THCB would not quite simply not be possible without the generous support of our sponsors and advertisers.  We'd like to extend a warm welcome to our newest corporate supporter, the wonderful folks at Sage, makers of industry leading healthcare applications including the Sage Intergy EHR  and Sage Intergy Practice Management Solutions.  If you're a physician trying to sort through  the complexities of the stimulus package for your practice, you may want to take a few minutes to visit the useful collection of resources they've pulled together to help you think about the decisions involved. Tell them THCB sent you They like that.

Meanwhile, we were sorry to hear that Sage VP of Market Strategy & Industry Relations James Mathews will not be attending Health 2.0 Boston after falling ill en route to Boston.  We wish James a speedy recovery and look forward to seeing him at Health 2.0 San Francisco in the fall .. 

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   What is the role of patients in this new environment?  Some useful historical background is provided by Paul Starr.  Comparing attitudes towards advances in medical science during the Jacksonian and Progressive periods, Starr has written:

The outcome in the 20th Century was that “American faith in democratic simplicity and common sense yielded to a celebration of science and efficiency.”⁵⁴  This involved acceptance of professional authority, a “retreat from private judgment” and a “general decline of confidence in the ability of laymen to deal with their own physical and personal problems.”⁵⁵  Patients thus became increasingly dependent on licensed, expert professionals for information, judgment and skillful performance.

   Now, with the Internet, patients have become less dependent on experts for information and judgment.  Simultaneously, new technologies are lessening patient dependence on experts for performance of some medical procedures, because simple devices for diagnostic testing and monitoring are increasingly becoming available to patients.  But these devices generate detailed data that must become part of the medical record.  The record must be organized for use by the patient and multiple caregivers.   And data must be selected and analyzed in light of medical knowledge. If these problems in managing clinical information can be solved with effective tools and standards of care, then patient autonomy and independence from expert practitioners can increase by an order of magnitude.  The extent to which this new independence occurs remains to be seen.

   The patient role might evolve in either of two directions.  First, providers could become better organized to deliver patient-centered care through some form of “medical home.”  Medical homes would have responsibility for delivering and coordinating care for defined populations.  Patients would use information tools but still depend on practitioners for guidance in decision making and for coordination of care.  Information tools would reduce but not remove the information asymmetry between patients and practitioners, under this scenario, because the tools could only capture formal, explicit knowledge from medical science, not informal, tacit knowledge from concrete experience in medical practice.  Unlike patients, practitioners accumulate experiences with multiple patients encountering a given disease condition and the processes of care for that condition.  Thus patients would naturally turn to the judgments of veteran practitioners, who could draw on their past experience in navigating the processes of care on behalf of multiple similar patients.  On this view, the insight conferred by that past experience is a form of medical expertise above and beyond any specific skills in performing medical procedures.  (Indeed, the market for that expertise might constitute a new definition for primary care.)  Thus, under this scenario, patients are dependent recipients of care chosen under the guidance of the experts who provide it.

   The other direction in which the patient role might evolve would involve a basic shift of responsibility for going through the decision making process from providers to patients.  Under this scenario, patients are autonomous users of a total system of care that provides resources, experts and accountability.  Rather than being dependent on expert providers for information or judgment, patients employ expert providers when needed for delivery of specific services.  Autonomy in this scenario does not mean that patients make difficult medical decisions on their own, without involvement of others, nor does it mean that patients decide among alternatives determined by experts.  Rather, as in other areas of their lives, patients may exercise private judgment after turning to (or being confronted by) trusted parties who provide dialogue, guidance, feedback and emotional support.

   In doing so, patients would have available a transparent, orderly, reliable system of care, they would be responsible for using it, and they would be accountable for the choices and behaviors their use of the system reflects.  This second scenario is a return to the Jacksonian vision of medical science as “knowledge that could be widely and easily diffused.”  In contrast, the first scenario is rooted in the Progressive vision of medical science as too complex and inaccessible to employed without expert guidance.

   This second scenario is most applicable to chronic disease, where the economic burdens of health care are concentrated.  Imagine the patient as the driver of a car (to borrow an analogy from Norbert Wiener, who used it to illustrate the importance of feedback in complex behaviors).  No one can drive a car blindfolded by listening to directions from a passenger.  This is so even if the passenger is more knowledgeable about driving the particular vehicle or navigating the particular route.  That expertise in the passenger is no substitute for the driver’s personally receiving and responding to visual feedback while driving.  So it is in the care of chronic disease.  There can be no substitute for the patient’s taking on the responsibility to exercise private judgment.  That is, the patient must personally learn about his or her condition, consider the pros and cons of therapeutic alternatives (including personal behavior changes), choose among those alternatives in light of personal values and circumstances, act on the choice, get feedback on the results and make corrective adjustments over time.

   The patient with chronic disease cannot escape this role, for two fundamental reasons.  First, the patient, not the expert caregiver, is the one who must live with the choices made, and the patient is the one who must summon the resolve to make the behavior changes those choices may entail.  Even if a medical expert would arrive at the same choices as a well-informed patient, the patient’s relying on another to make those choices detracts from the personal involvement and commitment essential to coping with chronic disease.  Depending on another for inherently personal decision making saps motivation and self-respect.  And this dependency state shifts decision making authority away from the person, who is, in Hayek’s terms, “closest to the subject matter of the decision,” with “intimate knowledge” of the disease as uniquely experienced by that individual.

