Robert L Davis

The University of Tennessee Health Science Center, Memphis, Tennessee, United States

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Publications (126)1084.23 Total impact

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    ABSTRACT: Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) carry a high mortality risk. While identifying clinical and genetic risk factors for these conditions has been hindered by their rarity, large electronic health databases hold promise for identifying large numbers of cases for study, especially with the introduction in 2008 of ICD-9 codes more specific for these conditions. The objective of this study is to estimate the validity of ICD-9 codes for ascertaining SJS/TEN in 12 collaborating research units in the USA, covering almost 60 million lives. From the electronic databases at each site, we ascertained potential cases of SJS/TEN using ICD-9 codes. At five sites, a subset of medical records was abstracted and standardized criteria applied by board-certified dermatologists to adjudicate diagnoses. Multivariate logistic regression was used to identify factors independently associated with validated SJS/TEN cases. A total of 56 591 potential cases of SJS/TEN were identified. A subset of 276 charts was selected for adjudication and 39 (of the 276) were confirmed as SJS/TEN. Patients with the ICD-9 codes introduced after 2008 were more likely to be confirmed as cases (OR 3.32; 95%CI 0.82, 13.47) than those identified in earlier years. Likelihood of case status increased with length of hospitalization. Applying the probability of case status to the 56 591 potential cases, we estimated 475-875 to be valid SJS/TEN cases. Newer ICD-9 codes, along with length of hospitalization, identified patients with a high likelihood of SJS/TEN. This is important for identification of subjects for future pharmacogenomics studies. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.
    Pharmacoepidemiology and Drug Safety 04/2015; 24(7). DOI:10.1002/pds.3778 · 2.94 Impact Factor
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    ABSTRACT: Background: Few previous studies have evaluated primary adherence, whether a new prescription is filled within 30 days, to controller medications in individuals with persistent asthma. The objective of this study was to compare adherence to the major controller medication regimens for asthma. Methods: This retrospective cohort study of enrollees from five large health plans. We used electronic medical data on patients with asthma of all ages who had experienced an asthma-related exacerbation in the prior 12 months. We studied adherence measures including proportion of days covered (PDC) and primary adherence (first prescription filled within 30 days). Results: Our population included 69,652 subjects who had probable persistent asthma and were prescribed inhaled corticosteroids (ICS), leukotriene antagonists (LTRA), or ICS/long acting beta agonist (LABA). Mean age was 37 years of age and 58% were female. We found that 14-20% of subjects who were prescribed controller medicines for the first time did not fill their prescriptions. Mean PDC was 19% for ICS, 30% for LTRA, and 25% for ICS/LABA over 12 months. Using multivariate logistic regression, subjects prescribed LTRA were less likely to be primary adherent than subjects prescribed ICS (OR 0.82 [CI 0.74-0.92]) or ICS/LABA (OR 0.88 [0.80-0.97]). Black and Latino patients were less likely to fill the prescription compared to white patients. Conclusions: Adherence to controller medications for is poor. In this insured population, primary adherence to ICSs is better than LTRAs and ICS/LABAs. Adherence as measured by PDC is better for LTRAs and ICS/LABA than ICS.
    01/2015; 12(2). DOI:10.1513/AnnalsATS.201410-459OC
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    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; 23(11). DOI:10.1089/jwh.2014.4779 · 2.05 Impact Factor
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    ABSTRACT: Background Based on results of clinical trials, inhaled corticosteroids (ICS) are the most-effective controller medications for preventing asthma-related exacerbations, yet few studies in real-life populations have evaluated the comparative effectiveness of ICS. Objective To determine the likelihood of asthma exacerbations among children with asthma after initiation of controller medications: ICS, leukotriene antagonists (LTRA), and ICS–long-acting β-agonist (LABA) combination therapy. Methods This was a retrospective cohort study of subjects who were part of the Population-Based Effectiveness in Asthma and Lung Diseases Network. We conducted Cox regression analyses by adjusting for baseline covariates, adherence by using proportion of days covered, and high-dimensional propensity scores. The main outcome measurements were emergency department visits, hospitalizations, or oral corticosteroid use. Results Our population included 15,567 health plan subjects and 10,624 TennCare Medicaid subjects with uncontrolled asthma. Overall adherence to controller medications was low, with no more than 50% of the subjects refilling the medication after the initial fill. For subjects with allergic rhinitis, the subjects in TennCare Medicaid treated with LTRAs were less likely to experience ED visits (hazard ratio 0.44 [95% CI, 0.21-0.93]) compared with the subjects treated with ICS. For all other groups, the subjects treated with LTRA or ICS-LABA were just as likely to experience ED visits or hospitalizations, or need oral corticosteroids as the subjects treated with ICS. Conclusion Risks of asthma-related exacerbations did not differ between children who initiated LTRA and ICS. These findings may be explainable by LTRA, which has similar effectiveness as ICS in real-life usage by residual confounding by indication or other unmeasured factors.
