1,721,419 research outputs found

    Haemoglobin targets: we were wrong, time to move on

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    BACKGROUND: The current 3rd edition of the Italian Society of Nephrology guidelines has been drawn up to summarize evidence of key intervention issues on the basis of systematic reviews (SR) of randomized trials (RCT) or RCT data only. In the present guideline, evidence of optimal haemoglobin (Hb) target levels in chronic kidney disease (CKD), either for pre-dialysis, dialysis or renal transplanted patients, is presented. METHODS: SR of RCT and RCT on different Hb target levels in patients with CKD were identified, referring to a Cochrane Library and Renal Health Library search (2005 update). Quality of SR and RCT was assessed according to current methodological standards. RESULTS: Four SR (19 RCT) were found addressing the point. Methodological quality of available trials was suboptimal. In CKD patients (non-dialysis patients) Hb targets of 11.3 g/dL should be preferred to Hb >13.5 g/dL (evidence from RCT). A Hb target of 11.0-11.5 g/dL should be preferred in CKD patients receiving dialysis treatment without significant cardiac disease, since no survival benefits has been showed with Hb >14 g/dL (evidence from RCT). The optimal Hb target in haemodialysis patients with severe cardiac disease should be 10.0-10.5 g/dL (evidence from SR). Increases in Hb target lev-els are associated with improved quality of life, although this was mainly noticed in observational studies and in few RCT often relying on unvalidated quality of life assessment scales. CONCLUSION: In CKD patients current available evidence supports the hypothesis that optimal Hb targets should be low to subnormal

    Formarsi all’obbedienza o all’autonomia? e come? [Education to autonomy or obedience? And how?]

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    The nurses' autonomy should be pursued and practiced at several levels: not only in practice but also in the way the knowledge is updated. Most of the initiatives and teaching-learning methods offered in basic and continuing education are more oriented to contents and techniques that to the development of a critical approach. A nursing approach should be oriented at focusing on the impact of interventions and techniques on patients problems and needs

    Clinical databases of patients receiving antidepressants: the missing link between research and practice?

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    Background: In the last 10 years the use of antidepressants has increased drastically. Unfortunately, the epidemiology of these compounds has shown significant gaps between recommendations derived from randomised controlled trials and current clinical practice. Methods: We argue for the need to develop and maintain clinical databases of patients receiving antidepressants as a way of bridging this situation. Results: In addition to experimental data generated in selected patients and settings, observational databases of large cohorts of typical patients, followed in typical settings, should be developed and maintained. Clinical databases could collect information on patient social and demographic characteristics, clinical symptoms, diagnosis and pharmacological and non-pharmacological treatments. In addition, they can provide accurate estimates of probabilities of different outcomes and on factors that affect outcome. Conclusion: Clinical databases should not be seen as another expensive administrative task for busy doctors. Clinical databases should be developed, organised and utilised only by clinicians who are interested in monitoring their clinical practice and want to provide patients, relatives and the public with information on prognosis and outcome in their specific context of care. Maintaining clinical databases is a routine process, nested in everyday clinical activity, which aims at constituting a permanent link between research and practice. © 2002 Elsevier Science B.V. All rights reserved

    PHARMACOSURVEILLANCE AND QUALITY OF CARE OF THALASSAEMIC PATIENTS: A LARGE SCALE EPIDEMIOLOGICAL SURVEY.

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    bjective: For adolescent thalassaemic patients, parenteral iron-chelation therapy is still a burden and a major reason for unsatisfactory compliance. The introduction of a new pharmaceutical preparation of deferoxamine (Desferal) claimed to be better tolerated was accompanied by an epidemiological study on the quality of care and life of the Italian thalassaemic population and on the acceptability and safety profile of the new preparation compared with the old one. Methods: This was a two-period prospective survey of 867 patients (12% of the registered thalassaemic patient population) in a sample of centres representative of the different contexts of care.Conclusion: While oral chelation therapies are still under evaluation, the overall quality of care and perceived quality of life of a representative sample of the Italian population of thalassaemic patients show that room for improvement depends more on the contexts of life and care than on strictly medical conditions. Comprehensive epidemiological surveillance is needed as a routine component of the care of this highly morbidity-burdened population to ensure timely appreciation of unmet needs and to assess the yield of innovative treatment schedules

    Clozapine-treated subjects with treatment-resistant schizophrenia: a systematic review of experimental and observational studies

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    Randomized clinical trials have limitations because they focus on small samples of highly selected patients. Observational studies, which follow large cohorts of typical patients receiving pharmacological treatments, should overcome some of these trial limitations and provide information that cannot be generated with clinical trials. The present study aimed to compare experimental and observational studies of clozapine-treated subjects with treatment-resistant schizophrenia. A systematic review of experimental and observational studies evaluating clozapine-treated subjects in treatment-resistant schizophrenia was carried out. We identified 50 studies that met the inclusion criteria. Less than one-third of clinical trials enrolled more than 50 patients compared to 44% of prospective and nearly 90% of retrospective studies. In addition, 78% of prospective and 89% of retrospective observational studies lasted more than 12 weeks, while the majority of trials lasted less than 8 weeks. Most clinical trials defined treatment-resistant schizophrenia according to Kane's criteria, while the majority of observational studies adopted implicit criteria. In comparison with clinical trials, observational studies provided a higher weighted mean rate of clozapine-responders and a lower weighted mean rate of clozapine-dropouts. This literature survey suggests that the role of observational studies in the evaluation of medicines should be reconsidered. A new generation of observational studies should be developed to provide evidence on patient outcome in typical settings and under real-world circumstances, and on variables which may affect outcome
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