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Aguas Peris M, Del Hoyo Francisco J, Nos Mateu P, Echarri Piudo A, Calvo Moya M, Gros B, Martín-Arranz MD, Monte Boquet E, Inglán Agustín S, Valdivia Martínez A, Correcher M, Barreiro-de Acosta M, Mañosa Ciria M, Rodriguez-Moranta F, Zabana Y, Gutiérrez Casbas A. Position statement of the Spanish Working Group on Crohn's Disease and Ulcerative Colitis on the use of Telemedicine in Inflammatory Bowel Disease. GASTROENTEROLOGIA Y HEPATOLOGIA 2025; 48:502320. [PMID: 39672505 DOI: 10.1016/j.gastrohep.2024.502320] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 12/07/2024] [Accepted: 12/08/2024] [Indexed: 12/15/2024]
Abstract
Inflammatory Bowel Disease (IBD) is a chronic digestive condition that requires continuous monitoring by healthcare professionals to determine appropriate therapy and manage short- and long-term complications. Telemedicine has become an essential approach for managing chronic conditions such as IBD, improving care accessibility and continuity, decreasing hospitalization rates, and optimizing patient follow-up. It enables rapid treatment adjustments and encourages patient self-management. Additionally, it reduces the burden on the healthcare system by decreasing unnecessary in-person visits and provides real-time support, thereby improving quality of life and clinical outcomes. The objective of this position statement by the Spanish Working Group on Crohn's Disease and Ulcerative Colitis (GETECCU) is to establish recommendations for the use of telemedicine in its different modalities (teleconsulting, telemonitoring, mobile applications and telepharmacy) for patients with IBD and address the legal, ethical, and technical aspects necessary for its proper implementation.
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Affiliation(s)
- Mariam Aguas Peris
- Servicio Aparato Digestivo, Hospital Universitario y Politécnico La Fe, Instituto de Investigación Sanitaria La Fe (IISLaFe), Valencia, España.
| | - Javier Del Hoyo Francisco
- Servicio Aparato Digestivo, Hospital Universitario y Politécnico La Fe, Instituto de Investigación Sanitaria La Fe (IISLaFe), Valencia, España
| | - Pilar Nos Mateu
- Servicio Aparato Digestivo, Hospital Universitario y Politécnico La Fe, Instituto de Investigación Sanitaria La Fe (IISLaFe), Valencia, España
| | - Ana Echarri Piudo
- Servicio Aparato Digestivo, Complejo Hospitalario Universitario Ferrol, A Coruña, España
| | - Marta Calvo Moya
- Servicio Aparato Digestivo, Hospital Universitario Puerta de Hierro Majadahonda, Madrid, España
| | - Beatriz Gros
- Servicio Aparato Digestivo, Hospital Universitario Reina Sofía, Córdoba, España; Instituto Maimónides de Investigación Biomédica (IMIBIC), Universidad de Córdoba, Córdoba, España; Centro de Investigación Biomédica en Enfermedades Hepáticas y Digestivas, CIBERehd, Madrid, España
| | - María Dolores Martín-Arranz
- Servicio Aparato Digestivo, Hospital Universitario La Paz, Facultad de Medicina, Universidad Autónoma de Madrid, Instituto de Investigación Sanitaria del Hospital Universitario La Paz (IdiPAZ), Madrid, España
| | - Emilio Monte Boquet
- Servicio de Farmacia, Hospital Universitario y Politécnico La Fe, Valencia, España
| | | | | | - Marisa Correcher
- Departamento Sistemas de Información, Hospital Universitario y Politécnico La Fe, Valencia, España
| | | | - Miriam Mañosa Ciria
- Centro de Investigación Biomédica en Enfermedades Hepáticas y Digestivas, CIBERehd, Madrid, España; Servicio Aparato Digestivo, Hospital Universitario Germans Trias i Pujol de Badalona, Barcelona, España
| | | | - Yamile Zabana
- Centro de Investigación Biomédica en Enfermedades Hepáticas y Digestivas, CIBERehd, Madrid, España; Servicio Aparato Digestivo, Hospital Universitario Mútua Terrassa, Barcelona, España
| | - Ana Gutiérrez Casbas
- Centro de Investigación Biomédica en Enfermedades Hepáticas y Digestivas, CIBERehd, Madrid, España; Servicio Aparato Digestivo, Hospital General Universitario Dr. Balmis e ISABIAL, Alicante, España
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Carboni E, Stalla FM, Mendolaro M, Rodriguez BM, Morello E, Stradella D, Lavagna A, Pagana G, Rocca R, Daperno M. Bowel urgency in ulcerative colitis assessed from patients' reports: Results of a telemonitoring programme. Dig Liver Dis 2025:S1590-8658(25)00300-7. [PMID: 40234158 DOI: 10.1016/j.dld.2025.03.019] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/18/2025] [Revised: 03/19/2025] [Accepted: 03/19/2025] [Indexed: 04/17/2025]
Abstract
BACKGROUND Bowel urgency is common in ulcerative colitis (UC), but which patients are affected, and how, has not been fully studied. OBJECTIVE We explored associations of bowel urgency with the clinical characteristics of unselected outpatients. DESIGN The study included adults with UC already enrolled in a telemonitoring programme using the IBD Tool platform. Between January 2021 and May 2024, patients repeatedly completed the Simple Clinical Colitis Activity Index (P-SCCAI) and Monitor at Home IBD - Ulcerative Colitis (MIAH-UC) questionnaires, plus other questionnaires. The submission of contemporary P-SCCAI and MIAH-UC scores was an "event" for analysis. The degree of bowel urgency was determined from responses to three P-SCCAI questions. RESULTS Overall, 277 UC patients submitted 2768 events. No urgency was reported in 1813 events (66 %), while mild urgency in 538 (19 %), moderate urgency in 272 (10 %) and severe urgency in 145 (5 %). Variables positively associated with moderate-severe urgency at multivariate analysis (P < 0.0001) were female sex, age at diagnosis, disease duration, extensive UC, higher disease activity (MIAH-UC score), higher disease-related disability (IBD Disk), and any medical treatment. In 1750 events, disease was in clinical remission (MIAH-UC ≤3.5), but moderate-severe urgency was reported in 67 (3.8 %) of them. At multivariate analysis, variables associated with urgency during UC remission were age at diagnosis, disease duration, IBD Disk score, any treatment, and female sex. CONCLUSION Bowel urgency affects UC patients' lives and is associated with more severe disability, worse quality of life and higher depression scores. Moderate-severe urgency was reported in 1 in 25 events with UC in remission and increased the patients' disease-related disability.
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Affiliation(s)
| | | | | | | | - Enrico Morello
- Gastroenterology Unit, Mauriziano Hospital, Turin, Italy
| | | | | | - Guido Pagana
- Polytechnic University of Turin, Turin, Italy; LINKS Foundation, Turin, Italy
| | - Rodolfo Rocca
- Gastroenterology Unit, Mauriziano Hospital, Turin, Italy
| | - Marco Daperno
- Gastroenterology Unit, Mauriziano Hospital, Turin, Italy.
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Bredero QM, Fleer J, Blom DM, Bourgonje AR, Dijkstra G, Schroevers MJ. The Substantial Role of Sleep, Stress, and Physical Activity in Persistent High Levels of Fatigue in Patients With Inflammatory Bowel Disease: A Longitudinal Trajectory Study. J Crohns Colitis 2025; 19:jjae163. [PMID: 39460691 PMCID: PMC12001343 DOI: 10.1093/ecco-jcc/jjae163] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/05/2024] [Revised: 10/01/2024] [Accepted: 10/25/2024] [Indexed: 10/28/2024]
Abstract
BACKGROUND AND AIMS Fatigue is a common and burdensome problem for patients with inflammatory bowel disease (IBD). Previous studies lack insight into the individual variability in fatigue severity and course over time, and the characteristics of patients at risk of severe and persistent fatigue. This study aimed to identify distinct groups of IBD patients based on their level and course of fatigue over 5 years. Subsequently, we examined the relationship between these trajectories, patient characteristics, and trajectories of perceived stress, sleep, and physical activity. METHODS This longitudinal cohort study used prospectively collected data from the myIBDcoach telemedicine monitoring tool, including 320 IBD patients who completed 3 or more online consultations between 2016 and 2021. Latent class growth analyses were performed to identify distinct trajectories. RESULTS We found 5 subgroups with distinct trajectories of fatigue, differing in level and course over time, with 33% of patients experiencing chronic stable and high levels of fatigue. Few differences in patient characteristics were found between trajectories, yet the chronic high fatigue subgroup was more likely to report persistent stable sleep problems, perceived stress, and little physical activity over time compared to the other groups. CONCLUSIONS Distinct subgroups of IBD patients can be identified based on longitudinal fatigue trajectories. The relatively stable levels of fatigue, stress, sleep, and physical activity suggest that a one-time screening of patients on these topics may be sufficient to identify those at risk. Interventions aiming to reduce fatigue should target persistent stress, sleep problems, and low levels of physical activity.
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Affiliation(s)
- Quirine M Bredero
- Department of Health Sciences, Unit Health Psychology, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands
| | - Joke Fleer
- Department of Health Sciences, Unit Health Psychology, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands
- University College Groningen, University of Groningen, Groningen, The Netherlands
| | - Denise M Blom
- Department of Health Sciences, Unit Health Psychology, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands
| | - Arno R Bourgonje
- Department of Gastroenterology and Hepatology, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands
- The Henry D. Janowitz Division of Gastroenterology, Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, United States
| | - Gerard Dijkstra
- Department of Gastroenterology and Hepatology, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands
| | - Maya J Schroevers
- Department of Health Sciences, Unit Health Psychology, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands
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Barth I, Stevens CL, Peters V, Lucassen DA, Feskens EJM, Dijkstra G, Campmans-Kuijpers MJE. Relative Validity of the Groningen IBD Nutritional Questionnaire (GINQ-FFQ): A Food Frequency Questionnaire Designed to Assess Nutritional Intake in Patients with Inflammatory Bowel Disease. Nutrients 2025; 17:239. [PMID: 39861369 PMCID: PMC11768067 DOI: 10.3390/nu17020239] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/23/2024] [Revised: 01/06/2025] [Accepted: 01/08/2025] [Indexed: 01/27/2025] Open
Abstract
Background and Objective: To assess nutritional intake of patients with inflammatory bowel disease (IBD), a disease-specific food frequency questionnaire (FFQ) was developed: the Groningen IBD Nutritional Questionnaire (GINQ-FFQ). Aim of this study was to assess the relative validity of the GINQ-FFQ. Methods: Between 2019 and 2022, participants of the 1000IBD cohort were included and filled out a 3-day food diary and the GINQ-FFQ. Nutritional intake of nutrients and food groups was calculated. Bland-Altman analysis was conducted for energy intake, while paired t-tests and Wilcoxon signed rank tests were used for nutrient and food group intake. Additionally, group-level bias, cross-classification, and correlation analysis were performed. Results: 142 patients (59.2% females, mean age of 49 ± 14 years) were included. Bland-Altman analysis showed a mean difference between the GINQ-FFQ and 3FD of -63.6 kcal (±638.4), with limits of agreement ranging from -1315 to 1188 kcal. Differences in energy intake was significantly associated with higher mean total energy intake (p < 0.001). When stratifying for sex, this association only was significant for males. Group-level bias showed that the GINQ-FFQ tends to result in lower intake reports for macro- and micronutrients. Ranking ability (cross-classification) of macro-, micronutrients and food groups was good. Correlation coefficients for nutrients and food groups were considered acceptable or good. Conclusions: Overall, the GINQ-FFQ is a valid food frequency questionnaire to assess nutritional intake specifically for patients with IBD. However, for males with high total energy intakes, dietary assessment could be less accurate.
