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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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Farrera-Soler L, Hu CW, Ricken B, Díaz-Perlas C, Gerhold CB, Heinis C. Structure-Affinity Relationship Analysis and Affinity Maturation of a Calprotectin-Binding Peptide. Chembiochem 2025; 26:e202500071. [PMID: 40237725 DOI: 10.1002/cbic.202500071] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/24/2025] [Revised: 04/14/2025] [Accepted: 04/16/2025] [Indexed: 04/18/2025]
Abstract
Peptide 3 is an 18-amino acid linear peptide binding with sub-micromolar affinity to the inflammation marker calprotectin. Its application in point-of-care diagnostic assays has shown promising results, yet improving its affinity for calprotectin could facilitate the development of sensitive and robust assays. Herein, a detailed structure-activity relationship analysis of Peptide 3 is reported to better understand the importance of each individual amino acid for the binding to calprotectin. Moreover, two different approaches have been followed here, one based on prolonging the peptide with random sequences and phage display selection, and one on screening chemically synthesized peptide variants containing non-canonical amino acids, to increase its binding affinity. Combining several mutations that enhance affinity by small factors yielded Peptide 4 binding human calprotectin with a KD of 39 ± 5 nM measured by surface plasmon resonance spectroscopy, which is a five-fold improvement compared to the previously reported Peptide 3.
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Affiliation(s)
- Lluc Farrera-Soler
- Institute of Chemical Sciences and Engineering, School of Basic Sciences, Ecole Polytechnique Fédérale de Lausanne (EPFL), CH-1015, Lausanne, Switzerland
| | - Che-Wei Hu
- Institute of Chemical Sciences and Engineering, School of Basic Sciences, Ecole Polytechnique Fédérale de Lausanne (EPFL), CH-1015, Lausanne, Switzerland
| | - Benjamin Ricken
- BÜHLMANN Laboratories AG, Baselstrasse 55, CH-4124, Schönenbuch, Switzerland
| | - Cristina Díaz-Perlas
- Institute of Chemical Sciences and Engineering, School of Basic Sciences, Ecole Polytechnique Fédérale de Lausanne (EPFL), CH-1015, Lausanne, Switzerland
| | | | - Christian Heinis
- Institute of Chemical Sciences and Engineering, School of Basic Sciences, Ecole Polytechnique Fédérale de Lausanne (EPFL), CH-1015, Lausanne, Switzerland
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3
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Michaelis S, Hochfellner A, Schneider C, Schnedl WJ, Baranyi A, Enko D. Performance evaluation of a smartphone-based home test for fecal calprotection. Clin Chem Lab Med 2025; 63:139-146. [PMID: 38986473 DOI: 10.1515/cclm-2024-0422] [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: 04/05/2024] [Accepted: 06/20/2024] [Indexed: 07/12/2024]
Abstract
OBJECTIVES Fecal calprotectin (FC) serves as a non-invasive marker for the assessment of gut inflammation in patients with inflammatory bowel disease (IBD). Laboratory measurements are usually performed with immunologic methods like enzyme-linked immunosorbent assay. Recently, quantitative home tests based on the lateral flow technology with smartphones as read-out devices have been developed. We compared the quantitative and qualitative performance of the quantitative lateral flow home test Preventis SmarTest® Calprotectin Home and the immunological test used in our laboratory (Eurospital Calprest® Turbo). METHODS Fourty-five routine samples were analyzed in parallel with both tests according to the manufacturer's instructions. The read-out of the home test was performed with two smartphones (Apple iPhone 14 Pro and Samsung Galaxy XCover 5). The qualitative interpretation (positive, negative, borderline) was conducted using the cut-offs provided by the manufacturers. RESULTS Statistically significant correlations with the laboratory standard method were observed for both smartphones (Spearman's rho 0.703 and 0.715, all p<0.005). The home test showed systematically higher concentrations compared to the routine assay. We found minimal qualitative agreement between the two tests (Cohen's kappas (κ)=0.323 and 0.300; p=0.003 and 0.005) showing a lower rate of positives with the home test. Both used smartphones showed good quantitative and qualitative agreement. CONCLUSIONS The tests are quantitatively not interchangeable. However, the home test may be applicable for the serial follow-up management of patients with IBD. The higher rate of samples classified as negative with the home test may lead to an underestimation of affected patients.
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Affiliation(s)
- Simon Michaelis
- Institute of Clinical Chemistry and Laboratory Medicine, General Hospital Hochsteiermark, Leoben, Austria
| | - Anna Hochfellner
- Institute of Clinical Chemistry and Laboratory Medicine, General Hospital Hochsteiermark, Leoben, Austria
| | - Christopher Schneider
- Institute of Clinical Chemistry and Laboratory Medicine, General Hospital Hochsteiermark, Leoben, Austria
| | | | - Andreas Baranyi
- Department of Psychiatry and Psychotherapeutic Medicine, Medical, University of Graz, Graz, Austria
| | - Dietmar Enko
- Institute of Clinical Chemistry and Laboratory Medicine, General Hospital Hochsteiermark, Leoben, Austria
- Clinical Institute of Medical and Chemical Laboratory Diagnostics, Medical University of Graz, Graz, Austria
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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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Dong MD, Salwen-Deremer JK, Siegel CA. Remote Monitoring for Patients With Inflammatory Bowel Disease: Current Status and the Future of the Field. Gastroenterol Hepatol (N Y) 2024; 20:621-627. [PMID: 40191010 PMCID: PMC11966233] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 04/09/2025]
Abstract
As a direct result of the COVID-19 pandemic, many advances in telehealth have been made that save time and reduce travel costs for patients. Telehealth, specifically video visits, was especially embraced by patients with inflammatory bowel disease (IBD). However, remote clinic visits are only one part of the equation for remote IBD care. Patients with Crohn's disease or ulcerative colitis have a significant testing burden, and many strides still need to be made to improve all aspects of their care, including remote monitoring (testing at home) of biochemical markers (eg, C-reactive protein and fecal calprotectin) and drug concentrations. Remote monitoring has the potential to decrease the burden of chronic disease on patients through improved ease of access, both when patients are feeling well and when they are having an exacerbation of symptoms. Numerous technologies are available in other countries, are used in other disease states, or are in the animal or early human testing phases. These innovations in home testing have the potential to improve testing adherence, disease control, and monitoring of IBD for all patients, and will have a particularly significant effect on those living in rural communities. This article reviews the current modalities for remote monitoring of patients with IBD as well as the methods in development to make monitoring of IBD easier for patients.
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Affiliation(s)
| | - Jessica K. Salwen-Deremer
- Geisel School of Medicine at Dartmouth, Hanover, New Hampshire
- Department of Psychiatry, Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire
| | - Corey A. Siegel
- Geisel School of Medicine at Dartmouth, Hanover, New Hampshire
- Center for Digestive Health, Section of Gastroenterology and Hepatology, Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire
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Wiley JW, Higgins GA. Epigenomics and the Brain-gut Axis: Impact of Adverse Childhood Experiences and Therapeutic Challenges. JOURNAL OF TRANSLATIONAL GASTROENTEROLOGY 2024; 2:125-130. [PMID: 40012740 PMCID: PMC11864786 DOI: 10.14218/jtg.2024.00017] [Citation(s) in RCA: 2] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Subscribe] [Scholar Register] [Indexed: 02/28/2025]
Abstract
The brain-gut axis represents a bidirectional communication network that integrates neural, hormonal, and immunological signaling between the central nervous system and the gastrointestinal tract. Adverse childhood experiences (ACEs) have increasingly been recognized for their profound impact on this axis, with implications for both mental and physical health outcomes. This mini-review explores the emerging field of epigenomics-specifically, how epigenetic modifications incurred by ACEs can influence the brain-gut axis and contribute to the pathophysiology of various disorders. We examine the evidence linking epigenetic mechanisms such as DNA methylation, histone modifications, and non-coding RNAs to the modulation of gene expression involved in stress responses, neurodevelopment, and immune function-all of which intersect at the brain-gut axis. Additionally, we discuss the emerging potential of the gut microbiome as both a target and mediator of epigenetic changes, further influencing brain-gut communication in the context of ACEs. The methodological and therapeutic challenges posed by these insights are significant. The reversibility of epigenetic marks and the long-term consequences of early life stress require innovative and comprehensive approaches to intervention. This underscores the need for comprehensive strategies encompassing psychosocial, pharmacological, neuromodulation, and lifestyle interventions tailored to address ACEs' individualized and persistent effects. Future directions call for a multi-disciplinary approach and longitudinal studies to uncover the full extent of ACEs' impact on epigenetic regulation and the brain-gut axis, with the goal of developing targeted therapies to mitigate the long-lasting effects on health.
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Affiliation(s)
- John W. Wiley
- Department of Internal Medicine, University of Michigan Medicine, Ann Arbor, MI, USA
| | - Gerald A. Higgins
- Department of Computational Medicine and Bioinformatics, University of Michigan, Ann Arbor, MI, USA
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Sofia MA, Feuerstein JD, Narramore L, Chachu KA, Streett S. White Paper: American Gastroenterological Association Position Statement: The Future of IBD Care in the United States-Removing Barriers and Embracing Opportunities. Clin Gastroenterol Hepatol 2024; 22:944-955. [PMID: 38428707 DOI: 10.1016/j.cgh.2024.01.050] [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: 09/19/2023] [Revised: 12/14/2023] [Accepted: 01/15/2024] [Indexed: 03/03/2024]
Abstract
Despite incredible growth in systems of care and rapidly expanding therapeutic options for people with inflammatory bowel disease, there are significant barriers that prevent patients from benefiting from these advances. These barriers include restrictions in the form of prior authorization, step therapy, and prescription drug coverage. Furthermore, inadequate use of multidisciplinary care and inflammatory bowel disease specialists limits patient access to high-quality care, particularly for medically vulnerable populations. However, there are opportunities to improve access to high-quality, patient-centered care. This position statement outlines the policy and advocacy goals that the American Gastroenterological Association will prioritize for collaborative efforts with patients, providers, and payors.
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Affiliation(s)
- M Anthony Sofia
- Division of Gastroenterology and Hepatology, Oregon Health and Science University, Portland Oregon.
| | - Joseph D Feuerstein
- Division of Gastroenterology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts
| | - Leslie Narramore
- American Gastroenterological Association, Government Affairs Department, Bethesda, Maryland
| | - Karen A Chachu
- Division of Gastroenterology, Department of Medicine, Duke University, Durham, North Carolina
| | - Sarah Streett
- Division of Gastroenterology and Hepatology, Stanford University, Stanford, California
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Schmidt ML, McCrady E, Lee A, Bowerbank T, Miller MR, Watson M, Dhandapani A, Woolfson JP, Zizzo AN, Bax K, Crowley E. Home-based fecal calprotectin utilization in a general pediatric gastroenterology clinic. J Pediatr Gastroenterol Nutr 2024; 78:790-799. [PMID: 38318970 DOI: 10.1002/jpn3.12150] [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: 06/18/2023] [Revised: 12/20/2023] [Accepted: 01/14/2024] [Indexed: 02/07/2024]
Abstract
OBJECTIVE Remote investigation and monitoring have gained importance in ambulatory practice. A home-based fecal calprotectin (FC) test has been developed where the sample is processed and analyzed at home through a smartphone application. We aimed to assess the use of standard ELISA (sFC) versus home-based (hFC) FC testing in a general pediatric gastroenterology clinic. METHODS Ambulatory pediatric patients with hFC or sFC performed between August 2019 and November 2020 were included. Data regarding demographics, clinical characteristics, medication use, investigations, and final diagnosis, categorized as inflammatory bowel disease (IBD), functional gastrointestinal (GI) disorders, organic non-IBD (ONI) GI disorders, non-GI disorders, and undetermined after 6 months of investigation, were recorded. RESULTS A total of 453 FC tests from 453 unique patients were included. Of those, 249 (55%) were hFC. FC levels (median) were higher in children with IBD compared to non-IBD diagnosis (sFC 795 vs. 57 μg/g, hFC 595 vs. 47 μg/g, p < 0.001), and in ONI compared to functional GI disorders (sFC 85 vs. 54 μg/g, p = 0.003, hFC 57 vs. 40 μg/g, p < 0.001). No significant difference was observed between different ONI GI disorders or subtypes of functional disorders. Age did not significantly influence levels. CONCLUSIONS Overall, hFC and sFC provide similar results in the general pediatric GI ambulatory setting. FC is a sensitive but not disease-specific marker to identify patients with IBD. Values appear to be higher in ONI GI disorders over functional disorders, although cut-off values have yet to be determined.
