Pretesting informed
consent forms with the intended audience is always a good
idea. This is especially true when developing forms for
low-literacy patients. While checking content accuracy with
clinicians is important, and assessing readability with
manual or automated formulas may also be helpful, only pre-testing
with actual patients will allow you to assess comprehensibility,
identify strong and weak points, determine personal relevance,
and gauge confusing, sensitive, or controversial elements.
In a way, this is just a preliminary and more formal way
of doing the “teach back” that is recommended
during each patient encounter. You want to hear the patient
tell you what they understand... and then work to supplement,
correct, or respond as needed. Assembled here are potential
methods, tips, and sample questions to help in pretesting
of consent forms.
These suggestions are based on information found in public
domain guides such as: Clear & Simple: Developing
Effective Print Materials for Low-Literate Readers and Pink
Book: Making Health Communications Programs Work, both
from the National Cancer Institute. These excellent publications
can be accessed at: www.cancer.gov/aboutnci/oc/clear-and-simple www.cancer.gov/pinkbook/page1
Patient Pretest For Assessing the
Informed
Consent Form
Methods to Consider
Self-administered surveys/questionnaires (by mail, handout,
or computer)
Individual interviews using surveys/questionnaires (by
telephone as follow-up to mail; through central location
intercepts; other face-to-face scenarios)
Group interviews (e.g., 8 to 10 people)
For informed consent forms, interviews
and focus groups are generally best. For low-literate audiences,
partnering with a local adult education group can provide
access to volunteers as well as a comfortable venue for
testing. The advantage of the individual interview is that
respondents are not influenced by others; the group interview
may be more difficult to coordinate.
Tips
When to test?
Since most informed consent forms are
not typeset or expensively produced, testing a rough draft
that is close to the final version is usually possible.
Where to Pretest?
Testing the form in the location where
it will most often be used is ideal. Thus, the clinic, hospital,
or doctor’s office may be best. Since consent forms
are sometimes sent home with patients to be discussed later,
this type of “take-home” testing with a follow-up
interview may also be appropriate.
How to introduce?
Make sure test participants know that
they are not being tested. Reassure them that there are
no “right” or “wrong” responses.
Since some patients are not comfortable offering criticism
or asking questions, distance yourself from the consent
form and assure the test participant that you want their
honest assessment. Also, since the consent form should always
be used in conjunction with some verbal education, develop
a brief introductory session during which you explain the
baseline scenario to the patient along with some basic medical
facts about the condition, the proposed procedure, and their
options.
Who to test?
In recruiting patients for testing,
try to match the demographics and general health profiles
of the patients who will actually use the form. In particular,
be sure to address the cultural and linguistic diversity
of the target patient audience when recruiting test participants.
You can also determine the reading level of pretest participants
(e.g., with the Wide Range Achievement Test or the Cloze
Technique) to ensure that your volunteers read at the same
level as your audience.
Who to do the testing?
Choose people for the recruiting and
interviewing who are culturally sensitive and who have good
social skills. In some cases, it may be helpful to have
the writer, medical educator, or clinician who actually
writes the consent form to be present during the interviews.
Sample Questions to Ask
What’s your general reaction to this draft form?
Is anything confusing?
What words do you not understand?
What questions do you have after reading this form?
What is the procedure/treatment that is described? What
does it do?
What are the benefits of this procedure? What are the
risks? The alternatives?
Do you understand that you can refuse to have this procedure?
If you were a patient in that position, what would you
do. Why? Would you need more information before you decided?
What information?
Developed with a grant from the Robert Wood Johnson Foundation
