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.

The utility of IGF1 in the evaluation of pediatric patients with endogenous hypercortisolemia.

BACKGROUND: Cushing Disease (CD) is a rare endocrine disorder associated with impaired growth hormone (GH) and short stature. Insulin-like growth factor-1 (IGF-1) is a marker of GH secretion. METHODS: Patients with young onset CD (<21 years old) and available IGF-1 levels at diagnosis and/or follow-up were studied (total = 194, diagnosis = 174, follow-up = 104). IGF-1 was reported as z-score (IGF1z). RESULTS: IGF1z was lower than expected in the general population (median IGF1z: -0.92 [-1.54, 0.07], p < 0.0001) at diagnosis and remained low at follow-up (median: -1.13 [-1.78, -0.66], p < 0.0001). There was no correlation of IGF1z at diagnosis with BMI; there was a weak correlation with height (rs = 0.19, p = 0.035). IGF1z was inversely correlated with markers of hypercortisolemia, including morning (rs = -0.31, p < 0.0001) and midnight cortisol (rs = -0.30, p < 0.0001), and with insulin resistance (Homeostatic Model Assessment for Insulin Resistance, HOMA-IR, rs = -0.27, p < 0.01). CONCLUSIONS: IGF-1 levels in CS are on the lower side of the normal range during active disease and remain low at one year after treatment. IGF-1 levels correlated mainly with markers of hypercortisolemia rather than the short stature of patients and should not be used in the assessment of growth in this population. IMPACT: We report that IGF-1 levels in childhood during active hypercortisolemia and up to 1 year after resolution are on the lower side of the normal range. Our results demonstrate that IGF-1 levels during active hypercortisolemia correlate mainly with markers of Cushing syndrome. This report adds data to the current literature where reports of IGF-1 in Cushing syndrome have shown variable results. Understanding the lack of utility of IGF-1 in assessing growth parameters in the pediatric Cushing syndrome population is important for physicians caring for these patients who should not use IGF-1 for diagnostic or treatment decisions.

False Negative Inferior Petrosal Sinus Sampling in Young-Onset Cushing Disease: What Happens Next.

INTRODUCTION: False negative results during inferior petrosal sinus sampling (IPSS) may complicate the diagnostic evaluation of patients with ACTH-dependent Cushing syndrome (CS). The management of these patients can be confusing for clinicians and lead to delayed management. METHODS: We studied patients with young-onset (<21yo) CD who underwent IPSS during their diagnostic evaluation. For all patients, diagnosis of CD was eventually confirmed based on histologic evaluation of a resected pituitary tumor or remission after transsphenoidal surgery (TSS). RESULTS: We recorded a rare incidence of false negative IPSS results in 5 out of the 142 IPSS procedures (3.5%), performed in 4 unique patients. Patients with negative IPSS did not differ in demographic (age and sex) or biochemical (diurnal ACTH/cortisol or 24hour urinary free cortisol) data from the remaining. Additional workup was performed in three of the four patients including evaluation for ectopic sources of CS and repeat IPSS. Two of these patients also received medical treatment for suppression of cortisol production. One patient decided to proceed with pituitary exploration without additional evaluation. All patients finally underwent surgery and achieved remission. DISCUSSION/CONCLUSION: In patients with CD, IPSS may rarely lead to false negative results. Management of these patients usually includes screening for ectopic sources of ACTH/CRH secretion, repeating IPSS if ectopic workup is negative, and considering medical management until final diagnosis of the source of hypercortisolism is made.

Evaluation of the "We Can Do This" Campaign Paid Media and COVID-19 Vaccination Uptake, United States, December 2020-January 2022.

