Information Ethics and Clinical Decision Making


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Information Ethics and Clinical Decision Making

  1. 1. TMHG 529 Information Ethics and  Clinical Decision Making Nawanan Theera-Ampornpunt, M.D., Ph.D.Faculty of Medicine Ramathibodi Hospital, Mahidol University April 22, 2013
  2. 2. Outline• Course Introduction• Introduction to Ethics & Bioethics• Ethical Issues in Health Informatics• Information Ethics & Clinical Decision Making• Case Studies 2
  3. 3. Course Introduction 3
  4. 4. Course Introduction• TMHG 529 Legal and Ethical Issues in Health Informatics (1 credit)• Topics  Information ethics and clinical decision making  Health information privacy and security  Legal aspects in health informatics  Medico-legal aspects in health informatics  Case Studies• Grading  Class Attendance (30%) & Class Participation (70%) 4
  5. 5. Introduction to Ethics & Bioethics 5
  6. 6. Introduction to Ethics & Bioethics • Ethics  a set of moral principles: a theory or system of moral values  the principles of conduct governing an individual or a group  the discipline dealing with what is good and bad and with moral duty and obligation • Moral  of or relating to principles of right and wrong in behavior  conforming to a standard of right behavior • Norm  A principle of right action binding upon the members of a group and serving to guide, control, or regulate proper and acceptable behaviorSource: Merriam‐Webster Dictionary 6
  7. 7. Standard of Acceptable Behaviors in Society Society’s Standard ? Option 1 Option 2 7
  8. 8. Law as Standard of Acceptable Behaviors Law ? Option 1 Option 2 8
  9. 9. Professional Code of Conduct as Standard  of Acceptable Behaviors Professional Code of Conduct ? Option 1 Option 2 9
  10. 10. Ethics as Standard of Acceptable Behaviors Ethics ? Option 1 Option 2 10
  11. 11. Reality Law Professional Code of Conduct? Option 1 Ethics Option 2 11
  12. 12. Reconciling Conflicts• Law  Is explicit but...  Often requires interpretation  Slow to create; outdated; sometimes not keep up with technologies or social changes  Conflicting laws• Professional Code of Conduct  Often explicit, but similar issues with law  Only focuses on narrow & traditional professional practice 12
  13. 13. Reconciling Conflicts• Ethics  Implicit  Requires interpretation, making arguments and debates  Is often the basis when law is created  Helpful in cases where law & code of conduct don’t cover or are conflicting 13
  14. 14. Branches of Ethics • Descriptive ethics  What do people think is right? • Normative ethics  How should people act? (prescriptive) • Applied ethics  How do we take moral knowledge and put it into practice? • Meta-ethics  What does “right” even mean?Source: 14
  15. 15. Sample Areas in Applied Ethics • Business ethics • Bioethics  Study of typically controversial ethics brought about by advances in biology and medicine • Decision ethics • Professional ethics  Computer ethics  Journalism ethics and standards  Research ethics  Legal ethics  Marketing ethics  Medical ethics  Nursing ethicsSource: 15
  16. 16. Some Terms in Ethics • Ethical Issue • Ethical Dilemma  A complex situation that often involves an apparent mental conflict between moral imperatives, in which to obey one would result in transgressing another. • Ethical Principle  a standard of conduct defining the kind of behavior an ethical person should and should not engage in. (Josephson, 2010)  Provides a guide to making decisions & establish criteria by which decisions will be judged by others. (Josephson, 2010)Source:‐ethical‐principles‐for‐business‐executives/ 16
  17. 17. Historic Cases in Bioethics• Real cases of unethical or controversial professional practice or research practice• Raised important ethical issues• Led to development of important ethical principles in use today 17
  18. 18. Nazi Human Experimentation & MurderSource:‐I.html#I‐6_MedExp 18
  19. 19. Nazi Human Experimentation & Murder • Doctors’ Trial at Nuremberg, Germany • Gave rise to the Nuremberg Code, a set of research ethics principles for human subject researchSource: 19
  20. 20. Points from The Nuremberg Code (1) • Voluntary consent of human subject is absolutely essential • Experiment should be to yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature • Should be based on animal study & knowledge of natural history of disease • Avoid all unnecessary physical & mental suffering & injurySource: 20
  21. 21. Points from The Nuremberg Code (2) • Avoid study where it’s believed death or disabling injury will occur • Risk should not exceed importance of study problem • Proper preparations to protect subjects against risks • Study conducted by qualified scientists • Subjects can decide to terminate participation • Researcher in charge must be prepared to terminate study if continuing is believed to likely to result in injury or deathSource: 21
