Patient Experience With Efanesoctocog Alfa for Severe Hemophilia A: Results From the XTEND-1 Phase 3 Clinical Study Exit Interviews.

PURPOSE: Hemophilia A is a rare bleeding disorder that leads to recurrent hemarthrosis, which can ultimately result in reduced mobility and poor quality of life. Qualitative exit interviews provide insights into patient perspectives and support the interpretation of quantitative trial data, such as patient-reported outcome measures. In the Phase 3 XTEND-1 study (NCT04161495) of efanesoctocog alfa in participants with severe hemophilia A, exit interviews were conducted to understand pre- and post-study experiences with pain and physical functioning and to evaluate participants' treatment experiences. METHODS: In XTEND-1, participants (≥12 years old) received once-weekly efanesoctocog alfa prophylaxis 50 IU/kg for 52 weeks (Arm A) or on-demand efanesoctocog alfa 50 IU/kg for 26 weeks followed by 26 weeks once-weekly prophylaxis (50 IU/kg; Arm B). Optional qualitative exit interviews were conducted using a semi-structured guide in a subset of participants following study completion. Interviews included open-ended questions about participants' pre- and post-study experiences with hemophilia A and targeted questions relating to improvements in patient-reported outcomes assessed during XTEND-1, including the Haemophilia Quality of Life Questionnaire for Adults Physical Health subscale (Haem-A-QoL PH). Content validity of the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity 3a measure was also assessed, particularly the worst pain item. FINDINGS: Exit interviews were conducted with 29 of 159 patients enrolled in XTEND-1 (mean [range] age 40 [16-73] years). Of 17 participants enrolled in Arm A, 13 (76.5%) reported a "wearing off" feeling with pre-study treatment, including more aches/pain, breakthrough bleeds, and limited physical activities. Joint pain was the most reported pre-study symptom (96.6%; n = 28/29), followed by a reduced ability to move without pain (89.7%, n = 26/29). Improvements following efanesoctocog alfa prophylaxis in ≥1 Haem-A-QoL PH domain were reported by 89.7% (n = 26/29) of participants, with improvements in joint pain, the ability to move without pain, and painful swellings reported by at least 21 (84%) participants. Participants reported that the PROMIS Pain Intensity 3a items were relevant, clear, and easy to answer. Most participants (96.6%) were "quite satisfied" or "very satisfied" with efanesoctocog alfa prophylaxis. All participants preferred efanesoctocog alfa over pre-study treatment. IMPLICATIONS: The exit interviews demonstrated that once-weekly efanesoctocog alfa prophylaxis resulted in patient-relevant and meaningful improvements in pain and physical functioning, consistent with the quantitative findings from XTEND-1. These results support the validity of the Haem-A-QoL PH and PROMIS Pain Intensity 3a assessed during XTEND-1, demonstrating the potential for change with efficacious treatment. TRIAL REGISTRY: ClinicalTrials.gov TRIAL REGISTRATION NUMBER: NCT04161495 REGISTRY URL: https://clinicaltrials.gov/study/NCT04161495.

The experience of people living with heart failure in Ethiopia: A qualitative descriptive study.

BACKGROUND: Heart failure is a serious chronic medical condition that negatively impacts daily living. Living with heart failure can be challenging due to the physical symptoms, unpredictable nature of the disease, and lifestyle changes required. The objective of this study was to explore and describe the experiences of people living with heart failure and how it affects their health-related quality of life in Ethiopia. METHODS: A qualitative descriptive design was employed to explore the experience of people living with heart failure, guided by the Theory of Symptom Management. A purposive sample of 14 participants was recruited from the cardiac outpatient clinics at two tertiary-level public hospitals in Ethiopia. Data were collected using a semi-structured interview. The recorded interviews were transcribed verbatim in Amharic, translated into English, and entered NVivo statistical software for analysis. An inductive-deductive hybrid thematic analysis method was used to analyse the data. RESULTS: Three themes were identified deductively, while an additional three themes emerged inductively:-"Journey from diagnosis to daily life with heart failure"; "Symptom experience"; "Impact of heart failure on health-related quality of life"; "Perception of health-related quality of life and influencing factors"; "Symptom management and coping strategies"; and "Challenges faced in the journey of living with heart failure". Fatigue, and depression were the most frequently reported symptoms. Participants described how their condition affected their overall physical functioning. Participants utilized consistent follow up-care, adhered to their medications, ensured adequate rest, made dietary modifications, sought social support and engaged in spiritual activities to manage their symptoms and cope with their condition. Challenges they faced included financial difficulties, unavailability of medications, and a lack of continuity of care. CONCLUSION: People living with heart failure in Ethiopia experience various symptoms. The impact of heart failure on various aspects of their lives, combined with the challenges they face while living with heart failure, significantly affect their health-related quality of life. Health care providers caring for these people need to understand their experiences and the impact on their daily life. Effective multimodal interventions are needed to reduce the impact of heart failure and improve health-related quality of life in this population.

The lasting effects of childhood trauma on developing psychiatric symptoms: A population-based, large-scale comparison study.

Background: Childhood trauma (CT) increases rates of psychiatric disorders and symptoms, however, the lasting effect of CT into adulthood has little exploration using large-scale samples. Objectives: This study estimated the prevalence of CT in a large sample of Chinese young adults, examining the risk factors of current psychological symptoms among those with CT experiences. Methods: 117,769 college students were divided into CT and non-CT groups. The propensity score matching method balanced the confounding sociodemographic factors between the two groups, compared to 16 self-reported psychiatric disorders (e.g., depression, anxiety, eating disorder, obsessive-compulsive disorder, autism, social anxiety disorder, post-traumatic stress disorder), and seven current psychiatric symptoms. Hierarchical regression employed the significant risk factors of the seven current psychiatric symptoms. Results: The prevalence of CT among young adults was 28.76% (95% CI: 28.47-29.04%). Youths with CT experiences reported higher psychiatric disorder rates and current symptom scores (P < 0.001). Sociodemographic factors (females, family disharmony, low socioeconomic status, poor relationship with parents, lower father's education level) and lifestyle factors (smoking status, alcohol consumption, lack of exercise) were significantly associated with current psychiatric symptoms. Results: Public health departments and colleges should develop strategies to promote mental health among those who have experienced CT.

