8
Quality of life in Chinese patients with inflammatory bowel disease: validation of the Chinese translation of the Inflammatory Bowel Disease Questionnaire R. W. L. LEONG, Y. T. LEE, J. Y. L. CHING & J. J. Y. SUNG Department of Medicine and Therapeutics, Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, Hong Kong, China Accepted for publication 12 December 2002 SUMMARY Background: Health-related quality of life is an import- ant outcome measure in inflammatory bowel disease. The Inflammatory Bowel Disease Questionnaire is a quality of life questionnaire that has not been validated previously in Chinese patients with inflammatory bowel disease. Aim: To develop and validate a Chinese translation of the Inflammatory Bowel Disease Questionnaire, specif- ically determining its construct validity, discriminant ability, reliability and sensitivity to change. Methods: We developed a Chinese version of the Inflam- matory Bowel Disease Questionnaire. Chinese patients with Crohn’s disease and ulcerative colitis completed the Chinese Inflammatory Bowel Disease Questionnaire and visual analogue scales measuring systemic, social, bowel and emotional well-being. Patients also comple- ted a validated Chinese SF-36 generic quality of life questionnaire, the Crohn’s disease activity index or the clinical activity index for ulcerative colitis. Results: One hundred and thirty-five patients (59 with Crohn’s disease and 76 with ulcerative colitis) were enrolled, 99 of whom also completed the Chinese Inflammatory Bowel Disease Questionnaire for a sec- ond time. The Chinese Inflammatory Bowel Disease Questionnaire correlated well with the SF-36 for all four domains (Spearman: r ¼ 0.55–0.80), the Crohn’s disease activity index (r ¼ )0.62–0.72) and the clin- ical activity index for ulcerative colitis (r ¼ )0.44– 0.68), as well as with the visual analogue scales. The Chinese Inflammatory Bowel Disease Questionnaire accurately distinguished between active and inactive disease. Test–re-test reliability showed excellent intra- class correlation (0.76–0.92; all P < 0.001). The Chinese Inflammatory Bowel Disease Questionnaire was also sensitive to changes in disease activity (P < 0.05). Conclusion: The Chinese Inflammatory Bowel Disease Questionnaire is a valid and reliable test that correlates well with the patients’ subjective well-being and clinical disease activity. INTRODUCTION Inflammatory bowel disease is a chronic debilitating illness with a significant impact on health status. 1 Intestinal and extra-intestinal disease activity, surgical interventions, drug-induced side-effects and related psychosocial factors all adversely impair the quality of life. Activity indices developed to score clinical disease activity focus mainly on the physical and biological aspects, 2–4 but fail to identify the impact of inflamma- tory bowel disease on the patients’ perceived quality of life, especially their emotional and social well-being. 1, 5 Health-related quality of life is a global measure of the subjective experience, from the patients’ standpoint, of Correspondence to: Professor J. J. Y. Sung, Department of Medicine and Therapeutics, Prince of Wales Hospital, Shatin, N.T., Hong Kong, China. E-mail: [email protected] Aliment Pharmacol Ther 2003; 17: 711–718. doi: 10.1046/j.0269-2813.2003.01489.x Ó 2003 Blackwell Publishing Ltd 711

Quality of life in Chinese patients with inflammatory bowel disease: validation of the Chinese translation of the Inflammatory Bowel Disease Questionnaire

Embed Size (px)

Citation preview

Page 1: Quality of life in Chinese patients with inflammatory bowel disease: validation of the Chinese translation of the Inflammatory Bowel Disease Questionnaire

Quality of life in Chinese patients with inflammatory bowel disease:validation of the Chinese translation of the Inflammatory BowelDisease Questionnaire

R. W. L. LEONG, Y. T. LEE, J . Y. L. CHING & J. J . Y. SUNG

Department of Medicine and Therapeutics, Chinese University of Hong Kong, Prince of Wales Hospital, Shatin,

Hong Kong, China

Accepted for publication 12 December 2002

SUMMARY

Background: Health-related quality of life is an import-

ant outcome measure in inflammatory bowel disease.

The Inflammatory Bowel Disease Questionnaire is a

quality of life questionnaire that has not been validated

previously in Chinese patients with inflammatory bowel

disease.

Aim: To develop and validate a Chinese translation of

the Inflammatory Bowel Disease Questionnaire, specif-

ically determining its construct validity, discriminant

ability, reliability and sensitivity to change.

