Beyond Accuracy: Methodological Advances for Assessing the Clinical Impact of Infectious Disease Diagnostics

Evaluating the clinical impact of <i>in vitro</i> diagnostic tests (IVDs) for infectious diseases is complex given their effectiveness depends on context, implementation, and provider behavior. Traditional methodologies for therapy interventions do not adequately capture this complexity, necessitating novel analytical approaches and study designs. This review highlights methodological considerations for improving evidence generation for infectious diseases IVDs. Design and analysis challenges leading to bias and related solutions are reviewed such as the target trial framework. Moreover, novel frameworks such as Benefit-Risk Evaluation of Diagnostics: A Framework, Desirability of Outcome Ranking Management of Antimicrobial Therapy, and Desirability of Outcome Ranking and study designs such as hybrid effectiveness-implementation designs are discussed which allow for holistic ways to assess real-world outcomes. By evaluating IVDs with practical, real-world evidence, tests can better inform clinical decision making, policy, and ultimately patient outcomes.