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Affiliation(s)
- Iris Barth
- Department of Gastroenterology and Hepatology, University Medical Centre Groningen (UMCG), 9713 GZ Groningen, The Netherlands (G.D.); (M.J.E.C.-K.)
- Graduate School of Medical Sciences (GSMS), University of Groningen (RUG), 9700 AB Groningen, The Netherlands
| | - Corien L. Stevens
- Department of Gastroenterology and Hepatology, University Medical Centre Groningen (UMCG), 9713 GZ Groningen, The Netherlands (G.D.); (M.J.E.C.-K.)
- Graduate School of Medical Sciences (GSMS), University of Groningen (RUG), 9700 AB Groningen, The Netherlands
| | - Vera Peters
- Department of Gastroenterology and Hepatology, University Medical Centre Groningen (UMCG), 9713 GZ Groningen, The Netherlands (G.D.); (M.J.E.C.-K.)
- Graduate School of Medical Sciences (GSMS), University of Groningen (RUG), 9700 AB Groningen, The Netherlands
| | - Desiree A. Lucassen
- Division of Human Nutrition and Health, Wageningen University & Research, 6700 AB Wageningen, The Netherlands; (D.A.L.); (E.J.M.F.)
| | - Edith J. M. Feskens
- Division of Human Nutrition and Health, Wageningen University & Research, 6700 AB Wageningen, The Netherlands; (D.A.L.); (E.J.M.F.)
| | - Gerard Dijkstra
- Department of Gastroenterology and Hepatology, University Medical Centre Groningen (UMCG), 9713 GZ Groningen, The Netherlands (G.D.); (M.J.E.C.-K.)
- Graduate School of Medical Sciences (GSMS), University of Groningen (RUG), 9700 AB Groningen, The Netherlands
| | - Marjo J. E. Campmans-Kuijpers
- Department of Gastroenterology and Hepatology, University Medical Centre Groningen (UMCG), 9713 GZ Groningen, The Netherlands (G.D.); (M.J.E.C.-K.)
- Graduate School of Medical Sciences (GSMS), University of Groningen (RUG), 9700 AB Groningen, The Netherlands
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Bredero QM, Fleer J, Smink A, Kuiken G, Potjewijd J, Laroy M, Visschedijk MC, Russel M, van der Lugt M, Meijssen MAC, van der Wouden EJ, Dijkstra G, Schroevers MJ. Long-term treatment outcomes of mindfulness-based cognitive therapy for fatigue in patients with inflammatory bowel disease: Results of a randomized controlled trial. J Psychosom Res 2024; 187:111949. [PMID: 39418854 DOI: 10.1016/j.jpsychores.2024.111949] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/11/2024] [Revised: 09/30/2024] [Accepted: 10/05/2024] [Indexed: 10/19/2024]
Abstract
OBJECTIVES Fatigue is prevalent in patients with inflammatory bowel disease (IBD) in remission. Previously, we showed that fatigued IBD patients experienced a significant decrease in fatigue after receiving mindfulness-based cognitive therapy (MBCT). The current study examined to what extent these short-term beneficial effects of MBCT on fatigue were maintained over nine months follow-up, and whether patient characteristics were associated with clinically relevant improvement in fatigue. METHODS A randomized controlled trial, including an MBCT and waiting-list control condition, was performed in fatigued IBD patients in remission. For this study, we analysed long-term outcomes of 108 patients who received MBCT (either directly or after three months waiting). The primary outcome was fatigue, assessed with the Checklist Individual Strenght-20. Secondary outcomes included fatigue interference, depression, anxiety, and quality of life. RESULTS The reduced level of fatigue post-treatment did not change significantly during follow-up (F(2,76) = 1.68, p = 0.19). In total, 29% of patients reported clinically relevant improvement from pre-treatment to nine months follow-up. We found few significant differences in baseline characteristics between those reporting clinically relevant improvement and those not, except that patients who improved were significantly more often unemployed (χ2(1, n = 73) = 4.40, p = 0.04). Secondary outcomes, which did not change significantly during MBCT, also remained stable during follow-up. CONCLUSION Findings suggest that reductions in IBD-related fatigue after receiving MBCT are sustained over nine months follow-up, with around one-third of patients reporting clinically relevant improvement from pre-treatment to follow-up. Employment status might be related to improvements in fatigue. Future research is needed to confirm these long-term outcomes. PREREGISTRATION ClinicalTrials.gov ID: NCT03162575.
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Affiliation(s)
- Quirine M Bredero
- Department of Health Psychology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.
| | - Joke Fleer
- Department of Health Psychology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.
| | - Ans Smink
- Department of Health Psychology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.
| | - Greetje Kuiken
- Department of Gastroenterology and Hepatology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.
| | | | - Marleen Laroy
- Mindfulness Training Twente - Zeilen op de wind, Boekelo, the Netherlands.
| | - Marijn C Visschedijk
- Department of Gastroenterology and Hepatology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.
| | - Maurice Russel
- Department of Gastroenterology and Hepatology, Medisch Spectrum Twente, Enschede, the Netherlands.
| | - Mark van der Lugt
- Department of Gastroenterology and Hepatology, Medisch Spectrum Twente, Enschede, the Netherlands.
| | | | | | - Gerard Dijkstra
- Department of Gastroenterology and Hepatology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.
| | - Maya J Schroevers
- Department of Health Psychology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.
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Janssen L, van Linschoten RCA, West RL, Gilissen LPL, Romberg-Camps M, Brandts L, Mujagic Z, Römkens TEH, Pierik M. Predicting mucosal inflammation in IBD patients using patient-reported symptom scores and a faecal calprotectin home test: protocol for a multicentre prospective validation study. BMJ Open 2024; 14:e076290. [PMID: 39375184 PMCID: PMC11459379 DOI: 10.1136/bmjopen-2023-076290] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/02/2023] [Accepted: 07/11/2024] [Indexed: 10/09/2024] Open
Abstract
INTRODUCTION Crohn's disease and ulcerative colitis are chronic inflammatory bowel diseases (IBD) with a relapsing-remitting nature. With adequate non-invasive prediction of mucosal inflammation, endoscopies can be prevented and treatment optimised earlier for better disease control. We aim to validate and recalibrate commonly used patient-reported symptom scores combined with a faecal calprotectin (FC) home test as non-invasive diagnostic tool for remote monitoring of IBD, both in daily practice and in a strict trial setting. Endoscopy will be used as the gold standard. METHODS AND ANALYSIS In this multicentre prospective validation study, adult IBD patients are asked to fill out questionnaires regarding disease activity (Monitor IBD At Home, mobile Health Index, Manitoba IBD Index, IBD control and patient-HBI/patient-Simple Clinical Colitis Activity Index), perform a FC home test and collect a stool sample for routine laboratory FC measurement, before the start of the bowel preparation for the ileocolonoscopy. Endoscopic disease activity will be scored according to the simplified endoscopic score for Crohn's disease (CD) for CD patients or Ulcerative Colitis Endoscopic Index for Severity and Mayo Endoscopic Subscore for ulcerative colitis patients. The main study outcome is the diagnostic test accuracy of the various patient-reported scores to assess mucosal inflammation in combination with a FC home test. ETHICS AND DISSEMINATION This study is approved by the Medical Research Ethics Committee of azM/UM in Maastricht dated 03 March 2021 (METC 20-085) and is monitored by the Clinical Trial Centre Maastricht according to Good Clinical Practice guidelines. Written informed consent will be obtained from all patients. Study results will be published in international peer-reviewed medical journals. TRIAL REGISTRATION NUMBER NCT05886322.
