Efficacy and safety of dual add-on therapy with dapagliflozin plus saxagliptin versus glimepiride in patients with poorly controlled type 2 diabetes on a stable dose of metformin: Results from a 52-week, randomized, active-controlled trial.

AIMS: To evaluate the efficacy and safety of dapagliflozin (DAPA) + saxagliptin (SAXA) compared with glimepiride (GLIM) in patients with type 2 diabetes who were inadequately controlled [glycated haemoglobin (HbA1c) 7.5-10.5% (58-91 mmol/mol)] on metformin monotherapy. MATERIALS AND METHODS: This 52-week, multicentre, double-blind, active-controlled study (NCT02419612) randomized (1:1) patients on metformin to add-on DAPA 10 mg + SAXA 5 mg (n = 227) or GLIM 1-6 mg (titrated; n = 217). The primary efficacy endpoint was change in HbA1c from baseline to week 52. RESULTS: Baseline mean ± standard deviation of age, duration of diabetes and HbA1c were 56.1 ± 9.7 years, 7.8 ± 6.4 years and 8.5% ± 0.8% (69 ± 9.0 mmol/mol), respectively. Adjusted mean change from baseline in HbA1c was -1.35% (-14.8 mmol/mol) with DAPA + SAXA versus -0.98% (-10.7 mmol/mol) with GLIM (P <0.001). Changes from baseline in body weight and systolic blood pressure were -3.1 kg and -2.6 mmHg with DAPA + SAXA versus +1.0 kg (P <0.001) and +1.0 mmHg (P = 0.007) with GLIM. More patients achieved HbA1c <7.0% (53 mmol/mol) (44.3% vs. 34.3%; P = 0.044), and fewer patients required treatment intensification (1.3% vs. 8.8%; P = 0.002) with DAPA + SAXA than with GLIM. CONCLUSIONS: Compared with GLIM, concurrent addition of DAPA + SAXA significantly improved glycaemic control, body weight and other metabolic parameters in patients inadequately controlled on metformin. Trial: NCT02419612, ClinicalTrials.gov.

The Current State of Surgical Ergonomics Education in U.S. Surgical Training: A Survey Study.

OBJECTIVE: The aim of this study was to characterize the current state of surgical ergonomics education in the United States. BACKGROUND: The burden of work-related musculoskeletal disorders (MSDs) in surgeons is high and no overarching strategy for redress exists. Twelve distinct specialties describe an unmet need for surgical ergonomics education (SEE). This study aimed to define the current state of SEE in U.S. surgical training programs. METHODS: We performed a descriptive analysis of a 20-item questionnaire of ACGME-certified program directors from 14 surgical and interventional medical specialties. Formal SEE was defined as any organized education module that reviewed the occupation-specific burden of common work-related MSDs and described a framework for prevention via occupation-specific applied ergonomics. Program directors were queried regarding SEE provision, characteristics, and perceived trainee attitude toward the education. RESULTS: Questionnaires were received from 130 of 441 (29.5%) program directors. Two (1.5%) provided formal SEE and 33 (25.4%) provided informal SEE, which consisted of unstructured intraoperative directives and isolated lectures. Two programs previously provided SEE but discontinued the effort due to lack of an evidence-based framework and instructors. Trainees appeared to think that learning surgical ergonomics skills was a worthwhile time investment in 100% and 76.7% of current formal and informal SEE, respectively. CONCLUSION: SEE is rarely provided in any capacity (25.4%), let alone in a consistent or evaluable fashion (1.5%). Impediments to sustainable SEE include lack of an evidence-based framework for education and instructors. An evidence-based, reproducible, and accreditation council-compliant SEE module would be a valuable resource for the surgical and interventional medical communities.

Nationwide Survey of Hospitalization Due to Pediatric Food-Induced Anaphylaxis in the United States.

