key: cord-0947433-wl2r5t6l
authors: Ostromohov, Gaiana; Fibelman, Morin; Hirsch, Ayal; Ron, Yulia; Cohen, Nathaniel Aviv; Kariv, Revital; Deutsch, Liat; Kornblum, Jasmine; Anbar, Ronit; Maharshak, Nitsan; Fliss‐Isakov, Naomi
title: Assessment of patients' understanding of inflammatory bowel diseases: Development and validation of a questionnaire
date: 2021-12-23
journal: United European Gastroenterol J
DOI: 10.1002/ueg2.12182
sha: 92863ecaaa5d7aa54087052fdc2711787037b136
doc_id: 947433
cord_uid: wl2r5t6l

BACKGROUND: Educating patients regarding thier inflammatory bowel disease (IBD) is important for their empowerment and disease management. We aimed to develop a questionnaire to evaluate patient understanding and knowledge of IBD. METHODS: We have developed the Understanding IBD Questionnaires (U‐IBDQ), consisting of multiple‐choice questions in two versions [for Crohn's disease (CD) and ulcerative colitis (UC)]. The questionnaires were tested for content and face validity, readability, responsiveness and reliability. Convergent validity was assessed by correlating the U‐IBDQ score with physician's subjective assessment scores. Discriminant validity was assessed by comparison to healthy controls (HC), patients with chronic gastrointestinal (GI) conditions other than IBD, and to GI nurses. Multivariate analysis was performed to determine factors associated with a high level of disease understanding. RESULTS: The study population consisted of IBD patients (n = 106), HC (n = 35), chronic GI disease patients (n = 38) and GI nurses (n = 19). Mean U‐IBDQ score among IBD patients was 56.5 ± 21.9, similar for CD and UC patients (P = 0.941), but significantly higher than that of HC and chronic GI disease patients and lower than that of GI nurses (P < 0.001), supporting its discriminant validity. The U‐IBDQ score correlated with physician's subjective score (r = 0.747, P < 0.001) and was found to be reliable (intra‐class correlation coefficient = 0.867 P < 0.001). Independent factors associated with high U‐IBDQ scores included academic education (OR = 1.21, 95% CI 1.10–1.33, P < 0.001), biologic therapy experience (OR = 1.24, 95% CI 1.01–1.53, P = 0.046), and IBD diagnosis at <21 years of age (OR = 2.97, 95% CI 1.05–8.87, P = 0.050). CONCLUSIONS: The U‐IBDQ is a validated, reliable and short, self‐reported questionnaire that can be used for assessing understanding of disease pathophysiology and treatment by IBD patients.

Inflammatory bowel diseases (IBD) are chronic inflammatory diseases of the gastrointestinal (GI) tract with major impact on patients' well-being and quality of life. During the past 2 decades understanding of disease pathophysiology and the variety of available therapeutic interventions and preventive medicine recommendations have expanded tremendously. 1, 2 The explosion of information and their public sources, which are often not accurate, may pose a challenge for both treating physicians and patients. 3 Patients' beliefs and knowledge regarding the disease may affect disease management, quality of life and disease-related psychological health. [4] [5] [6] Therapyrelated disinformation is associated with low adherence to treatment, 7, 8 while understanding of disease course empowers patients, improves their satisfaction 9 and compliance with treatment, 5, [10] [11] [12] probably resulting in better therapeutic efficacy. 13 Furthermore, structured educational programs were associated with increased patient adherence to therapy. 13 Hence, patients' education regarding their disease and therapeutic aims and options have been adopted as an appropriate strategy to empower patients, enhance their autonomy, encourage them to become full healthcare partners and to determine their therapeutic goals. 14 Unfortunately, patient's knowledge and understanding of their disease is not of high priority for most health care systems, and patient education is not implemented in most practices. 15 One of the obstacles to achieving this aim is the lack of a standardized and validated tool for assessing the knowledge of IBD patients. Current available questionnaires for assessing patients' knowledge regarding IBD do not discriminate between Crohn's Disease (CD) and ulcerative colitis (UC). 16, 17 The Crohn's and Colitis Knowledge (CCKNOW) score was developed and validated to enable assessment of patients' understanding of their disease, 18 but this questionnaire has not been updated to assess recent knowledge of IBD pathophysiology and treatment, nor does it reflect important IBD-related topics such as diet, lifestyle and legal rights. 19 A Korean Inflammatory Bowel Disease Knowledge (IBD-KNOW) questionnaire, 16 and a French IBD-INFO questionnaire 17 were recently developed and validated. Both questionnaires are based on the CCKNOW questionnaire, which better reflects knowledge about CD than UC. 18 The IBD-INFO is extensive and its length may reduce patients' compliance. Therefore, we aimed to develop a short questionnaire to evaluate IBD patients' understanding of disease pathophysiology and treatment, with different versions for CD and UC.

