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）：作为一名肺移植肺科医生和加州大学旧金山分校的初级教员，我的长期职业目标是成为一名成功的独立研究者，研究肺移植受者以患者为导向的结果，特别是残疾和健康相关的生活质量（HRQL）。重要的是，虽然 HRQL 较差是肺移植的主要指征，并且 HRQL 是许多其他慢性疾病的核心、以患者为中心的结果衡量标准，但 HRQL 仍然是肺移植领域中相对未被充分研究的领域。因此，为了追求我的长期职业目标并解决这一知识差距，我建议 1) 前瞻性评估肺移植如何影响患有终末期肺病的受试者的残疾和 HRQL 变化，以及 2) 确定肺移植受者残疾和 HRQL 变化的关键预测因素，包括肺内和肺外的预测因素。三个具体目标使这些目标得以实现： 目标 1：确定肺移植受者的残疾和 HRQL 随着时间的推移的变化；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 AIM 3. 估计其他心理社会因素对肺移植受者 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，该方法利用了我目前正在进行的试点研究，该研究目前由我的 F32 奖项和诺华的校外资助支持。将确定 105 名接受肺移植的受试者，并在移植后进行为期三年的前瞻性随访。 移植前，将通过病历审查、家访和结构化电话调查来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，将在移植后 3、6、12、18、24、30 和 36 个月重复这些措施。 15 名受试者的子集将完成半结构化定性访谈，检查心理社会因素对 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测量性质。为了确定残疾和 HRQL 随时间的变化，将残疾和 HRQL 分数的纵向变化与移植前基线分数进行比较。接下来，将使用混合效应建模的分层方法来确定移植后残疾和 HRQL 变化的生理预测因子。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。这一贡献将使临床医生能够就肺移植可预期减少残疾和改善 HRQL 的轨迹、程度和持久性提供数据驱动的术前咨询。此外，强调肺外损伤作为移植后残疾和 HRQL 受损的危险因素的重要性可能会影响护理并改善结果。此外，识别移植后功能状态的残余或新的限制会给残疾/HRQL结果带来特殊风险，从而允许开发新的干预策略。尽管我的研究生涯已经有了一个富有成效的开端，但为了实现这个项目的目标和作为一名研究者的独立性，我需要进一步的培训。加州大学旧金山分校的肺科提供了一个丰富的环境，在培养成功的学术肺科医师方面有着悠久的历史，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。在这种环境下，我确定了 5 个短期职业目标。这些目标包括（1）设计和实施多波数据的前瞻性研究； (2) 先进的定量方法，包括重复测量分析，以最好地处理多波数据集； (3) 使用现有仪器测量残疾和 HRQL 的额外培训； 4）与HRQL工具开发相关的定性研究方法； (5) 通过 UCSF 临床和转化 K 学者 (CTSK) 计划进行有针对性和结构化的职业发展。为了帮助我实现这 5 个目标，在导师的指导下，我设计了一个 5 年职业发展计划，其中包括高级生物统计学的教学课程，包括混合效应模型、使用问卷测量自我报告的健康状况（包括 HRQL）以及定性研究方法。该计划还包括设计和实施前瞻性队列研究的一对一学徒培训；先进的生物统计学；如何概念化和解释残疾、功能和 HRQL 的衡量标准；定性研究方法，包括半结构化访谈的设计、访谈回答的编码和数据解释。最后，我的计划包括实施前瞻性研究、解释肺移植背景下的残疾和 HRQL 数据、在混合效应建模框架内分析我的研究结果以及执行该研究项目定性部分的各个方面的“实践”实践经验。这个量身定制的 5 年职业发展计划，加上为该奖项提出的前瞻性队列研究，将帮助我实现作为一名研究者的独立性，拥有自己明确的研究领域，这在加州大学旧金山分校是独一无二的，并且还涉及该领域一个重要但相对而言研究不足的领域。 肺移植医学。