Translation into Spanish and validation of a short questionnaire to measure the control of inflammatory bowel disease from the patient's perspective: IBD-Control, EII-Control

Lidón, Raquel Vicente; López, Santiago García; Roche, Pilar Corsino; Barraca, José Miguel Boudet; Segura, Patricia; Camara, P.; Moros, Eva Sierra; García, Fernando L. de la Vega

doi:10.1016/j.gastre.2022.07.001

Cited by 2 publications

(2 citation statements)

References 26 publications

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“…Reassuringly, no significant changes were made to commonly used instruments as a result of cross-cultural validations such as the IBDQ 43–46 or IBD control. 47 , 48 …”

Section: Discussionmentioning

confidence: 99%

Development and Validation of a Remote Monitoring Tool for Assessment of Mild, Moderate, and Severe Infections in Inflammatory Bowel Disease

Ardabili

Esser

Wintjens

et al. 2023

Journal of Crohn's and Colitis

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Background Immunomodulators and biologicals are cornerstones in the management of Inflammatory Bowel Disease (IBD), but are associated with increased risk of infections. Post-marketing surveillance registries are pivotal to assess this risk, yet mainly focus on severe infections. Data on the prevalence of mild and moderate infections are scarce. We developed and validated a remote monitoring tool for real-world assessment of infections in IBD patients. Methods A 7-item Patient-Reported Infections Questionnaire (PRIQ) covering 15 infection categories was developed with a 3-month recall period. Infection severity was defined as mild (self-limiting or topical treatment), moderate (oral antibiotics, antivirals or antifungals) or severe (hospitalisation or IV treatment). Comprehensiveness and comprehensibility were ascertained through cognitive interviewing of 36 IBD outpatients. After implementation in telemedicine platform myIBDcoach, a prospective multicentre cohort study was performed between June 2020 and June 2021 in 584 patients to assess diagnostic accuracy. Events were cross-checked with GP and pharmacy data (gold standard). Agreement was evaluated using linear-weighted kappa with cluster-bootstrapping to account for within-patient level correlation. Results Patient understanding was good and interviews did not result in reduction of PRIQ-items. During validation, 584 IBD patients (57.8% female, mean age 48.6 [SD: 14.8], disease duration 12.6 years [SD: 10.9]) completed 1386 periodic assessments, reporting 1626 events. Linear-weighted kappa for agreement between PRIQ and gold standard was 0.92 (95%CI 0.89-0.94). Sensitivity and specificity for infection (y/n) were 93.9% (95%CI 91.8-96.0) and 98.5% (95%CI 97.5-99.4). Conclusions The PRIQ is a valid and accurate remote monitoring tool to assess infections in IBD patients, providing means to personalise medicine based on adequate benefit-risk assessments.

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“…Reassuringly, no significant changes were made to commonly used instruments as a result of cross-cultural validations such as the IBDQ 43–46 or IBD control. 47 , 48 …”

Section: Discussionmentioning

confidence: 99%

Development and Validation of a Remote Monitoring Tool for Assessment of Mild, Moderate, and Severe Infections in Inflammatory Bowel Disease

Ardabili

Esser

Wintjens

et al. 2023

Journal of Crohn's and Colitis

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“… Quality of life: Patients’ quality of life will be evaluated with the 32-item Inflammatory Bowel Disease Questionnaire (IBDQ-32) and the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaires [ 23 , 24 ]. Patient-reported outcome measures (PROMs) will be also collected using the IBD-Control questionnaire [ 25 ]. All the questionnaires may be found in Additional file 2 .…”

Section: Methodsmentioning

confidence: 99%

Endoscopic treatment (endoscopic balloon dilation/self-expandable metal stent) vs surgical resection for the treatment of de novo stenosis in Crohn’s disease (ENDOCIR study): an open-label, multicentre, randomized trial

Loras,

Ruiz-Ramirez,

Romero

et al. 2023

Trials

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Background Stenosis is one of the most common complications in patients with Crohn’s disease (CD). Endoscopic balloon dilation (EBD) is the treatment of choice for a short stenosis adjacent to the anastomosis from previous surgery. Self-expandable metal stents (SEMS) may be a suitable treatment option for longer stenoses. To date, however, there is no scientific evidence as to whether endoscopic (EBD/SEMS) or surgical treatment is the best approach for de novo or primary stenoses that are less than 10 cm in length. Methods/design Exploratory study as “proof-of-concept”, multicentre, open-label, randomized trial of the treatment of de novo stenosis in the CD; endoscopic treatment (EBD/SEMS) vs surgical resection (SR). The type of endoscopic treatment will initially be with EDB; if a therapeutic failure occurs, then a SEMS will be placed. We estimate 2 years of recruitment and 1 year of follow-up for the assessment of quality of life, costs, complications, and clinical recurrence. After the end of the study, patients will be followed up for 3 years to re-evaluate the variables over the long term. Forty patients with de novo stenosis in CD will be recruited from 15 hospitals in Spain and will be randomly assigned to the endoscopic or surgical treatment groups. The primary aim will be the evaluation of the patient quality of life at 1 year follow-up (% of patients with an increase of 30 points in the 32-item Inflammatory Bowel Disease Questionnaire (IBDQ-32). The secondary aim will be evaluation of the clinical recurrence rate, complications, and costs of both treatments at 1-year follow-up. Discussion The ENDOCIR trial has been designed to determine whether an endoscopic or surgical approach is therapeutically superior in the treatment of de novo stenosis in CD. Trial registration ClinicalTrials.gov NCT 04330846. Registered on 1 April 1 2020. https://clinicaltrials.gov/ct2/home

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Translation into Spanish and validation of a short questionnaire to measure the control of inflammatory bowel disease from the patient's perspective: IBD-Control, EII-Control

Cited by 2 publications

References 26 publications

Development and Validation of a Remote Monitoring Tool for Assessment of Mild, Moderate, and Severe Infections in Inflammatory Bowel Disease

Development and Validation of a Remote Monitoring Tool for Assessment of Mild, Moderate, and Severe Infections in Inflammatory Bowel Disease

Endoscopic treatment (endoscopic balloon dilation/self-expandable metal stent) vs surgical resection for the treatment of de novo stenosis in Crohn’s disease (ENDOCIR study): an open-label, multicentre, randomized trial

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