These authors contributed equally to this study.
The inflammatory bowel disease (IBD)-disk is a validated, visual, 10-item, self-administered questionnaire used to evaluate IBD-related disability. The present study aimed to evaluate IBD-disk in assessment of IBD daily life burden and its relation with disease activity.
A cross-sectional study was conducted between June 2021 and December 2021. Patients with IBD were asked to complete the IBD-disk and a visual analogue scale of IBD daily-life burden (scored from 0–10, score >5 indicative of high burden). The internal consistency of IBD-disk, correlation with IBD daily life burden and disease activity (assessed by partial Mayo score and Harvey Bradshaw Index in patients with ulcerative colitis [UC] and Crohn’s disease [CD], respectively) and diagnostic performance of IBD-disk to detect high burden were analyzed.
Out of the 546 patients (mean age 40.33±13.74 years, 282 [51.6%] males) who completed the IBD-disk, 464 (84.98%) had UC and the remaining (n=82, 15.02%) had CD. A total of 311 patients (291 UC and 20 CD; 56.95%) had active disease. The mean IBD-disk total score and IBD daily life burden were 18.39±15.23 and 2.45±2.02, respectively. The IBD-disk total score correlated strongly with the IBD daily life burden (ρ=0.94,
The IBD-disk accurately predicts the daily life burden and parallels disease activity in patients with IBD and can be applied in clinical practice. (Intest Res, Published online)
The treatment of inflammatory bowel disease (IBD), including both ulcerative colitis (UC) and Crohn’s disease (CD), is focused on clinical, endoscopic, and/or histological healing; and the importance of disease-related disability and quality of life is often underestimated [
The patient acceptability, understanding, and response to self-administered tools like IBD-disk are influenced by the local socio-cultural sensitivities and practices [
This is a cross-sectional study of patients with IBD (both UC and CD) who attended the outpatient clinic at Dayanand Medical College and Hospital Ludhiana, India between June 2021 and December 2021. Consecutive adult ( ≥ 18 years) patients with an established diagnosis of IBD (based on European Crohn’s and Colitis Organisation and the European Society of Gastrointestinal and Abdominal Radiology guidelines) [
The IBD-disk includes 10 components (joint pain, abdominal pain, body image, education and work, emotions, energy, interpersonal interactions, regulation of defecation, sexual function, and sleep) (
Patients with both UC and CD were classified according to the Montreal classification [
The quantitative data were expressed as mean ± standard deviation and the qualitative data as frequency. The associations between IBD-disk total score and patient and disease characteristics were evaluated using the Mann‐Whitney test. A probability value of < 0.05 was considered statistically significant. Spearman’s correlation coefficient (ρ) was applied to assess the correlation between IBD-disk total score, IBD-disk subscores, IBD daily life burden, and disease activity. The values of ρ between 0.1–0.39, 0.40–0.69, 0.70–0.89, and ≥ 0.90 were interpreted as weak, moderate, strong, and very strong correlations, respectively [
During the study period, a total of 613 patients were asked to complete the IBD-disk questionnaire. After exclusion of the patients with incomplete questionnaires, 546 patients (84.9%; mean age, 40.33 ± 13.74 years, 282 males [51.6%]) were enrolled and analyzed. The majority of the patients (n = 464, 84.98%) had UC. Out of the 546 patients, 311 patients (56.95%) had the active disease (291 UC and 20 CD), while the remaining 235 patients (173 UC and 62 CD) were in remission. The baseline characteristics of the study population are summarized in
The mean IBD-disk total score of the enrolled patients was 18.39 ± 15.23. The mean IBD-disk subscores ranged between 0.07 (sexual functions) and 4.40 (energy). Forty-four patients (8.05%; 38 UC and 6 CD) had high IBD daily life burden. The mean IBD daily life burden score was 2.45 ± 2.02.
