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
. 2025 Jun;34(6):1633-1646.
doi: 10.1007/s11136-025-03940-z. Epub 2025 Mar 5.

Young children (6-7 years) can meaningfully participate in cognitive interviews assessing comprehensibility in health-related quality of life domains: a qualitative study

Affiliations

Young children (6-7 years) can meaningfully participate in cognitive interviews assessing comprehensibility in health-related quality of life domains: a qualitative study

Victoria Gale et al. Qual Life Res. 2025 Jun.

Abstract

Purpose: Establishing the comprehensibility of patient reported outcome measures (PROMs) in quality of life research is essential. Cognitive interviews are recommended as a 'gold standard' for evaluating comprehensibility among adult populations but are not routinely used with young children (≤ 7 years). The current study therefore aimed to evaluate the feasibility of cognitive interviewing using traditional and adapted methods with children aged 6-7 years to evaluate PROM item comprehensibility.

Methods: Fourteen children (6-7 years) with a range of diagnosed health conditions participated in individual cognitive interviews. Each child answered six mock PROM items (physical, psychological, and social health-related quality of life domains) and concurrent verbal probes were used to evaluate item comprehensibility. Interviews were audio recorded and transcribed verbatim. Transcripts were analysed using a novel Comprehensibility Continuum which coded the extent of alignment between children's explanations of items and intended meanings.

Results: Cognitive interviews were successful; extent of comprehensibility could be determined for 83/84 (99%) item discussions. Most items were comprehensible, with children describing the intended item meaning for 74/84 (88%) items evidenced by contextual examples and/or de-contextual definitions in children's responses to verbal probes. Three items ('walk', 'sad', and 'made fun of') were identified as requiring further testing and/or refinement, where a lower percentage of discussions contained evidence of intended item meaning.

Conclusion: Despite previous uncertainty, this study demonstrates how methodological challenges can be addressed to enable young children's participation in cognitive interviews evaluating item comprehensibility, ultimately contributing to the accurate measurement of young children's health outcomes in healthcare and research.

Keywords: Cognitive interview; Comprehensibility; Content validity; Patient reported outcome measures; Young children.

PubMed Disclaimer

Conflict of interest statement

Declarations. Conflict of interest: Philip A. Powell is an Associate Editor at Quality of Life Research. Victoria Gale and Jill Carlton declare no competing interests. The authors have no relevant financial interests to disclose. Ethical approval: Ethical approval for this research was granted by the Sheffield School of Medicine and Population Health Research Ethics Committee (Date: 02.03.2023, Reference number: 051410). Consent to participate: Written informed consent was obtained from the parents of all children included in the research. Consent for publication: The authors affirm that written informed consent was obtained from the parents of all children included in the research for the publication of anonymised participant quotes.

Figures

Fig. 1
Fig. 1
Example presentation of mock patient reported outcome measure items
Fig. 2
Fig. 2
Example visual timetable listing interview activities and spinner prop used to ask follow-up probes
Fig. 3
Fig. 3
Bar chart showing overall Comprehensibility Continuum (CC) codes for each mock PROM item
Fig. 4
Fig. 4
Bar chart showing the number of responses coded as ≥ Level 3 after the first, second, and third or later probe in discussion of an item

References

    1. Arsiwala, T., Afroz, N., Kordy, K., Naujoks, C., & Patalano, F. (2021). Measuring what matters for children: A systematic review of frequently used pediatric generic PRO instruments. Therapeutic Innovation & Regulatory Science,55(5), 1082–1095. 10.1007/s43441-021-00311-x - PMC - PubMed
    1. Matza, L., Patrick, D., Riley, A., Alexander, J., Rajmil, L., Pleil, A., & Bullinger, M. (2013). Pediatric patient-reported outcome instruments for research to support medical product labeling: Report of the ISPOR PRO good research practices for the assessment of children and adolescents task force. Value in Health,16(4), 461–479. 10.1016/j.jval.2013.04.004 - PubMed
    1. Bevans, K., Moon, J., Carle, A., Mara, C., Lai, J., DiMarco, L., Muller, N., & Woods, D. (2014). Patient reported outcomes as indicators of pediatric health care quality. Academic Pediatrics,14(5), S90–S96. 10.1016/j.acap.2014.06.002 - PubMed
    1. Ravens-Sieberer, U., Gosch, A., Abel, T., Auquier, P., Bellach, B., Bruil, J., Dür, W., Power, M., Rajmil, L., the European KIDSCREEN Group. (2001). Quality of life in children and adolescents: A European public health perspective. Sozial und Praventivmedizin,46(5), 294–302. - PubMed
    1. Food and Drug Administration. (2009). Guidance for industry-patient-reported outcome measures: Use in Medical product development to support labeling claims. Food and Drug Administration. - PMC - PubMed

LinkOut - more resources