The Food & Drug Administration (FDA) oversees product labeling, which more and more includes patient-facing materials like patient manuals or handbooks or guides for patients to use.
The FDA requires that patient materials be “readable.” To them, this means more than just ink-on-paper or pixels-on-screen. It means that the content must be assessed to determine if the average patient could understand it. To this end, the FDA uses readability tests known as the FOG or SMOG scales or the Fry scale. These are all algorithms or methods which allow a person to take sections from the proposed patient material and calculate whether or not it is “readable.”
Now let me tell you the secret of readability. You can score through the roof on readability if you do these two things (the main things that get you dinged):
- Never use a three-syllable word
- Keep all sentences short
It does not matter how illogical, obscure, or weasely your document is, it just can’t have big words or long sentences.
My first encounter with readability occurred many years ago when I was working on a patient manual for an implantable cardioverter-defibrillator. You can see my dilemma. The product was called a defibrillator. At five syllables, this word was banned from the manual by the in-house regulatory group. It was implantable which was four syllables and likewise unmentionable. We could say the doctor implants, but not implantable. As for cardioverter, forget about i.
Back then regulatory people did not have a well developed sense of irony. When I explained to the regulatory powers who wanted the patient manual that it would be impossible to write a defibrillator manual if I was not allowed to say the word defibrillator they sort of looked at me with what I call the “regulatory will-bending mind-control stare.” In this look, which kind of resembles how a person looks in the split second before a sneeze, the regulatory official acts as if your comment is ludicrous beyond all measure and that a person with any degree of resourcefulness at all could clearly work around this minor inconvenience.
Writing a defibrillator manual that cannot use the word defibrillator is not challenging. It’s impossible. But the regulatory team and I reached a begrudging compromise. I got to use the word once–and only once–and thereafter we called it an ICD. Apparently, ICD is not a three-syllable word. We said something that the device they had was a defibrillator or ICD. We used the term ICD (which is not used very much by patients) alternately with device (a somewhat unpleasant-sounding term, only slightly less off-putting than apparatus). This created a manual for patients that did not call their therapy by the commonly used term. A doctor, nurse, friend, or family might ask them about their defibrillator, but unless they caught that one fleeting mention in the manual upfront, they only knew from the manual that they had a device called an ICD.
It gets worse. You get an ICD because you have or are at risk for ventricular fibrillation or other forms of ventricular tachyarrhythmias. Those words are out. We said you got the device if you had a heart in which the lower chambers beat too fast.
The end result was a manual that was not readable at all. True, it had lots of very short words and short sentences. But by avoiding discussing the product by name, the manual was useless.
Which brings me to my main point. Just who does the FDA think reads patient manuals? Obviously, they believe that the average American cannot handle a three-syllable word or a long sentence. This outrages me not because some people really cannot read well, but because I am a member of the American public and like all public citizens, a potential candidate for medical therapies of all types. If I get a three-syllable disease or need to take a four-syllable drug or undergo a five-syllable procedure, I would like to think my government thinks that they can mention it by name to me.
Of course, we are nothing at LeQ Medical if we are not practical and helpful. So here are our suggestions:
- Let’s write a patient manual that is clear, describes things in plain terms, is logical, but uses the real medical words (at least some of the time) because this will empower patients to better understand and look up their condition. Let’s assume patients are smart and not dumb.
- But let’s recognize that many Americans do not have good reading skills. So why not create a second alternate manual written at a very low level for such individuals. Don’t make this the main booklet, make it an alternate. We at LeQ Medical know and work in our community with some adults with poor reading skills and we know that these folks do not often seek out or even want printed materials. So devoting all the company’s printed efforts at this demographic is not helpful. Have something, even a photocopied handout, written at a lower reading level if it is needed. If it is more efficient to print only one patient manual put the simplified version in the front (and call it the “Quick Start” or something like that) and put the full version in the back.
- Let’s further recognize that there are illiterate adults in America. What about them? For those people and for those with vision impairment, companies should also produce an audio version of patient materials. It need not be elaborate or expensive. If the company has recording equipment, an employee can read the patient materials onto a computer and generate an MP3 file. Alternately, a recording studio and voice studio could be employed. But this is a super-quick, low-budget way to reach two important (but small) constituencies of the public who are not recipients of good patient education materials.
- Now let’s recognize that many Americans do not speak English as their first language. Sometimes, such individuals may have a family member who can read and translate materials, but this is not always the case (and not all family members are competent translators, even if they are bilingual). It pays to get patient materials translated. Before companies cry poverty, this need not be overwhelmingly expensive. True, expert translations cost money but the final materials can be posted online eliminating printing costs.
Patients are not stupid and writing stupid-facing materials serves no one. Let’s all wise up and write the best possible patient-facing materials and also recognize the needs of patients with poor reading skills, illiteracy, vision impairment, and poor English skills.