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.

Complexity of Data Displays in Prescription Drug Advertisements for Healthcare Providers.

BACKGROUND: Healthcare providers (HCPs) often encounter clinical trial results in the form of data displays in prescription drug promotions. Information conveyed in data displays vary in their presentation and complexity. This study describes characteristics of data displays in prescription drug advertising targeted to HCPs. METHODS: This study characterized the content of 140 data displays in 98 unique print advertisements from 2009 to present and identified in AdPharm, an online database of pharmaceutical advertisements. Two reviewers independently coded the advertisements for characteristics (κ = 0.85) including complexity, format, and quality. RESULTS: About one-third (32%) of the advertisements contained multiple data displays (range 2 to 6) and 44% showed clinical data from oncology trials; other disease domains were mental and behavioral health (14%), rheumatology and autoimmune disorders (8%), endocrinology (7%), cardiology (6%), infectious disease (6%), pulmonology and allergy (4%), and others (< 2% each). About one-half (51%) of displays were classified as "simple" which included "pseudographs" and basic tables or charts. "Complex" displays appeared as survival curves, line graphs, or bar graphs with complex features. Most complex displays included a comparator drug (90%), plain language restatement of the key finding (93%) and disclosure statements (91%) with additional study details, although their placement varied. Complex displays were of high quality, according to our selected indicators; our analysis found no data distortion or errors. CONCLUSION: Data displays in prescription drug advertising are often highly complex. Future research assessing understanding of data displays and the potentially beneficial effect of disclosures and other features is warranted.

A scoping review of empirical research on prescription drug promotion.

BACKGROUND: Pharmaceutical spending on prescription drug promotion is considerable, and exposure to advertising can influence demand and behavior. The U.S. Food and Drug Administration (FDA) provides industry guidance to help ensure that communications to consumers and health care providers about prescription drug promotion are truthful, balanced, and accurately communicated. As empirical research has accelerated on this topic in the past decade, an understanding of the current landscape of the science will help inform future research. OBJECTIVES: Using systematic methods, this rigorous scoping review of the literature over the past decade (2012-2021) (1) examined the extent to which prescription drug promotion has been empirically investigated with consumers, patients, and health care providers; (2) examined the extent to which content and features of prescription drug promotion have been empirically investigated; and (3) identified themes across the literature to better understand the current landscape of prescription drug promotion. METHODS: Databases searched include PubMed, Web of Science, CINAHL, APA PsycInfo, Business Source Corporate, Communication Source, Cochrane Library, and ClinicalTrials.gov for original research published in English from January 1, 2012, through November 10, 2021, using terms related to direct-to-consumer advertising, prescription drugs, and outcomes of interest (e.g., attitudes, perceptions, intentions, behaviors). RESULTS: Of 804 screened references, 151 studies addressed the first research question, and 40 studies addressed the second. The most common theme across the body of evidence focused on testing of features and content in prescription drug promotional materials (84), followed by studies examining attitudes, perceptions, and behaviors toward prescription drug promotion more generally (43). Some (27) studies focused on targeted populations, such as patients, the elderly, non-English speaking people or individuals of a non-white race/ethnicity. Twenty-four studies assessed influence of exposure to prescription drug promotion on actual clinical outcomes, while 11 studies examined emerging technologies around prescription drug promotion. Seven studies evaluated the extent to which prescription drug promotion complied with existing guidelines and requirements. CONCLUSIONS: Findings from this scoping review suggest there has been an increase in the number of empirical studies conducted on prescription drug promotion over the past decade. Potential areas that warrant further study include examination of emerging technologies, an expanded focus on targeted populations, and construct measurement.

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.

Character-space-limited online prescription drug communications: Four experimental studies.

BACKGROUND: Character-space-limited (CSL) communications (e.g., tweets) present a challenge for maintaining fair balance between risks and benefits in direct-to-consumer prescription drug promotion. Current FDA guidance advises incorporating risk information within the CSL communication. Because space is limited, others suggest only linking to risk information. OBJECTIVES: The primary objectives were to examine the effects of (1) including substantive risk information in CSL communications versus only providing a link to risk information and (2) including risks and benefits versus only risks on the linked landing page. METHODS: Four experimental studies (N = 469 per study) were conducted. Participants self-reported migraine (Studies 1 and 2) or being overweight (Studies 3 and 4). Participants were instructed to either browse or search a mock Google (Studies 1 and 3) or Twitter (Studies 2 and 4) search page that included the study CSL communication. The CSL communication either did or did not include risk information, and its linked landing page either did or did not include benefit information. Half the participants used a mobile device and half used a desktop/laptop. Participants viewed the search page once without prompting to pay attention to the CSL communication and a second time with prompting. RESULTS: Including the risk in the CSL communication increased the likelihood that participants would recognize the risk after the first viewing (three studies) and second viewing (four studies). However, after the second viewing, including the risk decreased the likelihood that participants would click the landing-page link (three studies), and decreased the number of landing-page-only risks recognized (three studies). Including the drug's benefit on the landing page increased benefit recognition (four studies) without negatively affecting risk recognition or risk perceptions (three studies). CONCLUSIONS: The results provide a first look at the tradeoffs for consumer understanding of drug risks and benefits when drugs are promoted in CSL communications.