Methods: We developed a Chinese version of the Inflam-

matory Bowel Disease Questionnaire. Chinese patients

with Crohn’s disease and ulcerative colitis completed

the Chinese Inflammatory Bowel Disease Questionnaire

and visual analogue scales measuring systemic, social,

bowel and emotional well-being. Patients also comple-

ted a validated Chinese SF-36 generic quality of life

questionnaire, the Crohn’s disease activity index or the

clinical activity index for ulcerative colitis.

Results: One hundred and thirty-five patients (59 with

Crohn’s disease and 76 with ulcerative colitis) were

enrolled, 99 of whom also completed the Chinese

Inflammatory Bowel Disease Questionnaire for a sec-

ond time. The Chinese Inflammatory Bowel Disease

Questionnaire correlated well with the SF-36 for all

four domains (Spearman: r ¼ 0.55–0.80), the Crohn’s

disease activity index (r ¼ )0.62–0.72) and the clin-

ical activity index for ulcerative colitis (r ¼ )0.44–

0.68), as well as with the visual analogue scales. The

Chinese Inflammatory Bowel Disease Questionnaire

accurately distinguished between active and inactive

disease. Test–re-test reliability showed excellent intra-

class correlation (0.76–0.92; all P < 0.001). The

Chinese Inflammatory Bowel Disease Questionnaire

was also sensitive to changes in disease activity

(P < 0.05).

Conclusion: The Chinese Inflammatory Bowel Disease

Questionnaire is a valid and reliable test that correlates

well with the patients’ subjective well-being and clinical

disease activity.

INTRODUCTION

Inflammatory bowel disease is a chronic debilitating

illness with a significant impact on health status.1

Intestinal and extra-intestinal disease activity, surgical

interventions, drug-induced side-effects and related

psychosocial factors all adversely impair the quality of

life. Activity indices developed to score clinical disease

activity focus mainly on the physical and biological

aspects,2–4 but fail to identify the impact of inflamma-

tory bowel disease on the patients’ perceived quality of

life, especially their emotional and social well-being.1, 5

Health-related quality of life is a global measure of the

subjective experience, from the patients’ standpoint, of

Correspondence to: Professor J. J. Y. Sung, Department of Medicine and

Therapeutics, Prince of Wales Hospital, Shatin, N.T., Hong Kong, China.

E-mail: [email protected]

Aliment Pharmacol Ther 2003; 17: 711–718. doi: 10.1046/j.0269-2813.2003.01489.x

� 2003 Blackwell Publishing Ltd 711

Page 2: Quality of life in Chinese patients with inflammatory bowel disease: validation of the Chinese translation of the Inflammatory Bowel Disease Questionnaire

good health or ill health, and how it affects their daily

lives.6 Health economics and therapeutic trials are

increasingly taking into account health-related quality

of life, as it has a direct bearing on the economic burden

incurred by disease states and on the patients’ overall

health status and level of functioning. The increasing

interest in quality of life issues in gastrointestinal

diseases has been demonstrated by the dramatic

increase in the number of publications on such issues

in recent years.6 Questionnaires, both generic and

disease specific, have shown that patients with inflam-

matory bowel disease have an impaired health-related

quality of life compared with healthy controls, and

patients with Crohn’s disease generally have a poorer

health-related quality of life than patients with ulcera-

tive colitis.7, 8 Multinational trials are becoming increas-

ingly common and questionnaires are now translated

into different languages. Such instruments, however,

can be unfavourably influenced by language and

idiomatic differences when translated, and, more

importantly, by cultural differences in the perception

of health problems and societal values placed upon

these problems.9, 10 Reliability and cross-cultural

validation of translated questionnaires are therefore

mandatory.

The Inflammatory Bowel Disease Questionnaire

(IBDQ) takes into consideration the four domains of

bowel, systemic, emotional and social disturbances to

calculate a score that reflects the disease-specific

health-related quality of life.7 The IBDQ has been

shown to be reliable in the clinical setting and

sensitive to changes over time,6, 8 and has also been vali-

dated when translated into different languages.11–14

The incidence of inflammatory bowel disease in the

Chinese population is increasing, and the quality of life

of Chinese patients with inflammatory bowel disease is

unknown.15 As yet, the IBDQ has not been translated

into Chinese or tested on Chinese patients. Our aim

was to develop and validate a Chinese version of the

IBDQ.

