Exploratory Analysis of Concordance Between Clinician-Collected and Self-Sampled Human Papillomavirus Tests in a Small Cohort of Average- and High-Risk Patients.

Objectives: Cervical cancer screening rates have stagnated, but self-sampling modalities have the potential to increase uptake. This study compares the test characteristics of self-sampled high-risk human papillomavirus (hrHPV) tests with clinician-collected hrHPV tests in average-risk (i.e., undergoing routine screening) and high-risk patients (i.e., receiving follow-up after abnormal screening results). Methods: In this cross-sectional study, a relatively small cohort of average-risk (n = 35) and high-risk (n = 12) participants completed both clinician-collected and self-sampled hrHPV testing, along with a brief phone survey. We assessed hrHPV positivity, concordance, positive predictive value (PPV), negative predictive value (NPV), sensitivity, and specificity across both methods (for types 16, 18, or other hrHPV). We also explored the relationship between test concordance and sociodemographic/behavioral factors. Results: Among average-risk participants, hrHPV positivity was 6% for both test methods (i.e., hrHPV-positive cases: n = 2), resulting in reported concordance, PPV, NPV, sensitivity, and specificity of 100%. Among high-risk participants, hrHPV positivity was 100% for clinician-collected tests but only 67% for self-sampled tests, showing varied concordance and sensitivity. Concordance was not associated with sociodemographic or behavioral factors. Conclusions: Self-sampled hrHPV testing demonstrated high accuracy for average-risk patients in this exploratory study. However, its performance was less consistent in high-risk patients who had already received an abnormal screening result, which could be attributed to spontaneous viral clearance over time. The limited number of participants, particularly HPV-positive cases, suggests caution in interpreting these results. Further research with larger cohorts is necessary to validate these findings and to explore the integration of self-sampled hrHPV testing into routine clinical care, particularly for patients with a history of cervical abnormalities. Clinical Trial Registration: NCT04591977, NCT04585243.

High-grade liver injuries with contrast extravasation managed initially with interventional radiology versus observation: A secondary analysis of a WTA multicenter study.

BACKGROUND: High-grade liver injuries with extravasation (HGLI â€‹+ â€‹Extrav) are associated with morbidity/mortality. For low-grade injuries, an observation (OBS) first-strategy is beneficial over initial angiography (IR), however, it is unclear if OBS is safe for HGLI â€‹+ â€‹Extrav. Therefore, we evaluated the management of HGLI â€‹+ â€‹Extrav patients, hypothesizing IR patients will have decreased rates of operation and mortality. METHODS: HGLI â€‹+ â€‹Extrav patients managed with initial OBS or IR were included. The primary outcome was need for operation. Secondary outcomes included liver-related complications (LRCs) and mortality. RESULTS: From 59 patients, 23 (39.0%) were managed with OBS and 36 (61.0%) with IR. 75% of IR patients underwent angioembolization, whereas 13% of OBS patients underwent any IR, all undergoing angioembolization. IR patients had an increased rate of operation (13.9% vs. 0%, p â€‹= â€‹0.049), but no difference in LRCs (44.4% vs. 43.5%) or mortality (5.6% vs. 8.7%) versus OBS patients (both p â€‹> â€‹0.05). CONCLUSION: Over 60% of patients were managed with IR initially. IR patients had an increased rate of operation yet similar rates of LRCs and mortality, suggesting initial OBS reasonable in appropriately selected HGLI â€‹+ â€‹Extrav patients.

Self-sampling tools to increase cancer screening among underserved patients: a pilot randomized controlled trial.