There was a strong correlation between the IBD-disk total score and the IBD daily life burden (ρ = 0.94,
On analyzing the subscores of the IBD-disk, 3 components (emotions, energy, and education and work) had a strong correlation, 6 components (abdominal pain, joint pain, body image, sleep, interpersonal interactions, and regulating defecation) had a moderate correlation while sexual functions had a weak correlation with the IBD daily life burden score. The correlations between IBD-disk subscores and IBD daily life burden in patients with UC and CD are summarized in
Cronbach’s α calculated for the IBD-disk total score was 0.82. To test the contribution and consistency of the IBD-disk, one-at-a-time deletion of different items was done. The Cronbach’s α (if item deleted) varied between 0.78 and 0.83 for all the 10 individual components of the IBD-disk. The corrected item-total correlations were > 0.4 for all the subscores except joint pain and sexual functions (
The IBD-disk total score correlated moderately with PMS (ρ = 0.50) and weakly with HBI (ρ = 0.34). The IBD daily life burden score had a moderate correlation with both PMS (ρ= 0.48) and HBI (ρ= 0.41). Amongst the IBD-disk subscores, regulating defecation had the maximum correlation with both PMS and HBI (
The correlations of IBD-disk total score and subscores with IBD daily life burden were compared for patients with active disease and disease in remission. The IBD-disk total score correlated more strongly with IBD daily life burden in patients with UC in remission than patients with active UC, the difference being significant (0.95 vs. 0.91,
The IBD-disk or IBD daily life burden scores were not influenced by the type of IBD (UC or CD). The IBD-disk total score, IBD-disk subscores (except sexual function) and IBD daily life burden were higher in females (
A significant association of IBD-disk total score and IBD daily life burden was also observed with PMS in patients with UC and with HBI in patients with CD (
There was no effect of age on the IBD-disk total score and IBD daily life burden. However, the mean IBD disk subscores of joint pains and sleep increased with increasing age. On subgroup analysis, younger adults (age < 40 years) with UC had higher mean scores for the body image subscore, as compared to older adults ( > 40 years) and elderly ( > 60 years). In contrast, older adults and elderly with CD had higher mean scores for joint pains (
The diagnostic accuracy of the IBD-disk total score in predicting a high IBD daily-life burden ( > 5) was evaluated by calculating the AUROC, which was 0.96 (95% confidence interval, 0.94–0.98;
For IBDs, patient-reported outcome measures evaluating both the disease activity as well as disability (and/or quality of life) are important to improve the long-term outcome and add value to the holistic IBD care. IBD disability index and IBD-disk are the 2 disability indices that have been validated in the European cohorts [
The mean IBD-disk total score was 18.39 ± 15.23 (range, 0–76). The IBD-disk total scores in the current study were lower than those reported in the west [
The IBD-disk total score correlated very strongly with IBD daily life burden (ρ= 0.94). There were no significant differences in the IBD-disk total score and IBD-disk subscores in patients with UC and CD, indicating a similar level of disability in both the types of IBD, consistent with the findings of the VALIDate study [
The IBD-disk total score had a significant association with the female sex. Similar findings were also observed in the VALIDate study [
Higher IBD-disk total scores were observed in patients with higher disease activity scores. Interestingly, the age, disease duration, extent, location, and behavior did not affect the disability scores. A total of 25 (16 UC and 9 CD) patients had IBD-disk total score > 30 despite the disease being in clinical remission. These observations suggest that nearly 1 in 7 patients with UC and one in 2 patients with CD have high disability despite the disease being in remission. The IBD-disk subscores that scored high in such patients were emotions, energy and sleep. The IBD-disk thus facilitates assessment of the “non-gastrointestinal” disability experienced by such patients. Filling up the IBD-disk questionnaire by the patient at each visit to the healthcare facility, before seeing the treating physician, will allow a meaningful discussion between the two, focussing on the specific disability-related issues.
Although our study is limited by being a single-center study, the large sample size, with the disease spectrum mimicking the epidemiological characteristics of the local IBD population, is expected to reflect the actual burden of the disease. A greater number of patients in the current study had UC, as compared to the previous IBD-disk validation studies, where CD patients dominated the inclusion cohorts. Also, a majority of the patients enrolled in the current study had mild-moderate disease activity. This is also reflected in relatively infrequent use of biologics in the included cohort. The performance of IBD disk in patients with severe disease activity, hence, needs to be assessed in future studies, as disease activity is an important modifier of the disease-related disability. The IBD-disk tool was administered in the English language. Misinterpretation in patients not well versed or fluent in English cannot be ruled out, however, the proportion of such patients is expected to be very small. Translation and validation in regional languages are nevertheless required. As repeated assessments of the IBD-disk were not performed in the current study, the test-retest reliability could not be evaluated. This has, however, been reported earlier [
In conclusion, the IBD-disk is a consistent and accurate tool to determine IBD-related disability. It parallels the disease activity in patients with both UC and CD and is not affected by other disease characteristics, demonstrating the ubiquity of the tool, although gender specificity needs to be accounted for. The response to the IBD-disk is influenced by social and cultural beliefs. A universal cutoff of the IBD-disk cannot be recommended and population-specific thresholds thus need to be determined. Longitudinal studies with a more objective assessment of the disease activity and determinants of IBD-related disability are needed to evaluate the dynamicity of the IBD-disk in response to therapy.
