Collected here are a number of tips for drafting simple and clear consent forms and related educational materials. You may want to photocopy this Style Guide and place a copy inside each of the separate folders you created for each informed consent form undergoing revision.
These basic recommendations were synthesized based on research studies as well as on the material in 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.
Use Plain Language
Word choice and sentence length and structure are critical in creating text that is easy to understand. Here are tips to keep in mind while writing:
Words
Use simple, common words (avoid medical terminology
or jargon)
Pick strong verbs
Use “you” to address the reader
Explain technical terms or use the simpler alternative
Examples:
“Chemotherapy
is the use of drugs to treat cancer”
“Noninvasive
means without surgery, needles, or cutting skin”
“arteriovenous
fistula (abnormal opening between any artery
and vein)”
“benign
(not cancer)”
“colonoscopy
(internal exam of the bowel using a bendable tube (colonoscope)
with an attached camera”
“hypertension
(high blood pressure)”
Avoid long words with many syllables
Avoid unnecessary adjectives
Avoid legal jargon
Avoid abbreviations and acronyms if possible
Use the same words consistently (ie, don’t use
a synonym just to avoid
repetition, and be careful with use of pronouns)
Sentences
Keep sentences short (8 to 10 words is good), direct,
and succinct
Use a conversational tone
Avoid complex sentence structures (e.g., compound sentences,
dependent or embedded clauses, lots of commas)
Consider breaking into a short list when there are more
than 3 points to the sentence
Use concrete nouns and give clear direction
Don’t say:
“Following postsurgical
safety precautions can reduce the likelihood of wound
infections.”
Do say:
“After your surgery:
(1) change your bandage daily,
(2) watch for pus or leakage,
(3) call the doctor if there is any change.”
Use the active voice
Don’t say:
“The instrument is
inserted by the doctor into the vein”
Do say:
“The doctor inserts
the instrument into the vein.”
Paragraphs
Avoid long paragraphs
(and dense blocks of text)
(3-4 lines or 2-5 sentences is good)
Start a new paragraph with a new thought
Organize the Flow of Ideas
Present one idea at a time
Rule:
If it does not add information or understanding,
delete it.
Sequence the ideas in the order a patient would want
them... or...
Consider using a standardized sequence of categories
for all forms
Add articles, chapters, background with related content
or graphics
Example:
The Queensland Government format generally recommends:
A] Interpreter/Cultural Needs
B] Condition and Procedure
C] Anaesthetic
D] General Risks of a Procedure
E] Risks of Procedure
F] Significant Risks and Relevant Treatment Options
G] Patient Consent
H] Interpreter’s Statement
I] Doctor’s Statement
Use headings and subheading to “chunk” text
together
Keep these sections short
Make your heads and subheads work to
organize and communicate
Don’t
say:
“Complications of the
Surgery.”
Do say:
“Infection is the Most
Common Complication.”
Use vertical lists to highlight a series of items
Select a Clear Layout and Design
Type
Choose a classic and common typeface (e.g., plain serif
style like Times New Roman or Garamond are best for print)
Choose a type size (at least 12 point) that is large
enough to read easily
For visually impaired patients, consider 14 or 16 point
text
Don’t use LONG SECTIONS OF ALL CAPITALIZED TEXT
LIKE THIS (this can be difficult to read, especially for
visually impaired readers)
Instead, to highlight important points,
consider:
Changing the type size
Using bold face
Underlining
Adding a light background screen
Don’t over-do the use of boldface because
this is annoying
Use bullets to highlight important points and create
lists
White Space and Visual Layout
Use a lot of white space, around edges and between copy
chunks
Make sure the white space is balanced with words and
illustrations
Use vertical lists to break up text
Use graphics to break up text
Use short sections to break up text
Use shorter rather than longer line lengths
(less than 65 characters is best)
(FYI, above line is 65 characters exactly)
Figures, Tables, Graphics
Use visuals like pictures or diagrams when appropriate
Make sure figures have a heading, description, or caption
Overall
Standardize the layout throughout the document (e.g., all same typeface, size, similar copy chunking)
Developed with a grant from the Robert Wood Johnson Foundation