MATERIALS AND METHODS

Patients

Consecutive Chinese patients with inflammatory bowel

disease, aged 17–75 years, were recruited from the

Prince of Wales Hospital, Hong Kong, China, which

serves a catchment population of over 1 million people

and is a tertiary referral centre with an interest in

inflammatory bowel disease. Inclusion criteria were

definite Crohn’s disease or ulcerative colitis for at least

6 months. The diagnosis of ulcerative colitis and

Crohn’s disease was made according to the Lennard-

Jones criteria.16 All patients were genetically homogen-

eous native southern Chinese, and Caucasians were

excluded. Additional exclusion criteria were the inabil-

ity to comprehend or complete the questionnaire, and

the presence of a psychiatric disorder, stoma or

malignancy.

Measurements

Chinese IBDQ. The IBDQ consists of 32 questions

divided into bowel-related, systemic, emotional and

social domains.7 Each question is answered with a

Likert graded response in the range 1–7 (1, worst

function; 7, best function). The final score ranges from

32 to 224, with a higher score indicating a better

quality of life. The translation–back-translation tech-

nique was used to translate the IBDQ into Chinese, and

was in accordance with previous questionnaire trans-

lations by the Department of Medicine, Chinese Univer-

sity of Hong Kong, Hong Kong, China. A bilingual

native Chinese gastroenterologist (YTL) performed the

initial translation into Chinese, which was reviewed and

revised by three other bilingual gastroenterologists

familiar with inflammatory bowel disease. The official

language translator of the hospital then independently

performed the back-translation from Chinese into

English. The back-translation was verified with the

original IBDQ and approved. Pilot test subjects with

inflammatory bowel disease given the Chinese IBDQ

found that it was comprehensible and easy to complete,

and no further changes were made.

Self-administration of the English IBDQ has been

validated previously and the same technique was

employed in this trial.17 Patients were asked to complete

the Chinese IBDQ to reflect the quality of life of the

previous 2 weeks. On completion, a research nurse

interviewed the patients and any difficulties encoun-

tered with the questionnaire were addressed.

Patients also completed a second Chinese IBDQ at least

2 weeks after, but within a month of, the first survey to

determine intra-individual variations. They indicated

whether, during the interval period, their IBDQ had

deteriorated, remained the same, or improved. The

university ethics committee approved the protocol and

712 R. W. L. LEONG et al.

� 2003 Blackwell Publishing Ltd, Aliment Pharmacol Ther 17, 711–718

Page 3: Quality of life in Chinese patients with inflammatory bowel disease: validation of the Chinese translation of the Inflammatory Bowel Disease Questionnaire

signed informed consent was obtained from the study

subjects.

SF-36. For validation purposes, patients also completed

a previously validated Chinese translation of the

Medical Outcomes Study (MOS) 36-Item Short Form

Health Survey (SF-36)18 and visual analogue scales

(VAS) of well-being. The SF-36 is a generic, non-

disease-specific, health-related quality of life assessment

questionnaire that assesses the domains of physical

functioning, physical health, bodily pain, general

health, vitality, social functioning, emotional health

and mental health. A higher score indicates a better

health status. The SF-36 has been extensively validated

and used in a wide variety of medical conditions,19, 20

including gastrointestinal diseases,21 and has been

translated into and validated in Hong Kong Chinese.18

VAS. The VAS is a horizontal Likert scale measured

from 0 to 10 cm. Four VAS were measured for the

domains of general well-being, bowel function, emo-

tional health and social health to correspond with the

four domains of the IBDQ.

Disease activity indices. A gastroenterologist (RWLL),

blind to the results of the Chinese IBDQ, VAS and SF-36,

independently interviewed the patients at the time of

completion of the questionnaires and scored the disease

activity by means of the Crohn’s disease activity index

(CDAI)3 and the clinical activity index (CAI) for

ulcerative colitis.4 The CDAI was scored according to

the parameters of soft stool frequency, abdominal pain,

general well-being, extra-intestinal manifestations, fis-

tulas, abdominal mass, use of opiates for diarrhoea,

anaemia and weight loss, with a higher score indicating

more severe disease activity and a score of < 150

considered as remission.3 The CAI was calculated from

the frequency of diarrhoea, nocturnal diarrhoea, visible

blood in stool, faecal incontinence, abdominal pain,

general well-being, abdominal tenderness and the need

for anti-diarrhoeal drugs. The total score ranged from 0

to 21, with remission defined as a score of below 10.4

Construct validity and discriminant ability. Non-paramet-

ric statistics were used for the analysis of the quality of

life scores, and were calculated separately for Crohn’s

disease and ulcerative colitis. Construct validity refers to

how well the equivalent domain scores of the Chinese

IBDQ, VAS and SF-36 correlate with each other, and

was analysed using the Spearman correlation coeffi-

cient. Discriminant ability refers to how well the

Chinese IBDQ differentiates active inflammatory bowel

disease from quiescent disease, and was compared

with the disease activity indices using the Mann–

Whitney U-test.