   The patient’s intimate knowledge of his or her own chronic disease is the second reason why the patient cannot escape responsibility for decision making.  The course of a chronic disease depends on numerous variables, none of which the caregiver personally experiences, most of which the caregiver does not control and some of which the caregiver is not aware.  In diabetes, for example, blood glucose levels depend on not only insulin levels but also diet, exercise, emotion, medications, infections and co-existing medical problems, among other variables.  The patient has more knowledge and control of many of these variables than the provider ever will.  Managing chronic conditions demands keeping track of these variables over time and examining them for medically significant patterns and relationships.  The provider’s expertise is limited to textbook generalizations and limited personal experience
with other patients, neither of which is sufficient to cope with detailed data and arrive at individualized decisions for the patient at hand.  Those decisions require expertise that resides only in that patient, feedback that only the patient can recognize and act on, and external tools that the patient has more time and incentive to carefully use than the provider ever will.  The patient feels what the disease and its treatments do to him or her, and can rapidly recognize correlations between those subjective symptoms and detailed data on physiological parameters.  Without any formal education, the patient is in the best position to observe these correlations.  What the patient needs beyond this personal knowledge is not the broad, sophisticated scientific understanding of a physician but rather a basic understanding of principles and data that bear specifically on choosing among the options relevant to his or her situation.  To that extent, information asymmetry exists in favor of the patient, not the expert provider.⁵⁶

   For patients to acquire the necessary understanding of their chronic conditions, decision making processes must move from Karl Popper’s World 2 to World 3, from personal recall, knowledge and judgment to highly organized records, including graphs and flowsheets for organizing objective data, plus decision support tools that bring objective knowledge to bear on this data in a usable manner, all in the hands of patients as well as providers.  Patients themselves can use decision support tools to identify options and evidence.  They can use medical records to discern their own unique patterns of response, to see what works and what doesn’t work.  And others can use these records to confront irresponsible patients with feedback on the medical consequences of their own actions or inaction.⁵⁷ External tools in World 3 thus provide concrete instruments for capitalizing upon the personal knowledge and motivation of patients, very much as the price system in a market economy capitalizes upon the personal knowledge and motivation of market participants.

   Consumers would naturally use the system of care in World 3, not expert caregivers in World 2, as the primary source of information for decision making.  The question remains, however—where do people turn for outside guidance and judgment?  Most people do not make important personal decisions based on purely private judgment.  Most people form judgments about their own needs based in part on dialogue with others.  But there is no reason for patients necessarily to choose medical experts for that dialogue.  Not all experts have the interpersonal skills or temperament to play that role effectively.  Nor do they often have a sufficiently close personal relationship with patients.  In many situations, the best source of guidance, feedback and emotional support may be other patients who are available in online communities oriented to particular diseases.

   As between the two scenarios outlined above, the first scenario is more compatible with the current medical culture, rooted in World 2.  But the second scenario is more compatible with the movement to World 3 made possible by modern information technology.  For that movement to be completed, the educational system will need to change.  If patient-consumers are to apply medical knowledge to their own medical data to manage their own health, then they as well as their caregivers need medical education.   But for consumers, medical education needs to begin in childhood.

   Every child has a natural interest in the workings of his or her own body and mind.  Every child personally experiences health care and the health care system.  Education designed to explore that personal interest and experience could involve learning by doing and learning from personal experience—elements that traditional education usually lacks.

   From their education consumers need to learn the principles, skills and attitudes required for maintenance of personal health, coping with health problems, using information tools and taking responsibility for medical decisions and health behaviors.  They need to learn about their own biological uniqueness and why it means they must take responsibility for their own health behaviors and their own care.  They need to learn why their uniqueness precludes relying uncritically on established medical knowledge, or accepting the marketing pitches of vendors, or becoming dependent on physicians to make inherently personal decisions for them.  They need to learn to interact with the health care system autonomously very much as they learn to navigate the transportation system.  They need to access and understand their own medical records, and to use software tools for applying medical knowledge to their own data.

   Consumers and caregivers alike face a medical culture not unlike the intellectual culture faced by Francis Bacon 400 years ago.  As described by Loren Eiseley, Bacon had to overcome an entrenched and stifling world view:  “The real problem was to break with the dead hand of the traditional past, to free latent intellectual talent, to arrest and touch with hope the popular mind, to carry word of that which lay beyond the scope of the isolated individual thinker …”⁵⁸  So we in medicine now must break with our past, if we are ever to control our own future.

Disclosure:  The corresponding author is the founder and a major shareholder in PKC Corporation (www.pkc.com), which develops and markets one of the information tools (knowledge coupling software) discussed in this article.  The other author is the son of the corresponding author.

Endnotes:

 ¹  The corresponding author is the original developer of these standards and tools, which are briefly described in part II.C below and presented in detail elsewhere, most recently in an unpublished manuscript entitled Medicine in Denial, which will be available on the Web in the near future.  

²  The manuscript cited in note 1 above includes references to numerous prior publications.

³  Bacon F.  Novum Organon (1620), Summary of the Second Part, Aphorisms Concerning the Interpretation of Nature and the Kingdom of Man, Aphorism No. 31 (Montague, trans., 1854); at http://history.hanover.edu/texts/Bacon/APHOR.html.  

⁴  NIH Working Group on Biomedical Computing, The Biomedical Information Science and Technology Initiative.  1999.  Available at http://www.nih.gov/about/director/060399.htm.  

⁵  Whitehead A. An Introduction to Mathematics, 1911 (American ed., Oxford Univ. Press, 1948, p. 83).  

⁶  Ibid., pp. 39-42.

⁷  Edward Gibbon, The History of the Decline and Fall of the Roman Empire, ch. IX; (Paris: Baudry’s European Library, 1840) , p. 200; available at http://books.google.com.

⁸  Grove W, Meehl P. Comparative efficiency of informal (subjective, impressionistic) and formal (mechanical, algorithmic) prediction procedures: the clinical-statistical controversy. Psychology, Public Policy and Law 1996; 2:293-323, p. 316, available at  http://www.tc.umn.edu/~pemeehl/167GroveMeehlClinstix.pdf.

 ⁹ Ibid.

¹⁰  Popper, K.  Objective Knowledge:  An Evolutionary Approach.  Oxford:  Clarendon Press, 1972 (pp. 72, 106). 

¹¹  Ibid., p. 108 (emphasis in original). 

¹²  Bacon F.  Novum Organon (1620), note 3 above, Aphorisms No. 2, No. 9.

¹³  Bacon F.  Novum Organon (1620), note 3 above, Aphorism No. 36.

¹⁴ Gaukroger S.  Francis Bacon and the Transformation of Early Modern Philosophy.  Cambridge University Press, 2001 (pp.10, 14-18); Kors A.  “The New Vision of Francis Bacon,” in Lecture 3 in The Birth of the Modern Mind:  The Intellectual History of the 17th and 18th Centuries (recorded lectures from The Teaching Company).

¹⁵  Bacon F.  Novum Organon (1620), note 3 above, Aphorisms No. 42-44.

¹⁶  Bacon F.  Novum Organon (1620), Preface to Second Part, note 3 above.

¹⁷  A popular exposition of this research is Gladwell, M.  Blink (New York:  Little Brown and Co., 2005).

¹⁸  Grove and Meehl, note 8 above.

¹⁹  Dawes R.  Rational Choice in an Uncertain World (New York:  Harcourt Brace Jovanovich, Inc. 1988), p. 143.

²⁰  Berg M.  Rationalizing Medical Work. Cambridge, MA:  MIT Press, 1997.

²¹  Ibid., p. 7.

²²  Institute of Medicine, To Err is Human (Washington, National Academy Press, 1999). p. 47 (“This report addresses primarily … errors of execution,” as distinguished from “errors of planning”).

²³  C.C. Weed.  The Philosophy, Use and Interpretation of Knowledge Couplers, PKC Corporation, 1982-2008 (p. 1), available at www.pkc.com.

²⁴  Bacon F.  Novum Organon (1620), note 3 above, Aphorism No. 47.

²⁵  Friedman M., Kuznets, S.  Income from Independent Professional Practice, 1929-1936 (National Bureau of Economic Research, 1954) (originally published in 1939), available at http://www.nber.org/books/frie54-1; Friedman, M.  Capitalism and Freedom (Chicago:  University of Chicago Press, 1962), pp. 137-60; Svorny S., Medical Licensing:  An Obstacle to Affordable, Quality Care, Cato Institute Policy Analysis No. 621, Sep. 17, 2008, available at http://www.cato.org/pubs/pas/pa-621.pdf; Kling A, Cannon M., Does the Doctor Need a Boss?, Cato Institute Briefing Paper No. 111, Jan. 13, 2009, available at http://www.cato.org/pubs/bp/bp111.pdf.  

²⁶  Dawes R.  Rational Choice in an Uncertain World (New York:  Harcourt Brace Jovanovich, Inc. 1988), p. 208.

²⁷  Ibid., p. 143 (emphasis in original).

²⁸  Blumgart H., “Medicine:  The Art and the Science,” Hippocrates Revisited, R. Bulger ed. (New York:  MEDCOM Press, 1973), p. 34.

²⁹  Nuland, S.  How We Die: Reflections on Life’s Final Chapter (New York: Alfred A. Knopf, 1994), pp. 248-49.

³⁰  Sowell T.  Knowledge and Decisions.  New York:  Basic Books, 1980, p. 26.  

³¹  F.A. Hayek, “The Use of Knowledge in Society,” American Economic Review, XXXV, No. 4, Sep. 1945, pp. 519-30 at p. 525 (emphasis added).

³²  Ibid. at 22.

³³  Ibid. at 18.

³⁴  Arrow K.  Uncertainty and the Welfare Economics of Medical Care.  American Economic Review.  1963.  LIII:941-73.  For further discussion of Arrow’s classic article in relation to Thomas Sowell’s analysis of knowledge and decision making, see , Part IV.B (pp. 5-8) of Weed LL, Weed L.  Opening the black box of clinical judgment, British Medical Journal, eBMJ Edition, Vol 319, issue 7220, 13 November 1999, available at http://bmj.bmjjournals.com/cgi/content/full/319/7220/1279/DC2.  

³⁵  Specific tools and standards of care for these purposes are described in parts IV and VI of the manuscript cited in note 1, as well as numerous prior publications cited therein.  These tools and standards have been used in clinical practice for many years.

³⁶  Herzlinger, R.  Who Killed Health Care:  America’s $2 Trillion Health Problem and the Consumer-Driven Cure (New York:  McGraw Hill, 2007), p. 185. 

  ³⁷  Knowledge and Decisions, note 30 above, pp. 10-11.

³⁸  IOM, Crossing the Quality Chasm (Washington, National Academies Press, 2001), Appendix B, Paul Plsek, “Redesigning Health Care with Insights from the Science of Complex Adaptive Systems,” pp. 326, 329. 

³⁹  IOM, Crossing the Quality Chasm, p. 69.  

⁴⁰  http://en.wikipedia.org/wiki/Double_entry_bookkeeping.

⁴¹  A company founded by the corresponding author, PKC Corporation, has developed “knowledge coupling software designed to implement this standard of care.  See www.pkc.com.

⁴²  The corresponding author originated the problem-oriented medical record standard.  

⁴³  Schattner A.  “Simple Is Beautiful:  The Neglected Power of Simple Tests.”  Arch Intern Med 164: 2198-2200 at 2199 (Nov. 8, 2004).  

⁴⁴ Groopman, J.  How Doctors Think (New York: Houghton Mifflin, 2007), pp. 193-94.

⁴⁵  Mendelson M., Murray, P.  Towards the appropriate use of diagnostic imaging, Medical Journal of Australia 2007; 187 (1): 5-6.  See  http://www.mja.com.au/public/issues/187_01_020707/men10331_fm.html.  

⁴⁶  Gottlieb, S.  Opening Pandora’s Pillbox:  Using Modern Information Tools To Improve Drug Safety.  Health Affairs, July/August 2005.  DOI 10.1377/hlthaff.24.4.938, pp. 938.  

⁴⁷  Schattner, A.  “Clinical paradigms revisited,” Medical Journal of Australia, 2006; 185 (5): 273-275, available at http://www.mja.com.au/public/issues/185_05_040906/sch10143_fm.html.  See also Dr. Schattner’s response to letters to the editor, criticizing “imaging without forethought.”  Ibid, 2006; 185 (11/12): 671-672 [Letters], available at  http://www.mja.com.au/public/issues/185_11_041206/arn11029_letters_fm-2.html.  It is remarkable that these issues are still the subject of debate.   

⁴⁸  Weed CC.  “Overview,” in Weed LL., et al., Knowledge Coupling: New Premises and New Tools for Medical Care and Education, New York: Springer-Verlag, 1991, pp. xviii-xix. 

⁴⁹  Groopman, J., How Doctors Think, note 44 above, p. 228.  Jauhar, S., “Many Doctors, Many Tests, No Rhyme or Reason,” The New York Times, March 11, 2008.  Dr. Jauhar’s essay generated remarkable commentary from many readers, both patients and caregivers, who further described the lack of “rhyme or reason” in medical services.  See  http://community.nytimes.com/article/comments/2008/03/11/health/views/11essa.html?s=1&pg=1.

⁵⁰  Congressional Budget Office.  The Long-Term Outlook for Health Care Spending, March 2008, p. 6. 

⁵¹  Bacon, F.  The Advancement of Learning, IX(1), at http://www.fullbooks.com/The-Advancement-of-Learning2.html 

⁵²  Heng, H.  The Conflict Between Complex Systems and Reductionism, JAMA 300;13: 1580-1581 (Oct. 1, 2008).  See also Wade N., A Dissenting Voice as the Genome is Sifted to Fight Disease, New York Times, Sep. 16, 2008, which states:  “the effort to nail down the genetics of most common diseases is not working. …  The common disease/common [genetic] variant idea is largely wrong.  What has happened is that a multitude of rare variants lie at the root of most common diseases ….”

⁵³  Starr P., The Social Transformation of American Medicine (New York: Basic Books, 1982), p. 140. 

⁵⁴  Ibid. 

⁵⁵  Ibid., p.  141. 

⁵⁶  For more detailed discussion of the patient’s central role, see Weed, LL, “Introduction: Scientific principles that tell us why people must manage their own health care,” in Your Health Care and How To Manage It (Essex Junction, VT:  Essex Publishing Co., Inc., 1975); Weed LL., et al., Knowledge Coupling, note 48 above; Part II of Weed LL, Weed L.  Opening the black box of clinical judgment, British Medical Journal, eBMJ Edition, Vol. 319, issue 7220, 13 November 1999, available at http://bmj.bmjjournals.com/cgi/content/full/319/7220/1279/DC2; 

⁵⁷  For two examples of this kind of interaction using problem-oriented medical records, see Dr. Ken Bartholomew’s descriptions in Knowledge Coupling (cited in the preceding note), p. 265.  

⁵⁸  Eisely, L., Francis Bacon and the Modern Dilemma (Lincoln: University of Nebraska Press 1962), p. 22.

   Medical knowledge is itself an element of the health care system.  Just as the system fails to organize health care providers for delivering patient-centered care, so it fails organize medical knowledge for solving the medical problems of unique individuals.  Instead, knowledge is organized for comprehension by the unaided minds of physicians.  Medical specialties, for example, are defined by body system, because that narrowing of focus reduces the burden of comprehension. Yet, patient problems normally implicate multiple body systems.  Similarly, because the mind more readily comprehends generalities about large populations than detailed data about individual variation, evidence-based medicine is oriented towards population-based forms of evidence that poorly describe the realities of unique individuals.  Indeed, that orientation characterizes medical knowledge in general.

   The reality is that every individual is a unique combination of resemblances to and differences from other individuals.  Medical knowledge is oriented towards the resemblances, not the differences.  All diabetics, for example, have in common some dysfunction in hormonal regulation of blood glucose levels; indeed, diabetes is defined in terms of that resemblance.  Of course, diabetics vary enormously in how the disease occurs, in the circumstances (physiological, psychological, social, economic) of its occurrence, and in the actions needed to manage the disease over time.  Some of these variations are specific to the individual, while others occur across definable subpopulations, which include broad groupings (e.g., Type I and Type II diabetics) to narrower ones (e.g., Type I diabetics with chronic renal insufficiency and cardiovascular disease).  Each individual diabetic is a unique and changing combination of some resemblances to some subpopulations, plus some variations specific to the individual.  Multiple dimensions of this uniqueness must be taken into account to manage diabetes over time.

   Medical knowledge about diabetes is oriented towards resemblances among individuals within subpopulations.  A great deal of medical knowledge about these interrelationships has been accumulated.  Much more such knowledge about diabetes remains to be discovered.  This illustrates the vital role of population-based analysis employed by scholars of evidence-based medicine.  But that role is crippled by failure to use the external tools—and corresponding standards of care—necessary to perceive and document medical realities encountered every day in diabetic patients.  Those are the very same tools and standards that caregivers and patients need for their daily functioning.  Were they consistently employed—that is, if more patient care took place in Popper’s World 3 rather than World 2—then new knowledge and errors in existing knowledge would constantly be coming to light.

   Medical knowledge long ago exceeded what the unaided mind is able to take into account or integrate with corresponding patient data (not to mention additional data about variations specific to the individual).  Were the missing standards and tools to be enforced in patient care, then the simultaneous use and development of knowledge could generate enormous synergies.  Health care cost and quality could become an arena of continuous improvement, rather than a quagmire of intractable dilemmas.

   Even now, with medical practice still mired in the status quo, science is transforming medical knowledge.  New understanding of disease at the genetic and molecular level is already making it possible to reconceive existing diagnostic entities and classifications.  These advances in medical science, however, demand a comparable transformation in medical practice.  To reiterate, more complete, organized, documented clinical observations in patient care, plus better linkages among these observations and existing knowledge of disease and therapy, would yield constant feedback on that knowledge.  There is reason to believe that we would learn how seemingly distinct disease conditions may actually be interrelated, how medical interventions that seem narrowly targeted at a specific gene or molecular pathway may actually disrupt multiple body systems, of how an individual’s phenotype may actually be more important than genotype for some diagnostic and therapeutic purposes, and how drugs and other powerful interventions sometimes may be more disruptive and less effective therapeutically than simple improvements in health behaviors.  These possibilities are reinforced by evidence that common disease conditions appear linked to many rare genetic variants among individuals rather than to a few common variants across populations.⁵²  Thus, individual heterogeneity and uniqueness, no less than patterns of resemblance across populations, must become the subject matter of medical knowledge.

> Part 5 – Patient Autonomy

         A. The domain of commerce

   Commercial enterprises, more so than research enterprises, must cope with the ongoing costs of gaining information resources and engaging in decision processes.  Although often overlooked, the economic importance of these costs, as Thomas Sowell observes, is fundamental:  

This basic problem is more difficult to solve in medical decision making than in settings (such as execution of decisions, or factory production) where the goal is to achieve uniformity of outputs by eliminating variation of inputs.   The goal of medical decision making is just the opposite, because the most important inputs come from patients.  Thus the goal is to individualize care by taking variation among patients into account.  A central difficulty in achieving this goal is that medical knowledge is usually expressed as generalizations that fit unique patients imperfectly.  Those generalizations are essential to take into account, because they capture medically important elements that different patients have in common.  Yet, these generalizations cannot properly be applied without also taking into account detailed, patient-specific data and individual preferences. 

   These disparate elements must be combined for individualized decisions, but those involved in medical decisions are not positioned to do so on their own. Caregivers cannot judge how patients’ personal preferences or values should be applied.  Nor are either patients or caregivers able to efficiently mobilize relevant general knowledge and couple that knowledge with detailed data.  Enabling them to do so should be a central task of health reform.

   A similar dilemma exists and is resolved to varying degrees in many economic contexts.  To understand how it is resolved, recall Whitehead’s principle—”civilization advances by extending the number of important operations which we can perform without thinking about them.”  F. A. Hayek observed that Whitehead’s principle has “profound significance in the social field.”  The significance is that social practices and institutions have evolved for avoiding dependence on limited personal knowledge and intellect:

   Hayek’s concern was “the price system as a mechanism for communicating information.”  He critiqued formal equilibrium analysis in economics, which assumes away the need for such a mechanism:  “there is something fundamentally wrong with an approach which habitually disregards an essential part of the phenomena with which we have to deal: the unavoidable imperfection of man’s knowledge and the consequent need for a process by which knowledge is constantly communicated and acquired” (emphasis added). He also critiqued central planning as inadequate for this purpose. The price system provides a superior alternative.  In contrast to centrally planned systems,   

