We appreciate the opportunity to provide oral testimony at the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria.
The National Center for Health Research (NCHR) is a nonprofit think tank that conducts, analyzes, and scrutinizes research on a range of health issues, with a particular focus on which prevention strategies and treatments are most effective for which patients and consumers. We do not accept funding from companies that make products that are the subject of our work, so we have no conflicts of interest.
Still, we realize that developing novel therapies to improve outcomes for patients with resistant disease is important. But, it is also crucial to recognize that antibiotics with biological activity in vitro do not guarantee improved patient survival over available therapies. This highlights the need to apply more clinically useful, patient-centered, metrics to evaluate bacterial infections with a limited response to current clinical therapies. Specifically, we urge the Department of Health and Human Services to consider the use of three patient-centered clinical outcome metrics, as proposed by Lawandi and Colleagues,3 to better ascertain the clinical relevance of resistant and nonresistant bacterial infections:
- By characterizing patient baseline clinical risk factors associated with a poor response to current treatment, clinicians would be better equipped to identify patients at higher risk for complications or treatment failure who might benefit from better interventions.
2. Measuring treatment outcomes based on direct measures of a patient’s health including survival, quality of life, and functional status, using validated questionnaires, would provide a more accurate assessment of a treatment’s effectiveness.
3. Shifting away from noninferiority trials and toward superiority trials would better align with the goal of improving patient outcomes when current standards are unable to provide satisfactory results.
Pivoting away from pathogen-specific metrics toward patient-centered metrics will provide value for patients, physicians, and public health overall. This information will also allow for a more comprehensive understanding of the clinical significance of resistant and nonresistant bacterial infections. Ultimately, this approach will lead to more effective treatment strategies that are shown to improve patient outcomes and address the broader issue of infection-associated death.
References:
- Mestrovic, et al. “The burden of bacterial antimicrobial resistance in the WHO European region in 2019: a cross-country systematic analysis. Lancet Public Health. 2022.
- The Antimicrobial Resistance Collaborators. Global burden of bacterial antimicrobial resistance in 2019: a systematic analysis. 2022.
- Lawandi, A; Kadri, S; Powers, J. “Focusing on antimicrobial resistant infections- are we missing the forest for the trees and the patients for pathogens?” Frontiers in Antibiotics. 2023.