Test–re-test reliability and sensitivity to change. Patients

who completed the follow-up Chinese IBDQ within

1 month of the initial questionnaire were divided into

those with stable disease activity and those with

changed disease activity. Patients with stable disease

was defined as those who reported no significant change

in symptoms and a minimal change in disease activity

index where available (change in CDAI < 50 or

CAI < 4). The reliability assessed the homogeneity of

the Chinese IBDQ in those with stable disease, using the

intra-class correlation coefficient (ICC), standardized

Cronbach’s alpha and Wilcoxon signed rank test. An

ICC of > 0.8 indicates excellent reliability. Sensitivity to

change measured the ability of the Chinese IBDQ to

detect a change in disease activity using the Spearman

correlation coefficient.

Statistical analyses were performed using SPSS version

10.0. A P value of less than 0.05 was deemed to be

statistically significant.

RESULTS

Patients

One hundred and forty-five consecutive Chinese

patients with inflammatory bowel disease fulfilled the

inclusion criteria. Ten patients were excluded due to

poor comprehension of or gross failure to complete the

Chinese IBDQ (four patients), presence of a stoma (four

patients), refusal (one patient) and previously diagnosed

anxiety/depression (one patient). One hundred and

thirty-five patients were included in the study, 59 with

Crohn’s disease and 76 with ulcerative colitis. The

mean age of the patients was 41 years and 40% were

females. The demographic data of the patients are listed

in Table 1 and Figure 1 summarizes the recruitment of

patients for this study. Ninety-nine patients completed

the questionnaire a second time at a mean of 20 days

following the initial questionnaire. Seventy-seven of

these patients remained stable, and 22 showed a change

in disease activity. Missing data were uncommon,

accounting for less than 1% of responses.

CHINESE IBDQ 713

� 2003 Blackwell Publishing Ltd, Aliment Pharmacol Ther 17, 711–718

Page 4: Quality of life in Chinese patients with inflammatory bowel disease: validation of the Chinese translation of the Inflammatory Bowel Disease Questionnaire

Construct validity (Table 2)

To validate that the Chinese IBDQ reflects the disease

activity and generic quality of life scores, correlation was

performed with the previously validated Chinese SF-36,

clinical activity indices and VAS. The Chinese IBDQ

domains for both Crohn’s disease and ulcerative colitis

correlated strongly and significantly with the SF-36

score (all four IBDQ domains, P < 0.001). The correla-

tion was strongest for the systemic domain (Spearman

correlation coefficients: r ¼ 0.801 and r ¼ 0.748 for

Crohn’s disease and ulcerative colitis, respectively),

followed by the emotional domain (0.791 and 0.749),

the bowel function domain (0.773 and 0.549) and the

social domain (0.673 and 0.567). For all Chinese IBDQ

domains, the correlation with SF-36 was stronger for

Crohn’s disease than for ulcerative colitis.

Similarly, the Chinese IBDQ scores for Crohn’s disease

and ulcerative colitis correlated well and significantly

with CDAI and CAI, respectively (all four domains,

P < 0.001). The correlation coefficients for disease

activity were as follows: bowel function domain,

r ¼ ) 0.719 and r ¼ )0.675 for Crohn’s disease and

ulcerative colitis, respectively; systemic domain,

) 0.642 and ) 0.511; emotional domain, )0.646 and

) 0.440; social domain, )0.623 and )0.485. Again,

the correlation scores were stronger for Crohn’s disease

than for ulcerative colitis.

The Chinese IBDQ domain scores correlated well with

VAS for Crohn’s disease only (all P < 0.001), but less

Table 1. Patient demographics

Total

IBD

Crohn’s

disease

Ulcerative

colitis

Total number 135 59 76

Males/females 81/54 42/17 39/37

Mean age (years) (s.d.) 41.5 (12.8) 39.2 (11.2) 43.5 (13.8)

Mean disease

duration (years)

6.7 7.3 6.2

IBD, inflammatory bowel disease; s.d., standard deviation.

