المؤلفون: Curtis, Melissa D., Griffith, Sandra D., Tucker, Melisa, Taylor, Michael D., Capra, William B., Carrigan, Gillis, Holzman, Ben, Torres, Aracelis Z., You, Paul, Arnieri, Brandon, Abernethy, Amy P.

المصدر: Health Services Research; Dec2018, Vol. 53 Issue 6, p4460-4476, 17p, 3 Charts, 2 Graphs

مصطلحات موضوعية: ELECTRONIC health records, CLINICAL trials, HOSPITAL admission & discharge, MORTALITY, MEDICAL care, COMPARATIVE studies, DATABASES, RESEARCH methodology, MEDICAL cooperation, ONCOLOGY, RESEARCH, TUMORS, EVALUATION research

مصطلحات جغرافية: UNITED States

مستخلص: Objective: To create a high-quality electronic health record (EHR)-derived mortality dataset for retrospective and prospective real-world evidence generation.Data Sources/study Setting: Oncology EHR data, supplemented with external commercial and US Social Security Death Index data, benchmarked to the National Death Index (NDI).Study Design: We developed a recent, linkable, high-quality mortality variable amalgamated from multiple data sources to supplement EHR data, benchmarked against the highest completeness U.S. mortality data, the NDI. Data quality of the mortality variable version 2.0 is reported here.Principal Findings: For advanced non-small-cell lung cancer, sensitivity of mortality information improved from 66 percent in EHR structured data to 91 percent in the composite dataset, with high date agreement compared to the NDI. For advanced melanoma, metastatic colorectal cancer, and metastatic breast cancer, sensitivity of the final variable was 85 to 88 percent. Kaplan-Meier survival analyses showed that improving mortality data completeness minimized overestimation of survival relative to NDI-based estimates.Conclusions: For EHR-derived data to yield reliable real-world evidence, it needs to be of known and sufficiently high quality. Considering the impact of mortality data completeness on survival endpoints, we highlight the importance of data quality assessment and advocate benchmarking to the NDI. [ABSTRACT FROM AUTHOR]

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المؤلفون: Capra, William B.¹ william_capra@chiron.com

المصدر: Controlled Clinical Trials. Apr2004, Vol. 25 Issue 2, p168. 10p.

مصطلحات موضوعية: *EXPERIMENTAL design, *CLINICAL trials, *WEIBULL distribution, *DISTRIBUTION (Probability theory), *PROGNOSIS

مستخلص: The discontinuation design has been proposed as an alternative to the classic randomized design for evaluating the effect of an experimental agent on time-to-disease progression and survival duration. With this design, all enrolled patients are treated with an experimental agent for a fixed course of therapy. Those patients with progressive disease at or before the end of this fixed period are removed from trial while those with stable disease or better are randomized to continued treatment with the experimental agent or standard of care. Simulations presented in this paper demonstrate that for realistic situations, the loss in information on patients enrolled but not randomized in the discontinuation design is of sufficient magnitude that it is underpowered as compared to the classic design of randomizing all enrolled subjects. [Copyright &y& Elsevier]