Lisa J Herrinton

Kaiser Permanente, Oakland, California, United States

Are you Lisa J Herrinton?

Claim your profile

Publications (145)651.49 Total impact

  • [Show abstract] [Hide abstract]
    ABSTRACT: 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.
    JAMA surgery. 10/2014;
  • [Show abstract] [Hide abstract]
    ABSTRACT: Abstract Background: 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. Methods: This retrospective cohort study included 339,123 deliveries at 35 weeks' gestation or greater. Linked health plan and birth certificate data provided information about induction, maternal medical conditions, and pregnancy complications. Induction was defined from diagnosis and procedure codes and birth certificate data and considered elective if no accepted indication was coded. We calculated induction prevalence across health plans and years. At four health plans, we reviewed medical records to validate induction measures. Results: Based on electronic data, induction prevalence rose from 28% in 2001 to 32% in 2005, then declined to 29% in 2007. The trend was driven by changes in the prevalence of apparent elective induction, which rose from 11% in 2001 to 14% in 2005 and then declined to 11% in 2007. The trend was similar for subgroups by parity and gestational age. Elective induction prevalence varied considerably across plans. On review of 86 records, 36% of apparent elective inductions identified from electronic data were confirmed as valid. Conclusions: Elective induction appeared to peak in 2005 and then decline. The decrease may reflect quality improvement initiatives or changes in policies, patient or provider attitudes, or coding practices. The low validation rate for measures of elective induction defined from electronic data has important implications for existing quality measures and for research studies examining induction's outcomes.
    Journal of Women's Health 10/2014; · 1.90 Impact Factor
  • Journal of Cataract and Refractive Surgery 09/2014; 40(9):1568. · 2.75 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: Examination of reliability and validity of a specialized health-related quality of life questionnaire for rectal cancer (RC) survivors (≥5 years post-diagnosis).
    Quality of Life Research 06/2014; · 2.86 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: Abstract Introduction: 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 for Quality Assurance (NCQA). Method: A retrospective cohort analysis using electronic healthcare data from youth ages 3 through 17 years with newly diagnosed ADHD between January 1, 2009 and December 31, 2010 was conducted. NCQA quality definitions for initiation and for continuation and maintenance (C&M) of ADHD medications were expanded to include preschoolers and adolescents. Poisson regression models with robust error variance were used to evaluate the association between NCQA-HEDIS adherence measures, provider type, patient characteristics and care process measures. Results: Of 6,864 youth ages 3-17 years old qualifying for incident treatment analyses, 5,538 (80.7%) were started on ADHD medication within a year of diagnosis. Adherence to NCQA-HEDIS® measures was 49.8% for initiation and 45.8% for C&M, with adherence rates higher for mental health than non-mental health providers, school-aged children than adolescents, and for patients concurrently on other psychotropic medications than those who were not. 62.3% of those started on ADHD medication were not eligible for C&M analyses according to HEDIS guidelines, because they did not receive continuous (210 of 300 days) ADHD medication treatment, with adolescents less likely than school-aged children to persist with medications. Conclusion: Study limitations must be considered, including reliance on electronic medical record data, absence of patient race and sociodemographic data, and limited generalizability to other care contexts. Nevertheless, findings suggest novel strategies are needed to improve the quality of ADHD care processes for children of all ages, because even within integrated delivery systems less than half of children with ADHD received care consistent with NCQA-HEDIS standards for initiation and C&M care. Results suggest the need to refine quality measures by including follow-up care in those children not receiving or discontinuing medication treatment, a considerable quality concern not currently captured in NCQA-HEDIS standards.
    Current Medical Research and Opinion 03/2014; · 2.37 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: Objective: To assess the accuracy of electronic health record (EHR)-derived diagnoses in identifying children with incident (i.e., newly diagnosed) ADHD. Method: In 10 large health care organizations, electronic diagnoses data were used to identify all potential cases of incident ADHD among 3- through 9-year-old children. A random sample of records was manually reviewed to determine whether a diagnosis of ADHD was documented in clinician notes. Results: From electronic diagnoses data, a total of 7,362 children with incident ADHD were identified. Upon manual review of 500 records, the diagnosis of incident ADHD was confirmed in clinician notes for 71.5% (95% confidence interval [CI] = [56.5, 86.4]) of records for 3- through 5-year-old children and 73.6% (95% CI = [65.6, 81.6]) of records for 6- through 9-year-old children. Conclusion: Studies predicated on the identification of incident ADHD cases will need to carefully consider study designs that minimize the likelihood of case misclassification. (J. of Att. Dis. 2014; XX(X) 1-XX).