145 Eligible patients

135 Eligible patients(59CD, 76UC)

10 excluded4 poor comprehension4 stoma1 refused1 psychiatric

99 Completed 2nd questionnaire

77 Unchanged disease activity

Reliability testing

22 Changed disease activity(15 improved, 7 deteriorated)

Sensitivity testing

Figure 1. Flow diagram of the study. CD, Crohn’s disease; UC,

ulcerative colitis.

Table 2. Construct validity of Chinese Inflammatory Bowel Disease Questionnaire (IBDQ) for Crohn’s disease and ulcerative colitis.

The Spearman correlation coefficients and P values of the Chinese IBDQ compared with the Chinese SF-36, disease activity indices and

visual analogue scales (VAS) are shown

Chinese IBDQ domain

SF-36 Disease activity index* VAS

r P r P r P

Crohn’s disease (n ¼ 59)

Bowel 0.773 < 0.001 ) 0.719 < 0.001 0.599 < 0.001

Systemic 0.801 < 0.001 ) 0.642 < 0.001 0.615 < 0.001

Social 0.673 < 0.001 ) 0.623 < 0.001 0.643 < 0.001

Emotional 0.791 < 0.001 ) 0.646 < 0.001 0.665 < 0.001

Ulcerative colitis (n ¼ 76)

Bowel 0.549 < 0.001 ) 0.675 < 0.001 0.322 0.10

Systemic 0.748 < 0.001 ) 0.511 < 0.001 0.332 0.008

Social 0.567 < 0.001 ) 0.485 < 0.001 0.113 0.378

Emotional 0.749 < 0.001 ) 0.440 < 0.001 0.445 < 0.001

SF-36, Medical Outcomes Study (MOS) 36-Item Short Form Health Survey.

* Crohn’s disease, Crohn’s disease activity index; ulcerative colitis, clinical activity index for ulcerative colitis.

714 R. W. L. LEONG et al.

� 2003 Blackwell Publishing Ltd, Aliment Pharmacol Ther 17, 711–718

Page 5: Quality of life in Chinese patients with inflammatory bowel disease: validation of the Chinese translation of the Inflammatory Bowel Disease Questionnaire

well for ulcerative colitis. The correlations were as

follows: bowel function domain, r ¼ 0.599 and

r ¼ 0.332 for Crohn’s disease and ulcerative colitis,

respectively; systemic domain, 0.615 and 0.332; social

domain, 0.643 and 0.113; emotional domain, 0.665

and 0.445. For ulcerative colitis, the bowel function and

social domains did not produce statistically significant

correlations (P > 0.05).

Discriminant ability (Table 3)

To validate that the Chinese IBDQ scores differ signifi-

cantly in patients in remission vs. those with active

disease, discriminant ability was measured. The Chinese

IBDQ scores of patients in remission were compared

with those with active disease. Disease activity was

determined objectively by the top and bottom tertile

VAS scores and the disease activity indices. In Crohn’s

disease, the Chinese IBDQ discriminated well between

groups of patients either in remission or with active

disease as measured by both VAS and CDAI (P < 0.001

for all domains). In ulcerative colitis, the Chinese IBDQ

also discriminated well between active and inactive CAI

(P < 0.001–0.005). For the differentiation of active and

inactive disease according to VAS, however, all domains

showed significance (P < 0.003–0.032), apart from the

bowel function domain which showed a strong trend

towards significance (P ¼ 0.052). Once again, the

discriminant ability of the Chinese IBDQ was more

definite for Crohn’s disease than for ulcerative colitis.

The association was stronger with the inflammatory

bowel disease activity indices rather than with the more

subjective VAS.

Test–re-test reliability (Table 4)

To validate that the Chinese IBDQ was internally

consistent amongst individuals whose disease activity

remained stable, the test–re-test reliability was meas-

ured. Patients with stable disease activity completed the

Chinese IBDQ on two occasions at a mean of 20 days

apart, and paired results were compared with the

Wilcoxon signed rank test and the ICC. The Wilcoxon

signed rank test for all four domains showed that there

was no statistical difference in the Chinese IBDQ in

those with unchanged disease activity (paired median

Chinese IBDQ scores, P > 0.05) for Crohn’s disease

(n ¼ 38 pairs) and ulcerative colitis (n ¼ 38 pairs). The

ICC showed very high test–re-test reliability for Crohn’s

disease (ICC ¼ 0.83–0.92) and ulcerative colitis

(ICC ¼ 0.76–90) for all four domains. The reliability

was significant in all cases (P < 0.001). In general, the

Table 3. Discriminant ability of the Chinese Inflammatory Bowel Disease Questionnaire (IBDQ) for Crohn’s disease and ulcerative

