Psychometric validation of the Chinese version of the Short Inflammatory Bowel Disease Questionnaire and evaluation of its measurement invariance across sex

Background This study aimed to evaluate the psychometric properties of the Chinese version of the Short Inflammatory Bowel Disease Questionnaire (C-SIBDQ), and its measurement invariance across sex in Chinese patients with inflammatory bowel disease (IBD). Methods Between September 2018 and July 2021, 284 patients with IBD were recruited from a spleen and stomach clinic. All participants completed the C-SIBDQ, 12-item Short-Form Health Survey (SF-12), nine-item Patient Health Questionnaire Depression Scale (PHQ-9), and the seven-item Generalized Anxiety Disorder Scale (GAD-7). Floor and ceiling effects were evaluated by testing frequencies and composition ratios for the minimum and maximum C-SIBDQ scores. Exploratory and confirmatory factor analysis (CFA) were used to evaluate the C-SIBDQ’s factor structure and construct validity. Convergent validity was evaluated through examining bivariate correlations between the C-SIBDQ and the SF-12, PHQ-9, and GAD-7. Internal consistency reliability and retest reliability were evaluated by respectively calculating the Cronbach’s α and the intraclass correlation coefficient (ICC) among a subsample (n = 79) after 2 weeks. The measurement invariance across sex was evaluated through multiple-group CFA. Results The C-SIBDQ scores showed no floor or ceiling effects and had a single-factor structure and good convergent validity, with significant correlations with the SF-12, PHQ-9 and GAD-7. Good internal consistency (Cronbach’s α = 0.920) and test–retest reliability (ICC = 959) were observed. The C-SIBDQ also showed measurement invariance across sex, and females showed higher C-SIBDQ scores than males. Conclusions The C-SIBDQ has high reliability, validity, and stability across sex, and can be used in clinics to assess the health-related quality of life of patients with IBD.

Calidad de vida en pacientes con enfermedad de Crohn ileocecal posterior a tratamiento quirúrgico.

Introducción: La localización ileocecal es la más frecuente en la enfermedad de Crohn y muchos de estos pacientes requieren tratamiento quirúrgico durante la evolución de su enfermedad. Existe escasa evidencia sobre el impacto del mismo en la calidad vida de estos enfermos.Materiales y métodos: Se llevó a cabo un estudio retrospectivo sobre una base de datos prospectiva, incluyendo los pacientes operados durante un período de 30 meses por enfermedad de Crohn con compromiso ileocecal. Como variable de resultado primaria se evaluó la calidad de vida de los mismos antes y 4 meses después de la cirugía usando dos cuestionarios validados (Short Form-36, Inflammatory Bowel Disease Questionnaire). También se evaluó la morbilidad de los procedimientos.Resultados: Se incluyeron en el estudio 19 pacientes. La edad media fue de 34 años (23-72), 18 pacientes fueron operados por vía laparoscópica y 2 pacientes requirieron re operación. La media de seguimiento fue de 16 meses (4 - 30). Tres pacientes (16%) presentaron complicaciones mayores. Los resultados obtenidos en este estudio muestran una mejoría promedio de 46% en los parámetros valorados por el cuestionario SF-36 (p=0.0001) y de 81 puntos (p=0.0001) en los valores del cuestionario IBDQ luego del tratamiento operatorio.Conclusión: El tratamiento quirúrgico de la enfermedad de Crohn con compromiso ileocecal presenta buenos resultados después del tratamiento quirúrgico y una mejora significativa en la calidad de vida de los pacientes.

