A retrospective cohort study investigated the association between having surgery and risk of mortality for up to 5 years and if this association was modified by incident ESRD during the follow-up period. Summary of Background Data: Mortality risk in individuals…
Malignant pleural mesothelioma (MPM) is a rare and aggressive tumor that should be managed by an experienced surgical and multidisciplinary group. Our objective was to determine the impact of proficient surgeons and MPM bi-disciplinary review on outcomes of patients with…
Follow-up of abdominal computed tomography (CT) and magnetic resonance imaging (MRI) findings suspicious for pancreatic cancer may be delayed if documentation is unclear. We evaluated whether standardized reporting and follow-up of imaging results reduced time to diagnosis of pancreatic cancer.…
For patients with a rash, the effect of teledermatology workflow on utilization has not been defined. We compared utilization across four teledermatology workflows in patients with a rash. The observational longitudinal cohort study included 28,857 Kaiser Permanente Northern California members…
In bilaterally pseudophakic patients who received immediate or delayed sequential bilateral cataract surgery (ISBCS or DSBCS), we sought to determine patient experience, particularly related to the loss of opportunity to modify the surgical plan for the second eye. Cross-sectional. Patients…
Knowledge is needed about the risk of cutaneous squamous cell carcinoma (cSCC) in solid organ transplant recipients (SOTRs) using contemporary immunosuppressive regimens. Evaluate the risk of cSCC in relation to medications used by SOTRs. The cohort and nest case-control study…
There is a high demand for managing skin disease, and dermatologists are in short supply. To better understand how rashes and other specific skin conditions are co-managed by primary care providers (PCPs) and dermatologists, we estimated the frequency with which…
Subspecialization of adrenal surgery through regionalization has not been adequately evaluated. We assessed implementation of subspecialization and the association of regionalization with adrenalectomy outcomes in a community-based setting. In this longitudinal retrospective cohort study, we used an interrupted time series analysis on consecutive adrenal surgeries at Kaiser Permanente Northern California, 2010-2019. The…
To investigate weight trajectories among patients with severe obesity undergoing sleeve gastrectomy (SG), Roux-en-Y gastric bypass (RYGB), and nonsurgical treatment. Although bariatric procedures are associated with substantial weight loss, few studies have compared surgical outcomes to nonsurgical treatment, particularly for…
This randomized controlled trial study is testing an intervention to reduce unsafe medication use in patients aged 75 years and older. The intervention uses collaborative drug therapy management between physicians and pharmacists, standard-of-care treatment protocols, shared decision-making, and the CEASE deprescribing protocol.…
In 2016, Kaiser Permanente Northern California regionalized gastric cancer care, introducing a regional comprehensive multidisciplinary care team, standardizing staging and chemotherapy, and implementing laparoscopic gastrectomy and D2 lymphadenectomy for patients eligible for curative-intent surgery. This study evaluated the effect of…
While electronic health records data provide unique opportunities for research, numerous methodological issues must be considered. Among these, selection bias due to incomplete/missing data has received far less attention than other issues. Unfortunately, standard missing data approaches (e.g. inverse-probability weighting…
To improve nutritional status and dysphagia, esophageal cancer patients starting neoadjuvant therapy in advance of curative-intent surgery may receive a jejunostomy tube (J-tube) or esophageal stent, or they may be managed without a feeding modality. We examined percent total weight…
To separately compare the long-term risk of mortality among bariatric surgical patients undergoing either RYGB or SG to large, matched, population-based cohorts of patients with severe obesity who did not undergo surgery. Bariatric surgery has been associated with reduced long-term…
The longitudinal risk of colorectal cancer (CRC) associated with subtypes of serrated polyps (SPs) remains incompletely understood. This community-based, case-control study included 317 178 Kaiser Permanente Northern California members who underwent their first colonoscopy during 2006-2016. Nested within this population,…
Beginning in March 2020, case reports and case series linked the COVID-19 pandemic with an increased occurrence of chilblains, but this association has not been evaluated in an epidemiologic study. To assess whether a correlation exists between COVID-19 incidence and…
Purpose: We studied adoption of an innovative laparoscopic technique for pediatric inguinal hernia repair by pediatric surgeons and pediatric urologists following dissemination of evidence for its benefits. Methods: This mixed methods study included children who received inguinal hernia repairs during…
To estimate the association of cefuroxime and moxifloxacin in relation to the occurrence of endophthalmitis following phacoemulsification cataract surgery. Retrospective clinical cohort study. We studied patients with noncomplex phacoemulsification cataract surgery in Kaiser Permanente Northern California during 2014-2019. Data were…
To compare visual outcomes in patients without a history of macular edema after phacoemulsification using combination topical nonsteroidal anti-inflammatory drug plus prednisolone with prednisolone alone. Kaiser Permanente Northern California, USA. Retrospective cohort study. Information was obtained from the electronic health…
Embedded researchers could play a central role in developing tools to personalize care using electronic medical records (EMRs). However, few studies have described the steps involved in developing such tools, or evaluated the key factors in success and failure. This…
