Harmonization of detailed clinical models with clinical study data standards.

INTRODUCTION: This article is part of the Focus Theme of METHODS of Information in Medicine on "Managing Interoperability and Complexity in Health Systems". BACKGROUND: Data sharing and integration between the clinical research data management system and the electronic health record system remains a challenging issue. To approach the issue, there is emerging interest in utilizing the Detailed Clinical Model (DCM) approach across a variety of contexts. The Intermountain Healthcare Clinical Element Models (CEMs) have been adopted by the Office of the National Coordinator awarded Strategic Health IT Advanced Research Projects for normalization (SHARPn) project for normalizing patient data from the electronic health records (EHR). OBJECTIVE: The objective of the present study is to describe our preliminary efforts toward harmonization of the SHARPn CEMs with CDISC (Clinical Data Interchange Standards Consortium) clinical study data standards. METHODS: We were focused on three generic domains: demographics, lab tests, and medications. We performed a panel review on each data element extracted from the CDISC templates and SHARPn CEMs. RESULTS: We have identified a set of data elements that are common to the context of both clinical study and broad secondary use of EHR data and discussed outstanding harmonization issues. CONCLUSIONS: We consider that the outcomes would be useful for defining new requirements for the DCM modeling community and ultimately facilitating the semantic interoperability between systems for both clinical study and broad secondary use domains.

Acute massive hydrothorax complicating peritoneal dialysis, report of 2 cases and a review of the literature.

Acute massive right-sided hydrothorax is a relatively rare but serious complication of peritoneal dialysis and may be responsible for the development of dyspnea during peritoneal dialysis. The pleural fluid appears to arise from the peritoneal dialyzate based on the time of its appearance and its chemical composition. It should be included in the differential diagnosis when a patient becomes dyspneic during peritoneal dialysis along with exaccerbation of congestive heart failure, pneumonia, atelectasis, and purulent bronchitis. Its occurrence is an indication to stop the peritoneal dialysis and contraindicates further use of this form of dialysis. Treatment may be conservative or aggressive (thoracentesis) depending on the clinical condition of the patient. Etiology is poorly understood. In some cases, there may be traumatic diaphragmatic fenestrations, but the majority of cases appear to be due to less well defined communications between the peritoneal and pleural spaces.

Respiratory function and symptoms in urban office workers in relation to oxidant air pollution exposure.

Similar populations of male and female office workers in San Francisco, which has little air pollution, and in Los Angeles, which experiences frequent photochemical smog episodes, were surveyed in an attempt to document excess respiratory symptoms and dysfunction in Los Angeles relatable to air pollution. Most results of forced expiratory tests, single-breath N2 tests, and questionnaire interviews did not differ significantly between cities. Los Angeles women reported nonpersistent cough and phlegm more often than did San Francisco women. Smokers in both cities showed increased functional abnormalities. These results suggested that Los Angeles oxidant exposure is far less significant than smoking as a risk factor in development of chronic respiratory disease in sedentary indoor workers in good general health. Oxidant exposure has not been ruled out as a significant risk to more heavily exposed on more highly susceptible persons.