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Affiliation(s)
- Melanie L Schmidt
- Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada
- Department of Pediatrics, Division of Pediatric Gastroenterology & Hepatology, Children's Hospital of Western Ontario, London Health Sciences Center, London, Ontario, Canada
- Children's Health Research Institute, London, Ontario, Canada
| | - Emma McCrady
- Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada
| | - Angus Lee
- Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada
| | | | - Michael R Miller
- Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada
- Department of Pediatrics, Division of Pediatric Gastroenterology & Hepatology, Children's Hospital of Western Ontario, London Health Sciences Center, London, Ontario, Canada
- Children's Health Research Institute, London, Ontario, Canada
| | - Melanie Watson
- Department of Pediatrics, Division of Pediatric Gastroenterology & Hepatology, Children's Hospital of Western Ontario, London Health Sciences Center, London, Ontario, Canada
| | - Ashok Dhandapani
- Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada
- Department of Pediatrics, Division of Pediatric Gastroenterology & Hepatology, Children's Hospital of Western Ontario, London Health Sciences Center, London, Ontario, Canada
- Children's Health Research Institute, London, Ontario, Canada
| | - Jessica P Woolfson
- Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada
- Department of Pediatrics, Division of Pediatric Gastroenterology & Hepatology, Children's Hospital of Western Ontario, London Health Sciences Center, London, Ontario, Canada
- Children's Health Research Institute, London, Ontario, Canada
| | - Andréanne N Zizzo
- Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada
- Department of Pediatrics, Division of Pediatric Gastroenterology & Hepatology, Children's Hospital of Western Ontario, London Health Sciences Center, London, Ontario, Canada
- Children's Health Research Institute, London, Ontario, Canada
| | - Kevin Bax
- Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada
- Department of Pediatrics, Division of Pediatric Gastroenterology & Hepatology, Children's Hospital of Western Ontario, London Health Sciences Center, London, Ontario, Canada
- Children's Health Research Institute, London, Ontario, Canada
| | - Eileen Crowley
- Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada
- Department of Pediatrics, Division of Pediatric Gastroenterology & Hepatology, Children's Hospital of Western Ontario, London Health Sciences Center, London, Ontario, Canada
- Children's Health Research Institute, London, Ontario, Canada
- Lawson Health Research Institute, London, Ontario, Canada
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Perry RW, Mummery D, Alexander JL, Hicks LC, Williams HRT. Faecal calprotectin in primary care: is its current use supported by the evidence? Br J Gen Pract 2024; 74:134-136. [PMID: 39222433 PMCID: PMC10904130 DOI: 10.3399/bjgp24x736665] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 09/04/2024] Open
Affiliation(s)
- Robert W Perry
- Departments of Gastroenterology and Hepatology, St Mary's Hospital, Imperial College Healthcare NHS Trust, London; Division of Digestive Diseases, Department of Metabolism, Digestion and Reproduction, Faculty of Medicine, Imperial College London, London
| | - David Mummery
- Department of Primary Care and Public Health, Imperial College London, London
| | - James L Alexander
- Departments of Gastroenterology and Hepatology, St Mary's Hospital, Imperial College Healthcare NHS Trust, London; Division of Digestive Diseases, Department of Metabolism, Digestion and Reproduction, Faculty of Medicine, Imperial College London, London
| | - Lucy C Hicks
- Departments of Gastroenterology and Hepatology, St Mary's Hospital, Imperial College Healthcare NHS Trust, London; Division of Digestive Diseases, Department of Metabolism, Digestion and Reproduction, Faculty of Medicine, Imperial College London, London
| | - Horace RT Williams
- Departments of Gastroenterology and Hepatology, St Mary's Hospital, Imperial College Healthcare NHS Trust, London; Division of Digestive Diseases, Department of Metabolism, Digestion and Reproduction, Faculty of Medicine, Imperial College London, London
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10
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Harnik S, Abitbol CM, Haj Natour O, Yavzori M, Fudim E, Picard O, Naftali T, Broide E, Hirsch A, Selinger L, Shachar E, Yablecovitch D, Albshesh A, Coscas D, Kopylov U, Eliakim R, Ben-Horin S, Ungar B. Prospective Observational Evaluation of the Time-Dependency of Adalimumab Immunogenicity and Drug Concentration in Ulcerative Colitis Patients: the POETIC II Study. J Crohns Colitis 2024; 18:341-348. [PMID: 37691574 DOI: 10.1093/ecco-jcc/jjad156] [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: 07/11/2023] [Revised: 08/20/2023] [Accepted: 09/08/2023] [Indexed: 09/12/2023]
Abstract
BACKGROUND AND AIMS Home self-injection of the human anti-tumour necrosis alpha [anti-TNFα] monoclonal adalimumab complicates prospective serial-sampling studies. Although a recent study examined adalimumab levels and immunogenicity in Crohn's disease [CD] patients, prospective real-world data from ulcerative colitis [UC] patients are lacking. METHODS A three-monthly home-visit programme from induction was established prospectively for UC patients. Clinical scores were determined at each visit, and sera were obtained for assessment of drug and anti-adalimumab antibody levels. Calprotectin was measured using a smartphone-based app. This cohort was compared to a parallel prospective cohort of adalimumab-treated CD patients [POETIC1]. RESULTS Fifty UC patients starting adalimumab [median follow-up 28 weeks] were compared to 98 adalimumab-treated CD patients [median follow-up 44 weeks]. Only 11/50 UC patients [22%] continued treatment to the end of the follow-up compared with 50/98 [51%] CD patients (odds ratio [OR] = 0.27, p = 0.001). Loss of response was significantly more common in UC patients [OR = 3.2, p = 0.001]. Seventeen patients [34%] in the UC cohort developed anti-adalimumab antibodies, 9/17 [52.9%] as early as week 2. There was no difference between patient cohorts in the overall development of anti-adalimumab antibodies [34% vs 30.6%, respectively, OR = 1.67, p = 0.67], nor was there a difference in early immunogenicity [OR = 1.39, p = 0.35]. There was no difference in low drug levels [<3 µg/mL] between the two cohorts [OR = 0.87, p = 0.83]. CONCLUSIONS Loss of response to adalimumab therapy was significantly more common in the UC compared to the CD cohort and was driven by a higher rate of non-immunogenic, pharmacodynamic parameters.
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Affiliation(s)
- Sivan Harnik
- Department of Gastroenterology, Sheba Medical Center Tel Hashomer, affiliated to Sackler School of Medicine, Tel-Aviv University, Tel Aviv, Israel
| | - Chaya M Abitbol
- Department of Gastroenterology, Sheba Medical Center Tel Hashomer, affiliated to Sackler School of Medicine, Tel-Aviv University, Tel Aviv, Israel
| | - Ola Haj Natour
- Department of Gastroenterology, Sheba Medical Center Tel Hashomer, affiliated to Sackler School of Medicine, Tel-Aviv University, Tel Aviv, Israel
| | - Miri Yavzori
- Department of Gastroenterology, Sheba Medical Center Tel Hashomer, affiliated to Sackler School of Medicine, Tel-Aviv University, Tel Aviv, Israel
| | - Ella Fudim
- Department of Gastroenterology, Sheba Medical Center Tel Hashomer, affiliated to Sackler School of Medicine, Tel-Aviv University, Tel Aviv, Israel
| | - Orit Picard
- Department of Gastroenterology, Sheba Medical Center Tel Hashomer, affiliated to Sackler School of Medicine, Tel-Aviv University, Tel Aviv, Israel
| | - Timna Naftali
- Department of Gastroenterology, Meir Medical Center, Kfar Saba, affiliated to Sackler School of Medicine, Tel-Aviv University, Tel Aviv, Israel
| | - Efrat Broide
- The Kamila Gonczarowski Institute of Gastroenterology, Assaf Harofeh Medical Center, Zerifin, affiliated to Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel
| | - Ayal Hirsch
- Department of Gastroenterology and Hepatology, Tel Aviv Sourasky Medical Center, Tel Aviv, affiliated to Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel
| | - Limor Selinger
- Department of Gastroenterology, Sheba Medical Center Tel Hashomer, affiliated to Sackler School of Medicine, Tel-Aviv University, Tel Aviv, Israel
| | - Eyal Shachar
- Department of Gastroenterology, Sheba Medical Center Tel Hashomer, affiliated to Sackler School of Medicine, Tel-Aviv University, Tel Aviv, Israel
| | - Doron Yablecovitch
- Department of Gastroenterology, Sheba Medical Center Tel Hashomer, affiliated to Sackler School of Medicine, Tel-Aviv University, Tel Aviv, Israel
| | - Ahmad Albshesh
- Department of Gastroenterology, Sheba Medical Center Tel Hashomer, affiliated to Sackler School of Medicine, Tel-Aviv University, Tel Aviv, Israel
| | - Daniel Coscas
- Department of Gastroenterology, Sheba Medical Center Tel Hashomer, affiliated to Sackler School of Medicine, Tel-Aviv University, Tel Aviv, Israel
| | - Uri Kopylov
- Department of Gastroenterology, Sheba Medical Center Tel Hashomer, affiliated to Sackler School of Medicine, Tel-Aviv University, Tel Aviv, Israel
| | - Rami Eliakim
- Department of Gastroenterology, Sheba Medical Center Tel Hashomer, affiliated to Sackler School of Medicine, Tel-Aviv University, Tel Aviv, Israel
| | - Shomron Ben-Horin
- Department of Gastroenterology, Sheba Medical Center Tel Hashomer, affiliated to Sackler School of Medicine, Tel-Aviv University, Tel Aviv, Israel
| | - Bella Ungar
- Department of Gastroenterology, Sheba Medical Center Tel Hashomer, affiliated to Sackler School of Medicine, Tel-Aviv University, Tel Aviv, Israel
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11
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D'Amico F, Fasulo E, Jairath V, Paridaens K, Peyrin-Biroulet L, Danese S. Management and treatment optimization of patients with mild to moderate ulcerative colitis. Expert Rev Clin Immunol 2024; 20:277-290. [PMID: 38059454 DOI: 10.1080/1744666x.2023.2292768] [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: 10/01/2023] [Accepted: 12/05/2023] [Indexed: 12/08/2023]
Abstract
INTRODUCTION Ulcerative colitis (UC) is a chronic inflammatory bowel disease with a significant health-care burden worldwide. While medical therapy aims to induce and maintain remission, optimal management of mild to moderate UC remains challenging due to heterogeneity in severity classifications and non-standardized approaches. This comprehensive review summarizes current evidence and knowledge gaps to optimize clinical decision-making in patients with mild to moderate UC. AREAS COVERED After an extensive literature search of PubMed, Medline, and Embase through August 2023, we provide an overview of definitions utilized to characterize mild to moderate UC severity and established therapeutic targets. Current medical treatments including mesalazine formulations, corticosteroids, and their combinations are surveyed. The role of emerging intestinal ultrasound, telemedicine, and home testing is explored. Individualized, patient-centered paradigms aiming to streamline care delivery through proactive identification of relapses are also examined. EXPERT OPINION Addressing inconsistencies in disease activity stratification will better align tailored regimens with each patient's profile. Advancing noninvasive technologies like ultrasound criteria and home testing could improve UC management by enabling personalized models. Realizing individualized plans through informed shared-decision making between health-care providers and fully engaged patients holds promise to maximize quality of life outcomes. Continuous improvement relies on innovation bridging different domains to overcome current limitations and push the field toward more predictive and tailored care.
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Affiliation(s)
- Ferdinando D'Amico
- Gastroenterology and Endoscopy, IRCCS Ospedale San Raffaele and Vita-Salute San Raffaele University, Milan, Italy
- Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy
| | - Ernesto Fasulo
- Gastroenterology and Endoscopy, IRCCS Ospedale San Raffaele and Vita-Salute San Raffaele University, Milan, Italy
| | - Vipul Jairath
- Division of Gastroenterology, Department of Medicine, Western University, London, Ontario, Canada
| | | | - Laurent Peyrin-Biroulet
- Department of Gastroenterology, Nancy University Hospital, Nancy, France
- INSERM, NGERE, University of Lorraine, Nancy, France
- INFINY Institute, Nancy University Hospital, Nancy, France
- FHU-CURE, Nancy University Hospital, Nancy, France
- Groupe Hospitalier privé Ambroise Paré - Hartmann, Paris IBD center, Neuilly sur Seine, France
- Division of Gastroenterology and Hepatology, McGill University Health Centre, Montreal, Quebec, Canada
| | - Silvio Danese
- Gastroenterology and Endoscopy, IRCCS Ospedale San Raffaele and Vita-Salute San Raffaele University, Milan, Italy
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12
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Fantini MC, Loddo E, Petrillo AD, Onali S. Telemedicine in inflammatory bowel disease from its origin to the post pandemic golden age: A narrative review. Dig Liver Dis 2024; 56:1-6. [PMID: 37330279 DOI: 10.1016/j.dld.2023.05.035] [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: 02/16/2023] [Revised: 05/22/2023] [Accepted: 05/23/2023] [Indexed: 06/19/2023]
Abstract
Inflammatory bowel disease (IBD), a chronic intestinal inflammatory disorder encompassing ulcerative colitis and Crohn's disease can be disabling and often requires lifelong treatment and follow-up. Digital health technologies and distance-management tools are less costly alternatives for IBD management and clinical monitoring. This review discusses how telephone/videoconference appointments enable treatment optimization from an early disease stage, provide complementary value-based patient care and educational resources, and allow consistent follow-up with a high standard of care. Replacing/supplementing traditional clinical consultations with telemedicine reduces healthcare utilization costs and the need for in-person consultations. The COVID-19 pandemic has accelerated the evolution of telemedicine in IBD, with several studies conducted since 2020 reporting high levels of patient satisfaction. Home-based injectable formulations coupled with telemedicine may become permanently embedded in healthcare systems in the post-pandemic period. While telemedicine consultations are well-accepted by many patients with IBD, they do not suit all patients or are not preferred (e.g., by elderly who do not have the means or ability to understand the associated technology). Ultimately, use of telemedicine should be decided by the patient and careful consideration is required to ensure that the patient is willing and capable of a successful remote visit.