The recent systematic adoption of intracameral antibiotic injection during cataract surgery in Sweden, India, and the US serves as a model for the successful transitioning of local quality improvement initiatives to organization-wide implementation. Although the delivery of eye care in…
Regionalization of care for acute myeloid leukemia (AML) has not been described for community-based settings. In 2015, we shifted AML induction from 21 local centers to 3 regional centers. Using time-specific inception cohorts, we assessed whether regionalization was associated with…
Risk of cutaneous squamous cell carcinoma (cSCC) after the diagnosis of actinic keratosis (AK) has not been studied during long follow-up periods. To estimate the risk up to 10 years and identify risk factors for cSCC development. This longitudinal cohort…
Missing data is common in electronic health records (EHR)-based obesity research. To avoid bias, it is critical to understand mechanisms that underpin missingness. We conducted a survey among bariatric surgery patients in three integrated health systems to (i) investigate predictors…
Phacoemulsification has been linked to lowered intraocular pressure (IOP) in patients with glaucoma, ocular hypertension, anatomic narrow angles, and in glaucoma suspects, but the magnitude of change has varied. Retrospective cohort study. Patients with glaucoma treated from June 2010 through…
To compare the long-term risks of reintervention following sleeve gastrectomy (SG) and Roux-en-Y gastric bypass (RYGB) in a large surgical cohort. The use of SG has increased dramatically relative to RYGB for the treatment of obesity. However, long-term risks following…
In 2016, Kaiser Permanente Northern California began regionalizing testicular cancer care using population-based tumor board review. This mixed methods evaluation describes implementation outcomes and learnings. We conducted in-depth interviews with key stakeholders, administered surveys to local oncologists and urologists, and…
To develop predictive models of final corrected distance visual acuity (CDVA) following cataract surgery using machine learning algorithms and electronic health record data. In this predictive modeling study we used decision tree, random forest, and gradient boosting. We included the…
Coordination of care between primary care providers and dermatologists is important to ensure high quality and cost efficiency. In our integrated care setting, we used a retrospective cohort study to assess which patients self-refer to dermatology and which returned for…
Follow-up of chest CT scan findings suspicious for lung cancer may be delayed because of inadequate documentation. Standardized reporting and follow-up may reduce time to diagnosis and care for lung cancer. We implemented a reporting system that standardizes tagging of…
Serrated polyp (SPs) are precursors to 20% to 30% of cases of colorectal tumors, but patients' long-term risk after removal of SPs is poorly understood. We investigated the risk of colorectal cancer (CRC) in individuals with a history of SPs.…
Key variables recorded as text in colonoscopy and pathology reports have been extracted using natural language processing (NLP) tools that were not easily adaptable to new settings. We aimed to develop a reliable NLP tool with broad adaptability. During 1996-2016,…
Robotic hysterectomy may offer advantages for complex cases over the conventional laparoscopic approach. To assess the association of surgical approach (robotic vs conventional) with blood loss, risks of readmission, reoperation, complications, and average operative time. In a retrospective cohort study,…
Evidence suggests use of proton pump inhibitors (PPIs) and H2 blockers may provoke disease flares in individuals with established inflammatory bowel disease (IBD); however, there are no studies investigating the relationship of these medications with risk of developing pediatric IBD.…
The effectiveness and value of teledermatology and face-to-face workflows for diagnosing lesions are not adequately understood. We compared the risks of biopsy and cancer diagnosis among 2 face-to-face workflows (direct referral and roving dermatologist) and 4 teledermatology workflows. Retrospective study…
We validated an algorithm to detect frequency errors in computerized healthcare data and estimated the incidence of these errors in an integrated healthcare system. We applied Sentinel System analytic tools on the electronic health records of Kaiser Permanente, Northern California,…
Hydroxychloroquine (HCQ) is a cornerstone to managing systemic lupus erythematosus (SLE), yet adherence to medication is poor. We sought to measure the association of adherence with 5 "dimensions of adherence" as articulated by the World Health Organization for chronic conditions:…
Kaiser Permanente Northern California will participate with the FDA Sentinel to validate the diagnosis of health outcomes of interest.
To assess the relation between diabetic retinopathy (DR) severity, duration of diabetes, insulin dependence, and preoperative hemoglobin A1c (HbA1c) with visual outcome after phacoemulsification for cataract in patients with type 2 diabetes. Kaiser Permanente Northern California, USA. Retrospective case series.…
Electronic medical records hold promise to transform clinical practice. However, technological and other barriers may preclude using them to guide care in real time. We used the Virtual Data Warehouse (VDW) to develop a tool that enables physicians to generate…
Pediatric laparoscopic inguinal hernia repair is not widely accepted. Children 0-14 years who underwent inguinal hernia repair during 2010-2016 at Kaiser Permanente Northern California were classified into five groups: (1) open unilateral repair without contralateral exploration; (2) open unilateral repair with…
The benefit of teledermatology for triaging skin rashes is not adequately understood. The study will assess how implementation of teledermatology (technology and staffing) improves the effectiveness and efficiency of diagnosis, including wait time to diagnosis, therapies, and need for follow-up…
