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JYNNEOS (Modified Vaccinia Ankara vaccine, Bavarian Nordic) is recommended in the United States for persons exposed to or at high risk for exposure to Monkeypox virus during the 2022 monkeypox (mpox) outbreak (1). JYNNEOS is a live, nonreplicating viral vaccine licensed for the prevention of smallpox and mpox in adults aged ≥18 years, administered as a 0.5-mL 2-dose series given 28 days apart by subcutaneous injection (2). On August 9, 2022, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for administration of 0.1 mL doses by intradermal injection for adults aged ≥18 years as a strategy to increase vaccine supply, and administration of 0.5 mL doses subcutaneously for persons aged18 years (3). During May 22-October 21, 2022, a total of 987,294 JYNNEOS vaccine doses were administered in the United States. CDC has monitored JYNNEOS vaccine safety using the Vaccine Adverse Event Reporting System (VAERS) and the Vaccine Safety Datalink (VSD) for vaccine recipients of all ages, and through single-patient emergency Investigational New Drug (EIND) procedures for persons aged18 years vaccinated before August 9, 2022. The most common adverse health events reported to VAERS for adults were nonserious and included injection site reactions, which was consistent with the prelicensure studies. Adverse health events were reported at similar rates for doses received by intradermal and subcutaneous administration. Serious adverse events were rare in adults, and no serious adverse events have been identified among persons aged18 years. Overall, postlicensure and postauthorization surveillance to date support JYNNEOS vaccine safety.

Chronic parental stress may negatively impact health among both parents and children. Adverse neighborhood social conditions like crime may increase stress while a supportive neighborhood may buffer stress and promote well-being. Our objective was to examine associations between neighborhood social factors and stress among mothers of young children.We surveyed 300 mothers/female caregivers of Medicaid-enrolled 2 to 4-year-old children in Philadelphia. Maternal stress was measured via the 10-item Perceived Stress Scale (range 0-40). Mothers' perceived neighborhood safety and collective efficacy were assessed using validated scales. Addresses were geocoded to link census tract-level violent crime rates. We used multivariable linear regression to examine associations of neighborhood safety, collective efficacy, and crime with maternal stress, adjusted for demographics, household socioeconomic status, and neighborhood poverty.Among mothers (mean age 31, 60% Black/African American), higher perceived neighborhood safety and collective efficacy were associated with lower stress scores after adjustment for covariates. Each 1-point increase (on a 5-point scale) in perceived neighborhood safety was associated with a 2.30-point decrease in maternal stress (95% CI: -3.07, -1.53). Similarly, each 1-point increase in perceived collective efficacy was associated with a 3.08-point decrease in maternal stress (95% CI: -4.13, -2.02). Police-recorded violent crime rates were not associated with maternal stress.Mothers of young children who perceive their neighborhood social environment more favorably report less stress compared to those who feel their neighborhood environment is less safe and cohesive. Future work is warranted to investigate whether interventions that increase perceived neighborhood safety and collective efficacy reduce stress.

COVID-19 vaccination is critical to ending the COVID-19 pandemic. Members of minority racial and ethnic groups have experienced disproportionate COVID-19-associated morbidity and mortality (1); however, COVID-19 vaccination coverage is lower in these groups (2). CDC used data from CDC's Vaccine Safety Datalink (VSD)* to assess disparities in vaccination coverage among persons aged ≥16 years by race and ethnicity during December 14, 2020-May 15, 2021. Measures of coverage included receipt of ≥1 COVID-19 vaccine dose (i.e., receipt of the first dose of the Pfizer-BioNTech or Moderna COVID-19 vaccines or 1 dose of the Janssen COVID-19 vaccine [Johnson & Johnson]) and full vaccination (receipt of 2 doses of the Pfizer-BioNTech or Moderna COVID-19 vaccines or 1 dose of Janssen COVID-19 vaccine). Among 9.6 million persons aged ≥16 years enrolled in VSD during December 14, 2020-May 15, 2021, ≥1-dose coverage was 48.3%, and 38.3% were fully vaccinated. As of May 15, 2021, coverage with ≥1 dose was lower among non-Hispanic Black (Black) and Hispanic persons (40.7% and 41.1%, respectively) than it was among non-Hispanic White (White) persons (54.6%). Coverage was highest among non-Hispanic Asian (Asian) persons (57.4%). Coverage with ≥1 dose was higher among persons with certain medical conditions that place them at higher risk for severe COVID-19 (high-risk conditions) (63.8%) than it was among persons without such conditions (41.5%) and was higher among persons who had not had COVID-19 (48.8%) than it was among those who had (42.4%). Persons aged 18-24 years had the lowest ≥1-dose coverage (28.7%) among all age groups. Continued monitoring of vaccination coverage and efforts to improve equity in coverage are critical, especially among populations disproportionately affected by COVID-19.

Despite its increasing use, few studies have reported on demographic representativeness and costs of research recruitment via social media. It was hypothesized that cost, reach, enrollment, and demographic representativeness would differ by social media recruitment approach. Participants were 18–25 year-olds at moderate to high risk of skin cancer based on phenotypic and behavioral characteristics. Paid Instagram, Facebook, and Twitter ads, unpaid social media posts by study staff, and unpaid referrals were used to recruit participants. Demographic and other characteristics of the sample were compared with the 2015 National Health Interview Survey (NHIS) sample. Analyses demonstrated significant differences among recruitment approaches regarding cost efficiency, study participation, and representativeness. Costs were compared across 4,274 individuals who completed eligibility screeners over a 7-month period from: Instagram, 44.6% (of the sample) = 1,907, $9 (per individual screened); Facebook, 31.5% = 1,345, $8; Twitter, 1% = 42, $178; unpaid posts by study staff, 10.6% and referred, 6.5%, $1. The lowest rates of study enrollment among individuals screened was for Twitter. Most demographic and skin cancer risk factors of study participants differed from those of the 2015 NHIS sample and across social media recruitment approaches. Considering recruitment costs and number of participants enrolled, Facebook and Instagram appeared to be the most useful approaches for recruiting 18–25 year-olds. Findings suggest that project budget, target population and representativeness, and participation goals should inform selection and/or combination of existing and emerging online recruitment approaches.

Objective Serum neurofilament light (sNfL) is a promising new biomarker in multiple sclerosis (MS). We explored the relationship between sNfL and health outcomes and resource use in MS patients. Methods MS patients with serum samples and health‐outcome measurements collected longitudinally between 2011 and 2016 were analyzed. sNfL values were evaluated across age and gender. Data were analyzed using correlation with log‐transformed sNfL values. Results A total of 304 MS patients with a mean age of 32.9 years, average EDSS of 1.6 (SD = 1.5) and baseline sNfL of 8.8 (range 1.23–78.3) pg/mL were studied. Baseline sNFL values increased with age and were higher in females. Baseline sNfL correlated with baseline Multiple Sclerosis Quality of Life physical composite (mean = 49.4 (9.1), P = 0.035) and baseline EDSS (P = 0.002). Other PRO measures at baseline did not show a significant relationship with baseline sNfL. Average of baseline and follow‐up sNfL correlated with MSQoL physical‐role limitations (mean = 48.9 (10.8), P = 0.043) and social‐functioning (mean = 52.3 (7), P = 0.034) at 24‐month follow‐up. We found a trend for numerically higher sNfL levels in nonpersistent patients compared to those who were persistent to treatment (11.13 vs. 8.53 pg/mL, P = 0.093) measured as average of baseline and 24‐month values. Baseline NfL was associated with number of intravenous steroid infusions (mean = 0.2; SD = 3.0, P = 0.013), whereas the average of baseline and 12 months NfL values related to inpatient stays at 12 months (mean = 0.2; SD = 3.0 P = 0.053). Conclusion Serum NfL is a patient‐centric biomarker that correlated with MS patient health‐outcomes and healthcare utilization measures in a real‐world cohort.

Pregnant women might be at increased risk for severe coronavirus disease 2019 (COVID-19), possibly related to changes in their immune system and respiratory physiology* (1) Further, adverse birth outcomes, such as preterm delivery and stillbirth, might be more common among pregnant women infected with SARS-CoV-2, the virus that causes COVID-19 (2,3) Information about SARS-CoV-2 infection during pregnancy is rapidly growing;however, data on reasons for hospital admission, pregnancy-specific characteristics, and birth outcomes among pregnant women hospitalized with SARS-CoV-2 infections are limited During March 1-May 30, 2020, as part of Vaccine Safety Datalink (VSD)(†) surveillance of COVID-19 hospitalizations, 105 hospitalized pregnant women with SARS-CoV-2 infection were identified, including 62 (59%) hospitalized for obstetric reasons (i e , labor and delivery or another pregnancy-related indication) and 43 (41%) hospitalized for COVID-19 illness without an obstetric reason Overall, 50 (81%) of 62 pregnant women with SARS-CoV-2 infection who were admitted for obstetric reasons were asymptomatic Among 43 pregnant women hospitalized for COVID-19, 13 (30%) required intensive care unit (ICU) admission, six (14%) required mechanical ventilation, and one died from COVID-19 Prepregnancy obesity was more common (44%) among pregnant women hospitalized for COVID-19 than that among asymptomatic pregnant women hospitalized for obstetric reasons (31%) Likewise, the rate of gestational diabetes (26%) among pregnant women hospitalized for COVID-19 was higher than it was among women hospitalized for obstetric reasons (8%) Preterm delivery occurred in 15% of pregnancies among 93 women who delivered, and stillbirths (fetal death at ≥20 weeks' gestation) occurred in 3% Antenatal counseling emphasizing preventive measures (e g , use of masks, frequent hand washing, and social distancing) might help prevent COVID-19 among pregnant women,(§) especially those with prepregnancy obesity and gestational diabetes, which might reduce adverse pregnancy outcomes