  22. 22. Beecher’s Article • Originally published in 1966 • Described 22 examples of research studies with controversial ethics conducted by reputable researchers and published in major journals. • “...unethical or questionably ethical procedures are not uncommon” (Beecher, 1966) • Full text reprinted in Bull World Health Organ. 2001;79(4):367-72 & available at 401/pdf/11368058.pdfSource: Beecher HK. Ethics and clinical research. N Engl J Med. 1966 Jun 16;274(24):1354‐60. 22
  23. 23. Common Ethical Problems in Research • Lack of informed consent • Coercion or undue pressure on volunteers (or on a parent to volunteer his/her child) • Use of a vulnerable population • Exploitation of a vulnerable population • Withholding information • Withholding available treatment • Withholding information about risks • Putting subjects at risk • Risks to subjects outweigh benefits • Deception • Violation of rightsSource: Bankert E, Cooper JA. History and ethical principles. Collaborative Institutional Training Initiative. 23
  24. 24. Tea Room Trade Study • Investigated homosexual practices in public restrooms. The researcher went undercover and acted as a “look out” to directly observe men engaging in sexual acts. • He then identified 100 subjects by tracing their car license numbers. • A year later, he distributed a “social health survey” throughout the communities where the subjects lived.Source: Bankert E, Cooper JA. History and ethical principles. Collaborative Institutional Training Initiative. 24
  25. 25. Tea Room Trade Study • Ethical Issues  Informed consent  Deception  Use of a vulnerable populationSource: Bankert E, Cooper JA. History and ethical principles. Collaborative Institutional Training Initiative. 25
  26. 26. Milgram Study • Group Exercise #1Source: 26
  27. 27. Stanford Prison Experiment • In 1971 Philip Zimbardo, a psychology professor at Stanford University conducted a study of psychological effects of becoming a prisoner or prison guard.Source: 27
  28. 28. Stanford Prison Experiment • 24 male students randomly assigned to roles of prisoners and guards in a mock prison in a basement at Stanford which continued for several daysSource: 28
  29. 29. Stanford Prison Experiment • Participants adapted to their roles beyond researcher’s expectations • Guards enforced authoritarian measures, became psychologically abusive & harassed prisoners • Some prisoners joined the guards in the abuse • Study stopped after 6 days (before 2-week intended period) when ethical issues were raisedSource: 29
  30. 30. Stanford Prison Experiment • Ethical Issues  Risks in terms of psychological harms present that should be anticipated and permitted to continue for some timeSource: 30
  31. 31. Tuskegee Study (1932‐1972) • Designed to document natural history of syphilis in African- American men • There was no known treatment for syphilis at the time • Hundreds of men with and without syphilis were enrolled but they were misinformed about the need for some of the procedures. • Some procedures were told as necessary and free treatmentSource: Bankert E, Cooper JA. History and ethical principles. Collaborative Institutional Training Initiative. 31
  32. 32. Tuskegee Study (1932‐1972) • After penicillin was found to be safe & effective treatment for syphilis in 1940s, they were not given penicillin. • The study continued to track the men until 1972 when the public became aware of study • 28 deaths, 100 cases of disabilities, and 19 cases of congenital syphilisSource: Bankert E, Cooper JA. History and ethical principles. Collaborative Institutional Training Initiative. 32
  33. 33. Tuskegee Study (1932‐1972) • Ethical issues  Lack of informed consent  Deception  Withholding information  Withholding available treatment, putting subjects & families at risk  Exploitation of a vulnerable group of subjects who would not benefit from participation (black men)Source: Bankert E, Cooper JA. History and ethical principles. Collaborative Institutional Training Initiative. 33
  34. 34. The Belmont Report • A report by the U.S. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research to address ethical issues in the Tuskegee Study • Identifies 3 basic ethical principles for all human subject research called “Belmont Principles”Source: E, Cooper JA. History and ethical principles. Collaborative Institutional Training Initiative. 34
  35. 35. Belmont Principles • Respect for Persons (or Autonomy) • Beneficence • JusticeSource: E, Cooper JA. History and ethical principles. Collaborative Institutional Training Initiative. 35
  36. 36. Belmont Principles • Respect for Persons (or Autonomy)  Treat individuals as autonomous human beings. People must be allowed to choose for themselves  We must also provide extra protection to those with limited autonomy  Autonomy includes mental capacity (ability to understand and process information) and voluntariness (freedom from control, coercion, or influence of others)Source: E, Cooper JA. History and ethical principles. Collaborative Institutional Training Initiative. 36
  37. 37. Belmont Principles • Beneficence  Minimize harms and maximize benefits within constraints of sound research design  Avoid research without a favorable risk- benefit ratioSource: E, Cooper JA. History and ethical principles. Collaborative Institutional Training Initiative. 37
