# Improving the measurement and analysis of long-term, patient-centered outcomes following acute respiratory failure

> **NIH NIH R00** · UNIVERSITY OF PENNSYLVANIA · 2021 · $249,000

## Abstract

PROJECT SUMMARY/ABSTRACT
This Pathway to Independence Award application is submitted by a pulmonary and critical care epidemiologist
committed to improving the quality of patient-oriented research for patients experiencing acute respiratory
failure (ARF). Worldwide, millions of patients develop ARF annually. In the U.S., nearly one million patients
with ARF require mechanical ventilation annually, accounting for a quarter of all intensive care unit (ICU)
admissions. As improvements in ICU care reduce such patients’ in-hospital mortality rates, attention has
shifted to the challenges ARF survivors face in regaining their prior cognitive, physical, and psychosocial
functioning. However, there is a key barrier for randomized clinical trials (RCTs) testing new interventions to
improve ARF survivorship – that is, the current lack of an endpoint that (1) captures long-term patient
dispositions, (2) incorporates patient preferences and perspectives, and (3) is able to be analyzed without
concern for statistical biases. The overarching goal of this research is to support clinical innovation by
developing new approaches to measure and report long-term patient-centered outcomes that overcome the
methodological barriers currently limiting ARF RCTs. The applicant will accomplish his goals under the
mentorship of established researchers in critical care, patient-centered outcomes research, statistics, and
informatics to assure his transition to a tenure-track faculty position in the R00 phase and his emergence as a
leading pulmonary and critical care epidemiologist. First, the applicant will use an innovative combination of
qualitative and quantitative research methods to elicit and integrate ARF survivors’ and their caregivers’
perspectives into a new patient-centered, long-term composite outcome measure (K99 phase). During the R00
phase, the applicant will recruit ARF survivors to participate in a prospective cohort, and follow these patients
to describe the burden of ARF survivorship over 1-year using the new endpoint developed during the K99
phase. This endeavor will also provide key
data that will facilitate sample size calculations in future ARF RCTs.
Data from this cohort will additionally be used
to develop an electronic health record (EHR)-based algorithm to
predict risks for adverse long-term outcomes among ARF patients early in their ICU stays. Thus, this K99/R00
will augment ARF research by establishing a new outcome measure anchored in patient perspectives,
improving the understanding and clinical prognostication of post-ICU morbidity following ARF, and facilitate the
efficiency and clinical relevance of future ARF RCTs by enabling measurement of patients’ baseline risks for
different outcomes. Concurrently, the didactic work, individual study, and hands-on learning in mixed-methods
research, natural language processing, and predictive analytics will fill key training gaps for the applicant,
thereby positioning him for a successful, independently...

## Key facts

- **NIH application ID:** 10064003
- **Project number:** 5R00HL141678-04
- **Recipient organization:** UNIVERSITY OF PENNSYLVANIA
- **Principal Investigator:** Michael Oscar Harhay
- **Activity code:** R00 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $249,000
- **Award type:** 5
- **Project period:** 2018-04-15 → 2022-12-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10064003

## Citation

> US National Institutes of Health, RePORTER application 10064003, Improving the measurement and analysis of long-term, patient-centered outcomes following acute respiratory failure (5R00HL141678-04). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10064003. Licensed CC0.

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