Comparative Effectiveness studies

Our researchers compare the benefits and harms of various methods for the prevention, treatment, and delivery of care to determine what will work best for specific people or populations. We collaborate with the Center for Effectiveness & Safety Research, a national Kaiser Permanente network that addresses questions in comparative effectiveness and on the safety of drugs, devices, biologics, and care delivery strategies.

Archimedes IndiGO End-Stage Renal Disease Tool Development and Validation

Archimedes IndiGO will be used to predict outcomes for Chronic Kidney Disease and provide an interface for patient management. The accuracy of outcomes prediction will be tested in this study.

Principal Investigator:

Stephen F. Derose, MD, MSHS

Funding Source:

Kaiser Foundation Health Plan, Inc.

Funding Years:

2013 - 2015

ASCEND Clinical Trial

A clinical trial to study the efficacy of natalizumab on reducing disability progression in subjects with secondary progressive multiple sclerosis.

Principal Investigator:

Annette M. Langer-Gould, MD, PhD, MS

Funding Source:

Biogen Idec, Inc.

Funding Years:

2011 - 2016

Cholesterol-lowering medication as risk factors for amyotrophic lateral sclerosis

The primary objective of this study is to investigate whether the use of cholesterol-lowering medications increases the risk of developing ALS or influences the rate of disease progression among individuals who have ALS.

Principal Investigator:

Annette M. Langer-Gould, MD, PhD, MS

Funding Source:

Centers for Disease Control and Prevention (CDC)

Funding Years:

2012 - 2013

Chronic Myelogenous Leukemia and Outcomes of Tyrosine Kinase Inhibitor Therapy

The aim of this investigation initiated retrospective cohort study are to examine long-term health effects in the cohort of CML and determine if health effects vary by drug adherence to TKIs.

Principal Investigator:

Reina Haque, PhD, MPH

Funding Source:

Novartis Pharmaceuticals Corporation

Funding Years:

2013 - 2018

Effectiveness of Gastric Sleeve vs. Gastric Bypass for Cardiovascular Disease (ENGAGE-CVD)

This study will include only bariatric surgery patients from Kaiser Permanente Southern California and is designed to achieve the following aims: 1) compare the effectiveness of vertical sleeve gastrectomy (VSG) and Roux-en-Y Gastric Bypass (RYGB) in remission of risk factors for cardiovascular disease (CVD) and reduction in overall CVD risk using advanced statistical and econometric techniques.; 2) compare VSG and RYGB surgical safety using similar methods; and 3) understand the treatment effect heterogeneity in remission of CVD risk factors, reduction in overall CVD risk, and safety outcomes for patients with different racial/ethnic backgrounds, sexes, and disease burdens at the time of surgery.

Principal Investigator:

Karen J. Coleman, PhD, MS

Funding Source:

National Heart, Lung, and Blood Institute (NHLBI)

Funding Years:

2016 - 2020

Effects of Medical Products on Suicidal Ideation and Behavior in Serious Mental Illness

Reducing risk of suicidal behavior is an urgent public health priority. Suicide accounted for approximately 45,000 deaths in the United States in 2016. While most major causes of death have steadily declined, suicide mortality in the US has increased by over 25% in the past 15 years, with greater increases in young people. Increasing rates of suicidal behavior are intertwined with prescription opioid use and opioid overdose. Traditional clinical trials will not be able to enroll large enough nor generalizable enough samples of patients to adequately inform regulation regarding these issues. We propose a comprehensive program of infrastructure development and methods development to support future generation of real-world evidence addressing these critical gaps. The project team will include health systems and embedded research organizations with deep expertise in stakeholder engagement, medical informatics, data science, clinical epidemiology, biostatistics, pragmatic clinical trial methods, implementation science, and innovations in care delivery. This program will be embedded in 4 integrated health systems serving a combined population of approximately 10 million members. This work will be conducted in collaboration with health system and patient/family stakeholders, to assure that methods and evidence developed will actually address real-world questions.

