Quality of life in clinical trials for children

Annalisa Trama1, Massimiliano Dieci

  • 1Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy. annalisa.trama@istitutotumori.mi.it

Insights

Measuring quality of life (QoL) in children is crucial due to rising survival rates of chronic conditions. However, current QoL assessment tools for children present challenges, necessitating further research for improved instruments.

Area of Science:

  • Pediatric Health Research
  • Quality of Life Assessment
  • Clinical Trial Methodology

Background:

  • Growing survival rates in children with chronic conditions highlight the need for QoL assessment.
  • Children represent a significant population with disabling conditions, underscoring QoL measurement importance.
  • Existing QoL measures developed for adults may not adequately capture child-specific concerns.

Purpose of the Study:

  • To emphasize the significance of measuring quality of life (QoL) in pediatric populations.
  • To review available QoL measurement instruments for children.
  • To identify methodological challenges in incorporating QoL outcomes in pediatric clinical trials.

Main Methods:

  • A comprehensive literature review was conducted using PubMed.
  • Articles published within the last 20 years focusing on QoL instruments for children were analyzed.
  • The review assessed the use and challenges of QoL measures in pediatric research.

Main Results:

  • QoL data are underutilized in pediatric clinical trials despite strong rationale.
  • Numerous generic and disease-specific QoL measures for children exist, but their psychometric quality is often questionable.
  • Methodological recommendations for incorporating QoL outcomes in study designs are provided.

Conclusions:

  • Measuring QoL in children is essential given increased survival with chronic illnesses and high prevalence of disabilities.
  • Limitations in current QoL measures pose significant challenges to accurate assessment in children.
  • Further research is required to establish consensus on optimal child-centered QoL instruments.
Abstract

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