OBJECTIVE: Anaphylaxis is a common, serious, systemic allergic reaction. In the United States, the change of annual hospitalization rates by anaphylaxis-trigger foods and risk factors associated with severity remain unclear. METHODS: Hospital discharge records of food-induced anaphylactic reactions of individuals younger than 20 years were obtained from Kids' Inpatient Database in 2006, 2009, and 2012 and were weighted to estimate the number of hospitalizations in the United States. We identified annual hospitalization rates by patients' characteristics and anaphylaxis-trigger foods and investigated factors associated with severity and use of mechanical ventilation with multivariable logistic regression. RESULTS: A total of 3427 hospitalizations were obtained, and annual hospitalization rates showed a significantly increasing trend from 1.2 per 100,000 children in 2006 to 1.5 per 100,000 children in 2012 (P < 0.001). The leading causes of hospitalizations due to food-induced anaphylaxis were peanuts (0.35-0.48 per 100,000 children), tree nuts and seeds (0.20-0.32 per 100,000 children), and milk products (0.09-0.13 per 100,000 children), with significantly increasing trends during 2006-2012. Milk products were significantly associated with severity (odds ratio [OR], 2.0; 95% confidence interval [CI], 1.3-2.9). Ages between 13 and 20 years (OR, 2.7; 95% CI, 1.4-5.1) and comorbidity of asthma (OR, 2.1; 95% CI, 1.3-3.4) were significantly associated with the use of mechanical ventilation. CONCLUSIONS: The annual hospitalization rates in the entire United States showed an increasing trend during 2006-2012. The rates of peanuts, tree nuts and seeds, and milk products demonstrated upward trends. Milk products, ages between 13 and 20 years, and comorbidities of asthma were related to severity and morbidity.

Nationwide Survey of Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis in Children in the United States.

Although Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are serious, life-threatening reactions to drug therapies, no efforts have been made to investigate the comprehensive change in epidemiology with respect to age, sex, and race and ethnicity in children. The risk of death was 0.3% to 1.5%, and the highest hospitalization rates were in children 15 to 19 years of age, boys, and black children. The highest proportions of hospitalizations were children with very low household income, those with private insurance, and those treated at large urban teaching hospitals in the West. A significant winter-autumn predominance was observed.

Continuous glucose monitoring in patients with type 2 diabetes treated with glucagon-like peptide-1 receptor agonist dulaglutide in combination with prandial insulin lispro: an AWARD-4 substudy.

AIM: To conduct a substudy, using 24-hour continuous glucose monitoring (CGM), of the AWARD-4 trial, which was designed to compare insulin + glucagon-like peptide-1 receptor agonist treatment with an insulin-only regimen. METHODS: The AWARD-4 trial randomized 884 conventional insulin regimen-treated patients to dulaglutide 1.5 mg, dulaglutide 0.75 mg and glargine, all in combination with prandial insulin lispro. The CGM substudy included 144 patients inserted with a Medtronic CGMS iPro CGM device to enable 3-day glucose monitoring. CGM sessions were completed at weeks 0, 13, 26 and 52. CGM measures included mean 24-hour glucose, percentage time in target glucose ranges, hyper- and hypoglycaemia and glucose variability. The primary objective was treatment comparison for percentage time spent with CGM glucose values in the 3.9-7.8 mmol/L range after 26 weeks. RESULTS: At week 26, mean CGM values decreased in all treatment groups (change from baseline -2.8 ± 0.3, -2.4 ± 0.3 and -2.5 ± 0.3 mmol/L for dulaglutide 1.5 mg, dulaglutide 0.75 mg and glargine, respectively); between-group differences were not statistically significant. Treatment groups were similar for percentage time in the 3.9-7.8 mmol/L range. Percentage time in the 3.9-10.0 mmol/L range was greater for dulaglutide 1.5 mg than for glargine (p < 0.05). Dulaglutide and glargine were associated with decreased glucose variability for all CGM variability indices. The overall within-patient standard deviation (s.d.) was significantly reduced with dulaglutide 1.5 mg versus glargine (p < 0.05). At week 52, there were no significant differences among the groups with regard to measures of normoglycaemia or near-normoglycaemia and for the overall within-patient s.d. Treatment with glargine was associated with greater increases in percentage time spent with glucose values ≤3.9 mmol/L, with statistically significant differences between the groups at 52 weeks (p < 0.05). CONCLUSIONS: In combination with prandial lispro, treatment with dulaglutide and glargine resulted in similar proportions of glucose values in the normoglycaemic range, but dulaglutide provided an improved balance between the proportion of values within the near-normoglycaemia range and values within the hypoglycaemic range.

Reliability and validity of the Haitian Creole PHQ-9.