Objectives: Indoor tanning, which is most common among 18-25-year-old white women, increases the risk of skin cancer. To address this problem, we developed and tested messages with a national sample of indoor tanners to determine beliefs that would encourage them to quit. Methods: Messages discouraging indoor tanning using different persuasive themes (skin cancer risk, appearance risk, well-being enhancement) were developed based on formative research and a review of intervention efforts. We conducted an online experiment to test the final messages with a national sample of 480 indoor tanners. Results: Messages that emphasized skin cancer risk out-performed messages that focused on well-being enhancement or damage to appearance in terms of intention to quit indoor tanning. Analyses revealed 2 key mediators: perceived argument strength and beliefs related to the effects of indoor tanning. Conclusions: Theory- and evidence-informed public health communications can contribute to improving health-related behaviors. Focusing on the risk of skin cancer may be the most effective strategy to reduce indoor tanning among young white women.

Background and purpose Cognitive impairment occurs frequently in multiple sclerosis (MS). However, the prevalence and clinical characteristics of cognitive MS phenotype are not well established. The aim of the study was to characterize the clinical course and neurocognitive impairment of patients with MS meeting an Expanded Disability Status Scale (EDSS)-defined cognitive phenotype. Methods A total of 2302 patients from the Comprehensive Longitudinal Investigation of Multiple Sclerosis at Brigham and Women's Hospital (CLIMB) study were studied. Predominant cognitive MS phenotype was defined as EDSS Cerebral Functional System (FS) subscore ≥3 and remaining EDSS FS subscores ≤2 on at least one clinical visit. Demographic/clinical characteristics, phenotype stability and neurocognitive domain impairment of these subjects were assessed. Results A total of 60 of 2302 (2.6%) patients (age 52.8 ± 10.8 years, 68% female, 82% relapsing MS) met criteria for phenotype designation. A total of 29 of 60 (48%) were designated within 10 years of their presenting MS symptom. The mean cohort annualized relapse rate was 0.38 and EDSS score at last clinical assessment was 3.2 ± 1.3. Cognitive phenotype status was poorly sustained, with only 27% of subjects maintaining Cerebral FS score ≥2 throughout all follow-up. However, predominant cognitive phenotype subjects with clinical neuropsychiatric testing [n = 39/60 (65%)] frequently had cognitive impairment (1.5 SD below mean) in ≥1 domain [n = 30/39 (77%) of subjects] affecting memory, attention/executive function and processing speed. A total of 11 of 39 (28%) patients had severe-range cognitive impairment (3.0 SD below mean). Cognitive phenotype designation was associated with low rate of employment at last clinical assessment. Conclusion Predominant cognitive MS phenotype is rare, although an EDSS-based definition identifies patients with multidomain cognitive impairment and may serve as a practical screen for identification of patients who might warrant close monitoring of neurocognitive status.

The purpose of the present cross-sectional clinical study was to check the ability of plaque detection and quantification by QLF-D against conventional digital photographs of disclosed plaque in multibracket appliance (MB) patients. 20 patients were included according to the following criteria: (1) upper and lower jaw treated by MB appliance, (2) patients being 16 years of age or older, (3) all central and lateral incisors as well as canines in situ, (4) absence of developmental defects, carious lesions, surface fillings, prosthetic restorations or recessions greater than 1/3 of root length in central/lateral incisors and canines as well as (5) declaration of consent. QLF-D and conventional photographs were analyzed planimetrically regarding plaque coverage on buccal and oral surfaces of central/lateral incisors and canines. The conventional photographs of stained plaque served as gold standard. On average, in QLF-D pictures 20.7% ± 17.4 of the tooth surfaces were covered with plaque, while the conventional photographs of disclosed plaque presented a mean plaque-covered area of 36.2% ± 23.5. The Bland-Altman plot for both imaging modalities showed a very large inconsistent scattering with both negative and positive deviations. The method discrepancy increased with increasing plaque coverage, thus indicating a systematic method error. On average, the deviation of the methods from the optimal line of accordance was −15.5%. In patients wearing MB appliances, there was no clinical significant agreement regarding the plaque-covered tooth surface depicted by QLF-D respectively conventional images of disclosed plaque. Due to the large method discrepancy, QLF-D is currently not reliable for precise plaque quantification in MB patients.

Key Points Question What is the relative effectiveness of financial incentives and environmental change strategies, alone and in combination, on initial weight loss and maintenance of weight loss in employees with obesity? Findings In this randomized clinical trial, at the 18-month primary end point, participants in the incentives group lost a mean of 5.4 lb (2.45 kg), those in the environmental strategies group lost a mean of 2.2 lb (1.00 kg), and the combination group lost a mean of 2.4 lb (1.09 kg) more than the usual care group. None of the strategies was significantly more effective than usual care. Meaning Across all study groups, participants lost a modest amount of weight but those who received interventions did not lose significantly more weight, suggesting that more intensive individualized weight loss strategies may be needed., This randomized clinical trial tests the relative effectiveness of financial incentives and environmental strategies, alone and in combination, on initial weight loss and maintenance of weight loss in employees with obesity at 3 large employers in Philadelphia, Pennsylvania., Importance Modest weight loss can lead to meaningful risk reduction in adults with obesity. Although both behavioral economic incentives and environmental change strategies have shown promise for initial weight loss, to date they have not been combined, or compared, in a randomized clinical trial. Objective To test the relative effectiveness of financial incentives and environmental strategies, alone and in combination, on initial weight loss and maintenance of weight loss in adults with obesity. Design, Setting, and Participants This randomized clinical trial was conducted from 2015 to 2019 at 3 large employers in Philadelphia, Pennsylvania. A 2-by-2 factorial design was used to compare the effects of lottery-based financial incentives, environmental strategies, and their combination vs usual care on weight loss and maintenance. Interventions were delivered via website, text messages, and social media. Participants included adult employees with a body mass index (BMI; weight in kilograms divided by height in meters squared) of 30 to 55 and at least 1 other cardiovascular risk factor. Data analysis was performed from June to July 2021. Interventions Interventions included lottery-based financial incentives based on meeting weight loss goals, environmental change strategies tailored for individuals and delivered by text messages and social media, and combined incentives and environmental strategies. Main Outcome and Measures The primary outcome was weight change from baseline to 18 months, measured in person. Results A total of 344 participants were enrolled, with 86 participants each randomized to the financial incentives group, environmental strategies group, combined financial incentives and environmental strategies group, and usual care (control) group. Participants had a mean (SD) age of 45.6 (10.5) years and a mean (SD) BMI of 36.5 (7.1); 247 participants (71.8%) were women, 172 (50.0%) were Black, and 138 (40.1%) were White. At the primary end point of 18 months, participants in the incentives group lost a mean of 5.4 lb (95% CI, −11.3 to 0.5 lb [mean, 2.45 kg; 95% CI, −5.09 to 0.23 kg]), those in the environmental strategies group lost a mean of a 2.2 lb (95% CI, −7.7 to 3.3 lb [mean, 1.00 kg; 95% CI, −3.47 to 1.49 kg]), and the combination group lost a mean of 2.4 lb (95% CI, −8.2 to 3.3 lb [mean, 1.09 kg; 95% CI, −3.69 to 1.49 kg]) more than participants in the usual care group. Financial incentives, environmental change strategies, and their combination were not significantly more effective than usual care. At 24 months, after 6 months without an intervention, the difference in the change from baseline was similar to the 18-month results, with no significant differences among groups. Conclusions and Relevance In this randomized clinical trial, across all study groups, participants lost a modest amount of weight but those who received financial incentives, environmental change, or the combined intervention did not lose significantly more weight than those in the usual care group. Employees with obesity may benefit from more intensive individualized weight loss strategies. Trial Registration ClinicalTrials.gov Identifier: NCT02878343

OBJECTIVES: Influenza vaccination coverage among pregnant women in the United States is suboptimal. We surveyed women who were pregnant during the 2016–17 influenza season to assess knowledge and attitudes regarding influenza vaccination. METHODS: We identified and sampled pregnant women to include approximately equal numbers of vaccinated and unvaccinated women from strata defined by vaccination status and trimester from four integrated health systems in the Vaccine Safety Datalink (VSD). Potential participants were contacted via mail and telephone to complete a standardized survey. Characteristics and responses of women vaccinated and unvaccinated during pregnancy were compared. RESULTS: The survey was completed by 510 (48%) of 1062 contacted women; 500 were included in the analysis. Vaccine receipt while pregnant was associated with primigravida status (p = 0.02), college degree (p = 0.01), employment in health care (p < 0.01), and history of routine annual influenza vaccination (p < 0.01). Among 330 vaccinated women, the primary reasons for vaccination included protection of self and baby from influenza (n = 233, 71%), and medical professional recommendation (n = 46, 14%). Multiple reasons were given for nonvaccination, but concern about ‘negative effects’ was cited most often (n = 44, 29%). Vaccinated women were significantly more likely to believe that influenza vaccines are safe and effective, and to recognize the potential for harm from influenza infection. Nearly all women reported receiving at least one influenza vaccination recommendation from a healthcare provider. CONCLUSIONS: Vaccinated pregnant women were more likely to receive routine annual influenza vaccine compared to those not vaccinated. Recommendations by obstetric providers should be supplemented with efforts to encourage women of childbearing age to receive annual vaccination.

