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Risk and Risk Preferences for Surgery and Medical Therapy in Ulcerative Colitis

溃疡性结肠炎手术和药物治疗的风险和风险偏好

基本信息

批准号：
7713717
负责人：
Meenakshi Bewtra
金额：
$ 15.26万
依托单位：
UNIVERSITY OF PENNSYLVANIA
依托单位国家：
美国
项目类别：
财政年份：
2009
资助国家：
美国
起止时间：
2009-08-20 至 2014-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7713717
关键词：
Abdominal Abscess Address Admission activity Adverse event Affect Age Algorithms Anti-Tumor Necrosis Factor Therapy Anus Biological Response Modifier Therapy Calcineurin inhibitor Cessation of life Chronic Classification Clinical Colectomy Colon Comorbidity Complication Consult Counseling Cox Proportional Hazards Models Data Databases Decision Making Diagnosis Disease Evaluation Excision Exposure to Failure Feces Flare Frequencies Future Gender General Population Guidelines Hospitals Ileal Reservoirs Ileostomy Immune system Immunomodulators Immunosuppressive Agents Infection Inflammatory Inflammatory disease of the intestine Intestines Life Logistic Regressions Lymphoma Malignant Neoplasms Marketing Medical Medicare/Medicaid Mesalamine Methodology Methods Morbidity - disease rate Operative Surgical Procedures Outcome Patient Preferences Patients Pattern Peritonitis Pharmaceutical Preparations Physicians Pneumonia Population Study Positioning Attribute Postoperative Period Quality of life Refractory Relapse Relative (related person)Research Personnel Resort Rest Risk Sample Size Sepsis Surgeon Therapeutic Time Toxic effect Ulcerative Colitis United Kingdom United States Urinary tract infection Wound Infection analog base disorder control effective therapy exhaust experience high risk improved mortality natalizumab preference prevent programs public health relevance sex thiopurine willingness wound

项目摘要

DESCRIPTION (provided by applicant): 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 [sic] 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 determine 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. PUBLIC HEALTH RELEVANCE: It is crtical [sic] 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 informed 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.

描述（由申请人提供）：