    09/2014; 2(5). DOI:10.1016/j.jaip.2014.05.009
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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 · 4.18 Impact Factor
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    ABSTRACT: One third of type 2 diabetic patients do not respond to metformin. Genetic variants in metformin transporters have been extensively studied as a likely contributor to this high failure rate. Here we investigate, for the first time, the effect of genetic variants in transcription factors on metformin pharmacokinetics and response. 546 patients and healthy volunteers contributed their genome-wide, pharmacokinetic (235 subjects) and HbA1c data (440 patients) for this analysis. Five variants in SP1, a transcription factor that modulates the expression of metformin transporters; associated with changes in treatment HbA1c (p<0.01) and metformin secretory clearance (p<0.05). Population pharmacokinetic modeling further confirmed a 24% reduction in apparent clearance in homozygous carriers of one such variant, rs784888. Genetic variants in other transcription factors, PPAR-alpha and HNF4-alpha, associated significantly with HbA1c change only. Overall, our study highlights the importance of genetic variants in transcription factors as modulators of metformin pharmacokinetics and response.Clinical Pharmacology & Therapeutics (2014); Accepted article preview online 21 May 2014 doi:10.1038/clpt.2014.109.
    Clinical Pharmacology &#38 Therapeutics 05/2014; 96(3). DOI:10.1038/clpt.2014.109 · 7.90 Impact Factor
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    ABSTRACT: Epidermal growth factor receptor (EGFR) inhibitors are approved for treating metastatic colorectal cancer (CRC); KRAS mutation testing is recommended prior to treatment. We conducted a non-inferiority analysis to examine whether KRAS testing has impacted survival in CRC patients. We included 1186 metastatic CRC cases from seven health plans. A cutpoint of July, 2008, was used to define two KRAS testing time period groups: "pre-testing" (n = 760 cases) and "post-testing" (n = 426 cases). Overall survival (OS) was estimated, and the difference in median OS between the groups was calculated. The lower bound of the one-sided 95% confidence interval (CI) for the difference in survival was used to test the null hypothesis of post-testing inferiority. Multivariable Cox regression models were constructed to adjust for covariates. The median unadjusted OS was 15.4 months (95% CI: 14.0-17.5) and 12.8 months (95% CI: 10.0-15.2) in the pre- and post-testing groups, respectively. The OS difference was -2.6 months with one-sided 95% lower confidence bound of -5.13 months, which was less than the non-inferiority margin (-5.0 months, unadjusted p = 0.06), leading to a failure to reject inferiority of OS in the post-testing period. In contrast, in the adjusted analysis, OS non-inferiority was identified in the post-testing period (p = 0.001). Sensitivity analyses using cutpoints before and after July, 2008, also met the criteria for non-inferiority. Implementation of KRAS testing did not influence CRC OS. Our data support the use of KRAS testing to guide administration of EGFR inhibitors for treatment of metastatic CRC without diminished OS.
    PLoS ONE 05/2014; 9(5):e94977. DOI:10.1371/journal.pone.0094977 · 3.23 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 · 4.53 Impact Factor
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    Yan V Sun · Robert L Davis ·
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    ABSTRACT: Epigenetics plays an important role in regulating gene expression, and can be modified by environmental factors and physiological conditions. Studying epigenetics is a promising approach to potentially improving the diagnosis, prevention and treatment of human diseases, and to providing personalized medical care. However, the role of epigenetics in the development of diseases is not clear because epigenetic markers may be both mediators and outcomes of human diseases. It is particularly complicated to study pharmacoepigenetics, as medication use may modify the epigenetic profile. To address the challenges facing pharmacoepigenetic research of human diseases, we developed a novel design to rapidly identify, contact, and recruit participants and collect specimens for longitudinal studies of pharmacoepigenetics. Using data in real-time from electronic medical record systems, we can identify patients recently start on new medications and who also have a blood test. Prior to disposal of the leftover blood by the clinical laboratory, we are able to contact and recruit these patients, enabling us to use both their leftover baseline blood sample as well as leftover specimens at future tests. With treatment-naïve and follow-up specimens, this system is able to study both epigenetic markers associated with disease without treatment effect as well as treatment-related epigenetic changes.
