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.

Physician Perceptions of the FDA's Breakthrough Therapy Designation: An Update.

The US Food and Drug Administration developed the Breakthrough Therapy designation to expedite the development and review of drugs that show a clear advantage over available therapy for serious conditions. Prior research has shown that physicians tend to misunderstand that a drug may receive a Breakthrough Therapy designation based on preliminary clinical evidence (eg, effect on a surrogate endpoint or intermediate clinical endpoint that is likely to predict clinical benefit). The objective of this article is to examine whether physicians' familiarity with and interpretation of the Breakthrough Therapy designation have changed since a survey on the topic was published in 2016. We replicated three of the questions in that study and explored beliefs that a Breakthrough Therapy designation automatically qualifies a drug for accelerated approval. We also draw comparisons by specialization (oncologists vs. primary care physicians). In general, physicians remain more likely than not to misunderstand the Breakthrough Therapy designation.

Detecting and Reporting Deceptive Prescription Drug Promotion: Differences Across Consumer and Physician Audiences and by Number and Type of Deceptive Claims and Tactics.

The U.S. Food and Drug Administration's (FDA) Bad Ad program provides an avenue for healthcare providers to report false or misleading prescription drug promotion. Yet, whether healthcare providers can detect such promotion, and whether they believe it should be reported to FDA, remain open questions. Consumer audiences may also be capable of detecting such promotion and believe it should be reported, but even less is known about capability and belief in this population. Across two experiments using mock pharmaceutical websites, this research investigated capability to detect and inclination to report deceptive prescription drug promotion among a sample of primary care physicians and consumers. Study 1 varied the number of deceptive claims and tactics on a website for a chronic pain medication, operationalized as none, two, or five. Study 2 varied the type of deceptive content on a website for a weight loss medication, operationalized as none, implicit, or explicit. Findings reveal that, in line with expectations from FDA's Bad Ad program, physicians can detect deceptive promotion and tend to believe it should be reported. Consumers are also capable of detecting deceptive promotion and tend to believe it should be reported, but their capabilities and beliefs regarding reporting are generally lower.

Physician Interpretation of Data of Uncertain Clinical Utility in Oncology Prescription Drug Promotion.

BACKGROUND: Little is known about how physicians interpret data displays that depict preliminary or exploratory clinical data in physician-targeted sales aids for oncology drugs. Using three factorial experiments, we examined whether disclosures of data limitations and clinical uncertainty adequately communicate the limitations and practical utility of this type of data. SUBJECTS, MATERIALS, AND METHODS: The studies used a 2 (disclosure of data limitations: technical, nontechnical) × 2 (disclosure of clinical uncertainty: present, absent) + 1 (control: no disclosure) between-subjects experimental design to examine the impact of disclosures as they relate to presentations of preliminary or exploratory data in promotional communications for oncology products. In each experiment, we randomized oncologists and primary care physicians with oncology experience to view one version of a two-page sales aid. Following this exposure, physicians completed a web-based survey. The design was replicated in three concurrently conducted experiments using sales aids for different fictitious oncology drugs, each featuring one of three common data displays: a forest plot (n = 495), a Kaplan-Meier curve (n = 504), or a bar chart (n = 532). RESULTS: Results provide initial evidence that in some contexts disclosures can improve understanding of the clinical utility of certain information about a drug and the limitations of results presented in a data display. Disclosures can also temper perceptions of how much evidence is presented that supports a conclusion that the drug is an appropriate treatment. In terms of the language used in the disclosure of data limitations, physicians in all three experiments strongly preferred the nontechnical disclosures. CONCLUSION: The findings from the three experiments in this study suggest that disclosures have the potential to increase relevant knowledge, but more research is needed to establish best practice recommendations for using disclosures to convey contextual information relevant for interpreting data displays in promotional communications. IMPLICATIONS FOR PRACTICE: This article reports the results from three large, online experimental studies that address a growing concern that drug companies often share favorable clinical trial results with physicians in promotional materials that lack important context for physicians to interpret the data. This series of studies investigates whether strategic use of two types of disclosures (disclosure of data limitations and a disclosure of clinical uncertainty) improves understanding and reduces misinterpretations among physicians. The results from these studies help identify communication factors that impact how physicians critically appraise preliminary or exploratory clinical trial data to inform policy and regulatory efforts.

