What the Future Holds for Bariatric Quality Management

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Beyond Centers of Excellence

• What the Future Holds for Bariatric Quality
  Management

Gail D. Hughes, Dr.P.H., M.P.H. Vice
President, Research
2007 Texas Managed Care Conference and Tradeshow
- October 16, 2007
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Surgical Review Corporation
Purpose of Formation Patient Safety and
Advocacy Our Mission To promote the delivery of
bariatric surgical care with the highest levels
of efficacy, efficiency and safety
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U.S. CDC Obesity trends in the U.S.
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Adapted from CONTROVERSIAL CARE - To Heal
Diabetes, Doctors Push Weight-Loss Surgery
Studies Suggest Benefit For Bariatric Procedure
Debate on Cost, Science. Ron Winslow, The Wall
Street Journal Online, August 22, 2007 Page A1.
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Adapted from CONTROVERSIAL CARE - To Heal
Diabetes, Doctors Push Weight-Loss Surgery
Studies Suggest Benefit For Bariatric Procedure
Debate on Cost, Science. Ron Winslow, The Wall
Street Journal Online, August 22, 2007 Page A1.
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Is Bariatric Surgery Safe?
Adapted from Dimick J.B., Welch H.G., Birkmeyer,
J.D. Surgical mortality as an indicator of
hospital quality. JAMA 2004 292847-51.
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Features of Research at SRC

• RAC and Research Consortium
• Thoughtful input and experienced guidance to
  establish research policy, protocols, and
  directives
• Grant funding
• Proposals for funding novel bariatric research
  initiatives supported by government as well as
  private foundation agencies
• Clinical Trials
• A centralized, streamlined process for
  implementing bariatric surgery clinical trials at
  BSCOE

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Research Initiatives at SRC

• BOLD
• An efficient, user-friendly, patient outcomes
  tracking archivable database
• Detailed Adverse Events Analysis
• Comprehensive analysis of sentinel adverse
  events with root cause determinations
• Data Management, Reporting and Distribution
• Secure, archivable database for the maintenance,
  storage and distribution of all data

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The RAC is Guiding the SRC Research Consortium

• Each BSCOE is being asked to join the Research
  Consortium
• The RAC and the Consortium will serve as a
  platform for clinical studies, clinical trials
  and data analysis
• Goal to create evidence-based clinical pathways
• Research findings will be utilized to enhance
  BSCOE criteria

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SRCs Research Advisory Committee
Research Division
Research Advisory Committee (RAC)
Eric DeMaria, M.D., FACS Walter Pories, M.D.,
FACS Harvey Sugerman, M.D., FACS Bruce Wolfe,
M.D., FACS
Sub committees
Research Consortium
Clinical trials Publications Grants Funding
Ancillary Research
Bariatric Surgery Centers of Excellence
(BSCOE) Surgeons Institutions
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Research at SRC An Overview

• Surgical Review Corporations Research Division
  was established by the ASMBS to
• Collect, track, and measure data on bariatric
  patients across the United States as well as
  countries throughout the world
• Develop clinical practice guidelines
• Conduct clinical research
• Conduct clinical trials
• research related to the surgical care of the
  obese.

