CONTEXT AND OBJECTIVE: Clinical trial registration is a prerequisite for publication in respected scientific journals. Recent Brazilian regulations also require registration of some clinical trials in the Brazilian Clinical Trials Registry (ReBEC) but there is little information available about practical issues involved in the registration process. This article discusses the importance of clinical trial registration and the practical issues involved in this process. DESIGN AND SETTING: Descriptive study conducted by researchers within a postgraduate program at a public university in São Paulo, Brazil. METHODS: Information was obtained from clinical trial registry platforms, article reference lists and websites (last search: September 2014) on the following topics: definition of a clinical trial, history, purpose and importance of registry platforms, the information that should be registered and the registration process.
RESULTS: Clinical trial registration aims to avoid publication bias and is required by Brazilian journals indexed in LILACS and SciELO and by journals affiliated to the International Committee of Medical Journal Editors (ICMJE). Recent Brazilian regulations require that all clinical trials (phases I to IV) involving newdrugs to be marketed in this country must be registered in ReBEC. The pros and cons of using different clinical trial registration platforms are discussed. CONCLUSIONS: Clinical trial registration is important and various mechanisms to enforce its implementation now exist. Researchers should take into account national regulations and publication requirements when choosing the platform on which they will register their trial.
RESUMO
The aim of the study was to evaluate the frailty syndrome in residents of a Long-Term Care Facility for the Elderly. A cross-sectional study was carried out on 24 subjects over the age of 60 years. For the screening of frailty syndrome, the criteria of the Cardiovascular Study were used, which classifies the subjects into fragile, pre-fragile and non-fragile according to five criteria: decreased handgrip strength; self-reported fatigue; decrease in walking speed; unintentional weight loss; and low level of physical activity. The average age of the population studied was 81.13 years, with 54.20% being female. Among the elderly, 83.33% were frail, 12.50% were pre-frail and 4.17% were not frail. Elderly people over 80 years old had a higher incidence of frailty when compared to those aged 60 - 79 years, with 85.7% and 80%, respectively. Since 66.67% of the elderly had decreased handgrip muscle strength, 37.50% reported fatigue, 41.67% demonstrated decreased gait speed, 12.50% unintentional weight loss and 87.50% were physically inactive. We identified a high prevalence of DES among the elderly residing in the institution studied, thus reinforcing the importance of early screening for frailty in institutionalized elderly.
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