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Lin Chang - One of the best experts on this subject based on the ideXlab platform.
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Gastrointestinal Symptom severity in irritable bowel syndrome inflammatory bowel disease and the general population
Neurogastroenterology and Motility, 2017Co-Authors: A D Lee, Ron D Hays, Gil Y Melmed, Puja P Khanna, Dinesh Khanna, Roger Bolus, B M Spiegel, Lin ChangAbstract:Background Irritable bowel syndrome (IBS) and inflammatory bowel disease (IBD) patients report similar Gastrointestinal (GI) Symptoms, yet comparisons of Symptom severity between groups and with the general population (GP) are lacking. Methods We compared Patient-Reported Outcomes Measurement Information System (PROMIS®) GI Symptom scales measuring gastro-esophageal reflux (GER), disrupted swallowing, diarrhea, bowel incontinence, nausea/vomiting, constipation, belly pain, and gas/bloating in: (i) USA GP sample, (ii) IBS patients, and (iii) IBD patients from tertiary care and community populations. Symptom severity scores were based on T-score metric with mean 50±10 (standard deviation) relative to the GP. Key Results Of 1643 patients enrolled, there were 253 IBS patients (68% F, mean age 45±15 years), 213 IBD patients (46% F, mean age 41±14 years), and 1177 GP subjects (57% F, mean age 46±16 years). IBS patients reported greater severity of GER, disrupted swallowing, nausea/vomiting, belly pain, gas/bloating, and constipation Symptoms than their IBD counterparts (all P<.05). Compared to the GP, IBD patients had worse belly pain, gas/bloating, diarrhea, and bowel incontinence, but less severe GER and disrupted swallowing (all P<.05), and IBS patients had more severe nausea/vomiting, belly pain, gas/bloating, and constipation (all P<.05). Women had more severe belly pain and gas/bloating than men, whereas men had more severe bowel incontinence (all P<.05). Conclusion & Inferences IBS and IBD are associated with more severe GI Symptoms compared to the GP excluding esophageal Symptoms. Unlike IBD, IBS is not characterized by observable GI inflammation but patients report more severe upper and lower GI Symptoms.
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adverse childhood experiences are associated with irritable bowel syndrome and Gastrointestinal Symptom severity
Neurogastroenterology and Motility, 2016Co-Authors: S H Park, Emeran A Mayer, Elizabeth J Videlock, Wendy Shih, Angela P Presson, Lin ChangAbstract:Background Early adverse life events (EALs) are associated with irritable bowel syndrome (IBS). Exposure to EALs as assessed by the Adverse Childhood Experiences (ACE) questionnaire is associated with greater disease prevalence, but ACE has not been studied in Gastrointestinal disorders. Study aims were to: (i) Estimate the prevalence of EALs in the IBS patients using the ACE questionnaire; (ii) Determine correlations between ACE and Early Trauma Inventory Self Report-Short Form (ETI-SR) scores to confirm its validity in IBS; and (iii) Correlate ACE scores with IBS Symptom severity. Methods A total of 148 IBS (73% women, mean age = 31 years) and 154 HCs (59% women, mean age = 30 years) completed the ACE and ETI-SR between June 2010 and April 2015. These surveys measured EALs before age 18 in the domains of physical, sexual, and emotional abuse, and general trauma. IBS and abdominal pain severity was measured by a 20-point scale (0 = none, 20 = worst Symptoms). Key Results The ACE score increased the odds of having IBS (odds ratio [OR] = 2.05, 95% confidence interval [CI]: 1.21–3.48, p = 0.008). Household mental illness (p < 0.001), emotional abuse (p = 0.004), and incarcerated household member (p = 0.019) were significant predictors of IBS. Adverse childhood experiences and ETI-SR scores were strongly correlated (r = 0.59, p < 0.001). ACE, but not ETI-SR, modestly correlated with IBS severity (r = 0.17, p = 0.036) and abdominal pain (r = 0.20, p = 0.015). Conclusions & Inferences The ACE questionnaire is a useful instrument to measure EALs in IBS based on its use in large studies, its ability to measure prevalence across different EAL domains, and its correlation with Symptom severity.
