If one wants to make something understandable for the largest possible audience, then it might make more sense to offer language that can be absorbed by an 8th grader, instead of an 11th grader, for instance. Institutional review boards, for example, recommend the lower level. However, a recent analysis of informed consent documents from 15 studies finds the forms aim too high.
The researchers used five validated, standardized readability tests to analyze consent forms for the studies, which were taking place at Duke University and the University of California, Los Angeles, according to Anesthesiology News. These included four observational-noninterventional studies, five observational-interventional studies, three evaluation studies and three randomized controlled trials, the paper notes.
The upshot? They were tested for readability, but the average reading level was consistent with the ability of an 11th grader, the paper reports. The observational-noninterventional studies rated highest, at grade 11.7, which is really 12th grade. "RCTs and evaluation studies were written at a mean reading level of grade 10.7," the newspaper writes, adding that "RCT consent forms were more readable, but also included the most sentences and words, as well as the most complex words."
The implications, of course, do not bode well for sponsors and those who carry out clinical trials, since some research subjects may not fully comprehend or appreciate the myriad issues raised by participation. This also speaks to ongoing concerns about clinical trial ethics, specifically the full and proper disclosure of health risks that subjects may encounter.
“Subjects who do not fully understand a consent form may initially consent to participate, but withdraw after realizing they are receiving an intervention or procedure they did not understand or agree with at the outset of the study," primary investigator Madhav Swaminathan, associate professor of anesthesiology and director of perioperative echocardiography in the Division of Cardiothoracic Anesthesiology and Critical Care Medicine at Duke University School of Medicine, tells the paper.
He offered a qualifier, though, by suggesting the 11th grade reading level may be acceptable for research conducted in more educated populations, such as participants living in urban areas with more educational institutions, according to the paper." Of course, there are urban settings where educational levels vary widely, which means that tailoring consent forms to specific regions can be dicey.
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We really need to get these things dumbed down even more IMO. As Jeff Foxworthy has proven time and again on his show, there are many people out there who are no smarter than a fifth grader.
Let's run those consents by Jeff Foxworthy. If the contestants can understand them they may be smarter than a fifth grader, although with the American education system in tatters the best way to go might be to bring back Mr Rodgers, and let him try his luck. Even better, bring in The Muppets, since today's generation can probably learn better from them than from their own teachers in today's excellence-starved schools.
"Subjects who do not fully understand a consent form may initially consent to participate, but withdraw after realizing they are receiving an intervention or procedure they did not understand or agree with at the outset of the study."
Grade Level 19.7
You should see the ICFs from Harvard. Many years ago, I took over a study and I could barely understand the consent myself (to make matters worse, the consent wasn't consistent with the protocol). This was a consent that had been approved by Harvard's IRB and had been in use for over a year when I brought it to the attention of the PI (a KOL who wrote the protocol) and a supervisor. The response I received when noting the consent was not written at an appropriate reading level was that the ICF was fine because it was approved by the IRB and "the bums here around Harvard are smarter than people with PhDs elsewhere". What I have found over the ensuing 15 years is that there are few CRAs and Study Managers capable of reviewing and approving ICFs and fewer still who will insist on revision/correction of an ICF if approved by an IRB - especially if that IRB is at a prominent academic institution (and/or the PI is a KOL). The quality of the consents will not improve until we improve the clinical operations & development model companies deploy to ensure the staff involved in study conduct are adequately trained and experienced to develop a trial, write and review the supporting documents and perform hands on study management
Sorry to shift the topic sideways, but I am wondering if anyone saw ABC's piece last night about clinical trials. Besides saying nothing whatsoever about informed consent, the story suggested that pts could choose to be in studies in which the potential "side effects" were minimal.
I understand that phase IV seeding trials might support such an assumption--relatively speaking, we know more. But, more generally, trials are trials, and risks/benefits are, by definition, generally toward the unknown end of the spectrum.
The context provided also suggested most such trials are done within AMCs (not that that solves the problems). There was no reference whatsoever to CROs, physician reimbursement, etc.
An accident that 80% of ads during the news are for drugs?
ABC presented it as, in essence, a way for "moms" to make some money with relatively minor risk.
sorry JiM, didn't see it (if I had you would have heard my head explode)
Sorry to go in a rhomboid direction - but they beheaded her for:
"...she had tricked people into thinking she could treat illnesses, charging them $800 per session...."
http://www.huffingtonpost.com/2011/12/12/saudi-arabia-woman-sorcery-executed_n_1142942.html?ref=world
But then again, Informed Consents are not used in Saudi Arabia.
I wonder what the raw data looked like that was generated by the sorceress? The evidence that a person was cured of illness is what, traditionally, death sentences were handed down upon...
There always needs to be a 50-50 demographic among Doctors - 50% men, 50% women.
8th grade readability may not be enough. According to Center for Health Care Strategies, 50 of African Americans and Hispanics read at or below the 5th grade reading level — that’s a steep difference from 11th grade. Another study showed that 40 percent of seniors read at or below the 5th grade.
What these data tell us is that Informed Consent needs to be written at a much lower level than 8th grade. And if we can’t condense the content simply (for a myriad of reasons), we should look at supporting Informed Consent with other learning tools, like educational videos, FAQs or one-to-one communication.
There is an enormous — even a desperate — need for clinical trial sponsors to include more diverse populations in their studies. I agree, Ed. To capture the vast majority of patients who could benefit from new investigational drugs means taking a hard look at exactly who we’re actually writing for.
@RBudd - I do not understand your concern about needing *diverse populations* participating in clinical trials.
Clinical trials are being conducted all over South/Central America so you have your Hispanic population information. Same story on the continent of Africa - clinical trials are being conducted.
Countries have different regulatory requirements concerning *Informed Consent*. Seems to me the level at which patients read and write is the final consideration in the process and the easily adjustable one - everything leading up to the need to issue an Informed Consent is the tough part, no?
Also, what is below 5th grade here in USA could easily be a higher comprehension in their native country/tongue.
dzieczko, The Informed Consent documents discussed in the article focus on studies occurring at Duke University and the University of California.
Here in the US, the number of diverse patients participating in clinical trials is seriously limited. Because the FDA requires a percentage of study patients to be from US sites for drug approval, we need to increase participation from minority populations.
If comprehension outside of the U.S. is higher, then of course, readability level for Informed Consent should be adjusted to fit that population. Ultimately, Inform Consent should be given in a format or approach that patients can understand — whether they are in the U.S. or elsewhere.
@RBudd - people who have been in USA for many generations are often unable to tell you how many different breeds, so to speak, are in their diverse genetic background - basically there are more *mutts* than pure breeds :-). I was thinking about that when I asked my question.
But I think I understand what you mean when you say *diverse* - you mean people who are actually pure breed - meaning 75% or more of a single race...?