Risk of community-acquired Clostridium difficile infection (CA-CDI) following antibiotic treatment specifically for urinary tract infection (UTI) has not been evaluated. We conducted a nested case-control study at Kaiser Permanente Northern California, 2007-2010, to assess antibiotic prescribing and other factors in…
In this report, we use data from FDA's Sentinel System to focus on how augmenting a diagnosis-based chronic kidney disease cohort with patients identified through laboratory results impacts cohort characteristics and outcomes. We used data from 2 Data Partners. Patients…
We surveyed cataract surgeons to gain insight into their perceptions of and attitudes about immediate sequential bilateral cataract surgery (ISBCS). Cross-sectional. All active cataract surgeons in Kaiser Permanente Northern California in 2016. Online survey that asked cataract surgeons why they…
This study has three primary aims: 1) to evaluate the effectiveness of Testicular Cancer Redesign on rates of use of guideline-adherent and avoidable utilization; 2) to evaluate users’ ability to adopt and maintain use of Testicular Cancer Redesign workflow changes…
The aim of this article is to describe the development and implementation of structured reporting of adnexal mass findings on pelvic ultrasound in a large integrated health care delivery system. A structured reporting system that includes standardized terminology for describing…
We investigated the effect of inflammatory biomarkers (neutrophil, platelet, and lymphocyte counts) on risk of progression in patients with metastatic melanoma treated with an immune checkpoint inhibitor targeting programmed cell death protein-1 (PD-1). This retrospective cohort study included 108 patients…
This project is proposed by University of California, San Francisco (UCSF) gastroenterology fellow Suzanne Sharpton, who is also earning an M.S. in public health. She is supported by Kaiser Permanente gastroenterologist Varun Saxton and bariatric surgeon Robert Li, as well…
This project consists of tasks required for data partners in the Food and Drug Administration’s Sentinel Initiative under the initiative’s “Year 4 Infrastructure” statement of work. Most of the requirements involve data partner staff running data requests or returning data…
Comparative safety studies typically use hierarchical treatment categories that lump monotherapy and combination therapy. The consequence of this approach on study results is not clear. For example, studies of tumor necrosis factor inhibitors usually lump users regardless of whether they…
Purpose To better understand diagnostic delay and doctor-patient communication during the diagnosis of systemic lupus erythematous in patients without malar rash, we conducted a qualitative study of primary care providers' perceptions. Methods We conducted in-depth interviews with a purposive sample…
Rectal cancer and its treatment impair survivors' productivity. To assess determinants of market and nonmarket employment, job search, volunteering, and homemaking among survivors five years or longer after diagnosis. We mailed questionnaires to 1063 survivors who were members of (Northern…
Physical activity (PA) is positively associated with numerous health benefits among cancer survivors. This study examined insufficiently investigated relationships among PA, health-related quality of life (HRQOL), and bowel function (BF) in rectal cancer survivors. RC survivors (n = 1063) ≥5 years from diagnosis…
Bowel function in long-term rectal cancer survivors with anastomosis has not been characterized adequately. We hypothesized that bowel function is associated with patient, disease, and treatment characteristics. The cohort study included Kaiser Permanente members who were long-term (≥5 years) rectal cancer…
Estimates of the incidence and prevalence of systemic lupus erythematosus (SLE) in the US have varied widely. The purpose of this study was to conduct the California Lupus Surveillance Project (CLSP) to determine credible estimates of SLE incidence and prevalence,…
We conducted a retrospective comparative-effectiveness study of best-corrected visual acuity (BCVA) and refractive error (RE) after immediate sequential (ISBCS) and delayed sequential (DSBCS) bilateral cataract surgery. We tested 2 hypotheses: (1) among DSBCS patients, second-eye outcomes were no different than…
Antibiotic prophylaxis in cataract surgery is intended to minimize endophthalmitis. We describe pathogenic organisms, antibiotic sensitivities and antibiotic prophylaxis in culture-proven endophthalmitis cases. Retrospective consecutive case series and community-based setting were used. Two hundred fifteen cases of endophthalmitis after cataract…
Antibiotic prophylaxis is critical to ophthalmology and other surgical specialties. We performed natural language processing (NLP) of 743 838 operative notes recorded for 315 246 surgeries to ascertain two variables needed to study the comparative effectiveness of antibiotic prophylaxis in cataract surgery.…
The objective of this study is to predict visual acuity and incidence rates of complications after cataract surgery.
To systematically analyze potential process failures related to bilateral same-day cataract surgery toward the goal of improving patient safety. Twenty-one Kaiser Permanente surgery centers, Northern California, USA. Retrospective cohort study. Quality experts performed a Failure Modes and Effects Analysis (FMEA)…
This program, with funding through Lupus Foundation of America, is a new initiative to improve health outcomes and health-related quality of life among individuals with lupus. The project will focus on creating sustainable lupus awareness and improve lupus-related health communications;…
The objective of this study is to provide surveillance of bariatric surgery outcomes and safety.
To conduct a CE study to assess whether differences in abx prophx for infection (during cataract surgery) result in different infection rates after accounting for surgical and patient risk factors.