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erratum development of the nih patient reported outcomes measurement information system promis Gastrointestinal Symptom scales american journal of gastroenterology 2014 109 1804 1814 doi 10 1038 ajg 2014 237
The American Journal of Gastroenterology, 2015Co-Authors: Brennan M R Spiegel, Ron D Hays, Gil Y Melmed, Lin Chang, Cynthia B Whitman, Puja P Khanna, Tonya Hays, Roger Bolus, Sylvia H Paz, Steve P ReiseAbstract:ORIGINAL CONTRIBUTIONS nature publishing group FUNCTIONAL GI DISORDERS see related editorial on page x Development of the NIH Patient-Reported Outcomes Measurement Information System (PROMIS) Gastrointestinal Symptom Scales Brennan M.R. Spiegel , MD, MSHS, RFF, FACG, AGAF 1 , 2 , 3 , 4 , Ron D. Hays , PhD 4 , 5 , Roger Bolus , PhD 2 , Gil Y. Melmed , MD, MS 1 , Lin Chang , MD 5 , 6 , Cynthia Whitman , MPH 2 , Puja P. Khanna , MD, MPH 7 , Sylvia H. Paz , PhD 4 , Tonya Hays , MS 4 , Steve Reise , PhD 8 and Dinesh Khanna , MD, MSc 7 OBJECTIVES: The National Institutes of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS ® ) is a standardized set of patient-reported outcomes (PROs) that cover physical, mental, and social health. The aim of this study was to develop the NIH PROMIS Gastrointestinal (GI) Symptom measures. METHODS: We fi rst conducted a systematic literature review to develop a broad conceptual model of GI symp- toms. We complemented the review with 12 focus groups including 102 GI patients. We developed PROMIS items based on the literature and input from the focus groups followed by cognitive de- briefi ng in 28 patients. We administered the items to diverse GI patients (irritable bowel syndrome (IBS), infl ammatory bowel disease (IBD), systemic sclerosis (SSc), and other common GI disorders) and a census-based US general population (GP) control sample. We created scales based on con- fi rmatory factor analyses and item response theory modeling, and evaluated the scales for reliability and validity. RESULTS: A total of 102 items were developed and administered to 865 patients with GI conditions and 1,177 GP participants. Factor analyses provided support for eight scales: gastroesophageal refl ux (13 items), disrupted swallowing (7 items), diarrhea (5 items), bowel incontinence / soilage (4 items), nausea and vomiting (4 items), constipation (9 items), belly pain (6 items), and gas / bloat / fl atulence (12 items). The scales correlated signifi cantly with both generic and disease-targeted legacy instru- ments, and demonstrate evidence of reliability. CONCLUSIONS: Using the NIH PROMIS framework, we developed eight GI Symptom scales that can now be used for clinical care and research across the full range of GI disorders. SUPPLEMENTARY MATERIAL is linked to the online version of the paper at http://www.nature.com/ajg Am J Gastroenterol 2014; 109:1804–1814; doi: 10.1038/ajg.2014.237; published online 9 September 2014 INTRODUCTION Patients typically seek health care because they experience symp- toms. Th is is especially true in gastroenterology where most digestive disorders initially present with Symptoms rather than biochemical abnormalities alone. To fully describe the illness experience of Gastrointestinal (GI) patients, providers must elicit, measure, and interpret patient Symptoms as part of their clinical evaluation ( 1,2 ). Department of Gastroenterology, Cedars-Sinai Medical Center , Los Angeles , California , USA ; 2 Cedars-Sinai Center for Outcomes Research and Education , Los Angeles , California , USA ; 3 Department of Gastroenterology, VA Greater Los Angeles Healthcare System , Los Angeles , California , USA ; 4 Department of Health Policy and Management, UCLA Fielding School of Public Health , Los Angeles , California , USA ; 5 Department of Medicine, David Geffen School of Medicine at UCLA , Los Angeles , California , USA ; 6 Gail and Gerald Oppenheimer Family Center for Neurobiology of Stress, David Geffen School of Medicine at UCLA , Los Angeles , California , USA ; 7 Division of Rheumatology, University of Michigan , Ann Arbor , Michigan , USA ; 8 Department of Psychology, UCLA , Los Angeles , California , USA . Correspondence: Brennan M.R. Spiegel, MD, MSHS, RFF, FACG, AGAF , Department of Gastroenterology and Health Services, Cedars-Sinai Medical Center, Pacifi c Theatre Building, 116 N. Robertson Blvd, 4th Floor , Los Angeles , California 90048 , USA or Dinesh Khanna, MD, MSc, University of Michigan Scleroderma Program, Division of Rheumatology / Department of Internal Medicine, 300 North Ingalls Street, Suite 7C27, Ann Arbor, Michigan 48109, USA. E-mail: bspiegel@ucla.edu or khannad@med.umich.edu Received 24 December 2013; accepted 24 June 2014 The American Journal of GASTROENTEROLOGY VOLUME 109 | NOVEMBER 2014 www.amjgastro.com
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development of the nih patient reported outcomes measurement information system promis Gastrointestinal Symptom scales
The American Journal of Gastroenterology, 2014Co-Authors: Brennan M R Spiegel, Ron D Hays, Roger E Bolus, Gil Y Melmed, Lin Chang, Cynthia B Whitman, Puja P Khanna, Tonya Hays, Steve P Reise, Dinesh KhannaAbstract:Development of the NIH Patient-Reported Outcomes Measurement Information System (PROMIS) Gastrointestinal Symptom Scales
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construct validity of the patient reported outcomes measurement information system Gastrointestinal Symptom scales in systemic sclerosis
Arthritis Care and Research, 2014Co-Authors: Vivek Nagaraja, Brennan M R Spiegel, Ron D Hays, Gil Y Melmed, Lin Chang, Puja P Khanna, Roger Bolus, Dinesh KhannaAbstract:Original Article Arthritis Care & Research DOI 10.1002/acr.22337 Construct validity of the Patient Reported Outcomes Measurement Information System (PROMIS®) Gastrointestinal Symptom Scales in Systemic Sclerosis Vivek Nagaraja, MD 1 ; Ron D. Hays, PhD 2, 3 ; Puja P. Khanna 1 ; MD, MPH 1 ; Brennan M.R. Spiegel, MD, MSHS 4, 5, 6 ; Lin Chang, MD 5, 7 ; Gil Y. Melmed, MD, MS 8 ; Roger Bolus, PhD 5, 6 ; Dinesh Khanna, MD, MSc 1 (1) Division of Rheumatology, University of Michigan, Ann Arbor, MI; (2) Division of General Internal Medicine & Health Services Research, David Geffen School of Medicine at UCLA, and Department of Health Services, UCLA School of Public Health; (3) RAND, Santa Monica, CA; (4) Department of Gastroenterology, VA Greater Los Angeles Healthcare System; (5) Division of Digestive Diseases, David Geffen School of Medicine at UCLA; (6) UCLA/VA Center for Outcomes Research and Education; (7) Gail and Gerald Oppenheimer Family Center for Neurobiology of Stress, David Geffen School of Medicine at UCLA; and (8) Division of Gastroenterology, Department of Medicine, Cedars-Sinai Medical Center Corresponding author: Dinesh Khanna, MD, MSc Associate Professor of Medicine Director, University of Michigan Scleroderma Program Division of Rheumatology/Dept. of Internal Medicine 300 North Ingalls Street, Suite 7C27 Ann Arbor, MI 48109 Email: khannad@med.umich.edu Phone: 734.647.8173 Fax: 734.763.5761 Grant support: The research reported in this publication was supported by NIH/NIAMS U01 AR057936A, the National Institutes of Health through the NIH Roadmap for Medical Research Grant (AR052177) The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. Dinesh Khanna was also supported by the NIH/NIAMS K24AR063120-02. Ron D. Hays was supported by NIH/NIA Grants P30-AG028748 and P30-AG021684, and NCMHD Grant 2P20MD000182. PROMIS® was funded with cooperative agreements from the National Institutes of Health (NIH) Common Fund Initiative (Northwestern University, PI: David Cella, PhD, U54AR057951, U01AR052177; Northwestern University, PI: Richard C. Gershon, PhD, U54AR057943; American Institutes for Research, PI: Susan (San) D. Keller, PhD, U54AR057926; State University of New York, Stony Brook, PIs: Joan E. Broderick, PhD and Arthur A. Stone, PhD, U01AR057948, This article has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process which may lead to differences between this version and the Version of Record. Please cite this article as an ‘Accepted Article’, doi: 10.1002/acr.22337 © 2014 American College of Rheumatology Received: Oct 11, 2013; Revised: Mar 18, 2014; Accepted: Mar 25, 2014
Magnus Simren - One of the best experts on this subject based on the ideXlab platform.