BACKGROUND: Screening can reduce cancer mortality, but uptake is suboptimal and characterized by disparities. Home-based self-sampling can facilitate screening for colorectal cancer (with stool tests, eg, fecal immunochemical tests) and for cervical cancer (with self-collected human papillomavirus tests), especially among patients who face barriers to accessing health care. Additional data are needed on feasibility and potential effects of self-sampling tools for cancer screening among underserved patients. METHODS: We conducted a pilot randomized controlled trial with patients (female, ages 50-65 years, out of date with colorectal and cervical cancer screening) recruited from federally qualified health centers in rural and racially segregated counties in Pennsylvania. Participants in the standard-of-care arm (n = 24) received screening reminder letters. Participants in the self-sampling arm (n = 24) received self-sampling tools for fecal immunochemical tests and human papillomavirus testing. We assessed uptake of screening (10-week follow-up), self-sampling screening outcomes, and psychosocial variables. Analyses used Fisher exact tests to assess the effect of study arm on outcomes. RESULTS: Cancer screening was higher in the self-sampling arm than the standard-of-care arm (colorectal: 75% vs 13%, respectively, odds ratio = 31.32, 95% confidence interval = 5.20 to 289.33; cervical: 79% vs 8%, odds ratio = 72.03, 95% confidence interval = 9.15 to 1141.41). Among participants who returned the self-sampling tools, the prevalence of abnormal findings was 24% for colorectal and 18% for cervical cancer screening. Cancer screening knowledge was positively associated with uptake (P < .05). CONCLUSIONS: Self-sampling tools can increase colorectal and cervical cancer screening among unscreened, underserved patients. Increasing the use of self-sampling tools can improve primary care and cancer detection among underserved patients. CLINICAL TRIALS REGISTRATION NUMBER: STUDY00015480.

Increasing the adoption of evidence-based communication practices for HPV vaccination in primary care clinics: The HPV ECHO study protocol for a cluster randomized controlled trial.

BACKGROUND: The safe, highly-effective human papillomavirus (HPV) vaccine remains underused in the US. The Announcement Approach Training (AAT) has been shown to effectively increase HPV vaccine uptake by training providers to make strong vaccine recommendations and answer parents' common questions. Systems communications, like recall notices, can further improve HPV vaccination by reducing missed clinical opportunities for vaccination. Never tested in supporting HPV vaccination, the ECHO (Extension for Community Healthcare Outcomes) model is a proven implementation strategy to increase best practices among healthcare providers. This trial uses a hybrid effectiveness-implementation design (type II) to evaluate two ECHO-delivered interventions intended to increase HPV vaccination rates. METHODS: This 3-arm cluster randomized controlled trial will be conducted in 36 primary care clinics in Pennsylvania. Aim 1 evaluates the impact of HPV ECHO (AAT to providers) and HPV ECHO+ (AAT to providers plus recall notices to vaccine-declining parents) versus control on HPV vaccination (≥1 dose) among adolescents, ages 11-14, between baseline and 12-month follow-up (primary outcome). Using a convergent mixed-methods approach, Aim 2 evaluates the implementation of the HPV ECHO and HPV ECHO+ interventions. Aim 3 explores exposure to and impact of vaccine information from providers and other sources (e.g., social media) on secondary acceptance among 200 HPV vaccine-declining parents within 12 months. DISCUSSION: We expect to demonstrate the effectiveness and evaluate the implementation of two highly scalable interventions to increase HPV vaccination in primary care clinics. Our study seeks to address the communication needs of both providers and parents, increase HPV vaccination, and, eventually, prevent HPV-related cancers. TRIAL REGISTRATION: ClinicalTrials.govNCT04587167. Registered on October 14, 2020.

Whole Blood Trauma Resuscitation in Community Trauma Centers Confers Survival Benefit Over Component Therapy.

Whole blood (WB) for trauma resuscitation in civilian populations has become more common. The utilization of WB in community trauma centers has not been reported. Previous studies have centered around large academic medical centers. We hypothesized that WB-based resuscitation compared to component-only resuscitation (CORe) would demonstrate a survival benefit and that WB resuscitation is safe, feasible, and benefits trauma patients regardless of setting. Our results indicate that receiving whole blood during resuscitation conferred a clear survival benefit to discharge, and this benefit was independent of ISS, age, gender, and initial SBP. We conclude WB should be incorporated into all resuscitation protocols for exsanguinating trauma patients and preferred over component therapy in all centers treating trauma patients.

An observation-first strategy for liver injuries with "blush" on computed tomography is safe and effective.