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Affiliation(s)
- Massimo Claudio Fantini
- Department of Medical Science and Public Health, University of Cagliari, Cagliari, Italy; Azienda Ospedaliero-Universitaria (AOU) di Cagliari, Cagliari, Italy.
| | - Erica Loddo
- Azienda Ospedaliero-Universitaria (AOU) di Cagliari, Cagliari, Italy
| | - Amalia Di Petrillo
- Department of Medical Science and Public Health, University of Cagliari, Cagliari, Italy
| | - Sara Onali
- Department of Medical Science and Public Health, University of Cagliari, Cagliari, Italy; Azienda Ospedaliero-Universitaria (AOU) di Cagliari, Cagliari, Italy
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13
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Murray J, Kok KB, Ayling RM. Fecal Calprotectin in Gastrointestinal Disease. Clin Chem 2023:7179811. [PMID: 37228058 DOI: 10.1093/clinchem/hvad051] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/05/2023] [Accepted: 03/14/2023] [Indexed: 05/27/2023]
Abstract
BACKGROUND Inflammatory bowel disease (IBD) comprises a group of chronic conditions characterized by relapsing and remitting inflammation of the gastrointestinal tract. The incidence is increasing worldwide, and the therapeutic options for management are expanding. Endoscopy is the gold standard investigation for diagnosis of IBD and for assessing mucosal healing, which is increasingly being used as a measure of disease control. However, it is an invasive procedure that is unpleasant for patients and expensive and time-consuming for hospitals. Fecal calprotectin has been shown to be an accurate surrogate marker of gastrointestinal inflammation in IBD. CONTENT Fecal calprotectin was initially used for the diagnosis of IBD but is now recognized as having a role in assisting in assessment of disease activity, prediction of relapse, and informing decisions around therapy and may help to minimize requirement for endoscopy. However, there are various preanalytical and analytical factors that can affect interpretation of the results; these need to be understood to optimize clinical care. SUMMARY Preanalytical and analytical factors that can potentially influence fecal calprotectin concentrations are examined, and an overview is provided of clinical situations in which fecal calprotectin is commonly measured.
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Affiliation(s)
- Jennifer Murray
- Department of Gastroenterology, Barts Health NHS Trust, Royal London Hospital, London, United Kingdom
| | - Klaartje B Kok
- Department of Gastroenterology, Barts Health NHS Trust, Royal London Hospital, London, United Kingdom
| | - Ruth M Ayling
- Department of Clinical Biochemistry, Barts Health NHS Trust, Royal London Hospital, London, United Kingdom
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14
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Díaz-Perlas C, Ricken B, Farrera-Soler L, Guschin D, Pojer F, Lau K, Gerhold CB, Heinis C. High-affinity peptides developed against calprotectin and their application as synthetic ligands in diagnostic assays. Nat Commun 2023; 14:2774. [PMID: 37198182 DOI: 10.1038/s41467-023-38075-7] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/19/2022] [Accepted: 04/14/2023] [Indexed: 05/19/2023] Open
Abstract
Common inflammatory disorders such as ulcerative colitis and Crohn's disease are non-invasively diagnosed or monitored by the biomarker calprotectin. However, current quantitative tests for calprotectin are antibody-based and vary depending on the type of antibody and assay used. Additionally, the binding epitopes of applied antibodies are not characterized by structures and for most antibodies it is unclear if they detect calprotectin dimer, tetramer, or both. Herein, we develop calprotectin ligands based on peptides, that offer advantages such as homogenous chemical composition, heat-stability, site-directed immobilization, and chemical synthesis at high purity and at low cost. By screening a 100-billion peptide phage display library against calprotectin, we identified a high-affinity peptide (Kd = 26 ± 3 nM) that binds to a large surface region (951 Å2) as shown by X-ray structure analysis. The peptide uniquely binds the calprotectin tetramer, which enabled robust and sensitive quantification of a defined species of calprotectin by ELISA and lateral flow assays in patient samples, and thus offers an ideal affinity reagent for next-generation inflammatory disease diagnostic assays.
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Affiliation(s)
- Cristina Díaz-Perlas
- Institute of Chemical Sciences and Engineering, School of Basic Sciences, École Polytechnique Fédérale de Lausanne (EPFL), CH-1015, Lausanne, Switzerland
| | - Benjamin Ricken
- BÜHLMANN Laboratories AG, Baselstrasse 55, CH-4124, Schönenbuch, Switzerland
| | - Lluc Farrera-Soler
- Institute of Chemical Sciences and Engineering, School of Basic Sciences, École Polytechnique Fédérale de Lausanne (EPFL), CH-1015, Lausanne, Switzerland
| | - Dmitrii Guschin
- BÜHLMANN Laboratories AG, Baselstrasse 55, CH-4124, Schönenbuch, Switzerland
| | - Florence Pojer
- Protein Production and Structure Core Facility, School of Life Sciences, Ecole Polytechnique Fédérale de Lausanne (EPFL), Lausanne, Switzerland
| | - Kelvin Lau
- Protein Production and Structure Core Facility, School of Life Sciences, Ecole Polytechnique Fédérale de Lausanne (EPFL), Lausanne, Switzerland
| | | | - Christian Heinis
- Institute of Chemical Sciences and Engineering, School of Basic Sciences, École Polytechnique Fédérale de Lausanne (EPFL), CH-1015, Lausanne, Switzerland.
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15
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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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16
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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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17
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Grego S, Welling CM, Miller GH, Coggan PF, Sellgren KL, Hawkins BT, Ginsburg GS, Ruiz JR, Fisher DA, Stoner BR. A hands-free stool sampling system for monitoring intestinal health and disease. Sci Rep 2022; 12:10859. [PMID: 35760855 PMCID: PMC9237014 DOI: 10.1038/s41598-022-14803-9] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/06/2022] [Accepted: 06/13/2022] [Indexed: 11/09/2022] Open
Abstract
Analysis of stool offers simple, non-invasive monitoring for many gastrointestinal (GI) diseases and access to the gut microbiome, however adherence to stool sampling protocols remains a major challenge because of the prevalent dislike of handling one's feces. We present a technology that enables individual stool specimen collection from toilet wastewater for fecal protein and molecular assay. Human stool specimens and a benchtop test platform integrated with a commercial toilet were used to demonstrate reliable specimen collection over a wide range of stool consistencies by solid/liquid separation followed by spray-erosion. The obtained fecal suspensions were used to perform occult blood tests for GI cancer screening and for microbiome 16S rRNA analysis. Using occult blood home test kits, we found overall 90% agreement with standard sampling, 96% sensitivity and 86% specificity. Microbiome analysis revealed no significant difference in within-sample species diversity compared to standard sampling and specimen cross-contamination was below the detection limit of the assay. Furthermore, we report on the use of an analogue turbidity sensor to assess in real time loose stools for tracking of diarrhea. Implementation of this technology in residential settings will improve the quality of GI healthcare by facilitating increased adherence to routine stool monitoring.
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Affiliation(s)
- Sonia Grego
- Electrical and Computer Engineering, Center for Water, Sanitation, Hygiene and Infectious Disease (WaSH-AID), Duke University, Durham, NC, USA.
| | - Claire M Welling
- Electrical and Computer Engineering, Center for Water, Sanitation, Hygiene and Infectious Disease (WaSH-AID), Duke University, Durham, NC, USA
| | - Graham H Miller
- Electrical and Computer Engineering, Center for Water, Sanitation, Hygiene and Infectious Disease (WaSH-AID), Duke University, Durham, NC, USA
| | - Peter F Coggan
- Electrical and Computer Engineering, Center for Water, Sanitation, Hygiene and Infectious Disease (WaSH-AID), Duke University, Durham, NC, USA
| | - Katelyn L Sellgren
- Electrical and Computer Engineering, Center for Water, Sanitation, Hygiene and Infectious Disease (WaSH-AID), Duke University, Durham, NC, USA
| | - Brian T Hawkins
- Electrical and Computer Engineering, Center for Water, Sanitation, Hygiene and Infectious Disease (WaSH-AID), Duke University, Durham, NC, USA
| | - Geoffrey S Ginsburg
- Duke Center for Applied Genomics and Precision Medicine, School of Medicine, Duke University, Durham, NC, USA
| | - Jose R Ruiz
- Division of Gastroenterology, School of Medicine, Duke University, Durham, NC, USA
| | - Deborah A Fisher
- Division of Gastroenterology, School of Medicine, Duke University, Durham, NC, USA
| | - Brian R Stoner
- Electrical and Computer Engineering, Center for Water, Sanitation, Hygiene and Infectious Disease (WaSH-AID), Duke University, Durham, NC, USA
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18
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Wilkens R, Dolinger M, Burisch J, Maaser C. Point-of-Care Testing and Home Testing: Pragmatic Considerations for Widespread Incorporation of Stool Tests, Serum Tests, and Intestinal Ultrasound. Gastroenterology 2022; 162:1476-1492. [PMID: 34995530 DOI: 10.1053/j.gastro.2021.10.052] [Citation(s) in RCA: 25] [Impact Index Per Article: 8.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/30/2021] [Revised: 10/13/2021] [Accepted: 10/28/2021] [Indexed: 12/12/2022]
Abstract
Breaking through the biologic therapy efficacy plateau for inflammatory bowel disease requires the strategic development of personalized biomarkers in the tight control model. After risk stratification early in the disease course, targeted serial monitoring consistently to assess clinical outcomes in response to therapy allows for quick therapeutic adjustments before bowel damage can occur. Point-of-care intestinal ultrasound performed by the treating gastroenterologist is an accurate cross- sectional biomarker that monitors intestinal inflammation in real-time, enhances patient care, and increases shared understanding to help achieve common treatment goals. Combining intestinal ultrasound during a clinic visit with existing serum and stool biomarkers in a home testing setup with electronic health monitoring allows for an optimized, patient-centered personalized treatment algorithm that may improve treatment outcomes. Here, we review the current state, pragmatic considerations, and future implications of point-of-care testing and home testing for noninvasive inflammatory bowel disease monitoring in the tight control model.
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Affiliation(s)
- Rune Wilkens
- Gastrounit, Division of Medicine, Copenhagen University Hospital Hvidovre, Hvidovre, Copenhagen, Denmark; Copenhagen Center for Inflammatory Bowel Disease in Children, Adolescents and Adults, University of Copenhagen, Hvidovre Hospital, Denmark; Digestive Disease Center, Copenhagen University Hospital - Bispebjerg & Frederiksberg, Copenhagen, Denmark.
| | - Michael Dolinger
- Susan and Leonard Feinstein Inflammatory Bowel Disease Center, Icahn School of Medicine at Mount Sinai, New York, New York
| | - Johan Burisch
- Gastrounit, Division of Medicine, Copenhagen University Hospital Hvidovre, Hvidovre, Copenhagen, Denmark; Copenhagen Center for Inflammatory Bowel Disease in Children, Adolescents and Adults, University of Copenhagen, Hvidovre Hospital, Denmark
| | - Christian Maaser
- Inflammatory Bowel Disease Outpatient Unit, Department of Geriatric Medicine, University Teaching Hospital Lueneburg, Lueneburg, Germany
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19
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Sinagra E, Busacca A, Guida L, Carrozza L, Brinch D, Crispino F, Maida M, Battaglia S, Celsa C, Cammà C, Cappello M. Telemedicine Is an Effective Tool to Monitor Disease Activity in IBD Patients in the COVID-19 Era: A Single Centre Experience Based on Objective Data. GASTROENTEROLOGY INSIGHTS 2022; 13:117-126. [DOI: 10.3390/gastroent13010013] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/01/2023] Open
Abstract
Background: The COVID-19 outbreak has led IBD clinics to adopt a remote monitoring approach in order to guarantee an adequate follow-up of patients with inflammatory bowel disease (IBD) and ensure the rules of social distancing. Aim: The aim of the study was to perform a survey on IBD patients who underwent remote monitoring in our tertiary referral center, to assess adherence, patients’ perceptions and satisfaction, and finally their opinions for future monitoring. Furthermore, we evaluated changes in disease activity and Quality of Life (QoL) using validated questionnaires. Methods: Consecutive patients with IBD scheduled for follow-up visits were switched to remote monitoring through e-mail from March 2020 to February 2021. Patients were asked to complete a questionnaire focusing on the following elements of the intervention: (1) self-assessment questions, (2) action plans, and (3) educational messages. Results: Four hundred and twenty four Caucasian patients completed the survey. 233 (55.1%) were male, 220 (52.0%) had Crohn’s Disease (CD). Median baseline Mayo Score and Harvey Bradshaw Index were 3 and 4, respectively. 9 (2.1%) patients were referred to the emergency department because of disease flares. 410 (96.9%) patients were satisfied with telemedicine, and 320 (76.5%) patients reported that they would maintain this approach also after COVID-19 pandemic. Overall, on univariate logistic regression analysis, none of the variables were related to patients’ satisfaction or to an improved QoL. The presence of ulcerative colitis was associated with the need for treatment change. Conclusions: Our results suggest that a telemedicine approach is well accepted by patients with IBD and could represent an effective tool in monitoring disease activity. Further controlled studies are warranted to properly assess if telemedicine can replace face-to-face consultations in IBD.
