Patient Understanding of Oncology Clinical Trial Endpoints in Direct-to-Consumer Television Advertising.

BACKGROUND: This study examined how people interpret overall survival (OS), overall response rate (ORR), and progression-free survival (PFS) endpoints in the context of direct-to-consumer television ads. Although there is little research on this topic, initial evidence suggests that people can misinterpret these endpoints. We hypothesized that understanding of ORR and PFS would be improved by adding a disclosure ("We currently do not know if [Drug] helps patients live longer") to ORR and PFS claims. METHODS: We conducted 2 online studies with US adults examining television ads for fictional prescription drugs indicated to treat lung cancer (N = 385) or multiple myeloma (N = 406). The ads included claims about OS, ORR with and without a disclosure, or PFS with and without a disclosure. In each experiment, we randomized participants to view 1 of 5 versions of a television ad. After viewing the ad twice, participants completed a questionnaire that measured understanding, perceptions, and other outcomes. RESULTS: In both studies, participants correctly differentiated between OS, ORR, and PFS via open-ended responses; however, participants in the PFS conditions (versus ORR conditions) were more likely to make incorrect inferences about OS. Supporting the hypothesis, adding a disclosure made expectations around living longer and quality-of-life improvements more accurate. CONCLUSION: Disclosures could help reduce the extent to which people misinterpret endpoints like ORR and PFS. More research is needed to establish best-practice recommendations for using disclosures to improve patient understanding of drug efficacy without changing their perception of the drug in unintended ways.

Attention to risk information in direct-to-consumer prescription drug print ads: An eye-tracking study.

PURPOSE: FDA regulations state print ads for prescription drugs must provide a true statement of information "in brief summary" describing "side effects, contraindications and effectiveness." To fulfill these requirements, these ads typically display risk information both as important safety information (ISI) on the "main" ad page with the product claims and on a separate "brief summary" page. The ISI can be lengthy and may repeat brief summary content. METHODS: The authors tested two versions of the ISI (short versus long) and the presence or absence of a brief summary in direct-to-consumer prescription drug print ads for two medical conditions: overactive bladder (N = 181) and rheumatoid arthritis (N = 179). Attention was measured with eye-tracking and self-report methods. Risk retention and perceptions were self-reported. RESULTS: Participants spent more time viewing ads with a long ISI or a brief summary and in some instances, recalled more risks. The combination of a long ISI and a brief summary did not increase or decrease attention to or retention of risk information. CONCLUSION: A long ISI and a brief summary may perform similar functions.

Consumers' experience with and attitudes toward direct-to-consumer prescription drug promotion: a nationally representative survey.

The way consumers get and seek health information reflects the current information landscape. To gather updated insights on consumer experiences with and attitudes towards direct-to-consumer (DTC) promotion of prescription drugs, we conducted a nationally representative survey of 1,744 US adults using a mail-push-to-web methodology with paper nonresponse follow-up. Results showed high exposure and indifferent attitudes to DTC promotion. Respondents reported DTC promotion has prompted action, particularly searches for more information, increased use of online resources, and some reported that they refused to take or stopped taking a prescription drug because they saw or heard about the drug's side effects.

Patients' Understanding of Oncology Clinical Endpoints: Environmental Scan and Focus Groups.

BACKGROUND: Understanding treatment options is important for patients with cancer and their caregivers. This may be difficult, however, because oncology treatments are often approved based on complex clinical endpoints. The study aimed to explore lay understanding of oncology clinical endpoints by assessing the definitions of clinical endpoints available online and gathering qualitative focus group data on cancer survivors' and the general public's understanding of clinical endpoints. METHODS: We conducted an environmental scan to find Web sites accessible by a general audience that defined three clinical endpoints: overall survival, progression-free survival, and response rate. Next, we conducted a series of eight focus groups across the U.S. with cancer survivors (n = 36) and general population adults (n = 36). RESULTS: We found several online resources defining each endpoint; however, many of the definitions we identified used technical language that may not be easily understood by patients and caregivers. Few focus group participants were familiar with the technical terms for these endpoints. When presented with the endpoint terms and definitions, participants had misconceptions about treatment efficacy. Specifically, they tended to expect that all endpoints were a variation on living longer. CONCLUSION: The results point to the need for more patient-friendly definitions of clinical endpoints developed with input from the general public and from patients with cancer. IMPLICATIONS FOR PRACTICE: As the number of oncology prescription drug approvals and the advertising of those drugs to consumers increase, it is timely and critical to understand how to discuss treatment benefits with patients. Patient-friendly definitions of common clinical endpoints, such as overall survival and progression-free survival, would help health care providers describe treatment benefits to patients. This research provides evidence regarding patients' understanding of these endpoints and suggests definitions for additional research. This represents a first step in creating evidence-based patient-friendly language to describe clinical endpoints.

