The Effects of Lung Transplant on Disability and Health-Related Quality of Life

肺移植对残疾和健康相关生活质量的影响

• 批准号: 8374331
• 负责人: Jonathan Paul Singer
• 金额: $ 15.84万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-09-01 至 2017-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8374331
• 关键词: Accounting; Address; Affect; Area; Attenuated; Award; Biometry; Caring; Chronic; Chronic Disease; Clinical; Clinical Research; Code; Cohort Studies; Comorbidity; Complex; Coupled; Data; Data Set; Decision Making; Development; Development Plans; Device or Instrument Development; Diabetes Mellitus; Effectiveness of Interventions; Enrollment; Environment; Extramural Activities; Faculty; Family; Future; Goals; Grant; Health; Home visitation; House Call; Impaired health; Impairment; Infection; Intervention; Interview; Investigation; Knowledge; Lead; Life; Lung; Lung Transplantation; Lung diseases; Malignant Neoplasms; Measurement; Measures; Mediating; Medical; Medical Records; Mentors; Mentorship; Methods; Modeling; Modification; Morbidity - disease rate; Myopathy; NCI Scholars Program; Nature; Operative Surgical Procedures; Osteoporosis; Outcome; Outcome Measure; Patient Self-Report; Patient-Focused Outcomes; Patients; Pharmaceutical Preparations; Phase; Physiological; Pilot Projects; Policies; Postdoctoral Individual National Research Service Award; Preparation; Process; Prospective Studies; Psychosocial Factor; Publishing; Pulmonology; Qualitative Methods; Qualitative Research; Questionnaires; Recording of previous events; Research; Research Infrastructure; Research Methodology; Research Personnel; Research Project Grants; Residual state; Risk; Risk Factors; San Francisco; Staging; Structure; Surveys; System; Telephone; Time; Training; Transplant Recipients; Transplantation; allograft rejection; base; career; career development; cohort; coping; design; disability; evidence base; experience; functional status; graft function; health related quality of life; improved; instrument; novel; organ allocation; patient oriented; preoperative counseling; prospective; psychosocial; pulmonary function; response; success; transplantation medicine

DESCRIPTION (provided by applicant): As a lung transplant pulmonologist and junior faculty at UC San Francisco, my long term career goal is to become a successful independent investigator of patient-oriented outcomes in recipients of lung transplantation, specifically disability and health related quality of life (HRQL). Importantly, while poor HRQL is a primary indication for lung transplant and, although HRQL is a central, patient-centered outcome measure in many other chronic diseases, HRQL remains a relatively understudied area of research in the field of lung transplantation. Thus, to pursue my long term career goal and address this knowledge gap, I propose to 1) prospectively evaluate how lung transplant effects change in disability and HRQL in subjects suffering from end-stage lung disease and 2) identify key predictors, both pulmonary and extra-pulmonary, of change in disability and HRQL in lung transplant recipients. Three Specific Aims make operational these objectives: Aim 1: Determine changes in disability and HRQL over time among lung transplant recipients; AIM 2: Identify pulmonary and extra-pulmonary physiological and psychosocial predictors of change in disability and HRQL among lung transplant recipients; and AIM 3. Estimate the effect of additional psychosocial factors on HRQL among lung transplant recipients. To accomplish these Aims, I propose a mixed-methods analytic approach that leverages my ongoing pilot study currently supported by my F32 award and an extramural grant from Novartis. 105 subjects listed for lung transplant will be identified and prospectively followed for three years after transplant. Before transplant, baseline measures of pulmonary and extra-pulmonary physiological functioning, co-morbidities, disability and HRQL will be assessed through medical record review, a home visit, and a structured telephone survey. After transplant these measures will be repeated at 3, 6, 12, 18, 24, 30, and 36 months post-transplant. A subset of 15 subjects will complete semi-structured qualitative interviews examining the impact of psychosocial factors on HRQL. Statistical analyses will employ mixed-effects models to analyze the repeated measures nature of the dataset. To determine the change in disability and HRQL over time, longitudinal changes in disability and HRQL scores will be compared to baseline pre-transplant scores. Next, a hierarchical approach to mixed-effects modeling will be used to identify physiological predictors of change in disability and HRQL following transplant. Delineating the effects of lung transplant on disability and HRQL has immediate clinical and research implications. This contribution will permit clinicians to provide data- driven preoperative counseling on the trajectory, magnitude, and durability of reduced disability and improved HRQL that can be anticipated from lung transplant. Also, highlighting the importance of extra-pulmonary impairments as risk factors for disability and impaired HRQL post-transplant could impact care and improve outcomes. Further, identifying residual or new limitations in post-transplant functional status impart particular risk for poor disability/HRQL outcomes permits the development of novel intervention strategies. Though I have had a productive start to my research career, to achieve objectives of this project and independence as an investigator I need further training. The Division of Pulmonary Medicine at UC San Francisco offers a rich environment with a long history of training successful academic pulmonologists that includes an impressive infrastructure and network of researchers dedicated to my career development. Within this environment, I have identified 5 short-term career goals. These goals include (1) the design and implementation of prospective studies with multiple waves of data; (2) advanced quantitative methods including repeated measures analysis to best handle multi-wave data sets; (3) additional training in measuring disability and HRQL with existing instruments; 4) qualitative research methodology relevant to HRQL instrument development; and (5) focused and structured career development through the UCSF Clinical and Translational K Scholars (CTSK) program. To help me achieve these 5 goals, under the guidance of my mentor, I have designed a 5-year career development plan that includes didactic coursework in advanced biostatistics including mixed effects models, measurement of self-reported health (including HRQL) using questionnaires, and qualitative research methodology. This plan also includes one-on-one apprenticeship training in the design and implementation of prospective cohort studies; advanced biostatistics; how to conceptualize and interpret measures of disability, functioning, and HRQL; and qualitative research methods including the design of semi- structured interviews, the coding of interview responses, and data interpretation. Finally, my plan includes "hands-on" practical experiences in implementing prospective studies, interpreting disability and HRQL data within the context of lung transplantation, analyzing results from my study within a mixed-effects modeling framework, and executing all aspects of the qualitative component of this research project. This tailored 5- year career development plan coupled with the prospective cohort study proposed for this award will help me to achieve independence as an investigator with a clearly defined research niche of my own that is unique at UC San Francisco and that also addresses an important but relatively understudied area of investigation in the field of lung transplant medicine.

