Health-related quality of life in mechanical circulatory support: Development of a new conceptual model and items for self-administration Kathleen L. Grady, PhD, RN, a Susan Magasi, PhD, b Elizabeth A. Hahn, MA, c Sarah Buono, BA, c Edwin C. McGee Jr, MD, d and Clyde Yancy, MSc, MD e From the a Division of Cardiac Surgery, Department of Surgery, Northwestern University, Chicago, Illinois; b Department of Occupational Therapy, University of Illinois at Chicago, Chicago, Illinois; c Department of Medical Social Sciences, Northwestern University, Chicago, Illinois; d Department of Thoracic and Cardiovascular Surgery, Loyola University, Maywood, Illinois; and the e Division of Cardiology, Department of Medicine, Northwestern University, Chicago, Illinois. KEYWORDS: health-related quality of life; mechanical circulatory support; heart failure; new model; content validity BACKGROUND: Generic and heart failure (HF)–specific health-related quality of life (HRQOL) instruments do not address unique burdens of mechanical circulatory support (MCS). This report describes (1) a conceptual model of adjustment to MCS and HRQOL, (2) the development of a new set of items to assess adjustment and HRQOL, and (3) establishes content validity of the new model and items. METHODS: We interviewed 15 expert clinicians, 16 patients with advanced HF, and 48 MCS patients. A grounded theory approach was used to systemically examine qualitative data. We developed a coding dictionary, with codes organized under concepts. A conceptual model of adjustment to MCS and HRQOL was developed. A set of relevant items was generated from the codes, concepts, and conceptual model. After items were refined, MCS patients participated in cognitive interviews to provide feedback on their relevance and acceptability. RESULTS: Patients described how having HF and MCS affected their daily lives. Three concepts regarding adjustment to MCS and its relationship to HRQOL emerged: (1) effect of disease and treatment (satisfaction with treatment, symptoms, and self-efficacy regarding self-care), (2) resources, and (3) implant strategy. From our codes, concepts, and model, we developed a set of 652 items that were categorized by concept. The item set was reduced from 652 items to 236 (36%), and 120 of these 236 items (51%) underwent cognitive debriefing. Our final set includes 239 items with evidence of content validity. CONCLUSIONS: Our newly developed model on adjustment to MCS and HRQOL and items will undergo further testing in the future. J Heart Lung Transplant 2015;34:1292–1304 r 2015 International Society for Heart and Lung Transplantation. All rights reserved. Patients with advanced heart failure (HF) have very poor outcomes; New York Heart Association (NYHA) Func- tional Classification IV HF survival is 8% to 40%. 1–3 Patients with advanced HF awaiting transplant may be bridged with mechanical circulatory support (MCS), where- as those who are not eligible for heart transplantation may be offered permanent MCS (i.e., destination therapy). As MCS technology evolves, survival has improved (70% survival at 2 years), and the risk of adverse events has decreased. 4–6 However, future use of MCS will depend not only on survival and the risk of adverse events but also on http://www.jhltonline.org 1053-2498/$ - see front matter r 2015 International Society for Heart and Lung Transplantation. All rights reserved. http://dx.doi.org/10.1016/j.healun.2015.04.003 E-mail address: kgrady@nmh.org Reprint requests: Kathleen L. Grady, PhD, RN, Northwestern Memorial Hospital, Division of Cardiac Surgery, 201 E Huron St, Galter Pavilion 11-140, Chicago, IL 60611-3056. Telephone: þ312 695 4860. Fax: þ312 695 1903.