Cynthia Nakasato

Kaiser Permanente, Oakland, California, United States

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Publications (21)60.84 Total impact

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    ABSTRACT: Objective. To explore the feasibility of identifying anterior cruciate ligament (ACL) allograft implantations and infections using claims. Design. Retrospective cohort study. Methods. We identified ACL reconstructions using procedure codes at 6 health plans from 2000 to 2008. We then identified potential infections using claims-based indicators of infection, including diagnoses, procedures, antibiotic dispensings, specialty consultations, emergency department visits, and hospitalizations. Patients' medical records were reviewed to determine graft type, validate infection status, and calculate sensitivity and positive predictive value (PPV) for indicators of ACL allografts and infections. Results. A total of 11,778 patients with codes for ACL reconstruction were identified. After chart review, PPV for ACL reconstruction was 96% (95% confidence interval [CI], 94%-97%). Of the confirmed ACL reconstructions, 39% (95% CI, 35%-42%) used allograft tissues. The deep infection rate after ACL reconstruction was 1.0% (95% CI, 0.7%-1.4%). The odds ratio of infection for allografts versus autografts was 0.41 (95% CI, 0.19-0.78). Sensitivity of individual claims-based indicators for deep infection after ACL reconstruction ranged from 0% to 75% and PPV from 0% to 100%. Claims-based infection indicators could be combined to enhance sensitivity or PPV but not both. Conclusions. While claims data accurately identify ACL reconstructions, they poorly distinguish between allografts and autografts and identify infections with variable accuracy. Claims data could be useful to monitor infection trends after ACL reconstruction, with different algorithms optimized for different surveillance goals.
    Infection Control and Hospital Epidemiology 06/2014; 35(6):652-9. DOI:10.1086/676430 · 3.94 Impact Factor
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    ABSTRACT: Background. The number of deaths in hepatitis C virus (HCV)-infected persons recorded on US death certificates has been increasing, but actual rates and causes of death in these individuals have not been well elucidated.Methods. Disease-specific, liver-related, and non-liver-related mortality data for HCV-infected patients in an observational cohort study, the Chronic Hepatitis Cohort Study (CHeCS) at 4 US healthcare systems, were compared with multiple cause of death (MCOD) data in 12 million death certificates in 2006-2010. Premortem diagnoses, liver biopsies, and FIB-4 scores (a noninvasive measure of liver damage) were examined.Results. Of 2 143 369 adult patients seen at CHeCS sites in 2006-2010, 11 703 (0.5%) had diagnosed chronic HCV infection, and 1590 (14%) died. The majority of CHeCS decedents were born from 1945 to 1965 (75%), white (50%), and male (68%); mean age of death was 59 years, 15 years younger than MCOD deaths. The age-adjusted mortality rate for liver disease in CHeCS was 12 times higher than the MCOD rate. Before death, 63% of decedents had medical record evidence of chronic liver disease, 76% had elevated FIB-4 scores, and, among those biopsied, 70% had moderate or worse liver fibrosis. However, only 19% of all CHeCS decedents and only 30% of those with recorded liver disease had HCV listed on their death certificates.Conclusions. HCV infection is greatly underdocumented on death certificates. The 16 622 persons with HCV listed in 2010 may represent only one-fifth of about 80 000 HCV-infected persons dying that year, at least two-thirds of whom (53 000 patients) would have had premortem indications of chronic liver disease. © 2014 Published by Oxford University Press on behalf of the Infectious Diseases Society of America 2014. This work is written by (a) US Government employee(s) and is in the public domain in the US.
