. Author manuscript; available in PMC: 2016 Dec 1.

Published in final edited form as: Gastroenterology. 2015 Aug 21;149(7):1762–1774.e4. doi: 10.1053/j.gastro.2015.08.008

Table 4.

Proportion of Patients with Improvement in GCSI (≥1 point on GCSI) at 48 Weeks for Baseline Predictors and Corresponding Mean Change from Baseline in GCSI Scores

Baseline Characteristics	Total No. (N=262)	Improved At 48 Wk N (%)	P^*	Mean Baseline GCSI	P^†	Mean Change in GCSI	P^†
Demographics:
Sex			.69		.01		.19
Male	47	12 (26%)		2.64		−0.23
Female	215	61 (28%)		3.01		−0.47
Race			.21		.96		.58
White	234	68 (29%)		2.98		−0.44
Non-white	28	5 (18%)		2.99		−0.31
Age			.04		.01		.16
≥ 50 years	83	30 (36%)		2.74		−0.58
<50 years	179	43 (24%)		3.09		−0.35
Education:			.22		.01		.16
College degree or higher	83	19 (23%)		2.75		−0.28
Some college or less	179	54 (30%)		3.10		−0.49
Income:			.25		.02		.55
$50,000 or higher	143	44 (31%)		2.85		−0.39
< $50,000	119	29 (24%)		3.15		−0.47
Symptoms: Investigator- and Patient-rated
Global symptom severity (investigator-rated)			.48		<.001		.48
Mild	36	11 (31%)		2.40		−0.44
Moderate	136	34 (25%)		2.99		−0.36
Gastric failure	87	28 (32%)		3.24		−0.55
Nausea/vomiting moderate/severe^‡			.004		<.001		<.001
Yes	114	42 (37%)		3.58		−0.75
No	148	31 (37%)		2.53		−0.17
Fullness moderate/severe^‡			.002		<.001		<.001
Yes	185	62 (34%)		3.40		−0.62
No	77	11 (14%)		1.98		0.06
Bloating moderate/severe^‡			.17		<.001		<.001
Yes	162	50 (31%)		3.52		−0.61
No	100	23 (23%)		2.11		−0.13
Abdominal pain mod/severe^‡			.81		<.001		.008
Yes	191	54 (28%)		3.28		−0.53
No	71	19 (27%)		2.18		−0.13
GERD moderate/severe^‡			.95		<.001		.10
Yes	65	18 (28%)		3.75		−0.62
No	196	55 (28%)		2.73		−0.36
Predominant symptom^‡:			.03		<.001		.003
Other PAGI-SYM	104	25 (24%)		2.63		−0.26
Nausea/vomiting	111	40 (36%)		3.33		−0.66
Upper abdominal pain	47	8 (17%)		2.95		−0.23
Gastric emptying scintigraphy:
Gastric Retention at 4 hours:			.04		.13		.23
≤ 20%	109	23 (21%)		2.97		−0.34
>21%	153	50 (33%)		3.15		−0.59
Medical history:
Etiology:			.63		.94		.45
Idiopathic	177	52 (29%)		3.00		−0.46
Diabetes Type 2	45	11 (28%)		2.96		−0.49
Diabetes Type 1	40	10 (22%)		2.92		−0.20
BMI category^‡			.006		.47		.05
Overweight or obese	147	31 (21%)		2.94		−0.30
Not overweight	115	42 (37%)		3.04		−0.58
Smoked (ever regularly)			.03		.41		.003
Yes	84	16 (19%)		2.91		−0.13
No	178	57 (32%)		3.02		−0.56
Acute onset of symptoms			.41		.20		.59
Acute	139	42 (30%)		2.91		−0.46
Insidious	121	31 (26%)		3.08		−0.46
Initial infectious prodrome			.02		.71		.38
Yes	48	20 (42%)		2.93		−0.55
No	214	53 (25%)		3.00		−0.39
Inflammation^‡			.41		.82		.71
Yes	111	28 (25%)		3.00		−0.39
No	151	45 (30%)		2.97		−0.45
HbA1c (%):			.49		.34		.33
< 7 %	208	60 (29%)		3.01		−0.46
≥ 7 %	54	13 (24%)		2.86		−0.29
Current medication use:
Narcotics			.09		.08		.49
Yes	115	26 (23%)		3.11		−0.37
No	147	47 (32%)		2.88		−0.46
Protein pump inhibitors			.28		.98		.42
Yes	212	56 (26%)		2.98		−0.40
No	50	17 (34%)		2.98		−0.54
Prokinetics			.24		.88		.98
Yes	148	37 (25%)		2.99		−0.42
No	114	36 (32%)		2.97		−0.42
Antiemetics			.89		<.001		.23
Yes	167	47 (28%)		3.17		−0.48
No	95	26 (27%)		2.66		−0.31
Antidepressants			.44		.70		.40
Yes	105	32 (30%)		3.02		−0.33
No	157	41 (26%)		2.97		−0.46
Anxiolytics			.02		.21		.03
Yes	50	7 (14%)		3.15		−0.11
No	212	66 (31%)		2.94		−0.50
Pain modulators			.07		.47		.55
Yes	63	12 (19%)		3.07		−0.34
No	199	61 (31%)		2.96		−0.45
TPN			.42		.04		.20
On	26	9 (35%)		3.38		−0.69
Not on	236	64 (27%)		2.94		−0.39
GES implantation			.99		.07		.94
Yes	18	5 (28%)		3.40		−0.40
No	244	68 (28%)		2.95		−0.42
Psychological & QOL
Depression (BDI)			.07		<.001		.68
Moderate/severe(> 20)	109	24 (22%)		3.31		−0.39
Mild to none (≤ 20)	153	49 (32%)		2.75		−0.45
State-Trait Anxiety Inventory:
State anxiety ≥ 50			.25		.01		.24
Yes	86	20 (23%)		3.21		−0.31
No	176	53 (30%)		2.87		−0.48
Trait anxiety ≥ 50			.49		.07		.57
Yes	80	20 (25%)		3.16		−0.36
No	182	53 (29%)		2.91		−0.45
PAGI-QOL score			.82		<.001		.88
Medium to high (≥ 3)	87	25 (29%)		2.29		−0.41
Low (score < 3)	175	48 (27%)		3.33		−0.43
SF-36v2 Overall Health:
Physical health:			.42		<.001		.28
Score ≥ 35	101	31 (31%)		2.59		−0.33
Score < 35	161	42 (26%)		3.23		−0.48
Mental health:			.33		.002		.73
Score ≥ 35	149	45 (30%)		2.81		−0.44
Score < 35	113	28 (25%)		3.21		−0.40

Improved defined as the 48 week PAGI-SYM GCSI being 1 or more points lower than the baseline (BS) GCSI. P (2-sided) determined from either a Pearson’s Chi-Square test.

^†

P (2-sided) determined from t-test or ANOVA for outcomes with 3 categories.

^‡

Definitions: Nausea/vomiting, fullness (post-prandial), bloating, and GERD symptoms were each defined as moderate to severe if the subscale was 3 or higher; abdominal pain was defined as moderate to severe if any of the components of the subscale was 3 or higher; Predominant symptom is the patient’s selection for the most severe among any symptom on the PAGI-SYM questionnaire in the previous 2 weeks, and the other category includes post-prandial fullness, bloating, lower abdominal pain, GERD, constipation, or diarrhea; Overweight or obese defined as BMI≥25kg/m², not overweight is BMI <25kg/m²; Inflammation defined as an elevated C-reactive protein (CRP) level or erythrocyte sedimentation rate (ESR).