The Ethics of Testing a Test: Randomized Trials of the Health Impact of Diagnostic Tests for Infectious Diseases

• Published in: Clinical infectious diseases 2012-12, Vol.55 (11), p.1522-1526
• Main Authors: Dowdy, David W., Gounder, Celine R., Corbett, Elizabeth L., Ngwira, Lucky G., Chaisson, Richard E., Merritt, Maria W.
• Format: Article
• Language: English
• Subjects: Bioethics; Biological and medical sciences; Clinical trials; Communicable Diseases - diagnosis; Diagnostic tests; Diagnostic Tests, Routine - ethics; Diagnostic Tests, Routine - methods; Ethics, Research; Health outcomes; Humans; Impact analysis; Infectious diseases; Informed Consent; Medical diagnostic tests; Medical ethics; Medical sciences; Morbidity; Mortality; Population health; Public health; Randomized Controlled Trials as Topic - ethics; Randomized Controlled Trials as Topic - methods; Reproducibility of Results; Setting; Tuberculosis; VIEWPOINTS
• ISSN: 1058-4838; 1537-6591
• DOI: 10.1093/cid/cis736

In the last decade, many new rapid diagnostic tests for infectious diseases have been developed. In general, these new tests are developed with the intent to optimize feasibility and population health, not accuracy alone. However, unlike drugs or vaccines, diagnostic tests are evaluated and licensed on the basis of accuracy, not health impact (eg, reduced morbidity or mortality). Thus, these tests are sometimes recommended or scaled up for purposes of improving population health without randomized evidence that they do so. We highlight the importance of randomized trials to evaluate the health impact of novel diagnostics and note that such trials raise distinctive ethical challenges of equipoise, equity, and informed consent. We discuss the distinction between equipoise for patient-important outcomes versus diagnostic accuracy, the equity implications of evaluating health impact of diagnostics under routine conditions, and the importance of offering reasonable choices for informed consent in diagnostic trials.