The inflammatory bowel diseases (IBD) ulcerative colitis (UC) and Crohn's disease (CD) cause significant morbidity and are increasing in prevalence among all populations, including African Americans. More than 200 susceptibility loci have been identified in populations of predominantly European ancestry,…
Cancer patients' participation in social, recreational, and civic activities is strongly associated with quality of life (QOL), but these activities are not well integrated into cancer survivorship research or interventions. Test the hypothesis that for long-term (≥ 5 years) survivors…
Laboratory test (lab) results may be useful to detect incident diabetes in electronic health record and claims-based studies. Using the Mini-Sentinel distributed database, we assessed the value of lab results added to diagnosis codes and dispensing claims to identify incident…
Types of surgery for rectal cancer (RC), including permanent ostomy (PO) or temporary ostomy followed by anastomosis (TO) or initial anastomosis (AN), can affect psychological and financial well-being during active treatment. However, these relationships have not been well studied among…
For some patients with low rectal cancer, ostomy (with elimination into a pouch) may be the only realistic surgical option. However, some patients have a choice between ostomy and sphincter-sparing surgery. Sphincter-sparing surgery has been preferred over ostomy because it…
To evaluate the association between refractive error and the prevalence of glaucoma by race or ethnicity. Cross-sectional study. Kaiser Permanente Northern California Health Plan members with refractive error measured at 35 years of age or older between 2008 and 2014…
To compare serious infection risk for systemic lupus erythematosus (SLE) patients starting glucocorticoids (GC), antimalarials (AM), or their combination. We conducted a new-user, historical cohort study, Kaiser Permanente Northern California, 1997-2013. Cox proportional hazards analysis was used to calculate adjusted…
Our purpose was to quantify missing baseline laboratory results, assess predictors of missingness, and examine performance of missing data methods. Using the Mini-Sentinel Distributed Database from three sites, we selected three exposure-outcome scenarios with laboratory results as baseline confounders. We…
Sexual dysfunction is a treatment sequela in survivors of rectal cancer (RC). Differences in health-related quality of life (HRQOL) can occur based on ostomy status (permanent ostomy vs anastomosis). To describe alterations in sexual function and HRQOL based on ostomy…
Intracameral injection is an effective method for preventing infection, but no controlled study has been published in the United States. We conducted an observational, longitudinal cohort study to examine the effect of topical and injected antibiotics on risk of endophthalmitis.…
To describe patient preferences in selecting specific biologics and compare clinical response using patient reported outcomes (PROs) among patients with rheumatoid arthritis (RA) started on different anti-tumor necrosis factor (TNF) therapies. Participants were enrollees in Kaiser Permanente Northern California. Patients…
Few studies have assessed the prevalence and features of axial spondyloarthritis (axSpA) and ankylosing spondylitis in diverse, population-based, community settings. We used computerized diagnoses to estimate the prevalence of axSpA and ankylosing spondylitis in Kaiser Permanente Northern California (KPNC). We…
To assess variations in rheumatoid arthritis treatment and outcomes at the community level from 1998 through 2009. The study used computerized data from 16 Kaiser Permanente Northern California Medical Centers. Mixed modeling was used to assess patterns across time and…
Bowel dysfunction is a known complication of colorectal cancer (CRC) surgery. Poor bowel control has a detrimental impact on survivors' health-related quality of life (HRQOL). This analysis describes the dietary and behavioral adjustments used by CRC survivors to manage bowel…
To study the relationship of chemoprophylaxis and other factors with the occurrence of acute, clinical, postoperative macular edema. Retrospective cohort study. The drug regimens consisted of postoperative topical prednisolone acetate (PA) alone or with a nonsteroidal anti-inflammatory drug (NSAID) or…
The cost to build and to maintain traditional registries for many dire, complex, low-frequency conditions is prohibitive. The authors used accessible technology to develop a platform that would generate miniregistries (small, routinely updated datasets) for surveillance, to identify patients who…
Objectives. To assess the relationship between infections and the risk of pediatric-onset inflammatory bowel disease (IBD). Methods. We conducted a nested case-control study of 501 incident cases aged ?17 years and 9,442 controls who were members of Kaiser Permanente Northern…
Examination of reliability and validity of a specialized health-related quality of life questionnaire for rectal cancer (RC) survivors (?5 years post-diagnosis). We mailed 1,063 Kaiser Permanente (KP) RC survivors (313 ostomy and 750 anastomosis) a questionnaire containing the Modified City…
Laparoscopic Roux-en-Y gastric bypass (RYGB) and laparoscopic adjustable gastric banding (AGB) are 2 of the most commonly performed bariatric procedures worldwide. However, few large, multisite studies have directly compared the benefits and harms of these procedures. To compare the effect…
To determine among patients with autoimmune diseases in the USA whether the risk of non-viral opportunistic infections (OI) was increased among new users of tumour necrosis factor ? inhibitors (TNFI), when compared to users of non-biological agents used for active…
To describe trends in labor induction, including elective induction, from 2001 to 2007 for six U.S. health plans and to examine the validity of induction measures derived from birth certificate and health plan data. This retrospective cohort study included 339,123…
Psoriasis may predispose to cardiovascular disease and diabetes. However, the role of tumor necrosis factor (TNF) inhibitor in mediating this risk is controversial. To assess this relationship, we estimated change in metabolic physiologic measures before and after initiation of TNF…
This study examines incident treatment patterns for attention-deficit/hyperactivity disorder (ADHD) in children seen in eight integrated healthcare delivery systems and identifies factors associated with adherence to Healthcare Effectiveness Data and Information Set (HEDIS) quality measures developed by the National Committee…
