The objective of this study is to describe the development and first implementation of a protocol for evaluating patient involvement in health technology assessment (HTA) within the Spanish HTA Network (RedETS), establishing a framework for continuous monitoring across agencies.

A multi-phase process informed protocol development. Indicators were proposed and refined based on international evidence and RedETS experience. Three concise questionnaires were designed for agency leads, HTA coordinators, and patients, and improved through consultation and pilot testing. The first evaluation cycle was conducted in March 2025 via online surveys. Quantitative data were summarized descriptively, and qualitative responses analyzed thematically. A stakeholder meeting reviewed findings.

Responses were received from all eight agencies, the coordinators of all forty-nine HTA reports published during the study period, and ten of the thirty-three patients involved in these reports. Twenty reports (41 percent) included patient involvement, mainly through protocol review, draft validation, consultation meetings, or qualitative research. Twenty-nine reports (59 percent) had no patient involvement; among these, six of twenty-nine (21 percent) had attempted recruitment but could not implement it due to recruitment or organizational barriers. In reports with involvement, participation represented a small proportion of assessment time and often relied on a single patient. Patient respondents valued their contribution but noted unclear expectations, technical language, and limited feedback.

The protocol proved feasible and valuable for monitoring whether, how, and when patients are involved in HTA. Strengthening planning, recruitment, and feedback will support more meaningful engagement. RedETS provides a scalable model for continuous monitoring in HTA.