1. 1 The Importance of Unambiguous Medical Terminology in Patient Care and Research Or, why doctors and healthcare administrators shouldnt glaze over when informatics is discussed Robert M Califf MD Vice Chancellor for Clinical Research Duke University

2. 2 The Information Situation We are increasingly able to assimilate information about the health of people when measurements are made by machines We are increasingly able to assimilate information about the health of people when measurements are made by machines Lab data Images Test results (ECG, PFTs, etc) Genomics, proteomics, metabolomics, etc. What are we missing? What are we missing? The synthetic terms that tie the raw data into actionable constructs about a person

3. 3 Clinical Terminology We have excellent compliance with terms when they are required for billing We have excellent compliance with terms when they are required for billing Unfortunately, these terms for billing are not the same as the preferred terms for clinical quality or research assessment Unfortunately, these terms for billing are not the same as the preferred terms for clinical quality or research assessment If billing, patient care and research terminology come together, we can make monumental strides in clinical quality at all levels (patient, practice, system, ? Population) If billing, patient care and research terminology come together, we can make monumental strides in clinical quality at all levels (patient, practice, system, ? Population)

4. 4

5. 5 People are dying because we dont use the same names for the same things!

6. 6 A Patient 60 yo woman admitted to the ED with chest pain 60 yo woman admitted to the ED with chest pain HR 100, sinus rhythm, BP 100/70, exam unremarkable ECG: sinus rhythm, ST segments abnormal Labs: K 4.2, creatinine 1.5, LDL 130, troponin WNL CXR: no abnormalities apparent in CV, lung, bone or tissue structures

7. 7 Possible Clinical Situations Mild throat tightness relieved with Mylanta Mild throat tightness relieved with Mylanta Ripping pain going down the back Ripping pain going down the back Midsternal chest pain, relieved after 2 nd NTG Midsternal chest pain, relieved after 2 nd NTG Pleuritic chest pain and extreme shortness of breath Pleuritic chest pain and extreme shortness of breath Stabbing pain that lasts a few seconds and then goes away Stabbing pain that lasts a few seconds and then goes away

8. 8 First AHRQ Unstable Angina Guidelines (1994) Eugene Braunwald, Chair Eugene Braunwald, Chair Bob Jones (Duke) coordinating contract Bob Jones (Duke) coordinating contract Largest RCT 650 patients with very few clinical outcome studies Largest RCT 650 patients with very few clinical outcome studies Recommendations largely based on expert opinion Recommendations largely based on expert opinion Then,…. Then,…. The terminology got fixed!

9. The Great Baltimore FireNo Standards!

10. 10 Great Baltimore Fire of 1904 One reason for the fire's duration was the lack of national standards in fire-fighting equipment. Fire crews fire engines came from as far away as Philadelphia and Washington that day (units from New York City were on the way, but were blocked by a train accident; they arrived the next day). The crews brought their own equipment. Most could only watch helplessly when they discovered that their hoses could not fit Baltimore's hydrants. High winds and freezing temperatures added to the difficulty for firefighters and further contributed to the severity of the fire. As a result, the fire burned over 30 hours, destroying 1,545 buildings spanning 70 city blocks amounting to over 140 acres. One reason for the fire's duration was the lack of national standards in fire-fighting equipment. Fire crews fire engines came from as far away as Philadelphia and Washington that day (units from New York City were on the way, but were blocked by a train accident; they arrived the next day). The crews brought their own equipment. Most could only watch helplessly when they discovered that their hoses could not fit Baltimore's hydrants. High winds and freezing temperatures added to the difficulty for firefighters and further contributed to the severity of the fire. As a result, the fire burned over 30 hours, destroying 1,545 buildings spanning 70 city blocks amounting to over 140 acres. standardsfire enginesPhiladelphiaNew York City standardsfire enginesPhiladelphiaNew York City Wikipedia 2009

11. 11 Great Baltimore Fire While Baltimore was criticized for its hydrants, this was a problem that was not unique to Baltimore. During the time of the Great Fire "American cities had more than six hundred different sizes and variations of fire hose couplings." It is known that as outside fire fighters returned to their home cities they gave interviews to newspapers that condemned Baltimore and talked up their own actions during the crisis. In addition, many newspapers were guilty of taking for truth the word of travelers who, in actuality, had only seen the fire as their trains passed through the area. All of this aside the responding agencies and their equipment did prove useful as their hoses only represented a small part of the equipment brought with them. One benefit to this tragedy was the standardization of hydrants nationwide Wikipedia 2009

12. 12 The Learning Health System at All Levels Individual health care transactions Individual health care transactionsProviderConsumer Clinic and health system quality Clinic and health system quality Research Research Early phase New products Comparative effectiveness Population level quality Population level quality

13. 13 UC Project for Global Inequality The Cost of a Long Life U.S.