The journey from diagnosis through treatment to survivorship can be challenging for colorectal cancer (CRC) survivors with permanent ostomies. Memories of both the positive and negative health-care interactions can persist years after the initial diagnosis and treatment. The purpose of…
The purpose of this review was to compare the efficacy and safety of biologics, immunomodulators, corticosteroids, and aminosalicylates in the treatment of Crohn's disease. We searched MEDLINE(®) (1966 through June 2011), Embase(®) (1974 through June 2011), and the Cochrane Central…
Current knowledge of racial disparities in healthcare utilization and disease outcomes for ulcerative colitis (UC) is limited. We sought to investigate these differences among Caucasian, African American, Asian, and Hispanic patients with ulcerative colitis in Kaiser Permanente, a large integrated…
Few population-based studies have reported the prevalence of psoriatic disease. We validated computerized diagnoses to estimate the prevalence of psoriasis and psoriatic arthritis. We identified adults with ?1 ICD-9 diagnosis codes of 696.0 (psoriatic arthritis) or 696.1 (psoriasis) in clinical…
OBJECTIVE: We tested the hypothesis that initiation of tumor necrosis factor alpha (TNFalpha) antagonists reduced the risk of fractures compared to nonbiologic comparators in patients with autoimmune diseases. METHODS: Using 4 large administrative databases, we assembled retrospective cohorts of patients…
Few studies based in well-defined North American populations have examined the occurrence of juvenile idiopathic arthritis (JIA), and none has been based in an ethnically diverse population. We used computerized healthcare information from the Kaiser Permanente Northern California membership to…
PURPOSE: This study describes practical considerations for implementation of near real-time medical product safety surveillance in a distributed health data network. METHODS: We conducted pilot active safety surveillance comparing generic divalproex sodium to historical branded product at four health plans…
PURPOSE: In post-marketing drug safety surveillance, data mining can potentially detect rare but serious adverse events. Assessing an entire collection of drug-event pairs is traditionally performed on a predefined level of granularity. It is unknown a priori whether a drug…
BACKGROUND: Anti-tumor necrosis factor-alpha (TNF-alpha) agents have been hypothesized to increase the risk of interstitial lung disease (ILD), including its most severe manifestation, pulmonary fibrosis. METHODS: We conducted a cohort study among autoimmune disease patients who were members of Kaiser…
IMPORTANCE: Herpes zoster reactivation disproportionately affects patients with rheumatoid arthritis (RA). It is unclear whether anti-tumor necrosis factor (anti-TNF) therapy elevates herpes zoster risk. OBJECTIVES: To ascertain whether initiation of anti-TNF therapy compared with nonbiologic comparators is associated with increased…
OBJECTIVE: In North America, tuberculosis and nontuberculous mycobacterial (NTM) disease rates associated with antitumour necrosis factor alpha (anti-TNFalpha) therapy are unknown. METHODS: At Kaiser Permanente Northern California, the authors searched automated pharmacy records to identify inflammatory disease patients who received…
PURPOSE: To evaluate the incidence of optic neuritis (ON) in patients using anti-tumor necrosis factor (TNF) alpha therapy. DESIGN: Retrospective, population-based cohort study. METHODS: We identified new users of anti-TNF therapy (etanercept, infliximab, or adalimumab) or nonbiologic disease-modifying antirheumatic drugs…
The purpose of this article was to describe persistent ostomy-specific concerns and adaptations in long-term (>5 years) colorectal cancer survivors with ostomies. Thirty-three colorectal cancer survivors who participated in 8 gender- and health-related quality of life stratified focus groups and…
Background: Drug adverse event (AE) signal detection using the Gamma Poisson Shrinker (GPS) is commonly applied in spontaneous reporting. AE signal detection using large observational health plan databases can expand medication safety surveillance. Methods: Using data from nine health plans,…
PURPOSE: To evaluate post-cataract-surgery endophthalmitis rates in relation to changing practice patterns in antibiotic administration. SETTING: Kaiser Permanente, Diablo Service Area, California. DESIGN: Ecological time-trend study. METHODS: During 2007 through 2011, 3 time periods were identified based on increasing adoption…
OBJECTIVE: To compare the incidence of cancer following tumor necrosis factor alpha (TNFalpha) inhibitor therapy to that with commonly used alternative therapies across multiple immune-mediated diseases. METHODS: The Safety Assessment of Biological Therapeutics study used data from 4 sources: national…
PURPOSE: To compare mortality among patients with selected autoimmune diseases treated with anti-tumor necrosis factor alpha (TNF-alpha) agents with similar patients treated with non-biologic therapies. METHODS: Cohort study set within several large health care programs, 1998-2007. Autoimmune disease patients were…
OBJECTIVE: To quantify the incremental direct medical expenditure associated with rheumatoid arthritis (RA) in the US population from a payer's perspective. METHODS: A probability-weighted sample of adult respondents from the Medical Expenditure Panel Survey (2008) was used to identify a…
BACKGROUND: Previous studies provide evidence that there is a greater frequency of autoimmune diseases among patients with psoriasis than in the general population. OBJECTIVE: This study examined the association between psoriasis and 21 common autoimmune diseases, specified a priori. METHODS:…
For some patients diagnosed with rectal cancer, surgery will involve the creation of a temporary or permanent ostomy. When the colostomy is located in the sigmoid or descending colon, regulation of fecal output can occur through irrigation, a procedure that…
BACKGROUND: The majority of studies that report early life risk factors for pediatric-onset inflammatory bowel disease (IBD) do not account for potential confounding, which can lead to spurious associations and incorrect inferences. AIMS: To assess the relationship between prenatal and…
BACKGROUND & AIMS: The relationship between inflammatory bowel disease (IBD) and the incidence and mortality of colorectal adenocarcinoma (CRC) has not been evaluated recently. METHODS: We calculated the incidence and standardized incidence and mortality rate ratios of CRC among adult…
