HLOL Podcast Transcripts

Health Literacy

Making Research Consent Forms Easier for Patients to Understand (HLOL #86)

Helen: Welcome to Health Literacy Out Loud. I’m Helen Osborne, President of Health Literacy Consulting, founder of Health Literacy Month and your host of Health Literacy Out Loud. In these podcasts you get to listen in on my conversations with some amazing people. You will hear what health literacy is, why it matters and ways we all can help improve health understanding.

Today I’m talking with Kristopher Griffith, or, as he prefers to be called, Kris. He is manager of Human Research Regulations at the University of Texas MD Anderson Cancer Center.

Among his many responsibilities, Kris manages regulatory aspects of human subjects research as submitted through their Office of Protocol Research. He edits the Human Subjects Research Bulletin and, along with an editorial staff, maintains MD Anderson’s Adverse Events database.

Kris and I are both members of AMWA, the American Medical Writer’s Association. We met last year when he agreed to be part of a health literacy panel I was leading at AMWA’s national conference. I learned a lot from Kris about writing understandable research consent forms, and I’m delighted he is now sharing this with you, the listeners of Health Literacy Out Loud. Welcome, Kris.

Kris: Hi, Helen. Thank you for calling.

Helen: What makes research consent forms so special?

Kris: That’s a great question. The number-one thing about research consent forms is that they’re all different. You have your Standard of Care consent forms and HIPPA authorizations that everyone signs at their doctor’s office.

Helen: Because we have worldwide listeners, HIPPA is the privacy protection notice, correct?

Kris: That’s correct.

Helen: We’re talking about research consent forms that are different from the routine forms that you sign when you go into the hospital to have something done.

Kris: Exactly. The research consent forms are required by federal regulations to be written at a certain grade level, and they’re different for every study or research project that a doctor submits to the Office of Protocol Research.

Helen: Really? The grade level is different?

Kris: Yes. The grade level required by the federal government is between sixth and eighth grade. As you can imagine, when a doctor writes one, it initially comes in at a much higher level.

Helen: Absolutely. That’s one reason they’re hard. The level you want to write them at is very low. What else makes them special and what makes them hard?

Kris: From personal experience working in the Anderson Cancer Center, it’s the oncology aspect of the research consent forms.

I don’t know if you can imagine, but some of the oncology drugs have 24 letters in their name. Some of the procedures are highly complicated, so it’s always a challenge to bring that readability level down so patients can understand exactly what they’ll be going through when they join a research study.

Helen: I’m sorry. I’m interjecting my personal opinion here, but I think that’s a ridiculous and almost unachievable standard. I don’t know how anyone can write something so complicated at a sixth to eighth grade reading level. Can you?

Kris: That’s basically the real question. There are a lot of people who argue that it really isn’t possible. You can use the readability metrics like Flesch-Kincaid, which is a program that many people use to measure readability. That is really just counting the number of sentences in a paragraph and the number of syllables in words. That’s not really readability, in my opinion.

Helen: Nor mine. When you look at readability, what are you looking at?

Kris: What you’re looking at is how you structure things so that they are consistent and so that when ideas are repeated many times in a particular study or consent form, patients become familiar with them and with how they look.

Very simply, if you have a bunch of words and letters crammed together in big blocks, it’s going to make it harder for patients to understand.

Helen: Those are the ways you start making these easier.

Let’s just get back to the beginning. You talked about what made these so hard, like the big drug names and the awful diseases that people have. For our listeners, please clue us in as to what is special about a research consent form as opposed to any other kind of a consent form.

Kris: What is being described in this consent form is investigational treatment. It’s never been FDA approved or, if it has, it’s being used in a novel way.

Let’s not even get into the length, although we can get into that later because it’s inevitably much longer than standard consent forms. It’s brand-new, and that’s what is so exciting about it, to me personally. Every consent form done for research is different than the last one.

Helen: They’re testing a drug. Is that what is referred to as those Phase 1, 2, or 3 studies?

Kris: Exactly. You also have Pilot Phases and Phase 4, but 1, 2 and 3 are the main ones.

Helen: They’re all at a very large place like MD Anderson.

Kris: Yes, we have over 4,000 protocols open.

Helen: Your department is the one that kind of touches all of these. Are you somewhere between the scientist, the investigator and the reader?

Kris: That’s absolutely correct. The scientist, or the PI, which is what we call the Principal Investigator, submits a protocol through our office. Then it goes through the administrative review. Then the Institutional Review Board is the body that reviews and approves the study. Once it’s approved and activated, that’s when it gets to the patients.

Helen: These are extremely difficult. There are many, each one is distinctive and you have these regulations or standards that are so hard to meet. I get it. It’s really hard. What do you do to make these easier?

Kris: Let’s touch on a couple of things I mentioned earlier. Formatting may be the simplest thing right off the bat. Bullets are incredibly important. Let’s say you have 100 different side effects that may occur with a drug. You could put those in a paragraph or bullet them.

In our department, we bullet them not only in three columns so that they’re nice and straight, but we also organize them by body systems so that the cardiacs are together and the hepatic toxicities are together.

