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Hasskamp J, Meinhardt C, Timmer A. Anti-IL-12/23p40 antibodies for induction of remission in Crohn's disease. Cochrane Database Syst Rev 2025; 5:CD007572. [PMID: 40357993 PMCID: PMC12070676 DOI: 10.1002/14651858.cd007572.pub4] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 05/15/2025]
Abstract
BACKGROUND Crohn's disease (CD) is a chronic inflammatory bowel disease leading to symptoms such as abdominal pain, diarrhea, weight loss, fatigue, and complications such as strictures and fistulas. Ustekinumab (CNTO 1275) and briakinumab (ABT-874) are monoclonal antibodies that target the standard p40 subunit of the cytokines interleukin-12 and interleukin-23 (IL-12/23p40), which are involved in the pathogenesis of CD. Briakinumab has been withdrawn for the treatment of CD, making ustekinumab the only available antibody against the p40 subunit of interleukin-12 and interleukin-23 approved for this purpose. OBJECTIVES To assess the benefits and harms of anti-IL-12/23p40 antibodies for induction of remission in CD, as compared to no treatment, placebo, other drug treatment, or varying dosing schedules. SEARCH METHODS We searched the following databases: Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, and MEDLINE (from inception to 2 February 2024) and Embase (from inception until 12 August 2022). We also searched ClinicalTrials.gov, WHO ICTRP, references, and conference abstracts to identify additional studies. SELECTION CRITERIA We included randomized controlled trials (RCTs) of at least four weeks' duration in which monoclonal antibodies against IL-12/23p40 were compared to placebo, no treatment, or another active comparator in people with active CD. We also included trials examining different doses of antibodies against IL-12/23p40. DATA COLLECTION AND ANALYSIS Two review authors independently screened studies for inclusion and extracted data. We assessed the methodological quality of the included studies using Cochrane's RoB 2 tool. The primary outcome was failure to induce clinical remission by week 8, or 6 to 12 as available. Secondary outcomes included failure to induce clinical improvement (clinical response), induction of endoscopic remission, quality of life, and adverse events, serious adverse events, and withdrawals due to adverse events. We calculated the risk ratio (RR) or risk difference (RD) and 95% confidence intervals (95% CI) for each outcome unless substantial heterogeneity was detected. We analyzed data on an intention-to-treat basis. We assessed the certainty of the evidence using the GRADE approach. MAIN RESULTS Eight RCTs involving a total of 3224 participants with CD met the inclusion criteria. All studies were double-blinded. We assessed the risk of bias for most outcomes as either low risk of bias or some concerns. Based on a pooled analysis of three trials, ustekinumab decreased the number of participants failing to achieve clinical remission at eight weeks when compared to placebo. Seventy-four per cent (693/938) of participants in the ustekinumab group and 87% (421/483) of those in the placebo group did not enter clinical remission (RR 0.85, 95% CI 0.81 to 0.89; 3 studies; 1421 participants; high-certainty evidence). Treatment with ustekinumab likely did not lead to more serious adverse events when compared to placebo, with 5% (48/966) and 6% (30/505) of participants affected in the ustekinumab and placebo groups, respectively (RD -0.01, 95% CI -0.03 to 0.01; 3 studies; 1471 participants; moderate-certainty evidence). A single small study in children compared two different induction doses of ustekinumab. The evidence for this outcome is very uncertain due to wide CIs. Eighty-one per cent (17/21) of participants receiving the higher induction dose (9 mg/kg or 390 mg) did not enter clinical remission at eight weeks, compared to 78% (18/23) of participants receiving the lower induction dose of 3 mg/kg or 130 mg (RR 1.03, 95% CI 0.77 to 1.39; 1 study; 44 participants; very low-certainty evidence). Separate safety data for the eight-week time point were not available for this comparison. Based on one trial comparing ustekinumab to adalimumab, the evidence is very uncertain about which is the more beneficial drug. Fifty per cent (95/191) of participants receiving ustekinumab did not enter remission compared to 52% (101/195) of participants receiving adalimumab (RR 0.96, 95% CI 0.79 to 1.17; 1 study; 386 participants; very low-certainty evidence). Separate results on adverse events at eight weeks were not reported for this comparison. AUTHORS' CONCLUSIONS Ustekinumab reduces the risk of people with CD failing to enter clinical remission at eight weeks. It probably does not lead to more serious adverse events when compared to placebo. There were inadequate data to conclude the more effective induction dose of ustekinumab in children. No studies evaluated adverse events at eight weeks for this comparison. There may be little to no difference between ustekinumab and other biologics, such as adalimumab or guselkumab, in inducing clinical remission at week 8, but the evidence is very uncertain, and separate data on adverse events at eight weeks were not available.
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Key Words
- humans
- antibodies, monoclonal
- antibodies, monoclonal/administration & dosage
- antibodies, monoclonal/therapeutic use
- antibodies, monoclonal, humanized
- antibodies, monoclonal, humanized/administration & dosage
- antibodies, monoclonal, humanized/therapeutic use
- crohn disease
- crohn disease/therapy
- injections, intravenous
- interleukin-12
- interleukin-12/antagonists & inhibitors
- interleukin-12/immunology
- interleukin-23
- interleukin-23/antagonists & inhibitors
- interleukin-23/immunology
- randomized controlled trials as topic
- remission induction
- remission induction/methods
- ustekinumab
- ustekinumab/administration & dosage
- ustekinumab/therapeutic use
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Affiliation(s)
- Johannes Hasskamp
- Division of Epidemiology and Biometry, Carl von Ossietzky University of Oldenburg, Oldenburg, Germany
| | - Christian Meinhardt
- Klinikum Oldenburg AÖR, University Clinic for Internal Medicine - Gastroenterology, Oldenburg, Germany
| | - Antje Timmer
- Division of Epidemiology and Biometry, Carl von Ossietzky University of Oldenburg, Oldenburg, Germany
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Richter V, Broide E, Shalem T, Cohen DL, Khoury T, Mansour A, Naftali T, Mari A. Association Between Ethnicity and Treatment Preferences in Patients with Irritable Bowel Syndrome. Rambam Maimonides Med J 2025; 16:RMMJ.10542. [PMID: 40305867 PMCID: PMC12053809 DOI: 10.5041/rmmj.10542] [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] [Indexed: 05/02/2025] Open
Abstract
BACKGROUND AND AIMS Irritable bowel syndrome (IBS) poses a significant healthcare challenge, characterized by chronic gastrointestinal and extraintestinal symptoms impacting individuals' well-being. Treatment preferences may vary among patients from different ethnic groups, such as Arab and Jewish Israelis, necessitating tailored approaches. METHODS A bilingual (Hebrew/Arabic) questionnaire assessing patients' preferences regarding treatment goals was developed. It was administered online in Israeli IBS Facebook groups, as well as in two hospital gastroenterology clinics. RESULTS The study included 267 IBS patients (91 Arabs and 176 Jews). Demographic analysis revealed a higher proportion of females in both groups, with a significantly greater percentage among Jews compared to Arabs (84% versus 64.8%, respectively, P<0.001). The median age was 32 years for both Arabs and Jews (interquartile ranges of 26-42 and 24-62, respectively). Arabs exhibited higher rates of mixed-type IBS and constipation, while Jews had a higher prevalence of predominant diarrhea IBS. Arabs reported more bloating, higher rates of IBS-related comorbidities, and more medication usage. When asked to rate the importance of treatment goals, both populations preferred improvement in abdominal pain, bloating, and regular defecation, while assigning lower importance to improving difficulty in mental and/or physical aspects of intercourse, as well as arthralgia and myalgia. Arab patients assigned lower importance scores to various symptoms compared to their Jewish counterparts. CONCLUSION This study highlights the impact of ethnicity on patients' treatment goals. Understanding patients' preferences will enable tailoring an individual approach to each IBS patient.