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Affiliation(s)
- Laura Janssen
- NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, Limburg, Netherlands
- Gastroenterology and Hepatology, Maastricht UMC+, Maastricht, Netherlands
| | - Reinier Cornelis Anthonius van Linschoten
- Gastroenterology and Hepatology, Franciscus Gasthuis en Vlietland, Rotterdam, Netherlands
- Gastroenterology and Hepatology, Erasmus Medical Center, Rotterdam, Netherlands
| | - Rachel Louise West
- Department of Gastroenterology & Hepatology, Franciscus Gasthuis, Rotterdam, Zuid-Holland, Netherlands
| | - Lennard P L Gilissen
- Department of Gastroenterology, Catharina Hospital, Eindhoven, North Brabant, Netherlands
| | - Mariëlle Romberg-Camps
- Gastroenterology, Zuyderland Medical Centre Sittard-Geleen, Sittard-Geleen, Limburg, Netherlands
| | - Lloyd Brandts
- Clinical Epidemiology and Medical Technology Assessment (KEMTA), Maastricht UMC+, Maastricht, Limburg, Netherlands
| | - Zlatan Mujagic
- NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, Limburg, Netherlands
- Division of Gastroenterology-Hepatology, Maastricht University Medical Centre+, Maastricht, Limburg, Netherlands
| | - Tessa EH Römkens
- Department of Gastroenteroloy and Hepatology, Jeroen Bosch Hospital, 's-Hertogenbosch, Noord-Brabant, Netherlands
| | - M Pierik
- NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, Limburg, Netherlands
- Department of Gastroenterology and Hepatology, Maastricht University Medical Centre+, Maastricht, Limburg, Netherlands
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Ueland TE, Horst SN, Shroder MM, Ye F, Bai K, McCoy AB, Bachmann JM, Hawkins AT. Surgically-relevant quality of life thresholds for the Short Inflammatory Bowel Disease Questionnaire in Crohn's disease. J Gastrointest Surg 2024; 28:1265-1272. [PMID: 38815800 DOI: 10.1016/j.gassur.2024.05.027] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/22/2024] [Revised: 05/12/2024] [Accepted: 05/25/2024] [Indexed: 06/01/2024]
Abstract
BACKGROUND Despite growing interest in patient-reported outcome measures to track the progression of Crohn's disease, frameworks to apply these questionnaires in the preoperative setting are lacking. Using the Short Inflammatory Bowel Disease Questionnaire (sIBDQ), this study aimed to describe the interpretable quality of life thresholds and examine potential associations with future bowel resection in Crohn's disease. METHODS Adult patients with Crohn's disease completing an sIBDQ at a clinic visit between 2020 and 2022 were eligible. A stoplight framework was adopted for sIBDQ scores, including a "Resection Red" zone suggesting poor quality of life that may benefit from discussions about surgery as well as a "Nonoperative Green" zone. Thresholds were identified with both anchor- and distribution-based methods using receiver operating characteristic curve analysis and subgroup percentile scores, respectively. To quantify associations between sIBDQ scores and subsequent bowel resection, multivariable logistic regression models were fit with covariates of age, sex assigned at birth, body mass index, medications, disease pattern and location, resection history, and the Harvey Bradshaw Index. The incremental discriminatory value of the sIBDQ beyond clinical factors was assessed through the area under the receiver operating characteristics curve (AUC) with an internal validation through bootstrap resampling. RESULTS Of the 2003 included patients, 102 underwent Crohn's-related bowel resection. The sIBDQ Nonoperative Green zone threshold ranged from 61 to 64 and the Resection Red zone from 36 to 38. When adjusting for clinical covariates, a worse sIBDQ score was associated with greater odds of subsequent 90-day bowel resection when considered as a 1-point (odds ratio [OR] [95% CI], 1.05 [1.03-1.07]) or 5-point change (OR [95% CI], 1.27 [1.14-1.41]). Inclusion of the sIBDQ modestly improved discriminative performance (AUC [95% CI], 0.85 [0.85-0.86]) relative to models that included only demographics (0.57 [0.57-0.58]) or demographics with clinical covariates (0.83 [0.83-0.84]). CONCLUSION In the decision-making process for bowel resection, disease-specific patient-reported outcome measures may be useful to identify patients with Crohn's disease with poor quality of life and promote a shared understanding of personalized burden.
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Affiliation(s)
- Thomas E Ueland
- Vanderbilt University School of Medicine, Nashville, Tennessee, United States
| | - Sara N Horst
- Department of Gastroenterology, Hepatology, and Nutrition, Vanderbilt University Medical Center, Nashville, Tennessee, United States
| | - Megan M Shroder
- Section of Colon & Rectal Surgery, Division of General Surgery, Vanderbilt University Medical Center, Nashville, Tennessee, United States
| | - Fei Ye
- Vanderbilt University School of Medicine, Nashville, Tennessee, United States; Department of Biostatistics, Vanderbilt University Medical Center, Nashville, Tennessee, United States
| | - Kun Bai
- Department of Biostatistics, Vanderbilt University Medical Center, Nashville, Tennessee, United States
| | - Allison B McCoy
- Department of Biomedical Informatics, Vanderbilt University Medical Center, Nashville, Tennessee, United States
| | - Justin M Bachmann
- Division of Cardiovascular Medicine, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, United States; Research Service, Veterans Affairs Tennessee Valley Healthcare System, Nashville, Tennessee, United States
| | - Alexander T Hawkins
- Section of Colon & Rectal Surgery, Division of General Surgery, Vanderbilt University Medical Center, Nashville, Tennessee, United States.
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Aliu A, Bosch DHCA, Keszthelyi D, Rezazadeh Ardabili A, Colombel JF, Sawyer R, Törnblom H, Hart A, Jonkers DMAE, Pierik MJ, Mujagic Z. Review article: A practical approach to persistent gastrointestinal symptoms in inflammatory bowel disease in remission. Aliment Pharmacol Ther 2024; 59:1470-1488. [PMID: 38590140 DOI: 10.1111/apt.17988] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/16/2023] [Revised: 11/29/2023] [Accepted: 03/25/2024] [Indexed: 04/10/2024]
Abstract
BACKGROUND Persistent gastrointestinal symptoms are prevalent in adult patients with inflammatory bowel disease (IBD), even when endoscopic remission is reached. These symptoms can have profound negative effects on the quality of life of affected patients and can be difficult to treat. They may be caused by IBD-related complications or comorbid disorders, but they can also be explained by irritable bowel syndrome (IBS)-like symptoms. AIMS To provide a practical step-by-step guide to diagnose and treat persistent gastrointestinal symptoms in patients with IBD in remission via a personalised approach. METHODS We scrutinised relevant literature on causes, diagnostics and treatment of persistent gastrointestinal symptoms (abdominal pain or discomfort, bloating, abdominal distension, diarrhoea, constipation and faecal incontinence) in patients with IBD in remission. RESULTS A graphical practical guide for several steps in diagnosing, identifying potential triggers and adequate treatment of persistent gastrointestinal symptoms in IBD in remission is provided based on supporting literature. The first part of this review focuses on the diagnostic and treatment approaches for potential IBD-related complications and comorbidities. The second part describes the approach to IBS-like symptoms in IBD in remission. CONCLUSIONS Persistent gastrointestinal symptoms in IBD in remission can be traced back to potential pathophysiological mechanisms in individual patients and can be treated adequately. For both IBD-related complications and comorbidities and IBS-like symptoms in IBD in remission, pharmacological, dietary, lifestyle or psychological treatments can be effective. A systematic and personalised approach is required to reduce the burden for patients, healthcare systems, and society.
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Affiliation(s)
- Arta Aliu
- Department Gastroenterology and Hepatology, Maastricht University Medical Center+, Maastricht, the Netherlands
- NUTRIM School of Nutrition and Translational Research in Metabolism, Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, the Netherlands
| | - Daan H C A Bosch
- Department Gastroenterology and Hepatology, Maastricht University Medical Center+, Maastricht, the Netherlands
- NUTRIM School of Nutrition and Translational Research in Metabolism, Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, the Netherlands
| | - Daniel Keszthelyi
- Department Gastroenterology and Hepatology, Maastricht University Medical Center+, Maastricht, the Netherlands
- NUTRIM School of Nutrition and Translational Research in Metabolism, Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, the Netherlands
| | - Ashkan Rezazadeh Ardabili
- Department Gastroenterology and Hepatology, Maastricht University Medical Center+, Maastricht, the Netherlands
- NUTRIM School of Nutrition and Translational Research in Metabolism, Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, the Netherlands
| | - Jean-Frederic Colombel
- The Henry D. Janowitz Division of Gastroenterology, Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, New York, USA
| | - Rachel Sawyer
- IBD Patient Advocacy, Founder of the Bottom Line IBD and IBD Women, UK
| | - Hans Törnblom
- Department of Molecular and Clinical Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
| | - Ailsa Hart
- IBD Unit, St Mark's Hospital & Imperial College, London, UK
| | - Daisy M A E Jonkers
- Department Gastroenterology and Hepatology, Maastricht University Medical Center+, Maastricht, the Netherlands
- NUTRIM School of Nutrition and Translational Research in Metabolism, Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, the Netherlands
| | - Marieke J Pierik
- Department Gastroenterology and Hepatology, Maastricht University Medical Center+, Maastricht, the Netherlands
- NUTRIM School of Nutrition and Translational Research in Metabolism, Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, the Netherlands
| | - Zlatan Mujagic
- Department Gastroenterology and Hepatology, Maastricht University Medical Center+, Maastricht, the Netherlands
- NUTRIM School of Nutrition and Translational Research in Metabolism, Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, the Netherlands
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9
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Herrlinger KR, Stange EF. To STRIDE or not to STRIDE: a critique of "treat to target" in Crohn´s disease. Expert Rev Gastroenterol Hepatol 2023; 17:1205-1219. [PMID: 38131269 DOI: 10.1080/17474124.2023.2296564] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/24/2023] [Accepted: 12/14/2023] [Indexed: 12/23/2023]
Abstract
INTRODUCTION The STRIDE consensus suggested to focus on mucosal healing, based on biomarkers and endoscopy, in addition to clinical endpoints as treatment target. This narrative review provides a critique of this concept in Crohn´s disease. AREAS COVERED We analyze and discuss the limitations of endpoints as targets, their currently limited achievability, and the controversial evidence relating to 'treat to target.' The relevant publications in Pubmed were identified in a literature review with the key word 'Crohn´s disease.' EXPERT OPINION All targets and endpoints have their limitations, and, even if reached, not all have unequivocally been shown to improve prognosis. The major deficiency of STRIDE is not only the lack of validation and agreement upon endpoints but little evidence of their achievability in a sizable proportion of patients by dose or timing adjustments or switching the medication. Above all, the concept should be based on clear evidence that patients indeed benefit from appropriate escalation of treatment and relevant controlled studies in this regard have been controversial. Until the STRIDE approach is proven to be superior to standard treatment focusing on clinical well-being, the field should remain reluctant and expect more convincing evidence before new targets are approved.
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Affiliation(s)
| | - Eduard F Stange
- Innere Medizin I, UniversitätsklinikTübingen, Tübingen, Germany
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10
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Dubinsky M, Bleakman AP, Panaccione R, Hibi T, Schreiber S, Rubin D, Dignass A, Redondo I, Gibble TH, Kayhan C, Travis S. Bowel Urgency in Ulcerative Colitis: Current Perspectives and Future Directions. Am J Gastroenterol 2023; 118:1940-1953. [PMID: 37436151 PMCID: PMC10617668 DOI: 10.14309/ajg.0000000000002404] [Citation(s) in RCA: 13] [Impact Index Per Article: 6.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/15/2022] [Revised: 06/02/2023] [Accepted: 06/13/2023] [Indexed: 07/13/2023]
Abstract
Bowel urgency (BU), the sudden or immediate need for a bowel movement, is one of the most common and disruptive symptoms experienced by patients with ulcerative colitis (UC). Distinct from the separate symptom of increased stool frequency, BU has a substantial negative impact on quality of life and psychosocial functioning. Among patients with UC, BU is one of the top reasons for treatment dissatisfaction and one of the symptoms patients most want improved. Patients may not discuss BU often due to embarrassment, and healthcare providers may not address the symptom adequately due to the lack of awareness of validated tools and/or knowledge of the importance of assessing BU. The mechanism of BU in UC is multifactorial and includes inflammatory changes in the rectum that may be linked to hypersensitivity and reduced compliance of the rectum. Responsive and reliable patient-reported outcome measures of BU are needed to provide evidence of treatment benefits in clinical trials and facilitate communication in clinical practice. This review discusses the pathophysiology and clinical importance of BU in UC and its impact on the quality of life and psychosocial functioning. Patient-reported outcome measures developed to assess the severity of BU in UC are discussed alongside overviews of treatment options and clinical guidelines. Implications for the future management of UC from the perspective of BU are also explored.