The authors received no financial support for the research, authorship, and/or publication of this article.
Sood A reports receiving honorarium for speaker events from Pfizer India and is an editorial board member of the journal but was not involved in the peer reviewer selection, evaluation, or decision process of this article. No other potential conflicts of interest relevant to this article were reported.
Not applicable.
Conceptualization: Singh A, Midha V, Sood A. Data curation: Singh A, Gupta YK, Dhaliwal AS, Kahlon BK, Bansal V, Singh D, Kaur R. Formal analysis: Singh A, Dhaliwal AS, Kahlon BK, Bansal V, Bansal N. Investigation: Singh A, Singh D, Kaur R, Sood A. Methodology: Singh A, Midha V, Sood A. Project administration: Midha V, Sood A. Resources: Singh A, Midha V, Sood A. Supervision: Midha V, Sood A. Visualization: Singh A, A Dhaliwal AS, Kahlon BK, Bansal V. Writing - original draft: Singh A, Gupta YK, Dhaliwal AS, Kahlon BK, Bansal V, Sood A. Writing - review & editing: Singh A, Gupta YK, Dhaliwal AS, Kahlon BK, Bansal V, Mahajan R, Mehta V, Singh D, Kaur R, Bansal N, Midha V, Sood A. Approval of final manuscript: all authors.
Supplementary materials are available at the Intestinal Research website (
Supplementary Table 1. Correlation between Different Components of the Inflammatory Bowel Disease (IBD)-Disk and IBD Daily Life Burden Score, Stratified by Sex
Supplementary Table 2. Correlation (Spearman’s Rho) between Inflammatory Bowel Disease (IBD)-Disk Total Score, IBD-Disk Sub Scores and IBD Daily Life Burden with Disease Activity Indices
Supplementary Table 3. Effect of Sex Differences on the Inflammatory Bowel Disease-Disk Subscores
Supplementary Table 4. Effect of Disease Activity on IBD-Disk Total Score and Subscores
Supplementary Table 5. Effect of Age on Inflammatory Bowel Disease (IBD)-Disk Scores and IBD Daily Life Burden
Supplementary Fig. 1. The inflammatory bowel disease (IBD)-disk. Each component is scored from 0 to 10 using a visual analogue scale (0, no disability 10, maximal disability). The IBD-disk total score is calculated as the sum of 10 individual component subscores.
The box plot distribution of the inflammatory bowel disease (IBD)-disk total score and the IBD daily life burden. aThe extreme outlier was defined as a value that lies outside the following ranges: 3rd quartile+3*IQR; 1st quartile-3*IQR. IQR, interquartile range.
Internal consistency for each pair of inflammatory bowel disease (IBD)-disk components.
The mean inflammatory bowel disease (IBD)-disk and IBD daily life burden scores in the enrolled patients based on disease activity.
Area under the receiver operating characteristic curve for prediction of high inflammatory bowel disease (IBD) daily life burden using the IBD-disk total score.
Baseline Characteristics of the Enrolled Population
Characteristics | Value (n = 546) |
---|---|
Age (yr) | 40.33 ± 13.74 |
Male sex | 282 (51.64) |
Disease duration (yr) | 6.20 ± 6.67 |
Type of inflammatory bowel disease | |
Ulcerative colitis | 464 (84.98) |
Crohn’s disease | 82 (15.02) |
Ulcerative colitis (n = 464) | |
Disease extent | |
E1 | 56 (12.07) |
E2 | 331 (71.34) |
E3 | 77 (16.59) |
Partial Mayo Clinic score | 2.57 ± 2.04 |
>1 | 291 (62.71) |
≤1 | 173 (37.28) |
Crohn’s disease (n = 82) | |
Age at diagnosis < 17 yr | 6 (7.31) |
Age at diagnosis 17–40 yr | 40 (48.78) |
Age at diagnosis > 40 yr | 36 (43.90) |
Ileal disease | 38 (46.34) |
Colonic disease | 23 (28.04) |
Ileo-colonic disease | 18 (21.95) |
Upper gastrointestinal disease | 3 (3.65) |
Non penetrating, non stricturing disease | 41 (50.00) |
Stricturing disease | 33 (40.24) |
Penetrating disease | 8 (9.75) |
Perianal disease | 3 (3.65) |
Harvey Bradshaw Index | 3.54 ± 1.78 |
≥5 | 20 (24.39) |
<5 | 62 (75.60) |
Concomitant treatment |
|
5-ASA | 502 (91.94) |
Thiopurines | 159 (29.12) |
Oral corticosteroids | 60 (10.98) |
Anti-TNF (infliximab/adalimumab) | 8 (1.46) |
Vedolizumab | 1 (0.18) |
Values are presnted as mean±standard deviation or number (%).
Patients on combination therapies: 5-ASA+thiopurines (n=134, 24.54%); anti-TNF+thiopurines (n=5, 0.91%); vedolizumab+thiopurines (n=1, 0.18%).
E1, proctitis; E2, left sided colitis; E3, pancolitis; 5-ASA, 5-aminosalicylates; TNF, tumour necrosis factor.
Correlation between Different Components of the IBD-Disk and IBD Daily Life Burden Score
Variable | Spearman’s rho |
Significance UC vs. CD |
|||
---|---|---|---|---|---|
All patients (n=546) | UC (n=464) | CD (n=82) | Z statistic | ||
Abdominal pain | 0.52 | 0.52 | 0.54 | –0.29 | 0.41 |
Joint pain | 0.44 | 0.46 | 0.35 | 1.08 | 0.14 |
Sexual functions | 0.12 | 0.13 | NR |
NR |
NRa |
Body image | 0.61 | 0.61 | 0.62 | –0.13 | 0.45 |
Emotions | 0.81 | 0.82 | 0.78 | 0.91 | 0.18 |
Energy | 0.77 | 0.78 | 0.68 | 1.78 | 0.04 |
Sleep | 0.57 | 0.58 | 0.55 | 0.36 | 0.36 |
Education & work | 0.73 | 0.73 | 0.80 | –1.40 | 0.08 |
Interpersonal interactions | 0.51 | 0.53 | 0.42 | 1.17 | 0.12 |
Regulating defecation | 0.57 | 0.56 | 0.64 | –1.03 | 0.15 |
IBD-disk total score | 0.94 | 0.94 | 0.94 | 0 | 0.50 |
All the patients reported a score of 0, hence no correlation coefficient value reported.
IBD, inflammatory bowel disease; UC, ulcerative colitis; CD, Crohn’s disease.
Cronbach’s Coefficients (α) to Check the Internal Consistency of the Inflammatory Bowel Disease Disk
Variable | Corrected item-total correlation | Cronbach’s α if item deleted |
---|---|---|
Abdominal pain | 0.48 | 0.81 |
Joint pain | 0.37 | 0.83 |
Sexual functions | 0.08 | 0.84 |
Body image | 0.54 | 0.81 |
Emotions | 0.73 | 0.78 |
Energy | 0.65 | 0.79 |
Sleep | 0.48 | 0.82 |
Education & work | 0.71 | 0.79 |
Interpersonal interactions | 0.49 | 0.82 |
Regulating defecation | 0.54 | 0.81 |
Correlation (Spearman’s rho) of IBD-Disk Total Score and Subscores with IBD Daily Life Burden, Stratified According to Disease Activity
Variable | Ulcerative colitis |
Crohn’s disease |
||||||
---|---|---|---|---|---|---|---|---|
Active disease Spearman’s rho (n=291) | Disease in remission Spearman’s rho (n=173) | z statistic | Active disease Spearman’s rho (n=20) | Disease in remission Spearman’s rho (n=62) | z statistic | |||
Abdominal pain | 0.47 | 0.45 | 0.26 | 0.40 | 0.67 | 0.46 | 1.14 | 0.13 |
Joint pain | 0.42 | 0.44 | –0.25 | 0.40 | 0.19 | 0.44 | –1.02 | 0.15 |
Sexual functions | 0.09 | 0.20 | –1.16 | 0.12 | NR |
NR |
||
Body image | 0.56 | 0.60 | –0.62 | 0.27 | 0.72 | 0.54 | 1.10 | 0.14 |
Emotions | 0.80 | 0.81 | –0.29 | 0.38 | 0.76 | 0.76 | 0 | 0.50 |
Energy | 0.70 | 0.80 | –2.39 | 0.01 | 0.47 | 0.73 | –1.52 | 0.06 |
Sleep | 0.58 | 0.52 | 0.89 | 0.19 | 0.69 | 0.54 | 0.89 | 0.19 |
Education & work | 0.66 | 0.70 | –0.77 | 0.22 | 0.90 | 0.74 | 1.90 | 0.03 |
Interpersonal interactions | 0.51 | 0.45 | 0.87 | 0.21 | 0.32 | 0.46 | –0.60 | 0.27 |
Regulating defecation | 0.49 | 0.39 | 1.29 | 0.10 | 0.76 | 0.54 | 1.42 | 0.08 |
IBD-disk total score | 0.91 | 0.95 | –3.15 | 0.01 | 0.92 | 0.93 | –0.25 | 0.40 |
All the patients reported a score of 0, hence no correlation coefficient value reported.
