Predictors of chronic opioid therapy in Medicaid beneficiaries with HIV who initiated antiretroviral therapy.

The factors associated with chronic opioid therapy (COT) in patients with HIV is understudied. Using Medicaid data (2002-2009), this retrospective cohort study examines COT in beneficiaries with HIV who initiated standard combination anti-retroviral therapy (cART). We used generalized estimating equations on logistic regression models with backward selection to identify significant predictors of COT initiation.

Alpha-1 Antitrypsin Deficiency-Associated Clinical Manifestations and Healthcare Resource Use in the United States.

Pulmonary events (PEs) associated with alpha-1 antitrypsin deficiency (AATD) can have a severe clinical course and increase healthcare resource use (HRU). However, AATD-associated HRU and healthcare costs have not been extensively described. This study describes and compares real-world HRU and healthcare costs among US patients with severe (requiring hospitalization after AATD-related PE) versus nonsevere AATD clinical course.

Leveraging unstructured data to identify hereditary angioedema patients in electronic medical records.

Background: The epidemiologic impact of hereditary angioedema (HAE) is difficult to quantify, due to misclassification in retrospective studies resulting from non-specific diagnostic coding. The aim of this study was to identify cohorts of patients with HAE-1/2 by evaluating structured and unstructured data in a US ambulatory electronic medical record (EMR) database.

Methods: A retrospective feasibility study was performed using the GE Centricity EMR Database (2006-2017).

Incidence of von Willebrand disease in Denmark, 1995-2016: A cohort study.

Introduction: Information about temporal development of von Willebrand disease (VWD) incidence at a population level is scarce. To our knowledge, no study has described the incidence of VWD at a population level.

Aim: To estimate overall and annual incidence rates of hospital diagnosed VWD in Denmark between 1995 and 2016 as well as the frequency of hospital treated bleeding episodes before and after VWD diagnosis.

Masking in Pragmatic Trials: Who, What, and When to Blind.

Masking (or blinding) of treatment assignment is routinely implemented in classical randomized clinical trials (RCTs) to isolate the effect of the intervention itself and to minimize the potential for bias that could occur with traditional trials. Such biases could be introduced with the conduct, assessment of endpoints, management of conditions, analysis, and reporting when the treatment assignments are known. However, masking of treatments is not only complex but it hinders how generalizable the findings are to the "real world" clinical setting.

Real-World Evidence: What It Is and What It Can Tell Us According to the International Society for Pharmacoepidemiology (ISPE) Comparative Effectiveness Research (CER) Special Interest Group (SIG).

On December 8, 2016, the New England Journal of Medicine published a sounding board on Real World Evidence (RWE) by the US Food and Drug Administration (FDA) leadership. While the value of RWE based on nonrandomized observational studies was appreciated, such as for hypothesis generating, safety, and measuring quality in healthcare delivery, the authors expressed concerns on the quality of data sources and the ability of methodologies to control for confounding. In response, we offer a few considerations regarding these concerns.

Using administrative data for your research project: 10 considerations before you begin.

With increasing pressure to conduct research during residency training, and given the availability of administrative claims data, pharmacy residents will likely consider using large administrative databases for their research project. With competing time commitments and the short duration of residencies, residents and their preceptors must consider the 10 factors outlined above in order to produce a thoughtful, clinically relevant research project. While this discussion focused on the completion of a residency research project, these topics are also relevant to a broader pharmacy audience.

Evaluating the incident user design in the HIV population: incident use versus naive?

Introduction: The incident user design is the preferred study design in comparative effectiveness (CER) research. Usually, 180-365 days of exposure free time is adequate to remove biases associated with inclusion of prevalent users. In HIV research, the use of antiretrovirals (ARVs) at any time in the past may influence future treatment choices and CER results; thus, identifying naive as opposed to incident users is of importance.

Effects of combination antiretroviral therapies on the risk of myocardial infarction among HIV patients.

Background: Cohort studies have demonstrated greater risk of myocardial infarction (MI) associated with specific antiretroviral use, while meta-analyses of randomized controlled trials (RCTs) have not. These differences may be due to inherent biases in the observational study design or to the limited duration of randomized trials. We conducted a new-user, active-comparator cohort study emulating an RCT comparing the initiation of several antiretrovirals as part of combination antiretroviral therapy (cART) and MI.