BACKGROUND: There is limited information on depression in Haitians and this is partly attributable to the absence of culturally and linguistically adapted measures for depression. OBJECTIVE: To perform a psychometric evaluation of the Haitian-Creole version of the PHQ-9 administered to men who have sex with men (MSM) in the Republic of Haiti. DESIGN: This study uses a cross-sectional design and data are from the Integrated Behavioral and Biological HIV Survey (IBBS) for MSM in Haiti. PARTICIPANTS: Inclusion criteria required that participants be male, ≥ 18 years, report sexual relations with a male partner in the last 12 months, and lived in Haiti during the past 3 months. Respondent Driven Sampling was used for participant recruitment. MAIN MEASURES: A structured questionnaire was verbally administered in Haitian-Creole capturing information on sociodemographics, sexual behaviors, human immunodeficiency virus (HIV) status and depressive symptomatology using the PHQ-9. Psychometric analyses of the translated PHQ-9 assessed unidimensionality, factor structure, reliability, construct validity, and differential item functioning (DIF) across subgroups (age, educational level, sexual orientation and HIV status). KEY RESULTS: In a study population of 1,028 MSM, the Haitian-Creole version of the PHQ-9 is unidimensional, has moderately high internal consistency reliability (α = 0.78), and shows evidence of construct validity where HIV-positive subjects have greater depression (p = 0.002). There is no evidence of DIF across age, education, sexual orientation or HIV status. HIV-positive MSM are twice as likely to screen positive for moderately severe and severe depressive symptoms compared to their HIV-negative counterparts. CONCLUSIONS: There is strong evidence for the psychometric adequacy of the translated PHQ-9 screening tool as a measure of depression with MSM in Haiti. Future research is necessary to examine the predictive validity of depression for subsequent health behaviors or clinical outcomes among Haitian MSM.

Measurement, geospatial, and mechanistic models of public health hazard vulnerability and jurisdictional risk.

CONTEXT: County and state health departments are increasingly conducting hazard vulnerability and jurisdictional risk (HVJR) assessments for public health emergency preparedness and mitigation planning and evaluation to improve the public health disaster response; however, integration and adoption of these assessments into practice are still relatively rare. While the quantitative methods associated with complex analytic and measurement methods, causal inference, and decision theory are common in public health research, they have not been widely used in public health preparedness and mitigation planning. OBJECTIVE: To address this gap, the Harvard School of Public Health PERLC's goal was to develop measurement, geospatial, and mechanistic models to aid public health practitioners in understanding the complexity of HVJR assessment and to determine the feasibility of using these methods for dynamic and predictive HVJR analyses. METHODS: We used systematic reviews, causal inference theory, structural equation modeling (SEM), and multivariate statistical methods to develop the conceptual and mechanistic HVJR models. Geospatial mapping was used to inform the hypothetical mechanistic model by visually examining the variability and patterns associated with county-level demographic, social, economic, hazards, and resource data. A simulation algorithm was developed for testing the feasibility of using SEM estimation. RESULTS: The conceptual model identified the predictive latent variables used in public health HVJR tools (hazard, vulnerability, and resilience), the outcomes (human, physical, and economic losses), and the corresponding measurement subcomponents. This model was translated into a hypothetical mechanistic model to explore and evaluate causal and measurement pathways. To test the feasibility of SEM estimation, the mechanistic model path diagram was translated into linear equations and solved simultaneously using simulated data representing 192 counties. CONCLUSIONS: Measurement, geospatial, and mechanistic models can be used to confirm and validate existing and proposed HVJR models and potentially increase the predictive validity of these models for optimizing and improving public health preparedness planning.

Continuous Glucose Monitoring Profiles and Health Outcomes after Dapagliflozin Plus Saxagliptin vs Insulin Glargine.

