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Validation of the Persian Version of Inflammatory Bowel Disease Questionnaire in Patients Who Referred to Clinics and Hospitals of Birjand University of Medical Science, Iran


1 Associate Professor, Department of Community Medicine, Birjand University of Medical Sciences, Birjand, Iran
2 MD, Birjand University of Medical Sciences Birjand, Iran
*Corresponding author: Bita Bijari, Associate Professor, Department of Community Medicine, Birjand University of Medical Sciences, Birjand, Iran. Tel: +98-5632381506, Fax: +98-5632433004, E-mail: bita.bijari@yahoo.com.
Annals of Colorectal Research. In Press(In Press): e46367 , DOI: 10.5812/acr.46367
Article Type: Research Article; Received: Feb 6, 2017; Revised: Feb 28, 2017; Accepted: Mar 11, 2017; epub: Mar 31, 2017;

Abstract


Background: Inflammatory bowel disease (IBD) questionnaire is a disease-specific questionnaire to measure the health related quality of life (QOL) in patients with inflammatory bowel disease.

Objectives: The current study aimed at assessing the validity of the Persian version of the QOL questionnaire in patients with inflammatory bowel disease referred to the clinics and hospitals affiliated to Birjand University of Medical Sciences, Iran.

Methods: The current cross sectional study included 87 patients who referred to the clinics and hospitals affiliated to Birjand University of Medical Sciences from 2014 to 2015; IBD diagnosis was confirmed in the subjects by the pathological analyses and accordingly they were asked to complete the Persian version of IBDQ. Data were analyzed by SPSS (15) using descriptive statistics, internal consistency reliability, construct validity (by the short-form 36), and factor analysis was used for the structural validity of the questionnaire.

Results: A total of 87 patients with the mean age of 38.80 ± 16.17 years enrolled in the study. Mean score of QOL based on IBDQ questionnaire, was 158.99 ± 24.9 out of 224. The factor analysis of the Persian version did not confirm the structural factor of the original questionnaire. Cronbach’s alpha for the questionnaire was 0.94, in domains from 0.68 to 0.89. The correlation between the domains of QOL in IBDQ and SF-36 inventory were 0.44 to 0.69

Conclusions: Due to the high internal consistency and correlation coefficients with SF-36 inventory, it can be used in the studies to evaluate the QOL in the patients.

Keywords: Inflammatory Bowel Disease; Quality of Life; Validity; Reliability

1. Background


Inflammatory bowel disease (IBD) includes the Crohn disease and ulcerative colitis that affects about 10% to 20% of the world population (1). The prevalence of IBD is increasing in the world for unknown reasons (2). Crohn disease and ulcerative colitis affect males and females equally, with the peak age group of 10 to 40 years and the highest prevalence in Europe and North America. There are various symptoms such as diarrhea, fatigue, weight loss, and abdominal pain associated with IBD (3).

Ulcerative colitis and the Crohn disease have a chronic nature and are associated with inflammatory lesions and ulcers; the early onset affects the social aspects of patients life and quality of life (QOL) (4). IBD is chronic with intermittent periods of onset and remission. Chronic nature, severity and recurrence of symptoms, extraintestinal manifestations, drug and surgical effects and side effects, concerns about the possibility of cancer and other characteristics of IBD affect the daily life of patients and considerably decrease their QOL (5).

Health-related QOL (HRQOL) is a dynamic subjective concept that according to the definition by the world health organization (WHO) is the people’s perception of their position in life, goals, expectations, standards and priorities; it is completely personal, and is based on individuals' perceptions of various aspects of their lives (6).

The quality of life is assessed by several tools that are categorized as general based on specific diseases. General tools to measure the QOL, such as SF-36 inventory, are translated into Persian and validated in Iran (7).

IBDQ questionnaire is a specific QOL questionnaire in patients with IBD that is a validated, reliable, sensitive, and culturally adapted questionnaire and is often used in clinical trials and epidemiologic studies. This questionnaire was translated into more than 13 languages (5).

