Factors affecting the quality of life of patients after gastrectomy as assessed using the newly developed PGSAS-45 scale: A nationwide multi-institutional study

Table 1 Structure of postgastrectomy syndrome assessment scale-45

Domains	Subdomains		Items		Subscales
QOL	SF-8 (QOL)	1	Physical functioning1	Five or six-point Likert scale	Physical component summary1
		2	Role physical1		Mental component summary1
		3	Bodily pain1
		4	General health1
		5	Vitality1
		6	Social functioning1
		7	Role emotional1
		8	Mental health1
Symptoms	GSRS	9	Abdominal pains	Seven-point Likert scale	Esophageal reflux subscale (item 10, 11, 13, 24)
	symptoms	10	Heartburn	Except item 29 and 32	Abdominal pain subscale (item 9, 12, 28)
		11	Acid regurgitation		Meal-related distress subscale (item 25-27)
		12	Sucking sensations in the epigastrium		Indigestion subscale (item 14-17)
		13	Nausea and vomiting		Diarrhea subscale (item 19, 20, 22)
		14	Borborygmus		Constipation subscale (item 18, 21, 23)
		15	Abdominal distension		Dumping subscale (item 30, 31, 33)
		16	Nausea and vomiting
		17	Increased flatus		Total symptom scale (above seven subscales)
		18	Decreased passage of stools
		19	Increased passage of stools
		20	Loose stools
		21	Hard stools
		22	Urgent need for defecation
		23	Feeling of incomplete evacuation
	PGSAS original	24	Bile regurgitation
	symptoms	25	Sense of foods sticking
		26	Postprandial fullness
		27	Early satiation
		28	Lower abdominal pains
		29	Number and type of early dumping symptoms
		30	Early dumping general symptoms
		31	Early dumping abdominal symptoms
		32	Number and type of late dumping symptoms
		33	Late dumping symptoms
Living status	Meals (amount) 1	34	Ingested amount of food per meal1		-
		35	Ingested amount of food per day1
		36	Frequency of main meals
		37	Frequency of additional meals
	Meals (quality)	38	Appetite1	Five-point Likert scale	Quality of ingestion subscale1 (item 38-40)
		39	Hunger feeling1
		40	Satiety feeling1
	Meals (amount) 2	41	Necessity for additional meals	Five-point Likert scale	-
	Social activity	42	Ability for working	Five-point Likert scale	-
QOL	Dissatisfaction (QOL)	43	Dissatisfaction with symptoms	Five-point Likert scale	Dissatisfaction for daily life subscale (item 43-45)
		44	Dissatisfaction at the meal
		45	Dissatisfaction at working

In items or subscales without¹, higher score indicating worse condition; in items or subscales with¹, higher score indicating better condition. Each subscale is calculated as the mean of composed items or subscales, except physical component summary and mental component summary of SF-8. Item 29 and 32 don't have score. Then, they were analyzed separately.