Questionnaire items related to IBD pathogenesis and treatment were initially listed after a literature review of IBD patients' interests and self-reported knowledge gaps. 6, 19 These items were reviewed by a multidisciplinary steering group, consisting of six IBD gastroenterologists [5 IBD specialists (AH, YR, NAC, RK, NM), one clinical OSTROMOHOV ET AL. . Each correct answer scored 3.33 points, and the total U-IBDQ score potentially ranged from 0 to 100 points.

To the best of our knowledge there is currently no "gold standard" questionnaire for the assessment of IBD patients' understanding of disease pathophysiology. Therefore, construct validity of the U-IBDQ was assessed by convergent validity and by discriminant validity. Reliability was assessed by a test of internal consistency and a test-retest evaluation among a sub-population of IBD patients (n = 34) who were asked to fill-in the U-IBDQ a second time, two weeks after the first. Patients were asked to abstain from actively gaining knowledge about IBD during that time period. Correlation between scores of the first and second questionnaires were assessed using intraclass correlation coefficients (ICC). Internal consistency of the questionnaire was assessed as the correlation between each item specific sub-score and the total U-IBDQ score using Cronbach's alpha.

Sample size was calculated as 180 participants including IBD patients and control participants (5 participants per question; 36 questions). 23, 24 A minimal sample size of 28 was determined for testretest reliability analysis with an alpha of 0.05 and a power of 80%. 25 Participants with IBD/other GI conditions were recruited during their clinical visits at the IBD Unit of the Department of Gastroenterology and Hepatology of the Tel Aviv Medical Center (TLVMC) during 2019-2020. GI nurses consisted of the staff of nurses at the Department of Gastroenterology and Hepatology. Healthy controls were recruited from the study team's personal associates. All study candidates were included if 18 < age <70 years, and excluded if suffering from severe chronic diseases such as heart disease, cancer, end stage liver disease etc., and the inability to complete the study protocol. Similarly, candidates were excluded if they had insufficient computer and internet use skills in order to prevent selection bias of participants with reduced chances of self-education on disease pathophysiology and treatment. Study participants answered the U-IBDQ, and a demographic and lifestyle questionnaire, that had been validated for the Israeli population. 26 Information on each patient's medical history, IBD phenotype disease characteristics, and medical treatment was retrieved from their medical files by a single blinded observer (GO). Test-retest reliability of the U-IBDQ scores of repeated tests was measured by calculating intraclass correlation coefficient (ICC) by applying a two-way mixed model for absolute agreement. A test statistic >0.7 was considered good. 25 An independent samples t-test and the Pearson Chi-square test were used to compare the demographic and disease-related characteristics of patients who scored high and low on their U-IBDQ. A high score was defined as a score >60 points, according to the study sample median. A multivariate analysis by logistic regression with adjustment for potential confounders was used to identify factors that were associated with high U-IBD scores.

The study protocol was approved by the Institutional Review Board of the Tel Aviv Medical Center, and all participants provided informed consent prior to study enrollment.

A total of 291 IBD patients were approached during their routine clinical visits at the IBD unit. From these, 106 (36.4%) were included and 33 (11.3%) were excluded based on exclusion criteria and 152 (52.2%) were not interested in participating, primarily (55.5% of nonresponders) due to the will to minimize the time spent in the clinic during the COVID-19 pandemic. The additional study groups included were healthy controls (n = 35), chronic GI disease patients (n = 38) and GI nurses (n = 19) (Figure 1 ). Demographic and clinical characteristics of the sample of IBD patients and the control group participants are depicted in Table 1 Physician's subjective score 0 F I G U R E 2 Pearson's correlation between the physician's subjective disease understanding score and the U-IBDQ score 108 -UNITED EUROPEAN GASTROENTEROLOGY JOURNAL patients was significantly higher than that of the healthy controls and the chronic GI disease patients, and lower than that of the GI nurses.