colitis. The Chinese IBDQ median scores in patients with low and high disease activity according to the lowest and highest tertiles of the

visual analogue scales (VAS) and disease activity indices are shown

Chinese IBDQ domain

VAS Disease activity index*

Bottom tertile Top tertile

P

Bottom tertile Top tertile

PMedian� Median� Median§ Median–

Crohn’s disease

Bowel 65.0 46.0 < 0.001 67.0 46.0 < 0.001

Systemic 30.0 19.0 < 0.001 30.0 20.0 < 0.001

Social 75.0 52.0 < 0.001 73.0 55.0 < 0.001

Emotional 34.0 24.0 < 0.001 35.0 23.0 < 0.001

Ulcerative colitis

Bowel 58.5 51.0 0.052 64.0 48.0 < 0.001

Systemic 28.5 19.0 0.003 28.0 18.0 < 0.001

Social 69.5 52.0 0.016 70.0 51.0 0.001

Emotional 33.0 27.0 0.032 34.0 25.5 0.005

* Crohn’s disease, Crohn’s disease activity index; ulcerative colitis, clinical activity index for ulcerative colitis.

� Crohn’s disease, n ¼17; ulcerative colitis, n ¼ 20.

� Crohn’s disease, n ¼17; ulcerative colitis, n ¼ 21.

§ Crohn’s disease, n ¼19; ulcerative colitis, n ¼ 23.

– Crohn’s disease, n ¼19; ulcerative colitis, n ¼ 20.

CHINESE IBDQ 715

� 2003 Blackwell Publishing Ltd, Aliment Pharmacol Ther 17, 711–718

Page 6: Quality of life in Chinese patients with inflammatory bowel disease: validation of the Chinese translation of the Inflammatory Bowel Disease Questionnaire

reliability was higher for Crohn’s disease than for

ulcerative colitis.

Sensitivity to change (Table 5)

To validate that the Chinese IBDQ was sensitive to

changes in disease activity within an individual, paired

Chinese IBDQ scores were analysed in patients who

showed a change in disease activity. To provide an

adequate sample size for this test, Crohn’s disease and

ulcerative colitis patients were pooled together (n ¼ 22

pairs). Each pair consisted of a lower Chinese IBDQ score

(indicating deterioration) compared with a higher

Chinese IBDQ score (indicating improvement). The

Wilcoxon signed rank test demonstrated a signifi-

cant difference between the paired Chinese IBDQ scores

in all four domains (bowel function domain, P ¼ 0.005;

social domain, P ¼ 0.007; systemic domain, P ¼0.019; emotional domain, P ¼ 0.041).

DISCUSSION

The incidence of inflammatory bowel disease in China is

lower than that in Western nations, but is increasing

rapidly.15 Inflammatory bowel disease may become an

important disease in China with the ongoing Western-

ization and economic development of the country.

There is also a growing emphasis on the quality of life

as an important end-point in the measurement of

inflammatory bowel disease activity.6 The quality of life

of Chinese patients with inflammatory bowel disease is

unknown, but is of interest and importance given the

sheer volume of potential patients in the most populous

nation in the world. The previous rarity of inflammatory

bowel disease in China may result in a paucity of

disease-related information, resources and social sup-

port groups and a low level of understanding from non-

specialized doctors. These factors may adversely impair

the quality of life and a prospective study is required to

determine this. The IBDQ has been translated into

different languages11–14 and validated to be reliable. For

the first time, a Chinese translation of the IBDQ is

available.

This study showed that the Chinese translation of the

IBDQ is a valid and reliable instrument for the

assessment of patients with inflammatory bowel disease

in Hong Kong. The Chinese IBDQ showed a high degree

of construct validity. The Chinese IBDQ scores correlated

well with the established Chinese translation of the

SF-36 and with the disease activity indices (CDAI and

CAI). There was good discriminant ability and the

Chinese IBDQ was able to differentiate between patients

with inactive and active disease as indicated by

subjective VAS scores and objective disease activity

indices. The test–re-test reliability also demonstrated

good internal validity in the paired intra-individual

scores in those with stable disease activity. To improve

the accuracy of the reliability test, we performed a

follow-up survey within 1 month of the initial ques-

tionnaire to ensure the accurate recall of any change in

disease activity during the interval period. In patients

who showed a change in disease activity, the Chinese

IBDQ changed correspondingly. All four domains pro-

duced similar results. In general, the results were very

acceptable and comparable with other translations.11–14

Although the Chinese IBDQ scores for ulcerative colitis

correlated less well with some of the VAS domain

scores, the more important comparisons with the CAI

were all significant. The poorer correlation with VAS

Table 5. Sensitivity to change of the Chinese Inflammatory Bowel

Disease Questionnaire (IBDQ) for combined Crohn’s disease and

ulcerative colitis (n ¼ 22). The paired median Chinese IBDQ

scores changed significantly with changing disease activity

(relative deterioration and improvement)

