Construction of the research question system of the <italic style="font-style: italic">Guideline for the Management of Therapeutic Drug Monitoring</italic> based on modified Delphi method

DUAN Rong; MIAO Liyan; LI Zhengxiang

doi:10.6039/j.issn.1001-0408.2026.10.01

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Construction of the research question system of the Guideline for the Management of Therapeutic Drug Monitoring based on modified Delphi method

更新时间：2026-05-26

- Construction of the research question system of the Guideline for the Management of Therapeutic Drug Monitoring based on modified Delphi method
- ZHONGGUO YAOFANG Vol. 37, Issue 10, Pages: 1241-1245(2026)
- 作者机构：
  
  1.天津医科大学总医院药学中心，天津　300052
  2.天津市药品使用监测和临床综合评价中心，天津　300052
  3.苏州大学附属第一医院药学部，江苏苏州　215006
- 作者简介：
- 基金信息：
- DOI：10.6039/j.issn.1001-0408.2026.10.01
  CLC： R95;R969.3
- Received：27 January 2026，
  
  Revised：2026-05-13，
  
  Accepted：14 May 2026，
  
  Published：30 May 2026
- 稿件说明：
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段蓉,缪丽燕,李正翔.基于改良德尔菲法的《治疗药物监测管理指南》研究问题体系构建 ^Δ[J].中国药房,2026,37(10):1241-1245. DOI: 10.6039/j.issn.1001-0408.2026.10.01.

DUAN Rong,MIAO Liyan,LI Zhengxiang.Construction of the research question system of the Guideline for the Management of Therapeutic Drug Monitoring based on modified Delphi method[J].ZHONGGUO YAOFANG,2026,37(10):1241-1245.
段蓉,缪丽燕,李正翔.基于改良德尔菲法的《治疗药物监测管理指南》研究问题体系构建 ^Δ[J].中国药房,2026,37(10):1241-1245. DOI: 10.6039/j.issn.1001-0408.2026.10.01. DOI：

DUAN Rong,MIAO Liyan,LI Zhengxiang.Construction of the research question system of the Guideline for the Management of Therapeutic Drug Monitoring based on modified Delphi method[J].ZHONGGUO YAOFANG,2026,37(10):1241-1245. DOI： 10.6039/j.issn.1001-0408.2026.10.01.

摘要

目的

构建《治疗药物监测管理指南》（以下简称《指南》）的研究问题体系，为《指南》的制定提供依据。

方法

在文献研究和专家访谈的基础上，初步构建《指南》研究问题调查问卷，通过改良德尔菲法对《指南》制定专家进行线上问卷调研并召开专家共识会议，确定《指南》研究问题体系。

结果

共发放调研问卷59份，回收有效问卷52份，专家积极系数为88.14%。纳入专家来自21个省/自治区/直辖市，涵盖治疗药物监测相关多学科专家，均具有高级专业技术职称。调研专家经过一轮调研即对研究问题达成共识，形成了涵盖治疗药物监测开展指征（4个一级研究问题、10个二级研究问题、31个三级研究问题）、治疗药物监测技术流程（3个一级研究问题、9个二级研究问题、13个三级研究问题）、结果解读及临床应用（3个一级研究问题、3个二级研究问题）、质量控制（8个一级研究问题、12个二级研究问题）4个板块的研究问题体系。4个板块的重要性评分为4.71～4.88分，满分率均不低于73.08%，专家权威系数均不低于0.90，重要性评分变异系数均不高于0.11，肯德尔协调系数

为0.464～0.626（

均小于0.05）。

结论

构建的研究问题体系具有较高的权威性、科学性和可靠性，可为《指南》标准化制定奠定基础。

Abstract

OBJECTIVE

To construct a research question system of the

Guideline for the Management of Therapeutic Drug Monitoring

（hereinafter referred to as the

Guideline

）， so as to provide the basis for the formulation of the

Guideline

METHODS

Based on literature research and expert interviews， the questionnaire about research questions of the

Guideline

was initially constructed. Through the modified Delphi method， the online questionnaire survey and expert consensus meeting were conducted among the

Guideline

development experts to determine the research question system of the

Guideline

RESULTS

A total of 59 questionnaires were distributed， and 52 valid questionnaires were collected. The positive coefficient of experts was 88.14%. The experts came from 21 provinces/autonomous regions/municipalities directly under the central government， covering multidisciplinary experts related to therapeutic drug monitoring， all of whom held senior professional titles. After one round of survey， a consensus was reached on the research questions， and a research question framework encompassing four research parts was constructed， including： indications for conducting therapeutic drug monitoring （4 first-level research questions，10 second-level research questions， 31 third-level research questions）； therapeutic drug monitoring technical process （3 first-level research questions， 9 second-level research questions， 13 third-level research questions）； result interpretation and clinical application （3 first-level research questions and 3 second-level research questions）； quality control （8 first-level research questions and 12 second-level research questions）. The importance scores for the four parts ranged from 4.71 to 4.88， with full-score rates all no less than 73.08%. The expert authori

ty coefficients were all no less than 0.90， the coefficients of variation of importance scores were all no higher than 0.11， and Kendall’s

ranged from 0.464 to 0.626 （all

＜0.05）.

CONCLUSIONS

The constructed research question system has high authority， scientificity， and reliability， laying a foundation for the standardized formulation of the

Guideline

关键词

Keywords

references

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Construction of the research question system of the Guideline for the Management of Therapeutic Drug Monitoring based on modified Delphi method

DOI：10.6039/j.issn.1001-0408.2026.10.01

摘要

Abstract

关键词

Keywords

references