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      Patient-Reported Impact of Symptoms in Crohn's Disease

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          INTRODUCTION:

          Patients with Crohn's disease (CD) experience a variety of symptoms that significantly affect their lives. In this study, we (i) ascertain the most prevalent and impactful symptoms in CD and (ii) identify modifying factors that are associated with a higher disease burden in CD.

          METHODS:

          We conducted semistructured interviews with adult participants with CD to determine what issues have the greatest impact on their lives. Next, we conducted a large cross-sectional study of individuals with CD to determine the prevalence and relative importance of those symptoms and themes and to identify the demographic features that are associated with a higher disease burden.

          RESULTS:

          Sixteen individuals with CD provided 792 direct quotes regarding their symptomatic burden. Four hundred three people with CD participated in our cross-sectional study. The symptomatic themes with the highest prevalence in CD were gastrointestinal issues (93.0%), fatigue (86.4%), dietary restrictions (77.9%), and impaired sleep or daytime sleepiness (75.6%). The symptomatic themes that had the greatest impact on patients' lives (0–4 scale) related to fatigue (1.82), impaired sleep or daytime sleepiness (1.71), gastrointestinal issues (1.66), and dietary restrictions (1.61). Symptomatic theme prevalence was strongly associated with a higher number of soft stools per day, greater number of bowel movements per day, missed work, employment and disability status, and having perianal disease.

          DISCUSSION:

          Patients with CD experience numerous symptoms that affect their daily life. These symptoms, some underrecognized, vary based on disease and demographic characteristics and represent potential targets for future therapeutic interventions.

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          Most cited references44

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          Increasing incidence and prevalence of the inflammatory bowel diseases with time, based on systematic review.

          We conducted a systematic review to determine changes in the worldwide incidence and prevalence of ulcerative colitis (UC) and Crohn's disease (CD) in different regions and with time. We performed a systematic literature search of MEDLINE (1950-2010; 8103 citations) and EMBASE (1980-2010; 4975 citations) to identify studies that were population based, included data that could be used to calculate incidence and prevalence, and reported separate data on UC and/or CD in full manuscripts (n = 260). We evaluated data from 167 studies from Europe (1930-2008), 52 studies from Asia and the Middle East (1950-2008), and 27 studies from North America (1920-2004). Maps were used to present worldwide differences in the incidence and prevalence of inflammatory bowel diseases (IBDs); time trends were determined using joinpoint regression. The highest annual incidence of UC was 24.3 per 100,000 person-years in Europe, 6.3 per 100,000 person-years in Asia and the Middle East, and 19.2 per 100,000 person-years in North America. The highest annual incidence of CD was 12.7 per 100,000 person-years in Europe, 5.0 person-years in Asia and the Middle East, and 20.2 per 100,000 person-years in North America. The highest reported prevalence values for IBD were in Europe (UC, 505 per 100,000 persons; CD, 322 per 100,000 persons) and North America (UC, 249 per 100,000 persons; CD, 319 per 100,000 persons). In time-trend analyses, 75% of CD studies and 60% of UC studies had an increasing incidence of statistical significance (P < .05). Although there are few epidemiologic data from developing countries, the incidence and prevalence of IBD are increasing with time and in different regions around the world, indicating its emergence as a global disease. Copyright © 2012 AGA Institute. Published by Elsevier Inc. All rights reserved.
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            Characterising and justifying sample size sufficiency in interview-based studies: systematic analysis of qualitative health research over a 15-year period

            Background Choosing a suitable sample size in qualitative research is an area of conceptual debate and practical uncertainty. That sample size principles, guidelines and tools have been developed to enable researchers to set, and justify the acceptability of, their sample size is an indication that the issue constitutes an important marker of the quality of qualitative research. Nevertheless, research shows that sample size sufficiency reporting is often poor, if not absent, across a range of disciplinary fields. Methods A systematic analysis of single-interview-per-participant designs within three health-related journals from the disciplines of psychology, sociology and medicine, over a 15-year period, was conducted to examine whether and how sample sizes were justified and how sample size was characterised and discussed by authors. Data pertinent to sample size were extracted and analysed using qualitative and quantitative analytic techniques. Results Our findings demonstrate that provision of sample size justifications in qualitative health research is limited; is not contingent on the number of interviews; and relates to the journal of publication. Defence of sample size was most frequently supported across all three journals with reference to the principle of saturation and to pragmatic considerations. Qualitative sample sizes were predominantly – and often without justification – characterised as insufficient (i.e., ‘small’) and discussed in the context of study limitations. Sample size insufficiency was seen to threaten the validity and generalizability of studies’ results, with the latter being frequently conceived in nomothetic terms. Conclusions We recommend, firstly, that qualitative health researchers be more transparent about evaluations of their sample size sufficiency, situating these within broader and more encompassing assessments of data adequacy. Secondly, we invite researchers critically to consider how saturation parameters found in prior methodological studies and sample size community norms might best inform, and apply to, their own project and encourage that data adequacy is best appraised with reference to features that are intrinsic to the study at hand. Finally, those reviewing papers have a vital role in supporting and encouraging transparent study-specific reporting. Electronic supplementary material The online version of this article (10.1186/s12874-018-0594-7) contains supplementary material, which is available to authorized users.
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              STRIDE-II: An Update on the Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE) Initiative of the International Organization for the Study of IBD (IOIBD): Determining Therapeutic Goals for Treat-to-Target strategies in IBD

              The Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE) initiative of the International Organization for the Study of Inflammatory Bowel Diseases (IOIBD) has proposed treatment targets in 2015 for adult patients with inflammatory bowel disease (IBD). We aimed to update the original STRIDE statements for incorporating treatment targets in both adult and pediatric IBD.
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                Author and article information

                Contributors
                Journal
                Am J Gastroenterol
                Am J Gastroenterol
                AJGAST
                ACG
                The American Journal of Gastroenterology
                Wolters Kluwer (Philadelphia, PA )
                0002-9270
                1572-0241
                December 2022
                22 August 2022
                : 117
                : 12
                : 2033-2045
                Affiliations
                [1 ]Center for Health + Technology, Rochester, New York, USA;
                [2 ]Department of Neurology, University of Rochester, Rochester, New York, USA;
                [3 ]Pittsford Sutherland High School, Pittsford, New York, USA;
                [4 ]Department of Medicine and Pediatrics, University of Rochester, Rochester, New York, USA;
                [5 ]Department of Colorectal Surgery, University of Rochester, Rochester, New York, USA;
                [6 ]Barclay Damon LLP, Rochester, New York, USA.
                Author notes
                Correspondence: Chad Heatwole, MD, MS-CI. E-mail: chad_heatwole@ 123456urmc.rochester.edu .
                Article
                AJG-22-0675 00027
                10.14309/ajg.0000000000001954
                9722385
                36375002
                c94eb184-5a47-4ce0-9ce0-c79420c5eb33
                Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of The American College of Gastroenterology

                This is an open access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.

                History
                : 11 March 2022
                : 05 July 2022
                Categories
                Article
                Inflammatory Bowel Disease
                Custom metadata
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                T

                Gastroenterology & Hepatology
                Gastroenterology & Hepatology

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