    12/2013; 3(4):263-74. DOI:10.3390/jpm3040263
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    ABSTRACT: Efforts to define the genetic architecture underlying variable statin response have met with limited success possibly because previous studies were limited to effect based on one-single-dose. We leveraged electronic medical records (EMRs) to extract potency (ED50) and efficacy (Emax) of statin dose-response curves and tested them for association with 144 pre-selected variants. Two large biobanks were used to construct dose-response curves for 2,026 (simvastatin) and 2,252 subjects (atorvastatin). Atorvastatin was more efficacious, more potent, and demonstrated less inter-individual variability than simvastatin. A pharmacodynamic variant emerging from randomized trials (PRDM16) was associated with Emax for both. For atorvastatin, Emax was 51.7 mg/dl in homozygous for the minor allele versus 75.0 mg/dl for those homozygous for the major allele. We also identified several loci associated with ED50. The extraction of rigorously defined traits from EMRs for pharmacogenetic studies represents a promising approach to further understand of genetic factors contributing to drug response.Clinical Pharmacology & Therapeutics (2013); Accepted article preview online 4 October 2013; doi:10.1038/clpt.2013.202.
    Clinical Pharmacology &#38 Therapeutics 10/2013; 95(3). DOI:10.1038/clpt.2013.202 · 7.90 Impact Factor
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    ABSTRACT: The assumption that the occurrence of outcome event must not alter subsequent exposure probability is critical for preserving the validity of the self-controlled case series (SCCS) method. This assumption is violated in scenarios in which the event constitutes a contraindication for exposure. In this simulation study, we compared the performance of the standard SCCS approach and two alternative approaches when the event-independent exposure assumption was violated. Using the 2009 H1N1 and seasonal influenza vaccines and Guillain-Barré syndrome as a model, we simulated a scenario in which an individual may encounter multiple unordered exposures and each exposure may be contraindicated by the occurrence of outcome event. The degree of contraindication was varied at 0%, 50%, and 100%. The first alternative approach used only cases occurring after exposure with follow-up time starting from exposure. The second used a pseudo-likelihood method. When the event-independent exposure assumption was satisfied, the standard SCCS approach produced nearly unbiased relative incidence estimates. When this assumption was partially or completely violated, two alternative SCCS approaches could be used. While the post-exposure cases only approach could handle only one exposure, the pseudo-likelihood approach was able to correct bias for both exposures. Violation of the event-independent exposure assumption leads to an overestimation of relative incidence which could be corrected by alternative SCCS approaches. In multiple exposure situations, the pseudo-likelihood approach is optimal; the post-exposure cases only approach is limited in handling a second exposure and may introduce additional bias, thus should be used with caution. Copyright
    Pharmacoepidemiology and Drug Safety 08/2013; 22(8). DOI:10.1002/pds.3451 · 2.94 Impact Factor
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    ABSTRACT: To validate classification of race/ethnicity based on the Bayesian Improved Surname Geocoding method (BISG) and assess variations in validity by gender and age. Secondary data on members of Kaiser Permanente Georgia, an integrated managed care organization, through 2010. For 191,494 members with self-reported race/ethnicity, probabilities for belonging to each of six race/ethnicity categories predicted from the BISG algorithm were used to assign individuals to a race/ethnicity category over a range of cutoffs greater than a probability of 0.50. Overall as well as gender- and age-stratified sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were calculated. Receiver operating characteristic (ROC) curves were generated and used to identify optimal cutoffs for race/ethnicity assignment. The overall cutoffs for assignment that optimized sensitivity and specificity ranged from 0.50 to 0.57 for the four main racial/ethnic categories (White, Black, Asian/Pacific Islander, Hispanic). Corresponding sensitivity, specificity, PPV, and NPV ranged from 64.4 to 81.4 percent, 80.8 to 99.7 percent, 75.0 to 91.6 percent, and 79.4 to 98.0 percent, respectively. Accuracy of assignment was better among males and individuals of 65 years or older. BISG may be useful for classifying race/ethnicity of health plan members when needed for health care studies.
    Health Services Research 07/2013; 49(1). DOI:10.1111/1475-6773.12089 · 2.78 Impact Factor
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    ABSTRACT: Purpose: Research on medication safety in pregnancy often utilizes health plan and birth certificate records. This study discusses methods used to link mothers with infants, a crucial step in such research. Methods: We describe how eight sites participating in the Medication Exposure in Pregnancy Risk Evaluation Program created linkages between deliveries, infants and birth certificates for the 2001-2007 birth cohorts. We describe linkage rates across sites, and for two sites, we compare the characteristics of populations linked using different methods. Results: Of 299,260 deliveries, 256,563 (86%; range by site, 74-99%) could be linked to infants using a deterministic algorithm. At two sites, using birth certificate data to augment mother-infant linkage increased the representation of mothers who were Hispanic or non-White, younger, Medicaid recipients, or had low educational level. A total of 236,460 (92%; range by site, 82-100%) deliveries could be linked to a birth certificate. Conclusions: Tailored approaches enabled linking most deliveries to infants and to birth certificates, even when data systems differed. The methods used may affect the composition of the population identified. Linkages established with such methods can support sound pharmacoepidemiology studies of maternal drug exposure outside the context of a formal registry.