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Volume for all Bariatric Surgeries at 235 SRC
Full Approval BSCOE Hospitals
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Bariatric Surgery Centers of Excellence Aggregate
Data
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Gender for all Bariatric Surgeries at 235 SRC
Full Approval BSCOE Hospitals
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Race and Ethnicity for all Bariatric Surgeries at
235 SRC Full Approval BSCOE Hospitals
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Age for all Bariatric Surgeries at 235 SRC Full
Approval BSCOE Hospitals
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Payer information for all Bariatric Surgeries at
235 SRC Full Approval BSCOE Hospitals
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Patient outcomes for all Bariatric Surgeries at
235 SRC Full Approval BSCOE Hospitals
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Summary of BSCOE Data to date
Analysis of 235 BSCOE Hospitals
demonstrated ? Strong preferences for type
of surgery ? Clearly evident patient and payer
data trends ? Quality surgical metrics
realized ? Excellent patient outcomes
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Yes, but what about.
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Texas Overweight and Obesity Statistics
GENERAL STATISTICS
In 2006, an estimated 10.1 million or 62 of
Texas adults were overweight or
obese. If the current trends continue, 20
million or 75 percent of Texas adults might be
overweight or obese by the year 2040. Texas
costs could quadruple from 10.5 billion today to
as much as 39 billion by 2040.
Source U.S. CDC
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Texas Overweight and Obesity Statistics
GENERAL STATISTICS
A report released in 2005 found that Texas
reported it had the 6th highest prevalence in
adult obesity in the U.S., with an average of
25.3 of the adult population obese between 2002
and 2003. According to the Texas Department of
State Health Services overweight and obesity are
more pronounced among men, minorities and
middle-aged.
Source U.S. CDC
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SRC BSCOE Hospital Surgical Volume () in Texas
(n 16) versus national average (n 235)
Gastric bypass, open
Gastric bypass, laparoscopic
Adjustable band
Revisions
All others
Texas
59.65 10.60 21.00 5.12
3.63
National average
60.51 21.44 12.49 3.24
2.32
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SRC BSCOE Hospital Patient Demographics in Texas
(n 16) versus national average (n 235)
Average Minimum Age (yrs)
Average Maximum Age (yrs)
Mean Age (yrs)
Male ()
Female ()
Texas
13 87 16.94 42.55 70.88

National average
17 83 18.43 43.04 68.26

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SRC BSCOE Hospital Patient Race/Ethnicity in
Texas (n 16) versus national average (n 235)
Caucasian
Hispanic
Asian
Native American
African American
Undefined
Texas
62.05 19.40 17.47 0.17
0.12 0.79
National average
59.45 10.69 4.52 0.24
0.09 25.01
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SRC BSCOE Hospital Payer Demographics in Texas
(n 16) versus national average (n 235)
Private Insurance
Other Insurance
Uninsured/ Self-pay
CHAMPUS
Undefined
Medicaid
77.10 1.40 5.79 12.02
0.10 3.58
Texas
National average
77.87 8.96 5.95 0.00
5.25 1.97
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SRC BSCOE Hospital Outcomes in Texas (n 16)
versus national average (n 235)
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What Is
?
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Basically
is

• a BSCOE compliance monitoring and reporting
  system
• a means of offering evidence-based validation of
  the safety and efficacy of bariatric surgery
• a source of credible and accessible data to
  convince payors of the value and effectiveness of
  bariatric surgery
• a data collection and reporting tool for
  bariatric surgery research
• NOT an Electronic Medical Record (EMR)

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Primary Research Focus BOLDTM

• A user-friendly, intuitive interface collecting
  large volumes of data to support in-depth
  statistical analyses
• All data element definitions are compatible with
  NIDDK LABS and Society for Thoracic Surgery
• In addition, it is fully compliant with HIPAA and
  other patient privacy requirements

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BOLDTM

• Designed to collect basic outcomes data required
  to maintain designation as a BSCOE
• All BSCOE participants will be required to enter
  their information in the BOLDTM format
• BOLD will eventually replace the BSCOE
  application for the BSCOE renewal process

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BOLDTM captures comprehensive clinical information
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Reports

• Adverse Event/Complications
• Medications Status
• COE Compliance Reporting
• Payor Mix and Reimbursement
• and many more

• Encounter Forms
• Patient Status
• Surgical Volume
• Co-morbidity Improvement/Resolution
• Aggregate Weight Loss by Procedure

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Preoperative Co-morbidities
Data User
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Postoperative Co-morbidities (Continued)
Data User
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Hospital Stay Adverse Events
Data User
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Post-discharge Adverse Event
Data User
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An Average Week at a Bariatric Program
Day Activity Average Data Entry
Time Monday Clinic (average 8 preoperative
visits) 40-45 minutes total Tuesday OR (4
surgeries) 7-10 minutes total Wednesday OR (4
surgeries) 7-10 minutes total Thursday Clinic
(average 25 postoperative visits) 20-25 minutes
total Friday OR (2 surgeries) Clinic (meetings
etc.) 10-15 minutes total Totals 1 ½ - 2
hours weekly No additional data entry time if
using a participating third-party bariatric
software vendor to automatically transmit your
data to SRC.
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Third-party Software
Will
work with my existing bariatric database?
SRC is offering a data integration interface to
interested third-party software vendors to enable
transmission of program data to BOLD without the
need for duplicate data entry.
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BOLDTM Outcomes Risk Stratification and Adverse
Events

