Communicating medical device recalls: A rapid review of the literature.

OBJECTIVES: The U.S. Food and Drug Administration (FDA) currently regulates more than 190,000 different medical devices. Like all products, these devices may be subject to manufacturing problems, flawed designs, or new and unexpected risks, which in some cases require devices to be recalled. In 2021, the FDA's Patient Engagement Advisory Committee (PEAC) recommended that the FDA consider changes to the communication approach used for medical device recalls to make them more patient-focused, timely, and action-oriented. METHODS: To support this recommendation, we conducted a rapid review of literature published from 2008-2022 to capture and examine information on risk communication approaches, methods, and best practices for recall-related communications about medical products. RESULTS: We identified 23 articles to include in our review. CONCLUSION: Our review found a lack of research-based studies as well as gaps in understanding about consumer perspectives, comprehension, and communication preferences related to recalls. Despite these limitations, we identified current communication approaches, numerous challenges, and recommendations for communicating medical products recall information to consumers. PRACTICE IMPLICATIONS: Further research is needed to assess consumer attitudes, understanding, and preferences and to reach consensus on best practices for effectively communicating recall information to consumers of medical products.

Effectiveness of Community-Engaged Research Strategies in Increasing COVID-19 Vaccinations in Targeted Communities: The Community Engagement Alliance (CEAL) Regional Teams.

Objectives. To explore a key outcome of interest for the Community Engagement Alliance (CEAL) Regional Teams by examining COVID-19 vaccinations over time in US counties where CEAL teams operated and comparing them to demographically similar counties in the same state. Methods. Our evaluation used a nonequivalent control group design. Each county where a CEAL team operated was matched to a unique non-CEAL county in the same state. Components of the Centers for Disease Control and Prevention's Social Vulnerability Index were used as the matching criteria. COVID-19 vaccinations (county-level percentage of residents aged 18 years or older who are fully vaccinated) for CEAL and matched counties were analyzed over time. Results. The mean percentage of vaccinated adults was significantly higher in CEAL counties than in matched non-CEAL counties. Sensitivity analyses confirmed conclusions did not change depending on the CEAL cohort or closeness of matches. Conclusions. Our findings support CEAL team efforts to increase COVID-19 vaccinations in target communities and employ community-engaged research more broadly within public health contexts. (Am J Public Health. 2024;114(S1):S124-S127. https://doi.org/10.2105/AJPH.2023.307517).

Common Measures to Evaluate Flavored Tobacco Products: Recommendations From the Tobacco Centers for Regulatory Science (TCORS) Flavored Tobacco Products Measurement Subcommittee.

INTRODUCTION: Flavored electronic nicotine delivery systems (ENDS) and tobacco products are associated with the initiation and progression of tobacco use. With recent restrictions around flavored products, it is critical to measure both the product and the flavor being used. The Tobacco Centers of Regulatory Science (TCORS) Flavored Tobacco Products Measurement Subcommittee (FTPMS) was established to develop core measures to assess flavored tobacco and ENDS product usage, facilitate data harmonization, replicability, and comparisons across studies. AIMS AND METHODS: The FTPMS used a mixed-method approach to inform the development of recommended measures (first use, current use, reasons for use) to assess tobacco and ENDS product flavors. This included reviewing existing surveys, identifying priority areas, developing new measures, cognitive testing, and finalization of recommended measures. RESULTS: Recommended measures were selected from national surveys (e.g. PATH study) and survey items used in TCORS studies to evaluate first use, current use, and reasons for use of tobacco and ENDS products. Response options were expanded for questions about specific flavors and adapted to allow for assessments relevant to recent federal policies. Supplemental measures were developed for researchers conducting more in-depth research around flavored products. CONCLUSIONS: Using an expert consensus process supplemented with cognitive testing, the FTPMS developed recommendations for core and supplemental measures for flavored tobacco and ENDS products. Harmonizing data on these factors for flavored tobacco and ENDS products are critical for researchers and may provide actionable evidence to federal, state, and local regulators and policymakers, as well as support evaluations of policies restricting flavors in these products. IMPLICATIONS: The development of core measures to assess first use, current use, and reasons for use of flavored tobacco and ENDS products will facilitate data harmonization, replicability, and comparisons across studies conducted in different samples or across communities with varying levels of regulation for these products. Use of these standardized measures will allow for a greater understanding of the role of flavors and helps to build a more robust evidence base to inform regulatory decisions to reduce tobacco and ENDS use at the population level.

Evaluating Partnerships for Practice Change in the Prevention, Identification, and Treatment of Fetal Alcohol Spectrum Disorders.

Background: In 2014, the Centers for Disease Control and Prevention funded a four-year partnership effort between university and health care professional associations (HCPAs) to reach health care providers (HCPs) nationally in six health disciplines and engage them to adopt evidence-based practices for the prevention, identification, and treatment of fetal alcohol spectrum disorders (FASDs). The aim of this project was to evaluate partnerships for their (1) structure and formation, (2) collaboration process, and (3) outcomes with regard to resources and strategies developed for FASD prevention and management. Methods: We used quantitative and qualitative data from quarterly progress reports, a semi-annual collaboration survey, and annual interviews with each discipline's members. Results: Partnerships in each discipline varied in the number of members and organizations, expertise in the discipline, and access to HCPs. Assigned partnerships with limited researchers' expertise in the discipline or the inability of HCPAs to reach priority audiences created challenges in the development and dissemination of resources. Two partnerships showed challenges in the collaboration process regarding understanding respective responsibilities, sharing similar ideas, and resolving disagreements despite efforts at facilitated discussion. Messaging and resource dissemination by HCPAs and the use of provider champions developed through HCPAs' national network emerged as promising approaches to engage HCPs. Conclusion: Circumstances under which partnerships are formed can facilitate or challenge collaboration and outcome efforts. Discipline-specific partnerships between researchers and HCPAs provide a model for evidence-based resources to be developed and disseminated widely for adoption by HCPs in their practice.

