The PCORnet Bariatric Study: Comparing effectiveness of the 3 most common weight loss procedures - pcori

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The PCORnet Bariatric Study: Comparing effectiveness of the 3 most common weight loss procedures - pcori
The PCORnet Bariatric Study: Comparing effectiveness of
the 3 most common weight loss procedures

Kathleen M. McTigue, MD MPH             Neely Williams, MDiv
Associate Professor of Medicine,        Community co-Principal Investigator, Mid-South Clinical
Epidemiology & Clinical/Translational   Research Network & Meharry-Vanderbilt Alliance
Science, University of Pittsburgh       Community Partner

                                                                                  #PCORI2018
The PCORnet Bariatric Study: Comparing effectiveness of the 3 most common weight loss procedures - pcori
Kathleen McTigue
Neely Williams
• Have nothing to disclose.

2 • November 17,
2018
The PCORnet Bariatric Study: Comparing effectiveness of the 3 most common weight loss procedures - pcori
Acknowledgements
• PCORI
• Core Scientific Team
      •   David Arterburn: Lead PI, clinician researcher
      •   Kathleen McTigue: Co-PI, clinician researcher
      •   Neely Williams: Co-PI, patient partner
      •   Karen Coleman: Researcher
      •   Cheri Janning: Patient investigator
      •   Anita Courcoulas: Surgeon investigator
      •   Darren Toh: Distributed analyst
      •   Jane Anau: Project manager
      •   Roy Pardee: Informatician
      •   Robert Wellman: Analyst
      •   Yates Coley: Analyst
      •   Andrea Cook: Analyst
• Stakeholder Advisory Board
• PCORnet CDRN & Coordinating Center teams

3 • November 17,
2018
The PCORnet Bariatric Study: Comparing effectiveness of the 3 most common weight loss procedures - pcori
Objectives
At the conclusion of this activity, the participant should be able to:
• Describe how the 3 most common US weight loss procedures
  compare in terms of weight loss, improvement in diabetes risk, &
  adverse events
• Explain how stakeholder engagement contributed to the project
• Make more informed decisions about which bariatric procedure
  may be right for a patient considering weight loss surgery

4 • November 17,
2018
The PCORnet Bariatric Study: Comparing effectiveness of the 3 most common weight loss procedures - pcori
Background
• Severe obesity is a serious health concern
  affecting 7.7% of Americans
      • Use of bariatric surgery has expanded considerably
                                                             (SG)

      • Sleeve gastrectomy procedure has been used
        increasingly over past decade – despite a lack of
        data comparing its effectiveness to other
        procedures
• PCORnet provided a unique opportunity to use
  real-world health data from 45 health systems
  to compare bariatric procedures
5 • November 17,
2018
The PCORnet Bariatric Study: Comparing effectiveness of the 3 most common weight loss procedures - pcori
How did stakeholders contribute to the research idea?
• PCORnet Obesity Task Force (2014) – Patients, clinicians & researchers
  prioritized obesity research topics. PCORI then released a funding
  announcement focusing on weight loss surgery.
• At PBS kick-off meeting, requested two major changes to science:
   • Do three pair-wise comparisons of bariatric procedures, as opposed to
     two pair-wise comparisons
   • Interview bariatric surgeons as part of qualitative aim – not just conduct
     patient focus groups
Study activities were carried out, with stakeholder input on data collection &
interpretation.

6 • November 17,
2018
The PCORnet Bariatric Study: Comparing effectiveness of the 3 most common weight loss procedures - pcori
How did our stakeholders help us develop & execute our
scientific aims?
• Reviewed plans to identify cohort.
    • Includes reviewing diabetes medication lists and bariatric surgery
      procedure codes.
• Using the same process as investigators, prioritized analyses of patient
  sub-groups. Final rankings were decided by investigators & stakeholders.
• Actively participated in development of focus group & surgeon interview
  templates.

7 • November 17,
2018
The PCORnet Bariatric Study: Comparing effectiveness of the 3 most common weight loss procedures - pcori
Among 46,510 patients from 22 states whose data
contributed to weight loss analyses…
• Most procedures were bypass or sleeve
      • 24,982 RYGB (53%)
      • 18,961 SG   (41%)
      • 2,567 AGB (6%)
• The sample was, on average, middle-aged, mostly female & fairly
  racially/ethnically diverse
      • Mean age 46; 80% female; 21% Hispanic; 21% African American
• Patients were severely obese
      • Mean BMI: 49 kg/m2 with 38% BMI 50+ kg/m2
• Comorbidities were common
      • 60% HTN; 49% Dyslipidemia; 49% OSA; 40% GERD; 37% T2DM
8 • November 17,
2018
SG & RYGB led to substantial weight loss, which reached a
nadir by 1.5 years of follow-up. AGB was less effective.
                                                   Weight
                                                   Regain