Helen: Do you have a table with three columns?

Kris: Exactly.

Helen: Is it really likely that any drug would have 100 side effects?

Kris: One hundred is small for some. I’ve seen side effects that go into three pages of three-column tables. It’s phenomenal.

What’s interesting is that because of the regulations, we’re required to put most of those in there. The FDA requires anything that’s considered serious and likely to be inserted in the consent form.

Anything likely is anything above 20%. Anything common is between 19% and 3%. Anything below 3% is rare, but even if it’s below rare, if it’s serious it also has to be inserted into the consent form. What you’re getting into is basically just about every side effect that occurs.

Helen: Wow. When you list these in the columns, and there are so many of them, do you list them alphabetically? How would you prioritize them?

Kris: I mentioned earlier about the body systems. We list them by body systems. Our body systems are actually alphabetical, so we start with the cardiacs and then move down lower to the hepatic. We’ve basically grouped each part of the body that could be affected by a side effect.

What’s really interesting is that we’ve created a database so that once we’ve developed this profile for a given drug, the investigators no longer need to rewrite the whole risk profile again. When there’s a new study using that same drug, they can just click a button and that drug name comes in along with all of our tables that have the side effects listed in table format.

Helen: Can you give an example? We’re auditory only right now and we’ll probably have some links to some of this, but tell us a story and make that real for our listeners. What do you mean by that database and those recurring situations?

Kris: That’s a great question. We call it the MD Anderson Adverse Event Database. Let’s say you’ve got a patient going on trial. It’s going to be a test of the drug Tamoxifen in breast cancer patients.

Tamoxifen has many side effects, and a doctor who is writing this research consent form already has to deal with a bunch of regulations and issues, so the last thing he wants to do is be concerned about checking out every single side effect associated with that drug. Instead of having to do that, he can go to our database, simply type in “Tamoxifen,” and it will bring up that whole side effect profile.

This is something that’s very individual to MD Anderson, but recently we worked with the NCCN, which is the National Comprehensive Cancer Network. Along with Dana-Farber and MD Anderson we’ve created the NCCN Informed Consent Language Database and that’s something everybody in the world can use.

Helen: How do people get hold of this? If everyone can use it, that’s wonderful. That would save people a lot of time and misery.

Kris: Absolutely. It’s online at www.NCCN.org. You can just find the clinical trials page and they’ll have the database right there.

Helen: Thanks. We’re going to put that link on Health Literacy Out Loud. You told me about this as we were getting ready. You have terms like “abnormal kidney function tests.” In this database, you have it in Lay-term 1 and Lay-term 2. One is much more descriptive than the other, and one is just a shorter way of saying it.

What do you do when you have to talk about abnormal kidney function tests? Which lay term would you use in your informed consent?

Kris: That’s also a great question. The reason we have two is because we were collaborating with Dana-Farber, so we’ve got two institutions that actually have slightly different processes for listing their side effects. It’s not different all the way through, but there are certain areas where they have a lot more verbiage and we have a lot fewer words, basically.

Our hypothesis is that the less patients have to read, the more they’ll retain. I’m certain that there’s some data out there to corroborate that, but it makes fairly common sense to me that if you have a giant paragraph versus a single sentence that tells patients what’s going to happen, it’s going to be more effective in the long run.

Helen: If our listeners want to go to this for whatever purposes they’re using, they could just adapt one of these to their own. It’s not like this is the best way. It’s just that this is a recommended way.

Kris: Exactly.

Helen: How else do you make it easier? You talked about the database. It looks like you have words and descriptions and people could just click on what should be included. How else do you make these forms easier?

Kris: There’s a lot more about databasing that really helps when you’re running a consent form. We’ve talked about side effects, but there are also procedures and definitions for biopsies and MRIs. If you manage to write these in a consistent form, patients will start to recognize them when they read them.

Some of you may not know that research patients often enroll in multiple protocols. They’re trying to fight their disease, and sometimes the first protocol doesn’t work so well or there is adjuvant protocol that they can do at the same time.

It’s not going to help them if they go into one consent form and read about an MRI and it’s completely different than the second one, so we’ve actually databased all of our procedures and tests.

Helen: It sounds like the consistency is really huge. You talked about that so things are more familiar. What else do you do?

Kris: I have a good example. I mentioned to you that some of our consent forms are truly long. It’s sad, but I’ve seen pediatric studies that have 35-page consent forms. That’s just tremendous.

Helen: A parent is dealing with a really sick child in a very scary situation and has this miserably long form to read and sign?

Kris: Exactly.

Helen: Let’s make that easier.

Kris: The NCI and the FDA have been looking into something called the short form. It’s not regulation at this point. It’s not even required or mandated by anybody. They’re starting to send out requests for how we can shorten our forms and provide something that is much easier for patients to handle.

What we’ve developed at MD Anderson is something called the study overview. This is a one- to two-page description of the study.

We highlight the purpose of the study in one or two sentences. We state the aim, whether it is to shrink the cancer or check quality of life, and then we briefly describe the possible tests that can happen. We won’t repeat how often or when they happen, just what may happen.

