Patient-reported outcomes as primary end points in clinical trials of inflammatory bowel disease

Williet, Nicolas; Sandborn, William J.; Peyrin–Biroulet, Laurent

doi:10.1016/j.cgh.2014.02.016

Cited by 260Inflammatory Bowel DiseaseHealth Systems, Economic Evaluations, Quality of LifeStatistical Methods in Clinical Trials

Patient-reported outcomes as primary end points in clinical trials of inflammatory bowel disease

Williet, Nicolas, Sandborn, William J., Peyrin–Biroulet, Laurent·2014·Clinical Gastroenterology and Hepatology

DOI 10.1016/j.cgh.2014.02.016

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Abstract

The Food and Drug Administration (FDA) is moving from the Crohn's Disease Activity Index to patient-reported outcomes (PROs) and objective measures of disease, such as findings from endoscopy. PROs will become an important aspect of assessing activity of inflammatory bowel disease (IBD) and for labeling specific drugs for this disease. PROs always have been considered in the management of patients with rheumatoid arthritis or multiple sclerosis, and have included measurements of quality of life, disability, or fatigue. Several disease-specific scales have been developed to assess these PROs and commonly are used in clinical trials. Outcomes reported by patients in clinical trials of IBD initially focused on quality of life, measured by the Short-Form 36 questionnaire or disease-specific scales such as the Inflammatory Bowel Disease Questionnaire or its shorter version. Recently considered factors include fatigue, depression and anxiety, and work productivity, as measured by the Functional Assessment Chronic Illness Therapy-Fatigue, the Hospital Anxiety Depression, and the Work Productivity Activity Impairment Questionnaire, respectively. However, few data are available on how treatment affects these factors in patients with IBD. Although disability generally is recognized in patients with IBD, it is not measured. The international IBD disability index currently is being validated. None of the PROs currently used in IBD were developed according to FDA guidance for PRO development. PROs will be a major primary end point of future trials. FDA guidance is needed to develop additional PROs for IBD that can be incorporated into trials, to better compare patients' experience with different therapies.

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From Brief and Telehealth Acceptance and Commitment Therapy (ACT) Interventions for Stress in Inflammatory Bowel Disease (IBD): A Series of Single Case Experimental Design (SCED) Studies (2022) · cites this paper as [16]

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Lichtenstein, G. R., Loftus, E. V., Isaacs, K. L., Regueiro, M. D., Gerson, L. B., & Sands, B. E. (2018) · The American Journal of Gastroenterology · doi:10.1038/ajg.2018.27 · Cited by 1,424 · see citing works
Quality of life in inflammatory bowel disease: a systematic review and meta-analyses—part I
Knowles, S. R., Graff, L. A., Wilding, H., Hewitt, C., Keefer, L., & Mikocka-Walus, A. (2018) · Inflammatory Bowel Diseases · doi:10.1093/ibd/izx100 · Cited by 503 · see citing works
ECCO-ESGAR Guideline for Diagnostic Assessment in IBD Part 2: IBD scores and general principles and technical aspects
Sturm, A., Maaser, C., Calabrese, E., Annese, V., Fiorino, G., Kucharzik, T. F., Vavricka, S. R., Verstockt, B., van Rheenen, P., Tolan, D. J. M., et al. (2018) · Journal of Crohn s and Colitis · doi:10.1093/ecco-jcc/jjy114 · Cited by 462 · see citing works
Defining Disease Severity in Inflammatory Bowel Diseases: Current and Future Directions
Peyrin‐Biroulet, L., Panés, J., Sandborn, W. J., Vermeire, S., Danese, S., Feagan, B. G., Colombel, J., Hanauer, S. B., & Rycroft, B. (2015) · Clinical Gastroenterology and Hepatology · doi:10.1016/j.cgh.2015.06.001 · Cited by 455 · see citing works
Quality of life in inflammatory bowel disease: a systematic review and meta-analyses—part II
Knowles, S. R., Keefer, L., Wilding, H., Hewitt, C., Graff, L. A., & Mikocka-Walus, A. (2018) · Inflammatory Bowel Diseases · doi:10.1093/ibd/izy015 · Cited by 416 · see citing works
Systematic review with meta-analysis: The efficacy of probiotics in inflammatory bowel disease
Derwa, Y., Gracie, D. J., Hamlin, P. J., & Ford, A. C. (2017) · Alimentary Pharmacology & Therapeutics · doi:10.1111/apt.14203 · Cited by 393 · see citing works
“These previous systematic reviews also pooled data from RCTs that did not meet our inclusion criteria, including studies that examined the effect of probiotics in children with IBD, and the effect of synbiotics in IBD.28,29 Studies investigating the effect of manipulation of the micro- biome on disease activity in IBD…”
BackgroundInfluential
Infliximab versus ciclosporin for steroid-resistant acute severe ulcerative colitis (CONSTRUCT): a mixed methods, open-label, pragmatic randomised trial
Williams, J. G., Alam, M. F., Alrubaiy, L., Arnott, I. D., Clement, C., Cohen, D. R., Gordon, J. N., Hawthorne, A. B., Hilton, M., Hutchings, H. A., et al. (2016) · The Lancet. Gastroenterology & hepatology · doi:10.1016/s2468-1253(16)30003-6 · Cited by 271 · see citing works
Randomised clinical trial: deep remission in biologic and immunomodulator naïve patients with Crohn's disease – a SONIC post hoc analysis
Colombel, J., Reinisch, W., Mantzaris, G. J., Kornbluth, A. A., Rutgeerts, P., Tang, K. L., Oortwijn, A. F., Bevelander, G. S., Cornillie, F. J., & Sandborn, W. J. (2015) · Alimentary Pharmacology & Therapeutics · doi:10.1111/apt.13139 · Cited by 198 · see citing works
“As such, the Food and Drug Administration is moving away from the CDAI score requiring a co-primary endpoint comprised of a pure patient-reported outcome measure in combination with an endoscopic measure of disease activity.(25)”
Background
Acceptance and Commitment Therapy Reduces Psychological Stress in Patients With Inflammatory Bowel Diseases
Wynne, B., McHugh, L., Gao, W., Keegan, D., Byrne, K., Rowan, C., Hartery, K., Kirschbaum, C., Doherty, G., Cullen, G., et al. (2019) · Gastroenterology · doi:10.1053/j.gastro.2018.11.030 · Cited by 188 · see citing works
“have stressed the value of mental health indices as patient reported outcomes in clinical trials (13), while psychological services are now considered an essential component of contemporary IBD therapy (14,15).”