    Clinical Infectious Diseases 04/2014; 58(8):1055-1061. DOI:10.1093/cid/ciu077 · 9.42 Impact Factor
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    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; DOI:10.1177/1087054713520616 · 2.40 Impact Factor
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    ABSTRACT: A number of studies have described influenza vaccination coverage during pregnancy but few publications have described rates of other vaccinations. To describe vaccination rates during pregnancy in the Vaccine Safety Datalink (VSD), with particular focus on vaccinations contraindicated during pregnancy. Pregnancies ending in 2002 through 2009 and vaccinations administered during these pregnancies were identified in the VSD. Vaccination rates per 1000 pregnancies during the study period were calculated by vaccine type, recommendation category, pregnancy year, maternal age, and trimester. Analyses were conducted in 2012-2013. In the VSD, 669,695 pregnancies and 141,389 vaccinations were identified. Trivalent inactivated influenza (TIV) was the most commonly administered vaccination (174.1 doses per 1000 pregnancies) and was most often administered during the 2nd and 3rd trimesters. The most common vaccines in the "consider if indicated" category were tetanus-diphtheria (6.1 per 1000) and hepatitis B (3.7 per 1000). Contraindicated vaccination was infrequent, and the majority of these were measles-mumps-rubella (MMR) (1.2 per 1000); varicella (1.0 per 1000); and live-attenuated influenza vaccine (LAIV) (0.3 per 1000). Both "consider if indicated" and contraindicated vaccines were more frequently administered during early pregnancy. TIV was the most commonly administered vaccine. With the exception of TIV, other vaccines were most frequently administered during early pregnancy and among younger women, suggesting that vaccination may occur when the woman and/or provider are unaware of the pregnancy. Contraindicated vaccines were infrequently administered during pregnancy; however, given that some women received contraindicated vaccines later in pregnancy, clearer recommendations and improved provider education may be needed.
    American journal of preventive medicine 02/2014; 46(2):150-7. DOI:10.1016/j.amepre.2013.10.010 · 4.28 Impact Factor
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    ABSTRACT: Objectives: Asian and Pacific Islanders (APIs) constitute less than 6% of the US population, but account for more than half of Americans with chronic hepatitis B virus (HBV) infection. We sought to examine the effect of country of origin on HBV testing and chronic HBV infection prevalence among APIs. Methods: We analyzed demographic and clinical data collected for adults from Kaiser Permanente Hawaii with 1 or more healthcare encounters during 2006 to 2008, 12 months or more of follow-up before 2009, and no HBV-related diagnosis within 6 months of enrollment. Persons who received a test and a positive test result for HBV surface antigen or HBV DNA were classified "tested" and with "chronic HBV infection," respectively. Results: Of 92,687 eligible APIs, 53,573 (58%) had country-of-origin data available. Among those, 41,263 were US born; 28.3% were tested; and 1.8% of those tested had chronic HBV infection. Of 12,310 foreign-born APIs, 30.5% were tested and 7.4% of those tested had chronic HBV infection. Foreignborn APIs had higher odds of being tested (odds ratio [OR] = 1.15) and testing positive (OR = 4.18) compared with US-born APIs. Persons with 2 or more abnormal tests for alanine aminotransferase (ALT) levels had higher odds of getting tested (OR = 6.12) and of testing positive (OR = 1.86) compared with persons with other ALT levels. Conclusions: Less than one-third of this managed care API population (29% of 53,573) was tested, yet the prevalence of chronic HBV infection (3.2%) was 12 times higher than that of the general US population. These findings underscore the importance of adherence to HBV testing guidelines to identify persons with infection so they may be linked to care.
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    ABSTRACT: Background/Aims In 2011, the US Food and Drug Administration (FDA) created the Blood Safety Continuous Active-Surveillance Network (Blood-SCAN), the first nationwide active surveillance system for monitoring the safety of FDA-regulated blood components and blood-derived products. Blood-SCAN employs the Mini-Sentinel Distributed Database (MSDD) which contains 126 million individuals within 17 Data Partners. Blood-SCAN is intended to augment the existing safety surveillance system and improve US biovigilance efforts. As a first step in creating Blood-SCAN, we assessed the feasibility of using the current MSDD to evaluate blood component and blood-derived product exposures and related health outcomes. Methods The assessment consisted of 4 activities: (1) an expert working group identified 20 blood components and blood-derived products and 10 health outcomes of interest (HOIs) to evaluate the data available in the MSDD, (2) a literature scan was conducted to identify electronic algorithms to capture these product exposures and HOIs, (3) HOI and exposure frequencies were tabulated using established Mini-Sentinel programs, and (4) structured discussions were conducted with all Mini-Sentinel Data Partners to assess the availability, content, and quality of data within their databases. Results Claims codes were available for all of the blood components and blood-derived products, and many of the claims codes for blood-derived products were sufficiently specific to allow analyses by product manufacturer, fulfilling an important regulatory need. Adequate counts of exposures to immunoglobulin products indicate the potential for future surveillance studies on these products. MSDD analyses suggest that blood-derived products are captured effectively in outpatient settings but not in inpatient settings, limiting the scope of therapeutic indications that can be assessed. Blood component exposures are also captured in outpatient settings within the MSDD; however, because most transfusions occur in inpatient settings, these data may not be completely representative of the patient population, reason for transfusion, and dose. Most Data Partners reported no current ability to access inpatient blood component exposures through existing claims data streams. Conclusions The current MSDD supports safety surveillance for a variety of blood components and blood-derived products in the outpatient setting. Expanding the MSDD to include inpatient data streams will ensure that Blood-SCAN achieves its full potential.
