SODA (severity of dyspepsia assessment): A new effective outcome measure for dyspepsia-related health

The aim of this research was to develop and evaluate an instrument fur meas uring dyspepsia-related health to serve as the primary outcome measure for randomized clinical trials. Building on our previous work we developed SODA (Severity of Dyspepsia Assessment), a multidimensional dyspepsia measure. We evaluated SODA by administering it at enrollment and seven follow-up vis its to 98 patients with dyspepsia who were randomized to a 6-week course of omeprazole versus placebo and followed over 1 year. The mean age was 53 ye ars, and six patients (6%) were women. Median Cronbach's alpha reliability estimates over the eight visits for the SODA Pain Intensity, Non-Pain Sympt oms. and Satisfaction scales were 0.97, 0.90, and 0.92. respectively. The m ean change scores for all three scales discriminated between patients who r eported they were improved versus those who were unchanged, providing evide nce of validity. The effect sizes for the Pain intensity (.98) and Satisfac tion (.87) scales were large, providing evidence for responsiveness. The ef fect size for the Non-Pain Symptoms scale was small(.24). indicating lower responsiveness in this study sample. SODA is a new. effective instrument fo r measuring dyspepsia-related health. SODA is multidimensional and responsi ve to clinically meaningful change with demonstrated reliability and validi ty. (C) 2001 Elsevier Science Inc. All rights reserved.