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Development of the Philippine guidance document for the use of real-world evidence for clinical assessment of health technologies

Title: Development of the Philippine guidance document for the use of real-world evidence for clinical assessment of health technologies
Authors: Tan-Lim, Carol Stephanie Chua; Cabaluna, Ian Theodore G.; Infantado-Alejandro, Myzelle Anne J.; Imbag, Mark Dale S.; Lopez, Larraine Franchesca L.; Esteban-Ipac, Natasha Ann R.; Macalalad-Josue, Anna Angelica; Bayona, Howell Henrian G.; Burog, Aldrich Ivan Lois D.; Cochon, Kim L.; Alejandria, Marissa M.
Source: International Journal of Technology Assessment in Health Care ; volume 41, issue 1 ; ISSN 0266-4623 1471-6348
Publisher Information: Cambridge University Press (CUP)
Publication Year: 2025
Description: Objectives Under the Universal Health Care Act of the Philippines, all health technologies should undergo health technology assessment. This manuscript details the process of the development of the Philippine guidance document for the use of real-world evidence (RWE) in the clinical evaluation of health technologies. Methods This study consisted of two phases. Phase 1 was a comprehensive, systematic review of all available HTA methods guides and literature related to the use of RWE in the clinical evaluation of health technologies. Based on the results of the review, a draft HTA methods guide on the use of RWE was created. Phase 2 was a validation study by expert consultation through key informant interviews (KIIs), and pilot assessment of the methods guide. Results Seventy-nine articles and nine guidance papers were included, with pertinent information extracted and organized into sections. The first draft covered definitions of RWE, guidance for RWE utilization, scoping and selecting RWE, critical appraisal, data extraction, and synthesis and analysis of RWE. Changes were made to this draft based on the KIIs and pilot assessment results to produce the final output of the methods guide. Conclusions This document describes the process of creating a Philippine guidance document that covers the definition of RWE and the appropriate methods for conducting systematic search, screening, critical appraisal, data extraction, data analysis, and synthesis of RWE.
Document Type: article in journal/newspaper
Language: English
DOI: 10.1017/s0266462325100512
Availability: https://doi.org/10.1017/s0266462325100512; https://www.cambridge.org/core/services/aop-cambridge-core/content/view/S0266462325100512
Rights: http://creativecommons.org/licenses/by-nc-sa/4.0
Accession Number: edsbas.2F83C776
Database: BASE