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Published on: September 20, 2019
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.
Purpose:
This review is aimed at: discussing the importance of measuring quality of life (QoL) in children, describing the measures actually available for measuring QoL in children, and listing methodological issues related to the inclusion of QoL outcomes in clinical trials.
Methods:
A literature review was carried out. Searches were conducted in Pubmed. All articles published within the last 20 years with the objectives of assessing and reviewing use and issues related to QoL instruments in children were reviewed.
Results:
Despite the numerous arguments in favour of assessing QoL, these data are not typically collected in paediatric clinical trials and research protocols. Because adult measures may fail to address the specific aspects of QoL that are important to the child, many different measures, both generic and disease-specific, have been developed to assess QoL in children; however, their quality in terms of psychometric properties often seems questionable. Methodological recommendations are provided for designing a study including QoL outcome.
Conclusions:
This review confirms the importance of measuring QoL in children because of increased survival rates of children with chronic health conditions and because children account for the highest prevalence of disabling conditions. However, measuring QoL in children is still a challenge mainly because of the limitations of the currently available measures. Further research is needed to reach a consensus on the most appropriate formats for child-centred instruments.
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