Novel approach to parental permission and child assent for research: improving comprehension.
Reads0
Chats0
TLDR
Multimedia approaches to the research P/A process may improveOverall understanding of research participation for children and parents and improved understanding of study-specific research components (rather than research rights) may improve overall comprehension.Abstract:
OBJECTIVE: The aim of this research was to test a multimedia permission/assent (P/A) process. The overall hypothesis was that children and their parents exposed to a multimedia P/A process would have better comprehension compared with those exposed to a text-based process. METHODS: Traditional and multimedia P/A processes were created by using an innovative learning-objective approach. A total of 194 parent-child dyads (children aged 11―14 years) were enrolled: 24 dyads in a prestudy testing P/A components for preference and effect on comprehension and 170 dyads in a randomized trial of a multimedia or paper P/A process for a hypothetical study. Participants were predominantly white and were from a metropolitan area served by a tertiary care pediatric hospital and outpatient facility. Comprehension of 8 essential elements of the P/A process was assessed. RESULTS: The majority of prestudy subjects preferred the video version of the dual-energy radiograph absorptiometry description over theanimated and paper versions combined (41 of 48 [85%]; P < .0001), and there were similar results for the abdominal ultrasound description (38 of 47 [81%]; P< .0001). Children exposed to the novel process showed significantly better overall comprehension compared with the paper P/A process (P = .0009), and there were highly significant differences in understanding of study procedures (P = .0002) and risks (P < .0001). The parental multimedia group had significantly better overall comprehension (P = .03). CONCLUSIONS: Multimedia approaches to the research P/A process may improve overall understanding of research participation for children and parents. Improved understanding of study-specific research components (rather than research rights) may improve overall comprehension.read more
Citations
More filters
Journal ArticleDOI
Informed consent in decision-making in pediatric practice
Aviva L. Katz,Sally A. Webb +1 more
TL;DR: This technical report, which accompanies the policy statement “Informed Consent in Decision-Making in Pediatric Practice” was written to provide a broader background on the nature of informed consent, surrogate decision-making in pediatric practice, information on child and adolescent decision- making, and special issues in adolescent informed consent.
Journal ArticleDOI
Strategies to improve recruitment to randomised trials
Shaun Treweek,Marie Pitkethly,Jonathan Cook,Cynthia Fraser,Elizabeth Mitchell,Frank Sullivan,Catherine Jackson,Tyna Taskila,Heidi Gardner +8 more
TL;DR: The literature on interventions to improve recruitment to trials has plenty of variety but little depth, and only 3 of 72 comparisons are supported by high-certainty evidence according to GRADE.
Journal ArticleDOI
Audio-visual presentation of information for informed consent for participation in clinical trials
TL;DR: The value of audio-visual interventions as a tool for helping to enhance the informed consent process for people considering participating in clinical trials remains largely unclear, although trends are emerging with regard to improvements in knowledge and satisfaction.
Journal ArticleDOI
Participant comprehension of research for which they volunteer: a systematic review.
Wanda Montalvo,Elaine Larson +1 more
TL;DR: A systematic review of published research on informed consent and participant comprehension of research for which they volunteer using the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) Statement as a guide found participants lacked basic understanding of research elements: randomization, placebo, risks, and therapeutic misconception.
Journal ArticleDOI
Child’s assent in research: Age threshold or personalisation?
TL;DR: A recommended age threshold is likely to serve the interests of children better than ambiguous and flexible criteria for personalised age determination and is proposed to place limits on personalisation by introducing a suggested requirement of assent starting at a school-age threshold.
References
More filters
Journal ArticleDOI
Statistical methods for assessing agreement between two methods of clinical measurement.
TL;DR: An alternative approach, based on graphical techniques and simple calculations, is described, together with the relation between this analysis and the assessment of repeatability.
Journal ArticleDOI
Statistical methods for assessing agreement between two methods of clinical measurement
TL;DR: In this article, an alternative approach, based on graphical techniques and simple calculations, is described, together with the relation between this analysis and the assessment of repeatability, which is often used in clinical comparison of a new measurement technique with an established one.
Journal ArticleDOI
Interventions to improve research participants' understanding in informed consent for research: a systematic review.
TL;DR: In this article, the authors reviewed research on interventions to improve research participants' understanding of information disclosed in the informed consent process and found that participants may frequently not understand information disclosed to them.
Journal ArticleDOI
Do They Understand? (Part II)Assent of Children Participating in Clinical Anesthesia and Surgery Research
TL;DR: Children approached for their assent to participate in a clinical anesthesia or surgery study have limited understanding of the elements of disclosure and their role as a research participant, particularly if they are aged less than 11 yr.