Ulcerative colitis (UC) is associated with significant morbidity and mortality. While removal of the colon is curative, most feel surgery to be a treatment of last resort and treatment paradigms for UC have shifted to emphasize an escalation of potent immunosuppressant therapy during disease flares before going to surgery. These medications come some significant potential risks including serious infections, lymphoma, medication failure, and death. An Increasing number of UC patients with moderate to severe disease have life-long exposure to these medications;and in those in whom medical therapy fails, these patients have this medication exposure prior to surgery. This carries the risk of increased mortality and post-operative surgical morbidity as a result of this exposure. An additional key component of treatment decisions is the preferences of the patients themselves. If faced with an appropriate representation of different treatment options and risks, UC patients may have very different willingness to accept certain risks in exchange for potential therapeutic benefit. Studies evaluating morbidity and mortality issues related to immunosuppressant therapy have suffered from lack of generalizability, lack of control for confounders, and lack of power due to small sample sizes. This study proposes utilizing the Medicaid-Medicare database, which assure generalizability, sample size, and allows evaluation of a number of potential confounders including medication use. Cox proportional hazards models with adjustment will be used to detemnine relative survival of UC patients treated with medical and surgical therapy. To further control for confounding on the basis of channeling, matching on propensity scores will be employed. Multivariate logistic regression will determine the relationship between medical exposure prior to surgery and post-operative morbidity. Additional analysis will evaluate the impact on the odds of morbidity of time from last exposure of medical therapy. Finally, by using conjoint analysis, the study will perform a systematic examination of UC patients'risk preferences for medical versus surgical therapy for UC.
(See Instructions): It is crtical to determine the mortality and morbidity risk associated with the use of medical therapy in preference of surgery. If delaying or avoiding surgery exposes UC patients to an increased mortality or post- operative morbidity, such information is critical in infomied decision-making. In turn, understanding how UC patients perceive and value the risks of medical versus surgical therapy will have far-reaching effects on management and treatment and will set new thresholds for future therapeutic options.
|Scott, Frank I; Vajravelu, Ravy K; Bewtra, Meenakshi et al. (2015) The benefit-to-risk balance of combining infliximab with azathioprine varies with age: a markov model. Clin Gastroenterol Hepatol 13:302-309.e11|
|Bewtra, Meenakshi; Brensinger, Colleen M; Tomov, Vesselin T et al. (2014) An optimized patient-reported ulcerative colitis disease activity measure derived from the Mayo score and the simple clinical colitis activity index. Inflamm Bowel Dis 20:1070-8|
|Bewtra, Meenakshi; Kilambi, Vikram; Fairchild, Angelyn O et al. (2014) Patient preferences for surgical versus medical therapy for ulcerative colitis. Inflamm Bowel Dis 20:103-14|
|Alenghat, Theresa; Osborne, Lisa C; Saenz, Steven A et al. (2013) Histone deacetylase 3 coordinates commensal-bacteria-dependent intestinal homeostasis. Nature 504:153-7|
|Bewtra, Meenakshi; Johnson, F Reed (2013) Assessing patient preferences for treatment options and process of care in inflammatory bowel disease: a critical review of quantitative data. Patient 6:241-55|
|Bewtra, Meenakshi; Lewis, James D (2010) Update on the risk of lymphoma following immunosuppressive therapy for inflammatory bowel disease. Expert Rev Clin Immunol 6:621-31|