Comparative Effectiveness studies
A Sequential Multiple Assignment Randomized Trial (SMART) Assessing Medication and CBT Sequencing Strategies in the Treatment of Predominantly Ethnic Minority, Underserved Youth with Anxiety Disorders
Anxiety disorders affect more than 20 percent of youth, often interfering with self-esteem, confidence, family relationships, friendships, or school performance. Although psychological and medication therapies are helpful to many patients, not all patients respond to a given therapy, and those who do frequently respond relapse later. Treatment of a child who has an anxiety disorder begins with the question of which treatment to begin first: psychological or medication therapy. Few studies, however, have compared these two treatments directly, leaving patients, parents, and clinicians without scientific evidence for which treatment is likely to be most helpful. Another question is what to do when the initial treatment is not as helpful as desired: Should the initial single treatment be intensified, or should the other treatment be added to the first, producing a combined psychological and medication therapy? This randomized trial will clarify whether treatment of anxiety should be initiated with medication or cognitive-behavioral therapy and how to proceed if the initial treatment is not as successful as desired.
Adverse Health Outcomes in Breast Cancer Survivors exposed to Pain Medications
The aim of this longitudinal cohort study is to evaluate the comparative safety and risk of opioids and psychotropic drugs in women with breast cancer who suffer from chronic pain due to cancer or its treatments.
ASCEND Clinical Trial
A clinical trial to study the efficacy of natalizumab on reducing disability progression in subjects with secondary progressive multiple sclerosis.
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.
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.
Comparing Strategies for Implementing Primary HPV Testing for Routine Cervical Cancer Screening
The major goal of this project is to compare two implementation strategies to facilitate adoption of primary HPV testing for routine cervical cancer screening measured by patient-, provider- and system-centered outcomes. A sub-analysis and survey data collection will evaluate the impact of the COVID pandemic on this practice change and cervical cancer screening.
Comparison of type 2 diabetes pharmacotherapy regimens using targeted learning
The multi-center study will compare newer classes of drugs with older, lower-cost medications, and take a close look at whether the benefits and harms differ between patients who are at low risk or high risk of developing heart problems. The study will also look at whether benefits and harms differ based on the patient’s age, sex, race or ethnicity, heart and kidney function, or other health problems. The findings will help patients with type 2 diabetes and their doctors make more personalized medication treatment decisions.
Comparison of vaccine effectiveness against hospitalization for influenza between cell-based and egg-based influenza vaccines
The proposed study aims to compare the vaccine effectiveness (VE) against hospitalization for influenza between Flucelvax Quadrivalent and egg-based influenza vaccines used in Kaiser Permanente Southern California (KPSC) during the 2017-2018 season.
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.
Effectiveness of pneumococcal conjugate vaccine against severe clinical outcomes of coronavirus disease 2019 (COVID-19) among adults: a cohort study
The objectives of this study were to assess the effectiveness of PCV13 against severe COVID-19 outcomes and to assess the burden of PCV13-preventable illness attributable to COVID-19.
Effectiveness of pneumococcal vaccination to prevent hospitalized all-cause pneumonia among adults =18 years at Kaiser Permanente Southern California
The objectives of this study are to estimate the incidence of invasive pneumococcal disease (IPD), pneumococcal pneumonia (PP), all-cause pneumonia, and lower respiratory tract infections (LRTI) by Advisory Committee on Immunization Practices (ACIP)-defined risk profile in adults =18 years.
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.
Management of direct oral anticoagulants to lower adverse events in atrial fibrillation (MODL-AF)
The overall objective of this project is to identify the direct oral anticoagulant care model(s) that maximize(s) (1) safety (major bleeding), (2) effectiveness (stroke), and (3) cost.
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.
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.
Real World Effectiveness and Economic Impact of Subcutaneous Methotrexate compared to Oral Methotrexate Treatment for Rheumatoid Arthritis
This prospective study will evaluate the real-world effectiveness of subcutaneous vs. oral methotrexate treatment on disease activity and functional status of rheumatoid arthritis patients. We will also evaluate effectiveness on patient centered outcomes, treatment adherence, cost, and work productivity. Lastly, using a discrete choice experiment, we will estimate patient’s valuation of these outcomes and their willingness to pay.
Reducing Childhood Obesity through EHR-supported Motivational Interviewing
Rates of childhood obesity in the U.S. remain at historic highs. Primary care settings lack interventions to address the childhood obesity epidemic that are feasible and sustainable without requiring significant resources. We will test a motivational interviewing-based intervention shown to lower children’s BMI in a real-world clinical setting with the goal of halting and reversing the childhood obesity epidemic.
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.
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.
COVID-19-Related Project Enhancement
Recent studies have reported that COVID-19 is associated with abnormal coagulation profiles and may predispose patients to VTE and other types of thrombotic events. The goals of this study are to determine the risk of VTE following COVID-19 hospitalization and whether the risk of post-hospitalization VTE varies by age, prior history of VTE or severity of COVID-19.
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.