Public education campaigns are promising methods for promoting vaccine uptake. In April 2021, the U.S. Department of Health and Human Services launched the We Can Do This COVID-19 public education campaign. This study is one of the first evaluations of this COVID-19 public education campaign. We tested associations between channel-specific campaign exposure (i.e. digital, TV, radio, print, and out-of-home advertising) and COVID-19 first-dose vaccinations among a nationally representative online sample of 3,278 adults. The study introduces novel ways to simultaneously evaluate short- and long-term cumulative media dose, filling an important gap in campaign evaluation literature. We observed a positive, statistically significant relationship between the short-term change in digital media dose and the likelihood of first-dose vaccination, and a positive, statistically significant relationship between long-term cumulative TV dose and the likelihood of first-dose vaccination. Results suggest that both digital and TV ads contributed to vaccination, such that digital media was associated with more immediate behavioral changes, whereas TV gradually shifted behaviors over time. As findings varied by media channel, this study suggests that public education campaigns should consider delivering campaign messages across multiple media channels to enhance campaign reach across audiences.

Usability and acceptability of virtual reality for chronic pain management among diverse patients in a safety-net setting: a qualitative analysis.

Objective: The aim of this study was to understand the usability and acceptability of virtual reality (VR) among a racially and ethnically diverse group of patients who experience chronic pain. Materials and Methods: Using the Technology Acceptance Model theory, we conducted semistructured interviews and direct observation of VR use with English-speaking patients who experience chronic pain treated in a public healthcare system (n = 15), using a commercially available VR technology platform. Interviews included questions about current pain management strategies, technology use, experiences and opinions with VR, and motivators for future use. Results: Before the study, none of the 15 participants had heard about or used VR for pain management. Common motivators for VR use included a previous history of substance use and having exhausted many other options to manage their pain and curiosity. Most participants had a positive experience with VR and 47% found that the VR modules distracted them from their pain. When attempting the navigation-based usability tasks, most participants (73%-92%) were able to complete them independently. Discussion: VR is a usable tool for diverse patients with chronic pain. Our findings suggest that the usability of VR is not a barrier and perhaps a focus on improving the accessibility of VR in safety-net settings is needed to reduce disparities in health technology use. Conclusions: The usability and acceptability of VR are rarely studied in diverse patient populations. We found that participants had a positive experience using VR, showed interest in future use, and would recommend VR to family and friends.

Virtual Reality for Chronic Pain Management Among Historically Marginalized Populations: Systematic Review of Usability Studies.

BACKGROUND: Virtual reality (VR) has potential to improve chronic pain management outcomes. However, the majority of studies assessing VR are conducted in predominantly White populations in well-resourced settings, thus leaving a gap in knowledge of VR use among diverse populations who experience a significant chronic pain burden. OBJECTIVE: This review aims to examine the extent to which usability of VR for chronic pain management has been studied within historically marginalized patient groups. METHODS: We conducted a systematic search to identify studies with usability outcomes located in high-income countries that included a historically marginalized population, defined by a mean age greater than or equal to 65 years, lower educational attainment (greater than or equal to 60% having attained high school education or less), and being a racial or ethnic minority (less than or equal to 50% non-Hispanic White people for studies based in the United States). RESULTS: Our analysis included 5 papers, which we used to conduct a narrative analysis. Three studies examined VR usability as a primary outcome. All studies assessed VR usability using different measures, of which 4 found VR to be usable by their respective study population. Only 1 study found a significant improvement in pain levels post-VR intervention. CONCLUSIONS: The use of VR shows promise for chronic pain management, but few studies include populations that are older, have limited educational attainment, or have racial or ethnic diversity. Additional studies with these populations are needed to further develop VR systems that work best for diverse patients with chronic pain.

Recalled Exposure to COVID-19 Public Education Campaign Advertisements Predicts COVID-19 Vaccine Confidence.

This study examined the relationship between recalled exposure to the We Can Do This COVID-19 Public Education Campaign (the Campaign) and COVID-19 vaccine confidence (the likelihood of vaccination or vaccine uptake) in the general population, including vaccine-hesitant adults (the "Movable Middle"). Analyses used three waves of a triannual, nationally representative panel survey of adults in the U.S. fielded from January to November 2021 (n = 3,446). Proportional odds regression results demonstrated a positive, statistically significant relationship between past 4-month Campaign recall and vaccine confidence, controlling for lagged reports of Campaign recall and vaccine confidence; concurrent and lagged fictional campaign recall; survey wave; and sociodemographics. Results indicated that as one moves from no Campaign recall to infrequent recall, there is a 29% increase in the odds of being in a higher vaccine confidence category. Findings offer evidence of the impact of a COVID-19 public education campaign on increasing vaccine confidence.