Background Disease-modifying therapy (DMT) for patients with relapsing-remitting multiple sclerosis (RRMS) have been shown to reduce relapses and new MRI lesions. However, few studies have assessed the impact of discontinuing DMT after a period of disease inactivity. Objective To investigate the impact of DMT discontinuation on clinical and radiological outcomes in RRMS patients. Methods 69 RRMS patients who discontinued DMT after a period of disease inactivity were identified from the Comprehensive Longitudinal Investigation of MS study at the Brigham and Women's Hospital, based on the following inclusion criteria: age 18 or older; treated with DMT ≥2 years; no clinical and radiological relapse ≥2 years until the discontinuation; not restarting DMT for ≥6 months after discontinuation. Patients matched by age, gender, treatment, treatment duration, disease duration and Expanded Disability Status Scale score who remained on DMT were identified. Univariate and multivariable Cox proportional hazard models with robust standard errors to account for the paired data were used to test the differences based on DMT discontinuation with the outcome measures: time to clinical relapse, MRI event, disability progression, and disease activity (either clinical relapse or MRI event). Results Based on the 69 pairs of patients, discontinuation was not associated with time to clinical relapse (HR = 0.87, 95% CI = 0.44–1.72, p = 0.69), MRI event (HR = 0.95, 95% CI = 0.57 to 1.59, p = 0.84), disability progression (HR = 1.24, 95% CI = 0.61 to 2.53, p = 0.55) and disease activity (HR = 0.89, 95% CI = 0.56 to 1.42, p = 0.62). When we performed subgroup analysis to compare the impact of DMT discontinuation between older (age > 45) and younger (age ≤ 45) patients, we found a significant difference in the association between young and old for time to MRI event (p = 0.012) and time to new disease activity (p = 0.0005). Conclusions This study found that patients who discontinued treatment after a period of disease inactivity had a similar time to next event compared to subjects who remained on first-generation DMTs. In our cohort, we found that discontinuation after age 45 was associated with a stable disease course, while patients younger than age 45 who discontinued treatment were more likely to experience a new clinical relapse or MRI event.

Introduction Tetanus, diphtheria, and acellular pertussis (Tdap) and influenza vaccines are recommended for pregnant women in each pregnancy, yet uptake is suboptimal. This study tested the efficacy of an online vaccine resource in increasing uptake of Tdap and influenza vaccines among pregnant women. Study design RCT. Setting/participants This study was conducted among women in the third trimester of pregnancy in an integrated healthcare system in Colorado in September 2013–July 2016, with data analysis in 2017–2018. Intervention Women were randomly assigned to 1 of 3 arms: website with vaccine information and interactive social media components, website with vaccine information only, or usual care. Participants in the website with vaccine information and interactive social media components and website with vaccine information only arms had access to the same base vaccine content. The website with vaccine information and interactive social media components also included a blog, discussion forum, and “Ask a Question” portal. Main outcome measures Tdap and influenza vaccination. These outcomes were analyzed separately. Results For influenza (n=289), women in both the website with vaccine information and interactive social media components (OR=2.19, 95% CI=1.06, 4.53) and website with vaccine information only (OR=2.20, 95% CI=1.03, 4.69) arms had higher vaccine uptake than the usual care arm. The proportions of women receiving the influenza vaccine were 57%, 55%, and 36% in the website with vaccine information and interactive social media components, website with vaccine information only, and usual care arms, respectively. For Tdap (n=173), there were no significant differences in vaccine uptake between study arms. The proportions of women receiving Tdap were 71%, 69%, and 68% in the website with vaccine information and interactive social media components, website with vaccine information only, and usual care arms, respectively. Conclusions Web-based vaccination information sent to pregnant women can positively influence maternal influenza vaccine uptake. Because of potential scalability, the impact of robust vaccination information websites should be studied in other settings. Trial registration This study is registered at www.clinicaltrials.gov NCT01873040.

Introduction A recent study reported an association between inactivated influenza vaccine (IIV) and spontaneous abortion (SAB), but only among women who had also been vaccinated in the previous influenza season. We sought to estimate the association between IIV administered in three recent influenza seasons and SAB among women who were and were not vaccinated in the previous influenza season. Methods We conducted a case-control study over three influenza seasons (2012–13, 2013–14, 2014–15) in the Vaccine Safety Datalink (VSD). Cases (women with SAB) and controls (women with live births) were matched on VSD site, date of last menstrual period, age group, and influenza vaccination status in the previous influenza season. Of 1908 presumptive cases identified from the electronic record, 1236 were included in the main analysis. Administration of IIV was documented in several risk windows, including 1–28, 29–56, and >56 days before the SAB date. Results Among 627 matched pairs vaccinated in the previous season, no association was found between vaccination in the 1–28 day risk window and SAB (adjusted odds ratio (aOR) 0.9; 95% confidence interval (CI) 0.6–1.5). The season-specific aOR ranged from 0.5 to 1.7 with all CIs including the null value of 1.0. Similarly, no association was found among women who were not vaccinated in the previous season; the season-specific aOR in the 1–28 day risk window ranged from 0.6 to 0.7 and the 95% CI included 1.0 in each season. There was no association found between SAB and influenza vaccination in the other risk windows, or when vaccine receipt was analyzed relative to date of conception. Conclusion During these seasons we found no association between IIV and SAB, including among women vaccinated in the previous season. These findings lend support to current recommendations for influenza vaccination at any time during pregnancy, including the first trimester.

Objective Evidence-based strategies to address vaccine hesitancy are lacking. Personal values are a measurable psychological construct that could be used to deliver personalized messages to influence vaccine hesitancy and behavior. Our objectives were to develop a valid, reliable self-report survey instrument to measure vaccine values based on the Schwartz theory of basic human values, and to test the hypothesis that vaccine values are distinct from vaccine attitudes and are related to vaccine hesitancy and behavior. Methods Parental Vaccine Values (PVV) scale items were generated using formative qualitative research and expert input, yielding 24 items for testing. 295 parents of children aged 14–30 months completed a self-report survey with measures of Schwartz’s global values, the PVV, vaccine attitudes, and vaccine hesitancy. Factor analysis was used to determine vaccine values factor structure. Associations between vaccine values, vaccine attitudes, vaccine hesitancy, and vaccination behavior were assessed using linear and logistic regression models. Late vaccination was assessed from electronic medical records. Results A six-factor structure for vaccine values was determined with good fit (RMSEA = 0.07, Bentler’s CFI = 0.91) with subscales for Conformity, Universalism, Tradition, Self-Direction, Security- Disease Prevention, and Security- Vaccine Risk. Vaccine values were moderately associated with Schwartz global values and vaccine attitudes, indicating discriminant validity from these constructs. Multivariable linear regression showed vaccine hesitancy was associated with vaccine values Conformity (partial R2 = 0.10) and Universalism (0.04) and vaccine attitudes Vaccine Safety (0.52) and Vaccine Benefit (0.16). Multivariable logistic regression showed that late vaccination was associated with vaccine value Self-direction (OR = 1.80, 95% CI: 1.26–2.65) and vaccine attitude of Vaccine Benefit (OR = 0.44, 95% CI: 0.32–0.60). Conclusions The PVV scale had good psychometric properties and appears related to but distinct from Schwartz global values and vaccine attitudes. Vaccine values are associated with vaccine hesitancy and late vaccination and may be useful in tailoring future interventions.

Smiling, laughing, and overt speech production are fundamental to human everyday communication. However, little is known about how the human brain achieves the highly accurate and differentiated control of such orofacial movement during natural conditions. Here, we utilized the high spatiotemporal resolution of subdural recordings to elucidate how human motor cortex is functionally engaged during control of real-life orofacial motor behaviour. For each investigated movement class—lip licking, speech production, laughing and smiling—our findings reveal a characteristic brain activity pattern within the mouth motor cortex with both spatial segregation and overlap between classes. Our findings thus show that motor cortex relies on sparse and action-specific activation during real-life orofacial behaviour, apparently organized in distinct but overlapping subareas that control different types of natural orofacial movements., Markus Kern et al. use subdural recordings to understand how the human motor cortex is engaged during orofacial motor behavior such as speech production, laughing, and smiling. They find the motor cortex makes use of sparse and action-specific activation during these behaviors, which are organized in distinct but overlapping subareas.

