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

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...

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Bibliographic Details
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
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Summary: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.
ISSN:1058-4838
1537-6591
DOI:10.1093/cid/cis736