    Journal of Attention Disorders 02/2014; · 2.40 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: 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 this paper is to describe the health-care experiences of long-term (>5 years) CRC survivors with ostomies. Thirty-three CRC survivors with ostomies who were members of Kaiser Permanente, an integrated care organization, in Oregon, southwestern Washington and northern California participated in eight focus groups. Discussions from the focus groups were recorded, transcribed, and analyzed for potential categories and themes. Health-care-related themes described CRC survivors' experiences with diagnosis, treatment decision-making, initial experiences with ostomy, and survivorship. Participants discussed both positive and negative health-care-related experiences, including the need for continued access to trained nurses for ostomy self-care, access to peer support, and resources related to managing persistent, debilitating symptoms. Long-term CRC survivors with ostomies have both positive and negative health-care experiences, regardless of health-related quality of life (HRQOL) and gender. Long-term support mechanisms and quality survivorship care that CRC survivors with ostomies can access are needed to promote positive adjustments and improved HRQOL. The current literature in CRC survivorship suggests that HRQOL concerns can persist years after treatment completion. The coordination of care to manage persistent late- and long-term effects are still lacking for CRC survivors living with an ostomy. Findings from this qualitative analysis will aid in the development of support strategies that foster more positive adjustments for CRC survivors living with an ostomy and support their ongoing ostomy-related needs.
    Supportive Care in Cancer 01/2014; 22(6). · 2.09 Impact Factor
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Background: Bowel dysfunction is a known complication of colorectal cancer (CRC) treatment, and has a detrimental impact on survivors’ health-related quality of life (HRQOL). The prevalence of dietary and behavioral modifications in CRC survivors has been described in only a small number of studies. To better understand dietary and behavioral adjustments that long-term (≥ 5 years) CRC survivors make to regulate their bowel function, we performed a mixed methods analysis, comparing survivors with a permanent ostomy and those with anastomosis. Methods: CRC survivors with or without permanent ostomies were surveyed with the modified version of the City of Hope Quality of Life for Ostomy tool (N=919). Dietary adjustments were compared by ostomy status (ostomy versus anastomosis) and higher quartile versus lower quartile HRQOL scores. Student’s t-tests were used to compare HRQOL measures between groups. Qualitative data from 13 focus groups (N=63) and interviews with 30 female ostomates were analyzed to explore specific strategies used for regulating bowel function. Results: CRC survivors make substantial and permanent dietary adjustments following treatment. The majority of survivors reported that they took more than one month to feel comfortable with their diet, and many (10% to 18%) never became comfortable. No significant dietary adjustment differences were noted based on ostomy status. Survivors who took less time (<1 month) to feel comfortable with their diet and for their appetite to return had better HRQOL (p < 0.001) ≥ 5 years later. Adjustments to control bowel function consisted of four overall strategies: dietary adjustments, behavioral adjustments, exercise, and medications. Conclusions: CRC survivors use a multitude of adaptive strategies to control their bowel function. Many survivors struggle with unpredictable bowel function continually for the rest of their lives, and many never find any set of management strategies to achieve regularity. Understanding the myriad of adjustments made by CRC survivors will lead to evidence-based recommendations to foster positive adjustments after cancer treatment.
    ASCO GI Cancers Symposium, San Francisco, CA; 01/2014
  • [Show abstract] [Hide abstract]
    ABSTRACT: : This review describes the history of U.S. government funding for surveillance programs in inflammatory bowel diseases (IBD), provides current estimates of the incidence and prevalence of IBD in the United States, and enumerates a number of challenges faced by current and future IBD surveillance programs. A rationale for expanding the focus of IBD surveillance beyond counts of incidence and prevalence, to provide a greater understanding of the burden of IBD, disease etiology, and pathogenesis, is provided. Lessons learned from other countries are summarized, in addition to potential resources that may be used to optimize a new form of IBD surveillance in the United States. A consensus recommendation on the goals and available resources for a new model for disease surveillance are provided. This new model should focus on "surveillance of the burden of disease," including (1) natural history of disease and (2) outcomes and complications of the disease and/or treatments.
