RESUMO
BACKGROUND: The National Institutes of Health has advocated for improved minority participation in clinical research, including clinical trials and observational epidemiologic studies since 1993. An understanding of Mexican Americans (MAs) participation in clinical research is important for tailoring recruitment strategies and enrollment techniques for MAs. However, contemporary data on MA participation in observational clinical stroke studies are rare. We examined differences between Mexican Americans (MAs) and non-Hispanic whites (NHWs) participation in a population-based stroke study. METHODS: We included 3,594 first ever stroke patients (57.7% MAs, 48.7% women, median [IQR] age 68 [58-79]) from the Brain Attack Surveillance in Corpus Christi Project, 2009-2020 in Texas, USA, who were approached and invited to participate in a structured baseline interview. We defined participation as completing a baseline interview by patient or proxy. We used log-binomial models adjusting for prespecified potential confounders to estimate prevalence ratios (PR) of participation comparing MAs with NHWs. We tested interactions of ethnicity with age or sex to examine potential effect modification in the ethnic differences in participation. We also included an interaction between year and ethnicity to examine ethnic-specific temporal trends in participation. RESULTS: Baseline participation was 77.0% in MAs and 64.2% in NHWs (Prevalence Ratio [PR] 1.20; 95% CI, 1.14-1.25). The ethnic difference remained after multivariable adjustment (1.17; 1.12-1.23), with no evidence of significant effect modification by age or sex (Pinteraction by age = 0.68, Pinteraction by sex = 0.83). Participation increased over time for both ethnic groups (Ptrend < 0.0001), but the differences in participation between MAs and NHWs remained significantly different throughout the 11-year time period. CONCLUSION: MAs were persistently more likely to participate in a population-based stroke study in a predominantly MA community despite limited outreach efforts towards MAs during study enrollment. This finding holds hope for future research studies to be inclusive of the MA population.
Assuntos
Estudos Clínicos como Assunto , Americanos Mexicanos , Acidente Vascular Cerebral , Brancos , Idoso , Feminino , Humanos , Masculino , Etnicidade , Americanos Mexicanos/estatística & dados numéricos , Fatores de Risco , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/etnologia , Texas/epidemiologia , Brancos/estatística & dados numéricos , População Branca , Estudos Clínicos como Assunto/estatística & dados numéricos , Seleção de Pacientes , Pessoa de Meia-Idade , Participação do Paciente/estatística & dados numéricosRESUMO
While several standards for metadata describing clinical studies exist, comprehensive metadata to support traceability of data from clinical studies has not been articulated. We examine uses of metadata in clinical studies. We examine and enumerate seven sources of data value-level metadata in clinical studies inclusive of research designs across the spectrum of the National Institutes of Health definition of clinical research. The sources of metadata inform categorization in terms of metadata describing the origin of a data value, the definition of a data value, and operations to which the data value was subjected. The latter is further categorized into information about changes to a data value, movement of a data value, retrieval of a data value, and data quality checks, constraints or assessments to which the data value was subjected. The implications of tracking and managing data value-level metadata are explored.
Assuntos
Estudos Clínicos como Assunto/estatística & dados numéricos , Confiabilidade dos Dados , Metadados , Humanos , National Institutes of Health (U.S.) , Estados UnidosRESUMO
La aproximación del médico práctico a la literatura científica no es sencilla. No hemos tenido una formación sistemática en tal sentido, y la disponibilidad de la literatura, que en una época pasada era muy dificultosa, ha evolucionado a una abundancia de publicaciones muy difícil de abarcar, llegando en muchas ocasiones a saturarnos de información, la cual no siempre nos resulta útil en su totalidad. Este trabajo está orientado a compartir una forma de leer los trabajos científicos para extraer información que pueda ser útil en la práctica clínica, a través de una serie de preguntas que debemos de formularnos al tener de frente una publicación científica, logrando analizar de forma secuencial la validez interna del estudio, evaluar los resultados, y determinar la aplicabilidad del mismo a la práctica clínica diaria...(AU)