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Evaluation of Consumer-Friendly Formats for Brief Summary in Direct-to-Consumer (DTC) Print Advertisements for Prescription Drugs, Executive Summary

Division of Drug Marketing, Advertising and Communications
Office of Medical Policy, Center for Drug Evaluation and Research
Food and Drug Administration 
May, 2011

The full technical research report may be obtained by contacting one of the Social Science Analysts listed on the DDMAC Research page.
 
EXECUTIVE SUMMARY
 
Section 502(n) of the Federal Food, Drug, and Cosmetic Act specifies that advertisements (ads) for prescription drugs and biological products must provide a true statement of information “in brief summary” about the advertised product’s “side effects, contraindications, and effectiveness.” The prescription drug advertising regulations (21 CFR 202.1(e)(3)(iii)) specify that the information about risks must include each specific side effect and contraindication from the advertised drug’s FDA-approved labeling, including the Warnings, Precautions, Adverse Reactions, and other relevant sections. Historically, sponsors have met this requirement by presenting a display page that has information about both the benefits and the risks of the product, and then either (1) reprinting the risk-related sections of the prescribing information (PI) for the product, originally designed for physician use, or (2) reprinting the entire PI, regardless of the audience for the ad. These approaches to fulfilling the brief summary requirement, while adequate from a regulatory perspective, result in ads that may be difficult to read and understand when used in consumer-directed promotion.
 
To improve its understanding of how consumers use the brief summary and explore ways in which it might be improved, the Food and Drug Administration (FDA) conducted studies to address the following three questions:
  • Does the risk information presented on the first page of the ad (the display page) influence the way that people read through and understand the information in the brief summary, and what topics do people think are important in the brief summary?
  • Do additional details and context about side effects negatively affect the reading and understanding of other risk information in the brief summary?
  • How do alternative formats compare with the commonly used format for the brief summary? 
We addressed each question in a separate study. The following summary provides a brief overview of the major findings from the three studies.
 
Findings from Study 1
 
Study 1 looked at how participants use the brief summary as it currently exists in its long form. The first question we examined was how the presence or absence of a serious risk (in this case, possible heart damage) might affect the way people read and understand the brief summary. 
 
The second question we examined in this study was what brief summary topics people find most useful. Based on the regulations, FDA has long considered certain topics, such as warnings and side effects, to be crucial information for people who are thinking about asking their doctor about a prescription drug. This study was designed to find out whether consumers’ preferences for different types of information in the brief summary overlaps with those topics. In addition to seeing if certain topics would be chosen more often than others, we explored whether participants could be grouped together based on their preferences for certain topics. This allowed us to see if there were individual factors such as literacy level that predicted participants’ preferences for different topics in the brief summary.
 
The study showed that adding a serious risk to the display page did not increase or decrease the time participants spent reading the ad as a whole, the comprehension of the important risk information presented in the brief summary, or participants’ intention to ask about the drug. Thus, we did not find support for the idea that serious risk information “scares people away” from further learning about a drug. We did find that those who spent more time reading the brief summary had higher comprehension. 
 
We also found that characteristics of the individual and not characteristics of the ad explained how much time participants spent on the display and the brief summary pages. Reading speed, age, and health literacy were significantly related to the amount of time spent reading the display page and the brief summary. Specifically, as reading speed decreased and as age increased, the time participants spent on the display page and brief summary increased. For health literacy, participants in the lowest level out of four levels (quartiles) spent less time on the display page and the brief summary than participants in the other three health literacy quartiles. It appears that the effort spent on reading through the brief summary is dependent on ability (e.g., health literacy) and age.
 
 
In addition to comprehension measures, participants were asked about their intentions to search for more information about the advertised product; specifically, to ask their doctor about the drug. Adding a serious risk to the ad did not affect participants’ intention to ask about the drug. Older age was associated with intention to search for more information as was race, with non-White participants reporting greater intention to ask a doctor about the drug than White participants. Those who spent more time reading the brief summary reported greater intention to talk to their doctor about the product. 
 
Participants selected an average of eight topics as most useful, out of a total of 24. The eight topics selected by the greatest percentage of respondents as most useful were: side effects (73.1%), warnings (61.6%), who should not use the product (contraindications; 61.1%), what the product is (54.1%), medical interactions (47.9%), dosing (46.9%), how long it takes to work (45.8%), and precautions (43.5%). Age and health literacy were significantly related to the number of topics selected. Older age was associated with selecting a greater number of topics. For health literacy, participants in the lowest quartile selected fewer topics than participants in the other health literacy quartiles.
 