    Inflammatory Bowel Diseases 11/2013; · 5.12 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: Background Psoriasis may predispose to cardiovascular disease and diabetes. However, the role of tumor necrosis factor (TNF) inhibitor in mediating this risk is controversial. Objective To assess this relationship, we estimated change in metabolic physiologic measures before and after initiation of TNF inhibitor therapy compared with methotrexate (MTX) therapy among psoriasis patients. Methods We conducted a retrospective cohort study, 2007–2012, using computerized clinical data for 1274 new users of TNF inhibitor and 979 new users of MTX therapy to compare change in blood pressure, lipids, triglycerides, fasting plasma glucose and body mass index (BMI) before and after start of TNF inhibitors or MTX. The study was restricted to new users. We computed within-person change in each measure, so that each patient served as their own control. In addition, we compared TNF inhibitor patients to MTX patients, by computing the adjusted difference in their group means. In secondary analyses, we examined phototherapy as a comparator. ResultsAmong starters of TNF inhibitor and MTX therapy, within-person change in physiologic measures at 6 months did not differ significantly. We observed no important or significant changes in any of the physiologic measures with initiation of TNF inhibitor compared with MTX. The same results were found in subgroup analyses focused on men, and on those with hypertension, diabetes mellitus, or obesity. The same results were observed with phototherapy, except that diastolic blood pressure declined by 0.6 mmHg within person during the 6 months after starting phototherapy (P < 0.05). Conclusions The study provides no evidence for improvement of physiologic measures associated with the metabolic syndrome resulting from TNF inhibitor use for psoriasis.
    Journal of the European Academy of Dermatology and Venereology 11/2013; · 2.69 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: 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 health-care system in Northern California. This retrospective cohort study used computerized clinical data from 5,196 Caucasians, 387 African-Americans, 550 Asians, and 801 Hispanics with prevalent UC identified between 1996 and 2007. Healthcare utilization and outcomes were compared at one and five-year follow-up by use of multivariate logistic regression analysis. Compared with whites, the male-to-female ratio differed for African-Americans (0.68 vs. 0.91, p < 0.01) and Asians (1.3 vs. 0.91, p < 0.01). Asians had fewer co-morbid conditions (p < 0.01) than whites, whereas more African-Americans had hypertension and asthma (p < 0.01). Use of immunomodulators did not differ significantly among race and/or ethnic groups. Among Asians, 5-ASA use was highest (p < 0.05) and the incidence of surgery was lowest (p < 0.01). Prolonged steroid exposure was more common among Hispanics (p < 0.05 at 1-year) who also had more UC-related surgery (p < 0.01 at 5-year) and hospitalization (<0.05 at 5-year), although these differences were not significant in multivariate analysis. In this population of UC patients with good access to care, overall health-care utilization patterns and clinical outcomes were similar across races and ethnicity. Asians may have milder disease than other races whereas Hispanics had a trend toward more aggressive disease, although the differences we observed were modest. These differences may be related to biological factors or different treatment preferences.