Objective This study was undertaken to investigate the gut microbiome in progressive multiple sclerosis (MS) and how it relates to clinical disease. Methods We sequenced the microbiota from healthy controls and relapsing-remitting MS (RRMS) and progressive MS patients and correlated the levels of bacteria with clinical features of disease, including Expanded Disability Status Scale (EDSS), quality of life, and brain magnetic resonance imaging lesions/atrophy. We colonized mice with MS-derived Akkermansia and induced experimental autoimmune encephalomyelitis (EAE). Results Microbiota β-diversity differed between MS patients and controls but did not differ between RRMS and progressive MS or differ based on disease-modifying therapies. Disease status had the greatest effect on the microbiome β-diversity, followed by body mass index, race, and sex. In both progressive MS and RRMS, we found increased Clostridium bolteae, Ruthenibacterium lactatiformans, and Akkermansia and decreased Blautia wexlerae, Dorea formicigenerans, and Erysipelotrichaceae CCMM. Unique to progressive MS, we found elevated Enterobacteriaceae and Clostridium g24 FCEY and decreased Blautia and Agathobaculum. Several Clostridium species were associated with higher EDSS and fatigue scores. Contrary to the view that elevated Akkermansia in MS has a detrimental role, we found that Akkermansia was linked to lower disability, suggesting a beneficial role. Consistent with this, we found that Akkermansia isolated from MS patients ameliorated EAE, which was linked to a reduction in RORγt+ and IL-17-producing γδ T cells. Interpretation Whereas some microbiota alterations are shared in relapsing and progressive MS, we identified unique bacteria associated with progressive MS and clinical measures of disease. Furthermore, elevated Akkermansia in MS may be a compensatory beneficial response in the MS microbiome. ANN NEUROL 2021;89:1195-1211.

This cohort study examines the risks for spontaneous abortion, preterm birth, small-for-gestational age birth, and major structural birth defects among female teenagers and adults who received the human papillomavirus vaccine., Key Points Question Is exposure to the 9-valent human papillomavirus (9vHPV) vaccine in pregnancy associated with adverse pregnancy or birth outcomes? Findings In this cohort study of 1493 pregnancies, in adjusted analyses, during-pregnancy or peripregnancy exposures to 9vHPV vaccine were not associated with spontaneous abortion. Among live births, 9vHPV vaccine exposures during or around the time of pregnancy were not associated with adverse birth outcomes. Meaning Results of this study suggest that, in an insured population, adverse events after exposure to 9vHPV vaccine during or around the time of pregnancy were uncommon; these findings can inform counseling after inadvertent 9vHPV vaccine exposures., Importance The 9-valent human papillomavirus (9vHPV) vaccine is recommended for individuals through age 26 years and may be administered to women up to age 45 years. Data on 9vHPV vaccine exposures during pregnancy are limited. Objective To evaluate the associations between 9vHPV vaccine exposures during pregnancy or peripregnancy and selected pregnancy and birth outcomes (spontaneous abortion [SAB], preterm birth, small-for-gestational age [SGA] birth, and major structural birth defect). Design, Setting, and Participants This cohort study analyzed data from 7 participating health systems in the Vaccine Safety Datalink. The cohort comprised pregnancies among girls and women aged 12 to 28 years that ended between October 26, 2015, and November 15, 2018. Singleton pregnancies that ended in a live birth, stillbirth, or SAB were included. Exposures Vaccine exposure windows were distal (9vHPV or 4vHPV vaccine administered from 22 to 16 weeks before last menstrual period [LMP]), peripregnancy (9vHPV vaccine administered from 42 days before LMP until LMP), and during pregnancy (9vHPV vaccine administered from LMP to 19 completed weeks’ gestation). Primary comparisons were (1) girls and women with 9vHPV vaccine exposures during pregnancy vs those with 4vHPV or 9vHPV distal vaccine exposures, (2) girls and women with vaccine exposures peripregnancy vs those with 4vHPV or 9vHPV distal vaccine exposures, and (3) girls and women with 9vHPV vaccine exposures during pregnancy or peripregnancy vs those with 4vHPV or 9vHPV distal vaccine exposure. Main Outcomes and Measures Spontaneous abortions were confirmed based on medical record review and adjudication. Preterm and SGA births were identified from electronic health record and birth data. Major structural birth defects were based on diagnostic codes using a validated algorithm. Inverse probability weighting was used to balance the covariates. Time-dependent covariate Cox proportional hazards regression models and Poisson regression were used to estimate the associations between 9vHPV vaccine exposures and pregnancy and birth outcomes. Results The final cohort included 1493 pregnancies among girls and women with a mean (SD) maternal age of 23.9 (2.9) years. Of these pregnancies, 445 (29.8%) had exposures to the 9vHPV vaccine during pregnancy, 496 (33.2%) had exposures to the 9vHPV vaccine peripregnancy, and 552 (37.0%) had 4vHPV or 9vHPV distal vaccine exposures. The 9vHPV vaccine administered during pregnancy was not associated with increased risk for SAB (hazard ratio, 1.12; 95% CI, 0.66-1.93) compared with distal vaccine exposures. Findings were similar for 9vHPV vaccine exposures peripregnancy (relative risk [RR], 0.72; 95% CI, 0.42-1.24). Among live births (n = 1409), 9vHPV vaccine exposures during pregnancy were not associated with increased risks for preterm birth (RR, 0.73; 95% CI, 0.44-1.20) or SGA birth (RR, 1.31; 95% CI, 0.78-2.20). Results were similar regarding the association between 9vHPV vaccine exposures peripregnancy and preterm birth (RR, 0.72; 95% CI, 0.45-1.17) and SGA birth (RR, 1.10; 95% CI, 0.65-1.88). Birth defects were rare in all exposure groups, occurring in about 1% of live births with available infant data. Conclusions and Relevance This study found that 9vHPV vaccine exposures during or around the time of pregnancy were uncommon and not associated with SABs or selected adverse birth outcomes. These findings can inform counseling for inadvertent 9vHPV vaccine exposures.

OBJECTIVE: To evaluate whether the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices recommended influenza and tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccinations in pregnancy are associated with increased risk of stillbirth. METHODS: We performed a case–control study in the Vaccine Safety Datalink that was matched 1:4 on site, month, and year of last menstrual period, comparing the odds of vaccination in pregnancies that ended in stillbirth (defined as fetal loss at or after 20 weeks of gestation) compared with those that ended in live birth from January 1, 2012, to September 30, 2015. We included patients with singleton pregnancies that ended in stillbirth or live birth who had at least one prenatal care visit, pregnancy dating information, and continuous health plan enrollment for the duration of pregnancy. Medical records for all stillbirths were reviewed. We were statistically powered to detect an odds ratio (OR) of 1.37 when evaluating the association between influenza or Tdap vaccination and stillbirth. We also examined stillbirth rates in pregnant patients aged 14–49 years in the Vaccine Safety Datalink between 2007 and 2015. RESULTS: In our matched analysis of 795 confirmed stillbirths in the case group and 3,180 live births in the control group, there was no significant association between influenza vaccination during pregnancy and stillbirth (343/795 [43.1%] stillbirths in the case group vs 1,407/3,180 [44.3%] live births in the control group, OR 0.94, adjusted OR 0.95, 95% CI 0.79–1.14, P5.54) and no significant association between Tdap vaccination during pregnancy and stillbirth (184/795 [23.1%] stillbirths in the case group vs 746/3,180 [23.5%] live births in the control group, OR 0.97, aOR 0.96, 95% CI 0.76–1.28, P=.91). From 2007 to 2015, the stillbirth rate in the Vaccine Safety Datalink was 5.2 per 1,000 live births and stillbirths. CONCLUSION: No association was found between vaccination during pregnancy and the odds of stillbirth. These findings support the safety of ACIP recommendations for vaccination during pregnancy.

OBJECTIVE: To assess consumers’ ability to correctly identify different types of milk in a blind taste test and correlates of plans to purchase lower-fat milk. METHODS: Adults from eight supermarkets in low-income neighborhoods tasted three types of unlabeled lower-fat or fat-free milk samples and guessed the type of each sample. RESULTS: Of the 1074 participants, only 7.6% were able to identify all three unlabeled samples correctly. CONCLUSIONS AND IMPLICATIONS: Most adults in this study reported consuming higher-fat milk and could not correctly identify milk type by taste alone. Blind taste tests may encourage consumers to drink lower-fat milk.

BACKGROUND: To increase vaccine acceptance, we created a Web-based the “Vaccines and Your Baby” intervention (VAYB) that provided new parents with vaccine information messages tailored to vaccine beliefs and values. We evaluated the effectiveness of the VAYB by comparing timely uptake of infant vaccines to an untailored version of the intervention (UT) or usual care intervention (UC) only. METHODS: Between April 2016 and June 2019, we conducted a randomized clinical trial. Pregnant women and new parents were randomly assigned to the VAYB, UT, or UC arms. In the VAYB and UT arms, participants were exposed to interventions at 4 time points from pregnancy until their child was 15 months of age. The primary outcome was up-to-date status for recommended vaccines from birth to 200 days of age. A modified intent-to-treat analysis was conducted. Data were analyzed with logistic regression to generate odds ratios (ORs) and 95% confidence intervals (CIs). RESULTS: We enrolled 824 participants (276 VAYB, 274 UT, 274 UC), 143 (17.4%) of whom were lost to follow-up. The up-to-date rates in the VAYB, UT, and UC arms were 91.44%, 92.86%, and 92.31%, respectively. Infants in the VAYB arm were not more likely to be up to date than infants in the UC arm (OR = 0.89; 95% CI, 0.45–1.76) or in the UT arm (OR = 0.82; 95% CI, 0.42–1.63). The odds of being up to date did not differ between UT and UC arms (OR = 1.08; 95% CI, 0.54–2.18). CONCLUSIONS: Delivering Web-based vaccine messages tailored to parents’ vaccine attitudes and values did not positively impact the timely uptake of infant vaccines.