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Affiliation(s)
- Emanuele Sinagra
- Gastroenterology and Endoscopy Unit, Fondazione Istituto G. Giglio, Contrada Pietra Pollastra Pis Ciotto, 90015 Cefalù, Italy
| | - Anita Busacca
- Gastroenterology and Hepatology Section, PROMISE, University of Palermo, 90127 Palermo, Italy
| | - Laura Guida
- Gastroenterology and Hepatology Section, PROMISE, University of Palermo, 90127 Palermo, Italy
| | - Lucio Carrozza
- Gastroenterology and Hepatology Section, PROMISE, University of Palermo, 90127 Palermo, Italy
| | - Daniele Brinch
- Gastroenterology and Hepatology Section, PROMISE, University of Palermo, 90127 Palermo, Italy
| | - Federica Crispino
- Gastroenterology and Hepatology Section, PROMISE, University of Palermo, 90127 Palermo, Italy
| | - Marcello Maida
- Gastroenterology and Endoscopy Unit, S. Elia-Raimondi Hospital, 93100 Caltanissetta, Italy
| | - Salvatore Battaglia
- Gastroenterology and Hepatology Section, PROMISE, University of Palermo, 90127 Palermo, Italy
| | - Ciro Celsa
- Gastroenterology and Hepatology Section, PROMISE, University of Palermo, 90127 Palermo, Italy
- Gastroenterology and Endoscopy Unit, S. Elia-Raimondi Hospital, 93100 Caltanissetta, Italy
- Department of Surgical, Oncological and Oral Sciences (Di.Chir.On.S.), University of Palermo, 90100 Palermo, Italy
| | - Calogero Cammà
- Gastroenterology and Hepatology Section, PROMISE, University of Palermo, 90127 Palermo, Italy
| | - Maria Cappello
- Gastroenterology and Hepatology Section, PROMISE, University of Palermo, 90127 Palermo, Italy
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20
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Can 2 Different Fecal Calprotectin Assays be Used Interchangeably in IBD Treatment? J Clin Gastroenterol 2022; 56:e27-e30. [PMID: 33116067 PMCID: PMC8647699 DOI: 10.1097/mcg.0000000000001460] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/21/2020] [Accepted: 09/24/2020] [Indexed: 12/10/2022]
Abstract
BACKGROUND Fecal calprotectin (FC) is a biomarker for inflammation in inflammatory bowel disease (IBD). Interpretation of results can be complicated because of the use of different assays to determine FC. GOALS To assess the agreement between 2 different assays for determining FC in patients with IBD. METHODS Samples from adults and children with IBD were tested with 2 assays: (1) EliA 2 Calprotectin and (2) EK-Cal. Samples were uniformly tested on the same day. Interassay variability was displayed in a Bland-Altman plot. The difference in categorization of the FC result (1: 0 to 250 mg/kg, 2: 250 to 500 mg/kg, 3: >500 mg/kg) was assessed with the linear weighted κ for adults and children separately. RESULTS A total of 171 patients [mean age: 33 (range: 7 to 81); 92 (54%) female; 117 (68%) Crohn's disease; 53 (31%) ulcerative colitis] were included. Median (interquartile ranges) FC levels were 281 mg/kg (70 to 971) (EK-Cal) and 159 mg/kg (31 to 778) (EliA 2), and the mean delta FC was 89 mg/kg. In the adult population, there was substantial agreement between the 2 assays (κ: 0.72; SE: 0.06; 95% confidence interval, 0.60-0.83) and for pediatric patients, the agreement was almost perfect (κ: 0.83; SE: 0.06; 95% confidence interval: 0.70-0.95). Five of 171 patients (all aged ≥17 y and all with colonic disease) had a difference of 2 categories (1 vs. 3) between assays. Interassay variability was the highest in category 3. CONCLUSIONS The agreement between the EliA 2 and EK-Cal assay in this cohort of IBD patients is substantial to almost perfect. Interassay variability is higher in the highest FC category.
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21
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Jones JL, Benchimol EI, Bernstein CN, Huang JG, Marshall JK, Mukhtar MS, Murthy SK, Nguyen GC, Kaplan GG, Kuenzig ME, Tandon P, Targownik LE, Windsor JW, Bitton A. Crohn's and Colitis Canada's 2021 Impact of COVID-19 and Inflammatory Bowel Disease in Canada: Health Care Delivery During the Pandemic and the Future Model of Inflammatory Bowel Disease Care. J Can Assoc Gastroenterol 2021; 4:S61-S67. [PMID: 34755041 PMCID: PMC8570426 DOI: 10.1093/jcag/gwab034] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/25/2021] [Accepted: 08/11/2021] [Indexed: 12/13/2022] Open
Abstract
The SARS-CoV-2 pandemic has had a profound impact on inflammatory bowel disease (IBD) health care delivery. The implementation of necessary public health restrictions has restricted access to medications, procedures and surgeries throughout the pandemic, catalyzing widespread change in how IBD care is delivered. Rapid large-scale implementation of virtual care modalities has been shown to be feasible and acceptable for the majority of individuals with IBD and health care providers. The SARS-CoV-2 pandemic has exacerbated pre-existing barriers to accessing high-quality, multidisciplinary IBD care that addresses health care needs holistically. Continued implementation and evaluation of both synchronous and asynchronous eHealthcare modalities are required now and in the future in order to determine how best to incorporate these modalities into patient-centred, collaborative care models. Resources must be dedicated to studies that evaluate the feasibility, acceptability and effectiveness of eHealth-enhanced models of IBD care to improve efficiency and cost-effectiveness, while increasing quality of life for persons living with IBD. Crohn's and Colitis Canada will continue to play a major leadership role in advocating for the health care delivery models that improve the quality of life for persons living with IBD.
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Affiliation(s)
- Jennifer L Jones
- Department of Medicine, Dalhousie University, Halifax, Nova Scotia, Canada
| | - Eric I Benchimol
- SickKids Inflammatory Bowel Disease Centre, Division of Gastroenterology, Hepatology and Nutrition, The Hospital for Sick Children, Toronto, Ontario, Canada
- Child Health Evaluative Sciences, SickKids Research Institute, Toronto, Ontario, Canada
- ICES, Toronto, Ontario, Canada
- Department of Paediatrics and Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada
| | - Charles N Bernstein
- Department of Internal Medicine, Max Rady College of Medicine, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Manitoba, Canada
- University of Manitoba IBD Clinical and Research Centre, Winnipeg, Manitoba, Canada
| | - James Guoxian Huang
- SickKids Inflammatory Bowel Disease Centre, Division of Gastroenterology, Hepatology and Nutrition, The Hospital for Sick Children, Toronto, Ontario, Canada
| | - John K Marshall
- Department of Medicine and Farncombe Family Digestive Health Research Institute, McMaster University, Hamilton, Ontario, Canada
| | - Mariam S Mukhtar
- Department of Internal Medicine, King Abdulaziz University Hospital, Jeddah, Saudi Arabia
| | - Sanjay K Murthy
- The Ottawa Hospital IBD Centre, Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada
| | - Geoffrey C Nguyen
- Mount Sinai Hospital Inflammatory Bowel Disease Centre, University of Toronto, Toronto, Ontario, Canada
| | - Gilaad G Kaplan
- Department of Medicine, University of Calgary, Calgary, Alberta, Canada
- Department of Community Health Sciences, University of Calgary, Calgary, Alberta, Canada
| | - M Ellen Kuenzig
- SickKids Inflammatory Bowel Disease Centre, Division of Gastroenterology, Hepatology and Nutrition, The Hospital for Sick Children, Toronto, Ontario, Canada
- Child Health Evaluative Sciences, SickKids Research Institute, Toronto, Ontario, Canada
| | - Parul Tandon
- Division of Gastroenterology and Hepatology, Mount Sinai Hospital, University of Toronto, Toronto, Ontario, Canada
| | - Laura E Targownik
- Division of Gastroenterology and Hepatology, Mount Sinai Hospital, University of Toronto, Toronto, Ontario, Canada
| | - Joseph W Windsor
- Department of Medicine, University of Calgary, Calgary, Alberta, Canada
| | - Alain Bitton
- Department of Medicine, McGill University Health Centre, McGill University, Montreal, Quebec, Canada
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22
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Real-life utility and diagnostic accuracy of a home-performed fecal calprotectin test to predict endoscopic activity in patients with inflammatory bowel disease under maintenance treatment with adalimumab. Eur J Gastroenterol Hepatol 2021; 33:e777-e782. [PMID: 34284415 DOI: 10.1097/meg.0000000000002248] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/10/2022]
Abstract
AIMS The home-performed fecal calprotectin (FC) test has been proposed for the remote management of inflammatory bowel disease (IBD) patients. We present our real-world experience on the use of FC home testing in IBD patients under maintenance treatment with adalimumab. METHODS Consecutive IBD patients on maintenance treatment with adalimumab were studied retrospectively on the basis of prospectively recorded data. FC calprotectin home test (IBDoc, Βühlmann Laboratories AG, Schönenbuch, Switzerland) was analyzed alongside sufficient information on baseline characteristics, follow-up data and treatment modifications, as well as serum biomarkers and endoscopic assessment data on the basis of validated endoscopic scores. RESULTS From a total of 72 IBD patients under maintenance treatment with adalimumab, 65 (90%) showed compliance with performing the home FC test. FC values were significantly higher in patients who finally needed treatment modification (37%) compared with those who were maintained on stable treatment (63%) (761 μg/g [537-1000] vs. 108 [41-335], P < 0.0001). In the logistic regression analysis FC and erythrocyte sedimentation rate (ESR) were independently correlated with endoscopically active disease (odds ratio: 1.003; 95% confidence interval, 1.001-1.006, P < 0.01 and odds ratio: 1.058; 95% confidence interval, 1.013-1.105, P < 0.05). FC identified patients with endoscopically active disease more effectively than other biomarkers with an area under the receiver operating characteristic curve of 0.78. FC levels >413 μg/g had a sensitivity of 75% and a specificity of 76% in predicting active disease in endoscopy. CONCLUSIONS These first real-life results indicate that in IBD patients under maintenance treatment with adalimumab FC home test is a valuable tool with high compliance rates that performs better than the other biomarkers in predicting disease endoscopic activity.
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23
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Bouhuys M, Lexmond WS, Dijkstra G, Lobatón T, Louis E, van Biervliet S, Groen H, Guardiola J, Rheenen PV. Efficacy of anti-TNF dosing interval lengthening in adolescents and young adults with inflammatory bowel disease in sustained remission (FREE-study): protocol for a partially randomised patient preference trial. BMJ Open 2021; 11:e054154. [PMID: 34732500 PMCID: PMC8572401 DOI: 10.1136/bmjopen-2021-054154] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/03/2021] [Accepted: 10/15/2021] [Indexed: 12/30/2022] Open
Abstract
INTRODUCTION Anti-tumour necrosis factor (TNF) therapy has greatly improved treatment outcomes in patients with inflammatory bowel disease (IBD), but long-term use is associated with cutaneous reactions, susceptibility to infections and frequent injections or hospital visits. Several non-controlled studies have demonstrated that dose reduction is feasible for a subset of patients, provided that early detection of a disease flare is possible. Here, we aim to compare the effectiveness of interval lengthening with standard dosing in maintaining remission in young patients with IBD. METHODS AND ANALYSIS In this international, prospective, non-inferiority, partially randomised patient preference trial, we aim to recruit 148 patients aged 12-25 years with luminal Crohn's disease or ulcerative colitis in sustained remission (ie, three consecutive in-range faecal calprotectin (FC) results or recently confirmed endoscopic remission). In the interventional arm, the dosing interval will be lengthened from 8 to 12 weeks for infliximab users and from 2 to 3 weeks for adalimumab users. In the control group, standard dosing will be continued. Rapid tests will be performed for FC every 4 weeks and for anti-TNF trough levels every 12 weeks. The primary outcome is the cumulative incidence of out-of-range FC results at 48-week follow-up. Secondary endpoints include time to get out-of-range FC results, cumulative incidence of adverse effects, proportion of patients progressing to loss of response and identification of predictors of successful interval lengthening. ETHICS AND DISSEMINATION The protocol has been approved by the Medical Ethics Review Committee of the University Medical Centre Groningen and is pending at the other participating centres. Results will be disseminated in peer-reviewed journals and presented at scientific meetings. TRIAL REGISTRATION NUMBER EudraCT number: 2020-001811-26; ClinicalTrials.gov Identifier: NCT04646187. Protocol version 4, date 17 September 2021.
