Modified Severity of Dyspepsia Assessment pain scale: a new tool for measuring upper abdominal pain in osteoarthritis patients taking NSAIDs

Figures & data

Figure 1 Assessment schedule for the modified Severity of Dyspepsia Assessment pain scale and validation items.

Abbreviations: mSODA, modified Severity of Dyspepsia Assessment pain scale; HSSR, Heartburn Symptom Severity Rating; WK, week; MDHAQ, Multi-Dimensional Health Assessment Questionnaire.

Figure 2 Modified Severity of Dyspepsia Assessment pain scale.

Copyright © 2011, AstraZeneca.

Table 1 Demographic characteristics of study population

	All subjects (n = 90)	Trial 1 (n = 45)	Trial 2 (n = 45)
Age (years)
Mean ± standard deviation	62.3 ± 8.5	62.6 ± 9.0	62.1 ± 8.0
Minimum, median, maximum	50.0, 61.0, 90.0	50.0, 61.0, 90.0	50.0, 61.0, 80.0
<65	53 (58.9%)	26 (57.8%)	27 (60.0%)
≥65	37 (41.1%)	19 (42.2%)	18 (40.0%)
Female, n (%)	53 (58.9%)	25 (55.6%)	28 (62.2%)
Race, n (%)
White	71 (78.9%)	34 (75.6%)	37 (82.2%)
Black	14 (15.6%)	9 (20.0%)	5 (11.1%)
Asian	5 (5.6%)	2 (4.4%)	3 (6.7%)
Hispanic or Latino ethnicity, n (%)	6 (6.7%)	2 (4.4%)	4 (8.9%)
Education, n (%)
Less than high school graduate	8 (9.2%)	5 (11.6%)	3 (6.8%)
High school graduate/GED	27 (31.0%)	15 (34.9%)	12 (27.3%)
Some college	25 (28.7%)	10 (23.3%)	15 (34.1%)
Bachelor’s degree	17 (19.5%)	8 (18.6%)	9 (20.5%)
Graduate degree	10 (11.5%)	5 (11.6%)	5 (11.4%)

Table 2 Means and standard deviations across assessments for the modified Severity of Dyspepsia Assessment pain scale and validation items

Measure^a	n	M ± SD
mSODA pain scale^b
Day 0	90	13.4 ± 11.4
Week 6 (days 36–42)	71	8.3 ± 8.6
Week 12 (days 78–84)	62	7.3 ± 8.0
HSSR^c
Day 0	90	0.61 ± 0.82
Week 6 (days 36–42)	71	0.36 ± 0.50
Week 12 (days 78–84)	62	0.33 ± 0.49
MDHAQ-GS scale^d
Day 0	88	6.2 ± 2.3
Week 6 (days 36–42)	49	4.2 ± 2.5
Week 12 (days 78–84)	50	3.7 ± 2.5
MDHAQ-GI Symptoms^e
Day 0	88	40% ± 49%
Week 6 (days 36–42)	49	47% ± 50%
Week 12 (days 78–84)	50	42% ± 50%

Notes:

a Nonmissing week 6 and week 12 responses are averaged across the associated seven-day period;

b mSODA pain scale (see scoring instructions; range 2–47);

c HSSR, 0–3 point scale (none, mild, moderate, severe);

d MDHAQ-GS, 0–10 point scale (very well, very poorly);

e MDHAQ-GI (any “Yes” response at a given assessment to any of the following: heartburn or stomach gas; stomach pain or cramps; nausea; or vomiting).

Abbreviations: HSSR, Heartburn Symptom Severity Rating; MDHAQ-GS, Multidimensional Health Assessment Questionnaire-Global Status Scale; MDHAQ-GI, Multi-dimensional Health Assessment Questionnaire-Gastrointestinal Symptom Scale; mSODA, modified Severity of Dyspepsia Assessment; M, mean; SD, standard deviation.

Table 3 Modified Severity of Dyspepsia Assessment construct validity (known-groups)

	n	mSODA M ± SD	P value
MDHAQ-GI symptoms
None	53	9.1 ± 10.0	0.039
Any	35	19.0 ± 10.4
Use of antacids* at day 41
None	54	6.4 ± 8.0	0.026
Any	5	15.0 ± 8.2
Use of antacids at day 42
None	51	8.0 ± 8.1	0.005
Any	13	15.5 ± 8.8
Use of antacids at day 43
None	50	6.6 ± 7.8	0.027
Any	13	12.2 ± 8.7
Use of antacids at day 84
None	41	6.9 ± 8.1	0.005
Any	6	17.5 ± 9.4

Note:

* Maalox^® regular strength tablet antacids were the only antacids allowed for antagonists were use during the trials. Use of other proton pump inhibitors or H₂ prohibited.

Abbreviations: MDHAQ-GI, Multi-dimensional Health Assessment Questionnaire-Gastrointestinal Symptom Scale; mSODA, modified Severity of Dyspepsia Assessment; M, mean; SD, standard deviation.

Table 4 Modified Severity of Dyspepsia Assessment responsiveness at week 6 and week 12

	Heartburn severity						Guyatt’s statistic
	Clinically improved ≤−1		Clinically stable >−1<1		Clinically worsened≥−1
	n	Mean ± SD	n	Mean ± SD	n	Mean ± SD
Week 6 change	16	−13.0 ± 9.6	49	−3.1 ± 7.8	6	−1.6 ± 14.7	−1.7
Week 12 change	16	−15.1 ± 8.9	39	−2.0 ± 5.8	7	−3.8 ± 14.9	−2.6

Note:

* Guyatt’s statistic is defined as the ratio of the average mSODA change score (at each time point) in the improved cohort to the SD of the mSODA change score in the stable cohort.

Abbreviations: mSODA, modified Severity of Dyspepsia Assessment; M, mean; SD, standard deviation.