Influence of data disclosures on physician decisions about off-label uses: findings from a qualitative study.

BACKGROUND: Prescribing approved products for unapproved uses (off-label use) is not uncommon among physicians in certain medical specialties. Available evidence about an off-label use - both supportive and unsupportive - can influence prescribers' decisions about a drug's appropriateness for a particular case. The objectives of this study were: (1) to examine physician perceptions about off-label uses generally, including their awareness of unsupportive data; and (2) to explore the influence of disclosure information about unsupportive data on off-label prescribing decisions. METHODS: Semi-structured interviews were conducted between December 2019 and January 2020 with oncologists (n = 35) and primary care physicians (n = 35). Interviews explored general prescribing practices, understanding of and information sources for learning about off-label use of prescription drugs, awareness of unsupportive data related to off-label uses, and preferences and reactions to disclosure statements about the existence of unsupportive data related to an off-label use. RESULTS: Most participants reported prescribing drugs for off-label uses (with half reporting regular off-label prescribing). However, among those who prescribe off-label, approximately two-thirds had never seen unsupportive data about off-label uses. Physicians preferred a disclosure statement that provided a summary of the unsupportive data about the off-label use; this statement also led most physicians to say they were unlikely or less likely to prescribe the drug for that use. CONCLUSIONS: This study suggests that physicians' decision-making about prescribing for off-label uses of approved drugs may be influenced by awareness of unsupportive data. Our interviews also suggest that providing more information about unsupportive study findings may result in a reduction in reported prescribing likelihood.

A Conceptual Model for Evaluating Emergency Risk Communication in Public Health.

Public health threats, such as emerging infectious diseases, terrorism, environmental catastrophes, and natural disasters, all require effective communication. Emergency risk communication is a critical component of public health emergency planning and response. It is a complex process involving a variety of constructs that interact in dynamic ways over time. While emergency risk communication is generally recognized as an important tool for risk management and emergency response, the specific elements, processes, and outcomes are not well described and have not been systematically assessed. In this article, we describe a conceptual model for public health developed in collaboration with the Centers for Disease Control and Prevention (CDC). We propose using this model to inform practice and to guide evaluations of emergency risk communication. The model was informed by an extensive review of the emergency risk communication literature, interviews with researchers, and discussions with CDC stakeholders. This model can be adapted for a wide range of emergency events and incorporates key constructs to assess internal processes, as well as outcomes of emergency risk communication on audiences. Evaluating internal processes can help identify and correct messaging deficiencies. Outcome constructs describe expected target audience responses to emergency risk communication, such as changes in knowledge, attitudes, beliefs, and behaviors that may occur over time. This can help public health communicators learn how their various activities contribute to emergency risk communication outcomes.

Mentoring for Success in Tobacco Regulatory Science: A Qualitative Study.

OBJECTIVES: Our study explores the experiences of early career and senior scientists regarding mentorship and career trajectories in tobacco regulatory science (TRS). METHODS: We conducted 22 phone interviews with early career and senior tobacco regulatory scientists from July 2015 to January 2016. All interviews were conducted using a structured interview guide and analyzed using a thematic approach by 2 independent coders. RESULTS: TRS presents specific opportunities and challenges to scientists due to its focused goal of informing tobacco regulation. An understanding of US Food and Drug Administration (FDA) research priorities and how science can inform tobacco regulation are essential for effective mentorship in TRS. Careers in TRS can be pursued in various academic and non-academic professional roles; both offer the distinct ability to conduct science that impacts public policy. Early career and senior scientists identified the importance and challenge of providing broad training across the diverse disciplines of TRS. CONCLUSIONS: Effective mentorship in TRS requires that mentors possess an in-depth understanding of the scientific, regulatory, and legislative processes inherent to tobacco regulatory policy-making. A training program for mentors specific to TRS has the potential to meet diverse professional needs of mentors and mentees aiming to impact tobacco policy.

Qualitative assessment of pica experienced by frequent blood donors.

BACKGROUND: Pica, the compulsive consumption of ice or other nonnutritious substances, is associated with iron deficiency, a common negative consequence of frequent blood donation. Because of this, blood donors, such as those participating in the Strategies to Reduce Iron Deficiency (STRIDE) study, are an ideal population to explore pica and iron deficiency. STUDY DESIGN AND METHODS: STRIDE was a 2-year intervention trial to assess the effectiveness of iron supplementation for mitigating iron deficiency in frequent blood donors. Subjects completed baseline and follow-up questionnaires that included questions about pica symptoms. In-depth telephone interviews were conducted with 14 of these subjects reporting pica symptoms and eight presumed controls (casual ice chewers) to gain a deeper understanding of pica symptoms and their impact on daily life and to make a final determination on the presence of pica. RESULTS: Pica was confirmed in five of the 14 subjects reporting symptoms and in two of eight controls. Outcome misclassification based on the questionnaire was attributed to inadequate assessment of several pica symptoms identified during the interview. Comparison of subjects' repeated quantitative iron measurements taken throughout STRIDE with subjects' final adjudicated pica status revealed a positive relationship between development of pica and worsening iron status; the opposite was found in those whose pica symptoms resolved. CONCLUSION: Continued refinement of pica symptom questions will allow for rapid and accurate detection of pica in frequent blood donors and confirmation of successful treatment with iron supplements.