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Externally-Funded Studies Led by the Center for Effectiveness & Safety Research

PORTAL (Patient Outcomes Research To Advance Learning) Clinical Data Research Network

Principal Investigators: Elizabeth McGlynn (Center for Effectiveness & Safety Research) and Tracy Lieu (Northern California)
Funder: Patient-Centered Outcomes Research Institute (PCORI)

The Patient-Centered Outcomes Research Institute (PCORI) is supporting the development of PCORnet, the national Patient-Centered Clinical Research Network, which will transform clinical research by engaging patients, care providers, and health systems in collaborative partnerships to improve healthcare and advance medical knowledge. By bringing research and patient care together, this innovative health data network will be able to explore the questions that matter most to patients and their families. Vast amounts of valuable health information are created every day during routine patient visits, but opportunities to use this information for research are often missed because the networks that hold this information cannot easily communicate or collaborate with each other. However, by building clinical research into the healthcare process and by working directly with patients and their advocates, PCORnet will be able to provide the answers that patients need quickly, efficiently, and at a lower cost than previously possible. Furthermore, PCORnet's unique focus on collaboration means that patients will be directly involved in making decisions about research priorities and efforts that will protect patient privacy and ensure data security.

PORTAL is one of thirteen Clinical Data Research Networks (CDRNs) funded by PCORI, and is a collaboration between Kaiser Permanente's seven regions, Group Health Cooperative, HealthPartners, and Denver Health. PORTAL will initially focus on three groups of patients: those who have been diagnosed with colorectal cancer; adolescents and adults with congenital heart disease; and individuals who are overweight or obese (all eleven CDRNS will develop research networks related to this third patient group).

Sentinel

Principal Investigator: Marsha Raebel (Colorado)
Funder: Food and Drug Administration

Sentinel is part of the U.S. Food and Drug Administration (FDA) Sentinel Initiative, which is developing capabilities that improve the Agency’s ability to quickly identify and assess safety issues in marketed medical products. Sentinel is using pre-existing electronic healthcare data from multiple sources to build a nationwide rapid-response electronic safety surveillance system. Many collaborating institutions across the United States provide access to data as well as scientific and organizational expertise. Four of the Kaiser Permanente regions are participating in Sentinel.

Studies funded by the Center for Effectiveness & Safety Research

Active Studies

Exposure to antibiotics in-utero and early childhood in relation to the risk of childhood obesity

Lead Principal Investigator: De-Kun Li (Northern California)
Participating Kaiser Permanente Regions: Northern California
The composition of gut microbiota has been related to growth patterns and weight gain. Recent studies have shown that changing microbiota composition through exposure to antibiotics in early life could potentially increase the risk of obesity. Such a link would have important clinical and public health implications given the worldwide obesity epidemic, and should be further examined. This cohort study will examine, among more than half a million mother-child dyads in Northern California, the reported effect of antibiotic use in early life and the possible synergistic effect with additional in-utero antibiotic use.

An evaluation of an abdominal aortic aneurysm screening program

Lead Principal Investigator: Andrew Avins (Northern California)
Participating Kaiser Permanente Regions: Northern California
This study will evaluate a new Northern California screening program for abdominal aortic aneurysm (AAA) in terms of its effects among relevant patients on their AAA-related outcomes of care and processes of care.

Completed Studies

Using Automated Reminder Messages to Improve Medication Adherence for Medicare Advantage Members

Lead Principal Investigator: John Steiner (Colorado)
Participating Kaiser Permanente Regions: Colorado
The purpose of this study is to design and conduct a randomized, controlled trial of a low-intensity outward bound Interactive Voice Response (IVR) tool versus a higher-intensity, bi-directional IVR program. The primary outcome of interest is impact on adherence to common medications for persons with diabetes. Secondary outcomes include the level of improvement in clinical parameters (HgA1c, blood pressure, and LDL cholesterol).

Comparative health systems study on the Kaiser Permanente member experience in the era of health care reform

Lead Principal Investigator: David Magid (Colorado)
Participating Kaiser Permanente Regions: Colorado, Georgia, Northern California
The purpose of this study is to describe the characteristics of individuals who sign up for Kaiser Permanente health plans though the ACA sponsored health insurance exchanges and compare them to the characteristics of other new Kaiser Permanente members who join through a more traditional route.