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Affiliation(s)
- Marla Dubinsky
- Susan and Leonard Feinstein Inflammatory Bowel Disease Clinical Center, Icahn School of Medicine at Mount Sinai, Icahn School of Medicine, New York, New York, USA
| | | | - Remo Panaccione
- Division of Gastroenterology, University of Calgary, Calgary, Alberta, Canada
| | - Toshifumi Hibi
- Center for Advanced IBD Research and Treatment, Kitasato Institute Hospital, Kitasato University, Tokyo, Japan
| | - Stefan Schreiber
- Department of Internal Medicine I, University Hospital Schleswig-Holstein, Kiel, Germany
| | - David Rubin
- The University of Chicago Medicine Inflammatory Bowel Disease Center, University of Chicago Medicine, Chicago, Illinois, USA
| | - Axel Dignass
- Department of Medicine I, Agaplesion Markus Hospital, Goethe University, Frankfurt/Main, Germany
| | | | | | - Cem Kayhan
- Eli Lilly and Company, Indianapolis, Indiana, USA
| | - Simon Travis
- Experimental Medicine Division, John Radcliffe Hospital, University of Oxford, Oxford, United Kingdom
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11
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Schneider KM, Blank N, Alvarez Y, Thum K, Lundgren P, Litichevskiy L, Sleeman M, Bahnsen K, Kim J, Kardo S, Patel S, Dohnalová L, Uhr GT, Descamps HC, Kircher S, McSween AM, Ardabili AR, Nemec KM, Jimenez MT, Glotfelty LG, Eisenberg JD, Furth EE, Henao-Mejia J, Bennett FC, Pierik MJ, Romberg-Camps M, Mujagic Z, Prinz M, Schneider CV, Wherry EJ, Bewtra M, Heuckeroth RO, Levy M, Thaiss CA. The enteric nervous system relays psychological stress to intestinal inflammation. Cell 2023; 186:2823-2838.e20. [PMID: 37236193 PMCID: PMC10330875 DOI: 10.1016/j.cell.2023.05.001] [Citation(s) in RCA: 136] [Impact Index Per Article: 68.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/28/2022] [Revised: 04/12/2023] [Accepted: 05/02/2023] [Indexed: 05/28/2023]
Abstract
Mental health profoundly impacts inflammatory responses in the body. This is particularly apparent in inflammatory bowel disease (IBD), in which psychological stress is associated with exacerbated disease flares. Here, we discover a critical role for the enteric nervous system (ENS) in mediating the aggravating effect of chronic stress on intestinal inflammation. We find that chronically elevated levels of glucocorticoids drive the generation of an inflammatory subset of enteric glia that promotes monocyte- and TNF-mediated inflammation via CSF1. Additionally, glucocorticoids cause transcriptional immaturity in enteric neurons, acetylcholine deficiency, and dysmotility via TGF-β2. We verify the connection between the psychological state, intestinal inflammation, and dysmotility in three cohorts of IBD patients. Together, these findings offer a mechanistic explanation for the impact of the brain on peripheral inflammation, define the ENS as a relay between psychological stress and gut inflammation, and suggest that stress management could serve as a valuable component of IBD care.
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Affiliation(s)
- Kai Markus Schneider
- Department of Microbiology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA
| | - Niklas Blank
- Department of Microbiology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA; Faculty of Biology, University of Freiburg, 79104 Freiburg, Germany
| | - Yelina Alvarez
- Department of Microbiology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA
| | - Katharina Thum
- Department of Microbiology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA
| | - Patrick Lundgren
- Department of Microbiology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA
| | - Lev Litichevskiy
- Department of Microbiology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA
| | - Madeleine Sleeman
- Department of Microbiology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA
| | - Klaas Bahnsen
- Department of Microbiology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA
| | - Jihee Kim
- Department of Microbiology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA
| | - Simon Kardo
- Department of Microbiology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA
| | - Shaan Patel
- Department of Microbiology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA
| | - Lenka Dohnalová
- Department of Microbiology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA
| | - Giulia T Uhr
- Department of Microbiology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA
| | - Hélène C Descamps
- Department of Microbiology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA
| | - Susanna Kircher
- Department of Microbiology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA
| | - Alana M McSween
- Department of Microbiology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA
| | - Ashkan Rezazadeh Ardabili
- Department of Internal Medicine, Division of Gastroenterology and Hepatology, Maastricht University Medical Centre, Maastricht, the Netherlands; School for Nutrition and Translational Research in Metabolism (NUTRIM), Maastricht University, Maastricht, the Netherlands
| | - Kelsey M Nemec
- Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA; Department of Neuroscience, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA
| | - Monica T Jimenez
- Department of Pathology and Laboratory Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA; Institute for Immunology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA
| | - Lila G Glotfelty
- Department of Microbiology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA
| | - Joshua D Eisenberg
- Department of Pediatrics, Children's Hospital of Philadelphia Research Institute, and Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA
| | - Emma E Furth
- Department of Pathology and Laboratory Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA
| | - Jorge Henao-Mejia
- Department of Pathology and Laboratory Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA; Institute for Immunology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA; Division of Protective Immunity, Department of Pathology and Laboratory Medicine, Children's Hospital of Pennsylvania, University of Pennsylvania, Philadelphia, PA 19104, USA
| | - F Chris Bennett
- Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA; Division of Neurology, Children's Hospital of Philadelphia, Philadelphia, PA 19104, USA
| | - Marie J Pierik
- Department of Internal Medicine, Division of Gastroenterology and Hepatology, Maastricht University Medical Centre, Maastricht, the Netherlands; School for Nutrition and Translational Research in Metabolism (NUTRIM), Maastricht University, Maastricht, the Netherlands
| | - Mariëlle Romberg-Camps
- Department of Gastroenterology, Geriatrics, Internal and Intensive Care Medicine (Co-MIK), Zuyderland Medical Centre, Sittard-Geleen, the Netherlands
| | - Zlatan Mujagic
- Department of Internal Medicine, Division of Gastroenterology and Hepatology, Maastricht University Medical Centre, Maastricht, the Netherlands; School for Nutrition and Translational Research in Metabolism (NUTRIM), Maastricht University, Maastricht, the Netherlands
| | - Marco Prinz
- Institute of Neuropathology, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, 79106 Freiburg, Germany; Signalling Research Centres BIOSS and CIBSS, University of Freiburg, 79104 Freiburg, Germany; Center for Basics in NeuroModulation, Faculty of Medicine, University of Freiburg, 79106 Freiburg, Germany
| | - Carolin V Schneider
- Institute for Translational Medicine and Therapeutics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA
| | - E John Wherry
- Institute for Immunology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA; Department of Systems Pharmacology and Translational Therapeutics, University of Pennsylvania, Philadelphia, PA 19104, USA; Immune Health, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA 19104, USA
| | - Meenakshi Bewtra
- Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA
| | - Robert O Heuckeroth
- Department of Pediatrics, Children's Hospital of Philadelphia Research Institute, and Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA
| | - Maayan Levy
- Department of Microbiology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA; Institute for Immunology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA.
| | - Christoph A Thaiss
- Department of Microbiology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA; Institute for Immunology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA.
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12
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Del Hoyo J, Millán M, Garrido-Marín A, Aguas M. Are we ready for telemonitoring inflammatory bowel disease? A review of advances, enablers, and barriers. World J Gastroenterol 2023; 29:1139-1156. [PMID: 36926667 PMCID: PMC10011957 DOI: 10.3748/wjg.v29.i7.1139] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/21/2022] [Revised: 11/02/2022] [Accepted: 02/09/2023] [Indexed: 02/21/2023] Open
Abstract
This review summarizes the evidence about telemonitoring in patients with inflammatory bowel disease (IBD). To give an overview of the advances performed, as well as the enablers and barriers which favoured/hindered telemonitoring implementation. We performed a literature search in PubMed, EMBASE, MEDLINE, Cochrane Database, Web of Science and Conference Proceedings. Titles and abstracts published up to September 2022 were screened for a set of inclusion criteria: telemonitoring intervention, IBD as the main disease, and a primary study performed. Ninety-seven reports were selected for full review. Finally, 20 were included for data extraction and critical appraisal. Most studies used telemonitoring combined with tele-education, and programs evolved from home telemanagement systems towards web portals through mHealth applications. Web systems demonstrated patients’ acceptance, improvement in quality of life, disease activity and knowledge, with a good cost-effectiveness profile in the short-term. Initially, telemonitoring was almost restricted to ulcerative colitis, but new patient reported outcome measures, home-based tests and mobile devices favoured its expansion to different patients´ categories. However, technological and knowledge advances led to legal, ethical, economical and logistic issues. Standardization of remote healthcare is necessary, to improve the interoperability of systems as well as to address liability concerns and users´ preferences. Telemonitoring IBD is well accepted and improves clinical outcomes at a lower cost in the short-term. Funders, policymakers, providers, and patients need to align their interests to overcome the emerging barriers for its full implementation.
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Affiliation(s)
- Javier Del Hoyo
- Department of Gastroenterology, La Fe University and Polytechnic Hospital, Valencia 46026, Spain
| | - Mónica Millán
- Department of Surgery, La Fe University and Polytechnic Hospital, Valencia 46026, Spain
| | - Alejandro Garrido-Marín
- Department of Gastroenterology, La Fe University and Polytechnic Hospital, Valencia 46026, Spain
| | - Mariam Aguas
- Department of Gastroenterology, La Fe University and Polytechnic Hospital, Valencia 46026, Spain
- Health Research Institute La Fe, La Fe University and Polytechnic Hospital, Valencia 46026, Spain
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13
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iSTART-II: An Update on the i Support Therapy-Access to Rapid Treatment (iSTART) Approach for Patient-Centered Therapy in Mild-to-Moderate Ulcerative Colitis. J Clin Med 2023; 12:jcm12031142. [PMID: 36769791 PMCID: PMC9918267 DOI: 10.3390/jcm12031142] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/08/2022] [Revised: 01/02/2023] [Accepted: 01/29/2023] [Indexed: 02/04/2023] Open
Abstract
The i Support Therapy-Access to Rapid Treatment (iSTART) was an initiative to improve patient-centered management in mild-to-moderate ulcerative colitis (UC). Our aim was to update the iSTART recommendations in order to include fecal calprotectin (FC) in the monitoring of patients with UC and improve their management. Twelve physicians from nine countries worldwide attended a virtual international consensus meeting on 4 May 2022. Data from three systematic reviews were analyzed, and a new systematic review investigating all studies reporting measurement of FC at home was conducted. Based on literature evidence, statements were formulated, discussed, and approved by voting. Statements were considered approved if at least 75% of participants agreed with a proposed statement. Fourteen statements were approved. Based on this consensus, FC measurement should be routinely performed for monitoring patients with mild-to-moderate UC to identify disease relapses early and initiate an appropriate treatment. Further studies are needed to assess whether self-monitoring of FC is associated with better disease control and improved patients' quality of life.
