The three-domain impact framework for characterizing impact of patient involvement in health technology assessment.

Objectives: Evaluating the impact of patient involvement in health technology assessments (HTA) may help improve practices and avoid ineffective activities. Evaluation, however, continues to be infrequent, inconsistent, and often only relates to process quantity or quality. The Patient and Citizen Involvement in HTA Interest Group (PCIG) within Health Technology Assessment International set out to contextualize this impact to support evaluation.

Methods: Given the lack of established methodology to measure impact, the team performed a qualitative analysis of first-hand accounts about perceived changes in HTA due to involvement of patient stakeholders. A questionnaire was developed, piloted, and rolled out to collect personal perspectives from stakeholders with relevant experience. The stories were analyzed in the aggregate to identify themes in the data.

Results: From January 2019 to September 2021, twenty-four responses were collected through PCIG's network. Responses (including one joint industry-HTA body submission) came from patient representatives (12), HTA bodies (11), and industry representatives (2) from North America (5), South America (3), Europe (13), and Asia Pacific (3). Based on themes commonly reported, a three-domain framework for evaluating impact is proposed: impact on basis of HTA result or recommendation, impact on HTA body, and impact on patient participants. The framework includes components under each domain to support reporting.

Conclusions: Using the Three-Domain Impact Framework may be useful in identifying, evaluating, and communicating the value of patient involvement in HTA. Enhancing and increasing reporting practices may improve transparency and facilitate process improvements for meaningful integration of patient stakeholders into HTA appraisals across jurisdictions.