Psychometrics of the chronic liver disease questionnaire for Southern Chinese patients with chronic hepatitis B virus infection

Table 1 Socio-demographic and clinical characteristics of subjects n (%)

	Uncomplicated CHB (n = 72)	Complicated CHB (n = 78)	Overall (n = 150)
Age, mean years ± SD1	50.2 ± 12.0	55.9 ± 9.5	53.2 ± 11.1
Sex1
Male	42 (58.3)	65 (83.3)	107 (71.3)
Female	30 (41.7)	13 (16.7)	43 (28.7)
Education attainment
No schooling	2 (2.8)	6 (7.7)	8 (5.3)
Primary	19 (26.4)	14 (17.9)	33 (22.0)
Secondary	35 (48.6)	46 (59.0)	81 (54.0)
Tertiary	16 (22.2)	12 (15.4)	28 (18.7)
Marital status
Now married, living with spouse	59 (81.9)	67 (85.9)	126 (84.0)
Never married	6 (8.3)	5 (6.4)	11 (7.3)
Widowed	1 (1.4)	1 (1.3)	2 (1.3)
Divorced/separated	6 (8.3)	5 (6.4)	11 (7.3)
Occupation
Managers, administrators & professional	19 (26.4)	17 (21.8)	36 (24.0)
Clerk, service and shop sales workers	16 (22.2)	19 (24.4)	35 (23.3)
Craft, machine operators & elementary	27 (37.5)	39 (50.0)	66 (44.0)
Others	10 (13.9)	3 (3.8)	13 (8.7)
Health status
CHB	72 (100)		72 (48.0)
Cirrhosis		30 (38.5)	30 (20.0)
HCC		48 (61.5)	48 (32.0)
Child-Pugh Classification
No cirrhosis/normal LF	72 (100)	8 (10.3)	80 (53.3)
Child A		47 (60.3)	47 (31.3)
Child B		8 (10.3)	8 (5.3)
Child C		15 (19.2)	15 (10.0)

CHB: Chronic hepatitis B; HCC: Hepatocellular carcinoma; LF: Liver function. Data are no. (%) of patients, unless otherwise indicated.

¹Significant difference between uncomplicated and complicated CHB groups by independent sample t or Fisher’s exact test, P < 0.05. Socio-demographic variables are recoded as binary categorical variables for performing Fisher’s exact test: male vs female; no schooling vs any formal education; living with spouse vs other marital status; managers, administrators and professional vs other occupations.

Table 2 Distribution of the Chinese (HK) CLDQ and SF-36v2 Health Survey scores¹

	Uncomplicated CHB2 (n = 72)				Complicated CHB2 (n = 78)				Overall (n = 150)
	Mean	(SD)	% floor3	% ceiling4	Mean	(SD)	% floor	% ceiling	Mean	(SD)	% floor	% ceiling	ES5
CLDQ
AS	6.3	(1.0)	0.0	47.2	5.6	(1.5)	0.0	28.2	5.9	(1.3)	0.0	37.3	0.5a
FA	5.2	(1.1)	0.0	6.9	4.6	(1.5)	0.0	5.1	4.9	(1.4)	0.0	6.0	0.4a
SS	5.8	(1.0)	0.0	19.4	5.2	(1.2)	0.0	6.4	5.5	(1.2)	0.0	12.7	0.5a
AC	6.2	(1.1)	0.0	48.6	5.4	(1.6)	0.0	28.2	5.8	(1.4)	0.0	38.0	0.6a
EF	5.5	(1.0)	0.0	8.3	5.0	(1.4)	0.0	5.1	5.2	(1.3)	0.0	6.7	0.4a
WO	5.9	(1.3)	1.4	37.5	5.0	(1.7)	0.0	17.9	5.4	(1.6)	0.7	27.3	0.6a
Overall	5.8	(0.8)	0.0	0.0	5.1	(1.2)	0.0	1.3	5.4	(1.1)	0.0	0.7	0.6a
SF-36v2 Health survey (HK norm)
PF (90.6)	89.0	(14.7)	0.0	34.7	80.4b	(15.4)	0.0	10.3	84.5	(15.6)	0.0	22.0	0.5a
RP (90.2)	83.6b	(21.0)	0.0	45.8	63.9b	(29.4)	1.3	24.4	73.4	(27.4)	0.7	34.7	0.7a
BP (82.6)	72.6b	(23.0)	0.0	31.9	70.1b	(28.6)	1.3	38.5	71.3	(26.0)	0.7	35.3	0.1
GH (53.2)	53.8	(21.7)	0.0	0.0	46.9b	(25.6)	0.0	2.6	50.2	(24.0)	0.0	1.3	0.3
VT (60.2)	63.9	(19.8)	1.4	1.4	58.0	(26.5)	5.1	5.1	60.8	(23.6)	3.3	3.3	0.2
SF (92.4)	86.1b	(19.3)	0.0	48.6	71.6b	(29.0)	1.3	35.9	78.6	(25.8)	0.7	42.0	0.6a
RE (88.5)	80.4b	(19.8)	0.0	36.1	75.0b	(26.9)	0.0	33.3	77.6	(23.8)	0.0	34.7	0.2
MH (72.0)	73.6	(18.4)	0.0	5.6	70.4	(21.9)	0.0	11.5	72.0	(20.3)	0.0	8.7	0.2
PCS (50)	46.4b	(9.9)	0.0	0.0	39.5b	(12.2)	0.0	0.0	42.8	(11.6)	0.0	0.0	0.6a
MCS (50)	50.1	(10.4)	0.0	0.0	47.8	(13.9)	0.0	0.0	48.9	(12.3)	0.0	0.0	0.2

