The National Patient-Centered Clinical Research Network (PCORnet) Bariatric Study Cohort: Rationale, Methods, and Baseline Characteristics

Sengwee Toh, Laura J Rasmussen-Torvik, Emily E Harmata, Roy Pardee, Rosalinde Saizan, Elisha Malanga, Jessica L Sturtevant, Casie E Horgan, Jane Anau, Cheri D Janning, Robert D Wellman, R Yates Coley, Andrea J Cook, Anita P Courcoulas, Karen J Coleman, Neely A Williams, Kathleen M McTigue, David Arterburn, James McClay, PCORnet Bariatric Surgery Collaborative, Jeffrey Brown, Gabrielle Purcell, Corrigan McBride, William G Adams, Caroline Apovian, Lydia Bazzano, Doug Bell, Jiang Bian, Cynthia Chuang, Julie Tice, Jeanne Clark, Matthew F Daley, Nirav Desai, Elizabeth Doane, Ali Tavakkoli, Xiao Dong, Meredith Duke, Ana Emiliano, Robert Greenlee, Amy Helwig, Michael Horberg, Thomas Inge, Michelle Lent, Amy Luke, Ellen McCarthy, David Meltzer, Marc Michalsky, Ellen Morrow, Sameer Murali, Gregory A Nichols, Elizabeth Nauman, Joe Nadglowski, Rabih Nemr, Andrew Odegaard, Alberto Odor, Anuradha Paranjape, Erin Roe, Jay R Desai, David Schlundt, Steven R Smith, Rebecca Zuvich Essner, Jeffrey Klann, Tammy St. Clair, Joseph Vitello, Stavra A Xanthakos, Roni Zeiger, Xiaobo Zhou, John Holmes, Stephanie L Fitzpatrick, Sengwee Toh, Laura J Rasmussen-Torvik, Emily E Harmata, Roy Pardee, Rosalinde Saizan, Elisha Malanga, Jessica L Sturtevant, Casie E Horgan, Jane Anau, Cheri D Janning, Robert D Wellman, R Yates Coley, Andrea J Cook, Anita P Courcoulas, Karen J Coleman, Neely A Williams, Kathleen M McTigue, David Arterburn, James McClay, PCORnet Bariatric Surgery Collaborative, Jeffrey Brown, Gabrielle Purcell, Corrigan McBride, William G Adams, Caroline Apovian, Lydia Bazzano, Doug Bell, Jiang Bian, Cynthia Chuang, Julie Tice, Jeanne Clark, Matthew F Daley, Nirav Desai, Elizabeth Doane, Ali Tavakkoli, Xiao Dong, Meredith Duke, Ana Emiliano, Robert Greenlee, Amy Helwig, Michael Horberg, Thomas Inge, Michelle Lent, Amy Luke, Ellen McCarthy, David Meltzer, Marc Michalsky, Ellen Morrow, Sameer Murali, Gregory A Nichols, Elizabeth Nauman, Joe Nadglowski, Rabih Nemr, Andrew Odegaard, Alberto Odor, Anuradha Paranjape, Erin Roe, Jay R Desai, David Schlundt, Steven R Smith, Rebecca Zuvich Essner, Jeffrey Klann, Tammy St. Clair, Joseph Vitello, Stavra A Xanthakos, Roni Zeiger, Xiaobo Zhou, John Holmes, Stephanie L Fitzpatrick

Abstract

Background: Although bariatric procedures are commonly performed in clinical practice, long-term data on the comparative effectiveness and safety of different procedures on sustained weight loss, comorbidities, and adverse effects are limited, especially in important patient subgroups (eg, individuals with diabetes, older patients, adolescents, and minority patients).

Objective: The objective of this study was to create a population-based cohort of patients who underwent 3 commonly performed bariatric procedures-adjustable gastric band (AGB), Roux-en-Y gastric bypass (RYGB), and sleeve gastrectomy (SG)-to examine the long-term comparative effectiveness and safety of these procedures in both adults and adolescents.

Methods: We identified adults (20 to 79 years old) and adolescents (12 to 19 years old) who underwent a primary (first observed) AGB, RYGB, or SG procedure between January 1, 2005 and September 30, 2015 from 42 health systems participating in the Clinical Data Research Networks within the National Patient-Centered Clinical Research Network (PCORnet). We extracted information on patient demographics, encounters with healthcare providers, diagnoses recorded and procedures performed during these encounters, vital signs, and laboratory test results from patients' electronic health records (EHRs). The outcomes of interest included weight change, incidence of major surgery-related adverse events, and diabetes remission and relapse, collected for up to 10 years after the initial bariatric procedure.