P245 Evaluation of quality of life in patients with perineal Crohn’s disease: a monocentric Tunisien study

Background Perianal manifestations of Crohn’s disease considerably affects the life quality of patients. This study aims to assess the quality of life of patients with perineal Crohn’s disease by using the SIBDQ (Short Inflammatory Bowel Disease Questionnaire) and to evaluate its correlation with the Perineal Disease Activity Index (PDAI). Methods We retrospectively reviewed the medical records of patients with perineal Crohn’s disease between January 2018 and December 2020. Patients with active luminal disease were not included in this study (Crohn’s Disease Activity Index (CDAI) > 150). All participants answered the SIBDQ. Active perineal disease was defined as a PDAI > 7. We studied the correlation between SIBDQ and PDAI. Patients were divided into 2 groups according to the duration of the disease greater or less than 5 years. SIBDQ and PDAI were compared between the 2 groups. Results We included 52 patients with a mean age of 37 years (range: 17–62 years). There were 34 males (65.4%) and 18 females (34.6%). Crohn’s disease has been diagnosed for 7.6 years in average (range 2–19 years). The PDAI varied from 1 to 15 (average=7) and the SIBDQ ranged from 11 to 66 (average= 41). The SIBDQ was inversely correlated to the PDAI with a Pearson’s correlation coefficient equal to -0.885 (p=0.01). Indeed, the SIBDQ score for patients with an active perineal disease was significantly lower than those with inactive one (28.3 ± 11.6 vs. 50.1 ± 7.7; p< 0.0001), which indicates a worse life quality. Comparing the 2 groups, there were no significant differences in terms of age, gender and PDAI. The SIBDQ was lower in patients who had the disease for more than 5 years compared to the other ones (38.3 ±15.6 vs.48.2 ± 7.5; p=0.003). Conclusion The quality of life for patients with perineal Crohn’s disease seems to be altered by both activeness and duration of the disease. The SIBDQ is a simple tool that helps physicians detect patients with poor life quality. Other studies are necessary to validate this questionnaire for the evaluation of the quality of life in patients with perineal Crohn’s disease.

Short Inflammatory Bowel Disease Questionnaire: translation and validation to the Portuguese language

Background The Short Inflammatory Bowel Disease Questionnaire (SIBDQ) is a widely used instrument to assess Health-related Quality of Life (HRQoL) among inflammatory bowel disease (IBD) patients. Our aim was to translate and adapt the SIBDQ so that it could be adequately used in Portugal. Methods This is a prospective design cohort study undertaken at a tertiary hospital. This study took place simultaneously with the first part of the SexIDI study, a study aiming to assess the impact of IBD on patients’ sexual QoL. The original SIBDQ was translated by two independent translators and adapted by an IBD expert panel following the opinions of a convenient sample of 5 IBD patients. Afterwards, IBD patients from the outpatient clinic were consecutively invited to fill the Portuguese version of the questionnaire (SIBDQ-PT) at three different timepoints (0, 2, 4 weeks). Ninety-two patients completed the SIBDQ-PT at baseline, whereas 33 did so after 2 and 4 weeks (approximately). Statistical analysis was performed using SPSS version 25, and the following aspects were analysed: reliability (through internal consistency, test–retest and intraclass correlation), validity (through exploratory factor analysis [EFA], and Pearson correlation coefficient for linear correlations), score distribution, and responsiveness analysis (through t-student tests). Results Overall, SIBDQ-PT was shown to have a high internal consistency (Cronbach's α = 0.80) and a high test–retest reliability (0.80 [CI 0.74–0.86] and 0.69 [CI 0.50–0.82]). EFA detected four dimensions—bowel, social, emotional and systemic. As expected, an overall SIBDQ-PT score was positively correlated with sexual satisfaction (r = 0.27; p < 0.05) and negatively correlated with depression (r = − 0.63; p < 0.01). Moreover, SIBDQ-PT was found to have an adequate score distribution, and to be responsive, as there was a significant subscore change for patients who reported an “overall worsening in general well-being” (0.93 ± 0.13 decrease; p < 0.01). Conclusions The Portuguese version of the SIBDQ hereby presented is a reliable, valid and responsive instrument that can be used to measure HRQoL among Portuguese IBD patients.