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Affiliation(s)
- Marleen Bouhuys
- Department of Paediatric Gastroenterology, Hepatology and Nutrition, University Medical Centre Groningen, Beatrix Childrens Hospital, Groningen, The Netherlands
| | - Willem S Lexmond
- Department of Paediatric Gastroenterology, Hepatology and Nutrition, University Medical Centre Groningen, Beatrix Childrens Hospital, Groningen, The Netherlands
| | - Gerard Dijkstra
- Department of Gastroenterology and Hepatology, University Medical Centre Groningen, Groningen, The Netherlands
| | - Triana Lobatón
- Department of Gastroenterology, University Hospital Ghent, Gent, Belgium
| | - Edouard Louis
- Department of Gastroenterology, Central University Hospital of Liege, Liege, Belgium
| | | | - Henk Groen
- Department of Epidemiology, University Medical Centre Groningen, Groningen, The Netherlands
| | - Jordi Guardiola
- Department of Gastroenterology, Bellvitge University Hospital, IDIBELL, L'Hospitalet de Llobregat, Spain
| | - Patrick van Rheenen
- Department of Paediatric Gastroenterology, Hepatology and Nutrition, University Medical Centre Groningen, Beatrix Childrens Hospital, Groningen, The Netherlands
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24
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Selinger CP, Rafferty H, Mooney P, Donnellan C. Utility of Fecal Calprotectin in Routine Clinical Practice Is Impaired by Poor Sample Return Rates. Dig Dis Sci 2021; 66:3209-3210. [PMID: 33164147 DOI: 10.1007/s10620-020-06694-5] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/18/2020] [Accepted: 10/22/2020] [Indexed: 12/09/2022]
Affiliation(s)
- Christian P Selinger
- Leeds Gastroenterology Institute, Leeds Teaching Hospitals NHS Trust, St James University Hospital, Bexley Wing, Leeds, LS9 7TF, UK.
| | - Helen Rafferty
- Leeds Gastroenterology Institute, Leeds Teaching Hospitals NHS Trust, St James University Hospital, Bexley Wing, Leeds, LS9 7TF, UK
| | - Peter Mooney
- Leeds Gastroenterology Institute, Leeds Teaching Hospitals NHS Trust, St James University Hospital, Bexley Wing, Leeds, LS9 7TF, UK
| | - Clare Donnellan
- Leeds Gastroenterology Institute, Leeds Teaching Hospitals NHS Trust, St James University Hospital, Bexley Wing, Leeds, LS9 7TF, UK
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25
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Ansems S, Berger M, Rheenen PV, Vermeulen K, Beugel G, Couwenberg M, Holtman G. Effect of faecal calprotectin testing on referrals for children with chronic gastrointestinal symptoms in primary care: study protocol for a cluster randomised controlled trial. BMJ Open 2021; 11:e045444. [PMID: 34301652 PMCID: PMC8311316 DOI: 10.1136/bmjopen-2020-045444] [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: 11/04/2022] Open
Abstract
INTRODUCTION Children with chronic gastrointestinal symptoms are frequently seen in primary care, yet general practitioners (GPs) often experience challenges distinguishing functional gastrointestinal disorders (FGID) from organic disorders. We, therefore, aim to evaluate whether a test strategy that includes point-of-care testing (POCT) for faecal calprotectin (FCal) can reduce the referral rate to paediatric specialist care among children with chronic gastrointestinal symptoms. The study findings will contribute to improving the recommendations on FCal use among children in primary care. METHODS AND ANALYSIS In this pragmatic cluster randomised controlled trial, we will randomise general practices into intervention and control groups. The intervention group will use FCal-POCT when indicated, after completing online training about its indication, interpretation and follow-up as well as communicating an FGID diagnosis. The control group will test and treat according to Dutch GP guidelines, which advise against FCal testing in children. GPs will include children aged 4-18 years presenting to primary care with chronic diarrhoea and/or recurrent abdominal pain. The primary outcome will be the referral rate for children with chronic gastrointestinal symptoms within 6 months after the initial assessment. Secondary outcomes will be evaluated by questionnaires completed at baseline and at 3- and 6-month follow-up. These outcomes will include parental satisfaction and concerns, gastrointestinal symptoms, impact of symptoms on daily function, quality of life, proportion of children with paediatrician-diagnosed FGID referred to secondary care, health service use and healthcare costs. A sample size calculation indicates that we need to recruit 158 GP practices to recruit 406 children. ETHICS AND DISSEMINATION The Medical Research Ethics Committee (MREC) of the University Medical Center Groningen (The Netherlands) approved this study (MREC number: 201900309). The study results will be made available to patients, GPs, paediatricians and laboratories via peer-reviewed publications and in presentations at (inter)national conferences. TRIAL REGISTRATION NUMBER The Netherlands Trial Register: NL7690 (Pre-results).
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Affiliation(s)
- Sophie Ansems
- General Practice and Elderly Care Medicine, University Medical Centre Groningen, Groningen, The Netherlands
| | - Marjolein Berger
- General Practice and Elderly Care Medicine, University Medical Centre Groningen, Groningen, The Netherlands
| | - Patrick van Rheenen
- Paediatric Gastroenterology, University Medical Centre Groningen Beatrix Childrens Hospital, Groningen, The Netherlands
| | - Karin Vermeulen
- Epidemiology, University Medical Centre Groningen, Groningen, The Netherlands
| | - Gina Beugel
- General Practice and Elderly Care Medicine, University Medical Centre Groningen, Groningen, The Netherlands
| | - Maria Couwenberg
- General Practice and Elderly Care Medicine, University Medical Centre Groningen, Groningen, The Netherlands
| | - Gea Holtman
- General Practice and Elderly Care Medicine, University Medical Centre Groningen, Groningen, The Netherlands
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26
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Solitano V, Alfarone L, D'Amico F, Peyrin-Biroulet L, Danese S. IBD goes home: from telemedicine to self-administered advanced therapies. Expert Opin Biol Ther 2021; 22:17-29. [PMID: 34116611 DOI: 10.1080/14712598.2021.1942833] [Citation(s) in RCA: 9] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/21/2022]
Abstract
Introduction: Major challenges have been posed by the coronavirus disease 2019 pandemic in the routine management of patients with inflammatory bowel disease (IBD). The need for constant monitoring of diseases activity and prompt adjustment of therapy have been balanced with the risk of contagion related to face-to-face consultations. Therefore, digital health initiatives have been pursued for safety reasons as vicarious instruments to avoid overcrowding of the IBD clinics. However, concerns and skepticism about the feasibility of digital health and telemedicine modalities limited their uptake in clinical practice in the pre-pandemic period.Areas covered: We conducted a literature overview on the current state of the art and the potential future benefits deriving from the integration of telemedicine systems, home-based laboratory tests, and self-administered drugs into IBD daily practice.Expert opinion: Digital health and telemedicine approaches at distance have been experimented as effective tools to avoid overcrowding of clinics and reduce risk from SARS-CoV2 exposure. Home-based point of care testing, such as fecal calprotectin and dried blood samples, might represent an effective method of remote monitoring of patients particularly when in-person visits are precluded. High expectations are placed on the use of self-administered advanced therapies, such as new subcutaneous formulation of biologics.
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Affiliation(s)
- Virginia Solitano
- Department of Biomedical Sciences, Humanitas University, Milan, Italy
| | - Ludovico Alfarone
- Department of Biomedical Sciences, Humanitas University, Milan, Italy
| | - Ferdinando D'Amico
- Department of Biomedical Sciences, Humanitas University, Milan, Italy.,IBD Center, Humanitas Clinical and Research Center, IRCCS, Milan, Italy
| | - Laurent Peyrin-Biroulet
- Department of Gastroenterology and Inserm NGERE U1256, University Hospital of Nancy, University of Lorraine, Vandoeuvre-lès-Nancy, France
| | - Silvio Danese
- Department of Biomedical Sciences, Humanitas University, Milan, Italy.,IBD Center, Humanitas Clinical and Research Center, IRCCS, Milan, Italy
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27
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D'Amico F, Rubin DT, Kotze PG, Magro F, Siegmund B, Kobayashi T, Olivera PA, Bossuyt P, Pouillon L, Louis E, Domènech E, Ghosh S, Danese S, Peyrin‐Biroulet L. International consensus on methodological issues in standardization of fecal calprotectin measurement in inflammatory bowel diseases. United European Gastroenterol J 2021; 9:451-460. [PMID: 33961734 PMCID: PMC8259254 DOI: 10.1002/ueg2.12069] [Citation(s) in RCA: 50] [Impact Index Per Article: 12.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/18/2021] [Accepted: 02/26/2021] [Indexed: 02/06/2023] Open
Abstract
BACKGROUND Fecal calprotectin (FC) is a non-invasive marker of gut inflammation which is frequently used to guide therapeutic decisions in patients with inflammatory bowel diseases (IBD). Each step of FC measurement can influence the results, leading to misinterpretations and potentially impacting the management of IBD patients. To date, there is high heterogeneity between FC measurements and no current method is universally accepted as a standard. AIMS Our aim was to provide clear position statementsabout the pre-analytical and the analytical phases of FC measurement to homogenize FC levels and to minimize variability and risk of misinterpretation through aninternational consensus. MATERIALS & METHODS Fourteen physicians with expertise in the field of IBD and FC from 11 countries attended a virtual international consensus meeting on July 17th, 2020. A systematic literature was conducted and the literature evidence was shared and discussedamong the participants. Statements were formulated, discussed, and voted. Statements were considered approved if all participants agreed. RESULTS Nine statements were formulated and approved. Based on the available evidence, quantitative tests should be preferred for measuring FC. Furthermore, FC measurement, if possible, should always be performed with the same method and factors influencing FC levels should be taken into account when interpreting the results. DISCUSSION FC has an increasingly important role in the management of patients with IBD. However, large multicenter studies should be conducted to define the reproducibility and to confirm the diagnostic accuracy of the available FC tests. CONCLUSION FC concentrations guide clinicians' treatment decisions. Our statements have a relevant impact in daily practice and could be applied in clinical trials to standardize FC measurement.
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Affiliation(s)
- Ferdinando D'Amico
- Department of Biomedical SciencesHumanitas UniversityMilanItaly
- Department of Gastroenterology and Inserm U1256Nutrition – Genetics and Exposure to Environmental RisksUniversity Hospital of NancyUniversity of LorraineVandoeuvre‐lès‐NancyFrance
| | - David T. Rubin
- Section of Gastroenterology, Hepatology and NutritionUniversity of Chicago Department of MedicineChicagoIllinoisUSA
| | | | - Fernando Magro
- Department of GastroenterologyCentro Hospitalar São JoãoPortoPortugal
| | - Britta Siegmund
- Medizinische Klinik m. S. Gastroenterologie, Infektiologie und RheumatologieCharité ‐ Universitätsmedizin BerlinCorporate Member of Freie Universität BerlinHumboldt‐Universität zu Berlinand Berlin Institute of HealthBerlinGermany
| | - Taku Kobayashi
- Center for Advanced IBD Research and TreatmentKitasato University Kitasato Institute HospitalTokyoJapan
| | - Pablo A. Olivera
- Gastroenterology SectionDepartment of Internal MedicineCentro de Educación Médica e Investigaciones Clínicas (CEMIC)Buenos AiresArgentina
| | - Peter Bossuyt
- Imelda GI Clinical Research CenterImelda General HospitalBonheidenBelgium
| | - Lieven Pouillon
- Imelda GI Clinical Research CenterImelda General HospitalBonheidenBelgium
| | - Edouard Louis
- Department of GastroenterologyCHU Liège University HospitalLiègeBelgium
| | - Eugeni Domènech
- Gastroenterology DepartmentHospital Universitari Germans Trias i PujolBadalonaCataloniaSpain
- Departament de MedicinaUniversitat Autònoma de BarcelonaBarcelonaSpain
- Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD)MadridSpain
| | - Subrata Ghosh
- NIHR Biomedical Research CentreUniversity of Birmingham and University Hospitals NHS Foundation TrustBirminghamUK
| | - Silvio Danese
- Department of Biomedical SciencesHumanitas UniversityMilanItaly
- IBD CenterHumanitas Research HospitalIRCCSMilanItaly
| | - Laurent Peyrin‐Biroulet
- Department of Gastroenterology and Inserm U1256Nutrition – Genetics and Exposure to Environmental RisksUniversity Hospital of NancyUniversity of LorraineVandoeuvre‐lès‐NancyFrance
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28
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Tandon P, Lee EY, Maxwell C, Hitz L, Ambrosio L, Dieleman L, Halloran B, Kroeker K, Huang VM. Fecal Calprotectin May Predict Adverse Pregnancy-Related Outcomes in Patients with Inflammatory Bowel Disease. Dig Dis Sci 2021; 66:1639-1649. [PMID: 32533542 DOI: 10.1007/s10620-020-06381-5] [Citation(s) in RCA: 9] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/18/2020] [Accepted: 05/30/2020] [Indexed: 12/17/2022]
Abstract
BACKGROUND The role of fecal calprotectin in predicting pregnancy-related outcomes in inflammatory bowel disease (IBD) remains unknown. AIM To determine whether increased fecal calprotectin during pregnancy is associated with adverse pregnancy outcomes in IBD. METHODS This is a multicenter cohort study of women with IBD who underwent fecal calprotectin monitoring during pregnancy. Fecal calprotectin levels were stratified by trimester, and adverse pregnancy-related outcomes were recorded. The Mann-Whitney U test assessed differences between continuous variables, whereas categorical variables were compared using the Chi-squared test. RESULTS Eighty-five women with IBD were included. First trimester fecal calprotectin was higher in patients who underwent emergency Cesarean birth compared to those who had a vaginal delivery (503 ug/g, IQR 1554.3 ug/g vs. 130 ug/g, IQR 482 ug/g, p = .030, respectively) and in those who delivered infants with low birth weight compared to normal birth weight (1511 ug/g, IQR 579 ug/g vs. 168 ug/g, IQR 413 ug/g, p = .049, respectively). Third trimester fecal calprotectin was higher in those with non-elective induction of labor (334.5 ug/g, IQR 1411.0 ug/g) compared to those with spontaneous delivery (116.5 ug/g, IQR 227.1 ug/g) (p = .025). Those with a fecal calprotectin ≥ 250 ug/g in the second trimester had an increased incidence of infants with low birth weight (35.3% vs. 3.8%) (p = .049), whereas those with a fecal calprotectin ≥ 250 ug/g in the third trimester had an increased incidence of non-elective induction of labor (43.8% vs. 10.3%, p = .030). CONCLUSIONS Fecal calprotectin may be a useful noninvasive marker to predict adverse pregnancy-related outcomes in patients with IBD.
