A recent publication in npj Digital Medicine introduced a novel framework called "Evidence in Digital Health for EFfectiveness of INterventions with Evaluative Depth” (Evidence Defined) that aims to evaluate evidence for digital health products. The framework was proposed by healthcare researchers and leaders in an effort to provide clear guidelines for hospitals, payers, and trade organisations to assess the evidence base of digital health solutions before adopting them. The authors developed this framework after discovering that existing assessment frameworks lacked specificity for healthcare stakeholders. Additionally, the Evidence Defined framework serves as a reference for digital health vendors to ensure their products meet the evidence requirements of healthcare customers. Expert contributors from Geisinger, Elevance Health, AstraZeneca, and UCSF Health collaborated on this strategy.
The authors emphasised the importance of meticulous evidence assessment in determining the effectiveness and safety of digital health interventions, which ultimately impacts patients' access to appropriate care. They highlighted examples where rigorous evidence evaluation can make a significant difference in patient outcomes, such as medication adherence, overcoming dependencies, and improving emotional well-being.
The Evidence Defined framework comprises four key steps. Firstly, organisations are encouraged to employ an existing evidence assessment framework developed for non-digital interventions, such as the GRADE framework. Secondly, organisations should utilise the supplementary checklist provided by Evidence Defined, which consists of 21 considerations specific to digital health. These include factors like inclusivity of underserved patients in trials, differentiation of clinical improvements from user effects, and addressing data gaps effectively. The third step involves producing actionable and justifiable recommendations. These recommendations guide organisations in determining the suitable level of adoption and the clinical areas in which the digital health product should be implemented.
By following these steps, healthcare stakeholders can make informed decisions about adopting evidence-based digital health solutions that meet their specific requirements. The Evidence Defined framework represents a significant contribution to the assessment of digital health interventions, promoting patient-centred care and improved outcomes.
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