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Grote C, Bohne AS, Blome C, Kähler KC. Quality of life under treatment with the immune checkpoint inhibitors ipilimumab and nivolumab in melanoma patients. Real-world data from a prospective observational study at the Skin Cancer Center Kiel. J Cancer Res Clin Oncol 2024; 150:454. [PMID: 39387946 PMCID: PMC11467021 DOI: 10.1007/s00432-024-05981-2] [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: 07/30/2024] [Accepted: 09/30/2024] [Indexed: 10/12/2024]
Abstract
PURPOSE Combined immunotherapy (ipilimumab + nivolumab) has improved survival in stage IV melanoma patients, making Health-related Quality of Life (HrQoL) crucial due to potential immune-related adverse events (irAEs). Previous studies treated HrQoL as secondary/explorative endpoint, and no specific HrQoL questionnaire for melanoma patients on immune checkpoint inhibitor (ICI) therapy exists. This study aimed to gather specific HrQoL data during combined ICI therapy, tracking changes during and after treatment, and examining associations with gender, irAEs, and treatment response. METHODS 35 melanoma patients (22 males, 13 females) undergoing combined ICI were surveyed using the Short-form 36 questionnaire (SF-36), the Inflammatory Bowel Disease Questionnaire - Deutsch (IBDQ-D), and the distress thermometer (DT). HrQoL was evaluated during treatment, after six months, and at the onset of autoimmune colitis. RESULTS irAEs occurred in 51.4% of patients, with colitis being the most common (26.1%). 45.7% had progressive disease. SF-36 showed stable HrQoL during treatment and follow-up. Women had worse HrQoL on the physical component scale than men (p = 0.019). Patients with progression showed worse HrQoL over time in physical (p = 0.015) and mental health scales (p = 0.04). IBDQ-D showed constant HrQoL throughout treatment and follow-up. Distress on DT remained constant, with women reporting higher levels of distress. CONCLUSION HrQoL remained stable during and after therapy. Female gender and disease progression negatively impacted HrQoL. The development of irAEs was not associated with HrQoL, though this may not apply to severe irAEs like colitis, which were not assessed.
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Affiliation(s)
- Carolin Grote
- University Medical Center Hamburg-Eppendorf (UKE), Hamburg, Germany
- University Hospital Schleswig- Holstein (UKSH), Kiel, Germany
| | | | - Christine Blome
- University Medical Center Hamburg-Eppendorf (UKE), Hamburg, Germany
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Pueschel L, Kockelmann F, Kueck M, Tegtbur U, Attaran-Bandarabadi M, Bachmann O, Wedemeyer H, Lenzen H, Wiestler M. Patients with Inflammatory Bowel Disease Show Fewer Sex-Related Differences in Their Dietary Behavior Than the General Population: A Qualitative Analysis. Nutrients 2024; 16:2954. [PMID: 39275270 PMCID: PMC11397495 DOI: 10.3390/nu16172954] [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: 07/30/2024] [Revised: 08/28/2024] [Accepted: 08/29/2024] [Indexed: 09/16/2024] Open
Abstract
BACKGROUND Since diet is generally recognized as an important factor directly modulating the gut microbiome, it is also considered a potential environmental triggering factor for the pathogenesis and onset of inflammatory bowel disease (IBD). While the habitual and sex-related dietary behavior of the general population has been the subject of extensive study and reporting, data on IBD patients' dietary behavior and especially its sex-related differences are underrepresented. However, as diet is an important factor in the course of IBD, we hypothesized that men and women with IBD have a different dietary profile than the general population. METHODS We performed a cohort analysis of a monocentric, cross-sectional study and compared the sex-related dietary behavior of 82 IBD patients (n = 40 women) to a sex- and age-matched cohort of the general German population [n = 328 (n = 160 women)]. Further on, disease-related quality of life and fecal calprotectin were correlated to the IBD patients' dietary behavior. RESULTS While sex-related dietary behavior was frequently of statistical difference in the general population within the IBD cohort, only minor numerical differences were observed between the sexes, which were rarely statistically significant. However, correlation analyses of disease-related quality of life (IBDQ) and diet revealed significant differences in male IBD patients but not in female IBD patients (p = 0.007; r = 0.409 for energy intake (kJ/d); p = 0.003, r = 0.449 for adherence to Mediterranean diet). CONCLUSION The dietary behavior of IBD patients showed more similarity between the sexes than the general German population. Distinct sex-related trends and differences in correlation with disease parameters demonstrated a significant difference for an adaptive dietary behavior, especially in IBD men.
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Affiliation(s)
- Lea Pueschel
- Department of Gastroenterology, Hepatology, Infectious Diseases and Endocrinology, Hannover Medical School, 30625 Hannover, Germany
| | - Fabian Kockelmann
- Department of Surgery, Hospital Dortmund, University Hospital of the University Witten/Herdecke, 44137 Dortmund, Germany
- Department for Human Medicine, Witten/Herdecke University, 58455 Witten, Germany
| | - Momme Kueck
- Clinic for Rehabilitation and Sports Medicine, Hannover Medical School, 30625 Hannover, Germany
| | - Uwe Tegtbur
- Clinic for Rehabilitation and Sports Medicine, Hannover Medical School, 30625 Hannover, Germany
| | | | - Oliver Bachmann
- Department of Internal Medicine I, Siloah St. Trudpert Hospital, 75179 Pforzheim, Germany
| | - Heiner Wedemeyer
- Department of Gastroenterology, Hepatology, Infectious Diseases and Endocrinology, Hannover Medical School, 30625 Hannover, Germany
| | - Henrike Lenzen
- Department of Gastroenterology, Hepatology, Infectious Diseases and Endocrinology, Hannover Medical School, 30625 Hannover, Germany
| | - Miriam Wiestler
- Department of Gastroenterology, Hepatology, Infectious Diseases and Endocrinology, Hannover Medical School, 30625 Hannover, Germany
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Bauer N, Löffler C, Oeznur O, Uecker C, Schlee C, Adamczyk A, Elsenbruch S, Pfuhlmann K, Reissmann R, Westendorf A, Keil T, Langhorst J. Evaluation of a Multimodal Stress Management and Comprehensive Lifestyle Modification Program on Quality of Life and Gastrointestinal Symptoms in Patients with Crohn's Disease: A Randomized Controlled Pilot Trial with 9-Month Follow-Up. Digestion 2024; 105:201-212. [PMID: 38350430 DOI: 10.1159/000536659] [Citation(s) in RCA: 4] [Impact Index Per Article: 4.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/14/2023] [Accepted: 01/24/2024] [Indexed: 02/15/2024]
Abstract
INTRODUCTION Stress and lifestyle factors impact the course of Crohn's disease (CD). Our primary objective was to assess whether patients with CD benefit from a mind-body-medicine stress management and lifestyle modification (MBM) program. METHODS This 9-month two-arm pilot trial was conducted in Bamberg, Germany (2020-2021). Patients (18-75 years) with mild to moderate activity of CD and stable medication were enrolled and randomly assigned to either a 10-week MBM program (intervention group, IG) or a single 90-min education session (waiting list control group, CG). Primary endpoints were quality of life (IBDQ) and disease activity (HBI). Secondary endpoints were emotional distress, core self-evaluation, and inflammatory biomarkers 3 and 9 months after baseline assessment. RESULTS We analyzed data from 37 patients (IG: n = 19, mean ± SD age 49.6 ± 13.1 years, 68% female; CG: 18, 46.8 ± 11.4, 67% female). Immediately after the intervention, 79% (IG) and 44% (CG) experienced a clinically relevant improvement (IBDQ score ≥16 points). This was similar after 9 months (63% vs. 44%). There was no difference in disease activity (3 months: p = 0.082, 95% CI -1.3 to 2.6; 9 months: p = 0.251, 95% CI -1.2 to 2.5). Secondary outcomes indicated improvements in emotional distress, core self-evaluation, erythrocyte sedimentation rate after three and in emotional distress, T-cell profiling in the blood, and fecal lactoferrin and calprotectin group after 9 months in the IG. CONCLUSION Our study suggested benefits of a multimodal stress management and lifestyle modification program for patients with CD. Larger trials are needed to determine if the program can supplement or at least partially replace pharmacological treatment approaches.
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Affiliation(s)
- Nina Bauer
- Department of Internal and Integrative Medicine, Sozialstiftung Bamberg, Bamberg, Germany
- Department of Integrative Medicine, Medical Faculty, University of Duisburg-Essen, Bamberg, Germany
| | - Claudia Löffler
- Department of Internal Medicine II, University Hospital of Würzburg, Würzburg, Germany,
| | - Oezlem Oeznur
- Department of Internal and Integrative Medicine, Sozialstiftung Bamberg, Bamberg, Germany
- Department of Integrative Medicine, Medical Faculty, University of Duisburg-Essen, Bamberg, Germany
| | - Christine Uecker
- Department of Internal and Integrative Medicine, Sozialstiftung Bamberg, Bamberg, Germany
- Department of Integrative Medicine, Medical Faculty, University of Duisburg-Essen, Bamberg, Germany
| | - Christoph Schlee
- Department of Internal and Integrative Medicine, Sozialstiftung Bamberg, Bamberg, Germany
- Department of Integrative Medicine, Medical Faculty, University of Duisburg-Essen, Bamberg, Germany
- Department of Sociology, University of Bamberg, Bamberg, Germany
| | - Alexandra Adamczyk
- Institute of Medical Microbiology, University Hospital Essen, University of Duisburg-Essen, Essen, Germany
| | - Sigrid Elsenbruch
- Department of Medical Psychology and Medical Sociology, Ruhr University Bochum, Bochum, Germany
| | - Katrin Pfuhlmann
- Department of Internal and Integrative Medicine, Sozialstiftung Bamberg, Bamberg, Germany
- Department of Integrative Medicine, Medical Faculty, University of Duisburg-Essen, Bamberg, Germany
| | - Ralf Reissmann
- Department of Internal and Integrative Medicine, Sozialstiftung Bamberg, Bamberg, Germany
- Department of Integrative Medicine, Medical Faculty, University of Duisburg-Essen, Bamberg, Germany
| | - Astrid Westendorf
- Department of Infectionimmunology, University Hospital Essen, Essen, Germany
| | - Thomas Keil
- Institute of Clinical Epidemiology and Biometry, Julius-Maximilians-Universität Würzburg, Würzburg, Germany
- State Institute of Health I, Bavarian Health and Food Safety Authority, Erlangen, Germany
- Institute of Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin Berlin, Berlin, Germany
| | - Jost Langhorst
- Department of Internal and Integrative Medicine, Sozialstiftung Bamberg, Bamberg, Germany
- Department of Integrative Medicine, Medical Faculty, University of Duisburg-Essen, Bamberg, Germany
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Basedow LA, Zerth SF, Salzmann S, Uecker C, Bauer N, Elsenbruch S, Rief W, Langhorst J. Pre-treatment expectations and their influence on subjective symptom change in Crohn's disease. J Psychosom Res 2024; 176:111567. [PMID: 38100897 DOI: 10.1016/j.jpsychores.2023.111567] [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: 09/17/2023] [Revised: 12/07/2023] [Accepted: 12/09/2023] [Indexed: 12/17/2023]
Abstract
BACKGROUND Treatment expectations reportedly shape treatment outcomes, but have not been studied in the context of multimodal therapy in Crohn's disease (CD). Therefore, the current study investigated the role of treatment expectations for subjective symptom changes in CD patients who have undergone an integrative multimodal therapy program. METHODS Validated questionnaires were completed at the start of the treatment program and post intervention. Pre-treatment expectations and experienced symptom change were assessed with the Generic Rating Scale for Previous Treatment Experiences, Treatment Expectations, and Treatment Effects (GEEE); stress levels were quantified with the Perceived Stress Scale (PSS-10) and disease specific quality of life was quantified with the disease-specific Inflammatory Bowel Disease Questionnaire (IBDQ). We performed multiple linear and Bayesian regression to determine how expectations related to symptom change. RESULTS N = 71 CD patients (66.2% female) were included. Stronger expectations regarding symptom improvement (b = 0.422, t = 3.70, p < .001) were associated with higher experienced symptom improvement. Additionally, Bayesian analysis provided strong evidence for including improvement expectations as a predictor of improvement experience (BFinclusion = 13.78). CONCLUSIONS In line with research in other disorders, we found that positive treatment expectations were associated with experienced symptom improvement. In contrast, we found no indication that an experience of symptom worsening was associated with positive or negative baseline treatment expectations. Induction of positive expectations might be a potential avenue for improving treatment outcomes in CD therapy.