ObjectiveThe goal of our study is to assess the role of microglial activation in MS-associated fatigue (MSAF) using [F-18]PBR06-PET.MethodsFatigue severity was measured using the Modified Fatigue Impact Scale (MFIS) in 12 subjects with MS (7 relapsing-remitting and 5 secondary progressive) and 10 healthy control participants who underwent [F-18]PBR06-PET. The MFIS provides a total fatigue score as well as physical, cognitive, and psychosocial fatigue subscale scores. Standardized Uptake Value (SUV) 60–90 minute frame PET maps were coregistered to 3T MRI. Voxel-by-voxel analysis using Statistical Parametric Mapping and atlas-based regional analyses were performed. SUV ratios (SUVRs) were global brain normalized.ResultsPeak voxel-based level of significance for correlation between total fatigue score and PET uptake was localized to the right substantia nigra (T-score 4.67, p = 0.001). Similarly, SUVRs derived from atlas-based segmentation of the substantia nigra showed significant correlation with MFIS (r = 0.76, p = 0.004). On multiple regression, the right substantia nigra was an independent predictor of total MFIS (p = 0.02) and cognitive MFIS subscale values (p = 0.007), after adjustment for age, disability, and depression. Several additional areas of significant correlations with fatigue scores were identified, including the right parahippocampal gyrus, right precuneus, and juxtacortical white matter (all p < 0.05). There was no correlation between fatigue scores and brain atrophy and lesion load in patients with MS.ConclusionSubstantia nigra microglial activation is linked to fatigue in MS. Microglial activation across key brain regions may represent a unifying mechanism for MSAF, and further evaluation of neuroimmunologic basis of MSAF is warranted.

To assess the intervention effects of BREATHE (BRief intervention to Evaluate Asthma THErapy), a novel brief shared decision-making intervention and evaluate feasibility and acceptability of intervention procedures.Group-randomized longitudinal pilot study.In total, 80 adults with uncontrolled persistent asthma participated in a trial comparing BREATHE (N = 40) to a dose-matched attention control intervention (N = 40). BREATHE is a one-time shared decision-making intervention delivered by clinicians during routine office visits. Ten clinicians were randomized and trained on BREATHE or the control condition. Participants were followed monthly for 3 months post-intervention. Data were collected from December 2017 - May 2019 and included surveys, lung function tests, and interviews.Participants were Black/multiracial (100%) mostly female (83%) adults (mean age 45). BREATHE clinicians delivered BREATHE to all 40 participants with fidelity based on expert review of audiorecordings. While the control group reported improvements in asthma control at 1-month and 3-month follow-up, only BREATHE participants had better asthma control at each timepoint (β = 0.77; standard error (SE)[0.17]; p ≤ 0.0001; β = 0.71; SE[0.16]; p ≤ 0.0001; β = 0.54; SE[0.15]; p = .0004), exceeding the minimally important difference. BREATHE participants also perceived greater shared decision-making occurred during the intervention visit (β = 7.39; SE[3.51]; p = .03) and fewer symptoms at follow-up (e.g., fewer nights woken, less shortness of breath and less severity of symptoms) than the controls. Both groups reported improved adherence and fewer erroneous medication beliefs.BREATHE is a promising brief tailored intervention that can be integrated into office visits using clinicians as interventionists. Thus, BREATHE offers a pragmatic approach to improving asthma outcomes and shared decision-making in a health disparity population.The study addressed the important problem of uncontrolled asthma in a high-risk vulnerable population. Compared with the dose-matched attention control condition, participants receiving the novel brief tailored shared decision-making intervention had significant improvements in asthma outcomes and greater perceived engagement in shared decision-making. Brief interventions integrated into office visits and delivered by clinicians may offer a pragmatic approach to narrowing health disparity gaps. Future studies where other team members (e.g., office nurses, social workers) are trained in shared decision-making may address important implementation science challenges as it relates to adoption, maintenance, and dissemination. TRAIL REGISTRATION: clinicaltrials.gov # NCT03300752.目的: 评估呼吸 (评估哮喘治疗的简短干预) 的干预效果, 一种新颖的简短共同决策干预, 并评估干预程序的可行性和可接受性。 设计: 分组随机纵向试点研究。 方法: 总共有80名患有不受控持续性哮喘的成人参与了一项对照呼吸 (N=40) 和剂量匹配的注意力控制干预 (N=40)试验。呼吸是临床医生在常规的门诊就诊中提供的一次性共同决策干预。10名临床医生被随机分配并接受呼吸或对照条件的培训。受试者在干预后的3个月内每月接受一次随访。数据收集于2017年12月至2019年5月, 其中包括调查、肺功能测试和访谈。 结果: 参与者为黑人/多种族 (100%) , 大部分为女性 (83%)成人 (平均年龄45岁) 。呼吸临床医生根据专家对录音的回顾, 准确地为所有40名参与者提供了呼吸服务。尽管对照组在1个月和3个月的随访中报告了哮喘控制的改善, 但只有呼吸参与者在每个时间点有更好的哮喘控制(β=0.77; 标准误差 (SE)【0.17】;p≤0.0001;β=0.71;SE【0.16】;p≤0.0001;β=0.54;SE【0.15】;p=.0004) , 超过了最小重要差异。与对照组相比, 呼吸参与者还认为在干预访视期间, 发生了更多的共同决策, (β=7.39;SE【3.51】;p=0.03) , 随访时症状出现地更少 (例如, 醒夜更少, 呼吸急促更少, 症状较轻) 。两组患者的依从性均有所改善, 错误的用药观念也有所减少。 结论: 呼吸是一种有效的短期定制干预, 可将临床医生作为干预与门诊就诊结合使用。因此, 呼吸提供了一个务实的方法来改善哮喘的结果和健康不平等人群的共同决策。 影响: 本项研究解决了高危易感人群中失控哮喘的重要问题。与剂量匹配的注意力控制条件相比, 接受新简短定制的共同决策干预的参与者在哮喘转归方面有显著改善, 且其在共同决策方面有更大的参与度。将简短的干预措施纳入到门诊就诊中, 并由临床医生提供, 可能提供缩小健康差距的务实方法。在未来的研究中, 其他团队成员 (如办公室护士、社会工作者) 将接受共同决策方面的培训, 这可能会解决实施科学在采用、维护和传播方面的重要挑战。 试验注册: clinicaltrials.gov # NCT03300752.

Background Serum hematological indices such as the neutrophil-lymphocyte ratio (NLR) or monocyte-lymphocyte ratio (MLR) have been used as biomarkers of pathogenic inflammation and prognostication in multiple areas of medicine; recent evidence shows correlation with psychological parameters as well. Objectives/Aims: To characterize clinical, neuroimaging, and psycho-neuro-immunological associations with NLR and MLR in persons with multiple sclerosis (MS). Methods We identified a large cohort of clinically well-defined patients from our longitudinal database that included MS-related outcomes, disease-modifying therapy, patient-reported outcome (PRO) measures, and quantified cerebral MRI at 1.5 T. We queried hospital records for complete blood counts within 2 months of each clinic visit and excluded those obtained during clinical relapses. Four hundred eighty-three patients, with a mean of 3 longitudinal observations each, were identified who met these criteria. Initial analyses assessed the association between NLR and MLR as the outcomes, and psychological and demographic predictors in univariable and multivariable models controlling for age, gender and treatment. The second set of analyses assessed the association between clinical and MRI outcomes including whole brain atrophy and T2-hyperintense lesion volume, with NLR and MLR as predictors in univariable and multivariable models. All analyses used a mixed effects linear or logistic regression model with repeated measures. Results Unadjusted analyses demonstrated significant associations between higher (log-transformed) NLR (but not MLR) and PRO measures including increasing depression (p = 0.01), fatigue (p 0.05) even after controlling for all clinical and demographic covariates. Sensitivity analyses using a subset of untreated patients (N = 146) corroborated these results. Conclusions Elevated NLR and MLR may represent hematopoetic bias toward increased production and pro-inflammatory priming of the myeloid innate immune system (numerator) in conjunction with dysregulated adaptive immune processes (denominator), and consequently reflect a complementary and independent marker for severity of MS-related neurological disability and MRI outcomes. Electronic supplementary material The online version of this article (10.1186/s12883-019-1245-2) contains supplementary material, which is available to authorized users.