Consumer understanding of the scope of FDA's prescription drug regulatory oversight: A nationally representative survey.

PURPOSE: Misperceptions of how the US Food and Drug Administration (FDA) regulates prescription drugs may affect how consumers assess the safety and efficacy of prescription drugs. The study objective was to survey the public on their knowledge of FDA oversight regarding prescription drug approval and advertising. METHODS: In 2017, we conducted a nationally representative mail-push-to-web survey with 1,744 US adults. RESULTS: Although most respondents (86%) knew that FDA approves prescription drugs, we found misperceptions about what that approval means. In addition, few respondents understood FDA oversight of prescription drug advertising, with approximately half of respondents reporting that they did not know whether FDA approved these ads or components of the ads, and several mis-reporting that FDA approves these ads (31%) or components of the ads (22%-41%). CONCLUSIONS: Enhanced collaboration and communication with the public by key stakeholders in this space could increase public understanding of the roles and responsibilities of FDA.

Direct-to-Consumer Advertising of Prescription Drugs and the Patient-Prescriber Encounter: A Systematic Review.

We systematically reviewed the research on patients' and prescribers' perceptions of, and self-reported behaviors prompted by, exposure to direct-to-consumer advertising (DTCA) (For ease of reading we use the term "advertising" to encompass advertising and promotional labeling. Broad use of this term does not imply endorsement by FDA) of prescription drugs that occurs in the context of a clinical encounter. This research offers an important perspective on the broader goal of incorporating patient and prescriber voices in decision-making. Outcomes included patient information seeking, medication adherence, patient requests for DTCA-promoted prescription drugs, prescribing behaviors, and perceptions of the patient-prescriber relationship and interactions. We searched PubMed and other databases from 1982-2017 and identified 38 studies meeting our study criteria. Of these, 24 studies used patient-reported outcomes and 18 used prescriber-reported outcomes (four used both). Studies suggested some potential benefits of exposure to DTCA, including patients' enhanced information-seeking, increased patient requests for appropriate prescriptions (when addressing potential underuse) and patients' perceptions of higher-quality interactions with prescribers. Most prescribers perceived a neutral influence on the quality of their clinical interactions with patients regarding DTCA. Harms included patients receiving prescriptions for drugs that were not appropriate for them or that the patients did not need, and the potential for DTCA to interfere with medication adherence in some populations, such as those with mental illness. The potential benefits of DTCA on the patient-provider encounter must be balanced with the potential for harms.

Aging and Direct-to-Consumer Prescription Drug Television Ads: The Effects of Individual Differences and Risk Presentation.

To determine how individual difference (age, cognition, and hearing) and risk presentation (audio frequency, speed, and organization) variables affect viewing of direct-to-consumer (DTC) prescription drug television ads, participants (N = 1,075) from four age groups across the adult lifespan took an in-person hearing examination, watched a DTC television ad, and responded to survey questions. Results showed that increased age was related to reduced cognition and hearing ability, as well as lower ad comprehension and risk recall. Greater speed and more complex organization of the ad's risk information lowered risk recall and claim recognition. Audio frequency had no effect. Cognitive abilities mediated the relationship between age and risk recall. Our findings suggest that older adults are likely to have more difficulty recalling and understanding the risks presented in DTC television ads. Risk information can be presented in ways that facilitate or inhibit recall and recognition among individuals across the lifespan.

Communicating Risk Information in Direct-to-Consumer Prescription Drug Television Ads: A Content Analysis.

Direct-to-consumer (DTC) television ads for prescription drugs are required to disclose the product's major risks in the audio or audio and visual parts of the presentation (sometimes referred to as the "major statement"). The objective of this content analysis was to determine how the major statement of risks is presented in DTC television ads, including what risk information is presented, how easy or difficult it is to understand the risk information, and the audio and visual characteristics of the major statement. We identified 68 DTC television ads for branded prescription drugs, which included a unique major statement and that aired between July 2012 and August 2014. We used subjective and objective measures to code 50 ads randomly selected from the main sample. Major statements often presented numerous risks, usually in order of severity, with no quantitative information about the risks' severity or prevalence. The major statements required a high school reading level, and many included long and complex sentences. The major statements were often accompanied by competing non-risk information in the visual images, presented with moderately fast-paced music, and read at a faster pace than benefit information. Overall, we discovered several ways in which the communication of risk information could be improved.