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14
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Ghosh S, Sanchez Gonzalez Y, Zhou W, Clark R, Xie W, Louis E, Loftus EV, Panes J, Danese S. Upadacitinib Treatment Improves Symptoms of Bowel Urgency and Abdominal Pain, and Correlates With Quality of Life Improvements in Patients With Moderate to Severe Ulcerative Colitis. J Crohns Colitis 2021; 15:2022-2030. [PMID: 34107013 PMCID: PMC8684481 DOI: 10.1093/ecco-jcc/jjab099] [Citation(s) in RCA: 33] [Impact Index Per Article: 8.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/12/2022]
Abstract
BACKGROUND AND AIMS Bowel urgency and abdominal pain are impactful, yet under-appreciated ulcerative colitis symptoms and not commonly assessed in clinical trials. We evaluated how these symptoms may improve with upadacitinib treatment and correlate with clinical and health-related quality of life [HRQOL] outcomes in the phase 2b U-ACHIEVE study. METHODS Patients aged 18-75 years, with moderately to severely active ulcerative colitis, were randomised to receive placebo or upadacitinib (7.5, 15, 30, or 45 mg once daily [QD]). Bowel urgency and abdominal pain were evaluated at baseline and Weeks 2, 4, 6, and 8. Week 8 correlations were evaluated between bowel urgency/abdominal pain with clinical [Mayo subscores and high-sensitivity C-reactive protein and faecal calprotectin measurements] and HRQOL outcomes [Inflammatory Bowel Disease Questionnaire and 36-Item Short Form Health Survey scores]. RESULTS A greater proportion of patients [n = 250] reported no bowel urgency and less abdominal pain with upadacitinib treatment compared with placebo, with improvements observed as early as 2 weeks. At Week 8, patients receiving the 45-mg QD dose had the greatest improvements versus placebo, with 46% reporting no bowel urgency [vs 9%; p ≤ 0.001] and 38% reporting no abdominal pain [vs 13%; p = 0.015]. At Week 8, moderate correlations were found between bowel urgency or abdominal pain and most clinical and HRQOL outcomes. CONCLUSIONS Induction treatment with upadacitinib demonstrated significant reductions in bowel urgency and abdominal pain compared with placebo. These symptoms also correlate to clinical and HRQOL outcomes, supporting their use to monitor disease severity and other treatment outcomes.
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Affiliation(s)
- Subrata Ghosh
- College of Medicine and Health, University College Cork, Cork, Ireland
| | - Yuri Sanchez Gonzalez
- Department of Health Economics and Outcomes Research, AbbVie Inc., North Chicago, IL, USA
| | - Wen Zhou
- Department of Clinical Development, AbbVie Inc., North Chicago, IL, USA
| | - Ryan Clark
- Department of Health Economics and Outcomes Research, AbbVie Inc., North Chicago, IL, USA
| | - Wangang Xie
- Department of Data and Statistical Sciences, AbbVie Inc., North Chicago, IL, USA
| | - Edouard Louis
- Department of Gastroenterology, University Hospital CHU of Liège, Liège, Belgium
| | - Edward V Loftus
- Division of Gastroenterology and Hepatology, Mayo Clinic College of Medicine, Rochester, MN, USA
| | - Julian Panes
- Department of Gastroenterology, Hospital Clinic Barcelona, IDIBAPS, CIBERehd, Barcelona, Spain
| | - Silvio Danese
- Department of Gastroenterology, Istituto Clinico Humanitas, Milan, Italy
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15
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Nagahori M, Watanabe K, Motoya S, Ogata H, Kanai T, Matsui T, Suzuki Y, Pinton P, Ursos L, Sakamoto S, Shikamura M, Hori T, Fernandez J, Hibi T, Watanabe M. Week 2 Symptomatic Response with Vedolizumab as a Predictive Factor in Japanese Anti-TNFα-Naive Patients with Ulcerative Colitis: A post hoc Analysis of a Randomized, Placebo-Controlled Phase 3 Trial. Digestion 2021; 102:742-752. [PMID: 33454706 PMCID: PMC8491515 DOI: 10.1159/000512235] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/03/2020] [Accepted: 10/11/2020] [Indexed: 02/04/2023]
Abstract
BACKGROUND AND AIM To evaluate the onset of symptomatic response with vedolizumab in patients with moderate-to-severe ulcerative colitis in Japan. METHODS Patients were randomized to receive vedolizumab 300 mg or placebo at Weeks 0, 2, and 6. Mayo subscores were analyzed in patients with baseline stool frequency (SF) ≥1 and rectal bleeding (RB) ≥1. In patients with baseline SF ≥2 and RB ≥1, the proportion who achieved SF ≤1 and RB = 0 was determined. RESULTS Patients were randomized to vedolizumab (n = 164) or placebo (n = 82). Decrease from baseline in mean SF subscore was greater with vedolizumab versus placebo from Week 2 (-6.6%; 95% confidence interval [CI], -16.2, 3.0), with a greater difference in anti-tumor necrosis factor (TNF)α-naive patients (vedolizumab vs. placebo, -13.2%; 95% CI, -29.7, 3.3). Mean percentage decrease from baseline RB subscore was numerically greater with vedolizumab versus placebo from Week 6 in anti-TNFα-naive patients (-10.7%; 95% CI, -33.0, 11.5). More patients in the anti-TNFα-naive subgroup achieved SF ≤1 and RB = 0 with vedolizumab versus placebo at Week 2 (14.8%; 95% CI, 2.5, 27.0) and Week 6 (20.3%; 95% CI, 4.4, 36.2). Patients with SF ≤1 and RB = 0 at Week 2 had higher clinical response, clinical remission, and mucosal healing rates at Week 10 than those without. CONCLUSIONS Our results indicate that vedolizumab induces a rapid symptomatic response, particularly in anti-TNFα-naive patients, and suggest that early symptomatic improvement predicts treatment response at Week 10 (NCT02039505).
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Affiliation(s)
- Masakazu Nagahori
- Department of Gastroenterology and Hepatology, Tokyo Medical and Dental University, Tokyo, Japan,*Masakazu Nagahori, Department of Gastroenterology and Hepatology, Tokyo Medical and Dental University, 1-5-45 Yushima Bunkyo-ku, Tokyo 113-8519 (Japan),
| | - Kenji Watanabe
- Department of Intestinal Inflammation Research, Hyogo College of Medicine, Hyogo, Japan
| | - Satoshi Motoya
- IBD Center, Hokkaido Prefectural Welfare Federation of Agricultural Cooperatives, Sapporo-Kosei General Hospital, Sapporo, Japan
| | - Haruhiko Ogata
- Endoscopic Center, Keio University School of Medicine, Tokyo, Japan
| | - Takanori Kanai
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan
| | - Toshiyuki Matsui
- Department of Gastroenterology, Fukuoka University Chikushi Hospital, Fukuoka, Japan
| | - Yasuo Suzuki
- Department of Internal Medicine, Toho University Medical Center Sakura Hospital, Chiba, Japan
| | - Philippe Pinton
- Japan Medical Office, Takeda Pharmaceutical Co., Ltd., Tokyo, Japan
| | - Lyann Ursos
- Global Medical Affairs, Takeda Pharmaceuticals USA, Inc., Deerfield, Illinois, USA
| | - Shigeru Sakamoto
- Takeda Development Center Japan, Takeda Pharmaceutical Co., Ltd., Osaka, Japan
| | - Mitsuhiro Shikamura
- Takeda Development Center Japan, Takeda Pharmaceutical Co., Ltd., Osaka, Japan
| | - Tetsuharu Hori
- Takeda Development Center Japan, Takeda Pharmaceutical Co., Ltd., Osaka, Japan
| | | | - Toshifumi Hibi
- Center for Advanced Inflammatory Bowel Disease Research and Treatment, Kitasato Institute Hospital, Kitasato University, Tokyo, Japan
| | - Mamoru Watanabe
- Advanced Research Institute, Tokyo Medical and Dental University, Tokyo, Japan
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16
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Gong W, Guo K, Zheng T, Xie H, Li W, Li M, Hong Z, Ren H, Gu G, Wang G, Wu X, Ren J. JINLING (Judicious INdex of Luminal INflammation Grade) score, an effective indicator to assess inflammation severity in Crohn's disease. Eur J Gastroenterol Hepatol 2021; 33:1049-1054. [PMID: 33136728 DOI: 10.1097/meg.0000000000001979] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/10/2022]
Abstract
BACKGROUND With the increasing demand for individualized treatment in Crohn's disease, a score for accurate evaluation of inflammation grade will be of great significance. We have developed the JINLING score to assess inflammation severity for Crohn's disease, which incorporates an endoscopic score (SES-CD) and a 2-item patient-reported outcome (PRO2). The aim of this study was to examine the performance of JINLING score in evaluating inflammation grade and the correlation with the clinical outcomes. METHODS The correlation between JINLING score and Global Histologic Disease Activity Score (GHAS), fecal calprotectin (FCP), and C-reactive protein (CRP) level was performed in an exploration phase with a retrospective data set. The data on clinical outcomes including medication effects, Crohn's disease-related surgery and biochemical results were collected from a single-center prospective validation cohort. RESULTS JINLING score correlated significantly with FCP, CRP, and hemoglobin in the exploration cohort (all P < 0.05). The receiver operating characteristic (ROC) curves based on a threshold Crohn's disease activity index value of 150, GHAS of 4, and FCP of 60 μg/g to identify disease activity, all showed a higher area under the curve with JINLING score than SES-CD or PRO2 alone. In the validation cohort, patients with high inflammation grade (JINLING ≥4) had higher GHAS, CRP, and FCP than low inflammation grade patients. High JINLING score was associated with an increased risk of treatment failure (hazard ratio 2.93; 95% confidence interval 1.13-7.61, P = 0.021). CONCLUSION This newly developed index served well for quantifying inflammation grade and predicting clinical outcomes. JINLING score has the potential to facilitate clinical decision-making and personalized therapy for Crohn's disease patients.