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cumulative effect of psychological alterations on Gastrointestinal Symptom severity in irritable bowel syndrome
The American Journal of Gastroenterology, 2020Co-Authors: Irina Midenfjord, Adam Borg, Hans Tornblom, Magnus SimrenAbstract:INTRODUCTION Psychological alterations are common and considered important for Symptom generation in irritable bowel syndrome (IBS). However, the possible cumulative effect of having multiple psychological alterations on Gastrointestinal (GI) Symptom severity in IBS is largely unknown. METHODS Patients with IBS (Rome IV) completed validated questionnaires assessing GI Symptoms (Gastrointestinal Symptom Rating Scale, IBS version and IBS Severity Scoring System), personality traits (Big Five), posttraumatic stress and psychological alterations, anxiety (Generalized Anxiety Disorder 7-item scale and State-Trait Anxiety Inventory), depression (Patient Health Questionnaire, 9-item version), fatigue (Multidimensional Fatigue Inventory), pain catastrophizing, somatization (Patient Health Questionnaire, 12-item version), stress (Perceived Stress Scale), and GI-specific anxiety (Visceral Sensitivity Index). Of the 18 possible psychological factors, those with significant associations with GI Symptom severity, corrected for multiple comparisons, were identified. The associations between increasing number of psychological alterations (validated cutoff values or uppermost tertile) and the severity of GI Symptoms were analyzed with linear trend analyses. RESULTS In total, 106 patients with IBS (Rome IV criteria) were included (72 [68%] women, median age of 35 [interquartile range: 26-45] years). Psychological alterations were common and overlap among these factors were frequently seen. Five psychological factors (physical fatigue, GI-specific anxiety, perceived stress, pain catastrophizing, and trait anxiety) demonstrated significant, noncollinear associations with GI Symptom severity. With increasing number of these psychological alterations, a gradual increase was seen in the overall severity of GI Symptoms (Gastrointestinal Symptom Rating Scale, IBS version: partial η = 0.268, P < 0.001; IBS Severity Scoring System: partial η = 0.219, P < 0.001, both large effect sizes). DISCUSSION Distinct associations were seen between the severity of GI Symptoms and individual, as well as an increasing number of psychological alterations. This highlights the importance of understanding different psychological alterations for the disease burden in IBS (visual abstract, Supplementary Digital Content 1, http://links.lww.com/AJG/B756).
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factor analysis defines distinct upper and lower Gastrointestinal Symptom groups compatible with rome iv criteria in a population based study
Clinical Gastroenterology and Hepatology, 2018Co-Authors: Hans Tornblom, Magnus Simren, Lukas Van Oudenhove, Jan Tack, Egbert Clevers, William E Whitehead, Olafur S Palsson, Ami D SperberAbstract:Background & Aims The Rome IV criteria define functional Gastrointestinal (GI) disorders by specific combinations of Symptoms. It is possible to empirically evaluate these Symptom combinations by factor analysis (a statistical procedure that groups variables that correlate). However, this analysis has not been performed for the Rome IV criteria, and factor analyses based on the previous versions of the Rome criteria did not use population-based data. We therefore investigated Symptom grouping by the Rome IV questionnaire using factor analysis of a population-based sample. Methods The Rome IV questionnaire was completed online in English by 5931 respondents from the United Kingdom, United States, and Canada (49% female, age range, 18–92 years). We performed an exploratory factor analysis on the Rome IV questions. Next, we performed a confirmatory factor analysis to compare the exploratory factor result to that of the Rome IV criteria. Results The exploratory factor analysis identified 8 factors that accounted for 45% of the variance in response: constipation, diarrhea, irritable bowel syndrome, abdominal pain, heartburn, nausea or vomiting, globus, and other upper GI Symptoms. Most factors corresponded to distinct functional GI disorders defined by the Rome IV criteria—exceptions included abdominal pain and upper GI Symptoms. In confirmatory factor analysis, the exploratory model fitted slightly better than that based on the Rome IV criteria (root mean square error of approximation, 0.063 vs 0.077). Conclusions We used factor analysis to identify distinct upper and lower GI Symptom groups that are compatible with the Rome IV criteria. Our findings support the use of the Rome IV criteria in research and clinical practice as a basis for development of diagnostics and management of patients.
