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Analyzing Health-Related Quality of Life in the EVOLVE Trial

Author

Listed:
  • Andrew H. Briggs
  • Patrick S. Parfrey
  • Nasreen Khan
  • Spring Tseng
  • Bastian Dehmel
  • Yumi Kubo
  • Glenn M. Chertow
  • Vasily Belozeroff

Abstract

Background: The Evaluation of Cinacalcet HCl Therapy to Lower Cardiovascular Events (EVOLVE) clinical trial evaluated the effects of cinacalcet on clinical events in patients with secondary hyperparathyroidism (sHPT) who were on hemodialysis. Health-related quality of life (HRQoL) was assessed by a generic, preference-based health outcome measure (EQ-5D) at scheduled visits and after a study event. Here, we report the HRQoL analysis from EVOLVE. Methods: We assessed changes in HRQoL from baseline to scheduled visits, and estimated the acute (3 mo) and chronic (beyond 3 mo) effects of sHPT-related events on HRQoL using generalized estimating equation analysis controlling for baseline HRQoL and randomized assignment. Results: Data on HRQoL were available for 3547 of 3883 subjects, with 1650 events in the placebo and 1502 in the cinacalcet arm. At the study end, no difference in change from baseline HRQoL was observed in the direct comparison of EQ-5D by treatment arms. The regression analysis showed significant effects of events on HRQoL and a modest positive effect of cinacalcet. Estimated quality-adjusted life-year gains were of similar magnitude based on the observed data or the predictions from the model, with only a small gain in precision from the predicted analysis. Conclusions: By contrast with a conventional comparison, a regression analysis demonstrated large decrements in HRQoL after events and a modest improvement in HRQoL with cinacalcet. As randomized controlled trials are rarely powered to detect differences in HRQoL, a prespecified regression analysis may be acceptable to improve precision of the effects and understand their origin.

Suggested Citation

  • Andrew H. Briggs & Patrick S. Parfrey & Nasreen Khan & Spring Tseng & Bastian Dehmel & Yumi Kubo & Glenn M. Chertow & Vasily Belozeroff, 2016. "Analyzing Health-Related Quality of Life in the EVOLVE Trial," Medical Decision Making, , vol. 36(8), pages 965-972, November.
    • Handle: RePEc:sae:medema:v:36:y:2016:i:8:p:965-972
    DOI: 10.1177/0272989X16638312
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    1. Etzioni, Ruth D. & Feuer, Eric J. & Sullivan, Sean D. & Lin, Danyu & Hu, Chengcheng & Ramsey, Scott D., 1999. "On the use of survival analysis techniques to estimate medical care costs," Journal of Health Economics, Elsevier, vol. 18(3), pages 365-380, June.
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    1. Catharine Ward Thompson & Aldo Elizalde & Steven Cummins & Alastair H. Leyland & Willings Botha & Andrew Briggs & Sara Tilley & Eva Silveirinha de Oliveira & Jenny Roe & Peter Aspinall & Richard Mitch, 2019. "Enhancing Health Through Access to Nature: How Effective are Interventions in Woodlands in Deprived Urban Communities? A Quasi-experimental Study in Scotland, UK," Sustainability, MDPI, vol. 11(12), pages 1-21, June.

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