The Role of Randomized and Nonrandomized Studies in Evaluating Diagnostic Strategies
Authors: M.G. Myriam Hunink, Kirsten E. Fleischmann
Journal: Annals of Internal Medicine (2016)

Editorials5 July 2016The Role of Randomized and Nonrandomized Studies in Evaluating Diagnostic StrategiesM.G. Myriam Hunink, MD, PhD and Kirsten E. Fleischmann, MD, MPHM.G. Myriam Hunink, MD, PhDFrom Erasmus University Medical Center, Rotterdam, the Netherlands, and University of California-San Francisco, San Francisco, California.Search for more papers by this author and Kirsten E. Fleischmann, MD, MPHFrom Erasmus University Medical Center, Rotterdam, the Netherlands, and University of California-San Francisco, San Francisco, California.Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/M16-0811 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail Evaluation of diagnostic strategies can be challenging. Diagnosis is in large part clinically relevant through its effect on treatment, which can beneficially affect long-term patient outcomes. The framework for the evaluation of tests and biomarkers was first introduced by Fryback and Thornbury in 1991 (1) and popularized by Hlatky and colleagues in 2009 (2). This framework includes evaluation of technical performance, diagnostic performance, clinical utility, therapeutic efficacy, patient outcomes, and societal cost-effectiveness. In Annals, the CE-MARC (Cardiovascular Magnetic Resonance and Single-Photon Emission Computed Tomography for Diagnosis of Coronary Heart Disease) trial investigators report the prognostic performance of stress cardiovascular magnetic ...References1. Fryback DG, Thornbury JR. The efficacy of diagnostic imaging. Med Decis Making. 1991;11:88-94. [PMID: 1907710] CrossrefMedlineGoogle Scholar2. Hlatky MA, Greenland P, Arnett DK, Ballantyne CM, Criqui MH, Elkind MS, et al; American Heart Association Expert Panel on Subclinical Atherosclerotic Diseases and Emerging Risk Factors and the Stroke Council. Criteria for evaluation of novel markers of cardiovascular risk: a scientific statement from the American Heart Association. Circulation. 2009;119:2408-16. [PMID: 19364974] doi:10.1161/CIRCULATIONAHA.109.192278 CrossrefMedlineGoogle Scholar3. Greenwood JP, Herzog BA, Brown JM, Everett CC, Nixon J, Bijsterveld P, et al. Prognostic value of cardiovascular magnetic resonance and single-photon emission computed tomography in suspected coronary heart disease: long-term follow-up of a prospective, diagnostic accuracy cohort study. Ann Intern Med. 2016;165:1-9. doi:10.7326/M15-1801 LinkGoogle Scholar4. Greenwood JP, Maredia N, Younger JF, Brown JM, Nixon J, Everett CC, et al. Cardiovascular magnetic resonance and single-photon emission computed tomography for diagnosis of coronary heart disease (CE-MARC): a prospective trial. Lancet. 2012;379:453-60. [PMID: 22196944] doi:10.1016/S0140-6736(11)61335-4 CrossrefMedlineGoogle Scholar5. Boldt J, Leber AW, Bonaventura K, Sohns C, Stula M, Huppertz A, et al. Cost-effectiveness of cardiovascular magnetic resonance and single-photon emission computed tomography for diagnosis of coronary artery disease in Germany. J Cardiovasc Magn Reson. 2013;15:30. [PMID: 23574690] doi:10.1186/1532-429X-15-30 CrossrefMedlineGoogle Scholar6. Genders TS, Petersen SE, Pugliese F, Dastidar AG, Fleischmann KE, Nieman K, et al. The optimal imaging strategy for patients with stable chest pain: a cost-effectiveness analysis. Ann Intern Med. 2015;162:474-84. [PMID: 25844996]. doi:10.7326/M14-0027 LinkGoogle Scholar7. Iwata K, Ogasawara K. Comparison of the cost-effectiveness of stress myocardial perfusion MRI and SPECT in patients with suspected coronary artery disease. Radiol Phys Technol. 2013;6:28-34. [PMID: 22806543] doi:10.1007/s12194-012-0165-2 CrossrefMedlineGoogle Scholar8. Walker S, Girardin F, McKenna C, Ball SG, Nixon J, Plein S, et al. Cost-effectiveness of cardiovascular magnetic resonance in the diagnosis of coronary heart disease: an economic evaluation using data from the CE-MARC study. Heart. 2013;99:873-81. [PMID: 23591668] doi:10.1136/heartjnl-2013-303624 CrossrefMedlineGoogle Scholar9. VanderWeele TJ. A unification of mediation and interaction: a 4-way decomposition. Epidemiology. 2014;25:749-61. [PMID: 25000145] doi:10.1097/EDE.0000000000000121 CrossrefMedlineGoogle Scholar10. Richiardi L, Bellocco R, Zugna D. Mediation analysis in epidemiology: methods, interpretation and bias. Int J Epidemiol. 2013;42:1511-9. [PMID: 24019424] doi:10.1093/ije/dyt127 CrossrefMedlineGoogle Scholar Author, Article, and Disclosure InformationAffiliations: From Erasmus University Medical Center, Rotterdam, the Netherlands, and University of California-San Francisco, San Francisco, California.Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M16-0811.Corresponding Author: M.G. Myriam Hunink, MD, PhD, PO Box 2040, 3000 CA Rotterdam, The Netherlands, internal postal address Na-2818; e-mail, m.[email protected]nl.Current Author Addresses: Dr. Hunink: PO Box 2040, 3000 CA Rotterdam, The Netherlands, internal postal address Na-2818.Dr. Fleischmann: PO Box 0124, 505 Parnassus Avenue, San Francisco, CA 94143-0124.This article was published at www.annals.org on 10 May 2016. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoPrognostic Value of Cardiovascular Magnetic Resonance and Single-Photon Emission Computed Tomography in Suspected Coronary Heart Disease: Long-Term Follow-up of a Prospective, Diagnostic Accuracy Cohort Study John P. Greenwood , Bernhard A. Herzog , Julia M. Brown , Colin C. Everett , Jane Nixon , Petra Bijsterveld , Neil Maredia , Manish Motwani , Catherine J. Dickinson , Stephen G. Ball , and Sven Plein Metrics 5 July 2016Volume 165, Issue 1Page: 61-62KeywordsAngiographyCardiac magnetic resonanceCohort studiesComputed axial tomographyCongenital heart diseaseCoronary heart diseaseDisclosureFactor analysisMedical risk factorsObservational studies ePublished: 10 May 2016 Issue Published: 5 July 2016 Copyright & PermissionsCopyright © 2016 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...