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Affiliation(s)
- Wenbin Gong
- School of Medicine, Southeast University
- Research Institute of General Surgery, Jinling Hospital
| | - Kun Guo
- Research Institute of General Surgery, Jinling Hospital
| | - Tao Zheng
- Research Institute of General Surgery, Jinling Hospital
| | - Haohao Xie
- Research Institute of General Surgery, Jinling Hospital
| | - Weijie Li
- Department of General Surgery, BenQ Medical Center, The Affiliated BenQ Hospital of Nanjing Medical University, Nanjing, P. R. China
| | - Mengxuan Li
- Department of General Surgery, BenQ Medical Center, The Affiliated BenQ Hospital of Nanjing Medical University, Nanjing, P. R. China
| | - Zhiwu Hong
- Research Institute of General Surgery, Jinling Hospital
| | - Huajian Ren
- Research Institute of General Surgery, Jinling Hospital
| | - Guosheng Gu
- Research Institute of General Surgery, Jinling Hospital
| | - Gefei Wang
- Research Institute of General Surgery, Jinling Hospital
| | - Xiuwen Wu
- Research Institute of General Surgery, Jinling Hospital
| | - Jianan Ren
- School of Medicine, Southeast University
- Research Institute of General Surgery, Jinling Hospital
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17
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Biemans VBC, Straatmijer T, Hoentjen F, Pierik MJ. Letter: tofacitinib in treatment-refractory ulcerative colitis-a single centre real-world experience in Australia. Authors' reply. Aliment Pharmacol Ther 2021; 54:534-535. [PMID: 34331810 DOI: 10.1111/apt.16505] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/09/2022]
Affiliation(s)
- Vince B C Biemans
- Department of Gastroenterology and Hepatology, Radboud University Medical Centre, Nijmegen, The Netherlands.,Gastroenterology and Hepatology, Maastricht Universitair Medisch Centrum+, Maastricht, The Netherlands
| | - Tessa Straatmijer
- Department of Gastroenterology and Hepatology, Amsterdam University Medical Centres, Amsterdam, The Netherlands
| | - Frank Hoentjen
- Department of Gastroenterology and Hepatology, Radboud University Medical Centre, Nijmegen, The Netherlands
| | - Marieke J Pierik
- Gastroenterology and Hepatology, Maastricht Universitair Medisch Centrum+, Maastricht, The Netherlands
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18
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Pinto S, Loddo E, Paba S, Favale A, Chicco F, Onali S, Usai P, Fantini MC. Crohn's disease and ulcerative colitis patient-reported outcomes signs and symptoms for the remote management of inflammatory bowel disease during the COVID-19 pandemic. J Patient Rep Outcomes 2021; 5:48. [PMID: 34165646 PMCID: PMC8223182 DOI: 10.1186/s41687-021-00323-z] [Citation(s) in RCA: 8] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/14/2021] [Accepted: 05/30/2021] [Indexed: 02/07/2023] Open
Abstract
Background and aims The COVID-19 pandemic has led to a deep reorganization of hospital services including inflammatory bowel disease (IBD) units. In this situation, conversion of in-person routine follow-up visits into phone consultations might be necessary. Here we explored the feasibility of using the validated Crohn’s Disease (CD) or Ulcerative Colitis (UC) Patient-Reported Outcomes Signs and Symptoms (CD- and UC-PRO/SS) to collect data about abdominal symptoms (abdominal/S) and bowel signs and symptoms (bowel/SS) remotely. Methods CD- and UC-PRO/SS were collected during phone consultations and compared among patients with active and inactive disease. The effectiveness of therapeutic intervention in patients with active disease was assessed by PRO/SS variation. Results Twenty-one CD and 56 UC patients were evaluated by phone. Six (28.6%) CD and 15 (26.8%) UC patients were considered to have active disease. In CD the bowel/SS but not the abdominal/S module was significantly higher in active patients (mean bowel/SS 2.50 [SE ± 0.44] active vs 0.76 [SE ± 0.18] remission, p = 0.008, AUC 0.87; mean abdominal/S 1.11 [SE ± 0.38] active vs 0.24 [SE ± 0.13] remission, p = 0.066). UC-PRO/SS measures were significantly higher in active patients as compared to patients in remission (median bowel/SS 1.63 [SE ± 0.24] active vs 0.33 [SE ± 0.04] remission; p < 0.0001, AUC 0.91; mean abdominal/S 1.03 [SE ± 0.24] vs 0.37 [SE ± 0.12]; p = 0.009, AUC 0.71). Therapy was escalated in 12 patients (3 CD and 9 UC) due to disease relapse. Therapy escalation resulted in the reduction of PRO/SS as evaluated at the subsequent phone consultation. Conclusions PRO/SS might represent a feasible tool to evaluate disease activity and therapy outcome in IBD patients during periods of limited access to outpatient clinics. Supplementary Information The online version contains supplementary material available at 10.1186/s41687-021-00323-z.
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Affiliation(s)
- Sergio Pinto
- Department of Medical Science and Public Health, Cagliari, University Hospital of Cagliari, University of Cagliari, Cagliari, Italy.,Department of Medical Science and Public Health, Gastroenterology Unit, University of Cagliari, Cagliari, Italy
| | - Erica Loddo
- Department of Medical Science and Public Health, Cagliari, University Hospital of Cagliari, University of Cagliari, Cagliari, Italy.,Department of Medical Science and Public Health, Gastroenterology Unit, University of Cagliari, Cagliari, Italy
| | - Salvatore Paba
- Department of Medical Science and Public Health, Cagliari, University Hospital of Cagliari, University of Cagliari, Cagliari, Italy.,Department of Medical Science and Public Health, Gastroenterology Unit, University of Cagliari, Cagliari, Italy
| | - Agnese Favale
- Department of Medical Science and Public Health, Cagliari, University Hospital of Cagliari, University of Cagliari, Cagliari, Italy.,Department of Medical Science and Public Health, Gastroenterology Unit, University of Cagliari, Cagliari, Italy
| | - Fabio Chicco
- Department of Medical Science and Public Health, Cagliari, University Hospital of Cagliari, University of Cagliari, Cagliari, Italy.,Department of Medical Science and Public Health, Gastroenterology Unit, University of Cagliari, Cagliari, Italy
| | - Sara Onali
- Department of Medical Science and Public Health, Cagliari, University Hospital of Cagliari, University of Cagliari, Cagliari, Italy.,Department of Medical Science and Public Health, Gastroenterology Unit, University of Cagliari, Cagliari, Italy
| | - Paolo Usai
- Department of Medical Science and Public Health, Cagliari, University Hospital of Cagliari, University of Cagliari, Cagliari, Italy.,Department of Medical Science and Public Health, Gastroenterology Unit, University of Cagliari, Cagliari, Italy
| | - Massimo Claudio Fantini
- Department of Medical Science and Public Health, Cagliari, University Hospital of Cagliari, University of Cagliari, Cagliari, Italy. .,Department of Medical Science and Public Health, Gastroenterology Unit, University of Cagliari, Cagliari, Italy.
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19
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Janssen L, Romberg-Camps M, van Bodegraven A, Haans J, Aquarius M, Boekema P, Munnecom T, Brandts L, Joore M, Masclee A, Jonkers D, Pierik M. Control Crohn Safe with episodic adalimumab monotherapy as first-line treatment study (CoCroS): study protocol for a randomised controlled trial. BMJ Open 2021; 11:e042885. [PMID: 33947729 PMCID: PMC8098960 DOI: 10.1136/bmjopen-2020-042885] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/05/2022] Open
Abstract
INTRODUCTION Crohn's disease (CD) is a chronic inflammatory bowel disease with a heterogeneous clinical presentation, relapse rate and treatment response. At present, no markers are available to adequately predict disease course at diagnosis. To prevent overtreatment of patients with a relative mild disease course, a step-up approach starting with corticosteroids is usually applied. Timely introduction of potentially disease modifying drugs and tight control of mucosal inflammation are crucial to prevent disease-related complications in patients with a complex disease course. We hypothesise that episodic treatment with adalimumab monotherapy in combination with close monitoring after drug discontinuation improves long-term outcome and reduces drug-related side effects, while preventing overtreatment. METHODS AND ANALYSIS In this pragmatic multicentre randomised controlled trial, newly diagnosed CD patients or CD patients with a flare, naïve to thiopurines and biologicals, will be included and randomised 1:1 to open-label episodic (ie, 24 weeks) adalimumab monotherapy or step-up care starting with corticosteroids. The primary outcome is the number of yearly quarters of corticosteroid free clinical (Monitor Inflammatory Bowel Disease At Home score ≤3) and biochemical (C reactive protein within normal range and faecal calprotectin ≤200 µg/g) remission at week 96. Secondary outcomes are total healthcare costs, cumulative corticosteroid dose, proportion of patients with endoscopic remission at week 24, corticosteroid-free clinical remission, time to remission and patient-reported outcome measures on quality of life, (work) disability and treatment adherence. Safety outcomes are drug-related and disease-related adverse events and disease progression on MRI-enterography at week 96. ETHICS AND DISSEMINATION This study is approved by the Medical Research Ethics Committee of azM/UM in Maastricht dated 21 August 2019 (METC18-076) and is monitored by the Clinical Trial Centre Maastricht according to Good Clinical Practice guidelines. Written informed consent will be obtained from all patients. Study results will be published in international peer-reviewed medical journals. TRIAL REGISTRATION NUMBER NCT03917303.