Then we talk about the most important side effects. As I mentioned earlier, you have 150 side effects, but the doctors who have experience with these drugs know what patients are likely to expect.

It’s important to say that this is not a signed document. It’s not going to meet any legal requirement, but what it can do is serve as a reminder for patients. They can take this home and put it on their fridge. They’ll also have the full consent form, but this will give them a quick reference guide. It’s something that’s understandable for patients.

Helen: That sounds like you’re really bringing the informed to the consent form.

Kris: Exactly.

Helen: Can we talk about formatting or the look of these?

Kris: Sure. I already mentioned the bulleting. When you have the big paragraphs, it’s clunky and not easy to read. We personally used 12-point Arial.

Helen: An Arial font is the sans serif font without little feet or wings on each letter.

Kris: Exactly. We use small paragraphs. When we can, we use bullets. It depends on the requirements of the particular institution or hospital.

It’s really interesting that we have something called ad hoc committees. Every month or two we get together and look at side effects. We look at layout, formatting and the way things are worded. The makeup of this committee is doctors, editors and lay members from the community.

Helen: What do they think of your forms?

Kris: They’ve helped to develop them, so in a way they are their forms as well. Without the input from the outside lay person, you’re sort of shooting in the dark.

Helen: That’s always an ongoing principle with health literacy. We say, “Go develop it or work with your readers. They are the true experts in what is readable.” How wonderful that you bring in the lay members.

With this whole process, it sounds like you almost have it down to a system. You must if you have over 4,000 open studies with more coming all the time.

The rhythm is that you can grab something from your databases, you have your consistency, you know that you do a simpler version too, or that summary, and you look at this committee.

Let’s get back to the beginning. You talked about those readability standards. You and I both agree that readability is more than just those two metrics of number of syllables and number of words. What do you do about that standard?

Kris: We constantly educate ourselves. I’ve been working here for 14 years. It’s not something that happens overnight. In the last decade plus, I’ve gained two certifications in medical writing.

How I did that was by going to the AMWA conferences and the PRIM&R Conferences, which is Public Responsibility in Medicine and Research. That is something where you can meet with fellow clinicians and editors and continually strive to find better ways to do things so you don’t become complacent.

Helen: I think this is probably on the mind of an awful lot of listeners. To meet these readability standards by going to these organizations and hearing from others, are you finding ways to meet those standards or are you coming up with counterarguments and reasons that you’re not but that these are still readable?

Kris: It’s a little bit of both, to be honest. When I first started, we didn’t use bullet points. I learned about bullets from AMWA. I found out that was a great way to do things. Then we learned about the readability scales and the metric systems that don’t work.

I guess the Flesh-Kincaid is the gold standard, but nobody really believes that it works. Maybe it’s not the gold standard, but it’s how we meet the regulations. It’s how institutions can say, “We have a document that’s at the right reading level because this is what this software tells us it’s at.”

To me, it’s all about community involvement. It’s getting input from the people who have been patients and the people who know people that are patients. It’s having them say at committee meetings that convene or at the board meetings, “This is how this should be written so that it’s understandable.”

Helen: I’m so glad you said it to me. That’s the gold standard too. Can readers really understand and use this information? You said that you were always learning. Our listeners of this podcast are always learning. Are there any resources other than the National Comprehensive Cancer Network that you would like to steer people toward?

Kris: Really, my staff veterans use everything under the sun from www.Dictionary.comto www.Wikipedia.com. I know that obviously you have to check your sources.

I would really recommend that if you have the resources to do it, attend these national conferences. There are so many people out there who have found and developed interesting ways of doing things and novel ways of approaching this really difficult problem that you’re going to benefit from it.

I know it’s not possible for everybody, but if you can somehow once every couple of years make it to one of these conferences, I think you’re really going to benefit.

Helen: What a wonderful circle this is coming to because that’s when you and I started. When you and I presented at AMWA, it was a panel discussion and we had somebody there from the Mayo Clinic.

We were just having this conversation with each other and with our audience about ways to make these research forms easier to understand, ways to make patient education easier to understand and putting that all into context of health literacy, and this podcast is doing just that. It’s spreading out the word.

Thank you so much, Kris, for passing along your lessons learned and tools and resources. Hopefully we can make that informed part of informed consent forms even easier. Thank you, Kris.

Kris: It’s my pleasure, Helen. Thank you.

Helen: I learned a lot from Kris Griffith, and I hope that you did too. Health literacy isn’t always easy. For help clearly communicating your health message, please visit my health literacy consulting website at www.HealthLiteracy.com. While you are there, sign up for the free monthly e-newsletter, What’s New in Health Literacy Consulting.

New Health Literacy Out Loud podcasts come up every few weeks. Subscribe for free to hear them all. You can find them on iTunes, Stitcher Radio and the Health Literacy Out Loud website, www.HealthLiteracyOutLoud.com.

Did you like this podcast? Did you learn something new? I sure hope so. If so, tell your colleagues and friends. Together, let’s let the whole world know why health literacy matters. Until next time, I’m Helen Osborne.


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