14. The Cycle of Quality: Generating Evidence to Inform Policy Califf RM et al, Health Affairs, 2007 Measurement and Education Early Translational Steps Clinical Trials Clinical Practice Guidelines Performance Measures Outcomes Discovery Science Data Standards Network Information Empirical Ethics Priorities and Processes InclusivenessInclusiveness Use for Feedback on Priorities Conflict-of-interest Management Evaluation of Speed and Fluency Pay for Performance Transparency to Consumers FDA Critical Path NIH Roadmap 1 2 3 4 5 6 7 8 9 10 11 12

15. NSTEMI Presentation Working Dx ECG Cardiac Biomarker Final Dx NQMIQw MI UA Unstable Angina Ischemic Discomfort Acute Coronary Syndrome Myocardial Infarction ST Elevation No ST Elevation Non-ST ACS Libby P. Circulation 2001;104:365, Hamm CW, Bertrand M, Braunwald E, Lancet 2001; 358:1533-1538; Davies MJ. Heart 2000; 83:361-366. Anderson JL, et al. J Am Coll Cardiol. 2007;50:e1-e157, Figure 1. Reprinted with permission.

16. 6 Medical Therapies Proven to Reduce Death Reduction in deaths: Therapy# ptsRelativeAbsoluteC/E Reduction in deaths: Therapy# ptsRelativeAbsoluteC/E MI: Aspirin18,77323%2.4%+++++ Fibrinolytics58,00018%1.8%++++ Beta blocker28,97013%1.3%++++ ACE inhibitor101,0006.5%.6%+ 2nd prev:Aspirin54,36015%1.2%+++++ Beta blocker20,31221%2.1%++++ Statins17,61723%2.7%++++ ACE inhibitor9,29717%1.9%++++ CHF:ACE inhibitor7,10523%6.1%+++++ Beta blocker 12,38526%4%+++++ Spironolactone1,66330%11%+++++

17. Goals for CRUSADE: Improve Adherence to ACC/AHA Guidelines for Patients with Unstable Angina/Non-STEMI Acute Therapies Aspirin AspirinClopidogrel Beta Blocker Beta Blocker Heparin (UFH or LMWH) Heparin (UFH or LMWH) Early Cath Early Cath GP IIb-IIIa Inhibitor GP IIb-IIIa Inhibitor All receiving cath/PCI Discharge Therapies Aspirin Aspirin Clopidogrel Clopidogrel Beta Blocker Beta Blocker ACE Inhibitor ACE Inhibitor Statin/Lipid Lowering Statin/Lipid Lowering Smoking Cessation Smoking Cessation Cardiac Rehabilitation Cardiac Rehabilitation Circulation, JACC 2002 ACC/AHA Guidelines update Evaluating the Process of Care An adherence score is applied to each patient. incorporating the components of process of care. An adherence score is applied to each patient. incorporating the components of process of care. The score from each patient then combined for all patients at each hospital. Typical scores ranged from 50 to 95%. The score from each patient then combined for all patients at each hospital. Typical scores ranged from 50 to 95%. All 400 hospital adherence scores then ranked in quartiles best to worst. All 400 hospital adherence scores then ranked in quartiles best to worst. Evaluating the Process of Care An adherence score is applied to each patient. incorporating the components of process of care. An adherence score is applied to each patient. incorporating the components of process of care. The score from each patient then combined for all patients at each hospital. Typical scores ranged from 50 to 95%. The score from each patient then combined for all patients at each hospital. Typical scores ranged from 50 to 95%. All 400 hospital adherence scores then ranked in quartiles best to worst. All 400 hospital adherence scores then ranked in quartiles best to worst.