CONTEXT: Glycemic variability and hypoglycemia during diabetes treatment may impact therapeutic effectiveness and safety, even when glycated hemoglobin (HbA1c) reduction is comparable between therapies. OBJECTIVE: We employed masked continuous glucose monitoring (CGM) during a randomized trial of dapagliflozin plus saxagliptin (DAPA+SAXA) vs insulin glargine (INS) to compare glucose variability and patient-reported outcomes (PROs). DESIGN: 24-week sub-study of a randomized, open-label, two-arm, parallel-group, phase 3b study. SETTING: Multicenter study (112 centers in 11 countries). PATIENTS: 283 adults with type 2 diabetes (T2D) inadequately controlled with metformin ± sulfonylurea. INTERVENTIONS: DAPA+SAXA vs INS. MAIN OUTCOME MEASURES: Changes in CGM profiles, HbA1c, and PROs. RESULTS: Changes from baseline in HbA1c with DAPA+SAXA were similar to those observed with INS, with mean difference [95% CI] between decreases of -0.12% [-0.37 to 0.12%], P = .33. CGM analytics were more favorable for DAPA+SAXA, including greater percent time in range (> 3.9 and ≤ 10 mmol/L; 34.3 ± 1.9 vs 28.5 ± 1.9%, P = .033), lower percent time with nocturnal hypoglycemia (area under the curve ≤ 3.9 mmol/L; 0.6 ± 0.5 vs 2.7 ± 0.5%, P = .007), and smaller mean amplitude of glycemic excursions (-0.7 ± 0.1 vs -0.3 ± 0.1 mmol/L, P = .017). Improvements in CGM were associated with greater satisfaction, better body weight image, less weight interference, and improved mental and emotional well-being. CONCLUSIONS: DAPA+SAXA and INS were equally effective in reducing HbA1c at 24 weeks, but people with T2D treated with DAPA+SAXA achieved greater time in range, greater reductions in glycemic excursions and variability, less time with hypoglycemia, and improved patient-reported health outcomes.

Validity and Reliability of a Smartphone Application for Home Measurement of Four-Meter Gait Speed in Older Adults.

The four-meter gait speed (4MGS) is a recommended physical performance test in older adults but is challenging to implement clinically. We developed a smartphone application (App) with a four-meter ribbon for remote 4MGS testing at home. This study aimed to assess the validity and reliability of this smartphone App-based assessment of the home 4MGS. We assessed the validity of the smartphone App by comparing it against a gold standard video assessment of the 4MGS conducted by study staff visiting community-dwelling older adults and against the stopwatch-based measurement. Moreover, we assessed the test-retest reliability in two supervised sessions and three additional sessions performed by the participants independently, without staff supervision. The 4MGS measured by the smartphone App was highly correlated with video-based 4MGS (r = 0.94), with minimal differences (mean = 0.07 m/s, ± 1.96 SD = 0.12) across a range of gait speeds. The test-retest reliability for the smartphone App 4MGS was high (ICC values: 0.75 to 0.93). The home 4MGS in older adults can be measured accurately and reliably using a smartphone in the pants pocket and a four-meter strip of ribbon. Leveraging existing technology carried by a significant portion of the older adult population could overcome barriers in busy clinical settings for this well-established objective mobility test.

Site nurse-initiated adherence and symptom support telephone calls for HIV-positive individuals starting antiretroviral therapy, ACTG 5031: substudy of ACTG 384.

BACKGROUND: Effective and easy to implement interventions to improve adherence to antiretroviral therapy are needed. OBJECTIVE: To compare site nurse-initiated adherence and symptom support telephone calls for HIV-positive individuals starting antiretroviral therapy to the study site's standard of care. METHODS: A randomized controlled trial of site nurse-initiated adherence and symptom support telephone calls for HIV-positive individuals starting antiretroviral therapy. Subjects were randomized to receive site nurse-initiated telephone calls (intervention) or no additional calls to the site's standard of care (control). Subjects received calls 1 to 3 days after initiating antiretrovirals, on weeks 1, 2, 3, 6, 10, 14, 18, 22, and 26, and every 8 weeks thereafter. Self-reported adherence was captured during study visits. RESULTS: A total of 333 subjects starting antiretrovirals as part of ACTG 384 were co-enrolled into ACTG 5031. Subjects were followed for up to 160 weeks and were contacted for 74% of scheduled calls. There was no significant difference in proportion of patients with ≯95% mean total adherence (87.9% and 91.2%; P = .34) and mean self-reported total adherence (97.9% and 98.4%) in the intervention and control groups, respectively, or in symptom distress and clinical endpoints. CONCLUSIONS: In the context of a clinical trial where self-reported adherence was exceptionally high, the site nurse-initiated telephone calls did not further improve self-reported adherence, symptom distress, or clinical outcomes.

Validation of the allergic rhinitis treatment satisfaction and preference scale.

