Evidence-Based Medicine for Guiding Better Care

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2 Evidence-Based Medicine for Guiding Better Care Jeffrey Rose, MD Senior Vice President, Clinical Strategy Hearst Health SEPTEMBER 17, 2018

3 The Need for Evidence-Based Practice Wasteful Care 30% of all healthcare delivered in the US is inappropriate or wasteful 1 Unwarranted Variations in Care Only 55% of appropriate healthcare services are delivered to patients 2 Nationwide, there are marked variations in services, costs, effectiveness of care and physician spending without rational explanation, within hospitals and across geographies and venues of care for normalized conditions and procedures 3,4 Harm Caused by Healthcare There are startling levels of harm and more than 70,000 deaths occur each year due to medical errors 4,5,6,7 MODERN EVIDENCE-BASED MEDICINE: The conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients 8 Sources: 1.Berwick DM and Hackbarth AD. Eliminating waste in US health care. JAMA Apr 11;307(14): McGlynn, et al, The Quality of Health Care Delivered to Adults in the United States, N Engl J Med 2003; 348: Tsugawa Y, Jha AK, Newhouse JP, Zaslavsky AM, Jena AB. Variation in Physician Spending and Association with Patient Outcomes. JAMA Intern Med. Published online March 13, Dartmouth Atlas of Healthcare, 5.Building a Safer Health System 2000 Institute of Medicine: To Err Is Human Washington, DC. National Academies Press and 6.James JT. A new, evidence-based estimate of patient harms associated with hospital care. J Patient Saf Sep;9(3): Makary MA, Daniel M. Medical error - the third leading cause of death in the US. British Medical Journal 2016;353:i Sackett DL, Rosenberg WM, Gray JA, et al. Evidence-based Medicine: What It Is and What It Isn t. BMJ Jan 13; 312(7023):

4 Complexities of Medical Evidence Volume and Velocity More than 6 million articles are published every year, and approximately 75 randomized controlled trials and 11 systematic reviews are published every day 1 Even as this mass of information was condensed and consolidated into guidelines, those guidelines themselves, created by hosts of governing groups and specialty medical societies, became overwhelming 2 Quality, Transparency, and Conflicts of Interest Problems include variable methods of guideline gradation and assessment, qualifications and biases of guideline developers, and variable guideline publication based on positivity or negativity of study outcomes and based on funding sources for studies or affiliation rewards of guideline authors 3,4 Competing Recommendations and Evidence Churn A study of articles published in the New England Journal of Medicine over the course of a decade ( ) demonstrated that 17% of the studies testing a new practice showed it was no better or worse than the current practice. 5 Of the studies testing an established practice, 40.2% showed the practice to be no better than what had preceded it. Continued use of widespread practices that are implemented in error because of weak or conflicting evidence may be wasteful and expensive, if not harmful to patients. 5,6 Sources: 1.Bastian H, Glasziou P, Chalmers I. Seventy-Five Trials and Eleven Systematic Reviews a Day: How Will We Ever Keep Up? PLoS Med 2010 Sep 21;7(9): e Allen D, Harkins KJ. Too much guidance? Lancet May 21-27;265(9473) Paul G. Shekelle, MD, PhD Clinical Practice Guidelines, What s Next, August 9, doi: /jama Ioannidis, JP. Evidence-based medicine has been hijacked: a report to David Sackett. J Clin Epidemiol May;73: Prasad V, Vandross A, Toomey C, et al. A Decade of Reversal: An Analysis of 146 Contradicted Medical Practices. Mayo Clin Proc Aug; 88(8): Prasad V, Cifu A, Ioannidis JPA. Reversals of established medical practices: evidence to abandon ship. JAMA. 2012;307(1):

5 Making the Evidence Actionable AGGREGATION AND APPRAISAL EMBEDDING IN THE CLINICAL WORKFLOW Three Principles 1 : Optimal clinical decision making requires awareness of the best available evidence Evidence-based medicine evaluates the totality of evidence and provides guidance to decide whether evidence is more or less trustworthy, based on systematic summaries Evidence alone is never sufficient to make a clinical decision: it is a complement to clinical judgment Research has demonstrated that guideline programs, order sets, protocols, and other clinical decision support formats can help to improve safety, efficiency, and clinical outcomes when adherence is achieved. 2,3,4,5,6 Unfortunately, studies show that guideline adherence by clinicians ranges only from 50% to 67%. 7,8,9 Similar lukewarm results have been observed with evidence-based clinical decision support efforts, which seems to indicate that influencing clinical and industrial behavior remains problematic. 10,11 Sources: 1.Guyatt, G, et al. Users Guides to the Medical Literature: A Manual for Evidence-Based Clinical Practice 3rd Ed. JAMA. 2.Bobb AM, Payne TH, Gross PA. Viewpoint: Controversies surrounding use of order sets for clinical decision support in computerized provider order entry. J Am Med Inform Assoc Jan-Feb;14(1): Ozdas A, Speroff T, Waitman LR, et al. Integrating 'best of care' protocols into clinicians' workflow via care provider order entry: impact on quality-of-care indicators for acute myocardial infarction. J Am Med Inform Assoc March;13(2): Santolin CJ, Boyer LS. Change of care for patients with acute myocardial infarctions through algorithm and standardized physician order sets. Crit Pathw Cardiol June;3(2): Kawamoto K, Houlihan CA, Balas EA, et al. Improving clinical practice using clinical decision support systems: a systematic review of trials to identify features critical to success. BMJ 2005 Apr 2;330(7494): Fonarow GC, Abraham WT, Albert NM, et al. Influence of a performance-improvement initiative on quality of care for patients hospitalized with heart failure: results of the Organized Program to Initiate Lifesaving Treatment in Hospitalized Patients With Heart Failure (OPTIMIZE-HF). Arch Intern Med 2007;167: Burstin HR, Conn A, Setnik G, et al. Benchmarking and quality improvement: the Harvard emergency department quality study. Am J Med 1999 Nov;107(5): Grol R. Successes and failures in the implementation of evidence-based guidelines for clinical practice. Med Care 2001 Aug;39(8 Suppl 2):II Grilli R and Lomas J. Evaluating the message: the relationship between compliance rate and the subject of a practice guideline. Med Care 1994 Mar;32(3): Osheroff JA, Teich JM, Levick D, et al. Improving outcomes with clinical decision support: an implementer's guide (Kindle Locations 19-21). Chapter 1, Evidence Base for CDS Value, HIMSS. Kindle Edition. 11.Tierney WM. Controlling costs with computer-based decision support: an ax, a scalpel, or an illusion? JAMA Intern Med 2013 May 27;173(10):

