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There is evidence that HBOT reduces the risk of major amputation in diabetic patients. For venous, arterial or pressure ulcers there is a lack of data. Further trials may be warranted.
Premature infants have an increased risk of developing complicated respiratory syncytial virus (RSV) infections. Epidemiological data on RSV-related hospitalizations are a prerequisite to develop guidelines for the use of preventive measures. The objective of this study was to determine incidence and risk factors of RSV-related rehospitalizations (RSV-RH) of premature infants. We recruited 1,103 infants with a gestational age of less than 35 weeks, primarily admitted to nine neonatologic care units in southern Germany between Nov. 1, 1998 and Oct. 31, 1999. Questionnaires were sent to all parents of infants discharged from neonatal care units to determine the risk of rehospitalization for acute respiratory infections (ARI-RH) and RSV-RH in the 1999-2000 season. The questionnaire response rate was 68.4%. The 717 included infants of the responders had a mean gestational age of 31.6 weeks (Range: 23-35) and a mean birth weight of 1,747 g (range: 430-4,050 g). The risk for an ARI-RH was 10.6% and the risk for RSV-RH 5.2% during the observation period. Premature infants with chronic lung disease (CLD) had a probability of 24.5% for ARI-RH and of 15% for RSV-RH. The following factors were independently associated with an increased risk of RSV-RH: male gender (adjusted Odds-Ratio (OR): 8.7; 95% confidence interval (CI): 2.6-29.1), chronic lung disease (OR: 3.99; 95%CI: 1.4-11.2), discharge between October and December (OR: 2.1; 95%CI: 0.99-4.4), day-care attendance of siblings (OR: 3.9; 95%CI: 1.9-8.3). Conclusions: The risk for RSV rehospitalization among premature infants discharged from neonatal care facilities in southern Germany was low. Additional risk factors and high costs of prophylaxis have to be considered when infants are selected for RSV prophylaxis using monoclonal antibodies.Abbreviations RSV Respiratory syncytial virus AE ARI Acute respiratory infection AE RSV-RH Rehospitalization related to RSV infection AE ARI-RH Rehospitalization related to acute respiratory infection AE CLD Chronic lung disease AE OR Odds-Ratio AE 95% CI 95% confidence interval AE GA Gestational age AE NICU Neonatal intensive care unit AE PDA Patent ductus arteriosus IntroductionPremature infants have an increased risk of developing complicated respiratory syncytial virus (RSV) infections [11]. The reported risk of RSV rehospitalization (RSV-RH) in preterm infants after discharge from primary neonatal care ranges between 2.7% and 37% [5, 10, 15, Eur J Pediatr (2003) 162: 230-236
Using placebos in day-to-day practice is an ethical problem. This paper summarises the available epidemiological evidence to support this difficult decision. Based on these data we propose to differentiate between placebo and "knowledge framing". While the use of placebo should be confined to experimental settings in clinical trials, knowledge framing--which is only conceptually different from placebo--is a desired, expected and necessary component of any doctor-patient encounter. Examples from daily practice demonstrate both, the need to investigate the effects of knowledge framing and its impact on ethical, medical, economical and legal decisions.
Palivizumab (Synagis, MedImmune Inc./Abbott Laboratories) has been shown to reduce the number of respiratory syncytial virus (RSV)-related hospitalizations in premature infants. The cost-effectiveness ratio of this prophylaxis, however, has not been evaluated in the German health-care system to date. The aim of the study was to assess the costs and benefits of Palivizumab among premature infants £ 35 weeks with different risk factors. Projecting a societal perspective, we used decision analysis to compare the strategies of a prophylaxis with and without Palivizumab. Probabilities and costs of hospitalization were derived from a retrospective, population-based cohort study on 1,103 prematurely born infants primarily admitted to nine neonatologic care units in southern Germany between November 1998 and October 1999. Costs of prophylaxis were based on hospital sources. Efficacy of prophylaxis and estimates of RSV mortality were derived from the literature. Effectiveness was defined as the number of averted hospitalizations. The cost-effectiveness ratio of Palivizumab varied strongly among the different risk groups. While demonstrating no net cost savings related to RSV prophylaxis for any of the risk groups analyzed, Palivizumab showed the best cost-effectiveness ratio among male infants with chronic lung disease, discharge from primary neonatal care between October and December, and the presence of siblings visiting a day-care group. One averted hospitalization in this high-risk group was associated with costs of Euro 6,639 (number needed to treat (NNT): 4). For infants in other risk groups, the ratios varied from Euro 25,288 (NNT: 8) to Euro 204,684 (NNT: 54) per hospitalization averted. The costeffectiveness ratios were sensitive to varying assumptions about probabilities and costs of rehospitalization, efficacy, and costs of Palivizumab prophylaxis. Conclusions:The results of this cost-effectiveness analysis do not justify the widespread use of Palivizumab among preterm infants. Lowering the costs of prophylaxis would be the most direct way to improve the cost-effectiveness ratio of Palivizumab.Keywords Cost-effectiveness analysis AE Respiratory syncytial virus infections AE Premature infants AE Hospitalization AE PalivizumabAbbreviations RSV respiratory syncytial virus AE RSV-RH rehospitalization related to RSV infection AE CLD chronic lung disease AE NNT number needed to treat AE NICU neonatal intensive care unit AE 95%-CI 95%confidence intervals and RSV-related rehospitalization [3,4,11,12,13,15,16,17,31].
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