Importance Family members are cited as a common source of prescription opioids used for nonmedical reasons. However, the overdose risk associated with exposure to opioids prescribed to family members among adolescents and young adults is not well established. Objective To assess the association of opioids prescribed to family members with pharmaceutical opioid overdose among youth. Design, Setting, and Participants This cohort study included 45 145 family units with a total of 72 040 adolescents and young adults aged 11 to 26 years enrolled in a Kaiser Permanente Colorado health plan in 2006 and observed through June 2018. Exposures Opioid prescriptions and dosage dispensed to family members and youth in the past month. Main Outcomes and Measures Fatal pharmaceutical opioid overdoses identified in vital records and nonfatal pharmaceutical opioid overdoses identified in emergency department and inpatient settings. Time to first overdose was modeled using Cox regression. Results The study population consisted of 72 040 adolescents and young adults (mean [SD] age across follow-up, 19.3 [3.7] years; 36 646 [50.9%] girls and women) nested in 45 145 family units. Youth were more commonly exposed to prescription opioids dispensed to a family member than through their own prescriptions. During follow-up, 26 284 youth (36.5%) filled at least 1 opioid prescription, and 47 461 youth (65.9%) had at least 1 family member with a prescription. Exposure to family members with opioid prescriptions in the past month was associated with increased risk of pharmaceutical opioid overdose (adjusted hazard ratio [aHR], 2.17; 95% CI, 1.24-3.79) independent of opioids prescribed to youth (aHR, 6.62; 95% CI, 3.39-12.91). Concurrent exposure to opioid prescriptions from youth and family members was associated with substantially increased overdose risk (aHR, 12.99; 95% CI, 5.08-33.25). High dosage of total morphine milligram equivalents (MME) prescribed to family members in the past month was associated with youth overdose (0 MME vs >0 to Conclusions and Relevance In this study of youth linked to family members, exposure to family members’ prescribed opioids was associated with increased risk of pharmaceutical opioid overdose, independent of opioids prescribed to youth. Further interventions targeting youth and families are needed, including counseling patients about the risks of opioids to youth in their families.

BackgroundVaccine hesitancy among parents leads to childhood undervaccination and outbreaks of vaccine-preventable disease. As the reasons for vaccine hesitancy are diverse, there is often not enough time during regular clinical visits for medical providers to adequately address all the concerns that parents have. Providing individually tailored vaccine information via the internet before a clinical visit may be a good mechanism for effectively allaying parents’ vaccination concerns while also being time efficient. Including tailoring based on values is a promising, but untested, approach to message creation.ObjectiveThis study aimed to describe the process by which we developed a Web-based intervention that is being used in an ongoing randomized controlled trial aimed at improving the timeliness of infant vaccination by reducing parental vaccine hesitancy.MethodsDevelopment of the intervention incorporated evidence-based health behavior theories. A series of interviews, surveys, and feedback sessions were used to iteratively develop the intervention in collaboration with vaccination experts and potential end users.ResultsIn all, 41 specific content areas were identified to be included in the intervention. User feedback elucidated preferences for specific design elements to be incorporated throughout the website. The tile-based architecture chosen for the website was perceived as easy to use. Creating messages that were two-sided was generally preferred over other message formats. Quantitative surveys identified associations between specific vaccine values and vaccination beliefs, suggesting that values tailoring should vary, depending on the specific belief being endorsed.ConclusionsUsing health behavior theories, qualitative and quantitative data, and significant expert and end user input, we created a novel, Web-based intervention to improve infant vaccination timeliness. The intervention is based on tailoring messages according to each individual’s values and beliefs. This intervention is currently being tested in a controlled randomized clinical trial.

The internet is an important source of vaccine information for parents. We evaluated and compared the interactive content on an expert moderated vaccine social media (VSM) website developed for parents of children 24 months of age or younger and enrolled in a health care system to a random sample of interactions extracted from publicly available parenting and vaccine-focused blogs and discussion forums. The study observation period was September 2013 through July 2016. Three hundred sixty-seven eligible websites were located using search terms related to vaccines. Seventy-nine samples of interactions about vaccines on public blogs and discussion boards and 61 interactions from the expert moderated VSM website were coded for tone, vaccine stance, and accuracy of information. If information was inaccurate, it was coded as corrected, partially corrected or uncorrected. Using chi-square or Fisher’s exact tests, we compared coded interactions from the VSM website with coded interactions from the sample of publicly available websites. We then identified representative quotes to illustrate the quantitative results. Tone, vaccine stance, and accuracy of information were significantly different (all p < .05). Publicly available vaccine websites tended to be more contentious and have a negative stance toward vaccines. These websites also had inaccurate and uncorrected information. In contrast, the expert moderated website had a more civil tone, minimal posting of inaccurate information, with very little participant-to-participant interaction. An expert moderated, interactive vaccine website appears to provide a platform for parents to gather accurate vaccine information, express their vaccine concerns and ask questions of vaccine experts.

Introduction Skin cancer prevention guidelines recommend practicing multiple behaviors to protect against harmful ultraviolet rays, yet few adults report practicing more than one recommended behavior. This study examines the extent to which skin cancer prevention behaviors are combined and may follow a pattern of compensation in which an individual's performance of one behavior (e.g., wearing sunscreen) precludes performing other protective behaviors (e.g., wearing a hat). Methods Data from qualitative semi-structured interviews (n=80) in 2015 and a quantitative online national survey (n=940) in 2016 with non-Hispanic white adults aged 18–49 years from the U.S. were used to examine combinations of skin cancer prevention behaviors. Data were analyzed in 2017. Results Protective behaviors like wearing sunglasses and sunscreen were a common approach to prevention, but protective, avoidant (i.e., seeking shade, avoiding outdoor tanning), and covering-up (i.e., wearing a hat, shirt) strategies were rarely used in combination. Regression analyses to determine correlates of protection, avoidance, and covering-up showed that age was positively associated with practicing each strategy; positive attitudes about tanning were negatively associated with avoidance and covering-up; and positive body image was positively associated with protection and negatively associated with avoidance. Demographics such as education, employment, and gender, but not skin cancer risk, were also related to the various strategies. Conclusions Although a full evaluation of compensation theory and skin cancer prevention was limited by the available data, the results suggest that application of the theory may yield clues for how to improve sun protection behaviors.

Background: To date, the computerized adaptive testing (CAT) version of the Neuro-quality of life (QOL) has not been assessed in a large sample of people with multiple sclerosis (MS). Objective: The aim of this study was to assess the associations between the CAT version of Neuro-QOL and other clinical and patient-reported outcome measures. Methods: Subjects ( n = 364) enrolled in SysteMS completed the CAT version of the Neuro-QOL and the 36-Item Short Form Survey (SF-36) within 4 weeks of a clinical exam that included the Multiple Sclerosis Functional Composite-4 (MSFC-4). The correlations between the Neuro-QOL domains and the MSFC-4 subscores and the SF-36 scores were calculated. The changes over time in the Neuro-QOL and other measures were also examined. Results: The lower extremity functioning score of the Neuro-QOL showed the highest correlations with MSFC-4 components including Timed 25-Foot Walk, 9-Hole Peg Test, and cognitive score. The expected domains of the Neuro-QOL showed high correlations with the SF-36 subscores, and some Neuro-QOL domains were associated with many SF-36 subscores. There was limited longitudinal change on the Neuro-QOL domains over 12 months, and the change was not associated with change on other measures. Conclusion: The CAT version of the Neuro-QOL shows many of the expected associations with clinical and patient-reported outcome measures.

Objective Our goal was to compare subjects treated with glatiramer acetate (GA) and interferon-beta (IFN-β) in terms of long-term clinical outcomes. Methods Subjects enrolled in the CLIMB who initiated either GA or IFN-β within five years of disease onset and prior to 2008 were identified (n = 150 for GA and n = 144 for IFN-β). The two treatment groups were compared in terms of long-term clinical outcomes: time to EDSS 4, time to EDSS 6 and EDSS score seven years after treatment initiation. Baseline confounders included in our analysis were age, gender, disease duration, attacks in the previous year, EDSS prior to treatment initiation, and year of treatment initiation. The groups were compared using three approaches to handle confounders: multiple regression adjusting for confounders, adjustment for the propensity score, and inverse probability of treatment weighting. In addition, we assessed potential predictors of differential treatment response using multiple regression models including appropriate interaction terms. Results Subjects initially treated with GA had a slightly higher hazard of reaching EDSS 4 and EDSS 6, but the difference between the groups was not statistically significant (adjusted HR for EDSS 4 = 1.48; 95% CI: 0.77,2.84; p = .24; adjusted HR for EDSS 6 = 1.46; 95% CI: 0.70,3.05; p = .316). For the EDSS score at year 7, there was also only a small difference between the groups. Subjects treated with GA had a longer time until treatment cessation (adjusted HR = 0.70; 95% CI: 0.53,0.93; p = .012). The interaction models did not show strong evidence for the baseline predictors being associated with treatment response. Conclusions Subjects treated with glatiramer acetate and interferon-beta had similar long-term clinical course.

BACKGROUND: Half of all Americans have a chronic disease. Promoting healthy behaviors to decrease this burden is a national priority. A number of behavioral interventions have proven efficacy; yet even the most effective of these has high levels of non-response. OBJECTIVES: In this study, we explore variation in response to an evidence-based community health worker intervention for chronic disease management. RESEARCH DESIGN: We used a convergent parallel design that combined a randomized controlled trial with a qualitative process evaluation that triangulated chart abstraction, in-depth interviews and participant observation. SUBJECTS: Eligible patients lived in a high-poverty region and were diagnosed with two or more of the following chronic diseases: diabetes, obesity, hypertension or tobacco dependence. There were 302 patients in the trial, 150 of whom were randomly assigned to the CHW intervention. Twenty patients and their community health workers were included in the qualitative evaluation. RESULTS: We found minimal differences between responders and non-responders by sociodemographic or clinical characteristics. A qualitative process evaluation revealed that health behavior change was challenging for all patients and most experienced failure (i.e. gaining weight or relapsing with cigarettes) along the way. Responders seemed to increase their resolve after failed attempts at health behavior change, while non-responders became discouraged and 'shut down'. CONCLUSIONS: Failure is a common and consequential aspect of health behavior change; a deeper understanding of failure should inform chronic disease interventions.

