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

http://www.ncbi.nlm.nih.gov/pubmed/22918990

Clin Infect Dis. 2012 Aug 23. [Epub ahead of print]

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

Dowdy DW, Gounder CR, Corbett EL, Ngwira LG, Chaisson RE, Merritt MW.

Source

Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.

Abstract

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 (e.g., 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.