Editor’s Perspective Leveraging Entrepreneurship as a Means to Improve the Translation of Outcomes Research to Healthcare Improvement John A. Spertus, MD, MPH

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he field of outcomes research is devoted to a multidisciplinary effort to understand patient, provider, and health system characteristics associated with clinically important patient outcomes.1 Moreover, the field has a commitment to learning what works in medicine and supporting interventions to improve care and outcomes. Tools used by the outcomes research community have included the creation of performance measures and appropriate use criteria to accelerate translation of guidelines into practice.2–4 There has been great effort in the creation of registries that can provide feedback reports to providers so that they can improve their quality. There have also been efforts to create new innovations in healthcare delivery, such as decision aids and shared decisionmaking tools,5–14 to support the tailoring of treatment to risk and patient engagement in improving outcomes. Yet despite these efforts, our field has made only modest progress in improving the safety, timeliness, evidence-based nature, efficiency, equity, and patient-centeredness of healthcare.15 I believe that we are, in part, limited by our perspective. Most outcomes researchers are academicians. We view the success of our efforts as our publications and grants. In fact, our job security and promotion are predicated on these successes, as if that is the endgame of our efforts. However, if we view changing and improving healthcare as the real benchmark of success, almost all of us would be found wanting. Consider a prototypical success story—you have created an intervention to improve evidence-based practice. You obtain a grant to prove that the innovation works and you find a significant improvement in the safety and outcomes of care. You publish the results in a prestigious journal and present it as a late-breaking clinical trial at a national meeting. After the congratulations from your colleagues and the media, what happens next? How do you sustain the program at the study sites?16 How do you support the dissemination of the intervention to other sites that were not included in the original grant? How do you further refine and improve the intervention? Although some may argue that you could write The opinions expressed in this article are not necessarily those of the American Heart Association. From the Saint Luke’s Mid America Heart Institute, Cardiovascular Research, University of Missouri - Kansas City. Correspondence to John Spertus, MD, MPH, Saint Luke’s Mid America Heart Institute, Cardiovascular Research, 4401 Wornall Rd, Kansas City, MO 64111. E-mail mailto:[email protected] (Circ Cardiovasc Qual Outcomes. 2015;8:2-3. DOI: 10.1161/CIRCOUTCOMES.114.001641.) © 2015 American Heart Association, Inc. Circ Cardiovasc Qual Outcomes is available at http://circoutcomes.ahajournals.org DOI: 10.1161/CIRCOUTCOMES.114.001641

additional grants to accomplish these goals, I think that this is an impractical, slow, ineffectual, and limited way to innovate in healthcare. Although it may help enhance one’s personal success and promotion, it will not have a meaningful effect on improving the deficiencies in health care that the intervention was developed to accomplish. One strategy that is rarely pursued in most academic circles is to create a commercial company to carry forth the intervention: to improve it, to sustain it, and to disseminate it throughout the US healthcare system. Although there have been calls for academic medical centers to develop companies to improve health care,17 and some institutions have created formal programs to support such entrepreneurship,18 this is rare and has not been embraced by the broader outcomes community, who often view commercialization as an anathema to the academic mission. Although it is true that founding a company can introduce substantial economic biases in one’s commitment to the success of an intervention, there are also philosophical biases to one’s ideas that are present, even if there is no transparent financial gain from widespread acceptance of the innovation. We need to recognize that all investigators have strong commitments to their research and that potential conflicts, financial, or philosophical are inherent in all that we do. How our profession develops checks and balances to insure that only the highest quality work is published and replicated, without presuming ill intent among those who seek to disseminate their work through commercial avenues, is an issue that warrants widespread discussion. In my personal experience, I was frustrated with the variability in health care; variability that was much more strongly associated with physician preferences than with patient benefit. We developed an intervention, ePRISM,19,20 to execute multivariable risk prediction models within the routine flow of clinical care to support the tailoring of treatment to risk. In our own healthcare system,14 and in a 9-center study, the use of ePRISM was associated with improved patient experiences with care, better use of bleeding avoidance strategies according to patients’ risks of bleeding with a 40% to 45% reduction in the odds of bleeding, and lower costs.21 Midway through our grants to test the tool, when I was concerned with how we would sustain and disseminate ePRISM, we formed a company to take over the tool. Our logic, consistent with recent calls for demonstrating the value of research,22 was that if there was real value in the tool, then hospitals would pay for it. Unexpectedly, I have been surprised by the negative reception of this effort to extend and improve our effort by journal reviewers and colleagues.

