[3] Improve Your Written Consent
Forms and Other Educational Materials
Having worked within
your institution to assess the major issues surrounding
informed consent, you should emerge with a prioritized list
of informed consent forms and related educational materials
that you want to create or improve. As described in previous
sections, improving the readability of your consent forms
and related educational materials will likely be a top priority
in helping patients understand the procedure to which they
are consenting. Again, the relatively complex sentence structure
and vocabulary of most consent forms makes it difficult
for the average adult to interpret the information. [Pizzi
2001] As illustrated in the nearby example, applying the
principles of plain language can improve understandability
without compromising the message. An added advantage of
simplifying and clarifying the consent form is that it will
also increase the likelihood of getting a high-quality translation
of the consent form for use by non-English-speaking patients.
In this step, we provide general advice on how to improve
the readability of these written materials. Much of this
advice is based on the types of studies reviewed in the
Background section of this guide. Other recommendations
are adapted from excellent public domain guides such as:
Clear & Simple: Developing Effective Print Materials
for Low-Literate Readers from the National Cancer
Institute
Simply Put from the Centers for Disease Control and
Prevention
Plain Language from the U.S. federal government
(see Resources
for web link and other sources).
Based on such sources, here are six steps to consider for
improving the readability of your consent forms. Tools to
help you accomplish these steps are presented on the following
pages and samples of actual informed consent forms (including
before and after versions) can be found in Appendix
C.
Do You Think Plain Language Improves
this Consent Form?
Consent Form #1 (college level)
“You voluntarily consent to participate in this
research investigation. You may refuse to participate
in this investigation or withdraw your consent and discontinue
participation in this study without penalty and without
affecting your future care or your ability to receive
alternative medical treatment at the university.”
Consent Form #2 (8th grade
level)
“Participation in this study is entirely voluntary.
You have the right to leave the study at any time. Leaving
the study will not result in any penalty or loss of benefits
to which you are entitled.”
Consent Form #3 (4th grade
level)
“You don’t have to be in this research study.
You can agree to be in the study now and change your mind
later. Your decision will not affect your regular care.
Your doctor’s attitude toward you will not change.”
Adapted from www.plainlanguage.gov
and Stockton 2004
Six Steps for Creating Simple and Effective Disclosure
Forms
Six Steps for Creating Simple and Effective Forms
1] Review the fundamental target audience,
setting, and communication goals
Your first step is deciding
what you need to say.
Be sure to get the following information
from clinicians:
Will this form be used on its own or with other
materials?
Will patient read this alone or interactively with
clinician?
Why is this procedure being suggested? How does
it work?
What is the main benefit?
What are the most common risks or side effects?
The most serious?
What are the alternatives? Risks and benefits of
those?
The risks of declining?
In addition, special questions related
to consent for patients who speak little or no English,
have low health literacy, or other communication barriers
(physical or mental disabilities, old age) must also be
considered:
Should we consider providing this in another language?
(And if so, can we ensure that all cultural, linguistic,
demographic, educational, and geographic issues as well
as the probable setting/ context are considered in the
translation?)
Will on-site interpretation or translation be required?
(And if so, can we meet HIPAA privacy and confidentiality
requirements if family/friends are used for interpretation
or support; and can we document the patient's permission?)
Will the target population's cultural values or
core beliefs impact consent?
2] Gather feedback on the existing item
Highlight what works well, what to keep
Circle or cross out what is confusing or too complex
Note what’s missing
What is the main benefit?
Consider testing the existing item with patients (Consider
using Tool 3CPatient Pretest,
which can also be used to test your own draft)
3] Create a file of ideas for the new/revised item
Create a file for all information gathered in first two steps
Add examples of other pieces from other sources (government websites, medical societies, other hospital or clinics)
Add articles, chapters, background with related content or graphics
4] Write a draft
Take a deep breath and remind yourself of the reader
Spend just 5
or 10 minutes reading some patient information brochures,
books, or Websites from large groups such as the American
Cancer Society, American Heart Association, Healthwise,
or WebMD. This often helps a clinician-writer “change
gears” in terms of overall structure, complexity,
and length; some writers keep a file of favorite examples
of writing about medicine for lay audiences—from
newspaper stories, magazine articles, or brochures—for
exactly this purpose of reminding themselves to shift
down in complexity.
Create categories for all the needed information (Note
that using a standard outline or template may help ensure
that you cover all the necessary points—for ideas,
see Tool 3BChecklist for Assessing
the Informed Consent Form and the sample Queensland
informed consent form (Figure 1).
Divide the information among the categories
Put the categories in appropriate sequences
Start creating subcategories
Flesh out the outline to create a first draft
Edit and revise (See Tool 3AStyle Guide for Improving the Informed Consent Form)
5] Test the draft
Use a checklist for quick evaluation for basic elements
(SeeTool 3B Checklist for
Assessing the Informed Consent Form)
Consider checking readability with a software program
or tool [Doak 1998] (but be aware that readability formulas
are controversial since they do not assess reader fluency,
motivation, anxiety. etc., and since they also ignore
text organization, visual design, and difficulty of words
other than related to word length (e.g., “lesion”
and “cancer” may be considered equally readable)
[Anckler 2004]
Ask clinicians who plan to use the form:
Everything covered? Anything missing?
Divide the information among the categories
Words or concepts your typical patient will not understand?
Specific suggestions for edits?
Will you be able to use this? How?
Testing the draft with patients (See Tool 3CPatient Pretest)
6] Revise based on evaluations and pretesting
A Note on the “Right” Grade
Level for Informed Consent Forms:
Don't Sweat It... Just Simplify It
As emphasized throughout this Guide, informed consent
forms should be written in simple sentences and in
the primary language of the patient. Many clinicians
and educators are anxious to use a “readability
score” to get an objective measure of their
progress toward simplification. But simplification
is about more than grade level scores. While some
research shows that understanding and recall increase
when consent forms are written at the 5th grade level,
which is considered appropriate for low literacy patients,
[Meade 1999, Campbell 2004, Paaschle-Orlow 2003, NWGLH
1998] many organizations aim for an 8th grade level,
which is deemed “plain language.” In some
cases, forms at both levels (and in multiple languages)
may be needed. However, there is so much room for
improvement in the typical informed consent form that
the difference between 5th grade level and 8th grade
level is often academic. Even the results of various
software programs for determining the exact grade
level have been criticized. [Ancker 2004] So, don’t
let the need to attain some supposedly objective measure
of readability stifle your efforts to simplify your
consent forms. Logical organization of information
and format are just as important as grade level. In
most cases, almost any change will be an improvement.
Let your common-sense guide you. Work as a team. Get
feedback. And use the Tools on the following pages
to help you accomplish this goal.
Developed with a grant from the Robert Wood Johnson Foundation
