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From: "Kerry Harwood" <harwo001@mc.duke.edu>
To: Multiple recipients of list <nifl-health@literacy.nifl.gov>
Subject: [NIFL-HEALTH:3656] Re: NIFL_Health-3648 Readability vs. Understandability
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Mark makes some interesting points regarding research done on benefits of
easy to read consent forms. I think its important to consider multiple
potential outcomes, not only comprehension. In my work with cancer
patients over the past 24 years, I've discovered that patients will go to
great effort to understand something that is very important to them, such
as their treatment for cancer. A recent study looking at easy-to-read
consent forms in oncology showed no difference in comprehension, similarly
to the results Mark cites. However, signficant benefits were seen in
improving patient satisfaction and reducing anxiety. I interpret these
data to mean that patients will work very hard to understand what is
important to them. When we go to the effort to make that process easier,
they are more satisfied and there is less anxiety associated with the
consent process.
Reference:
Satisfaction and anxiety are improved with the use of an Easy-to-read
informed consent document: a randomized multi-group study.
PC Raich, R Xu,, C Coyne, et al. abstract 948, American Society of
Clinical Oncology, May 2001.
you should be able to access the abstract through CancerLit
Kerry Harwood, RN, MSN
Director, Cancer Patient Education Program
Duke University Health System
MarkH38514@aol.com@nifl.gov on 04/09/2002 10:47:40 AM
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Subject: [NIFL-HEALTH:3655] Re: NIFL_Health-3648 Readability vs.
Understandability
>From a slightly different perspective, consider the work that's been done
on
the readability of informed consent forms. Many researchers have concluded
that to be better understood, consent forms should be written at about a
junior high reading level. But where's the research to support that
conclusion?
At best, the research is inconclusive.
One study of consent forms rewritten from a grade 16 to a grade 7 reading
level found virtually no difference in understanding. [Davis, T.C.,
Holcombe,
R.F., et al (1998) Informed Consent for Clinical Trials: A Comparative
Study
of Standard versus Simplified Forms. Journal of the National Cancer
Institute, 90(9), 668-674.]
Another study found no difference in understanding between consent forms
written at a grade 12 level versus a grade 8 level.
Cardinal, B.J. (2000). (Un)informed Consent in Exercise and Sport Science
Research? A comparison of Forms Written for Two Reading Levels. Research
Quarterly for Exercise and Sport, 71(3), 295-301.
One study did find improved understanding at a 6th grade level vs a grade
16
level. Comprehension improved with education. College educated participants
did better at both reading levels than did participants with a high school
or
less education level.
Young, D.R., Hooker, D.T. & Freeberg, F.E. (1990) Informed Consent
Documents:
Increasing Comprehension by Reducing Reading level. IRB: A Review of Human
Subjects Research, May-June 1990, 1-5.
But you have to consider the educational level of the participants, the
length of the consent form, the ways understanding was measured, etc.
There are ways to measure how well people understand the consent
form/consent
process.
Joffe, S., Cook, E.F., et al (2001) Quality of Informed Consent: A New
Measure of Understanding Among Research Subjects. Journal of the National
Cancer Institute, 93(2), 139-147. [Note that the research was done on
subjects who were predominantly white (91%) female (55%), well educated
(53%
had a college education), averaging 55 years old.]
Another study [Joffe, S., Cook, E.F., Cleary, P.D., et al (2001) Quality of
informed consent in cancer clinical trials: a cross-sectional survey. The
Lancet, 358 (9295), 1772-1777] found that 90% reported being satisfied with
the informed consent process. But, 74% did not recognize that they would be
getting non-standard treatment, 73% did not understand the extra risks from
being in a research study, 70% did not understand the unproved nature of
the
experimental treatment. So what did they really understand?
There is also the DICCT: Deaconess Informed Consent Comprehension Test.
[Miller, C.K., O'Donnell, D.C., Searight, H.R. & Barbarash, R.A. (1996) The
Deaconess Informed Consent Comprehension Test: An Assessment Tool for
Clinical Research Subjects. Pharmacotherapy, 16(5), 872-878.]
You mentioned the Suitability Assessment of Materials. You might also
consider the RFP (Readability and Processability Evaluation) Form. See:
Philipson, S.J., Doyle, M.A., Gabram, S.G.A., et al (1995) Informed Consent
for Research. A Study to Evaluate Readability and Processability to Effect
Change. Journal of Investigative Medicine, 43(5), 459-467.
Mark Hochhauser
For more information, contact:
Mark Hochhauser, Ph.D.
Readability Consulting
3344 Scott Avenue North
Golden Valley, MN 55422
Phone: (763) 521-4672
Fax: (763) 521-5069
E-mail: MarkH38514@aol.com
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