The ADAPTABLE Trial and PCORnet: Shining Light on a New Research Paradigm
Authors: Adrian F. Hernandez, Rachael L. Fleurence, Russell L. Rothman
Journal: Annals of Internal Medicine (2015)

Ideas and Opinions20 October 2015The ADAPTABLE Trial and PCORnet: Shining Light on a New Research ParadigmAdrian F. Hernandez, MD, MHS, Rachael L. Fleurence, PhD, and Russell L. Rothman, MD, MPPAdrian F. Hernandez, MD, MHSFrom Duke Clinical Research Institute, Durham, North Carolina; Patient-Centered Outcomes Research Institute, Washington, DC; and Vanderbilt University, Nashville, Tennessee., Rachael L. Fleurence, PhDFrom Duke Clinical Research Institute, Durham, North Carolina; Patient-Centered Outcomes Research Institute, Washington, DC; and Vanderbilt University, Nashville, Tennessee., and Russell L. Rothman, MD, MPPFrom Duke Clinical Research Institute, Durham, North Carolina; Patient-Centered Outcomes Research Institute, Washington, DC; and Vanderbilt University, Nashville, Tennessee.Author, Article, and Disclosure Informationhttps://doi.org/10.7326/M15-1460 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail Every day, patients and health care providers must make choices about medical care in circumstances where the best treatment is unknown and the balance of benefits and risks is unclear. Amid this uncertainty, the need for a pragmatic, efficient, nationwide solution that yields accurate scientific evidence to support informed decision making is obvious. However, our existing national research infrastructure is expensive, inefficient, and often slow to provide results. Most clinical trials focus on surrogate end points that are easier to obtain instead of clinical outcomes that matter most to patients (1). Moreover, growing complexity and administrative burdens are making clinical ...References1. Micheel CM, Ball JR, eds. Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease. Washington, DC: National Academies Pr; 2010. Accessed at www.iom.edu/Reports/2010/Evaluation-of-Biomarkers-and-Surrogate-Endpoints-in-Chronic-Disease.aspx on 10 June 2015. Google Scholar2. Kramer JM, Smith PB, Califf RM. Impediments to clinical research in the United States. Clin Pharmacol Ther. 2012;91:535-41. [PMID: 22318614] doi:10.1038/clpt.2011.341 CrossrefMedlineGoogle Scholar3. Patient-Centered Outcomes Research Institute. PCORnet: The National Patient-Centered Clinical Research Network. Washington, DC: Patient-Centered Outcomes Research Institute; 2015. Accessed at www.pcori.org/research-results/pcornet-national-patient-centered-clinical-research-network on 10 June 2015. Google Scholar4. Collins FS, Hudson KL, Briggs JP, Lauer MS. PCORnet: turning a dream into reality [Editorial]. J Am Med Inform Assoc. 2014;21:576-7. [PMID: 24821744] doi:10.1136/amiajnl-2014-002864 CrossrefMedlineGoogle Scholar5. Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, Blaha MJ, et al; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics—2014 update: a report from the American Heart Association. Circulation. 2014;129:e28-e292. [PMID: 24352519] doi:10.1161/01.cir.0000441139.02102.80 CrossrefMedlineGoogle Scholar6. Yusuf S, Reddy S, Ounpuu S, Anand S. Global burden of cardiovascular diseases: part I: general considerations, the epidemiologic transition, risk factors, and impact of urbanization. Circulation. 2001;104:2746-53. [PMID: 11723030] CrossrefMedlineGoogle Scholar7. Hall HM, deLemos JA, Enriquez JR, McGuire DK, Peng SA, Alexander KP, et al. Contemporary patterns of discharge aspirin dosing after acute myocardial infarction in the United States: results from the National Cardiovascular Data Registry (NCDR). Circ Cardiovasc Qual Outcomes. 2014;7:701-7. [PMID: 25116897] doi:10.1161/CIRCOUTCOMES.113.000822 CrossrefMedlineGoogle Scholar8. National Patient-Centered Clinical Research Network. ADAPTABLE: The Aspirin Study. Washington, DC: Patient-Centered Outcomes Research Institute. Accessed at www.pcornet.org/aspirin on 22 July 2015. Google Scholar9. Thorpe KE, Zwarenstein M, Oxman AD, Treweek S, Furberg CD, Altman DG, et al. A pragmatic-explanatory continuum indicator summary (PRECIS): a tool to help trial designers. CMAJ. 2009;180:E47-57. [PMID: 19372436] doi:10.1503/cmaj.090523 CrossrefMedlineGoogle Scholar10. National Patient-Centered Clinical Research Network. PCORnet Common Data Model (CDM). Washington, DC: Patient-Centered Outcomes Research Institute; 2015. Accessed at www.pcornet.org/pcornet-common-data-model on 10 June 2015. Google Scholar Author, Article, and Disclosure InformationAuthors: Adrian F. Hernandez, MD, MHS; Rachael L. Fleurence, PhD; Russell L. Rothman, MD, MPPAffiliations: From Duke Clinical Research Institute, Durham, North Carolina; Patient-Centered Outcomes Research Institute, Washington, DC; and Vanderbilt University, Nashville, Tennessee.Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M15-1460.Corresponding Author: Adrian F. Hernandez, MD, MHS, Duke Clinical Research Institute, PO Box 17969, Durham, NC 27715; e-mail, adrian.[email protected]edu.Current Author Addresses: Dr. Hernandez: Duke Clinical Research Institute, PO Box 17969, Durham, NC 27715.Dr. Fleurence: Patient-Centered Outcomes Research Institute, 1828 L Street, Washington, DC 20036.Dr. Rothman: Vanderbilt Center for Health Services Research, Vanderbilt University Medical Center, Suite 6000, Medical Center East, Nashville, TN 37232-8300.Author Contributions: Conception and design: A.F. Hernandez, R.L. Fleurence, R.L. Rothman.Drafting of the article: A.F. Hernandez, R.L. Fleurence, R.L. Rothman.Critical revision of the article for important intellectual content: R.L. Fleurence, R.L. Rothman.Final approval of the article: A.F. Hernandez, R.L. Fleurence, R.L. Rothman.This article was published online first at www.annals.org on 25 August 2015. 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Selby, MD, MPHProton-Pump Inhibitors Reduce Gastrointestinal Events Regardless of Aspirin Dose in Patients Requiring Dual Antiplatelet TherapyGood Clinical Practice Guidance and Pragmatic Clinical TrialsTransfusion in Ischemic Heart Disease 20 October 2015Volume 163, Issue 8Page: 635-636KeywordsAspirinCardiovascular therapyChild healthClinical trialsElectronic medical recordsHealth information technologyMyocardial infarctionOutpatient clinicsPatientsPrevention, policy, and public health ePublished: 20 October 2015 Issue Published: 20 October 2015 Copyright & PermissionsCopyright © 2015 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...