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Development of a conceptual model evaluating the humanistic and economic burden of Crohn’s disease: implications for patient-reported outcomes measurement and economic evaluation

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References

  • Mills SC, von Roon AC, Tekkis PP, et al. Crohn’s Disease. BMJ Clin Evid 2011;2011:pii0416
  • Molodecky NA, Soon IS, Rabi DM, et al. Increasing incidence and prevalence of the inflammatory bowel diseases with time, based on systematic review. Gastroenterology 2012;142(1):46-54
  • Economou M, Zambeli E, Michopoulos S. Incidence and prevalence of Crohn’s disease and its etiological influences. Ann Gastroenterol 2009;22(3):158-67
  • Wilkins T, Jarvis K, Patel J. Diagnosis and management of Crohn’s disease. Am Fam Physician 2011;84(12):1365-75
  • Munkholm P, Langholz E, Davidsen M, Binder V. Disease activity courses in a regional cohort of Crohn’s disease patients. Scand J Gastroenterol 1995;30(7):699-706
  • Danese S, Colombel JF, Reinisch W, Rutgeerts PJ. Review article: infliximab for Crohn’s disease treatment--shifting therapeutic strategies after 10 years of clinical experience. Aliment Pharmacol Ther 2011;33(8):857-69
  • Lichtenstein GR, Yan S, Bala M, Hanauer S. Remission in patients with Crohn’s disease is associated with improvement in employment and quality of life and a decrease in hospitalizations and surgeries. Am J Gastroenterol 2004;99(1):91-6
  • Cohen RD. The quality of life in patients with Crohn’s disease. Aliment Pharmacol Ther 2002;16(9):1603-9
  • Casellas F, Lopez-Vivancos J, Casado A, Malagelada JR. Factors affecting health related quality of life of patients with inflammatory bowel disease. Qual Life Res 2002;11(8):775-81
  • Bodger K. Cost of illness of Crohn’s disease. Pharmacoeconomics 2002;20(10):639-52
  • Feagan BG, Vreeland MG, Larson LR, Bala MV. Annual cost of care for Crohn’s disease: a payor perspective. Am J Gastroenterol 2000;95(8):1955-60
  • Mowat C, Cole A, Windsor A, et al. Guidelines for the management of inflammatory bowel disease in adults. Gut 2011;60(5):571-607
  • Hanauer SB, Cohen RD, Becker RVIII, et al. Advances in the management of Crohn’s disease: economic and clinical potential of infliximab. Clin Ther 1998;20(5):1009-28
  • Schnitzler F, Fidder H, Ferrante M, et al. Long-term outcome of treatment with infliximab in 614 patients with Crohn’s disease: results from a single-centre cohort. Gut 2009;58(4):492-500
  • Chaparro M, Panes J, Garcia V, et al. Long-term durability of infliximab treatment in Crohn’s disease and efficacy of dose “escalation” in patients losing response. J Clin Gastroenterol 2011;45(2):113-18
  • Katz S. "Mind the Gap": an unmet need for new therapy in IBD. J Clin Gastroenterol 2007;41(9):799-809
  • Rothman ML, Beltran P, Cappelleri JC, et al. Patient-reported outcomes: conceptual issues. Value Health 2007;10(Suppl 2):S66-75
  • Earp JA, Ennett ST. Conceptual models for health education research and practice. Health Educ Res 1991;6(2):163-71
  • Wilson IB, Cleary PD. Linking clinical variables with health-related quality of life. A conceptual model of patient outcomes. JAMA 1995;273(1):59-65
  • Food and Drug Administration. Guidance for Industry: Patient Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims 2009
  • Patrick DL, Burke LB, Gwaltney CJ, et al. Content validity--establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO good research practices task force report: part 1--eliciting concepts for a new PRO instrument. Value Health 2011;14(8):967-77
  • Patrick DL, Burke LB, Gwaltney CJ, et al. Content validity--establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO Good Research Practices Task Force report: part 2--assessing respondent understanding. Value Health 2011;14(8):978-88
  • Baars JE, Zelinkova Z, Mensink PB, et al. High therapy adherence but substantial limitations to daily activities amongst members of the Dutch inflammatory bowel disease patients’ organization: a patient empowerment study. Aliment Pharmacol Ther 2009;30(8):864-72