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Affiliation(s)
- Parul Tandon
- Division of Gastroenterology, Mount Sinai Hospital, Sinai Health System, University of Toronto, Suite 441-600 University Avenue, Toronto, ON, M5G 1X5, Canada.,Department of Medicine, University of Toronto, 441-600 University Avenue, Toronto, ON, M5G 1X5, Canada
| | - Eugenia Y Lee
- Department of Medicine, University of Toronto, 441-600 University Avenue, Toronto, ON, M5G 1X5, Canada
| | - Cynthia Maxwell
- Department of Obstetrics and Gynaecology, University of Toronto, 901-700 University Avenue, Toronto, ON, M5G 1Z5, Canada
| | - Lara Hitz
- Division of Gastroenterology, Mount Sinai Hospital, Sinai Health System, University of Toronto, Suite 441-600 University Avenue, Toronto, ON, M5G 1X5, Canada
| | - Lindsy Ambrosio
- Division of Gastroenterology, University of Alberta, Edmonton, AB, Canada
| | - Levinus Dieleman
- Division of Gastroenterology, University of Alberta, 2-24A Zeidler Building, Edmonton, AB, T6G 2X8, Canada
| | - Brendan Halloran
- Division of Gastroenterology, University of Alberta, 130 University Campus NW, Edmonton, AB, T6G 2X8, Canada
| | - Karen Kroeker
- Division of Gastroenterology, University of Alberta, 8540 112th Street NW, Edmonton, AB, T6G 2X8, Canada
| | - Vivian M Huang
- Division of Gastroenterology, Mount Sinai Hospital, Sinai Health System, University of Toronto, Suite 441-600 University Avenue, Toronto, ON, M5G 1X5, Canada. .,Department of Medicine, University of Toronto, 441-600 University Avenue, Toronto, ON, M5G 1X5, Canada.
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29
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Jere M, Garrick V, Curtis L, Tayler R, Gervais L, Gerasimidis K, Hansen R. Point-of-care faecal calprotectin testing in patients with paediatric inflammatory bowel disease during the COVID-19 pandemic. BMJ Open Gastroenterol 2021; 8:e000631. [PMID: 33947712 PMCID: PMC8098232 DOI: 10.1136/bmjgast-2021-000631] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/16/2021] [Revised: 04/09/2021] [Accepted: 04/11/2021] [Indexed: 11/04/2022] Open
Abstract
OBJECTIVES Following the disruption of normal paediatric inflammatory bowel disease (IBD) services during the peak of the COVID-19 pandemic, we prospectively audited the first-time use of home faecal calprotectin testing. We aimed to provide an alternative to laboratory tests and to assess the value of home testing as part of our regular services going forward. METHODS Home test kits as well as accompanying user instructions were made available to our patients with paediatric IBD that required faecal calprotectin test between 17 April and 12 August 2020. Once the user completed the test, results were automatically uploaded to the result portal and clinical staff were alerted. A user feedback questionnaire was sent to users that had completed the home test. RESULTS Of the 54 patients, 41 (76%) aged between 4.7 and 18.1 years used the home test. A total of 45 home tests were done, one of which produced an invalid result. The decision to modify management was made in 12 (29%) of the patients, while 14 (34%) had no changes made and 15 (37%) required further assessment. Twenty (48.8%) responded to the questionnaire and 85% stated that they preferred the home test to the laboratory testing method. CONCLUSIONS Home calprotectin tests were useful in guiding clinical management during a time when laboratory testing was less available. They may offer benefits as part of routine paediatric IBD monitoring to help target appointments and reduce unnecessary hospital attendances in the future.
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Affiliation(s)
- Mwansa Jere
- Department of Paediatric Gastroenterology, Royal Hospital for Children, Glasgow, UK
| | - Vikki Garrick
- Department of Paediatric Gastroenterology, Royal Hospital for Children, Glasgow, UK
| | - Lee Curtis
- Department of Paediatric Gastroenterology, Royal Hospital for Children, Glasgow, UK
| | - Rachel Tayler
- Department of Paediatric Gastroenterology, Royal Hospital for Children, Glasgow, UK
| | - Lisa Gervais
- Department of Paediatric Gastroenterology, Royal Hospital for Children, Glasgow, UK
| | | | - Richard Hansen
- Department of Paediatric Gastroenterology, Royal Hospital for Children, Glasgow, UK
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30
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Din S, Gaya D, Kammermeier J, Lamb CA, Macdonald J, Moran G, Parkes G, Pollok R, Sebastian S, Segal J, Selinger C, Smith PJ, Steed H, Arnott ID. Inflammatory bowel disease clinical service recovery during the COVID-19 pandemic. Frontline Gastroenterol 2021; 13:77-81. [PMID: 34966535 PMCID: PMC8666864 DOI: 10.1136/flgastro-2021-101805] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/09/2021] [Revised: 03/12/2021] [Accepted: 03/26/2021] [Indexed: 02/04/2023] Open
Affiliation(s)
- Shahida Din
- Edinburgh IBD Unit, Western General Hospital, Edinburgh, UK
| | - Daniel Gaya
- Gastroenterology Unit, Glasgow Royal Infirmary, Glasgow, UK
| | - Jochen Kammermeier
- Pediatric Gastroenterology, Evelina London Children's Hospital, London, UK
| | - Christopher A Lamb
- Institute of Cellular Medicine, Newcastle University, Newcastle Upon Tyne, UK
- Department of Gastroenterology, Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, UK
| | - Jonathan Macdonald
- Department of Gastroenterology, Queen Elizabeth University Hospital, NHS Greater Glasgow and Clyde, Glasgow, UK
| | - Gordon Moran
- NIHR Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust, Nottingham, UK
- Nottingham Digestive Diseases Centre, University of Nottingham, Nottingham, UK
| | - Gareth Parkes
- Department of Gastroenterology, Royal London Hospital, London, UK
| | | | - Shaji Sebastian
- IBD Unit, Hull University Teaching Hospitals NHS Trust, Hull, UK
| | - Jonathan Segal
- Department of Gastroenterology, The Hillingdon Hospitals NHS Foundation Trust, Uxbridge, UK
| | - Christian Selinger
- Leeds Gastroenterology Institute, St James's University Hospital, Leeds, UK
| | - Philip J Smith
- Department of Hepatology and Liver Transplantation, Royal Liverpool and Broadgreen Hospitals NHS Trust, Liverpool, UK
| | - Helen Steed
- Department of Gastroenterology, New Cross Hospital, Wolverhampton, UK
| | - Ian D Arnott
- The Edinburgh IBD Unit, Western General Hospital, Edinburgh, UK
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Osredkar J, Kurent T, Fabjan T, Kumer K, Božnar Alič E, Drobne D. The comparison of the three assays for determination of fecal calprotectin in inflammatory bowel disease. Biochem Med (Zagreb) 2021; 31:020707. [PMID: 33927557 PMCID: PMC8047788 DOI: 10.11613/bm.2021.020707] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/09/2020] [Accepted: 03/06/2021] [Indexed: 11/03/2022] Open
Abstract
Introduction Fecal calprotectin is a biomarker for monitoring inflammatory bowel disease (IBD) activity. Our aim, therefore, was to evaluate two new assays, the point of care test Quantum Blue and the Liaison Calprotectin with respect to the Calprest, commonly used assay, and to determine their performance for IBD diagnosis. Materials and methods We included 73 prospective patients with IBD. Fecal calprotectin was measured and analysed with the routine Calprest assay and two recently introduced assays, the Quantum Blue and the Liaison Calprotectin. Furthermore, we compared the results by Bland and Altman analysis, and Passing-Bablok regression. Results We observed no difference in median calprotectin values obtained by the Calprest (94.6 µg/g, 95%CI 66.5 to 166.1) and Liaison assay (101.0 µg/g, 95%CI 48.1 to 180.1) whereas significantly higher concentrations were obtained with the Quantum Blue assay (240.0 µg/g, 95%CI 119.9 to 353.2). The mean absolute and relative difference between the Calprest and Quantum Blue methods was statistically significant (- 162.3 µg/g and
- 143.1%). Mean absolute difference between the Calprest and Liaison calprotectin methods was positive (2.2 µg/g). The agreement between assays revealed that Quantum Blue and Calprest have fair agreement with Kappa coefficient of 0.38 (95%CI 0.26 to 0.51). Liaison Calprotectin and Calprest revealed moderate agreement with a weak Kappa coefficient of 0.47 (95%CI 0.32 to 0.62). Conclusion Clinicians should be aware of these differences between the assays and avoid comparison of their respective results.
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Affiliation(s)
- Joško Osredkar
- Institute of Clinical Chemistry and Biochemistry, University Medical Centre Ljubljana, Ljubljana, Slovenia.,Faculty of Pharmacy, University of Ljubljana, Ljubljana, Slovenia
| | - Tina Kurent
- Department of Gastroenterology, University Medical Centre Ljubljana, Ljubljana, Slovenia
| | - Teja Fabjan
- Institute of Clinical Chemistry and Biochemistry, University Medical Centre Ljubljana, Ljubljana, Slovenia.,Faculty of Pharmacy, University of Ljubljana, Ljubljana, Slovenia
| | - Kristina Kumer
- Institute of Clinical Chemistry and Biochemistry, University Medical Centre Ljubljana, Ljubljana, Slovenia.,Faculty of Pharmacy, University of Ljubljana, Ljubljana, Slovenia
| | - Elizabeta Božnar Alič
- Institute of Clinical Chemistry and Biochemistry, University Medical Centre Ljubljana, Ljubljana, Slovenia
| | - David Drobne
- Department of Gastroenterology, University Medical Centre Ljubljana, Ljubljana, Slovenia.,Medical Faculty, University of Ljubljana, Ljubljana, Slovenia
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Lewin S, Lees C, Regueiro M, Hart A, Mahadevan U. International Organization for the Study of Inflammatory Bowel Disease: Global Strategies for Telemedicine and Inflammatory Bowel Diseases. J Crohns Colitis 2020; 14:S780-S784. [PMID: 33085971 PMCID: PMC7665391 DOI: 10.1093/ecco-jcc/jjaa140] [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] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/12/2022]
Abstract
Before the onset of the COVID-19 pandemic, the majority of care for inflammatory bowel disease patients was provided in-person. The practice of gastroenterology care has since rapidly transformed, with telemedicine emerging as an essential tool to provide medical care to patients while maintaining social distancing and conserving personal protective equipment. This article provides insight into past and current practices among inflammatory bowel disease specialists and shares regulatory, financial and practical considerations for incorporating telemedicine into clinical practice. Continued government and other payer support for telemedicine and ongoing innovation to provide remote objective patient data will help to sustain the use of telemedicine long after the current pandemic subsides.
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Affiliation(s)
- Sara Lewin
- Division of Gastroenterology, University of California, San Francisco, CA, USA
| | - Charles Lees
- Institute of Genetics & Molecular Medicine, University of Edinburgh, Edinburgh, UK
| | - Miguel Regueiro
- Department of Gastroenterology, Hepatology & Nutrition, Cleveland Clinic, Cleveland, OH, USA
| | - Ailsa Hart
- IBD Unit, St Mark’s Hospital, London, UK
| | - Uma Mahadevan
- Division of Gastroenterology, University of California, San Francisco, CA, USA
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33
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Stallmach A, Sturm A, Dignass A, Kucharzik T, Blumenstein I, Helwig U, Koletzko S, Lynen P, Schmidt C. Addendum to S3-Guidelines Crohn’s disease and ulcerative colitis: Management of Patients with Inflammatory Bowel Disease in the COVID-19 Pandemic – open questions and answers. ZEITSCHRIFT FUR GASTROENTEROLOGIE 2020; 58:982-1002. [PMID: 33036052 DOI: 10.1055/a-1234-8079] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 01/08/2023]
Abstract
AbstractThe COVID-19 pandemic is a global outbreak of new onset infections with the SARS-CoV-2 virus. To date, more than 3.4 million people have been infected throughout the world. In Germany, approximately 450,000 patients suffer from inflammatory bowel disease; these patients generally require continuous expert care and support. Against the background of a rapidly accumulating knowledge base on SARS-CoV-2, 68 expert authors of the current DGVS guidelines for Crohn’s disease and ulcerative colitis took part in a virtual meeting to compile up-to-date, practice-orientated recommendations aimed at improving the care of patients with IBD. These recommendations address the risk of infection, including the risk for specific patient groups, the possible course of the disease, and consequences for pharmacological and surgical therapies of the underlying disease, as well as general measures for infection prevention and adjuvant prophylactic and therapeutic options.