Chinese IBDQ domain Deterioration Improvement P

Bowel 44.0 50.5 0.005

Systemic 19.1 21.7 0.019

Social 50.2 57.9 0.007

Emotional 26.0 29.0 0.041

Table 4. Test–re-test reliability of the Chinese Inflammatory

Bowel Disease Questionnaire (IBDQ) for Crohn’s disease and

ulcerative colitis. The follow-up paired median Chinese IBDQ

scores remained stable in patients in whom the disease activity

was unchanged

Chinese IBDQ domain Baseline Follow-up ICC P

Crohn’s disease (n ¼ 38 pairs)

Bowel 56.0 57.0 0.8767 < 0.001

Systemic 25.0 24.0 0.8321 < 0.001

Social 63.0 61.0 0.9066 < 0.001

Emotional 32.5 33.0 0.9164 < 0.001

Ulcerative colitis (n ¼ 38 pairs)

Bowel 58.0 57.0 0.7572 < 0.001

Systemic 26.5 24.0 0.8781 < 0.001

Social 67.0 61.3 0.8712 < 0.001

Emotional 34.0 33.0 0.9016 < 0.001

ICC, intra-class correlation coefficient.

716 R. W. L. LEONG et al.

� 2003 Blackwell Publishing Ltd, Aliment Pharmacol Ther 17, 711–718

Page 7: Quality of life in Chinese patients with inflammatory bowel disease: validation of the Chinese translation of the Inflammatory Bowel Disease Questionnaire

may indicate the lack of reliability of VAS, which is a

crude measure of well-being subject to variable inter-

pretation by patients. In ulcerative colitis, the appear-

ance of a small amount of red blood in the bowel

motion, which can commonly occur with mild distal

disease, is often misinterpreted by patients to indicate a

more severe flare. This may then be reflected by a high

grading on the VAS score, whereas the corresponding

Chinese IBDQ and CAI scores do not reflect the

dysfunction to the same degree. In addition, most

patients with ulcerative colitis were in remission at the

time of completion of the questionnaire, and the lack of

a range of disease activity may make it difficult for the

Chinese IBDQ scale to produce a good correlation. The

higher construct validity for Crohn’s disease compared

with ulcerative colitis was also noted in the Greek

translation of the IBDQ.14

The very encouraging results in patients with Crohn’s

disease in all domains and in all comparisons indicate

that there are no significant idiomatic disparities, cul-

tural barriers or societal differences with this translation

of the questionnaire. Importantly, patients had no

difficulty in completing the self-administered question-

naire. It was easily incorporated into the routine at the

out-patient department without any significant changes

to the routines of the staff. Consultation was also

obtained from the original authors of the questionnaire

at McMaster University and, to our knowledge, this

translation is the only translation into an Asian language

that has been performed with their approval and help.

In conclusion, the Chinese IBDQ is a valid and reliable

instrument that correlates well with the patients’

subjective well-being and clinical disease activity. We

believe that the Chinese IBDQ will be a useful tool in

patients with inflammatory bowel disease for the assess-

ment of the quality of life in clinical trials and health

surveys and for the assessment of therapeutic efficacy.

ACKNOWLEDGEMENTS

The use of the IBDQ, authored by Dr Jan Irvine, was

made under license from McMaster University, Hamil-

ton, Canada.

The use of the Chinese (HK) SF-36 was by agreement

with Dr Cindy Lam, University of Hong Kong, Hong

Kong SAR.

Dr R. W. L. Leong is supported by an Overseas

Research Fellowship from the University of Western

Australia.

REFERENCES

1 Kjeldsen J, Schaffalitzky de Muckadell OB. Assessment of dis-

ease severity and activity in inflammatory bowel disease.

Scand J Gastroenterol 1993; 28: 1–9.