Actors in whitespace: Communicating risk information on pharmaceutical websites.

This study examined the use of an actor to communicate prescription drug risks on pharmaceutical websites. Participants viewed risk information for a fictitious drug in one of several static visual formats or as a paragraph plus an animated actor; and with or without a signal directing them to the risk information text. The signal had little effect on outcomes. Format did not affect risk processing, but participants in the actor condition thought the website placed less emphasis on benefits. Actors communicating risk information on a pharmaceutical website do not appear to improve consumers' understanding of prescription drug information.

Disclosing accelerated approval on direct-to-consumer prescription drug websites.

PURPOSE: We examined direct-to-consumer (DTC) websites for brand-name accelerated approval prescription drugs to determine whether and how accelerated approval is communicated to consumers. METHODS: From the 34 brand-name prescription drugs under the Food and Drug Administration's accelerated approval pathway presubmission requirement for promotional materials in December 2016, we identified a sample of 26 that had active DTC websites. Two raters independently coded the websites for the presence, placement, content, and readability of an accelerated approval disclosure. RESULTS: Most (73%) of the websites contained an accelerated approval disclosure. Most of the disclosures (84%) included the basis for accelerated approval, whereas 68% stated that the clinical benefit of the product was unknown and 47% conveyed the need for additional research to confirm study findings. On average, the disclosures required at least a high school reading level, and most conveyed the information in medical terms. CONCLUSIONS: Direct-to-consumer websites for brand-name accelerated approval prescription drugs do not consistently communicate the accelerated approval information for the product to consumers in a prominent, comprehensive, or readable manner.

Testimonials and Informational Videos on Branded Prescription Drug Websites: Experimental Study to Assess Influence on Consumer Knowledge and Perceptions.

BACKGROUND: Direct-to-consumer (DTC) promotion of prescription drugs can affect consumer behaviors and health outcomes, and Internet drug promotion is growing rapidly. Branded drug websites often capitalize on the multimedia capabilities of the Internet by using videos to emphasize drug benefits and characteristics. However, it is unknown how such videos affect consumer processing of drug information. OBJECTIVE: This study aimed to examine how videos on prescription drug websites, and the inclusion of risk information in those videos, influence consumer knowledge and perceptions. METHODS: We conducted an experimental study in which online panel participants with acid reflux (n=1070) or high blood pressure (n=1055) were randomly assigned to view 1 of the 10 fictitious prescription drug websites and complete a short questionnaire. On each website, we manipulated the type of video (patient testimonial, mechanism of action animation, or none) and whether the video mentioned drug risks. RESULTS: Participants who viewed any video were less likely to recognize drug risks presented only in the website text (P≤.01). Including risk information in videos increased participants' recognition of the risks presented in the videos (P≤.01). However, in some cases, including risk information in videos decreased participants' recognition of the risks not presented in the videos (ie, risks presented in text only; P≤.04). Participants who viewed a video without drug risk information thought that the website placed more emphasis on benefits, compared with participants who viewed the video with drug risk information (P≤.01). Compared with participants who viewed a video without drug risk information, participants who viewed a video with drug risk information thought that the drug was less effective in the high blood pressure sample (P=.03) and thought that risks were more serious in the acid reflux sample (P=.01). There were no significant differences between risk and nonrisk video conditions on other perception measures (P>.05). In addition, we noted a few differences among the types of videos. CONCLUSIONS: Including risks in branded drug website videos may increase in-video risk retention at the expense of text-only risk retention.

Quantitative Information on Oncology Prescription Drug Websites.

Our objective was to determine whether and how quantitative information about drug benefits and risks is presented to consumers and healthcare professionals on cancer-related prescription drug websites. We analyzed the content of 65 active cancer-related prescription drug websites. We assessed the inclusion and presentation of quantitative information for two audiences (consumers and healthcare professionals) and two types of information (drug benefits and risks). Websites were equally likely to present quantitative information for benefits (96.9 %) and risks (95.4 %). However, the amount of the information differed significantly: Both consumer-directed and healthcare-professional-directed webpages were more likely to have quantitative information for every benefit (consumer 38.5 %; healthcare professional 86.1 %) compared with every risk (consumer 3.1 %; healthcare professional 6.2 %). The numeric and graphic presentations also differed by audience and information type. Consumers have access to quantitative information about oncology drugs and, in particular, about the benefits of these drugs. Research has shown that using quantitative information to communicate treatment benefits and risks can increase patients' and physicians' understanding and can aid in treatment decision-making, although some numeric and graphic formats are more useful than others.

