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Hippocrates, Winslow

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Title: 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.org12th Annual
Meeting Renaissance HotelWashington,
DCFebruary 24, 2005AGENDA
  • Annual Report
  • Data Collection
  • Educational Archives
  • Meetings
  • By-Laws
  • Certification

2
HWB Mission Statement
  • The mission of the HWB foundation is to collect
    uniform and well specified clinical data in the
    form of text and graphics from reliable,
    university-affiliated sources and make that data,
    in quantities of statistical significance,
    available in the public domain.
  • There, in an electronic bulletin board database
    format, collected data may be evaluated and
    re-evaluated by any party - particularly
    university affiliated research groups.
  • The foundation endeavors to establish a new
    pattern of research whereby instead of the basic
    data being available only in small samples within
    the purview of a select few determined to make a
    specific case - an open database deriving input
    from multiple sources is created to permit a
    larger sample size with equal access from all
    points of view. Thus, enhanced validation of the
    reporting is possible.

3
Data Collection - 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

4
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.

5
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

6
Open Tibia Fracture ICD 823.3

7
Practice Profiling
Data Collection by Default
  • Pennsylvania Health Care Cost Containment Council
  • Maine Quality Forum
  • Medicare Hospital Quality Initiative

8
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
9
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
10
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

11
Data Collection Failure - Causes JAMIA Feb
2005
  • EMR Problems
  • Malaligned Incentives
  • Product Viability
  • Data Quality
  • Standards - Interoperability

12
Data Collection Failure - Causes JAMIA Feb
2005
  • Malaligned Incentives
  • Minimal Return On Investment
  • with
  • Information vs Imaging technology.
  • CT study billable - not EMR data.

13
Data Collection Failure - Causes JAMIA Feb
2005
  • Malaligned Incentives - Rx
  • Indirect Reduction
  • through Practice Management Integration
  • Billing
  • Reporting
  • Scheduling
  • Transcription
  • Archiving

14
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

15
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

16
Data Collection Failure - Causes JAMIA Feb
2005
  • EMR Problems
  • Malaligned Incentives
  • Product Viability
  • Data Quality
  • Standards - Interoperability

17
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.

18
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

19
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

20
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.

21
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.

22
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.

23
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

24
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 --
25
Data Collection Failure - Causes JAMIA Feb
2005
  • EMR Problems
  • Malaligned Incentives
  • Product Viability
  • Data Quality
  • Standards - Interoperability

26
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

27
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.

28
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

29
Data Quality Barrie, Marsh, BMJ. 1992
  • Manchester physician-entered orthopaedic
    database
  • Data Quality
  • Completeness X Accuracy
  • 62 96

30
Data QualityPolitical Factors
  • Health Info Tech Success
  • 80 dependent on political factors
  • 20 dependent on info technologyReed Gardner
    1998 Past President of AMIA

31
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
32
Data Quality Prospective vs. Retrospective
  • Do clinical databases give rise to
  • retrospective paper mills ?

33
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

34
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.

35
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.

36
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

37
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

38
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.

39
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.

40
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.

41
Data Quality End User Impact
42
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

43
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.

44
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

45
Data Collection Failure - Causes JAMIA Feb
2005
  • EMR Problems
  • Malaligned Incentives
  • Product Viability
  • Data Quality
  • Standards - Interoperability

46
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

47
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
48
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
49
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."

50
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.

51
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52
HWB Finances
 Item 2004   2003  2002  2001  2000  1999
 Annual Mtg   3227.56  1640.01   1091.16  1532.93  1516.86  556.62
 Bank Charges  00.00   26.13  12.96  34.55  77.08  107.57
 Contribution 20,225.00  18,500.00  52,400.00  33,300.00  4050.00  5200.00
 AMIA Dues 450.00   525.00  450.00  375.00  375.00  365.00
 Consult 2378.00  100.00  30,000.00  30,000.00  00.00  00.00
 Hardware 211.09   40.50  1038.75  00.00  391.50  00.00
 Legal fees  00.00  00.00  00.00  00.00  00.00  00.00
 Library 44.43  00.00  00.00  00.00  00.00  00.00
 Maintenance 00.00  00.00  00.00  00.00  00.00  00.00
 Office Eqpt 00.00  00.00  00.00  00.00  00.00  34.32
 Software 770.00  00.00  990.43  00.00  229.90  22.00
 Telephone/ISP 1038.93  1147.48  1138.60  1081.42  1174.99  763.19
 Total Outflows 8158.81  3929.12  34,729.90  33,023.90  3765.33  1848.70
 Total Inflows 20,225.00 18,500.00  52,400.00  33,300.00  4050.00  5200.00
 Balance (EOY) 57,680.71 45,614.52  31,543.64  13,365.54  13,019.44  12,804.77
53
HWB Benefactors
Michael Baumgaertner
Robert Day
Sol Frankel
Nadubeethi Jayaram
David Husian
Edward Jones
Robert Keller
Richard Lampert
Henry Mankin
Mark McAndrew
OTA
Henry Sprague
Marc Swiontkowski
Peter Trafton
Daniel Willett
Edward Yang
Joseph Zuckerman
54
Database Costs
Database Cost Cases FTEs
Mayo CORR 344 400,000/yr 56,000 5
Brigham JBJS 82A 350,000/yr 15,000 7
AORI CORR 421 50,000/yr 8000 1
Mass EMR NPR 02/04/05 35,000/GP -- 1
HWB www.hwbf.org 12,700/yr 45,000 --
55
Data QualityPolitical Considerations
  • 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

56
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