title: Background and design of the profiling biobehavioral responses to mechanical support in advanced heart failure study.
abstract: BACKGROUND
  Unexplained heterogeneity in response to ventricular assist device (VAD) implantation for the management of advanced heart failure impedes our ability to predict favorable outcomes, provide adequate patient and family education, and personalize monitoring and symptom management strategies. The purpose of this article was to describe the background and the design of a study entitled "Profiling Biobehavioral Responses to Mechanical Support in Advanced Heart Failure" (PREMISE).
  
  
  METHODS
  PREMISE is a prospective cohort study designed to (1) identify common and distinct trajectories of change in physical and psychological symptom burden; (2) characterize common trajectories of change in serum biomarkers of myocardial stress, systemic inflammation, and endothelial dysfunction; and (3) quantify associations between symptoms and biomarkers of pathogenesis in adults undergoing VAD implantation. Latent growth mixture modeling, including parallel process and cross-classification modeling, will be used to address the study aims and will entail identifying trajectories, quantifying associations between trajectories and both clinical and quality-of-life outcomes, and identifying predictors of favorable symptom and biomarker responses to VAD implantation.
  
  
  CONCLUSIONS
  Research findings from the PREMISE study will be used to enhance shared patient and provider decision making and to shape a much-needed new breed of interventions and clinical management strategies that are tailored to differential symptom and pathogenic responses to VAD implantation.
authors.affiliation: Christopher S. Lee, PhD, RN, FAHA Associate Professor, Schools of Nursing and Medicine, Oregon Health & Science University, Portland. James O. Mudd, MD Assistant Professor, Director of Heart Failure/Transplant Cardiology, School of Medicine, Oregon Health & Science University, Portland. Jill M. Gelow, MD, MPH Assistant Professor, School of Medicine, Oregon Health & Science University, Portland. Thuan Nguyen, MD, PhD Assistant Professor, School of Medicine, Oregon Health & Science University, Portland. Shirin O. Hiatt, MPH, MS, RN Research Project Director, School of Nursing, Oregon Health & Science University, Portland. Jennifer K. Green, MS Research Associate, School of Nursing, Oregon Health & Science University, Portland. Quin E. Denfeld, BSN, RN, CCRN Research Associate, School of Nursing, Oregon Health & Science University, Portland. Julie T. Bidwell, BSN, RN Research Associate, School of Nursing, Oregon Health & Science University, Portland. Kathleen L. Grady, PhD, APN, FAHA, FAAN Associate Professor, Administrative Director, Center for Heart Failure, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.
authors.forename: Christopher S
authors.initials: CS
authors.lastname: Lee
authors.forename: James O
authors.initials: JO
authors.lastname: Mudd
authors.forename: Jill M
authors.initials: JM
authors.lastname: Gelow
authors.forename: Thuan
authors.initials: T
authors.lastname: Nguyen
authors.forename: Shirin O
authors.initials: SO
authors.lastname: Hiatt
authors.forename: Jennifer K
authors.initials: JK
authors.lastname: Green
authors.forename: Quin E
authors.initials: QE
authors.lastname: Denfeld
authors.forename: Julie T
authors.initials: JT
authors.lastname: Bidwell
authors.forename: Kathleen L
authors.initials: KL
authors.lastname: Grady
mesh_terms: D004730:Endothelium, Vascular / Q000503:physiopathology; D006333:Heart Failure / Q000503:physiopathology / Q000628:therapy*; D006353:Heart-Assist Devices; D006801:Humans; D064887:Observational Studies as Topic; D011788:Quality of Life; D012107:Research Design