Placement and Format of Risk Information on Direct-to-Consumer Prescription Drug Websites.

We investigated whether the location and format of risk information on branded prescription drug websites influence consumers' knowledge and perceptions of the drug's risks. Participants (Internet panelists with high cholesterol [n = 2,609] or seasonal allergies [n = 2,637]) were randomly assigned to view a website promoting a fictitious prescription drug for their condition. The website presented risk information at the bottom of the homepage, or at the bottom of the homepage with a signal above indicating that the risk information was located below, or on a linked secondary page. We also varied the format of risk information (paragraph, checklist, bulleted list, highlighted box). Participants then answered questions on risk recall and perceptions. Participants recalled fewer drug risks when the risks were placed on a secondary page. The signal had little effect, and risk information format did not affect outcomes. The location of risk information on prescription drug websites can affect consumer knowledge of drug risks; however, signals and special formatting may not be necessary for websites to adequately inform consumers about drug risks. We recommend that prescription drug websites maintain risk information on their homepages to achieve "fair balance" as required by the U.S. Food and Drug Administration.

Direct-to-Consumer Promotion of Prescription Drugs on Mobile Devices: Content Analysis.

BACKGROUND: US Food and Drug Administration (FDA) regulations state that any prescription drug promotion that presents drug benefits to consumers must also disclose certain information about the drug's risks in a similar manner. Nearly three-quarters of all US mobile phone subscribers use a smartphone, and over half report receiving mobile advertisements on their device. OBJECTIVE: The objective of this project was to investigate how prescription drugs are being promoted to consumers using mobile technologies. We were particularly interested in the presentation of drug benefits and risks, with regard to presence, placement, and prominence. METHODS: We analyzed a sample of 51 mobile promotional communications and their associated linked landing pages. We assessed the content and format of the mobile communications and landing pages with regard to presentation of drug benefits and risks. RESULTS: Of the 51 mobile communications we coded, 41% (21/51) were product claim communications (includes the drug name, benefits, and risks), 22% (11/51) were reminder communications (includes drug name only), and 37% (19/51) were help-seeking communications (includes information about the medical condition but not the drug name). Some of the product claim communications (5/21, 24%) required scrolling to see all the benefit information; in contrast, 95% (20/21) required scrolling to see all the risk information. Of the 19 product claim communications that presented both benefits and risks, 95% (18/19) presented benefits before risks and 47% (9/19) used a bigger font for benefits than for risks. Most mobile communications (35/51, 69%) linked to branded drug websites with both benefits and risks, 25% (13/51) linked to a landing page with benefits but no visible risks, and 6% (3/51) linked to a landing page with risks but no visible benefits. Few landing pages (4/51, 8%) required scrolling to see all the benefit information; in contrast, 51% (26/51) required scrolling to see all the risk information. Of the 35 landing pages with both benefit and risk information, 71% (25/35) presented benefits before risks and 51% (18/35) used a bigger font for benefits than for risks. CONCLUSIONS: These results indicate that, while risks and benefits are both represented in mobile communications and their associated landing pages, they are not equally prominent and accessible. This has implications for compliance with FDA fair balance regulations.

Disease Information in Direct-to-Consumer Prescription Drug Print Ads.

Direct-to-consumer (DTC) prescription drug advertisements sometimes include information about the disease condition in addition to information about the advertised product. Although the intent of such information is to educate about the disease condition, in some cases consumers may mistakenly assume that the drug will address all of the potential consequences of the condition mentioned in the ad. We investigated the effects of adding disease information to DTC prescription drug print ads on consumer product perceptions and understanding. Participants (4,064 adults) viewed 1 of 15 DTC print ads for fictitious prescription drugs indicated to treat chronic obstructive pulmonary disease, anemia, or lymphoma that varied in disease information presence, type, and format. Participants answered questions that assessed risk and benefit memory, perception, and behavioral intention. Results indicate that exposure to disease information as part of DTC prescription drug ads can promote the impression that the drug addresses consequences of the condition that are not part of the drug's indication.

Consumers' Understanding of FDA Approval Requirements and Composite Scores in Direct-to-Consumer Prescription Drug Print Ads.

