OBJECTIVE

2

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

2

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

2

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

W

ranged from 0.464 to 0.626 （all

P

＜0.05）.

CONCLUSIONS

2

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

Guideline

.