RESUMO
Alex McMahon and colleagues critique the International Conference on Harmonisation (ICH) guidance on good clinical practice (GCP), arguing that it is having a disastrous effect on noncommerical randomized clinical trials in Europe.
Assuntos
Ensaios Clínicos como Assunto/legislação & jurisprudência , Medicina Baseada em Evidências/legislação & jurisprudência , Regulamentação Governamental , Guias de Prática Clínica como Assunto/normas , Ensaios Clínicos como Assunto/economia , Ensaios Clínicos como Assunto/normas , Congressos como Assunto , Aprovação de Drogas/economia , Aprovação de Drogas/legislação & jurisprudência , Indústria Farmacêutica/economia , Indústria Farmacêutica/legislação & jurisprudência , Europa (Continente) , Medicina Baseada em Evidências/economia , Medicina Baseada em Evidências/normas , HumanosAssuntos
Prescrições de Medicamentos , Educação Médica/organização & administração , Farmacologia Clínica , Medicina Estatal/organização & administração , Necessidades e Demandas de Serviços de Saúde , Humanos , Farmacologia Clínica/educação , Farmacologia Clínica/organização & administração , Sociedades Científicas , Reino UnidoRESUMO
BACKGROUND AND PURPOSE: Markers of low socioeconomic status (deprivation) are associated with stroke and its causes. In the United Kingdom, area-based deprivation measures are available routinely through links with postal codes. We hypothesized that deprivation is associated with ischemic stroke risk factors, severity, subtype, and outcome. METHODS: We studied 2026 patients, each with at least 2 years of outcome follow-up by record linkage after first admission with ischemic stroke to an acute stroke unit. Baseline factors recorded routinely were age, sex, medical history, blood pressure, and stroke severity and subtype. Deprivation was assessed by the Womersley score (WS) and Murray score (MS). RESULTS: Higher WS and MS were associated with stroke at younger age (eg, WS linear regression coefficient (r)=-0.26; 95% confidence interval [CI], -0.51 to -0.01 per additional point), smoking (odds ratio [OR], 1.12; 95% CI, 1.08 to 1.17), and claudication (OR, 1.09; 95% CI, 1.01 to 1.17); WS was associated with higher systolic blood pressure (r=0.13; 95% CI, 0.02 to 0.24); and MS was associated with severe stroke. Deprivation was not associated with case fatality in univariate analysis or after correction for all baseline factors. Deprivation was associated with readmission to hospital as a result of any vascular event in univariate analysis (hazard ratio [HR], 1.05; 95% CI, 1.02 to 1.09) and after correction for all baseline factors (HR, 1.06; 95% CI, 1.02 to 1.10). CONCLUSIONS: Tackling health inequalities in stroke should focus on stroke primary prevention by tackling deprivation, including promoting changes in lifestyle.
