Dr. Christopher Cox's long-term objectives for this proposed K23 Career Development Award are to: (1) advance the measurement and understanding of health-related quality of life (HRQL) among survivors of acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) and (2) obtain advanced training in epidemiology, biostatistics, and survey methods essential to establishing his career in critical care outcomes research. Dr. Cox, an Assistant Professor at Duke, proposes a combined didactic and clinical research experience to achieve these goals. This training program will include formal coursework at the UNC School of Public Health, attendance at clinical research seminars, and conducting a 5-year clinical research project performed under the mentorship of Dr. James Tulsky, an established investigator. Most ALI/ARDS survivors leave the hospital with multisystemic critical illness-associated problems that may impact their HRQL. To improve their HRQL one must be able to measure it. However, there is no gold standard HRQL measure for ALI/ARDS survivors. Generic questionnaires such as the Short Form 36 (SF36) and the EuroQol (EQ5D) have been used most commonly for this purpose, though they do not assess many concerns unique to ALI/ARDS survivors and their responsiveness and interpretability are not well defined for these patients. To move the field forward, HRQL instruments must be developed that are unique to this population.
My specific aims are to: (1) Identify the important attributes of ALI/ARDS survivors'HRQL, (2) Develop and perform the initial validation of an ALI/ARDS survivor-specific HRQL questionnaire based on these attributes, (3) Perform final validation of the ALI/ARDS questionnaire in a prospective cohort of ALI/ARDS survivors, and (4) Identify clinical factors that predict the rate and magnitude of ALI/ARDS survivors'HRQL recovery using state-of-the-art statistical techniques. I will enroll a total of 380 ALI/ARDS survivors from Duke, the Durham VA Medical Center, and UNC in a single project composed of three related studies. First, qualitative analysis of focus groups of 50 patients and caregivers will identify important ways that ALI/ARDS impacts their lives. Next, these unique attributes will be incorporated into an ALI/ARDS-specific HRQL questionnaire that will be validated and refined in a cross-sectional study of 200 ALI/ARDS survivors using factor analysis and comparison of questionnaire scores with other scales and clinical variables. Lastly, we will collect data prospectively at baseline, 2, 4, and 6 months on 130 ALI/ARDS survivors to evaluate the psychometric measurement performance (e.g., construct validity, sensitivity to change, reliability, interpretability) of the ALI/ARDS questionnaire as well as the SF36 and the EQ5D. Linear mixed effects and general growth mixture modeling will identify specific ICU- and post-discharge factors that are associated with HRQL improvement among ALI/ARDS survivors, as well as define specific subgroups of patients with the greatest need. These results will inform clinical trial outcomes measures as well as highlight targets for interventions designed to improve survivors'HRQL.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Mentored Patient-Oriented Research Career Development Award (K23)
Project #
5K23HL081048-05
Application #
7667746
Study Section
Special Emphasis Panel (ZHL1-CSR-M (M1))
Program Officer
Colombini-Hatch, Sandra
Project Start
2005-08-10
Project End
2010-07-31
Budget Start
2009-08-01
Budget End
2010-07-31
Support Year
5
Fiscal Year
2009
Total Cost
$125,783
Indirect Cost
Name
Duke University
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
044387793
City
Durham
State
NC
Country
United States
Zip Code
27705
Cox, Christopher E; Porter, Laura S; Hough, Catherine L et al. (2012) Development and preliminary evaluation of a telephone-based coping skills training intervention for survivors of acute lung injury and their informal caregivers. Intensive Care Med 38:1289-97
Cox, Christopher E; Lewis, Carmen L; Hanson, Laura C et al. (2012) Development and pilot testing of a decision aid for surrogates of patients with prolonged mechanical ventilation. Crit Care Med 40:2327-34
Unroe, Mark; Kahn, Jeremy M; Carson, Shannon S et al. (2010) One-year trajectories of care and resource utilization for recipients of prolonged mechanical ventilation: a cohort study. Ann Intern Med 153:167-75
Cox, Christopher E; Docherty, Sharron L; Brandon, Debra H et al. (2009) Surviving critical illness: acute respiratory distress syndrome as experienced by patients and their caregivers. Crit Care Med 37:2702-8
Cox, Christopher E; Martinu, Tereza; Sathy, Shailaja J et al. (2009) Expectations and outcomes of prolonged mechanical ventilation. Crit Care Med 37:2888-94; quiz 2904
Cox, Christopher E; Reed, Shelby D; Govert, Joseph A et al. (2008) Economic evaluation of propofol and lorazepam for critically ill patients undergoing mechanical ventilation. Crit Care Med 36:706-14
Carson, Shannon S; Garrett, Joanne; Hanson, Laura C et al. (2008) A prognostic model for one-year mortality in patients requiring prolonged mechanical ventilation. Crit Care Med 36:2061-9
Cox, Christopher E; Carson, Shannon S; Govert, Joseph A et al. (2007) An economic evaluation of prolonged mechanical ventilation. Crit Care Med 35:1918-27
Cox, Christopher E; Carson, Shannon S; Lindquist, Jennifer H et al. (2007) Differences in one-year health outcomes and resource utilization by definition of prolonged mechanical ventilation: a prospective cohort study. Crit Care 11:R9