Burden of untreated transthyretin amyloid cardiomyopathy on patients and their caregivers by disease severity: results from a multicenter, non-interventional, real-world study.

Background: The humanistic burden of transthyretin amyloid cardiomyopathy (ATTR-CM) is poorly defined. Methods: An international study to comprehensively characterize the burden of ATTR-CM on patients naïve to disease-modifying therapy and their unpaid primary caregivers using study-specific and established surveys (patients: Kansas City Cardiomyopathy Questionnaire Overall Summary [KCCQ-OS], 12-Item Short Form Health Survey [SF-12], Hospital Anxiety and Depression Scale [HADS], Patient-Reported Outcomes Measurement Information System [PROMIS] Fatigue and Dyspnea; caregivers: SF-12, HADS, PROMIS Fatigue, Zarit Burden Interview [ZBI]). All data were summarized descriptively. Results: 208 patient and caregiver pairs were included. 86% of patients were male, median age was 81 years, and 91% (141/155 with genetic testing) had wild-type ATTR-CM. Patient responses characterized the mental and physical burden of ATTR-CM, which was numerically higher among those who were New York Heart Association (NYHA) class III (n = 43) vs. class I/II (n = 156). NYHA class III patients had particularly low KCCQ-OS (36) and SF-12 physical component (27) scores, and 67% had a HADS depression score ≥8. Caregivers (median age 68 years; 85% female; 59% spouse of the patient; median duration of caregiving 1.5 years) reported that NYHA III patients more frequently required help with a range of physical activities than NYHA class I/II patients. 51% of caregivers to NYHA class III patients reported at least a mild-to-moderate burden in the ZBI. A plain language summary of this paper can be found as a supplemental material. Conclusions: Untreated ATTR-CM is a burden to both patients and their caregivers.

Developing, optimizing, and evaluating patient infographics for diagnosing cardiac amyloidosis.

Objective: Advancements in diagnostics and treatment options for cardiac amyloidosis have improved patient outcomes, yet few patient education materials exist to help patients understand the disease and diagnosis process. We sought to develop and evaluate a set of plain language, patient-centered infographics describing the condition and common diagnostic tests. Methods: Using health literacy best practices, we developed 7 infographics which were further revised based on multilevel stakeholder feedback. To evaluate the materials, we recruited 100 patients from healthcare settings in Chicago, IL; participants completed a web-assisted interview during which they were randomized 1:1 to first view either our infographics or a standard material. Participants completed a knowledge assessment on their assigned material and subsequently reported impressions of both materials. Results: No differences were found between study arms in knowledge. The infographics took significantly less time to read and were more highly rated by participants in terms of appearance and understandability. Over two-thirds of participants preferred the infographics to the standard. Conclusions: The infographics created may improve the learning process about a complex condition and diagnosis process unknown to most adults. Innovation: These infographics are the first of their kind for cardiac amyloidosis and were created using health literacy best practices.

Assessing Recall and Recognition for Important Safety Information in Digital Promotion for Pharmaceutical Products: Implications for Website Design.

BACKGROUND: To date, there has been little research with digital direct-to-consumer (DTC) communication regarding pharmaceutical products (eg, product websites), so this study was designed to measure perception and recall of Important Safety Information (ISI) in websites viewed on desktops and smartphone devices. METHODS: A quantitative survey was conducted with 1600 self-identified asthma patients. Participants viewed 1 of 4 mocked-up websites for a fictitious asthma product in either a desktop or smartphone format that varied in the way in which risk information was presented and accessed. The "websites" were embedded in survey software that enabled behavior to be tracked and facilitated presentation of questions designed to assess memory and user experience. RESULTS: Statistically significant differences in likelihood of interacting with, and memory of, the ISI were observed across the 4 different presentation formats-2 typical of existing website formats and 2 representing alternative formats-for both desktop and smartphone media. The traditional formats consistently outperformed the alternative formats overall, but when analyses are restricted to the subset of participants who view ISI, elements of one of the alternative formats proved to be superior. CONCLUSIONS: Digital presentation of different formats of risk information has a significant effect on recall and recognition of ISI associated with pharmaceutical products, and the interactive nature of digital material adds a layer of complexity to assessing the performance of the various formats.