Health Values and Minimally Important Differences in Systemic Sclerosis

系统性硬化症的健康价值观和最不重要的差异

基本信息

批准号：
8321754
负责人：
DINESH KHANNA
金额：
$ 12.34万
依托单位：
UNIVERSITY OF MICHIGAN AT ANN ARBOR
依托单位国家：
美国
项目类别：
财政年份：
2007
资助国家：
美国
起止时间：
2007-09-15 至 2012-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8321754
关键词：
Affect Award Behavioral Benchmarking Body Image California Characteristics Chronic Client satisfaction Clinic Clinical Clinical Trials Clinical Trials Design Commit Data Analyses Data Collection Decision Making Educational process of instructing Feeling Future Goals Health Health Sciences Health Status Healthcare Immunology Individual Intervention Interview Joints Lead Life Longitudinal Studies Los Angeles Measures Mediating Mentors Modeling Outcome Pain Pathogenesis Pathway interactions Patients Perception Population Positioning Attribute Public Health Quality of life Quality-of-Life Assessment Recruitment Activity Research Research Design Research Personnel Rheumatism Sample Size Scleroderma Social Environment Social Sciences Social support Systemic Scleroderma Time Training Universities Value of Life behavioral/social science career coping cytokine demographics design disability effective therapy health care delivery health related quality of life improved insight instrument novel optimism patient oriented programs psychologic satisfaction skills social sound therapy design

项目摘要

DESCRIPTION (provided by applicant): Systemic Sclerosis (Scleroderma, SSc) is a chronic rheumatic disease with no effective treatment or cure, in which patients cope with pain, disfigurement, disability, and feelings of helplessness, each of which can affect his or her health-related quality of life (HRQoL). The candidate will be part of a large Scleroderma Program at University of California, Los Angeles (UCLA) and is committed to improving the HRQoL of people with SSc. The long-term goals of the candidate are to conduct interventions to improve the health values and the satisfaction with life of people with SSc, and to design methodologically sound SSc clinical trials. The candidate has enlisted leading experts in the fields of SSc, HRQoL assessment, and clinical trial design to mentor him and teach him the skills he needs to complete the proposed research, and to help him develop his career as an independent researcher. The specific objectives for this award are: a) to take additional training and acquire advanced methodological skills in HRQoL, clinical trial design, and data analysis; b) to define a conceptual model that integrates the biomedical perspective with the psychological, behavioral, and social mechanisms that influence health outcomes of people with SSc; and c) to determine the difference in the score of HRQoL instruments that people with SSc consider clinically meaningful, also known as the minimally important difference (MID). The two specific research aims are: a) to estimate the MID for health status and health value measures used in evaluating SSc, and b) to assess the relationships of demographics, health status, psychological characteristics, and social environment to SSc patients' health values and satisfaction with life. Two hundred and fifty subjects with SSc will be recruited from the UCLA Scleroderma Clinic. Aim 1 will provide estimates of the MID for the HRQoL measures that are used in SSc research, and Aim 2 will consist of administering instruments assessing functioning, social support, optimism, helplessness, body-image, satisfaction with life, and health values in two data collection sessions separated by approximately 12 months. The longitudinal study design will inform the hypothesized associations between the independent variables (e.g., health status) and health values and life satisfaction. Findings from these preliminary studies will lead to the design of methodologically sound interventions to target non-health-related factors that impact the HRQoL of people with SSc. Relevance to public health: The study will provide estimates that will aid in the sample size calculation for future clinical trials in scleroderma, determine which factors are associated with life satisfaction and valuation or desirability of life, and will design interventions targeted toward these factors in order to improve the quality of life for people with scleroderma.

