Computerized System for Outcomes-Based Antiemetic Therapy in Children

Author:

Holdsworth Mark T1,Adams Val R2,Raisch Dennis W3,Wood Jim G4,Winter Stuart S5

Affiliation:

1. Mark T Holdsworth PharmD BCPS BCOP, Associate Professor, College of Pharmacy, University of New Mexico, Albuquerque, NM

2. Val R Adams PharmD, Assistant Professor, College of Pharmacy, University of Kentucky, Lexington, KY

3. Dennis W Raisch PhD, Associate Director, Veterans Affairs Cooperative Studies Program, Clinical Research Pharmacy Coordinating Center, Albuquerque

4. Jim G Wood PharmD BCOP, Senior Regional Medical Scientist, US Medical Affairs, Glaxo Wellcome, Research Triangle Park, NC

5. Stuart S Winter MD, Assistant Professor, Division of Pediatric Hematology/Oncology, School of Medicine, University of New Mexico

Abstract

OBJECTIVE: To introduce a computerized data collection system used for an outcomes-based approach to antiemetic therapy in children, and to present data collected with this system in support of a new antiemetic dosing regimen. METHODS: A validated nausea/vomiting survey was used to collect data on nausea severity (NSEV), vomiting severity (VSEV), daily activity interference (DAI), and the number of vomiting episodes. NSEV, VSEV, and DAI were rated as 0 = none to 3 = severe. All children and/or their parents were surveyed following the completion of each highly emetogenic chemotherapy regimen. This survey was computerized and transferred to a handheld data entry unit. Time and motion studies were performed to compare the time required to collect nausea/vomiting data and transfer the data to a computerized database with the handheld system versus traditional paper (manual) surveys. The handheld technology was used to collect survey data for children receiving a new antiemetic regimen (daily ondansetron and dexamethasone [OD]), which was then compared with data obtained with a previously employed regimen (thrice-daily ondansetron and daily methylprednisolone [OM]). Statistical analysis and a cost-effectiveness analysis (CEA) were performed to compare the two antiemetic regimens. RESULTS: The mean time required for total data entry with the manual system was 5.2 minutes per survey versus 2.4 minutes with the handheld technology (p = 0.0026). A total of 376 nausea/vomiting surveys in 78 children receiving the OM antiemetic regimen were compared with 153 surveys in 38 children treated with the OD regimen. The mean survey scores were as follows: NSEV (1.2 vs. 0.8), VSEV (1.0 vs. 0.7), DAI (1.0 vs. 0.7), and number of vomiting episodes (4.3 vs. 2.1) for OM and OD, respectively; all were significantly lower with the OD regimen (p < 0.05). The percentage of patients with complete control of nausea and vomiting (19.2% vs. 39.2%) and good control (55.6% vs. 65.4%) were significantly greater with the OD regimen (p < 0.05). The CEA revealed that the OD resulted in a reduction of approximately $31 per patient for good protection and a $258 reduction for complete protection from nausea and vomiting. CONCLUSIONS: A computerized outcomes-based system aided by handheld technology allowed for more prompt and efficient collection of nausea/vomiting data. The OD antiemetic regimen was shown to be a more cost-effective alternative for children receiving severely emetogenic chemotherapy.

Publisher

SAGE Publications

Subject

Pharmacology (medical)

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