Understanding US Physician and Pharmacist Attitudes Toward Biosimilar Products: A Qualitative Study.

BACKGROUND: Biosimilars account for 30-40% of biologic medications dispensed in the United States (US), yet healthcare providers in relevant medical specialties have limited awareness of biosimilars and their characteristics. Likewise, many providers perceive biosimilars as less safe and effective than original biologics and are more comfortable prescribing original biologics to patients. METHODS: We conducted in-person focus groups at three clinical sites in California and Texas (n = 49) to explore the reasons behind US healthcare providers' limited understanding of, cautious attitudes toward, and reluctance to prescribe biosimilars. We conducted thematic analysis by having three researchers independently analyze verbatim transcripts and identify patterns in provider responses. RESULTS: Providers' limited knowledge of and cautious attitudes toward biosimilars are driven by uncertainty about how biosimilarity is defined and operationalized as well as negative past experiences with generic drugs that did not perform as well as branded counterparts. Additionally, healthcare providers are unfamiliar with the Food and Drug Administration's (FDA's) approval pathway for biosimilars and are skeptical that an abbreviated approval process is rigorous enough to ensure biosimilars deliver the same efficacy and have the same side effect profiles as original biologics. Physicians also expressed concerns about pharmacy substitution of biosimilars and interchangeables, explaining they would be unaware of which medication was ultimately given to their patients. CONCLUSIONS: Educating physicians and pharmacists about biosimilars-including how biosimilarity is defined and operationalized, the structure of the biosimilar approval process, and how analytical data can ensure biosimilar safety and efficacy-will be important for reducing healthcare providers' concerns and increasing biosimilar adoption in the US.

Air Aware: Improving Use of an Existing Air Quality and Health Tool.

Exposure to air pollutants is a significant health risk for individuals with asthma, cardiovascular disease, and chronic obstructive pulmonary disease. Measures such as limiting time outdoors or performing less strenuous tasks when air quality levels are better can mitigate these risks, but only if people are aware of both these recommendations and how to know when air quality is best, and worst. Formative audience assessment determined that applications developed for mobile devices are the optimal way to provide this information, but knowledge of the existing United States Environmental Protection Agency (EPA) and partners' AirNow tool was minimal. We developed, field-tested, adapted, and implemented pilot efforts at both the national and local levels to address this knowledge gap, and present findings suggesting a concentrated local effort can heighten use of AirNow, leading to more pro-healthy behavior.

Examining Information Needs of Heart Failure Patients and Family Companions Using a Previsit Question Prompt List and Audiotaped Data: Findings From a Pilot Study.

BACKGROUND: Question prompt lists (QPLs) are an effective tool for improving communication during medical visits. However, no studies have attempted to correlate intentions related to question asking and actual questions asked during visits. Moreover, few studies have used QPLs with patients with heart failure (HF) or family companions who accompany them to visits. We examined the use of a previsit QPL for patients with HF and their family companions intended to enhance engagement in HF care. The aim of this research was to assess which questions from the QPL patients and companions selected most frequently to ask and compare this item with which questions were actually asked during the medical visit. METHODS AND RESULTS: This secondary analysis of QOLs and audiotaped visit data from a pilot study enrolled and consented patients with HF, family companions, and HF clinicians. A single group of 30 patients with HF and 23 family companions received the QPL to complete in the waiting room immediately before their cardiology visit. To meet our aims, we calculated the frequencies for each question selected and asked from the QPL, using data derived from completed prompt lists and audiotaped medical visits. A follow-up survey was administered 2 days after the appointment to assess differences in how participants filled out and used the prompt list. Patients and companions primarily selected and asked questions from the QPL regarding the management and treatment of the disease, general questions about HF, and questions about prognosis. Participants rarely asked questions about support for family and friends or health care team roles and responsibilities. Patients and companions did not ask many of the questions they reported wanting to ask. CONCLUSIONS: Prompt lists may empower patients and companions to communicate with their clinician by identifying important questions to help overcome patients' and companions' knowledge gaps. More research is needed to understand the true impact of prompt lists on patient-family-clinician communication and subsequent HF outcomes, and how best to implement them in clinical workflows to increase their potential usefulness.

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.

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.

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.

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.

Virtual Versus In-Person Focus Groups: Comparison of Costs, Recruitment, and Participant Logistics.

