Clinical data collection

TM Thomas J. Marrie
GT Gregory J. Tyrrell
SM Sumit R. Majumdar
DE Dean T. Eurich
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Research nurses collected sociodemographic, clinical, functional, and laboratory data using a standardized case report form (CRF). The research nurses received training on data collection prior to the start of the study. In addition to the CRF, standard operating procedures documents, definitions, drug classification and underlying illness categorization were part of their working documents. With respect to underlying illnesses, if the attending physician recorded such an illness it was accepted as such for the purpose of the study. If there was no recording of an underlying illness, it was assumed that the illness was not present. Complete data capture was available for sociodemographic and functional status. Approximately 2% of patients were missing laboratory values (hemoglobin, white blood cell count, or platelets) from the no septic arthritis group exclusively and were otherwise excluded from analyses specific to those endpoints. This study received approval from the institutional research review committees of the Alberta Health Regions as well as the University of Alberta ethics review board.

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