Background
Poor Correlation Between Clinical Disease Activity and Mucosal Inflammation, and the Role of Psychological Comorbidity, in Inflammatory Bowel Disease
Gracie, D. J., Williams, C. J. M., Sood, R., Mumtaz, S., Bholah, H. M., Hamlin, J. P., & Ford, A. C. (2016) · American Journal of Gastroenterology · doi:10.1038/ajg.2016.59 · Cited by 173 · see citing works
Fecal Microbiota Signatures Are Associated with Response to Ustekinumab Therapy among Crohn’s Disease Patients
Doherty, M. K., Ding, T., Koumpouras, C. C., Telesco, S., Monast, C. S., Das, A., Brodmerkel, C. M., & Schloss, P. D. (2018) · mBio · doi:10.1128/mbio.02120-17 · Cited by 166 · see citing works
“While the field appears to be moving away from CDAI and toward patient-reported outcomes and more objectively quantifiable measures such as endoscopic verification of mucosal healing (21, 46), research is ongoing to discover less invasive and more quantifiable biomarkers (24, 25, 36).”
Patient-reported Outcomes in a French Nationwide Survey of Inflammatory Bowel Disease Patients
Williet, N., Sarter, H., Gower‐Rousseau, C., Adrianjafy, C., Olympie, A., Buisson, A., Beaugerie, L., & Peyrin‐Biroulet, L. (2016) · Journal of Crohn s and Colitis · doi:10.1093/ecco-jcc/jjw145 · Cited by 162 · see citing works
Validation of the Inflammatory Bowel Disease Disability Index in a population-based cohort
Gower‐Rousseau, C., Sarter, H., Savoye, G., Tavernier, N., Fumery, M., Sandborn, W. J., Feagan, B. G., Duhamel, A., Guillon-Dellac, N., Colombel, J., et al. (2015) · Gut · doi:10.1136/gutjnl-2015-310151 · Cited by 157 · see citing works
Development of the IBD Disk
Ghosh, S. K., Louis, E. J., Beaugerie, L., Bossuyt, P. J., Bouguen, G., Bourreille, A., Ferrante, M., Franchimont, D. P., Frost, K., Hébuterne, X., et al. (2017) · Inflammatory Bowel Diseases · doi:10.1097/mib.0000000000001033 · Cited by 142 · see citing works
“Body image: problem with the way your body or body parts look (11) Body image: not liking the way body or body parts look Body image: not liking the way body or body parts look”
Efficacy of Medical Therapies for Fistulizing Crohn’s Disease: Systematic Review and Meta-analysis
Lee, M. J., Parker, C. E., Taylor, S. R., Guizzetti, L., Feagan, B. G., Lobo, A., & Jairath, V. (2018) · Clinical Gastroenterology and Hepatology · doi:10.1016/j.cgh.2018.01.030 · Cited by 138 · see citing works
EHealth Technologies in Inflammatory Bowel Disease: A Systematic Review.
Jackson, B. D., Gray, K., Knowles, S. R., & De Cruz, P. (2016) · Journal of Crohn's and Colitis · doi:10.1093/ecco-jcc/jjw059 · Cited by 126 · see citing works
Patient-Reported Outcome Measures for Use in Clinical Trials and Clinical Practice in Inflammatory Bowel Diseases: A Systematic Review
de Jong, M. J., Huibregtse, R., Masclee, A., Jonkers, D. M. A. E., & Pierik, M. J. (2017) · Clinical Gastroenterology and Hepatology · doi:10.1016/j.cgh.2017.10.019 · Cited by 132 · see citing works
“ability, and ability to detect change should be evaluated to finalize the instrument.(7,8)”
Background
Risk of Anxiety and Depression in Patients with Inflammatory Bowel Disease: A Nationwide, Population-Based Study
Choi, K., Chun, J., Han, K., Park, S., Soh, H., Kim, J., Lee, J., Lee, J., Im, J., & Im, J. P. (2019) · Journal of Clinical Medicine · doi:10.3390/jcm8050654 · Cited by 134 · see citing works
“Anxiety and depression are the most common psychological disorders in patients with IBD and patient-reported outcome measures (PROMs) for anxiety and depression are considered to be critical to IBD patient care [11,12].”
