western medicine, Delphi method

摘要:

背景

痔病是肛肠科最常见的疾病,《痔中西医结合诊疗指南(2025版)》对规范痔的中西医结合诊疗意义重大。

目的

详细阐述筛选《痔中西医结合诊疗指南(2025版)》核心临床问题与结局指标的过程。

方法

通过文献分析、专家访谈及临床调研形成初稿问题清单,采用德尔菲法开展两轮专家咨询。运用SPSS 26.0和Excel 2021进行数据分析,计算积极系数、均值、满分率、变异系数及Cronbach's α系数,纳入标准:临床问题均分≥3分、结局指标均分≥7分、满分率≥50%、变异系数<30%。质量控制标准:专家积极系数≥75%、肯德尔和谐系数>0.7、Cronbach's α系数≥0.7作为德尔菲法问卷质量控制标准。

结果

经过初步调研,拟定了27个临床问题(9个基础问题和18个PICO化临床问题)与9个结局指标。对34位相关领域专家进行两轮德尔菲法调查后,形成28个临床问题(9个基础问题和19个PICO化临床问题)与9个关键结局指标。两轮问卷专家的积极系数分别为85.3%和97.0%,肯德尔和谐系数分别为0.837、0.826,临床问题和结局指标各条目的Cronbach's α系数分别为0.929、0.866和0.923、0.803,表明专家对本研究的关注度高,分歧小,协调程度高,问卷信度良好,结果可靠性高。经研究组内专家讨论后,最终确定28个临床问题(9个基础问题和19个PICO化临床问题)纳入指南。临床问题涵盖痔病中医特征、术前评估、中西医诊疗方式、围术期管理等。

结论

基于多维度调研与德尔菲法建立的临床问题及结局指标体系具有完整的科学框架,可为相关中医药循证指南的制定提供参考。

关键词: 痔, 临床实践指南, 问题构建, 疗效评价, 中西医结合, 德尔菲法

CLC Number: