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Science as a Profession, Art as Individual Physicians . Horner Lecture University of Tennessee October 17, 2003 James L. Reinertsen, M.D. www.reinertsengroup.com. “Every system is perfectly designed to achieve the results it gets.” Donald Berwick, M.D.

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Science as a Profession, Art as Individual Physicians

Horner Lecture

University of Tennessee

October 17, 2003

James L. Reinertsen, M.D.

www.reinertsengroup.com



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The American health care system is perfectly designed to produce dazzling technologies, large numbers of exceptionally well-trained doctors, very high costs, serious safety risks, underuse, overuse, and misuse of resources, mind-boggling administrative waste, lack of access for a significant number of Americans, and distrust and dissatisfaction for virtually everyone—including the key professionals who are needed to deliver quality care.


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Perhaps the most troublesome piece of data from the past 3 years…

More than 40% of nurses surveyed would not feel comfortable having a family member or loved one cared for in the facility where they worked.

American Nurses Association, 2001


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It’s not just the nurses: years…Sources of MD unrest

  • Hassles of daily practice

    • Documentation

    • Billing and coding

  • Not enough time for each patient

    • 28 minutes per office hour?

  • Loss of autonomy

    • Everyone, it seems, is looking over our shoulders


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A glimpse of a solution years…

Jody the medical office assistant asks:

“Why can’t you guys do this the same way?”


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The IOM’s Questions years…

  • Can you use all the science you know?

  • Can you think and act as a system?

  • Could you center the design and delivery of care on the patient?

    Crossing the Quality Chasm


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We aren’t using all the science we know years…

  • Ten-year time lag between new knowledge and widespread application

  • Geographic variation: isn’t science constant across geography?

  • Creating versus applying clinical practice guidelines


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Barriers to using the science we know years…

  • Professional culture

    • High Science and Low Science

    • Autonomy—individual and professional

  • Daily workflow

    • Time

    • Hassles and barriers

  • Business Case

    • Can doctors do well by doing good?


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Barriers to using the science we know years…

  • Professional culture

    • High Science and Low Science

    • Autonomy—individual and professional

  • Daily workflow

    • Time

    • Hassles and barriers

  • Business Case

    • Can doctors do well by doing good?


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Professional culture years…

We were taught to revere pure science and descriptive statistical evidence, and to disdain applied science and operational (analytic) statistics


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Two types of statistics years…

  • Descriptive:

    • Key question: “Is population A different from population B?” (comparison)

    • Variables are controlled in order to focus on a single variable of interest

    • High science, RCTs, publications…

  • Analytic

    • Key question: “How will this process perform the next time a patient experiences it?” (prediction)

    • Complex variables are inherent in the system

    • Low science, quality improvement “run charts,” ….


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High Science and Low Science: Two Pathways to Improved Care

Better Results

Clinical Sciences

Process Improvement

Change Leadership

System Design

Basic Sciences

Theory of systems

Theory of variation

Theory of human psychology

Theory of knowledge

Current Results


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Tacrolimus: A “Low Science” Project to Improved Care

  • Useful, dangerous transplant drug

  • Therapeutic blood levels have a narrow window

  • Typical process: each physician measures blood level and uses individual “best judgment” to adjust dosage

  • Despite best efforts, renal toxicity is 30%

  • A transplant physician asks: “Could we improve this process?”


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T to Improved Careacrolimus levels before intervention>12 months after transplantation, 15 patients

Target range


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Tacrolimus Levels in an individual patient to Improved Care

Target range


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This system of tacrolimus administration perfectly designed to achieve…

  • Wildly variable, often toxic blood levels

  • 40% of the time, blood levels will be out of therapeutic range

  • 30% incidence of renal toxicity, and a high frequency of other drug-related complications


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Low science: Statistical Process Control applied to tacrolimus administration

  • Depict the most recent 20 tacrolimus blood levels from each patient on a run chart.

  • Team meets daily to adjust drug levels.

  • If the mean value for the baseline is within specifications, continue the present dose. Dose will not be adjusted based on common cause variation unless the level exceeds 20ng/ml.

  • If tacrolimus blood levels are out of control then special cause variation will be considered. Contact the family and proceed with a structured interview to identify potential cause.

  • If no special cause variation is identified to account for the out of control process, then the drug dose will be adjusted by 25% or more to achieve the target range.