    Pharmacoepidemiology and Drug Safety 07/2013; 22(7). DOI:10.1002/pds.3443 · 2.94 Impact Factor
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    ABSTRACT: Purpose: To validate an algorithm that uses delivery date and diagnosis codes to define gestational age at birth in electronic health plan databases. Methods: Using data from 225,384 live born deliveries to women aged 15-45 years in 2001-2007 within eight of the 11 health plans participating in the Medication Exposure in Pregnancy Risk Evaluation Program, we compared (1) the algorithm-derived gestational age versus the "gold-standard" gestational age obtained from the infant birth certificate file and (2) the prenatal exposure status of two antidepressants (fluoxetine and sertraline) and two antibiotics (amoxicillin and azithromycin) as determined by the algorithm-derived versus the gold-standard gestational age. Results: The mean algorithm-derived gestational age at birth was lower than the mean obtained from the birth certificate file among singleton deliveries (267.9 vs 273.5 days) but not among multiple-gestation deliveries (253.9 vs 252.6 days). The algorithm-derived prenatal exposure to the antidepressants had a sensitivity and a positive predictive value of ≥95%, and a specificity and a negative predictive value of almost 100%. Sensitivity and positive predictive value were both ≥90%, and specificity and negative predictive value were both >99% for the antibiotics. Conclusions: A gestational age algorithm based upon electronic health plan data correctly classified medication exposure status in most live born deliveries, but trimester-specific misclassification may be higher for drugs typically used for short durations.
    Pharmacoepidemiology and Drug Safety 05/2013; 22(5). DOI:10.1002/pds.3407 · 2.94 Impact Factor
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    ABSTRACT: 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. 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. 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. 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
    Pharmacoepidemiology and Drug Safety 05/2013; DOI:10.1002/pds.3423 · 2.94 Impact Factor
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    ABSTRACT: This study describes practical considerations for implementation of near real-time medical product safety surveillance in a distributed health data network. We conducted pilot active safety surveillance comparing generic divalproex sodium to historical branded product at four health plans from April to October 2009. Outcomes reported are all-cause emergency room visits and fractures. One retrospective data extract was completed (January 2002–June 2008), followed by seven prospective monthly extracts (January 2008–November 2009). To evaluate delays in claims processing, we used three analytic approaches: near real-time sequential analysis, sequential analysis with 1.5 month delay, and nonsequential (using final retrospective data). Sequential analyses used the maximized sequential probability ratio test. Procedural and logistical barriers to active surveillance were documented. We identified 6586 new users of generic divalproex sodium and 43 960 new users of the branded product. Quality control methods identified 16 extract errors, which were corrected. Near real-time extracts captured 87.5% of emergency room visits and 50.0% of fractures, which improved to 98.3% and 68.7% respectively with 1.5 month delay. We did not identify signals for either outcome regardless of extract timeframe, and slight differences in the test statistic and relative risk estimates were found. Near real-time sequential safety surveillance is feasible, but several barriers warrant attention. Data quality review of each data extract was necessary. Although signal detection was not affected by delay in analysis, when using a historical control group differential accrual between exposure and outcomes may theoretically bias near real-time risk estimates towards the null, causing failure to detect a signal. Copyright
    Pharmacoepidemiology and Drug Safety 05/2013; 22(5). DOI:10.1002/pds.3412 · 2.94 Impact Factor
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    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. DOI:10.3390/pharmaceutics5010179
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    Robert L Davis ·
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    ABSTRACT: Since the late 1990s, there have been tremendous strides made in improving the capacity for carrying out routine active surveillance of new vaccines in the United States. These strides have led to new surveillance systems that are now in place. Some of the critical elements that are part of successful vaccine or drug safety surveillance systems include their use of (i) longitudinal data from a discrete enumerated population base, (ii) frequent, routine transfers of small amounts of data that are easy to collect and collate, (iii) avoidance of mission creep, (iv) statistical capabilities, (v) creation of an "industrialized process" approach and (vi) political safe harbor.
