Informed consent during the clinical emergency of @entity583 ( XXXX -2 consent substudy): a prospective observational study.

@entity1 @entity148 @entity1286 @entity158 @entity432 @entity583
BACKGROUND: @entity148 , fear, @entity158 , and treatment with @entity1286 might compromise the ability of @entity1 to comprehend information about, and give informed consent for, participation in clinical trials. We aimed to assess whether @entity1 with @entity583 could understand written and verbal information and whether they were competent to give autonomous informed consent to participate in a clinical trial. METHODS: We prospectively studied 399 @entity1 with @entity583 in 16 hospitals in New Zealand and Australia who were eligible for participation in the @entity432 ( @entity432 )-2 trial. We assessed readability of @entity1 information sheets, @entity1 ' educational status, their views of the consent process, comprehension of verbal and written information, and competence to give consent. FINDINGS: The @entity1 information sheet needed a year 13 (age 18) educational level for comprehension, although only 75 of 345 @entity1 (22%) had been educated beyond secondary school. Only 63 of 346 (18%) read the @entity1 information sheet before giving or refusing consent to participate. @entity1 who gave consent were more likely to report good or partial comprehension of the information provided than were those who refused consent (272 [89%] vs 14 [70%], respectively; p=0.009). In an assessment of competence to make an autonomous decision, 75 of 145 (52%) were ranked at the lowest grade and 26 (18%) were not competent to consent. INTERPRETATION: Although the consent process for @entity432 -2 met regulatory requirements for clinical trials, it was inappropriate for the needs of most @entity1 . The @entity1 ' comprehension of the information provided and their competence to autonomously give consent was less than optimum.