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.

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.

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.

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.

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.

Awareness of the Food and Drug Administration's Bad Ad Program and Education Regarding Pharmaceutical Advertising: A National Survey of Prescribers in Ambulatory Care Settings.

The U.S. Food and Drug Administration's Bad Ad program educates health care professionals about false or misleading advertising and marketing and provides a pathway to report suspect materials. To assess familiarity with this program and the extent of training about pharmaceutical marketing, a sample of 2,008 health care professionals, weighted to be nationally representative, responded to an online survey. Approximately equal numbers of primary care physicians, specialists, physician assistants, and nurse practitioners answered questions concerning Bad Ad program awareness and its usefulness, as well as their likelihood of reporting false or misleading advertising, confidence in identifying such advertising, and training about pharmaceutical marketing. Results showed that fewer than a quarter reported any awareness of the Bad Ad program. Nonetheless, a substantial percentage (43%) thought it seemed useful and 50% reported being at least somewhat likely to report false or misleading advertising in the future. Nurse practitioners and physician assistants expressed more openness to the program and reported receiving more training about pharmaceutical marketing. Bad Ad program awareness is low, but opportunity exists to solicit assistance from health care professionals and to help health care professionals recognize false and misleading advertising. Nurse practitioners and physician assistants are perhaps the most likely contributors to the program.

Randomized study of placebo and framing information in direct-to-consumer print advertisements for prescription drugs.

BACKGROUND: Research suggests that quantitative information in direct-to-consumer (DTC) prescription drug ads may be helpful for consumers. PURPOSE: The objective was to examine the effect of adding placebo rates and framing to DTC ads. METHODS: In study 1, 2,000 Internet panel members with chronic pain participated in a randomized controlled experiment of DTC ads varying in placebo rate and framing. In study 2, 596 physicians ranked DTC ads varying in placebo rate and framing by how well they conveyed scientific information and their usefulness for patients. RESULTS: In study 1, participants who viewed placebo rates were able to recall them and use them to form certain perceptions. A mixed frame led to lower placebo rate recall and perceived efficacy. In study 2, overall, physicians preferred a placebo/single frame ad. CONCLUSIONS: Adding placebo rates to DTC ads may be useful for consumers. The evidence does not support using a mixed frame.

Physician interpretation of information about prescription drugs in scientific publications vs. promotional pieces.

BACKGROUND: Physicians gain knowledge about medical product uses from a variety of information vehicles including FDA-approved labeling, peer-reviewed journal articles, compendia, continuing medical education (CME), and physician-directed promotion. The source of this information, the quality of the information, and environmental pressures such as lack of time may impact perceptions. OBJECTIVE: The authors tested the effect of three types of information sources (journal abstract, sales aid without graphics, sales aid with graphics), the presence or absence of time pressure to read the information, and two levels of methodological rigor (high, low) on perceptions of study quality, perceptions of product effectiveness and riskiness, and prescribing likelihood. METHODS: Primary care physicians (n = 630) were randomly assigned to view one version of a study abstract and then answered questions. RESULTS: Participants who viewed a high-methodological rigor study reported more perceived credibility and importance of the data (ps < .05), and less need for interpreting the study data with caution and less bias than those who viewed a low-rigor study. Those who were not under time pressure to read the stimuli rated the fictitious study description as more credible, rigorous, important, and had more confidence in study data than those who were under time pressure. Participants who had less time to review high-rigor journal abstracts and sales aids with graphics were less likely to agree the study data should be interpreted with caution than doctors who had more time with the stimuli. No effects of source type were observed. CONCLUSIONS: The results suggest that prominently disclosing methodological rigor helps the audience form an accurate perception of the presented information. This also further highlights the importance that any promotional communications should be truthful and non-misleading.

Influence of data disclosures on physician decisions about off-label uses: findings from a qualitative study.

