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.

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.

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.

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.

Effects of additional context information in prescription drug information sheets on comprehension and risk and efficacy perceptions.

OBJECTIVE: To determine how additional explanatory text (context) about drug side effects in a patient medication information handout affected comprehension and perceptions of risk and efficacy. METHODS: We conducted an online experiment with a national sample of 1,119 U.S. adults with rheumatoid arthritis and related conditions, sampled through random-digit dialing, address-based sampling, and online ads. We randomized participants to receive one of several versions of a patient information handout for a fictitious drug, either with or without additional context, then measured comprehension and other outcomes. RESULTS: Additional qualitative context about warnings and side effects resulted in lower comprehension of side effect information, but not information about uses of the drug or warnings. The effect of additional context on risk perceptions depended on whether the medication handout was delivered online or through the mail. Those who received a hardcopy of the handout with additional context had higher perceived risk of side effects than those who saw the version without additional context. CONCLUSION: More clarifying information is not always better and may lead to cognitive overload, inhibiting comprehension. PRACTICE IMPLICATIONS: Additional research should further explore effects of context in online vs. hard-copy formats before practice implications can be determined.

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.

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.

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.

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.

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.

What influences healthcare providers' prescribing decisions? Results from a national survey.

BACKGROUND: Prior U.S. Food and Drug Administration (FDA) surveys with healthcare providers (HCPs) have focused on attitudes toward direct-to-consumer advertising and have not specifically examined professionally-targeted prescription drug promotion. Similarly, there are no recent national surveys of HCPs examining their interactions with the pharmaceutical industry. OBJECTIVES: The goal of this study was to use a national sample of HCPs to examine exposure to professionally-targeted prescription drug promotions and interactions with industry, and knowledge, attitudes and practices related to FDA approval of prescription drugs. METHODS: An online national survey was conducted with 2000 HCPs representing primary care physicians (PCPs), specialists (SPs), physician assistants (PAs), and nurse practitioners (NPs). The sample was randomly drawn from WebMD's Medscape subscriber network, stratified by HCP group, and designed to yield target numbers of completed surveys in each group. Weights were computed to correct for unequal selection probabilities, differential response rates, and differential coverage and used to generalize completed surveys to a national population of PCPs, SPs, NPs, and PAs. RESULTS: Exposure and attention to pharmaceutical promotions and contact with industry were significantly associated with reported increase in pharmaceutical industry influence on decisions about prescription drugs. SPs were significantly more likely to prescribe off-label and serve as opinion leaders for the pharmaceutical industry compared to other provider groups. CONCLUSIONS: Findings indicate pharmaceutical promotions directed at HCPs occur in many forms and are disseminated through multiple channels. By using a nationally representative sample of HCPs, this study provides population-level estimates for exposure and attention to prescription drug promotion and contact with industry and evidence for their influence on prescriber decisions. Findings from this study will help to inform FDA of HCP responses to and impacts of prescription drug promotion.

Experimental evidence of consumer and physician detection and rejection of misleading prescription drug website content.

BACKGROUND: Consumers and primary care physicians (PCPs) sometimes encounter deceptive promotional claims about prescription drugs. Whether consumers and PCPs can detect deceptive claims or whether those claims negatively affect medical decision making, however, remain important, unanswered research questions. OBJECTIVES: This article explores (1) the ability of consumers and PCPs to identify deceptive prescription drug promotion at various levels of deception, (2) the influence of such tactics on obstructing risk recognition, and (3) whether perceived deception mediates relationships between exposure to deceptive tactics and various outcomes (including false-claim acceptance, attitudes, information-seeking intentions, and interest toward the promoted drug). METHODS: Two experiments-1 with consumers (N = 366) and 1 with PCPs (N = 378)-were conducted to determine whether participant exposure to deceptive prescription drug website content corresponds to detection and acceptance (or rejection) of claims and tactics. In each experiment, the number of deceptive claims and tactics on a consumer- or PCP-targeted website for a fictitious chronic pain medication were varied, in a 1 × 3 (none, fewer, more) between-subjects design. RESULTS: Among consumers, exposure to more deceptive claims or tactics did not increase suspicion about the veracity of the website (relative to fewer claims and tactics) and actually had a limited positive direct effect on false-claim acceptance and attitudes toward the drug. Among PCPs, a mediation effect existed such that exposure to more deceptive claims and tactics resulted in higher perceived website deceptiveness relative to those in the fewer deceptive claims condition, which, in turn, resulted in lower acceptance of deceptive claims and tactics, lower perceived drug effectiveness, more negative attitudes toward the drug, and lower interest and intentions. CONCLUSION: These experiments demonstrate potential differences between consumers and PCPs as well as implications for consumer and PCP vulnerability to website deception.

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.

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.

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.

Assessing hearing and cognition challenges in consumer processing of televised risk information: Validation of self-reported measures using performance indicators.

Public health researchers face important challenges if they wish to include measures of hearing or cognitive ability in risk communication studies. We sought validity evidence for self-report measures of hearing and cognitive ability by comparing those measures to performance-based measures and risk information recall. We measured hearing ability (with audiologist-assisted assessment and self report), cognitive ability (with an established performance task and self report), and reactions to direct-to-consumer prescription drug promotion with adults 18 and older (n = 1064) in North Carolina, USA, in 2017. We found moderate correspondence between self-reported hearing loss and audiologist-assessed hearing loss. Both measures also showed a small negative association with recall of presented risk information. Cognitive ability results suggested less substantial correspondence between self report and performance task and the measures differed in predicting risk recall. Our results suggested a moderately efficient measure for hearing ability for research on risk information exposure and retention, and yet also suggested the need for caution regarding future use of self-reported cognitive ability as a substitute for a performance-based measure.