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coping skills are associated with Gastrointestinal Symptom severity and somatization in patients with irritable bowel syndrome
Clinical Gastroenterology and Hepatology, 2017Co-Authors: Katarina Wilpart, Hans Tornblom, Magnus Simren, Jan Tack, Jan Svedlund, Lukas Van OudenhoveAbstract:Background & Aims Coping resources and processes are altered in patients with irritable bowel syndrome (IBS). We investigated the relationship between coping resources and Gastrointestinal (GI) and extraintestinal Symptom severity in patients with IBS and potential mediators of this relationship. Methods We performed a cross-sectional study of 216 patients with IBS attending a secondary/tertiary care specialized outpatient center in Sweden from 2003 through 2007. We collected data on coping resources, levels of anxiety (general and GI specific), depressive Symptoms, levels of GI Symptoms, and extraintestinal somatic Symptoms (somatization) by administering validated self-report questionnaires. General Linear Models were used to assess associations and mediation. Results GI Symptoms: low levels of physical coping resources (practice of activities that are beneficial for health; P = .0016), high levels of general anxiety Symptoms ( P = .033), and GI-specific anxiety Symptoms ( P P = .89), were independently associated with GI Symptom levels ( R 2 = 0.31). Anxiety and GI-specific anxiety partially mediated the effect of physical coping. Somatization: low levels of physical coping resources ( P = .003), high levels of anxiety ( P = .0147), depressive ( P = .0005), and GI-specific anxiety Symptoms ( P = .06) were associated with somatization levels ( R 2 = 0.35). Levels of general and GI-specific anxiety and depressive Symptoms partially mediated this physical coping effect. The effect of psychological coping resources (including optimism, social support, and accepting/expressing emotions) on somatization levels was not significant ( P = .98), but was fully mediated by levels of anxiety and depressive Symptoms, and partially by levels of GI-specific anxiety Symptoms. Conclusions In a cross-sectional study of patients with IBS in Sweden, we found associations of levels of coping resources with GI and extraintestinal Symptom severity; these associations were mediated by levels of anxiety and depressive Symptoms. Although confirmation in longitudinal studies is needed, this identifies coping as a potential psychological treatment target in IBS.
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postprandial plasma glucose response and Gastrointestinal Symptom severity in patients with diabetic gastroparesis
Journal of diabetes science and technology, 2014Co-Authors: Eva A Olausson, Hakan Grundin, Mats Isaksson, Christina Brock, Asbjorn Mohr Drewes, Stig Attvall, Magnus SimrenAbstract:Gastroparesis is a well-known diabetic complication. The pathogenesis is not fully understood. However, it is important to early diagnose these patients. This study evaluated the plasma glucose response after a test meal, and Gastrointestinal (GI) Symptom severity in patients with clinical suspicion of diabetic gastroparesis, and assessed its usefulness to predict gastroparesis. In all, 83 subjects with insulin-treated diabetes mellitus (DM) type 1 and 2 were included; 53 subjects had gastroparesis and 30 had normal gastric emptying determined by gastric scintigraphy. GI Symptom severity during the preceding 2 weeks was evaluated with a validated questionnaire. The test meal consisted of 100 g meat, 40 g pasta, 150 g carrot, and 5 g oil. The subjects ingested the meal under fasting conditions, and plasma glucose was followed during 180 minutes. Patients with gastroparesis demonstrated a blunted plasma glucose response after a test meal versus patients with normal gastric emptying (P < .005), reflected by lower maximum increase in plasma glucose response and incremental area under the curve of the plasma glucose, but a similar time to the maximum plasma glucose level. All GI Symptoms were more severe in patients with gastroparesis. GI Symptom severity had the best discriminative value to identify patients with gastroparesis with an area under the receiver operating curve of 0.83 (optimal cutoff: sensitivity 87%, specificity 80%). Patients with diabetic gastroparesis have a blunted postprandial plasma glucose response. Combining this information with the presence of GI Symptoms can help clinicians identify diabetic patients with gastroparesis.
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Gastrointestinal Symptoms in patients with liver cirrhosis: Associations with nutritional status and health-related quality of life
Scandinavian Journal of Gastroenterology, 2006Co-Authors: Evangelos Kalaitzakis, Magnus Simren, Rolf Olsson, Pia Henfridsson, Irene Hugosson, Maria Bengtsson, Einar BjörnssonAbstract:Objective. Gastrointestinal Symptoms can lead to decreased food intake and thereby increased morbidity. There is a general lack of data on the prevalence of Gastrointestinal Symptoms and their potential association with malnutrition and health-related quality of life (QoL) in cirrhosis. Our aim was to prospectively evaluate Gastrointestinal Symptoms, malnutrition, and QoL in patients with cirrhosis. Material and methods. Two validated questionnaires were used to measure Gastrointestinal Symptoms (Gastrointestinal Symptom rating scale (GSRS)) and health-related QoL (SF-36) in 128 consecutive cirrhotics (mean age 57 years, Child-Pugh score 8.6, MELD score 13.2) at a tertiary referral center. The results were compared with those of controls from the general population. Nutritional status was assessed by anthropometry and estimation of recent weight change. Results. Compared to controls, cirrhotic patients showed higher Gastrointestinal Symptom severity (total GSRS score: 1.53, 95% CI 1.50–1.55 versus 2.21, 9...
Dinesh Khanna - One of the best experts on this subject based on the ideXlab platform.