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Affiliation(s)
- Vered Richter
- The Gonczarowski Family Institute of Gastroenterology and Liver Disease, Shamir (Assaf Harofeh) Medical Center, Zerifin, Israel
- Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel
| | - Efrat Broide
- Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel
- The Jecheskiel Sigi Gonczarowski Pediatric Gastroenterology Unit, Shamir (Assaf Harofeh) Medical Center, Zerifin, Israel
| | - Tzippora Shalem
- The Jecheskiel Sigi Gonczarowski Pediatric Gastroenterology Unit, Shamir (Assaf Harofeh) Medical Center, Zerifin, Israel
| | - Daniel L. Cohen
- The Gonczarowski Family Institute of Gastroenterology and Liver Disease, Shamir (Assaf Harofeh) Medical Center, Zerifin, Israel
| | - Tawfik Khoury
- Gastroenterology and Hepatology Institute, Nazareth Hospital EMMS, Nazareth, Israel
- The Azrieli Faculty of Medicine, Bar Ilan University, Israel
| | - Atallah Mansour
- Gastroenterology and Hepatology Institute, Nazareth Hospital EMMS, Nazareth, Israel
| | - Timna Naftali
- Department of Gastroenterology, Meir Medical Center, Kfar Saba, Israel
| | - Amir Mari
- Gastroenterology and Hepatology Institute, Nazareth Hospital EMMS, Nazareth, Israel
- The Azrieli Faculty of Medicine, Bar Ilan University, Israel
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Timmer A, Neuser J, de Sordi D, Schmidt-Lauber M, Allgayer H, Reichel C, Klebl F, Obermeier F, Schnoy E, Jessen P, Morgenstern J, Helwig U, Maaser C, Leifeld L, Schmidt S, Meinhardt C, Böcker U, Arlt A, Bästlein E, Bokemeyer A, Preiß JC, Otto-Sobotka F, Kaltz B, Sander C, Kruis W. Integrating the Patient Perspective to Validate a Measure of Disease Severity in Inflammatory Bowel Disease: Online Survey of Patients and Their Physicians. Inflamm Bowel Dis 2025; 31:983-994. [PMID: 38944765 DOI: 10.1093/ibd/izae127] [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: 11/25/2023] [Indexed: 07/01/2024]
Abstract
BACKGROUND The patient perspective is essential for assessing disease severity, but it is not always adequately considered. We describe how a comprehensive clinical disease severity index (DSI) for inflammatory bowel disease (IBD) correlates with patient global self-assessment (PGSA). METHODS In an individually linked parallel online survey, physicians provided the DSI, and patients provided self-assessed severity using a global question and visual analog scale (0-100) (PGSA). Mean DSI values by PGSA were calculated with 95% confidence intervals. Pearson correlation (r) and the intraclass correlation coefficient were calculated for PGSA vs DSI. Positive predictive values for identifying severe disease with PGSA categories as a reference were based on a threshold >22 points. RESULTS The primary analysis included 89 pairs (46 Crohn's disease [CD], 43 ulcerative colitis [UC]) with strict criteria and 147 pairs when less stringent. Common reasons for exclusion were missing values for albumin or colonoscopy. Mean DSI values showed no clear trend with increasing PGSA in CD but good discrimination between moderate, severe, and very severe PGSA in UC. For PGSA on the visual analog scale, r was 0.54 for CD and 0.59 for UC (difference in means: CD 27.7, UC 13.8; intraclass correlation coefficient: CD 0.48, UC 0.58). A high DSI predicted severe disease in 76.2% of CD and 65.2% of UC. CONCLUSIONS The DSI showed good discrimination for patient-reported disease severity in UC but performed unsatisfactorily in CD. Correlations were moderate. Further refinement of the DSI is suggested to better reflect the patient perspective.
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Affiliation(s)
- Antje Timmer
- Division of Epidemiology and Biometry, Department of Human Medicine, Carl von Ossietzky Universität Oldenburg, Oldenburg, Germany
| | - Johanna Neuser
- Division of Epidemiology and Biometry, Department of Human Medicine, Carl von Ossietzky Universität Oldenburg, Oldenburg, Germany
| | - Dominik de Sordi
- Division of Epidemiology and Biometry, Department of Human Medicine, Carl von Ossietzky Universität Oldenburg, Oldenburg, Germany
| | | | - Hubert Allgayer
- Rehazentrum Bad Brückenau, Klinik Hartwald, Bad Brückenau, Germany
| | - Christoph Reichel
- Rehazentrum Bad Brückenau, Klinik Hartwald, Bad Brückenau, Germany
- Institute for Hygiene and Public Health, Rheinische-Friedrich-Wilhelms-Universität, Bonn, Germany
| | - Frank Klebl
- Praxiszentrum Alte Mälzerei, Regensburg, Germany
| | | | | | - Petra Jessen
- Gemeinschaftspraxis im Medicum, Altenholz, Germany
| | | | - Ulf Helwig
- Internistische Praxisgemeinschaft, Oldenburg, Germany
| | - Christian Maaser
- Ambulanzzentrum Gastroenterologie, Klinikum Lüneburg, Lüneburg, Germany
| | - Ludger Leifeld
- Med Klinik III, Innere und Gastroenterologie, St. Bernward Krankenhaus, Hildesheim, Germany
| | - Sebastian Schmidt
- Med Klinik III, Innere und Gastroenterologie, St. Bernward Krankenhaus, Hildesheim, Germany
| | - Christian Meinhardt
- Universitätsklinik für Innere Medizin, Klinikum Oldenburg, Oldenburg, Germany
| | - Ulrich Böcker
- Klinik für Innere Medizin - Gastroenterologie, Diabetologie und Hepatologie, Vivantes Klinikum Neukölln, Berlin, Germany
| | - Alexander Arlt
- Universitätsklinik für Innere Medizin, Klinikum Oldenburg, Oldenburg, Germany
- Medizinische Klinik, Israelitisches Krankenhaus Hamburg, Hamburg, Germany
| | | | - Arne Bokemeyer
- Klinik für Gastroenterologie, Hepatologie und Transplantationsmedizin, Universitätsmedizin Essen, Essen, Germany
| | - Jan C Preiß
- Klinik für Innere Medizin - Gastroenterologie, Diabetologie und Hepatologie, Vivantes Klinikum Neukölln, Berlin, Germany
| | - Fabian Otto-Sobotka
- Division of Epidemiology and Biometry, Department of Human Medicine, Carl von Ossietzky Universität Oldenburg, Oldenburg, Germany
| | | | | | - Wolfgang Kruis
- Evangelisches Krankenhaus Kalk, University of Cologne, Cologne, Germany
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Pipicella JL, Gu B, McNamara J, Wilson W, Palmer LJ, Connor SJ, Andrews JM. Proposal and exploration of a novel score to quantify patient-perceived burden of inflammatory bowel disease under routine care. Intern Med J 2025; 55:589-598. [PMID: 39797610 PMCID: PMC11981025 DOI: 10.1111/imj.16634] [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: 06/10/2024] [Accepted: 12/18/2024] [Indexed: 01/13/2025]
Abstract
BACKGROUND The burden of inflammatory bowel disease (IBD) is often reported on from a system or cost viewpoint. We created and explored a novel patient-perceived burden of disease (PPBoD) score in a large Australasian cohort. AIM To create and explore a novel patient-perceived burden of disease (PPBoD) score in a large Australasian cohort, and correlate PPBoD scores with demographics, disease and treatment factors. METHODS The Crohn Colitis Care Registry was interrogated in October 2023. Data from adults with IBD with an outpatient care encounter in the last 14 months among 17 centres were included. A novel PPBoD score was designed for ulcerative colitis (UC), Crohn disease (CD) and IBD-unclassified (IBDU). Correlations between PPBoD scores and demographics, disease and treatment factors were examined. RESULTS Of those with adequate data, 46.7% (2653/5685) had no PPBoD, 34.6% (1969/5685) had mild, 11.3% (641/5685) had moderate and 7.4% (422/5685) had significant PPBoD. New Zealanders were more likely to have higher PPBoD compared to Australians (P = 0.047). Greater PPBoD was seen in patients with CD and IBDU compared to patients with UC (P < 0.001) and females were more likely to have significant PPBoD (8.7%) than males (6.1%) (P < 0.001). People with no or mild PPBoD were more likely to be on advanced therapies (55.7% and 59.5% respectively) than those with significant PPBoD (46.3%) (P < 0.001). The proportion of people on advanced therapies in Australia was higher than in New Zealand (61.2% vs 38.5% respectively, P < 0.001). Steroid usage was significantly higher in people with greater PPBoD (significant BoD 7.1% vs no BoD 1.1%; P < 0.001). CONCLUSION Most of this real-world care cohort had no or mild PPBoD. Data suggest that higher PPBoD levels may be resolved by appropriate therapeutic escalations.
