Nguyen Thanh Tam, Nguyen Tien Huy, Le Thi Bich Thoa, Nguyen Phuoc Long, Nguyen Thi Huyen Trang, Kenji Hirayama, Juntra Karbwang
Abstract
To estimate the proportion of participants in clinical trials who understand different components of informed consent.
Relevant studies were identified by a systematic review of PubMed, Scopus and Google Scholar and by manually reviewing reference lists for publications up to October 2013. A meta-analysis of study results was performed using a random-effects model to take account of heterogeneity.
The analysis included 103 studies evaluating 135 cohorts of participants. The pooled proportion of participants who understood components of informed consent was 75.8% for freedom to withdraw at any time, 74.7% for the nature of study, 74.7% for the voluntary nature of participation, 74.0% for potential benefits, 69.6% for the study's purpose, 67.0% for potential risks and side-effects, 66.2% for confidentiality, 64.1% for the availability of alternative treatment if withdrawn, 62.9% for knowing that treatments were being compared, 53.3% for placebo and 52.1% for randomization. Most participants, 62.4%, had no therapeutic misconceptions and 54.9% could name at least one risk. Subgroup and meta-regression analyses identified covariates, such as age, educational level, critical illness, the study phase and location, that significantly affected understanding and indicated that the proportion of participants who understood informed consent had not increased over 30 years.
The proportion of participants in clinical trials who understood different components of informed consent varied from 52.1% to 75.8%. Investigators could do more to help participants achieve a complete understanding.
Pharmacology, Toxicology and Pharmaceutical Science
4
3%
Social Sciences
3
3%
Business, Management and Accounting
2
2%
Engineering
2
2%
Other
8
7%
Unknown
89
75%
Attention Score in Context
Attention Score in Context
This research output has an Altmetric Attention Score of 27. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 18 June 2024.
All research outputs
#1,491,258
of 26,375,196 outputs
Outputs from Bulletin of the World Health Organization
#417
of 3,328 outputs
Outputs of similar age
#19,491
of 363,533 outputs
Outputs of similar age from Bulletin of the World Health Organization
#6
of 42 outputs
Altmetric has tracked 26,375,196 research outputs across all sources so far. Compared to these this one has done particularly well and is in the 94th percentile: it's in the top 10% of all research outputs ever tracked by Altmetric.
So far Altmetric has tracked 3,328 research outputs from this source. They typically receive a lot more attention than average, with a mean Attention Score of 18.0. This one has done well, scoring higher than 87% of its peers.
Older research outputs will score higher simply because they've had more time to accumulate mentions. To account for age we can compare this Altmetric Attention Score to the 363,533 tracked outputs that were published within six weeks on either side of this one in any source. This one has done particularly well, scoring higher than 94% of its contemporaries.
We're also able to compare this research output to 42 others from the same source and published within six weeks on either side of this one. This one has done well, scoring higher than 85% of its contemporaries.
