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Physician Choice : Variation in practice, clinical judgment, and

Physician Choice : Variation in practice, clinical judgment, and The rise of evidence-based medicine William A. Norcross, M.D . Jan Mulligan, J.D. David E. J. Bazzo, M.D. Ed. 5/13 /13 American Law Center . California Business & Professions Code 725. (a ) :.

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Physician Choice : Variation in practice, clinical judgment, and

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  1. Physician Choice: Variation in practice, clinical judgment, and The rise of evidence-based medicineWilliam A. Norcross, M.D. Jan Mulligan, J.D.David E. J. Bazzo, M.D. Ed. 5/13/13 American Law Center

  2. California Business & Professions Code 725. (a) : Repeated acts of clearly excessive…furnishing …of drugs or treatment…clearly excessive use of diagnostic procedures, as determined by the standard of the community of licensees is unprofessional conduct for a physician and surgeon….

  3. What is “clearly excessive”? How Much is Too Much???

  4. “The Standard of Care” : Perfection not required. Physician liable only if he/she fails to use the skill, knowledge or care that a reasonably careful physician would have used in similar circumstances.

  5. Theoretically….Should the Standard of Care Be the Same Everywhere in U.S.?…In the World?

  6. The U.S. Practice of Medicine • U.S. medical schools are all accredited by the same criteria(AAMC) • U.S. hospitals are all accredited by the same criteria(TJC) • U.S. post-graduate residency training programs are all accredited by the same criteria(ACGME)

  7. Yet, Does Wide Variation Happen?

  8. “The Dartmouth Group”- Study :Variation in Treatment • Compared treatment of hospitalized patients nationwide between 1993 and 1995 for three conditions: acute myocardial infarction, hip fracture, and colorectal cancer • Enormous, geographical differences in spending for each condition • Billing difference between the top and the bottom was 60%, enough to erase the U.S. national debt • No difference in clinical outcomes • Preventive care better in lowest spending group! Fisher ES, et al. The implications of regional variations in Medicare spending: Part 1: The content, quality, and accessibility of care. Ann Intern Med 2003; 138: 273.

  9. Study of 164 patients under the care of 11 primary care physicians in same city. • Range of revisits doctor ordered: 1 week to 1 year • Almost all the variance was attributed to physician whim; • The patients and their conditions were remarkably uniform. • Schwartz LM, et al. Setting the re-visit interval in primary care. • J Gen Intern Med 1999; 14: 230.

  10. Study: Variation in Treatment of Urinary Tract Infections (UTI) • Survey of 8942 primary care and OB physicians • All patients were 30 year-old non-pregnant healthy women with uncomplicated UTI • Wide variation in diagnostic tests and therapeutic treatment (and huge difference incosts) Wigton RS, et al. Variation by specialty in the treatment of urinary tract infection in women. J Gen Intern Med 1999; 14: 491.

  11. Study: Variation in TreatmentManagement of melanoma in situ cancer • 597 questions given to 1200 dermatologists • “Considerable variability exists”in response • No consensus on appropriate surgical margins or depth of excision to remove cancer Charles CA, et al. Variation in the diagnosis, treatment, and management of melanoma in situ. Arch Dermatol 2005; 141: 723

  12. Study: Variation in Treatment of Atrial Fibrillation • Cross-sectional survey of medical records of 1068 study patients (88.3% with atrial fibrillation and 11.7% with atrial flutter) • “High degree of variation in management approaches….” • Individual hospital site, patient age, previous associated heart failure were independent predictors for the use of treatment. StiellIG, et al. Variation in management of recent-onset atrial fibrillation and flutter among academic hospital emergency departments. Ann Emerg Med 2011; 57: 13.

  13. Is This Variance Just in U.S.?

  14. Study: Variation in Cell Transplant • International survey of 526 bone marrow transplant physicians assessing management of several clinical scenarios • Found wide variation in practice within each country • “Local preferences or biases likely result in similar patients being offered different transplant and treatment procedures” • Lee SJ, et al. Individual physician practice variation in hematopoietic cell transplantation. J ClinOncol 2008; 26: 2162.

