Improving patient education	December 2007

Med Ad News spoke with Sylvia Aruffo, Ph.D., research and design, Communication Science Inc., about the state of patient education and how to move forward in improving health literacy among patients.

Med Ad News: What is wrong with patient-education materials today?

Sylvia Aruffo: The answer is very simple. There’s no accountability for efficacy. No one holds the producers of patient education accountable for whether the education works. If the patient is not doing what they’re supposed to do, we tend to blame the patient rather than the materials.

Med Ad News: Who is responsible for the creation of patient education materials?

Sylvia Aruffo: For the pharmaceutical companies to address directly to the consumer is fairly new. In fact, some pharmaceutical companies still feel that the only education that matters is the education of the physician, and I certainly wouldn’t downplay that because if you get started well with your doctor you probably do have a better foundation for building compliance, but it is surprising to most people to learn that all the blockbuster drugs, even Lipitor, those empires are built on just one or two fillings of the prescription. A person who is supposed to take a drug for the rest of their lives will only take it for a few months. There was a presentation at a pharmaceutical convention last April in Edison N.J., where five pharmaceutical companies had collaborated in Canada to see what the decay profile was for five drugs, not competing drugs, in different therapeutic categories. And, all five followed the same decay profile, that by 22 months, 90% of the people had stopped taking their drugs all together.

Med Ad News: You mean by decay profile, the lack of compliance?

Sylvia Aruffo: Yes. When they stop refilling the prescription for this drug that they’re supposed to take the rest of their lives.

Med Ad News: Who should be held accountable?

Sylvia Aruffo: I believe the people who write the material should be.

Med Ad News: What kind of crucial changes are needed?

Sylvia Aruffo: What we have today is something like this. Imagine, if the trials for a drug through the FDA were only for safety and there were no efficacy trials. Now maybe this is a bad analogy because sometimes that would be a better way, and the market sorts out what works and what doesn’t, but what we have today with patient education materials is we get approvals for whether education is clinically correct. You can go to an organization like URAC and you’ll get their opinion as to whether the medicine reflected in your instructions is evidence-based. But there is no efficacy trial, whatsoever, to see whether that content actually communicates to people that they understand it and are inspired by it, and people tend to think, well how could you possibly measure that. I would say extremely strongly, as strong language as you could possibly say that if the purpose of patient education is to make people equipped and motivated to care for themselves then you measure patient education efficacy by a reduction in unscheduled use of the health-care system.

That is, you’d want to see, fewer calls to the doctor’s office, fewer unscheduled visits to the doctor’s office, less use of the emergency room, shorter stays in the hospital, and fewer readmissions. Those are absolutely legitimate tests of the efficacy of patient education. … You would see higher numbers of refills and of course that’s the only line item that goes up, everything else goes. You’re going to see greater numbers of refills of prescriptions, and that includes greater refills of medical device disposables. Those are absolutely legitimate measures of patient education. That’s what we’ve been doing for the last 10 years, and we have 14 trials where we have been able to reduce the rate of readmission, increase the rate of refills, and not by trivial percentages, by double-digit percentages that are least successful trial decreased the rate of readmission by 38%.

Med Ad News: How does poorly written material affect the overall industry?

Sylvia Aruffo: The first way is in clinical trials. If patients do not understand how to take their medicine, why to take their medicine, when to take it, they’re not going to comply properly during the clinical trial, and you’re putting your outcomes at risk for getting the drug approved in the first place. Then of course is the total sales of the prescription, the number of refills. Most pharmaceutical companies simply abandon that because they assume that it’s impossible to significantly affect compliance.

Med Ad News: How do poor education materials for patients affect the patient-doctor relationship?

Sylvia Aruffo: Our experience is that the doctors use materials from either the pharmaceutical companies or actually, how do I say this without insulting them, we have on videotape multiple doctors admitting as if it is not even an admission, stating that they don’t even read the materials that they hand to the patients. … So, how could a patient even ask a question about the material if the doctor hasn’t read it? I don’t mean to criticize the doctor for that, doctors are overwhelmed; they have too much to do already. They tend to trust that these associations or industries have provided reliable materials, and indeed they probably are reliable materials with respect to clinical accuracy, but they don’t communicate.

Med Ad News: Are patient education messages not worked into the physician education? Is there any cohesion?

Sylvia Aruffo: That’s certainly part of it. One of the things that I would love to do, and we’ve begun to talk with a few pharmaceutical companies about the possibility, now that direct to consumer messaging is increasing in importance, is doing some CME courses that prepare doctors to be better communicators of this patient information. But, we have to start without that because right now doctors are unaware of the extent of noncompliance. I don’t think that we should take a 2x4 and start battering the doctors that their patients are noncompliant, because no one will listen to that message. They don’t believe it. And, we have to use the avenues and channels that exist to address the issue without having to make the doctor raise his right hand and say, “My name is Doctor Jones and my patients are not compliant.” We have to find a positive way to deliver to the doctor reliable materials. We know the doctor gives the patient materials. If we could give the doctor materials that genuinely are as effective as the doctor thinks they are, then we solve the problem without having to bash the doctor.

