Improving Transparency to Build Trust in Real-World Secondary Data Studies for Hypothesis Testing-Why, What, and How: Recommendations and a Road Map from the Real-World Evidence Transparency Initiative.

Real-world data (RWD) and the derivations of these data into real-world evidence (RWE) are rapidly expanding from informing healthcare decisions at the patient and health system level to influencing major health policy decisions, including regulatory approvals and coverage. Recent examples include the approval of palbociclib in combination with endocrine therapy for male breast cancer and the inclusion of RWE in the label of paliperidone palmitate for schizophrenia. This interest has created an urgency to develop processes that promote trust in the evidence-generation process.

Improving transparency to build trust in real-world secondary data studies for hypothesis testing-Why, what, and how: recommendations and a road map from the real-world evidence transparency initiative.

Real-world data (RWD) and the derivations of these data into real-world evidence (RWE) are rapidly expanding from informing healthcare decisions at the patient and health system level to influencing major health policy decisions, including regulatory approvals and coverage. Recent examples include the approval of palbociclib in combination with endocrine therapy for male breast cancer and the inclusion of RWE in the label of paliperidone palmitate for schizophrenia. This interest has created an urgency to develop processes that promote trust in the evidence-generation process.

An evaluation of health-related quality of life in patients with systemic lupus erythematosus using PROMIS and Neuro-QoL.

Systemic lupus erythematosus (SLE) is a multi-organ chronic autoimmune disease that can negatively affect patients' health-related quality of life (HRQOL). This study evaluated HRQOL of SLE patients using questionnaires from the Patient-Reported Outcomes Measurement Information System (PROMIS) and Quality of Life in Neurological Disorders (Neuro-QoL). Individuals with SLE completed an online survey consisting of the PROMIS-29 health profile, PROMIS Psychosocial Illness Impact-Negative, and Neuro-QoL Applied Cognition.

Health-Related Quality of Life in Patients with Idiopathic Pulmonary Fibrosis.

Purpose: Idiopathic pulmonary fibrosis (IPF) produces symptoms and activity limitations that impair health-related quality of life (HRQOL). The Patient-Reported Outcomes Measurement Information System(®) (PROMIS(®)) includes measures of self-reported health and HRQOL for a range of conditions. This study evaluated the HRQOL of individuals with IPF using PROMIS measures and examined associations between HRQOL and key symptoms or supplemental oxygen need.

Medication costs to private insurers of diversion of medications for attention-deficit hyperactivity disorder.

Background: The diversion of prescription stimulants for misuse, particularly those used in the treatment of attention-deficit hyperactivity disorder (ADHD), is potentially a significant problem for public health and for healthcare funding and delivery. Most prior research on the diversion of prescription stimulants for misuse, particularly those used in the treatment of ADHD, has focused on the 'end users' of diverted medications rather than the suppliers. Furthermore, little is known about the direct costs of diversion for third-party insurance payers in the US.

Associations of nonrestorative sleep with insomnia, depression, and daytime function.

Study Objectives: Nonrestorative sleep (NRS) complaints are common but associations with insomnia, daytime function or depressive symptoms are not well-established. This study aims to (1) describe insomnia related symptoms and sleep quality in those with NRS compared to those with no NRS; (2) identify the independent associations between NRS, insomnia severity, and depression; and (3) identify the association between NRS and daytime function independent of insomnia severity and depression.

Design: Cross sectional survey of enrollees at a health plan in the Midwestern United States.

Structure and diagnosis of adult attention-deficit/hyperactivity disorder: analysis of expanded symptom criteria from the Adult ADHD Clinical Diagnostic Scale.

Context: Controversy exists about the appropriate criteria for a diagnosis of adult attention-deficit/hyperactivity disorder (ADHD).

Objective: To examine the structure and symptoms most predictive of DSM-IV adult ADHD.

Design: The data are from clinical interviews in enriched subsamples of the National Comorbidity Survey Replication (n = 131) and a survey of a large managed health care plan (n = 214).

Stimulant formulation and motivation for nonmedical use of prescription attention-deficit/hyperactivity disorder medications in a college-aged population.

There is relatively little research examining motives for nonmedical use (NMU) of attention-deficit/hyperactivity disorder (ADHD) medications and predictors of motivation. We present results of a secondary analysis of an Internet-based epidemiological survey to explore the relationship between stimulant formulation and motivation for NMU of ADHD stimulant medications in a college-aged population. Demographic predictors of motivation to engage in NMU were also explored to investigate the potential correlates of recreational versus performance-enhancement motivations.

Test-retest reliability of two patient-report measures for use in adults with ADHD.

Aims: Childhood attention-deficit/hyperactivity disorder (ADHD) frequently persists into adulthood and continues to impair health-related quality of life (HRQL). Thus, it is important to have validated symptom and HRQL measures for assessing treatment outcomes in this population. The purpose of the current analysis was to assess test-retest reliability of two measures designed specifically for adults with ADHD: the Adult ADHD Self-Report Screener (ASRS) and the Adult ADHD Quality of Life Measure (AAQoL).

A retrospective claims analysis of combination therapy in the treatment of adult attention-deficit/hyperactivity disorder (ADHD).

Background: Combination therapy in managing psychiatric disorders is not uncommon. While combination therapy has been documented for depression and schizophrenia, little is known about combination therapy practices in managing attention-deficit/hyperactivity disorder (ADHD). This study seeks to quantify the combination use of ADHD medications and to understand predictors of combination therapy.

Prevalence of nonmedical methamphetamine use in the United States.

Background: Illicit methamphetamine use continues to be a public health concern in the United States. The goal of the current study was to use a relatively inexpensive methodology to examine the prevalence and demographic correlates of nonmedical methamphetamine use in the United States.

