Methods of information in medicine
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Sampling from a large cohort in order to derive a subsample that would be sufficient for statistical analysis is a frequently used method for handling large data sets in epidemiological studies with limited resources for exposure measurement. For clinical studies however, when interest is in the influence of a potential risk factor, cohort studies are often the first choice with all individuals entering the analysis. ⋯ Nested case-control and case-cohort studies, but not random subsamples yield an attractive alternative for analyzing clinical studies in the situation of a low event rate. Power calculations can be conducted straightforwardly to quantify the loss of power compared to the savings in the num-ber of patients using a sampling design instead of analyzing the full cohort.
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In China, deployment of electronic data capture (EDC) and clinical data management system (CDMS) for clinical research (CR) is in its very early stage, and about 90% of clinical studies collected and submitted clinical data manually. This work aims to build an open metadata schema for Prospective Clinical Research (openPCR) in China based on openEHR archetypes, in order to help Chinese researchers easily create specific data entry templates for registration, study design and clinical data collection. ⋯ OpenPCR is an open metadata schema based on research registration standards, standards of the Clinical Data Interchange Standards Consortium (CDISC) and Chinese healthcare related standards, and is to be publicly available throughout China. It considers future integration of EHR and CR by adopting data structure and data terms in Chinese EHR Standard. Archetypes in openPCR are modularity models and can be separated, recombined, and reused. The authors recommend that the method to develop openPCR can be referenced by other countries when designing metadata schema of clinical research. In the next steps, openPCR should be used in a number of CR projects to test its applicability and to continuously improve its coverage. Besides, metadata schema for research protocol can be developed to structurize and standardize protocol, and syntactical interoperability of openPCR with other related standards can be considered.
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The World Health Assembly (WHA) of the World Health Organization (WHO) and three of the six WHO Regional Committees adopted a number of resolutions on eHealth: the use of information and communication technology for health. These resolutions have given legitimacy to eHealth as an area of work for WHO and its member states. The implementation of these resolutions will contribute to the achievement of the Millennium Development Goals (MDGs) and the Universal Health Coverage. eHealth has been perceived as reducing the cost of healthcare, improving quality and equitable access to health services.
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Comparative Study
Location tests for biomarker studies: a comparison using simulations for the two-sample case.
Gene, protein, or metabolite expression levels are often non-normally distributed, heavy tailed and contain outliers. Standard statistical approaches may fail as location tests in this situation. ⋯ The standard U-test was a powerful and robust location test for most of the simulated scenarios except for very heavy tailed or heavy skewed data, and it is thus to be recommended except for these cases. The non-parametric adaptive tests were powerful for both normal and non-normal distributions under sample variance homogeneity. But when sample variances differed, they did not keep the type I error level. The parametric adaptive test lacks power for skewed and heavy tailed distributions.
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Comparative Study Observational Study
Caregivers' time utilization before and after the introduction of an electronic nursing documentation system in a residential aged care facility.
Despite increasing research on caregivers' interaction with technology, there has been no attempt to investigate how the introduction of an electronic system in a residential aged care facility (RACF) may affect caregivers' use of their time. ⋯ It may take over a year for some caregivers in an RACF to integrate the use of a newly introduced electronic documentation system into their daily work. Organisations implementing such systems should develop strategies that support and accelerate the caregivers' integration of the new documentation practice into their routine activities. The electronic documentation system may not however, replace the role of verbal communication between caregivers in aged care service.