title: Health-related quality of life in mechanical circulatory support: Development of a new conceptual model and items for self-administration.
abstract: 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.
authors.affiliation: Division of Cardiac Surgery, Department of Surgery, Northwestern University, Chicago, Illinois. Electronic address: kgrady@nmh.org.
authors.forename: Kathleen L
authors.initials: KL
authors.lastname: Grady
authors.affiliation: Department of Occupational Therapy, University of Illinois at Chicago, Chicago, Illinois.
authors.forename: Susan
authors.initials: S
authors.lastname: Magasi
authors.affiliation: Department of Medical Social Sciences, Northwestern University, Chicago, Illinois.
authors.forename: Elizabeth A
authors.initials: EA
authors.lastname: Hahn
authors.affiliation: Department of Medical Social Sciences, Northwestern University, Chicago, Illinois.
authors.forename: Sarah
authors.initials: S
authors.lastname: Buono
authors.affiliation: Department of Thoracic and Cardiovascular Surgery, Loyola University, Maywood, Illinois.
authors.forename: Edwin C
authors.initials: EC
authors.lastname: McGee
authors.affiliation: Division of Cardiology, Department of Medicine, Northwestern University, Chicago, Illinois.
authors.forename: Clyde
authors.initials: C
authors.lastname: Yancy
mesh_terms: D000328:Adult; D000368:Aged; D000066498:Emotional Adjustment; D005260:Female; D066296:Grounded Theory; D006304:Health Status; D006333:Heart Failure / Q000523:psychology* / Q000628:therapy*; D006353:Heart-Assist Devices; D006801:Humans; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D011788:Quality of Life; D057566:Self Report; D055815:Young Adult
keywords: content validity; health-related quality of life; heart failure; mechanical circulatory support; new model