Background
Early intervention in Crohn’s disease: towards disease modification trials
Danese, S., Fiorino, G., & Peyrin‐Biroulet, L. (2017) · Gut · doi:10.1136/gutjnl-2017-314519 · Cited by 113 · see citing works
Rapid Response to Vedolizumab Therapy in Biologic-Naive Patients With Inflammatory Bowel Diseases
Feagan, B. G., Lasch, K. L., Lissoos, T. W., Cao, C., Wojtowicz, A. M., Khalid, J. M., & Colombel, J. (2018) · Clinical Gastroenterology and Hepatology · doi:10.1016/j.cgh.2018.05.026 · Cited by 108 · see citing works
Ulcerative Colitis Care Pathway
Dassopoulos, T., Cohen, R. D., Scherl, E., Schwartz, R. M., Kosinski, L. R., & Regueiro, M. D. (2015) · Gastroenterology · doi:10.1053/j.gastro.2015.05.036 · Cited by 106 · see citing works
Tofacitinib in Patients with Ulcerative Colitis: Health-Related Quality of Life in Phase 3 Randomised Controlled Induction and Maintenance Studies
Panés, J., Vermeire, S., Lindsay, J. O., Sands, B. E., Su, C. G., Friedman, G. S., Zhang, H., Yarlas, A. S., Bayliss, M. S., Maher, S. M., et al. (2017) · Journal of Crohn s and Colitis · doi:10.1093/ecco-jcc/jjx133 · Cited by 100 · see citing works
Development and reliability of the new endoscopic virtual chromoendoscopy score: the PICaSSO (Paddington International Virtual ChromoendoScopy ScOre) in ulcerative colitis
Iacucci, M., Daperno, M., Lazarev, M., Arsenascu, R., Tontini, G. E., Akinola, O., Gui, X. S., Villanacci, V., Goetz, M., Lowerison, M., et al. (2017) · Gastrointestinal Endoscopy · doi:10.1016/j.gie.2017.03.012 · Cited by 92 · see citing works
Quality of life, work productivity impairment and healthcare resources in inflammatory bowel diseases in Brazil
Parra, R. S., Chebli, J. M., Amarante, H. M., Flores, C., Parente, J. M., Ramos, O., Fernandes, M., Rocha, J. J., Feitosa, M. R., Feres, O., et al. (2019) · World Journal of Gastroenterology · doi:10.3748/wjg.v25.i38.5862 · Cited by 92 · see citing works
Mucosal Healing in Ulcerative Colitis – When Zero is Better
Carvalho, P. B., de Castro, F. D., Rosa, B. J. F., Moreira, M. J., & Cotter, J. B. (2015) · Journal of Crohn s and Colitis · doi:10.1093/ecco-jcc/jjv180 · Cited by 92 · see citing works
Etrolizumab for the Treatment of Ulcerative Colitis and Crohn’s Disease: An Overview of the Phase 3 Clinical Program
Sandborn, W. J., Vermeire, S., Tyrrell, H. E. J., Hassanali, A., Lacey, S., Tole, S., & Tatro, A. R. (2020) · Advances in Therapy · doi:10.1007/s12325-020-01366-2 · Cited by 92 · see citing works
Assessment of mucosal healing in inflammatory bowel disease: review
Dulai, P. S., Levesque, B. G., Feagan, B. G., D’Haens, G., & Sandborn, W. J. (2015) · Gastrointestinal Endoscopy · doi:10.1016/j.gie.2015.03.1974 · Cited by 89 · see citing works
Impact of Drug Therapy and Surgery on Quality of Life in Crohnʼs Disease
Wright, E. K., & Kamm, M. A. (2014) · Inflammatory Bowel Diseases · doi:10.1097/mib.0000000000000271 · Cited by 83 · see citing works
“Results from the validation of the disability index is expected in 2014.(1) Another disability questionnaire had a significant inverse correlation with QoL measures and a significant correlation with the Crohn’s Disease Activity Index.”
BackgroundMethod
Health‐related quality of life in diabetes mellitus and its social, demographic and clinical determinants: A nationwide cross‐sectional survey
Rodríguez‐Almagro, J., García‐Manzanares, Á., Lucendo, A. J., & Hernández‐Martínez, A. (2018) · Journal of Clinical Nursing · doi:10.1111/jocn.14624 · Cited by 80 · see citing works
Development and Validation of an Inflammatory Bowel Diseases Monitoring Index for Use With Mobile Health Technologies
van Deen, W. K., Jong, A. E. V. D. M., Parekh, N. K., Kane, E., Zand, A., DiNicola, C. A., Hall, L., Inserra, E. K., Choi, J. M., Ha, C. Y., et al. (2015) · Clinical Gastroenterology and Hepatology · doi:10.1016/j.cgh.2015.10.035 · Cited by 74 · see citing works
“14 Furthermore, the use of PROs as primary outcome measures for evaluating effectiveness of IBD interventions is progressively supported by the Food and Drug Administration.”
Clinical Effects of a Topically Applied Toll-like Receptor 9 Agonist in Active Moderate-to-Severe Ulcerative Colitis
Atreya, R. N., Bloom, S. L., Scaldaferri, F., Gerardi, V., Admyre, C., Karlsson, A. E., Knittel, T. E., Kowalski, J. H., Lukáš, M., Löfberg, R., et al. (2016) · Journal of Crohn s and Colitis · doi:10.1093/ecco-jcc/jjw103 · Cited by 71 · see citing works
Patient preferences for inflammatory bowel disease treatment objectives
Casellas, F., Guise, C. H.-D., Robles, V., Navarro-Correal, E., & Borruel, N. (2016) · Digestive and Liver Disease · doi:10.1016/j.dld.2016.09.009 · Cited by 69 · see citing works
“009 linical trials, assessing symptoms such as abdominal pain, bowel ovements, or bloody stools, and the repercussion perceived by atients expressed as their quality of life [6,7].”
Background
Heterogeneity in Definitions of Endpoints for Clinical Trials of Ulcerative Colitis: A Systematic Review for Development of a Core Outcome Set
Ma, C., Panaccione, R., Fedorak, R. N., Parker, C. E., Nguyen, T. M., Khanna, R., Siegel, C. A., Peyrin‐Biroulet, L., D’Haens, G., Sandborn, W. J., et al. (2017) · Clinical Gastroenterology and Hepatology · doi:10.1016/j.cgh.2017.08.025 · Cited by 69 · see citing works
“As PROs become an increasingly central component of assessing treatment response, standardization of definitions and units of meaningful change will be needed.(3) Endoscopic endpoints are nearly universally reported as an outcome domain in contemporary RCTs.”
Background
Treatment with Immunosuppressive Therapy May Improve Depressive Symptoms in Patients with Inflammatory Bowel Disease
Horst, S., Chao, A., Rosen, M., Nohl, A., Duley, C., Wagnon, J. H., Beaulieu, D. B., Taylor, W., Gaines, L., & Schwartz, D. A. (2015) · Digestive Diseases and Sciences · doi:10.1007/s10620-014-3375-0 · Cited by 75 · see citing works
“Measuring disease activity using the Harvey Bradshaw Index (HBI) has limitations including capturing functional gastrointestinal symptoms that can be associated with depression, and there is literature regarding lack of precision of this tool as a measure for active inflammatory bowel disease [31].”
