A group of healthcare researchers and health system leaders recently proposed a new framework to evaluate evidence for digital health products. The set of guidelines — titled “Evidence in Digital health for EFfectiveness of INterventions with Evaluative Depth” (Evidence Defined) — was published last week in npj Digital Medicine.
The framework seeks to provide hospitals, payers and trade organizations with a clear set of steps they can use to determine whether or not a digital health product is evidence-based and therefore suitable for their company to adopt. The authors created this new guide after examining 78 existing frameworks designed for the assessment of digital health intervention evidence — they found that none were specific enough to meet the needs of healthcare stakeholder organizations.
The Evidence Defined framework also aims to equip digital health vendors with a guide they can reference to ensure their solutions have the evidence needed for healthcare customers to adopt them. The new strategy was developed by experts from organizations such as Geisinger, Elevance Health, AstraZeneca and UCSF Health.
“Careful evidence assessment can mean the difference between identifying critical evidence flaws and failing to do so. This can, in turn, impact countless patients, by dictating whether patients get access to digital health interventions that are effective and safe. For some patients, rigorous [digital health intervention] evidence assessment may mean the difference between medication adherence and nonadherence; between overcoming nicotine dependence and developing lung cancer; between resolution of affective symptoms and chronic emotional struggles,” the authors wrote.
Their framework includes four steps, which are defined below.
Screen the product for failure to meet your organization’s absolute requirements
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Each organization will need to specify its non-negotiable requirements based on its specific needs. Some examples of absolute requirements include HIPAA compliance, FDA clearance and language that can be understood by people with a fifth grade reading level.
Apply an existing evidence assessment framework
The second step requires the organization to apply an established evidence assessment framework that has been developed for non-digital interventions, such as the GRADE framework.
Use the Evidence Defined supplementary checklist
There are 21 considerations unique to digital health on the supplementary checklist. Some of these include ensuring that underserved patients are included in the product’s trials, determining whether clinical improvements are attributable to healthy user effects or other selection biases, and checking whether data gaps have been addressed appropriately.
Produce actionable, justifiable recommendations
These recommendations should focus on determining which level of adoption will be suitable for the organization, as well the clinical areas in which the product should be deployed.
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