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Affiliation(s)
- Lukas Andreas Basedow
- Philipps-Universität Marburg, Department of Clinical Psychology and Psychotherapy, 35037 Marburg, Germany.
| | - Simon Felix Zerth
- Philipps-Universität Marburg, Department of Clinical Psychology and Psychotherapy, 35037 Marburg, Germany.
| | - Stefan Salzmann
- Philipps-Universität Marburg, Department of Clinical Psychology and Psychotherapy, 35037 Marburg, Germany; Health and Medical University, Medical Psychology, 99084 Erfurt, Germany.
| | - Christine Uecker
- Sozialstiftung Bamberg, Department of Internal and Integrative Medicine, 96049 Bamberg, Germany; University of Duisburg Essen, Medicinal Faculty, Department of Integrative Medicine, 96049 Bamberg, Germany.
| | - Nina Bauer
- Sozialstiftung Bamberg, Department of Internal and Integrative Medicine, 96049 Bamberg, Germany; University of Duisburg Essen, Medicinal Faculty, Department of Integrative Medicine, 96049 Bamberg, Germany
| | - Sigrid Elsenbruch
- Department of Medical Psychology and Medical Sociology, Ruhr University Bochum, 44789 Bochum, Germany; Department of Neurology, Center for Translational Neuro- and Behavioral Sciences (C-TNBS), University Hospital Essen, University of Duisburg-Essen, 45122 Essen, Germany.
| | - Winfried Rief
- Philipps-Universität Marburg, Department of Clinical Psychology and Psychotherapy, 35037 Marburg, Germany.
| | - Jost Langhorst
- Sozialstiftung Bamberg, Department of Internal and Integrative Medicine, 96049 Bamberg, Germany; University of Duisburg Essen, Medicinal Faculty, Department of Integrative Medicine, 96049 Bamberg, Germany.
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Schulz A, Welsch SK, Etringer S, Hansen G, Milbert L, Schneider J, Taddei G, Gomez Bravo R, Lygidakis C, van Dyck Z, Lutz A, Wilmes P, Vögele C. Lower gastric sensitivity in quiescent inflammatory bowel disease than in irritable bowel syndrome. Physiol Behav 2023; 270:114293. [PMID: 37468056 DOI: 10.1016/j.physbeh.2023.114293] [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: 08/01/2022] [Revised: 04/18/2023] [Accepted: 07/11/2023] [Indexed: 07/21/2023]
Abstract
OBJECTIVE Visceral hypersensitivity is considered a key symptom in inflammatory bowel disease (IBD) and irritable bowel syndrome (IBS), both of which seriously affect health-related quality of life (HrQoL). Previous findings are mostly based on invasive procedures that may interfere with the assessment of visceral perception. The current study, therefore, investigates whether IBD and IBS are characterized by altered perception of 'natural' gastric distensions ('interoception'). METHODS Twenty IBD patients in remission (13 Crohn's disease, 7 ulcerative colitis), 12 IBS patients, and 20/12 matched healthy control (HC) individuals, respectively, underwent the water load test, in which they could drink ad libitum until the subjective thresholds of satiation (stage 1) and fullness (stage 2) were reached. Gastric motility was assessed using electrogastrography. RESULTS IBD patients drank significantly more water until satiation than IBS patients, whereas no differences between patients and HC groups were observed. Electrogastrographic patterns were comparable between groups, suggesting no pathologies in gastric motility in IBD or IBS. The amount of water consumed until satiation negatively correlated with HrQoL related to bowel symptoms in IBD patients, but was positively associated with emotional well-being in IBS patients. CONCLUSION Our findings implicate relative gastric hypersensitivity in IBS, and relative hyposensitivity in IBD patients, which are both related to specific HrQoL aspects.
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Affiliation(s)
- André Schulz
- Clinical Psychophysiology Laboratory, Department of Behavioural and Cognitive Sciences, University of Luxembourg, Esch-sur-Alzette, Luxembourg; Institute for Cognitive and Affective Neuroscience, Trier University, Trier, Germany.
| | - Sina-Katharina Welsch
- Clinical Psychophysiology Laboratory, Department of Behavioural and Cognitive Sciences, University of Luxembourg, Esch-sur-Alzette, Luxembourg
| | - Sarah Etringer
- Clinical Psychophysiology Laboratory, Department of Behavioural and Cognitive Sciences, University of Luxembourg, Esch-sur-Alzette, Luxembourg
| | - Greta Hansen
- Clinical Psychophysiology Laboratory, Department of Behavioural and Cognitive Sciences, University of Luxembourg, Esch-sur-Alzette, Luxembourg
| | - Léa Milbert
- Clinical Psychophysiology Laboratory, Department of Behavioural and Cognitive Sciences, University of Luxembourg, Esch-sur-Alzette, Luxembourg
| | - Jochen Schneider
- Saarland University Medical Center, Department of Internal Medicine II, Homburg/Saar, Germany; Luxembourg Centre for Systems Biomedicine, University of Luxembourg, Esch-sur-Alzette, Luxembourg; Department of Gastroenterology, Centre Hospitalier Emile Mayrisch, Esch-sur-Alzette, Luxembourg
| | - Gennaro Taddei
- Department of Gastroenterology, Centre Hospitalier Emile Mayrisch, Esch-sur-Alzette, Luxembourg
| | - Raquel Gomez Bravo
- Clinical Psychophysiology Laboratory, Department of Behavioural and Cognitive Sciences, University of Luxembourg, Esch-sur-Alzette, Luxembourg
| | - Charilaos Lygidakis
- Clinical Psychophysiology Laboratory, Department of Behavioural and Cognitive Sciences, University of Luxembourg, Esch-sur-Alzette, Luxembourg
| | - Zoé van Dyck
- Clinical Psychophysiology Laboratory, Department of Behavioural and Cognitive Sciences, University of Luxembourg, Esch-sur-Alzette, Luxembourg
| | - Annika Lutz
- Clinical Psychophysiology Laboratory, Department of Behavioural and Cognitive Sciences, University of Luxembourg, Esch-sur-Alzette, Luxembourg
| | - Paul Wilmes
- Luxembourg Centre for Systems Biomedicine, University of Luxembourg, Esch-sur-Alzette, Luxembourg
| | - Claus Vögele
- Clinical Psychophysiology Laboratory, Department of Behavioural and Cognitive Sciences, University of Luxembourg, Esch-sur-Alzette, Luxembourg
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Demmer S, Kleindienst N, Hjortswang H, Thomann P, Ebert M, Reindl W, Thomann A. Validation of the German version of the Short Health Scale - a brief, valid and reliable instrument to assess health-related quality of life in German-speaking patients with inflammatory bowel diseases. ZEITSCHRIFT FUR GASTROENTEROLOGIE 2023; 61:1207-1213. [PMID: 37309101 PMCID: PMC10629489 DOI: 10.1055/a-1976-9971] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Subscribe] [Scholar Register] [Received: 04/26/2022] [Accepted: 10/06/2022] [Indexed: 06/14/2023]
Abstract
BACKGROUND Health-related quality of life (hrQoL) may be the most important patient-reported outcome for patients with chronic disorders. The Short Health Scale (SHS) is a brief four-item instrument to assess hrQoL in patients with bowel disorders. This study examined the validity, reliability and sensitivity of the German translation of the SHS in a cohort of outpatients with inflammatory bowel diseases (IBD). METHODS The study was preregistered in April 2021 (https://doi.org/10.17605/OSF.IO/S82D9). Outpatients with IBD (n=225) in different stages of disease activity (as determined by the Harvey-Bradshaw index or partial Mayo score) completed the German SHS and the short Inflammatory Bowel Disease Questionnaire (sIBDQ) as an established measure of hrQoL to examine the convergent validity. To assess reliability, a subset of patients (n=30) in remission completed the same questionnaires after 4-8 weeks. Sensitivity to change was established from questionnaires of patients with either decreased (n=15) or increased (n=16) disease activity after 3-6 months. RESULTS The internal consistency of the German SHS was high (Cronbach's α=0.860). SHS total scores correlated strongly with sIBDQ scores (ρ=-0.760, p<0.001) and disease activity (ρ=0.590, p<0.001). Retest reliability was high (ρ=0.695, p<0.001). Sensitivity to change was statistically significant for patients with decreased (p=0.013) but not increased (p=0.134) disease activity. CONCLUSION The German version of the SHS is a valid and reliable tool to measure hrQoL in persons with IBD.