AS: Abdominal Symptoms; FA: Fatigue; SS: Systemic Symptoms; AC: Activity; EF: Emotional Function; WO: Worry; PF: Physical Functioning; RP: Role Physical; BP: Bodily Pain; GH: General Health; VT: Vitality; SF: Social Functioning; RE: Role Emotional; MH: Mental Health; PCS: Physical Component Summary; MCS: Mental Component Summary; ES: Effect Size. ¹The Chinese (HK) CLDQ score range 1-7 and SF-36v2 score range 0-100; higher scores indicate better health-related quality of life;

²Uncomplicated CHB are patients who had no cirrhosis or hepatocellular carcinoma (HCC) and normal liver function; Complicated CHB refers to those with cirrhosis or HCC;

³% floor: Percentage of CHB patients at the lowest possible score;

⁴% ceiling: Percentage of CHB patients at the highest possible score;

⁵Effect size was calculated as the difference between uncomplicated and complicated mean score, divided by the overall SD.

^aSignificant difference between uncomplicated and complicated CHB patients by independent sample t (P < 0.05);

^bSignificant difference between CHB groups and HK norm by independent sample t (P < 0.05).

Table 3 Item descriptive statistics and item-subscale correlations of the Chinese (HK) CLDQ

Items	Mean	(SD)	Item-subscale correlations1						Success2 (%)
			AS	FA	SS	AC	EF	WO
AS
1: Abdominal bloating	5.7	(1.6)	0.571	0.48	0.45	0.44	0.52	0.49	100
5: Abdominal pain	6.1	(1.4)	0.631	0.45	0.47	0.37	0.49	0.39	100
17: Abdominal discomfort	6.0	(1.5)	0.731	0.49	0.52	0.50	0.52	0.50	100
									(100)
FA
2: Tiredness or fatigue	4.3	(1.6)	0.52	0.791	0.68	0.57	0.61	0.48	100
4: Feel sleepy during the day	4.4	(1.6)	0.35	0.701	0.55	0.45	0.49	0.36	100
8: Decreased strength	5.6	(1.7)	0.53	0.721	0.59	0.70	0.63	0.53	100
11: Decreased energy	5.0	(1.6)	0.40	0.771	0.59	0.61	0.66	0.47	100
13: Drowsiness	5.1	(1.7)	0.40	0.661	0.56	0.46	0.58	0.47	100
									(100)
SS
3: Bodily pain	5.5	(1.7)	0.513	0.533	0.441	0.443	0.603	0.40	20
6: Shortness of breath	6.0	(1.5)	0.51	0.603	0.571	0.54	0.55	0.50	80
21: Muscle cramps	5.9	(1.4)	0.29	0.47	0.521	0.38	0.37	0.28	100
23: Dry mouth	4.7	(1.8)	0.37	0.473	0.471	0.41	0.513	0.543	40
27: Itching	5.4	(1.7)	0.30	0.493	0.491	0.41	0.42	0.41	80
									(64)
AC
7: Not able to eat as much as you would like	5.6	(1.9)	0.42	0.593	0.46	0.561	0.48	0.47	80
9: Trouble in lifting or carrying heavy objects	5.8	(1.7)	0.40	0.513	0.553	0.421	0.523	0.40	40
14: Bothered by a limitation of the diet	6.0	(1.6)	0.37	0.47	0.44	0.651	0.50	0.50	100
									(73)
EF
10: Anxiety	5.1	(1.8)	0.54	0.57	0.53	0.46	0.741	0.61	100
12: Unhappiness	5.2	(1.6)	0.43	0.58	0.52	0.44	0.721	0.52	100
15: Irritability	5.4	(1.5)	0.47	0.54	0.52	0.44	0.731	0.56	100
16: Difficulty in sleeping at night	5.1	(1.7)	0.45	0.46	0.46	0.45	0.591	0.48	100
19: Mood swings	5.5	(1.5)	0.46	0.60	0.57	0.50	0.791	0.54	100
20: Difficulty in falling asleep at night	4.5	(2.0	0.36	0.49	0.50	0.45	0.521	0.41	100
24: Depression	5.5	(1.4)	0.42	0.56	0.52	0.41	0.761	0.60	100