    Clinical Medicine &amp Research 09/2013; 11(3):169. DOI:10.3121/cmr.2013.1176.ps3-6
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    ABSTRACT: Determining the baseline mortality rate in a vaccinated population is necessary to be able to identify any unusual increases in deaths following vaccine administration. Background rates are particularly useful during mass immunization campaigns and in the evaluation of new vaccines. Provide background mortality rates and describe causes of death following vaccination in the Vaccine Safety Datalink (VSD). Analyses were conducted in 2012. Mortality rates were calculated at 0-1 day, 0-7 days, 0-30 days, and 0-60 days following vaccination for deaths occurring between January 1, 2005, and December 31, 2008. Analyses were stratified by age and gender. Causes of death were examined, and findings were compared to National Center for Health Statistics (NCHS) data. Among 13,033,274 vaccinated people, 15,455 deaths occurred between 0 and 60 days following vaccination. The mortality rate within 60 days of a vaccination visit was 442.5 deaths per 100,000 person-years. Rates were highest in the group aged ≥85 years, and increased from the 0-1-day to the 0-60-day interval following vaccination. Eleven of the 15 leading causes of death in the VSD and NCHS overlap in both systems, and the top four causes of death were the same in both systems. VSD mortality rates demonstrate a healthy vaccinee effect, with rates lowest in the days immediately following vaccination, most apparent in the older age groups. The VSD mortality rate is lower than that in the general U.S. population, and the causes of death are similar.
    American journal of preventive medicine 07/2013; 45(1):91-7. DOI:10.1016/j.amepre.2013.02.020 · 4.28 Impact Factor
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    ABSTRACT: BACKGROUND: Poor glycemic control in patients with diabetes may be associated with adverse surgical outcomes. We sought to determine the association of diabetes status and preoperative glycemic control with several surgical outcomes, including revision arthroplasty and deep infection. METHODS: We conducted a retrospective cohort study in five regions of a large integrated health-care organization. Eligible subjects, identified from the Kaiser Permanente Total Joint Replacement Registry, underwent an elective first primary total knee arthroplasty during 2001 through 2009. Data on demographics, diabetes status, preoperative hemoglobin A1c (HbA1c) level, and comorbid conditions were obtained from electronic medical records. Subjects were classified as nondiabetic, diabetic with HbA1c < 7% (controlled diabetes), or diabetic with HbA1c ≥ 7% (uncontrolled diabetes). Outcomes were deep venous thrombosis or pulmonary embolism within ninety days after surgery and revision surgery, deep infection, incident myocardial infarction, and all-cause rehospitalization within one year after surgery. Patients without diabetes were the reference group in all analyses. All models were adjusted for age, sex, body mass index, and Charlson Comorbidity Index. RESULTS: Of 40,491 patients who underwent total knee arthroplasty, 7567 (18.7%) had diabetes, 464 (1.1%) underwent revision arthroplasty, and 287 (0.7%) developed a deep infection. Compared with the patients without diabetes, no association between controlled diabetes (HbA1c < 7%) and the risk of revision (odds ratio [OR], 1.32; 95% confidence interval [CI], 0.99 to 1.76), risk of deep infection (OR, 1.31; 95% CI, 0.92 to 1.86), or risk of deep venous thrombosis or pulmonary embolism (OR, 0.84; 95% CI, 0.60 to 1.17) was observed. Similarly, compared with patients without diabetes, no association between uncontrolled diabetes (HbA1c ≥ 7%) and the risk of revision (OR, 1.03; 95% CI, 0.68 to 1.54), risk of deep infection (OR, 0.55; 95% CI 0.29 to 1.06), or risk of deep venous thrombosis or pulmonary embolism (OR, 0.70; 95% CI, 0.43 to 1.13) was observed. CONCLUSIONS: No significantly increased risk of revision arthroplasty, deep infection, or deep venous thrombosis was found in patients with diabetes (as defined on the basis of preoperative HbA1c levels and other criteria) compared with patients without diabetes in the study population of patients who underwent elective total knee arthroplasty. LEVEL OF EVIDENCE: Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.