INTRODUCTION: The management of liver injuries in hemodynamically stable patients is variable and includes primary treatment strategies of observation (OBS), angiography (interventional radiology [IR]) with angioembolization (AE), or operative intervention (OR). We aimed to evaluate the management of patients with liver injuries with active extravasation on computed tomography (CT) imaging, hypothesizing that AE will have more complications without improving outcomes compared with OBS. METHODS: This is a prospective, multicenter, observational study. Patients who underwent CT within 2 hours after arrival with extravasation (e.g., blush) on imaging were included. Exclusion criteria included cirrhosis, nontraumatic hemorrhage, transfers from outside facilities, and pregnancy. No hemodynamic exclusion criteria were used. The primary outcome was liver-specific complications. Secondary outcomes include length of stay and mortality. Angioembolization patients were compared with patients treated without AE. Propensity score matching was used to match based on penetrating mechanism, liver injury severity, arrival vital signs, and early transfusion. RESULTS: Twenty-three centers enrolled 192 patients. Forty percent of patients (n = 77) were initially OBS. Eleven OBS patients (14%) failed nonoperative management and went to IR or OR. Sixty-one patients (32%) were managed with IR, and 42 (69%) of these had AE as an initial intervention. Fifty-four patients (28%) went to OR+/- IR. After propensity score matching (n = 34 per group), there was no difference in baseline characteristics between AE and OBS. The AE group experienced more complications with a higher rate of IR-placed drains for abscess or biloma (22% vs. 0%, p = 0.01) and an increased overall length of stay ( p = 0.01). No difference was noted in transfusions or mortality. CONCLUSION: Observation is highly effective with few requiring additional interventions. Angioembolization was associated with higher rate of secondary drain placement for abscesses or biloma. Given this, a trial of OBS and avoidance of empiric AE may be warranted in hemodynamically stable, liver-injured patient with extravasation on CT. LEVEL OF EVIDENCE: Therapeutic/Care Management; Level II.

Support for HPV vaccine school-entry requirements in the United States: The role of exemption policies.

In the United States (U.S.), only five states or territories require human papillomavirus (HPV) vaccination for school attendance, even though almost all U.S. jurisdictions have debated adopting this type of policy. In this U.S. based study, we sought to estimate the level of support for HPV vaccine school-entry requirements with varying exemption policies and documentation procedures to obtain exemptions. Between July and August 2019, we conducted a web-based survey with a national sample of 1,109 U.S. parents of 11- to 17-year-olds. The survey assessed support for four school-entry vaccine requirement policies: without exemption or with exemption for medical, religious or philosophical reasons. Analyses used multivariable logistic regression to assess correlates of support for each policy. Overall, 38% of parents agreed with laws requiring HPV vaccination for school attendance without exemptions. When including exemption provisions, agreement increased to 45% for philosophical reasons, 50% for religious reasons, and 59% for medical reasons. Parents more often agreed on requirements without any exemptions if they were female (OR = 1.37, 95% CI:1.01-1.87), their child had initiated HPV vaccination (OR = 2.05, 95% CI:1.50-2.87), reported high levels of vaccine confidence (OR = 2.41, 95% CI:1.77-3.27), or reported having values similar to those of the people in their community (OR = 1.85, 95% CI:1.39-2.47). Parents more often agreed with requirements that included religious or philosophical exemptions if they reported having values similar to their community or high levels of psychological reactance (all p <.05). Many parents also supported requiring a written notice signed by a health care provider (40%) or religious leader (49%) to obtain a medical or religious exemption, respectively. In conclusion, exemption policies greatly increase parent support of school-entry requirements for HPV vaccination but may decrease their impact in practice. A large number of U.S. parents support strict documentation to obtain exemptions, signaling a promising area of policymaking to strengthen vaccine policies for school attendance.

Utilization of Mammography During the Last Year of Life Among Older Breast Cancer Survivors.

