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    Fadia Shaya

    To assess the risk of incident cardiovascular events that led to hospitalizations or emergency department visits following atypical antipsychotic (AAP) treatment initiation in youth according to dose, duration of use, and concomitant use... more
    To assess the risk of incident cardiovascular events that led to hospitalizations or emergency department visits following atypical antipsychotic (AAP) treatment initiation in youth according to dose, duration of use, and concomitant use of leading psychotropic medication classes. We used computerized Medicaid claims to conduct a retrospective cohort study of youth (5-20 years) who initiated AAP treatment. AAP use was operationalized in a time-dependent manner according to current vs. former use, average daily dose (in risperidone dose equivalents), and duration of use. In a secondary analysis, concomitant use of (1) stimulants and (2) serotonin-reuptake inhibitors (SSRI/SNRIs) with AAPs was also assessed. To account for confounding, disease risk score methodology was used in discrete time failure models. There were 74,700 youth who initiated AAP treatment (average follow-up = 24.8 months). During follow-up, the risk of cardiovascular events was significantly greater during current ...
    ABSTRACT Confounding is of central importance in epidemiologic studies. Its definition has been under wide debate over the past decades. The classical definition is straightforward and easy-to-implement. Nevertheless, it is data-driven... more
    ABSTRACT Confounding is of central importance in epidemiologic studies. Its definition has been under wide debate over the past decades. The classical definition is straightforward and easy-to-implement. Nevertheless, it is data-driven and has drawbacks. The more recent counterfactual definition captures the essential roles a confounder plays in causal inference. It would be beneficial for researchers to grasp substantive knowledge in causal structure and broadly adopt the latter definition. There are various methods of handling confounding issues. The choice of one option over another depends on various factors, including the nature of the study, sample size and rarity of events.
    To identify patient characteristics that are associated with the incidence of thiadolidinediones (TZDs) or metformin prescnbing in Medicaid managed care plans. We utilized a retrospective cohort study design. Two-and-one-half years of... more
    To identify patient characteristics that are associated with the incidence of thiadolidinediones (TZDs) or metformin prescnbing in Medicaid managed care plans. We utilized a retrospective cohort study design. Two-and-one-half years of prescription claims of Medicaid managed care organizations (MCOs) patients who were new utilizers of metformin or TZDs were analyzed using univariate, bivariate and multivariate models. Multivariate logistic regression models were built to assess the combined effect of all variables on the likelihood of incident use of TZDs or metformin. Claims for 3,041 patients were analyzed for the period between January 15, 2000 and June 15, 2002. African Americans and urban residents were less likely to be started on TZDs (OR = 0.678, 95% C1 = 0.830-1.206; OR = 0.579, 95% CI = 0.479-0.699, respectively). Advanced age, preexisting comorbidities and diabetes complications, and prior use of other oral diabetes drugs or insulin were predictors of increased likelihood ...
    Background: Maryland expanded its "Statewide Naloxone Standing Order" (NSO) in 2017 to eliminate training and prescription requirements for obtaining naloxone, improve naloxone access, help reverse opioid overdose, and reduce... more
    Background: Maryland expanded its "Statewide Naloxone Standing Order" (NSO) in 2017 to eliminate training and prescription requirements for obtaining naloxone, improve naloxone access, help reverse opioid overdose, and reduce overdose fatality rates.Objectives: To assess the change in the trends of fatal opioid overdose rates following the expansion of the Naloxone Standing Order (eNSO) and its association with the social determinants of health (SDoH).Methods: Data on overdose deaths and SDoH from 2015-2019 was collected and analyzed using interrupted time series and multivariate Poisson regression models to study the change in trends and the associations.Results: There was a significant decrease in the rate of fatal overdoses after the intervention: prescription opioid estimate number of deaths declined by .25 per 100,000 (p = .02), heroin estimate number of deaths declined by 1.83 per 100,000 (p < .001), fentanyl estimate number of deaths declined by 2.54 per 100,000 (p < .001). After controlling for eNOS implementation in Maryland, state-level estimates with high proportions of female residents and those with bachelor's degree or higher were associated with reduction in overdose, while state-level estimates with high proportions of African Americans and higher employment rates were associated with an increase in overdose.Conclusions: Our analysis shows that the expanded naloxone standing order is associated with reducing opioid-related overdose death rates. Even though we observed a significant reduction in overdose death rate in fentanyl-related deaths, the rate of deaths post-eNSO was still increasing, suggesting the need for additional measures to impact the rates of fentanyl.
