Objectives: The objective was to investigate the correlation of the visual analog scale (VAS) and numeric rating scale (NRS) for nausea severity measurement and to explore options for improved reporting of antiemetic efficacy trial results.Methods: This was a multicenter observational study of adult emergency department (ED) patients with nausea. Participants rated severity at enrollment and 30 minutes posttreatment using an adjectival scale, a VAS, and an NRS. Posttreatment, patients described symptom change and rated satisfaction.Results: Ratings were performed by 258 patients. Both the VAS (0 to 100 mm) and the NRS (0 to 10) discriminated between adjectival severity categories. Median ratings with interquartile ranges (IQRs) were "severe" VAS 90.5 (IQR = 79 to 97) and NRS 9 (IQR = 8 to 9), "moderate" VAS 59 (IQR = 48 to 71) and NRS 6 (IQR = 5 to 7), "mild" VAS 34 (IQR = 25 to 49) and NRS 4 (IQR = 3 to 5), and "none" VAS 5 (IQR = 0 to 9) and NRS 0 (IQR = 0 to 1). Correlation between the VAS and NRS was high (0.83, Spearman). For the VAS, median mm (IQR) reductions for posttreatment change were "a lot less" -42 (IQR = -26 to -58.5), "a little less" -20.5 (IQR = -11 to -33), "the same" -2 (IQR = -8 to 3.5), "a little more" 14 (IQR = -2 to 22), and "a lot more" 17 (IQR = 6 to 23) and for satisfaction were "very satisfied" -45 (IQR = -27 to 63), "satisfied" -27 (IQR = -13 to 46), "unsure" -15 (IQR = -3 to -24), "dissatisfied" 4.5 (IQR = -5.5 to 13.5), and "very dissatisfied" 8.5 (IQR = 0 to 23). A VAS cutoff of ≥-5 mm detected symptom improvement with sensitivity 91.6% (95% CI = 86.7% to 95.1%), specificity 72.1% (95% CI = 59.9% to 82.3%), and positive predictive value 90.2% (95% CI = 85.1% to 94.0%).
Conclusions:The VAS and NRS correlate highly. A VAS cutoff level of ≥-5 mm was a good predictor of symptom improvement, suggesting that its inclusion as an outcome measure would enhance reporting in antiemetic efficacy trials.ACADEMIC EMERGENCY MEDICINE 2015;22:685-693
Objective: The objective was to separately compare effectiveness of 1.25 mg of intravenous (IV) droperidol and 8 mg of IV ondansetron with 0.9% saline placebo for adult emergency department (ED) patients with nausea. A novel primary outcome measure, expected to aid clinical interpretation of reported results, was employed.Methods: A randomized controlled trial was conducted at the three EDs of Monash Health, Melbourne, Australia. The design was to demonstrate superiority of the active drugs over placebo. The primary outcome measure of symptom improvement was defined as a visual analog scale (VAS) rating change of -8 mm or more from baseline at 30 minutes posttreatment. Mean VAS changes per group and percentages experiencing the desired treatment effect were also compared. The study was concluded after recruitment of 215 of the planned 378 patients, as interim analysis confirmed that continuation could not result in a finding of superiority.Results: Of 215 patients, 73 (34%), 71 (33%), and 71 (33%) received droperidol, ondansetron, and placebo.Symptom improvement occurred in 75% (95% confidence interval [CI] = 64% to 85%), 80% (95% CI = 69% to 89%), and 76% (95% CI = 64% to 85%), respectively. Mean VAS changes were -29 mm (95% CI = -36 to -23 mm), -34 mm (95% CI = -41 to -28 mm), and -24 mm (95% CI = -29 to -19 mm), respectively. Desired treatment effects were experienced by 77% (95% CI = 65% to 86%), 73% (95% CI = 61% to 83%), and 59% (95% CI = 47% to 71%), respectively.
Conclusion:For adult ED patients with nausea, superiority was not demonstrated for droperidol or ondansetron over placebo.
Fellows of the Australasian College for Emergency Medicine anti-emetic choice in Australasian ED has been described. The main influences on anti-emetic choice were patient age, perceived drug efficacy and drug side-effect profiles.
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