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Affiliation(s)
- Andreas Stallmach
- Klinik für Innere Medizin IV (Gastroenterologie, Infektiologie und Hepatologie), Universitätsklinikum Jena, Jena
| | - Andreas Sturm
- Klinik für Innere Medizin, Schwerpunkt Gastroenterologie, DRK Kliniken Berlin
- Westend, Berlin
| | - Axel Dignass
- Medizinische Klinik I, Agaplesion Markus Krankenhaus, Frankfurt
| | - Torsten Kucharzik
- Klinik für Innere Medizin, Gastroenterologie, Klinikum Lüneburg, Lüneburg
| | - Irina Blumenstein
- Medizinische Klinik 1 (Gastroenterologie und Hepatologie, Pneumologie und Allergologie, Endokrinologie und Diabetologie sowie Ernährungsmedizin), Universitätsklinikum Frankfurt, Goethe-Universität, Frankfurt
| | - Ulf Helwig
- Internistische Praxengemeinschaft Oldenburg, Oldenburg
| | - Sibylle Koletzko
- Kinderklinik und Kinderpoliklinik im Dr. von Hauner Kinderspital, LMU Klinikum der Universität München, München
| | - Petra Lynen
- Deutsche Gesellschaft für Gastroenterologie, Verdauungs- und Stoffwechselerkrankungen, Berlin
| | - Carsten Schmidt
- Medizinische Klinik II (Gastroenterologie, Hepatologie, Endokrinologie, Diabetologie und Infektiologie), Klinikum Fulda, Universitätsmedizin Marburg – Campus Fulda, Fulda
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van Rheenen PF, Aloi M, Assa A, Bronsky J, Escher JC, Fagerberg UL, Gasparetto M, Gerasimidis K, Griffiths A, Henderson P, Koletzko S, Kolho KL, Levine A, van Limbergen J, Martin de Carpi FJ, Navas-López VM, Oliva S, de Ridder L, Russell RK, Shouval D, Spinelli A, Turner D, Wilson D, Wine E, Ruemmele FM. The Medical Management of Paediatric Crohn's Disease: an ECCO-ESPGHAN Guideline Update. J Crohns Colitis 2020; 15:jjaa161. [PMID: 33026087 DOI: 10.1093/ecco-jcc/jjaa161] [Citation(s) in RCA: 320] [Impact Index Per Article: 64.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/05/2023]
Abstract
OBJECTIVE We aimed to provide an evidence-supported update of the ECCO-ESPGHAN guideline on the medical management of paediatric Crohn's disease [CD]. METHODS We formed 10 working groups and formulated 17 PICO-structured clinical questions [Patients, Intervention, Comparator, and Outcome]. A systematic literature search from January 1, 1991 to March 19, 2019 was conducted by a medical librarian using MEDLINE, EMBASE, and Cochrane Central databases. A shortlist of 30 provisional statements were further refined during a consensus meeting in Barcelona in October 2019 and subjected to a vote. In total 22 statements reached ≥ 80% agreement and were retained. RESULTS We established that it was key to identify patients at high risk of a complicated disease course at the earliest opportunity, to reduce bowel damage. Patients with perianal disease, stricturing or penetrating behaviour, or severe growth retardation should be considered for up-front anti-tumour necrosis factor [TNF] agents in combination with an immunomodulator. Therapeutic drug monitoring to guide treatment changes is recommended over empirically escalating anti-TNF dose or switching therapies. Patients with low-risk luminal CD should be induced with exclusive enteral nutrition [EEN], or with corticosteroids when EEN is not an option, and require immunomodulator-based maintenance therapy. Favourable outcomes rely on close monitoring of treatment response, with timely adjustments in therapy when treatment targets are not met. Serial faecal calprotectin measurements or small bowel imaging [ultrasound or magnetic resonance enterography] are more reliable markers of treatment response than clinical scores alone. CONCLUSIONS We present state-of-the-art guidance on the medical treatment and long-term management of children and adolescents with CD.
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Affiliation(s)
- Patrick F van Rheenen
- Department of Paediatric Gastroenterology, University of Groningen, University Medical Centre Groningen, Beatrix Children's Hospital, Groningen, The Netherlands
| | - Marina Aloi
- Pediatric Gastroenterology and Liver Unit, Maternal and Child Health Department, Sapienza - University of Rome, Rome, Italy
| | - Amit Assa
- Department of Gastroenterology, Nutrition and Liver Diseases, Schneider Children's Medical Center, Petach Tikvah, Affiliated to the Sackler Faculty of Medicine, Tel-Aviv University, Israel
| | - Jiri Bronsky
- Paediatric Gastroenterology Unit, Department of Paediatrics, University Hospital Motol, Prague, Czech Republic
| | - Johanna C Escher
- Department of Paediatric Gastroenterology, Erasmus MC-Sophia Children's Hospital, Rotterdam, The Netherlands
| | - Ulrika L Fagerberg
- Department of Pediatrics/Centre for Clinical Research, Västmanland Hospital, Västeras and Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden
| | - Marco Gasparetto
- Department of Paediatric Gastroenterology, Barts Health Trust, The Royal London Children's Hospital, London, UK
| | | | - Anne Griffiths
- Department of Paediatrics, Division of Gastroenterology, Hepatology and Nutrition, Hospital for Sick Children, University of Toronto, Toronto, Canada
| | - Paul Henderson
- Child Life and Health, University Of Edinburgh, Edinburgh, UK
| | - Sibylle Koletzko
- Department of Pediatrics, Division of Gastroenterology and Hepatology, Dr. von Hauner Children's Hospital, University Hospital, LMU Munich, Munich, Germany
- Department of Pediatrics, Gastroenterology and Nutrition, School of Medicine Collegium Medicum University of Warmia and Mazury, Olsztyn, Poland
| | - Kaija-Leena Kolho
- Department of Paediatrics, Children´s Hospital, University of Helsinki and Tampere University, Tampere, Finland
| | - Arie Levine
- Pediatric Gastroenterology and Nutrition Unit, Wolfson Medical Center, Tel Aviv University, Israel
| | - Johan van Limbergen
- Division of Pediatric Gastroenterology and Nutrition, Amsterdam UMC - location AMC, Amsterdam, The Netherlands
| | | | - Víctor Manuel Navas-López
- Pediatric Gastroenterology and Nutrition Unit, IBIMA, Hospital Regional Universitario de Málaga, Málaga, Spain
| | - Salvatore Oliva
- Pediatric Gastroenterology and Liver Unit, Maternal and Child Health Department, Sapienza - University of Rome, Rome, Italy
| | - Lissy de Ridder
- Department of Paediatric Gastroenterology, Erasmus MC-Sophia Children's Hospital, Rotterdam, The Netherlands
| | - Richard K Russell
- Department of Paediatric Gastroenterology and Nutrition, Royal Hospital for Sick Children, Edinburgh, UK
| | - Dror Shouval
- Pediatric Gastroenterology Unit, Edmond and Lily Safra Children's Hospital, Sheba Medical Center, Ramat Gan, Israel
- Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel
| | - Antonino Spinelli
- Department of Colon and Rectal Surgery, Humanitas Clinical and Research Center - IRCCS, Rozzano Milano, Italy
- Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy
| | - Dan Turner
- Paediatric Gastroenterology, Shaare Zedek Medical Centre, the Hebrew University of Jerusalem, Israel
| | - David Wilson
- Child Life and Health, University Of Edinburgh, Edinburgh, UK
| | - Eytan Wine
- Division of Pediatric Gastroenterology, Edmonton Pediatric IBD Clinic (EPIC), Departments of Pediatrics & Physiology, University of Alberta, Edmonton, Canada
| | - Frank M Ruemmele
- Assistance Publique- Hôpitaux de Paris, Hôpital Necker Enfants Malades, Pediatric Gastroenterology, Paris, France
- Faculté de Médecine, Université Sorbonne Paris Cité, Paris Descartes, Paris, France
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Lees CW, Regueiro M, Mahadevan U. Innovation in Inflammatory Bowel Disease Care During the COVID-19 Pandemic: Results of a Global Telemedicine Survey by the International Organization for the Study of Inflammatory Bowel Disease. Gastroenterology 2020; 159:805-808.e1. [PMID: 32474119 PMCID: PMC7256529 DOI: 10.1053/j.gastro.2020.05.063] [Citation(s) in RCA: 48] [Impact Index Per Article: 9.6] [Reference Citation Analysis] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/14/2020] [Accepted: 05/15/2020] [Indexed: 02/08/2023]
Affiliation(s)
| | - Miguel Regueiro
- Department of Gastroenterology, Hepatology & Nutrition, Cleveland Clinic, Cleveland, Ohio
| | - Uma Mahadevan
- Division of Gastroenterology, University of California, San Francisco, San Francisco, California and, Member, International Organization for the study of Inflammatory Bowel Disease
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36
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D’Amico F, Netter P, Baumann C, Veltin M, Zallot C, Aimone-Gastin I, Danese S, Peyrin-Biroulet L. Setting up a Virtual Calprotectin Clinic in Inflammatory Bowel Diseases: Literature Review and Nancy Experience. J Clin Med 2020; 9:jcm9092697. [PMID: 32825383 PMCID: PMC7563857 DOI: 10.3390/jcm9092697] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/03/2020] [Revised: 08/07/2020] [Accepted: 08/18/2020] [Indexed: 12/12/2022] Open
Abstract
Technological progress, including virtual clinics, web or smartphone-based applications, and assessment of fecal calprotectin (FC) at home has favored the implementation of treat to target strategies for patients with inflammatory bowel diseases (IBD). Although these innovations are promising and have been associated with a significant reduction in health costs, their application in clinical practice is limited. Here, we summarize the most recent literature on virtual clinics and available FC home tests. In addition, we report the experience of IBD patients monitored through the IBDoc® test at the Nancy University Hospital, focusing on usability testing and patient’s satisfaction. This pilot experience shows that a virtual calprotectin clinic doubles adherence rate to FC in IBD patients. This finding is especially clinically relevant in the post-coronavirus disease 2019 (COVID-19) pandemic era, with an increasing use of e-health.
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Affiliation(s)
- Ferdinando D’Amico
- Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, 20090 Milan, Italy; (F.D.); (S.D.)
- Department of Gastroenterology and Inserm NGERE U1256, University Hospital of Nancy, University of Lorraine, 54500 Vandoeuvre-lès-Nancy, France; (M.V.); (C.Z.)
| | - Patrick Netter
- Ingénierie Moléculaire et Ingénierie Articulaire (IMoPA), UMR-7365 CNRS, Faculté de Médecine, University of Lorraine and University Hospital of Nancy, 54000 Nancy, France;
| | - Cedric Baumann
- Clinical Research Support Facility, Methodological and Statistical Unit, University Hospital of Nancy, 54000 Nancy, France;
| | - Muriel Veltin
- Department of Gastroenterology and Inserm NGERE U1256, University Hospital of Nancy, University of Lorraine, 54500 Vandoeuvre-lès-Nancy, France; (M.V.); (C.Z.)
| | - Camille Zallot
- Department of Gastroenterology and Inserm NGERE U1256, University Hospital of Nancy, University of Lorraine, 54500 Vandoeuvre-lès-Nancy, France; (M.V.); (C.Z.)
| | - Isabelle Aimone-Gastin
- Department of Biochemistry-Molecular Biology-Nutrition, Nancy University Hospital, 54000 Nancy, France;
- Inserm UMR_S1256 N-GERE, Nutrition-Genetics-Environmental Risk Exposure, University Hospital of Nancy, University of Lorraine, 54500 Vandoeuvre-lès-Nancy, France
| | - Silvio Danese
- Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, 20090 Milan, Italy; (F.D.); (S.D.)
- IBD center, Department of Gastroenterology, Humanitas Clinical and Research Center—IRCCS, Rozzano, 20089 Milan, Italy
| | - Laurent Peyrin-Biroulet
- Department of Gastroenterology and Inserm NGERE U1256, University Hospital of Nancy, University of Lorraine, 54500 Vandoeuvre-lès-Nancy, France; (M.V.); (C.Z.)
- Correspondence: ; Tel.: +33-383-153661; Fax: +33-383-153633
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Stallmach A, Sturm A, Blumenstein I, Helwig U, Koletzko S, Lynen P, Schmidt C, Dignaß A, Kucharzik T. [Addendum to S3-Guidelines Crohn's disease and ulcerative colitis: Management of Patients with Inflammatory Bowel Disease in the COVID-19 Pandemic - open questions and answers]. ZEITSCHRIFT FUR GASTROENTEROLOGIE 2020; 58:672-692. [PMID: 32659830 PMCID: PMC7416209 DOI: 10.1055/a-1193-5475] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Indexed: 01/08/2023]
Abstract
Die COVID-19-Pandemie ist ein weltweiter Ausbruch von neu aufgetretenen Infektionen mit dem SARS-CoV-2-Virus, von denen weltweit derzeit mehr als 10.670.000 Menschen erkrankt sind bzw. waren. In Deutschland leiden ca. 450.000 Patienten an einer chronisch entzündlichen Darmerkrankung; diese Patienten benötigen in der Regel eine kontinuierliche und kompetente Betreuung. Vor dem Hintergrund eines rasch zunehmenden Wissenszuwachses haben 68 Experten, die die derzeit gültigen Leitlinien der DGVS zum Morbus Crohn und zur Colitis ulcerosa erstellt haben, im Rahmen einer virtuellen Konferenz aktuelle und praxisnahe Empfehlungen formuliert, um die Versorgung von CED-Patienten zu verbessern. Diese adressieren das Infektionsrisiko einschließlich des Risikos für besondere Gruppen, den möglichen Verlauf der Erkrankung und die Konsequenzen für die medikamentöse und die operative Therapie der Grunderkrankung sowie allgemeine Maßnahmen zur Infektionsprävention und adjuvante Präventions- und Therapiemöglichkeiten.
