Hippocrates, Winslow

1
Hippocrates, Winslow Babbage HWB Foundation
Richard Ghillani, M.D.Bradford Henley,
M.D.David Karges, D.O.Henry Mankin, M.D.
Jeffrey Mast, M.D.Augusto Sarmiento, M.D.Marc
Swiontkowski, M.D.Edward Yang, M.D.
not-for-profithttp//www.hwbf.org13th Annual
Meeting McCormick Place E266Chicago, ILMarch
23, 2005AGENDA

• Annual Report
• Data Collection
• Educational Archives
• Meetings
• By-Laws
• Certification

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Registries - Why?

• "Maintenance of an active registry must be viewed
  as important as the medical care rendered, if the
  right person is going to receive the right
  treatment in a timely fashion without undue cost
  to society.
• Gillot et al, Development of a Statewide Trauma
  Registry, J Trauma 291667, 1989

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Registries - Why?

• It is our professional responsibility to try to
  continuously improve our performance, which
  cannot be done without the collection of end
  result information.
• Swiontkowski M, Why we should collect outcomes
  data, JBJS 35A Supplement 114 2003

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Data QualityPolitical Factors

• Health Info Tech Success
• 80 dependent on political factors
• 20 dependent on info technologyReed Gardner
  1998 Past President of AMIA

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Data Collection - Why?

• "The future belongs to whoever best measures
  quality of care and then markets it best.
• Whoever does will absolutely control the market,
  and everyone who doesn't will disappear."
• Richard L. Scott, Esq, former CEO Columbia/HCA
  HealthCare Corp.

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Data Collection - Why?

• "Tens of millions of dollars have been spent in
  the establishment of trauma databases over the
  past 15 years. Much data is gleaned from ICD
  entries into administrative databases.
• The emphasis here is for maximum reimbursement.
  Because of the lack of clinical detail the data
  within these registries, the data is inadequate
  for sophisticated research and outcome analysis.
  "
• Cushing, Champion - J TRAUMA 1995

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Open Tibia Fracture ICD 823.3

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Practice Profiling
Data Collection by Default

• Pennsylvania Health Care Cost Containment Council
  
• Maine Quality Forum
• Medicare Hospital Quality Initiative

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Data Collection How?
UMC HOSPITAL Records
Vanderbilt Medical Center 13,199
Elmhurst Hospital Center 10,886
Bellevue Hospital Center 6983
Detroit Receiving Hospital 6636
Hartford Hospital 4262
Hennepin County Med Ctr 1043
Norfolk Norwich (UK) 633
Southern Illinois University 456
Denver General Hospital 450
MIEMSS 168
University of Geneva 46
Rhode Island Hospital 0
Maricopa County Hospital 0
Grady Memorial 0
Henry Ford Hospital 0
TOTAL 44,762
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Data Collection How?HWB Shortfall Not Unique

• Electronic Medical Record - a cresting wave for
  30 years - has not broken.
• 10 adoption - Berner et al, JAMIA Feb 2005

Katsushika Hokusai wood engraving "The Great
Wave off Kanagawa" - cerca 1830
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Data Collection How?President Bush State of
the Union

• Proposes all Americans have an EMR in 10 years to
  prevent medical errors and needless costs.
• Spend 125 million
  to get the job done.
• 
  
  http//www.jibjab.com

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Data Collection Failure - Causes JAMIA Feb
2005

• EMR Problems
• Malaligned Incentives
• Product Viability
• Data Quality
• Standards - Interoperability

13
Data Collection Failure - Causes JAMIA Feb
2005

• Malaligned Incentives
• Minimal Return On Investment
• with
• Information vs Imaging technology.
• CT study billable - not EMR data.

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Data Collection Failure - Causes JAMIA Feb
2005

• Malaligned Incentives - Rx
• Indirect Reduction
• through Practice Management Integration
• Billing
• Reporting
• Scheduling
• Transcription
• Archiving

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Data Collection Failure - Causes JAMIA Feb
2005

• Malaligned Incentives Rx
• Indirect Reduction
• through facilitation of
• Risk Adjusted Practice Profiling
• Error Checking - Liability Reduction
• RRC Certification
• Academic Promotion

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Data Collection Failure - Causes Leape,
Massachusetts Plan, NPR 02/04/05

• Malaligned Incentives Rx
• 3rd Party Payors to purchase MD EMR.
• EMR Cost _at_ 35,000/MD (800 million)
• 3rd Party Savings ( 5 billion) through
• fewer errors and complications
• fewer inappropriate tests
• fewer inappropriate meds
• fewer billing errors

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Data Collection Failure - Causes JAMIA Feb
2005

• EMR Problems
• Malaligned Incentives
• Product Viability
• Data Quality
• Standards - Interoperability

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Database Production and Maintenance Engh et al.
CORR 421 April 2004Product Viability

• 1977
• Starts porous coated THA stem.
• Seeks documentation of outcomes.
• Data stored on paper forms in a physical chart.