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Affiliation(s)
- Sina Demmer
- Department of Medicine II, Medical Faculty Mannheim, Heidelberg University, University Medical Centre Mannheim, Mannheim, Germany
| | - Nikolaus Kleindienst
- Department of Psychosomatic Medicine and Psychotherapy, Medical Faculty Mannheim, Heidelberg University, Central Institute of Mental Health, Mannheim, Germany
| | - Henrik Hjortswang
- Department of Health, Medicine, and Caring Sciences, Linköping University, Linkoping, Sweden
| | - Philipp Thomann
- Center for Mental Health, Odenwald District Healthcare Centre, Odenwald District, Erbach, Germany
| | - Matthias Ebert
- Department of Medicine II, Medical Faculty Mannheim, Heidelberg University, University Medical Centre Mannheim, Mannheim, Germany
| | - Wolfgang Reindl
- Department of Medicine II, Medical Faculty Mannheim, Heidelberg University, University Medical Centre Mannheim, Mannheim, Germany
| | - Anne Thomann
- Department of Medicine II, Medical Faculty Mannheim, Heidelberg University, University Medical Centre Mannheim, Mannheim, Germany
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Uhlir V, Stallmach A, Grunert PC. Fatigue in patients with inflammatory bowel disease-strongly influenced by depression and not identifiable through laboratory testing: a cross-sectional survey study. BMC Gastroenterol 2023; 23:288. [PMID: 37608313 PMCID: PMC10463723 DOI: 10.1186/s12876-023-02906-0] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/12/2023] [Accepted: 07/25/2023] [Indexed: 08/24/2023] Open
Abstract
BACKGROUND Fatigue is a debilitating and highly relevant symptom in patients with inflammatory bowel disease (IBD). However, awareness of fatigue and treatment options remains limited. This study was aimed at elucidating the influence of disease activity and common complications (pain, anemia, depression, anxiety and quality of life) on fatigue in patients with IBD to identify potential interventional targets for treating physicians. METHODS A cross-sectional survey including five questionnaires (HADS, Fatigue Assessment Scale, McGill Pain Questionnaire, IBDQ and general well-being) was performed on patients with IBD (n = 250) at a university IBD clinic. Additionally, demographic data, laboratory data, IBD history, treatment and current disease activity (Harvey-Bradshaw Index, partial Mayo Score, calprotectin and CRP) were recorded. RESULTS A total of 189 patients were analyzed (59.8% with Crohn's disease (CD) and 40.2% with ulcerative colitis (UC)). A total of 51.3% were fatigued, and 12.2% were extremely fatigued. Multiple factors showed significant correlations in univariate analysis. Multivariate analysis revealed that fatigue was correlated with depression (CD, p = 0.002; UC, p = 0.02), diminished quality of life (CD, p = 0.015), female sex (CD, p = 0.015) and younger age (UC, p = 0.024), whereas the influence of anemia or disease activity was non-significant. CONCLUSIONS Fatigue is burdensome and highly prevalent in patients with active and inactive IBD. Considerations for fatigue treatment, beyond targeting inflammation and anemia, should include investigation of underlying sub-clinical depression.
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Affiliation(s)
- Victoria Uhlir
- Department of Internal Medicine IV, Jena University Hospital, Universitätsklinikum Jena, Am Klinikum 1, 07747, Jena, Germany
| | - Andreas Stallmach
- Department of Internal Medicine IV, Jena University Hospital, Universitätsklinikum Jena, Am Klinikum 1, 07747, Jena, Germany
| | - Philip Christian Grunert
- Department of Internal Medicine IV, Jena University Hospital, Universitätsklinikum Jena, Am Klinikum 1, 07747, Jena, Germany.
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Scholz KAM, Thomann AK, Teich N, Baumann H, Walldorf J, Büning C, Rosania R, Canbay A, Arnim UV. Validation of the German Inflammatory Bowel Disease Fatigue (IBD-F) Questionnaire. ZEITSCHRIFT FUR GASTROENTEROLOGIE 2023; 61:164-171. [PMID: 35533686 DOI: 10.1055/a-1797-2688] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 02/07/2023]
Abstract
INTRODUCTION Fatigue is a common symptom in patients with inflammatory bowel diseases (IBD). To date, there is no instrument to assess IBD-specific fatigue in German. The aim of this study was to translate the IBD Fatigue (IBD-F) scale and to test its psychometric properties in a German IBD population. METHODS After completing the translation process, 20 IBD patients participated in a pilot testing phase. For further analyses, 180 IBD patients with fatigue answered the IBD-F (Sections I, II, III) and the IBD Questionnaire (IBDQ-D). Reliability was tested by using Cronbach's alpha and corrected item-total correlation. Exploratory factor analyses (EFA) were carried out. Spearman's correlation was calculated between the IBD-F and IBDQ-D . 78 patients could be included to calculate the test-retest reliability. RESULTS The German version of the IBD-F shows high face and content validity. Internal consistency was excellent, with a Cronbach's alpha of 0.93-0.98. Corrected item-total correlations ranged from 0.51 to 0.89. The correlation between the IBD-F and the IBDQ-D was statistically significant for Section I (rs=-0.59; p<0.01) and Section II (rs=-0.76; p<0.01) of the IBD-F. The EFA identified one relevant factor for each section. Test-retest reliability was acceptable for Section I (intraclass correlation coefficient (ICC)=0.73) and Section II (ICC=0.84). CONCLUSION The German version of the IBD-F is a reliable and valid tool to assess fatigue in IBD.
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Affiliation(s)
| | - Anne Kerstin Thomann
- Department of Medicine II, University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany
| | - Niels Teich
- Internal medicine practice for Digestive and Metabolic Diseases, Leipzig, Germany
| | - Hartmut Baumann
- Gastroenterological practice Gardelegen, Gardelegen, Germany
| | - Jens Walldorf
- Department of Internal Medicine I, Martin-Luther-Universität Halle-Wittenberg, Halle, Germany
| | - Carsten Büning
- Department of Internal Medicine, Hospital Waldfriede, Berlin-Zehlendorf, Germany
| | - Rosa Rosania
- Department of Gastroenterology, Hepatology and Infectious Diseases, University Hospital Magdeburg, Magdeburg, Germany
| | - Ali Canbay
- Department of Medicine, Knappschaftskrankenhaus, Ruhr University Bochum, Bochum, Germany
| | - Ulrike von Arnim
- Department of Gastroenterology, Hepatology and Infectious Diseases, University Hospital Magdeburg, Magdeburg, Germany
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Krausz M, Uhlmann A, Rump IC, Ihorst G, Goldacker S, Sogkas G, Posadas-Cantera S, Schmidt R, Feißt M, Alsina L, Dybedal I, Recher M, Warnatz K, Grimbacher B. The ABACHAI clinical trial protocol: Safety and efficacy of abatacept (s.c.) in patients with CTLA-4 insufficiency or LRBA deficiency: A non controlled phase 2 clinical trial. Contemp Clin Trials Commun 2022; 30:101008. [PMID: 36262801 PMCID: PMC9573884 DOI: 10.1016/j.conctc.2022.101008] [Citation(s) in RCA: 10] [Impact Index Per Article: 3.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/24/2022] [Revised: 08/26/2022] [Accepted: 09/17/2022] [Indexed: 11/30/2022] Open
Abstract
Background Cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) insufficiency and lipopolysaccharide-responsive and beige-like anchor protein (LRBA) deficiency are both complex immune dysregulation syndromes with an underlying regulatory T cell dysfunction due to the lack of CTLA-4 protein. As anticipated, the clinical phenotypes of CTLA-4 insufficiency and LRBA deficiency are similar. Main manifestations include hypogammaglobulinemia, lymphoproliferation, autoimmune cytopenia, immune-mediated respiratory, gastrointestinal, neurological, and skin involvement, which can be severe and disabling. The rationale of this clinical trial is to improve clinical outcomes of affected patients by substituting the deficient CTLA-4 by administration of CTLA4-Ig (abatacept) as a causative personalized treatment. Objectives Our objective is to assess the safety and efficacy of abatacept for patients with CTLA-4 insufficiency or LRBA deficiency. The study will also investigate how treatment with abatacept affects the patients’ quality of life. Methods /Design: ABACHAI is a phase IIa prospective, non-randomized, open-label, single arm multi-center trial. Altogether 20 adult patients will be treated with abatacept 125 mg s.c. on a weekly basis for 12 months, including (1) patients already pretreated with abatacept, and (2) patients not pretreated, starting with abatacept therapy at the baseline study visit. For the evaluation of drug safety infection control during the trial, for efficacy, the CHAI-Morbidity Score will be used. Trial registration The trial is registered in the German Clinical Trials Register (Deutsches Register Klinischer Studien, DRKS) with the identity number DRKS00017736, registered: 6 July 2020, https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00017736.
Clinical trial for safety and efficacy of abatacept in CTLA-4 or LRBA deficiency. Substitution of CTLA4-deficiency by abatacept, a causative treatment approach. Primary endpoint: no. of episodes of failed infection control under trial treatment. Development of disease severity score.
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10
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Bauer N, Löffler C, Öznur Ö, Uecker C, Keil T, Langhorst J. Mind-body-medicine and comprehensive lifestyle-modification in patients with Crohn's disease—Feasibility of a randomized controlled trial under pandemic circumstances. Front Integr Neurosci 2022; 16:960301. [PMID: 36081609 PMCID: PMC9447476 DOI: 10.3389/fnint.2022.960301] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/02/2022] [Accepted: 07/08/2022] [Indexed: 11/21/2022] Open
Abstract
Introduction Mind-body medicine (MBM) focuses on stress reduction and lifestyle changes. The primary objective of this pilot trial was to test study feasibility of a complex integrative MBM program for patients with Crohn's disease (CD), especially in rural regions, and under pandemic conditions. Methods Patients were stratified and randomized to the intervention group (IG) or the control group (CG). The intervention included a weekly 6-h session for 10 weeks. The CG (waiting list) received an initial 90-min workshop and started the intervention 9 months later. The primary outcome for study feasibility was recruitment and retention rates, as well as reasons for drop-out. The trial took place in Bamberg, Germany (September 2020 to December 2021). Results Totally 700 members of the German Crohn's and Colitis Organization—DCCV—were contacted. A total of 15% (102/700; 95% CI 12–17%) expressed interest to participate. Following screening, 41% (95% CI 32–50) were randomized to IG (n = 22) and CG (n = 20). The patients were on average (±standard deviation) 48 ± 13 years old, 67% were female, and have been suffering from CD for 20 ± 12 years. Patients traveled 71.5 ± 48.7 km (range: 9–227 km) to the intervention with no differences between IG and CG. At the 6-month follow-up, 36/42 (86%, 95% CI 74–95%) participants completed final assessment and 19/22 (86%, 95% CI 70–100%) the intervention. The most important reasons for non-responding were work-related (12/60; 20%) and for or drop-out pandemic-related anxiety (3/6). No patient and staff member became infected with SARS-CoV-2 during the study. Conclusion The feasibility of the MBM study was confirmed in terms of predefined recruitment and retention criteria, both despite difficult conditions (including the rural setting) and patients' fears associated with the pandemic. It was crucial to develop appropriate hygiene and safety concepts that enable chronically ill patients to participate in helpful group-based interventions even under pandemic conditions. Clinical trial registration ClinicalTrials.gov, identifier: NCT05182645.