    The aim of this project was construction of a universal platform for rapid development and implementation of interactive computer-based collection of clinical data. A TabletPC was used to pilot-test the platform and to implement two... more
    The aim of this project was construction of a universal platform for rapid development and implementation of interactive computer-based collection of clinical data. A TabletPC was used to pilot-test the platform and to implement two self-administered questionnaires: SF-12 Health Survey (SF-12) and Health Utilities Index (HUI). Qualitative analysis of the system acceptance in 12 patients showed that computer-assisted data collection in elderly patients with no previous computer experience can be successfully implemented using a TabletPC.
    Division of Epidemiology, Office of Pharmacovigilance and Epidemiology, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration University of Maryland, School of Pharmacy... more
    Division of Epidemiology, Office of Pharmacovigilance and Epidemiology, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration University of Maryland, School of Pharmacy Baltimore, MD, United States Office of Pharmacovigilance and Epidemiology, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration US Food and Drug Administration, Office of Biostatistics United States
    Chronic insomnia is the most common sleep disorder among adults and is associated with a wide range of negative outcomes. This article reviews the economic consequences of the disorder and the cost effectiveness of insomnia treatments.... more
    Chronic insomnia is the most common sleep disorder among adults and is associated with a wide range of negative outcomes. This article reviews the economic consequences of the disorder and the cost effectiveness of insomnia treatments. First, the total costs of insomnia are reviewed; in aggregate these costs exceed $100 billion USD per year, with the majority being spent on indirect costs such as poorer workplace performance, increased health care utilization, and increased accident risk. Next, the deleterious impact of insomnia on quality of life and the impact of treatment on quality of life are briefly considered. Finally, ten published studies evaluating the cost effectiveness of both pharmacological and behavioral treatments for insomnia are reviewed in detail. A significant majority of studies reviewed found that the cost of treating primary and comorbid insomnia is less than the cost of not treating it. Treatments were generally found to be cost-effective using commonly employed standards, with treatment costs being recouped within 6-12 mo.
    Although numerous studies have shown that anticoagulants can reduce the risk of stroke and thromboembolic events in patients with nonvalvular atrial fibrillation, they are underprescribed in the clinical setting. While standardized risk... more
    Although numerous studies have shown that anticoagulants can reduce the risk of stroke and thromboembolic events in patients with nonvalvular atrial fibrillation, they are underprescribed in the clinical setting. While standardized risk scoring assessments are recommended in treatment guidelines to determine when anticoagulant use may be appropriate, they are not widely used in the real-world clinical setting. Many factors contribute to anticoagulant underuse, including patient characteristics and comorbidities. Reluctance to prescribe an anticoagulant may also stem from concerns about bleeding or other perceived risks. In addition, physicians may be discouraged from prescribing anticoagulant therapy, particularly warfarin, if follow-up care and monitoring is potentially unfeasible. Patient fears of treatment and lack of access to the healthcare system also contribute to underuse. Increased awareness and education, medical therapy management programs, better care coordination, and i...
    This paper examines the association between mental health and comorbid obesity and hypertension among US children and adolescents using data from the National Health and Nutritional Examination Survey (NHANES). Questionnaires from NHANES... more
    This paper examines the association between mental health and comorbid obesity and hypertension among US children and adolescents using data from the National Health and Nutritional Examination Survey (NHANES). Questionnaires from NHANES were used to assess mental health during the previous 30 days. Respondents were then categorized into two groups namely "poor mental health" and "good mental health" based on their responses to these survey questions. Three multiple logistic regression models, based on these categories, are estimated to compute the odds ratios and 95 % confidence intervals in the association of obesity and hypertension and mental health. As a select example, the results of Model 2 reveal that compared with respondents who are not obese, obese respondents have increased odds (OR = 1.24; P < 0.0001) of poor mental health. Furthermore compared with non-hypertensive respondents, hypertensive respondents have higher odds (OR = 2.96; P < 0.0001) ...