18. CRUSADE: Overall Adherence Score Trends Over Time

19. Peterson et al, ACC 2004 CRUSADE: Link Between Overall ACC/AHA Guidelines Adherence and Mortality Every 10% in guidelines adherence 11% in mortality

20. Impact of Quality Improvement on Outcomes in ACS Trilogy in American Heart Journal January 2009

21. Treatment of STEMI Patients 19902006Fibrinolysis52.5%27.6% Primary PCI 2.6%43.2% D2N time* 59 min 29 min In-hosp mortality 7%6% D2B time** 111 min 79 min *Fibrinolysis-eligible pts who recd fibrinolysis **Non-transfer pts who recd primary PCI since 1994

22. Acute Therapy Trends STEMISTEMI NSTEMINSTEMI % Adherence AspirinAspirin Beta blockers Any heparin

23. STEMISTEMI NSTEMINSTEMI % Adherence AspirinAspirin Beta blockers Lipid-lowering agent Discharge Therapy Trends

24. In-hospital Mortality 1994–2006 19942006 Overall10.4%6.3% STEMI11.5%8.0% NSTEMI7.1%5.2%

25. In 20 Years… All people in developed nations will have All people in developed nations will have An electronic health record Biological samples Digitized images Healthcare will be personalized using an individuals images, samples and clinical data. Healthcare will be personalized using an individuals images, samples and clinical data. The health of a community will be monitored using aggregate records. The health of a community will be monitored using aggregate records.

26. 26GenomeGene Genome Life

27. Reproduced from Moses et al., JAMA 2005;294:1333-42 Device firms Biotech firms Pharma firms Federal non-NIH State/local Source: Private NIH 1994 1995 1996 1997199819992000200120022003 100 – 80 – 60 – 40 – 20 – 0 – Funding ($ in billions)

28. ** All R&D costs (basic research and preclinical development) prior to initiation of clinical testing *** Based on a 5-year shift and prior growth rates for the preclinical and clinical periods DiMasi et al. 2003 Comparative Pre-Approval Capitalized Costs per Approved New Molecule

29. Innovation Gap Getting Wider Burrill & Company Pharma Innovation Gap Pharma Innovation Gap

30. Real Clinical TrialsDone in the Setting of Health Care Delivery 3 sets of data recording 3 sets of data recording Clinical documentation Billing Clinical trials documentation Tremendous cost of training for 3 different vocabularies Tremendous cost of training for 3 different vocabularies Redundant personnel costs of collecting same data in different ways is massive Redundant personnel costs of collecting same data in different ways is massive

31. Clinical Trial Cost Estimates Full Cost Industry Streamlined Industry More Streamlined $ In US 2007 Millions

32. Life Expectancy Around the World

34. Integrated at enterprise level Disease RegistriesGranular, Detailed Primary Care Cancer Mental Health Cardiov ascular Etc… Health System A Health System B Etc… Electronic Health Records Adaptable to all! Fundamental Informatics Infrastucture--Matrix Organizational Structure

35. Cardiac Hospitalizations – Counts & Rates

36. Problem List Vocabularies Dr. Kim Wah Fung National Library of Medicine

37. The problem list u The problem list is a powerful way to organize and communicate clinical data and reasoning - recommended as an essential feature of an electronic medical record (EMR) u Often the first (if not the only) part of clinical narration in an EMR that uses a controlled vocabulary u Most institutions develop and use their own problem list vocabularies l Often linked to ICD codes for billing or reporting l Some are mapped to SNOMED CT 37

38. Goals of research u To study the problem list vocabularies of large health care institutions - size, pattern of use and the extent to which they overlap with (or differ from) each other u To identify a CORE (Clinical Observations Recording and Encoding) set of terms that are of high usage in most problem lists 38

39. The CORE subset u The set of concepts that often appear in problem list vocabularies and are frequently used u Ways to use this subset l As a starter set to build local problem list vocabularies. If subsequent local extensions can be added in a standardized way, the divergence of these vocabularies can be minimized l Existing problem list vocabularies can be mapped to the CORE concepts u Benefits l Reduce variability of problem list vocabularies l Facilitate sharing of problem list data 39

40. Desirable features of the CORE subset u High coverage of usage u Small number of concepts u Linkable to standard terminologies u Supports reasoning u Supports a standard mechanism for adding local extensions 40

41. 41

42. 42 Effective Methods of Getting the Attention of Doctors and Health System Administrators Appeal to humanitarian instinct Appeal to humanitarian instinct Publicity for doing good Publicity for doing good Shame for doing bad Shame for doing bad Distribute $34 Billion! Distribute $34 Billion!

43. 43 It will be shameful is some portion of that $34 billion allocation is not devoted to finalizing a core terminology that is agreed to by all sectors Payors Payors Government and private Provider groups Provider groups Primary care and specialties Research regulators Research regulators FDA, NIH, CMS, VA, DOD Pharma, Devices With international harmonization With international harmonization

44. 44 How do we resolve the Tower of Babel of data from EHRs, PHRs, registries, databases, literature, and clinical trials?