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Affiliation(s)
- Nina Bauer
- Department of Internal and Integrative Medicine, Sozialstiftung Bamberg, Bamberg, Germany
- Department of Integrative Medicine, Medical Faculty, University of Duisburg-Essen, Bamberg, Germany
| | - Claudia Löffler
- Department of Internal Medicine II, University Hospital of Würzburg, Würzburg, Germany
| | - Özlem Öznur
- Department of Internal and Integrative Medicine, Sozialstiftung Bamberg, Bamberg, Germany
- Department of Integrative Medicine, Medical Faculty, University of Duisburg-Essen, Bamberg, Germany
| | - Christine Uecker
- Department of Internal and Integrative Medicine, Sozialstiftung Bamberg, Bamberg, Germany
- Department of Integrative Medicine, Medical Faculty, University of Duisburg-Essen, Bamberg, Germany
| | - Thomas Keil
- Institute of Clinical Epidemiology and Biometry, Julius Maximilians University of Würzburg, Würzburg, Germany
- State Institute of Health, Bavarian Health and Food Safety Authority, Erlangen, Germany
- Institute of Social Medicine, Epidemiology and Health Economics, Charité – Universitätsmedizin Berlin, Berlin, Germany
| | - Jost Langhorst
- Department of Internal and Integrative Medicine, Sozialstiftung Bamberg, Bamberg, Germany
- Department of Integrative Medicine, Medical Faculty, University of Duisburg-Essen, Bamberg, Germany
- *Correspondence: Jost Langhorst
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11
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The personality traits activity, self-reproach, and negative affect jointly predict clinical recurrence, depressive symptoms, and low quality of life in inflammatory bowel disease patients. J Gastroenterol 2022; 57:848-866. [PMID: 35900592 PMCID: PMC9596530 DOI: 10.1007/s00535-022-01902-7] [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: 02/25/2022] [Accepted: 06/24/2022] [Indexed: 02/04/2023]
Abstract
BACKGROUND The bidirectional "gut-brain axis" has been implicated in the pathogenesis of inflammatory bowel diseases (IBD). While the influence of stress and depressive symptoms on IBD is well-characterized, the role of personality remains insufficiently investigated. METHODS Personality was assessed in 1154 Swiss IBD cohort study (SIBDCS) patients via the NEO-Five-Factor Inventory (NEO-FFI) as well as in 2600 participants of the population-based CoLaus¦PsyCoLaus cohort study (NEO-FFI-revised). The NEO-FFI subcomponents activity, self-reproach and negative affect were associated with higher IBD disease activity and were combined to a NEO-FFI risk score. This risk score was validated and its effect on clinical IBD course and psychological endpoints was analysed in time-to-event and cumulative incidence analyses. RESULTS In time-to-event analyses, a high NEO-FFI risk score was predictive for the clinical endpoints of new extraintestinal manifestation [EIM, adjusted hazard ratio (aHR) = 1.64, corrected p value (q) = 0.036] and two established composite flare endpoints (aHR = 1.53-1.63, q = 0.003-0.006) as well as for the psychological endpoints depressive symptoms (aHR = 7.06, q < 0.001) and low quality of life (aHR = 3.06, q < 0.001). Furthermore, cumulative incidence analyses showed that patients at high NEO-FFI risk experienced significantly more episodes of active disease, new EIMs, one of the flare endpoints, depressive episodes and low disease-related quality of life. Personalities of IBD patients showed only minor differences from the general population sample (Pearson's r = 0.03-0.14). CONCLUSIONS Personality assessed by the NEO-FFI contained considerable predictive power for disease recurrence, depressive symptoms and low quality of life in IBD patients. Nevertheless, the personalities of IBD patients did not substantially differ from the general population.
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Villiger R, Cabalzar-Wondberg D, Zeller D, Frei P, Biedermann L, Schneider C, Scharl M, Rogler G, Turina M, Rickenbacher A, Misselwitz B. Perianal fistulodesis – A pilot study of a novel minimally invasive surgical and medical approach for closure of perianal fistulae. World J Gastrointest Surg 2021; 13:187-197. [PMID: 33643538 PMCID: PMC7898183 DOI: 10.4240/wjgs.v13.i2.187] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/01/2020] [Revised: 11/20/2020] [Accepted: 12/23/2020] [Indexed: 02/06/2023] Open
Abstract
BACKGROUND Perianal fistulae strongly impact on quality of life of affected patients.
AIM To challenge and novel minimally invasive treatment options are needed.
METHODS Patients with Crohn’s disease (CD) in remission and patients without inflammatory bowel disease (non-IBD patients) were treated with fistulodesis, a method including curettage of fistula tract, flushing with acetylcysteine and doxycycline, Z-suture of the inner fistula opening, fibrin glue instillation, and Z-suture of the outer fistula opening followed by post-operative antibiotic prophylaxis with ciprofloxacin and metronidazole for two weeks. Patients with a maximum of 2 fistula openings and no clinical or endosonographic signs of a complicated fistula were included. The primary end point was fistula healing, defined as macroscopic and clinical fistula closure and lack of patient reported fistula symptoms at 24 wk.
RESULTS Fistulodesis was performed in 17 non-IBD and 3 CD patients, with a total of 22 fistulae. After 24 wk, all fistulae were healed in 4 non-IBD and 2 CD patients (overall 30%) and fistula remained closed until the end of follow-up at 10-25 mo. In a secondary per-fistula analysis, 7 out of 22 fistulae (32%) were closed. Perianal disease activity index (PDAI) improved in patients with fistula healing. Low PDAI was associated with favorable outcome (P = 0.0013). No serious adverse events were observed.
CONCLUSION Fistulodesis is feasible and safe for perianal fistula closure. Overall success rates is at 30% comparable to other similar techniques. A trend for better outcomes in patients with low PDAI needs to be confirmed.
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Affiliation(s)
- Roxanne Villiger
- Department of Gastroenterology and Hepatology, University Hospital of Zurich, Zurich 8091, Switzerland
| | | | - Daniela Zeller
- Department of Surgery, Zeller Surgery, Zurich 8008, Switzerland
| | - Pascal Frei
- Department of Gastroenterology and Hepatology, University Hospital of Zurich, Zurich 8091, Switzerland
| | - Luc Biedermann
- Department of Gastroenterology and Hepatology, University Hospital of Zurich, Zurich 8091, Switzerland
| | - Christian Schneider
- Department of Gastroenterology and Hepatology, University Hospital of Zurich, Zurich 8091, Switzerland
| | - Michael Scharl
- Department of Gastroenterology, University Hospital of Zurich, Zurich 8091, Switzerland
| | - Gerhard Rogler
- Department of Gastroenterology and Hepatology, University Hospital of Zurich, Zurich 8091, Switzerland
| | - Matthias Turina
- Visceral- and Transplant Surgery, University Hospital of Zurich, Zurich 8091, Switzerland
| | - Andreas Rickenbacher
- Visceral- and Transplant Surgery, University Hospital of Zurich, Zurich 8091, Switzerland
| | - Benjamin Misselwitz
- Department of Gastroenterology and Hepatology, University Hospital of Zurich, Zurich 8091, Switzerland
- Visceral Surgery and Medicine, University Hospital of Bern, Bern 3010, Switzerland
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13
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Langhorst J, Schöls M, Cinar Z, Eilert R, Kofink K, Paul A, Zempel C, Elsenbruch S, Lauche R, Ahmed M, Haller D, Cramer H, Dobos G, Koch AK. Comprehensive Lifestyle-Modification in Patients with Ulcerative Colitis-A Randomized Controlled Trial. J Clin Med 2020; 9:E3087. [PMID: 32987894 PMCID: PMC7599849 DOI: 10.3390/jcm9103087] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/29/2020] [Revised: 09/17/2020] [Accepted: 09/21/2020] [Indexed: 12/15/2022] Open
Abstract
Patients with ulcerative colitis suffer from impaired health-related quality of life (HrQoL). Comprehensive lifestyle-modification might increase HrQoL and decrease disease activity. Ninety-seven patients in clinical remission with impaired HrQoL were randomly assigned to a 10 week comprehensive lifestyle-modification program (LSM; n = 47; 50.28 ± 11.90 years) or control (n = 50; 45.54 ± 12.49 years) that received a single workshop of intense training in naturopathic self-help strategies. Primary outcome was HrQoL (Inflammatory Bowel Disease Questionnaire; IBDQ) at week 12. Secondary outcomes included IBDQ subscales; generic HrQoL; disease activity and microbiome. Both groups showed improvement in HrQoL from baseline to post-treatment at week 12. The IBDQ sum score showed no significant group difference (p = 0.251). If patients attended more than 50% of the training sessions, a significant group effect (p = 0.034) was evident in favor of LSM. In addition, the SF-36 mental component summary (p = 0.002) was significantly different between the groups in favor of LSM. Disease activity microbiome and adverse events did not differ. Both a single workshop and a 10-week comprehensive lifestyle-modification program can improve HrQoL in patients with ulcerative colitis in remission with no apparent effects on clinical disease activity. A treatment difference was observed when examining a subsample of patients who attended ≥ 50% of sessions.
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Affiliation(s)
- Jost Langhorst
- Department of Internal and Integrative Medicine, Sozialstiftung Bamberg, Germany, Chair for Integrative Medicine, University of Duisburg-Essen, Buger Straße 80, 96049 Bamberg, Germany
- Integrative Gastroenterology, University of Duisburg-Essen, Evang. Kliniken-Essen-Mitte, Am Deimelsberg 34 a, 45276 Essen, Germany; (M.S.); (Z.C.); (R.E.); (K.K.)
| | - Margarita Schöls
- Integrative Gastroenterology, University of Duisburg-Essen, Evang. Kliniken-Essen-Mitte, Am Deimelsberg 34 a, 45276 Essen, Germany; (M.S.); (Z.C.); (R.E.); (K.K.)
| | - Zehra Cinar
- Integrative Gastroenterology, University of Duisburg-Essen, Evang. Kliniken-Essen-Mitte, Am Deimelsberg 34 a, 45276 Essen, Germany; (M.S.); (Z.C.); (R.E.); (K.K.)
| | - Ronja Eilert
- Integrative Gastroenterology, University of Duisburg-Essen, Evang. Kliniken-Essen-Mitte, Am Deimelsberg 34 a, 45276 Essen, Germany; (M.S.); (Z.C.); (R.E.); (K.K.)
| | - Kerstin Kofink
- Integrative Gastroenterology, University of Duisburg-Essen, Evang. Kliniken-Essen-Mitte, Am Deimelsberg 34 a, 45276 Essen, Germany; (M.S.); (Z.C.); (R.E.); (K.K.)
| | - Anna Paul
- Department of Internal and Integrative Medicine, Evang. Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen, Am Deimelsberg 34 a, 45276 Essen, Germany; (A.P.); (C.Z.); (H.C.); (G.D.); (A.K.K.)
| | - Christina Zempel
- Department of Internal and Integrative Medicine, Evang. Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen, Am Deimelsberg 34 a, 45276 Essen, Germany; (A.P.); (C.Z.); (H.C.); (G.D.); (A.K.K.)
| | - Sigrid Elsenbruch
- Department of Medical Psychology and Medical Sociology, Ruhr University Bochum, Universitätsstraße 150, 44801 Bochum, Germany;
| | - Romy Lauche
- National Centre for Naturopathic Medicine, Southern Cross University, Lismore, Lismore Campus, Military Rd, Lismore, NSW 2480, Australia;
| | - Mohamed Ahmed
- Technical University of Munich, Chair of Nutrition and Immunology, Gregor-Mendel-Str. 2, 85354 Freising-Weihenstephan, Germany; (M.A.); (D.H.)
| | - Dirk Haller
- Technical University of Munich, Chair of Nutrition and Immunology, Gregor-Mendel-Str. 2, 85354 Freising-Weihenstephan, Germany; (M.A.); (D.H.)