Utilization of low-value interventions for cancer care

Lead Principal Investigator: Michael Gould (Southern California)
Participating Kaiser Permanente Regions: Mid-Atlantic States, Northwest, Southern California
The purpose of this study was to a) assess the feasibility of measuring adherence with the five ABIM/American Society of Clinical Oncology "Choosing Wisely" practices for low-value cancer care; and b) identify the system-level factors associated with adherence to these measures within three Kaiser Permanente Regions.

PubMed Abstract

Meaningful use of EHRs for improved efficiency in lower back pain imaging: A cross-system analysis

Lead Principal Investigator: Rachel Gold (Northwest)
Participating Kaiser Permanente Regions: Mid-Atlantic States, Northwest
The purpose of this study was to compare rates of ordered imaging for incident low back pain in two care delivery systems differing in their abilities to provide integrated care, to track care with a unified electronic health record, and in their patients' insurance status.

PubMed Abstract

PSA screening and prostate cancer mortality

Lead Principal Investigators: Steven Jacobsen & Lauren Wallner (Southern California)
Participating Kaiser Permanente Regions: Colorado, Georgia, Hawaii, Mid-Atlantic States, Northern California, Northwest, Southern California
The goal of this study was to examine how different methodologic approaches to evaluating the association between Prostate-Specific Antigen (PSA) screening and prostate cancer mortality affect the biases and findings from such studies. 

PubMed Abstract

Use of beta blockers in patients with stable coronary artery disease

Lead Principal Investigators: Jersey Chen (Mid-Atlantic States), Michael Johnson (Utility for Care Data Analysis), Elizabeth McGlynn (CESR)
Participating Kaiser Permanente Regions: Colorado, Georgia, Hawaii, Mid-Atlantic States, Northern California, Northwest, Southern California
This study replicates an analysis originally done on the REACH registry to examine outcomes for patients with stable coronary artery disease who are being treated with beta blockers compared to those who are not receiving these medications. The study will examine whether the REACH registry findings can be replicated in Kaiser Permanente and, if so, what the implications are for clinical practice. This study responds to a question from the Kaiser Permanente Integrated Cardiovascular Health Chiefs.

Predicting the risk of end-stage renal disease in patients with stage 3 and 4 chronic kidney disease

Lead Principal Investigator: Emily Schroeder (Colorado)
Participating Kaiser Permanente Regions: Colorado, Northwest
This study validated a prediction tool, named the Kidney Credit Score, developed by Kaiser Permanente Northwest for use in other Kaiser Permanente regions. The study also compared the performance of the tool against a non-Kaiser Permanente risk score.

Long-term use of antihypertensive agents and breast cancer risk

Lead Principal Investigator: Marsha Raebel (Colorado)
Participating Kaiser Permanente Regions: Colorado, Northwest, Southern California
This study tested the hypothesis that use of calcium-channel blockers for ten or more years increases the risk of breast cancer. The study employed an observational design to identify whether or not there is a relationship between long-term use of five different classes of antihypertensive medications and incident breast cancer.

Software to automate the implementation and evaluation of causal inference methods with time-varying interventions

Lead Principal Investigator: Romain Neugebauer (Northern California)
Participating Kaiser Permanente Regions: Northern California
This study developed and evaluated software to streamline marginal structural modeling analyses across the Kaiser Permanente program. The aim was to develop Statistical Analysis System (SAS) macros to automate the data structuring required for implementation of Causal Inference methods with electronic health records data in studies with time-varying exposures, confounding and selection bias (e.g., marginal structural modeling with inverse probability weighting). SAS macros were validated with simulated data, and their applicability evaluated using secondary data analyses in cardiovascular, diabetes, and health services research.  End-user feedback was used to validate and refine the implementation and documentation of the SAS software.

Examining patient and system-level factors associated with HEDIS AOD-IET measure performance

Lead Principal Investigator: Jennifer Mertens (Northern California)
Participating Kaiser Permanente Regions: Colorado, Mid-Atlantic States, Northern California, Northwest
This study assessed how performance on Alcohol and Other Drug (AOD) initiation and engagement measures varied by population and system characteristics. In addition, it examined structural differences and policies within each Kaiser Permanente region that might explain variations in performance on those measures.

