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Any significant improvement in the usefulness of informed consent documents requires a new approach from the provider, says Mark Hochhauser, PhD, a psychologist in Golden Valley, MN, who specializes in readability consulting and works extensively with health care providers.
Writing the documents for a lower reading level is good, but that is only the beginning, he says. "If you write at a lower grade level, you usually cut long sentences into shorter sentences. [This leads to] very choppy reading. If you cut a 50-word sentence into three 17-word sentences, the grade level will come down, but it still might not be easier to read in any meaningful way." Here is Hochhauser’s advice for improving informed consent documents:
• Start from scratch. You’ll be more successful if you write a new document, including all the elements that you decide are necessary, rather than taking the old version and trying to improve it.
• Watch for word familiarity. Word familiarity probably is as important as sentence length, Hochhauser says. People won’t understand a document full of unfamiliar words, even if the sentence structure is short and simple. Look for opportunities to use more familiar words. Don’t say, "Possible adverse reactions include contusions" when you can say, "You might get a bruise."
• Define abstract concepts. Remember that doctors and lawyers are more used to some abstract concepts than the average patient. "Randomness" is a good example. If the consent form for a study states the patient’s treatment will be determined randomly, you might add, "like by flipping a coin."
• Use images, other tools to explain. Look for nontraditional ways to explain concepts to patients. If the wording of a document is trying to explain how a medical device works, maybe it should use a photo or diagram of the device. Explain quantities in real-world terms, such as teaspoon and quart. Use comparisons to familiar household objects when explaining size.
• Write in the first person ("I consent . . .") or the second person ("You consent . . ."), but not both. Either format works, but avoid switching between the two. That’s confusing to the patient.
• Avoid using multiple subjects such as "You/Your spouse/Your minor child." Many forms use this technique to try to cover all possible situations. But it often just confuses the reader and depersonalizes the form. Instead, word the document carefully so that it applies to most situations, or use different documents for different people.
• Involve patients from the beginning. The best method for ensuring the average patient will understand the document is to let them help you write it. Put together a focus group and explain to them what the procedure or study involves, and listen carefully to the questions they ask as you explain. Note where they stop the doctor and ask for clarification, or where their eyes begin to glaze over and it’s clear you’ve lost them. Once they understand the concept, ask them how you should explain it to others just like themselves.
• Have patients critique the new form. Once you have written the new consent form, have a different focus group of patients review it. Give highlighters and leave them alone to read the document with instructions to highlight any word or part they are do not fully understand. That should help you pinpoint what parts need more work. This method also can be useful in revising existing forms. As an alternative, you can even take the forms home to your teen-age children and ask them to read them and explain the contents.
"You really have to focus on the reader and what it will take for them to understand it," Hochhauser says. "You’ll find that they want to write things in much plainer language than you ever would have dreamed of. But that’s what you have to do sometimes."