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Affiliation(s)
- Joseph L. Pipicella
- Crohn's Colitis CureSydneyNew South WalesAustralia
- Medicine & Health (South Western Sydney Clinical School)University of New South WalesSydneyNew South WalesAustralia
- Gastroenterology, Hepatology and Inflammatory Bowel Disease Research GroupIngham Institute for Applied Medical ResearchLiverpoolNew South WalesAustralia
| | - Bonita Gu
- Medicine & Health (South Western Sydney Clinical School)University of New South WalesSydneyNew South WalesAustralia
- Department of Gastroenterology and HepatologyLiverpool HospitalSydneyNew South WalesAustralia
| | - Jack McNamara
- Gastroenterology, Hepatology and Inflammatory Bowel Disease Research GroupIngham Institute for Applied Medical ResearchLiverpoolNew South WalesAustralia
- Department of Gastroenterology and HepatologyLiverpool HospitalSydneyNew South WalesAustralia
| | - William Wilson
- Department of Surgical Specialties and AnesthesiaLyell McEwin HospitalAdelaideSouth AustraliaAustralia
- Medical Information OfficeSA HealthAdelaideSouth AustraliaAustralia
| | - Lyle J. Palmer
- School of Public HealthUniversity of AdelaideAdelaideSouth AustraliaAustralia
| | - Susan J. Connor
- Crohn's Colitis CureSydneyNew South WalesAustralia
- Medicine & Health (South Western Sydney Clinical School)University of New South WalesSydneyNew South WalesAustralia
- Gastroenterology, Hepatology and Inflammatory Bowel Disease Research GroupIngham Institute for Applied Medical ResearchLiverpoolNew South WalesAustralia
- Department of Gastroenterology and HepatologyLiverpool HospitalSydneyNew South WalesAustralia
| | - Jane M. Andrews
- Crohn's Colitis CureSydneyNew South WalesAustralia
- Gastroenterology, General & GI SurgeryCentral Adelaide Local Health NetworkAdelaideSouth AustraliaAustralia
- Faculty of Health Sciences, School of MedicineUniversity of AdelaideAdelaideSouth AustraliaAustralia
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Mokkink LB, Elsman EBM, Terwee CB. COSMIN guideline for systematic reviews of patient-reported outcome measures version 2.0. Qual Life Res 2024; 33:2929-2939. [PMID: 39198348 PMCID: PMC11541334 DOI: 10.1007/s11136-024-03761-6] [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] [Accepted: 08/10/2024] [Indexed: 09/01/2024]
Abstract
PURPOSE Systematic reviews of patient-reported outcome measures (PROMs) are important tools to select the most suitable PROM for a study or clinical application. Conducting these reviews is challenging, and the quality of these reviews needs to be improved. We updated the COSMIN guideline for systematic reviews of PROMs, including the COSMIN Risk of Bias checklist, and the COSMIN criteria for good measurement properties. METHODS Adaptations to the methodology were based on our experience with applying the COSMIN guideline, through discussions among the authors, and results from two related Delphi studies. RESULTS The updated guideline places more emphasis on key aspects that are often missing or sub optimally conducted in published systematic reviews of PROMs, such as formulating a well-defined research question and developing a comprehensive search strategy, assessing risk of bias, applying criteria for good measurement properties, summarizing results, and grading the quality of the evidence. We also stress the importance of evaluating the measurement properties of each subscale of a PROM separately and evaluating content validity of all included PROMs. CONCLUSION The quality of systematic reviews of PROMs can be improved by using this updated version of the COSMIN guideline for systematic reviews of PROMs. Improved quality will lead to better PROM selection and increased standardization of PROM use.
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Affiliation(s)
- Lidwine B Mokkink
- Department of Epidemiology and Data Science, Amsterdam UMC, Vrije Universiteit Amsterdam, Location AMC, J1B -225, Meibergdreef 9, Amsterdam, 1105 AZ, The Netherlands.
- Amsterdam Public Health research institute, Methodology, Amsterdam, The Netherlands.
| | - Ellen B M Elsman
- Department of Epidemiology and Data Science, Amsterdam UMC, Vrije Universiteit Amsterdam, Location AMC, J1B -225, Meibergdreef 9, Amsterdam, 1105 AZ, The Netherlands
- Amsterdam Public Health research institute, Methodology, Amsterdam, The Netherlands
| | - Caroline B Terwee
- Department of Epidemiology and Data Science, Amsterdam UMC, Vrije Universiteit Amsterdam, Location AMC, J1B -225, Meibergdreef 9, Amsterdam, 1105 AZ, The Netherlands
- Amsterdam Public Health research institute, Methodology, Amsterdam, The Netherlands
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Janssen L, van Linschoten RCA, West RL, Gilissen LPL, Romberg-Camps M, Brandts L, Mujagic Z, Römkens TEH, Pierik M. Predicting mucosal inflammation in IBD patients using patient-reported symptom scores and a faecal calprotectin home test: protocol for a multicentre prospective validation study. BMJ Open 2024; 14:e076290. [PMID: 39375184 PMCID: PMC11459379 DOI: 10.1136/bmjopen-2023-076290] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/02/2023] [Accepted: 07/11/2024] [Indexed: 10/09/2024] Open
Abstract
INTRODUCTION Crohn's disease and ulcerative colitis are chronic inflammatory bowel diseases (IBD) with a relapsing-remitting nature. With adequate non-invasive prediction of mucosal inflammation, endoscopies can be prevented and treatment optimised earlier for better disease control. We aim to validate and recalibrate commonly used patient-reported symptom scores combined with a faecal calprotectin (FC) home test as non-invasive diagnostic tool for remote monitoring of IBD, both in daily practice and in a strict trial setting. Endoscopy will be used as the gold standard. METHODS AND ANALYSIS In this multicentre prospective validation study, adult IBD patients are asked to fill out questionnaires regarding disease activity (Monitor IBD At Home, mobile Health Index, Manitoba IBD Index, IBD control and patient-HBI/patient-Simple Clinical Colitis Activity Index), perform a FC home test and collect a stool sample for routine laboratory FC measurement, before the start of the bowel preparation for the ileocolonoscopy. Endoscopic disease activity will be scored according to the simplified endoscopic score for Crohn's disease (CD) for CD patients or Ulcerative Colitis Endoscopic Index for Severity and Mayo Endoscopic Subscore for ulcerative colitis patients. The main study outcome is the diagnostic test accuracy of the various patient-reported scores to assess mucosal inflammation in combination with a FC home test. ETHICS AND DISSEMINATION This study is approved by the Medical Research Ethics Committee of azM/UM in Maastricht dated 03 March 2021 (METC 20-085) and is monitored by the Clinical Trial Centre Maastricht according to Good Clinical Practice guidelines. Written informed consent will be obtained from all patients. Study results will be published in international peer-reviewed medical journals. TRIAL REGISTRATION NUMBER NCT05886322.
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Affiliation(s)
- Laura Janssen
- NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, Limburg, Netherlands
- Gastroenterology and Hepatology, Maastricht UMC+, Maastricht, Netherlands
| | - Reinier Cornelis Anthonius van Linschoten
- Gastroenterology and Hepatology, Franciscus Gasthuis en Vlietland, Rotterdam, Netherlands
- Gastroenterology and Hepatology, Erasmus Medical Center, Rotterdam, Netherlands
| | - Rachel Louise West
- Department of Gastroenterology & Hepatology, Franciscus Gasthuis, Rotterdam, Zuid-Holland, Netherlands
| | - Lennard P L Gilissen
- Department of Gastroenterology, Catharina Hospital, Eindhoven, North Brabant, Netherlands
| | - Mariëlle Romberg-Camps
- Gastroenterology, Zuyderland Medical Centre Sittard-Geleen, Sittard-Geleen, Limburg, Netherlands
| | - Lloyd Brandts
- Clinical Epidemiology and Medical Technology Assessment (KEMTA), Maastricht UMC+, Maastricht, Limburg, Netherlands
| | - Zlatan Mujagic
- NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, Limburg, Netherlands
- Division of Gastroenterology-Hepatology, Maastricht University Medical Centre+, Maastricht, Limburg, Netherlands
| | - Tessa EH Römkens
- Department of Gastroenteroloy and Hepatology, Jeroen Bosch Hospital, 's-Hertogenbosch, Noord-Brabant, Netherlands
| | - M Pierik
- NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, Limburg, Netherlands
- Department of Gastroenterology and Hepatology, Maastricht University Medical Centre+, Maastricht, Limburg, Netherlands
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Noe MTN, Baysal Y, Masserey A, Hartnack S, Guseva Canu I. Measurement of compassion fatigue in animal health care professionals: a systematic review of available instruments and their content validity. Front Vet Sci 2024; 11:1425741. [PMID: 39132439 PMCID: PMC11310126 DOI: 10.3389/fvets.2024.1425741] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/23/2024] [Accepted: 07/11/2024] [Indexed: 08/13/2024] Open
Abstract
Introduction Compassion fatigue (CF) refers to emotional or physical exhaustion and emotional reactions resulting from prolonged exposure to traumatic events, commonly experienced by professionals in caregiving roles. CF is prevalent among healthcare professionals, including those in animal care. Several Patient-Reported Outcome Measures (PROMs) were developed to measure CF, but their psychometric validity was not reviewed systematically. This study aims to identify and review the content validity of CF PROMs used in animal health care professionals. Methods Literature was searched in PubMed, PsycINFO, and EMBASE (1973-2023). We included studies conducted in animal health care professionals, using a PROM to measure CF, reporting at least one psychometric property of this PROM, and published as original research. For each identified PROM, additional literature search was conducted to identify PROM development and content validation studies. Three independent reviewers evaluated the content validity of each PROM using COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology and summarized the quality of evidence using a modified GRADE approach. The protocol was registered in PROSPERO (CRD42023433982) and results reported following PRISMA guidelines. Results Initially, 1709 studies were identified. After a double screening, 17 eligible studies were included. CF was measured using six different PROMs or their modified versions. Only one PROM specifically targeted animal health care professionals: the ProQOL-5 Veterinary Medicine Version. This and three other original CF PROMs were reviewed. For all PROMs, the quality of content validity was rated as insufficient due to deficiencies in the concept and items elicitation, inadequate target population representation, and inadequate details on cognitive interview procedures. The overall evidence quality was rated as low due to a limited number of PROM validation studies, poor methodological and reporting quality, and indirect result. Discussion There is a scarcity of studies examining CF within the target population, and the quality of evidence for content validity of the reviewed PROMs for CF measurement is currently low. CF definition and construct description in PROM development studies suffer from vagueness and seem inadequately reflected by the content of the reviewed PROMs. Further research with a robust methodology seems necessary to address the identified flows. Systematic review registration Measurement of compassion fatigue in people working with animals: protocol for a systematic review. PROSPERO 2023 CRD42023433982. Available from: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42023433982.