    Digestive Diseases and Sciences 10/2013; 59(2). · 2.26 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: Background/Aims The two most common bariatric surgical procedures are laparoscopic gastric band (LAGB) and laparoscopic gastric bypass (RYGB). Single site comparisons suggest that RYGB may result in greater weight loss at the expense of more short-term complications, whereas LAGB may be associated with less weight loss and more long-term complications. It is unclear whether these results extend to other populations. Methods This is a multi-site retrospective cohort investigation of LAGB vs. RYGB. Outcomes are: 30-day operative complications; rehospitalization at 1 and 2 years; and weight loss at 2 years. Multivariable logistic regression, Cox proportional hazards, and repeated measures will be used to assess outcomes as a function of type of surgery. Results From 2005-2009, there were 1,521 LAGB and 5,963 RYGB procedures at 11 sites. Mean pre-surgical BMI was 42.6 and 44.6, and mean age was 47.0 and 45.8 for each procedure respectively. RYGB patients were more likely to have diabetes, hypertension, gastric reflux, and sleep apnea. RYGB patients had more commercial insurance (89% vs. 72%), were less likely to be Caucasian (67% vs. 73%), and were 84% (vs. 82%) female. Results at 30-days for LAGB vs. RYGB respectively were: Failure to discharge, 0 (0%) vs. 8 (0.1%); mortality, 0 (0%) vs. 1 (0.02%); thrombotic diagnoses, 6 (0.5%) vs. 63 (1.1%); and reintervention, 10 (0.9%) vs. 30 (0.5%). Mean long-term follow-up BMI was 37.2 for LAGB and 33.3 for RYGB. All differences were statistically significant at P = 0.05 in bivariate models. Conclusions Across multiple sites, individuals with higher BMI and morbidity burden were more likely to receive RYGB surgery. Preliminary results suggest that long-term weight loss and certain short-term complications are significantly greater for RYGB than LAGB procedures, and that LAGB procedures are more likely to have 30-day reintervention. Multivariable comparisons adjusting for pre-operative covariates and follow up time will better clarify risks and benefits of these procedures.
    Clinical Medicine &amp Research 09/2013; 11(3):175.
  • [Show abstract] [Hide abstract]
    ABSTRACT: Background/Aims Rectal cancer surgery includes a colostomy (or ileostomy) or, more frequently, anastomosis of the rectum. Both surgery types may create long-term after-effects. We examined differences reported between survivors with ostomies versus anastomoses regarding levels of work, volunteering, and financial burdens, and how much they perceived their cancer operations affected these experiences. Methods We mailed questionnaires to 1,063 rectal cancer survivors (5+ years post-diagnosis) in Kaiser Permanente (Northern California, Northwest) during 2010-2011. We asked about current employment status and the impact of their cancers on labor force participation, demotions, job discrimination, forced retirement, volunteering, social activities, and marital status. Our overall response rate was 60.5% (578/955). We analyzed usable responses from 390 survivors with anastomoses (69%) and 178 survivors with ostomies (31%) for differences in self-reported functional health status, work, volunteer, and perceived financial burden. Results Survivorship ranged from 5 to 25 years. Mean ages for both groups were significantly beyond retirement age (anastomoses = 72 years, colostomies = 74 years) (NS). 56% of patients with anastomoses were male compared to 66% of ostomates (P <0.03). About 35% of all survivors were not married or partnered at time of survey. Survivors with anastomoses were more likely to be currently working (FT+PT=33% (128/383)) than survivors with colostomies (FT+PT=20% (35/178)), while survivors with ostomies were more likely to be retired or homemakers (77% (137/178) vs. 64% (247/383) or on Disability (ostomies = 3.4% (6/178), anastomoses = 2.1% (8/383)) (P <0.01). Stage at diagnosis was not associated with employment or volunteer activities among survivors, but employed survivors had significantly shorter survivorship periods than non-working survivors (P <0.05). Compared to survivors with anastomoses, survivors with ostomies reported significantly higher perceived financial burden from their cancer and its treatment (P <0.001). Permanently disabled survivors reported even higher perceived financial burden than non-disabled survivors, with no differences by ostomy and anastomosis status. Conclusions Compared to survivors with ostomies, survivors with anastomoses were more likely to report being currently employed/working in the home and having lesser financial burdens from their illness. Interventions are needed to support survivors with ostomies to participate in work and volunteer activities, to manage their personal finances, and to maintain their social networks and personal relationships.
    Clinical Medicine &amp Research 09/2013; 11(3):130.