描述（由申请人提供）：全身性硬化症（Scleroderma，SSC）是一种慢性风湿病，没有有效的治疗或治愈，其中患者应对疼痛，毁容，残疾和无助感，每种都会影响他或她与健康相关的生活质量（HRQOL）。候选人将成为加利福尼亚大学洛杉矶分校（UCLA）的大型硬皮病计划的一部分，并致力于改善SSC的HRQOL。候选人的长期目标是采取干预措施，以提高健康价值观和对SSC患者生活的满意度，并在方法论上设计SSC临床试验。这候选人曾在SSC，HRQOL评估和临床试验设计领域中吸引了领先的专家，以指导他，并教他完成拟议研究所需的技能，并帮助他发展自己的独立研究人员的职业。该奖项的具体目标是：a）接受额外的培训并获得HRQOL，临床试验设计和数据分析的先进方法论技能； b）定义一种概念模型，将生物医学观点与影响SSC患者健康结果的心理，行为和社会机制融为一体； c）确定SSC患者认为具有临床意义的HRQOL仪器分数的差异，也称为最小重要差异（MID）。这两个具体研究的目的是：a）估计用于评估SSC的健康状况和健康价值测量中的MID，b）评估人口统计学，健康状况，心理特征和社会环境与SSC患者的健康价值和对生活满意的关系。 SSC的250名受试者将从UCLA硬皮病诊所招募。 AIM 1将为SSC研究中使用的HRQOL措施的MID估算，AIM 2将包括管理评估功能，社会支持，在两个数据收集课程中，乐观，无助，身体形象，对生活的满意度以及大约12个月的数据收集课程。纵向研究设计将为自变量（例如，健康状况）与健康价值和生活满意度之间的假设关联提供信息。这些初步研究的发现将导致设计理性的干预措施，以针对影响SSC患者HRQOL的非健康相关因素。与公共卫生的相关性：该研究将提供估计值，这些估计值将有助于硬皮病中未来的临床试验的样本量计算，确定哪些因素与生活满意度，估值或生命的可取性相关，并将设计针对这些因素的干预措施，以改善患有硬皮病患者的生活质量。

项目成果

期刊论文数量（30）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

Rapamycin versus methotrexate in early diffuse systemic sclerosis: results from a randomized, single-blind pilot study.

DOI：
10.1002/art.24986
发表时间：
2009-12
期刊：
ARTHRITIS AND RHEUMATISM
影响因子：
0
作者：
Su, Tien-I Karleen;Khanna, Dinesh;Furst, Daniel E.;Danovitch, Gabriel;Burger, Christina;Maranian, Paul;Clements, Philip J.
通讯作者：
Clements, Philip J.

Screening and therapy for malnutrition and related gastro-intestinal disorders in systemic sclerosis: recommendations of a North American expert panel.

系统性硬化症营养不良和相关胃肠道疾病的筛查和治疗：北美专家小组的建议。

DOI：
发表时间：
2010
期刊：
Clinical and experimental rheumatology
影响因子：
3.7
作者：
Baron,Murray;Bernier,Paule;Côté,Louis-François;Delegge,MarkH;Falovitch,Glenda;Friedman,Gad;Gornitsky,Mervyn;Hoffer,John;Hudson,Marie;Khanna,Dinesh;Paterson,WilliamG;Schafer,Donna;Toskes,PhillipP;Wykes,L
通讯作者：
Wykes,L

Evidence-based management of rapidly progressing systemic sclerosis.

DOI：
10.1016/j.berh.2009.12.002
发表时间：
2010-06
期刊：
BEST PRACTICE & RESEARCH IN CLINICAL RHEUMATOLOGY
影响因子：
5.2
作者：
Khanna, Dinesh;Denton, Christopher P.
通讯作者：
Denton, Christopher P.

Validating and assessing the sensitivity of the Health Assessment Questionnaire-Disability Index-derived Short Form-6D in patients with early aggressive rheumatoid arthritis.

DOI：
10.3899/jrheum.080959
发表时间：
2009-06
期刊：
The Journal of rheumatology
影响因子：
0
作者：
Amjadi SS;Maranian PM;Paulus HE;Kaplan RM;Ranganath VK;Furst DE;Khanna PP;Khanna D;Western Consortium of Practicing Rheumatologists
通讯作者：
Western Consortium of Practicing Rheumatologists

The minimally important difference and patient acceptable symptom state for the Raynaud's condition score in patients with Raynaud's phenomenon in a large randomised controlled clinical trial.