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Affiliation(s)
- May Thet Nu Noe
- Centre for Primary Care and Public Health (Unisanté), University of Lausanne, Lausanne, Switzerland
| | - Yigit Baysal
- Section of Epidemiology, Vetsuisse Faculty, University of Zurich, Zurich, Switzerland
| | - Anaïs Masserey
- Centre for Primary Care and Public Health (Unisanté), University of Lausanne, Lausanne, Switzerland
| | - Sonja Hartnack
- Section of Epidemiology, Vetsuisse Faculty, University of Zurich, Zurich, Switzerland
| | - Irina Guseva Canu
- Centre for Primary Care and Public Health (Unisanté), University of Lausanne, Lausanne, Switzerland
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Tanaka M, Kawakami A, Sakagami K, Terai T, Fernandez J, Keefer L, Ito H. Development and validation of a 13-item short version of the inflammatory bowel disease self-efficacy scale. BMC Gastroenterol 2024; 24:190. [PMID: 38822266 PMCID: PMC11141053 DOI: 10.1186/s12876-024-03206-x] [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: 11/13/2023] [Accepted: 03/15/2024] [Indexed: 06/02/2024] Open
Abstract
BACKGROUND The inflammatory bowel disease self-efficacy scale (IBD-SES) is an instrument used across many countries to measure important health outcomes of patients with inflammatory bowel disease (IBD). We aimed to develop and validate a substantially shorter version of this scale to reduce patients' response burden. METHODS A total of 919 patients with IBD, 482 recruited from an IBD clinic and 437 recruited online, completed the Japanese version of the original, 29-item IBD-SES. These data were then used to develop a shorter version of the scale. The original 29 items of the IBD-SES were reduced with three analytic steps: assessing ceiling and floor effect, testing correlation between items, and assessing test-retest reliability. The resulting 13-item IBD-SES was evaluated for construct validity by confirmatory factor analysis, criterion validity by Pearson correlation coefficients with original version, and internal consistency by item-total correlations and the Cronbach's α coefficient. RESULTS The short version consisted of the same four subscales "managing stress and emotions," "managing medical care," "managing symptoms and disease," and "maintaining remission" as the original scale. The fit indices of the final model were as follows: normed chi-square, 7.18 (p < 0.001); comparative fit index, 0.94; goodness-of-fit index, 0.93; adjusted goodness-of-fit index, 0.89; parsimony goodness-of-fit index, 0.60; and root mean square error of approximation, 0.084. Correlation of each subscale with the original scale was high (0.97-0.98). Cronbach's α for each subscale ranged from 0.68 to 0.86. CONCLUSIONS A short version of the IBD-SES was developed. The results confirmed the improved validity, reliability, and psychometric properties of the IBD-SES. TRIAL REGISTRATION Not applicable.
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Affiliation(s)
- Makoto Tanaka
- Graduate School of Health Care Sciences, Tokyo Medical and Dental University (TMDU), Tokyo, Japan.
| | - Aki Kawakami
- Graduate School of Health Care Sciences, Tokyo Medical and Dental University (TMDU), Tokyo, Japan
| | | | - Tomoko Terai
- Japan Medical Office, Takeda Pharmaceutical Company Limited, Tokyo, Japan
| | - Jovelle Fernandez
- Japan Medical Office, Takeda Pharmaceutical Company Limited, Tokyo, Japan
- L.L.C., Middletown, DE, USA
| | - Laurie Keefer
- Icahn School of Medicine at Mount Sinai, New York City, NY, USA
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9
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Baysal Y, Goy N, Hartnack S, Guseva Canu I. Moral distress measurement in animal care workers: a systematic review. BMJ Open 2024; 14:e082235. [PMID: 38643012 PMCID: PMC11033641 DOI: 10.1136/bmjopen-2023-082235] [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: 11/17/2023] [Accepted: 04/09/2024] [Indexed: 04/22/2024] Open
Abstract
OBJECTIVES The mental health of veterinary and other animal health professionals is significantly impacted by the psychological stressors they encounter, such as euthanasia, witnessing animal suffering and moral distress. Moral distress, initially identified in nursing, arises when individuals are aware of the right action but are hindered by institutional constraints. We aimed to review existing research on moral distress scales among animal care workers by focusing on the identification and psychometric validity of its measurement. DESIGN Two-step systematic review. First, we identified all moral distress scales used in animal care research in the eligible original studies. Second, we evaluated their psychometric validity, emphasising content validity, which is a critical aspect of patient-reported outcome measures (PROMs). This evaluation adhered to the Consensus-based Standards for the Selection of Health Measurement Instruments (COSMIN). The results were reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses. DATA SOURCES PubMed, EMBASE and PsycINFO to search for eligible studies published between January 1984 and April 2023. ELIGIBILITY CRITERIA FOR SELECTING STUDIES We included original (primary) studies that (1) were conducted in animal care workers; (2) describing either the development of a moral distress scale, or validation of a moral distress scale in its original or modified version, to assess at least one of the psychometric properties mentioned in COSMIN guidelines. DATA EXTRACTION AND SYNTHESIS Two independent reviewers used standardised methods to search, screen and code included studies. We considered the following information relevant for extraction: study reference, name and reference of the moral distress scale used, psychometric properties assessed and methods and results of their assessments. The collected information was then summarised in a narrative synthesis. RESULTS The review identified only one PROM specifically adapted for veterinary contexts: the Measure of Moral Distress for Animal Professionals (MMD-AP), derived from the Measure of Moral Distress for Healthcare Professionals (MMD-HP). Both MMD-HP and MMD-AP were evaluated for the quality of development and content validity. The development quality of both measures was deemed doubtful. According to COSMIN, MMD-HP's content validity was rated as sufficient, whereas MMD-AP's was inconsistent. However, the evidence quality for both PROMs was rated low. CONCLUSION This is the first systematic review focused on moral distress measurement in animal care workers. It shows that moral distress is rarely measured using standardised and evidence-based methods and that such methods should be developed and validated in the context of animal care. PROSPERO REGISTRATION NUMBER CRD42023422259.