    The Journal of Bone and Joint Surgery 02/2013; 95A(6). DOI:10.2106/JBJS.L.00109 · 4.31 Impact Factor
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    ABSTRACT: A new meningococcal conjugate vaccine (MCV4) was introduced in 2005. Shortly after, case reports of Guillain–Barré syndrome (GBS), a serious demyelinating disease, began to be reported to the Vaccine Adverse Event Reporting System. In 2006, the Centers for Disease Control and Prevention and the Food and Drug Administration requested the evaluation of GBS risk after MCV4 vaccination. We conducted a study to assess the risk of GBS after MCV4 vaccination using health plan administrative and claims data together with the review of primary medical records of potential cases. Retrospective cohort study among 12.6 million 11- to 21-year-old members of five US health plans with a total membership of 50 million. Automated enrollment and medical claims data from March 2005 through August 2008 were used to identify the population, the vaccinations administered, and the medical services associated with possible GBS. Medical records were reviewed and adjudicated by a neurologist panel to confirm cases of GBS. The study used distributed data analysis methods that minimized sharing of protected health information. We confirmed 99 GBS cases during 18,322,800 person-years (5.4/1,000,000 person-years). More than 1.4 million MCV4 vaccinations were observed. No confirmed cases of GBS occurred within 6 weeks after vaccination. The upper 95% CI for the attributable risk of GBS associated with MCV4 is estimated as 1.5 cases per 1,000,000 doses. Among members of five US health plans, MCV4 vaccination was not associated with increased GBS risk. Copyright
    Pharmacoepidemiology and Drug Safety 12/2012; 21(12). DOI:10.1002/pds.3321 · 3.17 Impact Factor
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    ABSTRACT: Background. The Chronic Hepatitis Cohort Study (CHeCS), a dynamic prospective, longitudinal, observational cohort study, was created to assess the clinical impact of chronic viral hepatitis in the United States. This report describes the cohort selection process, baseline demographics, and insurance, biopsy, hospitalization, and mortality rates.Methods. Electronic health records of >1.6 million adult patients seen from January 2006 through December 2010 at 4 integrated healthcare systems in Detroit, Michigan; Danville, Pennsylvania; Portland, Oregon; and Honolulu, Hawaii were collected and analyzed.Results. Of 2202 patients with chronic hepatitis B virus (HBV) infection, 50% were aged 44-63 years, 57% male, 58% Asian/Pacific Islander, and 13% black; and 5.1% had Medicaid, 16.5% Medicare, and 76.3% private insurance. During 2001-2010, 22.3% had a liver biopsy and 37.9% were hospitalized. For the 8810 patients with chronic hepatitis C virus (HCV) infection, 75% were aged 44-63 years, 60% male, 23% black; and 12% had Medicaid, 23% Medicare, and 62% private insurance. During 2001-2010, 38.4% had a liver biopsy and 44.3% were hospitalized. Among persons in care, 9% of persons with HBV and 14% of persons with HCV infection, mainly those born during 1945-1964, died during the 2006-2010 five-year period.Conclusions. Baseline demographic, hospitalization, and mortality data from CHeCS highlight the substantial US health burden from chronic viral hepatitis, particularly among persons born during 1945-1964.
