Developing and Evaluating Quality-Weighted Hospital-Free Days as a Novel, Patient-Centered Outcome for Trials of Patients with Acute Respiratory Failure

制定和评估质量加权的非住院日作为急性呼吸衰竭患者试验的一种新颖的、以患者为中心的结果

• 批准号: 10427764
• 负责人: Catherine Louise Auriemma
• 金额: $ 19.37万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-08-05 至 2027-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10427764
• 关键词: Acute; Acute respiratory failure; Admission activity; Adult; American; Caregiver Burden; Caregiver research; Caregivers; Clinical Trials; Cognitive; Cohort Studies; Consensus; Critical Care; Critical Illness; Data; Data Reporting; Development Plans; Electronic Health Record; Enrollment; Environment; Family; Family Caregiver; Family member; Financial Support; Frequencies; Future; Goals; Health; Home; Hospital Mortality; Hospitals; Impaired health; Impairment; Incidence; Institution; Intensive Care Units; Interdisciplinary Study; International; Intervention; K-Series Research Career Programs; Knowledge; Lead; Lung; Measurable; Measures; Mentors; Methodology; Methods; Modality; National Heart, Lung, and Blood Institute; Outcome; Outcome Measure; Patient Outcomes Assessments; Patient-Focused Outcomes; Patients; Pennsylvania; Physicians; Population; Positioning Attribute; Property; Prospective Studies; Prospective cohort; Prospective cohort study; Psychometrics; Public Health; Quality of life; Quality-of-Life Assessment; Records; Reporting; Research; Research Design; Research Personnel; Sample Size; Scholarship; Science; Scientist; Statistical Models; Structure; Surveys; Survivors; Techniques; Training; Translating; Universities; Weight; Work; acute care; career; career development; cohort; design; digital; experience; follow-up; functional status; health care service utilization; health goals; hospital readmission; improved; innovation; instrument; models and simulation; mortality; novel; palliative; patient engagement; patient oriented; prospective; psychosocial; randomized trial; recruit; response; skills; social; success; survivorship

Project Summary/Abstract Candidate: Catherine Auriemma, MD, is a pulmonary and critical care physician-scientist passionate about understanding and improving long-term outcomes of patients with acute respiratory failure (ARF). To advance her career towards research independence, she seeks didactic and experiential training to develop expertise in consensus methods, prospective study design, and statistical modeling and simulation. Research Context: Rising incidence and decreasing mortality of ARF has produced a growing population of survivors facing significant physical, cognitive, and social impairments requiring increased healthcare utilization. A crucial barrier to advancing ARF survivorship research is the lack of an outcome measure that is patient-centered and appropriate for evaluating interventions with either palliative or restorative intent. Hospital- free days (HFDs), the number of days spent alive and outside an acute care hospital, has become common in studies of other acutely ill populations. However, HFDs does not account for decrements in functional status or quality of life; and the bimodal distribution of HFDs among ARF patients raises questions regarding the statistical power and construct validity of HFDs for ARF. This study proposes to design and evaluate a method to quality-weight HFDs using patient-reported assessments of function, quality of life, or caregiver burden. Specific Aims: 1) Develop an optimal approach to quality-weight HFDs using consensus methods with key stakeholders; 2) Assess quality-weighted HFDs among a prospective cohort of ARF patients; 3) Compare statistical power and construct validity of HFDs with and without quality-weighting in a large ARF cohort. Research Plan: To accomplish these aims, Dr. Auriemma will convene a Delphi panel of ARF survivors, family caregivers, clinicians, and trialists to develop best practices for integrating patient- and caregiver-reported data into assessments of HFDs. She will then apply the novel method to a prospective cohort of ARF patients to assess acceptability, responsiveness, and variability of quality-weighted HFDs. Finally, she will use observed values in the Aim 2 cohort to simulate quality-weighted HFDs in a large clinical trial among patients with ARF to compare statistical power and construct validity of unweighted and quality-weighted HFDs. Career Development Plan: Working closely with her mentors and advisors, Dr. Auriemma will 1) develop expertise in consensus methods necessary to convert multiple patient-identified core values into measurable outcomes; 2) obtain the skills necessary to design, launch, oversee, and complete a multisite, prospective cohort study; and 3) gain methodologic expertise in advanced statistical modeling and simulation techniques. Environment: The University of Pennsylvania offers an ideal environment to pursue this training, with well- established mentors and her home department heavily dedicated to Dr. Auriemma’s success, and several multi-disciplinary research centers with long track records of producing successful, independent investigators.

项目总结/文摘