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Affiliation(s)
- Yigit Baysal
- Section of Epidemiology, University of Zurich Vetsuisse Faculty, Zurich, Switzerland
| | - Nastassja Goy
- Department of Occupational and Environmental Health, Center for Primary Care and Public Health (Unisanté), University of Lausanne, Lausanne, Switzerland
| | - Sonja Hartnack
- Section of Epidemiology, University of Zurich Vetsuisse Faculty, Zurich, Switzerland
| | - Irina Guseva Canu
- Department of Occupational and Environmental Health, Center for Primary Care and Public Health (Unisanté), University of Lausanne, Lausanne, Switzerland
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10
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Khan S, Sebastian SA, Parmar MP, Ghadge N, Padda I, Keshta AS, Minhaz N, Patel A. Factors influencing the quality of life in inflammatory bowel disease: A comprehensive review. Dis Mon 2024; 70:101672. [PMID: 38143196 DOI: 10.1016/j.disamonth.2023.101672] [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] [Indexed: 12/26/2023]
Abstract
Inflammatory bowel disease (IBD) is a group of chronic relapsing disorders, including Crohn's disease (CD) and ulcerative colitis (UC), which affects an increasing number of people worldwide. In the last few decades, the scientific world has witnessed many developments in IBD management by controlling debilitating symptoms and remaining in remission for more protracted periods. Even so, we still have a large population suffering from active IBD. An individual's quality of life (QoL) can be severely affected by IBD, like any other chronic illness. In this article, we have reviewed factors influencing the QoL in IBD patients, including chronic pain, diet, physical activity, and psychological factors like depression, anxiety, and stress symptoms. We also discussed the mechanisms of diet-microbial-immune system interaction, currently available dietary therapies for active CD and UC, and early psycho-social interventions that can reduce the disease burden and improve QoL in IBD patients.
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Affiliation(s)
- Samina Khan
- University of Alberta Hospital, Edmonton, Alberta, Canada
| | | | | | - Nitin Ghadge
- Independent Researcher, Albany, NY, United States of America
| | - Inderbir Padda
- Richmond University Medical Center/Mount Sinai, Staten Island, NY, United States of America
| | | | - Naofel Minhaz
- Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
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11
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Janssen LM, Creemers RH, van Bodegraven AA, Pierik MJ. A Systematic Review on Long-Term Efficacy Outcome Measures in Crohn's Disease Patients. J Crohns Colitis 2023; 17:1528-1536. [PMID: 36913233 PMCID: PMC10588778 DOI: 10.1093/ecco-jcc/jjad037] [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: 09/22/2022] [Indexed: 03/14/2023]
Abstract
BACKGROUND The traditional long-term treatment goal of Crohn's disease [CD] is maintenance of corticosteroid-free clinical remission. Additional treatment targets, such as biochemical, endoscopic and patient-reported remission, are advocated. The relapsing-remitting nature of CD provides a challenge to the timing of target assessment. Cross-sectional assessment at predetermined moments disregards the health state in between measurements. In this systematic review, we provide an overview of outcomes used to assess long-term efficacy in clinical trials in CD. METHODS A systematic search of the PubMed and EMBASE databases was performed to identify clinical trials in luminal CD reporting on maintenance treatment [strategies] since 1995. Two independent reviewers selected eligible articles for full text retrieval, and assessed if long-term corticosteroid-free clinical, biochemical, endoscopic or patient-reported efficacy outcomes were used. RESULTS The search resulted in 2452 hits and 82 articles were included. Clinical activity was used in 80 studies [98%] as the long-term efficacy outcome, and in 21 [26%] of these concomitant corticosteroid use was taken into account. C-reactive protein was used in 32 studies [41%], faecal calprotectin in 15 studies [18%], endoscopic activity in 34 studies [41%] and patient-reported outcome in 32 studies [39%]. In seven studies, clinical, biochemical, endoscopic activity and the patient's perspective were measured. In most studies cross-sectional measures or multiple measurements over time were used. CONCLUSION In none of the published clinical trials in CD was sustained remission on all treatment targets reported. Cross-sectional outcomes at predetermined times were widely applied, leading to lack of information regarding sustained corticosteroid-free remission for this relapsing-remitting chronic disease.
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Affiliation(s)
- Laura M Janssen
- Department of Internal Medicine, Division of Gastroenterology and Hepatology, Maastricht University Medical Centre+, Maastricht, The Netherlands
- School for Nutrition and Translational Research in Metabolism (NUTRIM), Maastricht University Medical Centre+, Maastricht, The Netherlands
| | - Rob H Creemers
- Department of Internal Medicine, Division of Gastroenterology and Hepatology, Maastricht University Medical Centre+, Maastricht, The Netherlands
- Department of Gastroenterology, Geriatrics, Internal and Intensive Care Medicine (Co-MIK), Zuyderland Medical Centre, Heerlen-Sittard-Geleen, The Netherlands
| | - Adriaan A van Bodegraven
- Department of Gastroenterology, Geriatrics, Internal and Intensive Care Medicine (Co-MIK), Zuyderland Medical Centre, Heerlen-Sittard-Geleen, The Netherlands
| | - Marie J Pierik
- Department of Internal Medicine, Division of Gastroenterology and Hepatology, Maastricht University Medical Centre+, Maastricht, The Netherlands
- School for Nutrition and Translational Research in Metabolism (NUTRIM), Maastricht University Medical Centre+, Maastricht, The Netherlands
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12
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Maspero M, Hull T. Patient-Reported Outcomes in Colorectal Surgery. Clin Colon Rectal Surg 2023; 36:240-251. [PMID: 37223227 PMCID: PMC10202545 DOI: 10.1055/s-0043-1761607] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 05/25/2023]
Abstract
Given the increased life expectancy and improvements in the treatment of colorectal patients, the success of a treatment course can no longer be determined only by objective outcomes. Health care providers ought to take into consideration the impact an intervention will have on the quality of life of patients. Endpoints that take into account the patient's perspective are defined as patient-reported outcomes (PROs). PROs are assessed through patient-reported outcome measures (PROMs), usually in the form of questionnaires. PROs are especially important in colorectal surgery, whose procedures can often be associated with some degree of postoperative functional impairment. Several PROMs are available for colorectal surgery patients. However, while some scientific societies have offered recommendations, there is no standardization in the field and PROMs are seldom implemented in clinical practice. The routine use of validated PROMs can guarantee that functional outcomes are followed over time; this way, they can be addressed in case of worsening. This review will provide an overview of the most commonly used PROMs in colorectal surgery, both generic and disease specific, as well as a summary of the available evidence in support of their routine utilization.
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Affiliation(s)
- Marianna Maspero
- Department of Colon and Rectal Surgery, Cleveland Clinic Foundation, Cleveland, Ohio
| | - Tracy Hull
- Department of Colon and Rectal Surgery, Cleveland Clinic Foundation, Cleveland, Ohio
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13
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Allalou A, Peng J, Robinson GA, Marruganti C, D’Aiuto F, Butler G, Jury EC, Ciurtin C. Impact of puberty, sex determinants and chronic inflammation on cardiovascular risk in young people. Front Cardiovasc Med 2023; 10:1191119. [PMID: 37441710 PMCID: PMC10333528 DOI: 10.3389/fcvm.2023.1191119] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/21/2023] [Accepted: 06/14/2023] [Indexed: 07/15/2023] Open
Abstract
Worrying trends of increased cardiovascular disease (CVD) risk in children, adolescents and young people in the Modern Era have channelled research and public health strategies to tackle this growing epidemic. However, there are still controversies related to the dynamic of the impact of sex, age and puberty on this risk and on cardiovascular health outcomes later in life. In this comprehensive review of current literature, we examine the relationship between puberty, sex determinants and various traditional CVD-risk factors, as well as subclinical atherosclerosis in young people in general population. In addition, we evaluate the role of chronic inflammation, sex hormone therapy and health-risk behaviours on augmenting traditional CVD-risk factors and health outcomes, ultimately aiming to determine whether tailored management strategies for this age group are justified.
