ReviewThe patient2013
"Not just little adults": qualitative methods to support the development of pediatric patient-reported outcomes.
Review in The patient, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 60 papers, 6 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
60 citing papers in PubMed, 6 syntheses or guidelines pooled it.
- A Systematic Review on Children's Participation in Healthcare From a Child's Perspective.Scandinavian journal of caring sciences · 2025Pooled it
- Quality of life of pediatric and adult individuals with osteogenesis imperfecta: a meta-analysis.Orphanet journal of rare diseases · 2023Pooled it
- Updating our understanding of health-related quality of life issues in children with cancer: a systematic review of patient-reported outcome measures and qualitative studies.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2023Pooled it
- A critical evaluation of the content validity of patient-reported outcome measures assessing health-related quality of life in children with cancer: a systematic review.Journal of patient-reported outcomes · 2023Pooled it
- A Systematic Review of the Use and Quality of Qualitative Methods in Concept Elicitation for Measures with Children and Young People.The patient · 2020Pooled it
- Pooled it
- Children's Communication Choices About Musculoskeletal Pain and Injury: Insights From a Public Involvement Event.Health expectations : an international journal of public participation in health care and health policy · 2025Trial
- A Multicenter, Randomized, Placebo-Controlled Study of Pseudoephedrine for the Temporary Relief of Nasal Congestion in Children With the Common Cold.Journal of clinical pharmacology · 2019Trial
- Using cognitive interviews with children to test the content validity of a paediatric patient reported experience measure.BMJ paediatrics open · 2026Article
- PAINception: identification of contents and methods for delivering information about pain to children, adolescents, parents, and teachers.Brazilian journal of physical therapy · 2026Article
- A child-centred measure of tooth hypersensitivity for molar incisor hypomineralisation (MIH-TH): development and psychometric evaluation.European archives of paediatric dentistry : official journal of the European Academy of Paediatric Dentistry · 2026Article
- "Reading level is just one component": best practices for cognitive debriefing patient-reported outcome instruments with pediatric populations.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2026Review
- Lived Experiences of Tooth Hypersensitivity in Children With Molar Incisor Hypomineralisation.International journal of paediatric dentistry · 2026Article
- Psychometric properties of MyCommunication-Children: an item bank for measuring communicative participation in children with speech, language, voice disorders or hearing loss.Journal of patient-reported outcomes · 2026Article
- Developing and Testing Electronic Versions of the Advance QoL Tools for Collecting Self-Reports of Quality of Life in Children and Adolescents With Advanced Cancer.Scandinavian journal of caring sciences · 2026Article
- Review
- Patient-reported Outcome Measures in Pediatric Orthopaedics.Journal of the Pediatric Orthopaedic Society of North America · 2025Review
- 'How low can you go?' Developers' perspectives on involving young children in the development of patient reported outcome measures.Journal of patient-reported outcomes · 2025Article
- Development and validation of MyCommunication-Youth: A self-report measure for communicative participation in children, adolescents and young adults.Journal of patient-reported outcomes · 2025Article
- Young children (6-7 years) can meaningfully participate in cognitive interviews assessing comprehensibility in health-related quality of life domains: a qualitative study.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The US FDA and the European Medicines Agency (EMA) have issued incentives and laws mandating clinical research in pediatrics. While guidances for the development and validation of patient-reported outcomes (PROs) or health-related quality of life (HRQL) measures have been issued by these agencies, little attention has focused on pediatric PRO development methods. With reference to the literature, this article provides an overview of specific considerations that should be made with regard to the development of pediatric PRO measures, with a focus on performing qualitative research to ensure content validity. Throughout the questionnaire development process it is critical to use developmentally appropriate language and techniques to ensure outcomes have content validity, and will be reliable and valid within narrow age bands (0-2, 3-5, 6-8, 9-11, 12-14, 15-17 years). For qualitative research, sample sizes within those age bands must be adequate to demonstrate saturation while taking into account children's rapid growth and development. Interview methods, interview guides, and length of interview must all take developmental stage into account. Drawings, play-doh, or props can be used to engage the child. Care needs to be taken during cognitive debriefing, where repeated questioning can lead a child to change their answers, due to thinking their answer is incorrect. For the PROs themselves, the greatest challenge is in measuring outcomes in children aged 5-8 years. In this age range, while self-report is generally more valid, parent reports of observable behaviors are generally more reliable. As such, 'team completion' or a parent-administered child report is often the best option for children aged 5-8 years. For infants and very young children (aged 0-4 years), patient rating of observable behaviors is necessary, and, for adolescents and children aged 9 years and older, self-reported outcomes are generally valid and reliable. In conclusion, the development of PRO measures for use in children requires careful tailoring of qualitative methods, and performing research within narrow age bands. The best reporter should be carefully considered dependent on the child's age, developmental ability, and the concept being measured, and team completion should be considered alongside self-completion and observer measures.
Indexed as
Identifiers
23912695What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.