Background: Mammography is generally recommended for breast cancer survivors. However, discussion is ongoing about stopping surveillance mammography when life expectancy is <5-10 years as the benefit of screening might be diminished toward the end of life. The utilization pattern of mammography in the last year of life among this population has not been well studied. Methods: We identified 58,736 females diagnosed with breast cancer between January 2002 and December 2015, who died at the age of at least 67, from the SEER-Medicare database. We examined the utilization patterns of mammography during their last year of life and investigated factors associated with the use of mammography at the end of life using a multivariable logistic regression model. Results: Overall, 28.5% of the patients received mammography during the last year of life. Multivariable logistic regression showed that older age (OR = 0.31, 95% CI = 0.29-0.34, p < 0.001 for 95 vs. 85 years old), more advanced cancer stage (OR = 0.22, 95% CI = 0.20-0.24 p < 0.001 for distant vs. localized disease), and higher comorbidity score (OR = 0.92, 95% CI = 0.91-0.93, p < 0.001 for every 1-point increase) were associated with less mammography use. Age was nonlinearly associated with mammography use, with a steady proportion of patients receiving a mammography until approximately age 80 and then a sharp decrease thereafter. Conclusion: This population-based study found that a sizable proportion of older breast cancer survivors received mammography during the last year of life.

Multilevel Associations with Cancer Screening Among Women in Rural, Segregated Communities Within the Northeastern USA: a Mixed-Methods Study.

We recruited women (primarily non-Hispanic White) from 14 rural, segregated counties in a Northeastern US state for an explanatory sequential study: 100 women (ages 50-65 years) completed a survey, and 16 women participated in focus groups. We sought to identify personal (e.g., healthcare mistrust) and environmental (e.g., travel time to healthcare providers) factors related to colorectal and cervical cancer screening. Quantitatively, 89% of participants were up-to-date for cervical screening, and 65% for colorectal screening. Factors interacted such that compounding barriers were associated with lower odds of screening (e.g., insurance status and healthcare mistrust: interaction p = .02 for cervical; interaction p = .05 for colorectal). Qualitatively, three themes emerged regarding barriers to screening: privacy concerns, logistical barriers, and lack of trust in adequacy of healthcare services. While cancer screening was common in rural, segregated counties, women who reported both environmental and personal barriers to screening had lower uptake. Future interventions to promote screening can target these barriers.

Changes in Serum, Red Blood Cell, and Colonic Fatty Acids in a Personalized Omega-3 Fatty Acid Supplementation Trial.

This study evaluated changes in fatty acids from sera, red blood cells, and colonic biopsies from a phase Ib clinical trial of personalized ω-3 fatty acid dosing in 47 healthy volunteers. The trial aimed to reduce colonic prostaglandin E2 (PGE2), a pro-inflammatory product of arachidonic acid (AA) oxidation. The personalized doses ranged 2-10 grams/day (54% eicosapentaenoic acid, EPA, 24% other ω-3 fatty acids). In colon, increases in ω-3 highly unsaturated fatty acids (HUFA) and EPA:AA ratios each were correlated with decreases in PGE2. Changes in either colonic EPA:AA ratios or ω-3 HUFA were significantly correlated with changes in the same fatty acid measures in red blood cells or serum. The only blood-based measure significantly correlated with changes in colonic PGE2 was change in red blood cell ω-3 HUFA (ρ = -0.39), and the increase in red blood cell ω-3 HUFA was significantly greater in participants who had at least a median reduction in colonic PGE2 vs. those who did not. In summary, fatty acid changes in blood did reflect fatty acid changes in the colon, but additional factors will be needed for optimizing dosing models that seek to predict the anti-inflammatory effects of ω-3 fatty acids on the colon.

Disparities in Cancer Screening: The Role of County-Level Metropolitan Status and Racial Residential Segregation.

Mortality from cervical and colorectal cancers can be reduced through routine screening, which can often be accessed through primary care. However, uptake of screening in the US remains suboptimal, with disparities observed across geographic characteristics, such as metropolitan status or level of racial residential segregation. Little is known about the interaction of metropolitan status and segregation in their relationship with cancer screening. We conducted a quantitative survey of 474 women aged 45-65 in central Pennsylvania. The survey collected county-level characteristics and participant-level demographics, beliefs, cancer screening barriers, and cervical and colorectal cancer screening. We used bivariate and multivariable logistic regression to analyze relationships between metropolitan status and segregation with screening. For cervical cancer screening, 82.8% of participants were up-to-date, which did not differ by county type in the final analysis. Higher healthcare trust, higher cancer fatalism, and reporting cost as a barrier were associated with cervical cancer screening. For colorectal cancer screening, 55.4% of participants were up-to-date, which differed by county type. In metropolitan counties, segregation was not associated with colorectal cancer screening, but in non-metropolitan counties, segregation was associated with greater colorectal cancer screening. The relationship between metropolitan status and being up-to-date with colorectal, but not cervical, cancer screening varied by segregation. Other important beliefs and barriers to screening varied by county type. This research can guide future cancer screening interventions in primary care settings in underserved communities.

