A tool to assess the registries quality: The Registry Evaluation and Quality Standards Tool (REQueST)

نویسندگان

چکیده

Abstract Background The use of registries is increasingly common in HTA as interest grows the observational data to complement trial and optimize access new technologies. Registry quality has been criticized, leading reluctance embed their HTA. During EUnetHTA Joint Action 3 network produced a draft standard tool assess registry quality. Methods development phase included: analysis current by bodies (HTAb), HTAb consultation on first tool, stakeholder second draftl, testing three HTAb. Finally, near-final version was submitted for public consultation. feedback helped prepare final available at https://eunethta.eu/request-tool-and-its-vision-paper/. Results standards REQueST are universal essential elements good practice evidence that relevant applicable different types. It includes sections: 8 ‘methodological' items relating suitability specific purpose; 13 ‘essential standards' any additional considerations purposes. builds upon existing guidance provides means adopt implement best practice. can be used both developers Regulators when considering whether them. partners encouraged all joint activities which defined or assessed. Moreover, individual basis assessing Since its publication two qualifications several national related Post Launch Evidence Generation (PLEG). Some PLEG reported very positive from holders.

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ژورنال

عنوان ژورنال: European journal of public health

سال: 2021

ISSN: ['1101-1262', '1464-360X']

DOI: https://doi.org/10.1093/eurpub/ckab164.573