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.

Physicians' use of and preferences for FDA-approved prescribing information.

BACKGROUND: The Prescribing Information (PI) is the US Food and Drug Administration (FDA)'s primary tool for communicating a summary of the essential scientific information needed for the safe and effective use of a prescription drug to healthcare providers.[1] One challenge with this type of communication is balancing the need to be thorough with the need to be concise. OBJECTIVES: This study aimed to explore physicians' preferences for and understanding of specific content and formatting in the PI. This study also explored physicians' use of and perceptions of the PI. METHODS: Seventy semi-structured qualitative interviews were conducted with primary care physicians (n = 35) and physicians from a wide range of specialties (n = 35) using web conferencing technology. Using fictitious PI examples, the guide assessed physicians' interpretation of language and preferences for how certain information is organized and communicated in select sections of the PI. The interview guide also included questions about the resources physicians use to find information about prescription drugs, when and how physicians access the PI, and their perceptions of the PI. RESULTS: The findings suggest that of the content and formatting items surveyed, physicians had the greatest preference for: (1) uniformly specifying the age group for which the drug is indicated in the INDICATIONS AND USAGE section, even for medical conditions that are highly associated with only one particular age group (e.g., adult patients), and (2) uniformly including administration information in relation to food (e.g., "with or without food") in the DOSAGE AND ADMINISTRATION section for drugs with oral dosing. The findings also suggest that including a long list of interacting drug examples in the DRUG INTERACTIONS section may be misinterpreted to be a comprehensive list. CONCLUSION: This qualitative research suggests physicians may prefer more clarity in some sections of the PI.

Assessing the Inclusion of Foil Items in a Scale to Measure Recognition of Health Messages.

Researchers frequently measure recognition of information in health messages by presenting participants with statements that were or were not in a message and then asking them to identify which were presented and which were not. Recognition scales are then calculated by summing the correct responses to both the true items and foils, or by summing the correct responses to the true items only. We used a sequence of psychometric analyses, including factor analysis and item response theory (IRT) analysis, to evaluate two recognition measures of this type, using data from previously published studies. We found that foils are less associated with true items than true items are with one another, or more practically, that foils are less associated with the underlying dimension of interest. These results provide researchers with insight into how recognition items function, as well as a better analytic approach for use in future studies.

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.

Visual images of prescription drug benefits in direct-to-consumer television advertisements.

OBJECTIVE: Images demonstrating a prescription drug's efficacy are often included in direct-to-consumer television advertisements. The current research assessed whether exaggerated efficacy images can mislead individuals, and whether providing accurate quantitative information can reduce these misperceptions. METHODS: We conducted two experimental studies with internet panelists 60 years and older testing drug efficacy images in television ads for wet age-related macular degeneration (N = 901) and plaque psoriasis (N = 902). In each study, participants viewed one of six ads that varied in the efficacy images included (no image, accurate image, exaggerated image) and the presentation of quantitative information (absent, present). Measures included recall, perceptions, and numeracy. RESULTS: In both studies, participants who saw exaggerated images were more likely than those who saw no image or accurate images to overestimate efficacy. Presenting quantitative information increased participants' gist and verbatim recall of drug efficacy, and in some cases, led participants to have more accurate perceptions of the drug's efficacy even in the presence of exaggerated images. Higher numeracy was associated with better gist and verbatim recall. CONCLUSIONS: These results support visual persuasion theory. Moreover, they show that exaggerating benefits visually can mislead viewers. PRACTICE IMPLICATIONS: Stakeholders should ensure that images in direct-to-consumer promotion are accurate and non-misleading.

Development and validation of prescription drug risk, efficacy, and benefit perception measures in the context of direct-to-consumer prescription drug advertising.