BACKGROUND: Prescribing approved products for unapproved uses (off-label use) is not uncommon among physicians in certain medical specialties. Available evidence about an off-label use - both supportive and unsupportive - can influence prescribers' decisions about a drug's appropriateness for a particular case. The objectives of this study were: (1) to examine physician perceptions about off-label uses generally, including their awareness of unsupportive data; and (2) to explore the influence of disclosure information about unsupportive data on off-label prescribing decisions. METHODS: Semi-structured interviews were conducted between December 2019 and January 2020 with oncologists (n = 35) and primary care physicians (n = 35). Interviews explored general prescribing practices, understanding of and information sources for learning about off-label use of prescription drugs, awareness of unsupportive data related to off-label uses, and preferences and reactions to disclosure statements about the existence of unsupportive data related to an off-label use. RESULTS: Most participants reported prescribing drugs for off-label uses (with half reporting regular off-label prescribing). However, among those who prescribe off-label, approximately two-thirds had never seen unsupportive data about off-label uses. Physicians preferred a disclosure statement that provided a summary of the unsupportive data about the off-label use; this statement also led most physicians to say they were unlikely or less likely to prescribe the drug for that use. CONCLUSIONS: This study suggests that physicians' decision-making about prescribing for off-label uses of approved drugs may be influenced by awareness of unsupportive data. Our interviews also suggest that providing more information about unsupportive study findings may result in a reduction in reported prescribing likelihood.

The impact of interactive advertising on consumer engagement, recall, and understanding: A scoping systematic review for informing regulatory science.

We conducted a scoping systematic review with respect to how consumer engagement with interactive advertising is evaluated and if interactive features influence consumer recall, awareness, or comprehension of product claims and risk disclosures for informing regulatory science. MEDLINE, PsycINFO, Business Source Corporate, and SCOPUS were searched for original research published from 1997 through February 2021. Two reviewers independently screened titles/abstracts and full-text articles for inclusion. Outcomes were abstracted into a structured abstraction form. We included 32 studies overall. The types of interactive ads evaluated included website banner and pop up ads, search engine ads, interactive TV ads, advergames, product websites, digital magazine ads, and ads on social network sites. Twenty-three studies reported objective measures of engagement using observational analyses or laboratory-based experiments. In nine studies evaluating the association between different interactivity features and outcomes, the evidence was mixed on whether more interactivity improves or worsens recall and comprehension. Studies vary with respect to populations, designs, ads evaluated, and outcomes assessed.

Opioid Education and Prescribing Practices.

BACKGROUND: Lack of training among health care providers (HCPs) to safely prescribe opioids is a contributing factor to the opioid crisis. Training and other resources have been developed to educate providers about safe and appropriate opioid prescribing practices. METHOD: The national survey was conducted with 2000 HCPs representing primary care physicians (PCPs), including family practice, general practice, and internal medicine; specialists (SPs); physician assistants (PAs); and nurse practitioners (NPs), a mix of primary care and specialists. This survey examined exposure to opioid educational information and opioid prescribing. RESULTS: PCPs reported prescribing opioids for chronic pain to significantly more patients compared with other HCP groups. PCPs (89.8%) and NPs (85.5%) reported significantly greater exposure to opioid educational information compared with both SPs (71.9%) and PAs (78.8%). Overall, HCPs had limited knowledge about abuse-deterrent formulations, but PCPs had greater knowledge than other groups. HCPs had an increased likelihood of prescribing opioids to fewer patients in the last 3 months relative to the prior 12 months if they worked in a state or county clinic vs a solo or group practice type (adjusted odds ratio [AOR] = 1.97; 95% confidence interval [CI], 1.12-3.49) and were exposed to more opioid educational information during the last 12 months (AOR = 1.19; 95% CI, 1.06-1.32). DISCUSSION: HCPs' exposure to opioid educational information was associated with less opioid prescribing for chronic pain. Findings indicated a difference in exposure and knowledge gaps across provider groups. More information is needed on the content of opioid educational information provided to HCPs.