Purpose: Indoor tanning is associated with an increased risk of developing skin cancer. In the United States, nearly 1 in 5 white women aged 18 to 25 are indoor tanners. This study elicited beliefs about tanning indoors and quitting/cutting back on indoor tanning. Design: Semi-structured interviews. Participants and Setting: Forty 18- to 25-year-old white females who engaged in frequent indoor tanning participated in either in-person or telephone interviews. Most were college students from southeastern Pennsylvania and Delaware. Method: A semi-structured interview was used to elicit beliefs about indoor tanning and quitting or cutting back. Data analyses using NVivo and multiple coders identified key themes about going and quitting/cutting back on indoor tanning. Results: Key themes stated as reasons for indoor tanning included improving physical appearance, social acceptance, increased confidence, and happiness. The main themes identified as advantages of quitting/cutting back on indoor tanning were to decrease skin cancer risk and save money. Perceived disadvantages of quitting/cutting back included themes of concerns about being pale and a decline in self-confidence. The prospect of saving money and warm weather were seen as facilitating quitting/cutting back. Conclusion: Findings suggest the necessity of addressing appearance concerns, psychological benefits associated with feeling more attractive, and short-term gains such as saving money. These findings provide a foundation for developing effective anti-indoor tanning communication.

Introduction Successful strategies are needed to address parental vaccine hesitancy, a significant public health issue. The study objective was to assess whether an Internet-based platform with vaccine information and interactive social media components improved parents’ vaccine-related attitudes. Study design A three-arm RCT. Setting/participants The study was conducted in a large Colorado integrated healthcare organization. Parents were enrolled during September 2013 through October 2015 and followed through November 2016; data were analyzed in 2017. Parents, recruited during pregnancy, were given a survey about vaccine-related attitudes at enrollment (i.e., baseline) and when their child was aged 3–5 months and 12–15 months (Timepoints 1 and 2, respectively). Parental vaccine hesitancy was assessed at baseline. Intervention Study participants were randomized to the following: a study website with vaccine information and social media components (VSM arm); a website with vaccine information only (VI); or usual care. Main outcome measures Change in parental vaccine attitudes over time by baseline degree of vaccine hesitancy. Results Among 1,093 study participants, 945 (86.5%) completed all three surveys. Comparing baseline with Timepoint 1 among vaccine-hesitant parents, the VSM and VI arms were associated with significant improvements in attitudes regarding vaccination benefits compared to usual care (VSM mean change 0.23 on a 5-point scale, 95% CI=0.05, 0.40, VI mean change 0.22, 95% CI=0.04, 0.40). Comparing baseline with Timepoint 2 among hesitant parents, the VSM and VI arms were also associated with significant reductions in parental concerns about vaccination risks compared to usual care (VSM mean change –0.37, 95% CI= –0.60, –0.14, VI mean change –0.31, 95% CI= –0.55, –0.07). Self-efficacy around vaccine decision making also improved among vaccine-hesitant parents. No intervention effect was observed among parents not vaccine-hesitant at baseline. Conclusions Among vaccine-hesitant parents, an Internet-based intervention improved parents’ attitudes about vaccines. Trial registration This study was registered at www.clinicaltrials.gov NCT01873040.

Introduction Amyotrophic lateral sclerosis (ALS) is a debilitating neurologic disorder with poor survival rates and no clear biomarkers for disease diagnosis and prognosis. Methods We compared serum microRNA (miRNA) expression from patients with ALS with healthy controls and patients with multiple sclerosis and Alzheimer disease. We also correlated miRNA expression in cross-sectional and longitudinal cohorts of ALS patients with clinical parameters. Results We identified 7 miRNAs (miR-192-5p, miR-192-3p, miR-1, miR-133a-3p, miR-133b, miR-144-5p, miR-19a-3p) that were upregulated and 6 miRNAs (miR-320c, miR-320a, let-7d-3p, miR-425-5p, miR-320b, miR-139-5p) that were downregulated in patients with ALS compared with healthy controls, patients with Alzheimer disease, and patients with multiple sclerosis. Changes in 4 miRNAs (miR-136-3p, miR-30b-5p, miR-331-3p, miR-496) correlated positively and change in 1 miRNA (miR-2110) correlated negatively with changes in clinical parameters in longitudinal analysis. Discussion Our findings identified serum miRNAs that can serve as biomarkers for ALS diagnosis and progression. Muscle Nerve 58: 261-269, 2018.

Indoor tanning is a risk factor for melanoma among young white women. Health communications can be an effective way of reaching this population and promoting behavior change. The purpose of this study was (i) to investigate the associations between intention to quit indoor tanning and attitudes, normative pressure, and efficacy about quitting, and (ii) to identify beliefs about quitting indoor tanning that can be used to design effective health communication messages to reduce skin cancer risk. A national online survey was conducted with 279 non-Hispanic white women ages 18-25 in the USA who are indoor tanners. The survey, based on the reasoned action approach, assessed intention, attitudes, norms, and efficacy and their corresponding underlying beliefs related to quitting indoor tanning, along with other known covariates. Data were collected in November/December 2015. Intention to quit indoor tanning was significantly associated with attitudes, specifically with the beliefs that it would "reduce damage to skin" (increased intention) and "make me less happy" (decreased intention). While self-efficacy was not related to intention to quit indoor tanning, injunctive normative beliefs were with key referent groups including mothers, friends, and romantic partners. Messages aimed at discouraging indoor tanning among young, non-Hispanic, white women should highlight the salient belief that quitting indoor tanning will reduce skin damage, counter the belief that it will make them less happy, and highlight key people who would approve of them quitting indoor tanning.

This study examines relationships between perceived and observed nutrition environments, diet, and BMI, in order to examine the criterion validity of the Nutrition Environment Measures Survey-Perceived (NEMS-P).In a cross-sectional study, perceived nutrition environments were assessed (NEMS-P) among 221 adults from four neighborhoods in the Philadelphia area in 2010 and 2011. A total of 158 food store environments were observed using the NEMS-Stores. Data analyses were conducted in 2016. Bivariate Spearman rank correlations were used to examine relationships between perceived and observed availability, quality, and price of fruits and vegetables in respondents' neighborhoods. Linear regression models were used to examine relationships between perceived neighborhood and home food environments and daily fruit and vegetable consumption and BMI.A significant, positive relationship was found between perceived and observed availability of fruits and vegetables in the neighborhood (r = 0.36, p0.001). A similar relationship was seen between perceived and observed quality of fruits and vegetables (r = 0.34, p0.001). Perceived availability and quality of fruits and vegetables in the neighborhood, and availability and accessibility of fruits and vegetables in the home, were significantly related to daily fruit and vegetable consumption. Perceived price of food in the neighborhood was significantly associated with BMI.Responses to a self-reported survey to assess perceived food environments related to fruits and vegetables were significantly associated with observed nutrition environments, fruit and vegetable consumption, and BMI. The perceived prices of fruits and vegetables were modestly associated with BMI and warrant further testing in prospective studies. When observations of food environments are not feasible, residents' survey responses are an acceptable indicator, with reasonable criterion validity.

Background Population-based estimates of influenza-associated outpatient visits including both pandemic and inter-pandemic seasons are uncommon. Comparisons of such estimates with laboratory-confirmed rates of outpatient influenza are rare. Objective To estimate influenza-associated outpatient visits in six US integrated health care delivery organizations enrolling ~7.7 million persons. Methods Using negative-binomial regression methods, we modeled rates of influenza-associated visits with ICD-9-CM-coded pneumonia or acute respiratory outpatient visits during 2001-10. These estimated counts were added to visits coded specifically for influenza to derive estimated rates. We compared these rates with those observed in two contemporaneous studies recording RT-PCR-confirmed influenza outpatient visits. Results Outpatient rates estimated with pneumonia visits were 39 (95% confidence interval [CI], 30-70) and 203 (95% CI, 180-240) per 10,000 person-years, respectively, for inter-pandemic and pandemic seasons. Corresponding rates estimated with respiratory visits were 185 (95% CI, 161-255) and 542 (95% CI, 441-823) per 10,000 person-years. During the pandemic, children aged 2-17 years had the largest increase in rates (when estimated with pneumonia visits, from 64 [95% CI, 50-121] to 381 [95% CI, 366-481]). Rates estimated with pneumonia visits were consistent with rates of RT-PCR-confirmed influenza visits during 4 of 5 seasons in one comparison study. In another, rates estimated with pneumonia visits during the pandemic for children and adults were consistent in timing, peak, and magnitude. Conclusions Estimated rates of influenza-associated outpatient visits were higher in children than adults during pre-pandemic and pandemic seasons. Rates estimated with pneumonia visits plus influenza-coded visits were similar to rates from studies using RT-PCR-confirmed influenza. This article is protected by copyright. All rights reserved.

