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.

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.

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.

Quantitative Information on Oncology Prescription Drug Websites.

Our objective was to determine whether and how quantitative information about drug benefits and risks is presented to consumers and healthcare professionals on cancer-related prescription drug websites. We analyzed the content of 65 active cancer-related prescription drug websites. We assessed the inclusion and presentation of quantitative information for two audiences (consumers and healthcare professionals) and two types of information (drug benefits and risks). Websites were equally likely to present quantitative information for benefits (96.9 %) and risks (95.4 %). However, the amount of the information differed significantly: Both consumer-directed and healthcare-professional-directed webpages were more likely to have quantitative information for every benefit (consumer 38.5 %; healthcare professional 86.1 %) compared with every risk (consumer 3.1 %; healthcare professional 6.2 %). The numeric and graphic presentations also differed by audience and information type. Consumers have access to quantitative information about oncology drugs and, in particular, about the benefits of these drugs. Research has shown that using quantitative information to communicate treatment benefits and risks can increase patients' and physicians' understanding and can aid in treatment decision-making, although some numeric and graphic formats are more useful than others.

Disease Information in Direct-to-Consumer Prescription Drug Print Ads.

Direct-to-consumer (DTC) prescription drug advertisements sometimes include information about the disease condition in addition to information about the advertised product. Although the intent of such information is to educate about the disease condition, in some cases consumers may mistakenly assume that the drug will address all of the potential consequences of the condition mentioned in the ad. We investigated the effects of adding disease information to DTC prescription drug print ads on consumer product perceptions and understanding. Participants (4,064 adults) viewed 1 of 15 DTC print ads for fictitious prescription drugs indicated to treat chronic obstructive pulmonary disease, anemia, or lymphoma that varied in disease information presence, type, and format. Participants answered questions that assessed risk and benefit memory, perception, and behavioral intention. Results indicate that exposure to disease information as part of DTC prescription drug ads can promote the impression that the drug addresses consequences of the condition that are not part of the drug's indication.

Do Prescription Drug Ads Tell Consumers Enough About Benefits and Side Effects? Results From the Health Information National Trends Survey, Fourth Administration.

Direct-to-consumer prescription drug advertising (DTCA) is a major source of consumer information about prescription drugs. The present study updates 2002 U.S. Food and Drug Administration phone survey questions that found that 44% and 61% of consumers thought that DTCA did not include enough information about benefits and risks, respectively. The present study was administered by mail using a nationally representative sample, and provides a more in-depth understanding of how these beliefs relate to demographic and health characteristics. Data collected from 3,959 respondents to the National Cancer Institute's 2011 Health Information National Trends Survey find results similar to the 2002 survey: 46% and 52% of respondents thought that DCTA did not include enough information about benefits and risks, respectively. Respondents fell into four groups: 23% agreed that DTCA tells enough about drug benefits and risks, 41% disagreed, 18% expressed no opinion, and 18% had discordant beliefs. DTCA attitudes were negatively associated with education, income, and whether respondents purchase prescription drugs; attitudes were positively associated with whether respondents understand prescription drug information. This study confirms that a plurality of Americans believe that DTCA does not include enough information about benefits and risks, suggesting that the educational effect of DTCA could be improved.

Requests for cancer prevention information: the cancer information service (2002-2006).

Prevention is crucial to reducing cancer burden. Awareness of prevention information is critical to engaging the public in prevention activities. We examined 106,610 information requests from the general public to the Cancer Information Service from 2002 to 2006. The percent of requests related to primary prevention decreased in 2003, but otherwise remained stable around 19%. The percent of requests related to secondary prevention decreased over time, from 38% (2003) to 14% (2006). Demographic characteristics were associated with patterns of change across time. Results suggest that efforts are needed to increase public awareness of cancer prevention, particularly among certain populations.

Lay representations of cancer prevention and early detection: associations with prevention behaviors.

INTRODUCTION: The Common Sense Model of illness representations posits that how people think about an illness affects how they try to prevent the illness. The purpose of this study was to determine whether prevention representations vary by cancer type (colon, lung, and skin cancer) and whether representations are associated with relevant behaviors. METHODS: We analyzed data from the Health Information National Trends Survey (HINTS 2005), a nationally representative survey of American adults (N = 5,586) conducted by telephone interview. RESULTS: Respondents reported that all 3 types of cancer can be prevented through healthy behaviors; however, fewer did so for colon cancer. More respondents reported screening as a prevention strategy for colon cancer than did so for lung or skin cancer. Representations were associated with colon cancer screening, smoking status, and sunscreen use. CONCLUSION: Representations of cancer were associated with relevant health behaviors, providing a target for health messages and interventions.

Cancer prevention information seeking: a signal detection analysis of data from the cancer information service.

Communication and health information seeking play a significant role in the promotion of cancer prevention behaviors, including screening. Data from a sample of information seekers who contacted the National Cancer Institute's (NCI's) Cancer Information Service (CIS; N = 20,412) were split randomly into an exploratory and validation sample to conduct signal detection analysis predicting cancer prevention information seeking. Important predictors of seeking prevention information in the exploratory sample were type of information seeker, communication channel, age, and gender; these findings generally were confirmed in the validation sample. Our findings also reveal important information about the demographic characteristics and communication channel preferences of cancer prevention information seekers.

What is my cancer risk? How internet-based cancer risk assessment tools communicate individualized risk estimates to the public: content analysis.

