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“Not Just Little Adults”: Qualitative Methods to Support the Development of Pediatric Patient-Reported Outcomes


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.

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We would like to acknowledge the support provided by Kate Bolton in preparing one draft of the manuscript, and the support of Nicola Moss in helping with formatting and quality checking. In addition, we are grateful for the helpful comments of two anonymous reviewers.

Disclosure of interests

Both Rob Arbuckle and Linda Abetz-Webb are employees of Adelphi Values, a health outcomes consultancy that specialises in working with healthcare companies on the development, validation, and use of PRO instruments. As such, both authors have been contracted to perform research for numerous pharmaceutical companies. Neither author owns stocks in any pharmaceutical company, nor have they been a direct employee of a pharmaceutical company.

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Both authors contributed to the conception and writing of all parts of the manuscript and both authors read and approved the final version.

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Correspondence to Rob Arbuckle.

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Arbuckle, R., Abetz-Webb, L. “Not Just Little Adults”: Qualitative Methods to Support the Development of Pediatric Patient-Reported Outcomes. Patient 6, 143–159 (2013).

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  • Focus Group
  • Recall Period
  • Cognitive Debriefing
  • Child Rating
  • Information Processing Theory