In a previous study, we reported the results of an early language screening program in which 306 children were screened using a parent-report questionnaire sent through the mail (Klee et al., 1998). A sample of the children screened were given clinical evaluations within a month of screening (n = 64) and again 1 year later (n = 36). Although the screening program correctly identified 91% of 2-year-olds with language delay, it produced a large number of over-referrals. In the present study we examine a revised screening criterion designed to reduce the number of false positives. The revised criterion generated fewer positive screens overall than the original and resulted in improved specificity (96% vs. 87%) and positive predictive value (77% vs. 51%), while maintaining the high sensitivity (91%) and negative predictive value (98%) of the original criterion. We also propose a screening score based on the new criterion, designed to inform the process of deciding which children to bring in for further evaluation.
Anxiety is an important comorbidity in chronic obstructive pulmonary disease (COPD). We investigated if cognitive behavioural therapy (CBT), delivered by respiratory nurses, reduced symptoms of anxiety and was cost-effective.Patients with COPD and anxiety were randomised to CBT or self-help leaflets. Anxiety, depression and quality of life were measured at baseline, 3, 6 and 12 months. A cost-effectiveness analysis was conducted from a National Health Service hospital perspective and quality-adjusted life-years estimated using the EuroQol-5D questionnaire.In total, 279 patients were recruited. Group mean change from baseline to 3 months in the Hospital Anxiety and Depression Anxiety Subscale was 3.4 (95% CI 2.62–4.17, p<0.001) for the CBT group and 1.88 (95% CI 1.19–2.55, p<0.001) in the leaflet group. The CBT group was superior to leaflets at 3 months (mean difference in the Hospital Anxiety and Depression Anxiety Subscale was 1.52, 95% CI 0.49–2.54, p=0.003). Importantly, the CBT intervention was more cost-effective than leaflets at 12 months, significantly lowering hospital admissions and attendance at emergency departments.CBT delivered by respiratory nurses is a clinically and cost-effective treatment for anxiety in patients with COPD relative to self-help leaflets.
GMP facilities successfully developing ATMPs are present in all MS. However, the implementation of regulations is heterogeneous between MS, with substantial differences in the definition of ATMPs and in the approved manufacturing environment. The cost of GMP compliance is underestimated by research funding bodies. This is detrimental to development of new ATMPs and commercialization of any that are successful in early clinical trials. Academic GMP practitioners should strengthen their political visibility and contribute to the development of functional and effective European Union legislation in this field.
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