- ZIEL-Institute for Food and Health, Technical University of Munich, 85354 Freising, Germany
| | - Holger Cramer
- Department of Internal and Integrative Medicine, Evang. Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen, Am Deimelsberg 34 a, 45276 Essen, Germany; (A.P.); (C.Z.); (H.C.); (G.D.); (A.K.K.)
| | - Gustav Dobos
- Department of Internal and Integrative Medicine, Evang. Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen, Am Deimelsberg 34 a, 45276 Essen, Germany; (A.P.); (C.Z.); (H.C.); (G.D.); (A.K.K.)
| | - Anna K. Koch
- Department of Internal and Integrative Medicine, Evang. Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen, Am Deimelsberg 34 a, 45276 Essen, Germany; (A.P.); (C.Z.); (H.C.); (G.D.); (A.K.K.)
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14
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Schütz L, Radke M, Menzel S, Däbritz J. Long-term implications of structured transition of adolescents with inflammatory bowel disease into adult health care: a retrospective study. BMC Gastroenterol 2019; 19:128. [PMID: 31324228 PMCID: PMC6642593 DOI: 10.1186/s12876-019-1046-5] [Citation(s) in RCA: 23] [Impact Index Per Article: 3.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/10/2019] [Accepted: 07/15/2019] [Indexed: 12/16/2022] Open
Abstract
Background We aimed to evaluate the long-term clinical and socioeconomic outcome of structured transition care in adolescents with inflammatory bowel disease (IBD). Methods We compared the clinical long-term course of 24 patients with and 11 patients without structured transition care within 24 months before and 24 months after transfer from paediatric to adult health care. Socio-economic parameters and quality of life were assessed by IBD Questionnaire (IBDQ-32) and additional items. Treatment costs were calculated for medication, surgery and hospitalisation. Results The percentage of transfer group patients with an IBD-related intestinal complication was higher compared to the transition group (64% vs. 21%, p = 0.022). We also found a tendency towards a higher number of IBD-related surgery in the transfer group compared to the transition group (46% vs. 13%, p = 0.077). Transfer group patients received higher mean cumulated doses of radiation compared with the transition group (4.2 ± 5.3 mSv vs. 0.01 ± 0.01 mSv, p = 0.036). Delayed puberty was only noted in the transfer group (27%, p = 0.025). Mean expenditures for surgeries and hospitalisation tended to be lower in the transition group compared to transfer group patients (744 ± 630€ vs. 2,691 ± 4,150€, p = 0.050). Sexual life satisfaction was significantly higher (p = 0.023) and rates of loose bowel movements tended to be lower (p = 0.053) in the transition group. Conclusions Structured transition of adolescents with IBD from paediatric into adult health care can lead to important clinical and economic benefits. Electronic supplementary material The online version of this article (10.1186/s12876-019-1046-5) contains supplementary material, which is available to authorized users.
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Affiliation(s)
- Lukas Schütz
- Department of Paediatrics, University Hospital Rostock, Ernst-Heydemann-Str. 8, D-18057, Rostock, Germany
| | - Michael Radke
- Department of Paediatrics, University Hospital Rostock, Ernst-Heydemann-Str. 8, D-18057, Rostock, Germany.,Department of Paediatrics, Klinikum Westbrandenburg, Potsdam, Germany
| | - Stephan Menzel
- Ernst-von-Bergmann Outpatient Clinic, Gastroenterology & Hepatology, Potsdam, Germany
| | - Jan Däbritz
- Department of Paediatrics, University Hospital Rostock, Ernst-Heydemann-Str. 8, D-18057, Rostock, Germany.
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15
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Engler H, Elsenbruch S, Rebernik L, Köcke J, Cramer H, Schöls M, Langhorst J. Stress burden and neuroendocrine regulation of cytokine production in patients with ulcerative colitis in remission. Psychoneuroendocrinology 2018; 98:101-107. [PMID: 30125791 DOI: 10.1016/j.psyneuen.2018.08.009] [Citation(s) in RCA: 18] [Impact Index Per Article: 2.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/08/2018] [Revised: 08/02/2018] [Accepted: 08/05/2018] [Indexed: 01/06/2023]
Abstract
Stress demonstrably contributes to disease course in patients with inflammatory bowel diseases but the underlying mechanisms remain elusive. Here, we investigated if neuroendocrine regulation of pro- and anti-inflammatory cytokine production by peripheral blood immune cells is altered in patients with ulcerative colitis in remission (UCR). Using a whole blood stimulation assay, we measured the sensitivity of lipopolysaccharide (LPS)-induced TNF-α and IL-10 production to the glucocorticoid receptor agonist dexamethasone (DEX), the β2-adrenergic receptor agonist terbutaline (TERB), and the α7-nicotinic acetylcholine receptor agonist 3-[2,4-dimethoxy-benzylidene]-anabaseine (GTS-21) in UCR patients (N = 26) and in healthy controls (HC, N = 25). Additionally, we assessed anxiety and depression symptoms as well as chronic perceived stress and disease-specific quality of life. Results showed that UCR patients exhibited greater anxiety, depression and chronic stress levels than HC, and reduced disease-specific quality of life. Plasma concentrations of TNF-α, IL-8, C-reactive protein (CRP) and lipopolysaccharide binding protein (LBP) were significantly higher, while LPS-induced IL-10 production was substantially lower in UCR compared to HC. Independent of group, DEX and GTS-21 dose-dependently inhibited TNF-α and IL-10 production, whereas TERB inhibited TNF-α and upregulated IL-10 production. However, at higher TERB doses (i.e., stress levels), upregulation of IL-10 production was significantly diminished in UCR compared to HC. Together, these findings demonstrate that downregulation of pro-inflammatory cytokine production in peripheral blood immune cells through glucocorticoid, adrenergic, and cholinergic mechanisms is essentially normal in UC in clinical remission and as efficient as in healthy individuals. However, UCR patients exhibited signs of systemic low-grade inflammation and dysregulation of anti-inflammatory IL-10 production. Impaired adrenergic upregulation of IL-10 production during remission could be one mechanism how stress facilitates relapse and conversion to symptomatic disease in these patients.
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Affiliation(s)
- Harald Engler
- Institute of Medical Psychology and Behavioral Immunobiology, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.
| | - Sigrid Elsenbruch
- Institute of Medical Psychology and Behavioral Immunobiology, University Hospital Essen, University of Duisburg-Essen, Essen, Germany
| | - Laura Rebernik
- Institute of Medical Psychology and Behavioral Immunobiology, University Hospital Essen, University of Duisburg-Essen, Essen, Germany
| | - Janina Köcke
- Department of Integrative Gastroenterology, Kliniken Essen-Mitte, University of Duisburg-Essen, Essen, Germany
| | - Holger Cramer
- Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, University of Duisburg-Essen, Essen, Germany
| | - Margarita Schöls
- Institute of Medical Psychology and Behavioral Immunobiology, University Hospital Essen, University of Duisburg-Essen, Essen, Germany; Department of Integrative Gastroenterology, Kliniken Essen-Mitte, University of Duisburg-Essen, Essen, Germany
| | - Jost Langhorst
- Department of Integrative Gastroenterology, Kliniken Essen-Mitte, University of Duisburg-Essen, Essen, Germany; Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, University of Duisburg-Essen, Essen, Germany; Chair for Integrative Medicine and Translational Gastroenterology, Klinikum Bamberg, Bamberg, Germany
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16
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Cramer H, Schäfer M, Schöls M, Köcke J, Elsenbruch S, Lauche R, Engler H, Dobos G, Langhorst J. Randomised clinical trial: yoga vs written self-care advice for ulcerative colitis. Aliment Pharmacol Ther 2017; 45:1379-1389. [PMID: 28378342 DOI: 10.1111/apt.14062] [Citation(s) in RCA: 35] [Impact Index Per Article: 4.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/25/2017] [Revised: 02/12/2017] [Accepted: 03/06/2017] [Indexed: 12/18/2022]
Abstract
BACKGROUND Perceived stress seems to be a risk factor for exacerbation of ulcerative colitis. Yoga has been shown to reduce perceived stress. AIMS To assess the efficacy and safety of yoga for improving quality of life in patients with ulcerative colitis. METHODS A total of 77 patients (75% women; 45.5 ± 11.9 years) with ulcerative colitis in clinical remission but impaired quality of life were randomly assigned to yoga (12 supervised weekly sessions of 90 min; n = 39) or written self-care advice (n = 38). Primary outcome was disease-specific quality of life (Inflammatory Bowel Disease Questionnaire). Secondary outcomes included disease activity (Rachmilewitz clinical activity index) and safety. Outcomes were assessed at weeks 12 and 24 by blinded outcome assessors. RESULTS The yoga group had significantly higher disease-specific quality of life compared to the self-care group after 12 weeks (Δ = 14.6; 95% confidence interval=2.6-26.7; P = 0.018) and after 24 weeks (Δ = 16.4; 95% confidence interval=2.5-30.3; P = 0.022). Twenty-one and 12 patients in the yoga group and in the self-care group, respectively, reached a clinical relevant increase in quality of life at week 12 (P = 0.048); and 27 and 17 patients at week 24 (P = 0.030). Disease activity was lower in the yoga group compared to the self-care group after 24 weeks (Δ = -1.2; 95% confidence interval=-0.1-[-2.3]; P = 0.029). Three and one patient in the yoga group and in the self-care group, respectively, experienced serious adverse events (P = 0.317); and seven and eight patients experienced nonserious adverse events (P = 0.731). CONCLUSIONS Yoga can be considered as a safe and effective ancillary intervention for patients with ulcerative colitis and impaired quality of life. TRIAL REGISTRATION ClinicalTrials.gov identifier: NCT02043600.