   The planners of a command and control economy are unable to apply their knowledge (statistical information) effectively, Hayek argues, because they are too isolated from practical knowledge of “the particular circumstances of time and place.”  This practical knowledge “by its nature cannot enter into statistics and therefore cannot be conveyed to any central authority in statistical form. The statistics which such a central authority would have to use would have to be arrived at precisely by abstracting from minor differences between the things, … which may be very significant for the specific decision” (emphasis added).  That practical knowledge of “minor differences” is only available to the “man on the spot” who is closest to the subject matter of the decision.  “But the ‘man on the spot’ cannot decide solely on the basis of his limited but intimate knowledge of the facts of his immediate surroundings.  There still remains the problem of communicating to him such further information as he needs to fit his decisions into the whole pattern of changes in the larger economic system.”³³   The pricing system communicates information in the form of prices and quantities, which all interested parties can easily translate into personalized conclusions about affordability and availability.

   Hayek characterizes the pricing system as part of “the foundation of the civilization that we have built up.”  Such a foundation is missing from medicine.  Rather than building upon practices and institutions that have proved successful in science and commerce, medicine has remained mired in dependence on the physician intellect.  In Karl Popper’s terms, medicine has failed to move from World 2 to World 3, from the world of subjective knowledge to the world of the objective knowledge embodied in external tools.

         B. Comparing commerce and medicine

   Just as market economies need a price system to efficiently communicate basic information in terms meaningful to interested parties, so patients and caregivers need an efficient system for accessing and processing the limited, personalized information relevant to solving individual patient problems.  The difficulty presented by medicine is that personalized information is a needle in the haystack of medical knowledge and data.  Patients thus face enormous uncertainty unless and until they can access the limited information relevant to their individual problems.  Resolving this uncertainty for patients is the traditional role of physician experts.³⁴  But this role is misconceived, for four reasons.  First, physicians lack the cognitive capacity to play this role.  Second, consumer dependence on physician experts imposes high costs in money and time.  Third, transferring inherently personal medical decisions from patients to third party agents inevitably degrades the quality of those decisions.  Fourth, traditional decision making by physician experts is not susceptible to organized improvement, because clinical judgment is opaque—its cognitive inputs are undefined. 

   In many economic contexts other than health care, we take for granted that personal consumption decisions do not require costly expert advice.  In transportation, for example, one need not hire an engineer to advise on buying a car, nor an expert to drive it, nor a guide to
navigate it.  Market and regulatory forces have developed systems enabling consumers to use cars autonomously.   In medicine, however, the systems necessary for consumer autonomy are absent.  As a result, consumers are expected to rely on decisions by physician agents acting on their behalf.  But this approach is unworkable, for the four reasons just stated.  The current response to this situation among policy makers is evidence-based medicine.  But this response is futile. To paraphrase Hayek, evidence-based medicine takes the form of statistical, generalizations, isolated from practical knowledge of each patient’s particular circumstances and characteristics.  That practical knowledge is only available to those who are closest to the subject matter of the decision—the patient and caregiver.  But those parties cannot decide solely on the basis of their personal knowledge.  They also need to access broader scientific knowledge, couple that knowledge with patient-specific data, and organize the entire process over time.³⁵  In no other way can they make informed, individualized decisions.

   Regina Herzlinger makes a related point in her critique of managed care.  Managed care is a form of group purchasing.  “The Achilles heel of group purchasing,” Herzlinger observes, “is that it inhibits product differentiation.  The fundamental tenet of a market-based economy is that competition among differentiated products is much more effective in controlling costs than the clout of group purchases.”³⁶  In medicine, the power of competition among differentiated products for consumer choice has been illustrated with Medicare Part D, where costs for the first several years turned out to be 40% below projections.  This outcome appears to have resulted from Web-based software enabling consumers to enter their personal medication profiles and thus efficiently differentiate among competing drug plans in a highly individualized way, finding the most precise and cost-effective matches between their personal needs and available plan offerings of generic and brand-name drugs.  This example illustrates how tools and systems external to the mind (World 3) provide an essential foundation for a market of autonomous consumers in which producers compete effectively.  Moreover, the lack of this foundation distorts the development of differentiated products and services generated by medical science.

         3. The need for simple rules to manage complex information

   Not only consumers but caregivers are unable to cope with complexity when left to their own devices.  Both caregivers and consumers need to rely on external systems to manage information for decision making.  Moreover, they need to use these systems jointly.  These systems must therefore be simple to use for everyone involved.  Indeed, simplicity at the consumer level is characteristic of much economic activity outside of health care.  “The growing complexity of science, technology and organization does not imply either a growing knowledge or a growing need for knowledge in the general population,” as Thomas Sowell has written.  “On the contrary, the increasingly complex processes tend to lead to increasingly simple and easily understood products.  … Organizational progress parallels that in science and technology, permitting ultimate simplicity through intermediate complexity.”³⁷  From this point of view, the health care system’s impenetrable complexity is anomalous.

