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In the fast-paced world of health technology innovation, early health technology assessment (HTA) gained recognition as a tool to help prioritize and steer the development of those innovations that potentially add value. Much of early HTA seems technology-driven; a certain novel technology is introduced and the focus is on assessing its expected cost-effectiveness. We argue that a first step in assessing innovation would be to derive proof-of-problem through combining evidence from literature and stakeholder engagement. We applied this approach to a novel surgical instrument aimed to facilitate meniscus surgery.
First, we identified a broad scope of stakeholders in meniscus surgery (i.e. meniscectomy). Through interviewing them we derived key problems in meniscectomy as-is, and determined which outcomes matter most. We used stakeholder and literature input to quantify the room for improvement in current meniscectomy. Together with stakeholders we interpreted the problem quantification and conducted an early assessment of the proposed surgical innovation. Finally, we made use of this early stakeholder engagement to uncover possible barriers and facilitators to the innovation's implementation.
While all stakeholders were enthusiastic about the innovation, there was a shared perception that there is little room for improvement in meniscectomy at present. Put differently; the innovation poses a great solution to problems that may not exist. In addition, by involving a broad range of stakeholders we were able to identify barriers and facilitators to future implementation early on, such as surgeons’ preferences.
We conclude that the innovation's value may lie with applications outside of meniscus surgery. Regarding methodology, we showed how a shift of focus from solution to problem definition provides a different perspective on an innovation's potential value, borne out of needs not currently met. In doing so, early HTA is in a unique position to help navigate the stream of health technology innovation before actual development of the innovation.
Priority setting in health care has been long recognized as an intrinsically complex and value-laden process. Yet, Health Technology Assessment (HTA) agencies presently employ value assessment frameworks that are ill-fitted to capture the range and diversity of stakeholder values, and thereby risk to compromise the legitimacy of their recommendations. We propose ‘evidence-informed deliberative processes’ as an alternative framework with the aim to enhance this legitimacy.
The framework is based on an integration of two increasingly popular and complementary frameworks for priority setting: multi-criteria decision analysis (MCDA) and accountability for reasonableness (A4R), Evidence-informed deliberative processes are, on the one hand, based on early, continued stakeholder deliberation to learn about the importance of relevant social values. On the other hand, they are based on rational decision-making – through evidence-informed evaluation of the identified values.
The framework has important implications for how HTA agencies should ideally organize their processes. Firstly, HTA agencies should take the responsibility to organize stakeholder involvement. Second, agencies are advised to integrate their assessment and appraisal phase, allowing for the timely collection of evidence on values that are considered relevant. Third, HTA agencies should subject their specification of decision-making criteria to public scrutiny. Fourth, agencies are advised to use a checklist of potentially relevant criteria, and to provide argumentation how each criterion affected the recommendation. Fifth, HTA agencies must publish their argumentation and install options for appeal.
Adopting ‘evidence-informed deliberative processes’ as a value assessment framework could be an important step forward for HTA agencies to optimize the legitimacy of their priority setting decisions. Agencies can incorporate elements according to their needs and affordances.
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