  15. Wide Variation Happens. Why?

  16. Differences Found Due to…. • Patients vary • Clinical situations vary • Local / Regional culture • Apprenticeship nature of medical training • Narcissism/Ego of doctor • Inadequate education • Financial motivation(both too much and too little) • Fear, defensive medicine

  17. Attempts at Transparencyand Greater Uniformity • Sunshine Act • requires manufacturers of drugs and medical devices to disclose payments and items of value given to physicians and teaching hospitals. • Hospital Report Cards • Physician Report Cards • Best practices (Evidenced-Based Medicine)

  18. “Evidence-based medicine is the use of best current evidence from research in the management of individual patients.” Sackett DL, Richardson WS, Rosenberg W, et al. Evidence-based medicine: how to practice and teach EBM. Edinburgh: Churchill Livingstone, 1997.

  19. How is Evidence-Based Medicine Different From How Doctors Usually Make Decisions?

  20. Traditional Medical Decision-Making • Diagnostic Reasoning: • Gather information from patients, medical records, imaging studies, results of laboratory tests, and other health care providers • Form an impression • Based on knowledge, experience (both years and condition), asking further questions (to further discriminate) 1. Bowen, J, “Educational Strategies to Promote Clinical Diagnostic Reasoning”. NEngl J Med 355;21. Nov 2006. 2. http://www.npr.org/2011/09/21/140438982/becoming-mindful-of-medical-decision-making

  21. Problem: Doctors take shortcuts • Mental abstraction or “problem representation” • Defining the case in a one-sentence summary

  22. “Heuristics” = Short cuts Begin to develop thoughts about cases before finish gathering all data Normal Human Response to Make First Impression and Not Keep Mind Open

  23. Metacognition= Think about how we are thinking • Is our logic consistent • What could we be missing • Are we subject to a bias error

  24. “Achieving Quality in Clinical Decision Making: Cognitive Strategies and Detection of Bias.” Croskerry, Pat. AcadEmerg Med. 2002 Nov;9(11):1184-204.

  25. Contributing Causes of Errors :Individual Problems • Education Issue (Lack of knowledge) • Judgment issue (Adequate knowledge BUT incorrect judgment) • Strong but Wrong Rule (Rule usually works but wasn’t appropriate for this individual patient) • Bad Rule (Generally held beliefs not supported by the evidence) • Confirmation Bias: Over-reliance on data (e.g. Lab results) that supports a tentative diagnosis but ignoring data that refutes diagnosis • Overconfidence Bias: Over-reliance on the opinions of another doctor that came before

  26. Contributing Causes of Individual Error: • What’s Common is Common Bias: This patient has whatever is commonly seen. • Unified Theory Bias: The tendency to decide that the patient’s current problem is related to the first thing diagnosed rather than more than one issue (e.g. chest pain can be due to both problem with digestion and heart condition) • Commission Bias: The tendency to need to do something more (e.g. patient having a complication from an angiogram when test wasn’t needed). • Hassle Bias: The tendency to take a course of action that is easiest.

  27. Contributing Causes of Errors: • Technical Error • Error related to performance of a procedure • System Issue • Supervision (inadequate supervision of medical student, intern or resident) • Workload (too much responsibility for one person) • Policy (particular policy or guidelines contributed to error) • Support (inadequate system support to prevent error)

  28. What Kind of Individual Errors Were Made By Libby Zion’s Doctors ???? • Why?? • What Kind of Systems Errors? • Why?

  29. What Could Doctors Have Done Different to Save Libby Zion?

  30. One Potential Solution: Shared Decision-Making Involving patient input in medical decisions * • Benefits of involving patients in decisions : When used, patients reported: • Improved knowledge of their options • Held more accurate expectations of harms and benefits • Reached choices consistent with their personal values. • But doctors often take a paternalistic approach to care, simply making the decision they think is best. • * 2011 Cochrane review, 86 studies examined patients who used decision aids (pamphlets, videos or Web-based tools) to help them make medical decisions

  31. Would Shared Decision Making Have Saved Libby?

  32. Informed Consent Requires All: • Discuss clinical issues or nature of decision • Discuss alternatives • Discuss pros and cons • Discuss uncertainties associated with a decision • Assess patient understanding • Explore patient preferences

  33. Informed Consent Rarely Informed: • 15% of visits included none of the 6 elements. • 51% included one 1 element • 24% included 2 elements • 6% included 3 elements • 2% included 4 elements • 1% included 5 elements • 0% included all 6 elements • Braddock and Levinson, 1999

  34. Haynes RB, Devereaux PJ, Guyatt GH. Clinical expertise in the era of evidence-based medicine and patient choice. ACP Journal Club 2002; 7: 36-38.

