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.

This paper aims to describe the development of a flowchart to guide the decisions of researchers in the Spanish Network for Health Technology Assessment of the National Health System (RedETS) regarding patient involvement (PI) in Health Technology Assessment (HTA). By doing so, it reflects on current methodological challenges in PI in the HTA field: how best to combine PI methods and what is the role of patient-based evidence.

A decisional flowchart for PI in HTA was developed between March and April 2019 following an iterative process, reviewed by the members of the PI Interest Group and other RedETS members and validated during an online deliberative meeting. The development of the flowchart was based on a previous methodological framework assessed in a pilot study.

The guidelines on how to involve patients in HTA in the RedETS were graphically represented in a flowchart. PI must be included in all HTA reports, except those that assess technologies with no relevant impact on patients’ experiences, values, and preferences. Patient organizations or expert patients related to the topic of the HTA report must be identified and invited. These patients can participate in protocol development, outcomes' identification, assessment process, and report review. When the technology assessed affects in a relevant way patient experiences, values, and preferences, patient-based evidence should be included through a systematic literature review or a primary study.

The decisional flowchart for PI in HTA contributes to the current methodological challenges by proposing a combination of direct involvement and patient-based evidence.