Table 2 Postgastrectomy syndrome assessment scale original items English version

PGSAS-45 is consisting of SF-8 (item 1-8), GSRS (item 9-23) and PGSAS original items (item 24-45)
24	Have you been bothered by bile regurgitation (having a bitter taste in your mouth) during the past month?
25	Have you been bothered by sense of foods sticking when swallowing during the past month? (Sticking food refers to uncomfortable feeling with foods piled up in the chest.)
26	Have you been bothered by postprandial fullness during the past month? (Fullness refers to uncomfortable or heavy feeling with foods piled up in the stomach.)
27	Have you been bothered by being unable to eat enough because you feel full before you finish your meal during the past month?
28	Have you been bothered by circumumbilical pains or lower abdominal pains during the past month?
29	Have you experienced following symptoms around 30 min after eating during the past month? Please encircle the number that describes your symptom. (Please check all the symptoms you have experienced.)
	(Ans. Q29)
	1. No symptoms below
	[You have experienced following general symptoms.]
	2. Cold sweat 3. Palpitations 4. Dizziness 5. Numbness 6. Fainting 7. Facial flushing
	8. Facial pallor 9. Feeling hot 10. Fatigue or weakness 11. Lassitude 12. Drowsiness
	13. Headache 14. Heaviness of the head 15. Tightness in the chest
	[You have experienced following abdominal symptoms.]
	16. Borborygmi (except after drinking milk) 17. Abdominal cramps (except after drinking milk)
	18. Diarrhoea (except after drinking milk) 19. Nausea 20. Vomiting 21. Bloating
	22. Abdominal discomfort
30	For those who encircled any of the general symptom-related items in Question 29, to what extent have you been bothered by all these general symptoms during the past month?
31	For those who encircled any of the abdominal symptom-related items in Question 29, to what extent have you been bothered by all these abdominal symptoms during the past month?
32	Have you experienced following symptoms within two to three hours after eating during the past month? Please circle the number that describes your symptom. (Please check all the symptoms you have experienced.)
	(Ans. Q32)
	1. No symptoms below
	[You have experienced following general symptoms.]
	2. Cold sweat 3. Palpitations 4. Dizziness 5. Headache 6. Fainting 7. Fatigue or weakness
	8. Lassitude 9. Languor 10. Shakiness 11. Hunger 12. Shortness of breath
33	For those who encircled any of the general symptom-related items in Question 32, to what extent have you been bothered by all these general symptoms during the past month?
	(Ans. Q24-28, 30 ,31, 33)
	1. No discomfort at all 2. Slight discomfort 3. Mild discomfort 4. Moderate discomfort
	5. Moderately severe discomfort 6. Severe discomfort 7. Very severe discomfort
34	On average what percent of preoperative food intake have you taken in single meal during the past month?
	(Ans. Q34)
	About ( ) % of the preoperative single ingested amount
35	On average, what percent of preoperative food intake have you taken per day during the past month?
	(Ans. Q35)
	About ( ) % of the preoperative total daily ingested amount
36	On average, how many main meals have you taken per day during the past month?
	(Ans. Q36)
	About ( ) times per day
37	On average, how often have you taken additional meals (light meal or snack) per day during the past month?
	(Ans. Q37)
	About ( ) times per day
38	Have you had appetite during the past month?
39	Have you felt hunger during the past month?
40	Have you felt satiety during the past month? (Satiety refers to comfortable feeling with your stomach being full.)
	(Ans. Q38-40)
	1. Never 2. Occasionally (less than once a week) 3. Often (twice to three times per week)
	4. Frequently (four to six times per week) 5. Always (every day)
41	Please encircle the number that most accurately describes the necessity for additional meals (light meal or snack) during the past month?
	(Ans. Q41)
	1. Food intake was enough with main meals; three times per day.
	2. Food intake was slightly insufficient with main meals; three times per day, and you sometimes needed to take additional meals.
	3. Food intake was significantly insufficient with main meals; three times per day, and you had to take additional meals.
	4. Even though you had taken additional meals besides main meals; three times per day, food intake was insufficient.
	5. Food intake was insufficient because you were not able to take additional meals besides breakfast, lunch and dinner.
42	Please encircle the number which exactly describes your living status (ability for working or housekeeping) during the past month?
	(Ans. Q42)
	1. You were able to handle your work or housework sufficiently and could even manage to work overtime. You enjoyed trip, sports, leisure activities, and dining out as you used to before operation.
	2. You were able to work or handle housework as usual (By work as usual we mean during normal working hours without overtime). (You felt no difficulty when avoiding excessive work)
	3. You had some difficulties with working or keeping house. You were able to handle lighter duties (70 to 80 percent of the previous activities).
	4. You had moderate difficulties with working or keeping house (about 50 percent of the previous activities).
	5. You could scarcely work or keep house.
43	How often have you felt dissatisfied with the chest or abdominal symptoms due to gastrectomy during the past month?
44	How often have you felt dissatisfied with being unable to eat as intended due to gastrectomy during the past month? ("being unable to eat as intended" here means that you are not able to eat what you like, with no limitation in amount and in speed.)
45	How often have you felt dissatisfied with your limited daily activities (working or housekeeping) due to gastrectomy during the past month?
	(Ans. Q43-45)
	1. Not at all 2. Slightly 3. Moderately 4. Significantly 5. Extremely
	PGSAS-45 original items [item 24-45] English version 1.0 © 2016 K Nakada, M Takahashi