  38. 38. Belmont Principles • Justice  Treat people fairly and design studies so that burdens and benefits are shared equitably  Select subjects equitably  Avoid exploitation of vulnerable populations or “populations of convenience”Source: E, Cooper JA. History and ethical principles. Collaborative Institutional Training Initiative. 38
  39. 39. An Additional Ethical Principle • Non-maleficence • Primum non nocere • “First, do no harm.” • Included in the Hippocratic Oath “...Whatever houses I may visit, I will come for the benefit of the sick...”Source: E, Cooper JA. History and ethical principles. Collaborative Institutional Training Initiative. 39
  40. 40. Ethical Issues in Health  Informatics 40
  41. 41. Why Important in Informatics?  Research ethics  Leads to patient outcomes, including deaths  Provider-patient relationship threatened by IT?  “Rationing” of health care through CDSS  Information risks  Informatics practitioners as “professionals” with specific skills, training, & competencies?  Most common question “Who owns the data?”Source: Goodman & Miller. Chapter 10: Ethics and Health Informatics: Users, Standards, and Outcomes. In Shortliffe (3rd Edition). 41
  42. 42. ELSI• ELSI - Ethical, Legal, and Social Issues• These three aspects are often interrelated• ELSI in Informatics  AMIA ELSI-WG  Professional Code of Conduct AMIA: IMIA: 42
  43. 43. IMIA General Ethical Principles in Informatics • Information Privacy & Disposition • Openness • Security • Access • Legitimate Infringement • Least Intrusive Alternative • AccountabilitySource: http://www.imia‐ 43
  44. 44. Some ELSI References Shortliffe 3rd Edition (2006)Chapter 10 by Goodman KW &  Anderson JG & Goodman KW (2002) Miller RA• Anderson JG. The role of ethics in information technology decisions: a case- based approach to biomedical informatics education. Int J Med Inform. 2004 Mar 18;73(2):145-50. 44
  45. 45. Information Ethics & Clinical Decision Making 45
  46. 46. A Model of Clinical Decision Making PATIENT Perception CLINICIAN Attention Long Term Memory External Memory Working Memory Knowledge Data Knowledge Data Inference DECISIONSource: Elson RB, Faughnan JG, Connelly DP. An industrial process view of information delivery to support clinical decision making: implications for system design and process measures. J Am Med Inform Assoc. 1997 Jul‐Aug;4(4):266‐78. 46
  47. 47. Clinical Decision Support Systems (CDSSs)• The real place where most of the values of health IT can be achieved• A variety of forms and nature of CDSSs  Expert systems • Based on artificial intelligence, machine learning, rules, or statistics • Examples: differential diagnoses, treatment options 47
  48. 48. Clinical Decision Support Systems (CDSSs)• A variety of forms and nature of CDSSs  Alerts & reminders • Based on specified logical conditions • Examples: drug-allergy checks, drug-drug interaction checks, drug-lab interaction checks, drug-formulary checks, reminders for preventive services or certain actions (e.g. smoking cessation), clinical practice guideline integration  Evidence-based knowledge sources e.g. drug database, literature  Simple UI designed to help clinical decision making 48
  49. 49. Example of “Alerts & Reminders” 49
  50. 50. Clinical Decision Support Systems (CDSSs)Issues• CDSS as a supplement or replacement of clinicians?  The demise of the “Greek Oracle” model (Miller & Masarie, 1990) The “Greek Oracle” Model The “Fundamental Theorem” Friedman CP. A ʺfundamental theoremʺ of biomedical informatics. J Am Med  Inform Assoc. 2009 Apr;16(2):169‐170. 50
  51. 51. Clinical Decision Support Systems (CDSSs)Issues• Alert sensitivity & alert fatigue 51
  52. 52. Workarounds 52
  53. 53. Workarounds (Zoomed In) 53
  54. 54. Unintended Consequences of Health IT• “Unanticipated and unwanted effect of health IT implementation” (• Must-read resources   Ash JS, Berg M, Coiera E. Some unintended consequences of information technology in health care: the nature of patient care information system-related errors. J Am Med Inform Assoc. 2004 Mar- Apr;11(2):104-12.  Campbell, EM, Sittig DF, Ash JS, et al. Types of Unintended Consequences Related to Computerized Provider Order Entry. J Am Med Inform Assoc. 2006 Sep-Oct; 13(5): 547-556.  Koppel R, Metlay JP, Cohen A, Abaluck B, Localio AR, Kimmel SE, Strom BL. Role of computerized physician order entry systems in facilitating medication errors. JAMA. 2005 Mar 9;293(10):1197-203. 54
  55. 55. Unintended Consequences of Health ITAsh et al. (2004) 55
  56. 56. Unintended Consequences of Health IT • Errors in the process of entering and retrieving information  A human-computer interface that is not suitable for a highly interruptive use context  Causing cognitive overload by overemphasizing structured and “complete” information entry or retrieval • Structure • Fragmentation • OvercompletenessAsh et al. (2004) 56
  57. 57. Unintended Consequences of Health IT • Errors in the communication and coordination process  Misrepresenting collective, interactive work as a linear, clearcut, and predictable workflow • Inflexibility • Urgency • Workarounds • Transfers of patients  Misrepresenting communication as information transfer • Loss of communication • Loss of feedback • Decision support overload • Catching errorsAsh et al. (2004) 57