Method
Interpretability of the PedsQL Gastrointestinal Symptoms Scales and Gastrointestinal Worry Scales in Pediatric Patients With Functional and Organic Gastrointestinal Diseases
Varni, J. W., Bendo, C. B., Shulman, R. J., Self, M. M., Nurko, S., Franciosi, J. P., Saps, M., Saeed, S. A., Zacur, G. M., Dark, C. V., et al. (2015) · Journal of Pediatric Psychology · doi:10.1093/jpepsy/jsv005 · Cited by 65 · see citing works
“This paradigm shift toward PROs in clinical trials has provided the opportunity to include the perspective of pediatric patients using PROs as efficacy outcomes (Mohammad et al., 2014; Williet et al., 2014).”
Background
Anti-TNFα therapy in IBD alters brain activity reflecting visceral sensory function and cognitive-affective biases.
Gray, M. A., Chao, C.-Y., Staudacher, H. M., Kolosky, N. A., Talley, N. J., & Holtmann, G. (2018) · PLOS ONE · doi:10.1371/journal.pone.0193542 · Cited by 63 · see citing works
Patient Reported Outcome Measures (PROMs) in Inflammatory Bowel Disease: New Data
Bojic, D., Bodger, K., & Travis, S. P. L. (2016) · Journal of Crohn s and Colitis · doi:10.1093/ecco-jcc/jjw187 · Cited by 60 · see citing works
Systematic review and meta‐analysis: assessment of factors affecting disability in inflammatory bowel disease and the reliability of the inflammatory bowel disease disability index
Lo, B. Z. S., Prosberg, M. V., Gluud, L. L., Chan, W. P. W., Leong, R. W. L., van der List, E., van der Have, M., Sarter, H., Gower‐Rousseau, C., Peyrin‐Biroulet, L., et al. (2017) · Alimentary Pharmacology & Therapeutics · doi:10.1111/apt.14373 · Cited by 60 · see citing works
“However, the United States food and drug administration (FDA) is beginning to shift from disease-related outcomes as its primary endpoints towards accepting patient-reported outcomes and clinician-reported outcomes.(3,4) Much effort has been put into investigating quality of life, while less work has been carried out…”
BackgroundMethod
Real-World Evidence: Bridging Gaps in Evidence to Guide Payer Decisions
Roberts, M. H., & Ferguson, G. T. (2020) · PharmacoEconomics - Open · doi:10.1007/s41669-020-00221-y · Cited by 59 · see citing works
“Of note, while disease impact on work productivity costs (to include absenteeism and/or presenteeism) may be included in economic evaluations, and may be particularly meaningful for a condition such as irritable bowel disease that impacts a much younger population [68], to date productivity costs have been minimally i…”
Background
Systematic Review: Disease Activity Indices in Eosinophilic Esophagitis
Warners, M. J., Hindryckx, P., Levesque, B. G., Parker, C. E., Shackelton, L. M., Khanna, R., Sandborn, W. J., D’Haens, G., Feagan, B. G., Bredenoord, A. J., et al. (2017) · The American Journal of Gastroenterology · doi:10.1038/ajg.2017.363 · Cited by 58 · see citing works
Burden of disease and patient-reported outcomes in patients with moderate to severe ulcerative colitis in the last 12 months – Multicenter European cohort study
Assche, G. V., Peyrin‐Biroulet, L., Sturm, A., Gisbert, J. P., Gaya, D. R., Bokemeyer, B., Mantzaris, G. J., Armuzzi, A., Sebastian, S., Lara, N., et al. (2016) · Digestive and Liver Disease · doi:10.1016/j.dld.2016.01.011 · Cited by 56 · see citing works
Development of the symptoms and impacts questionnaire for Crohn's disease and ulcerative colitis
Dulai, P. S., Jairath, V., Khanna, R., Ma, C., McCarrier, K. P., Martin, M. L., Parker, C. E., Morris, J. C., Feagan, B. G., & Sandborn, W. J. (2020) · Alimentary Pharmacology & Therapeutics · doi:10.1111/apt.15726 · Cited by 56 · see citing works
Clinical Trials in Ulcerative Colitis: A Historical Perspective
Hindryckx, P., Baert, F., Hart, A. L., Magro, F., Armuzzi, A., & Peyrin‐Biroulet, L. (2015) · Journal of Crohn s and Colitis · doi:10.1093/ecco-jcc/jjv074 · Cited by 55 · see citing works
The contribution of clinical and psychosocial factors to fatigue in 182 patients with inflammatory bowel disease: a cross‐sectional study
Artom, M., Czuber‐Dochan, W., Sturt, J. A., Murrells, T., & Norton, C. S. (2016) · Alimentary Pharmacology & Therapeutics · doi:10.1111/apt.13870 · Cited by 55 · see citing works
“0 (20–83) Education Up to 16 2 (3) 19 (16) 0 (0) 21 (12) Up to 18 8 (13) 22 (19) 1 (17) 31 (17) Higher education 50 (83) 75 (65) 5 (83) 130 (71) Marital status Married/living with partner 35 (58) 76 (66) 3 (50) 115 (63) Widowed/divorced 2 (4) 7 (6) 0 (0) 9 (5) Single/single parent/other 23 (38) 33 (28) 3 (50) 58 (32)…”
The Inflammatory Bowel Disease Questionnaire in Randomized Controlled Trials of Treatment for Ulcerative Colitis: Systematic Review and Meta-Analysis
Yarlas, A. S., Maher, S. M., Bayliss, M. S., Lovley, A., Cappelleri, J. C., Bushmakin, A. G., & DiBonaventura, M. (2020) · Journal of patient-centered research and reviews · doi:10.17294/2330-0698.1722 · Cited by 55 · see citing works
Diagnostic Performance of the Simple Clinical Colitis Activity Index Self-Administered Online at Home by Patients With Ulcerative Colitis: CRONICA-UC Study