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Affiliation(s)
- Amal Allalou
- University College London Medical School, University College London, London, United Kingdom
| | - Junjie Peng
- Centre for Adolescent Rheumatology Versus Arthritis, University College London, London, United Kingdom
- Centre for Rheumatology Research, Division of Medicine, University College London, London, United Kingdom
| | - George A. Robinson
- Centre for Adolescent Rheumatology Versus Arthritis, University College London, London, United Kingdom
- Centre for Rheumatology Research, Division of Medicine, University College London, London, United Kingdom
| | - Crystal Marruganti
- Eastman Dental Hospital, University College London Hospital, London, United Kingdom
| | - Francesco D’Aiuto
- Eastman Dental Hospital, University College London Hospital, London, United Kingdom
| | - Gary Butler
- Department of Paediatric Endocrinology, University College London Hospital, London, United Kingdom
- Institute of Child Health, University College London, London, United Kingdom
| | - Elizabeth C. Jury
- Centre for Rheumatology Research, Division of Medicine, University College London, London, United Kingdom
| | - Coziana Ciurtin
- Centre for Adolescent Rheumatology Versus Arthritis, University College London, London, United Kingdom
- Centre for Rheumatology Research, Division of Medicine, University College London, London, United Kingdom
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14
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Naftali T, Richter V, Mari A, Khoury T, Shirin H, Broide E. Do inflammatory bowel disease patient preferences from treatment outcomes differ by ethnicity and gender? A cross-sectional observational study. World J Clin Cases 2022; 10:12899-12908. [PMID: 36569023 PMCID: PMC9782943 DOI: 10.12998/wjcc.v10.i35.12899] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/08/2022] [Revised: 05/05/2022] [Accepted: 08/21/2022] [Indexed: 12/14/2022] Open
Abstract
BACKGROUND Inflammatory bowel disease (IBD) patients' expectations of treatment outcomes may differ by ethnicity. AIM To investigate treatment preferences of Jewish and Arabs patients. METHODS This prospective survey ranked outcomes treatment preferences among Arab IBD patients, based on the 10 IBD-disk items compared to historical data of Jews. An anonymous questionnaire in either Arabic or Hebrew was distributed among IBD patients. Patients were required to rank 10 statements describing different aspects of IBD according to their importance to the patients as treatment goals. Answers were compared to the answers of a historical group of Jewish patients. RESULTS IBD-disk items of 121 Arabs were compared to 240 Jewish patients. The Jewish patients included more females, [151 (62.9%) vs 52 (43.3%); P < 0.001], higher education level (P = 0.02), more urban residence [188 (78.3%) vs 54 (45.4%); P < 0.001], less unemployment [52 (21.7%) vs 41 (33.9%); P = 0.012], higher income level (P < 0.001), and more in a partnership [162 (67.8%) vs 55 (45.4%); P < 0.001]. Expectations regarding disease symptoms: abdominal pain, energy, and regular defecation ranked highest for both groups. Arabs gave significantly lower rankings (range 4.29-6.69) than Jewish patients (range 6.25-9.03) regarding all items, except for body image. Compared to Arab women, Jewish women attached higher priority to abdominal pain, energy, education/work, sleep, and joint pain. Multivariable regression analysis revealed that higher patient preferences were associated with Jewish ethnicity (OR 4.77; 95%CI 2.36-9.61, P < 0.001) and disease activity. The more active the disease, the greater the odds ratio for higher ranking of the questionnaire items (1-2 attacks per year: OR 2.13; 95%CI 1.02-4.45, P = 0.043; and primarily active disease: OR 5.29; 95%CI 2.30-12.18, P < 0.001). Factors inversely associated with higher patient preference were male gender (OR 0.5; 95%CI 0.271-0.935, P = 0.030), UC (OR 0.444; 95%CI 0.241-0.819, P = 0.009), and above average income level (OR 0.267; 95%CI: 0.124-0.577, P = 0.001). CONCLUSION The highest priority for treatment outcomes was symptom relief., Patients preferences were impacted by ethnicity, gender, and socio-economic disparity. Understanding patients' priorities may improve communication and enable a personalized approach.
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Affiliation(s)
- Timna Naftali
- Institute of Gastroenterology, Meir Medical Center, Kfar-saba 4428164, Israel
| | - Vered Richter
- Department of Gastroenterology, Shamir Medical Center, Zerifin 70300, Israel
| | - Amir Mari
- Department of Gastroenterology, Nazareth Hospital, Nazareth 16100, Israel
| | - Tawfik Khoury
- Department of Gastroenterology, Nazareth Hospital, Nazareth 16100, Israel
| | - Haim Shirin
- Shamir (Assaf Harofeh) Medical Center, Affiliated to Sackler School of Medicine, The Gonczarowski Family Institute of Gastroenterology and Liver Diseases, Tel Aviv University, Zerifin 70300, Israel
| | - Efrat Broide
- Pediatric Gastroenterology Unit, Asaf Harofeh Medical Center, Zrifin 70300, Israel
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15
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Wong C, van Oostrom J, Bossuyt P, Pittet V, Hanzel J, Samaan M, Tripathi M, Czuber-Dochan W, Burisch J, Leone S, Saldaña R, Baert F, Kopylov U, Jaghult S, Adamina M, Gecse K, Arebi N. A Narrative Systematic Review and Categorisation of Outcomes in Inflammatory Bowel Disease to Inform a Core Outcome Set for Real-world Evidence. J Crohns Colitis 2022; 16:1511-1522. [PMID: 35512352 DOI: 10.1093/ecco-jcc/jjac057] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/12/2021] [Revised: 02/01/2022] [Accepted: 04/08/2022] [Indexed: 02/08/2023]
Abstract
BACKGROUND Heterogeneity exists in reported outcomes and outcome measurement instruments [OMI] from observational studies. A core outcome set [COS] for observational and real-world evidence [RWE] in inflammatory bowel disease [IBD] will facilitate pooling large datasets. This systematic review describes and classifies clinical and patient-reported outcomes, for COS development. METHODS The systematic review of MEDLINE, EMBASE, and CINAHL databases identified observational studies published between 2000 and 2021 using the population exposure outcome [PEO] framework. Studies meeting eligibility criteria were included. After titles and abstracts screening, full-text articles were extracted by two independent reviewers. Primary and secondary outcomes with corresponding OMI were extracted and categorised in accordance with OMERACT Filter 2.1 framework. The frequency of outcomes and OMIs are described. RESULTS From 5854 studies, 315 were included: 129 [41%] Crohn's disease [CD], 60 [19%] ulcerative colitis [UC], and 126 [40%] inflammatory bowel disease [IBD] studies with 600 552 participants. Totals of 1632 outcomes and 1929 OMI were extracted mainly from medical therapy [181; 72%], surgical [34; 11%], and endoscopic [6; 2%] studies. Clinical and medical therapy-related safety were frequent outcome domains recorded in 194 and 100 studies. Medical therapy-related adverse events [n = 74] and need for surgery [n = 71] were the commonest outcomes. The most frequently reported OMI were patient or event numbers [n = 914], Harvey-Bradshaw Index [n = 45], and Montreal classification [n = 42]. CONCLUSIONS There is substantial variability in outcomes reporting and OMI types. Categorised outcomes and OMI from this review will inform a Delphi consensus on a COS for future RWE in IBD. Data collection standardisation may enhance the quality of RWE applied to decision-making.
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Affiliation(s)
- Charlotte Wong
- Department of Inflammatory Bowel Disease, St Mark's Hospital, London, UK
| | - Joep van Oostrom
- Department of Gastroenterology and Hepatology, Amsterdam University Medical Center, Amsterdam, The Netherlands
| | - Peter Bossuyt
- Department of Gastroenterology, Imelda General Hospital and Imelda Clinical Research Centre, Bonheiden, Belgium
| | - Valerie Pittet
- Center for Primary Care and Public Health, University of Lausanne, Department of Epidemiology and Health Systems, Lausanne, Switzerland
| | - Jurij Hanzel
- Department of Gastroenterology, University Medical Centre Ljubljana, Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia
| | - Mark Samaan
- Inflammatory Bowel Diseases Unit, Guy's and St Thomas' Hospital, London, UK
| | - Monika Tripathi
- Department of Histopathology, Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK
| | - Wladyslawa Czuber-Dochan
- Florence Nightingale Faculty of Nursing, Midwifery and Palliative Care, King's College London, London, UK
| | - Johan Burisch
- Department of Gastroenterology, Hvidovre Hospital, University of Copenhagen, Copenhagen, Denmark.,Copenhagen Centre for Inflammatory Bowel Disease in Children, Adolescents and Adults, Hvidovre Hospital, University of Copenhagen, Copenhagen, Denmark
| | - Salvatore Leone
- European Federation of Crohn's and Ulcerative Colitis Associations, Brussels, Belgium
| | - Roberto Saldaña
- European Federation of Crohn's and Ulcerative Colitis Associations, Brussels, Belgium.,Confederation of Patients with Crohn's Disease and Ulcerative Colitis, Madrid, Spain
| | - Filip Baert
- Department of Gastroenterology, AZ Delta, Roeselare, Belgium
| | - Uri Kopylov
- Department of Gastroenterology, Sheba Medical Center, Tel Hashomer, Israel
| | - Susanna Jaghult
- Stockholm Gastro Center, Karolinska Institutet, Stockholm, Sweden
| | - Michel Adamina
- Department of Surgery, Cantonal Hospital Winterthur, Zurich, Switzerland.,Department of Biomedical Engineering, University of Basel, Allschwil, Switzerland
| | - Krisztina Gecse
- Department of Gastroenterology and Hepatology, Amsterdam University Medical Center, Amsterdam, The Netherlands
| | - Naila Arebi
- Department of Inflammatory Bowel Disease, St Mark's Hospital, London, UK.,Imperial College London, London, UK
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16
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Ulcerative Colitis and Acute Severe Ulcerative Colitis Patients Are Overlooked in Infliximab Population Pharmacokinetic Models: Results from a Comprehensive Review. Pharmaceutics 2022; 14:pharmaceutics14102095. [PMID: 36297530 PMCID: PMC9610912 DOI: 10.3390/pharmaceutics14102095] [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: 07/31/2022] [Revised: 09/07/2022] [Accepted: 09/15/2022] [Indexed: 11/18/2022] Open
Abstract
Ulcerative colitis (UC) is part of the inflammatory bowels diseases, and moderate to severe UC patients can be treated with anti-tumour necrosis α monoclonal antibodies, including infliximab (IFX). Even though treatment of UC patients by IFX has been in place for over a decade, many gaps in modelling of IFX PK in this population remain. This is even more true for acute severe UC (ASUC) patients for which early prediction of IFX pharmacokinetic (PK) could highly improve treatment outcome. Thus, this review aims to compile and analyse published population PK models of IFX in UC and ASUC patients, and to assess the current knowledge on disease activity impact on IFX PK. For this, a semi-systematic literature search was conducted, from which 26 publications including a population PK model analysis of UC patients receiving IFX therapy were selected. Amongst those, only four developed a model specifically for UC patients, and only three populations included severe UC patients. Investigations of disease activity impact on PK were reported in only 4 of the 14 models selected. In addition, the lack of reported model codes and assessment of predictive performance make the use of published models in a clinical setting challenging. Thus, more comprehensive investigation of PK in UC and ASUC is needed as well as more adequate reports on developed models and their evaluation in order to apply them in a clinical setting.
