Comparing the Benefits and Harms of Three Types of Weight Loss Surgery — The PCORnet® Bariatric Study

Study Updated 03/05/2024

Study Website: The PCORnet Bariatric Study (PBS)
ClinicalTrials.gov#: NCT02741674
Study Design: Retrospective Observational
PCORnet Infrastructure: Collaboration, CDM, Engagement
Principal Investigator: David Arterburn
Site Name: Kaiser Permanente Washington Health Research Institute
PCORnet® Network Partner: Legacy PCORnet Partner
Funder: Patient-Centered Outcomes Research Institute (PCORI); (Project webpage)
Funding Date: 2015
Study Duration: 2016 – 2018
Participating Clinical Research Networks: ADVANCE, GPC, INSIGHT, OneFlorida+, PaTH, PEDSnet, REACHnet, STAR
Therapeutic Area: Gastroenterology
Condition: Bariatrics, Body Weight, Diabetes, Gastric Bypass, Obesity
Population: up to 79 Years (Child,  Adult,  Older Adult)
Status: Completed

Research Question(s):
We don’t know much about the long-term effectiveness of bariatric interventions. Can we use PCORnet to compare compare weight loss and safety among three popular bariatric procedures?

Primary Publication(s):
Comparative effectiveness of bariatric procedures among adolescents: the PCORnet bariatric study
Inge TH, Coley RY., Bazzano LA,. et al. Comparative effectiveness of bariatric procedures among adolescents: the PCORnet bariatric study. SOARD, 2018, 14(9):1374-1386.

Comparing the 5-Year Diabetes Outcomes of Sleeve Gastrectomy and Gastric Bypass: The National Patient-Centered Clinical Research Network (PCORNet) Bariatric Study
McTigue KM, Wellman R, Nauman E, et al. PCORnet Bariatric Study Collaborative. Comparing the 5-Year Diabetes Outcomes of Sleeve Gastrectomy and Gastric Bypass: The National Patient-Centered Clinical Research Network (PCORNet) Bariatric Study. JAMA Surg. 2020;155(5):e200087. doi: 10.1001/jamasurg.2020.0087. Epub 2020 May 20. PMID: 32129809; PMCID: PMC7057171.

Empagliflozin Diabetic Kidney Disease (Empa DKD)

Study Updated 03/28/2024

Study Design: Retrospective Observational
PCORnet Infrastructure: Collaboration, CDM, Engagement
Principal Investigator: Neha Pagidipati
Site Name: Duke Clinical Research Institute
PCORnet® Network Partner: Coordinating Center
Funder: Boehringer Ingelheim
Funding Date: 2021
Study Duration: 2021 – 2024
Participating Clinical Research Networks: OneFlorida+, PaTH, REACHnet, STAR
Therapeutic Area: Cardiovascular
Condition: Diabetes/Cardiovascular
Population: 18 Years and older (Adult, Older Adult)
Status: Completed

Research Question(s):

  1. Can we better understand why patients with type-2 diabetes may not receive guideline-recommended screening for diabetic kidney disease?
  2. Which medications may be most effective at improving kidney and heart outcomes in patients with and without type-2 diabetes?

A Patient-Centered PaTH to Addressing Diabetes

Study Updated 03/05/2024

Study Website: The PaTH to Health: Diabetes Study
ClinicalTrials.gov#: NCT02788903
Study Design: Retrospective Observational
PCORnet Infrastructure: Collaboration, CDM (+supplemental data), Engagement
Principal Investigator: Jennifer Kraschnewski
Site Name: Pennsylvania State University
PCORnet® Network Partner: PaTH
Funder: Patient-Centered Outcomes Research Institute (PCORI)
Funding Date: 2016
Study Duration: 2016 – 2021
Participating Clinical Research Networks: GPC, PaTH
Therapeutic Area: Metabolic Disorders
Condition: COVID-19; Diabetes; Obesity
Population: 18 Years and older (Adult, Older Adult)
Status: Completed

Research Question(s):

  1. How often is intensive behavioral therapy (IBT) being utilized in primary care and how has it impacted weight and diabetes outcomes for patients with and at-risk of type 2 diabetes?
  2. What is the impact of telemedicine utilization during the COVID-19 pandemic for patients with and at-risk of type 2 diabetes?
  3. What are demographic and clinical characteristics associated with severe COVID-19 outcomes across multiple phases of the COVID pandemic for patients with or at-risk of type 2 diabetes?

