Protocol for Needs Examination Evaluation and Dissemination (NEED) research projects

Abstract The NEED (Needs Examination, Evaluation and Dissemination) initiative aims to identify patient and societal unmet needs linked to specific health conditions and highlight gaps that warrant intervention. This presentation outlines the NEED protocol-a standardised and transparent methodology to evaluate unmet health-related needs and support evidence-informed policy and innovation. The protocol follows a four-step model. Step 1 identifies health conditions with potentially high levels of unmet need through existing databases and an open call for proposals. Step 2 involves prioritising and selecting conditions based on defined criteria, including population impact, patient life expectancy, and expert input. Step 3 guides the structured collection of evidence on unmet needs, using the NEED assessment framework composed of 26 criteria and 46 indicators across multiple domains. Step 4 ensures dissemination of results via reports, fact sheets, and integration into the public NEED database using a standardised format. For each step, the protocol provides preferred and alternative methods to adapt to various research contexts. For example, condition selection in Step 2 relies on transparent scoring and expert validation. For Step 3, it is specified for each indicator which data source could be used, e.g. literature, expert panels, patient input, and routine data sources (administrative databases, registries etc). The NEED protocol offers a replicable, flexible approach for identifying and assessing unmet health-related needs across diseases and settings. It enables structured input into the NEED database and supports decision-makers in setting priorities and shaping public health responses.