Marín‐Jiménez, I., Nos, P., Domènech, E., Riestra, S., Gisbert, J. P., Calvet, X., Cortés, X., Iglesias, E. L., Huguet, J. M., Taxonera, C., et al. (2016) · The American Journal of Gastroenterology · doi:10.1038/ajg.2015.403 · Cited by 54 · see citing works
Heterogeneity in Definitions of Efficacy and Safety Endpoints for Clinical Trials of Crohn’s Disease: A Systematic Review
Ma, C., Hussein, I. M., Al-Abbar, Y. J., Panaccione, R., Fedorak, R. N., Parker, C. E., Nguyen, T. M., Khanna, R., Siegel, C. A., Peyrin‐Biroulet, L., et al. (2018) · Clinical Gastroenterology and Hepatology · doi:10.1016/j.cgh.2018.02.051 · Cited by 53 · see citing works
“First, the formal construction and validation of a CD-specific PRO appropriate for use in randomized controlled trials (RCTs) could take years.(4) Second, current endoscopic indices, including the Crohn’s Disease Endoscopic Index of Severity (CDEIS)(5) and Simple Endoscopic Score for Crohn’s Disease (SES-CD)(6) are to…”
Method
Disease activity indices in coeliac disease: systematic review and recommendations for clinical trials
Hindryckx, P., Levesque, B. G., Holvoet, T., Durand, S., Tang, C., Parker, C. E., Khanna, R., Shackelton, L. M., D’Haens, G., Sandborn, W. J., et al. (2016) · Gut · doi:10.1136/gutjnl-2016-312762 · Cited by 52 · see citing works
Coping strategies, satisfaction with life, and quality of life in Crohn’s disease: A gender perspective using structural equation modeling analysis
Sarid, O., Slonim‐Nevo, V., Pereg, A., Friger, M. D., Sergienko, R., Schwartz, D., Greenberg, D., Shahar, I., Chernin, E., Vardi, H., et al. (2017) · PLoS ONE · doi:10.1371/journal.pone.0172779 · Cited by 50 · see citing works
The Inflammatory Bowel Disease Symptom Inventory: A Patient-report Scale for Research and Clinical Application
Sexton, K. A., Walker, J. R., Targownik, L. E., Graff, L. A., Haviva, C., Beatie, B. E., Petty, S. K., Bernstein, M. T., Singh, H., Miller, N., et al. (2019) · Inflammatory Bowel Diseases · doi:10.1093/ibd/izz038 · Cited by 51 · see citing works
Impact of Obesity on Inflammatory Bowel Disease
Khakoo, N. S., Ioannou, S., Khakoo, N. S., Vedantam, S., & Pearlman, M. Y. (2022) · Current Gastroenterology Reports · doi:10.1007/s11894-022-00840-x · Cited by 51 · see citing works
“In IBD, HRQoL is generally assessed by patient-reported outcomes obtained via the Short-Form 36 questionnaire or disease-specific scales, such as the Inflammatory Bowel Disease Questionnaire (IBDQ) [53].”
Development of the Harvey-Bradshaw Index-pro (HBI-PRO) Score to Assess Endoscopic Disease Activity in Crohn’s Disease
Zittan, E., Kabakchiev, B., Kelly, O., Milgrom, R., Nguyen, G. C., Croitoru, K., Steinhart, A. H., & Silverberg, M. S. (2016) · Journal of Crohn s and Colitis · doi:10.1093/ecco-jcc/jjw200 · Cited by 48 · see citing works
Review article: moving towards common therapeutic goals in Crohn's disease and rheumatoid arthritis
Allen, P. B., Olivera, P. A., Emery, P., Moulin, D., Jouzeau, J., Netter, P., Danese, S., Feagan, B. G., Sandborn, W. J., & Peyrin‐Biroulet, L. (2017) · Alimentary Pharmacology & Therapeutics · doi:10.1111/apt.13995 · Cited by 48 · see citing works
“was not developed and validated according to FDA guidance for the development of patient-reported outcomes (PROs).(45)”
Method
PedsQL Gastrointestinal Symptoms Scales and Gastrointestinal Worry Scales in Pediatric Patients with Inflammatory Bowel Disease in Comparison with Healthy Controls
Varni, J. W., Franciosi, J. P., Shulman, R. J., Saeed, S. A., Nurko, S., Neigut, D. A., Bendo, C. B., Patel, A., Self, M. M., Saps, M., et al. (2015) · Inflammatory Bowel Diseases · doi:10.1097/mib.0000000000000351 · Cited by 47 · see citing works
“Future research with these new scales will also benefit from direct comparisons with the IMPACT-III in the validation process, as was done in the validation of the PedsQL 4.0 Generic Core Scales and the PedsQL Multidimensional Fatigue Scale in pediatric patients with IBD.18 The PedsQL Gastrointestinal Symptoms Scales…”
Influential
Fecal calprotectin: current and future perspectives for inflammatory bowel disease treatment
Bertani, L., Mumolo, M. G., Tapete, G., Albano, E., Svizzero, G. B., Zanzi, F., Ceccarelli, L., Bellini, M., Marchi, S., & Costa, F. (2020) · European Journal of Gastroenterology & Hepatology · doi:10.1097/meg.0000000000001731 · Cited by 44 · see citing works
Patient-Reported Outcome Measures in Inflammatory Bowel Disease
El‐Matary, W. (2014) · Canadian Journal of Gastroenterology and Hepatology · doi:10.1155/2014/792386 · Cited by 42 · see citing works
Development of a core outcome set for clinical trials in inflammatory bowel disease: study protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey
Ma, C., Panaccione, R., Fedorak, R. N., Parker, C. E., Khanna, R., Levesque, B. G., Sandborn, W. J., Feagan, B. G., & Jairath, V. (2017) · BMJ Open · doi:10.1136/bmjopen-2017-016146 · Cited by 40 · see citing works
“Furthermore, recognising the need to accurately measure the patient experience with IBD, the US Food and Drug Administration (FDA) has advocated for measurement of patient-reported outcomes (PROs) in clinical trials.(20) The utilisation of PROs as a treatment end point in IBD trials poses unique challenges: importantl…”
