title: Design and rationale of health-related quality of life and patient-reported outcomes assessment in the Frequent Hemodialysis Network trials.
abstract: BACKGROUND
  End-stage renal disease patients experience significant impairments in health-related quality of life (HRQOL). Testing various strategies to improve patient HRQOL in multicenter clinical trials, such as the Frequent Hemodialysis Network (FHN) trials is vitally important.
  
  
  OBJECTIVE
  The aim of this paper is to describe the design and conduct of HRQOL and patient-reported outcomes (PRO) assessment in the FHN trials.
  
  
  METHODS
  In the FHN trials, HRQOL was examined as a multidimensional concept, and the SF-36 RAND Physical Health Composite score was one of the co-primary outcomes. The instruments completed to assess HRQOL included the Medical Outcomes Study Short Form SF-36, Health Utilities Index 3, Sleep Problems Index, Beck Depression Inventory and feeling thermometer. These instruments have been shown to have high reliability, validity and responsiveness to change in the end-stage renal disease population. Additional items evaluating PRO including sexual function, time to recovery after dialysis and patients' self-perceived burden to caregiver were also assessed. All questionnaires were administered by trained interviewers using computer-assisted telephone interviewing to ensure blinding and minimizing selection bias. Interim analysis reveals that these instruments can be used to collect a comprehensive set of HRQOL measures with minimal patient burden.
  
  
  CONCLUSIONS
  Accurate measurement of HRQOL and PRO can help us test whether hemodialysis interventions improve the health and well-being of this compromised patient population. We have shown that a comprehensive set of HRQOL measures can be centrally collected through telephone interviews in a blinded fashion, in a way that is well tolerated with minimum respondent burden.
authors.affiliation: Division of Nephrology, University of Western Ontario, London, Ontario, Canada.
authors.forename: Manisha
authors.initials: M
authors.lastname: Jhamb
authors.forename: Manjula K
authors.initials: MK
authors.lastname: Tamura
authors.forename: Jennifer
authors.initials: J
authors.lastname: Gassman
authors.forename: Amit X
authors.initials: AX
authors.lastname: Garg
authors.forename: Robert M
authors.initials: RM
authors.lastname: Lindsay
authors.forename: Rita S
authors.initials: RS
authors.lastname: Suri
authors.forename: George
authors.initials: G
authors.lastname: Ting
authors.forename: Fredric O
authors.initials: FO
authors.lastname: Finkelstein
authors.forename: Scott
authors.initials: S
authors.lastname: Beach
authors.forename: Paul L
authors.initials: PL
authors.lastname: Kimmel
authors.forename: Mark
authors.initials: M
authors.lastname: Unruh
mesh_terms: D002986:Clinical Trials as Topic; D006801:Humans; D007676:Kidney Failure, Chronic / Q000523:psychology*; D017063:Outcome Assessment, Health Care; D011788:Quality of Life; D006435:Renal Dialysis / Q000523:psychology*; D012107:Research Design