Clinical Scorecard: The Rationale Behind Utilizing the Test-Negative Design for Ongoing Vaccine Surveillance

At a Glance

Key Highlights

• Updated COVID-19 vaccine reduced ED/UC encounters by 50% and hospitalizations by 55%.
• Test-negative design allows for efficient estimation of vaccine effectiveness without a fully enumerated cohort.
• TND has been used for decades in influenza vaccine monitoring.
• Bias adjustment is a challenge; TND restricts to test-negative controls seeking care.
• Routine estimates of vaccine effectiveness are vital for public health decision making.

Guideline-Based Recommendations

Diagnosis

• Utilize the test-negative design for estimating vaccine effectiveness in COVID-19.

Management

• Continue to monitor vaccine effectiveness using integrated respiratory virus surveillance systems.

Monitoring & Follow-up

• Conduct extensive sensitivity analyses to assess potential bias in TND studies.

Risks

• Be aware of confounding by health-care seeking behavior and frailty bias in TND analyses.

Patient & Prescribing Data

Immunocompetent adults receiving the updated COVID-19 vaccine.

Vaccination significantly reduces COVID-19-related healthcare encounters.

Clinical Best Practices

• Invest in data modernization to improve electronic health record quality for vaccination data.
• Strengthen networks like VISION for large sample size generation in vaccine effectiveness studies.
• Publish estimates of vaccine effectiveness in populations with changing immunity.

Related Resources & Content

• Wiegand et al. Study
• CDC Morbidity and Mortality Weekly Report
• US Flu Vaccine Effectiveness Network