J. B. Bernstein

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Well-defined and reliable clinical outcome assessments are essential for determining whether a drug provides clinically meaningful treatment benefit for patients. In 2015, FDA convened a workshop, "Assessing Neurocognitive Outcomes in Inborn Errors of Metabolism." Topics covered included special challenges of clinical studies of inborn errors of metabolism(More)
Vaccines have led to some of the greatest public health achievements in history, including the worldwide eradication of naturally occurring smallpox and the near eradication of polio. In addition, vaccines have contributed to significant reduction in the disease burden imposed by measles, mumps, hepatitis, influenza, diphtheria, and many other infections.(More)
Tuberculosis (TB) has been a persistent public health concern for hundreds of years. Despite advances in medicine and science, eliminating this disease has been beyond our reach. Several organizations, including the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), have expressed their commitment(More)
OBJECTIVES To adapt the self-administered comorbidity questionnaire (SCQ) into the Early Inflammatory Arthritis-SCQ (EIA-SCQ) and assess its clinimetric properties in EIA. METHODS The EIA-SCQ and indices of disease activity, function, pain, health-related quality of life (HRQoL) and health resource utilization were administered to 320 patients with EIA.(More)
OBJECTIVE To assess the validity of self-reports by patients with systemic sclerosis (SSc) of 5 common, chronic conditions (hypertension, diabetes, cancer, depression, and osteoarthritis/back pain) as compared to chart review. METHODS SSc patients at a large referral hospital self-reported on a number of comorbidities. Their inpatient and outpatient(More)
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