ArticleClinical infectious diseases : an official publication of the Infectious Diseases Society of America2012
The ethics of testing a test: randomized trials of the health impact of diagnostic tests for infectious diseases.
Article in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
10 citing papers in PubMed, 1 synthesis or guideline pooled it, 17 citations in OpenAlex.
- Utility of broad-spectrum antibiotics for diagnosing pulmonary tuberculosis in adults: a systematic review and meta-analysis.The Lancet. Infectious diseases · 2020Pooled it
- Gaps in the Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials: a citation analysis reveals a need for updated ethics guidelines.Research integrity and peer review · 2025Article
- Medical Diagnostic Tests: A Review of Test Anatomy, Phases, and Statistical Treatment of Data.Computational and mathematical methods in medicine · 2019Review
- Rapid urine-based screening for tuberculosis to reduce AIDS-related mortality in hospitalized patients in Africa (the STAMP trial): study protocol for a randomised controlled trial.BMC infectious diseases · 2016Article
- Advances in Diagnostic Assays for Tuberculosis.Cold Spring Harbor perspectives in medicine · 2015Review
- Impact of GeneXpert MTB/RIF on patients and tuberculosis programs in a low-burden setting. a hypothetical trial.American journal of respiratory and critical care medicine · 2014Observational
- Diagnostic point-of-care tests in resource-limited settings.The Lancet. Infectious diseases · 2014Review
- Challenges in evaluating the cost-effectiveness of new diagnostic tests for HIV-associated tuberculosis.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2013Article
- Tuberculosis screening in high human immunodeficiency virus prevalence settings: turning promise into reality.The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease · 2013Review
- Integrating clinical services for HIV, tuberculosis, and cryptococcal disease in the developing world: a step forward with 2 novel diagnostic tests.Journal of the International Association of Providers of AIDS CareArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 4 institutions in 3 countries.
Funding
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 (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.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.