The PCORnet Bariatric Study: Comparing effectiveness of the 3 most - - PowerPoint PPT Presentation

▶

Mar 22, 2023 315 likes •547 views

The PCORnet Bariatric Study: Comparing effectiveness of the 3 most common weight loss procedures Neely Williams, MDiv Kathleen M. McTigue, MD MPH Associate Professor of Medicine, Community co-Principal Investigator, Mid-South Clinical

SLIDE 1

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

Kathleen M. McTigue, MD MPH

Associate Professor of Medicine, Epidemiology & Clinical/Translational Science, University of Pittsburgh

Neely Williams, MDiv

Community co-Principal Investigator, Mid-South Clinical Research Network & Meharry-Vanderbilt Alliance Community Partner

#PCORI2018

SLIDE 2

2 • November 17, 2018

Kathleen McTigue Neely Williams

Have nothing to disclose.

SLIDE 3

3 • 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

SLIDE 4

4 • 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

SLIDE 5

5 • November 17, 2018

Background

Severe obesity is a serious health concern

affecting 7.7% of Americans

Use of bariatric surgery has expanded considerably
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

(SG)

SLIDE 6

6 • 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.

SLIDE 7

7 • 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.

SLIDE 8

8 • 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

SLIDE 9

9 • 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.

3.6 kg ↑ 8.2 kg ↑ 7.6 kg ↑ Weight Regain

AGB SG RYGB

SLIDE 10

10 • November 17, 2018

RYGB & SG showed similar DM Remission rates; both led to more remission than AGB

Adjusted cumulative remission (%n) 0 1 2 3 4 5

Years since surgery RYGB SG AGB

SLIDE 11

11 • November 17, 2018

Cumulative relapse was ~67% lower for RYGB (HR 0.32) or SG (HR 0.33) patients compared with AGB patients

Years since surgery

0 1 2 3 4 5 0 1 2 3 4 5

AGB SG RYGB

Adjusted cumulative remission (%n)

RYGB SG AGB AGB SG RYGB

SLIDE 12

12 • November 17, 2018

RYGB patients had 25% lower relapse rate than SG patients (HR 0.75, 95% CI: 0.67-0.84)

Years since surgery

0 1 2 3 4 5 0 1 2 3 4 5

AGB SG RYGB

Adjusted cumulative remission (%n)

RYGB SG AGB AGB SG RYGB

SLIDE 13

13 • November 17, 2018

RYGB had the largest & most persistent impact on HbA1c

Years since surgery Adjusted HbA1c ∆ from Baseline

0.45% (-0.63, -0.27)

∆ HbA1c

0.42% (-0.78, -0.05)

0 0.5 1 1.5 2 2.5 3 3.5 4 4.5 5

AGB SG RYGB

SLIDE 14

14 • 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

SLIDE 15

15 • November 17, 2018

Adjusted 5-year Adverse Events

blank SG (n=15504) RYGB (n=18056) AGB (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%

SLIDE 16

16 • 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
f 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

SLIDE 17

17 • 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

SLIDE 18

18 • 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

SLIDE 19

19 • November 17, 2018

Learn More

www.pcori.org
info@pcori.org
#PCORI2018

SLIDE 20

20 • November 17, 2018

Questions?

SLIDE 21

21 • November 17, 2018

Thank You!

Kathleen M. McTigue, MD MPH

Associate Professor of Medicine, Epidemiology & Clinical/Translational Science, University of Pittsburgh

Neely Williams, MDiv

Community co-Principal Investigator, Mid-South Clinical Research Network & Meharry-Vanderbilt Alliance Community Partner