26: Problems with concentration	5.4	(1.6)	0.44	0.69	0.61	0.61	0.691	0.61	100
									(100)
WO
18: Worries about the impact of the liver disease	5.5	(1.8)	0.56	0.49	0.44	0.50	0.64	0.641	100
22: Worries that symptoms will develop into major problem	5.1	(1.8)	0.43	0.42	0.45	0.37	0.52	0.791	100
25: Worries that the condition is getting worse	5.2	(1.8)	0.44	0.49	0.54	0.49	0.59	0.851	100
28: Worries about never feeling any better	5.6	(1.7)	0.44	0.54	0.57	0.59	0.67	0.831	100
29: Availability of a liver for transplant	5.7	(2.0)	0.36	0.45	0.47	0.55	0.48	0.621	100
									(100)

¹Spearman correlation between item and its hypothesized subscale corrected for overlap (relevant item removed from its subscale for correlation);

²Level of scaling success, item-subscale correlation is higher for hypothesized subscale than competing subscale;

³Item-subscale correlation is lower for hypothesized subscale than for competing subscale, but not statistically significant at the cutoff point of two standard errors (0.16).

Table 4 Factor loadings of the Chinese (HK) CLDQ

Item	Factor 1 EF	Factor 2 WO	Factor 3 SS + FA	Factor 4 AS	Factor 5 AC	Factor 6 SL
Abdominal symptom (AS)
1: Abdominal bloating	0.18	0.27	0.16	0.70	0.14	0.15
5: Abdominal pain	0.20	0.06	0.13	0.81	0.08	0.14
17: Abdominal discomfort	0.17	0.23	0.17	0.82	0.20	0.08
Fatigue (FA)
2: Tiredness or fatigue	0.33	0.03	0.51	0.31	0.45	0.22
4: Feel sleepy during the day	0.28	-0.05	0.47	0.14	0.44	0.14
8: Decreased strength	0.37	0.14	0.37	0.24	0.60	0.24
11: Decreased energy	0.56	0.06	0.37	0.11	0.51	0.12
13: Drowsiness	0.49	0.09	0.47	0.15	0.36	-0.17
Systemic symptoms (SS)
3: Bodily pain	0.49	0.00	0.18	0.39	0.14	0.22
6: Shortness of breath	0.22	0.22	0.59	0.39	0.18	0.03
21: Muscle cramps	0.09	0.08	0.76	0.17	0.10	0.14
23: Dry mouth	0.24	0.42	0.48	0.16	0.08	-0.02
27: Itching	0.10	0.27	0.65	-0.01	0.02	0.28
Activity (AC)
7: Not able to eat as much as you would like	0.05	0.29	0.04	0.24	0.81	0.12
9: Trouble in lifting or carrying heavy objects	0.41	0.18	0.37	-0.05	0.35	0.17
14: Bothered by a limitation of the diet	0.11	0.43	0.09	0.10	0.67	0.12
Emotional function (EF)
10: Anxiety	0.67	0.32	0.15	0.39	0.14	0.04
12: Unhappiness	0.77	0.25	0.15	0.20	0.13	0.01
15: Irritability	0.78	0.27	0.15	0.17	0.06	0.13
16: Difficulty in sleeping at night	0.27	0.17	0.17	0.18	0.14	0.79
19: Mood swings	0.78	0.24	0.10	0.19	0.20	0.21
20: Difficulty in falling asleep at night	0.16	0.14	0.25	0.22	0.25	0.71
24: Depression	0.8	0.31	0.15	0.08	0.03	0.22
26: Problems with concentration	0.52	0.28	0.29	0.18	0.37	0.27
Worry (WO)
18: Worries about the impact of the liver disease	0.40	0.47	0.03	0.50	0.25	0.07
22: Worries that symptoms will develop into major problem	0.29	0.80	0.11	0.16	0.04	0.05
25: Worries that the condition is getting worse	0.29	0.84	0.13	0.17	0.17	0.09
28: Worries about never feeling any better	0.27	0.77	0.13	0.18	0.26	0.24
29: Availability of a liver for transplant	0.16	0.64	0.26	0.14	0.30	0.10

