Involving patient in the early stages of health technology assessment (HTA): a study protocol.

BACKGROUND: Public and patient involvement in the different stages of the health technology assessment (HTA) process is increasingly encouraged. The selection of topics for assessment, which includes identifying and prioritizing HTA questions, is a constant challenge for HTA agencies because the number of technologies requiring an assessment exceeds the resources available. Public and patient involvement in these early stages of HTA could make assessments more relevant and acceptable to them. Involving them in the development of the assessment plan is also crucial to optimize their influence and impact on HTA research. The project objectives are: 1) setting up interventions to promote patient participation in three stages of the HTA process: identification of HTA topics, prioritization, and development of the assessment plan of the topic prioritized; and 2) assessing the impact of patient participation on the relevance of the topics suggested, the prioritization process, and the assessment plan from the point of view of patients and other groups involved in HTA.

METHODS: Patients and their representatives living in the catchment area of the HTA Roundtable of Université Laval's Integrated University Health Network (covering six health regions of the Province of Quebec, Canada) will be involved in the following HTA activities: 1) identification of potential HTA topics in the field of cancer; 2) revision of vignettes developed to inform the prioritization of topics; 3) participation in deliberation sessions for prioritizing HTA topics; and 4) development of the assessment plan of the topic prioritized. The research team will coordinate the implementation of these activities and will evaluate the process and outcomes of patient involvement through semi-structured interviews with representatives of the different stakeholder groups, structured observations, and document analysis, mainly involving the comparison of votes and topics suggested by various stakeholder groups.

DISCUSSION: This project is designed as an integrated approach to knowledge translation and will be conducted through a close collaboration between researchers and knowledge users at all stages of the project. In response to the needs expressed by HTA producers, the knowledge produced will be directly useful in guiding practices regarding patient involvement in the early phases of HTA.