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Affiliation(s)
- Laura Janssen
- NUTRIM - School for Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, The Netherlands
- Gastroenterology and Hepatology, Maastricht UMC+, Maastricht, The Netherlands
| | - Mariëlle Romberg-Camps
- Gastroenterology, Zuyderland Medical Centre Sittard-Geleen, Sittard-Geleen, Limburg, The Netherlands
| | - Ad van Bodegraven
- Gastroenterology, Zuyderland Medical Centre Sittard-Geleen, Sittard-Geleen, Limburg, The Netherlands
| | - Jeoffrey Haans
- Gastroenterology and Hepatology, Maastricht UMC+, Maastricht, The Netherlands
| | - Michèl Aquarius
- Gastroenterology, VieCuri Medical Centre, Venlo, The Netherlands
| | - Paul Boekema
- Gastroenterology, Maxima Medical Centre, Eindhoven, The Netherlands
| | - Tamara Munnecom
- Gastroenterology, Laurentius Hospital, Roermond, The Netherlands
| | - Lloyd Brandts
- Clinical Epidemiology and Medical Technology Assessment (KEMTA), Maastricht UMC+, Maastricht, The Netherlands
| | - Manuela Joore
- Clinical Epidemiology and Medical Technology Assessment (KEMTA), Maastricht UMC+, Maastricht, The Netherlands
- CAPHRI - School for Care and Public Health Research Institute, Maastricht University, Maastricht, The Netherlands
| | - Adrian Masclee
- Gastroenterology and Hepatology, Maastricht UMC+, Maastricht, The Netherlands
| | - D Jonkers
- NUTRIM - School for Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, The Netherlands
| | - M Pierik
- Gastroenterology and Hepatology, Maastricht UMC+, Maastricht, The Netherlands
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20
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Abstract
As technology advances, diagnostic tests continue to improve and each year, we are presented with new alternatives to standard procedures. Given the plethora of diagnostic alternatives, diagnostic tests must be evaluated to determine their place in the diagnostic armamentarium. The first step involves determining the accuracy of the test, including the sensitivity and specificity, positive and negative predictive values, likelihood ratios for positive and negative tests, and receiver operating characteristic (ROC) curves. The role of the test in a diagnostic pathway has then to be determined, following which the effect on patient outcome should be examined.
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Affiliation(s)
- Brendan J Barrett
- Department of Medicine, Memorial University of Newfoundland, St. John's, NF, Canada.
| | - John M Fardy
- Department of Medicine, Memorial University of Newfoundland, St. John's, NF, Canada.
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21
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Pauwels RWM, van der Woude CJ, Erler NS, de Vries AC. Fecal calprotectin is an early predictor of endoscopic response and histologic remission after the start of vedolizumab in inflammatory bowel disease. Therap Adv Gastroenterol 2020; 13:1756284820979765. [PMID: 33488771 PMCID: PMC7768861 DOI: 10.1177/1756284820979765] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/19/2020] [Accepted: 11/19/2020] [Indexed: 02/04/2023] Open
Abstract
BACKGROUND AND AIMS Early prediction of the effect of vedolizumab (VDZ) in inflammatory bowel disease (IBD) is of paramount importance to guide clinical decisions. This study assessed whether early fecal calprotectin (FC) can predict endoscopic response and histologic remission after VDZ initiation. METHODS This was a prospective study. Inclusion criteria were endoscopic inflammation and FC >100 µg/g. FC was determined at baseline and weeks 2, 4, 8 and 16. At week 16, endoscopies with ileal and colonic biopsies were performed. FC changes were assessed with Wilcoxon Rank Sum tests. ROC statistics were used to assess the diagnostic accuracy of FC. RESULTS In total, 45 patients [27 Crohn's disease (CD), 16/2 ulcerative colitis (UC)/IBD-unclassified] [40% males, median age 39 (28-51) years] were included. Week 16 endoscopic response and histologic remission rates were 58% and 33%. A median 37% decline in FC at week 2 was observed only in endoscopic responders, p = 0.025. FC <250 µg/g at week 8 predicted endoscopic response in both UC and CD (positive predictive value 100%), whereas absence of FC decline at week 8 corresponded with absence of endoscopic response in CD [negative predictive value (NPV) 82%] and absence of histologic remission in both UC and CD (NPV 90%). CONCLUSION The onset of a decline in FC as early as week 2 is associated with endoscopic response to VDZ induction. FC <250 µg/g at week 8 is associated with endoscopic response, whereas absence of FC decline at week 8 is associated with absence of both endoscopic response and histologic remission. FC levels 8 weeks after the start of VDZ could be used to guide clinical decisions and might substitute for endoscopic response evaluation.
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Affiliation(s)
- Renske W. M. Pauwels
- Erasmus MC, Department of Gastroenterology and Hepatology, Rotterdam, The Netherlands
| | | | - Nicole S. Erler
- Erasmus MC, Department of Biostatistics, Rotterdam, The Netherlands
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22
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Pauwels RWM, de Vries AC, van der Woude CJ. Fecal calprotectin is a reliable marker of endoscopic response to vedolizumab therapy: A simple algorithm for clinical practice. J Gastroenterol Hepatol 2020; 35:1893-1901. [PMID: 32291796 PMCID: PMC7687080 DOI: 10.1111/jgh.15063] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/20/2019] [Revised: 02/18/2020] [Accepted: 03/29/2020] [Indexed: 12/15/2022]
Abstract
BACKGROUND AND AIM The association of fecal calprotectin (FC) and endoscopic response in inflammatory bowel disease patients during vedolizumab (VDZ) treatment is largely unknown. The aim of this study is to assess the diagnostic value of FC to predict endoscopic response. METHODS Patients with active endoscopic disease at baseline were included. Endoscopies and FC tests were performed at baseline and week 16. Patients with a confirmed endoscopic response at week 16 continued VDZ maintenance therapy, and endoscopy and FC tests were performed at week 52. Endoscopic response was defined as endoscopic Mayo score reduction of ≥ 1, SES-CD of ≥ 50%, or Rutgeerts' score of ≥ 1. Correlations were assessed using Spearman and receiver operating characteristic statistics. RESULTS A total of 114 patients, 46 ulcerative colitis and 68 Crohn's disease patients (44 men, median age 40 years), were included after the start of VDZ; 85% was anti-tumor necrosis factor alpha refractory. Endoscopic response was observed in 60 (53%) patients at week 16; the response sustained in 73% at week 52. FC decreased significantly from 819 at baseline to 154 μg/g at week 16. FC at weeks 16 and 52 were significantly correlated to (sustained) endoscopic response (r = -0.62 / r = -0.67, P < 0.001). FC < 200 μg/g indicates endoscopic response (area under the curve = 0.89, positive predictive value = 94%), whereas FC > 450 μg/g indicates endoscopic non-response after induction (negative predictive value = 83%). An increase in FC level of > 400 μg/g after induction indicates endoscopic loss of response (area under the curve = 0.97, negative predictive value = 96%). CONCLUSION This prospective study demonstrates a significant correlation between FC and endoscopic response to VDZ. FC < 200 μg/g prognosticate endoscopic response, and FC > 450 μg/g endoscopic non-response. An increase in FC of > 400 μg/g after induction indicates endoscopic loss of response. This simple FC algorithm may guide clinical decisions on the continuation and optimization of VDZ in inflammatory bowel disease patients.
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23
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D'Arcangelo G, Aloi M. Treat-to-Target in Pediatric Inflammatory Bowel Disease: What Does the Evidence Say? Paediatr Drugs 2020; 22:463-472. [PMID: 32572841 DOI: 10.1007/s40272-020-00406-2] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/18/2022]
Abstract
The traditional management of inflammatory bowel disease, based on treatment intensification guided by clinical activity alone, has been revised in the last 10 years and a treat-to-target approach has been proposed and is currently under evaluation as a disease-modifying strategy. Treat-to-target focuses on objective and scheduled measures to monitor intestinal damage, with consequent therapeutic adjustments in case of failure to achieve pre-defined targets. Identification of targets has been set out by the Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE) committee in 2015. Mucosal healing is universally accepted as the main target both in Crohn's disease and ulcerative colitis, given its proven association with better long-term outcomes than clinical remission alone. Equally important is to ensure patients' clinical remission and improve patient-reported outcomes. Transmural healing (for Crohn's disease) and histological remission (for ulcerative colitis), listed as adjunctive targets, are likely to become primary targets in the near future. The ultimate goal of this approach is to modify the natural history of inflammatory bowel diseases by trying to block bowel damage progression, with interventions in the pre-clinical stage. In this review, we will discuss the current recommended therapeutic targets, as well as those that are considered adjunctive targets, with a focus on the limited pediatric literature available. Prospective long-term trials are warranted in order to identify the most appropriate target for the pediatric population and its specific issues. Identification of reliable predictors of disease course, outcome, and response to treatment will help to individually adapt each step of this monitoring algorithm and consequent therapeutic decision.
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Affiliation(s)
- Giulia D'Arcangelo
- Department of Women's and Children's Health, Pediatric Gastroenterology and Liver Unit, Sapienza University of Rome, Viale Regina Elena 324, 00161, Rome, Italy
| | - Marina Aloi
- Department of Women's and Children's Health, Pediatric Gastroenterology and Liver Unit, Sapienza University of Rome, Viale Regina Elena 324, 00161, Rome, Italy.
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24
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van Andel EM, Koopmann BDM, Crouwel F, Noomen CG, de Boer NKH, van Asseldonk DP, Mokkink LB. Systematic Review of Development and Content Validity of Patient-reported Outcome Measures in Inflammatory Bowel Disease: Do We Measure What We Measure? J Crohns Colitis 2020; 14:1299-1315. [PMID: 32211749 PMCID: PMC7493218 DOI: 10.1093/ecco-jcc/jjaa057] [Citation(s) in RCA: 23] [Impact Index Per Article: 4.6] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/07/2023]
Abstract
BACKGROUND AND AIMS Patient-reported outcome measures are increasingly important in daily care and research in inflammatory bowel disease [IBD]. This study provides an overview of the content and content validity of IBD-specific patient-reported outcome measures on three selected constructs. METHODS Databases were searched up to May 2019 for development and/or content validity studies on IBD-specific self-report measures on health-related quality of life, disability, and self-report disease activity in adults. Evidence was synthesised on content validity in three aspects: relevance, comprehensiveness, and comprehensibility following the COnsensus-based Standards for the selection of health Measurement INstruments methodology. Questionnaire items were organised in themes to provide an overview of important aspects of these constructs. RESULTS For 14/44 instruments, 25 content validity studies were identified and 25/44 measures had sufficient content validity, the strongest evidence being of moderate quality, though most evidence is of low or very low quality. The Crohn's Life Impact Questionnaire and IBD questionnaire-32 on quality of life, the IBD-Control on disease activity, and the IBD Disability Index Self-Report and its 8-item version on disability, have the strongest evidence of sufficient relevance, comprehensiveness, and comprehensibility, ranging from moderate to very low quality. A fair number of recurring items themes, possibly important for the selected constructs, was identified. CONCLUSIONS The body of evidence for content validity of IBD-specific health-related quality of life, self-report disease activity, and disability self-report measures is limited. More content validity studies should be performed after reaching consensus on the constructs of interest for IBD, and studies should involve patients.
