Proxy assessment of quality of life in pediatric clinical trials: application of the Health Utilities Index 3

Qual Life Res. 2005 May;14(4):1045-56. doi: 10.1007/s11136-004-4714-y.

Abstract

Background: With increased cure rates, pediatric oncology protocols increasingly seek to document the impact of treatment on patients' disease, symptoms, and functional capacity.

Procedure: Nurses as proxy respondents used the Health Utilities Index 3 (HUI3) to assess the health-related quality of life (HRQL) in twenty-five patients (age 6 years or older) enrolled on a frontline protocol for leukemia. HRQL observations (n = 70) were made at three different time points to coincide with high-dose methotrexate therapy. Additionally, the proxy respondents evaluated the ease of use of the instrument and the data quality.

Results: As patients' health status declined, the number of unassessable HRQL items increased. These missing data made scoring cumbersome and precluded calculation of the overall HRQL scores for nearly 50% of the patients.

Conclusions: Use of the provider proxy-assessed HUI3 in pediatric cancer trials may result in a high proportion of missing data. Trials may benefit more from the use of HRQL measures that consider the acuity of the child's illness, domains specific and sensitive to both disease and treatment, and items that can be proxy-assessed independent of input from parent or patient. Evaluations that combine child self-reports with both parent and provider reports may ultimately provide the most reliable and comprehensive perspective on children's quality of life.

Publication types

  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adolescent
  • Child
  • Clinical Trials as Topic*
  • Female
  • Health Status
  • Humans
  • Leukemia / drug therapy
  • Leukemia / physiopathology*
  • Leukemia / psychology
  • Male
  • Pediatrics*
  • Proxy*
  • Quality of Life / psychology*
  • Sickness Impact Profile*