In 2 studies, we investigated how laypersons perceive the Food and Drug Administration (FDA) approval process, FDA authority, and the presentation of composite scores in direct-to-consumer (DTC) prescription drug print ads. The 1st study consisted of 4 focus groups (N = 38) in 2 cities. Using a semi-structured guide, a moderator led participants through the viewing of 3 existing DTC print ads that differed in the presence or absence of composite score information, and participants discussed their views of the ads and their understanding of composite scores. The 2nd study surveyed a nationally representative sample of 1,629 individuals from the general population who saw a fictitious DTC print ad and answered closed-ended questions about the same topics. Results showed that knowledge of FDA approval and authority was mixed, with several misconceptions apparent. Many consumers were not familiar with the use of composite scores in a medical context or in advertising and, in the 1st study, expressed distrust of the product and the ad after learning about how composite scores are used. In the 2nd study, receiving composite score information changed the perceived clarity of the ad but not the perceived risk or benefits. Implications for the presentation of complex medical information are discussed.

Are Disease Awareness Links on Prescription Drug Websites Misleading? A Randomized Study.

We sought to determine whether links from branded prescription drug websites to websites containing disease information mislead participants about drug benefits and whether nonsponsorship disclosures diminish this potential effect. We randomly assigned online panelists with depression (N = 1,071) to view a fictitious prescription drug website that had (a) no link to a disease information website (control), (b) a link with no disclosure, (c) a link with a simple nonsponsorship disclosure, or (d) a link with a detailed nonsponsorship disclosure. If participants in the link conditions did not click the link, they were returned to the drug website and encouraged to click it. All participants then completed an online questionnaire assessing recall, perceptions, and intentions. Few participants (12%) clicked the link without prompting; 67% did so when prompted. Compared with control participants, participants in link conditions were more likely to confuse disease information with drug benefits and to recall fewer true drug benefits. Disclosures did not diminish these effects, and exposure to disease information did not affect other perceptions or intentions. Consumers seem to confuse information on disease websites with information on branded prescription drug websites. Disclosures may not adequately help consumers to distinguish between the 2 types of information.

Peer-Generated Health Information: The Role of Online Communities in Patient and Caregiver Health Decisions.

Individuals increasingly access peer-generated health information (PGHI) through social media, especially online health communities (OHCs). Previous research has documented PGHI topics, credibility assessment strategies, and PGHI's connection with well-being. However, there is limited evidence on where, when, and why individuals seek PGHI and how they use PGHI in health decisions. We conducted in-person and online focus groups with verified OHC members (N = 89)-representing 50 different medical conditions and 77 OHCs-to explore these topics. Two researchers independently coded transcripts with NVivo 9.2 and thematically analyzed responses. Most individuals accidentally discovered PGHI during Web searches rather than intentionally seeking it. Individuals valued PGHI primarily as an alternative information source about treatment options, self-care activities, and health care provider questions rather than a source of emotional support, and they acknowledged PGHI's limitation as anecdotal evidence. Individuals used PGHI as a springboard for additional research and patient-provider discussions, ultimately making treatment decisions alongside providers. These findings suggest that individuals use PGHI in much the same way they use traditional online health information and that PGHI facilitates, rather than obstructs, shared decision making with health care providers.

Consumer perceptions of prescription and over-the-counter drug advertisements with promotional offers.

Information on the effects of promotional offers in direct-to-consumer prescription drug ads is limited. In two studies, we examined the effect of promotional offers (e.g., money-back guarantee) and ad type (creating prescription and over-the-counter drug ads by varying the presence of benefit and risk information). We found little effect of promotional offers. Adding benefit (risk) information to the ad increased consumers' knowledge of the benefit (risk) information and their efficacy (risk) perceptions. In most cases, adding risk information to an ad with benefit information increased risk knowledge and perceptions without decreasing benefit knowledge or perceptions.

Do Prescription Drug Ads Tell Consumers Enough About Benefits and Side Effects? Results From the Health Information National Trends Survey, Fourth Administration.

Direct-to-consumer prescription drug advertising (DTCA) is a major source of consumer information about prescription drugs. The present study updates 2002 U.S. Food and Drug Administration phone survey questions that found that 44% and 61% of consumers thought that DTCA did not include enough information about benefits and risks, respectively. The present study was administered by mail using a nationally representative sample, and provides a more in-depth understanding of how these beliefs relate to demographic and health characteristics. Data collected from 3,959 respondents to the National Cancer Institute's 2011 Health Information National Trends Survey find results similar to the 2002 survey: 46% and 52% of respondents thought that DCTA did not include enough information about benefits and risks, respectively. Respondents fell into four groups: 23% agreed that DTCA tells enough about drug benefits and risks, 41% disagreed, 18% expressed no opinion, and 18% had discordant beliefs. DTCA attitudes were negatively associated with education, income, and whether respondents purchase prescription drugs; attitudes were positively associated with whether respondents understand prescription drug information. This study confirms that a plurality of Americans believe that DTCA does not include enough information about benefits and risks, suggesting that the educational effect of DTCA could be improved.