• BOLD will track complications and adverse events
  in an effort to identify risk factors and develop
  risk stratification guidelines
• Upon entering an adverse event, a new series of
  queries will appear to gather information on the
  details of the adverse event

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Risk Stratification
Risk factors for perioperative death can be
separated into (A.) Patient characteristics
(B.) Complications The access method, open
versus laparoscopic, is not independently
predictive of death. However, operation type,
i.e., proximal versus long limb, is predictive.
Impact of major co-morbidities on mortality and
complications after gastric bypass.  Jamal, M,
DeMaria, E, Johnson, E, Carmody, B, Wolfe, L,
Kellum, B, Meador, J. Surgery for Obesity and
Related Diseases,  Vol.1, Issue 6, Pages 511-516,
2005.
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Risk Stratification (contd.)
Current data do not suggest that superobese
patients (BMI gt50) should not undergo
surgery. However, these patients are high risk
for early death due to their body weight and
co-morbidities without surgery. Surgery should
not be reserved as a desperate last measure for
weight loss in any indicated population.
Multivariate Analysis of Risk Factors for Death
Following Gastric Bypass for Treatment of Morbid
Obesity. Fernandez, AZ Jr, Demaria, EJ,
Tichansky, DS Kellum, JM, Wolfe, LG, Meador, J
Sugerman, HJ. Annals of Surgery. 239(5)698-703,
May 2004.
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Co-Morbidity Scale
The co-morbidity scale used in BOLD was created
by the SRC RAC and through the concerted efforts
of Bariatric surgeons, Bruce Wolfe, M.D. and
Mohamed Ali, M.D. NIH/NIDDK/LABS
co-investigators Representatives from national
health plans
Assessment of Obesity-Related Comorbidities A
Novel Scheme for Evaluating Bariatric Surgical
Patients.  Ali, M, Maguire, M, Wolfe, B. Journal
of the American College of Surgeons, Vol.
202, Issue 1, Pages 70-77, 2006.
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Co-Morbidity Scale
The co-morbidity scale provides a quantifiable
measure of the effect of bariatric surgery on
co-morbidities longitudinally over time. The
scale guides SRC in setting new standards for its
BSCOE program. The scale has direct importance
to payers and legislators regarding the value and
efficacy of bariatric surgery.
Assessment of Obesity-Related Comorbidities A
Novel Scheme for Evaluating Bariatric Surgical
Patients.  Ali, M, Maguire, M, Wolfe, B. Journal
of the American College of Surgeons, Vol.
202, Issue 1, Pages 70-77, 2006.
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BOLDTM drills down into clinical complications
Data User
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BOLDTM Outcomes Detailed Adverse Events Analysis

• Detailed analysis of adverse events will target
  the root cause of the problem
• The goal is improved clinical outcomes and
  prevention of future adverse events
• This will benefit the patients, doctors,
  hospitals and payers

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BOLDTM analytically follows patient performance
and outcomes
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Summary

• Patient safety is still paramount and must remain
  that way
• Other medical specialties starting to take
  notice bariatric surgeons recognized for their
  efforts
• Overwhelming support by ASBS members has taken
  the program to a new level
• This enables us to do more!
• Establishing centers, compliance with standards
  and access to care still important

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Summary

• Data and research is new focus
• Goal data must be given to those who can
  improve from it
• With data, SRC is taking a more aggressive stance
  with payors
• Communications keeping everyone informed
  vital to the success of the program
• Let us hear from you. Good, bad or otherwise!
• Keep on doing an excellent job. It makes our
  job easier.

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Summary

• Through BOLD, the SRC Research Division will
• ? Provide detailed adverse events analyses
• ? Generate risk stratification protocols
• ? Promote increased safety
• ? Help to achieve better patient outcomes

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For More Information on Research at SRC
www.surgicalreview.org [phone]
gail.hughes_at_surgicalreview.org