PURPOSE: Infliximab, a chimeric monoclonal anti-TNFalpha antibody, has been found to increase the risk of serious infections compared with the TNF receptor fusion protein etanercept in some studies. It is unclear whether the risk varies by patient characteristics. We conducted…
BACKGROUND: Hepatosplenic T-cell lymphoma (HSTCL), a rare and rapidly progressive subtype of peripheral T-cell lymphoma, has been reported following TNF-alpha-blocker therapy. To better understand this relationship, we conducted an epidemiologic study in the Kaiser Permanente membership. METHODS: The retrospective cohort…
The US Food and Drug Administration's Mini-Sentinel pilot program is developing an organizational structure as well as principles and policies to govern its operations. These will inform the structure and function of the eventual Sentinel System. Mini-Sentinel is a collaboration…
CONTEXT: Although tumor necrosis factor (TNF)-alpha antagonists are increasingly used in place of nonbiologic comparator medications, their safety profile remains incomplete. OBJECTIVES: To determine whether initiation of TNF-alpha antagonists compared with nonbiologic comparators is associated with an increased risk of…
OBJECTIVES: The objective of this study was to assess inflammatory bowel disease (IBD) medications in relation to lymphoma risk. METHODS: Information on IBD and relevant medications and other utilization was obtained from the Kaiser Permanente IBD Registry, 1996-2009. Lymphoma cases…
BACKGROUND: Although biologic treatments have excellent efficacy for many autoimmune diseases, safety concerns persist. Understanding the absolute and comparative risks of adverse events in patient and disease subpopulations is critical for optimal prescribing of biologics. PURPOSE: The Safety Assessment of…
Objective. We hypothesized that initiation of a new disease-modifying antirheumatic drug (DMARD) for treatment of rheumatoid arthritis (RA) would decrease the use of corticosteroids, nonsteroidal antiinflammatory drugs (NSAIDs), and narcotics.Methods. Using administrative databases, we assembled 4 retrospective cohorts of RA…
PURPOSE/OBJECTIVES: To describe how gender shapes the concerns and adaptations of long-term (i.e., more than five years) colorectal cancer survivors with ostomies. DESIGN: Qualitative study using content analysis of focus group content. SETTING: Oregon, southwestern Washington, and northern California. SAMPLE:…
PURPOSE: Anti-tumor necrosis factor-alpha (anti-TNF) therapies are associated with severe mycobacterial infections in rheumatoid arthritis patients. We developed and validated electronic record search algorithms for these serious infections. METHODS: The study used electronic clinical, microbiologic, and pharmacy records from Kaiser…
BACKGROUND: Societal preference-weighted health-related quality of life (HRQOL) scores enable comparing multidimensional health states across diseases and treatments for research and policy. OBJECTIVE: To assess the effects of living with a permanent intestinal stoma, compared with a major bowel resection,…
OBJECTIVE: To determine whether urine bisphenol-A (BPA) levels are associated with lower semen quality. DESIGN: Cohort study. SETTING: Four regions in China where high exposure to BPA in the workplace existed. PATIENT(S): 218 men with and without BPA exposure in…
BACKGROUND & AIMS: The absence of grade A supporting evidence for surveillance colonoscopy in patients with ulcerative colitis (UC) has led to controversy regarding its benefit, yet it is routinely recommended in practice guidelines. Limited data are available on rates…
The adverse effect of bisphenol-A (BPA) on the male reproductive system observed in animal studies has not been well examined in human populations. BPA is potentially a serious public health problem because of its widely detected presence in the human…
INTRODUCTION: A large study on the safety of biologics required pooling of data from multiple data sources, but while extensive confounder adjustment was necessary, private, individual-level covariate information could not be shared. OBJECTIVES: To describe the methods of pooling data…
PURPOSE: Among long-term (>or=5 y) colorectal cancer survivors with permanent ostomy or anastomosis, we compared the incidence of medical and surgical complications and examined the relationship of complications with health-related quality of life. BACKGROUND: The incidence and effects of complications…
BACKGROUND: Animal studies have suggested that bisphenol-A (BPA) is a potential human endocrine disrupter; but evidence from human studies is needed. METHODS: We conducted an occupational cohort study to examine the effect of occupational exposure to BPA on the risk…
BACKGROUND & AIMS: Thiopurines (azathioprine and 6-mercaptopurine) can induce life-threatening myelosuppression. This study determined the frequency, timing, and outcomes of mild and severe myelosuppression after initiation of thiopurine therapy. METHODS: This retrospective cohort study included patients with inflammatory bowel disease…
PURPOSE: Resources for studying inflammatory bowel disease (IBD) are needed in evaluations of drug safety including traditional drugs and new biologics agents. We developed an IBD registry, with ascertainment from computerized visit information. OBJECTIVE: We sought to characterize the positive…
PURPOSE: Intestinal stomas can pose significant challenges for long-term (> or = 5 years) rectal cancer (RC) survivors. Specifying common challenges and sociodemographic or clinical differences will further the development of tailored interventions to improve health-related quality of life (HRQOL).…
STUDY OBJECTIVES: The aim of this study is to examine differences in sleep disruption and fatigue of men and women colorectal cancer (CRC) survivors with intestinal ostomies and associated health-related quality of life (HR-QOL). METHODS: Participants in this cross-sectional study…
BACKGROUND & AIMS: The management of inflammatory bowel disease (IBD) has become increasingly complicated, and it is unknown whether poor outcomes (prolonged steroid use, hospitalizations, and surgery) have declined in the general population. METHODS: This multilevel study used computerized clinical…
PURPOSE: To describe the concerns raised by health plan members, providers and purchasers related to studying the comparative effectiveness of therapeutics using cluster randomized trials (CRTs) within health plans. An additional goal was to develop recommendations for increasing acceptability. METHODS:…