2. Objectives


According to the fact that IBD affects the QOL of patients in different aspects and due to lack of a proper and practical tool to assess the QOL of such patients, the current study aimed at assessing the validity of the Persian version of the QOL questionnaire in patients with IBD.

3. Methods


The current cross sectional, descriptive-analytic study included all patients who referred to the clinics and hospitals affiliated to Birjand University of Medical Sciences from 2014 to 2015; the subjects were recruited by the convenience sampling method and IBD diagnosis was confirmed in them based on the pathological analyses. The exclusion criteria were: lack of access to patients, non-compliance of patients to participate into the study, and the presence of other chronic diseases that affected their QOL. All participants were enrolled after signing the informed consent.

The IBDQ was 1st translated into Persian by the researcher and 2 other experts in English translation, and then, the translated versions were compared and the questions were matched and the questionnaire again was back translated into English. The 2 versions of the questionnaire were compared by the researcher and any differences were discussed and resolved.

Finally, the Persian versions of IBDQ were matched with the original version, and the final Persian version was developed.

After preparation of the questionnaire, the researcher referred to the pathology clinics of Vali-Asr and Imam Reza hospitals and internal clinic in Vali-Asr Hospital and gastroenterologist clinics and the data of patients with IBD diagnosis were extracted. After referring to the medical records of patients, the address and phone numbers of the patients were collected and patients were contacted. Then, the researcher introduced the objectives and goals of the study to patients; those who were willing to cooperate were enrolled. When patients referred to the internal clinics, the questionnaire was completed through interview.

To collect data, the information checklist containing the study variables, and the IBDQ and SF-36 inventory were completed.

IBDQ specifically assesses the QOL inpatients with IBD; it includes 32 questions in 4 domains: bowel, systemic, emotional, and social. Each question has 7 options that the patients choose 1 of them according to their condition in the past 2 weeks. Each question has 7 points with the best as score 7 and the worst as score1; scores ranging from 32 to 224 and the higher scores show better QOL. In this questionnaire, 10 questions assess the bowel symptoms, 12 questions the emotional status and 5 questions the social function. This questionnaire was translated into 13 languages, validated, and had high validity and reliability in clinical and epidemiological studies (5).

SF-36 inventory has 36 questions in 2 physical and mental domains and 8 subdomains. The score of each question is determined by a scoring system table of SF-36. SF-36 inventory is a tool to check the general QOL. The questionnaire includes the following domains: role limitations due to physical health (4 items), physical function (10 items), general health (6 items), pain (2 items), energy/fatigue (4 items), social functioning (2 items), emotional wellbeing (5 items), and role limitations due to emotional problems (3 items). The questionnaire was validated in Iran (7).

After completing the questionnaire, data were assessed by SPSS software (16). To examine the reliability and structural validity of the questionnaire, Cronbach’s alpha coefficient and factor analysis were used for internal consistency.

To determine the structural validity of IBDQ, factor analysis was used by the varimax rotation method. Factors with Eigen value greater than 1 were designated as appropriate, variables loads greater than 0.5 were accepted as presentable variable in factors.

To assess convergent validity, the correlation between different aspects of IBDQ and SF-36 were analyzed using the Pearson correlation coefficient. To compare the mean scores of the variables, independent t test and ANOVA were used at a significant level of 0.05.

3.1. Ethics

The study protocol was approved by the ethics committee of Birjand University of Medical Sciences (code: Ir.bums.1394.14). The study objectives were explained to the patients prior to participation and if agreed, written informed consent was obtained from them.

4. Results


The current study included 87 patients with the mean age of 38.80 ± 16.17 years; 69 patients were diagnosed with ulcerative colitis (79.3%) and 16 patients (20.7%) with the Crohn disease. Mean duration of the disease was 90.96 ± 3.22 months that was 90.78 ± 3.47 in ulcerative colitis and 91.66 ± 1.87 in the Crohn disease. Table 1 presents the demographic and clinical characteristics of the patients with IBD.