Background
Preventing disability in inflammatory bowel disease
Allen, P. B., Gower‐Rousseau, C., Danese, S., & Peyrin‐Biroulet, L. (2017) · Therapeutic Advances in Gastroenterology · doi:10.1177/1756283x17732720 · Cited by 40 · see citing works
Performance of Crohn’s disease Clinical Trial Endpoints based upon Different Cutoffs for Patient Reported Outcomes or Endoscopic Activity: Analysis of EXTEND Data
Feagan, B. G., Sandborn, W. J., Rutgeerts, P. J., Levesque, B. G., Khanna, R., Huang, B., Zhou, Q., Maa, J., Wallace, K. L., Lacerda, A. P., et al. (2018) · Inflammatory Bowel Diseases · doi:10.1093/ibd/izx082 · Cited by 40 · see citing works
The state of the art on treatment of Crohn’s disease
Shi, H. Y., & Ng, S. C. (2018) · Journal of Gastroenterology · doi:10.1007/s00535-018-1479-6 · Cited by 39 · see citing works
Impact of Inflammatory Bowel Disease on Disability
Büsch, K., Sonnenberg, A., & Bansback, N. J. (2014) · Current Gastroenterology Reports · doi:10.1007/s11894-014-0414-0 · Cited by 39 · see citing works
Review article: treating‐to‐target for inflammatory bowel disease‐associated anaemia
Peyrin‐Biroulet, L., Lopez, A., Cummings, F. J. R., Dignass, A. U., Detlie, T. E., & Danese, S. (2018) · Alimentary Pharmacology & Therapeutics · doi:10.1111/apt.14922 · Cited by 38 · see citing works
“PROs are increasingly replacing conventional endpoints such as the Crohn's disease Activity Index (CDAI) for the assessment of disease activity.(39) The primary outcome of most interventional studies PEYRIN‐BIROULET ET AL.”
Health‐related quality of life in inflammatory bowel disease in a Danish population‐based inception cohort
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Development of a Microscopic Colitis Disease Activity Index: a prospective cohort study
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Tumor Necrosis Factor’s Pathway in Crohn’s Disease: Potential for Intervention
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Review article: Measuring disease severity in inflammatory bowel disease – Beyond treat to target
Swaminathan, A., Day, A. S., Sparrow, M., Peyrin‐Biroulet, L., Siegel, C. A., & Gearry, R. B. (2024) · Alimentary Pharmacology & Therapeutics · doi:10.1111/apt.18231 · Cited by 35 · see citing works
The IBD-disk Is a Reliable Tool to Assess the Daily-life Burden of Patients with Inflammatory Bowel Disease
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Poor Sleep in Inflammatory Bowel Disease Is Reflective of Distinct Sleep Disorders
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“Changes in HRQL are now considered as an integral part in the assessment of therapeutic interventions for chronic or prolonged pathologies (23,24).”
Background
Perception of disease burden and treatment satisfaction in patients with ulcerative colitis from outpatient clinics in Spain: UC-LIFE survey
Carpio, D., López–Sanromán, A., Calvet, X., Romero, C., Cea‐Calvo, L., Juliá, B., & Argüelles‐Arias, F. (2016) · European Journal of Gastroenterology & Hepatology · doi:10.1097/meg.0000000000000658 · Cited by 34 · see citing works
Disability and quality of life before and during the COVID-19 outbreak: A cross-sectional study in inflammatory bowel disease patients
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“[6,7] Our current targets in the care for patients effected by IBD is to alleviate disease symptoms, decrease the incidence of flares, prevention of long term complications, as well as to 'improve patients HRQoL.[8,9] Numerous studies have focused on HRQoL assessment to measure and provide insight on the disability st…”
Background
The Harvey–Bradshaw Index Adapted to a Mobile Application Compared with In-Clinic Assessment: The MediCrohn Study
Echarri, A., Vera, I., Ollero, V., Aràjol, C., Riestra, S., Robledo, P., Calvo, M., Gallego, F., CEBALLOS, D. S., Castro, B., et al. (2019) · Telemedicine Journal and e-Health · doi:10.1089/tmj.2018.0264 · Cited by 32 · see citing works
Patient-Reported Outcomes Measurement Information System in Children with Crohn's Disease
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Treatment algorithms in Crohn's – Up, down or something else?
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“there is a growing interest for PROs in IBD [67], none of those currently used in IBD were developed according to FDA guidance.”
BackgroundMethod
The IBD-F Patient Self-Assessment Scale Accurately Depicts the Level of Fatigue and Predicts a Negative Effect on the Quality of Life of Patients With IBD in Clinical Remission
Varbobitis, I. C., Kokkotis, G., Gizis, M., Perlepe, N., Laoudi, E., Bletsa, M., Bekiari, D., Koutsounas, I. S., Kounadis, G., Xourafas, V., et al. (2020) · Inflammatory Bowel Diseases · doi:10.1093/ibd/izaa201 · Cited by 31 · see citing works
Quality of care in inflammatory bowel diseases: What is the best way to better outcomes?
Strohl, M., Gönczi, L., Kurt, Z., Bessissow, T., & Lakatos, P. L. (2018) · World Journal of Gastroenterology · doi:10.3748/wjg.v24.i22.2363 · Cited by 31 · see citing works
Twenty‐five years of biologicals in IBD: What´s all the hype about?