The objective of the study was to describe the background bisphenol A (BPA) levels in urine and serum of a Chinese population without occupational exposure and to examine the personal characteristics influencing these levels. Workers from 10 factories and their…
PURPOSE: The purpose of this analysis was to determine the unique contribution of household income to the variance explained in psychological well-being (PWB) among a sample of colorectal cancer (CRC) survivors. METHODS: This study is a secondary analysis of data…
PURPOSE: Active surveillance of population-based health networks may improve the timeliness of detection of adverse events (AEs). Our objective was to expand our previous signal detection work by investigating the effect on signal detection of alternative study specifications. METHODS: We…
PURPOSE: Outpatients with cancer receive complicated medication regimens in the clinic and home. Medication errors in this setting are not well described. We aimed to determine rates and types of medication errors and systems factors associated with error in outpatients…
BACKGROUND & AIMS: We sought to evaluate long-term outcomes of patients with severe ulcerative colitis (UC) after their first hospitalization for the disease. METHODS: A cohort of 656 patients hospitalized for UC during 1996 to 2004 was followed up for…
BACKGROUND: Cervical cancer risk is high among immune suppressed women. AIM: To evaluate inflammatory bowel disease (IBD) with medications and risk of cervical cancer. METHODS: Members of Kaiser Permanente Northern California (KPNC), 15-68 years from 1996 to 2006 with IBD…
BACKGROUND: Information on infliximab use in a community setting is important to understand patterns of medication use and to anticipate and plan for costs associated with the drug. We sought to understand predictors of initiation and discontinuation of infliximab in…
OBJECTIVE: There are few estimates of the incidence and prevalence of inflammatory bowel disease in North American communities. We sought to estimate the incidence and prevalence of inflammatory bowel disease (IBD), including Crohn's disease (CD), and ulcerative colitis (UC), among…
OBJECTIVES: The objective of this paper is to describe the complex mixed-methods design of a study conducted to assess health-related quality of life (HRQOL) outcomes and ostomy-related obstacles and adjustments among long-term (>5 years) colorectal cancer (CRC) survivors with ostomies…
BACKGROUND: The purpose was to assess organization-, physician-, and patient-based aspects of inflammatory bowel disease (IBD) practice variation within an integrated care delivery system and the extent to which physicians are interested in adopting a chronic care model and/or nurse…
PURPOSE: Clinical trials demonstrated adjuvant aromatase inhibitor treatment is superior for decreasing breast cancer recurrence risk over adjuvant tamoxifen treatment as early as 2001. Yet clinical use for adjuvant treatment was not recommended by the American Society of Clinical Oncology…
Because of recent studies showing strong prevention benefit and acceptable psychosocial outcomes, more women may be considering prophylactic mastectomy. A growing literature shows some positive psychosocial outcomes for women with bilateral prophylactic mastectomy, but less is known about women with…
PURPOSE: Active surveillance of population-based health networks may improve the timeliness of detection of adverse drug events (ADEs). Active monitoring requires sequential analysis methods. Our objectives were to (1) evaluate the utility of automated healthcare claims data for near real-time…
BACKGROUND & AIMS: Most previous population-based studies of mortality in inflammatory bowel disease (IBD) did not account for medication use. We evaluated mortality by IBD medication use among members of the Kaiser Permanente Northern California IBD Registry. METHODS: The retrospective,…
BACKGROUND: Cluster randomized trials (CRTs) offer unique advantages over standard randomized controlled clinical trials (RCTs) and observational methodologies, and may provide a cost-efficient alternative for answering questions about the best treatments for common conditions. OBJECTIVES: To describe health plan leaders'…
Women dying of ovarian cancer vary considerably in their complications and in the types of health care they receive. The objective of this study was to describe the complications of ovarian cancer, other than pain, and their treatment at the…
BACKGROUND: Among patients with chronic medical conditions, unrelated conditions are often undertreated. OBJECTIVE: To compare the quality of diabetes care delivered to diabetic patients with and without cancer in a large regional integrated delivery system. DESIGN: Observational cohort study using…
Although prophylactic mastectomy significantly reduces the incidence and recurrence of breast cancer, little is known about women's information needs before the procedure. We surveyed 967 women, from 6 healthcare systems, with bilateral or contralateral prophylactic mastectomy performed between 1979 and…
BACKGROUND AND AIMS: Previous studies provide evidence that some immune-mediated diseases occur at greater frequency among inflammatory bowel disease (IBD) patients than in the general population. The present study examined the co-occurrence of IBD with common immune-mediated disorders including asthma,…
GOALS OF WORK: We investigated the effects of social support in the last 6 months of life for women who died of ovarian cancer. MATERIALS AND METHODS: The study population included women enrolled in one of three Managed Care Organizations…
BACKGROUND: There are few contemporary estimates of prevalence rates for inflammatory bowel disease (IBD) in diverse North American communities. METHODS: We estimated the period prevalence of IBD for January 1, 1999, through June 30, 2001, among 1.8 million randomly sampled…
BACKGROUND: Millions of women receive clinical breast examination (CBE) each year, as either a breast cancer screening test or a diagnostic test for breast symptoms. While screening CBE had moderately high specificity (approximately 94%) in clinical trials, community clinicians may…
BACKGROUND: Bilateral prophylactic mastectomy in women with increased breast cancer risk dramatically reduces breast cancer occurrence but little is known about psychosocial outcomes. METHODS: To examine long-term quality of life after bilateral prophylactic mastectomy, we mailed surveys to 195 women…
BACKGROUND: Despite declining death rates from colorectal cancer (CRC), racial disparities have continued to increase. In this study, the authors examined disparities in a racially diverse group of insured patients. METHODS: This study was conducted among patients who were diagnosed…