Sex differences in benzodiazepine use in the HIV-infected population.

In the HIV-infected population there is a high prevalence of psychiatric disorders, conditions that often coexist with drug and alcohol dependence. Symptoms associated with psychiatric disorders are frequently managed with benzodiazepines, a class of medication often abused. We examined whether HIV-infected patients were more likely to fill a benzodiazepine prescription than their uninfected counterparts using a privately insured, nationally representative sample receiving clinical care between January 2007 and December 2009.

Validation of Medicaid Claims-based Diagnosis of Myocardial Infarction Using an HIV Clinical Cohort.

Background: In nonexperimental comparative effectiveness research using health care databases, outcome measurements must be validated to evaluate and potentially adjust for misclassification bias. We aimed to validate claims-based myocardial infarction (MI) algorithms in a Medicaid population using an HIV clinical cohort as the gold standard.

Methods: Medicaid administrative data were obtained for the years 2002-2008 and linked to the UNC CFAR HIV Clinical Cohort based on social security number, first name, and last name and MI were adjudicated.

Communicating quantitative risks and benefits in promotional prescription drug labeling or print advertising.

Purpose: Under the Food, Drug, and Cosmetic Act, all promotional materials for prescription drugs must strike a fair balance in presentation of risks and benefits. How to best present this information is not clear. We sought to determine if the presentation of quantitative risk and benefit information in drug advertising and labeling influences consumers', patients', and clinicians' information processing, knowledge, and behavior by assessing available empirical evidence.

Comparative effectiveness research using electronic health records: impacts of oral antidiabetic drugs on the development of chronic kidney disease.

Purpose: Little is known about the comparative effects of common oral antidiabetic drugs ([OADs] metformin, sulfonylureas, or thiazolidinediones [THZs]) on chronic kidney disease (CKD) outcomes in patients newly diagnosed with type 2 diabetes (T2DM) and followed in community primary care practices. Electronic health records (EHRs) were used to evaluate the relationships between OAD class use and incident proteinuria and prevention of glomerular filtration rate decline.

Methods: A retrospective cohort study on newly diagnosed T2D cases requiring OADs documented in the EHRs of two primary care networks between 1998 and 2009 was conducted.

Initial and subsequent therapy for newly diagnosed type 2 diabetes patients treated in primary care using data from a vendor-based electronic health record.

Background: Diabetes is a leading cause of death and disability, and its prevalence is increasing. When diet fails, patients with type 2 diabetes mellitus (T2DM) are prescribed oral hypoglycemics for glycemic control. Few studies have explored initial use or change from initial oral hypoglycemic therapy in the primary care setting.

Self-report of current and prior antiretroviral drug use in comparison to the medical record among HIV-infected patients receiving primary HIV care.

Objective: Patient antiretroviral (ARV) therapy knowledge is essential for regimen adherence, successful therapeutic response, and minimization of resistance evolution. Moreover, a complete and accurate patient ARV history is needed to construct efficacious and tolerable future regimens. In this study we assessed the ability of HIV-infected patients receiving care in a university infectious diseases clinic to accurately recall current and past ARVs.

Is HIV infection a risk factor for multi-drug resistant tuberculosis? A systematic review.

Background: Tuberculosis (TB) is an important cause of human suffering and death. Human immunodeficiency virus (HIV), multi-drug resistant TB (MDR-TB), and extensive drug resistant tuberculosis (XDR-TB) have emerged as threats to TB control. The association between MDR-TB and HIV infection has not yet been fully investigated.

Geographic Information System mapping as a tool to assess nonresponse bias in survey research.

Background: Surveys are a useful tool for assessing professional practice patterns, although declining response rates have caused concern over external validity. This is particularly relevant to Web-based surveys, where response rates traditionally have been lower than with paper mail surveys. In a 2005 survey of North Carolina community pharmacy managers using a Web-based data collection instrument, we achieved an overall response rate of 23%.

Medication therapy management services in North Carolina community pharmacies: current practice patterns and projected demand.

Objective: To evaluate the types of cognitive services offered and the number of patients being served in community pharmacies, determine the number of pharmacies that plan to offer medication therapy management (MTM) services under the Medicare Part D prescription drug benefit, and assess whether current and expected practices will meet the potential needs of enrollees.

Design: Cross-sectional study.

Setting: North Carolina in January 2005.