2 Truelove SC, Witts LJ. Cortisone in ulcerative colitis.

Preliminary report in a therapeutic trial. Br Med J 1954; 2:

374–8.

3 Best WR, Becktel JM, Singleton JW. Rederived values of the

eight coefficients of the Crohn’s Disease Activity Index (CDAI).

Gastroenterology 1979; 77: 843–6.

4 Lichtiger S, Present DH, Kornbluth A, et al. Cyclosporine in

severe ulcerative colitis refractory to steroid therapy. N Engl J

Med 1994; 330: 1841–5.

5 Hodgson HJF, Bhatti M. Assessment of disease activity in

ulcerative colitis and Crohn’s disease. Inflamm Bowel Dis

1995; 1: 117–43.

6 Irvine EJ, Borgaonkar MR. Quality of life measurement in

gastrointestinal and liver disorders. Gut 2000; 47: 444–54.

7 Guyatt G, Mitchell A, Irvine EJ, et al. A new measure of health

status for clinical trials in inflammatory bowel disease. Gas-

troenterology 1989; 96: 804–10.

8 Irvine EJ. Quality of life measurement in IBD. Scand J Gas-

troenterol 1993; 199: 36–9.

9 Guillemin F, Bombardier C, Beaton D. Cross-cultural adapta-

tion of health-related quality of life measures: literature review

and proposed guidelines. J Clin Epidemiol 1993; 46: 1417–32.

10 Kleinman A, Eisenberg L, Good B. Culture, illness, and

care: clinical lessons from anthropologic and cross-cultural

research. Ann Intern Med 1978; 88: 251–8.

11 Russel MG, Pastoor CJ, Brandon S, et al. Validation of

the Dutch translation of the inflammatory bowel disease

questionnaire (IBDQ): a health-related quality of life ques-

tionnaire in inflammatory bowel disease. Digestion 1997; 58:

282–8.

12 Lopez-Vivancos J, Casellas F, Badia X, Vilaseca J, Malagelada

JR. Validation of the Spanish version of the inflammatory

bowel disease questionnaire on ulcerative colitis and Crohn’s

disease. Digestion 1999; 60: 274–80.

13 Kim WH, Cho YS, Yoo HM, Park IS, Park EC, Lim JG. Quality

of life in Korean patients with inflammatory bowel disease:

ulcerative colitis, Crohn’s disease and intestinal Behcet’s dis-

ease. Int J Colorectal Dis 1999; 14: 52–7.

14 Pallis AG, Vlachonikolis IG, Mouzas IA. Quality of life of Greek

patients with inflammatory bowel disease. Validation of the

Greek translation of the inflammatory bowel disease ques-

tionnaire. Digestion 2001; 63: 240–6.

15 Jiang XL, Cui HF. An analysis of 10218 ulcerative colitis cases

in China. World J Gastroenterol 2002; 8: 158–61.

16 Lennard-Jones JE. Classification of inflammatory bowel dis-

ease. Scand J Gastroenterol Suppl 1989; 24: 2–6.

17 Irvine EJ. Does self-administration of a quality of life index for

inflammatory bowel disease change the results? J Clin Epi-

demiol 1996; 49: 1177–85.

18 Lam CL, Gandek B, Ren XS, Chan MS. Tests of scaling

assumptions and construct validity of the Chinese (HK) ver-

sion of the SF-36 health survey. J Clin Epidemiol 1998; 51:

1139–47.

CHINESE IBDQ 717

� 2003 Blackwell Publishing Ltd, Aliment Pharmacol Ther 17, 711–718

Page 8: Quality of life in Chinese patients with inflammatory bowel disease: validation of the Chinese translation of the Inflammatory Bowel Disease Questionnaire

19 Ware JE, Sherbourne CD. The MOS 36-item short form health

survey (SF-36): Conceptual framework and item selection.

Med Care 1993; 31: 327–63.

20 McHorney CA, Ware JE, Lu R, Sherbourne CD. The MOS

36-item Short Form Health Survey (SF-36). Test of data

quality, scaling assumptions, and reliability across diverse

patient groups. Med Care 1994; 32: 40–66.

21 Bensoussan A, Chang SW, Menzies RG, Talley NJ. Application

of the general health status questionnaire SF36 to patients

with gastrointestinal dysfunction: initial validation and val-

idation as a measure of change. Aust NZ J Public Health

2001; 25: 71–7.

718 R. W. L. LEONG et al.

� 2003 Blackwell Publishing Ltd, Aliment Pharmacol Ther 17, 711–718