6 OUR NETWORK OUR REACH 1 OUR MISSION 85% of discharged patients 205 Million insured individuals 70 Million home health visits 3.2 Billion dispensed prescriptions To guide the most important care moments by delivering vital information into the hands of everyone who touches a person s health journey 38 YEARS in the health information industry PIONEERS of new and leading solutions INDEPENDENT unbiased, evidence-based 6 1 Annually in the United States

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9 Becoming the Best: Recent Developments in Evidence-Based Medicine Mitch DeKoven, MHSA Senior Principal Health Economics/ Outcomes Research IQVIA September 17, 2018 Copyright 2017 IQVIA. All rights reserved.

10 A better world More effective health delivery Focus on value and outcomes Improved health 10

11 Bigger picture, bigger data, more precise insights and outcomes Imagine if every healthcare decision was the right decision for you Breadth of insights VS. Volume and diversity of needed data Diagnosis & Treatment Plan Diagnosis & Treatment Plan 11

12 The main sources of data relevant to health are everywhere 12

13 The promise of big data is exciting Increasing potential to have more data Proven value of using it Additional growth of companies applying data-driven decision making compared to competitors* 5 % 6 % Productivit y Profitabilit y *Source: Harvard Business Review (2012) 13

14 The promise of big data is exciting (cont d) Clinical trials are designed around the patient Predictive analytics prevent medical errors Treatment costs reflect the value they bring Precision medicines find their way to the right patient Every medical decision is informed by evidence 14

15 Payers and Regulators see the value of Real-World Evidence Scott Gottlieb, MD, FDA Commissioner FDA The more widespread use of RWE can make our medical product development process more efficient. This will ultimately help us achieve better outcomes, and safer and more efficient use of expensive technology. EMA EMA needs RWE to support adaptive approval pathways Number of Patients Intensive monitoring of patients Additional indication(s) Intensive monitoring of patients Initial Approval of niche indication FULL APPROVAL Time 15

16 Using RWE for more sophisticated site selection CASE STUDY Better execution SITE A SITE B Two sites look the same Total Crohn s Patients IQVIA can see actual available patients Eligible Crohn s Patients Faster recruitment by understanding treatment patterns Reduces costs by selecting better sites and reducing non-recruiting sites 16

17 Finding patients in rare disease CASE STUDY Rare Diseases Making diagnosis possible Diagnosis rates for high-risk patients* 0.01 % 5.20 % Machine learning: 100+ medical and demographic predictors of 100M patients Physician and patient data: Identifying doctors with high-risk patients to increase diagnosis New tools: Increase screening, diagnosis Without the model With the model *Group defined as top 5% of undiagnosed rare disease patients 17

18 Evidence hubs in NFL CASE STUDY Evidence infrastructure DATA COLLECTION Novel application of registry technology Electronic medical record system Focus on customized medical staff training ANALYSIS AND INSIGHTS Incidence and trends in injury occurrence Injury prevention analyses REPORTS Specialty reports Published findings Updates to league 18

19 Multiple Sclerosis Collect and link existing MRI and clinical data in the real world CASE STUDY Evidence platforms MS patients under routine clinical management Network of public & private neurology practices Quantitative MRI data Whole/regional atrophy T1, T2, Gd lesion activity & volume Structured EMR data Comorbidities Treatment patterns Clinical assessments (EDSS, relapse, symptoms) Data anonymised, extracted, linked, and harmonized across sources Structured MRI+EMR Real World Dataset Generation of novel observational research studies in MS 19

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21 Generating Robust Evidence to Support Innovation

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24 What is StrataGraft? Multli-layer skin substitute in development for the treatment of severe burns Fully developed, multi-layered epidermis Dermal fibroblasts in collagen-rich matrix Creates physical barrier Cryopreserved to maintain viability and biological activity Off-the-shelf availability; being studied as an option to reduce the need for autologous skin graft harvesting Shelf life enables on-site or on-demand availability 24

25 StrataGraft s clinical trials builds on evidence-based approach to severe burn care Substantial evidence supports early excision and grafting as best approach, but adoption is not universal 25

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