Allergic rhinitis (AR) affects 7.8% of U.S. adults and 10-30% of the population worldwide. AR symptoms (rhinorrhea, congestion, sneezing, nasal/ocular pruritus, and postnasal drainage) significantly impact sleep and reduce cognitive and emotional functioning affecting work and school productivity. Although effective, intranasal corticoid (INS) steroid delivery systems are often associated with adverse sensory attributes, affecting patient adherence and reducing efficacy. Patient satisfaction with treatment characteristics predicts adherence levels that can better inform treatment decisions. This study was designed to evaluate psychometric evidence for the self-administered Allergic Rhinitis Treatment Satisfaction and Preference (ARTSP) scale as a patient-reported outcomes measure for use in clinical research. Analytic methods included qualitative analysis of patient focus groups and psychometric analysis of scale data collected from 185 AR subjects enrolled in a randomized, 2-week, crossover, comparative U.S. clinical trial. Qualitative analysis conceptually supported nine treatment satisfaction subscales. Reliability by Cronbach alpha met accepted standards. Evidence was found for construct validity using structural equation modeling, criterion validity from correlation patterns between treatment satisfaction and health-related quality of life scales, and discriminant validity analysis based on AR symptom-defined groups. Responsiveness was shown by significant change in treatment satisfaction subscales among AR symptom change groups. Scores on treatment preference items discriminated between the aqueous and aerosol INS formulations. The ARTSP scale is a conceptually sound, reliable, valid, and responsive measure of patient evaluations of alternative therapies, providing detailed information about treatment characteristics that are likely to influence adherence levels and subsequent AR clinical control.

Benefits and Barriers of Technology for Home Function and Mobility Assessment: Perspectives of Older Patients With Blood Cancers, Caregivers, and Clinicians.

PURPOSE: Advances in digital health technology can overcome barriers to measurement of function and mobility for older adults with blood cancers, but little is known about how older adults perceive such technology for use in their homes. METHODS: To characterize potential benefits and barriers associated with using technology for home functional assessment, we conducted three semistructured focus groups (FGs) in January 2022. Eligible patients came from the Older Adult Hematologic Malignancies Program at Dana-Farber Cancer Institute (DFCI), which includes adults 73 years and older enrolled during their initial consult with their oncologist. Eligible caregivers were 18 years and older and identified by enrolled patients as their primary caregiver. Eligible clinicians were practicing DFCI hematologic oncologists, nurse practitioners, or physician assistants with ≥2 years of clinical experience. A qualitative researcher led thematic analysis of FG transcripts to identify key themes. RESULTS: Twenty-three participants attended the three FGs: eight patients, seven caregivers, and eight oncology clinicians. All participants valued function and mobility assessments and felt that technology could overcome barriers to their measurement. We identified three themes related to potential benefits: making it easier for oncology teams to consider function and mobility; providing standardized, objective data; and facilitating longitudinal data. We also identified four themes related to barriers to home functional assessment: concerns related to privacy and confidentiality, burden of measuring additional patient data, challenges in operating new technology, and concerns related to data improving care. CONCLUSION: These data suggest that specific concerns raised by older patients, caregivers, and oncology clinicians must be addressed to improve acceptability and uptake of technology used to measure function and mobility in the home.

Psychometric evaluation of the HIV symptom distress scale.

The objective of this article is to psychometrically validate the HIV symptom distress scale (SDS), an instrument that can be used to measure overall HIV symptom distress or clinically relevant groups of HIV symptoms. A secondary data analysis was conducted using the Collaborations in HIV Outcomes Research US Cohort (CHORUS). Inclusion criteria required study participants (N=5521) to have a valid baseline measure of the AIDS Clinical Trial Group Symptom Distress Module, with an SF-12 or SF-36 completed on the same day. Psychometric testing assessed unidimensionality, internal consistency, and factor structure using exploratory and confirmatory factor analysis, and structural equation modeling (SEM). Construct validity examined whether the new measure discriminates across clinical significance (CD4 and HIV viral load). Findings show that the SDS has high reliability (α=0.92), and SEM supports a correlated second-order factor model (physical and mental distress) with acceptable fit (GFI=0.88, AGFI=0.85, NFI=0.99, NNFI=0.99; RMSEA=0.06, [90% CI 0.06 - 0.06]; Satorra Bentler scaled, C (2) =3274.20; p=0.0). Construct validity shows significant differences across categories for HIV-1 viral load (p<0.001) and CD4 (p<0.001). Differences in mean SDS scores exist across gender (p<0.001), race/ethnicity (p<0.05), and educational attainment (p<0.001). Hence, the HIV SDS is a reliable and valid instrument, which measures overall HIV symptoms or clinically relevant groups of symptoms.

