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A study was conducted to evaluate the structure, operations, and preliminary findings from the Research on Adverse Drug events And Reports (RADAR) project and related dissemination efforts by pharmaceutical suppliers and the US Food and Drug Administration. The result showed that a new, clinically based, hypothesis-driven approach to postmarketing surveillance may supplement existing regulatory surveillance and improve patients safety.

Ambulatory training in internal medicine residency programs has historically been considered less robust than inpatient-focused training, which prompted a 2009 revision of the Accreditation Council for Graduate Medical Education (ACGME) Program Requirements in Internal Medicine. This revision was intended to create a balance between inpatient and outpatient training standards and to spur innovation in the ambulatory setting. We explored innovations in ambulatory education in internal medicine residency programs since the 2009 revision of the ACGME Program Requirements in Internal Medicine. The authors conducted a scoping review of the literature from 2008 to 2017, searching PubMed, ERIC, and Scopus databases. Articles related to improving educational quality of ambulatory components of US-based internal medicine residency programs were eligible for inclusion. Articles were screened for relevance and theme categorization and then divided into 6 themes: clinic redesign, curriculum development, evaluating resident practice/performance, teaching methods, program evaluation, and faculty development. Once a theme was assigned, data extraction and quality assessment using the Medical Education Research Study Quality Instrument (MERSQI) score were completed. A total of 967 potentially relevant articles were discovered; of those, 182 were deemed relevant and underwent full review. Most articles fell into curriculum development and clinic redesign themes. The majority of included studies were from a single institution, used nonstandardized tools, and assessed outcomes at the satisfaction or knowledge/attitude/skills levels. Few studies showed behavioral changes or patient-level outcomes. While a rich diversity of educational innovations have occurred since the 2009 revision of the ACGME Program Requirements in Internal Medicine, there is a significant need for multi-institution studies and higher-level assessment. [ABSTRACT FROM AUTHOR]

Background: Gemcitabine is a commonly used chemotherapeutic agent structurally and pharmacologically similar to cytarabine. Recently, instances of severe gemcitabine-associated lung injury have been reported. Herein, investigators affiliated with the Research on Adverse Drug Events and Reports (RADAR) pharmacovigilance program evaluated clinical characteristics of gemcitabine-associated severe acute lung injury from clinical trial reports, medical literature case reports, and spontaneous reports to the Food and Drug Administration (FDA) Adverse Event Reporting System (AERS)., Methods: Clinical data were obtained by reviewing adverse event case reports for gemcitabine-associated lung injury as reported in the medical literature and in the FDA AERS database. Upper limit estimates of ADE rate were derived from review of published clinical trials reporting gemcitabine-associated lung injury rates of 10% or higher., Results: A total of 178 reports of gencitabine-associated lung injury were identified; in AERS, there were 55 cases from clinical trials and 92 spontaneous reports. A comprehensive search revealed 31 medical literature reports. Clinical features of gemcitabine-associated lung injury included dyspnea, fever, pulmonary infiltrate, and cough with recognition of toxicity occurring after a median duration of 48 (range, 1-529) days after initiation of gemcitabine. The taxanes, docetaxel and paclitaxel, were frequently reported as coadministered therapies. Eleven Phase II or Phase III clinical trials with 317 patients identified gemcitabine-associated lung injury rates of greater than 10%, with the highest rates (22% and 42%) being observed in Phase III clinical trials where Hodgkin disease patients were treated with a regimen that included gemcitabine and bleomycin., Conclusions: High rates of gemcitabine-associated severe lung injury were observed when gemcitabine was combined with other therapies known to also cause lung injury. Physicians should have a high index of suspicion for this toxicity and report the relevant clinical findings to the FDA's AERS.

Prostate cancer treatments have positive and negative outcomes that must be taken into account when deciding how to proceed with a patient's care. One way to quickly determine a patient's preferences in this situation is to ascertain their health utilities for various health states. Health utilities are underutilized but powerful tools in aiding shared decision making between patients and physicians. This review is intended to inform physicians about the different techniques available, help the physician choose among them, and aid initial development of utilities for use in the clinic by way of the tables' references. A brief history, summary of applications and current directions of health utilities, and collection of references are provided to increase the reader's overall knowledge of health utilities and encourage their use in the clinic. Ultimately, the use and choice of one of these direct preference-based measures depends on the needs of the physician.