Table 1.
Frequency Distribution of Demographic Characteristics in the Study Subjects

Total mean score of QOL based on IBDQ was 158.99 ± 24.9 out of 224 (Table 2).

Table 2.
Descriptive Characters and Internal Consistency Coefficients of IBDQ and the Domains

Mean score of QOL was 157.68 ± 25.8 in ulcerative colitis and 164 ± 20.8 in the Crohn disease that was higher in patients with the Crohn disease without significant difference (P value = 0.34) (Table 3).

Table 3.
Comparison of QOL in the Study Subjects Based on the Study Variable

Mean score of QOL had no significant difference based on the type of disease, gender, family history, and marital status (P value > 0.05) (Table 3).

Comparison of the QOL and its domains by age showed that people under 30 years had significantly higher QOL in intestinal (P value = 0.04) and systemic symptoms (P value = 0.01) than other age groups.

Cronbach’s alpha for the whole questionnaire was 0.94 and in the domain of 0.68 to 0.89 (Table 2).

The factor analysis of the Persian version did not confirm the structural factor of the original questionnaire. In this method, 7 factors had Eigen value greater than 1 that described 69.43% of variance in the variables. Question 5 (bowel movements loose) was not included in any of the factors and question 12 (difficulty in leisure or sports activities) had the highest factor load in factor 3, but it was lower than 0.5 (0.48) (Table 4).

Table 4.
Factor Analysis: Factor Load for the Core Domain of IBDQ

To assess the construct validity of the questionnaire, the correlation between the domains of QOL in IBDQ and SF-36 inventory were calculated. Correlation coefficients between the domains of the questionnaire showed the highest correlation coefficient between the general health of SF-36 inventory and the emotional status of IBDQ (0.69), and the physical functioning scale of SF-36 and the social function of IBDQ(0.67) (Table 5).

Table 5.
Correlations of IBD Domains With Short-Form 36 Domainsa

5. Discussion


The current study aimed at validating the Persian version of the QOL questionnaire in patients with IBD who referred to clinics and hospitals affiliated to Birjand University of Medical Sciences.

Factor analysis of the Persian version could not confirm the structural factor of the original questionnaire. In the study by Hjortswang H. et al., on validation of the Swedish version of IBDQ, the factor analysis did not support 4 domains in the Swedish version. The domains scores had high convergence, but low valid differentiation and homogeneity (8).

In the English version of the questionnaire, 5 domains were detected and the load factor for similar questions did not resemble the original version (9).

Pallis et al., evaluated the validity of IBDQ in 9 studies in Britain, the Netherlands, Spain, Korea, Sudan, Greece, and China, but only 2 studies supported the distribution of questions in 5 domains. Also, they showed that IBDQ had high reliability and validity in different nations and cultures (10).

In these studies, factor distribution of the questions in the questionnaire was not identical with the original version that is similar to the present study.

In the current study, Cronbach’s alpha for the whole questionnaire was 0.94, ranged from 0.68 to 0.89. In the German (11) and Chinese (12) versions of IBDQ, similar Cronbach’s alpha coefficients were reported in different domains.

In the current study, the mean score of QOL was 158.99 ± 24.9 out of 224 that was higher in patients with the Crohn disease, but had no statistically significant difference in patients with ulcerative colitis. In the study by Pallis et al., to validate the health-related QOL in patients with IBD in Greece, the scores were higher than those of the current study, but there was no difference between the Crohn disease and ulcerative colitis (13), consistent with the present study.

The reason of differences between the results of different studies may be due to differences in sample size and supportive measures in various areas that can affect the QOL of patients. Also, various degrees of disease in patients could be another reason for the difference in the results.

In the current study, there was a high correlation between the domains of the 2 questionnaires, IBDQ and SF-36, which showed the high convergent validity of the Persian version. In most studies, to assess the convergence validity correlation between the domains of the questionnaire with those of the SF-36 questionnaire, a high correlation was found (13-15), consistent with the results of the current study.