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Spertus  To me, this highlights the challenges confronting the outcomes research community. If we truly want our work to affect care, then we need to embrace a myriad of tactics, from public policy to entrepreneurship, as strategies to effect change. Limiting our efforts to publications and grants is slow and inefficient and limits our ability to make the changes in health care that drew us to this field in the first place. What we need is a dialogue within the academic outcomes community to debate how best to support healthcare improvement, to learn from each other what works and what does not, and embrace efforts to move our science from the pages of journals into routine clinical care.

Disclosures Dr Spertus has an equity interest in Health Outcomes Sciences.

References 1. Krumholz HM. Outcomes research: generating evidence for best practice and policies. Circulation. 2008;118:309–318. doi: 10.1161/ CIRCULATIONAHA.107.690917. 2. Spertus JA, Bonow RO, Chan P, Diamond GA, Drozda JP Jr, Kaul S, Krumholz HM, Masoudi FA, Normand SL, Peterson ED, Radford MJ, Rumsfeld JS; ACCF/AHA Task Force on Performance Measures. ACCF/ AHA new insights into the methodology of performance measurement: a report of the American College of Cardiology Foundation/American Heart Association Task Force on performance measures. Circulation. 2010;122:2091–2106. doi: 10.1161/CIR.0b013e3181f7d78c. 3. Spertus JA, Eagle KA, Krumholz HM, Mitchell KR, Normand SL; American College of Cardiology; American Heart Association Task Force on Performance Measures. American College of Cardiology and American Heart Association methodology for the selection and creation of performance measures for quantifying the quality of cardiovascular care. Circulation. 2005;111:1703–1712. doi: 10.1161/01. CIR.0000157096.95223.D7. 4. Patel MR, Spertus JA, Brindis RG, Hendel RC, Douglas PS, Peterson ED, Wolk MJ, Allen JM, Raskin IE; American College of Cardiology Foundation. ACCF proposed method for evaluating the appropriateness of cardiovascular imaging. J Am Coll Cardiol. 2005;46:1606–13. 5. Strauss CE, Porten BR, Chavez IJ, Garberich RF, Chambers JW, Baran KW, Poulose AK, Henry TD. Real-time decision support to guide percutaneous coronary intervention bleeding avoidance strategies effectively changes practice patterns. Circ Cardiovasc Qual Outcomes. 2014;7:960– 967. doi: 10.1161/CIRCOUTCOMES.114.001275. 6. Naci H, van Valkenhoef G, Higgins JP, Fleurence R, Ades AE. Evidence-based prescribing: combining network meta-analysis with multicriteria decision analysis to choose among multiple drugs. Circ Cardiovasc Qual Outcomes. 2014;7:787–792. doi: 10.1161/ CIRCOUTCOMES.114.000825. 7. Hess EP, Coylewright M, Frosch DL, Shah ND. Implementation of shared decision making in cardiovascular care: past, present, and future. Circ Cardiovasc Qual Outcomes. 2014;7:797–803. doi: 10.1161/ CIRCOUTCOMES.113.00035.

