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
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
Kathleen McTigue Neely Williams • Have nothing to disclose. 2 • November 17, 2018
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
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
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
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
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
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,
2018SG & 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,
2018RYGB & 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,
2018Cumulative 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,
2018RYGB 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,
2018RYGB 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,
2018Adverse 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,
2018Adjusted 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,
2018Limitations
• 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,
2018Conclusions
• 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,
2018Broader 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,
2018Learn 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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