The study by Leong et al., on validation of the Chinese version of IBDQ showed a high correlation with SF-36 in all 4 domains, activity index of the Crohn and colitis disease and visual analogue scale (14).

The study by Maleki et al., on 68 patients with ulcerative colitis compared the results of the SF-36 inventory and IBDQ, the results showed a high correlation between all domains of the questionnaires, except in the bowel symptoms (15).

In the study by Verissimo et al., the questionnaire was proven as a promising simple tool that can easily assess the QOL in patients with IBD (16).

The main limitation of the current study was small the sample size. The sample size was low for a validation study. Also, the association between QOL with the severity of the disease that can affect the QOL in patients with IBD was not assessed.

5.1.Conclusion

The factor analysis of the Persian version did not confirm the structural factor of the original questionnaire, but due to the high internal consistency and correlation coefficients with those of SF-36 inventory, it can be used in studies evaluating the QOL of such patients.

Acknowledgments

Authors would like to thank all patients who participated in the study. They also thank the deputy of research and technology of Birjand University of Medical Sciences for the financial support of the work.

Footnotes

Authors’ Contribution: Bita Bijari: study design, writing of the manuscript, and statistical analyses; Behnam Soltani: study design, data collection, and writing of the manuscript.
Conflicts of Interest: The authors declared no conflicts of interest.
Funding/Support: The current study was financially supported by the deputy of research and technology of Birjand University of Medical Sciences, Iran.

References


  • 1. Knowles SR, Austin DW, Sivanesan S, Tye-Din J, Leung C, Wilson J, et al. Relations between symptom severity, illness perceptions, visceral sensitivity, coping strategies and well-being in irritable bowel syndrome guided by the common sense model of illness. Psychol Health Med. 2017;22(5):524-34. [DOI] [PubMed]
  • 2. Burisch J, Munkholm P. Inflammatory bowel disease epidemiology. Curr Opin Gastroenterol. 2013;29(4):357-62. [DOI] [PubMed]
  • 3. Jordan C, Sin J, Fear NT, Chalder T. A systematic review of the psychological correlates of adjustment outcomes in adults with inflammatory bowel disease. Clin Psychol Rev. 2016;47:28-40. [DOI] [PubMed]
  • 4. Umanskiy K, Fichera A. Health related quality of life in inflammatory bowel disease: the impact of surgical therapy. World J Gastroenterol. 2010;16(40):5024-34. [PubMed]
  • 5. Gholamrezaei A, Haghdani S, Shemshaki H, Tavakoli H, Emami MH. Linguistic validation of the inflammatory bowel disease questionnaire-short form (IBDQ-9) in Iranian population. J Isfahan Med School. 2011;28(123)
  • 6. Nejat S. Quality of Life and its Measurement. irje. 2008;4(2):57-62.
  • 7. Montazeri A, Goshtasebi A, Vahdaninia M, Gandek B. The Short Form Health Survey (SF-36): translation and validation study of the Iranian version. Qual Life Res. 2005;14(3):875-82. [PubMed]
  • 8. Hjortswang H, Jarnerot G, Curman B, Sandberg-Gertzen H, Tysk C, Blomberg B, et al. Validation of the inflammatory bowel disease questionnaire in Swedish patients with ulcerative colitis. Scand J Gastroenterol. 2001;36(1):77-85. [PubMed]
  • 9. Cheung W, Garratt AM, Russell IT, Williams JG. The UK IBDQ-A British version of the inflammatory bowel disease questionnaire. J Clin Epidemiol. 2000;53(3):297-306. [DOI]
  • 10. Pallis AG, Mouzas IA, Vlachonikolis IG. The inflammatory bowel disease questionnaire: a review of its national validation studies. Inflamm Bowel Dis. 2004;10(3):261-9. [PubMed]
  • 11. Hauser W, Dietz N, Grandt D, Steder-Neukamm U, Janke KH, Stein U, et al. Validation of the inflammatory bowel disease questionnaire IBDQ-D, German version, for patients with ileal pouch anal anastomosis for ulcerative colitis. Z Gastroenterol. 2004;42(2):131-9. [DOI] [PubMed]
  • 12. Ren WH, Lai M, Chen Y, Irvine EJ, Zhou YX. Validation of the mainland Chinese version of the Inflammatory Bowel Disease Questionnaire (IBDQ) for ulcerative colitis and Crohn's disease. Inflamm Bowel Dis. 2007;13(7):903-10. [DOI] [PubMed]
  • 13. Pallis AG, Vlachonikolis IG, Mouzas IA. Assessing health-related quality of life in patients with inflammatory bowel disease, in Crete, Greece. BMC Gastroenterol. 2002;2:1. [PubMed]
  • 14. Leong R, Lee YT, Ching J, Sung J. Quality of life in Chinese patients with inflammatory bowel disease: validation of the Chinese translation of the inflammatory bowel disease questionnaire. Aliment Pharmacol Ther. 2003;17(5):711-8.
  • 15. Maleki I, Taghvaei T, Barzin M, Amin K, Khalilian A. Validation of the Persian version of the inflammatory bowel disease questionnaire (IBDQ) in ulcerative colitis patients. Caspian J Intern Med. 2015;6(1):20-4. [PubMed]
  • 16. Verissimo R. Quality of life in inflammatory bowel disease: psychometric evaluation of an IBDQ cross-culturally adapted version. J Gastrointestin Liver Dis. 2008;17(4):439-44. [PubMed]