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Gastrointestinal Symptom severity in irritable bowel syndrome inflammatory bowel disease and the general population
Neurogastroenterology and Motility, 2017Co-Authors: A D Lee, Ron D Hays, Gil Y Melmed, Puja P Khanna, Dinesh Khanna, Roger Bolus, B M Spiegel, Lin ChangAbstract:Background Irritable bowel syndrome (IBS) and inflammatory bowel disease (IBD) patients report similar Gastrointestinal (GI) Symptoms, yet comparisons of Symptom severity between groups and with the general population (GP) are lacking. Methods We compared Patient-Reported Outcomes Measurement Information System (PROMIS®) GI Symptom scales measuring gastro-esophageal reflux (GER), disrupted swallowing, diarrhea, bowel incontinence, nausea/vomiting, constipation, belly pain, and gas/bloating in: (i) USA GP sample, (ii) IBS patients, and (iii) IBD patients from tertiary care and community populations. Symptom severity scores were based on T-score metric with mean 50±10 (standard deviation) relative to the GP. Key Results Of 1643 patients enrolled, there were 253 IBS patients (68% F, mean age 45±15 years), 213 IBD patients (46% F, mean age 41±14 years), and 1177 GP subjects (57% F, mean age 46±16 years). IBS patients reported greater severity of GER, disrupted swallowing, nausea/vomiting, belly pain, gas/bloating, and constipation Symptoms than their IBD counterparts (all P<.05). Compared to the GP, IBD patients had worse belly pain, gas/bloating, diarrhea, and bowel incontinence, but less severe GER and disrupted swallowing (all P<.05), and IBS patients had more severe nausea/vomiting, belly pain, gas/bloating, and constipation (all P<.05). Women had more severe belly pain and gas/bloating than men, whereas men had more severe bowel incontinence (all P<.05). Conclusion & Inferences IBS and IBD are associated with more severe GI Symptoms compared to the GP excluding esophageal Symptoms. Unlike IBD, IBS is not characterized by observable GI inflammation but patients report more severe upper and lower GI Symptoms.
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development of the nih patient reported outcomes measurement information system promis Gastrointestinal Symptom scales
The American Journal of Gastroenterology, 2014Co-Authors: Brennan M R Spiegel, Ron D Hays, Roger E Bolus, Gil Y Melmed, Lin Chang, Cynthia B Whitman, Puja P Khanna, Tonya Hays, Steve P Reise, Dinesh KhannaAbstract:Development of the NIH Patient-Reported Outcomes Measurement Information System (PROMIS) Gastrointestinal Symptom Scales
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construct validity of the patient reported outcomes measurement information system Gastrointestinal Symptom scales in systemic sclerosis
Arthritis Care and Research, 2014Co-Authors: Vivek Nagaraja, Brennan M R Spiegel, Ron D Hays, Gil Y Melmed, Lin Chang, Puja P Khanna, Roger Bolus, Dinesh KhannaAbstract:Original Article Arthritis Care & Research DOI 10.1002/acr.22337 Construct validity of the Patient Reported Outcomes Measurement Information System (PROMIS®) Gastrointestinal Symptom Scales in Systemic Sclerosis Vivek Nagaraja, MD 1 ; Ron D. Hays, PhD 2, 3 ; Puja P. Khanna 1 ; MD, MPH 1 ; Brennan M.R. Spiegel, MD, MSHS 4, 5, 6 ; Lin Chang, MD 5, 7 ; Gil Y. Melmed, MD, MS 8 ; Roger Bolus, PhD 5, 6 ; Dinesh Khanna, MD, MSc 1 (1) Division of Rheumatology, University of Michigan, Ann Arbor, MI; (2) Division of General Internal Medicine & Health Services Research, David Geffen School of Medicine at UCLA, and Department of Health Services, UCLA School of Public Health; (3) RAND, Santa Monica, CA; (4) Department of Gastroenterology, VA Greater Los Angeles Healthcare System; (5) Division of Digestive Diseases, David Geffen School of Medicine at UCLA; (6) UCLA/VA Center for Outcomes Research and Education; (7) Gail and Gerald Oppenheimer Family Center for Neurobiology of Stress, David Geffen School of Medicine at UCLA; and (8) Division of Gastroenterology, Department of Medicine, Cedars-Sinai Medical Center Corresponding author: Dinesh Khanna, MD, MSc Associate Professor of Medicine Director, University of Michigan Scleroderma Program Division of Rheumatology/Dept. of Internal Medicine 300 North Ingalls Street, Suite 7C27 Ann Arbor, MI 48109 Email: khannad@med.umich.edu Phone: 734.647.8173 Fax: 734.763.5761 Grant support: The research reported in this publication was supported by NIH/NIAMS U01 AR057936A, the National Institutes of Health through the NIH Roadmap for Medical Research Grant (AR052177) The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. Dinesh Khanna was also supported by the NIH/NIAMS K24AR063120-02. Ron D. Hays was supported by NIH/NIA Grants P30-AG028748 and P30-AG021684, and NCMHD Grant 2P20MD000182. PROMIS® was funded with cooperative agreements from the National Institutes of Health (NIH) Common Fund Initiative (Northwestern University, PI: David Cella, PhD, U54AR057951, U01AR052177; Northwestern University, PI: Richard C. Gershon, PhD, U54AR057943; American Institutes for Research, PI: Susan (San) D. Keller, PhD, U54AR057926; State University of New York, Stony Brook, PIs: Joan E. Broderick, PhD and Arthur A. Stone, PhD, U01AR057948, This article has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process which may lead to differences between this version and the Version of Record. Please cite this article as an ‘Accepted Article’, doi: 10.1002/acr.22337 © 2014 American College of Rheumatology Received: Oct 11, 2013; Revised: Mar 18, 2014; Accepted: Mar 25, 2014
Ron D Hays - One of the best experts on this subject based on the ideXlab platform.
