Method Development for Clinical Comprehensive Evaluation of Pediatric Drugs Based on Multi-Criteria Decision Analysis: Application to Inhaled Corticosteroids for Children with Asthma
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Establishing a comprehensive clinical evaluation system is critical in enacting national drug policy and promoting rational drug use. In China, the ‘Clinical Comprehensive Evaluation System for Pediatric Drugs’ (CCES-P) project, which aims to compare drugs based on clinical efficacy and cost effectiveness to help decision makers, was recently proposed; therefore, a systematic and objective method is required to guide the process.
An evidence-based multi-criteria decision analysis model that involved an analytic hierarchy process (AHP) was developed, consisting of nine steps: (1) select the drugs to be reviewed; (2) establish the evaluation criterion system; (3) determine the criterion weight based on the AHP; (4) construct the evidence body for each drug under evaluation; (5) select comparative measures and calculate the original utility score; (6) place a common utility scale and calculate the standardized utility score; (7) calculate the comprehensive utility score; (8) rank the drugs; and (9) perform a sensitivity analysis. The model was applied to the evaluation of three different inhaled corticosteroids (ICSs) used for asthma management in children (a total of 16 drugs with different dosage forms and strengths or different manufacturers).
By applying the drug analysis model, the 16 ICSs under review were successfully scored and evaluated. Budesonide suspension for inhalation (drug ID number: 7) ranked the highest, with comprehensive utility score of 80.23, followed by fluticasone propionate inhaled aerosol (drug ID number: 16), with a score of 79.59, and budesonide inhalation powder (drug ID number: 6), with a score of 78.98. In the sensitivity analysis, the ranking of the top five and lowest five drugs remains unchanged, suggesting this model is generally robust.
An evidence-based drug evaluation model based on AHP was successfully developed. The model incorporates sufficient utility and flexibility for aiding the decision-making process, and can be a useful tool for the CCES-P.
Author contributions statement
Xiaoling Wang and Lulu Jia contributed to the conception and design of the study; Yuncui Yu, Yao Meng, Lulu Jia, Lihua Hu, Yiwei Liu, Xiaolu Nie, Meng Zhang, and Xuan Zhang contributed to the evidence collection; Yuncui Yu and Lulu Jia contributed to the data analysis; Lulu Jia and Yuncui Yu contributed to the interpretation of data and drafting the article; and Sheng Han and Xiaoxia Peng gave important recommendations in terms of methodology. All authors approved the final version to be published.
Compliance with Ethical Standards
Conflict of interest
Yuncui Yu, Lulu Jia, Yao Meng, Lihua Hu, Yiwei Liu, Xiaolu Nie, Meng Zhang, Xuan Zhang, Sheng Han, Xiaoxia Peng, and Xiaoling Wang report no conflicts of interest relevant to this article.
This work was supported by the China-WHO Biennial Collaborative Projects 2014–2015 (WPCHN1408195,5.1,61775), the project founded by the National Health and Family Planning Commission Drug Policy and Essential Medicines Department (Pharmacist  No. 25), and the National Natural Science Foundation of China (81400766).
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