Defining the Clinical Questions and Outcomes of <italic style="font-style: italic">Clinical Guideline for Prevention and Treatment of Colorectal Adenomas by the Integration of Chinese and Western Medicine</italic>

HUI Yifan; CHENG Haibo; LI Liu; LIAO Xing

doi:10.13288/j.11-2166/r.2023.11.005

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Defining the Clinical Questions and Outcomes of Clinical Guideline for Prevention and Treatment of Colorectal Adenomas by the Integration of Chinese and Western Medicine

更新时间：2023-06-05

- Defining the Clinical Questions and Outcomes of Clinical Guideline for Prevention and Treatment of Colorectal Adenomas by the Integration of Chinese and Western Medicine
- Journal of Traditional Chinese Medicine Vol. 64, Issue 11, Pages: 1100-1106(2023)
- 作者机构：
  
  1.南京中医药大学第一临床医学院/江苏省中医药防治肿瘤协同创新中心，江苏省南京市栖霞区仙林大道138号，210023
  2.南京中医药大学附属医院/江苏省中医院
  3.中国中医科学院中医临床基础医学研究所
- 作者简介：
- 基金信息：
- DOI：10.13288/j.11-2166/r.2023.11.005
  CLC：
- Received：06 June 2022，
  
  Revised：2022-12-10，
  
  Published：02 June 2023
- 稿件说明：
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惠逸帆,程海波,李柳等.《结直肠腺瘤中西医结合防治指南》临床问题与结局指标的确定[J].中医杂志,2023,64(11):1100-1106.

HUI Yifan,CHENG Haibo,LI Liu,et al.Defining the Clinical Questions and Outcomes of Clinical Guideline for Prevention and Treatment of Colorectal Adenomas by the Integration of Chinese and Western Medicine[J].Journal of Traditional Chinese Medicine,2023,64(11):1100-1106.
惠逸帆,程海波,李柳等.《结直肠腺瘤中西医结合防治指南》临床问题与结局指标的确定[J].中医杂志,2023,64(11):1100-1106. DOI： 10.13288/j.11-2166/r.2023.11.005.

HUI Yifan,CHENG Haibo,LI Liu,et al.Defining the Clinical Questions and Outcomes of Clinical Guideline for Prevention and Treatment of Colorectal Adenomas by the Integration of Chinese and Western Medicine[J].Journal of Traditional Chinese Medicine,2023,64(11):1100-1106. DOI： 10.13288/j.11-2166/r.2023.11.005.

摘要

目的

探讨《结直肠腺瘤中西医结合防治指南》中的临床问题与结局指标，为该指南形成推荐意见提供指导，并为同类指南内容构建提供方法学参考。

方法

采用文献调研与德尔菲法相结合的方法。检索中国期刊全文数据库、中文科技期刊数据库、万方数据库建库至2021年11月30日收录的中医药治疗结直肠腺瘤临床研究文献，整理涉及的临床问题与结局指标。德尔菲法通过三轮线上问卷的形式，第一轮遴选调研专家对各条目是否纳入指南进行勾选，以票选率＞60%为标准纳入指南讨论临床问题与结局指标清单。第二轮、第三轮德尔菲法遴选项目组专家采用李克特计分方法，基础问题与临床问题均按5分制评分，以变异系数≤25%且均值≥4分纳入临床问题；结局指标根据重要性进行9分制评分分级，以变异系数≤25%纳入标准。第二轮变异系数＞25%进入第三轮，第三轮变异系数＞25%剔除；同时以积极系数≥60%、权威系数≥0.7、协调系数中变异系数≤25%，克朗巴赫系数≥0.7进行质量控制。

结果

最终纳入文献50篇，划分临床问题与结局指标的范围，临床问题涉及中西医病名、中西医诊断、西医筛查及方法、中医体质辨识、中西医预防、中西医治疗，结局指标涉及症状改善率、中医证候积分、腺瘤（大小、数目、病理等）、复发率、癌变率等。第一轮德尔菲法回收调研专家问卷50份，确定了6个基础问题、21个临床问题和12个结局指标。第二、三轮德尔菲法分别回收项目组专家问卷19、20份，最终纳入4个基础问题、15个临床问题、10个结局指标。三轮问卷积极系数分别为100%、86%、91%，第二轮、第三轮权威系数分别为0.93、0.89，肯德尔和谐系数分别为0.63、0.31，克朗巴赫系数分别为0.94、0.89，说明本指南专家积极性与权威系数较高，问卷结果可信度较高。

结论

通过文献调研与德尔菲法确定《结直肠腺瘤中西医结合防治指南》的临床问题与结局指标，可为同领域指南的核心内容构建提供方法学参考。

Abstract

Objective

To define the clinical questions and outcomes of

Clinical Guideline for Prevention and Treatment of Colorectal Adenomas by the Integration of Chinese and Western Medicine

， so as to provide guidance for the formulation of recommendations for this guideline and give methodological hints for developing similar guidelines.

Methods

The method combining literature review with Delphi survey was adopted. We searched CNKI， VIP and WANFANG databases from inception to November 30

2021 for clinical research literature on colorectal adenomas （CRA） treated by traditional Chinese medicine （TCM）， and the clinical questions and outcomes involved in the included literature were extracted. A three-round online Delphi survey was conducted. The first round was carried out by asking research experts to choose whether each potential item was included in the guideline or not. Clinical problems and outcomes with ＞60% of voting rate would be included in the guideline. The second and third rounds were developed in the way that experts of the project team scored the importance of items by using Likert scoring method. Basic questions and clinical questions were scored on a 5-point scale， and clinical questions were included with the coefficient of variation ≤25% and the average score ≥4 points. The outcomes were graded on a 9-point scale according to the importance， and those with coefficients ≤25% were included. The items with coefficient of variation ＞25% in the second round would be included temporarily， but would be excluded if still ＞25% in the third round. At the same time， quality control was conducted with the positive coefficient ≥60%， authority coefficient ≥0.7， coordination coefficient ≤25% and Cronbach coefficient ≥0.7.

Results

Finally， 50 articles were included， and the categories of clinical questions and outcomes were extracted and formed. Clinical questions included disease name and diagnosis in TCM and western medicine， screening of western medicine， TCM constitution identification， prevention and treatment of TCM and western medicine. Outcomes included symptom improvement rate， TCM syndrome score， adenoma condition （size， number， pathology）， recurrence rate， canceration rate， and others. The first round questionnaire of Delphi survey obtained 50 respondence. Six basic questions， 21 clinical questions and 12 outcomes were generated. The second and third rounds respectively obtained 19 and 20 respondence from experts， and finally four basic questions， 15 clinical questions and 10 outcomes were included. The positive coefficients of three rounds of questionnaires were 100%， 86% and 91%， respectively. The authority coefficients of the second and third rounds were 0.93 and 0.89， respectively； Kendall harmony coefficients were 0.63 and 0.31， and Cronbach coefficients were 0.94 and 0.89， respectively. It showed that the guideline had high coefficient of enthusiasm and authority of experts and high reliability of questionnaire results.

Conclusion

The determination of clinical questions and outcomes by literature review and Delphi survey in

Clinical Guideline for Prevention and Treatment of Colorectal Adenomas by the Integration of Chinese and Western Medicine

can provide methodological reference for the construction of the core content of the guideline in the same field

关键词

Keywords

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Defining the Clinical Questions and Outcomes of Clinical Guideline for Prevention and Treatment of Colorectal Adenomas by the Integration of Chinese and Western Medicine

DOI：10.13288/j.11-2166/r.2023.11.005

摘要

Abstract

关键词

Keywords

references