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

Abstract

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