Naloxone is a life-saving opioid antagonist. Chronic pain guidelines recommend that physicians co-prescribe naloxone to patients at high risk for opioid overdose. However, clinical tools to efficiently identify patients who could benefit from naloxone are lacking. To develop and validate an overdose predictive model which could be used in primary care settings to assess the need for naloxone. Retrospective cohort. Derivation site was an integrated health system in Colorado; validation site was a safety-net health system in Colorado. We developed a predictive model in a cohort of 42,828 patients taking chronic opioid therapy and externally validated the model in 10,708 patients. Potential predictors and outcomes (nonfatal pharmaceutical and heroin overdoses) were extracted from electronic health records. Fatal overdose outcomes were identified from state vital records. To match the approximate shelf-life of naloxone, we used Cox proportional hazards regression to model the 2-year risk of overdose. Calibration and discrimination were assessed. A five-variable predictive model showed good calibration and discrimination (bootstrap-corrected c-statistic = 0.73, 95% confidence interval [CI] 0.69–0.78) in the derivation site, with sensitivity of 66.1% and specificity of 66.6%. In the validation site, the model showed good discrimination (c-statistic = 0.75, 95% CI 0.70–0.80) and less than ideal calibration, with sensitivity and specificity of 82.2% and 49.5%, respectively. Among patients on chronic opioid therapy, the predictive model identified 66–82% of all subsequent opioid overdoses. This model is an efficient screening tool to identify patients who could benefit from naloxone to prevent overdose deaths. Population differences across the two sites limited calibration in the validation site.

None of the disease-modifying therapies (DMTs) currently being used for the management of multiple sclerosis (MS) are 100% effective. In addition, side effects associated with the use of these DMTs have limited the practice of combination therapy. Hence, there is a need for safe immunomodulatory agents to fine-tune the management of MS. The gut microbiome plays an important role in autoimmunity, and several studies have reported alterations in the gut microbiome of MS patients. Studies in animal model of MS have identified members of the gut commensal microflora that exacerbate or ameliorate neuroinflammation. Probiotics represent an oral, non-toxic immunomodulatory agent that could be used in combination with current MS therapy. We designed a pilot study to investigate the effect of VSL3 on the gut microbiome and peripheral immune system function in healthy controls and MS patients. VSL3 administration was associated with increased abundance of many taxa with enriched taxa predominated by Lactobacillus, Streptococcus, and Bifidobacterium species. At the immune level, VSL3 administration induced an anti-inflammatory peripheral immune response characterized by decreased frequency of intermediate monocytes (CD14highCD16low), decreased mean fluorescence intensity (MFI) of CD80 on classical monocytes as well as decreased human leukocyte antigen–antigen D related (HLA-DR) MFI on dendritic cells.

Background Alcohol and in particular red wine have both immunomodulatory and neuroprotective properties, and may exert an effect on the disease course of multiple sclerosis (MS). Objective To assess the association between alcohol and red wine consumption and MS course. Methods MS patients enrolled in the Comprehensive Longitudinal Investigation of Multiple Sclerosis at the Brigham and Women's Hospital (CLIMB) who completed a self-administered questionnaire about their past year drinking habits at a single time point were included in the study. Alcohol and red wine consumption were measured as servings/week. The primary outcome was the Expanded Disability Status Scale (EDSS) at the time of the questionnaire. Secondary clinical outcomes were the Multiple Sclerosis Severity Score (MSSS) and number of relapses in the year before the questionnaire. Secondary MRI outcomes included brain parenchymal fraction and T2 hyperintense lesion volume (T2LV). Appropriate regression models were used to test the association of alcohol and red wine intake on clinical and MRI outcomes. All analyses were controlled for sex, age, body mass index, disease phenotype (relapsing vs. progressive), the proportion of time on disease modifying therapy during the previous year, smoking exposure, and disease duration. In the models for the MRI outcomes, analyses were also adjusted for acquisition protocol. Results 923 patients (74% females, mean age 47 ± 11 years, mean disease duration 14 ± 9 years) were included in the analysis. Compared to abstainers, patients drinking more than 4 drinks per week had a higher likelihood of a lower EDSS score (OR, 0.41; p = 0.0001) and lower MSSS (mean difference, − 1.753; p = 0.002) at the time of the questionnaire. Similarly, patients drinking more than 3 glasses of red wine per week had greater odds of a lower EDSS (OR, 0.49; p = 0.0005) and lower MSSS (mean difference, − 0.705; p = 0.0007) compared to nondrinkers. However, a faster increase in T2LV was observed in patients consuming 1–3 glasses of red wine per week compared to nondrinkers. Conclusions Higher total alcohol and red wine intake were associated with a lower cross-sectional level of neurologic disability in MS patients but increased T2LV accumulation. Further studies should explore a potential cause-effect neuroprotective relationship, as well as the underlying biological mechanisms.

Background Previous research has examined the components of depression and fatigue in multiple sclerosis (MS), but the findings have been inconsistent. The aim of this study was to explore the associations between overall and subscale scores of the Center for Epidemiologic Studies-Depression Scale (CES-D) and the Modified Fatigue Impact Scale (MFIS) as well as the longitudinal changes in scores in a large cohort of MS patients. Methods MS subjects who completed a battery of patient reported outcome (PRO) measures including the CES-D and MFIS ( N = 435) were included in our analysis. At the first available MFIS measurement, Pearson's correlation coefficient was used to estimate the association between the CES-D and MFIS in terms of both total scores and subscale scores. In addition, the longitudinal change in each total score and subscale score was estimated using a linear mixed model, and the association between the measures in terms of longitudinal change was estimated using Pearson's correlation coefficient and linear mixed models. Results At baseline, 15% of subjects were classified as high on both depression and fatigue scales, 16% were classified as high on the fatigue scale only, and 9% were classified as high on the depression scale only. There was a high correlation between CES-D and MFIS total scores ( r = 0.62). High correlations were also observed between the somatic and retarded activity subscales of the CES-D and each of the MFIS subscales ( r ≥ 0.60). In terms of longitudinal change, the change over the first year between the CES-D and MFIS total scores showed a moderate correlation ( r = 0.49). Subjects with high fatigue scores but low depression scores at baseline were more likely than subjects with low baseline fatigue and depression scores to develop high depression scores at follow-up. Conclusions Our study demonstrated that depression and fatigue in MS share several features and have a similar longitudinal course. But using cut-off scores to define depression and fatigue, our study also found that non-depressed subjects with high fatigue may be at a greater risk for developing depression.

BACKGROUND AND PURPOSE Two common approaches for measuring disease severity in multiple sclerosis (MS) are the clinical exam and brain magnetic resonance imaging (MRI) scan. Although most patients show similar disease severity on both measures, some patients have clinical/MRI dissociation. METHODS Subjects from a comprehensive care MS center who had a concurrent brain MRI, spinal cord MRI, clinical examination, and patient reported outcomes were classified into three groups based on the Expanded Disability Status Scale (EDSS) and cerebral T2 hyperintense lesion volume (T2LV). The first group was the low lesion load/high disability group (LL/HD) with T2LV < 2 ml and EDSS ≥ 3. The second group was the high lesion load/low disability group (HL/LD) with T2LV > 6 ml and EDSS ≤ 1.5. All remaining subjects were classified as not dissociated. The three groups were compared using regression techniques for unadjusted analyses and to adjust for age, disease duration, and gender. RESULTS Twenty‐two subjects were classified as LL/HD (4.1%; 95% CI: 2.6%, 6.2%), and 50 subjects were classified as HL/LD (9.4%; 95% CI: 7.0%, 12.2%). Subjects in the LL/HD group were more likely to have a progressive form of MS and had significantly lower physical quality of life in adjusted and unadjusted analysis. Subjects in HL/LD had significantly more gadolinium‐enhancing lesions, and subjects in the LL/HD group had significantly more cervical spinal cord lesions. CONCLUSIONS Our results indicate that dissociation may occur between physical disability and cerebral lesion volume in either direction in patients with MS. Type of MS, brain atrophy, and spinal cord lesions may help to bridge this dissociation.

Background Recommendations for skin cancer prevention include behaviors such as using sunscreen, seeking shade, and wearing a shirt with sleeves, but the best way to persuasively communicate this information to the public is not clear. Purpose To test whether a messaging strategy using videos that focus on one specific behavior at a time versus a more general or multibehavior sun protection message is effective at changing attitudinal beliefs and intention with regard to sun protection behaviors. Methods Online experiment among non-Hispanic white 18–49 year old adults in the USA. Participants were randomly assigned to one of four conditions, each one with health messages on a different sun protection prevention behavior: “using sunscreen” (Condition 1, n = 259), “seeking shade” (Condition 2, n = 245), or “covering up” (Condition 3, n = 289). Condition 4 (the control, n = 251) is a multibehavior message that equally promotes sunscreen, seeking shade, and covering up and features a general message on sun safety. Results ANOVA and path analysis results suggest that messages which emphasize a single sun protection behavior compared with general sun safety messaging could potentially be a promising approach. The effectiveness of the videos in influencing attitudinal beliefs varied by behavior, with some gender and age moderation. There was an indirect effect on intention to use sunscreen. Conclusions This study advances our understanding of strategies for skin cancer prevention campaigns. Specifically, it suggests that focusing on a single sun protection behavior with targeted beliefs may be valuable as a first step in encouraging sun safety.