Methodological challenges in appraising evidence on diagnostic testing for WHO guidelines on hepatitis B and...

Area of Science:

• Hepatology and Infectious Diseases
• Public Health and Diagnostics

Background:

• Effective diagnosis of hepatitis B (HBV) and hepatitis C (HCV) is crucial for linking patients to prevention and treatment.
• The World Health Organization (WHO) has established its inaugural guidelines for chronic HBV and HCV infection testing.

Purpose of the Study:

• To outline the methodology and challenges in applying the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) framework to viral hepatitis diagnostic testing.
• To present WHO's first guidelines on testing for chronic HBV and HCV infection.

Main Methods:

• Utilized the GRADE framework to formulate recommendations, assessing evidence quality, benefits, harms, values, feasibility, and resource implications.
• Addressed methodological challenges and considerations specific to applying these procedures to viral hepatitis diagnostic testing.
• Considered diagnostic accuracy as a surrogate for clinical outcomes due to the availability of effective treatments.

Main Results:

• Direct evidence on test effects on clinical outcomes was limited.
• Recommendations prioritize tests and strategies balancing diagnostic accuracy with factors like cost, access, uptake, linkage to care, feasibility, and patient preference.
• The Guidelines Development Group (GDG) determined that slightly lower diagnostic accuracy is acceptable if other factors improve patient identification and care linkage.

Conclusions:

• WHO guidelines offer a framework for selecting HBV and HCV diagnostic tests and strategies.
• The approach balances diagnostic accuracy with broader considerations to maximize patient identification and access to care.
• These guidelines aim to increase the number of individuals diagnosed with chronic HBV and HCV, enabling them to benefit from available treatments.