Tofacitinib in Patients with Ulcerative Colitis: Inflammatory Bowel Disease Questionnaire Items in Phase 3 Randomized Controlled Induction Studies

Background Tofacitinib is an oral, small molecule Janus kinase inhibitor for the treatment of ulcerative colitis (UC). We examined the effect of tofacitinib induction treatment on Inflammatory Bowel Disease Questionnaire (IBDQ) items in adults with moderate to severe UC. Methods Data were pooled from the randomized, 8‑week, double-blind, phase 3 OCTAVE Induction 1 and 2 studies. The IBDQ was self-administered by patients at baseline, week 4, and week 8, with higher scores indicating better health-related quality of life (HRQoL). Change from baseline in IBDQ items was analyzed for 10 mg of tofacitinib twice daily (BID) vs placebo using a linear mixed-effects model, with no multiplicity adjustment performed. Effect sizes were calculated. Subgroup analyses by tumor necrosis factor inhibitor (TNFi) experience were performed. Results Significant improvements (nominal P &lt; 0.05) were observed in all IBDQ items with 10 mg of tofacitinib BID vs placebo at weeks 4 and 8. For the overall population, the largest treatment differences across all items were reported for “bowel movements been loose” at weeks 4 and 8, and “problem with rectal bleeding” at week 8 (mean treatment differences all 1.1; both in bowel symptoms domain). These items also showed the largest effect sizes. Treatment benefits were generally slightly numerically higher in TNFi-experienced vs TNFi-naïve patients. Conclusions Tofacitinib induction therapy improved all IBDQ items vs placebo in patients with UC, reflecting improvements in HRQoL, with greatest benefits reported in bowel symptoms domain items (Funded by Pfizer Inc; OCTAVE Induction 1 and OCTAVE Induction 2; ClinicalTrials.gov, NCT01465763 and NCT01458951, respectively).

QUALITY OF LIFE OF PATIENTS FROM A MULTIDISCIPLINARY CLINIC OF INFLAMMATORY BOWEL DISEASE

ABSTRACT BACKGROUND: Inflammatory bowel disease encompasses pathological entities, the main being Crohn’s disease and ulcerative rectocolitis. Both are characterized by chronic inflammation of the intestine. It affects young people of active age, compromising the situation of those patients, especially their quality of life, experiencing a strong deterioration in their clinical condition, from physical to social and emotional aspects. OBJECTIVE: Evaluate the quality of life of patients assisted in the multidisciplinary reference outpatient clinic for the treatment of inflammatory bowel diseases, through sociodemographic data and specific questionnaires on the disease, evaluating the intestinal and systemic symptoms and the social and emotional aspects. Make a comparison between the two scales used to obtain the data. METHODS: A cross-sectional study was carried out in which patients diagnosed with inflammatory bowel disease were evaluated and observed at a reference outpatient clinic for treatment from May 2017 through December 2018. The participants responded to the Socio-demographic and Clinical Protocol, the SF-36 general quality of life questionnaire and the specific Inflammatory Bowel Disease questionnaire, in addition the correlation between the two scales was performed using Pearson’s Correlation (metric scale), which data were analyzed by means of descriptive statistics and the significance level adopted was 5% (P≤0.05). The population studied consisted of 71 patients, excluding pregnant or nursing women and patients under 18 years of age. RESULTS: Seventy-one patients participated in the study, with an average age of 46.5 years and standard deviation of ±13.8; 45 patients had Crohn’s disease and 26 were diagnosed with ulcerative rectocolitis; 73.2% were women; 64.8% married; 8.4%, smokers; 50.7% reported practising some type of physical activity. A good distribution of patients was observed between the domains of each questionnaire; no low scores were found for quality of life, and systemic symptoms and emotional aspects were those with the lowest scores among the parameters of the Inflammatory Bowel Disease Questionnaire; physical (40.6±44.4) and emotional aspects (49.5±46.0) had lower scores among the Short Form-36 domains. The correlation between the two questionnaires proved to be significant. CONCLUSION: The clinical profile of the patients followed the characteristics of distribution and prevalence of these diseases. The impact of diseases on quality of life was observed in several aspects, especially those related to psychological components. Multidisciplinary follow-up, as well as psychological, social, nutritional and educational support should be considered important determinants to maintain or improve the quality of life of these patients.