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.

Modifications in Primary Care Clinics to Continue Colorectal Cancer Screening Promotion During the COVID-19 Pandemic.

COVID-19 caused significant declines in colorectal cancer (CRC) screening. Health systems and clinics, faced with a new rapidly spreading infectious disease, adapted to maintain patient safety and address the effects of the pandemic on healthcare delivery. This study aimed to understand how CDC-funded Colorectal Cancer Control Program recipients and their partner health systems and clinics may have modified evidence-based intervention (EBI) implementation to promote CRC screening during the COVID-19 pandemic; to identify barriers and facilitators to implementing modifications; and to extract lessons that can be applied to support CRC screening, chronic disease management, and clinic resilience in the face of future public health crises. Nine recipients were selected to reflect the diversity inherent among all CRCCP recipients. Recipient and clinic partner staff answered unique sets of pre-interview questions to inform tailoring of interview guides that were developed using constructs from the Framework for Reporting Adaptations and Modifications to Evidence-based Implementation Strategies (FRAME-IS) and Consolidated Framework for Implementation Research (CFIR). The study team then interviewed recipient, health system, and clinic partner staff incorporating pre-interview responses to focus each conversation. We employed a rapid qualitative analysis approach then conducted virtual focus groups with recipient representatives to validate emergent themes. Three modifications that emerged from thematic analysis include: (1) offering mailed fecal immunochemical test (FIT) kits for CRC screening with mail or drop off return; (2) increasing the use of patient education and engagement strategies; and (3) increasing the use of or improving automated patient messaging systems. With improved tracking and automated reminder systems, mailed FIT kits paired with tailored patient education and clear instructions for completing the test could help primary care clinics catch up on the backlog of missed screenings during COVID-19. Future research can assess the effectiveness and cost-effectiveness of offering mailed FIT kits on maintaining or improving CRC screening, especially among people who are medically underserved.

Approaches for Implementing Healthy Food Interventions in Settings With Limited Resources: A Case Study of Sodium Reduction Interventions in Emergency Food Programs Addressing Food Insecurity.

PURPOSE: This study describes how recipients of the Centers for Disease Control and Prevention funded Sodium Reduction in Communities Program (SRCP) worked with emergency food programs to improve access to healthy food to address chronic conditions. DESIGN: SRCP recipients partnered with emergency food programs to implement sodium reduction strategies including nutrition standards, procurement practices, environmental strategies, and behavioral economics approaches. SETTING: SRCP recipients and emergency food programs in Washington County and Benton County, Arkansas and King County, Washington. SUBJECTS: SRCP recipient staff, emergency food program staff, and key stakeholders. MEASURES: We conducted semi-structured interviews with key stakeholders and systematic review of program documents. ANALYSIS: Data were analyzed using effects matrices for each recipient. Matrices were organized using select implementation science constructs and compared in a cross-case analysis. RESULTS: Despite limited resources, emergency food programs can implement sodium reduction interventions which may provide greater access to healthy foods and lead to reductions in health disparities. Emergency food programs successfully implemented sodium reduction interventions by building on the external and internal settings; selecting strategies that align with existing processes; implementing change incrementally and engaging staff, volunteers, and clients; and sustaining changes. CONCLUSION: Findings contribute to understanding the ways in which emergency food programs and other organizations with limited resources have implemented public health nutrition interventions addressing food insecurity and improving access to healthy foods. These strategies may be transferable to other settings with limited resources.

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

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

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.

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.