LURN II: Enhanced Characterization of Patients with LUTS Using Biopsychosocial Approaches
LURN II: Enhanced Characterization of Patients with LUTS Using Biopsychosocial Approaches
批准号:
10011827
负责人:
James William Griffith
金额:
$57.79万
依托单位国家:
美国
项目类别:
财政年份:
2012
资助国家:
美国
项目状态:
已结题
起止时间:
2012-09-30 至 2024-08-31
关键词:
AnxietyBiologicalBiological MarkersBladderCharacteristicsClinicClinicalClinical TrialsCluster AnalysisCommunitiesConsensusDataDiagnosisDistressEnsureFunctional disorderFundingFutureGleanHealthHouseholdImageImprisonmentInfrastructureInternistJournalsKnowledgeLaboratoriesLeadLinkLower urinary tractMeasurementMeasuresMental DepressionMental HealthMentally Ill PersonsMethodsModelingMothersMotorNatureOrganOutcomeParentsParticipantPatient MonitoringPatient RecruitmentsPatient Self-ReportPatientsPhasePhenotypePhysiologicalPlasmaPsychosocial StressPublicationsQuality of lifeQuestionnairesReportingResearchResearch PersonnelRisk FactorsRoleSamplingSelf AssessmentSensorySeveritiesSexual abuseSiteStressStructureSubgroupSymptomsTestingTimeUrethraUrinary tractUrodynamicsUrologistViolenceWomanWorkadverse childhood eventsbasebiomarker panelbiopsychosocialclinically relevantcohortcomorbidityeffective therapyemotional abuseexperiencefollow-upimprovedlower urinary tract symptomsmedical specialtiesmembermenmobile applicationmodifiable risknovelnovel therapeuticspatient subsetsphysical abuseprotein biomarkersrecruitresearch clinical testingresponsesexsubstance abusersuccesssuicidaltoolurinary
中文摘要
下尿路功能障碍症状研究网络(LURN)于2012年成立,
通过识别下尿路症状的重要亚型,增加我们对下尿路症状(LUTS)的理解。
LUTS患者,并改善LUTS患者体验的测量。网络的做法
定义患者亚型是基于一种基于重新采样的共识聚类方法,
报告的患者数据,导致识别出统计学上和
临床上不同。改善LUTS患者报告测量的方法是
系统地开发一个新的,高质量的试题库的基础上定性输入从病人,社区,
参与者,内科医生,泌尿科医生,泌尿妇科医生和临床研究人员。最后,为了理解
下尿路功能障碍的一些病理生理学基础,生物学信息是
从患者样本和成像中获得并分析。在成功完成最初的5年供资周期后,
团结会准备在所获得的知识的基础上采取以下步骤,具体目标如下:
1)使用包括更广泛症状严重程度的队列测试和改进原始聚类模型
和更广泛的生理测量,2)为了鉴定包含在
可用于鉴定患有LUTS的男性和女性的特定亚组的血浆
下尿路症状(LUTS)女性的表型特征,通过测量功能
下尿路的组成部分,4)为了验证男性和女性的综合结果工具,
LUTS,以及5)确定心理社会压力-特别是不良童年经历-在
LUTS的严重程度和病程。LURN II将招募1380例患者,按性别分层。本站将招聘1/6
这些参与者(N = 230)。我们有一种多方法的方法来对LUTS患者进行表型分型,
将包括问卷调查,实验室测试,移动的应用程序,膀胱和尿道的尿动力学。数据
将使用基于重采样的聚类分析以及纵向症状建模进行分析,
时间我们假设,我们评估LUTS患者的生物心理社会方法将产生临床-
有意义的患者群,这反过来又可以与因果机制以及治疗方案联系起来。
此外,我们假设,随着时间的推移,可改变的风险因素将与LUTS的过程相关,
治疗的新途径。这项研究的影响将有助于更好地了解
LUTS的原因和性质,这将为临床试验奠定基础,以改善这些患者的生活质量。
患者
英文摘要
The Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN) was assembled in 2012 to
increase our understanding of lower urinary tract symptoms (LUTS) by identifying important subtypes of
patients with LUTS, and improving the measurement of patient experiences of LUTS. The Network's approach
to defining patient subtypes was based on a re-sampling-based consensus clustering approach using self-
reported patient data, resulting in the identification of novel LUTS-based clusters that are statistically and
clinically distinct. The approach to improving the measurement of patient reports of LUTS was to
systematically develop a new, high-quality item bank based on qualitative input from patient, community
participants, internists, urologists, urogynecologists, and clinical researchers. Finally, in order to understand
some of the pathophysiologic basis underlying lower urinary tract dysfunction, biologic information was
obtained and analyzed from patient samples and imaging. After a successful initial 5-year funding cycle,
LURN is prepared to build on the knowledge gained and take the next steps with the following Specific Aims:
1) To test and refine the original clustering model with a cohort including a wider range of symptom severity
and a wider range of physiological measures, 2) To identify protein biomarker signatures contained within
plasma that can be used to identify specific subgroups of men and women with LUTS 3) To determine
phenotypic characteristics of women with lower urinary tract symptoms (LUTS) by measuring the functional
components of the lower urinary tract, 4) To validate a comprehensive outcome tool for men and women with
LUTS, and 5) To determine the role of psychosocial stress – especially adverse childhood experiences – in the
severity and course of LUTS. The LURN II will recruit 1380 patients, stratified by sex. Our site will recruit 1/6
of these participants (N = 230). We have a multi-method approach to phenotyping patients with LUTS, which
will include questionnaires, laboratory tests, mobile apps, and urodynamics of the bladder and urethra. Data
will be analyzed using resampling-based cluster analyses, as well as longitudinal modelling of symptoms over
time. We hypothesize that our biopsychosocial approach to assessing patients with LUTS will yield clinically-
meaningful patient clusters, which in turn can be linked to causal mechanisms as well as treatment options.
Moreover, we hypothesize that modifiable risk factors will be related to the course of LUTS over time, creating
novel avenues for treatment. The impact of this study will lend itself to an improved understanding of the
causes and nature of LUTS, which will set the stage for clinical trials to improve quality of life for these
patients.
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海外基金