Predictors of knowledge of H1N1 infection and transmission in the U.S. population.

BACKGROUND: The strength of a society's response to a public health emergency depends partly on meeting the needs of all segments of the population, especially those who are most vulnerable and subject to greatest adversity. Since the early stages of the H1N1 pandemic, public communication of H1N1 information has been recognized as a challenging issue. Public communication is considered a critical public health task to mitigating adverse population health outcomes before, during, and after public health emergencies. To investigate knowledge and knowledge gaps in the general population regarding the H1N1 pandemic, and to identify the social determinants associated with those gaps, we conducted a survey in March 2010 using a representative random sample of U.S. households. METHODS: Data were gathered from 1,569 respondents (66.3% response rate) and analyzed using ordered logistic regression to study the impact of socioeconomic factors and demographic characteristics on the individual's knowledge concerning H1N1 infection and transmission. RESULTS: Results suggest that level of education and home ownership, reliable indicators of socioeconomic position (SEP), were associated with knowledge of H1N1. Level of education was found to be directly associated with level of knowledge about virus transmission [OR = 1.35, 95% C.I. 1.12-1.63]. Home ownership versus renting was also positively associated with knowledge on the signs and symptoms of H1N1 infection in particular [OR = 2.89, 95% C.I. 1.26-6.66]. CONCLUSIONS: Policymakers and public health practitioners should take specific SEP factors into consideration when implementing educational and preventive interventions promoting the health and preparedness of the population, and when designing communication campaigns during a public health emergency.

Exploring the Association between Misinformation Endorsement, Opinions on the Government Response, Risk Perception, and COVID-19 Vaccine Hesitancy in the US, Canada, and Italy.

The COVID-19 pandemic has highlighted the adverse consequences created by an infodemic, specifically bringing attention to compliance with public health guidance and vaccine uptake. COVID-19 vaccine hesitancy is a complex construct that is related to health beliefs, misinformation exposure, and perceptions of governmental institutions. This study draws on theoretical models and current data on the COVID-19 infodemic to explore the association between the perceived risk of COVID-19, level of misinformation endorsement, and opinions about the government response on vaccine uptake. We surveyed a sample of 2697 respondents from the US, Canada, and Italy using a mobile platform between 21-28 May 2021. Using multivariate regression, we found that country of residence, risk perception of contracting and spreading COVID-19, perception of government response and transparency, and misinformation endorsement were associated with the odds of vaccine hesitancy. Higher perceived risk was associated with lower odds of hesitancy, while lower perceptions of government response and higher misinformation endorsement were associated with higher hesitancy.

Exploring the Association between Negative Emotions and COVID-19 Vaccine Acceptance: A Cross-Sectional Analysis of Unvaccinated Adults in Sweden.

The coronavirus disease 2019 (COVID-19) pandemic has had a significant impact on individuals' mental health. This study aimed to investigate how negative emotions toward the COVID-19 pandemic, including feeling anxious, depressed, upset, and stressed, were associated with COVID-19 vaccine acceptance in Sweden. The study is a cross-sectional online survey conducted between 21-28 May 2021, using three nested hierarchical logistic regression models to assess the association. The study included 965 unvaccinated individuals, 51.2% (n = 494) of whom reported their intention to get vaccinated. We observed graded positive associations between reported negative emotions and vaccine acceptance. Individuals who experienced economic stress had lower odds of vaccine acceptance while having a positive opinion of the government's response to COVID-19 was associated with higher odds of being vaccine-acceptant. In conclusion, unvaccinated individuals experiencing negative emotions about the pandemic were more willing to get the vaccine. On the contrary, those with a negative opinion about the government's response, and those that had experienced economic stress were less likely to accept the immunization.

Freedom of Choice to Vaccinate and COVID-19 Vaccine Hesitancy in Italy.

