Publications by authors named "Nicholas Stine"

Health system leaders sometimes adopt quality metrics without robust supporting evidence of improvements in quality and/or quantity of life, which may impair rather than facilitate improved health outcomes. In brief, there is now no easy way to measure how much "health" is conferred by a health system. However, we argue that this goal is achievable.

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Background: Carbapenem-resistant Klebsiella pneumoniae (CRKP) is resistant to almost all antimicrobial agents, and CRKP infections are associated with substantial morbidity and mortality.

Objective: To describe an outbreak of CRKP in Puerto Rico, determine risk factors for CRKP acquisition, and detail the successful measures taken to control the outbreak.

Design: Two case-control studies.

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Context: In January 2002, the US Food and Drug Administration (FDA) issued a draft guidance requiring more detailed financial conflict of interest disclosure at advisory committee meetings.

Objectives: To characterize financial conflict disclosures at drug-related meetings, and to assess the relationship between conflicts and voting behavior at meetings that considered specific products.

Design And Setting: Cross-sectional study using agendas and transcripts from all FDA Drug Advisory Committee meetings (2001-2004) listed on the FDA Web site.

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