Outcome selection in primary care antimicrobial stewardship research

Area of Science:

• Primary care research
• Antimicrobial stewardship
• Clinical trial design

Background:

• Clinical and antimicrobial stewardship (AMS) outcomes are crucial for primary care trials, encompassing symptom persistence, relapses, antibiotic use, and antimicrobial resistance.
• Current primary care trials exhibit a wide variability in outcome measures, lacking standardized design protocols.

Purpose of the Study:

• To review existing outcome measures in primary care trials related to AMS and clinical aspects.
• To propose recommendations for the design of future primary care research focusing on AMS interventions and outcomes.

Main Methods:

• Review of outcome measures in previous primary care trials.
• Analysis of antimicrobial stewardship interventions and their targets.
• Development of recommendations for future research designs.

Main Results:

• Significant heterogeneity exists in outcome measures used in primary care trials.
• No universally agreed-upon standards for designing clinical and AMS outcomes in these trials.

Conclusions:

• Investigators should pre-specify the interpretation of co-primary outcomes.
• AMS effectiveness measures must include prescriptions from all sources.
• Antimicrobial resistance should be included as an outcome where feasible.
• In certain contexts, antibiotics used within the intervention should be part of the outcome.
• Patient involvement is essential for prioritizing AMS versus clinical outcomes.