Abstract
Objective
The aim of the study was to evaluate the effectiveness of an audio and animated cartoon questionnaire (AACQ) at improving consent process in child for biospecimen donation.
Methods
A multi-center randomized and controlled survey was performed at two pediatric hospitals in China from 2019 to 2020. Children aged from 7 to 18 years in the pediatric surgery wards were invited to investigate the participants’ willingness and attitudes for donating biospecimens. A total of 264 children, including 119 in the AACQ group and 145 in the TQ group, and 67 parents of children were analyzed. A separate knowledge test was acquired in the questionnaires.
Results
Our findings showed that the response rate of the AACQ group (89.85%) was significantly higher than that of the TQ group (68.44%; p < 0.001). AACQ can improve the child’s understanding, increase children’s engagement in biospecimen donation, reduced the differences in selected characteristics affecting children understanding, and enhanced their risk awareness of donating biospecimens. We also found that increasing pain and privacy disclosure were the most popular concern among children for the refusal to donate biospecimens.
Conclusions
AACQ is an effective and standardized tool of content delivery to children from the surgical wards. Children who fully understood of biospecimen donation are suggested to participate in the consent signing.
Impact
-
Using audio and animated cartoon questionnaire is a more effective and standardized tool of content delivery to children.
-
This study expanded the use of an animated cartoon to a children’s survey. Audio and animated cartoon questionnaire (AACQ) can improve the child’s understanding, increase children’s engagement in biospecimen donation compared to text questionnaire (TQ) group, and enhanced their risk awareness of donating biospecimens.
-
More AACQ should be used with children in the future to effectively deliver content to children and improve children’s participation in the survey.
Similar content being viewed by others
Log in or create a free account to read this content
Gain free access to this article, as well as selected content from this journal and more on nature.com
or
References
Joly, Y., Dyke, S. O. M., Knoppers, B. M. & Pastinen, T. Are data sharing and privacy protection mutually exclusive? Cell 167, 1150–1154 (2016).
Hobbs, A., Starkbaum, J., Gottweis, U., Wichmann, H. E. & Gottweis, H. The privacy-reciprocity connection in biobanking: comparing German with UK strategies. Public Health Genomics 15, 272–284 (2012).
Pullman, D., Etchegary, H., Gallagher, K., Hodgkinson, K. & Street, C. Personal privacy, public benefits, and biobanks: a conjoint analysis of policy priorities and public perceptions. Genet. Med. 14, 229–235 (2012).
Sanderson, S. C. et al. Public attitudes toward consent and data sharing in biobank research: a large multi-site experimental survey in the US. Am. J. Hum. Genet. 100, 414–427 (2017).
Yang, Y., Qin, Y., Chi, H., Li, A. H. & Li, Y. Management of data sharing of human genetic resources and its enlightenment to China. Zhongguo Yi Xue Ke Xue Yuan Xue Bao 41, 396–401 (2019).
Qiu, S. et al. Factors that affect Chinese parents’ willingness to donate children’s biospecimens in pediatric research. Biopreserv. Biobank. 16, 402–410 (2018).
Davidson, A. J. & O’Brien, M. Ethics and medical research in children. Paediatr. Anaesth. 19, 994–1004 (2009).
Hein, I. M. et al. Informed consent instead of assent is appropriate in children from the age of twelve: policy implications of new findings on children’s competence to consent to clinical research. BMC Med. Ethics 16, 76 (2015).
Joseph, P. D., Craig, J. C. & Caldwell, P. H. Y. Clinical trials in children. Br. J. Clin. Pharmacol. 79, 357–369 (2015).
Rose, K. & Kummer, H. A new ethical challenge for institutional review boards (IRBs)/ethics committees (ECs) in the assessment of pediatric clinical trials. Children 2, 198–210 (2015).
Hens, K., Lévesque, E. & Dierickx, K. Children and biobanks: a review of the ethical and legal discussion. Hum. Genet. 130, 403–413 (2011).
Klima, J. et al. Understanding of informed consent by parents of children enrolled in a genetic biobank. Genet. Med. 16, 141–148 (2014).
Kong, C. C., Tarling, T. E., Strahlendorf, C., Dittrick, M. & Vercauteren, S. M. Opinions of adolescents and parents about pediatric biobanking. J. Adolesc. Health 58, 474–480 (2016).
Jia, M. Animation as Instructional Manual: The Effects of Representational and Motivational Animation on Usability. MSc thesis, University of Twente (2016).