These differences were significant with stratification to both questionnaire versions (CD vs. UC) (Figure 3) .

A higher U-IBDQ score among all IBD patients was associated with being a non-smoker, having an academic education, a younger age at diagnosis, and biologic therapy experience (Table 3 ). Correlations between age of diagnosis and U-IBDQ total score and item sub-scores were consistent (Supplementary Table 2 ). Among patients with CD, a higher U-IBDQ score was associated with a perianal disease. Disease duration was not significantly associated with higher disease understanding ( Table 3) .

The U-IBDQ scores of IBD patients diagnosed at a young age (≤21 years, n = 54) were higher compared to those of patients with IBD 

The internal consistency of the U-IBDQ was demonstrated by the correlations between the U-IBDQ total score and item specific subscores (Cronbach's alpha = 0.77). Furthermore, item specific scores of the questionnaire were correlated with each other. Weaker correlations were detected between the "Dietary therapy of IBD" and "Patients' rights and social support mechanisms" and "Diagnosis and follow-up tests" sub-scores, and the rest of all item specific subscores (Supplementary Table 3 ). Abbreviations: IBD, inflammatory bowel diseases; U-IBDQ, Understanding-IBD Questionnaire.

Mean U-IBDQ scores among the study groups (a) and stratified by questionnaire version (b) A significant difference from IBD patients *P < 0.05, **P < 0.001 OSTROMOHOV ET AL. The results of this study are compatible with previous reports that showed a mean understanding score of ∼50% of total score. 16, 17 This relatively low score emphasizes the need to prioritize patient education and understanding of their disease. The sample of IBD patients who participated in both the development and the validation cohorts was large, in addition to having been recruited systematically and non-differentially from all clinics of our IBD unit. In spite of the relatively low response rate, our study sample included patients from a wide spectrum of demographic and clinical characteristics. Study population heterogeneity was also reflected by the wide range of U-IBDQ scores. We assume that our results apply to the general population of IBD patients since the main reason for refusal to participate in the study had not been directly related to the questionnaire itself.

Several other possible limitations of this study include the possible referral filter bias and limited validity to pediatric patients who were excluded in this validation cohort. Also, information bias may exist regarding the capture of knowledge items, which had not been included in the U-IBDQ, and may be important to specific patient groups, such as reproduction and family planning, and transition from pediatric to adult clinics. 36, 37 Also, in future studies, use of the U-IBDQ will require the adaptation of the 'legal and social rights' item questions, to the population under investigation. These items should be implemented in future population-specific questionnaires developed in future studies. Also, due to lack of an empirical gold standard for assessing patients' knowledge of their disease, U-IBDQ scores were compared to a subjective score given by the same study physician, in a blinded and standardized manner for all patients. Thus, the potential information bias is expected to be non-differential between patients.

We have developed and meticulously validated the U-IBDQ, a short, self-report questionnaire that has demonstrated good reliability and validity in measuring understanding of disease pathophysiology and treatment in IBD. Future studies should correlate disease understanding with adherence to therapy, and long-term clinical and patient-reported outcomes.

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SUPPORTING INFORMATION Additional supporting information may be found in the online version of the article at the publisher's website. How to cite this article

We would like to thank the Israeli foundation of Crohn's Disease and Ulcerative Colitis for its support. We thank Sigalit Lahav We also thank Ester Eshkol for assistance with manuscript preparation.

No financial disclosures or conflicts of interest to any of the authors.

The data presented in this study are available on request from the corresponding author. The data are not publicly available due to ongoing analysis for further publication.

https://orcid.org/0000-0001-5128-7169Nathaniel Aviv Cohen https://orcid.org/0000-0001-9252-9208Liat Deutsch https://orcid.org/0000-0001-5022-4318Naomi Fliss-Isakov https://orcid.org/0000-0003-4849-0291