Citation

Staphorst MS, Hunfeld JA, Timman R, Passchier J, van Goudoever JB. BMJ Open 2015; 5(10): e009053.

Affiliation

Department of Pediatrics, VU University Medical Center (VUmc), Amsterdam, The Netherlands Department of Pediatrics, Academic Medical Center (AMC), Amsterdam, The Netherlands.

Copyright

(Copyright © 2015, BMJ Publishing Group)

DOI

10.1136/bmjopen-2015-009053

PMID

26474942

Abstract

INTRODUCTION: In paediatric research, there is a tension between what you can ask from a child and what is needed for the development of evidence-based treatments. To find an optimal balance in conducting clinical research and protecting the child, it is necessary to have empirical data on children's experiences. Until now, there are scarce empirical data on the experiences from the perspective of the child. In this manuscript, we describe the protocol of a two-phase study measuring children's self-reported experiences during research procedures.

METHODS AND ANALYSIS: In the first phase of our study, we aim to interview approximately 40 children (6-18 years) about their self-reported experiences during research procedures. In the second phase, we will develop a questionnaire to measure children's experiences during research procedures in a quantitative way. We will use the interview outcomes for the development of this questionnaire. Next, we will measure the experiences of children during seven research procedures with this questionnaire. A one-month follow-up is conducted to investigate the emotional impact of the research procedures on the children. Children will be recruited from different research studies in three academic children's hospitals in the Netherlands. ETHICS AND DISSEMINATION: The ethics committee of the VU University medical center evaluated both studies and indicated that there was no risk/discomfort associated, stating that both phases are exempt from getting approval under the Dutch Law. Dissemination of results will occur by conference presentations and peer-reviewed publications. The findings of our project can help Institutional Review Boards and paediatric researchers when evaluating the discomforts of research procedures described in study protocols or when designing a study. Information on experiences of children involved in previous studies may also help children and parents in future research with their decision-making about participation in clinical research, or parts thereof.

Language: en