    Clinical Infectious Diseases 09/2012; 56(1). DOI:10.1093/cid/cis815 · 9.42 Impact Factor
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    ABSTRACT: Background. Little is known about viral hepatitis testing and infection prevalence among persons in private healthcare organizations (HCOs) in the United States. Methods. To determine the frequency of and characteristics associated with viral hepatitis testing and infection prevalence among adults with access to care, we conducted an observational cohort study among 1.25 million adults from 4 US HCOs and included persons with ≥1 clinical encounter during 2006-2008 and ≥12 months of continuous follow-up before 2009. We compared the number of infections identified with the number expected based on adjusted data from the National Health and Nutrition Examination Survey (NHANES). Results. Of 866 886 persons without a previous hepatitis B virus (HBV) diagnosis, 18.8% were tested for HBV infection, of whom 1.4% tested positive; among 865 659 without a previous hepatitis C virus (HCV) diagnosis, 12.7% were tested, of whom 5.5% tested positive. Less than half of those with ≥2 abnormal alanine aminotransferase (ALT) levels were subsequently tested for HBV or HCV. When tested, Asians (adjusted odds ratio [aOR] 6.33 relative to whites) were most likely HBV infected, whereas those aged 50-59 years were most likely HCV infected (aOR 6.04, relative to age <30 years). Based on estimates from NHANES, nearly one-half of HCV and one-fifth of HBV infections in this population were not identified. Conclusions. Even in this population with access to care and lengthy follow-up, only a fraction of expected viral hepatitis infections were identified. Abnormal ALT levels often but not consistently triggered testing. These findings have implications for the identification and care of 4-5 million US residents with HBV and HCV infection.
    Clinical Infectious Diseases 08/2012; 55(8):1047-1055. DOI:10.1093/cid/cis616 · 9.42 Impact Factor
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    ABSTRACT: Background/Aims Approximately two billion people worldwide have been infected with hepatitis B virus (HBV) and about 350 million live with chronic infection. Over half of all liver cancer cases in the world are attributable to chronic, or persistent, HBV infection. Of US residents chronically infected with HBV, 40% to 70% are foreign-born immigrants, mainly Asian/Pacific Islanders (APIs). Disparity by race exists for APIs which makeup approximately 4% of the U.S. population and more than 2% of these races are affected with chronic HBV. The purpose of this study is to investigate the demographic differences between the foreign-born and US-born HBV infected APIs of Kaiser Permanente, Hawai'i (KPHI). Methods This substudy is a part of a prospective, dynamic, longitudinal and observational study, the Chronic Hepatitis Cohort Study (CHeCS). Patients included in this analysis were APIs identified from electronic medical records who met the CHeCS definition for chronic HBV infection at KPHI. Date of birth, race, gender, and country of origin (COO), household income and education were obtained from the Virtual Data Warehouse (VDW) demographic and census tables. Information about the country of origin was also supplemented by surveys and chart abstractions. Results Of the 513 HBV infected APIs, 76% were foreign-born and 24 % were US-born. HBV infected foreign-born APIs were significantly younger than the US-born APIs; approximately 50% of HBV infected foreign-born APIs were in 40-59 years old age group compared to 32% of the US-born. Foreign-born APIs also had significantly higher proportion of females (55%) than US-born (50%). Most of the HBV infected APIs had a median household income between 50,000 and 75,000 with no significant differences between the groups. Approximate prevalence was also calculated using the KPHI utilization data. APIs had an overall HBV prevalence of 0.7%; foreign-born APIs had 2.6% and US-born APIs had 0.3% prevalence. Discussion In summary, foreign-born APIs have higher prevalence of chronic HBV infections compared to US-born APIs in Kaiser Permanente Hawai'i. Foreign-born APIs infected with HBV are younger and more likely to be females than US-born APIs.