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Affiliation(s)
- H Cramer
- Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine Essen, University of Duisburg-Essen, Essen, Germany.,Australian Research Centre in Complementary and Integrative Medicine (ARCCIM), University of Technology Sydney, Sydney, NSW, Australia
| | - M Schäfer
- Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine Essen, University of Duisburg-Essen, Essen, Germany.,Department of Integrative Gastroenterology, Faculty of Medicine, University of Duisburg-Essen, Essen, Germany
| | - M Schöls
- Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine Essen, University of Duisburg-Essen, Essen, Germany.,Department of Integrative Gastroenterology, Faculty of Medicine, University of Duisburg-Essen, Essen, Germany.,Institute of Medical Psychology and Behavioral Immunobiology, University Hospital Essen, University of Duisburg-Essen, Essen, Germany
| | - J Köcke
- Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine Essen, University of Duisburg-Essen, Essen, Germany.,Department of Integrative Gastroenterology, Faculty of Medicine, University of Duisburg-Essen, Essen, Germany
| | - S Elsenbruch
- Institute of Medical Psychology and Behavioral Immunobiology, University Hospital Essen, University of Duisburg-Essen, Essen, Germany
| | - R Lauche
- Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine Essen, University of Duisburg-Essen, Essen, Germany.,Australian Research Centre in Complementary and Integrative Medicine (ARCCIM), University of Technology Sydney, Sydney, NSW, Australia
| | - H Engler
- Institute of Medical Psychology and Behavioral Immunobiology, University Hospital Essen, University of Duisburg-Essen, Essen, Germany
| | - G Dobos
- Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine Essen, University of Duisburg-Essen, Essen, Germany
| | - J Langhorst
- Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine Essen, University of Duisburg-Essen, Essen, Germany.,Department of Integrative Gastroenterology, Faculty of Medicine, University of Duisburg-Essen, Essen, Germany
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Berding A, Witte C, Gottschald M, Kaltz B, Weiland R, Gerlich C, Reusch A, Kruis W, Faller H. Beneficial Effects of Education on Emotional Distress, Self-Management, and Coping in Patients with Inflammatory Bowel Disease: A Prospective Randomized Controlled Study. Inflamm Intest Dis 2017; 1:182-190. [PMID: 29922675 DOI: 10.1159/000452989] [Citation(s) in RCA: 21] [Impact Index Per Article: 2.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/12/2016] [Accepted: 11/01/2016] [Indexed: 12/16/2022] Open
Abstract
BACKGROUND Patients with inflammatory bowel disease (IBD) suffer from various physical as well as psychological impairments, and patient education may help improve their well-being. Therefore, we developed a manualized education program for IBD patients addressing medical and psychological issues. This study aimed to evaluate it in a large controlled trial. METHODS A total of 181 IBD outpatients participated in a prospective, randomized, waitlist-controlled trial; assessments were made before as well as 2 weeks and 3 months after intervention. Analysis of covariance was used to assess intervention effects on disease-related worries and concerns (primary outcome), fear of progression, coping with anxiety, health competencies, health-related quality of life (HRQoL), perceived disease activity, symptoms of depression and anxiety, disease-related knowledge, and coping strategies. Participants' satisfaction with the program was also evaluated. RESULTS At 2 weeks and 3 months after intervention, we found significant large effects of our education program on skill and technique acquisition, knowledge, and coping with IBD. Moreover, we found significant medium effects on disease-related worries and concerns, fear of progression, coping with anxiety, constructive attitudes and approaches, as well as coping with disease-related negative emotions. The number of coping strategies used was significantly higher at 3 months. We did not find any effects on perceived disease activity, HRQoL, positive and active engagement in life, or symptoms of anxiety and depression. The program was rated very favorably by the attendees. CONCLUSION Our education program contributed to improvements in psychological distress, self-management skills, and coping and was appreciated by its attendees.
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Affiliation(s)
- Anja Berding
- German Crohn's and Colitis Association (DCCV e.V.), Berlin, Germany.,Department of Medical Psychology, Medical Sociology, and Rehabilitation Sciences, University of Würzburg, Würzburg, Germany
| | - Christine Witte
- German Crohn's and Colitis Association (DCCV e.V.), Berlin, Germany
| | | | - Birgit Kaltz
- German Crohn's and Colitis Association (DCCV e.V.), Berlin, Germany
| | - Romy Weiland
- Department of Medical Psychology, Medical Sociology, and Rehabilitation Sciences, University of Würzburg, Würzburg, Germany
| | - Christian Gerlich
- Department of Medical Psychology, Medical Sociology, and Rehabilitation Sciences, University of Würzburg, Würzburg, Germany
| | - Andrea Reusch
- Department of Medical Psychology, Medical Sociology, and Rehabilitation Sciences, University of Würzburg, Würzburg, Germany
| | - Wolfgang Kruis
- Department of Internal Medicine, Protestant Hospital Kalk, Cologne, Germany
| | - Hermann Faller
- Department of Medical Psychology, Medical Sociology, and Rehabilitation Sciences, University of Würzburg, Würzburg, Germany
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Reusch A, Weiland R, Gerlich C, Dreger K, Derra C, Mainos D, Tuschhoff T, Berding A, Witte C, Kaltz B, Faller H. Self-management education for rehabilitation inpatients suffering from inflammatory bowel disease: a cluster-randomized controlled trial. HEALTH EDUCATION RESEARCH 2016; 31:782-791. [PMID: 27651394 DOI: 10.1093/her/cyw042] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 05/13/2016] [Accepted: 09/02/2016] [Indexed: 06/06/2023]
Abstract
Although inflammatory bowel disease (IBD) affects patients' psychological well-being, previous educational programs have failed to demonstrate effects on psychosocial outcomes and quality of life. Therefore, we developed a group-based psychoeducational program that combined provision of both medical information and psychological self-management skills, delivered in an interactive manner, and evaluated it in a large, cluster-randomized trial. We assigned 540 rehabilitation inpatients suffering from IBD (mean age 43 years, 66% female) to either the new intervention or a control group comprising the same overall intensity and the same medical information, but only general psychosocial information. The primary outcome was patient-reported IBD-related concerns. Secondary outcomes included disease knowledge, coping, self-management skills, fear of progression, anxiety, depression and quality of life. Assessments took place at baseline, end of rehabilitation and after 3 and 12 months.The psychoeducational self-management program did not prove superior to the control group regarding primary and secondary outcomes. However, positive changes over time occurred in both groups regarding most outcomes. The superior effectiveness of the newly developed psychoeducational program could not be demonstrated. Since the intervention and control groups may have been too similar, this trial may have been too conservative to produce between-group effects.
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Affiliation(s)
- A Reusch
- Department of Medical Psychology and Psychotherapy, Medical Sociology and Rehabilitation Sciences, University of Würzburg, Klinikstr. 3, Würzburg, D 97070, Germany
| | - R Weiland
- Department of Medical Psychology and Psychotherapy, Medical Sociology and Rehabilitation Sciences, University of Würzburg, Klinikstr. 3, Würzburg, D 97070, Germany
| | - C Gerlich
- Department of Medical Psychology and Psychotherapy, Medical Sociology and Rehabilitation Sciences, University of Würzburg, Klinikstr. 3, Würzburg, D 97070, Germany
| | - K Dreger
- Department of Medical Psychology and Psychotherapy, Medical Sociology and Rehabilitation Sciences, University of Würzburg, Klinikstr. 3, Würzburg, D 97070, Germany
- Rehabilitation Centre Bad Mergentheim, Clinic Taubertal, Bad Mergentheim, 97980, Germany
| | - C Derra
- Rehabilitation Centre Bad Mergentheim, Clinic Taubertal, Bad Mergentheim, 97980, Germany
| | - D Mainos
- Rehabilitation Centre Bad Mergentheim, Clinic Taubertal, Bad Mergentheim, 97980, Germany
| | - T Tuschhoff
- Rehabilitation Centre Bad Mergentheim, Clinic Taubertal, Bad Mergentheim, 97980, Germany
| | - A Berding
- Department of Medical Psychology and Psychotherapy, Medical Sociology and Rehabilitation Sciences, University of Würzburg, Klinikstr. 3, Würzburg, D 97070, Germany
- German Crohn's and Colitis Association (Deutsche Morbus Crohn/Colitis ulcerosa Vereinigung, DCCV e.V.), Berlin, 10179, Germany
| | - C Witte
- German Crohn's and Colitis Association (Deutsche Morbus Crohn/Colitis ulcerosa Vereinigung, DCCV e.V.), Berlin, 10179, Germany
| | - B Kaltz
- German Crohn's and Colitis Association (Deutsche Morbus Crohn/Colitis ulcerosa Vereinigung, DCCV e.V.), Berlin, 10179, Germany
| | - H Faller
- Department of Medical Psychology and Psychotherapy, Medical Sociology and Rehabilitation Sciences, University of Würzburg, Klinikstr. 3, Würzburg, D 97070, Germany
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Volz MS, Farmer A, Siegmund B. Reduction of chronic abdominal pain in patients with inflammatory bowel disease through transcranial direct current stimulation: a randomized controlled trial. Pain 2016; 157:429-437. [PMID: 26469395 DOI: 10.1097/j.pain.0000000000000386] [Citation(s) in RCA: 37] [Impact Index Per Article: 4.1] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/25/2022]
Abstract
Inflammatory bowel disease (IBD) is frequently associated with chronic abdominal pain (CAP). Transcranial direct current stimulation (tDCS) has been proven to reduce chronic pain. This study aimed to investigate the effects of tDCS in patients with CAP due to IBD. This randomized, sham-controlled, double blind, parallel-designed study included 20 patients with either Crohn disease or ulcerative colitis with CAP (≥3/10 on the visual analog scale (VAS) in 3/6 months). Anodal or sham tDCS was applied over the primary motor cortex for 5 consecutive days (2 mA, 20 minutes). Assessments included VAS, pressure pain threshold, inflammatory markers, and questionnaires on quality of life, functional and disease specific symptoms (Irritable Bowel Syndrome-Severity Scoring System [IBS-SSS]), disease activity, and pain catastrophizing. Follow-up data were collected 1 week after the end of the stimulation. Statistical analyses were performed using analysis of variance and t tests. There was a significant reduction of abdominal pain in the anodal tDCS group compared with sham tDCS. This effect was evident in changes in VAS and pressure pain threshold on the left and right sides of the abdomen. In addition, 1 week after stimulation, pain reduction remained significantly decreased in the right side of the abdomen. There was also a significant reduction in scores on pain catastrophizing and on IBS-SSS when comparing both groups. Inflammatory markers and disease activity did not differ significantly between groups throughout the experiment. Transcranial direct current stimulation proved to be an effective and clinically relevant therapeutic strategy for CAP in IBD. The analgesic effects observed are unrelated to inflammation and disease activity, which emphasizes central pain mechanisms in CAP.
