Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2021 Sep;55(5):1082-1095.
doi: 10.1007/s43441-021-00311-x. Epub 2021 Jun 17.

Measuring What Matters for Children: A Systematic Review of Frequently Used Pediatric Generic PRO Instruments

Tasneem Arsiwala  1 , Nuzhat Afroz  2 , Kattayoun Kordy  3 , Christel Naujoks  4 , Francesco Patalano  4
Affiliations

Measuring What Matters for Children: A Systematic Review of Frequently Used Pediatric Generic PRO Instruments

Tasneem Arsiwala et al. Ther Innov Regul Sci. 2021 Sep.

Abstract

Objective: To provide an assessment of the quality of the most frequently used self-reported, generic patient-reported outcome measures (PROMs) that measure health-related quality of life (HRQoL) in children against the good research practices recommended by ISPOR task force for the pediatric population.

Method: Literature search was conducted on OvidSP database to identify the generic pediatric PROMs used in published clinical studies. The quality of PROMs used in more than ten clinical studies were descriptively evaluated against the ISPOR task force's good research practices.

Results: Six PROMs were evaluated, namely Pediatric Quality-of-Life inventory 4.0 (PedsQL), Child Health Questionnaire (CHQ), KIDSCREEN, KINDL, DISABKIDS and Child Health and Illness Profile (CHIP). All PROMs, except KIDSCREEN, had versions for different age ranges. Domains of physical, social, emotional health and school activities were common across all the instruments, while domains of family activities, parent relations, independence, and self-esteem were not present in all. Children's input was sought during the development process of PROMs. Likert scales were used in all the instruments, supplemented with faces (smileys) in instruments for children under 8 years. KIDSCREEN and DISABKIDS were developed in a European collaboration project considering the cross-cultural impact during development.

Conclusion: The comparison of the instruments highlights differences in the versions for different pediatric age groups. None of the PROMs fulfill all the good research practices recommended by the ISPOR task force. Further research is needed to define which age-appropriate domains are important for older children and adolescents.

Keywords: Adolescents; Children; Health-related quality of life; ISPOR; Patient-reported outcomes; Pediatrics.

PubMed Disclaimer

Conflict of interest statement

TA, NA, CN, KK and FP are full time employees of Novartis. CN, KK, and FP have Novartis stock(s)/stock options. The views and opinions expressed in this article are those of the authors and do not necessarily represent the views of Novartis.

Figures

Fig. 1
Fig. 1
Flow chart showing the final selection of the eligible PRO measures (PROMs) for further evaluation
See this image and copyright information in PMC

References

    1. Forrest CB. Advancing pediatric patient-reported outcome assessment. Value Health. 2013;16(6):907–908. doi: 10.1016/j.jval.2013.07.003. - DOI - PubMed
    1. Till JE, Osoba D, Pater JL, Young JR. Research on health-related quality of life: dissemination into practical applications. Qual Life Res. 1994;3(4):279–283. doi: 10.1007/BF00434902. - DOI - PubMed
    1. Cieza A, Stucki G. The international classification of functioning disability and health: its development process and content validity. Eur J Phys Rehabil Med. 2008;44(3):303–313. - PubMed
    1. Food and Drug Administration. Guidance for industry- patient-reported outcome measures: use in medical product development to support labeling claims. Food and Drug Administration, 2009. - PMC - PubMed
    1. Cremeens J, Eiser C, Blades M. Characteristics of health-related self-report measures for children aged three to eight years: a review of the literature. Qual Life Res. 2006;15(4):739–754. doi: 10.1007/s11136-005-4184-x. - DOI - PubMed

Publication types

LinkOut - more resources