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Database Production and Maintenance Engh et al.
CORR 421 April 2004 Product Viability

• 1983 1992
• Starts electronic archiving - 1 data entry person
• dBASE II (Ashton-Tate)
• dBASE III
• dBASE IV

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Database Production and Maintenance Engh et al.
CORR 421 April 2004 Product Viability

• Early 1990's
• Need
• Automated data entry
• Standardized classifications and outcomes
• dBASE IV to International Documentation and
  Evaluation System (IDES) migration

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Database Production and Maintenance Engh et al.
CORR 421 April 2004 Product Viability

• Mid 1990's
• IDES does not allow local modification.
• IDES to FoxPro 2.6 migration with
• Customized scanable forms.
• Codes for a comprehensive Orthopedic Research
  Database (ORDB)
• Third-party applications to facilitate data
  entry, maintenance, and report generation.

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Database Production and Maintenance Engh et al.
CORR 421 April 2004Product Viability

• 2004
• 3rd party apps not compatible with new FoxPro
• FoxPro 2.6 no longer supported by Microsoft
• FoxPro 2.6 not compatible with Windows XP.
• Database not reflecting contemporary clinical
  concerns
• Currently migrating to another database
  application.

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Database Production and Maintenance Engh et al.
CORR 421 April 2004Product Viability

• Summary
• 7 major database changes in 21 years
• associated data corruption/loss
• 50,000 - estimated annual data entry
  maintenance cost ( does not include the surgeons
  time).
• New upgrades will substantially increase annual
  cost.
• Consider saving the paper.

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Database Production and Maintenance HWB
Experience Software Changes in 12 yearsProduct
Viability

• 5 major database changes in 12 years
• Hypercard 1.0
• Fox Pro 2.5
• Visual Fox Pro 3.0
• FileMaker Pro
• MySQL PHP
• 4 major front-end changes in 12 years
• Hypercard 1.0
• Hypercard 2.0
• Metacard 2.5
• HTML

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Database Costs
Database Cost Cases FTEs
Mayo 1972 CORR 344 400,000/yr 56,000 5
TRACS 1995 NTDB 400,000/yr 1,000,000 3
Brigham 1970 JBJS 82A 350,000/yr 15,000 7
AORI 1977 CORR 421 50,000/yr 8000 1
Mass EMR NPR 02/04/05 35,000/GP -- 1
HWB 1993 www.hwbf.org 12,700/yr 45,000 --
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Data Collection Failure - Causes JAMIA Feb
2005

• EMR Problems
• Malaligned Incentives
• Product Viability
• Data Quality
• Standards - Interoperability

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Data Quality

• "It has become increasingly clear that much of
  the clinical research that has long been
  published and on which we base much of our
  education and practice activity is, in fact,
  severely flawed."Keller, SPINE 20 384 1995
• OTA Specialty Day Debate 1999
• Swiontkowski

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Data Quality Tang, Shortliffe et al, JAMIA Proc
1994

• An observational study of physicians using 168
  medical records in an internal medicine
  outpatient clinic
• 81 of cases failure of chart to provide all
  information deemed necessary by the physician for
  appropriate management of the patient.
• 38 of a clinic encounter is taken up by chart
  review.

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Data QualityGIGO

• What is written without pain is in general read
  without pleasure
• Samuel Johnson 1709-1784
• The quality of the data begins with the diligence
  of those who generate it.
• Charles Engh - CORR 421

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Data Quality Barrie, Marsh, BMJ. 1992

• Manchester physician-entered orthopaedic
  database
• Data Quality
• Completeness X Accuracy
• 62 96

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Data QualityPolitical Factors

• Health Info Tech Success
• 80 dependent on political factors
• 20 dependent on info technologyReed Gardner
  1998 Past President of AMIA

32
Data QualityPolitical Factors

• 2 surgeons over 55 have a major interest in
  orthopaedic trauma.
• As it is these surgeons who tend to be
  politically influential it is clear that
  orthopaedic trauma is considerably disadvantaged.

JBJS 1997 79B1, Court-Brown, McQueen Editorial
Trauma management in the UK
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Data Quality Prospective vs. Retrospective

• Do clinical databases give rise to
• retrospective paper mills ?

34
Data Quality Random vs. Non-Random

• Prospective randomized trials are well-proven for
  evaluating pharmaceuticals.
• Different hands administering a pill, however,
  have less influence on the result than different
  hands performing a surgical procedure.
• Matta JOT August 2001

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Prospective vs. Retrospective Swiontkowski, JOT
2001 Aug

• Because of the difficulty with performing
  high-quality control trials, observational
  studies are often the best evidence we have.
• However
• When orthopaedists rely on these weaker forms of
  evidence, they must acknowledge the risk of
  utilizing a suboptimal or potentially even
  detrimental intervention for patients.

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Prospective vs. Retrospective Benson et al, NEJM
- June 22, 2000

• Observational study advantages over PRCT
• lower cost
• greater timeliness
• a broader range of patients
• However
• Bias is a problem
• Some say
• observational studies are not reliable.
• observational studies should not be funded.
• observational studies should not be published.