  58. 58. Unintended Consequences of Health ITCampbell et al. (2006) 58
  59. 59. Unintended Consequences of Health ITCampbell et al. (2006) 59
  60. 60. Unintended Consequences of Health ITKoppel et al. (2005) 60
  61. 61. Unintended Consequences of Health ITKoppel et al. (2005) 61
  62. 62. Appropriate Use of Health IT Standard view  With uncertainties around new technology, “scientific evidence counsels caution and prudence.”  Evidence & reason determine appropriate level of caution  If such systems improve care at acceptable cost in time & money, there’s an obligation to use it  Follows evolving evidence and standards of careGoodman & Miller. Chapter 10: Ethics and Health Informatics: Users, Standards, and Outcomes. In Shortliffe (3rd Edition). 62
  63. 63. Appropriate Use of Health IT Standard view  For computer-assisted clinical diagnosis CDS, human cognitive processes are more suited to complex task of diagnosis than machine, and should not be overridden or trumped by computers.  When adequate CDS tools are developed, they should be viewed and used as supplementary and subservient to human clinical judgmentGoodman & Miller. Chapter 10: Ethics and Health Informatics: Users, Standards, and Outcomes. In Shortliffe (3rd Edition). 63
  64. 64. Fundamental Theorem of Informatics (Friedman, 2009) 64
  65. 65. Appropriate Use of Health IT Standard view  Practitioners have obligation to use tools responsibly, through adequate training & understanding the system’s abilities & limitations  Practitioners must not ignore their clinical judgment reflexively when using CDS.Goodman & Miller. Chapter 10: Ethics and Health Informatics: Users, Standards, and Outcomes. In Shortliffe (3rd Edition). 65
  66. 66. Appropriate Use of Health IT  Health IT “should be used in clinical practice only after appropriate evaluation of its efficacy and the documentation that it performs its intended task at an acceptable cost in time & money”  Qualified (licensed, trained & experienced) health professionals as users  Systems should be used to augment/supplement, rather than replace or supplant individuals’ decision making  Adequate trainingGoodman & Miller. Chapter 10: Ethics and Health Informatics: Users, Standards, and Outcomes. In Shortliffe (3rd Edition). 66
  67. 67. Ethics for Developers  Follow standard of care & scientific progress (evidence-based)  System evaluation is ethically imperativeGoodman & Miller. Chapter 10: Ethics and Health Informatics: Users, Standards, and Outcomes. In Shortliffe (3rd Edition). 67
  68. 68. Why Clinical Judgment Is Still Necessary?• Nothing is certain in medicine & health care• Large variations exist in patient presentations, clinical course, underlying genetic codes, patient & provider behaviors, biological responses & social contexts• Human is good at pattern recognition, while machine is good at logic & computations.• Diagnosis is often achieved through recognizing clinical patterns• Not everything can be digitized or digitally acquired• Experience, context & human touch matters 68
  69. 69. “Learned Intermediary” Doctrine • A defense doctrine used in the U.S. legal system (and some other countries) which states that “a manufacturer of a product has fulfilled his duty of care when he provides all of the necessary information to a ‘learned intermediary’ who then interacts with the consumer of a product.” (Wikipedia) • Primarily used by pharmaceutical & medical device manufacturers in defense of tort lawsuits.Source: 69
  70. 70. “Learned Intermediary” Doctrine• Because health IT developers can’t expect a CDS advice (e.g., alerts & reminders) to be 100% appropriate for each individual patient, clinical judgment is still necessary.• Health IT developers & manufacturers are protected from liabilities for poor/inappropriate advices or for bad outcomes associated with them, as long as there is a clinician using it that can intervene• What about software bugs (e.g. wrong dose calculations)? 70
  71. 71. “Learned Intermediary” Doctrine• Applicability of this doctrine varies based on legal jurisdictions, context of each case, and legal arguments• Recently, this doctrine has been noted by some legal and informatics experts that it doesn’t apply to health IT cases• It remains unclear until there are rulings from real legal cases 71
  72. 72. Summary• Ethical principles are guides and standards of practice that can help us navigate through situations that arise.• History was full of unethical conduct• 4 important principles in bioethics  Respect for persons (autonomy)  Beneficence  Justice  Non-maleficence 72
  73. 73. Summary• Ethical issues are present in informatics practice (whether as developers, implementers, executives, users, researchers, etc.)• Codes of conduct & ethics codes by professional organizations govern acceptable & ethical behaviors by informaticians• In use of health IT in clinical decision making, there are standard & appropriate guidelines that are based on ethical principles 73