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Methodological issues in the design and analyses of neonatal research studies: Experience of the NICHD Neonatal Research Network.

ABSTRACT: Impressive advances in neonatology have occurred over the 30 years of life of The Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network (NRN). However, substantial room for improvement remains in investigating and further developing the evidence base for improving outcomes among the extremely premature. We discuss some of the specific methodological challenges in the statistical design and analysis of randomized trials and observational studies in this population. Challenges faced by the NRN include designing trials for unusual or rare outcomes, accounting for and explaining center variations, identifying other subgroup differences, and balancing safety and efficacy concerns between short-term hospital outcomes and longer-term neurodevelopmental outcomes. In conclusion, the constellation of unique patient characteristics in neonates calls for broad understanding and careful consideration of the issues identified in this article for conducting rigorous studies in this population.

SUBMITTER: Das A

PROVIDER: S-EPMC5065743 | biostudies-other | 2016 Oct

REPOSITORIES: biostudies-other

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Methodological issues in the design and analyses of neonatal research studies: Experience of the NICHD Neonatal Research Network.

Das Abhik A Tyson Jon J Pedroza Claudia C Schmidt Barbara B Gantz Marie M Wallace Dennis D Truog William E WE Higgins Rosemary D RD

Seminars in perinatology 20160622 6

Impressive advances in neonatology have occurred over the 30 years of life of The Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network (NRN). However, substantial room for improvement remains in investigating and further developing the evidence base for improving outcomes among the extremely premature. We discuss some of the specific methodological challenges in the statistical design and analysis of randomized trials and observational studies ...[more]

PMID: 27344192

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Project description:ObjectivesThe purpose of this study is to provide an updated systematic review to identify studies describing the prevalence of psychosis in order to explore methodological factors that could account for the variation in prevalence estimates.MethodsStudies with original data related to the prevalence of psychosis (published between 1990 and 2015) were identified via searching electronic databases and reviewing manual citations. Prevalence estimates were sorted according to prevalence type (point, 12-months and lifetime). The independent association between key methodological variables and the mean effect of prevalence was examined (prevalence type, case-finding setting, method of confirming diagnosis, international classification of diseases, diagnosis category, and study quality) by meta-analytical techniques and random-effects meta-regression.ResultsSeventy-three primary studies were included, providing a total of 101 estimates of prevalence rates of psychosis. Across these studies, the pooled median point and 12-month prevalence for persons was 3.89 and 4.03 per 1000 respectively; and the median lifetime prevalence was 7.49 per 1000. The result of the random-effects meta-regression analysis revealed a significant effect for the prevalence type, with higher rates of lifetime prevalence than 12-month prevalence (p<0.001). Studies conducted in the general population presented higher prevalence rates than those carried out in populations attended in health/social services (p = 0.006). Compared to the diagnosis of schizophrenia only, prevalence rates were higher in the probable psychotic disorder (p = 0.022) and non-affective psychosis (p = 0.009). Finally, a higher study quality is associated with a lower estimated prevalence of psychotic disorders (p<0.001).ConclusionsThis systematic review provides a comprehensive comparison of methodologies used in studies of the prevalence of psychosis, which can provide insightful information for future epidemiological studies in adopting the most relevant methodological approach.

Dataset Information

Methodological issues in the design and analyses of neonatal research studies: Experience of the NICHD Neonatal Research Network.

Publications

Methodological issues in the design and analyses of neonatal research studies: Experience of the NICHD Neonatal Research Network.

Similar Datasets

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