   Analysis by the Institute of Medicine (IOM) points in the same direction—simplicity must be built into the health care system for patients and caregivers.  The IOM points to a theoretical basis for this conclusion in scientific study of “complex adaptive systems.” Occurring in various social and natural contexts, complex adaptive systems are not built according to external, pre-conceived designs.  Rather, complex systems “can emerge from a few simple rules that are locally applied” by individual participants in the system (emphasis added).   “It is liberating to realize that the task of complex system design does not itself need to be complex.” To design an effective complex system means to “create the conditions for self-organization through simple rules under which massive and diverse experimentation can happen.”³⁸  Based on these scientific insights, the IOM has concluded that “important lessons about simple rules for complex adaptive systems can be applied to health care systems as well.   In redesigning health care, the building blocks are the simple processes that make up the work of small systems of care and their interconnections.”³⁹  The IOM proceeds to formulate “Ten Simple Rules for the 21st Century Health Care System” (pp. 70-88), but these are in reality general goals, not specific, operational rules for achieving the goals.

   What are the “simple rules” needed by the health care system?  A basic reality of health care is its information-intensive nature.  That reality suggests that simple rules for managing complex clinical information are pivotal.  Consider an analogy from the domain of commerce:  accounting rules for managing complex financial information.

   At first glance, accounting rules may seem like an unfortunate analogy.  Complexity, not simplicity, is what most of us associate with financial accounting.   Moreover, accounting rules have been powerless to prevent either the financial scandals that occurred at the beginning of this decade in cases like Enron and Worldcom, or the financial crisis occurring now near the end of the decade.  Yet, the analogy with accounting reveals much about the health care system.

   Accounting rules are indeed complex.  But that complexity exists only at the margin.  The core concepts of double-entry bookkeeping are so simple that they are taken for granted.  They apply universally, and yet allow for enormous diversity.  They help to organize the economic relationships among individuals who may or may not have any awareness of them.  First codified in Renaissance Italy 500 years ago, the core concepts of double-entry bookkeeping still provide a foundation for commerce.⁴⁰  On this foundation have been built “generally accepted accounting principles” (GAAP) in the U.S. and similar standards in other countries.  Accounting principles are generally accepted for internal use, not simply imposed as an external compliance obligation.  This general acceptance results from the order, transparency, feedback and accountability they make possible.  To secure these benefits, private sector organizations codify and refine accounting standards, governments incorporate them in regulation, and the accounting profession is employed to enforce them with periodic audits.

   The profound social and economic importance of accounting standards became obvious in cases like Enron and Worldcom, where egregious accounting violations occurred.  In the current financial crisis, financial risks have been magnified, concentrated and obscured in unprecedented ways.  Financial accounting standards then could not be relied upon to maintain order and transparency.  Thus, the scandal was that generally accepted accounting standards were violated or allowed to become ineffective.  By comparison, in health care the scandal is that generally accepted standards for managing clinical information are absent.

   If health care needs standards of care for managing clinical information, what would those standards look like?  And given the infinite variety of patients, medical problems and practice settings, how could a single set of simple standards be universally ap
plicable and useful?

   All medical care involves two problems in managing information: (1) applying general knowledge to patient-specific data (information processing), and (2) organizing the flood of data generated by complex processes of patient care over time.  Two corresponding standards of care can and should govern these activities:

• First, a combinatorial approach (as opposed to judgmental, algorithmic and probabilistic approaches) must be employed for using medical knowledge to inform selection and analysis of detailed patient data.  A combinatorial approach systematically combines multiple items of knowledge and data to identify medically significant linkages (for example, the linkage between a set of findings on the patient and a set of diagnostic or treatment possibilities).  This is a simple matching process that external tools can perform, before the exercise of judgment.⁴¹

• Second, providers and patients must jointly use external tools (medical records with a problem-oriented structure) to organize patient data over time.  The organizing principle is to rigorously follow the basic steps of orderly problem-solving:  gathering information, defining problems, formulating plans of action for each problem, executing the plans, obtaining feedback on the results, and taking corrective action in response to feedback.⁴²

   These two simple standards of care are not technical or obscure.  Instead, they embody common-sense principles of thoroughness and organization.  These are principles that everyone grasps, that minimize dependence on unstructured, subjective judgments, and that apply in all medical contexts.  That simplicity, order and unity are essential to making the health care system transparent, usable and affordable for all. 

         D. The effects of unmanageable complexity

   To reiterate, the manifold failures of quality and economy in health care arise from failure to bridge the gap between the mind’s limited capacities and the complexity of ordinary medical practice. Consider the problem of managing the use of expensive new technologies and procedures. For these advances to be used cost-effectively, two issues must be addressed.  First, they should be used only when superior to other options—which requires taking into account all available options, their applicability to the individual patient and their pros and cons for that patient.  Second, once an expensive technology or procedure is determined to be the superior option for a given patient’s circumstances, using the technology effectively may itself require taking additional detailed information into account.

   In short, managing the use of expensive technologies is fundamentally a problem of managing information—of applying extensive medical knowledge to detailed patient data.  This reality means that judging the effectiveness of imaging technologies, drugs and other costly medical interventions is context-specific.  Generalized “comparative effectiveness” studies are virtually useless.  To be useful, judgments of effectiveness must take into account all relevant factors (and filter out the irrelevant) on a case-by-case basis.  This can only occur in Popper’s World 3, using external tools to organize detailed patient data and integrate that data with comprehensive medical knowledge.