BACKGROUND: Internet-based cancer risk assessment tools have the potential to inform the public about cancer risk and promote risk-reducing behaviors. However, poorly communicated information on these websites may result in unintended adverse health outcomes. OBJECTIVE: This study examined whether: (1) Internet-based cancer risk assessment tools use risk communication formats that facilitate comprehension and reduce bias (as identified by the empirical literature); (2) the use of these formats varies by website affiliation; and (3) the websites provided information necessary to evaluate the quality of the risk estimate. METHODS: A content analysis of Internet-based cancer risk assessment tools was conducted. The terms calculate cancer risk, cancer risk calculator, estimate cancer risk, assess cancer risk, and cancer risk assessment were searched using three search engines. We identified 47 risk assessment tools and coded each according to standardized criteria. We calculated simple frequencies on all coding categories and performed crosstabulations but did not conduct formal statistical analysis due to small cell sizes. RESULTS: Use of risk communication formats that facilitate comprehension and reduce bias varied widely (eg, 30% of websites [14/47] provided absolute and comparative risk information but 83% [39/47] provided safety messages). Use of formats that facilitate comprehension varied by website affiliation and communication strategy (eg, only 8.3% [1/12] websites affiliated with the health care industry provided absolute and comparative risk information, but 83% [5/6] of websites affiliated with a governmental organization did so). Only 53% (25/47) of websites provided information about the statistical model or the peer-reviewed literature that was used to calculate the risk estimate. CONCLUSION: Internet-based cancer risk assessment tools varied in their use of risk communication formats that facilitate comprehension and reduce bias. Formats that are difficult to understand may cause people to misperceive their cancer risk and consequently take inappropriate action.

Cancer prevention information-seeking among Hispanic and non-Hispanic users of the National Cancer Institute's Cancer Information Service: trends in telephone and LiveHelp use.

Evidence-based strategies to enable, encourage, and support cancer prevention information seeking among Hispanic populations are needed. We examined cancer prevention information requests to the Cancer Information Service (CIS) via telephone (1-800-4-CANCER toll-free telephone information service) and LiveHelp (an instant messaging service provided in English only) from 2003 to 2006. We summarized differences in the communication channel utilized by ethnicity (Hispanic vs. non-Hispanic) and, among Hispanic information seekers, the language used during the contact (English vs. Spanish). Utilization of LiveHelp was higher among non-Hispanic than Hispanic seekers of cancer prevention information. LiveHelp use for seeking cancer prevention information increased between 2003 and 2006 for both groups, but the increase was greater among non-Hispanics than Hispanics. Nearly half of Hispanics who sought cancer prevention information did so in Spanish. Because LiveHelp is not available in Spanish, the number of Spanish-only speakers who preferred to contact CIS via LiveHelp instead of telephone is unknown. When communicating cancer prevention information via multiple channels, it is important to consider differences in access to communication technologies and preferred communication channels among ethnic minority groups.

What is my cancer risk? Identifying how Internet-based cancer risk calculators convey individualized risk estimates to the public.

This study examined how Internet-based cancer risk calculators presented individualized risk estimates to the public. The 47 calculators varied in their use of empirically-supported risk communication strategies. The type of organization responsible for the website (government, cancer center, etc) was associated with differential use of risk communication strategies. Organizations should refer to the existing risk communication literature before developing an Internet-based cancer risk calculator.

Nutrition-related cancer prevention cognitions and behavioral intentions: testing the risk perception attitude framework.

This study tested whether the risk perception attitude framework predicted nutrition-related cancer prevention cognitions and behavioral intentions. Data from the 2003 Health Information National Trends Survey were analyzed to assess respondents' reported likelihood of developing cancer (risk) and perceptions of whether they could lower their chances of getting cancer (efficacy). Respondents with higher efficacy were more likely to report that good nutrition can prevent cancer, and they reported more preventive dietary changes, as compared to respondents with lower efficacy. Respondents with higher efficacy were more likely to report intentions to change their diets to prevent cancer, and they reported more preventive dietary changes to their own diets but only at higher levels of risk. Results suggest that to improve cognitions about the role of nutrition in cancer prevention, interventions should target cancer prevention efficacy; however, to increase intentions to change nutrition behaviors, interventions should target efficacy and risk perceptions.

Nutrition-related cancer prevention attitudes in low-income women.

OBJECTIVE: To investigate the nutrition-related cancer prevention attitudes of low-income African American women, determine whether a nutrition education program can alter these attitudes, and determine whether these attitudes are related to diet and dietary changes. METHOD: One-hundred and fifty-seven African American women from Washington, D.C. public housing communities participated in a nutrition education program from 2001 to 2003. They completed questionnaires assessing their attitudes about the role of nutrition in cancer prevention at baseline, post-intervention, and 4 months later. They also completed 24-hour food recalls at baseline, post-intervention, and 4 months later. RESULTS: Women agreed that good nutrition prevents cancer, especially women with higher literacy, women with fewer children living at home, women who had not had experience with cancer, and women who were worried about their health. Participation in the program increased agreement that good nutrition prevents cancer over 4 months. Women whose agreement increased over the intervention were able to maintain dietary changes they made over 4 months. CONCLUSION: Nutrition-related cancer prevention attitudes were strong and were strengthened by a nutrition education program. These attitudes may contribute to people's ability to maintain dietary changes.