All topics fell into four types of related information: Actions (what to do in the case of an overdose, how to report side effects, and how to store the medication), Warnings (warnings, precautions, and side effects), Information (how to get more information, information to think about when using the medication, and clinical trial information), and Details (how long it takes to work, ingredients, and how the drug works). Participants could be grouped into five clusters depending on how much information they preferred. The largest cluster, or group, of participants (39.5% of participants) expressed a preference for all four types of information (Actions, Warnings, Information and Details) in the brief summary. In comparison, the second largest cluster, or group, expressed less preference for all of the topics, especially warning-related information. Thus, no one-size fits-all solution seems likely, although the majority of participants were interested in receiving greater amounts of information.
 
Findings from Study 2
 
In this study we explored the idea that adding information to the side effect section of the brief summary (context) can help people better understand the side effects and other, more serious risks as a whole. We added different types of context to the side effect section, varying the presence of information about how likely side effects were to occur (frequency) and, separately, about how long they might last (duration). We were interested in how these changes influence the understanding of the risks of the product, particularly the more serious risks. Additionally, we looked at three levels of information about how well the product worked (the efficacy), providing either no information about the product’s efficacy or information that it worked marginally or well. Finally, we measured individual characteristics of the participants that might affect their understanding of the information, such as age, gender, and health literacy.
 
We found that adding frequency or duration information about the side effects of a product did not affect participants’ risk comprehension for better or worse, nor did it change the amount of time participants spent looking at the display page or brief summary page of the ad. Similarly, adding a sentence to the end of the indication paragraph in the brief summary about how well the product worked did not change the amount of time participants spent reading the display page or brief summary page, and did not affect their comprehension of major risk information in the brief summary. Together, these findings suggest that adding contextual information to the brief summary does not interfere with participants’ understanding of the information. 
 
People come to the brief summary with a wide variety of individual differences that may influence how important they feel certain parts of the information are compared to other parts. These differences, which include numerical skills, health literacy, education, and demographic variables such as gender and age, may also influence participants’ motivation and ability to understand the information. One of the advantages of our study was that we allowed participants to view the brief summary as they normally would, without directing them specifically to particular sections. This enabled us to explore these other factors.
 
We found that participants who spent more time viewing the brief summary understood the risks better and reported a greater likelihood to search for more information about the drug. In terms of individual differences, both motivation and ability played a role in reading through and understanding the brief summary. Risk comprehension was a function of both motivation (gender, perceived symptom severity, and severity of medical condition) and ability (numeracy, literacy, and education). The amount of time spent viewing the ad was also a function of both motivation (BMI, age, gender, perceived symptom severity, and severity of medical condition) and ability (numeracy and literacy). Participants’ likelihood of searching for more information was a function of motivation only (BMI, age, gender, perceived symptom severity, and severity of medical condition). Finally, participants’ judgments about the risk/benefit tradeoff (in other words, the extent to which they agreed that the benefits of using the product were greater than the risks) appeared to be a function of ability (numeracy and education).
 
Findings from Study 3
 
In the final study, we examined the understanding of and preference for four different brief summary designs: a Traditional, multi-column format; a Question and Answer (Q&A) format, resembling some FDA-approved patient package inserts; a Highlights version from the content and format rule of 2006[1]; and a Prescription Drug Facts box format, based on the over-the-counter (OTC) Drug Facts Box. We found that the format of the information mattered in several ways. Participants who viewed the Drug Facts format were better able to recall risks than those who saw the Traditional format but they did not differ in their ability to apply the risk information to new situations. Participants who viewed the Drug Facts format reported greater confidence to perform tasks related to the information in the brief summary than those who saw the Traditional format. 
 
In terms of preference, the Drug Facts format was ranked highest, followed by the Q&A format, the Traditional format, and finally the Highlights format. Participants had more positive attitudes toward the Drug Facts format than any other format and had more positive attitudes toward the Q&A format and the Highlights format than toward the Traditional format.
 