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Process Definitions tacrolimus administration

  • Out of control process

    • 2 of 3 drug levels beyond 1 standard deviation

    • 6 consecutive levels above or below the mean

    • 5 consecutive ascending or descending blood levels

    • Any drug level beyond 2 standard deviations


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Tacrolimus levels in 15 patients without “tampering” tacrolimus administration>12 months after transplantation

Target range


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Tacrolimus blood levels in an individual patient without “tampering”

Stopped Tampering

intervention

Target range


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The new system is perfectly designed to produce…. “tampering”

  • No episodes of allograft rejection

  • No opportunistic infections

  • No episodes of increased serum creatinine

  • 5 more hours per week of nurse’s time!


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Questions about this “Low Science”Project” “tampering”

  • Is this improvement?

  • Is it research?

  • Is the knowledge generated from this project potentially useful to others in the profession?

  • Could this “experiment” be published?

  • Could the lessons from this work be applied to drugs other than tacrolimus?

  • Where did the doctor and nurse who did this project learn about SPC and tampering?


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If evidence-based medicine is to be reliably implemented…. “tampering”

  • Physicians need to use both descriptive and analytical statistics

  • Physicians need to know both pathways for improvement

  • Knowledge gained by “Low Science” needs to be valued more highly, and shared more widely

  • We must lead this change in our own profession


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Barriers to using all the science we know “tampering”

  • Professional culture

    • High Science and Low Science

    • Autonomy—individual and professional

  • Daily workflow

    • Time

    • Hassles and barriers

  • Business Case


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How did medicine earn its autonomy? “tampering”

  • Dedication to welfare of the patient??

  • Skilful building of political power?

  • Modern science, and its miracles?

    “Having a craft worth knowing, and applying it for the benefit of our patients”


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Why have physicians lost autonomy? “tampering”

  • Failure of the many to clean up the messes of the few

  • Fading political power, as more physicians put self-interest above patient interest

  • Not practicing the art of medicine

  • Not practicing the science?


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We are losing our clinical autonomy “tampering”in part because the public has learned that the basis for it, the full power of our scientific knowledge, is not being consistently applied for their benefit.


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Example: Ventilator “Bundle” “tampering”

  • By the evidence, virtually every patient on mechanical ventilation should receive

    • HOB 30 degrees elevation

    • PUD prophylaxis

    • DVT prophylaxis

    • Sedation vacation daily

    • Intensive insulin therapy

  • Mortality, morbidity, LOS…potentially reduced up to 20-30% if all 5 of these are done for every patient


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Another example: Surgical Wound Infection “Bundle” “tampering”

  • Use prophylactic antibiotics appropriately

  • Maintain normothermia peri-operatively

  • Maintain glucose control

  • Optimize oxygen tension

  • Avoid shaving surgical site

  • Use basic prevention strategies

    Surgical Wound Site Infection Prevention Collaborative, www.ihi.org


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Grand Rounds: “tampering”Individual Autonomy meets Evidence

  • If this were Grand Rounds, and I had just reviewed the evidence for these evidence-based bundles…

  • What would happen next?


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PHYSICIAN CULTURE “tampering”

We regularly engage in vigorous conversations about clinical evidence with our colleagues.

But we seldom enter into those conversations with the clear understanding that any conclusions we reach will be translated into a system of standing orders, reminders, measurements, feedback loops, and other steps to implement any consensus that emerges from the dialogue.


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A paradox: more “tampering”individual autonomy means less professional autonomy

  • We talk about evidence in groups

  • We implement it as individuals

  • The resulting variation looks like the Tower of Babel, to our nurses and pharmacists.

  • Our results fall short of what we and our patients want

  • Society acts to reduce our professional autonomy


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Questions for the Medical Staff “tampering”

  • Beyond sterile technique in the OR, could you agree on evidence-based practices that should be done for a particular diagnosis or procedure for every patient, even if a doctor doesn’t order them?

  • If you reached agreement on a list of these “operating systems,” how would you make sure that they are done, reliably?

  • How would incorporate new evidence into these operating systems?


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Good changes being made by our profession “tampering”

  • Hospital-wide order sets based on evidence

  • Automatic substitution of orders based on evidence

  • Closed units based on evidence

  • “Operating systems” based on evidence

  • Computer order entry where the default orders and options are based on evidence



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Practicing science as a team: for patients? CABG mortality at BIDMC


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Note: for patients?Our professional challenge is not just about standardizing to the science. It’s also about standardizing within the science.


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Yes, buts… for patients?