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17
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van Gennep S, de Boer NKH, Gielen ME, Rietdijk ST, Gecse KB, Ponsioen CY, Duijvestein M, D'Haens GR, Löwenberg M, de Boer AGEM. Impaired Quality of Working Life in Inflammatory Bowel Disease Patients. Dig Dis Sci 2021; 66:2916-2924. [PMID: 33063191 PMCID: PMC8379106 DOI: 10.1007/s10620-020-06647-y] [Citation(s) in RCA: 18] [Impact Index Per Article: 4.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/17/2020] [Accepted: 09/28/2020] [Indexed: 01/01/2023]
Abstract
BACKGROUND Work-related aspects are important determinants of health for inflammatory bowel disease (IBD) patients. AIMS We aimed to describe quality of working life (QWL) in IBD patients and to assess variables that are associated with QWL. METHODS Employed IBD patients of two tertiary and two secondary referral hospitals were included. QWL (range 0-100) was measured using the Quality of Working Life Questionnaire (QWLQ). Work productivity (WP), fatigue, and health-related quality of life (HRQL) were assessed using the Work Productivity and Activity Impairment questionnaire, Multidimensional Fatigue Inventory, and Short Inflammatory Bowel Disease Questionnaire, respectively. Active disease was defined as a score > 4 for the patient-reported Harvey-Bradshaw index in Crohn's disease (CD) or Simple Clinical Colitis Activity Index in ulcerative colitis patients. RESULTS In total, 510 IBD patients were included (59% female, 53% CD, mean age 43 (SD 12) years). The mean QWLQ score was 78 (SD 11). The lowest subscore (54 (SD 26)) was observed for "problems due to the health situation": 63% reported fatigue-related problems at work, 48% agreed being hampered at work, 46% had limited confidence in their body, and 48% felt insecure about the future due to their health situation. Intermediate/strong associations were found between QWL and fatigue (r = - 0.543, p < 0.001), HRQL (r = 0.527, p < 0.001), WP loss (r = - 0.453, p < 0.001) and disease activity (r = - 0.331, p < 0.001). Independent predictors of impaired QWL in hierarchical regression analyses were fatigue (B = - 0.204, p < 0.001), WP loss (B = - 0.070, p < 0.001), and impaired HRQL (B = 0.248, p = 0.001). CONCLUSIONS IBD-related problems at work negatively influence QWL. Fatigue, reduced HRQL, and WP loss were independent predictors of impaired QWL in IBD.
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Affiliation(s)
- Sara van Gennep
- Department of Gastroenterology and Hepatology, Amsterdam UMC, Amsterdam Gastroenterology and Metabolism Research Institute, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.
| | - Nanne K H de Boer
- Department of Gastroenterology and Hepatology, Amsterdam UMC, Amsterdam Gastroenterology and Metabolism Research Institute, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands
| | - Marieke E Gielen
- Department of Gastroenterology and Hepatology, Amstelland Ziekenhuis, Amstelveen, The Netherlands
| | - Svend T Rietdijk
- Department of Gastroenterology and Hepatology, OLVG, Amsterdam, The Netherlands
| | - Krisztina B Gecse
- Department of Gastroenterology and Hepatology, Amsterdam UMC, Amsterdam Gastroenterology and Metabolism Research Institute, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands
| | - Cyriel Y Ponsioen
- Department of Gastroenterology and Hepatology, Amsterdam UMC, Amsterdam Gastroenterology and Metabolism Research Institute, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands
| | - Marjolijn Duijvestein
- Department of Gastroenterology and Hepatology, Amsterdam UMC, Amsterdam Gastroenterology and Metabolism Research Institute, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands
| | - Geert R D'Haens
- Department of Gastroenterology and Hepatology, Amsterdam UMC, Amsterdam Gastroenterology and Metabolism Research Institute, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands
| | - Mark Löwenberg
- Department of Gastroenterology and Hepatology, Amsterdam UMC, Amsterdam Gastroenterology and Metabolism Research Institute, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands
| | - Angela G E M de Boer
- Department of Public and Occupational Health, Amsterdam UMC, Coronel Institute of Occupational Health, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands
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18
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Role of Quality of Life as Endpoint for Inflammatory Bowel Disease Treatment. INTERNATIONAL JOURNAL OF ENVIRONMENTAL RESEARCH AND PUBLIC HEALTH 2021; 18:ijerph18137159. [PMID: 34281095 PMCID: PMC8296948 DOI: 10.3390/ijerph18137159] [Citation(s) in RCA: 25] [Impact Index Per Article: 6.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Subscribe] [Scholar Register] [Received: 05/05/2021] [Revised: 06/18/2021] [Accepted: 07/01/2021] [Indexed: 02/06/2023]
Abstract
Inflammatory bowel diseases (IBDs) are chronic disabling conditions, characterized by an unpredictable course with flare-ups and periods of remission, that frequently affect young people and require lifelong medical follow-up and treatment. For years, the main endpoints of IBD treatment had been clinical remission and response, followed by biomarker normalization and mucosal healing. In the last decades, different therapies have been proved to be effective to treat IBD and the use of patient reported outcome (PRO) have become more relevant. Therefore, health-related quality of life (HRQoL) that has been defined as the value assigned to the duration of life influenced by physical and mental health, has been suggested as an important endpoint for IBD management since multiple studies have shown that IBD impairs it, both physically and psychologically. Thus, HRQoL has been included as an outcome in numerous studies evaluating different IBD therapies, both clinical trials and real-life studies. It has been assessed by using both generic and specific disease tools, and most treatments used in clinical practice have been demonstrated to improve HRQoL. The relevance of HRQoL as an endpoint for new drugs is going to increase and its management and improvement will also improve the prognosis of IBD patients.
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19
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Patient-Reported Outcomes in Inflammatory Bowel Disease: A Measurement of Effect in Research and Clinical Care. GASTROENTEROLOGY INSIGHTS 2021. [DOI: 10.3390/gastroent12020020] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/19/2022] Open
Abstract
The measurement of outcomes is key in evaluating healthcare or research interventions in inflammatory bowel disease (IBD). In patient-centred care, patient-reported outcome measures (PROMs) are central to this evaluation. In this review, we provide an overview of validated, adult disease-specific PROMs developed for use in IBD. Our aim is to assist clinicians and researchers in selection of PROMs to measure outcomes in their patient cohort. The Consensus-based Standards for the Selection of Health Measurement Instruments database of systematic reviews was the primary resource used to identify PROMs used in IBD. Search terms were ‘Crohn’s disease’, ‘ulcerative colitis’, and ‘IBD’. Seven systematic reviews were identified from this search. In addition, the publication by the IBD Core Outcome Set Working Group was used to identify further PROMs. Three systematic reviews were excluded as they did not meet the inclusion criteria. From the five included systematic reviews, we identified 21 PROMs and their shortened versions. In conclusion, it does not appear that any one PROM is entirely suitable for both research and clinical practice. Overall, the IBDQ-32 is most widely used in research but has the limitation of cost, whereas the IBD-Control has been recommended in the clinical core outcome set.