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Prospective vs. Retrospective Bhandari et al,
Arch Orthop Trauma Surg. 2004 Jan

• Femoral Neck Fx
• THA vs ORIF
• 14 randomized vs
• 13 non-randomized

THA Random Non-Ran
Mort 1.04 1.44
Rev Redn 0.38 0.23

• Non-randomized studies
• Over estimated THA risk - mortality 40
• Under estimated THA benefit - revision reduction
  20

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Prospective vs. Retrospective Benson et al, NEJM
- June 22, 2000

• 136 reports about 19 diverse treatments
• We found little evidence that estimates of
  treatment effects in observational studies
  reported after 1984 are either consistently
  larger than or qualitatively different from those
  obtained in randomized, controlled trials

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Prospective vs. Retrospective Concato et al,
NEJM - June 22, 2000

• 99 reports about 5 clinical topics
• The results of well-designed observational
  studies (with either a cohort or a case-control
  design) do not systematically overestimate the
  magnitude of the effects of treatment as compared
  with those in randomized, controlled trials on
  the same topic.

40
Prospective vs. Retrospective Tornetta et al,
OTA 2000

• Randomized trials are subject to Beta (Type II)
  error - insufficient sample size.
• Beta (Type II) error is the probability of
  concluding that no difference between treatment
  groups exists, when, in fact, there is a
  difference.
• The beta (Type II) error rate for randomized
  trials in orthopaedic trauma is exceedingly high,
  averaging 90.

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Prospective vs. Retrospective Sarmiento, JOT
2001 Aug

• There is not a system today, and there will not
  be a system tomorrow, that will guarantee the
  elimination of intended or unintended bias or
  prejudice from the medical literature.
• That being the case, let us accept outcome
  studies as well as traditional retrospective
  ones.

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Data Quality End User Impact
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Data QualityEMR Design - Embi, JAMIA April 2004

• End User Impact
• Portland VAH
• Documentation Availability
• Work Processes and Communication
• Alterations in Document Structure and Content
• Mistakes, Concerns, and Decreased Confidence

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Data QualityPatel, JAMIA November 2000

• End User Impact
• EMR use changes physician information gathering
  and reasoning strategies.
• Technology has a profound influence in shaping
  cognitive behavior.
• Effects on cognition by technology design needs
  to be explored.

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Data QualityAMNews Feb. 17, 2003

• End User Impact
• EMR Rejection - Cedars Sinai Revolt
• "They poorly designed the system, poorly sold it
  and then jammed it down our throats and had the
  audacity to say everybody loves it and that it's
  a great system.
• Cedars-Sinai Medical Center in Los Angeles has
  indefinitely suspended use of its computerized
  physician order entry (CPOE) system, after
  hundreds of doctors complained it was difficult
  to use and compromised patient safety
• Los Angeles Times

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Data Collection Failure - Causes JAMIA Feb
2005

• EMR Problems
• Malaligned Incentives
• Product Viability
• Data Quality
• Standards - Interoperability

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Standards Interoperability Open Source

• ?? Solution ?? - Open Source Software e.g.
  Linux
• PROS
• Low Cost - Free
• Stable
• Could provide essential infrastructure
• US Interstate Highways System
• Internet Transmission Control Protocol / Internet
  Protocol
• Public Library of program components
• CONS
• Difficult to program and obtain local support
• Microsoft buys IT lunch Significant kickbacks
  barriers

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Standards Interoperability Open Source

• ?? Solution ?? - Open Source Software e.g.
  Linux
• PROS
• Low Cost - Free
• Stable
• Could provide essential infrastructure
• US Interstate Highways System
• Internet Transmission Control Protocol / Internet
  Protocol
• Public Library of program components
• CONS
• Difficult to program and obtain local support
• Microsoft buys IT lunch Significant kickbacks
  barriers

49
Summary EMR Potential
benefits risks
Availability Workflow integration Cognitive enhancement Legibility Connectivity Remote Access Error checking Expiration Workflow disruption Cognitive impairment Data fog Diminished privacy Cultural demise Error propagation
50
Data Collection How?
UMC HOSPITAL Records
Vanderbilt Medical Center 13,199
Elmhurst Hospital Center 10,886
Bellevue Hospital Center 6983
Detroit Receiving Hospital 6636
Hartford Hospital 4262
Hennepin County Med Ctr 1043
Norfolk Norwich (UK) 633
Southern Illinois University 456
Denver General Hospital 450
MIEMSS 168
University of Geneva 46
Rhode Island Hospital 0
Maricopa County Hospital 0
Grady Memorial 0
Henry Ford Hospital 0
TOTAL 44,762
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Conclusion Hill, NEJM 1953

• "One must go seek more facts, paying less
  attention to technique of handling the data and
  far more to the development and perfection of the
  method for obtaining them."

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Revised HWB Mission Statement

• The mission of the HWB foundation is to find
  methods to routinely collect well-specified,
  structured and privacy-protected clinical data
  from reliable sources and make that data, in
  quantities of statistical significance, available
  in the public domain where it may be interpreted
  from all points of view.