    scribing and use of cyclooxegenase-2 (COX-2) inhibitors and nonsteroidal anti-inflammatory drugs (NSAIDs) continue to linger, the population in need for their indications continues to grow. Physicians are placed in a situation in which... more
    scribing and use of cyclooxegenase-2 (COX-2) inhibitors and nonsteroidal anti-inflammatory drugs (NSAIDs) continue to linger, the population in need for their indications continues to grow. Physicians are placed in a situation in which they have to seek out a number of resources to back their prescribing decisions with evidence from large population studies. They seek to maximize the benefit and minimize the drawbacks of such therapies for their patients. Drug Use Patterns
    Natalizumab is a monotherapy for relapsing forms of multiple sclerosis (MS) and maintaining remission in Crohn's... more
    Natalizumab is a monotherapy for relapsing forms of multiple sclerosis (MS) and maintaining remission in Crohn's disease (CD). Evaluation of natalizumab's clinical relevance must be performed before considering its place in treatment of these diseases. MEDLINE and PubMed searches were performed using the keywords multiple sclerosis, Crohn's disease, natalizumab and clinical trials. The manufacturer's product information was consulted to extract additional data. Pivotal clinical trials included: Natalizumab Safety and Efficacy in Relapsing Remitting Multiple Sclerosis (AFFIRM), Safety and Efficacy of Natalizumab in Combination With Interferon Beta-1a in Patients With Relapsing Remitting Multiple Sclerosis (SENTINEL), Efficacy of Natalizumab as Active Crohn's Therapy (ENACT)-1 and 2 and Efficacy of Natalizumab in Crohn's Disease Response and Remission (ENCORE). AFFIRM and SENTINEL showed improvements in progression of MS. ENACT-1 failed to show a significant effect, but the follow-up trials ENACT-2 and ENCORE were able to demonstrate a response to natalizumab. Two trials on efficacy of Tysabri for treatment of MS demonstrated positive results. Efficacy for CD was mixed. More research demonstrating head-to-head evidence against other agents is necessary to determine if Tysabri's benefits are significant.
    The association between a diagnosis of depression after a thromboembolic event (TEE) and an increase in acute health care use was examined. A cohort of Medicare beneficiaries who were 65 years of age and older, who resided in the... more
    The association between a diagnosis of depression after a thromboembolic event (TEE) and an increase in acute health care use was examined. A cohort of Medicare beneficiaries who were 65 years of age and older, who resided in the community, and who also experienced a TEE was constructed from the 1997-2001 Medicare Current Beneficiary Survey. Beneficiaries were assessed for TEEs and depression using the International Classification of Diseases, 9th Revision, Clinical Modification codes listed on Medicare claims. Time to first emergency department (ED) visit, inpatient hospitalization, and outpatient hospital visit were assessed using Cox-proportional hazard models. Counts of offices visits were assessed using negative binomial-regression models. Of the 7051 elderly patients included in the analysis, the total number with a claim for depression within 6 months of having a TEE was 380 (5.4%), including 259 antidepressant users (68.2% of depressed elders) and 198 selective serotonin-reuptake inhibitor (SSRI) users (76.4% of antidepressant users). Over half of elders with a depression claim (52.4%) had an inpatient hospitalization within 12 months of having a TEE compared to one third of the entire study sample (36.4%). Depressed elders had a 51% greater risk of hospitalization, a 56% greater risk of ED visits, and a 19% greater risk of outpatient visits. Antidepressant use did not affect the findings and was not found to be associated with health care use. A claim for depression by Medicare patients was associated with the increased use of acute health care services, including hospitalizations and ED visits, in the 12 months following a TEE. Neither antidepressant use nor SSRI use was associated with an increase or reduction in risk of using such services.