                                                   3.6 kg ↑
                     AGB

                      SG                           8.2 kg ↑

                                                   7.6 kg ↑
                     RYGB

9 • November 17,
2018
RYGB & SG showed similar DM Remission rates; both led to
more remission than AGB

                    Adjusted cumulative remission (%n)
                                                                                       RYGB
                                                                                       SG
                                                                                       AGB

                                                         0   1     2    3    4     5

                                                             Years since surgery
10 • November 17,
2018
Cumulative relapse was ~67% lower for RYGB (HR 0.32) or
SG (HR 0.33) patients compared with AGB patients
      Adjusted cumulative remission (%n)

                                                               RYGB
                                                               SG                             AGB
                                                                                             AGB
                                                               AGB                           SG
                                                                                             SG
                                                                                              RYGB

                                                                                             RYGB
                                           0   1   2   3   4     5        0      1   2   3   4      5
                                                           Years since surgery

11 • November 17,
2018
RYGB patients had 25% lower relapse rate than SG patients
(HR 0.75, 95% CI: 0.67-0.84)
      Adjusted cumulative remission (%n)

                                                               RYGB
                                                               SG                             AGB
                                                                                             AGB
                                                               AGB                           SG
                                                                                             SG
                                                                                              RYGB

                                                                                             RYGB
                                           0   1   2   3   4     5        0      1   2   3   4      5
                                                           Years since surgery

12 • November 17,
2018
RYGB had the largest & most persistent impact on HbA1c

                    Adjusted HbA1c ∆ from Baseline
                                                                                                             ∆ HbA1c
                                                                         AGB                                 -0.42% (-0.78, -0.05)

                                                                                                             -0.45% (-0.63, -0.27)
                                                                         SG
                                                                         RYGB

                                                     0   0.5   1   1.5   2     2.5   3   3.5   4   4.5   5
                                                                     Years since surgery
13 • November 17,
2018
Adverse event analyses were restricted to a subset of sites:

• Health systems with existing linkages to insurance claims & death
  data or sites with sufficient samples & ability to link to claims &
  death data
• 34,089 adults from 10 sites in 5 CDRNs
• Focus here on 5-year outcomes:
      • Reoperation
      • Reoperation with endoscopy
      • Rehospitalization
      • Mortality

14 • November 17,
2018
Adjusted 5-year Adverse Events

                                                SG         RYGB        AGB
                    blank                    (n=15504)   (n=18056)   (n=1154)
             Any reoperation                   18%         20%         28%
             Any reoperation or endoscopy      23%         30%         31%
             Rehospitalization (all cause)     33%         38%         42%
             Death (all cause)                0.84%       0.89%       1.08%

15 • November 17,
2018
Limitations
• Confounding that may have persisted despite covariate & propensity score
  adjustment
• Missing BMI, HbA1c data may introduce bias
      • Sensitivity analyses suggest missing data were unlikely to change the interpretation
        of our main results
• Comorbid health conditions identified from ICD-9 may underestimate
  prevalence, can be inaccurately coded, & do not account for severity
• AGB procedure under-represented as often carried out in small ambulatory
  surgical centers
• DM medication use estimated from prescribing data, not dispensing, &
  does not account for adherence
16 • November 17,
2018
Conclusions
• Among patients from diverse clinical & geographical settings, SG &
  RYGB led to substantial weight loss & improvements in diabetes
      • Plus superior weight loss & diabetes outcomes, and less reoperation,
        reintervention and rehospitalization than AGB
• Compared with SG, RYGB resulted in:
      •   Moderate additional weight loss
      •   Overall, similar rates of DM remission
      •   Larger & more persistent improvement in glycemic control
      •   Lower rates of diabetes relapse
      •   More reoperation, reintervention, & rehospitalization

17 • November 17,
2018
Broader Implications
• PCORnet allows for efficient research in a large, geographically- &
  racially-diverse population accessing academic & community health
  care settings
• Stakeholder engagement ensured clinical relevance
• The data enabled timely comparisons of the effectiveness of common
  procedures that:
      • Can help patients & clinicians make clinical decisions that best reflect the
        individual’s risks & benefits
      • Can help payers understand when a particular procedure may/may not hold
        particular benefit

18 • November 17,
2018
Learn More
 • www.pcori.org
 • info@pcori.org
 • #PCORI2018

19 • November 17,
2018
Questions?

20 • November 17,
2018
Thank You!

Kathleen M. McTigue, MD MPH             Neely Williams, MDiv
Associate Professor of Medicine,        Community co-Principal Investigator, Mid-South
Epidemiology & Clinical/Translational   Clinical Research Network & Meharry-Vanderbilt
Science, University of Pittsburgh       Alliance Community Partner
21 • November 17,
2018
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