Healthy Skepticism Library item: 20190

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Hochhauser M
Consumer-Friendly Patient Information Should Replace DTC Brief Summaries.
Product Management Today 2004; 15:(1):26-28

Abstract:

Lately, consumers have been seeking health information more than ever. However, DTC brief summaries are often written at a degree that a first-year Masters-level reader may find challenging. According to the author, the reading level of most DTC briefs should be geared toward the general population.

Full text:

In a 2002 survey of consumer’s attitudes and behaviours regarding DTC ads, the FDA found that only 10% read the entire “brief summary” accompanying DTC ads, with 41% of those polled reading none of it. However, if consumers were “especially interested” in an ad, 27% read the entire summary, whereas 15% read none of the summary. Likewise, the Coalition for Healthcare Communication, Greenwhich, Connecticut, analyzed several surveys of how consumers use the brief summary. Across these studies, about one-third of consumers claimed to read the brief summary. One study found that among the 31% who reported reading the brief summary, 48% said they read all of it, 31% most of it, and 19% some of it. Other studies found a fairly high brief summary readership, although 30% to 40% reported reading little or none of it.

Although such surveys ask whether consumers have read the brief summary, they do not ask the following four questions: (1) “Did you understand the ad?” (2) “What drug was it for?” (3) “What do you remember from the brief summary?” or (4) “How long did it take you to read it?” Asking only if consumers read a brief summary gives little information about the psychological processes involved in reading, understanding, and using complex health information that is often unreadable and illegible.

The Tooth-Flossing Test
When a dentist asks how often patients floss their teeth, many patients give a deceptive answer such as “every day” instead of “almost never”. People do not always tell the truth for a number of possible reasons: it may be that they want to maintain the image of a good patient, they do not want to disappoint their dentist or be criticized, or they want to give a socially desirable answer.

The same phenomenon can often be noted in telephone surveys. Respondents may say they read the brief summary because they want to present an image of a responsible consumer, give the answer they think the researcher wants to hear, or say what seems to be the right answer. For those reasons, as well as the two following reasons, telephone-survey statistics on the percentage of consumers who report reading brief summaries should be scruntinized and not automatically believed.

Brief Summaries and Patient Summaries Are Unreadable.

Table 1: Readability of six brief summaries and four patient summaries

Document / Average Flesch Reading Ease Score* / Grade Level / Sentence Complexity^ / Vocabulary Complexity^

Brief Summaries / 18 / First-year graduate school / 60 / 70

Patient Summaries / 54 / 11-12 / 31 / 40

*The Flesch Reading Ease Score is as follows: 0-30: very difficult/college graduate; 30-50: difficult/high school graduate or some college; 50-60: fairly difficult/some high school; 60-70: standard/7th-8th grade; 70-80: fairly easy/6th grade; 80-90: easy/5th grade; 90-100: very easy/4th grade

^Using Grammatik 6.0 = least complex, 100 = most complex

Note: This table was composed with several readability software programs. The grade levels were calculated using “Prose: Readability Analyst”, and MS-DOS-based programs that give an average 8 readability formulas.
Adapted from Hochhauser M: Which prescription for the illegible and unreadable DTC (direct-to-consumer) brief summary-major surgery or euthanasia? Manage Care Q 2002; 10(3):6-10

Table 1 presents a summary of research conducted on brief summaries and patient summaries of information. Written at a graduate-school reading level, the six brief summaries are very difficult for the average consumer to understand. The four patient summaries of information are easier to read, averaging at a high-school reading level. Nevertheless, they do not meet the junior-high reading level that health literacy researchers recommend for information written for the general public, although one of the four patient summaries was written at a junior-high reading level.

It is unlikely that average consumers will be able to read and understand brief summaries written at a graduate-school reading level (Table 11). It should also be noted that readability software programs do not score higher than grade 17; therefore, some of the brief summaries may have even higher grade-level scores. Therefore, readability formulas only give a statistical summary of written materials; they are not capable of providing specific information with regard to what readers might find difficult to understand.

Why is so much material written at this level? Much health information is written not to inform the reader, but to protect the company from being sued. From a lawsuit-prevention perspective, companies apparently believe that they are safer if they write brief summaries in a combination of medical and legal jargon, even if patients cannot understand them. In other documents, such as informed-consent forms in clinical trials or privacy notices, language may be taken directly out of the Federal Register. Companies assume that they cannot get into trouble with the FDA if they use the FDA’s own language.

If drug companies really want consumers to read and understand brief summaries, why not include some consumers in the writing and editing process? One problem is that the brief summaries that appear in medical and pharmaceutical magazines. It is probably cheaper to have a one-size-fits-all summary.

Legibility is a major problem as well. The summaries are often printed in very tiny type that is virtually illegible to readers who wear bifocals. One brief summary in Newsweek had 38 characters per inch, about 24 words per line, with 100 lines on the page; there would have been even more words on each line if so many of them had not been long medical terms. The summary had two columns of justified text with no paragraph breaks, containing 13 lines per vertical inch. The total included between 4,000 and 5,000 words on one page, which was too dense to read.