Med Ad News: And what is the best way to establish good writing?

Sylvia Aruffo: The ethnography. Focus groups are a real problem. Focus groups are intended for the final stage when you have already written something and you want to see how people react to it. … It’s too late by the time you get to the focus group to tell whether you have instructions that are going to work. You have to start before you write something. You have to go on a fishing trip to find out what kind of instructions are going to resonate and inspire and engage your audience by doing ethnography.

Number one, you have to understand their misunderstanding, you have to understand the extent of it, and you have to understand the nature of it. Those are two very different things you have to understand just how much they don’t understand and in what ways they have it distorted. You have to understand what it is they misunderstand and the extent of that misunderstanding. I would be willing to say that you can never underestimate the depth of misunderstanding.

So, that’s the first thing you have to do is find out how much and where things are off track, and the second whole huge category is to find out what is familiar, what is fitting to the environment where the majority of the patients live and think and work, so that you can pick images, analogies, explanations, that make a patient go “Oh, I get it.” You don’t want your explanation to come across as something new. And I think this is a tremendous challenge for a brand manager because the whole concept of a brand is you want “This is NEW you’re going to have a NEW regimen in your life, you’re going to have a NEW thing to do.” When in fact I think we need to turn it around, and say that what this medicine is going to enable you to do is to continue your life as you already know and love it. … That’s just a radical difficult thing for a brand manager to look at seriously.

Med Ad News: What about demographics?

Sylvia Aruffo: While eventually you do get to demographics, the most important thing is that people with the same disease have more in common than they don’t have in common. And, in fact we should be able to leverage that commonality. There is power in an immigrant hotel housekeeper knowing that she has something in common with the heir to the soapsuds fortune. She’s using this soap everyday and she has learned that the heir to that soap fortune has the same affliction that she does. There’s power in that, in connecting people.

I think you remember the AstraZeneca advertising campaign “if you were my sister” and the I believe it was Time magazine at one point put an enormous array of people who had had breast cancer across the demographic spectrum, the thing about disease is that it does go across demographics. … In health care, disease is not a respecter of persons, you can pick up the power of the universal experience, and it’s also cheaper for the pharmaceutical company to aim for an approach that hits 80% of their market and then worry about the segmentation afterward.

This is not to trivialize the cultural approach. You can get to the demographics later when you’re ready to refine and go after that last 20%. The universal experience has tremendous power.

I’d like to talk about that Institute of Medicine study, certainly very well intentioned, but it has two problems, one is that there is some awareness of this, it tends to blame the victim. That the reason that the person can’t read is because they are illiterate, rather than the health-care provider can’t write. Then the second problem with it is that when they came out with a book and a program on health literacy, they have trivialized the writing for patients by talking about vocabulary and fourth-grade reading level, and using the right font, it’s trivializing it. The issue is whether you have engaged and inspired and explained whether you have effectively communicated, not merely whether you have a checklist. No words that end in ed, no sentences longer than seven words, no paragraphs longer than five lines. This is not a checklist. The critical part of communicating is linking the content, structure, and tone to your discoveries through ethnography. You’ll eventually get to those final tweakings, but they are just tweakings. They are not going to magically make something that is poor content, structure, and tone into an effective piece of communication. The idea of writing for effective health-care communication is not a trivial matter.

Med Ad News: Does Communication Science write patient education material for pharmaceutical companies?

Sylvia Aruffo: Yes, we do. And, we do it through a process of first ethnography, so that we have a base of evidence and then we can create evidence-based patient education. Just like you’d expect to get efficacious medicine out of evidence-based medicine, we do evidence-based education, and that’s what makes it effective.

Med Ad News: Would you say that it is fairly new to use ethnography?

Sylvia Aruffo: Absolutely, it’s brand new. Probably the next most crucial thing is that once you have a really solid ethnography, you’ve got a description of the patient’s lives. Here’s what the day in the life of the patient is, here’s what happens at home, at work, and so on. It’s a collection of facts. It doesn’t automatically tell you how to write, so I would say the most critical thing starting from there is to apply to your ethnography, principals of adult education and sociolinguistics.

For example, the quickest, best example I have is that through ethnographic research, we found that the majority of diabetics don’t want to be called diabetics. They don’t want to use the word diabetes. They are in denial that they have this disease. That’s a fact. Now, what do you do about that fact in your education program? … Rather than slamming that head on, why not just drop the word. Everyone is willing to admit that they have a little blood sugar problem, they have a little blood sugar to control, so what we did in our materials is we eliminated the word diabetes altogether. Here’s how to manage your blood sugar, here’s what to do if you have a touch of the sugar, and that was our Spanish version, because that’s the phrasing that the patients use. … Just having the ethnography does not guarantee the result. You have to take that base of facts and know what to do with it by applying principals of a adult learning, how adults learn, and principles of sociolinguistics of what kinds of language. That’s not just vocabulary, that’s grammar, that’s structure. What kinds of language will communicate.