Site Principal Investigator:

Karen J. Coleman, PhD, MS

Funding Source:

Food and Drug Administration (FDA)

Funding Years:

09/30/2018 - 09/30/2021

Occurrence of Herpes Zoster Among Elderly Population 60 or More Years of Age: A Comparison Between Vaccinated and Unvaccinated Population

The specific aims of the study are to evaluate the incidence of HZ among elderly population 60 or more years of age who were either vaccinated or not vaccinated with the vaccine and to evaluate whether some potential chronic conditions would modify the effect of the vaccine. The additional aims are to compare the healthcare utilization between vaccinated HZ cases and unvaccinated HZ cases, to compare the incidence of stroke in one year after HZ episode between vaccinated HZ cases and unvaccinated HZ cases, and to compare the incidence of HZ between concomitant and sequential administration of PPV 23 and Zostavax.

Principal Investigator:

Hung Fu Tseng, PhD, MPH

Funding Source:

Centers for Disease Control and Prevention (CDC)

Funding Years:

2012

Optimizing Risk Stratification and Comparative Effectiveness Research for Atrial Fibrilliation

The major goals of this project was to develop a collaboration of population-based researchers as well as a research platform using a contemporary cohort of about 40,000 adults with atrial fibrillation to improve comparative effectiveness studies, risk stratification of outcomes and the planning and conduct of future observational studies and randomized trials for atrial fibrillation.

Site Principal Investigator:

Kristi Reynolds, PhD, MPH

Funding Source:

National Heart, Lung, and Blood Institute (NHLBI)

Funding Years:

2009 - 2012

PCORnet Bariatric Study

This study is designed to address the following aims in over 30 clinical sites participating in the national Patient-Centered Outcomes Research Network (PCORnet) Bariatric Study: Aim 1: To what extent does weight loss and weight regain differ across bariatric surgical procedures (Roux-en-Y gastric bypass, sleeve gastrectomy, and adjustable gastric banding) at 1, 3, and 5 years? Aim 2: To what extent does bariatric surgery lead to improvements in diabetes risk at 1, 3, and 5 years? Aim 3: What is the frequency of adverse events following different bariatric surgical procedures at 1, 3, and 5 years? Aim 4: To elicit patient preferences around the risks and benefits regarding the choice of (a) whether to undergo bariatric surgery; (b) which bariatric procedure to utilize; and (c) follow-up care after bariatric surgery.

Site Principal Investigator:

Karen J. Coleman, PhD, MS

Funding Source:

Patient-Centered Outcomes Research Institute (PCORI)

Funding Years:

2016 - 2018

Skeletal Outcomes in Primary Hyperparathyroidism

The aim of the study is to retrospectively compare fracture rates and BMD changes in patients with PHPT who have received the following types of treatment: observation, bisphosphonate therapy, surgery, or both surgery and bisphosphonate therapy.

Principal Investigator:

Annette L. Adams, PhD, MPH

Funding Source:

University of California, Los Angeles (UCLA)

Funding Years:

2013 - 2019

The Comparative effectiveness of Warfarin and New Oral Anticoagulants for the Extended Treatment of Venous Thromboembolism

The overall goal of this project is to provide information on the benefits and harms comparing different treatment options for the extended treatment of VTE, information that can be used by clinicians and patients in deciding on the optimal treatment strategy.

Principal Investigator:

Kristi Reynolds, PhD, MPH

Funding Source:

Patient-Centered Outcomes Research Institute (PCORI)

Funding Years:

2016 - 2020

Use of Multiple Biomarkers with the Risk of Ovarian Cancer Algorithm (ROCA) for Early Detection of Ovarian Cancer in Female Carriers of BRCA1 and BRCA2 mutations

The goal of this prospective recruitment study is to determine if ovarian cancer screening is enhanced by more frequent biomarker testing (CA125 & HE4) versus usual testing frequency in women with BRCA1/2 mutations.

Principal Investigator:

Reina Haque, PhD, MPH

Funding Source:

Garfield Memorial Fund

Funding Years:

2016 - 2019