    Clinical Medicine &amp Research 08/2012; 10(3):172-3. DOI:10.3121/cmr.2012.1100.cb3-02
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    ABSTRACT: Background/Aims The infectious risk of human tissue allografts is unknown. Healthcare claims data from large populations may be useful for quantifying and monitoring rates of infection after tissue allograft transplantation, but require accurate algorithms to identify allograft implantations and infections. We explored the feasibility of identifying allograft implantations and infections using claims data. Methods We identified all patients with procedure codes for anterior cruciate ligament (ACL) surgery within four HMO Research Network sites during calendar years 2000-2008. Charts were randomly selected for review to determine the frequency of allograft versus autograft use. We then flagged patients with claims-based indicators of possible infection including suggestive ICD9 diagnosis codes, procedures, antibiotic prescriptions, specialty consultations, emergency department visits, and readmissions within the 90 days following surgery. We reviewed charts of patients with and without infection indicators and calculated the sensitivity and positive predictive value of individual indicators as well as combinations of multiple indicators. Results We identified 6,615 patients with codes for ACL surgeries in four HMO Research Network sites. On review of randomly selected charts, allografts were utilized in 128/536 (24%) surgeries and autografts in 392/536 (73%) surgeries. Implant type was inadequately documented in the remaining 16 charts (3%). Possible claims-based infection indicators were present in 1,827/6,615 (28%) surgeries. We reviewed 765 charts with indicators of possible infection and 475 charts without infectious indicators. There were 30 confirmed deep tissue infections, all amongst patients with possible infection indicators. Correcting for sampling weights, we estimated 1.6 versus 1.0 infections per 100 surgeries in allograft versus autograft implants (crude odds ratio 1.7, 95% CI 1.1-2.8). The sensitivity of individual indicators ranged from 0 to 70% and positive predictive value from 0 to 24%. Combining indicators increased sensitivity to >90% but positive predictive values remained poor. Discussion Procedure codes for ACL surgeries are not specific for allograft versus autograft implants. Claims-based indicators of possible infections reliably capture all patients with serious infections but also flag many false positives. We are now validating the sensitivity and positive predictive value of claims-based infection indicators using data from two additional HMO Research Network sites.
    Clinical Medicine &amp Research 08/2012; 10(3):178. DOI:10.3121/cmr.2012.1100.ps2-16
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    ABSTRACT: Background/Aims Approximately two billion people worldwide have been infected with hepatitis B virus (HBV) and about 350 million live with chronic infection. Over half of all liver cancer cases in the world are attributable to chronic, or persistent, HBV infection. Of US residents chronically infected with HBV, 40% to 70% are foreign-born immigrants, mainly Asian/Pacific Islanders (APIs). Disparity by race exists for APIs which makeup approximately 4% of the U.S population and more than 2% of these races are affected with chronic HBV. The purpose of this study is to estimate the prevalence of HBV in foreign and US born APIs and test the differences in these groups for testing (HBV DNA or HBsAg), testing positive for HBV, alanine aminotranferase (ALT) level and other demographic variables. Methods Utilization data from Kaiser Permanente, Hawai'i (KPHI) was used. All adults (18 yrs and older) with enrollment for any length of time from 2006 to 2008, with at least one health plan encounter and twelve months of continuous enrollment at any time were included. Persons with HBV diagnosis within six months of first encounter were excluded. We limited the analysis to Asians and Pacific Islanders. Date of birth, race, gender, and country of origin (COO), household income and education were obtained from the Virtual Data Warehouse (VDW) demographic and census tables. Results and Discussion Among who met the inclusion criteria (N= 191,335), 69,923 were APIs and of these 68% had information on country of origin. We plan to report the prevalence of HBV in foreign and US born APIs test the difference between the these two groups with respect to testing, testing positive for HBV infection, age, gender, annual income and ALT levels.
    Clinical Medicine &amp Research 08/2012; 10(3):172. DOI:10.3121/cmr.2012.1100.ps2-03
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    ABSTRACT: The risk of immune thrombocytopenic purpura (ITP) after childhood vaccines other than measles-mumps-rubella vaccine (MMR) is unknown. Using data from 5 managed care organizations for 2000 to 2009, we identified a cohort of 1.8 million children ages 6 weeks to 17 years. Potential ITP cases were identified by using diagnostic codes and platelet counts. All cases were verified by chart review. Incidence rate ratios were calculated comparing the risk of ITP in risk (1 to 42 days after vaccination) and control periods. There were 197 chart-confirmed ITP cases out of 1.8 million children in the cohort. There was no elevated risk of ITP after any vaccine in early childhood other than MMR in the 12- to 19-month age group. There was a significantly elevated risk of ITP after hepatitis A vaccine at 7 to 17 years of age, and for varicella vaccine and tetanus-diphtheria-acellular pertussis vaccine at 11 to 17 years of age. For hepatitis A, varicella, and tetanus-diphtheria-acellular pertussis vaccines, elevated risks were based on one to two vaccine-exposed cases. Most cases were acute and mild with no long-term sequelae. ITP is unlikely after early childhood vaccines other than MMR. Because of the small number of exposed cases and potential confounding, the possible association of ITP with hepatitis A, varicella, and tetanus-diphtheria-acellular pertussis vaccines in older children requires further investigation.
