Clinically significant changes in nausea as measured on a visual analog scale
Study objective
Our objective is to determine the minimum clinically significant change in nausea as measured on a visual analog scale.
Methods
This was a prospective, descriptive, convenience sample study of consenting adults presenting to the emergency department with nausea, excluding intoxicated patients and those with mild nausea (measuring <30 mm on a visual analog scale). Patients rated their nausea severity on a 100-mm visual analog scale and reported whether their nausea was “a lot less,” “a little less,” “unchanged,” “a little more,” or “a lot more” compared with previous assessments. We defined the minimum clinically significant change as the mean difference in visual analog scale in patients reporting “a little less” or “a little more” nausea.
Results
Eighty-three paired visual analog scale measurements were collected from 50 patients. Fifty-eight percent of patients were women, and the mean age was 41 years. Mean changes in visual analog scale with corresponding qualitative descriptors were “a lot less” in 16 paired measurements (−42.2 mm; 95% confidence interval [CI] −54.9 to −29.5); “a little less” in 34 paired measurements (−15.4 mm; 95% CI −20.0 to −10.8); “no change” in 28 paired measurements (−0.4 mm; 95% CI −5.6 to 4.8); “a little more” in 2 paired measurements (16 mm; 95% CI −86 to 118); and “a lot more” in 3 paired measurements (23.7 mm; 95% CI −5.4 to 52.8). Patients reported “a little more” or “a little less” nausea in 36 paired measurements, with a mean change in visual analog scale of 15.4 mm (95% CI 11.0 to 19.8).
Conclusion
The minimum clinically significant visual analog scale change in nausea was 15 mm, which is similar to previous studies of other symptoms, and helps in the interpretation of clinical studies reporting changes in nausea.
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Author contributions: GWH conceived the study and designed the trial. GWH, NFD, and KF supervised the conduct of the trial and data collection. NFD and KF undertook recruitment of participating patients and managed the data, including quality control. GWH provided statistical advice and analyzed the data. GWH and NFD drafted the manuscript, and all authors contributed to its revision. GWH takes responsibility for the paper as a whole.Presented as an abstract at the Society of Academic Emergency Medicine annual meeting, May 2003, Boston, MA.The authors report this study did not receive any outside funding or support.Reprints not available from the authors.
PII: S0196-0644(04)01205-3
doi:10.1016/j.annemergmed.2004.07.446
© 2005 American College of Emergency Physicians. Published by Elsevier Inc. All rights reserved.