    Pharmaceutics 03/2013; 5(1):168-178. DOI:10.3390/pharmaceutics5010168
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    ABSTRACT: To evaluate the prevalence, trends, timing and duration of exposure to antiviral medications during pregnancy within a US cohort of pregnant women and to evaluate the proportion of deliveries with a viral infection diagnosis among women given antiviral medication during pregnancy. Live-born deliveries between 2001 and 2007, to women aged 15-45 years, were included from the Medication Exposure in Pregnancy Risk Evaluation Program, a collaborative research program between the U.S. Food and Drug Administration and eleven health plans. They were evaluated for prevalence, timing, duration, and temporal trends of exposure to antiviral medications during pregnancy. We also calculated the proportion of deliveries with a viral infection diagnosis among those exposed to antiviral medications. Among 664,297 live births, the overall prevalence of antiviral exposure during pregnancy was 4 % (n = 25,155). Between 2001 and 2007, antiviral medication exposure during pregnancy doubled from 2.5 to 5 %. The most commonly used antiviral medication was acyclovir, with 3 % of the deliveries being exposed and most of the exposure occurring after the 1st trimester. Most deliveries exposed to antiviral medications were exposed for less than 30 days (2 % of all live births). Forty percent of the women delivering an infant exposed to antiviral medications had a herpes diagnosis. Our findings highlight the increased prevalence of women delivering an infant exposed to antiviral medications over time. These findings support the need for large, well-designed studies to assess the safety and effectiveness of these medications during pregnancy.
    Maternal and Child Health Journal 02/2013; 18(1). DOI:10.1007/s10995-013-1234-9 · 2.24 Impact Factor
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    ABSTRACT: This study aims to estimate the prevalence of and temporal trends in prenatal antipsychotic medication use within a cohort of pregnant women in the U.S. We identified live born deliveries to women aged 15-45 years in 2001-2007 from 11 U.S. health plans participating in the Medication Exposure in Pregnancy Risk Evaluation Program. We ascertained prenatal exposure to antipsychotics from health plan pharmacy dispensing files, gestational age from linked infant birth certificate files, and ICD-9-CM diagnosis codes from health plan claims files. We calculated the prevalence of prenatal use of atypical and typical antipsychotics according to year of delivery, trimester of pregnancy, and mental health diagnosis. Among 585,615 qualifying deliveries, 4,223 (0.72 %) were to women who received an atypical antipsychotic and 548 (0.09 %) were to women receiving a typical antipsychotic any time from 60 days before pregnancy through delivery. There was a 2.5-fold increase in atypical antipsychotic use during the study period, from 0.33 % (95 % confidence interval: 0.29 %, 0.37 %) in 2001 to 0.82 % (0.76 %, 0.88 %) in 2007, while the use of typical antipsychotics remained stable. Depression was the most common mental health diagnosis among deliveries to women with atypical antipsychotic use (63 %), followed by bipolar disorder (43 %) and schizophrenia (13 %). The number and proportion of pregnancies exposed to atypical antipsychotics has increased dramatically in recent years. Studies are needed to examine the comparative safety and effectiveness of these medications relative to other therapeutic options in pregnancy.
    Archives of Women s Mental Health 02/2013; 16(2). DOI:10.1007/s00737-013-0330-6 · 2.16 Impact Factor

Publication Stats

12k Citations
1,084.23 Total Impact Points


  • 2014-2015
    • The University of Tennessee Health Science Center
      • Department of Pediatrics
      Memphis, Tennessee, United States
  • 2008-2014
    • Kaiser Permanente
      • Center for Health Research (Oregon, Hawaii, and Georgia)
      Oakland, California, United States
  • 2002-2009
    • Centers for Disease Control and Prevention
      • Immunization Safety Office
      Atlanta, Michigan, United States
  • 2007
    • Harvard Medical School
      • Department of Population Medicine
      Boston, MA, United States
  • 2003-2007
    • Group Health Cooperative
      • Group Health Research Institute
      Seattle, Washington, United States
    • University of Chicago
      Chicago, Illinois, United States
  • 1988-2007
    • University of Washington Seattle
      • • Department of Pediatrics
      • • Department of Epidemiology
      • • Department of Pathology
      Seattle, Washington, United States
  • 1989-2006
    • Fred Hutchinson Cancer Research Center
      Seattle, Washington, United States
  • 2003-2005
    • Harvard University
      Cambridge, Massachusetts, United States
  • 2001
    • Institute for Child Health Policy (ICHP)
      Seattle, Washington, United States
  • 1998
    • Trinity Washington University
      Washington, Washington, D.C., United States
  • 1991
    • Massachusetts Institute of Technology
      • Department of Biology
      Cambridge, Massachusetts, United States