The Predicament of Comparative Effectiveness Research Using Observational Data
Authors: Jeptha P. Curtis, Harlan M. Krumholz
Journal: Annals of Internal Medicine (2015)

Editorials17 November 2015The Predicament of Comparative Effectiveness Research Using Observational DataJeptha P. Curtis, MD and Harlan M. Krumholz, MD, SMJeptha P. Curtis, MDFrom Yale School of Medicine, New Haven, Connecticut. and Harlan M. Krumholz, MD, SMFrom Yale School of Medicine, New Haven, Connecticut.Author, Article, and Disclosure Informationhttps://doi.org/10.7326/M15-2490 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail Every day, patients and their physicians confront decisions without the evidence they need to inform the choice. Absent this evidence, guidelines are replete with recommendations that rely on expert opinion because needed studies are absent (1). Moreover, even when there is high-grade clinical trial evidence, the reported efficacy in idealized settings may not necessarily reflect what can be achieved in actual practice. As a result, interest in developing evidence that flows from the experience of clinical practice is growing. In fact, the concept of the learning health care system derives from the notion that data produced in the course of ...References1. Tricoci P, Allen JM, Kramer JM, Califf RM, Smith SC. Scientific evidence underlying the ACC/AHA clinical practice guidelines. JAMA. 2009;301:831-41. [PMID: 19244190] CrossrefMedlineGoogle Scholar2. Institute of Medicine. Best Care at Lower Cost: The Path to Continuously Learning Health Care in America. Washington, DC: National Academies Pr; 2012. Accessed at http://iom.nationalacademies.org/Reports/2012/Best-Care-at-Lower-Cost-The-Path-to-Continuously-Learning-Health-Care-in-America.aspx#sthash.9DYy3qAV.dpuf on 15 October 2015. Google Scholar3. Tunis SR, Stryer DB, Clancy CM. Practical clinical trials: increasing the value of clinical research for decision making in clinical and health policy. JAMA. 2003;290:1624-32. [PMID: 14506122] CrossrefMedlineGoogle Scholar4. Hansen KW, Sorensen R, Madsen M, Madsen JK, Jensen JS, von Kappelgaard LM, et al. Effectiveness of an early versus a conservative invasive treatment strategy in acute coronary syndromes. A nationwide cohort study. Ann Intern Med. 2015;163:737-46. doi:10.7326/M15-0303 LinkGoogle Scholar5. Mehta SR, Cannon CP, Fox KA, Wallentin L, Boden WE, Spacek R, et al. Routine vs selective invasive strategies in patients with acute coronary syndromes: a collaborative meta-analysis of randomized trials. JAMA. 2005;293:2908-17. [PMID: 15956636] CrossrefMedlineGoogle Scholar6. Horwitz RI, Viscoli CM, Clemens JD, Sadock RT. Developing improved observational methods for evaluating therapeutic effectiveness. Am J Med. 1990;89:630-8. [PMID: 1978566] CrossrefMedlineGoogle Scholar7. Anglemyer A, Horvath HT, Bero L. Healthcare outcomes assessed with observational study designs compared with those assessed in randomized trials. Cochrane Database Syst Rev. 2014;4:MR000034. [PMID: 24782322] MedlineGoogle Scholar8. Methodology Committee of the Patient-Centered Outcomes Research Institute (PCORI). Methodological standards and patient-centeredness in comparative effectiveness research: the PCORI perspective. JAMA. 2012;307:1636-40. [PMID: 22511692] CrossrefMedlineGoogle Scholar9. Helfand M, Tunis S, Whitlock EP, Pauker SG, Basu A, Chilingerian J, et al; Methods Work Group of the National CTSA Strategic Goal Committee on Comparative Effectiveness Research. A CTSA agenda to advance methods for comparative effectiveness research. Clin Transl Sci. 2011;4:188-98. [PMID: 21707950] doi:10.1111/j.1752-8062.2011.00282.x CrossrefMedlineGoogle Scholar Author, Article, and Disclosure InformationAuthors: Jeptha P. Curtis, MD; Harlan M. Krumholz, MD, SMAffiliations: From Yale School of Medicine, New Haven, Connecticut.Grant Support: Drs. Curtis and Krumholz are supported by grant U01 HL105270-05 (Center for Cardiovascular Outcomes Research at Yale University) from the National Heart, Lung, and Blood Institute.Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M15-2490.Corresponding Author: Harlan M. Krumholz, MD, SM, Yale School of Medicine, 1 Church Street, Suite 200, New Haven, CT 06510; e-mail, harlan.krumholz@yale.edu.Current Author Addresses: Dr. Curtis: Yale School of Medicine, PO Box 208017, 333 Cedar Street, New Haven, CT 06520-8017.Dr. Krumholz: Yale School of Medicine, 1 Church Street, Suite 200, New Haven, CT 06510.This article was published online first at www.annals.org on 27 October 2015. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoEffectiveness of an Early Versus a Conservative Invasive Treatment Strategy in Acute Coronary Syndromes Kim Wadt Hansen , Rikke Sorensen , Mette Madsen , Jan Kyst Madsen , Jan Skov Jensen , Lene Mia von Kappelgaard , Poul Erik Mortensen , Theis Lange , and Soren Galatius Metrics Cited byEffectiveness of Inferior Vena Cava Filters in Patients With Stable and Unstable Pulmonary Embolism and Trends in Their UseInferior Vena Cava Filters in Stable Patients With Pulmonary Embolism and Heart FailureUsefulness of Inferior Vena Cava Filters in Stable Patients with Acute Pulmonary EmbolismFactors That Influence Selectionof Urinary Diversion Among Bladder Cancer Patients in 3 Community-based Integrated Health Care SystemsAssociation of Inferior Vena Cava Filter Use With Mortality Rates in Older Adults With Acute Pulmonary EmbolismInferior Vena Cava Filters to Prevent Pulmonary EmbolismEditorial: Evoked potentials and Chiari malformation Type 1The evolution of left atrial appendage occlusion: EWOLUTION and the WATCHMAN in practiceEffect of Adherence to Oral Anticoagulants on Risk of Stroke and Major Bleeding Among Patients With Atrial Fibrillation 17 November 2015Volume 163, Issue 10Page: 799-800KeywordsAcute coronary syndromeAngiographyClinical trial reportingComparative effectiveness researchComputed axial tomographyDisclosureObservational studiesResearch designTroponinUnstable angina ePublished: 27 October 2015 Issue Published: 17 November 2015 Copyright & PermissionsCopyright © 2015 by American College of Physicians. 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