UMB Data Catalog

A project of the Health Sciences and Human Services Library
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Results Found: 26
  • UMB Dataset

    Test Record

    Description

    This is a test

    Subject
    Aged
  • UMB Dataset

    Dataset (data extraction spreadsheet) of an Exploratory Review of Clinical Study Reports of Randomised Controlled Trials

    Authors
    Peter Doshi
    Tom Jefferson
    Description

    This dataset (data extraction spreadsheet) is associated with an exploratory evaluation of pharmaceutical industry clinical study reports (CSR) for possible use in evidence synthesis and systematic reviews. 78 CSRs from public sources were selected for data extraction. The report dates range from 1991 through 2011, inclusive, and represent 90 randomized controlled trials of 14 pharmaceuticals. The...

    Subject
    Drug Industry
    Access Rights
    Unrestricted access
  • UMB Dataset

    Patient Consent to Publication and Data Sharing in Industry and NIH-Funded Clinical Trials

    Authors
    O'Mareen Spence
    Richie Onwuchekwa Uba
    Seongbin Shin
    Peter Doshi
    Description

    Clinical trial participants are often motivated by the altruistic assumption that study results will contribute to medical knowledge. Additionally, the sharing of research data is rapidly developing into an ethical standard. An evaluation of 144 blank (sample) informed consent forms (ICF) was undertaken to determine the extent to which clinical trial participants were apprised of researchers’ intent...

    Subject
    Informed Consent
    Access Rights
    Unrestricted access
  • UMB Dataset

    Clinical Study Reports (CSR) Used in the Systematic Review of Neuraminidase Inhibitors for Preventing and Treating Influenza in Healthy Adults and Children with Confirmed or Suspected Exposure to Natural Influenza

    Alternate Title(s)
    CSRs used in Cochrane review of neuroaminidase inhibitors for influenza
    Authors
    Peter Doshi
    Description

    Dataset consists of 107 full clinical study reports (CSRs) of published and unpublished randomized, placebo-controlled clinical trials of two neuraminidase inhibitors. A systematic review of the CSRs and other regulatory documents was conducted to determine the potential benefits and harms of oseltamivir (Tamiflu) and zanamivir (Relenza). Outcome measures included time to first alleviation of symptoms,...

    Subject
    Influenza, Human
    Access Rights
    Unrestricted access
  • UMB Dataset

    The Possible Harms of Statins: What do Product Labels, Patient Package Inserts, and Pharmacy Leaflets Tell Us?

    Authors
    Peter Doshi
    Jan Sieluk
    Anna Hung
    Description

    This cross-sectional study evaluated three sources of written medical documents for consistency of language with regard to the adverse effects of 8 single-agent statins. Full prescribing information (PI’s, also called package inserts or drug labels), patient package inserts (PPIs), and pharmacy leaflets differ according to regulatory status, issuing body, and intended audience. The first two sources...

    Subject
    Consumer Health Information/standards
    Drug Labeling/standards
    Timeframe
    2015
    Access Rights
    Unrestricted access
  • UMB Dataset

    Dataset for Communicating Nonefficacy Benefits of New Drugs Approved on the Basis of Noninferiority Trials Alone

    Authors
    Peter Doshi
    O'Mareen Spence
    Aida Kuzucan
    John H. Powers, III
    Description

    This dataset is the result of an investigation characterizing nonefficacy benefits of newly approved molecular entities (NMEs) based exclusively on noninferiority trials. Qualifying NMEs were identified using the FDA’s Novel Drug Approval website, sponsor press releases at market entry, FDA Drug Trials Snapshots, and statistical and medical officer reports. A total of 18 were selected for analysis....

    Subject
    Drug Industry
    Equivalence Trials as Topic
    Human Experimentation/ethics
    United States. Food and Drug Administration
    Access Rights
    Unrestricted access
  • UMB Dataset

    Reporting of Drug Benefit in FDA-Approved Prescription Drug Labeling

    Authors
    Peter Doshi
    Bansri Desai
    Kyungwan Hong
    John H. Powers, III
    Description

    Clinicians prescribing therapeutic agents newly approved by the FDA must rely on the information reported through drug labels (also known as “package inserts”). Ideally, labels should incorporate details regarding key efficacy information, including the magnitude of treatment benefit, and measures of precision and random error (confidence intervals and p values). This study assessed the degree to which...

    Subject
    Drug Labeling/standards
    Access Rights
    Unrestricted access
  • Nationwide Readmissions Database

    Alternate Title(s)
    NRD, HCUP Nationwide Readmissions Database
    Description

    The Nationwide Readmissions Database is part of the Healthcare Cost and Utilization Project (HCUP) family of databases. The NRD is derived from the HCUP State Inpatient Databases (SID), and aims to provide nationally represenative data to support hospital readmission analyses. The NRD includes all-payer inpatient discharges from HCUP partner community hospitals in the SID which have verifiable patient...

    Subject
    Hospitalization
    Patient Readmission
    Quality of Health Care
    Access Rights
    Fee required
    Registration required
    Local Experts
    Najdat Bazarbashi
  • ACGME Case Log Graduate Statistic National Report: Ophthalmology

    Description

    The Accreditation Council for Graduate Medical Education (ACGME) sets standards for US graduate medical education (residency and fellowship) programs and the institutions that sponsor them, and renders accreditation decisions based on compliance with these standards. Residents and fellows provide regular feedback to the ACGME about their programs, offering an inside view that helps the organization...

    Subject
    Internship and Residency
    Ophthalmology/education
    Access Rights
    Unrestricted access
  • UMB Dataset

    US Regional and Demographic Differences in Prescription Opioid and Heroin-Related Overdose Hospitalizations

    Authors
    George J. Unick
    Daniel Ciccarone
    Description

    Dataset is comprised of heroin overdose-related and prescription opioid overdose-related hospitalization rates for the years 2000 through 2014. Data is derived from the Healthcare Cost and Utilization Project (HCUP) Nationwide Inpatient Sample (NIS). Included are rates by census region and division with separate rates for age and race.

    Subject
    Substance-Related Disorders