Association Between Dense Breast Legislation and Cancer Stage at Diagnosis.

INTRODUCTION: Many states have mandated breast density notification and insurance coverage for additional screening; yet, the association between such legislation and stage of diagnosis for breast cancer is unclear. This study investigates this association and examines the differential impacts among different age and race/ethnicity subgroups. METHODS: The Surveillance, Epidemiology, and End Results database was queried to identify patients with breast cancer aged 40-74 years diagnosed between 2005 and 2016. Using a difference-in-differences multinomial logistic model, the odds of being diagnosed at different stages of cancer relative to the localized stage depending on legislation and individual characteristics were examined. Analyses were conducted in 2020-2021. RESULTS: The study included 689,641 cases. Overall, the impact of notification legislation was not significant, whereas insurance coverage legislation was associated with 6% lower odds (OR=0.94, 95% CI=0.91, 0.96) of being diagnosed at the regional stage. The association between insurance coverage legislation and stage of diagnosis was even stronger among women aged 40-49 years, with 11% lower odds (OR=0.89, 95% CI=0.82, 0.96) of being diagnosed at the regional stage and 12% lower odds (OR=0.88, 95% CI=0.81, 0.96) of being diagnosed at the distant stage. Hispanic women benefited from notification laws, with 11% lower odds (OR=0.89, 95% CI=0.82, 0.97) of being diagnosed at distant stage. Neither notification nor supplemental screening insurance coverage legislation showed a substantial impact on Black women. CONCLUSIONS: The findings imply that improving insurance coverage is more important than being notified overall. Raising awareness is important among Hispanic women; improving communication about dense breasts and access to screening might be more important than legislation among Black women.

Predictors of Human Papillomavirus Seropositivity in Appalachian Women Aged 18 to 26 Years.

BACKGROUND: Key informants of the Appalachian community questioned whether their unique environmental stressors would alter their immune response to human papillomavirus (HPV) infections. The primary aim of this study is to determine predictors of HPV seroprevalence to at least 1 of the 4 vaccine-related HPV types before vaccination using a psychoneuroimmunologic model in Appalachian women. METHOD: Women aged 18 to 26 years (n = 185) who had not received HPV vaccination provided cervical HPV DNA and blood samples. Human papillomavirus DNA was identified through Hybrid Capture 2 assay and then genotyped for HPV types 6, 11, 16, and 18 by Roche Linear Array. Competitive Luminex Immunoassay measured the type-specific antibodies to HPV types 6, 11, 16, and 18 in milli-Merck units per milliliter. Nine psychoneuroimmunology scales measuring attributes of stress were self-completed. RESULTS: Human papillomavirus DNA was detected in 50% (92/183) of participants, with only 14% (26/183) positive for HPV-6/11/16/18 DNA. Seropositivity for at least one anti-HPV-6/11/16 or 18, on the other hand, was present in 35% (64/183) of women, with only 10% (19/183) concomitantly infected and seropositive for the vaccine-related types. The Perceived Stress Scale was not a strong predictor of HPV seropositivity. CONCLUSIONS: Both HPV infection and vaccine-related HPV type seropositivity is common among Appalachian women aged 18 to 26 years. The anticipated effect of environmental stressors on HPV seropositivity was not seen when multiple predictors were considered.

Knowledge, Perceptions, and Preferred Information Sources Related to COVID-19 Among Central Pennsylvania Adults Early in the Pandemic: A Mixed Methods Cross-Sectional Survey.