    PEDIATRICS 02/2012; 129(2):248-55. DOI:10.1542/peds.2011-1111 · 5.30 Impact Factor
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    ABSTRACT: Background The frequency of human tissue allograft contamination leading to infection is unknown. Attributing infections to allograft contamination versus surgical factors is elusive. National claims data may facilitate study of allograft-associated infections but first require accurate algorithms to identify implantations and infections. We explored the feasibility of using claims data to identify anterior cruciate ligament (ACL) allograft implants and infections. Methods We selected candidate diagnosis, procedure, visit type, and antibiotic prescription criteria to identify ACL allograft repairs and infections. Candidate criteria were categorized by likelihood of infection and putative pathogen type. Criteria were then applied to HMO Research Network Virtual Data Warehouse files for 2000-2008 from six sites. We defined the infection risk period as 90 days following ACL repair. We reviewed charts flagged by each criterion to determine implant type and to assess for infection. Sensitivity and positive predictive values (PPV) were calculated. Results Preliminary results are available from five of six sites. Procedure codes 29888 and 81.45 (ACL repair, unspecified) flagged 11,202 episodes of care. Diagnosis codes compatible with infection flagged 139 episodes (1.2%) of which 71 were categorized as high probability (0.63%). Microbiology and infection management procedure codes flagged 1,029 episodes (9.2%) and 68 episodes (0.6%) respectively. Antibiotics were prescribed for 1,523 episodes (14%) of which 580 were deemed high likelihood prescriptions (5.2%). There were 1011 hospitalizations within 90 days of ACL implantation (9.0%), 787 emergency department visits (7.0%), and 43 infectious disease specialist visits (0.4%). Over 1500 chart reviews are planned of which 107 have been completed thus far. The PPV for allograft implantation is 33% (95% CI 25-43%). Sufficient data are currently available to confirm 14 infections. Antibiotic prescribing was the most sensitive criterion while infectious disease visit had the highest PPV (sensitivities 86% and 7%, PPVs 35% and 100% respectively). Conclusions Claims data do not discriminate between allografts and autografts in ACL repair but do identify a subset of patients with possible infections. Once chart reviews are complete we will assess whether combinations of criteria can increase accuracy.
    Clinical Medicine &amp Research 11/2011; 9(3-4):179. DOI:10.3121/cmr.2011.1020.c-c5-04
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    ABSTRACT: Background/Aims The International Serious Adverse Events Consortium (iSAEC) is a pharmaceutical industry and FDA-led consortium focused on identifying DNA variants useful for predicting risk of drug-induced rare serious adverse events (SAEs). We assessed the feasibility of using electronic medical databases at six HMORN sites to identify provisional cases of three SAEs: drug-induced liver injury (DILI), serious skin rashes (SSR), including Stevens-Johnson syndrome, toxic epidermal necrolysis, and angioedema, and extreme weight gain (EWG) among adults on atypical antipsychotics. Methods Project work was divided among three teams. HealthPartners and Marshfield Clinic led the DILI team, Kaiser Permanente Hawaii and Kaiser Permanente Georgia led the SSR team and Group Health and Geisinger guided the EWG study. Teams met routinely via biweekly conference calls to coordinate their study efforts; monthly conference calls were conducted to coordinate the overall project, mark progress and discuss challenges and solutions. For each study, standardized case identification criteria were developed with input from iSAEC, expert panels, and medical literature. Potential cases were identified through electronic data searches using diagnoses, medication histories, laboratory test results, and other clinical data elements indicative of DILI and SSR during 2000-2009, or EWG from 2004-2009. Potential cases of DILI and SSR were abstracted to assess provisional case status and determine implicated drugs. Weight trajectories of suspected EWG cases were visually inspected to confirm EWG during atypical antipsychotic treatment period. Results A total of 99 provisional cases of DILI, 41 cases of SJS/TEN and 56 provisional cases of angioedema were identified from the electronic records of the participating HMOs. For EWG, 249 cases were confirmed and an additional 341 were categorized as "possible" cases, with additional chart review and patient interview required for confirmation. Confirmation rates varied from 17% for DILI to 2-79% for SSR and 23-30% for EWG. Conclusions The SAEC and HMORN study sites identified well-phenotyped cases with the targeted drug-induced SAEs of interest. The relative success of these efforts has been critical in the planning of a larger second study that will include analyses of genetic factors associated with provisional case SAEs.