Comparative effectiveness of angiotensin system inhibitors in stage IIIB/IV non-small-cell lung cancer

Lead Principal Investigator: Alexander Menter (Colorado)
Participating Kaiser Permanente Regions: Colorado, Northern California, Northwest, Southern California
This study examined survival for patients with and without the use of angiotensin I converting enzyme inhibitors (ACEIs) and angiotensin II type-1 receptor blockers (ARBs) during bevacizumab and non-bevacizumab containing chemotherapy for advanced stage non-small-cell lung cancer.

Safety of a bisphosphonate drug holiday

Lead Principal Investigator: Annette Adams (Southern California)
Participating Kaiser Permanente Regions: Colorado, Hawaii, Northwest, Southern California
Long-term bisphosphonate (BP) use is thought to be associated with the occurrence of atypical femur fractures, a rare but serious adverse event. Efforts to reduce the risk of atypical femur fractures, including cessation of BP use for substantial periods of time (i.e., a drug holiday), must not increase the risk of osteoporosis-related fragility fractures. This study examined the frequency of BP drug holidays in a large cohort of women, and then compared the incidence of osteoporosis-related fragility fractures in subjects with and without a drug holiday.

Incidence, treatment and recurrence of DCIS in Kaiser Permanente

Lead Principal Investigator: Heather Feigelson (Colorado)
Participating Kaiser Permanente Regions: Colorado, Georgia, Hawaii, Mid-Atlantic States, Northern California, Northwest, Southern California
Considerable debate exists about how to best treat Ductal Carcinoma In-Situ (DCIS) breast cancer, and many have expressed concern that DCIS is overdiagnosed and overtreated. This study estimated the age and race/ethnicity-adjusted incidence of DCIS overall for Kaiser Permanente, and separately by region, for 2000-2010 (inclusive). The study examined how rates vary over time and by region, described the initial course of treatment for DCIS by region, for 2000-2010, and examined variation in treatment for DCIS over time, across regions, tumor characteristics, patient age and comorbidity status.
PubMed Abstract

Statin use in relation to prostate cancer recurrence in multiple Kaiser

Lead Principal Investigator: Sheila Weinmann (Northwest)
Participating Kaiser Permanente Regions: Colorado, Northern California, Northwest
Recently, results from several studies have suggested that cholesterol-lowering statins—which reduce overall mortality by decreasing fatal heart attacks and strokes—may also be effective against cancer. This study investigated whether statins have a beneficial effect on patients following treatment for prostate cancer.

The Medicare STAR program and medication adherence in the diabetes population

Lead Principal Investigator: Julie Schmittdiel (Northern California)
Participating Kaiser Permanente Regions: Colorado, Northern California, Northwest
CMS announced in July 2011 that it would introduce three new diabetes-relevant metrics to the Medicare STAR portfolio in 2012: adherence to antiglycemic, antilipidemic, and antihypertensive medications.  Rapid-cycle information on how different methods of measuring adherence for diabetes-related medications compare with each other, and vary across key system, provider, and patient-level factors, would be of significant value to Kaiser Permanente regions developing their approach to addressing this substantial CMS policy change. This study compared the effectiveness of CMS-approved medication adherence measures with other published measures of adherence in predicting important clinical outcomes, and assessed variation in performance on medication adherence metrics across modifiable patient, physician, and system-level characteristics.
Abstract 1
Abstract 2

Investigation of patient-reported pain outcomes to inform diabetic peripheral neuropathy (DPN) treatment and research

Lead Principal Investigator: Alyce Adams (Northern California)
Participating Kaiser Permanente Regions: Colorado, Mid-Atlantic States, Northern California
This study explored strategies for validating and collecting patient-reported pain outcomes to facilitate comparative effectiveness and safety studies related to painful diabetic peripheral neuropathy (DPN) in diverse patient populations.  The study:  1) identified validated instruments for data collection, 2) evaluated the quality and utility of available pain reports in the electronic medical record for comparative effectiveness research, 3) explored patient values for treatment outcomes and preferences for data collection, and 4) developed explicit criteria for Patient-Reported Outcome data collection related to DPN pain.