描述（由申请人提供）：作为旧金山分校的肺移植肺科医生和初级教职员工，我的长期职业目标是成为成功的独立研究者，是肺移植者的患者以患者为导向的结果，特别是残疾和健康相关的与健康相关的生活质量（HRQL）。重要的是，尽管较差的HRQL是肺移植的主要指标，尽管HRQL是许多其他许多慢性疾病的中心，以患者为中心的结果指标，但HRQL仍然是肺移植领域中相对研究的研究领域。因此，为了实现我的长期职业目标并解决这一知识差距，我建议1）前瞻性评估患有末期肺部疾病的受试者的肺移植作用如何变化和HRQL的变化； 2）确定肺部和肺部肺内的关键预测因子，无论是肺和肺部的变化，在肺移植者中的变化和HRQL。三个具体的目标使这些目标运行：目标1：确定肺移植受者的残疾和HRQL随时间的变化；目标2：确定肺移植受者残疾和HRQL变化的肺和肺外生理和社会心理预测因素；和目标3。估计其他社会心理因素对肺移植受者中HRQL的影响。为了实现这些目标，我提出了一种混合方法分析方法，该方法利用了我正在进行的试点研究，目前由我的F32奖和Novartis的校外拨款提供了支持。移植后三年，将确定并前瞻性地识别和前瞻性地鉴定出肺移植的受试者的105名受试者。 在移植之前，将通过病历审查，家庭访问和结构化的电话调查评估肺和肺外生理功能，合并症，残疾和HRQL的基线测量。移植后，这些措施将在移植后3、6、12、18、24、30和36个月重复。 15个受试者的子集将完成半结构化的定性访谈，以研究心理社会因素对HRQL的影响。统计分析将采用混合效应模型来分析数据集的重复度量性质。为了确定残疾和HRQL随时间的变化，将将残疾和HRQL分数的纵向变化与基线前移植前分数进行比较。接下来，将使用分层的混合效应建模方法来识别移植后残疾和HRQL变化的生理预测指标。描述肺移植对残疾和HRQL的影响具有直接的临床和研究意义。这项贡献将使临床医生能够就残疾降低的轨迹，幅度和耐用性提供数据驱动的术前咨询，并改善了HRQL，这可以预见肺移植物。同样，强调肺外障碍作为残疾的危险因素和HRQL移植后的危险因素的重要性可能会影响护理和改善结果。此外，确定移植后功能状况的残留或新限制给予差残疾/HRQL结果的特殊风险允许发展新颖的干预策略。尽管我的研究生涯有一个富有成效的开始，为了实现该项目的目标和作为研究者的独立性，我需要进一步的培训。加州大学旧金山加州大学肺部医学部门提供了丰富的环境，并拥有悠久的培训成功的学术肺科医生的历史，其中包括令人印象深刻的基础设施和致力于我职业发展的研究人员网络。在这种环境中，我确定了5个短期职业目标。这些目标包括（1）具有多个数据浪潮的前瞻性研究的设计和实施； （2）高级定量方法，包括重复测量分析以最佳处理多波数据集； （3）用现有工具测量残疾和HRQL的额外培训； 4）与HRQL仪器开发有关的定性研究方法； （5）通过UCSF临床和转化K学者（CTSK）计划的重点和结构化的职业发展。为了帮助我实现这5个目标，在我的导师的指导下，我设计了一项为期5年的职业发展计划，其中包括高级生物统计学中的教学课程，包括混合效应模型，使用问卷的自我报告的健康（包括HRQL）以及定性研究方法。该计划还包括一对一的学徒培训，以设计和实施潜在的队列研究；晚期生物统计学；如何概念化和解释残疾，功能和HRQL的度量；以及定性研究方法，包括设计半结构化访谈的设计，访谈响应的编码和数据解释。最后，我的计划包括实施前瞻性研究，在肺移植的背景下解释残疾和HRQL数据的“动手”实践经验，在混合效应建模框架内分析我的研究结果，并执行该研究项目的定性组成部分的所有方面。这项量身定制的5年职业发展计划以及为该奖项提出的潜在队列研究，将有助于我成为独立的独立性，该研究人员拥有明确定义的我自己的研究，该研究人员在加州大学旧金山UC独特，这也涉及一个重要但相对被忽略的研究领域的研究领域。 肺移植药。