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CAPTURING RESEARCH DATA AT POINT OF CARE: ELECTRONIC RESEARCH. Pamela
Roberts, RN, MSN, Vanderbilt-Ingram Cancer Center, Nashville, TN.
Capturing accurate toxicity data in a timely manner is an ongoing challenge
in the clinical trials arena. A group of research nurses at a large clinical
trials office attempted to solve this dilemma by creating a standardized
paper toxicity assessment form. This development was further improved
by the creation of an electronic version of this form, The Universal Toxicity
Database (UTdb). The UTdb allows collection of research data at point
of care.
The process begins when a research nurse initiates a patient visit electronically
by entering all toxicities and medications for a particular visit. Toxicity
information is standardized in drop-down choice sets from the NCI Common
Toxicity Criteria. Toxicities and medications without stop dates are rolled
forward for subsequent visits. Each entry is stored in a relational database
and then printed as a visit summary in text format to the patient’s
electronic medical record within one hour.
The outcomes were observed as follows: The UTdb promotes better assessment
and collection of toxicities in the research setting for several reasons.
The roll-forward feature saves time and prevents error in transcription,
ensures follow-up of all previously reported toxicities, and promotes
continuity of care for cross-coverage. Point-of-care data collection,
standardization, and relational storage allow immediate data extracts.
These extracts are beneficial for safety concerns, recognition of toxicity
trends across studies utilizing the same drug, dose changes for phase
I studies, and abstract information for papers. Printing this information
to the electronic medical record allows faster access to clinical data
for all concerned in patient care and a more timely completion of study
case report forms.
Because the system has been so successful, future plans are to implement
Web- and palm-based versions to further support the effort toward a paperless
system and for greater portability.
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