The Initial Relationship Between the United States Department of Health and Human Services' Digital COVID-19 Public Education Campaign and Vaccine Uptake: Campaign Effectiveness Evaluation.

BACKGROUND: Over 1 million people in the United States have died of COVID-19. In response to this public health crisis, the US Department of Health and Human Services launched the We Can Do This public education campaign in April 2021 to increase vaccine confidence. The campaign uses a mix of digital, television, print, radio, and out-of-home channels to reach target audiences. However, the impact of this campaign on vaccine uptake has not yet been assessed. OBJECTIVE: We aimed to address this gap by assessing the association between the We Can Do This COVID-19 public education campaign's digital impressions and the likelihood of first-dose COVID-19 vaccination among US adults. METHODS: A nationally representative sample of 3642 adults recruited from a US probability panel was surveyed over 3 waves (wave 1: January to February 2021; wave 2: May to June 2021; and wave 3: September to November 2021) regarding COVID-19 vaccination, vaccine confidence, and sociodemographics. Survey data were merged with weekly paid digital campaign impressions delivered to each respondent's media market (designated market area [DMA]) during that period. The unit of analysis was the survey respondent-broadcast week, with respondents nested by DMA. Data were analyzed using a multilevel logit model with varying intercepts by DMA and time-fixed effects. RESULTS: The We Can Do This digital campaign was successful in encouraging first-dose COVID-19 vaccination. The findings were robust to multiple modeling specifications, with the independent effect of the change in the campaign's digital dose remaining practically unchanged across all models. Increases in DMA-level paid digital campaign impressions in a given week from -30,000 to 30,000 increased the likelihood of first-dose COVID-19 vaccination by 125%. CONCLUSIONS: Results from this study provide initial evidence of the We Can Do This campaign's digital impact on vaccine uptake. The size and length of the Department of Health and Human Services We Can Do This public education campaign make it uniquely situated to examine the impact of a digital campaign on COVID-19 vaccination, which may help inform future vaccine communication efforts and broader public education efforts. These findings suggest that campaign digital dose is positively associated with COVID-19 vaccination uptake among US adults; future research assessing campaign impact on reduced COVID-19-attributed morbidity and mortality and other benefits is recommended. This study indicates that digital channels have played an important role in the COVID-19 pandemic response. Digital outreach may be integral in addressing future pandemics and could even play a role in addressing nonpandemic public health crises.

Focus Groups to Inform the Development of a Patient-Reported Outcome Measure (PROM) for Temporomandibular Joint Disorders (TMDs).

BACKGROUND: Understanding symptoms of temporomandibular joint disorders (TMDs) can help doctors and patients document, monitor, and manage the disease and help researchers evaluate interventions. Patients with TMDs experience symptoms ranging from mild to severe, primarily in the head and neck region. This study describes findings from formative patient focus groups to capture, categorize, and prioritize symptoms of TMDs towards the development of a patient-reported outcome measure (PROM). METHODS: We conducted ten focus groups with 40 men and women with mild, moderate, and severe TMD. Focus groups elicited descriptions of symptoms and asked participants to review a list of existing patient-reported outcomes (PROs) from the literature and patient advisor input and speak to how those PROs reflect their own experience, including rating their importance. RESULTS: We identified 52 distinct concepts across six domains: somatic, physical, social, sexual, affective, and sleep. Focus groups identified the ability to chew and eat; clicking, popping, and other jaw noises; jaw pain and headaches; jaw misalignment or dislocation; grinding, clenching, or chewing, including at night; and ear sensations as most important. Participants with severe TMDs more often reported affective concepts like depression and shame than did participants with mild or moderate TMDs. CONCLUSION: Findings support PROM item development for TMDs, including selecting existing PROMs or developing new ones that reflect patients' lived experiences, priorities, and preferred terminology. Such measures are needed to increase understanding of TMDs, promote accurate diagnosis and effective treatment, and help advance research on TMDs.

