Risk and Risk Preferences for Surgery and Medical Therapy in Ulcerative Colitis
Risk and Risk Preferences for Surgery and Medical Therapy in Ulcerative Colitis
批准号:
8484395
负责人:
Meenakshi Bewtra
金额:
$15.26万
依托单位国家:
美国
项目类别:
财政年份:
2009
资助国家:
美国
项目状态:
已结题
起止时间:
2009-08-20 至 2014-06-30
关键词:
Abdominal AbscessAddressAdmission activityAdverse eventAffectAgeAlgorithmsAnti-Tumor Necrosis Factor TherapyAnusBiological Response Modifier TherapyCalcineurin inhibitorCessation of lifeChronicClinicalColectomyColonComorbidityComplicationConsultCounselingCox Proportional Hazards ModelsDataDatabasesDecision MakingDiagnosisDiseaseEvaluationExcisionExposure toFailureFecesFlareFrequenciesFutureGenderGeneral PopulationGuidelinesHospitalsIleal ReservoirsIleostomyImmune systemImmunomodulatorsImmunosuppressive AgentsInfectionInflammatoryInflammatory disease of the intestineInstructionIntestinesLifeLogistic RegressionsLymphomaMalignant NeoplasmsMarketingMedicalMedicare/MedicaidMesalamineMethodologyMethodsMorbidity - disease rateOperative Surgical ProceduresOutcomePatient PreferencesPatientsPatternPeritonitisPharmaceutical PreparationsPhysiciansPneumoniaPopulation StudyPositioning AttributePostoperative PeriodQuality of lifeRefractoryRelapseRelative (related person)Research PersonnelResortRestRiskSample SizeSepsisSurgeonTherapeuticTimeToxic effectUlcerative ColitisUnited KingdomUnited StatesUrinary tract infectionWound Infectionanalogbasedisorder controleffective therapyexhaustexperiencehigh riskimprovedmortalitynatalizumabpreferencepreventprogramssexthiopurinewillingnesswound
中文摘要
溃疡性结肠炎(UC)与显著的发病率和死亡率相关。虽然切除结肠是
治愈性,大多数人认为手术是最后的治疗手段,UC的治疗模式已经转向
强调在疾病爆发期间加强强效免疫抑制剂治疗,
手术这些药物有一些重大的潜在风险,包括严重感染,淋巴瘤,
药物治疗失败和死亡。越来越多的中重度UC患者
终生暴露于这些药物;在那些药物治疗失败的患者中,这些患者有这种
手术前的药物暴露。这会增加死亡率和术后手术风险。
由于这种暴露而导致的发病率。治疗决策的另一个关键组成部分是
患者自己的喜好。如果遇到合适的代表不同的待遇
选择和风险,UC患者可能有非常不同的意愿接受某些风险,以换取
潜在的治疗益处。
评估与免疫抑制剂治疗相关的发病率和死亡率问题的研究受到了
缺乏普遍性,缺乏对混杂因素的控制,以及由于样本量小而缺乏功效。
这项研究建议利用医疗补助-医疗保险数据库,这保证了普遍性,样本量,
并允许评估包括药物使用在内的许多潜在混杂因素。考克斯比例
调整后的风险模型将用于确定接受以下治疗的UC患者的相对生存期:
内科和外科治疗。为了进一步控制混杂的基础上,通道,匹配上
将采用倾向评分。多变量logistic回归将确定
手术前的医疗暴露和术后发病率。其他分析将评估影响
从最后一次暴露于药物治疗的时间的发病率。最后,通过联合分析,
该研究将对UC患者的药物与手术风险偏好进行系统检查,
治疗UC。
相关性(见说明):
关键是要确定死亡率和发病率的风险与使用药物治疗,
偏好手术。如果延迟或避免手术使UC患者的死亡率增加或术后
手术发病率,这些信息是至关重要的信息决策。反过来,了解UC如何
患者感知和重视药物与手术治疗的风险将对
管理和治疗,并将为未来的治疗选择设定新的门槛。
英文摘要
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.
RELEVANCE (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.
期刊论文(2)
专著(0)
科研奖励(0)
会议论文
Lymphoma in inflammatory bowel disease and treatment decisions.
炎症性肠病中的淋巴瘤和治疗决策。
DOI:
10.1038/ajg.2011.479
发表时间:
2012
期刊:
The American journal of gastroenterology
影响因子:
--
作者:
[Bewtra,Meenakshi]
通讯作者:
Bewtra,Meenakshi
RFA-DP-23-002, Improving Outcomes and Reducing Disparities for Patients with Inflammatory Bowel Disease through Epidemiology, Enhanced Disease Management, Dissemination, and Education
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批准号:10762688
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项目类别:
-
资助金额:$70.0万
-
财政年份:2023
-
负责人:Meenakshi Bewtra
-
依托单位:
Risk and Risk Preferences for Surgery and Medical Therapy in Ulcerative Colitis
-
批准号:8317686
-
项目类别:
-
资助金额:$15.26万
-
财政年份:2009
-
负责人:Meenakshi Bewtra
-
依托单位:
Risk and Risk Preferences for Surgery and Medical Therapy in Ulcerative Colitis
-
批准号:7713717
-
项目类别:
-
资助金额:$15.26万
-
财政年份:2009
-
负责人:Meenakshi Bewtra
-
依托单位:
Risk and Risk Preferences for Surgery and Medical Therapy in Ulcerative Colitis
-
批准号:8088163
-
项目类别:
-
资助金额:$15.26万
-
财政年份:2009
-
负责人:Meenakshi Bewtra
-
依托单位:
Risk and Risk Preferences for Surgery and Medical Therapy in Ulcerative Colitis
-
批准号:7916797
-
项目类别:
-
资助金额:$15.26万
-
财政年份:2009
-
负责人:Meenakshi Bewtra
-
依托单位:
海外基金