   An example is clinical imaging technologies.  Ordinarily, these technologies should not be used until first eliciting the information available from a carefully designed initial workup (history, physical and basic laboratory tests).  The initial workup for a given presenting problem can and should be designed in advance of the patient encounter.  Habitually conducting this pre-defined initial workup will sometimes elicit the information needed to solve the problem presented, or else point to further inexpensive, readily available data.⁴³ When this is not the case, when costly imaging technologies prove necessary, their effective use requires taking into account a bewildering array of factors in judging alternative tests, test protocols, test limitations and the significance of test results.  In particular, the initial workup often contains elements relevant to formulating inquiries and interpreting results.⁴⁴  The complexity is such that effective use of imaging technologies demands external guidance, which should be in electronic form, continuously updated and integrated with other information tools.⁴⁵  Caregivers need information tools to use clinical imaging tools cost-effectively no less than they need the imaging tools themselves to reveal internal organs.  In both contexts, ignoring modern technology is unacceptable.

   Another example is decisions about drug therapies.  Pharmaceutical use is fraught with complexity and peril:

 Our pharmaceutical habits today might actually make pharmacotherapy more risky than it was when all we had were herbal remedies and liquefied tree bark…. doctors today use an increasing number of drugs in combinations, and more drugs are being used more often by older people, a group that is likely to recognize fewer of the benefits of some medicines and more of their side effects. All of these trends are likely to continue to make adverse drug reactions more prevalent and profound and our efforts to mitigate them even more difficult.⁴⁶

The difficulties make it critical to weigh drug therapies against other therapeutic alternatives, to keep track of the drugs patients are already taking, to take into account the patient’s medical problems other than the problem for which the drug is prescribed, to anticipate side effects and interactions with other medical interventions, to carefully select physiological parameters for monitoring, and to meticulously collect and analyze the relevant data, including the patient’s subjective responses.  

   One would hope that economic pressures (not to mention concern for patient safety) induce practitioners to use costly technologies and risky procedures in a careful, highly selective manner.  But precisely the opposite has occurred.  Dr. Ami Schattner writes of clinical imaging technologies:  “physicians have become ‘fascinated’, ‘preoccupied’ and ‘obsessed’ with their new instruments,” which “are vigorously promoted by the large companies that supply them.”  This state of affairs is destructive at many levels:

With the increasing availability of powerful diagnostic instruments, physicians have become distanced from both their patients and the basic clinical data.  Today, tests and procedures are considered infallible and ordered in increasing numbers—often almost blindly, repeatedly and sometimes even without examining the patient.  Thus, many are redundant, inconclusive or misleading, in addition to being unnecessarily expensive.  Uncertainty, false positive findings and fear of lawsuits often beget more tests or procedures and may trigger dangerous cascades. This testing-dominated approach undermines the value of clinical skills, which tend to become underestimated, underused and finally lost.⁴⁷

   The key “clinical skills” at issue are those involved in conducting the initial workup—that is, taking a history, performing a physical exam and selecting basic laboratory tests.  The specific elements that these components should include depend on the patient’s presenting problem.  No practitioner will know what clinical observations are needed for each problem that patients might present.  Equally difficult is comprehending all the data generated by a thorough workup.

   These realities lead Dr. Schattner to argue that fully exploiting information from the patient history “mandates a closely linked and thoughtful use of large, preferably electronic, databases.”  But Dr. Schattner does not address the core issues of how and when external databases are to be used.  In traditional medical practice, the physician’s unaided mind largely determines the content of the initial patient history during the patient encounter; afterwards the physician may go to medical libraries and electronic databases for external guidance, if time permits.  This sequence is backwards.   What should happen is that before the initial workup guidance should be captured in external tools for use during the workup. In contrast to the unaided mind (Karl Popper’s World 2), the external tools (World 3) can perform rapid combinatorial analysis to select relevant data and reveal the data’s implications based on medical knowledge.  Then the practitioner and patient may supplement this objective process with additional observations suggested by their personal knowledge, experience and judgment of the practitioner who may have seen many other similar patients, and that of the patient whose intimate personal knowledge and experience of his or her own condition may reveal crucial variations from what the practitioner expects.

   The tool-driven, combinatorial approach just described contrasts sharply with the judgmental a
pproach that now prevails in medicine.  Without the necessary tools, a combinatorial approach is not practical for either provider or patient.  The patient will thus continue to rely on the apparently expert judgment of practitioners.  In turn,

    By default, practitioners act in accordance with their own interests, which may be driven by financial concerns, intellectual bias or simply convenience.  Vendors thus encounter little resistance as they market new technologies aggressively.  Reinforcing this effect are practitioner relationships:  “the current culture of medicine fosters lucrative networks of referrals and procedures but discourages critical examination of their value.”⁴⁹  Further reinforcing this effect are patients, influenced by vendor advertising, who demand the latest innovations.  Physicians are powerless to resist this pressure, because their patients will simply find other physicians who accede to patient demands.  These elements have led analysts to conclude that technological advances are a root cause of excess cost growth in health care.⁵⁰

   Technological innovation might have exactly the opposite effect if an objective, transparent, combinatorial approach to data collection and analysis were employed.  Patients and caregivers would be equipped to critically examine the value of new technologies and use them only when superior to existing alternatives in quality and cost, based on each patient’s individual needs in specific problem situations.  In that environment, innovation could be become a source of cost decreases—which is the role that technological innovation often plays in other sectors of the economy.

   For this to occur in health care, medical knowledge must be reconceived, and the patient must play a central role in the use of knowledge.  Those issues are the subject of the next two sections.

> Part 4 – Harvesting Medical Knowledge from Patient Care