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Affiliation(s)
- Magdalena S Volz
- Department of Medicine I (Gastroenterology, Infectious Diseases, Rheumatology), Charité-Universitätsmedizin Berlin, Berlin, Germany
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Burkhalter H, Stucki-Thür P, David B, Lorenz S, Biotti B, Rogler G, Pittet V. Assessment of inflammatory bowel disease patient's needs and problems from a nursing perspective. Digestion 2015; 91:128-41. [PMID: 25677558 DOI: 10.1159/000371654] [Citation(s) in RCA: 9] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/11/2014] [Accepted: 12/18/2014] [Indexed: 02/04/2023]
Abstract
BACKGROUND In this study, we aimed at assessing Inflammatory Bowel Disease patients' needs and current nursing practice to investigate to what extent consensus statements (European Crohn's and Colitis Organization) on the nursing roles in caring for patients with IBD concur with local practice. METHODS We used a mixed-method convergent design to combine quantitative data prospectively collected in the Swiss IBD cohort study and qualitative data from structured interviews with IBD healthcare experts. Symptoms, quality of life, and anxiety and depression scores were retrieved from physician charts and patient self-reported questionnaires. Descriptive analyses were performed based on quantitative and qualitative data. RESULTS 230 patients of a single center were included, 60% of patients were males, and median age was 40 (range 18-85). The prevalence of abdominal pain was 42%. Self-reported data were obtained from 75 out of 230 patients. General health was perceived significantly lower compared with the general population (p < 0.001). Prevalence of tiredness was 73%; sleep problems, 78%; issues related to work, 20%; sexual constraints, 35%; diarrhea, 67%; being afraid of not finding a bathroom, 42%; depression, 11%; and anxiety symptoms, 23%. According to experts' interviews, the consensus statements are found mostly relevant with many recommendations that are not yet realized in clinical practice. CONCLUSION Identified prevalence may help clinicians in detecting patients at risk and improve patient management.
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Affiliation(s)
- Hanna Burkhalter
- Department of Abdominal Surgery, University Hospital Zurich, Zurich, Switzerland
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Alrubaiy L, Rikaby I, Dodds P, Hutchings HA, Williams JG. Systematic review of health-related quality of life measures for inflammatory bowel disease. J Crohns Colitis 2015; 9:284-92. [PMID: 25576752 DOI: 10.1093/ecco-jcc/jjv002] [Citation(s) in RCA: 55] [Impact Index Per Article: 5.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/27/2022]
Abstract
BACKGROUND AND AIM Several measures have been developed to assess the health-related quality of life [HRQoL] of patients with inflammatory bowel disease [IBD]. Our aim is to systematically review the HRQoL measures specific for patients with IBD and to appraise their measurement properties and methodological quality. METHODS We searched the PubMed, Embase, and PsycINFO databases for original articles describing the development and/or evaluation of one or more of the measurement properties [e.g. internal consistency, reliability, validity, responsiveness] of HRQoL measures specific for IBD. We assessed the measurement properties and examined the methodological quality of the measurement properties of each instrument using a standardized checklist. RESULTS We examined the full text of 75 articles that we deemed potentially eligible and identified 10 disease-specific HRQoL measures in IBD that covered different aspects of patients' lives. Internal consistency, construct validity, and content validity were the commonly evaluated measurement properties. Seven HRQoL measures scored positive for at least four of eight measurement properties. The majority of studies were rated as 'fair' to 'poor' when assessing their methodology quality. The most established HRQoL measure in the literature was the Inflammatory Bowel Disease Questionnaire [IBDQ]. CONCLUSIONS Most of the included HRQoL measures did not include all the required measurement properties or had a problem with their methodological quality. The most widely used and validated measure was the IBDQ. Further validation studies are required to support the use of other HRQoL measures.
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Affiliation(s)
- Laith Alrubaiy
- Patient and Population Health and Informatics Research, College of Medicine, Swansea University, Swansea, UK
| | - Ibtihal Rikaby
- Cardiff and Vale University Health Board, Heath Park, Cardiff, UK
| | - Phedra Dodds
- Patient and Population Health and Informatics Research, College of Medicine, Swansea University, Swansea, UK
| | - Hayley Anne Hutchings
- Patient and Population Health and Informatics Research, College of Medicine, Swansea University, Swansea, UK
| | - John Gordon Williams
- Patient and Population Health and Informatics Research, College of Medicine, Swansea University, Swansea, UK
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Alrubaiy L, Hutchings HA, Williams JG. Assessing patient reported outcome measures: A practical guide for gastroenterologists. United European Gastroenterol J 2014; 2:463-70. [PMID: 25452841 DOI: 10.1177/2050640614558345] [Citation(s) in RCA: 40] [Impact Index Per Article: 3.6] [Reference Citation Analysis] [Abstract] [Key Words] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/18/2014] [Accepted: 10/10/2014] [Indexed: 12/12/2022] Open
Abstract
Gastrointestinal illnesses cause physical, emotional and social impact on patients. Patient reported outcome measures (PROMs) are increasingly used in clinical decision-making, clinical research and approval of new therapies. In the last decade, there has been a rapid increase in the number of PROMs in gastroenterology and, therefore, the choice between which of these PROMs to use can be difficult. Not all PROM instruments currently used in research and clinical practice in gastroenterology have gone through a rigorous development methodology. New drugs and therapies will not have access to the market if the PROMs used in their clinical trials are not validated according to the guidelines of the international agencies. Therefore, it is important to know the required properties of PROMs when choosing or evaluating a drug or a clinical intervention. This paper reviews the current literature on how to assess the validity and reliability of PROMs. It summarises the required properties into a practical guide for gastroenterologists to use in assessing an instrument for use in clinical practice or research.
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Affiliation(s)
- Laith Alrubaiy
- Patient and Population Health and Informatics Research, Swansea University, Swansea, UK
| | - Hayley A Hutchings
- Patient and Population Health and Informatics Research, Swansea University, Swansea, UK
| | - John G Williams
- Patient and Population Health and Informatics Research, Swansea University, Swansea, UK
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Sexual function and quality of life after surgical treatment for anal fistulas in Crohn's disease. Tech Coloproctol 2012; 17:89-94. [PMID: 22956209 DOI: 10.1007/s10151-012-0890-x] [Citation(s) in RCA: 44] [Impact Index Per Article: 3.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/07/2012] [Accepted: 08/07/2012] [Indexed: 01/03/2023]
Abstract
BACKGROUND The aim of this study was to assess sexual function and quality of life (QoL) in patients after surgery for perianal Crohn's disease. METHODS Eighty-eight consecutive patients with perianal Crohn's disease, operated on at the Medical University of Vienna, completed a self-administered questionnaire including the International Index of Erectile Function (IIEF), Female Sexual Function Index (FSFI), Short Form-12 Health Survey (SF-12), and the Inflammatory Bowel Disease Questionnaire (IBDQ). Patients with a current stoma were excluded from further analysis. The median follow-up time was 104 months (range 3-186 months). Healthy subjects served as controls for each case and were matched by age (±6 years) and gender. Forty-seven (68 %) female and 22 male patients with a median age of 46.5 years (range 18-64 years) were analyzed. Eleven (16 %) patients had simple and 58 (84 %) complex anal fistulas. RESULTS The median SF-12 physical health score of the patients was significantly lower (47.9 (range 25.5-57.2)) than that of the controls (54.3 (range 34.6-61.8); p = 0.03). Not surprisingly, the median total sore of the IBDQ of the controls was significantly better than that of the patients (controls: 188.5 (range 125-206.5), patients: 157 (range 60-199.5); p < 0.0001). Analysis with the multiple logistic regression test showed that type of operation, >1 perianal fistula opening, and active Crohn's disease were independent risk factors for a worse IBDQ (p = 0.03, p = 0.015 and p < 0.0001). Interestingly, the median FSFI and IIEF score were not found to be significant different in any domain. CONCLUSIONS QoL but not sexual function is significantly influenced by surgery for perianal Crohn's disease.
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Boye B, Lundin KEA, Jantschek G, Leganger S, Mokleby K, Tangen T, Jantschek I, Pripp AH, Wojniusz S, Dahlstroem A, Rivenes AC, Benninghoven D, Hausken T, Roseth A, Kunzendorf S, Wilhelmsen I, Sharpe M, Blomhoff S, Malt UF, Jahnsen J. INSPIRE study: does stress management improve the course of inflammatory bowel disease and disease-specific quality of life in distressed patients with ulcerative colitis or Crohn's disease? A randomized controlled trial. Inflamm Bowel Dis 2011; 17:1863-73. [PMID: 21287660 DOI: 10.1002/ibd.21575] [Citation(s) in RCA: 77] [Impact Index Per Article: 5.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/22/2010] [Accepted: 10/11/2010] [Indexed: 12/12/2022]
Abstract
BACKGROUND The use of stress management psychotherapy is hypothesized to produce greater improvement in disease course and disease-specific quality of life (IBDQ) compared to usual medical care alone in patients with ulcerative colitis (UC) or Crohn's disease (CD) showing high levels of stress (based on the Perceived Stress Questionnaire [PSQ]). METHODS Fifty-eight patients with UC and 56 patients with CD who had experienced continuous disease activity or had relapsed over the previous 18 months, with an activity index for UC or CD ≥ 4, a PSQ ≥ 60, and without serious psychiatric disorders or other serious medical conditions were randomized to receive either treatment as usual (TAU) or TAU plus stress management psychotherapy. Psychotherapy consisted of three group sessions (psychoeducation, problem-solving, relaxation) and 6-9 individual sessions based on cognitive behavior therapy-related methods with 1-3 booster sessions at 6 and 12 months follow-up. Gastroenterologists blinded to intervention group assessed disease activity and course at baseline and at 3, 6, 12, and 18 months. Patients completed the IBDQ at baseline, 6, 12, and 18 months. RESULTS The intervention did not improve disease or reduce relapse; however, it increased the IBDQ score (P = 0.009, mean differences 16.3 [SD 6.1]). On analysis of UC and CD separately, improvement of IBDQ was only found in the UC group. CONCLUSIONS Stress management psychotherapy does not appear to improve disease course or reduce relapse in patients with IBD. It might improve quality of life, particularly in patients with UC.
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Affiliation(s)
- Birgitte Boye
- Department of Neuropsychiatry and Psychosomatic Medicine, Oslo University Hospital, Norway.
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Liu FB, Li XY. Research of the quality of life of patients with ulcerative colitis: current status and future prospects. Shijie Huaren Xiaohua Zazhi 2011; 19:498-504. [DOI: 10.11569/wcjd.v19.i5.498] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/07/2023] Open
Abstract
Since there is a currently increasing incidence of ulcerative colitis (UC) in China, the research of the quality of life (QOL) of UC patients is of great significance. UC influences many aspects of patients' QOL, including physical functions, psychological functions, social relationship, and emotional functions. There are generic and specific instruments available for the estimation of the QOL of UC patients, and the combination of them can be more informative. Compared to abundant findings obtained in developed countries, the research of the QOL of UC patients is still in infancy stage in China. Therefore, it is essential to conduct extensive research of the QOL of UC patients to improve the efficacy of possible interventions.
