Development of a decisional flowchart for meaningful patient involvement in Health Technology Assessment

Abstract

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

Can We Afford to Exclude Patients Throughout Health Technology Assessment?

“…Guidance on how to involve patients in HTA in the Spanish Network RedETS are presented in a flowchart. Patient organizations or expert patients can participate in protocol development, outcomes' identification, assessment process, and report review (67).…”

Recommendations for patient involvement in health technology assessment in Central and Eastern European countries

“…Numerous HTA bodies publish guides and materials aiding patient involvement like the National Institute for Health and Care Excellence (England), 11 the Scottish Medicines Consortium (Scotland) 12 and Canada’s Drug and Health Technology Agency (Canada). 13 The Patient Involvement Interest Group of the Spanish Network for Health Technology Assessment of the National Health System (RedETS) developed and published a decisional flowchart for meaningful patient involvement in HTA ( 15 ).…”

Shared decision-making in Spain in 2022: An updated revision of the current situation

“…Likewise, the Spanish RedETS has developed a Patient Involvement Strategy aimed to promote patients' participation from the first phases of the elaboration of Health Technologies Assessment reports [22]. This strategy was built by integrating results from a literature review, semi-structured interviews with health technology assessment managers and researchers with experience in patients' involvement, a consultation to patient organisations, and a Delphi process among the members of the RedETS Governing Council [14].…”

“…The strategy used involvement as an inclusive concept with three levels of participation: communication, consultation, and engagement. The objective of the strategy is to increase impact and understand the appropriate role of patient-based evidence [22,23].…”