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.

Impact of messages about scientific uncertainty on risk perceptions and intentions to use electronic vaping products.

BACKGROUND: The science surrounding e-cigarettes and other electronic vaping products (EVPs) is rapidly evolving, and the health effects of vaping are unclear. Little research has explored how individuals respond to information acknowledging scientific uncertainty. The aim of the present study was to understand the impact of messages about scientific uncertainty regarding the health effects of vaping on risk perceptions and behavioral intentions. METHODS: Adults in an online experiment (n = 2508) were randomly exposed to view either a control message (a short factual statement about EVPs) or an uncertainty message (the control message plus additional information describing why EVP-related research is limited or inconclusive). Participants rated the risks of vaping and their intentions to try or stop vaping. RESULTS: Individuals who viewed the uncertainty message rated vaping as less risky than those who viewed the control message. Message exposure did not impact intentions to try vaping soon or intentions to stop vaping in the next 6 months. CONCLUSIONS: Acknowledging scientific uncertainty made EVP use seem less risky. Future research should explore possible drivers of this response, such as deeper message processing or emotional reactions. Researchers and practitioners designing public health campaigns about vaping might consider a cautious approach to presenting information about scientific uncertainty.

Making Decisions About Medication Use During Pregnancy: Implications for Communication Strategies.

Objective To explore women's perceptions of the risks and benefits associated with medication use during pregnancy and to better understand how women make decisions related to medication use in pregnancy. Methods We conducted online focus groups with 48 women who used medication during pregnancy or while planning a pregnancy, and 12 in-depth follow-up interviews with a subset of these women. Results We found that women were aware of general risks associated with medication use but were often unable to articulate specific negative outcomes. Women were concerned most about medications' impact on fetal development but were also concerned about how either continuing or discontinuing medication during pregnancy could affect their own health. Women indicated that if the risk of a given medication were unknown, they would not take that medication during pregnancy. Conclusion This formative research found that women face difficult decisions about medication use during pregnancy and need specific information to help them make decisions. Enhanced communication between patients and their providers regarding medication use would help address this need. We suggest that public health practitioners develop messages to (1) encourage, remind, and prompt women to proactively talk with their healthcare providers about the risks of taking, not taking, stopping, or altering the dosage of a medication while trying to become pregnant and/or while pregnant; and (2) encourage all women of childbearing age to ask their healthcare providers about medication use.

Serious and actionable risks, plus disclosure: Investigating an alternative approach for presenting risk information in prescription drug television advertisements.

BACKGROUND: Broadcast direct-to-consumer (DTC) prescription drug ads that present product claims are required to also present the product's major risks. Debate exists regarding how much information should be included in these major risk statements. Some argue that such statements expose people to unnecessary amounts of information, while others argue that they leave out important information. OBJECTIVES: Examine the impact of type of risk statement (unedited versus serious and actionable risks only) and a disclosure indicating that not all risks are presented on consumers' ability to remember the important risks and benefits of a drug following exposure to a DTC television advertisement (ad). Risk and benefit perceptions, ad-prompted actions, recognition of the disclosure statement, and evaluations of both the disclosure and risk statement were also examined. METHODS: A web-based experiment was conducted in which US adults who self-reported as having depression (N = 500), insomnia (N = 500), or high cholesterol (N = 500) were randomly assigned to view one of four versions of the television ad, and then complete a questionnaire. RESULTS: The type of risk statement had a significant effect on risk recall and recognition, benefit recognition, perceived risk severity (depression condition only), and perceived benefit magnitude (high cholesterol condition only). Disclosure recognition (using bias-corrected scores) ranged from 63% to 70% across the three illness samples. CONCLUSIONS: The revised risk statement improved overall processing of the television ad, as evidenced by improved risk recall and recognition and improved benefit recognition. Further, the presence of the disclosure did not adversely affect consumers' processing of drug risk and benefit information. Therefore, limiting the risks presented in DTC television ads and including a disclosure alerting consumers that not all risks are presented may be an effective strategy for communicating product risks.

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

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

The SmokefreeTXT (SFTXT) Study: Web and Mobile Data Collection to Evaluate Smoking Cessation for Young Adults.