  • Bernklev T, Jahnsen J, Lygren I, et al. Health-related quality of life in patients with inflammatory bowel disease measured with the short form-36: psychometric assessments and a comparison with general population norms. Inflamm Bowel Dis 2005;11(10):909-18
  • Bernklev T, Jahnsen J, Schulz T, et al. Course of disease, drug treatment and health-related quality of life in patients with inflammatory bowel disease 5 years after initial diagnosis. Eur J Gastroenterol Hepatol 2005;17(10):1037-45
  • Bernklev T, Jahnsen J, Henriksen M, et al. Relationship between sick leave, unemployment, disability, and health-related quality of life in patients with inflammatory bowel disease. Inflamm Bowel Dis 2006;12(5):402-12
  • Bryant RV, van Langenberg DR, Holtmann GJ, Andrews JM. Functional gastrointestinal disorders in inflammatory bowel disease: impact on quality of life and psychological status. J Gastroenterol Hepatol 2011;26(5):916-23
  • Casellas F, Arenas JI, Baudet JS, et al. Impairment of health-related quality of life in patients with inflammatory bowel disease: a Spanish multicenter study. Inflamm Bowel Dis 2005;11(5):488-96
  • Casellas F, Vivancos JL, Sampedro M, et al. Relevance of the phenotypic characteristics of Crohn’s disease in patient perception of health-related quality of life. Am J Gastroenterol 2005;100(12):2737-42
  • Cohen BL, Zoega H, Shah SA, et al. Fatigue is highly associated with poor health-related quality of life, disability and depression in newly-diagnosed patients with inflammatory bowel disease, independent of disease activity. Aliment Pharmacol Ther 2014;39(8):811-22
  • Cohen RD, Waters HC, Tang B, Rahman MI. Effects of fistula on healthcare costs and utilization for patients with Crohn’s disease treated in a managed care environment. Inflamm Bowel Dis 2008;14(12):1707-14
  • Cross RK, Lapshin O, Finkelstein J. Patient subjective assessment of drug side effects in inflammatory bowel disease. J Clin Gastroenterol 2008;42(3):244-51
  • Czuber-Dochan W, Dibley LB, Terry H, et al. The experience of fatigue in people with inflammatory bowel disease: an exploratory study. J Adv Nurs 2013;69(9):1987-99
  • Dur M, Sadlonova M, Haider S, et al. Health determining concepts important to people with Crohn’s disease and their coverage by patient-reported outcomes of health and wellbeing. J Crohns Colitis 2014;8(1):45-55
  • Farrokhyar F, Marshall JK, Easterbrook B, et al. Functional gastrointestinal disorders and mood disorders in patients with inactive inflammatory bowel disease: prevalence and impact on health. Inflamm Bowel Dis 2006;12(1):38-46
  • Feagan BG, Bala M, Yan S, et al. Unemployment and disability in patients with moderately to severely active Crohn’s disease. J Clin Gastroenterol 2005;39(5):390-5
  • Feagan BG, Sandborn WJ, Hass S, et al. Health-related quality of life during natalizumab maintenance therapy for Crohn’s disease. Am J Gastroenterol 2007;102(12):2737-46
  • Fletcher PC, Schneider MA. Is there any food I can eat? Living with inflammatory bowel disease and/or irritable bowel syndrome. Clin Nur Specialist 2006;20(5):241-7
  • Fletcher PC, Schneider MA, Van RV, et al. I am doing the best that I can!: Living with inflammatory bowel disease and/or irritable bowel syndrome (part II). Clin Nurse Spec 2008;22(6):278-85
  • Gingold-Belfer R, Peled N, Levy S, et al. Impaired sleep quality in Crohn’s disease depends on disease activity. Dig Dis Sci 2014;59(1):146-51
  • Graff LA, Walker JR, Lix L, et al. The relationship of inflammatory bowel disease type and activity to psychological functioning and quality of life. Clin Gastroenterol Hepatol 2006;4(12):1491-501
  • Graff LA, Vincent N, Walker JR, et al. A population-based study of fatigue and sleep difficulties in inflammatory bowel disease. Inflamm Bowel Dis 2011;17(9):1882-9
  • Hoivik ML, Bernklev T, Solberg IC, et al. Patients with Crohn’s disease experience reduced general health and vitality in the chronic stage: ten-year results from the IBSEN study. J Crohns Colitis 2012;6(4):441-53
  • Hommel KA, Davis CM, Baldassano RN. Medication adherence and quality of life in pediatric inflammatory bowel disease. J Pediat Psychol 2008(8):867-74