Herrlinger, K. R., & Stange, E. F. (2021) · Journal of Internal Medicine · doi:10.1111/joim.13345 · Cited by 30 · see citing works
Early vedolizumab trough levels predict combined endoscopic and clinical remission in inflammatory bowel disease
Hanžel, J., Sever, N., Ferkolj, I., Štabuc, B., Smrekar, N., Kurent, T., Koželj, M., Novak, G., Compernolle, G., Tops, S., et al. (2019) · United European Gastroenterology Journal · doi:10.1177/2050640619840211 · Cited by 29 · see citing works
Effect of risankizumab on health‐related quality of life in patients with Crohn's disease: results from phase 3 MOTIVATE , ADVANCE and FORTIFY clinical trials
Peyrin‐Biroulet, L., Ghosh, S. K., Lee, S. D., Lee, W., Griffith, J. M., Wallace, K. L., Berg, S., Liao, X., Panés, J., Loftus, E. V., et al. (2022) · Alimentary Pharmacology & Therapeutics · doi:10.1111/apt.17242 · Cited by 28 · see citing works
Resilience as a Mediator of the Association Between Perceived Stigma and Quality of Life Among People With Inflammatory Bowel Disease
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“The quality of life (QOL) among patients with IBD is of growing significance since the patient-reported outcomes are recognized as primary endpoints by regulatory agencies (6).”
Background
Association between disease activity and quality of life in ulcerative colitis: Results from the CRONICA‐UC study
Panés, J., Domènech, E., Peris, M. A., Nos, P., Riestra, S., Paramo, B. J. D., Cea‐Calvo, L., Romero, C., & Marín‐Jiménez, I. (2017) · Journal of Gastroenterology and Hepatology · doi:10.1111/jgh.13795 · Cited by 27 · see citing works
A pilot feasibility trial of cognitive–behavioural therapy for insomnia in people with inflammatory bowel disease
Salwen‐Deremer, J. K., Smith, M. T., Aschbrenner, K. A., Haskell, H. G., Speed, B. C., & Siegel, C. A. (2021) · BMJ Open Gastroenterology · doi:10.1136/bmjgast-2021-000805 · Cited by 26 · see citing works
“Examples from participants for whom the sleep/IBD relationship was a novel idea include: It was an unexpected avenue to take but one of the best things I have done in a long time, I know sleep in general is important, but I don’t think I would have thought of it initially as a treatment to help with IBD, and It met a…”
Influential
Brief and Telehealth Acceptance and Commitment Therapy (ACT) Interventions for Stress in Inflammatory Bowel Disease (IBD): A Series of Single Case Experimental Design (SCED) Studies
Lavelle, J., Storan, D., Eswara Murthy, V., De Dominicis, N., Mulcahy, H. E., & McHugh, L. (2022) · Journal of Clinical Medicine · doi:10.3390/jcm11102757 · Cited by 23 · see citing works
“Given such convincing evidence of a psychological component and impact in and of IBD, psychological support is now considered an integral component of modern IBD management [16,17].”
Background
Week 6 Calprotectin Best Predicts Likelihood of Long-term Endoscopic Healing in Crohn’s Disease: A Post-hoc Analysis of the UNITI/IM-UNITI Trials
Narula, N., Wong, E. C. L., Dulai, P. S., Marshall, J. K., Colombel, J., & Reinisch, W. (2020) · Journal of Crohn s and Colitis · doi:10.1093/ecco-jcc/jjaa189 · Cited by 25 · see citing works
Pain Characteristics in Patients with Inflammatory Bowel Disease: A Monocentric Cross-Sectional Study
Hardy, P., Fikri, J., Libbrecht, D., Louis, E. J., & Joris, J. L. (2022) · Journal of Crohn s and Colitis · doi:10.1093/ecco-jcc/jjac051 · Cited by 25 · see citing works
Factors affecting clinical decision-making in inflammatory bowel disease and the role of point-of-care calprotectin
Derwa, Y. H., Williams, C. J. M., Sood, R., Mumtaz, S., Bholah, M. H., Selinger, C. P., Hamlin, P. J., Ford, A. C., & Gracie, D. J. (2018) · Therapeutic Advances in Gastroenterology · doi:10.1177/1756283x17744739 · Cited by 25 · see citing works
Clinical efficacy of the Toll-like receptor 9 agonist cobitolimod using patient-reported-outcomes defined clinical endpoints in patients with ulcerative colitis
Atreya, R. N., Reinisch, W., Peyrin‐Biroulet, L., Scaldaferri, F., Admyre, C., Knittel, T. E., Kowalski, J. H., Neurath, M. F., & Hawkey, C. J. (2018) · Digestive and Liver Disease · doi:10.1016/j.dld.2018.06.010 · Cited by 25 · see citing works
Clinical Activity and Quality of Life Indices Are Valid Across Ulcerative Colitis But Not Crohn’s Disease Phenotypes
Taleban, S., Stewart, K. O., Li, D. K., Singh, P., Pardi, D. S., Sturgeon, H. C., Yajnik, V., Xavier, R. J., Ananthakrishnan, A. N., & Khalili, H. (2016) · Digestive Diseases and Sciences · doi:10.1007/s10620-016-4180-8 · Cited by 24 · see citing works
“Recently, the FDA has mandated that clinical trial endpoints move away from using CAIs and toward endoscopic disease assessment and patient-reported outcome measures [38].”
How Will Evolving Future Therapies and Strategies Change How We Position the Use of Biologics in Moderate to Severely Active Inflammatory Bowel Disease
Dulai, P. S., Singh, S., Casteele, N. V., Boland, B. S., & Sandborn, W. J. (2016) · Inflammatory Bowel Diseases · doi:10.1097/mib.0000000000000661 · Cited by 23 · see citing works
Biomarker-Based Models Outperform Patient-Reported Scores in Predicting Endoscopic Inflammatory Disease Activity
Morris, M. W., Stewart, S. A., Heisler, C., Sandborn, W. J., Loftus, E. V., Zello, G. A., Fowler, S. A., & Jones, J. (2018) · Inflammatory Bowel Diseases · doi:10.1093/ibd/izx018 · Cited by 23 · see citing works
Placebo Effect on the Health-related Quality of Life of Inflammatory Bowel Disease Patients: A Systematic Review With Meta-analysis
Estevinho, M. M., Afonso, J., Rosa, I., Lago, P. M., Trindade, E., Correia, L., Dias, C. C., Magro, F., & GEDII [Portuguese IBD Group] (2018) · Journal of Crohn s and Colitis · doi:10.1093/ecco-jcc/jjy100 · Cited by 23 · see citing works
Usefulness of fecal calprotectin for the early prediction of short-term outcomes of remission-induction treatments in ulcerative colitis in comparison with two-item patient-reported outcome
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Evaluation of fatigue in inflammatory bowel disease - a useful tool in daily practice
Saraiva, S., Cortez-Pinto, J., Barosa, R., Castela, J., Moleiro, J., Rosa, I., da Siva, J. P., & Dias Pereira, A. (2019) · Scandinavian Journal of Gastroenterology · doi:10.1080/00365521.2019.1602669 · Cited by 22 · see citing works
“More recently, Williet et al. [9], developed a nationwide cohort study in order to test all the dimensions of PROs in the context of IBD.”