BACKGROUND: Text messaging (short message service, SMS) has been shown to be effective in delivering interventions for various diseases and health conditions, including smoking cessation. While there are many published studies regarding smoking cessation text messaging interventions, most do not provide details about the study's operational methods. As a result, there is a gap in our understanding of how best to design studies of smoking cessation text messaging programs. OBJECTIVE: The purpose of this paper is to detail the operational methods used to conduct a randomized trial comparing three different versions of the National Cancer Institute's SmokefreeText (SFTXT) program, designed for smokers 18 to 29 years of age. We detail our methods for recruiting participants from the Internet, reducing fraud, conducting online data collection, and retaining panel study participants. METHODS: Participants were recruited through website advertisements and market research online panels. Screening questions established eligibility for the study (eg, 18 to 29 years of age, current smoker). Antifraud measures screened out participants who could not meet the study requirements. After completing a baseline survey, participants were randomized to one of three study arms, which varied by type and timing of text message delivery. The study offered US $20 gift cards as incentives to complete each of four follow-up surveys. Automated email reminders were sent at designated intervals to increase response rates. Researchers also provided telephone reminders to those who had not completed the survey after multiple email reminders. We calculated participation rates across study arms and compared the final sample characteristics to the Current Population Survey to examine generalizability. RESULTS: Recruitment methods drove 153,936 unique visitors to the SFTXT Study landing page and 27,360 began the screener. Based on the screening questions, 15,462 out of 27,360 responders (56.51%) were eligible to participate. Of the 15,462 who were eligible, 9486 passed the antifraud measures that were implemented; however, 3882 failed to verify their email addresses or cell phone numbers, leaving 5604 who were invited to complete the baseline survey. Of the 5604 who were invited, 4432 completed the baseline survey, but only 4027 were retained for analysis because 405 did not receive the intervention. CONCLUSIONS: Although antifraud measures helped to catch participants who failed study requirements and could have biased the data collected, it is possible that the email and cell phone verification check excluded some potentially eligible participants from the study. Future research should explore ways to implement verification methods without risking the loss of so many potential participants. CLINICALTRIAL: Clinical Trials.gov NCT01885052; https://clinicaltrials.gov/ct2/show/NCT01885052; (Archived by WebCite at http://www.webcitation.org/6iWzcmFdw).

Prostate-specific antigen testing: men's responses to 2012 recommendation against screening.

BACKGROUND: The U.S. Preventive Services Task Force (USPSTF) released a draft recommendation advising against prostate-specific antigen (PSA) testing in October 2011, a major shift from previous years of recommending neither for or against PSA testing due to insufficient evidence. PURPOSE: The purpose of this study was to assess men's awareness of the new recommendation, and their responses to it. METHODS: This study comprised a web survey of men aged 40-74 years that was conducted through GfK Custom Research, LLC's Knowledge Panel® from November 22 to December 2, 2011. Chi-square tests and logistic regression analyses were conducted to identify factors associated with disagreement with and intention to follow the recommendation. Data were analyzed in March 2012. RESULTS: The survey sample included 1089 men without a history of prostate cancer. After reviewing the recommendation, 62% agreed with the recommendation. Age and worry about getting prostate cancer were significantly related to disagreement with the recommendation. Only 13% of respondents were intenders (they planned to follow the U.S. Preventive Services Task Force recommendation and not get a prostate-specific antigen test in the future); 54% were non-intenders (they planned to not follow the U.S. Preventive Services Task Force recommendation and get a prostate-specific antigen test in the future; and 33% were undecided. Black race, higher income, having a PSA test in the past 2 years, and being somewhat/very worried about getting prostate cancer were all positively associated with being a non-intender. CONCLUSIONS: Study findings suggest that consumers are favorably disposed to PSA testing, despite new evidence suggesting that the harms outweigh the benefits. The new USPSTF recommendation against PSA testing in all men may be met with resistance.

Consumers' perceptions of preconception health.

PURPOSE: To inform the development of a preconception health (PCH) social marketing plan, we conducted qualitative research with prospective consumers. APPROACH: We present formative findings based on the four Ps of social marketing: product, price, promotion, and place. SETTING: We conducted focus groups with 10 groups of women in Atlanta, Georgia, in fall 2010. PARTICIPANTS: We classified women aged 18 to 44 into five groups based on their pregnancy plans, and then further segmented the groups based on socioeconomic status for a total of 10 groups. METHOD: The focus group guide was designed to elicit participants' responses about the product, price, promotion, and placement of PCH. We used NVivo 9 software to analyze focus group data. RESULTS: Women planning a pregnancy in the future had different perspectives on PCH as a product than women not planning a pregnancy. Barriers to PCH included lack of social support, addiction, and lack of awareness about PCH. Participants preferred to think of PCH behaviors as "promoting" a healthy baby rather than preventing an unhealthy birth outcome. Many women in the focus groups preferred to hear PCH messages from a health care provider, among other channels. CONCLUSION: The results from this research will inform the development of a social marketing plan for PCH and the development of concepts that will be tested with consumers to determine their viability for use in a national campaign.