  • We can’t agree on all the science

  • Specialties will make self-serving judgments about the science

  • Guidelines expose us to legal risks

  • It’s cookbook medicine

  • Protocols stifle innovation

  • Guidelines are unprofessional

  • …..?



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Standardization, simplification, and time for physicians?

  • Evidence-based medicine, practiced as a team, usually also involves standardization and/or simplification, and this frees up “touch time.”

    • “Start Methotrexate”

    • Acute MI admission orders…

    • Preventive care system


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Putting it all together: for physicians?Science, Art, Autonomy, and Time

Practice the science of medicine as a team, so that society will continue to give us the privilege of practicing the art of medicine as individuals. By sharing individual autonomy in the science, we can regain professional autonomy, and rediscover precious touch time.


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“Now, isn’t that better?” for physicians?

Jody, my medical office assistant


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Ventilator Bundle References for physicians?

  • Kress JP, Pohlman AS, O’Connor MF, Hall JB. Daily interruption of sedative infusions in critically ill patients undergoing mechanical ventilation. The New England Journal of Medicine. 2000; 342: 1471-1477.

  • Drakulovic MB, Torres A, Bauer TT, Nicolas JM, Nogue S, Rerrer M. Supine body position as a risk factor for nosocomial pneumonia in mechanically ventilated patients: a randomized trial. The Lancet. 1999; 354: 1851-1858.

  • Cook DJ, Fuller HD et al. Risk factors for gastrointestinal bleeding in critically ill patients. Canadian Critical Care Trials Group. N Engl J Med 1994;330(6):377-81

  • Attia J, Ray JG, Cook DJ, et al: Deep vein thrombosis in critically ill adults. Arch Intern Med 161(10):1268-79, 2001.

  • Van den Berghe G, Wouters P, Weekers F, et al. Intensive insulin therapy in the critically ill patients. N Engl J Med. 2001 Nov 8;345(19):1359-67

  • Torres A, Serra-Batlles J, Ros E, Piera C, Puig de la Bellacasa J, Cobos A, Lomena F, Rodrigues-Roisin R. Pulmonary aspiration of gastric contents in patients receiving mechanical ventilation: the effect of body position. Annals of Internal Medicine. 1992;116:540-543.


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Surgical Wound Infection References for physicians?

  • www.qualityhealthcare.org/QHC/Topics/PatientSafety/SurgicalSiteInfections/Literature

  • Balthazar ER, Colt JD, Nichols RL. Preoperative hair removal: A random prospective study of shaving versus clipping. Southern Medical Journal. 1982;75(7):799–801.

  • Kurz A, Sessler DI, Lenhardt R.: Perioperative normothermia to reduce the incidence of surgical-wound infection and shorten hospitalization. Study of Wound Infection and Temperature Group. New England Journal of Medicine. 1996;334(19):1209–1215

  • Silver A, Eichorn A, Kral J, et al. Timeliness and use of antibiotic prophylaxis in selected inpatient surgical procedures. The Antibiotic Prophylaxis Study Group. American Journal of Surgery. 1996;171(6):548–552.


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Surgical wound infection references contd. for physicians?

  • Rivers EP, Ander DS, Powell D. Central venous oxygen saturation monitoring in the critically ill patient. Critical Care. 2001;7(3):204-211.

  • Horan TC, Gaynes RP, Martone WJ, Jarvis WR, Emori TG. CDC definitions of nosocomial surgical site infections, 1992: A modification of CDC definitions of surgical wound infections. American Journal of Infection Control. 1992;20(5):271–274.

  • Burke JP. Maximizing appropriate antibiotic prophylaxis for surgical patients: An update from LDS Hospital, Salt Lake City. Clinical Infectious Diseases. 2001;33(Suppl 2):S78–83

  • Pomposelli JJ, Baxter JK 3rd, Babineau TJ, Pomfret EA, Driscoll DF, Forse RA, Bistrian BR. Early postoperative glucose control predicts nosocomial infection rate in diabetic patients. Journal of Parenteral and Enteral Nutrition. 1998;22(2):77–81.

  • Greif R, Akca O, Horn EP, Kurz A, Sessler DI. Supplemental perioperative oxygen to reduce the incidence of surgical-wound infection. Outcomes Research Group. New England Journal of Medicine. 2000;342(3):161–167.


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Other Resources for physicians?

  • Gosfield, A, and J Reinertsen. Doing Well By Doing Good: Improving the Business for Quality (White paper available at www.uft-a.com)

  • Reinertsen, JL. Zen and the art of physician autonomy maintenance. Ann Intern Med 2003;138:992-5


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