Understanding enterprise data warehouses to support clinical and translational research

Objectives: At the National Institutes of Health Clinical and Translational Science Award (CTSA) hub, the adoption of electronic data warehouse for research (EDW4R) which contains data from electronic health records systems almost everywhere. Although the benefits EDW4R including support more effective, efficient scientists, little is known about how the CTSA hub has implemented EDW4R services. The purpose of this qualitative study was to understand the ways in which CTSA EDW4R hub has been operationalized to support clinical and translational researchers.


Materials and methods: After conducting semi-structured interviews with leaders of the 20 hubs CTSA informatics, we perform content analysis of interview transcripts informed directed by naturalistic inquiry.


Results: We identified 12 themes: organization and data; oversight and governance; A data access request process; access modalities of the data; data access for users with different skill sets; engagement, communication, and literacy; coordinated service management with information technology companies; coordinated service management in CTSA hub; service management coordinated between informatics and biostatistics; funding approach; performance metrics; and future trends and challenges of today’s technology.


Discussion: This study is a step in developing a better understanding and create a common vocabulary about EDW4R operations throughout the institution. The findings suggest an opportunity to establish best practices for the operation EDW4R in academic medicine. The guidance can reduce the costs associated with developing EDW4R by establishing a roadmap and a clear maturity path for agencies to follow.


Conclusion: CTSA hub described various approaches to surgery EDW4R that can help other institutions in better serving researchers with electronic patient data.

Assessment of the Regulatory Dialogue Between Pharmaceutical Companies and the European Medicines Agency on the Choice of Noninferiority Margins
Assessment of the Regulatory Dialogue Between Pharmaceutical Companies and the European Medicines Agency on the Choice of Noninferiority Margins

Analysis of the data count in the setting of cervical cancer detection

Women with abnormal Pap smear is often called a colposcopy, a procedure in which an endocervical curettage (ECC) can be performed. ECC is erode the endocervical canal. Our aim was to compare the performance of the naive Poisson regression model (NP) with the model of zero-inflated Poisson (ZIP) when identifying predictors of the number of distress vocalization / pain made by women undergoing ECC.

Data on women seen at colposcopy clinics in a medical school in El Paso, Texas, were analyzed. The result is the number of vocalizations made by the patient’s pain during the ECC. Six dichotomous predictors evaluated. Initially, NP regression is used to model the data. Most of the patients do not make any vocalizations, and therefore ZIP models also fit and relative levels (RR) and 95% CI were calculated.

AIC is used to identify the best model (NP or ZIP). Of the 210 women, 154 (73.3%) have a value of 0 for the number of vocalizations ECC. NP identified three statistically significant predictors (subject language preferences, sexual harassment and a long history of colposcopy), whereas ZIP identify one: a history of sexual abuse (yes vs. no; adjusted RR = 2.70, 95% CI 1.47 to 4, 97). ZIP preferably NP. ZIP done better than NP regression. Doctors and epidemiologists should consider using ZIP models (or models of zero-inflated negative binomial) for data on the number of zero-inflated.

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Coronavirus disease-19 (COVID-19) has quickly spread to over 200 countries around the world, who face challenges in controlling its spread. The Italian government initiated public health interventions unprecedented to contain the epidemic by closing all movements of people. Two weeks after the start of the lockdown, a daily rate of hospital admissions was significantly decreased.