Trial reportBMJ open2019
Improved parental understanding by an enhanced informed consent form: a randomized controlled study nested in a paediatric drug trial.
Trial report in BMJ open, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
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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
2 citing papers in PubMed.
- The challenges and potential solutions of achieving meaningful consent amongst research participants in northern Thailand: a qualitative study.BMC medical ethics · 2023Article
- Public Awareness of Medical Research Terminology in Japan, and the Accuracy of Physicians' Predictions regarding that Awareness.Asian bioethics review · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveThis study was designed to evaluate the applicability and effectiveness of the enhanced informed consent form (ICF) methodology, proposed by the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER), in paediatric research requiring parental consent. The objective of this study was to compare the parental understanding of information between the parents who read the SIDCER ICF and those who read the conventional ICF.
designA prospective, randomized, controlled design.
settingPaediatric Outpatients Department, Phramongkutklao Hospital, Thailand.
participants210 parents of children with thalassemia (age=35.6 ± 13.1 years).
interventionsThe parents were randomly assigned to read either the SIDCER ICF (n=105) or the conventional ICF (n=105) of a paediatric drug trial. PRIMARY AND SECONDARY OUTCOME MEASURES: Parental understanding of trial information was determined using 24 scenario-based questions. The primary endpoint was the proportion of parents who obtained the understanding score of more than 80%, and the secondary endpoint was the total score.
resultsForty-five parents (42.9%) in the SIDCER ICF group and 29 parents (27.6%) in the conventional ICF group achieved the primary endpoint (relative risk=1.552, 95% CI 1.061 to 2.270, p=0.021). The total score of the parents in the SIDCER ICF group was significantly higher than the conventional ICF group (18.07±3.71 vs 15.98±4.56, p=0.001).
conclusionsThe SIDCER ICF was found to be superior to the conventional ICF in improving parental understanding of trial information.
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Registered trials
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