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Affiliation(s)
- Andreas Stallmach
- Klinik für Innere Medizin IV (Gastroenterologie, Infektiologie und Hepatologie), Universitätsklinikum Jena, Jena
| | - Andreas Sturm
- Klinik für Innere Medizin, Schwerpunkt Gastroenterologie, DRK Kliniken Berlin | Westend, Berlin
| | - Irina Blumenstein
- Medizinische Klinik 1 (Gastroenterologie und Hepatologie, Pneumologie und Allergologie, Endokrinologie und Diabetologie sowie Ernährungsmedizin), Universitätsklinikum Frankfurt, Goethe-Universität, Frankfurt
| | - Ulf Helwig
- Internistische Praxengemeinschaft Oldenburg, Oldenburg
| | - Sibylle Koletzko
- Kinderklinik und Kinderpoliklinik im Dr. von Hauner Kinderspital, LMU Klinikum der Universität München, München
| | - Petra Lynen
- Deutsche Gesellschaft für Gastroenterologie, Verdauungs- und Stoffwechselerkrankungen, Berlin
| | - Carsten Schmidt
- Medizinische Klinik II (Gastroenterologie, Hepatologie, Endokrinologie, Diabetologie und Infektiologie), Klinikum Fulda, Universitätsmedizin Marburg - Campus Fulda, Fulda
| | - Axel Dignaß
- Medizinische Klinik I, Agaplesion Markus Krankenhaus, Frankfurt
| | - Torsten Kucharzik
- Klinik für Innere Medizin Gastroenterologie, Klinikum Lüneburg, Lüneburg
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D'Amico F, Bonovas S, Danese S, Peyrin-Biroulet L. Review article: faecal calprotectin and histologic remission in ulcerative colitis. Aliment Pharmacol Ther 2020; 51:689-698. [PMID: 32048751 DOI: 10.1111/apt.15662] [Citation(s) in RCA: 57] [Impact Index Per Article: 11.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/06/2019] [Revised: 01/06/2020] [Accepted: 01/27/2020] [Indexed: 12/13/2022]
Abstract
BACKGROUND Histologic healing is emerging as a new therapeutic goal in both routine practice and clinical trials in ulcerative colitis (UC). However, it requires repeated endoscopies and biopsies. Faecal calprotectin is a non-invasive marker of mucosal healing (endoscopic and histologic healing). AIM To conduct a systematic review to clarify the correlation between faecal calprotectin levels and histologic activity in UC patients. METHODS We searched PubMed/MEDLINE, EMBASE and Web of Science through September 2019 to identify studies in patients with confirmed diagnosis of UC, reporting the correlation between faecal calprotectin levels and histologic analysis. RESULTS Twelve studies enrolling 1168 patients were included in the final review. Histologic remission was defined according to nonvalidated scores in five articles and using partially validated scores in seven articles. Faecal calprotectin values were measured in 6 of 12 studies (50%) with the same kit, while the remaining six studies adopted individually different kits. A clear correlation between faecal calprotectin levels and histology was showed in all included studies. Eleven different faecal calprotectin cut-off points were identified to distinguish histological remission from histological activity, ranging from 40.5 to 250 μg/g. CONCLUSIONS Faecal calprotectin can be used to predict histologic remission in patients with UC, but the cut-off level varies across studies, according to the test used to measure this biomarker and according to the definition of histologic remission. Larger prospective studies using validated histologic indexes are needed to identify a globally accepted faecal calprotectin cut-off level to discriminate between histologic remission and histologically active disease.
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Affiliation(s)
- Ferdinando D'Amico
- Department of Biomedical Sciences, Humanitas University, Milan, Italy.,Department of Gastroenterology and Inserm NGERE U1256, University Hospital of Nancy, University of Lorraine, Vandoeuvre-lès-Nancy, France
| | - Stefanos Bonovas
- Department of Biomedical Sciences, Humanitas University, Milan, Italy.,Department of Gastroenterology, IBD Center, Humanitas Research Hospital, Rozzano, Italy
| | - Silvio Danese
- Department of Biomedical Sciences, Humanitas University, Milan, Italy.,Department of Gastroenterology, IBD Center, Humanitas Research Hospital, Rozzano, Italy
| | - Laurent Peyrin-Biroulet
- Department of Gastroenterology and Inserm NGERE U1256, University Hospital of Nancy, University of Lorraine, Vandoeuvre-lès-Nancy, France
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Kadam R, White W, Banks N, Katz Z, Dittrich S, Kelly-Cirino C. Target Product Profile for a mobile app to read rapid diagnostic tests to strengthen infectious disease surveillance. PLoS One 2020; 15:e0228311. [PMID: 31995628 PMCID: PMC6988927 DOI: 10.1371/journal.pone.0228311] [Citation(s) in RCA: 18] [Impact Index Per Article: 3.6] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/16/2019] [Accepted: 01/07/2020] [Indexed: 02/06/2023] Open
Abstract
The essential role of rapid diagnostic tests (RDTs) in disease control is compromised every time a test is not performed correctly or its result is not reported accurately and promptly. A mobile app that utilizes the camera and connectivity of a common smartphone can fill this role of supporting the test's proper execution and the automatic transmission of results. In a consensus process with 51 expert participants representing the needs of clinical users, healthcare programs, health information systems, surveillance systems, and global public health stakeholders, we developed a Target Product Profile describing the minimal and optimal characteristics of such an app. We collected feedback over two rounds and refined the characteristics to arrive at a preferred agreement level of greater than 75%, with an average of 92% agreement (range: 79-100%). As per this feedback, such an app should be compatible with many RDTs and mobile devices without needing accessories. The app should assist the user with RDT-specific instructions, include checks to facilitate quality control of the testing process and suggest results with ≥ 95% accuracy across common lighting conditions while allowing the user to determine the final result. Data from the app must be under the control of the health program that operates it, and the app should support at least one of the common data exchange formats HL7, FHIR, ASTM or JSON. The Target Product Profile also lays out the minimum data security and privacy requirements for the app.
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Affiliation(s)
- Rigveda Kadam
- Foundation for Innovative Diagnostics (FIND), Geneva, Switzerland
| | - Wallace White
- Foundation for Innovative Diagnostics (FIND), Geneva, Switzerland
| | - Nicholas Banks
- Foundation for Innovative Diagnostics (FIND), Geneva, Switzerland
| | - Zachary Katz
- Foundation for Innovative Diagnostics (FIND), Geneva, Switzerland
| | - Sabine Dittrich
- Foundation for Innovative Diagnostics (FIND), Geneva, Switzerland
- Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom
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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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Goll R, Heitmann R, Moe ØK, Carlsen K, Florholmen J. Head to head comparison of two commercial fecal calprotectin kits as predictor of Mayo endoscopic sub-score and mucosal TNF expression in ulcerative colitis. PLoS One 2019; 14:e0224895. [PMID: 31790426 PMCID: PMC6886764 DOI: 10.1371/journal.pone.0224895] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/25/2019] [Accepted: 10/23/2019] [Indexed: 12/13/2022] Open
Abstract
BACKGROUND Fecal calprotectin is widely used to monitor disease activity in patients with inflammatory bowel disease. Multiple commercial kits exist, however, since the analyses are not standardized, these kits cannot be used interchangeably. We aimed to perform a technical evaluation of two kits (Calpro from Calprolab, Norway and Calprest from Eurospital, Italy) and perform a tuning for detection of clinically relevant disease states in ulcerative colitis. MATERIALS AND METHODS For tuning against different clinical states a total of 116 patients with ulcerative colitis were recruited (67 of which were part of an earlier publication). For the technical evaluation an additional series of 80 random samples from the hospital lab were included. Technical evaluation was done by correlation and limits of agreement analysis; cut-off levels were explored by ROC analysis against clinically relevant actual states. RESULTS The technical evaluation revealed good correlation between assays, however a non-linear difference was found: At values below 200 mg/kg, no significant bias was found; in the interval 200-1000 mg/kg the Calprest assay measured on average 30% lower than Calpro; and at higher values Calprest measured 60% higher values than Calpro. Both assays predicted Mayo endoscopic score (MES) 0 (cutoff 28: sensitivity 0.38; specificity 0.82 for Calprest; cutoff 28: sensitivity 0.50; specificity 0.77 for Calpro), and MES 2-3 (cutoff 148: sensitivity 0.72; specificity 0.80 for Calprest; cutoff 208: sensitivity 0.64; specificity 0.80 for Calpro), but did not predict normalization of mucosal TNF transcript per se. A combination of calprotectin and MES predicted mucosal TNF transcript values reasonably well (Calpro: sensitivity 0.85, specificity 0.58; Calprest: sensitivity 0.85, specificity 0.61). CONCLUSION The Calpro and Calprest assays correlated well, but subtle differences were found, underlining the need for kit-specific cut-off values. Both kits were most precise in predicting active inflammation (MES 2-3), but less so for prediction of mucosal healing (MES 0) and normalization of mucosal TNF gene expression.
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Affiliation(s)
- Rasmus Goll
- Institute of Clinical Medicine, UiT the Arctic University of Norway, Tromsø, Norway
- Medical Gastroenterology, Division of Internal medicine, University Hospital of North Norway, Tromsø, Norway
- * E-mail:
| | - Richard Heitmann
- Department of Gastroenterology, Telemark Hospital, Skien, Norway
| | - Øystein Kittel Moe
- Medical Gastroenterology, Division of Internal medicine, University Hospital of North Norway, Tromsø, Norway
| | - Katrine Carlsen
- Department of Pediatrics, Hvidovre University Hospital, Copenhagen, Denmark
| | - Jon Florholmen
- Institute of Clinical Medicine, UiT the Arctic University of Norway, Tromsø, Norway
- Medical Gastroenterology, Division of Internal medicine, University Hospital of North Norway, Tromsø, Norway
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Yin AL, Hachuel D, Pollak JP, Scherl EJ, Estrin D. Digital Health Apps in the Clinical Care of Inflammatory Bowel Disease: Scoping Review. J Med Internet Res 2019; 21:e14630. [PMID: 31429410 PMCID: PMC6718080 DOI: 10.2196/14630] [Citation(s) in RCA: 58] [Impact Index Per Article: 9.7] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/09/2019] [Revised: 07/02/2019] [Accepted: 07/04/2019] [Indexed: 12/12/2022] Open
Abstract
BACKGROUND Digital health is poised to transform health care and redefine personalized health. As Internet and mobile phone usage increases, as technology develops new ways to collect data, and as clinical guidelines change, all areas of medicine face new challenges and opportunities. Inflammatory bowel disease (IBD) is one of many chronic diseases that may benefit from these advances in digital health. This review intends to lay a foundation for clinicians and technologists to understand future directions and opportunities together. OBJECTIVE This review covers mobile health apps that have been used in IBD, how they have fit into a clinical care framework, and the challenges that clinicians and technologists face in approaching future opportunities. METHODS We searched PubMed, Scopus, and ClinicalTrials.gov to identify mobile apps that have been studied and were published in the literature from January 1, 2010, to April 19, 2019. The search terms were ("mobile health" OR "eHealth" OR "digital health" OR "smart phone" OR "mobile app" OR "mobile applications" OR "mHealth" OR "smartphones") AND ("IBD" OR "Inflammatory bowel disease" OR "Crohn's Disease" (CD) OR "Ulcerative Colitis" (UC) OR "UC" OR "CD"), followed by further analysis of citations from the results. We searched the Apple iTunes app store to identify a limited selection of commercial apps to include for discussion. RESULTS A total of 68 articles met the inclusion criteria. A total of 11 digital health apps were identified in the literature and 4 commercial apps were selected to be described in this review. While most apps have some educational component, the majority of apps focus on eliciting patient-reported outcomes related to disease activity, and a few are for treatment management. Significant benefits have been seen in trials relating to education, quality of life, quality of care, treatment adherence, and medication management. No studies have reported a negative impact on any of the above. There are mixed results in terms of effects on office visits and follow-up. CONCLUSIONS While studies have shown that digital health can fit into, complement, and improve the standard clinical care of patients with IBD, there is a need for further validation and improvement, from both a clinical and patient perspective. Exploring new research methods, like microrandomized trials, may allow for more implementation of technology and rapid advancement of knowledge. New technologies that can objectively and seamlessly capture remote data, as well as complement the clinical shift from symptom-based to inflammation-based care, will help the clinical and health technology communities to understand the full potential of digital health in the care of IBD and other chronic illnesses.
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Affiliation(s)
- Andrew Lukas Yin
- Medical College, Weill Cornell Medicine, New York, NY, United States
- Cornell Tech, New York, NY, United States
| | - David Hachuel
- Cornell Tech, New York, NY, United States
- augGI Technologies, New York, NY, United States
| | | | - Ellen J Scherl
- Jill Roberts Center for Inflammatory Bowel Disease, Weill Cornell Medicine, New York, NY, United States
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