Despite the availability of effective vaccines that lower mortality and morbidity associated with COVID-19, many countries including Italy have adopted strict vaccination policies and mandates to increase the uptake of the COVID-19 vaccine. Such mandates have sparked debates on the freedom to choose whether or not to get vaccinated. In this study, we examined the people's belief in vaccine choice as a predictor of willingness to get vaccinated among a sample of unvaccinated individuals in Italy. An online cross-sectional survey was conducted in Italy in May 2021. The survey collected data on respondents' demographics and region of residence, socioeconomic factors, belief in the freedom to choose to be vaccinated or not, risk perception of contracting and transmitting the disease, previous vaccine refusal, opinion on adequacy of government measures to address the pandemic, experience in requesting and being denied government aid during the pandemic, and intent to accept COVID-19 vaccination. The analysis employed binary logistic regression models using a hierarchical model building approach to assess the association between intent to accept vaccination and belief in the freedom to choose to vaccinate, while adjusting for other variables of interest. 984 unvaccinated individuals were included in the study. Respondents who agreed that people should be free to decide whether or not to vaccinate with no restrictions on their personal life had 85% lower odds of vaccine acceptance (OR = 0.15; 95% CI, 0.09,0.23) after adjusting for demographic and socioeconomic factors and their risk perception of contracting and transmitting COVID-19. Belief in the freedom to choose whether or not to accept vaccinations was a major predictor of COVID-19 vaccine acceptance among a sample of unvaccinated individuals in Italy in May 2021. This understanding of how individuals prioritize personal freedoms and the perceived benefits and risks of vaccines, when making health care decisions can inform the development of public health outreach, educational programs, and messaging.

HIV+ caregivers and HIV+ non-caregivers: differences in sociodemographics, immune functioning, and quality-of-life.

OBJECTIVE: To examine a cohort of HIV+ study participants, who are caregivers (CGs) and non-caregivers (NCGs), to determine whether differences exist across their sociodemographic backgrounds, immune functioning, and quality-of-life (i.e., symptom distress, physical, and mental quality-of-life). METHODS: A secondary analysis of the cross-sectional subset of the population-based Collaborations HIV Outcomes Research US Cohort (CHORUS). Sample consists of 5521 HIV+ adults; median age 43 years (SD 8.7); 88.6% male; 70.7% non-Hispanic White, 17.6% African-American, and 7.8% Hispanic. Measures include the HIV Symptom Distress Scale and the SF-12. Analytical models included t-tests and multivariate linear regression. RESULTS: HIV+ CGs have lower educational attainment than HIV+ NCGs (p=0.02). Seropositive CGs also experience greater HIV symptom distress (adjusted p<0.006) and poorer physical quality-of-life (adjusted p<0.001) than their seropostive NCG counterparts. CONCLUSION: HIV+ CGs may require different supportive services than HIV+ NCGs, suggesting a need to develop tailored interventions to address modifiable factors, such as lower education and poor physical health. Both of these factors have been associated with suboptimal antiretroviral adherence, suggesting a role for the routine screening of adherence predictors amongst HIV+ CGs. These findings may have more relevance in resource-poor settings where the prevalence of HIV is higher, with a likely growing population of informal and family CGs infected with HIV.

COVID-19 Vaccine Early Skepticism, Misinformation and Informational Needs among Essential Workers in the USA.

This study presents the results of a survey of 1591 hesitant U.S. essential workers, conducted over Pollfish in December 2020 when they were the only group eligible for the vaccine, aiming to describe their concerns regarding COVID-19 vaccine safety, effectiveness and distribution policies. We computed frequencies using the SAS software for each answer, using chi-squared statistics and Cochran-Armitage trend tests to determine how informational needs differ by age, gender, level of education, race, source of COVID-19 information and levels of vaccine acceptance. The results of this study show that freedom of choice, equal access to the vaccine and being able to live a life with no restrictions once vaccinated were important concerns since the early days of the distribution campaign, with 53% (836/1591), 42% (669/1591) and 35% (559/1591) of hesitant respondents, respectively, indicating they would be more likely to receive the COVID-19 vaccine if they felt these issues were satisfactorily addressed. Early risk communication and immunization campaign strategies should address not only the reported efficacy and safety of new vaccines, but, as equally important, the population's perceptions and beliefs regarding personal choice, effectiveness and adverse consequences.