Table 1.

Frequency Distribution of Demographic Characteristics in the Study Subjects

CharacteristicsUlcerative Colitis, N (%)The Crohn Disease, N (%)IBD, N (%)
Gender
Male45 (65.2)10 (55.6)55 (63.2)
Female24 (34.8)8 (44.4)32 (36.8)
Age group
< 3029 (42)4 (22.2)33 (37.9)
30 - 4021 (30.4)4 (22.2)25 (28.7)
> 4019 (17.5)10 (55.5)29 (33.3)
Educational level
Under high school diploma17 (24.6)11 (61.1)28 (32.2)
High school graduated52 (75.4)7 (38.9)59 (67.8)
Family history
Positive6 (8.7)0 (0)6 (6.9)
Negative63 (91.3)18 (100)81 (93.1)
Marital status
Married55 (59.7)16 (88.9)71 (81.6)
Single14 (20.3)2 (11.1)16 (18.4)
Smoking
Yes5 (7.2)2 (11.1)7 (8)
No64 (92.8)16 (88.9)80 (92)
Phase
Remission56 (81.2)14 (77.8)70 (80.5)
Relapse13 (18.8)4 (22.2)17 (19.5)

Table 2.

Descriptive Characters and Internal Consistency Coefficients of IBDQ and the Domains

DomainsMean ± SDRangeMedian25th Percentile75th PercentileCronbach’s Alpha
Total IBDQ158.99 ± 24.966 - 2101661441760.94
Bowel symptoms47.27 ± 7.4620 - 614942520.77
Emotional status59.72 ± 10.3424 - 826153670.89
Systemic symptoms23.98 ± 4.2810 - 322521270.75
Social function28 ± 4.6512 - 352926310.68

Table 3.

Comparison of QOL in the Study Subjects Based on the Study Variable

CharacteristicsMean ± SDP Value
Gender0.47
Male157.63 ± 24.91
Female161.50 ± 25.07
Age group0.03
< 30166.88 ± 21.45
30 - 40158.60 ± 25.47
> 40150.34 ± 25.90
Family history0.98
Positive158.83 ± 27.78
Negative159 ± 24.86
Marital status0.05
Married156.58 ± 25.28
Single169.69 ± 20.57
Smoking0.007
Yes135 ± 24.81
No161.09 ± 23.93
IBD0.34
Ulcerative colitis157.68 ± 25.83
The Crohn disease164 ± 20.83
Phase0.00
Remission166.67 ± 18.36
Relapse127.35 ± 23.58

Table 4.