  • [Show abstract] [Hide abstract]
    ABSTRACT: Elevated tumor necrosis factor (TNF)-α likely contributes to the excess cardiovascular risk observed in rheumatoid arthritis. We compared the cardiovascular risk in rheumatoid arthritis patients starting a TNF-α blocking agent versus a nonbiologic disease-modifying antirheumatic drug (nbDMARD). Subjects with rheumatoid arthritis participating in several different US insurance programs between 1998 and 2007 who received methotrexate were eligible. Those who added a TNF-α blocking agent were compared with subjects who added a nbDMARD in Cox regression models stratified by propensity score decile and adjusted for oral glucocorticoid dosage. We examined the composite cardiovascular end point of myocardial infarction, stroke, or coronary re-vascularization after 6 months. We compared 8656 new users of a nbDMARD with 11,587 new users of a TNF-α blocking agent with similar baseline covariates. Incidence rates per 100 person-years for the composite cardiovascular end point were 3.05 (95% confidence interval [CI], 2.54-3.65) for nbDMARDs and 2.52 (95% CI, 2.12-2.98) for TNF-α blocking agents. The hazard ratio (HR) for the TNF-α blocking agent compared with nbDMARD carrying the first exposure forward was 0.80 (95%, CI 0.62-1.04), while the HR for the as-treated analysis was 0.71 (95% CI, 0.52-0.97). The potential cardiovascular benefit of TNF-α blocking agents was strongest among individuals ≥65 years of age (HR 0.52; 95% CI, 0.34 -0.77; P for interaction = 0.075). Among subjects with rheumatoid arthritis, TNF-α blocking agents may be associated with a reduced risk of cardiovascular events compared with an nbDMARD. Randomized controlled clinical trials should be considered to test this hypothesis.
    The American journal of medicine 08/2013; 126(8):730.e9-730.e17. · 5.30 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: 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 α inhibitors (TNFI), when compared to users of non-biological agents used for active disease. We identified new users of TNFI among cohorts of rheumatoid arthritis (RA), inflammatory bowel disease and psoriasis-psoriatic arthritis-ankylosing spondylitis patients during 1998-2007 using combined data from Kaiser Permanente Northern California, two pharmaceutical assistance programmes for the elderly, Tennessee Medicaid and US Medicaid/Medicare programmes. We compared incidence of non-viral OI among new TNFI users and patients initiating non-biological disease-modifying antirheumatic drugs (DMARD) overall and within each disease cohort. Cox regression models were used to compare propensity-score and steroid- adjusted OI incidence between new TNFI and non-biological DMARD users. Within a cohort of 33 324 new TNFI users we identified 80 non-viral OI, the most common of which was pneumocystosis (n=16). In the combined cohort, crude rates of non-viral OI among new users of TNFI compared to those initiating non-biological DMARD was 2.7 versus 1.7 per 1000-person-years (aHR 1.6, 95% CI 1.0 to 2.6). Baseline corticosteroid use was associated with non-viral OI (aHR 2.5, 95% CI 1.5 to 4.0). In the RA cohort, rates of non-viral OI among new users of infliximab were higher when compared to patients newly starting non-biological DMARD (aHR 2.6, 95% CI 1.2 to 5.6) or new etanercept users (aHR 2.9, 95% CI 1.5 to 5.4). In the USA, the rate of non-viral OI was higher among new users of TNFI with autoimmune diseases compared to non-biological DMARD users.
    Annals of the rheumatic diseases 07/2013; · 9.27 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: BACKGROUND: Few population-based studies have reported the prevalence of psoriatic disease. OBJECTIVE: We validated computerized diagnoses to estimate the prevalence of psoriasis and psoriatic arthritis. METHOD: We identified adults with ≥1 ICD-9 diagnosis codes of 696.0 (psoriatic arthritis) or 696.1 (psoriasis) in clinical encounter data during 1996-2009 and used chart review to confirm the diagnoses in random samples of patients. We then used the best performing case-finding algorithms to estimate the point prevalence of psoriasis and psoriatic arthritis. RESULTS: The number of persons with a diagnosis for psoriasis (ICD-9 code 696.1) was 87 827. Chart review of a random sample of 101 cases with at least one dermatologist-rendered psoriasis code revealed a positive predictive value (PPV) of 90% (95% CI, 83-95) with sensitivity of 88% (95% CI, 80-93). Psoriatic arthritis (code 696.0) was recorded for 5187 patients, with the best performing algorithm requiring ≥2 diagnoses recorded by a rheumatologist or ≥1 diagnosis recorded by a rheumatologist together with ≥1 psoriasis diagnoses recorded by a dermatologist; the PPV was 80% (95% CI, 70-88) with sensitivity 73% (95% CI, 63-82). Among KPNC adults, the point prevalence of psoriasis, with or without psoriatic arthritis, was 939 (95% CI, 765-1142) per 100 000, and the overall prevalence of psoriatic arthritis, with or without psoriasis, was 68 (95% CI, 54-84) per 100 000. CONCLUSION: Within an integrated health care delivery system, the use of computerized diagnoses rendered by relevant disease specialists is a valid method for identifying individuals with psoriatic disease. Copyright © 2013 John Wiley & Sons, Ltd.
