The Importance of Unambiguous Medical Terminology in Patient Care and Research

1. The Importance of Unambiguous Medical Terminology in Patient Care and Research Or, why doctors and healthcare administrators shouldn’t glaze over when informatics is discussed Robert M Califf MD Vice Chancellor for Clinical Research Duke University

2. The Information Situation • 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? • The synthetic terms that tie the raw data into actionable constructs about a person

3. Clinical Terminology • 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 • If billing, patient care and research terminology come together, we can make monumental strides in clinical quality at all levels (patient, practice, system, ? Population)

5. People are dying because we don’t use the same names for the same things!

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

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

9. The Great Baltimore Fire—No Standards!

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. • Wikipedia 2009

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

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

14. 3 2 4 1 DataStandards NIH Roadmap NetworkInformation FDACritical Path Early TranslationalSteps 5 EmpiricalEthics Discovery Science 6 Prioritiesand Processes Measurement andEducation ClinicalTrials Outcomes 12 7 Transparencyto Consumers Inclusiveness 11 8 ClinicalPracticeGuidelines Pay forPerformance PerformanceMeasures Use forFeedbackon Priorities 9 10 Conflict-of-interestManagement Evaluation of Speedand Fluency The Cycle of Quality: Generating Evidence to Inform Policy Califf RM et al, Health Affairs, 2007

15. Ischemic Discomfort Acute Coronary Syndrome Presentation Working Dx ECG ST Elevation No ST Elevation Non-ST ACS Cardiac Biomarker UA NSTEMI Unstable Angina Myocardial Infarction Final Dx NQMI Qw MI 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 # pts Relative Absolute C/E MI: Aspirin 18,773 23% 2.4% +++++ Fibrinolytics 58,000 18% 1.8% ++++ Beta blocker 28,970 13% 1.3% ++++ ACE inhibitor 101,000 6.5% .6% + 2nd prev: Aspirin 54,360 15% 1.2% +++++ Beta blocker 20,312 21% 2.1% ++++ Statins 17,617 23% 2.7% ++++ ACE inhibitor 9,297 17% 1.9% ++++ CHF: ACE inhibitor 7,105 23% 6.1% +++++ Beta blocker 12,385 26% 4% +++++ Spironolactone 1,663 30% 11% +++++

17. Acute Therapies Aspirin Clopidogrel Beta Blocker Heparin (UFH or LMWH) Early Cath GP IIb-IIIa Inhibitor All receiving cath/PCI Discharge Therapies Aspirin Clopidogrel Beta Blocker ACE Inhibitor Statin/Lipid Lowering Smoking Cessation Cardiac Rehabilitation Goals for CRUSADE:Improve Adherence to ACC/AHA Guidelines for Patients with Unstable Angina/Non-STEMI Evaluating the 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%. • All 400 hospital adherence scores then ranked in quartiles — best to worst. Circulation, JACC 2002 — ACC/AHA Guidelines update

18. CRUSADE: Overall Adherence Score Trends Over Time

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

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

21. Treatment of STEMI Patients *Fibrinolysis-eligible pts who rec’d fibrinolysis **Non-transfer pts who rec’d primary PCI since 1994

22. Acute Therapy Trends Beta blockers Any heparin Aspirin STEMI % Adherence NSTEMI

23. Discharge Therapy Trends Beta blockers Lipid-lowering agent Aspirin STEMI % Adherence NSTEMI

24. In-hospital Mortality 1994–2006

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

26. Genome Genome Life Gene

27. 100 – 80 – 60 – 40 – 20 – 0 – Source: Device firms Biotech firms Funding ($ in billions) Pharma firms Private State/local Federal—non-NIH NIH 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 Reproduced from Moses et al., JAMA 2005;294:1333-42

28. Comparative Pre-Approval Capitalized Costs per Approved New Molecule ** 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

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

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

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

32. Life Expectancy Around the World

34. Fundamental Informatics Infrastucture--Matrix Organizational Structure Disease Registries—Granular, Detailed Integrated at “enterprise level” Primary Care Mental Health Cancer Cardiovascular Etc… Health System A ElectronicHealth Records Adaptable to all! Health System B Etc…

35. Cardiac Hospitalizations – Counts & Rates

36. Problem List VocabulariesDr. Kim Wah FungNational Library of Medicine

37. The problem list • 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) • Often the first (if not the only) part of clinical narration in an EMR that uses a controlled vocabulary • Most institutions develop and use their own problem list vocabularies • Often linked to ICD codes for billing or reporting • Some are mapped to SNOMED CT 37

38. Goals of research 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 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 • The set of concepts that often appear in problem list vocabularies and are frequently used • Ways to use this subset • 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 • Existing problem list vocabularies can be mapped to the CORE concepts • Benefits • Reduce variability of problem list vocabularies • Facilitate sharing of problem list data 39

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

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

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 • Government and private • Provider groups • Primary care and specialties • Research regulators • FDA, NIH, CMS, VA, DOD • Pharma, Devices • With international harmonization

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