NCATS Director of Clinical Innovation
Mike's Blog
Lost in Translation along that Last Mile
By: Michael Kurilla, M.D., Ph.D., NCATS Director of the Division of Clinical Innovation
February 27, 2023
A major emphasis of the CTSA Program is ‘translating’ scientific discoveries into practical, implementable interventions, procedures, and general advice that positively impact human health. What has become abundantly clear is that the academic medicine tendency to throw complex scientific analyses through the transom to the health care practicing community doesn’t always equate with productive dissemination and uptake. Many health care providers simply do not have time to read the primary medical literature in detail. Furthermore, most professional societies’ guidance comes off similar to a cooking show where the celebrity chef is explaining how simple and easy a recipe is while they just happen to have freshly cut basil and freshly ground nutmeg all premeasured in little bowls.
A recent article, Revisiting the Time Needed to Provide Adult Primary Care highlights the disconnect between recommendations for health care practice and practicality. The analysis sought to calculate the time required for a PCP to provide the panoply of guidelines-recommended care for prevention, chronic disease management, and acute treatment in a typical patient practice. The result was a logic defying 26.7 hours per day. A parallel analysis was conducted with a team based approach which required ‘only’ 9.3 hours per day, but then it’s unlikely that reimbursements would be increased to support the team. Obviously, simply ‘bolting’ on more activities to an already overpacked schedule is impractical, but is it any wonder why all these professional guidelines are largely ignored? Incorporating all these recommendations will require a reworking of how primary care is delivered, but the primary care community is not in a position to tackle this conundrum. Overall, health care delivery, especially primary care delivery is a stumbling block to better health outcomes, but little focus has been directed to improving this area. Plenty of effort is expended to ensure that complex medical and surgical procedures can be effectively delivered in tertiary care centers; similar efforts are needed to upgrade primary care delivery for the 21st century.
One outcome of deployed medical interventions during COVID was the use of limited clinical trial data to support FDA authorizations. As a result, the FDA was very much interested in follow-up studies. When an investigator suggested a unique opportunity to utilize statewide Electronic Health Records data from the largest health system in Colorado plus state-level vaccine and mortality data to evaluate Real-world effectiveness of MAbs in a large population of COVID-19 patients and matched controls, Operation Warp Speed asked NCATS to manage the project. The Colorado CTSA has published numerous articles on statewide real-world evidence supporting MAb use as well as Paxlovid treatments. As part of their hybrid study design (effectiveness and implementation), one additional component of the project was to assess both patient and provider perceptions regarding MAbs. The provider assessment, Clinician Perspectives on Monoclonal Antibody Treatment for High-Risk Outpatients with COVID-19: Implications for Implementation and Equitable Access is quite insightful. Depending on the specific MAb, two-thirds to three-quarters of PCPs reported ‘little to no knowledge” about MAbs, while just over half reported “little to no familiarity” with eligibility criteria and only a quarter indicated their clinical setting was very prepared to facilitate referrals. Given a Nobel prize in 1984 for MAbs and about 100 MAbs in clinical use today, these provider perceptions are quite disappointing and highlight a deficit in delivery (until Paxlovid became available) of the only outpatient intervention to keep high-risk patients out of the hospital. Better educational dissemination and access to resources is needed before implementation of 21st century health care can occur.
Until the last mile is addressed, the vision of the CTSA to innovate health care and health care delivery cannot be fully realized.
Pursue what is meaningful, not what is expedient.
- Gregg Hurwitz, Orphan X
This Mike's Blog was featured in March 2023's Ansible. Subscribe to receive upcoming Ansible newsletters.