PURPOSE: To explore public knowledge, understanding of public health recommendations, perceptions, and trust in information sources related to COVID-19. METHODS: A cross-sectional survey of central Pennsylvanian adults evaluated self-reported knowledge, and a convergent, mixed methods design was used to assess beliefs about recommendations, intended behaviors, perceptions, and concerns related to infectious disease risk, and trust of information sources. RESULTS: The survey was completed by 5,948 adults. The estimated probability of correct response for the basic knowledge score, weighted with confidence, was 0.79 (95% CI, 0.79-0.80). Knowledge was significantly higher in patients with higher education and nonminority race. While the majority of respondents reported that they believed following CDC recommendations would decrease the spread of COVID-19 in their community and intended to adhere to them, only 65.2% rated social isolation with the highest level of belief and adherence. The most trusted information source was federal public health websites (42.8%). Qualitative responses aligned with quantitative data and described concerns about illness, epidemiologic issues, economic and societal disruptions, and distrust of the executive branch's messaging. The survey was limited by a lack of minority representation, potential selection bias, and evolving COVID-19 information that may impact generalizability and interpretability. CONCLUSIONS: Knowledge about COVID-19 and intended adherence to behavioral recommendations were high. There was substantial distrust of the executive branch of the federal government, however, and concern about mixed messaging and information overload. These findings highlight the importance of consistent messaging from trusted sources that reaches diverse groups.

Pharmacogenomic testing for mental health (Part I): documenting early adopter perceptions of use for eight scenarios.

Aim: We sought to understand how early adopters used pharmacogenomic (PGx) testing for treating depression and attention deficient hyperactivity disorder (ADHD). Patients & methods: We conducted a phone survey with prescribers who had previously ordered an Informed PGx (Progenity, Inc., MI, USA) test. Results: We identified 1037 prescribers in our sampling period. Respondents (n = 64) were predominantly female (61.5%) and in pediatrics (n = 42; 64.6%). PGx testing was used for multiple scenarios (mean 3.3 ± 1.6); the most common was after no response to medication was observed (80%; 51/64). Most respondents state that test results typically reveal an altered metabolizer status. Conclusion: PGx test results ordered by early adopters often reveal altered metabolizers which leads them to change the depression/ADHD medication regimen. Future work should evaluate the clinical utility of PGx testing for depression/ADHD treatment.

Pharmacogenomic testing for mental health (Part II): qualitative analysis of early adopter prescriber perceptions.

Aim: We sought to explore how early adopters use pharmacogenomic (PGx) testing for treating depression and attention-deficit/hyperactivity disorder. Patients & methods: Prescribers of the Informed PGx (Progenity, Inc., Ann Arbor, MI 48108, USA) test completed a phone survey assessing use of PGx testing for different scenarios. We conducted a qualitative thematic text analysis of transcribed audio recordings of open-ended responses (n = 62). Results: PGx testing was used when treating multiple comorbidities or resistant disease, and to ease patients' concerns with future therapy. Use of PGx testing is influenced by insurance coverage, interpretability of results and results turnaround time. Conclusion: Prescribers used PGx tests to modify medications for complex patients with depression, attention-deficit/hyperactivity disorder and other disorders to alleviate concerns related to adverse effects and lack of effectiveness.

Examining Older Adults' Attitudes and Perceptions of Cancer Screening and Overscreening: A Qualitative Study.

INTRODUCTION/OBJECTIVES: Screening guidelines for breast, cervical, and colorectal cancer (CRC) are less clear for older adults due to the potential harms that may result from screening. Understanding older adults' attitudes and perceptions, especially racial/ethnic minority and underserved adults, of cancer screening can help health care providers determine how best to communicate with older adults about cancer screening and screening cessation. The objective of this study was to determine how older adults primarily from minority/underserved backgrounds perceive cancer screening and overscreening. METHODS: Four focus groups (n = 39) were conducted with adults (>=65 years of age) in 3 community settings in south-central Pennsylvania. Two focus groups were conducted in Spanish and translated to English upon transcription. Focus group data was managed and analyzed using QSR NVivo 12. Inductive thematic analysis was used to analyze the data where themes emerged following the coding process. RESULTS: The focus group participants had an average age of 74 years and were primarily female (74%) and Hispanic (69%), with 69% reporting having less than a high school degree. Four key themes were identified from the focus groups: (1) importance of tailored and targeted education/information; (2) impact of physician/patient communication; (3) impact of barriers and facilitators to screening on cancer screening cessation; and (4) awareness of importance of screening. Participants were more likely to be agreeable to screening cessation if they received specific information regarding their health status and previous medical history from their physician as to why screening should be stopped and told by their physician that the screening decision is up to them. CONCLUSIONS: Older adults prefer individualized information from their physician in order to justify screening cessation but are against incorporating life expectancy into the discussion. Future research should focus on developing interventions to test the effectiveness of culturally tailored screening cessation messages for older adults.