The brief summary format affected participants’ attitudes toward the ad itself. Participants in the Drug Facts format condition had more positive attitudes toward the ad than did those in the Highlights condition and the Traditional format condition. In addition, participants in the Q&A format condition had more positive attitudes toward the ad than did those in the Traditional format condition.
The formats did not differ from each other in terms of intention to seek more information about the product, the weighing of benefits and risks, or, interestingly, time spent reading the display page or the brief summary.
 
Conclusions
 
Taken together, the results of these studies provide insights into how consumers use information in the brief summary and ways in which the information could be improved. We found that the addition of a serious risk to the display page and the addition of frequency and duration information about side effects in the brief summary did not negatively affect the understanding of the risk information as a whole, including the most serious warnings and precautions. Thus, the addition of other types of context to the brief summary, such as numerical (quantitative) summaries, can be explored with less concern about overloading readers.
 
Furthermore, we identified groups of participants with distinctly different information needs and preferences. These groups had different approaches to the brief summary. Whereas some participants agreed that fewer topics could be presented in the brief summary of print advertising, a larger number of participants thought that all of the topics presented were important. This suggests that many consumers would not prefer a reduction in the number of topics presented in the brief summary.
 
The results also demonstrate that when people choose to spend time reading the brief summary, they are able to understand the major risk concepts in the document, are more likely to choose additional topics of importance, and are more likely to try to find more information about the product. These findings are consistent with the basic idea that people who are more interested in an issue will spend more time thinking about and learning about that issue. We found no systematic differences across medical conditions, a finding that strengthens the applicability of these results.
 
Health literacy emerged as an important variable in Studies 1 and 2. Participants’ level of health literacy significantly determined the amount of attention to and understanding of the ad in general, and the brief summary in particular. The participants in our studies that scored at the lowest level of health literacy spent less time reading the ad and chose fewer topics as important compared to study participants who scored higher on our measure of health literacy. Based on these findings, we recognize the need to address the challenges faced by lower health literacy patients when reading an information-dense document like the brief summary. Exactly how to balance the needs of lower health literacy patients versus those with higher literacy cannot be answered by the current studies, however, and we encourage further investigation of this issue in future research.
 
Finally, the third study demonstrated that format plays a role in terms of the recall of information, format preference, and how confident participants felt in using the information from the brief summary. These results suggest that format is a variable that should be considered seriously, especially with regard to creating alternatives to the traditional multi-column format.
 
As with any research, these studies have limitations. First, we used volunteers who self-identified as having the medical condition treated by the advertised drug, or, in the case of Study 1, self-identified as a caregiver for another person with that condition. We did not weight our sample to estimate effect sizes for alternative samples or to extrapolate to the U.S. population. Therefore, although we did not find systematic differences between medical conditions or patients versus caregivers, future research may address alternative conditions and groups of participants. Second, these studies attempted to balance the tension between the need for experimental control and external realism. One example of this is illustrated by the varied efficacy information in Study 2, which involved realistic information presented in a conservative, realistic manner by adding a short description to the indication section of the brief summary. This was one way to present this variable; other methods may yield different results. 
 
Although we could not assess all aspects of the brief summary, these results point toward future avenues of research. For instance, additional research is needed to clarify the role that the brief summary plays within consumers’ total search for information about the advertised product and treatment options in general. Under the adequate provision requirement sponsors must provide consumers with detailed product information in an anonymous and readily available manner. The brief summary portion of print ads provides one way for meeting this requirement. In study 1 we found dramatic differences among consumers in their preferences for what topics should be provided there. This research did not, however, look at whether these differences reflect specific motivations related to the brief summary (such as participants’ need for anonymity or perceptions of trustworthiness) or whether these differences reflect levels of general information use that might be seen with regard to any source of information.
 
This research presented consumers with print ads in a “virtual” (computer) but fairly limited “e-zine” format. Participants had the ability to page back and forth between the display page and the brief summary. This format provided useful data on reading speed and dwell times. Future research is needed to extend this work and to assess the effects of increased interactivity provided by today’s technologies. As consumers gain increased access to numerous sources of information, the issues addressed in these studies – literacy, format, topics, context and quantitative representations – will become even more important. 
 
This series of studies is one of the most in-depth investigations of the brief summary to date. Our studies provide policy makers and researchers with important information regarding the topics and amount of information people want in the brief summary and the role of context and format in the understanding of the document. It is our hope that the application of these findings will contribute to the improvement of communication to consumers regarding their use of prescription drugs.


[1] See 21 CFR 201.56, 201.57, 201.58, 201.80.

 

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