    Pharmacoepidemiology and Drug Safety 05/2013; · 2.90 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: OBJECTIVE: 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 validate JIA diagnoses and estimate the incidence and prevalence of the disease in this well-characterized population. METHODS: We identified children aged ≤ 15 years with ≥ 1 relevant International Classification of Diseases, 9th edition, diagnosis code of 696.0, 714, or 720 in computerized clinical encounter data during 1996-2009. In a random sample, we then reviewed the medical records to confirm the diagnosis and diagnosis date and to identify the best-performing case-finding algorithms. Finally, we used the case-finding algorithms to estimate the incidence rate and point prevalence of JIA. RESULTS: A diagnosis of JIA was confirmed in 69% of individuals with at least 1 relevant code. Forty-five percent were newly diagnosed during the study period. The age- and sex-standardized incidence rate of JIA per 100,000 person-years was 11.9 (95% CI 10.9-12.9). It was 16.4 (95% CI 14.6-18.1) in girls and 7.7 (95% CI 6.5-8.9) in boys. The peak incidence rate occurred in children aged 11-15 years. The prevalence of JIA per 100,000 persons was 44.7 (95% CI 39.1-50.2) on December 31, 2009. CONCLUSION: The incidence rate of JIA observed in the Kaiser Permanente population, 1996-2009, was similar to that reported in Rochester, Minnesota, USA, but 2 to 3 times higher than Canadian estimates.
    The Journal of Rheumatology 04/2013; · 3.17 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: 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 causes a very specific or a set of related adverse events, such as mitral valve disorders, all valve disorders, or different types of heart disease. This methodological paper evaluates the tree-based scan statistic data mining method to enhance drug safety surveillance. METHODS: We use a three-million-member electronic health records database from the HMO Research Network. Using the tree-based scan statistic, we assess the safety of selected antifungal and diabetes drugs, simultaneously evaluating overlapping diagnosis groups at different granularity levels, adjusting for multiple testing. Expected and observed adverse event counts were adjusted for age, sex, and health plan, producing a log likelihood ratio test statistic. RESULTS: Out of 732 evaluated disease groupings, 24 were statistically significant, divided among 10 non-overlapping disease categories. Five of the 10 signals are known adverse effects, four are likely due to confounding by indication, while one may warrant further investigation. CONCLUSION: The tree-based scan statistic can be successfully applied as a data mining tool in drug safety surveillance using observational data. The total number of statistical signals was modest and does not imply a causal relationship. Rather, data mining results should be used to generate candidate drug-event pairs for rigorous epidemiological studies to evaluate the individual and comparative safety profiles of drugs. Copyright © 2013 John Wiley & Sons, Ltd.
    Pharmacoepidemiology and Drug Safety 03/2013; · 2.90 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: 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. To ascertain whether initiation of anti-TNF therapy compared with nonbiologic comparators is associated with increased herpes zoster risk. We identified new users of anti-TNF therapy among cohorts of patients with RA, inflammatory bowel disease, and psoriasis, psoriatic arthritis, or ankylosing spondylitis from 1998 through 2007 within a large US multi-institutional collaboration combining data from Kaiser Permanente Northern California, Pharmaceutical Assistance Contract for the Elderly, Tennessee Medicaid, and national Medicaid/Medicare programs. We compared herpes zoster incidence between new anti-TNF users (n=33,324) and patients initiating nonbiologic disease-modifying antirheumatic drugs (DMARDs) (n=25,742) within each inflammatory disease cohort (last participant follow-up December 31, 2007). Within these cohorts, we used Cox regression models to compare propensity score-adjusted herpes zoster incidence between new anti-TNF and nonbiologic DMARD users while controlling for baseline corticosteroid use. Incidence of herpes zoster cases occurring after initiation of new anti-TNF or nonbiologic DMARD therapy. Among 33,324 new users of anti-TNF therapy, we identified 310 herpes zoster cases. Crude incidence rates among anti-TNF users were 12.1 per 1000 patient-years (95% CI, 10.7-13.6) for RA, 11.3 per 1000 patient-years (95% CI, 7.7-16.7) for inflammatory bowel disease, and 4.4 per 1000 patient-years (95% CI, 2.8-7.0) for psoriasis, psoriatic arthritis, or ankylosing spondylitis. Baseline use of corticosteroids of 10 mg/d or greater among all disease indications was associated with elevated risk (adjusted hazard ratio [HR], 2.13 [95% CI, 1.64-2.75]) compared with no baseline use. For patients with RA, adjusted incidence rates were similar between anti-TNF and nonbiologic DMARD initiators (adjusted HR, 1.00 [95% CI, 0.77-1.29]) and comparable between all 3 anti-TNF therapies studied. Across all disease indications, the adjusted HR was 1.09 (95% CI, 0.88-1.36). CONCLUSION AND RELEVANCE: Among patients with RA and other inflammatory diseases, those who initiated anti-TNF therapies were not at higher risk of herpes zoster compared with patients who initiated nonbiologic treatment regimens.