    Clinical Medicine &amp Research 11/2011; 9(3-4):180-181. DOI:10.3121/cmr.2011.1020.ps1-18
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    ABSTRACT: Background/Aims Stevens-Johnson syndrome (SJS) and toxic epidermal necrolyssis (TEN) are life-threatening widespread serious skin rashes (SSR), often accompanied by extensive epidermal detachment and/or mucous membrane involvement. Recent genetic studies have shown a strong link in Han Chinese between HLA-B*1502 and risk for SJS with use of Carbamazepine; however, more research is needed to identify similar markers among other ethnic groups. With support from The International Serious Adverse Event Consortium, we evaluated the potential for using electronic clinical and administrative data from Kaiser Permanente Hawaii and Kaiser Permanente Georgia to identify provisional SSR cases. Methods We searched inpatient encounters, problem lists and allergy tables for codes specific to SJS/TEN and for related non-specific codes for erythema multiforme, drug dermatitis, and drug allergies. All records from 1/1/00-8/1/09 that were identified as potential cases were reviewed manually for confirmation and abstraction of suspected implicated drugs. In addition, we reviewed medical records of patients with two additional SSR: angioedema on ACE inhibitors, and drug hypersensitivity syndrome (DHSS). Results Of 29 patients with codes specific for SJS/TEN, 23 (79%) were confirmed on chart review. Of 140 patients with non-specific SJS/TEN codes, 13 (9%) were confirmed. The most commonly implicated medications included amoxicillin, dilantin, trimethoprim and sulfamethoxazole, and isoniazid. Of 56 subjects with angioedema while on ACE inhibitors, 20 (36%) were confirmed. Of patients with DHSS, 1 of 29 (3%) that had inpatient codes plus abnormal lab values were confirmed on record review, while only 1 of 51 (2%) with inpatient DHSS codes and normal lab values were confirmed. Conclusions We found that large linked electronic HMORN datasets efficiently identified highly probable cases of SJS/TEN. Searches for angioedema following ACE inhibitor exposure were also relatively successful. However, searches for DHSS were unsuccessful and only yielded 2 potential cases. These findings will be useful for planning the next study phase where patients will be recruited for genomic studies from a larger number of HMO sites.
    Clinical Medicine &amp Research 11/2011; 9(3-4):179-180. DOI:10.3121/cmr.2011.1020.ps1-29
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    ABSTRACT: The purpose of this study was to obtain genetic counselors' perspectives about the identification of appropriate patients and barriers to referral of high-risk patients for cancer genetic counseling services. Genetic service providers from eight integrated health systems were surveyed. Data analysis included descriptive statistics. Twenty-eight of 40 potential participants responded (70%). Referrals for familial cancer risk assessment overwhelmingly came from providers (89%); only 10% were self-referrals. Use of guidelines to assist providers with referral was reported by 46% of the respondents. Genetic service providers perceived patient barriers to seeking genetic counseling after referral included: risk evaluation viewed as a non-priority (72%), concerns about impact on insurability (52%), distance to appointments (48%), lack of insurance (44%), lack of patient/provider knowledge about the value of genetic counseling (36%), discouragement by family members (28%), and fear (20%). The best approaches suggested by respondents to increase appropriate referrals were attending meetings and giving presentations to oncologists, surgeons, primary care and gynecologists. The genetic service providers reported several barriers to the referral and use of genetic counseling. This finding is consistent with current literature from the providers' perspective. Our survey adds the genetic service providers' perspective and identifies areas of opportunity for further research and intervention as few of the perceived barriers are being addressed through current educational efforts.
    Journal of Genetic Counseling 06/2011; 20(3):314-22. DOI:10.1007/s10897-011-9351-3 · 1.75 Impact Factor
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    ABSTRACT: Background and Aims: Little of what we know about the use of family history and genetic risk assessment services has been gathered from those engaged in counseling. To fill this gap, we conducted a survey to understand the processes of identifying and referring high-risk patients for genetic counseling and testing for familial cancer from the perspective of genetic service providers.
    Clinical Medicine &amp Research 12/2010; DOI:10.3121/cmr.2010.943.ps1-08