BACKGROUND: Virtual focus groups-such as online chat and video groups-are increasingly promoted as qualitative research tools. Theoretically, virtual groups offer several advantages, including lower cost, faster recruitment, greater geographic diversity, enrollment of hard-to-reach populations, and reduced participant burden. However, no study has compared virtual and in-person focus groups on these metrics. OBJECTIVE: To rigorously compare virtual and in-person focus groups on cost, recruitment, and participant logistics. We examined 3 focus group modes and instituted experimental controls to ensure a fair comparison. METHODS: We conducted 6 1-hour focus groups in August 2014 using in-person (n=2), live chat (n=2), and video (n=2) modes with individuals who had type 2 diabetes (n=48 enrolled, n=39 completed). In planning groups, we solicited bids from 6 virtual platform vendors and 4 recruitment firms. We then selected 1 platform or facility per mode and a single recruitment firm across all modes. To minimize bias, the recruitment firm employed different recruiters by mode who were blinded to recruitment efforts for other modes. We tracked enrollment during a 2-week period. A single moderator conducted all groups using the same guide, which addressed the use of technology to communicate with health care providers. We conducted the groups at the same times of day on Monday to Wednesday during a single week. At the end of each group, participants completed a short survey. RESULTS: Virtual focus groups offered minimal cost savings compared with in-person groups (US $2000 per chat group vs US $2576 per in-person group vs US $2,750 per video group). Although virtual groups did not incur travel costs, they often had higher management fees and miscellaneous expenses (eg, participant webcams). Recruitment timing did not differ by mode, but show rates were higher for in-person groups (94% [15/16] in-person vs 81% [13/16] video vs 69% [11/16] chat). Virtual group participants were more geographically diverse (but with significant clustering around major metropolitan areas) and more likely to be non-white, less educated, and less healthy. Internet usage was higher among virtual group participants, yet virtual groups still reached light Internet users. In terms of burden, chat groups were easiest to join and required the least preparation (chat = 13 minutes, video = 40 minutes, in-person = 78 minutes). Virtual group participants joined using laptop or desktop computers, and most virtual participants (82% [9/11] chat vs 62% [8/13] video) reported having no other people in their immediate vicinity. CONCLUSIONS: Virtual focus groups offer potential advantages for participant diversity and reaching less healthy populations. However, virtual groups do not appear to cost less or recruit participants faster than in-person groups. Further research on virtual group data quality and group dynamics is needed to fully understand their advantages and limitations.

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.

Consumer confusion between prescription drug precautions and side effects.

OBJECTIVE: Multiple studies have identified consumers' difficulty correctly interpreting risk information provided about prescription drugs, whether in printed format or online. This study's purpose was to explore whether consumers can distinguish between prescription drug precautions and side effects presented on brand-name drug websites. METHODS: Participants (n=873) viewed fictitious drug websites that presented both precautions and side effects for one of four drugs, and they completed a survey assessing recall and comprehension. We coded open-ended recall data to identify whether drug precautions were mentioned and, if so, how they were interpreted. RESULTS: Approximately 15% of participants mentioned at least one drug precaution. The majority (59.7%) misinterpreted precautions as potential side effects. Participants who misinterpreted precautions rated the drugs as significantly more likely to cause side effects than participants who accurately interpreted the precautions. Age, education, literacy, and other factors did not appear to predict precaution interpretation. CONCLUSION: At least some consumers are likely to interpret precautions on drug websites as potential side effects, which might affect consumer preferences, treatment decisions, and medication safety. PRACTICE IMPLICATIONS: Healthcare providers should be aware of this potential confusion, assess patients' understanding of precautions and potential side effects, and address any misunderstandings.

Correction of misleading information in prescription drug television advertising: The roles of advertisement similarity and time delay.

BACKGROUND: Prescription drug television advertisements containing potentially consequential misinformation sometimes appear in the United States. When that happens, the U.S. Food and Drug Administration can request that companies distribute corrective advertisements to address misinformation and inaccurate claims. Previous research has demonstrated effectiveness in corrective advertising for various products. OBJECTIVES: The present article builds on that work with a randomized experimental study (n = 6454) of corrective advertising investigating the extent to which visual similarity matters between violative and corrective ads and the extent to which time delay matters between violative and corrective advertisement exposure. METHODS: Our study sample included overweight or obese U.S. adults recruited from an existing online consumer panel representative of the U.S. adult population. We created a brand for a fictitious prescription weight-loss drug and produced corresponding direct-to-consumer (DTC) television ads. All participants viewed the same violative ad, but were randomly assigned to view corrective ads with different levels of visual similarity and exposure time delay using a 4 × 4 between-subjects factorial design. RESULTS: Results suggest corrective ad exposure can influence consumer perceptions of drug efficacy, risks, and benefits previously established by violative ads that overstated drug efficacy, broadened drug indication, and omitted important risk information. Corrective ads also can weaken consumer intentions to consider and investigate a drug. However, ad similarity does not appear to affect consumer perceptions and preferences. Although we found that the effects of violative ad exposure tend to diminish over time, the length of the delay between violative and corrective ad exposure has limited influence. An exception to this was observed with regard to recall of drug benefits and risks, where the impact of corrective ad exposure increases with greater time delay. CONCLUSIONS: These results extend previous research to a new health condition and hold implications for regulatory policy.

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.

Future Challenges and Opportunities in Online Prescription Drug Promotion Research Comment on "Trouble Spots in Online Direct-to-Consumer Prescription Drug Promotion: A Content Analysis of FDA Warning Letters".

Despite increased availability of online promotional tools for prescription drug marketers, evidence on online prescription drug promotion is far from settled or conclusive. We highlight ways in which online prescription drug promotion is similar to conventional broadcast and print advertising and ways in which it differs. We also highlight five key areas for future research: branded drug website influence on consumer knowledge and behavior, interactive features on branded drug websites, mobile viewing of branded websites and mobile advertisements, online promotion and non-US audiences, and social media and medication decisions.