Methods: The sample was obtained through an internet survey of noninstitutionalized adults (n = 4,297) aged 18 to 49 in the United States in 2005.

Weight management using the internet a randomized controlled trial.

Background: Most weight-loss research targets obese individuals who desire large weight reductions. However, evaluation of weight-gain prevention in overweight individuals is also critical as most Americans become obese as a result of a gradual gain of 1-2 pounds per year over many years.

Method: This study evaluated the efficacy of an Internet-based program for weight-loss and weight-gain prevention with a two-group, prospective, randomized controlled trial.

The nonmedical use of prescription ADHD medications: results from a national Internet panel.

Background: Emerging evidence suggests that nonmedical use (NMU) of prescription attention deficit/hyperactivity disorder (ADHD) medications is rising, but many previous investigations have used clinical or regionally based samples or limited their investigations to stimulants rather than to medications specifically used to treat ADHD. Using an Internet-based epidemiological survey, this paper advances understanding of the prevalence and correlates of NMU of medications used to treat ADHD, sources of diverted medications, motivations for use, and consumption patterns.

Methods: The study used a self-administered Internet survey of civilian, noninstitutionalized adults (N = 4,297) aged 18 to 49 in the United States.

Validity of the World Health Organization Adult ADHD Self-Report Scale (ASRS) Screener in a representative sample of health plan members.

The validity of the six-question World Health Organization Adult ADHD Self-Report Scale (ASRS) Screener was assessed in a sample of subscribers to a large health plan in the US. A convenience subsample of 668 subscribers was administered the ASRS Screener twice to assess test-retest reliability and then a third time in conjunction with a clinical interviewer for DSM-IV adult ADHD. The data were weighted to adjust for discrepancies between the sample and the population on socio-demographics and past medical claims.

The relationship between quality of life and clinical efficacy from a randomized trial comparing olanzapine and ziprasidone.

Objective: To examine treatment-specific changes in health-related quality of life (QOL) among patients with schizophrenia and to assess the association between clinical and QOL improvement.

Method: This post hoc analysis used the findings of a 28-week, randomized, multicenter trial of patients with schizophrenia (DSM-IV) treated with olanzapine (10-20 mg/day) or ziprasidone (80-160 mg/day). Data were collected from August 2001 to December 2002.

Decreased use of clonidine following treatment with atomoxetine in children with ADHD.

The objectives of the present study were to examine clonidine use before and after initiation of atomoxetine in a cohort of children with attention deficit/hyperactivity disorder (ADHD). For this purpose, medical and pharmaceutical claims data for patients from 75 managed health care plans across the United States were extracted to identify a cohort of patients aged 18 years and younger at the time of a first atomoxetine prescription. Clonidine users were characterized on the basis of demographics, comorbid conditions, medication use and provider types, and prescribing patterns before and after the index atomoxetine prescription assessed.

Factors associated with initiation with atomoxetine versus stimulants in the treatment of adults with ADHD: retrospective analysis of administrative claims data.

Objective: To determine which factors are associated with use of atomoxetine (ATX) relative to stimulant medications (STIMs) for treatment initiation in adults with attention-deficit/hyperactivity disorder (ADHD). A similar exploratory analysis of the use of ATX versus STIMs in children has been published previously.

Methods: This was an exploratory analysis using a retrospective observational cohort design applied to administrative pharmacy and medical claims from an integrated managed care database.

Nonmedical use of prescription stimulants in the United States.

Objective: This study estimated prevalences and correlates of stimulant diversion in the United States and examined relationships between diversion and measures of abuse or dependence.

Methods: We conducted descriptive and multivariate analysis of data from the National Survey on Drug Use and Health. Key measures were nonmedical use (misuse) of any prescription stimulant, any stimulant other than methamphetamine, and stimulants indicated for attention-deficit/hyperactivity disorder (ADHD).

Predictors of selecting atomoxetine therapy for children with attention-deficit-hyperactivity disorder.

Study Objective: To investigate predictors of beginning treatment with atomoxetine, a new attention-deficit-hyperactivity disorder (ADHD) drug, shortly after it was introduced into the marketplace compared with well-established stimulants for children in a managed care setting.

Design: Retrospective cohort analysis.

Data Source: Managed care claims database.

Impact of a statewide Medicaid managed care system on healthcare utilization and outcomes for people living with HIV.

Background: Medicaid managed care (MMC) systems provide insurance for many persons living with HIV and AIDS (PLWH). This study sought to assess the impact of a statewide MMC system (TennCare) on healthcare utilization and outcomes for PLWH.

Methods: A retrospective longitudinal analysis of trends in population characteristics was performed.

Outpatient use of major antipsychotic drugs in ambulatory care settings in the United States, 1997-2000.

Objective: To describe the prescription of antipsychotic agents in the United States and to investigate the association between demographic characteristics, clinical diagnosis, and antipsychotic prescribed.

Methods: Four years (1997-2000) of data from the National Ambulatory Medical Care Survey (NAMCS) and National Hospital Ambulatory Care Survey (NHAMCS) were combined for analysis. Distributions for patient age, race, gender, primary diagnosis, and provider's medical specialty were assessed.

Improvements in access to care for HIV and AIDS in a statewide Medicaid managed care system.

Background: Some experimental Medicaid managed care systems have expanded eligibility criteria for chronically ill persons, but these systems' impact on access to care remains unknown.

Objective: To determine whether initiating a statewide Medicaid managed care system (TennCare) guaranteeing universal access for persons living with HIV or AIDS (PLWHs) increased their enrollment in public sector insurance.

Design, Setting, And Participants: A retrospective longitudinal descriptive analysis of trends in population characteristics during the study period was performed.