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Gastrointestinal Symptom severity in irritable bowel syndrome inflammatory bowel disease and the general population
Neurogastroenterology and Motility, 2017Co-Authors: A D Lee, Ron D Hays, Gil Y Melmed, Puja P Khanna, Dinesh Khanna, Roger Bolus, B M Spiegel, Lin ChangAbstract:Background Irritable bowel syndrome (IBS) and inflammatory bowel disease (IBD) patients report similar Gastrointestinal (GI) Symptoms, yet comparisons of Symptom severity between groups and with the general population (GP) are lacking. Methods We compared Patient-Reported Outcomes Measurement Information System (PROMIS®) GI Symptom scales measuring gastro-esophageal reflux (GER), disrupted swallowing, diarrhea, bowel incontinence, nausea/vomiting, constipation, belly pain, and gas/bloating in: (i) USA GP sample, (ii) IBS patients, and (iii) IBD patients from tertiary care and community populations. Symptom severity scores were based on T-score metric with mean 50±10 (standard deviation) relative to the GP. Key Results Of 1643 patients enrolled, there were 253 IBS patients (68% F, mean age 45±15 years), 213 IBD patients (46% F, mean age 41±14 years), and 1177 GP subjects (57% F, mean age 46±16 years). IBS patients reported greater severity of GER, disrupted swallowing, nausea/vomiting, belly pain, gas/bloating, and constipation Symptoms than their IBD counterparts (all P<.05). Compared to the GP, IBD patients had worse belly pain, gas/bloating, diarrhea, and bowel incontinence, but less severe GER and disrupted swallowing (all P<.05), and IBS patients had more severe nausea/vomiting, belly pain, gas/bloating, and constipation (all P<.05). Women had more severe belly pain and gas/bloating than men, whereas men had more severe bowel incontinence (all P<.05). Conclusion & Inferences IBS and IBD are associated with more severe GI Symptoms compared to the GP excluding esophageal Symptoms. Unlike IBD, IBS is not characterized by observable GI inflammation but patients report more severe upper and lower GI Symptoms.
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erratum development of the nih patient reported outcomes measurement information system promis Gastrointestinal Symptom scales american journal of gastroenterology 2014 109 1804 1814 doi 10 1038 ajg 2014 237
The American Journal of Gastroenterology, 2015Co-Authors: Brennan M R Spiegel, Ron D Hays, Gil Y Melmed, Lin Chang, Cynthia B Whitman, Puja P Khanna, Tonya Hays, Roger Bolus, Sylvia H Paz, Steve P ReiseAbstract:ORIGINAL CONTRIBUTIONS nature publishing group FUNCTIONAL GI DISORDERS see related editorial on page x Development of the NIH Patient-Reported Outcomes Measurement Information System (PROMIS) Gastrointestinal Symptom Scales Brennan M.R. Spiegel , MD, MSHS, RFF, FACG, AGAF 1 , 2 , 3 , 4 , Ron D. Hays , PhD 4 , 5 , Roger Bolus , PhD 2 , Gil Y. Melmed , MD, MS 1 , Lin Chang , MD 5 , 6 , Cynthia Whitman , MPH 2 , Puja P. Khanna , MD, MPH 7 , Sylvia H. Paz , PhD 4 , Tonya Hays , MS 4 , Steve Reise , PhD 8 and Dinesh Khanna , MD, MSc 7 OBJECTIVES: The National Institutes of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS ® ) is a standardized set of patient-reported outcomes (PROs) that cover physical, mental, and social health. The aim of this study was to develop the NIH PROMIS Gastrointestinal (GI) Symptom measures. METHODS: We fi rst conducted a systematic literature review to develop a broad conceptual model of GI symp- toms. We complemented the review with 12 focus groups including 102 GI patients. We developed PROMIS items based on the literature and input from the focus groups followed by cognitive de- briefi ng in 28 patients. We administered the items to diverse GI patients (irritable bowel syndrome (IBS), infl ammatory bowel disease (IBD), systemic sclerosis (SSc), and other common GI disorders) and a census-based US general population (GP) control sample. We created scales based on con- fi rmatory factor analyses and item response theory modeling, and evaluated the scales for reliability and validity. RESULTS: A total of 102 items were developed and administered to 865 patients with GI conditions and 1,177 GP participants. Factor analyses provided support for eight scales: gastroesophageal refl ux (13 items), disrupted swallowing (7 items), diarrhea (5 items), bowel incontinence / soilage (4 items), nausea and vomiting (4 items), constipation (9 items), belly pain (6 items), and gas / bloat / fl atulence (12 items). The scales correlated signifi cantly with both generic and disease-targeted legacy instru- ments, and demonstrate evidence of reliability. CONCLUSIONS: Using the NIH PROMIS framework, we developed eight GI Symptom scales that can now be used for clinical care and research across the full range of GI disorders. SUPPLEMENTARY MATERIAL is linked to the online version of the paper at http://www.nature.com/ajg Am J Gastroenterol 2014; 109:1804–1814; doi: 10.1038/ajg.2014.237; published online 9 September 2014 INTRODUCTION Patients typically seek health care because they experience symp- toms. Th is is especially true in gastroenterology where most digestive disorders initially present with Symptoms rather than biochemical abnormalities alone. To fully describe the illness experience of Gastrointestinal (GI) patients, providers must elicit, measure, and interpret patient Symptoms as part of their clinical evaluation ( 1,2 ). Department of Gastroenterology, Cedars-Sinai Medical Center , Los Angeles , California , USA ; 2 Cedars-Sinai Center for Outcomes Research and Education , Los Angeles , California , USA ; 3 Department of Gastroenterology, VA Greater Los Angeles Healthcare System , Los Angeles , California , USA ; 4 Department of Health Policy and Management, UCLA Fielding School of Public Health , Los Angeles , California , USA ; 5 Department of Medicine, David Geffen School of Medicine at UCLA , Los Angeles , California , USA ; 6 Gail and Gerald Oppenheimer Family Center for Neurobiology of Stress, David Geffen School of Medicine at UCLA , Los Angeles , California , USA ; 7 Division of Rheumatology, University of Michigan , Ann Arbor , Michigan , USA ; 8 Department of Psychology, UCLA , Los Angeles , California , USA . Correspondence: Brennan M.R. Spiegel, MD, MSHS, RFF, FACG, AGAF , Department of Gastroenterology and Health Services, Cedars-Sinai Medical Center, Pacifi c Theatre Building, 116 N. Robertson Blvd, 4th Floor , Los Angeles , California 90048 , USA or Dinesh Khanna, MD, MSc, University of Michigan Scleroderma Program, Division of Rheumatology / Department of Internal Medicine, 300 North Ingalls Street, Suite 7C27, Ann Arbor, Michigan 48109, USA. E-mail: bspiegel@ucla.edu or khannad@med.umich.edu Received 24 December 2013; accepted 24 June 2014 The American Journal of GASTROENTEROLOGY VOLUME 109 | NOVEMBER 2014 www.amjgastro.com