Results: A total of 65,093 adults and 777 adolescents met the eligibility criteria of the study. The adult subcohort had a mean age of 45 years and was predominantly female (79.30%, 51,619/65,093). Among adult patients with non-missing race or ethnicity information, 72.08% (41,248/57,227) were White, 21.13% (12,094/57,227) were Black, and 20.58% (13,094/63,637) were Hispanic. The average highest body mass index (BMI) recorded in the year prior to surgery was 49 kg/m2. RYGB was the most common bariatric procedure among adults (49.48%, 32,208/65,093), followed by SG (45.62%, 29,693/65,093) and AGB (4.90%, 3192/65,093). The mean age of the adolescent subcohort was 17 years and 77.5% (602/777) were female. Among adolescent patients with known race or ethnicity information, 67.3% (473/703) were White, 22.6% (159/703) were Black, and 18.0% (124/689) were Hispanic. The average highest recorded BMI in the year preceding surgery was 53 kg/m2. The majority of the adolescent patients received SG (60.4%, 469/777), followed by RYGB (30.8%, 239/777) and AGB (8.9%, 69/777). A BMI measurement (proxy for follow-up) was available in 84.31% (44,978/53,351), 68.09% (20,783/30,521), and 68.56% (7159/10,442) of the eligible adult patients at 1, 3, and 5 years of follow-up, respectively. The corresponding proportion was 82.0% (524/639), 49.9% (174/349), and 38.8% (47/121) in the adolescent subcohort.

Conclusions: Our study cohort is one of the largest cohorts of patients with bariatric procedures in the United States. Patients are geographically and demographically diverse, which improves the generalizability of the research findings and allows examination of treatment effect heterogeneity. Ongoing and planned investigations will provide real-world evidence on the long-term benefits and risks of these most commonly used bariatric procedures in current clinical practice.

Keywords: bariatric surgery; comparative effectiveness; obesity; real-world evidence; weight loss.

Conflict of interest statement

Conflicts of Interest: Thomas Inge reports funding or other support from Standard Bariatrics, Up To Date, Independent Medical Expert Consulting Services, Zafgen Corporation, Biomedical Insights, L&E Research, Sanofi Corporation, and grants from Ethicon Endosurgery outside the submitted work. Anita P Courcoulas reports grants from Covidien/Ethicon Johnson & Johnson, during the conduct of the study. Caroline Apovian reports personal fees from Nutrisystem, personal fees from Zafgen, personal fees from Sanofi-Aventis, grants and personal fees from Orexigen, personal fees from NovoNordisk, grants from Aspire Bariatrics, grants and personal fees from GI Dynamics, grants from Myos, grants and personal fees from Takeda, personal fees from Scientific Intake, grants and personal fees from Gelesis, other from Science-Smart LLC, personal fees from Merck, personal fees from Johnson & Johnson, grants from Vela Foundation, grants from Dr Robert C and Veronica Atkins Foundation, grants from Coherence Lab, and grants from Energesis outside the submitted work. Erin Roe reports that she is a virtual advisory board member for Eli Lilly. Joe Nadglowski reports other support from the Obesity Action Coalition outside the submitted work.

©Sengwee Toh, Laura J Rasmussen-Torvik, Emily E Harmata, Roy Pardee, Rosalinde Saizan, Elisha Malanga, Jessica L Sturtevant, Casie E Horgan, Jane Anau, Cheri D Janning, Robert D Wellman, R Yates Coley, Andrea J Cook, Anita P Courcoulas, Karen J Coleman, Neely A Williams, Kathleen M McTigue, David Arterburn, James McClay, PCORnet Bariatric Surgery Collaborative. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 05.12.2017.

Figures

Figure 1
Figure 1
Flow diagram for identification of the PCORnet Bariatric Study cohort in 11 Clinical Data Research Network (CDRNs). BMI: body mass index.
Figure 2
Figure 2
Shift in choice of bariatric procedure in adults in the PCORnet Bariatric Study from 2005 to 2015.Size of the data point is proportionate to the number of patients at that time point. All 11 Clinical Data Research Network (CDRNs) that participate in the study contribute data to all study years, but not all 42 participating health systems have data in all years. AGB: adjustable gastric banding; RYGB: Roux-en-Y gastric bypass; SG: sleeve gastrectomy.
Figure 3
Figure 3
Variability in use of the three most common bariatric procedure types in adults in the PCORnet Bariatric Study, by Clinical Data Research Network (CDRN), 2005-2015. AGB: adjustable gastric banding; RYGB: Roux-en-Y gastric bypass; SG: sleeve gastrectomy.

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