Patients with temporomandibular joint disorders, or TMDs, have pain and other problems in their jaw, and face and neck areas. We talked to 40 patients with mild, moderate, and severe TMDs to learn about their symptoms. We also asked patients to review a list of TMD symptoms. They then chose the most important ones based on their experience. The data showed 52 TMD symptoms and functions across six domains. The patients chose the ability to chew and eat; clicking, popping, and other jaw noises; and jaw pain and headaches as most important. They also chose jaw misalignment or dislocation; grinding, clenching, or chewing, including at night; and ear feelings as important. Findings support creating patient-reported outcome measures, or PROMs, for TMDs. These PROMs should reflect patients' experiences and what is most important to them. Such measures can help doctors treat TMDs and help advance research on TMDs.

Patient-reported outcome measures for individuals with temporomandibular joint disorders: a systematic review and evaluation.

OBJECTIVE: We used consensus-based, systematic protocols to evaluate the reliability and validity of patient-reported outcome measures (PROMs) for use in documenting treatment outcomes for temporomandibular disorders (TMDs). STUDY DESIGN: Following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, we conducted a focused search of 5 literature databases resulting in a yield of 445 articles that qualified for full-text review. Our review identified 124 PROMs, from which we selected 19 directly related to symptoms of TMD including temporomandibular joint (TMJ) function. RESULTS: We abstracted data on 9 Consensus-based Standards of the selection of health Measurements INstruments (COSMIN) measurement properties and analyzed these data according to COSMIN criteria. Only 3 PROMs provided evidence for at least half of the COSMIN properties: Eight-item Jaw Function Limitations Scale, Oral Health Impact Profile (OHIP)-TMD (OHIP-TMD), and TMJ Ankylosis Specific Quality of Life Questionnaire. Only the OHIP-TMD provided evidence for properties essential to evaluating change over time: reliability, measurement error, and responsiveness. CONCLUSION: We believe these results can alert clinical practitioners to gaps in our knowledge about the most widely used PROMs in TMD practice, and identify topics requiring further study for clinical researchers.

The FDA's Message Testing: Putting Health Literacy Advice into Practice.

Acting on health literacy principles in a large agency requires not only knowledge of the research base, but also creative work to implement the concepts in practice. Sound scientific advice needs practical development, shaped for the specific working environment. For example, the U.S. Food and Drug Administration (FDA) needs to test communications with intended audiences, but must work within constraints including: Widely varied audiences Significant time pressure Complying with multiple reviews designed to protect potential message testers Testing messages with the intended audiences is a basic communications responsibility, not just an option. Yet, how to do the testing can be challenging. The FDA's experience suggests two practical approaches for user testing: Internal message testing with a network of employee volunteers External message testing with consumer panelists The report briefly explains how the FDA assesses some public communication internally and externally to attain insights about a target audience or a health message as well as discover how a communication might be modified to improve its usability by an intended audience. The report suggests internal or external message testing is superior to controls (no testing) and such testing can be accomplished by a large governmental agency embedded within a complex regulatory environment.

Qualitative Perspective on the Learning Health System: How the Community Health Applied Research Network Paved the Way for Research in Safety-Net Settings.

BACKGROUND: Safety-net populations are underrepresented in health research networks. To address this deficit, the Community Health Applied Research Network (CHARN) was created to promote integration of research in health centers (HCs). CHARN embodies a learning health system (LHS) model to advance the evidence base for improved care in safety-net settings. OBJECTIVES: We sought to identify lessons learned from the development of research infrastructure to promote the inclusion of safety-net populations in research. METHODS: We conducted nine qualitative interviews with a purposive sample of CHARN members, as well as content analysis of work plans and project reports, and identified barriers and facilitators to building research capacity in HCs. RESULTS: Lessons learned include the importance of linking research to the HC mission, encouraging mentoring, and investing in data infrastructure at HCs to tailor health services to communities. CONCLUSIONS: Findings can inform safety-net providers on the process of building research infrastructure and capacity.