    The prognosis of some of the most prevalent conditions seems to be intricately related to myriad risk factors, largely modifi able, but often leading to irreversible complications when left unmanaged. This study exemplifi es the... more
    The prognosis of some of the most prevalent conditions seems to be intricately related to myriad risk factors, largely modifi able, but often leading to irreversible complications when left unmanaged. This study exemplifi es the multidisciplinary approach necessary, to successfully control diabetic retinopathy, one of the leading complications of diabetes, and to discuss promising therapies. Based on a Medline Ovid database search, we present a clinical and economic review of the evidence on the epidemiology and risk factors of diabetic retinopathy, its prognosis and economic implications. Among adults aged 20-74, diabetic retinopathy (DR) is the most frequent cause of blindness. However, in both types 1 and 2 DM, improved glycemic control reduces the development and progression of DR. Risk factors of DR include duration of diabetes, pregnancy, renal disease, age, smoking, alcohol, hyperlipidemia and antioxidants. A number of drugs may play a role in DR therapy in the coming few yea...
    To evaluate blood pressure (BP) control utilizing the International Society on Hypertension in Blacks (ISHIB) cardiovascular risk reduction toolkit in an African American community with uncontrolled hypertension. This is a randomized... more
    To evaluate blood pressure (BP) control utilizing the International Society on Hypertension in Blacks (ISHIB) cardiovascular risk reduction toolkit in an African American community with uncontrolled hypertension. This is a randomized controlled pilot study conducted in two Baltimore community-based physicians' offices assigned adults (18-64 years) with uncontrolled hypertension (systolic blood pressure [SBP] ≤ 169 mm Hg; diastolic blood pressure [DBP] ≤ 109 mm Hg). The study compares usual care to a community-based intervention. In the usual care group, the patients' BP was managed by the treating physician based on their normal office patient care protocol. In the intervention group, usual care was provided but, a community health worker also gave comprehensive education and assessment to the patients based on the ISHIB IMPACT cardiovascular toolkit during study initiation and follow-up visits. The main outcome of study was change in BP from baseline to six months. A second...
    The prognosis of some of the most prevalent conditions seems to be intricately related to myriad risk factors, largely modifiable, but often leading to irreversible complications when left unmanaged. This study exemplifies the... more
    The prognosis of some of the most prevalent conditions seems to be intricately related to myriad risk factors, largely modifiable, but often leading to irreversible complications when left unmanaged. This study exemplifies the multidisciplinary approach necessary, to successfully control diabetic retinopathy, one of the leading complications of diabetes, and to discuss promising therapies. Based on a Medline Ovid database search, we present a clinical and economic review of the evidence on the epidemiology and risk factors of diabetic retinopathy, its prognosis and economic implications. Among adults aged 20-74, diabetic retinopathy (DR) is the most frequent cause of blindness. However, in both types 1 and 2 DM, improved glycemic control reduces the development and progression of DR. Risk factors of DR include duration of diabetes, pregnancy, renal disease, age, smoking, alcohol, hyperlipidemia and antioxidants. A number of drugs may play a role in DR therapy in the coming few years...
    To determine the effect of medication burden on persistent use of newly added lipid-lowering (LL) drugs among patients with hypertension. This retrospective database study used medical and pharmacy claims from a mid-Atlantic managed care... more
    To determine the effect of medication burden on persistent use of newly added lipid-lowering (LL) drugs among patients with hypertension. This retrospective database study used medical and pharmacy claims from a mid-Atlantic managed care organization. The cohort was obtained from continuous member enrollment in pharmacy and medical benefits from January 1, 2003, to December 31, 2005. Prescription claims were obtained for 18 months following the date of the first filled LL prescription (ie, index date). Patients were stratified into patients who changed LL drug or strength (group 1) and patients who did not change LL drug or strength (group 2). The primary outcome measure was persistence to newly added LL therapy. Persistence was defined by the length of time a member remained on therapy following the index date. The secondary outcome measure was the medication possession ratio (MPR). The MPR was calculated as the ratio of the sum of the days' supply of prescription filled divide...

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