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)具有显著的发病率和死亡率。而切除结肠则是
治愈,大多数人认为手术是最后的治疗手段,UC的治疗模式已经转变为
强调在疾病暴发期间升级有效的免疫抑制治疗
做手术。这些药物带来了一些重大的潜在风险,包括严重感染、淋巴瘤、
药物治疗失败,导致死亡。越来越多的患有中重度疾病的UC患者
终生接触这些药物;在那些药物治疗失败的人中,这些患者患有这种疾病
手术前药物暴露。这会增加死亡率和手术后的风险。
由于这种接触而导致的发病率。治疗决策的另一个关键组成部分是
患者本身的喜好。如果面对不同待遇的适当代表
选项和风险,UC患者可能会有非常不同的意愿接受某些风险以换取
潜在的治疗益处。
评估与免疫抑制治疗有关的发病率和死亡率问题的研究遭受了
从缺乏概括性,缺乏对混杂因素的控制,以及由于样本量小而缺乏力量。
这项研究建议利用Medicaid-Medicare数据库,它确保了概括性、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9个相对存活率
内科和外科治疗。在疏导、配套的基础上进一步治理混杂
将使用倾向性评分。多元Logistic回归将决定两者之间的关系
手术前的医疗暴露和术后的发病率。其他分析将评估影响
最后一次接受药物治疗后发病的几率。最后,通过使用联合分析,
这项研究将对UC患者内科和外科手术的风险偏好进行系统的检查
UC的治疗。
相关性(请参阅说明):
确定与使用药物治疗相关的死亡率和发病风险是至关重要的
首选手术治疗。如果推迟或避免手术使UC患者面临更高的死亡率或术后
手术发病率,这些信息在信息化决策中是至关重要的。反过来,了解UC如何
患者感知和评价内科治疗与外科治疗的风险将对
管理和治疗,并将为未来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: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:
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:
海外基金