  • Hyphantis TN, Triantafillidis JK, Pappa S, et al. Defense mechanisms in inflammatory bowel disease. J Gastroenterol 2005;40(1):24-30
  • Lynch T, Spence D. A qualitative study of youth living with Crohn disease. Gastroenterol Nurs 2008;31(3):224-30
  • Magro F, Portela F, Lago P, et al. Inflammatory bowel disease: a patient’s and caregiver’s perspective. Dig Dis Sci 2009;54(12):2671-9
  • Mahadev S, Young JM, Selby W, et al. Quality of life in perianal Crohn’s disease: what do patients consider important? Dis Colon Rect 2011;54(5):579-85
  • Norton BA, Thomas R, Lomax KG, et al. Patient perspectives on the impact of Crohn’s disease: results from group interviews. Patient Prefer Adherence 2012;6:509-20
  • Nurmi E, Haapamaki J, Paavilainen E, et al. The burden of inflammatory bowel disease on health care utilization and quality of life. Scand J Gastroenterol 2013;48(1):51-7
  • Opheim R, Fagermoen MS, Bernklev T, et al. Fatigue interference with daily living among patients with inflammatory bowel disease. Qual Life Res 2014;23(2):707-17
  • Rochelle TL, Fidler H. The importance of illness perceptions, quality of life and psychological status in patients with ulcerative colitis and Crohn’s disease. J Health Psychol 2013;18(7):972-83
  • Romberg-Camps MJ, Bol Y, Dagnelie PC, et al. Fatigue and health-related quality of life in inflammatory bowel disease: results from a population-based study in the Netherlands: the IBD-South Limburg cohort. Inflamm Bowel Dis 2010;16(12):2137-47
  • Schirbel A, Reichert A, Roll S, et al. Impact of pain on health-related quality of life in patients with inflammatory bowel disease. World J Gastroenterol 2010;16(25):3168-77
  • Stjernman H, Tysk C, Almer S, et al. Worries and concerns in a large unselected cohort of patients with Crohn’s disease. Scand J Gastroenterol 2010;45(6):696-706
  • Zutshi M, Hull TL, Hammel J. Crohn’s disease: a patient’s perspective. Int J Colorectal Dis 2007;22(12):1437-44
  • Loga S, Sosic B, Kulenovic AD, et al. Chronic illness and family: impact of schizophrenia and Crohn’s disease on the family quality of life. Psychiatr Danub 2012;24(4):359-66
  • Gibson TB, Ng E, Ozminkowski RJ, et al. The direct and indirect cost burden of Crohn’s disease and ulcerative colitis. J Occupat Environ Med 2008;50(11):1261-72
  • Kappelman MD, Rifas-Shiman SL, Porter CQ, et al. Direct health care costs of Crohn’s disease and ulcerative colitis in US children and adults. Gastroenterology 2008;135(6):1907-13
  • Leighton JA, Gralnek IM, Richner RE, et al. Capsule endoscopy in suspected small bowel Crohn’s disease: economic impact of disease diagnosis and treatment. World J Gastroenterol 2009;15(45):5685-92
  • Mesterton J, Jonsson L, Almer SH, et al. Resource use and societal costs for Crohn’s disease in Sweden. Inflamm Bowel Dis 2009;15(12):1882-90
  • Odes S, Vardi H, Friger M, et al. Cost analysis and cost determinants in a European inflammatory bowel disease inception cohort with 10 years of follow-up evaluation. Gastroenterology 2006;131(3):719-28
  • Prenzler A, Bokemeyer B, von der Schulenburg JM, et al. Health care costs and their predictors of inflammatory bowel diseases in Germany. Eur J Health Econom 2011;12(3):273-83
  • Sprakes MB, Ford AC, Suares NC, et al. Costs of care for Crohn’s disease following the introduction of infliximab: a single-centre UK experience. Aliment Pharmacol Ther 2010;32(11-12):1357-63
  • Stark R, Konig HH, Leidl R. Costs of inflammatory bowel disease in Germany. Pharmacoeconomics 2006;24(8):797-814
  • Venu N, Cohen RD. The new economic reality in the world of IBD. Inflammatory Bowel Disease 2011;295-313
  • Yu AP, Cabanilla LA, Wu EQ, et al. The costs of Crohn’s disease in the United States and other Western countries: a systematic review. Cur Med Res Opin 2008;24(2):319-28
  • Nguyen GC, Tuskey A, Dassopoulos T, et al. Rising hospitalization rates for inflammatory bowel disease in the United States between 1998 and 2004. Inflam Bowel Dis 2007;13(12):1529-35
  • Rubin DT, Mody R, Davis KL, Wang CC. Real-world assessment of therapy changes, suboptimal treatment and associated costs in patients with ulcerative colitis or Crohn’s disease. Aliment Pharmacol Ther 2014;39(10):1143-55
