As there is no standard definition of unmet patient or societal needs, the Needs Examination, Evaluation, Dissemination (NEED) project defined criteria for assessing these needs. This study describes the creation of an exploitable evidence database on unmet health-related patient and societal needs for various health conditions, and how this can be used in decision-making.

The NEED framework defines explicit dimensions (patient, societal, and future needs), domains (health, healthcare, and social needs), and criteria, along with specific measurable indicators, to identify unmet health-related patient and societal needs for various health conditions. For each indicator, information sources were sought, including both quantitative and qualitative evidence. For some indicators, guidance on evidence generation was developed. Possible uses of the NEED database were discussed with national and international panels of experts, stakeholders, and decision-makers.

Data sources were identified for some but not all patient and societal needs criteria. They included existing databases (e.g., the Global Burden of Disease database and administrative databases), literature, and primary data collection. A standardized methodology was defined for primary data collection (quantitative and qualitative). The NEED evidence database can be used by researchers, research funders, regulators, health technology assessment agencies, policymakers, patients, healthcare providers, etcetera for prioritizing areas of research as well as—thanks to the level of detail provided in the database—to assess the extent to which proposed “solutions” meet the most pressing unmet needs of patients or society.

Once operational, an unmet patient and societal needs evidence database, anchored to an explicit framework, can serve different stakeholders and decision-makers for various purposes. It collects evidence on unmet health-related patient and societal needs for various health conditions, given the current standard of care, independent of any new product or service, and therefore supports a needs-driven healthcare innovation and policy system.

The healthcare ecosystem is predominantly supply-driven, leading to a lack of innovation in financially less-attractive health areas, inefficient use of public resources for healthcare, and unmet patient and societal needs. This study proposes a framework to identify unmet health-related patient and societal needs for different health conditions, to inform and support the development of needs-driven healthcare policy and innovations.

Two systematic literature reviews were conducted: one to update an already published literature review that identified tools for measuring patient needs; another to identify criteria for measuring health-related societal needs. Ovid MEDLINE and Embase were searched for English, French, and Dutch publications. In April 2023, 22 Belgian stakeholders and experts reviewed selected societal needs criteria. The NEED (Needs Examination, Evaluation and Dissemination) assessment framework, incorporating literature-derived patient and societal needs criteria, underwent discussions with the Health Minister’s Cabinet and federal health agencies from May to July 2023. The framework was challenged in November 2023 during international and national advisory committee meetings.

The literature reviews covered 52 studies. The NEED framework addresses patient, societal, and future needs across health, healthcare, and social domains. Patient-level criteria (13) include health (e.g., impact on quality of life), healthcare (e.g., burden of treatment), and social (e.g., social support). Societal needs criteria (6) encompass health (e.g., transmissibility), healthcare (e.g., value for money), and social (e.g., productivity losses). Future needs criteria (2) consider future burden of disease and economic burden. Each criterion (total: 40) has measurable indicators with calculation methods and data sources. Equity is recognized as a transversal dimension, requiring unmet needs data disaggregated by population group.

For the first time, a transparent scientific framework containing criteria and indicators for assessing the unmet needs of patients and society has been developed. This lays the foundations for a major shift towards a more needs-driven healthcare policy and innovation.

The NEED (Needs Examination, Evaluation and Dissemination) assessment framework aims to identify patient and societal unmet needs in various diseases, highlighting gaps for intervention. This approach is exemplified through a malignant melanoma case study, ranking sixth in European cancers. Therapeutic progress has been made over the last decade, prompting an assessment of remaining unmet needs.

The applicability of the NEED framework has been evaluated through a case study of melanoma in Belgium. The methodology had four components: (i) an overall description of the disease based on the scientific (published and grey) literature and clinical expert input; (ii) an online survey on the unmet needs of patients (n=37); (iii) semistructured interviews with individuals affected by melanoma (n=9); and (iv) secondary data collection for each NEED framework criterion, including scientific literature and public databases. The survey results were analyzed with descriptive statistics, and the interview transcripts were analyzed using a thematic analysis.

Unmet needs in melanoma were categorized as patient-level health, healthcare, and social needs, alongside wider societal needs. Patients experienced a substantial burden from mortality in advanced stages, burdensome symptoms such as fatigue, and notable side effects of systemic treatment. Inadequate psychological support contributed to high levels of fear and anxiety. A scarcity of dermatologists posed a barrier to timely care access, and low awareness of melanoma risk led many patients to delay seeking medical attention, with significant societal implications for melanoma prevention efforts. The case study also identified research gaps concerning social and ethnic inequalities in melanoma care in Europe.

Using the NEED framework highlighted melanoma patients’ most crucial unmet needs. This evidence can be used to assess whether new interventions address the highest unmet patient or societal needs. Challenges in ensuring adequate sample size limit the generalizability of results. Capturing melanoma’s complexity in a snapshot masks some needs heterogeneity.