PURPOSE: Understanding patient perceptions of prescription drug risks and benefits is an important component of determining risk-benefit tradeoffs and helping patients make informed medication decisions. However, few validated measures exist for capturing such perceptions. The purpose of this study was to develop and validate measures of perception of prescription drug risk, efficacy, and benefit. METHODS: We conducted a mixed-methods study to develop and validate the measures, including three waves of quantitative testing (item nonresponse, criterion-related validity, and convergent validity). We conducted quantitative testing with a probability-based online consumer panel of U.S. adults (n = 7635), eliminating weaker items after each testing wave. RESULTS: Upon completion of all testing, we identified 21 validated measures that represent 11 distinct risk/benefit constructs. The final measures demonstrated face validity, convergent validity, criterion-related validity, and scale reliability in both illness and general population samples, among patients with both symptomatic and asymptomatic health conditions, and in response to both television and print direct-to-consumer prescription drug advertisements. CONCLUSIONS: Our study produced a set of items that researchers and practitioners can use to assess patient perceptions of prescription drug risk, benefit, and efficacy and to ensure greater future comparability between studies.

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.

Patients' understanding of oncology clinical endpoints: A literature review.

OBJECTIVES: Oncology clinical trials use a variety of clinical endpoints. Patients' understanding of the differences between clinical endpoints is important because misperceptions of treatment efficacy may affect treatment decisions. The objective of this literature review is to find and synthesize available empirical publications assessing patients' understanding of common oncology clinical endpoints. METHODS: We conducted a literature search of 5 databases and 3 conferences, limiting the search to articles and abstracts published in English through September 2018. We reviewed the titles and abstracts for inclusion, then reviewed full texts to determine if they reported empirical research studies focused on (1) clinical endpoints, (2) oncology, and (3) patient understanding. The original search identified 497publications, of which 13 met the inclusion criteria. RESULTS: Available literature yields little information on this topic.The few publications that do exist suggest that healthcare professionals and cancer patients generally do not discuss clinical endpoint concepts and that patients can be confused about the purpose of a treatment based on misperceptions about endpoints. CONCLUSIONS: Research is needed on how to discuss oncology clinical endpoints with patients. PRACTICE IMPLICATIONS: Patient-friendly definitions of clinical endpoints may help healthcare providers communicate important information about treatments to patients.

Direct-to-Consumer Prescription Drug Advertising and Patient-Provider Interactions.

BACKGROUND: Direct-to-consumer prescription drug advertising is prevalent and affects patient care. Previous research that examined its effect on the patient-provider relationship predates many changes in the advertising and medical landscape that have occurred in the last decade, such as the rise in online promotion and the push for value-based medicine. METHODS: We conducted a nationally representative mail-push-to-web survey of 1744 US adults in 2017 to explore how patients view the effects of direct-to-consumer prescription drug advertising on patient-provider interactions. RESULTS: Most respondents (76%) said they were likely to ask a health care provider about advertised drugs; 26% said they had already done so. Among the 26% of respondents who talked to a health care provider about a specific prescription drug they saw advertised, 16% said they received a prescription for the advertised drug. Few respondents (5%) reported that advertising had caused conflict with a health care provider, 16% said it had caused them to question their provider's advice, and 23% said they were likely to look for a different provider if their provider refused to prescribe a requested brand name drug. DISCUSSION: These results suggest that direct-to-consumer advertising is driving some patients to discuss specific products with their health care providers but that most patients do not believe advertising has a negative influence on the patient-provider interaction itself.

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.

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.

The Effect of Including Quantitative Information on Multiple Endpoints in Direct-to-Consumer Prescription Drug Television Advertisements.

Background. Previous research found that adding a single piece of quantitative information about prescription drug benefits to direct-to-consumer (DTC) ads helps consumers understand how well the drug works. However, drug information often includes quantitative information on multiple benefit outcomes and risks. Thus, we examined whether consumer understanding was similarly improved when DTC television ads include varying amounts of quantitative information. Methods. We randomly assigned participants (945 Internet panelists ≥ 60 years old) to view 1 of 9 fictitious prescription drug television ads that varied the presentation of quantitative information for benefits (none, single outcome, 2 outcomes) and risks (none, 1 risk category, 3 risk categories) and then measured gist and verbatim recall/estimation and drug perceptions. Results. Adding a single benefit outcome and a single risk category replicated past results. Compared with an ad containing no quantitative information, presenting 2 benefit outcomes and multiple risk categories increased gist and verbatim recall and affected drug perceptions. Compared with presenting a single benefit outcome, presenting 2 benefit outcomes increased verbatim recall for the second outcome but decreased verbatim recall for the first outcome. Likewise, compared with presenting a single risk category, presenting multiple risk categories increased gist and verbatim recall for the multiple risk categories but decreased gist recall for a concept more closely associated with the single risk category. Adding multiple risk categories decreased risk perceptions even more than did the single risk category. Limitations. This study may have limited generalizability because it examined an ad for only 1 medical condition. Conclusions. There are tradeoffs to adding multiple quantitative benefit outcomes in DTC ads. However, presenting multiple quantitative risk categories helps consumers better understand a drug's risks.

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.

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.