BackgroundInfluential
Cognitive behavioural therapy for the management of inflammatory bowel disease-fatigue with a nested qualitative element: study protocol for a randomised controlled trial
Artom, M., Czuber‐Dochan, W., Sturt, J. A., & Norton, C. S. (2017) · Trials · doi:10.1186/s13063-017-1926-3 · Cited by 23 · see citing works
“In line with the international expert consensus of the recent Therapeutic Targets in Inflammatory Bowel Disease (STRIDE) initiative [14] on treatment targets for IBD, it is therefore important to shift from management of IBD aimed solely at achieving endoscopic remission to also evaluating patient reported outcomes (P…”
Result
Interpreting Registrational Clinical Trials of Biological Therapies in Adults with Inflammatory Bowel Diseases
Ghosh, S. K., Sandborn, W. J., Colombel, J., Feagan, B. G., Panaccione, R., Hanauer, S. B., Schreiber, S., Peyrin‐Biroulet, L., Vermeire, S., Eichner, S. F., et al. (2016) · Inflammatory Bowel Diseases · doi:10.1097/mib.0000000000000909 · Cited by 22 · see citing works
“Ideally, future trials will include PROs and endoscopic measures of disease activity as co-primary endpoints.(44) Evidence from UC populations has shown that there is still a subjective interpretation of endoscopic and cross-sectional images,(46,47) which may be aided by using a central reader.”
Background
Disease activity, steroid use and extraintestinal manifestation are associated with increased disability in patients with inflammatory bowel disease using the inflammatory bowel disease disability index: a cross-sectional multicentre cohort study
Lo, B. Z. S., Julsgaard, M., Vester-Andersen, M. K., Vind, I., & Burisch, J. M. (2018) · European Journal of Gastroenterology & Hepatology · doi:10.1097/meg.0000000000001199 · Cited by 22 · see citing works
Unmet Psychosocial Needs of Patients with Newly Diagnosed Ulcerative Colitis: Results from the Nationwide Prospective Cohort Study in Korea
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Predictors of Response to Vedolizumab in Patients with Ulcerative Colitis: Results from the Greek VEDO-IBD Cohort
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Prime Time Was Yesterday for Patient-reported Outcomes in Daily Care of Patients With Inflammatory Bowel Diseases
Bossuyt, P. J., Hoefkens, E., & Pouillon, L. (2018) · Clinical Gastroenterology and Hepatology · doi:10.1016/j.cgh.2018.05.029 · Cited by 3 · see citing works
PROMises Made, PROMises To Be Kept: Patient-Reported Outcome Measures in Inflammatory Bowel Diseases
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Making a Case for Patient-Reported Outcomes in Clinical Inflammatory Bowel Disease Practice
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Patient-Reported Outcomes in Inflammatory Bowel Diseases: Another Piece in the Puzzle
Restellini, S., & Lakatos, P. L. (2020) · Journal of Crohn s and Colitis · doi:10.1093/ecco-jcc/jjaa261 · Cited by 1 · see citing works
A Novel Index to Measure Patient-Reported Outcomes in Clinical Practice and Research: The Inflammatory Bowel Disease Symptom Inventory—Ready for Prime Time?
Long, M. D. (2019) · Inflammatory Bowel Diseases · doi:10.1093/ibd/izz041 · Cited by 1 · see citing works

Authors: Williet, N., Sandborn, W. J., & Peyrin–Biroulet, L.
Affiliations: Inserm (FR)
University of California San Diego (US)
ORCID: Williet, Nicolas
Sandborn, William J.
Venue: Clinical Gastroenterology and Hepatology
Publisher: Elsevier BV
Published: 2014-08
Volume: 12
Issue: 8
Pages: 1246-1256.e6
ISSN: 1542-3565 (ISSN-L)
DOI: 10.1016/j.cgh.2014.02.016
OpenAlex: W2033081617
Cited by: 260
References: 150
Citations by year: 2026: 9 · 2025: 19 · 2024: 16 · 2023: 14 · 2022: 21 · 2021: 19 · 2020: 26 · 2019: 18 · 2018: 30 · 2017: 24 · 2016: 33 · 2015: 22 · 2014: 8 · 2012: 1
FWCI: 3.83
Type: journal article
Language: en
Open access: closed
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
www.elsevier.com/legal/tdmrep-license (tdm)
Locations: Clinical Gastroenterology and Hepatology (publishedVersion)
PubMed (publishedVersion)
HAL (submittedVersion)
Funders: Optimer Pharmaceuticals
Boehringer Ingelheim
Shire
Bristol-Myers Squibb
Pfizer
Orexigen Therapeutics
UCB Pharma
Novartis
Roche
Gilead Sciences
Genentech
Merck
Topics: Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Inflammatory Bowel Disease
Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Health Systems, Economic Evaluations, Quality of Life
Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
Keywords: patient-reported outcomes, inflammatory bowel disease, Crohn's disease, primary endpoint, clinical trial endpoints, CDAI, quality of life, fatigue, anxiety and depression, labor productivity, disability, IBDQ, Short Form-36
MeSH terms: Humans, Surveys and Questionnaires, Inflammatory Bowel Diseases, Treatment Outcome, Drug Monitoring, Patient Satisfaction

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Patient-reported outcomes as primary end points in clinical trials of inflammatory bowel disease

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