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Affiliation(s)
- Emma M van Andel
- Department of Gastroenterology and Hepatology, Noordwest Ziekenhuisgroep, Alkmaar, The Netherlands
| | - Brechtje D M Koopmann
- Department of Gastroenterology and Hepatology, Noordwest Ziekenhuisgroep, Alkmaar, The Netherlands
| | - Femke Crouwel
- Department of Gastroenterology and Hepatology, Noordwest Ziekenhuisgroep, Alkmaar, The Netherlands
| | - Casper G Noomen
- Department of Gastroenterology and Hepatology, Noordwest Ziekenhuisgroep, Alkmaar, The Netherlands
| | - Nanne K H de Boer
- Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Gastroenterology and Hepatology, Amsterdam; Gastroenterology and Metabolism Research Institute, Amsterdam, The Netherlands
| | - Dirk P van Asseldonk
- Department of Gastroenterology and Hepatology, Noordwest Ziekenhuisgroep, Alkmaar, The Netherlands
| | - Lidwine B Mokkink
- Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Epidemiology and Biostatistics; Amsterdam Public Health Research Institute, Amsterdam, The Netherlands
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Biemans VBC, Hoentjen F, Pierik MJ. Letter: ustekinumab's effectiveness compared with vedolizumab in Crohn's disease-what about mucosal healing and biomarkers? Authors' reply. Aliment Pharmacol Ther 2020; 52:753-754. [PMID: 32886363 DOI: 10.1111/apt.15959] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/09/2022]
Affiliation(s)
- Vince B C Biemans
- Radboud University Medical Centre, Nijmegen, the Netherlands.,Maastricht University Medical Centre, Maastricht, the Netherlands
| | - Frank Hoentjen
- Radboud University Medical Centre, Nijmegen, the Netherlands
| | - Marieke J Pierik
- Maastricht University Medical Centre, Maastricht, the Netherlands
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26
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Annese V, Lakatos PL. A further "stri(v)de" in IBD management. Dig Liver Dis 2020; 52:721-722. [PMID: 32197889 DOI: 10.1016/j.dld.2020.02.005] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/21/2020] [Revised: 01/30/2020] [Accepted: 02/01/2020] [Indexed: 12/11/2022]
Affiliation(s)
- Vito Annese
- Valiant Clinic & American Hospital, Dubai, United Arab Emirates
| | - Peter L Lakatos
- McGill University Health Centre, Montreal, Canada; Semmelweis University, Budapest, Hungary
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Adaptation of TECCU App Based on Patients´ Perceptions for the Telemonitoring of Inflammatory Bowel Disease: A Qualitative Study Using Focus Groups. INTERNATIONAL JOURNAL OF ENVIRONMENTAL RESEARCH AND PUBLIC HEALTH 2020; 17:ijerph17061871. [PMID: 32183103 PMCID: PMC7143635 DOI: 10.3390/ijerph17061871] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 12/31/2019] [Revised: 03/06/2020] [Accepted: 03/10/2020] [Indexed: 01/18/2023]
Abstract
Background: Despite the continuous adaptation of eHealth systems for patients with inflammatory bowel disease (IBD), a significant disconnection persists between users and developers. Since non-adherence remains high, it is necessary to better understand the patients’ perspective on telemonitoring for IBD. Accordingly, this study aimed to adapt the TECCU telemonitoring app to the preferences and needs of IBD patients. Methods: A qualitative study was carried out using successive focus groups of IBD patients. Meetings were audio-recorded and a thematic analysis was employed until data saturation was achieved. The first group included patients who had used the TECCU App in a pilot clinical trial, and subsequent meetings included patients with Crohn’s disease and ulcerative colitis recruited from the Spanish Confederation of patient associations. The information collected at each meeting guided consecutive changes to the platform. Results: Data saturation was reached after three focus groups involving a total of 18 patients. Three main themes emerged: (1) platform usability, (2) the communication process, and (3) platform content. All participants indicated that TECCU is easy to use, permitting continuous and personalized feedback. According to patients´ perspectives, the platform was adapted to foster a flexible follow-up and shared decision-making using open and safe communication networks. Many participants appreciated the educational elements and, consequently, the app was connected to reliable and continuously updated webpages. Conclusions: IBD patients valued the usability and personalized monitoring offered by the TECCU App. Improvements in the messaging system and continuously updated educational content were introduced to address patients´ needs and favor their engagement.
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SFED recommendations for IBD endoscopy during COVID-19 pandemic: Italian and French experience. Nat Rev Gastroenterol Hepatol 2020; 17:507-516. [PMID: 32528139 PMCID: PMC7288265 DOI: 10.1038/s41575-020-0319-3] [Citation(s) in RCA: 13] [Impact Index Per Article: 2.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 05/15/2020] [Indexed: 02/07/2023]
Abstract
The current coronavirus disease 2019 (COVID-19) pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection has required a complete change in the management of patients with inflammatory bowel disease (IBD) who need to undergo endoscopic procedures. Several preventive measures must be taken to avoid the spread of infection among health-care professionals and patients with IBD, including the use of personal protective equipment, greater attention to endoscopic room hygiene and rescheduling of non-urgent procedures. This Perspective aims to provide a guide based on the Italian and French experience to better face the difficulties encountered by endoscopists during this global health emergency. In particular, recommendations regarding the use of personal protective equipment to prevent COVID-19 transmission, both for patients and health-care professionals, are proposed and different scenarios in endoscopic IBD management are evaluated to suggest when endoscopy could be rescheduled and replaced by alternative biomarkers.
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Peters V, Alizadeh BZ, de Vries JHM, Dijkstra G, Campmans-Kuijpers MJE. Nutritional Assessment in Inflammatory Bowel Disease (IBD)-Development of the Groningen IBD Nutritional Questionnaires (GINQ). Nutrients 2019; 11:E2739. [PMID: 31726688 PMCID: PMC6893781 DOI: 10.3390/nu11112739] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/29/2019] [Revised: 10/30/2019] [Accepted: 11/07/2019] [Indexed: 12/15/2022] Open
Abstract
Diet plays a key role in the complex etiology and treatment of inflammatory bowel disease (IBD). Most existing nutritional assessment tools neglect intake of important foods consumed or omitted specifically by IBD patients or incorporate non-Western dietary habits, making the development of appropriate dietary guidelines for (Western) IBD patients difficult. Hence, we developed a food frequency questionnaire (FFQ), the Groningen IBD Nutritional Questionnaires (GINQ-FFQ); suitable to assess dietary intake in IBD patients. To develop the GINQ-FFQ, multiple steps were taken, including: identification of IBD specific foods, a literature search, and evaluation of current dietary assessment methods. Expert views were collected and in collaboration with Wageningen University, division of Human Nutrition and Health, this semi-quantitative FFQ was developed using standard methods to obtain a valid questionnaire. Next, the GINQ-FFQ was digitized into a secure web-based environment which also embeds additional nutritional and IBD related questions. The GINQ-FFQ is an online self-administered FFQ evaluating dietary intake, taking the previous month as a reference period. It consists of 121 questions on 218 food items. This paper describes the design process of the GINQ-FFQ which assesses dietary intake especially (but not exclusively) in IBD patients. Validation of the GINQ-FFQ is needed and planned in the near future.
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Affiliation(s)
- Vera Peters
- Department of Gastroenterology and Hepatology, University Medical Center Groningen and University of Groningen, 9713 GZ Groningen, The Netherlands; (B.Z.A.); (G.D.); (M.J.C.-K.)
- Department of Epidemiology, University Medical Center Groningen and University of Groningen, 9713 GZ Groningen, The Netherlands
| | - Behrooz Z Alizadeh
- Department of Gastroenterology and Hepatology, University Medical Center Groningen and University of Groningen, 9713 GZ Groningen, The Netherlands; (B.Z.A.); (G.D.); (M.J.C.-K.)
- Department of Epidemiology, University Medical Center Groningen and University of Groningen, 9713 GZ Groningen, The Netherlands
| | - Jeanne HM de Vries
- Division of Human Nutrition and Health, Wageningen University and Research, 6708 PB Wageningen, The Netherlands;
| | - Gerard Dijkstra
- Department of Gastroenterology and Hepatology, University Medical Center Groningen and University of Groningen, 9713 GZ Groningen, The Netherlands; (B.Z.A.); (G.D.); (M.J.C.-K.)
| | - Marjo JE Campmans-Kuijpers
- Department of Gastroenterology and Hepatology, University Medical Center Groningen and University of Groningen, 9713 GZ Groningen, The Netherlands; (B.Z.A.); (G.D.); (M.J.C.-K.)
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Gonczi L, Bessissow T, Lakatos PL. Disease monitoring strategies in inflammatory bowel diseases: What do we mean by "tight control"? World J Gastroenterol 2019; 25:6172-6189. [PMID: 31749591 PMCID: PMC6848014 DOI: 10.3748/wjg.v25.i41.6172] [Citation(s) in RCA: 28] [Impact Index Per Article: 4.7] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/08/2019] [Revised: 09/26/2019] [Accepted: 10/30/2019] [Indexed: 02/06/2023] Open
Abstract
In recent years, there has been a critical change in treatment paradigms in inflammatory bowel diseases (IBD) triggered by the arrival of new effective treatments aiming to prevent disease progression, bowel damage and disability. The insufficiency of symptomatic disease control and the well-known discordance between symptoms and objective measures of disease activity lead to the need of reviewing conventional treatment algorithms and developing new concepts of optimal therapeutic strategy. The treat-to-target strategies, defined by the selecting therapeutic targets in inflammatory bowel disease consensus recommendation, move away from only symptomatic disease control and support targeting composite therapeutic endpoints (clinical and endoscopical remission) and timely assessment. Emerging data suggest that early therapy using a treat-to-target approach and an algorithmic therapy escalation using regular disease monitoring by clinical and biochemical markers (fecal calprotectin and C-reactive protein) leads to improved outcomes. This review aims to present the emerging strategies and supporting evidence in the current therapeutic paradigm of IBD including the concepts of "early intervention", "treat-to-target" and "tight control" strategies. We also discuss the real-word experience and applicability of these new strategies and give an overview on the future perspectives and areas in need of further research and potential improvement regarding treatment targets and ("tight") disease monitoring strategies.
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Affiliation(s)
- Lorant Gonczi
- First Department of Medicine, Semmelweis University, Budapest H-1083, Hungary
| | - Talat Bessissow
- Division of Gastroenterology, McGill University Health Centre, Montreal H3G 1A4, Quebec, Canada
| | - Peter Laszlo Lakatos
- First Department of Medicine, Semmelweis University, Budapest H-1083, Hungary
- Division of Gastroenterology, McGill University Health Centre, Montreal H3G 1A4, Quebec, Canada
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