  • van der Valk ME, Mangen MJ, Leenders M, et al. Healthcare costs of inflammatory bowel disease have shifted from hospitalisation and surgery towards anti-TNF alpha therapy: results from the COIN study. Gut 2014;63(1):72-9
  • Kane SV, Loftus EVJr, Dubinsky MC, et al. Disease perceptions among people with Crohn’s disease. Inflamm Bowel Dis 2008;14(8):1097-101
  • Sainsbury A, Heatley RV. Psychosocial factors in the quality of life of patients with inflammatory bowel disease. Ailment Pharmacol Ther 2005;21:499-508
  • Solberg IC, Vatn MH, Hoie O, et al. Clinical course in Crohn’s disease: results of a Norwegian population-based ten-year follow-up study. Clin Gastroenterol Hepatol 2007;5(12):1430-8
  • Jewell DP, Satsangi J, Lobo A, et al. Infliximab use in Crohn’s disease: impact on health care resources in the UK. Eur J Gastroenterol Hepatol 2005;17(10):1047
  • Ekbom A. The changing faces of Crohn’s disease and ulcerative colitis. In: Targan SR, Shanahan F, Karp LC, Editors. Inflammatory bowel disease: From bench to bedside. Springer, New York, US; 2005
  • Norton BA, Thomas R, Lomax KG, Dudley-Brown S. Patient perspectives on the impact of Crohn’s disease: results from group interviews. Patient Prefer Adherence 2012;6:509-20
  • Lix LM, Graff LA, Walker JR, et al. Longitudinal study of quality of life and psychological functioning for active, fluctuating, and inactive disease patterns in inflammatory bowel disease. Inflamm Bowel Dis 2008;14(11):1575-84
  • Dimenas E, Glise H, Hallerback B, et al. Well-being and gastrointestinal symptoms among patients referred to endoscopy owing to suspected duodenal ulcer. Scand J Gastroenterol 1995;30(11):1046-52
  • Guyatt GH, Mitchell A, Irvine EJ. A new measure of health status for clinical trials in inflammatory bowel disease. Gastroenterology 1989;96:804-10
  • Love JR, Irvine EJ, Fedorak RN. Quality of life in inflammatory bowel disease. J Clin Gastroenterol 1992;14(1):15-19
  • Drossman DA, Leserman J, Li ZM, et al. The rating form of IBD patient concerns: a new measure of health status. Psychosom Med 1991;53(6):701-12
  • Ware JEJr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992;30(6):473-83
  • Rabin R, de CF. EQ-5D: a measure of health status from the EuroQol Group. Ann Med 2001;33(5):337-43
  • EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy 1990;16(3):199-208
  • Reilly MC, Brown M, Brabant Y, et al. Defining the minimally important difference of WPAI-CD scores: what is a relevant impact on work productivity in active Crohn’s disease? Gut 2007;56(Suppl. III
  • Reilly MC, Gerlier L, Brabant Y, Brown M. Validity, reliability, and responsiveness of the work productivity and activity impairment questionnaire in Crohn’s disease. Clin Ther 2008;30(2):393-404
  • Vergara M, Montserrat A, Casellas F, et al. Development and Validation of the Crohn’s Disease Perceived Work Disability Questionnaire. Inflamm Bowel Dis 2011;17(11):2350-7
  • Norquist JM, Girman C, Fehnel S, et al. Choice of recall period for patient-reported outcome (PRO) measures: criteria for consideration. Qual Life Res 2012;21(6):1013-20
  • Alrubaiy L, Rikaby I, Dodds P, et al. Systematic Review of Health-related Quality of Life Measures for Inflammatory Bowel Disease. J Crohns Colitis 2015;9(3):284-92
  • Konig HH, Ulshofer A, Gregor M, et al. Validation of the EuroQol questionnaire in patients with inflammatory bowel disease. Eur J Gastroenterol Hepatol 2002;14(11):1205-15
  • Revicki DA, Wood R, Wiklund I, Crawley J. Reliability and validity of the gastrointestinal symptom rating scale in patients with gastroesophageal reflux disease. Qual Life Res 1998;7:75-83
  • Feinstein AR. Clinimetrics. Yale University Press, New Haven, CT; 1987
  • Hanauer SB, Feagan BG, Lichtenstein GR, et al. Maintenance infliximab for Crohn’s disease: the ACCENT I randomised trial*. Lancet 2002;359(9317):1541-9
  • Devlen J, Beusterien K, Yen L, et al. The burden of inflammatory bowel disease: a patient-reported qualitative analysis and development of a conceptual model. Inflamm Bowel Dis 2014;20(3):545-52