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development of the nih patient reported outcomes measurement information system promis Gastrointestinal Symptom scales
The American Journal of Gastroenterology, 2014Co-Authors: Brennan M R Spiegel, Ron D Hays, Roger E Bolus, Gil Y Melmed, Lin Chang, Cynthia B Whitman, Puja P Khanna, Tonya Hays, Steve P Reise, Dinesh KhannaAbstract:Development of the NIH Patient-Reported Outcomes Measurement Information System (PROMIS) Gastrointestinal Symptom Scales
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construct validity of the patient reported outcomes measurement information system Gastrointestinal Symptom scales in systemic sclerosis
Arthritis Care and Research, 2014Co-Authors: Vivek Nagaraja, Brennan M R Spiegel, Ron D Hays, Gil Y Melmed, Lin Chang, Puja P Khanna, Roger Bolus, Dinesh KhannaAbstract:Original Article Arthritis Care & Research DOI 10.1002/acr.22337 Construct validity of the Patient Reported Outcomes Measurement Information System (PROMIS®) Gastrointestinal Symptom Scales in Systemic Sclerosis Vivek Nagaraja, MD 1 ; Ron D. Hays, PhD 2, 3 ; Puja P. Khanna 1 ; MD, MPH 1 ; Brennan M.R. Spiegel, MD, MSHS 4, 5, 6 ; Lin Chang, MD 5, 7 ; Gil Y. Melmed, MD, MS 8 ; Roger Bolus, PhD 5, 6 ; Dinesh Khanna, MD, MSc 1 (1) Division of Rheumatology, University of Michigan, Ann Arbor, MI; (2) Division of General Internal Medicine & Health Services Research, David Geffen School of Medicine at UCLA, and Department of Health Services, UCLA School of Public Health; (3) RAND, Santa Monica, CA; (4) Department of Gastroenterology, VA Greater Los Angeles Healthcare System; (5) Division of Digestive Diseases, David Geffen School of Medicine at UCLA; (6) UCLA/VA Center for Outcomes Research and Education; (7) Gail and Gerald Oppenheimer Family Center for Neurobiology of Stress, David Geffen School of Medicine at UCLA; and (8) Division of Gastroenterology, Department of Medicine, Cedars-Sinai Medical Center Corresponding author: Dinesh Khanna, MD, MSc Associate Professor of Medicine Director, University of Michigan Scleroderma Program Division of Rheumatology/Dept. of Internal Medicine 300 North Ingalls Street, Suite 7C27 Ann Arbor, MI 48109 Email: khannad@med.umich.edu Phone: 734.647.8173 Fax: 734.763.5761 Grant support: The research reported in this publication was supported by NIH/NIAMS U01 AR057936A, the National Institutes of Health through the NIH Roadmap for Medical Research Grant (AR052177) The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. Dinesh Khanna was also supported by the NIH/NIAMS K24AR063120-02. Ron D. Hays was supported by NIH/NIA Grants P30-AG028748 and P30-AG021684, and NCMHD Grant 2P20MD000182. PROMIS® was funded with cooperative agreements from the National Institutes of Health (NIH) Common Fund Initiative (Northwestern University, PI: David Cella, PhD, U54AR057951, U01AR052177; Northwestern University, PI: Richard C. Gershon, PhD, U54AR057943; American Institutes for Research, PI: Susan (San) D. Keller, PhD, U54AR057926; State University of New York, Stony Brook, PIs: Joan E. Broderick, PhD and Arthur A. Stone, PhD, U01AR057948, This article has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process which may lead to differences between this version and the Version of Record. Please cite this article as an ‘Accepted Article’, doi: 10.1002/acr.22337 © 2014 American College of Rheumatology Received: Oct 11, 2013; Revised: Mar 18, 2014; Accepted: Mar 25, 2014
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reliability and validity of the Gastrointestinal Symptom rating scale gsrs and quality of life in reflux and dyspepsia qolrad questionnaire in dyspepsia a six country study
Health and Quality of Life Outcomes, 2008Co-Authors: Karoly R Kulich, Ahmed Madisch, Franco Pacini, Jose M Pique, Jaroslaw Regula, Christo Van Rensburg, Laszlo Ujszaszy, Jonas Carlsson, Katarina Halling, Ingela WiklundAbstract:Symptoms of dyspepsia significantly disrupt patients' lives and reliable methods of assessing Symptom status are important for patient management. The aim of the current study was to document the psychometric characteristics of the Gastrointestinal Symptom Rating Scale (GSRS) and the Quality of Life in Reflux and Dyspepsia questionnaire (QOLRAD) in Afrikaans, German, Hungarian, Italian, Polish and Spanish patients with dyspepsia. 853 patients with Symptoms of dyspepsia completed the GSRS, the QOLRAD, the 36-item Short-Form Health Survey (SF-36) and the Hospital Anxiety and Depression scale. The internal consistency reliability of the GSRS was 0.43–0.87 and of the QOLRAD 0.79–0.95. Test-retest reliability of the GSRS was 0.36–0.75 and of the QOLRAD 0.41–0.82. GSRS Abdominal pain domain correlated significantly with all QOLRAD domains in most language versions, and with SF-36 Bodily pain in all versions. QOLRAD domains correlated significantly with the majority of SF-36 domains in most versions. Both questionnaires were able to differentiate between patients whose health status differed according to Symptom frequency and severity. The psychometric characteristics of the different language versions of the GSRS and QOLRAD were found to be good, with acceptable reliability and validity. The GSRS and QOLRAD were found to be useful for evaluating dyspeptic Symptoms and their impact on patients' daily lives in multinational clinical trials.