Table 3 Comparison of patients' characteristics, living status and quality of life between total and distal gastrectomy

		TG (n = 393)		DG (n = 1384)		P value	Cohen's d
		mean	SD	mean	SD
Patients'	Age (yr)	63.4	9.2	61.8	9.1	0.00192	(0.18)
characteristics	Sex (male: n/%)	276/71.0%		912/66.2%		0.07983	-
	Postoperative period (mo)	35.0	24.6	37.9	27.4	0.09182	(0.10)
Symptoms	Total symptom score	2.2	0.7	1.9	0.7	< 0.00012	0.35
Living status	Change in body weight (%)1	-13.8%	7.9%	-8.3%	7.6%	< 0.00012	0.71
	Necessity for additional meals	2.4	0.8	1.9	0.8	< 0.00012	0.61
	Ability for working	2.0	0.9	1.8	0.9	< 0.00012	0.31
QOL	Dissatisfaction for daily life SS	2.3	0.9	1.9	0.8	< 0.00012	0.53
	Physical component summary1	49.6	5.6	50.6	5.6	0.00202	(0.18)
	Mental component summary1	49.2	6.0	49.9	5.7	0.04262	(0.12)
The interpretation of effect size		Cohen's d
None-very small		< (0.2)
Small		≥ 0.2
Medium		≥ 0.5
Large		≥ 0.8

Outcome measures with¹, higher score indicating better condition; Outcome measures without¹, higher score indicating worse condition.

²t-test;

³χ² test. TG: Total gastrectomy; DG: Distal gastrectomy; QOL: Quality of life.

Table 4 Clinical factors affecting quality of life in the patients after gastrectomy (Multiple Regression Analysis)

	Dissatisfaction for daily life SS		Physical component summary1		Mental component summary1
	β	P value	β	P value	β	P value
Type of gastrectomy [TG]	(0.047)	0.0132	(0.008)	NS	(-0.056)	0.0238
Age	(-0.091)	< 0.0001	(-0.052)	0.0236	(0.090)	0.0002
Sex [Male]	(-0.016)	NS	(0.043)	0.0576	(0.025)	NS
Period after gastrectomy	(-0.026)	NS	(-0.019)	NS	(-0.004)	NS
Total symptoms score	0.429	< 0.0001	-0.354	< 0.0001	-0.357	< 0.0001
Change in body weight1	(-0.036)	0.0551	(0.026)	NS	(-0.008)	NS
Necessity for additional meals	0.176	< 0.0001	(0.057)	0.0206	(-0.020)	NS
Ability for working	0.360	< 0.0001	-0.377	< 0.0001	-0.321	< 0.0001
R2 (P value)	0.606	< 0.0001	0.368	< 0.0001	0.333	< 0.0001
If βis positive, the score of the outcome measure of the patients belonging to the category in [brackets] is higher in cases when the factor is
a nominal scale, and the score of outcome measure of the patients with larger values is higher in cases when the factor is a numeral scale.
The interpretation of effect size	β	R2
None-very small	< (0.100)	< (0.020)
Small	≥ 0.100	≥ 0.020
Medium	≥ 0.300	≥ 0.130
Large	≥ 0.500	≥ 0.260

Outcome measures with¹, higher score indicating better condition; outcome measures without¹, higher score indicating worse condition. TG: Total gastrectomy.