Public Intent to Comply with COVID-19 Public Health Recommendations.

Stay-at-home orders have been an essential component of coronavirus 2019 (COVID-19) management in the United States. As states start lifting these mandates to reopen the economy, voluntary public compliance with public health recommendations may significantly influence the extent of resurgence in COVID-19 infection rates. Population-level risk from reopening may therefore be predicted from public intent to comply with public health recommendations. We are conducting a global, convergent design mixed-methods survey on public knowledge, perceptions, preferred health information sources, and understanding of and intent to comply with public health recommendations. With over 9,000 completed surveys from every US state and over 70 countries worldwide, to our knowledge this is the largest pandemic messaging study to date. Although the study is still ongoing, we have conducted an analysis of 5,005 US surveys completed from April 9-15, 2020 on public intent to comply with public health recommendations and offer insights on the COVID-19 pandemic-related risk of reopening. We found marked regional differences in intent to follow key public health recommendations. Regional efforts are urgently needed to influence public behavior changes to decrease the risk of reopening, particularly in higher-risk areas with low public intent to comply with preventive health recommendations. [HLRP: Health Literacy Research and Practice. 2020;4(3):e160-e165.].

An Adaptive Bayesian Design for Personalized Dosing in a Cancer Prevention Trial.

INTRODUCTION: In biomarker-driven clinical trials, translational strategies typically involve moving findings from animal experiments to human trials. Typically, the translation is static, using a fixed model derived from animal experiments for the duration of the trial. Bayesian designs, capable of incorporating information external to the experiment, provide a dynamic translational strategy. This article demonstrates an example of such a dynamic Bayesian strategy in a clinical trial. METHODS: This study explored the effect of a personalized dose of fish oil for reducing prostaglandin E2, an inflammatory marker linked to colorectal cancer. A Bayesian design was implemented for the dose-finding algorithm that adaptively updated a dose-response model derived from a previously completed animal study during the clinical trial. In the initial stages of the trial, the dose-response model parameters were estimated from the rodent data. The model was updated following a Bayesian algorithm after data on every 10‒15 subjects were obtained until the model stabilized. Subjects were enrolled in the study between 2013 and 2015, and the data analysis was carried out in 2016. RESULTS: The 3 dosing models were used for groups of 16, 15, and 15 subjects. The mean target dose significantly decreased from 6.63 g/day (Model 1) to 4.06 g/day (Model 3) (p=0.001). Compared with the static strategy of dosing with a single model, the dynamic modeling reduced the dose significantly by about 1.38 g/day on average. CONCLUSIONS: A Bayesian design was effective in adaptively revising the dosing algorithm, resulting in a lower pill burden. TRIAL REGISTRATION: This study is registered at www.clinicaltrials.gov NCT01860352.

Japanese Women's Concerns and Satisfaction With Pregnancy Care in the United States.

Immigrant women report a high level of stress during pregnancy due to language barriers, cultural differences, and differences in the standard of prenatal care. In this study, we evaluated the level of concern Japanese women in the United States feel during pregnancy and their level of satisfaction with their care. This data can be used to modify prenatal care programs and education to address these concerns. Data collected from 96 women showed there was a high level of prenatal concern regarding their baby's health, pain control, the short length of hospitalization after birth, and the lack of breastfeeding support. Despite these concerns, postpartum women ended up being satisfied with all items except the short duration of their hospital stay.