The brief summary is often the condensed version of the complete prescribing information. Whereas drug companies need to meet FDA requirements, there is no reason that those requirements cannot be meet FDA requirements, there is no reason that those requirements cannot be met by writing in an easier-to-read style. To paraphrase an old joke about legal writing: “There are two problems with brief summary writing – the style and the content”.

Consumers Have Difficult Understanding Research and Pharmacology Concepts.
As a way to identify concepts that readers might find more difficult to understand in two typical brief summaries, the following concepts from five recent DTC ads were classified into “research concepts” and “pharmacology concepts”. Even if consumers read the entire brief summary, they would not be able to understand it if they could not understand these terms. To truly understand brief summaries as they are presently written, readers need a solid academic background in research and pharmacology. There is simply no other way for them to make sense of the brief summary.

Brief summaries are often difficult to understand not just because they use long and unfamiliar words: A large portion of brief summary language contains abstract concepts that readers cannot look up in a dictionary, the way they might be accustomed to looking up unfamiliar words. Even if readers could find a relatively simple definition, they may not understand the information because research and pharmacology are ways of thinking, not just a vocabulary set.

The information in brief summaries may be compliant with FDA regulatory guidelines, but it is often non compliant with plain English guidelines. It makes no sense to give consumers important information in a style that they cannot read or understand. For example, examine the 50 concepts in Table 2

Table 2: Can consumers understand these concepts from six DTC ads?

*Research concepts
Adverse effects; adverse event
Animal studies; animal testing
Between group differences
Clinically significant systemic effects
Clinical study
Controlled trials; controlled clinical trials
Coprimary efficacy variables
Double-blind study
1st/2nd treatment cycle
Incidence of events
Investigator’s assessment endpoint
Median duration of therapy
Open-label study
Parallel group
Placebo; placebo based
Premarketing development program
Postmarketing report
Randomized
Responder; responder rates
Risk factors
Side effects
Single-dose clinical pharmacology study
Statistically different
Statistically significant
Treatment arm

*Pharmacology concepts
Active ingredient
Biologic plausibility
Carcinogenesis; carcinogenic potential
Chronic overdosage
Contraindications
Drug interactions
Fetotoxicity
Genotoxicity
Immunogenicity
Impairment of fertility
Inactive ingredient
Intramuscular injection
Long-term effect
Maternal toxicity
MCG (brief summary did not include spellout)
Mutatgenesis
Myelotoxicity
Nonteratogenic effects
Nontherapeutic use
Organogenesis
Pharmacologically active
Symptomatic resolution
Teratogenic effects
Tolerability
Tumorigenicity

To understand a brief summary, readers have to understand the words in that summary. If a brief summary has too many unfamiliar and uncommon words, readers must decode them, either by using a dictionary or by trying to make sense of them based on familiar words in the sentence. An occasional unfamiliar word might not present problems, but if a 25 word sentence has six unfamiliar words, what is a reader to do? Some words are common to a very small percentage of the population (Table 2); using that kind of specific terminology means that people who do not have the same vocabulary cannot understand the brief summary. It is like reading a foreign language.

The following examples illustrate the difference between unreadable and readable text.

Unreadable: “Warnings. [Drug] should not be used in pregnant women except in clinical circumstances where no alternative therapy is appropriate. If pregnancy occurs while taking [drug] the patient should be apprised of the potential hazard to the fetus”. (36 words, 64 syllables; from a brief summary)

Readable: Warning. Pregnant women shouldn’t take this drug unless there’s no other treatment. Tell pregnant women about risks to their fetus”. (19 words, 31 syllables; author’s “translation” of the brief summary text above).

Brief summaries can be made shorter by converting them to patient information, which follows some basic plain-English principles. The Sidebar presents a summary of these guidelines as a way to make patient summaries more readable.

Conclusion
Direct-to-consumer brief summaries are more unreadable than they need to be, but some drug companies have been willing to move away from the traditional jargon-filled “brief summary” to the much more user-friendly “patient information”. The content and style of DTC materials should be based on an understanding of the individual who takes prescription drugs and the person who needs to read the brief summary or patient information. The two strategies that could most improve the readability of brief summaries are: (1) include consumers in the writing and editing process and (2) use plain-English principles. As the author was told be a lawyer in a federal agency. “You can’t be sued for telling the truth”.

How to write in plain English

Readers *Know the readers. What are the demographics of the individuals taking this drug? *Write for the individual, not for the pharmaceutical company or for the FDA

Words *Avoid jargon and doublespeak that sounds impressive but only confuses people *Take out unnecessary words *Use words that readers know. Let a few consumers be part of the writing and editing team for the brief summary or patient information *Use personal pronouns; write in a more personal style

Sentences *Write an average of 20 words per sentence *Use the active voice instead of the passive voice *Include a summary. Brief summaries are neither “brief” not a “summary” *Use bullet points *Organize the material logically *Follow basic document-design principles *Run the document-design principles *Employ reader testing to see if readers can understand the brief summary