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20
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Rezazadeh Ardabili A, Hendrix EMB, Pierik MJ. Remote Monitoring of Inflammatory Bowel Disease: What Kind of Patient-Reported Questionnaires Should We Use? J Crohns Colitis 2021; 15:869-870. [PMID: 33179021 PMCID: PMC8095386 DOI: 10.1093/ecco-jcc/jjaa228] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/08/2023]
Affiliation(s)
- Ashkan Rezazadeh Ardabili
- School for Nutrition and Translational Research in Metabolism (NUTRIM), Maastricht University, Maastricht, The Netherlands
- Department of Internal Medicine, Division of Gastroenterology and Hepatology, Maastricht University Medical Center+, Maastricht, The Netherlands
| | - Evelien M B Hendrix
- School for Nutrition and Translational Research in Metabolism (NUTRIM), Maastricht University, Maastricht, The Netherlands
- Department of Internal Medicine, Division of Gastroenterology and Hepatology, Maastricht University Medical Center+, Maastricht, The Netherlands
| | - Marie J Pierik
- School for Nutrition and Translational Research in Metabolism (NUTRIM), Maastricht University, Maastricht, The Netherlands
- Department of Internal Medicine, Division of Gastroenterology and Hepatology, Maastricht University Medical Center+, Maastricht, The Netherlands
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21
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Nuñez F P, Mahadevan U, Quera R, Bay C, Ibañez P. Treat-to-target approach in the management of inflammatory Bowel disease. GASTROENTEROLOGIA Y HEPATOLOGIA 2021; 44:312-319. [PMID: 33070988 DOI: 10.1016/j.gastrohep.2020.06.032] [Citation(s) in RCA: 8] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 05/23/2020] [Accepted: 06/29/2020] [Indexed: 12/11/2022]
Abstract
With the advent of biologic and small molecule therapies, there has been a substantial change in the treatment of inflammatory bowel disease. These advances have had a great impact in preventing disease progression, intestinal damage and, therefore, have contributed to a better quality of life. Discordance between symptom control and mucosal healing has been demonstrated. This has led to the search for new disease control targets. The treat to target strategy, based on expert recommendations and now a randomized controlled trial, has determined that clinical and endoscopic remission should be the goal of therapy. Biomarkers (fecal calprotectin) can be a surrogate target. Although histological healing has shown benefits, there is inadequate evidence and inadequate therapy for that to be a fixed goal at this time. This review will focus on therapeutic goals, according to the evidence currently available, and evaluate strategies to achieve them.
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Affiliation(s)
- Paulina Nuñez F
- Division of Gastroenterology, Unversity of Chile, Hospital San Juan de Dios, Santiago, Chile a Division of Gastroenterology, Unversity of Chile, Hospital San Juan de Dios, Santiago, Chile.
| | - Uma Mahadevan
- Division of Gastroenterology, University of California, San Francisco, United States
| | - Rodrigo Quera
- Inflammatory Bowel Disease Program, Gastroenterology Department, Clínica Las Condes, Santiago, Chile
| | - Constanza Bay
- Department of Pediatrics, Pontifical Catholic University of Chile, Santiago, Chile
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22
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Tran F, Schirmer JH, Ratjen I, Lieb W, Helliwell P, Burisch J, Schulz J, Schrinner F, Jaeckel C, Müller-Ladner U, Schreiber S, Hoyer BF. Patient Reported Outcomes in Chronic Inflammatory Diseases: Current State, Limitations and Perspectives. Front Immunol 2021; 12:614653. [PMID: 33815372 PMCID: PMC8012677 DOI: 10.3389/fimmu.2021.614653] [Citation(s) in RCA: 8] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/06/2020] [Accepted: 03/02/2021] [Indexed: 01/20/2023] Open
Abstract
Chronic inflammatory diseases (CID) are emerging disorders which do not only affect specific organs with respective clinical symptoms but can also affect various aspects of life, such as emotional distress, anxiety, fatigue and quality of life. These facets of chronic disease are often not recognized in the therapy of CID patients. Furthermore, the symptoms and patient-reported outcomes often do not correlate well with the actual inflammatory burden. The discrepancy between patient-reported symptoms and objectively assessed disease activity can indeed be instructive for the treating physician to draw an integrative picture of an individual's disease course. This poses a challenge for the design of novel, more comprehensive disease assessments. In this mini-review, we report on the currently available patient-reported outcomes, the unmet needs in the field of chronic inflammatory diseases and the challenges of addressing these.
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Affiliation(s)
- Florian Tran
- Institute of Clinical Molecular Biology, Christian-Albrechts-University Kiel, Kiel, Germany
- Department of Internal Medicine I, University Medical Center Schleswig-Holstein, Kiel, Germany
| | - Jan Henrik Schirmer
- Department of Internal Medicine I, University Medical Center Schleswig-Holstein, Kiel, Germany
| | - Ilka Ratjen
- Institute of Epidemiology and Biobank PopGen, Christian-Albrechts-University of Kiel, Kiel, Germany
| | - Wolfgang Lieb
- Institute of Epidemiology and Biobank PopGen, Christian-Albrechts-University of Kiel, Kiel, Germany
| | - Philip Helliwell
- UK and Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals NHS Trust, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, United Kingdom
| | - Johan Burisch
- Gastrounit, Medical Section, Hvidovre University Hospital, Hvidovre, Denmark
| | - Juliane Schulz
- Department of Internal Medicine I, University Medical Center Schleswig-Holstein, Kiel, Germany
- Department of Oral and Maxillofacial Surgery, University Hospital Schleswig-Holstein, Kiel, Germany
| | - Florian Schrinner
- Institute of Clinical Molecular Biology, Christian-Albrechts-University Kiel, Kiel, Germany
| | - Charlot Jaeckel
- Institute of Clinical Molecular Biology, Christian-Albrechts-University Kiel, Kiel, Germany
| | - Ulf Müller-Ladner
- Department of Rheumatology and Clinical Immunology, Justus-Liebig-University Giessen, Kerckhoff-Klinik GmbH, Giessen, Germany
| | - Stefan Schreiber
- Department of Internal Medicine I, University Medical Center Schleswig-Holstein, Kiel, Germany
| | - Bimba F. Hoyer
- Department of Internal Medicine I, University Medical Center Schleswig-Holstein, Kiel, Germany
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23
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McKenna SP, Heaney A. Setting and maintaining standards for patient-reported outcome measures: can we rely on the COSMIN checklists? J Med Econ 2021; 24:502-511. [PMID: 33759686 DOI: 10.1080/13696998.2021.1907092] [Citation(s) in RCA: 25] [Impact Index Per Article: 6.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/13/2022]
Abstract
As test-developers we have often been troubled by published reviews of patient-reported outcome measures (PROMs). Too often minor issues are judged important while other reviews exclude the best measures available. Perhaps this led several groups to make recommendations for evaluating the quality of PROMs. The COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist is the latest set of recommendations. While reviewing the COSMIN literature and reviews conducted using their recommendations several concerns became apparent. The checklist is not evidence-based, relying on the opinion of researchers experienced in health-related quality of life. PROMs measuring other types of outcomes are inadequately covered by the checklist. COSMIN choose to focus on Classical Test Theory and the checklists are not appropriate for use with PROMs developed using modern measurement. Such an approach only obstructs progress in the field of outcome measurement. The retrospective nature of the evaluations also penalizes new PROMs. While the checklists imply that composite, ordinal level measurement is acceptable, crucial aspects of instrument development and quality are excluded. Reviews based on the COSMIN checklist produce contradictory conclusions and fail to provide evidence to support the recommendations. These problems suggest that the checklists themselves lack reliability and validity. It is also clear that several reviewers lack the expertise to apply the checklists. Researchers require a good grounding in instrument development and psychometrics to produce quality reviews. The science of modern PROM development is still in an early phase. Few available PROMs have sufficient quality, limiting the need for complex reviews. Standards need to be agreed for high quality outcome measurement. The issue is who should set these standards? Most published reviews merely scratch the surface and lack essential detail. All reviews of PROMs should be treated with caution, irrespective of whether the COSMIN checklist was employed.
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Affiliation(s)
- Stephen P McKenna
- Galen Research, Manchester, UK
- School of Health Sciences, University of Manchester, Manchester, UK
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