406 research outputs found

    Informatic Tools and Approaches in Postmarketing Pharmacovigilance Used by FDA

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    The safety profile of newly approved drugs and therapeutic biologics is less well developed by pre-marketing clinical testing than is the efficacy profile. The full safety profile of an approved product is established during years of clinical use. For nearly 40 years, the FDA has relied on the voluntary reporting of adverse events by healthcare practitioners and patients to help establish the safety of marketed products. Epidemiologic studies, including case series, secular trends, case-control and cohort studies, are used to supplement the investigation of a safety signal. Ideally, active surveillance systems would supplement the identification and exploration of safety signals. The FDA has implemented a number of initiatives to help identify safety problems with drugs and continues to evaluate their efforts

    Patients' Experience of therapeutic footwear whilst living at risk of neuropathic diabetic foot ulceration: an interpretative phenomenological analysis (IPA).

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    BACKGROUND: Previous work has found that people with diabetes do not wear their therapeutic footwear as directed, but the thinking behind this behaviour is unclear. Adherence to therapeutic footwear advice must improve in order to reduce foot ulceration and amputation risk in people with diabetes and neuropathy. Therefore this study aimed to explore the psychological influences and personal experiences behind the daily footwear selection of individuals with diabetes and neuropathy. METHODS: An interpretative phenomenological analysis (IPA) approach was used to explore the understanding and experience of therapeutic footwear use in people living at risk of diabetic neuropathic foot ulceration. This study benefited from the purposive selection of a small sample of four people and used in-depth semi structured interviews because it facilitated the deep and detailed examination of personal thoughts and feelings behind footwear selection. FINDINGS: Four overlapping themes that interact to regulate footwear choice emerged from the analyses: a) Self-perception dilemma; resolving the balance of risk experienced by people with diabetes and neuropathy day to day, between choosing to wear footwear to look and feel normal and choosing footwear to protect their feet from foot ulceration; b) Reflective adaption; The modification and individualisation of a set of values about footwear usage created in the minds of people with diabetes and neuropathy; c) Adherence response; The realignment of footwear choice with personal values, to reinforce the decision not to change behaviour or bring about increased footwear adherence, with or without appearance management; d) Reality appraisal; A here and now appraisal of the personal benefit of footwear choice on emotional and physical wellbeing, with additional consideration to the preservation of therapeutic footwear. CONCLUSION: For some people living at risk of diabetic neuropathic foot ulceration, the decision whether or not to wear therapeutic footwear is driven by the individual 'here and now', risks and benefits, of footwear choice on emotional and physical well-being for a given social context

    Lifestyle and diet in relation to risk of type 2 diabetes in Vietnam: a hospital-based case-control study.

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    BACKGROUND: Lifestyle and diet are important determinants of type 2 diabetes (T2D). Their impact on T2D can be evaluated using clinical and epidemiological approaches. Randomised controlled trials are the most rigorous design but expensive to conduct, whereas prospective cohort studies are time-consuming and less powerful for populations with a low incidence of the disease. Case-control studies are considered appropriate in resource-limited settings. A hospital-based case-control study protocol has been developed to investigate the role of lifestyle and dietary factors in T2D aetiology for adults in Vietnam. METHODS: A total of 1100 patients aged 40-65 years (550 T2D cases and 550 controls) will be recruited from a tertiary hospital in Hanoi, the capital city of Vietnam. Cases and controls will be frequency-matched on age (±3 years), gender, and residential location. T2D will be diagnosed according to the 2006 World Health Organisation criteria. Habitual physical activity will be assessed by the Vietnamese version of the International Physical Activity Questionnaire-Short Form. Food and beverage consumption will be ascertained using a Validated Food Frequency Questionnaire, specifically developed for the Vietnamese population. Information on demographic and other personal characteristics will be collected, together with anthropometric and blood pressure measurements. Descriptive statistics and unconditional logistic regression analyses will be performed to examine factors associated with the T2D prevalence. DISCUSSION: The proposed study will elucidate the role of lifestyle and diet in T2D prevalence among Vietnamese adults. Findings concerning pertinent factors will provide epidemiological evidence for the development of focused interventions, and contribute to the formulation of national policies to prevent and control T2D in Vietnam
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