IBD, inflammatory bowel disease; NR, not reported.
Association between Disease Characteristics and Disability Assessed Using IBD-Disk and IBD Daily Life Burden
Characteristics | No. | IBD-disk total score |
IBD daily life burden |
||||
---|---|---|---|---|---|---|---|
Mean ± SD | Mean ± SD | ||||||
UC | 464 | 18.39 ± 15.29 | 0.99 | 2.45 ± 2.05 | 0.92 | ||
CD | 82 | 18.38 ± 14.97 | 2.43 ± 1.85 | ||||
Sex | 0.01 | < 0.001 | |||||
Male | 282 | 15.65 ± 13.84 | 2.09 ± 1.81 | ||||
Female | 264 | 21.27 ± 16.11 | 2.84 ± 2.16 | ||||
Disease duration | 0.65 | 0.99 | |||||
≤ 2 yr | 208 | 19.11 ± 14.68 | 2.46 ± 1.85 | ||||
2–5 yr | 120 | 17.58 ± 15.02 | 2.43 ± 2.04 | ||||
> 5 yr | 218 | 18.15 ± 15.89 | 2.44 ± 2.16 | ||||
Disease extent (UC) | 0.07 | 0.09 | |||||
E1 | 56 | 13.96 ± 14.32 | 1.89 ± 1.89 | ||||
E2 | 331 | 19.02 ± 14.89 | 2.53 ± 2.02 | ||||
E3 | 77 | 18.90 ± 17.25 | 2.49 ± 2.22 | ||||
Disease location (CD) | 0.87 | 0.57 | |||||
L1 | 38 | 17.82 ± 16.45 | 2.39 ± 1.91 | ||||
L2 | 23 | 18.70 ± 13.01 | 2.61 ± 2.15 | ||||
L3 | 18 | 20.11 ± 15.36 | 2.50 ± 1.38 | ||||
L4 | 3 | 12.67 ± 11.01 | 1.00 ± 1.00 | ||||
Disease behavior (CD) | 0.19 | 0.29 | |||||
B1 | 41 | 15.93 ± 11.00 | 2.17 ± 1.53 | ||||
B2 | 33 | 19.61 ± 15.98 | 2.55 ± 1.87 | ||||
B3 | 8 | 25.88 ± 25.07 | 3.25 ± 3.01 | ||||
Disease activity (UC) | < 0.001 | < 0.001 | |||||
Partial Mayo Clinic score | |||||||
≤1 | 173 | 10.39 ± 11.17 | 1.50 ± 1.57 | ||||
2–4 | 200 | 19.28 ± 13.54 | 2.48 ± 1.78 | ||||
5–7 | 78 | 29.85 ± 14.77 | 4.00 ± 2.15 | ||||
>7 | 13 | 42.38 ± 19.50 | 5.31 ± 2.59 | ||||
Disease activity (CD) | 0.01 | 0.01 | |||||
Harvey Bradshaw Index | |||||||
<5 | 62 | 16.06 ± 13.20 | 1.97 ± 1.34 | ||||
5–7 | 17 | 22.18 ± 13.96 | 3.47 ± 2.30 | ||||
8–16 | 3 | 44.67 ± 29.67 | 6.00 ± 2.65 | ||||
> 16 | Nil | - | - |
IBD, inflammatory bowel disease; SD, standard deviation; UC, ulcerative colitis; CD, Crohn’s disease; E1, proctitis; E2, left sided colitis; E3, pancolitis; L1, ileal disease; L2, colonic disease; L3, ileo-colonic disease; L4, upper gastrointestinal disease; B1, non stricturing non penetrating disease; B2, stricturing disease; B3, fistulising disease.