  • Food and Drug Administration. Guidance for Industry and Review Staff: Target Product Profile - A Strategic Development Process Tool 2007
  • Dur M, Sadlonova M, Haider S, et al. Health determining concepts important to people with Crohn’s disease and their coverage by patient-reported outcomes of health and wellbeing. J Crohns Colitis 2014;8(1):45-55
  • Williet N, Sandborn WJ, Peyrin-Biroulet L. Patient-reported outcomes as primary end points in clinical trials of inflammatory bowel disease. Clin Gastroenterol Hepatol 2014;12(8):1246-56
  • EMEA. Reflection paper on the regulatory guidance for the use of health-related quality of life (HRQL) measures in the evaluation of medicinal products 2009. Available from: www.emea.eu.int
  • DeMuro C, Clark C, Doward L, et al. Assessment of PRO Label Claims Granted by the FDA as Compared to the EMA (2006–2010). Value Health 2013;16(8):1150-5
  • Brettschneider C, Luhmann D, Raspe H. Informative value of Patient Reported Outcomes (PRO) in Health Technology Assessment (HTA). GMS Health Technol Assess 2011;7:Doc01
  • Brazier J, Roberts J, Deverill M. The estimation of a preference-based measure of health from the SF-36. J Health Econ 2002;21(2):271-92
  • Swedish Pharmaceutical Benefitgs Board (TLV). General Guidelines for Economic Evaluations from the Pharmaceutical Benefits Board (LFNAR) 2003
  • Healthcare Insurance Board (CVZ). Guidelines for Pharmacoeconomic Research Updated Version 2006
  • Healthcare Cost and Utilization Project (HCUP). (14 A.D.)
  • Clinical Practice Research Datalink 2014
  • Health & Social Care Information System. Hospital Episode Statistics 2014
  • Peyrin-Biroulet L, Cieza A, Sandborn WJ, et al. Development of the first disability index for inflammatory bowel disease based on the international classification of functioning, disability and health. Gut 2012;61(2):241-7
  • Wilburn J, McKenna SP, Twiss J, et al. Assessing quality of life in Crohn’s disease: development and validation of the Crohn’s Life Impact Questionnaire (CLIQ). Qual Life Res 2015; Epub ahead of print
  • Bodger K, Ormerod C, Shackcloth D, et al. Development and validation of a rapid, generic measure of disease control from the patient’s perspective: the IBD-control questionnaire. Gut 2014;63(7):1092-102
  • United States Food and Drug Administration. Gastroenterology regulatory endpoints and the advancement of therapeutics II public workshop 2013. Available from: www.regulations.gov/#!documentDetail;D=FDA-2013-N-0001-0130 [Last accessed 21-22 October 2013]
  • Stjernman H, Granno C, Bodemar G, et al. Evaluation of the Inflammatory Bowel Disease Questionnaire in Swedish patients with Crohn’s disease. Scand J Gastroenterol 2006;41(8):934-43
  • Pallis AG, Mouzas IA, Vlachonikolis IG. The inflammatory bowel disease questionnaire: a review of its national validation studies. Inflamm Bowel Dis 2004;10(3):261-9
  • Hlavaty T, Persoons P, Vermeire S, et al. Evaluation of short-term responsiveness and cutoff values of inflammatory bowel disease questionnaire in Crohn’s disease. Inflamm Bowel Dis 2006;12(3):199-204
  • Jelsness-Jørgensen LP, Moum B, Bernklev T. Worries and concerns among inflammatory bowel disease patients followed prospectively over one year. Gastroenterol Res Pract 2011;2011
  • Bernkley T, Jahnsen J, Lygren I, et al. Health-related quality of life in patients with inflammatory bowel disease measured with the short form-36. Inflamm Bowel Dis 2005;11(10):909-18
  • Stark RG, Reitmeir P, Leidl R, et al. Validity, reliability, and responsiveness of the EQ-5D in inflammatory bowel disease in Germany. Inflamm Bowel Dis 2010;16(1):42-51
  • Vergara M, Montserrat A, Casellas F, et al. A new validation of the Spanish work productivity and activity impairment questionnaire-Crohn’s disease version. Value Health 2011;14(6):859-61
  • Vergara M, Montserrat A, Casellas F, et al. Validation of the Spanish Work Productivity and Activity impairment questionnaire: Crohn’s disease version. Eur J Gastroenterol Hepatol 2009;21(7):809-15

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