SL: Sleep.

Table 5 Reliability and correlations of the Chinese (HK) CLDQ and SF-36v2 health survey scores

	AS	FA	SS	AC	EF	WO	Cronbach’s α	ICC1
CLDQ
AS							0.84	0.58
FA	0.54						0.88	0.82
SS	0.54	0.72					0.74	0.86
AC	0.5.0	0.67	0.60				0.72	0.66
EF	0.58	0.72	0.68	0.61			0.90	0.86
WO	0.52	0.57	0.60	0.58	0.69		0.90	0.89
Overall	0.72	0.87	0.84	0.80	0.86	0.81	0.90	0.85
SF-36v2 Health Survey
PF	0.47	0.56	0.65	0.54	0.47	0.46	0.81	0.93
RP	0.56	0.72	0.70	0.67	0.60	0.62	0.91	0.90
BP	0.44	0.44	0.62	0.42	0.48	0.44	0.89	0.77
GH	0.46	0.66	0.56	0.57	0.60	0.62	0.82	0.89
VT	0.51	0.79	0.63	0.58	0.67	0.54	0.86	0.85
SF	0.44	0.56	0.52	0.60	0.58	0.52	0.88	0.54
RE	0.53	0.51	0.52	0.46	0.66	0.50	0.89	0.74
MH	0.41	0.58	0.49	0.49	0.78	0.61	0.84	0.89

¹All analyses were performed with the total sample of 150 patients, except for the Intra-class Correlation Coefficient (ICC), which was based on the results from 46 uncomplicated CHB patients.

Table 6 Psychometric properties of the revised Chinese (HK) CLDQ subscales

Revised subscales	Mean	SD	% floor	% ceiling	Scaling success	Cronbach’s α	ICC
AS	5.9	1.3	0.0	37.3	100.0	0.84	0.58
SS + FA	5.2	1.1	0.0	4.7	95.0	0.84	0.88
AC	5.6	1.4	0.0	20.7	88.0	0.84	0.75
EF	5.3	1.3	0.0	12.0	93.3	0.92	0.87
WO	5.4	1.6	0.7	27.3	100.0	0.90	0.89
SL	4.8	1.7	1.3	17.3	100.0	0.78	0.79
Overall Scores	5.4	1.1	0.0	0.7	NA	0.89	0.85

