PMID- 28205056
OWN - NLM
STAT- MEDLINE
DCOM- 20170828
LR  - 20181202
IS  - 1865-8652 (Electronic)
IS  - 0741-238X (Print)
IS  - 0741-238X (Linking)
VI  - 34
IP  - 3
DP  - 2017 Mar
TI  - Analyzing Health-Related Quality of Life Data to Estimate Parameters for 
      Cost-Effectiveness Models: An Example Using Longitudinal EQ-5D Data from the 
      SHIFT Randomized Controlled Trial.
PG  - 753-764
LID - 10.1007/s12325-016-0471-x [doi]
AB  - INTRODUCTION: The aim of this article is to discuss methods used to analyze 
      health-related quality of life (HRQoL) data from randomized controlled trials 
      (RCTs) for decision analytic models. The analysis presented in this paper was 
      used to provide HRQoL data for the ivabradine health technology assessment (HTA) 
      submission in chronic heart failure. METHODS: We have used a large, longitudinal 
      EuroQol five-dimension questionnaire (EQ-5D) dataset from the Systolic Heart 
      Failure Treatment with the I (f) Inhibitor Ivabradine Trial (SHIFT) 
      (clinicaltrials.gov: NCT02441218) to illustrate issues and methods. HRQoL weights 
      (utility values) were estimated from a mixed regression model developed using 
      SHIFT EQ-5D data (n = 5313 patients). The regression model was used to predict 
      HRQoL outcomes according to treatment, patient characteristics, and key clinical 
      outcomes for patients with a heart rate >/=75 bpm. RESULTS: Ivabradine was 
      associated with an HRQoL weight gain of 0.01. HRQoL weights differed according to 
      New York Heart Association (NYHA) class (NYHA I-IV, no hospitalization: standard 
      care 0.82-0.46; ivabradine 0.84-0.47). A reduction in HRQoL weight was associated 
      with hospitalizations within 30 days of an HRQoL assessment visit, with this 
      reduction varying by NYHA class [-0.07 (NYHA I) to -0.21 (NYHA IV)]. CONCLUSION: 
      The mixed model explained variation in EQ-5D data according to key clinical 
      outcomes and patient characteristics, providing essential information for 
      long-term predictions of patient HRQoL in the cost-effectiveness model. This 
      model was also used to estimate the loss in HRQoL associated with 
      hospitalizations. In SHIFT many hospitalizations did not occur close to EQ-5D 
      visits; hence, any temporary changes in HRQoL associated with such events would 
      not be captured fully in observed RCT evidence, but could be predicted in our 
      cost-effectiveness analysis using the mixed model. Given the large reduction in 
      hospitalizations associated with ivabradine this was an important feature of the 
      analysis. FUNDING: The Servier Research Group.
FAU - Griffiths, Alison
AU  - Griffiths A
AD  - Research Economics and Consultancy in Healthcare Ltd, Solihull, UK. 
      Alison.Griffiths@ResearchEconomics.co.uk.
FAU - Paracha, Noman
AU  - Paracha N
AD  - ICON plc, Abingdon, UK.
FAU - Davies, Andrew
AU  - Davies A
AD  - ICON plc, Abingdon, UK.
FAU - Branscombe, Neil
AU  - Branscombe N
AD  - Servier Laboratories Ltd, Suresnes, France.
FAU - Cowie, Martin R
AU  - Cowie MR
AD  - Imperial College London (Royal Brompton Hospital), London, UK.
FAU - Sculpher, Mark
AU  - Sculpher M
AD  - Centre for Health Economics, University of York, York, UK.
LA  - eng
SI  - ClinicalTrials.gov/NCT02441218
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20170215
PL  - United States
TA  - Adv Ther
JT  - Advances in therapy
JID - 8611864
RN  - 0 (Benzazepines)
RN  - 0 (Cardiovascular Agents)
RN  - 3H48L0LPZQ (Ivabradine)
MH  - Aged
MH  - *Benzazepines/economics/therapeutic use
MH  - Cardiovascular Agents/economics/therapeutic use
MH  - Cost-Benefit Analysis
MH  - Female
MH  - *Heart Failure, Systolic/drug therapy/economics/psychology
MH  - Hospitalization/statistics & numerical data
MH  - Humans
MH  - Ivabradine
MH  - Male
MH  - Middle Aged
MH  - Models, Statistical
MH  - *Quality of Life
MH  - Severity of Illness Index
MH  - Surveys and Questionnaires
PMC - PMC5350196
OTO - NOTNLM
OT  - Application areas
OT  - Cardiovascular
OT  - Cost-effectiveness
OT  - Economics
OT  - Heart failure
OT  - Ivabradine
OT  - Quality of life
EDAT- 2017/02/17 06:00
MHDA- 2017/08/29 06:00
PMCR- 2017/02/15
CRDT- 2017/02/17 06:00
PHST- 2015/09/22 00:00 [received]
PHST- 2017/02/17 06:00 [pubmed]
PHST- 2017/08/29 06:00 [medline]
PHST- 2017/02/17 06:00 [entrez]
PHST- 2017/02/15 00:00 [pmc-release]
AID - 10.1007/s12325-016-0471-x [pii]
AID - 471 [pii]
AID - 10.1007/s12325-016-0471-x [doi]
PST - ppublish
SO  - Adv Ther. 2017 Mar;34(3):753-764. doi: 10.1007/s12325-016-0471-x. Epub 2017 Feb 
      15.