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8. Coylewright M, Branda M, Inselman JW, Shah N, Hess E, LeBlanc A, Montori VM, Ting HH. Impact of sociodemographic patient characteristics on the efficacy of decision AIDS: a patient-level meta-analysis of 7 randomized trials. Circ Cardiovasc Qual Outcomes. 2014;7:360–367. doi: 10.1161/HCQ.0000000000000006. 9. McIlvennan CK, Allen LA, Nowels C, Brieke A, Cleveland JC, Matlock DD. Decision making for destination therapy left ventricular assist devices: “there was no choice” versus “I thought about it an awful lot”. Circ Cardiovasc Qual Outcomes. 2014;7:374–380. doi: 10.1161/ CIRCOUTCOMES.113.000729. 10. Tisdale JE, Jaynes HA, Kingery JR, Overholser BR, Mourad NA, Trujillo TN, Kovacs RJ. Effectiveness of a clinical decision support system for reducing the risk of QT interval prolongation in hospitalized patients. Circ Cardiovasc Qual Outcomes. 2014;7:381–390. doi: 10.1161/ CIRCOUTCOMES.113.000651. 11. Maddox TM. Promise and peril of clinical decision support: translating medical evidence to the individual patient. Circ Cardiovasc Qual Outcomes. 2013;6:7–8. doi: 10.1161/CIRCOUTCOMES.112.970160. 12. Hess EP, Knoedler MA, Shah ND, Kline JA, Breslin M, Branda ME, Pencille LJ, Asplin BR, Nestler DM, Sadosty AT, Stiell IG, Ting HH, Montori VM. The chest pain choice decision aid: a randomized trial. Circ Cardiovasc Qual Outcomes. 2012;5:251–259. doi: 10.1161/ CIRCOUTCOMES.111.964791. 13. DeBusk RF, Miller NH, Raby L. Technical feasibility of an on line decision support system for acute coronary syndromes. Circ Cardiovasc Qual Outcomes. 2010;3:694–700. doi: 10.1161/ CIRCOUTCOMES.109.931915. 14. Arnold SV, Decker C, Ahmad H, Olabiyi O, Mundluru S, Reid KJ, Soto GE, Gansert S, Spertus JA. Converting the informed consent from a perfunctory process to an evidence-based foundation for patient decision making. Circ Cardiovasc Qual Outcomes. 2008;1:21–28. doi: 10.1161/ CIRCOUTCOMES.108.791863. 15. Institute of Medicine. Crossing the Quality Chasm: A New Health System for the Twenty-first Century. Washington: National Academy Press; 2001. 16. Seow H, Phillips CO, Rich MW, Spertus JA, Krumholz HM, Lynn J. Isolation of health services research from practice and policy: the example of chronic heart failure management. J Am Geriatr Soc. 2006;54:535–540. doi: 10.1111/j.1532-5415.2005.00638.x. 17. Dzau VJ, Yoediono Z, Ellaissi WF, Cho AH. Fostering innovation in medicine and health care: what must academic health centers do? Acad Med. 2013;88:1424–1429. doi: 10.1097/ACM.0b013e3182a32fc2. 18. Niiler E. $150M for stanford bio-X center. Nat Biotechnol. 1999;17:1148. doi: 10.1038/70662. 19. Soto GE, Jones P, Spertus JA. PRISM™: a web-based framework for deploying predictive clinical models. Comput Cardiol. 2004;31:193–196. 20. Soto GE, Spertus JA. EPOCH and ePRISM: a web-based translational framework for bridging outcomes research and clinical practice. Comput Cardiol. 2007;34:205–208. 21. Rao SC, Chhatriwalla AK, Kennedy KF, Decker CJ, Gialde E, Spertus JA, Marso SP. Pre-procedural estimate of individualized bleeding risk impacts physicians’ utilization of bivalirudin during percutaneous coronary intervention. J Am Coll Cardiol. 2013;61:1847–1852. doi: 10.1016/j. jacc.2013.02.017. 22. Krumholz HM. How do we know the value of our research? Circ Cardiovasc Qual Outcomes. 2013;6:371–372. doi: 10.1161/ CIRCOUTCOMES.113.000423.

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Leveraging Entrepreneurship as a Means to Improve the Translation of Outcomes Research to Healthcare Improvement John A. Spertus Circ Cardiovasc Qual Outcomes. 2015;8:2-3 doi: 10.1161/CIRCOUTCOMES.114.001641 Circulation: Cardiovascular Quality and Outcomes is published by the American Heart Association, 7272 Greenville Avenue, Dallas, TX 75231 Copyright © 2015 American Heart Association, Inc. All rights reserved. Print ISSN: 1941-7705. Online ISSN: 1941-7713

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Leveraging entrepreneurship as a means to improve the translation of outcomes research to healthcare improvement.

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