  35. Medical Evidence: Its Meanings and Uses in Health Care Law…. /

  36. Types of Evidence Medical Experts May Rely Upon: • Experience-Based Medicine = Standards of Care • Evidence-Based Medicine = Research Based Medicine • Clinical Practice Guidelines

  37. “Hierarchy of Evidence”

  38. Experienced-Based Medicine Traditional Medicine Based on Individual Clinical Experience and Clinical Practice Based on Custom and Consensus. Standard of Care* : “A medical provider is negligent if he/she fails to use the level of skill, knowledge, and care in diagnosis and treatment that other reasonably careful medical providers would use in similar circumstances. *CACI 502

  39. Risk of Experience-Based Medicine By itself, it risks becoming rapidly out of date. Some of it may be without scientific basis, and may be inexact or flat out wrong. Yet…this is the type of evidence that is traditionally used for standard of care!

  40. “Evidence-Based Medicine” “Conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients.” • David L. Sackett et al., Evidence-Based Medicine : what It Is and What It Isn’t, 312 Brit. Med. J. 71,71 (1996)

  41. Evidence-Based Medicine Relies on Best Available External Clinical Evidence From Systematic Research. Sometimes called “research-based medicine”.

  42. Evidence-Based Medicine often invalidates previously accepted tests and treatment and seeks to replace them with new ones that are allegedly more powerful, more accurate, more efficacious and safe.

  43. Increasingly common pressure on physicians from to reduce variation in diagnosis and treatment of patients .

  44. Evidence-Based Medicine seeks to shift the focus of decision making from the traditional practice of experienced based medicine to a more stringent review and application of high-grade scientific evidence gathered from clinical trials and studies. • John M. Eisenberg, What Does Evidence Mean? Can Law and Medicine be Reconciled? 26 J. Health Pol., Policy & Law 369, 370 (2011)

  45. Risks of Evidence-Based Medicine Risk of discounting or ignoring individual patient history, clinical examination and/or personal clinical expertise. Without clinical experience, risk of too much reliance on “external evidence” whichmay not be applicable to an individual patient.

  46. Optimal Goal of Evidence-Based Medicine Evidence-Based Medicine should integrate best research evidence with clinical expertise and patient values, with an emphasis on current best evidence. Clinical Expertise in the Era of Evidence-Based Medicine Patient Choice/ Haynes, Devereaux, Guyatt, Evid Based Med (2002) 7:36-38

  47. Haynes RB, Devereaux PJ, Guyatt GH. Clinical expertise in the era of evidence-based medicine and patient choice. ACP Journal Club 2002; 7: 36-38.

  48. Use of Evidence-Based Medicine in Courtroom….

  49. California Evidence Code 721(b) : An expert may not be cross-examined on any scientific, technical, or professional text, treatise, journal unlessoneof the following occurs: (1) The witness referred to, considered, or relied upon such publication in arriving at or forming his or her opinion. (2) The publication has been admitted in evidence. (3) The publication has been established as a reliable authority by the testimony or admission of the witness or by other expert testimony or by judicial notice. If admitted, relevant portions of the publication may be read into evidence but may not be received as exhibits.

  50. What Does Evidence-Based Medicine Mean in Judicial Decision Making ? Standardsare practices that are medically necessary services that any practitioner under any circumstance would be required to perform. Evidence-based medicine ismeant to be tailored to meet individual circumstances; Standards are meant to be inflexible and should always be followed, not tailored. Evidence: Its Meanings in Health Care and in Law (2000)Havighurst, et. al., Institute of Medicine http://www.ahrq.gov/clinic/jhppl/havighurst1.htm

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