Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Editorial
. 2012 Aug 16:13:137.
doi: 10.1186/1745-6215-13-137.

Diagnostic randomized controlled trials: the final frontier

Marc Rodger  1 , Tim Ramsay, Dean Fergusson
Affiliations
Editorial

Diagnostic randomized controlled trials: the final frontier

Marc Rodger et al. Trials. .

Abstract

Clinicians, patients, governments, third-party payers, and the public take for granted that diagnostic tests are accurate, safe and effective. However, we may be seriously misled if we are relying on robust study design to ensure accurate, safe, and effective diagnostic tests. Properly conducted, randomized controlled trials are the gold standard for assessing the effectiveness and safety of interventions, yet are rarely conducted in the assessment of diagnostic tests. Instead, diagnostic cohort studies are commonly performed to assess the characteristics of a diagnostic test including sensitivity and specificity. While diagnostic cohort studies can inform us about the relative accuracy of an experimental diagnostic intervention compared to a reference standard, they do not inform us about whether the differences in accuracy are clinically important, or the degree of clinical importance (in other words, the impact on patient outcomes). In this commentary we provide the advantages of the diagnostic randomized controlled trial and suggest a greater awareness and uptake in their conduct. Doing so will better ensure that patients are offered diagnostic procedures that will make a clinical difference.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Primer on venous thrombosis.
Figure 2
Figure 2
Prospective diagnostic accuracy cohort study.
Figure 3
Figure 3
Open diagnostic intervention randomized controlled trial.
Figure 4
Figure 4
Blind diagnostic intervention randomized controlled trial.
See this image and copyright information in PMC

References

    1. Kearon C, Ginsberg JS, Douketis J, Crowther MA, Turpie AG, Bates SM, Lee A, Brill-Edwards P, Finch T, Gent M. A randomized trial of diagnostic strategies after normal proximal vein ultrasonography for suspected deep venous thrombosis: d-dimer testing compared with repeated ultrasonography. Ann Intern Med. 2005;142:490–496. - PubMed
    1. Jaeschke R, Guyatt G, Sackett DL. Users’ guide to the medical literature. III. How to use an article about a diagnostic test. B. What are the results and will they help me in caring for my patients? JAMA. 1994;271:703–707. doi: 10.1001/jama.1994.03510330081039. - DOI - PubMed
    1. Jaeschke R, Guyatt G, Sackett DL. Users’ guides to the medical literature. III. How to use an article about a diagnostic test A. Are the results of the study valid? JAMA. 1994;271:389–391. doi: 10.1001/jama.1994.03510290071040. - DOI - PubMed
    1. Lijmer JG, Mol BW, Heisterkamp S, Bonsel GJ, Prins MH, van der Meulen JH, Bossuyt PM. Empirical evidence of design-related bias in studies of diagnostic tests. JAMA. 1999;282:1061–1066. doi: 10.1001/jama.282.11.1061. - DOI - PubMed
    1. Bossuyt PM, Reitsma JB, Bruns DE, Gatsonis CA, Glasziou PP, Irwig LM, Moher D, Rennie D, de Vet HC, Lijmer JG. Standards for Reporting of Diagnostic Accuracy. The STARD statement for reporting studies of diagnostic accuracy: explanation and elaboration. Ann Intern Med. 2003;138:1W–12W. - PubMed

Publication types