Previous studies indicate that the symptoms of many dying cancer patients are undertreated and many suffer unnecessary pain. We obtained data retrospectively from three large health maintenance organizations, and examined the analgesic drug therapies received in the last six months…
BACKGROUND: Previous studies have documented that hospice enrollment by terminally ill cancer patients varies substantially by patient characteristics and across broad geographic regions, but little is known about how local practice patterns and individual physicians contribute to these variations. We…
PURPOSE: To understand psychosocial outcomes after prophylactic removal of the contralateral breast in women with unilateral breast cancer. METHODS: We mailed surveys to women with contralateral prophylactic mastectomy after breast cancer diagnosis between 1979 and 1999 at six health care…
BACKGROUND: The efficacy of breast cancer screening in the community may differ from that suggested by the results of randomized trials, and no data have been available on efficacy among women who have different levels of breast cancer risk. METHODS:…
PURPOSE: We investigated the efficacy of contralateral prophylactic mastectomy (CPM) in reducing contralateral breast cancer incidence and breast cancer mortality among women who have already been diagnosed with breast cancer. METHODS: This retrospective cohort study comprised approximately 50,000 women who…
BACKGROUND: Findings from several studies suggest that bilateral prophylactic mastectomy reduces breast cancer incidence by 90% or more, but the studies used highly selected patients from referral centers, and the comparison groups were not population based. We studied the efficacy…
BACKGROUND: Although rates of survival for women with breast cancer have improved, the survival disparity between African American and white women in the United States has increased. PURPOSE: To determine whether this survival disparity persists in an insured population with…
Critical questions about cancer prevention, care, and outcomes increasingly require research involving large patient populations and their care delivery organizations. The Cancer Research Network (CRN) includes 11 integrated health systems funded by the National Cancer Institute (NCI) to conduct collaborative…
Understanding and eliminating health disparities requires accurate data on race/ethnicity. To assess the quality of race/ethnicity data, we compared medical record classifications to self-report of a study of prophylactic mastectomy. A total of 788 women had race/ethnicity from both sources;…
BACKGROUND: Although most American women regularly receive screening clinical breast examination (CBE), little is known about CBE accuracy in community practice. We sought to estimate the rate of cancer detection (sensitivity) of screening CBE performed by community-based clinicians on women…
BACKGROUND: Bilateral prophylactic mastectomy significantly decreases breast cancer risk, but complications of the procedure have only been described in single-site studies. We describe the frequency and type of complications in women who underwent bilateral prophylactic mastectomy in a multisite community-based…
BACKGROUND: Contralateral prophylactic mastectomy (CPM) is the removal of a nonaffected breast in a woman with unilateral breast cancer and is effective in reducing the risk of recurrences. Little is known about women's decision-making roles regarding CPM. METHODS: Women aged…
OBJECTIVE: To determine the sensitivity and positive predictive value (PPV) of computerized diagnostic data from health maintenance organizations (HMOs) in identifying incident breast cancer cases. STUDY DESIGN: An HMO without a cancer registry developed an algorithm identifying incident breast cancer…
Population laboratories with complete clinical information on episodes of care are needed to support research on the quality of care delivered to cancer patients. Data resources within the Cancer Research Network (CRN) may overcome many of the limitations of existing…
We investigated the role of toe implants in systemic disease and evaluated local complications after foot surgery. Information was obtained from the medical records of Kaiser Permanente (northern California) patients who had undergone toe surgery between 1979 and 1988. Computerized…
OBJECTIVE: To implement a computerized system to gather and transmit medical record information from six sites to a centralized database for two cancer prevention studies. METHODS: Microsoft Access 97 was selected as the application for the system. Sites purchased Access…
Cryptorchism is an established risk factor for testicular cancer, but the role of age at surgical correction is unclear. The authors investigated this relation using information obtained from comprehensive medical records dating to childhood. They conducted a case-control study of…
Clinical studies using medical record review should include careful training and quality assurance methods to enhance the reliability and validity of data obtained from the records. Because of time and budget constraints, comprehensive assessments of data quality and reliability, including…
BACKGROUND: African-American ovarian cancer patients present with more advanced disease and have poorer survival than do white patients. METHODS: To determine whether these differences occur among African-American and white patients who have equal access to medical care, we analyzed ovarian…
PURPOSE: The incidence of synchronous primary endometrial and ovarian cancer is 2- to 10-fold higher than that expected based on the incidence of each cancer alone. We sought to evaluate reasons for this in a case-control study. METHODS: We combined…
The authors sought to examine the hypothesis that girls who were relatively tall during the prepubescent period (indicative of an affluent diet and good general health) were at increased risk of subsequent breast cancer. They conducted a case-control study of…
We sought to assess the reliability of information regarding the maternal history of cancer by comparing the medical records of 214 women with breast cancer, ages 26-59 years and diagnosed in 1974-1995, and of their controls with the medical records…
We examined the hypothesis that cigarette smoking increases the risk of non-Hodgkin's lymphoma (NHL) subtypes in a cohort of approximately 253,000 members of the Kaiser Permanente Medical Care Program, ages 16-84 years, who completed a self-administered questionnaire during the period…
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