    JAMA The Journal of the American Medical Association 03/2013; 309(9):887-95. · 29.98 Impact Factor
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: 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, we conducted a pilot study to evaluate the implementation and findings of the GPS approach for two antifungal drugs, terbinafine and itraconazole, and two diabetes drugs, pioglitazone and rosiglitazone. We evaluated 1676 diagnosis codes grouped into 183 different clinical concepts and four levels of granularity. Several signaling thresholds were assessed. GPS results were compared to findings from a companion study using the identical analytic dataset but an alternative statistical method-the tree-based scan statistic (TreeScan). Results: We identified 71 statistical signals across two signaling thresholds and two methods, including closely-related signals of overlapping diagnosis definitions. Initial review found that most signals represented known adverse drug reactions or confounding. About 31% of signals met the highest signaling threshold. Conclusions: The GPS method was successfully applied to observational health plan data in a distributed data environment as a drug safety data mining method. There was substantial concordance between the GPS and TreeScan approaches. Key method implementation decisions relate to defining exposures and outcomes and informed choice of signaling thresholds.
    Pharmaceutics 03/2013; 5(1):179-200.

Publication Stats

2k Citations
651.49 Total Impact Points


  • 2000–2014
    • Kaiser Permanente
      • Center for Health Research (Oregon, Hawaii, and Georgia)
      Oakland, California, United States
  • 2011–2013
    • Oregon Health and Science University
      • Department of Public Health & Preventive Medicine
      Los Angeles, CA, United States
    • Vanderbilt University
      • Department of Preventive Medicine
      Nashville, MI, United States
  • 2010–2013
    • University of California, San Francisco
      • • Department of Dermatology
      • • Division of Gastroenterology
      San Francisco, California, United States
  • 2012
    • City of Hope National Medical Center
      • Division of Nursing Research and Education
      Duarte, California, United States
  • 2011–2012
    • Beckman Research Institute
      Duarte, California, United States
  • 2008–2012
    • Johns Hopkins University
      Baltimore, Maryland, United States
    • Group Health Cooperative
      • Group Health Research Institute
      Seattle, Washington, United States
  • 2005–2012
    • Harvard Pilgrim Health Care
      Quincy, Massachusetts, United States
  • 2009
    • Arizona State University
      • College of Nursing and Health Innovation
      Mesa, AZ, United States
    • University of Pennsylvania
      • Department of Medicine
      Philadelphia, PA, United States
  • 2007
    • University of California, Davis
      • Department of Family and Community Medicine
      Davis, CA, United States
    • University of Massachusetts Medical School
      • Meyers Primary Care Institute
      Worcester, MA, United States
  • 2006–2007
    • Brigham and Women's Hospital
      • Center for Brain Mind Medicine
      Boston, MA, United States
  • 2005–2007
    • Harvard University
      • Department of Epidemiology
      Boston, MA, United States
  • 2004–2007
    • HealthPartners Institute for Education and Research
      Bloomington, Minnesota, United States
  • 2003–2005
    • University of Washington Seattle
      • Division of General Internal Medicine
      Seattle, Washington, United States
    • Permanente Medical Group
      Pasadena, California, United States