OBJECTIVES

The purpose of this study was to investigate the quality of TDM guidelines using a standard tool (AGREE Ⅱ instrument). Such systematical investigation is important as it may provide an overview of the existing TDM guidelines, and provide suggestions for better TDM guidelines thus benefiting more patients.

METHODS

We searched six biomedical research literature databases, four main guideline databases, and official websites of governments and societies associated with TDM from inception dates to May 2018. Four independent reviewers rated the quality of each TDM guidelines using the AGREE II instrument and mean score of each AGREE II item was calculated. The intra-class correlation coefficient (ICC) was used to appraise the agreement among reviewers.

RESULTS

Thirty TDM guidelines satisfied the eligibility criteria from 12,235 references. The overall agreement among appraisers was moderate ranging from 0.713 to 0.879. The mean scores for the six AGREE II domains were: scope and purpose, 67.5% (95% CI, 64.00-71.06%); stakeholder involvement, 40.2% (95% CI, 34.08-46.38%); rigor of development, 36.2% (95% CI, 28.84-43.56%); clarity and presentation, 61.8% (95% CI, 56.35-67.31%); applicability, 31.3% (95% CI, 27.33-35.20%) and editorial independence, 47.0% (95% CI, 37.95-56.05%). Reviewers recommended only four guidelines, most of the TDM guidelines were rated as “recommended with modifications”.

CONCLUSIONS

Overall, the quality of TDM guidelines was suboptimal according to the appraisal of AGREE II instrument. These findings indicate particular focus should be put on the domain of applicability, rigorous of development, stakeholder involvement, and editorial independence. In addition, guideline developers adhere closely to the AGREE II instrument are required to produce high quality and reliable TDM guidelines.