Decisional Capacity for Informed Consent in Males and Females with Fragile X Syndrome.
Anne C Wheeler, Amanda Wylie, Melissa Raspa and 6 others
PMID 30825084WHAT IT FOUND
Many adolescents and adults with fragile X syndrome understood concrete trial details but struggled with placebo, randomization and research versus treatment.
Females scored higher than males, and repetition or multiple-choice prompts helped some answer correctly.
Key findings
01Females performed better than males on all decisional capacity domains, but their profiles of strengths and weaknesses were similar.
02Concrete details were easier than abstract concepts: 82% of females and 49% of males received full credit for understanding study duration, while 36% of females and 3% of males understood that the trial was research rather than clinical care.
03After missed understanding questions, 19% of missed questions were credited after one repetition and 30% were credited during a recognition trial.
STILL TO COME
How it was doneWhat they foundWhat it means for SLPs
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What it does not show
Participants considered a hypothetical trial, so their answers may not show how they would decide about a real trial. The sample was mostly white and relatively wealthy, so the results may not generalise to more diverse families. There was no comparison group of people without fragile X syndrome, so the study cannot say how much capacity differs from typical development. The MacCAT-CR scoring was modified for this study, which limits direct comparison with other MacCAT-CR studies. Expressing a Choice had little variability and was not modelled in the regression analyses.
Declared interests
The authors declared no conflicts of interest.
The easy way to misread this
Do not conclude that repetition and recognition cues make trial information fully understandable for everyone with fragile X syndrome. Abstract concepts such as placebo and research versus treatment remained difficult, and 19% of males received no credit on Expressing a Choice even with support.