Person-to-person interventions targeted to parents and other caregivers to improve adolescent health: a community guide systematic review.

CONTEXT: Adolescence marks a time when many young people engage in risky behaviors with potential implications for long-term health. Interventions focused on adolescents' parents and other caregivers have the potential to affect adolescents across a variety of risk and health-outcome areas. EVIDENCE ACQUISITION: Community Guide methods were used to evaluate the effectiveness of caregiver-targeted interventions in addressing adolescent risk and protective behaviors and health outcomes. Sixteen studies published during the search period (1966-2007) met review requirements and were included in this review. EVIDENCE SYNTHESIS: Effectiveness was assessed based on changes in whether or not adolescents engaged in specified risk and protective behaviors; frequency of risk and protective behaviors, and health outcomes, also informed the results. Results from qualifying studies provided sufficient evidence that interventions delivered person-to-person (i.e., through some form of direct contact rather than through other forms of contact such as Internet or paper) and designed to modify parenting skills by targeting parents and other caregivers are effective in improving adolescent health. CONCLUSIONS: Interventions delivered to parents and other caregivers affect a cross-cutting array of adolescent risk and protective behaviors to yield improvements in adolescent health. Analysis from this review forms the basis of the recommendation by the Community Preventive Services Task Force presented elsewhere in this issue.

The public's response to the U.S. Preventive Services Task Force's 2009 recommendations on mammography screening.

BACKGROUND: On November 16, 2009, the U.S. Preventive Services Task Force (USPSTF) released new breast cancer screening recommendations, resulting in considerable controversy. PURPOSE: The purpose of this investigation was to assess the volume and framing of the public discourse around the mammography recommendations and determine if women were knowledgeable about the new recommendations. METHODS: Two different types of data collection methods were used for this study: (1) a content analysis of news stories and social media posts around the time of the USPSTF announcement and (2) a web-based survey of women aged 40-74 years conducted through Knowledge Networks from December 17, 2009, to January 6, 2010. Data were analyzed in 2010. RESULTS: The survey sample included 1221 women aged 40-74 years who had never had breast cancer. The majority of the articles and posts (51.9%) did not support the screening recommendations, and 17.6% were supportive. Less than one quarter of the sample could identify the new recommendations for women aged 40-49 years and 50-74 years. Results from logistic regression analyses identified characteristics associated with correct knowledge of the recommendations for each age group. Level of attention paid to the recommendations was significantly associated with accurate knowledge of the recommendations for each age group. Having a mammogram within the past 2 years, "other" race (i.e., not black or white), and having higher levels of education, confidence that recommendations were based on the latest research, and attention paid to the new guidelines were all significantly and positively associated with correct knowledge of the new recommendation for women aged 40-49 years. CONCLUSIONS: The new recommendations confused women (30.0%) more than they helped them understand when to get a mammogram (6.2%). Confusion was greatest among women aged 40-49 years and women who had never had a mammogram or who had one more than 2 years ago. Communication about future recommendations should be pretested to identify strategies and language that may reduce confusion among providers, consumers, and advocacy groups.

Perspectives from the front lines of tobacco control.

This research is designed to share valuable experiences and transferable principles from program staff of the Legacy/Community Voices initiative who have been involved in planning, implementing, evaluating, and sustaining tobacco control activities in underserved communities. Interviews were conducted with 13 front line staff from 9 sites: Alameda County, California; Detroit, Michigan; El Paso, Texas; Ingham County, Michigan; Miami, Florida; New Mexico; North Carolina; Northern Manhattan; and West Virginia. A model emerged from these interviews that places the life cycle of a program in a central position, with many of the identified themes (working with local champions, obtaining support from multiple partners, increasing organizational capacity) repeated throughout, albeit in different forms at different stages. Reflecting upon wisdom gained and identifying best processes for such work may help ensure that tobacco control programs are developed that are culturally safe and effective in meeting the needs of diverse communities throughout the United States.