Outcome study clinical setting

The Mini-International Neuropsychiatric Interview (MINI) is a short structured diagnostic interview for DSM-IV and ICD-10 psychiatric disorders. With an administration time of approximately 15 min, it was designed to meet the need for a short but accurate structured psychiatric interview for multicenter clinical trials and epidemiology studies, and to be used as a first step in outcome tracking in non-research clinical settings (Sheehan et al.y 1998). 

This study shows that assessment of ERCC 1 mRNA expression in patient tumor tissue is feasible in the clinical setting and predicts response to docetaxel plus cisplatin. Further studies are warranted to optimize methodologies for ERCCI analysis in small tumor samples and to refine a multi-biomarker profile predictive of patient outcome. Other... 

Accurate estimation of the early risk of stroke after TIA or minor stroke requires particular study methods. First, potential patients must be recruited as rapidly as possible after the event so that strokes following very early after TIA are included. Second, patients should be assessed initially by an expert stroke physician to ensure that the diagnosis is made reliably and mimics are excluded. Third, follow-up should be in person and outcome events should be independently adjudicated to ensure correct identification of subsequent strokes. Lastly, patients should ideally be recruited from a defined population as opposed to a particular clinical setting in order to reduce selection bias. 

A particular problem in interpreting the beneficial role and efficacy of oximes in clinical practice is a deficiency of published data, especially those evaluated in controlled clinical trials. Studies related to the efficacy of oximes in a clinical setting showed the heterogeneity of therapeutic approaches (i.e. dose regimen, oxime choice, and final outcome of the treatment). 

Effectiveness characteristics considered desirable in healthcare antiseptic drug products are described in Table 4, and the requirements for assessment of efficacy depend on the indication sought. The methods used to examine these product characteristics are controversial since many methods are available to assess efficacy and each may produce different outcomes with the same product. Also lacking is interpretation of the data obtained from these test methods. The relationship of the outcome measure of efficacy defined by the test method and its relevance to the clinical setting is not well established. Efforts to close this gap are not forthcoming. Consequently, the FDA must use methods at its disposal to assess product efficacy. Thus, protocols whose purpose is to explore product characteristics and to assess whether the product meets the minimum efficacy requirements for an indication are recommended. Due to limitations associated with each of these test protocols, they cannot be used independently of each other but must be used in concert to gain an overall perspective of product efficacy. The in vitro assays are used to define the use of the antiseptic in a specific instance while the in vivo assays are used to define its use in a particular clinical setting. Ideally, both approaches must produce similar results, but this may not always be the case. Despite these limitations, preclinical and clinical simulation studies attempt to provide predictive evidence of clinical efficacy. 

The ideal setting for assessment of the efficacy of antiseptics is the clinical settings where these products are used. The desired outcome would be a reduction of the nosocomial infection rates below that historically seen within the study setting. However, many scientists suggest that these studies are not feasible, and we are left with surrogate methods that are assumed to be predictive of an acceptable outcome. 

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