Factor Analysis: Factor Load for the Core Domain of IBDQ

Rotated Component MatrixComponent
1234567
Q2Feeling fatigue or being tired0.570.340.260.140.29-0.110.66
Q6Energy0.520.210.18-0.170.190.130.45
Q16Avoid attending events where there was no bathroom at hand0.570.250.430.140.110.280.07
Q29Troubled by feeling sick to your stomach0.530.350.220.180.210.350.04
Q30Felt irritable0.740.110.170.270.140.090.13
Q31Felt a lack of understanding others0.700.050.080.320.250.170.13
Q32Satisfied, happy, or pleased in personal life0.710.230.100.100.210.240.04
Q3Felt frustrated, impatient, or restless0.460.520.120.23-0.040.180.30
Q4Unable to attend school or work0.230.610.280.340.10-0.020.25
Q9Troubled by cramps in your abdomen0.140.790.090.120.290.07-0.04
Q10Felt generally unwell0.230.510.460.030.220.18-0.01
Q11Troubled due to fear of not finding a bathroom0.440.540.340.100.170.100.08
Q13Troubled by pain in the abdomen0.230.740.110.240.110.100.10
Q21Felt relaxed and free of tension-0.0040.650.03-0.050.180.470.22
Q7Feel worried about the possibility of the for a surgery-0.140.120.580.250.29-0.030.27
Q8Delay or cancel a social engagement0.220.090.800.070.200.00-0.03
Q12Difficulty with doing leisure or sports activities0.280.250.480.160.430.110.02
Q14Problems getting a good night sleep0.320.160.690.15-0.100.150.12
Q18Problem with maintaining or getting to the weight0.310.140.020.590.440.000.07
Q19Worries about getting cancer, never feeling better, and having a relapse0.410.410.140.63-0.03-0.02-0.02
Q22Problem with rectal bleeding0.080.070.180.630.090.280.41
Q24Troubled by a feeling of having to go to the bathroom even with empty bowels0.280.260.220.510.250.300.23
Q26Troubled by accidental soiling of your underpants0.240.160.350.58-0.070.35-0.11
Q17Problem with passing large amounts of gas0.260.100.160.030.740.140.09
Q20Troubled by a feeling of abdominal bloating0.170.230.110.030.780.060.10
Q23Felt embarrassed as the result of soiling or an unpleasant odor0.090.360.180.440.520.180.28
Q15Felt depressed or discouraged0.400.310.16-0.12-0.080.600.29
Q25Felt tearful of upset0.330.180.060.240.320.560.05
Q27Felt angry as a result of your bowel problems0.270.150.270.310.040.640.01
Q28Limited sexual activity0.060.00-0.050.080.080.76-0.08
Q1Frequent bowel movements0.120.280.020.140.29-0.110.66

Table 5.

Correlations of IBD Domains With Short-Form 36 Domainsa

SF-36IBD
Bowel SymptomsSystemic SymptomsEmotional StatusSocial Function
Physical functioningr = 0.57br = 0.62br = 0.63br = 0.67b
Role limitations due to physical healthr = 0.63br = 0.64br = 0.66br = 0.51b
Role limitations due to emotional problemsr = 0.53br = 0.50br = 0.59br = 0.49b
Energy/ fatiguer = 0.50br = 0.54br = 0.56br = 0.49b
Emotional well beingr = 0.44br = 0.52br = 0.61br = 0.41b
Social functioningr = 0.44br = 0.48br = 0.50br = 0.50b
Painr = 0.58br = 0.61br = 0.64br = 0.59b
General healthr = 0.58br = 0.59br = 0.69br = 0.54b
a r: Pearson correlation (2-tailed test).
b P value < 0.001.