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UMB Dataset
Test Record
- Description
This is a test
- Subject
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Aged
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UMB Dataset
Dataset (data extraction spreadsheet) of an Exploratory Review of Clinical Study Reports of Randomised Controlled Trials
- Authors
- Peter DoshiTom 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
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Drug Industry
- Access Rights
- Unrestricted access
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UMB Dataset
Patient Consent to Publication and Data Sharing in Industry and NIH-Funded Clinical Trials
- Authors
- O'Mareen SpenceRichie Onwuchekwa UbaSeongbin ShinPeter 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
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Informed Consent
- Access Rights
- Unrestricted access
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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Dataset consists of 107 full clinical study reports (CSRs) of published and unpublished randomized, placebo-controlled clinical trials of two neuraminidase inhibitors.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
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Influenza, Human
- Access Rights
- Unrestricted access
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UMB Dataset
The Possible Harms of Statins: What do Product Labels, Patient Package Inserts, and Pharmacy Leaflets Tell Us?
- Authors
- Peter DoshiJan SielukAnna 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
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Consumer Health Information/standardsDrug Labeling/standards
- Timeframe
- 2015
- Access Rights
- Unrestricted access
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UMB Dataset
Dataset for Communicating Nonefficacy Benefits of New Drugs Approved on the Basis of Noninferiority Trials Alone
- Authors
- Peter DoshiO'Mareen SpenceAida KuzucanJohn 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
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Drug IndustryEquivalence Trials as TopicHuman Experimentation/ethicsUnited States. Food and Drug Administration
- Access Rights
- Unrestricted access
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UMB Dataset
Reporting of Drug Benefit in FDA-Approved Prescription Drug Labeling
- Authors
- Peter DoshiBansri DesaiKyungwan HongJohn 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
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Drug Labeling/standards
- Access Rights
- Unrestricted access
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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
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HospitalizationPatient ReadmissionQuality of Health Care
- Access Rights
- Fee requiredRegistration required
- Local Experts
- Najdat Bazarbashi
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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
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Internship and ResidencyOphthalmology/education
- Access Rights
- Unrestricted access
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UMB Dataset
US Regional and Demographic Differences in Prescription Opioid and Heroin-Related Overdose Hospitalizations
- Authors
- George J. UnickDaniel 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
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Substance-Related Disorders