PubMed Abstract

Use of Beacon® data for advanced cancer research

Lead Principal Investigator: Debra Ritzwoller (Colorado)
Participating Kaiser Permanente Regions: Colorado, Northern California, Northwest
The aim of this study was to assess the shift in oncology clinical care from the paper-copy to the computerized medical record world via an informatics application that would promote consistent practice, ensure patient safety, maximize quality outcomes and affordability, and manage medication costs across all Kaiser Permanente regions. Using data from 2007 through 2010 from three regions, the study examined the temporal trends and patterns of use of bevacizumab among advanced colorectal, breast, and lung cancer patients and erlotinib among advanced lung cancer patients, before and after the implementation of the HealthConnect Oncology Beacon® module.
Abstract 1
Abstract 2

Evaluating safety of antiviral medication use during pregnancy

Lead Principal Investigator: De-Kun Li (Northern California)
Participating Kaiser Permanente Regions: Colorado, Georgia, Northern California, Southern California
Antiviral medications have been used to treat or prevent viral infections such as Herpes, Influenza A and B, Hepatitis B and C, or HIV. The presence of these infections during pregnancy may increase the risk of pregnancy complications including adverse pregnancy outcomes such as preterm delivery, low birth weight and fetal anomalies. Thus, early treatment of viral infections with antiviral agents could potentially be beneficial to pregnant women, to reduce complications and improve pregnancy outcomes. As with any treatment during pregnancy, the potential benefits of antiviral treatment need to be weighed against the potential risk of such treatment to pregnant women and fetuses. This study used a large cohort of pregnant women from four Kaiser Permanente sites to determine the prevalence of pregnancies exposed to antiviral medication.
PubMed Abstract

Cancer Statistics Reporting Initiative

Lead Principal Investigator: Debra Ritzwoller (Colorado) 
Participating Kaiser Permanente Regions: Colorado, Georgia, Hawaii, Mid-Atlantic States, Northern California, Northwest, Southern California
The Kaiser Permanente Care Management Institute, along with CESR and Cancer Research Network investigators across the program have collaborated to produce annual Incidence and Outcomes of Cancer Reports.  All seven Kaiser Permanente regions participated in this initiative.  The data came from the Virtual Tumor Registry (a subset of the Virtual Data Warehouse) as well as from regional tumor registries.  The resultant reports included nine cancer types (female breast, colorectal, lung, prostate, bladder, kidney, melanoma, leukemia, and non-Hodgkin lymphoma). The metrics reported were age-adjusted incidence and stage at diagnosis, and 5-year relative survival rates (the latter stratified by race and ethnicity).

Kaiser Permanente survey of critical topics in comparative effectiveness

Lead Principal Investigators: Joseph Selby (Northern California) and Evelyn Whitlock  (Northwest)
Participating Kaiser Permanente Regions: Colorado, Georgia, Hawaii, Mid-Atlantic States, Northern California, Northwest, Southern California
Approximately 800 clinical and operational leaders in Kaiser  Permanente were surveyed to obtain nominations of significant comparative  effectiveness research questions, and, subsequently to prioritize nominated research questions.
PubMed Abstract

A large, population-based study of 2009 pandemic Influenza A virus subtype H1N1 infection diagnosis during pregnancy and outcomes for mothers and neonates

Lead Principal Investigators: Robert Davis & Craig Hansen (Georgia)
Participating Kaiser Permanente Regions: Colorado, Georgia, Mid-Atlantic States, Northern California, Southern California
Pregnant women were at increased risk for serious outcomes from 2009 pandemic influenza A virus subtype H1N1 infection, but little was known about the overall impact of the pandemic on neonatal and maternal outcomes. The study found that pregnant women with H1N1 were twice as likely to be hospitalized within 30 days as those with seasonal flu. Additionally, those who had antiviral treatments more than two days after diagnosis were three times as likely to be hospitalized as those who had the treatments less than two days after diagnosis.
PubMed Abstract 1
PubMed Abstract 2

Surgical outcomes in total knee replacement patients by diabetes status and glycemic control, 2001-2009

Lead Principal Investigator: Annette Adams (Southern California)
Participating Kaiser Permanente Regions: Colorado, Hawaii, Northern California, Northwest, Southern California
Poor glycemic control in patients with diabetes may be associated with adverse surgical outcomes. This study examined the association between diabetes status and pre-surgical glycemic control and several surgical outcomes, including revision and deep infection.
PubMed Abstract