Computerized system for outcomes-based antiemetic therapy in children

OBJECTIVE: To introduce a computerized data collection system used for an o utcomes-based approach to antiemetic therapy in children, and to present da ta collected with this system in support of a new antiemetic dosing regimen . METHODS: A validated nausea/vomiting survey was used to collect data on nau sea 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. Th is survey was-computerized and transferred to a handheld data entry unit. T ime and motion studies were performed to compare the time required to colle ct nausea/vomiting data and transfer the data to a computerized database wi th the handheld system versus traditional paper (manual) surveys. The handh eld technology was used to collect survey data for children receiving a new antiemetic regimen (daily ondansetron and dexamethasone [OD]), which was t hen 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 a ntiemetic 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 receiv ing 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), DA1 (1.0 vs. 0.7), and number of vomitin g episodes (4.3 vs. 2.1) for OM and OD, respectively; all were significantl y lower with the OD regimen (p < 0.05). The percentage of patients with com plete 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). T he CEA revealed that the OD resulted in a reduction of approximately $31 pe r patient for good protection and a $258 reduction for complete protection from nausea and vomiting. CONCLUSIONS: A computerized outcomes-based system aided by handheld technol ogy allowed for more prompt and efficient collection of nausea/vomiting dat a. The OD antiemetic regimen was shown to be a more cost-effective alternat ive for children receiving severely emetogenic chemotherapy.