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. 2025 Jul 15;9(1):91.
doi: 10.1186/s41687-025-00924-y.

'How low can you go?' Developers' perspectives on involving young children in the development of patient reported outcome measures

Victoria Gale  1   2 , Philip A Powell  2 , Jill Carlton  3
Affiliations

'How low can you go?' Developers' perspectives on involving young children in the development of patient reported outcome measures

Victoria Gale et al. J Patient Rep Outcomes. .

Abstract

Background: Recommendations suggest that children need to be ≥ 8 years-old to participate in concept elicitation (CE) and cognitive interviewing (CI) when developing patient reported outcome measures (PROMs). However, these recommendations have not been subject to thorough scrutiny and recent evidence suggests that younger children may be enabled to participate. This study audited current opinions of PROM developers regarding the feasibility of conducting CE and CI research with children.

Methodology: An online survey was developed to capture PROM developers' perspectives, recruited from existing networks (UK PROMs, International Society for Quality of Life Research) and outcomes research groups from English-speaking countries between August-November 2024. Survey questions explored the ages from which developers considered it feasible to include children in CE and CI research, their previous experiences conducting CE/CI research with children, and respondents' background experiences with children. Results were analysed descriptively, and exploratory comparisons were made based on developers' characteristics.

Results: Fifty-eight responses were analysed. The mean youngest ages considered feasible to include children in CE and CI research were 6.66 years and 7.36 years, respectively. The mean youngest ages respondents reported involving children in CE and CI research in practice were 7.67 years and 8.13 years, respectively. Concern that children would have insufficient cognitive and/or linguistic skills was the most often endorsed reason for considering the involvement of younger children to be infeasible. Respondents who had recent parental experience with younger children tended to consider it feasible to include children from younger ages. Those who had conducted CI with children considered it feasible to include children in CI from younger ages. Opposingly, those who had conducted CE with children considered it less feasible to include younger children in CE research.

Conclusions: In-line with established precedent, PROM developers included children from ∼ 8 years-old in CE and CI research, while in principle considering it feasible to include younger ages. Reasons for including (or not including) certain age groups in CE and CI research need critical evaluation and PROM developers may wish to consider ways in which more inclusive opportunities for younger children can be provided.

Keywords: Children; Cognitive interview; Concept elicitation; Patient reported outcome measures; Qualitative research.

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Conflict of interest statement

Declarations. Ethics approval and consent to participate: Research ethics approval was obtained from the School of Medicine and Population Health Research Ethics Committee at the University of Sheffield (reference number: 063895). Informed consent to participate was obtained via a consent form at the start of the survey; participants could not proceed to complete the survey until consent had been obtained. Consent for publication: Participants were informed that results of the study may be published and that it would not be possible to identify them individually in any way. The authors affirm that participant consent to publish study results was obtained via the consent form presented at the start of the survey. Competing interests: The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Overview of survey content. All survey questions are included in Supplementary File 2
Fig. 2
Fig. 2
Youngest ages respondents perceived it was feasible to include children in concept elicitation and cognitive interviews, and youngest ages respondents included in concept elicitation and cognitive interviews in practice. Graph shows median youngest ages (solid line), mean youngest ages (“X”), and interquartile range (box)
Fig. 3
Fig. 3
Reported reasons why conducting concept elicitation/cognitive interviewing research with children younger than the reported feasibility age would not be typically feasible (there were no restrictions on the number of reasons that could be selected)
Fig. 4
Fig. 4
Number of respondents reporting factors that would be needed to demonstrate the feasibility of children younger than currently perceived feasible participating in concept elicitation and cognitive interviewing research (there were no restrictions on the number of response options that could be selected)
Fig. 5
Fig. 5
Comparison of mean perceived feasibility ages for concept elicitation research across respondents with different background characteristics. Green bars show mean perceived feasibility ages for respondents with the characteristic, red bars show mean perceived feasibility ages for respondents without the characteristic. Error bars show standard error of the mean. CE = concept elicitation
Fig. 6
Fig. 6
Comparison of mean perceived feasibility ages for cognitive interviewing across respondents with different background characteristics. Green bars show mean perceived feasibility ages for respondents with the characteristic, red bars show mean perceived feasibility ages for respondents without the characteristic. Error bars show standard error of the mean. CI = cognitive interviewing
See this image and copyright information in PMC

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