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psychometric validation of the polish translation of the Gastrointestinal Symptom rating scale gsrs and quality of life in reflux and dyspepsia qolrad questionnaire in patients with reflux disease
Polskie Archiwum Medycyny Wewnetrznej-polish Archives of Internal Medicine, 2005Co-Authors: Karoly R Kulich, Jaroslaw Regula, Jonas Carlsson, Jan Stasiewicz, Boleslaw Jasinski, Ingela WiklundAbstract:UNLABELLED Symptoms of heartburn and their impact on health-related quality of life (HRQL) are often evaluated in clinical trials. When a questionnaire is translated into a new language, a linguistic validation is necessary but not sufficient unless the psychometric characteristics have been verified. The aim of the study is to document the psychometric characteristics of the Polish translation of the Gastrointestinal Symptom Rating Scale (GSRS) and quality of life in reflux and dyspepsia (QOLRAD) questionnaire. One hundred and thirty-five patients with Symptoms of heartburn (mean age: 44, SD = 14.6; females % = 60.7) completed the Polish translation of GSRS, the heartburn version of QOLRAD, the Short-Form-36 (SF-36) and the Hospital Anxiety and Depression (HAD) scale. Seventy patients were scheduled for a second visit a week later to complete the GSRS and QOLRAD again. The internal consistency reliability of GSRS ranged from 0.58 to 0.88 and of QOLRAD from 0.84 to 0.95, and the test-retest reliability of GSRS ranged from 0.34 to 0.63 and of QOLRAD from 0.51 to 0.74. The relevant domains of the GSRS, "reflux", "abdominal pain" and "indigestion", and all QOLRAD domain scores significantly correlated. GSRS domains "abdominal pain" and "indigestion" were related to all SF-36 domains. All QOLRAD domains significantly correlated with all SF-36 domains. CONCLUSIONS the psychometric characteristics of the Polish translations of GSRS and QOLRAD were found to be good, with satisfactory reliability and validity. The test-retest reliability of the GSRS "reflux" domain was however not optimal.
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the visceral sensitivity index development and validation of a Gastrointestinal Symptom specific anxiety scale
Alimentary Pharmacology & Therapeutics, 2004Co-Authors: Jennifer S Labus, Lin Chang, Roger Bolus, Ingela Wiklund, Jorgen Naesdal, Emeran A Mayer, Bruce D NaliboffAbstract:Summary Background : Anxiety related to Gastrointestinal sensations, Symptoms or the contexts in which these may occur is thought to play a significant role in the pathophysiology as well as in the health outcomes of patients with irritable bowel syndrome. Aim : To develop a valid and reliable psychometric instrument that measures Gastrointestinal Symptom-specific anxiety. Methods : External and internal expert panels as well as a patient focus group evaluated a large pool of potential item stems gathered from the psychological and Gastrointestinal literature. Potential scale items were then administered to 96 patients diagnosed with irritable bowel syndrome along with a set of validating questionnaires. Final item selection was based upon rigorous empirical criteria and the psychometric properties of the final scale were examined. Results : A final unidimensional 15-item scale, the Visceral Sensitivity Index, demonstrated excellent reliability as well as good content, convergent, divergent and predictive validity. Conclusions : The findings suggest that the Visceral Sensitivity Index is a reliable, valid measure of Gastrointestinal Symptom-specific anxiety that may be useful for clinical assessment, treatment outcome studies, and mechanistic studies of the role of Symptom-related anxiety in patients with irritable bowel syndrome.
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psychometric validation of the italian translation of the Gastrointestinal Symptom rating scale and quality of life in reflux and dyspepsia questionnaire in patients with gastro oesophageal reflux disease
Clinical Drug Investigation, 2004Co-Authors: Karoly R Kulich, Franco Pacini, Jonas Carlsson, Carlo Calabrese, S Vigneri, Ingela WiklundAbstract:Background: Symptoms of heartburn and their impact on health-related quality of life (HR-QOL) are often evaluated in clinical trials. When a questionnaire is translated into a new language, a linguistic validation is necessary but not sufficient unless the psychometric characteristics have been verified.
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psychometric validation of the german translation of the Gastrointestinal Symptom rating scale gsrs and quality of life in reflux and dyspepsia qolrad questionnaire in patients with reflux disease
Health and Quality of Life Outcomes, 2003Co-Authors: Karoly R Kulich, Ahmed Madisch, Jonas Carlsson, Peter Malfertheiner, Joachim Labenz, E Bayerdorffer, Stephan Miehlke, Ingela WiklundAbstract:Symptoms of heartburn has an impact on health-related quality of life (HRQL). When a questionnaire is translated into a new language, a linguistic validation is necessary but not sufficient unless the psychometric characteristics have been verified. The aim is to document the psychometric characteristics of the German translation of the Gastrointestinal Symptom Rating Scale (GSRS) and Quality of Life in Reflux and Dyspepsia (QOLRAD) questionnaire. 142 patients with Symptoms of heartburn (Age: M = 47.5, ± 14.6; Males = 44.4%) completed the German translation of GSRS, the QOLRAD, the Short-Form-36 (SF-36) and the Hospital Anxiety and Depression (HAD) scale. The internal consistency reliability of GSRS ranged from 0.53–0.91 and of QOLRAD from 0.90–0.94, respectively. The test-retest reliability of GSRS ranged from 0.49–0.73 and of QOLRAD from 0.70–0.84. The relevant domains of the GSRS and QOLRAD domain scores significantly correlated. GSRS domains of Abdominal Pain and Constipation correlated (negatively) with most of the domains of the SF-36. The relevant QOLRAD domains significantly correlated with all SF-36 domains. The psychometric characteristics of the German translation of GSRS and QOLRAD were found to be good, with satisfactory reliability and validity. The reliability of the GSRS Abdominal Pain domain was moderate.