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Holtmeier W, Zeuzem S, Preiss J, Kruis W, Böhm S, Maaser C, Raedler A, Schmidt C, Schnitker J, Schwarz J, Zeitz M, Caspary W. Randomized, placebo-controlled, double-blind trial of Boswellia serrata in maintaining remission of Crohn's disease: good safety profile but lack of efficacy. Inflamm Bowel Dis 2011; 17:573-82. [PMID: 20848527 DOI: 10.1002/ibd.21345] [Citation(s) in RCA: 52] [Impact Index Per Article: 3.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/17/2022]
Abstract
BACKGROUND Complementary therapies are frequently used by patients with inflammatory bowel disease (IBD). The aim of this study was to evaluate the efficacy and safety of long-term therapy with a new Boswellia serrata extract (Boswelan, PS0201Bo) in maintaining remission in patients with Crohn's disease (CD). METHODS In 22 German centers a double-blind, placebo-controlled, randomized, parallel study was performed. In all, 108 outpatients with CD in clinical remission were included. Patients were randomized to Boswelan (3×2 capsules/day; 400 mg each) or placebo for 52 weeks. The primary endpoint was the proportion of patients in whom remission was maintained throughout the 52 weeks. Secondary endpoints were time to relapse, changes of Crohn's Disease Activity Index (CDAI), and IBD Questionnaire (IBDQ) scores. RESULTS The trial was prematurely terminated due to insufficient discrimination of drug and placebo with regard to the primary efficacy endpoint. A total of 82 patients were randomized to Boswelan (n=42) or placebo (n=40). Sixty-six patients could be analyzed for efficacy. 59.9% of the actively treated patients and 55.3% of the placebo group stayed in remission (P=0.85). The mean time to diagnosis of relapse was 171 days for the active group and 185 days for the placebo group (P=0.69). With respect to CDAI, IBDQ, and laboratory measurements of inflammation, no advantages in favor of active treatment were detected. Regarding safety concerns, no disadvantages of taking the drug compared to placebo were observed. CONCLUSIONS The trial confirmed good tolerability of a new Boswellia serrata extract, Boswelan, in long-term treatment of CD. However, superiority versus placebo in maintenance therapy of remission could not be demonstrated.
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Affiliation(s)
- Wolfgang Holtmeier
- Department of Gastroenterology, Diabetes and Internal Medicine, Hospital Porz am Rhein, Cologne, Germany.
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Lam MY, Lee H, Bright R, Korzenik JR, Sands BE. Validation of interactive voice response system administration of the Short Inflammatory Bowel Disease Questionnaire. Inflamm Bowel Dis 2009; 15:599-607. [PMID: 19023897 DOI: 10.1002/ibd.20803] [Citation(s) in RCA: 15] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/28/2022]
Abstract
BACKGROUND The Short Inflammatory Bowel Disease Questionnaire (SIBDQ) is a written, self-administered instrument measuring quality of life in IBD. We assessed the validity of an interactive voice response system (IVRS) as a new mode of administering the SIBDQ. METHODS An IVRS was designed using prerecorded questions to collect data via touchtone telephone. Subjects with Crohn's disease (CD) or ulcerative colitis (UC) were randomized into 2 groups with different orders of administration: written, self-administered followed by IVRS (S-I) or IVRS followed by written, self-administered (I-S). Half of the S-I group was also randomized to receive a second IVRS. Sixty-four subjects were studied: 30 in S-I, 34 in I-S. RESULTS The mean SIBDQ scores were not different between written and IVRS modes (P = 0.26) with r = 0.93. IVRS scores were lower in active than inactive CD (36.1 +/- 9.6 versus 54.7 +/- 8.6, P < 0.001) and lower in active than inactive UC (40.8 +/- 9.6 versus 59.8 +/- 10.0, P < 0.001). Mean scores correlated highly with disease activity indices, and were not different between first and second IVRS administrations (P = 0.85) with r = 0.92. IVRS had excellent internal consistency (Cronbach alpha = 0.90). CONCLUSIONS IVRS administration of the SIBDQ yields results similar to written self-administration, with excellent procedural validity, test-retest reliability, and internal consistency.
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Affiliation(s)
- Manuel Y Lam
- MGH Crohn's & Colitis Center and Gastrointestinal Unit, Massachusetts General Hospital and Harvard Medical School, Boston, MA 02114, USA
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[Is evidence-based assessment fact or fiction? A bibliometric analysis of three German journals]. ZEITSCHRIFT FUR PSYCHOSOMATISCHE MEDIZIN UND PSYCHOTHERAPIE 2008; 54:393-408. [PMID: 19049688 DOI: 10.13109/zptm.2008.54.4.393] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 11/27/2022]
Abstract
OBJECTIVES Despite the ongoing process for the development and dissemination of empirically supported treatments, little attention has been paid to the development of evidence-based diagnostics. The article aims at evaluating diagnostic procedures and instruments in current clinical research in terms of evidence-based assessment. METHODS Volumes 2006 and 2007 of three German psychological journals "Psychotherapeut," "Psychotherapie, Psychosomatik und Medizinische Psychologie," and "Zeitschrift für Psychiatrie, Psychologie und Psychotherapie" were screened for empirical reports and articles dealing with diagnostic issues. 93 articles were identified and evaluated. RESULTS Most studies used psychometrically valid and established instruments for assessment. However, diagnostic interviews were relatively scarce, as were multimodal assessments. Measures used for outcome evaluation often lacked evidence of sensitivity to change. CONCLUSION Clinical assessment to date does not meet criteria for evidence-based diagnostics. Implications for research and guideline development are discussed.
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Roggenbuck C, Lammert F, Berthold HK, Giese T, Stallmach A, Stehle P, Ellinger S. High-dose oral supplementation of antioxidants and glutamine improves the antioxidant status in patients with Crohn's disease: A pilot study. ACTA ACUST UNITED AC 2008. [DOI: 10.1016/j.eclnm.2008.06.012] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/10/2023]
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Boye B, Jahnsen J, Mokleby K, Leganger S, Jantschek G, Jantschek I, Kunzendorf S, Benninghoven D, Wilhelmsen I, Sharpe M, Blomhoff S, Malt UF, Lundin KEA. The INSPIRE study: are different personality traits related to disease-specific quality of life (IBDQ) in distressed patients with ulcerative colitis and Crohn's disease? Inflamm Bowel Dis 2008; 14:680-6. [PMID: 18509900 DOI: 10.1002/ibd.20367] [Citation(s) in RCA: 36] [Impact Index Per Article: 2.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/06/2023]
Abstract
BACKGROUND To explore the relationship between personality and disease-specific quality of life [Inflammatory Bowel Disease Questionnaire (IBDQ)] in distressed [Perceived Stress Questionnaire (PSQ)] patients with ulcerative colitis (UC) and Crohn's disease (CD). METHODS Included in the study were 56 patients with UC and 54 patients with CD ranging in age from 18 to 60 years with a relapse in the previous 18 months, a UC or CD activity index 4, a PSQ 60, and without serious mental or other serious medical condition. The patients completed the Buss-Perry Aggression Questionnaire, the Neuroticism and Lie (social conformity/desirability) scales of the Eysenck Personality Questionnaire, the Multidimensional Health Locus of Control (LOC) Scale [Internal (I), Powerful Other (PO), Chance (C)], the Toronto Alexithymia Scale, and the IBDQ. RESULTS In linear regression controlling for sex, education (years), and clinical disease activity (AI) in separate analyses of UC and CD patients, higher IBDQ score was related to less social conformity in CD and less neuroticism in UC; higher emotional function score was related to less neuroticism in both CD and UC and less PO-LOC in UC. Higher social function score was related to less social conformity in CD and lower I-LOC and PO-LOC in UC. Bowel function and systemic symptoms were unrelated to personality in either UC or CD. CONCLUSIONS Although the emotional function subscale was related to neuroticism in both UC and CD, the social function subscale and total IBDQ were related to different personality traits in UC and CD. Personality traits should be taken into account when using IBDQ in studies.
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Affiliation(s)
- Birgitte Boye
- Institute of Psychiatry, University of Oslo, Norway.
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Schmidt C, Häuser W, Giese T, Stallmach A. Irritable pouch syndrome is associated with depressiveness and can be differentiated from pouchitis by quantification of mucosal levels of proinflammatory gene transcripts. Inflamm Bowel Dis 2007; 13:1502-8. [PMID: 17712839 DOI: 10.1002/ibd.20241] [Citation(s) in RCA: 11] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/18/2022]
Abstract
BACKGROUND Pouchitis and irritable pouch syndrome (IPS) are 2 of the most frequent sequelae of ileal pouch-anal anastomosis (IPAA) after restorative proctocolectomy in patients with ulcerative colitis. These complications can compromise the gain in health-related quality of life (HRQOL) substantially. The pathophysiological mechanisms underlying IPS and the predictors of HRQOL in IPS have not been studied so far. METHODS In IPAA patients in remission (n = 10), patients with pouchitis (n = 18) and patients with IPS (n = 15) symptoms, endoscopical and histological patterns, anxiety and depressiveness (Hospital Anxiety and Depression Scale HADS), and HRQOL scores (Inflammatory Bowel Disease Questionnaire, IBDQ-D) were assessed. Mucosal expression of 5 proinflammatory gene transcripts (MRP-14, IL-1beta, IL-8, MIP-2alpha, and MMP-1) were quantified using real-time polymerase chain reaction. RESULTS Clinical symptoms and HRQOL differed significantly (P < 0.01) between patients in remission on the one hand and those with pouchitis or IPS on the other. However, between IPS and pouchitis no such differences could be found. Depressiveness scores differed between IPS and patients in remission (P = 0.05). HRQOL in IPS was predicted by depressiveness (P < 0.001). Cytokine transcripts discriminated between pouchitis and IPS (P < 0.01), whereas between IPS patients and asymptomatic patients no such differences were observed. CONCLUSIONS Patients with IPS and pouchitis cannot be differentiated by clinical symptoms or HRQOL, which is associated with depressiveness in IPS patients. IPS is a noninflammatory sequela in IPAA patients that shares clinical features with IBD. Quantification of mucosal proinflammatory gene transcripts differentiates objectively and simply between IPS and pouchitis.
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Affiliation(s)
- Carsten Schmidt
- Department of Gastroenterology, Hepatology and Infectology, Friedrich Schiller University Jena, Germany
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Stöbel-Richter Y, Berger U, Watzke B, Luppa M. Erfassung der sozialen Ungleichheit in empirischen Untersuchungen. PSYCHOTHERAPEUT 2007. [DOI: 10.1007/s00278-007-0567-5] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 12/01/2022]
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