Primary Publication(s):
A Patient-Centered PaTH to Address Diabetes: Protocol for a Study on the Impact of Obesity Counseling
Kraschnewski JL, Kong L, Francis E, Yeh HC, Bryce C, Poger J, Lehman E. A Patient-Centered PaTH to Address Diabetes: Protocol for a Study on the Impact of Obesity Counseling. JMIR Res Protoc. 2019 Apr 4;8(4):e12054. doi: 10.2196/12054. PubMed PMID: 30946024

Evaluating the Comparative Effectiveness of Telemedicine in Primary Care: Learning from the COVID-19 Pandemic

Study Updated 03/05/2024

Study Website: Evaluating the Comparative Effectiveness of Telemedicine in Primary Care: Learning from the COVID-19 Pandemic
ClinicalTrials.gov#:NCT04684836
Study Design: Telephone survey of primary care practice leadership, Qualitative interview study with patients and primary care providers, Observational data analysis
PCORnet Infrastructure: Collaboration, CDM (+supplemental data), Engagement, Single IRB
Principal Investigator: Rainu Kaushal, Jessica Ancker
Site Name: Weill Cornell Medicine
PCORnet® Network Partner: INSIGHT
Funder: Patient-Centered Outcomes Research Institute (PCORI)
Funding Date: 2020
Study Duration: 2020 – 2022
Participating Clinical Research Networks: INSIGHT, OneFlorida+, STAR
Therapeutic Area: Health Disparities
Condition: Asthma; Chronic Obstructive Pulmonary Disease (COPD); Congestive Heart Failure; Diabetes; Hypertension
Population: 19 Years and older (Adult, Older Adult)
Status: Completed

Research Question(s):
What are the features of primary care telemedicine programs that have been newly implemented or expanded in response to the COVID-19 pandemic, and how do diverse populations experience these programs?

Primary Publications(s):
An urgent need for guidelines for telemedicine use. Lin JJ, Horowitz CR, Ancker JS. Journal of General Internal Medicine. 2022;38(4):1061-1062. doi:10.1007/s11606-022-07905-7

Patient experiences with and preferences for telemedicine relative to in-person care during the COVID-19 pandemic. Yu J, Andreadis K, Schpero WL, Abedian S, Kaushal R, Ancker JS. Telemedicine and e-Health. Published online 2023. doi:10.1089/tmj.2022.0311

Provider and patient experiences of delays in primary care during the early COVID-19 pandemic. Journal for Healthcare Quality. 2023;45(3):169-176. doi:10.1097/jhq.0000000000000380

Medications and Weight Gain in PCORnet: The MedWeight Study

Study Updated 03/28/2024

Study Website: Medications and Weight Gain in PCORnet: The MedWeight Study
Study Design: Prospective Observational
PCORnet Infrastructure: Collaboration, CDM, Engagement, Single IRB
Principal Investigator: Jason Block
Site Name: Harvard Pilgrim Healthcare Institute
PCORnet® Network Partner: Legacy PCORnet Partner
Funder: NIH
Funding Date: 2020
Study Duration: 2020 – 2024
Participating Clinical Research Networks: GPC, OneFlorida+, PEDSnet, STAR
Therapeutic Area: Metabolic Disorders
Condition: Obesity; Diabetes
Population: Children 5 to 19 Years and Adults 20+ Years (Child, Adult)
Status: Completed

Research Question(s):
How do six classes of commonly prescribed medications influence weight, risk for diabetes, and cholesterol over time?