Appendix table Appendix: Back-translation of Chinese (HK) CLDQ

Original wording	Backward translation
This questionnaire is designed to find out how you have been feeling during the last 2 wk.	The purpose of this questionnaire is to understand how you felt in the past 2 wk.
You will be asked about you symptoms related to your liver disease, how you have been affected in doing activities, and how your mood has been.	The questions are about the symptoms resulting from your liver illness and how these symptoms affect your participation in activities, and your emotions.
Please complete all of questions and select only one response for each question.	Please answer all questions. You can only choose one answer for each question.
1 How much of the time during the last 2 wk have you been troubled by a feeling of abdominal bloating?	1 In the past 2 wk, how much time you have been bothered by your bloating problem?
All of the time	All the time
Most of the time	Most of the time
A good bit of the time	Quite Often
Some of the time	Sometimes
A little of the time	A Short Time
Hardly any of the time	Hardly Any
None of the time	Never
2 How much of the time have you been tired or fatigued during the last 2 wk?	2 In the past 2 wk, how much time did you feel tired or exhausted?
3 How much of the time during the last 2 wk have you experienced bodily pain?	3 In the past 2 wk, how much time did your body ache?
4 How often during the last 2 wk have you felt sleepy during the day?	4 In the past 2 wk, how often did you feel sleepy during the daytime?
5 How much of the time during the last 2 wk have you experienced abdominal pain?	5 In the past 2 wk, how much time did you have abdominal pain?
6 How much of the time during the last 2 wk has shortness of breath been a problem for you in your daily activities?	6 In the past 2 wk, how much time were your daily activities affected by your shortness of breath?
7 How much of the time during the last 2 wk have you not been able to eat as much as you would like?	7 In the past 2 wk, how much time were you unable to eat as much as you want?
8 How much of the time in the last 2 wk have you been bothered by having decreased strength?	8 In the past 2 wk, how much time have you been bothered by the decline in your physical energy?
9 How often during the last 2 wk have you had trouble lifting or carrying heavy objects?	9 In the past 2 wk, how often did you find it difficult when you were lifting or carrying heavy objects?
10 How often during the last 2 wk have you felt anxious?	10 In the past 2 wk, how often did you feel anxious?
11 How often during the last 2 wk have you felt a decreased level of energy?	11 In the past 2 wk, how often did you find your energy level decreasing?
12 How much of the time during the last 2 wk have you felt unhappy?	12 In the past 2 wk, how much time did you feel unhappy?
13 How often during the last 2 wk have you felt drowsy?	13 In the past 2 wk, how often did you feel sleepy?
14 How much of the time during the last 2 wk have you been bothered by a limitation of your diet?	14 In the past 2 wk, how much time have you been bothered by your restricted diet?
15 How often during the last 2 wk have you been irritable?	15 In the past 2 wk, how often did you become irritable?
16 How much of the time during the last 2 wk have you had difficulty sleeping at night?	16 In the past 2 wk, how much time did you find it difficult to sleep at night?
17 How much of the time during the last 2 wk have you been troubled by a feeling of abdominal discomfort?	17 In the past 2 wk, how much time have you been bothered by your abdominal discomfort?
18 How much of the time during the last 2 wk have you been worried about the impact your liver disease has on your family?	18 In the past 2 wk, how much time did you worry that your liver illness will affect your family?
19 How much of the time during the last 2 wk have you had mood swings?	19 In the past 2 wk, how much time did your emotions fluctuate?
20 How much of the time during the last 2 wk have you been unable to fall asleep at night?	20 In the past 2 wk, how much time were you unable to sleep until sunrise?
21 How often during the last 2 wk have you had muscle cramps?	21 In the past 2 wk, how often did your muscle cramp?
22 How much of the time during the last 2 wk have you been worried that your symptoms will develop into major problems?	22 In the past 2 wk, how much time did you worry that your symptoms will become a serious problem?
23 How much of the time during the last 2 wk have you had a dry mouth?	23 In the past 2 wk, how much time did you have dry mouth?
24 How much of the time during the last 2 wk have you felt depressed?	24 In the past 2 wk, how much time did you feel depressed?
25 How much of the time during the last 2 wk have you been worried about your condition getting worse?	25 In the past 2 wk, how much time did you worry that your condition will deteriorate?
26 How much of the time during the last 2 wk have you had problems concentration?	26 In the past 2 wk, how much time did you find it hard to concentrate?
27 How much of the time have you been troubled by itching during the last 2 wk?	27 In the past 2 wk, how much time have you been bothered by itchiness?
28 How much of the time during the last 2 wk have you been worried about never feeling any better?	28 In the past 2 wk, how much time did you worry that your health condition will not improve?
29 How much of the time during the last 2 wk have you been concerned about the availability of a liver if you need a liver transplant?	29 In the past 2 wk, how much time have you worried that you could not get a liver if you have to undergo a liver transplant?