Table 5 Clinical factors affecting quality of life in the patients after each of total or distal gastrectomy (Subgroup Multiple Regression Analysis)

	Dissatisfaction for daily life SS		Physical component summary1		Mental component summary1
	β	P value	β	P value	β	P value
TG
Age	-0.135	0.0007	-0.160	0.0006	0.118	0.0141
Sex (male)	(0.003)	NS	(0.065)	NS	(-0.074)	NS
Period after gastrectomy	(-0.036)	NS	(0.029)	NS	(-0.054)	NS
Total symptoms score	0.428	< 0.0001	-0.441	< 0.0001	-0.350	< 0.0001
Change in body weight1	(-0.001)	NS	(0.020)	NS	(-0.034)	NS
Necessity for additional meals	0.281	< 0.0001	(0.085)	0.0653	(-0.028)	NS
Ability for working	0.335	< 0.0001	-0.334	< 0.0001	-0.415	< 0.0001
R2 (P value)	0.565	< 0.0001	0.434	< 0.0001	0.393	< 0.0001
DG
Age	(-0.081)	0.0001	(-0.018)	NS	(0.081)	0.0029
Sex (male)	(0.025)	NS	(0.036)	NS	(0.052)	0.0502
Period after gastrectomy	(-0.027)	NS	(-0.033)	NS	(0.011)	NS
Total symptoms score	0.441	< 0.0001	-0.316	< 0.0001	-0.355	< 0.0001
Change in body weight1	(-0.044)	0.0265	(0.024)	NS	(0.006)	NS
Necessity for additional meals	0.139	< 0.0001	(0.043)	NS	(-0.019)	NS
Ability for working	0.377	< 0.0001	-0.390	< 0.0001	-0.289	< 0.0001
R2 (P value)	0.598	< 0.0001	0.347	< 0.0001	0.322	< 0.0001
If βis positive, the score of the outcome measure of the patients belonging to the category in [brackets] is higher in cases when the factor is
a nominal scale, and the score of outcome measure of the patients with larger values is higher in cases when the factor is a numeral scale.
The interpretation of effect size	β	R2
None-very small	< (0.100)	< (0.020)
Small	≥ 0.100	≥ 0.020
Medium	≥ 0.300	≥ 0.130
Large	≥ 0.500	≥ 0.260

Outcome measures with¹, higher score indicating better condition; outcome measures without¹, higher score indicating worse condition. TG: Total gastrectomy; DG: Distal gastrectomy.

Table 6 Influence of various symptoms on patients' living status and quality of life (Multiple regression analysis)

	Change in body weight1		Necessity for additional meals		Ability for working		Dissatisfaction for daily life SS		Physical component summary1		Mental component summary1
	β	P value	β	P value	β	P value	β	P value	β	P value	β	P value
Esophageal reflux SS	(-0.04)	NS	(0.052)	NS	(0.081)	0.0126	(0.085)	0.0011	-0.126	< 0.0001	(-0.085)	0.0062
Abdominal pain SS	(0.042)	NS	(-0.004)	NS	(0.096)	0.0046	0.146	< 0.0001	-0.261	< 0.0001	(-0.094)	0.0039
Meal-related distress SS	-0.170	< 0.0001	0.279	< 0.0001	0.116	0.0012	0.282	< 0.0001	(-0.074)	0.0263	-0.144	< 0.0001
Indigestion SS	(-0.036)	NS	(0.004)	NS	(-0.001)	NS	(0.015)	NS	(0.024)	NS	(-0.058)	0.0699
Diarrhea SS	(0.023)	NS	(-0.037)	NS	(-0.076)	0.0061	(0.011)	NS	(0.022)	NS	(-0.054)	0.0441
Constipation SS	(0.062)	0.0431	(0.007)	NS	(0.093)	0.0008	(0.006)	NS	(-0.037)	NS	(-0.056)	0.0356
Dumping SS	(-0.051)	NS	0.113	0.0015	0.214	< 0.0001	0.283	< 0.0001	-0.168	< 0.0001	-0.141	< 0.0001
R2 (P value)	0.040	< 0.0001	0.148	< 0.0001	0.202	< 0.0001	0.483	< 0.0001	0.276	< 0.0001	0.240	< 0.0001
If βis positive, the score of outcome measure of the patients with larger values is higher
The interpretation of effect size		β	R2
None-very small		< (0.100)	< (0.020)
Small		≥ 0.100	≥ 0.020
Medium		≥ 0.300	≥ 0.130
Large		≥ 0.500	≥ 0.260

¹Outcome measures with, higher score indicating better condition; outcome measures without, higher score indicating worse condition.