Visual presentations of efficacy data in direct-to-consumer prescription drug print and television advertisements: A randomized study.

OBJECTIVE: To determine whether visual aids help people recall quantitative efficacy information in direct-to-consumer (DTC) prescription drug advertisements, and if so, which types of visual aids are most helpful. METHODS: Individuals diagnosed with high cholesterol (n=2504) were randomized to view a fictional DTC print or television advertisement with no visual aid or one of four visual aids (pie chart, bar chart, table, or pictograph) depicting drug efficacy. We measured drug efficacy and risk recall, drug perceptions and attitudes, and behavioral intentions. RESULTS: For print advertisements, a bar chart or table, compared with no visual aid, elicited more accurate drug efficacy recall. The bar chart was better at this than the pictograph and the table was better than the pie chart. For television advertisements, any visual aid, compared with no visual aid, elicited more accurate drug efficacy recall. The bar chart was better at this than the pictograph or the table. CONCLUSION: Visual aids depicting quantitative efficacy information in DTC print and television advertisements increased drug efficacy recall, which may help people make informed decisions about prescription drugs. PRACTICE IMPLICATIONS: Adding visual aids to DTC advertising may increase the public's knowledge of how well prescription drugs work.

Perceived healthcare provider reactions to patient and caregiver use of online health communities.

OBJECTIVE: Many Internet users seek health information through online health communities (OHCs) and other social media. Yet few studies assess how individuals use peer-generated health information, and many healthcare providers (HCPs) believe OHCs interfere with patient-provider relationships. This study explored how individuals use OHC content in clinical discussions and how HCPs react to it. METHODS: We conducted in-person and virtual focus groups with patients/caregivers who visited OHCs (n=89). A trained moderator asked about reasons for membership, sharing OHC content with providers, HCP reactions, and preferred roles for HCPs. Two researchers independently coded verbatim transcripts (NVivo 9.2) and conducted thematic response analysis. RESULTS: Participants described OHCs as supplementing information from HCPs, whom they perceived as too busy for detailed discussions. Almost all participants shared OHC content with HCPs, although only half cited OHCs as the source. Most HCPs reacted negatively to OHC content, making participants feel disempowered. Despite these reactions, participants continued to use OHCs, and most desired HCP feedback on the accuracy of OHC content. CONCLUSIONS: Individuals do not use OHCs to circumvent HCPs but instead to gather more in-depth information. PRACTICE IMPLICATIONS: HCPs should discuss OHC content with patients to help them avoid misinformation and make more informed decisions.

Presenting efficacy information in direct-to-consumer prescription drug advertisements.

OBJECTIVE: We evaluated whether presenting prescription drug efficacy information in direct-to-consumer (DTC) advertising helps individuals accurately report a drug's benefits and, if so, which numerical format is most helpful. METHODS: We conducted a randomized, controlled study of individuals diagnosed with high cholesterol (n=2807) who viewed fictitious prescription drug print or television ads containing either no drug efficacy information or efficacy information in one of five numerical formats. We measured drug efficacy recall, drug perceptions and attitudes, behavioral intentions, and drug risk recall. RESULTS: Individuals who viewed absolute frequency and/or percentage information more accurately reported drug efficacy than participants who viewed no efficacy information. Participants who viewed relative frequency information generally reported drug efficacy less accurately than participants who viewed other numerical formats. CONCLUSION: Adding efficacy information to DTC ads-both in print and on television-may potentially increase an individual's knowledge of a drug's efficacy, which may improve patient-provider communication and promote more informed decisions. PRACTICE IMPLICATIONS: Providing quantitative efficacy information in a combination of formats (e.g., absolute frequency and percent) may help patients remember information and make decisions about prescription drugs.

Communicating risk of hereditary breast and ovarian cancer with an interactive decision support tool.

OBJECTIVE: Women with hereditary breast and ovarian cancer syndrome (HBOC) face a higher risk of earlier, more aggressive cancer. Because of HBOC's rarity, screening is recommended only for women with strong cancer family histories. However, most patients do not have accurate history available and struggle to understand genetic concepts. METHODS: Cancer in the Family, an online clinical decision support tool, calculated women's HBOC risk and promoted shared patient-provider decisions about screening. A pilot evaluation (n=9 providers, n=48 patients) assessed the tool's impact on knowledge, attitudes, and screening decisions. Patients used the tool before wellness exams and completed three surveys. Providers accessed the tool during exams, completed exam checklists, and completed four surveys. RESULTS: Patients entered complete family histories (67%), calculated personal risk (96%), and shared risk printouts with providers (65%). HBOC knowledge increased dramatically for patients and providers, and many patients (75%) perceived tool results as valid. The tool prompted patient-provider discussions about HBOC risk and cancer family history (88%). CONCLUSIONS: The tool was effective in increasing knowledge, collecting family history, and sparking patient-provider discussions about HBOC screening. PRACTICE IMPLICATIONS: Interactive tools can effectively communicate personalized risk and promote shared decisions, but they are not a substitute for patient-provider discussions.