TY - JOUR AU - Burisch, J. AU - Jess, T. AU - Martinato, M. AU - Lakatos, P. L. AU - EpiCom, E. PY - 2013 DA - 2013// TI - The burden of inflammatory bowel disease in Europe JO - Journal of Crohn's & Colitis VL - 7 UR - https://doi.org/10.1016/j.crohns.2013.01.010 DO - 10.1016/j.crohns.2013.01.010 ID - Burisch2013 ER - TY - JOUR AU - Kappelman, M. D. AU - Moore, K. R. AU - Allen, J. K. AU - Cook, S. F. PY - 2013 DA - 2013// TI - Recent trends in the prevalence of Crohn's disease and ulcerative colitis in a commercially insured US population JO - Digestive Diseases and Sciences VL - 58 UR - https://doi.org/10.1007/s10620-012-2371-5 DO - 10.1007/s10620-012-2371-5 ID - Kappelman2013 ER - TY - JOUR AU - M'Koma, A. E. PY - 2013 DA - 2013// TI - Inflammatory bowel disease: An expanding global health problem JO - Clin Med Insights Gastroenterol VL - 6 UR - https://doi.org/10.4137/CGast.S12731 DO - 10.4137/CGast.S12731 ID - M'Koma2013 ER - TY - JOUR AU - Ye, Y. AU - Pang, Z. AU - Chen, W. AU - Ju, S. AU - Zhou, C. PY - 2015 DA - 2015// TI - The epidemiology and risk factors of inflammatory bowel disease JO - International Journal of Clinical and Experimental Medicine VL - 8 ID - Ye2015 ER - TY - JOUR AU - Baumgart, D. C. AU - Sandborn, W. J. PY - 2007 DA - 2007// TI - Inflammatory bowel disease: Clinical aspects and established and evolving therapies JO - Lancet VL - 369 UR - https://doi.org/10.1016/S0140-6736(07)60751-X DO - 10.1016/S0140-6736(07)60751-X ID - Baumgart2007 ER - TY - JOUR AU - Best, W. R. AU - Becktel, J. M. AU - Singleton, J. W. AU - Kern, F. PY - 1976 DA - 1976// TI - Development of a Crohn's disease activity index JO - National Cooperative Crohn's Disease Study Gastroenterology VL - 70 ID - Best1976 ER - TY - STD TI - Food and Drug Administration (2009). Guidance for industry—Patient-reported outcome measures: Use in medical product development to support labeling claims. Available at: http://www.fda.gov/downloads/Drugs/Guidances/UCM193282.pdf. Fed Regist, 74, 65132–65133. UR - http://www.fda.gov/downloads/Drugs/Guidances/UCM193282.pdf ID - ref7 ER - TY - JOUR AU - Spiegel, B. M. AU - Bolus, R. AU - Agarwal, N. AU - Sayuk, G. AU - Harris, L. A. AU - Lucak, S. AU - Esrailian, E. AU - Chey, W. D. AU - Lembo, A. AU - Karsan, H. AU - Tillisch, K. AU - Talley, J. AU - Chang, L. PY - 2010 DA - 2010// TI - Measuring symptoms in the irritable bowel syndrome: Development of a framework for clinical trials JO - Alimentary Pharmacology & Therapeutics VL - 32 UR - https://doi.org/10.1111/j.1365-2036.2010.04464.x DO - 10.1111/j.1365-2036.2010.04464.x ID - Spiegel2010 ER - TY - STD TI - FDA and CDER (2014) Guidance for industry and FDA staff: Qualification process for drug development tools. Available at: https://www.fda.gov/downloads/drugs/guidances/ucm230597.pdf. UR - https://www.fda.gov/downloads/drugs/guidances/ucm230597.pdf ID - ref9 ER - TY - JOUR AU - Sandler, R. S. AU - Jordan, M. C. AU - Kupper, L. L. PY - 1988 DA - 1988// TI - Development of a Crohn's index for survey research JO - Journal of Clinical Epidemiology VL - 41 UR - https://doi.org/10.1016/0895-4356(88)90046-7 DO - 10.1016/0895-4356(88)90046-7 ID - Sandler1988 ER - TY - JOUR AU - Leidy, N. K. AU - Vernon, M. PY - 2008 DA - 2008// TI - Perspectives on patient-reported outcomes: Content validity and qualitative research in a changing clinical trial environment JO - PharmacoEconomics VL - 26 UR - https://doi.org/10.2165/00019053-200826050-00002 DO - 10.2165/00019053-200826050-00002 ID - Leidy2008 ER - TY - JOUR AU - Guyatt, G. AU - Mitchell, A. AU - Irvine, E. J. AU - Singer, J. AU - Williams, N. AU - Goodacre, R. AU - Tompkins, C. PY - 1989 DA - 1989// TI - A new measure of health status for clinical trials in inflammatory bowel disease JO - Gastroenterology VL - 96 UR - https://doi.org/10.1016/0016-5085(89)90905-0 DO - 10.1016/0016-5085(89)90905-0 ID - Guyatt1989 ER - TY - JOUR PY - 1990 DA - 1990// TI - EuroQol--a new facility for the measurement of health-related quality of life JO - Health Policy VL - 16 UR - https://doi.org/10.1016/0168-8510(90)90421-9 DO - 10.1016/0168-8510(90)90421-9 ID - ref13 ER - TY - BOOK AU - Muthén, L. K. AU - Muthén, B. O. PY - 1998 DA - 1998// TI - Mplus user’s guide PB - Muthén CY - Los Angeles ID - Muthén1998 ER - TY - BOOK AU - Andrich, D. AU - Lyne, A. AU - Sheridan, B. AU - Luo, G. PY - 2012 DA - 2012// TI - RUMM 2030: Rasch Unidimensional measurement models PB - RUMM Laboratory Try Ltd. CY - Australia ID - Andrich2012 ER - TY - BOOK AU - Rasch, G. PY - 1980 DA - 1980// TI - Probabilistic models for some intelligence and attainment tests PB - University of Chicago Press CY - Chicago ID - Rasch1980 ER - TY - JOUR AU - Cronbach, L. J. PY - 1951 DA - 1951// TI - Coefficient alpha and the internal structure of tests JO - Psychometrika VL - 16 UR - https://doi.org/10.1007/BF02310555 DO - 10.1007/BF02310555 ID - Cronbach1951 ER - TY - BOOK AU - Nunnally, J. C. AU - Bernstein, I. H. PY - 1994 DA - 1994// TI - Psychometric theory PB - McGraw-Hill CY - New York ID - Nunnally1994 ER - TY - JOUR AU - Leidy, N. K. AU - Revicki, D. A. AU - Geneste, B. PY - 1999 DA - 1999// TI - Recommendations for evaluating the validity of quality of life claims for labeling and promotion JO - Value in Health VL - 2 UR - https://doi.org/10.1046/j.1524-4733.1999.02210.x DO - 10.1046/j.1524-4733.1999.02210.x ID - Leidy1999 ER - TY - BOOK AU - Cohen, J. PY - 1988 DA - 1988// TI - Statistical power analysis for the behavioral sciences PB - Lawrence Erlbaum Associates Inc. CY - Hillsdale ID - Cohen1988 ER - TY - STD TI - Food and Drug Administration (FDA). (2012). Gastroenterology regulatory endpoints and the advancement of therapeutics (GREAT I) Workshop. College Park, Food and Drug Administration, Center for Drug Evaluation and Research. ID - ref21 ER - TY - BOOK PY - 2013 DA - 2013// TI - Gastroenterology regulatory endpoints and the advancement of therapeutics (GREAT II) Workshop PB - Food and Drug Administration, Center for Drug Evaluation and Research CY - Bethesda ID - ref22 ER - TY - BOOK PY - 2015 DA - 2015// TI - Gastroenterology regulatory endpoints and the advancement of therapeutics (GREAT III) Workshop PB - Food and Drug Administration, Center for Drug Evaluation and Research CY - Silver Spring ID - ref23 ER - TY - STD TI - European Medicines Agency (EMA) (2016). Guideline on the development of new medicinal products for the treatment of Crohn's disease (Draft). London: European Medicines Agency. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2016/07/WC500211430.pdf. UR - http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2016/07/WC500211430.pdf ID - ref24 ER - TY - STD TI - Gasink, C., Friedman, J., Gao, L. L., Chan, D., Sandborn, W. J., & Feagan, B. (2015). Evaluation of an interim Crohn's disease outcome measure (PRO-2) based on two patient-reported components (stool frequency, abdominal pain) of the Crohn's disease activity index (CDAI) in the ustekinumab CERTIFI study. 10th congress of European Crohn's and colitis organization (ECCO-2015); 18–21 February 2015; Barcelona. ID - ref25 ER - TY - JOUR AU - Khanna, R. AU - Zou, G. AU - D'Haens, G. AU - Feagan, B. G. AU - Sandborn, W. J. AU - Vandervoort, M. K. AU - Rolleri, R. L. AU - Bortey, E. AU - Paterson, C. AU - Forbes, W. P. AU - Levesque, B. G. PY - 2015 DA - 2015// TI - A retrospective analysis: The development of patient reported outcome measures for the assessment of Crohn's disease activity JO - Alimentary Pharmacology & Therapeutics VL - 41 UR - https://doi.org/10.1111/apt.13001 DO - 10.1111/apt.13001 ID - Khanna2015 ER -