Science as a Profession, Art as Science as a Profession, Art as Individual Physicians Individual Physicians

Horner LectureUniversity 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.

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.

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

It’s not just the nurses:It’s not just the nurses:Sources of MD unrestSources 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

A glimpse of a solutionA glimpse of a solution

Jody the medical office assistant asks:

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

The IOM’s QuestionsThe IOM’s Questions

• 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

We aren’t using all the science we knowWe aren’t using all the science we know

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

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

• Creating versus applying clinical practice guidelines

Barriers to using the science we knowBarriers to using the science we know

• 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?

Barriers to using the science we knowBarriers to using the science we know

• 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?

Professional culture Professional culture

We were taught to revere pure science and descriptive

statistical evidence, and to disdain applied science and

operational (analytic) statistics

Two types of statisticsTwo types of statistics

• 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,” ….

Current Results

Basic Sciences

Better Results

Theory of systems

Theory of variation

Theory of human psychology

Theory of knowledge

Process Improvement

Change Leadership

System Design

Clinical Sciences

High Science and Low Science: Two Pathways to Improved Care

Tacrolimus: A “Low Science” ProjectTacrolimus: A “Low Science” Project• 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?”

TTacrolimus levels before interventionacrolimus levels before intervention>12 months after transplantation, 15 patients>12 months after transplantation, 15 patients

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Tacrolimus Levels in an individual patientTacrolimus Levels in an individual patient

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This system of tacrolimus administration This system of tacrolimus administration perfectly designed to achieve…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

Low science: Statistical Process Control applied Low science: Statistical Process Control applied to tacrolimus administrationto 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.

Process DefinitionsProcess Definitions

• 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

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

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Tacrolimus blood levels in an individual patient Tacrolimus blood levels in an individual patient without “tampering”without “tampering”

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Stopped Tampering

The new system is perfectly designed The new system is perfectly designed to produce….to produce….

• No episodes of allograft rejection

• No opportunistic infections

• No episodes of increased serum creatinine

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

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

• 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?

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

• 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

Barriers to using all the science we Barriers to using all the science we knowknow

• Professional culture– High Science and Low Science

– Autonomy—individual and professional

• Daily workflow– Time– Hassles and barriers

• Business Case

How did medicine earn its autonomy?How did medicine earn its autonomy?

• 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”

Why have physicians lost autonomy?Why have physicians lost autonomy?

• 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?

We are losing our clinical autonomy 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.

Example: Ventilator “Bundle”Example: Ventilator “Bundle”

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

1. HOB 30 degrees elevation2. PUD prophylaxis3. DVT prophylaxis4. Sedation vacation daily5. Intensive insulin therapy

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

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

1. Use prophylactic antibiotics appropriately

2. Maintain normothermia peri-operatively

3. Maintain glucose control

4. Optimize oxygen tension

5. Avoid shaving surgical site

6. Use basic prevention strategies

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

Grand Rounds:Grand Rounds:Individual Autonomy meets EvidenceIndividual Autonomy meets Evidence

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

• What would happen next?

PHYSICIAN CULTURE

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.

A paradox: more individualindividual autonomy autonomy means less means less professionalprofessional autonomy 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

Questions for the Medical StaffQuestions for the Medical Staff

• 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?

Good changes being made by our professionGood changes being made by our profession

• 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

Does practicing clinical Does practicing clinical science as a team make science as a team make

a difference for a difference for patients?patients?

Practicing science as a team:Practicing science as a team: CABG mortality at BIDMC CABG mortality at BIDMC

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Jan-Apr 01

Note:Note:Our professional challenge is not Our professional challenge is not

just about standardizing just about standardizing toto the the science. It’s also about science. It’s also about

standardizing standardizing withinwithin the science. the science.

Yes, buts…Yes, buts…

• 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• …..?

Does practicing clinical Does practicing clinical science as a team make science as a team make

life better for life better for physicians?physicians?

Standardization, simplification, and timeStandardization, simplification, and time

• 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

Putting it all together:Putting it all together:Science, Art, Autonomy, and TimeScience, 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.

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

Jody, my medical office assistant

Ventilator Bundle ReferencesVentilator Bundle References

• 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.

Surgical Wound Infection ReferencesSurgical Wound Infection References

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

Surgical wound infection references Surgical wound infection references contd.contd.

• 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.

Other ResourcesOther Resources

• 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