Validation of the NEED assessment framework: an EU level Delphi study

Abstract The NEED (Needs Examination, Evaluation and Dissemination) assessment framework was developed to identify and measure health-related patient and societal unmet needs across different health conditions, supporting the creation of needs-driven healthcare policy and innovation. It includes 25 criteria of needs and 46 related indicators allowing to estimate if the needs are met. The current study aims to validate this framework on the EU level using a modified Delphi approach. The selection of national and European institutes invited to participate in the Delphi process was based on their respective roles; specifically, public health, health technology assessment (HTA), medicine authorisation, pricing and reimbursement (P&R), and patient advocacy. Through a modified Delphi approach, the experts were able to express their opinion on the framework structure (dimensions and domains), health-related needs criteria and indicators. Two Delphi rounds were performed using online questionnaires. Consensus was reached when 85% of the respondents agree or totally agree with a proposal and less than 5% of the respondents totally disagree. A panel of 27 experts participated in the first round of the study. The majority of the experts worked in HTA agencies (39%) and P&R agencies (24%), followed by national medicine authorities (9%) and umbrella patient organisations (9%). Seventeen EU Member States were represented, with a higher representation of experts from Austria, Belgium, France, Germany, The Netherlands, Spain and Sweden. Consensus was reached for 22 out of the 25 criteria and 41 out of the 46 indicators after the first round. The modified Delphi technique was an adequate approach to aid the validation of the NEED framework at the EU level. This represents an important first step in achieving consensus on how to define and identify unmet health-related needs and move towards a more needs-driven healthcare policy and innovation landscape. Key messages • Consensus on the definition and identification of unmet health-related needs is crucial to transform public health innovation. • Expert consultation by means of the Delphi technique assumed a pivotal role to reach consensus on the NEED framework.