PubMed · 10171740
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M Crane. 1993-11-22. The medication errors that get doctors sued.. https://pubmed.ncbi.nlm.nih.gov/10171740/
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We develop the randomized analysis for repeated binary outcomes with non-compliance. A break randomization-based semi-parametric estimation procedure for both the causal risk difference and the causal risk ratio is proposed for repeated binary data. Although we assume the simple structural models for potential outcomes, we choose to avoid making any assumptions about comparability beyond those implied by randomization at time zero. The proposed methods can incorporate non-compliance information, while preserving the validity of the test of the null hypothesis, and even in the presence of non-random non-compliance can give the estimate of the causal effect that treatment would have if all individuals complied with their assigned treatment. The methods are applied to data from a randomized clinical trial for reduction of febrile neutropenia events among acute myeloid leukaemia patients, in which a prophylactic use of macrophage colony-stimulating factor (M-CSF) was compared to placebo during the courses of intensive chemotherapies.
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Many therapeutic agents, including recently introduced biologic response modifiers, can induce a variety of vasculitic manifestations ranging from small vessel hypersensitivity vasculitis and leukocytoclastic vasculitis to distinct vasculitic syndromes such as Wegener's granulomatosis, polyarteritis nodosa, and Churg Strauss syndrome. The pathogenic mechanisms remain to be defined and appear to be multifactorial, with cell-mediated and humural immune mechanisms playing important roles. Clinical presentation varies in severity from mild to severe and even fatal illness, can be self-limiting, or follows a more chronic protracted course. There are no significant differences in clinical presentation, serologic abnormalities, and pathologic findings with the idiopathic forms of vasculitis. However, it is extremely important to identify the offending drug because the discontinuation of the drug is often followed by a rapid improvement of the underlying vasculitic disorder.