McGlashan, H. L. et al. Evaluation of an internet-based animated preparatory video for children undergoing non-sedated MRI. Br. J. Radiol. 91, 20170719 (2018).
Fox, C. & Newton, J. T. A controlled trial of the impact of exposure to positive images of dentistry on anticipatory dental fear in children. Community Dent. Oral. Epidemiol. 34, 455–459 (2006).
Kamel, D. O., Wahba, N. A. & Talaat, D. M. Comparison between positive dental images and neutral images in managing anticipatory anxiety of children. J. Clin. Pediatr. Dent. 41, 116–119 (2017).
Gangwal, R. R., Badjatia, S. R. & Dave, B. H. Effect of exposure to positive images of dentistry on dental anxiety among 7 to 12 years old children. Int. J. Clin. Pediatr. Dent. 7, 176–179 (2015).
Myint-u, A. et al. Safe in the city: developing an effective video-based intervention for STD clinic waiting rooms. Health Promot. Pract. 11, 408–417 (2010).
Wendler, D. S. Assent in paediatric research: theoretical and practical considerations. J. Med. Ethics 32, 229–234 (2006).
Susman, E. J., Dorn, L. D. & Fletcher, J. C. Participation in biomedical research: the consent process as viewed by children, adolescents, young adults, and physicians. J. Pediatr. 121, 547–552 (1992).
Mayer, R. E. Applying the science of learning: evidence-based principles for the design of multimedia instruction. Am. Psychol. 63, 760–769 (2008).
Schachter, D., Tharmalingam, S. & Kleinman, I. Informed consent and stimulant medication: adolescents’ and parents’ ability to understand information about benefits and risks of stimulant medication for the treatment of attention-deficit/hyperactivity disorder. J. Child Adolesc. Psychopharmacol. 21, 139–148 (2011).
Ondrusek, N., Abramovitch, R., Pencharz, P. & Koren, G. Empirical examination of the ability of children to consent to clinical research. J. Med. Ethics 24, 158–165 (1998).
Acknowledgements
We are grateful to all participants. We thank LetPub (www.letpub.com) for its linguistic assistance during the preparation of this manuscript. This research was sponsored by the National Science Foundation of China [81872637, 81728017, 81974231], Shanghai Municipal Commission of Health and Family Planning [201840324, 20164Y0095], Program of National Science and Technology Commission for association of diabetes and nutrition in adolescent [2016YFC1305203], Medical and Engineering Cooperation Project of Shanghai Jiao Tong University [YG2017ZD15], The Project of Shanghai Children’s Health Service Capacity Construction [GDEK201708], Science and Technology Development Program of Pudong Shanghai New District [PKJ2017-Y01], Shanghai Professional and Technical Services Platform [18DZ2294100], Shanghai Science and Technology Commission of Shanghai Municipality [17411965300, 17XD1402800, 18411962800], 2019 Science and Technology Innovation -Biomedical Supporting Program of Shanghai Science and Technology Committee [19441904400], Biological Sample Bank and Database Platform of Henan Children’s Hereditary Diseases [182102310415], the Foundation of National Facility for Translational Medicine, Shanghai [TMSK-2020-124], and the Key Subject Program for Clinical Nutrition from Shanghai Municipal Health Commission [2019ZB0103].
Author information
Authors and Affiliations
Contributions
S.Q. and Y.X. designed the study, participated in its implementation, analyzed, and wrote the initial draft of the manuscript; F.T., Y.Y., J.S., and L.C. collected data and carried out the initial analyses; H.M. and F.J. reviewed the study results; N.B. and S.L. conceptualized and designed the study, coordinated and supervised data collection, and critically reviewed the manuscript. All authors approved the final manuscript and agreed to be responsible for all aspects of the work.
Corresponding author
Ethics declarations
Competing interests
The authors declare no competing interests.
Patient consent
Written informed consent was obtained from each patient and his/her parent.
Additional information
Publisher’s note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
Rights and permissions
About this article
Cite this article
Qiu, S., Xia, Y., Tian, F. et al. Using a cartoon questionnaire to improve consent process in children: a randomized controlled survey. Pediatr Res 90, 411–418 (2021). https://doi.org/10.1038/s41390-020-01227-2
Received:
Revised:
Accepted:
Published:
Version of record:
Issue date:
DOI: https://doi.org/10.1038/s41390-020-01227-2
