OBJECTIVES: The PARENT Framework, which provided "Methodological guidelines and recommendations for efficient and rational governance of patient registries", is a useful reference to support an assessment of patient registries . In order to improve its utility to HTA and regulatory agencies, the framework development group have worked with EUnetHTA to present the key recommendations for the registries in HTA an assessment tool with graphic outcome. We present the tool in its pilot form for discussion, with a focus on specific outcomes assessment perspective.

METHODS: The draft REQUEST tool items are presented with a special focus on reporting those aspects relevant to assessment outcomes..

RESULTS: The tool has 11 ‘methodological’ items relating to suitability of the register for a specific purpose; 14 ‘essential’ standards relevant to any register for regulatory and HTA purposes and 4 additional considerations for specific purposes. Several items relate to outcomes assessment: (1) clear objectives that define proper data collection and address specific HTA questions; (2) design of the registry which must be aligned with the purpose of the outcome analysis desired by the HTA; (3) outcomes must be clearly defined in a formal protocol, (4) data dictionary (5) Identification of confounding factors and a strategy for their management (6) data validation strategy. Many other aspects are considered in the tool but are not focused on outcomes assessment e.g. governance, data security, dataset standards or ethical aspects.

CONCLUSIONS: Tools like REQUEST, allow assessment agencies or other stakeholders like notified bodies to achieve consistent data requirements and support robust outcomes data collection. Federated or other type of registry holders are empowered to generate and share excellent evidence with HTA and regulatory bodies.