Case Studies on the use of Microsampling for Nonclinical Studies in Pharmaceutical Drug Discovery and Development.

The implementation of microsampling approaches for use in nonclinical discovery and development pharmaceutical studies can have a major impact on improving animal ethics through the use of fewer animals and less invasive procedures for the collection of toxicokinetic and pharmacokinetic samples. In addition, the approach offers the opportunity for obtaining improved quality of data for these studies. This can include the determination of additional timepoints and endpoints, and the ability to obtain exposure data from the same animals utilized to measure other study endpoints. This manuscript presents a number of cases where a variety of microsampling approaches have been successfully implemented by a number of organizations and serves as a guide for those considering the use of microsampling approaches as part of their drug discovery and development programs, as the adoption of these approaches are not yet universal.

Buprenorphine treatment and clinical outcomes under the opioid use disorder cascade of care.

BACKGROUND: Challenges to engagement and retention on buprenorphine undermine treatment of individuals with opioid use disorder (OUD). Under the OUD Cascade of Care framework, we sought to identify patient characteristics and treatment response associated with superior clinical outcomes. METHODS: A retrospective cohort study of specialty buprenorphine treatment patients entering treatment (n=19,487) based on EHR records from a large multi-state buprenorphine treatment network (2011-2019). Person-level care episodes were evaluated across treatment intake, engagement (i.e. 2+ visits in the month following intake), and retention at 6, 12, and 24 months. Time to achieving 90 days of continuous opioid abstinence was assessed using Cox proportional hazards regressions models and also assessed as a predictor of long-term retention. RESULTS: Most patients engaged (82.4 %), but retention steadily declined over 6-month (38.7 %), 12-month (26.2 %), and 24-month (17.1 %) timepoints. Opioid-positive baseline tests were associated with lower hazards of achieving continuous abstinence for both buprenorphine-positive (aHR=0.33, p<.001) and buprenorphine-negative (aHR=0.49,p<.001) intakes. Opioid abstinence was associated with buprenorphine-positive baseline testing (aHR=1.59,p<.001), especially for those testing opioid-negative (aHR=1.82,p<.001). Patients who achieved and sustained abstinence at 6 months in care were 4.1 and 5.5 times as likely to achieve 12-month and 24-month retention, respectively, compared to patients with intermittent opioid use. CONCLUSION: Treatment discontinuation was concentrated early in care and buprenorphine and opioid status at intake were prognostic of achieving and sustaining abstinence. Early abstinence was associated with higher likelihood of subsequent stage progression. Implementing interventions to support early clinical stability for high-risk patients is critical to improve clinical outcomes.

Optimized LC-MS/MS methods for quantifying antibody-drug conjugate payloads in cell culture media containing phenol red.

Aim: Phenol red is commonly used in cell culture media, but can be detrimental to bioanalysis of in vitro samples as it may impact instrument reliability. Many researchers do their final stage of culture in 'phenol red free' media, but in collaborative work this is not always feasible.Materials & methods: A comparison was made between typical extraction methods to reduce phenol red matrix interferences, including organic solvent precipitation and solid phase extraction.Results: The final method was demonstrated to be precise and accurate for the measurement of a target analyte by LC-MS/MS, and was applied to an in vitro ADC deconjugation study.Conclusion: This method allows for for continued bioanalytical support of in vitro models used in drug development.

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Impact of terminal cleaning in rooms previously occupied by patients with healthcare-associated infections.

Healthcare associated infections (HAIs) are costly but preventable. A limited understanding of the effects of environmental cleaning on the riskiest HAI associated pathogens is a current challenge in HAI prevention. This project aimed to quantify the effects of terminal hospital cleaning practices on HAI pathogens via environmental sampling in three hospitals located throughout the United States. Surfaces were swabbed from 36 occupied patient rooms with a laboratory-confirmed, hospital- or community-acquired infection of at least one of the four pathogens of interest (i.e., Acinetobacter baumannii (A. baumannii), methicillin resistant Staphylococcus aureus (MRSA), vancomycin resistant Enterococcus faecalis/faecium (VRE), and Clostridioides difficile (C. difficile)). Six nonporous, high touch surfaces (i.e., chair handrail, bed handrail, nurse call button, desk surface, bathroom counter near the sink, and a grab bar near the toilet) were sampled in each room for Adenosine Triphosphate (ATP) and the four pathogens of interest before and after terminal cleaning. The four pathogens of interest were detected on surfaces before and after terminal cleaning, but their levels were generally reduced. Overall, C. difficile was confirmed on the desk (n = 2), while MRSA (n = 24) and VRE (n = 25) were confirmed on all surface types before terminal cleaning. After cleaning, only MRSA (n = 6) on bed handrail, chair handrail, and nurse call button and VRE (n = 5) on bathroom sink, bed handrail, nurse call button, toilet grab bar, and C. difficile (n = 1) were confirmed. At 2 of the 3 hospitals, pathogens were generally reduced by >99% during terminal cleaning. One hospital showed that VRE increased after terminal cleaning, MRSA was reduced by 73% on the nurse call button, and VRE was reduced by only 50% on the bathroom sink. ATP detections did not correlate with any pathogen concentration. This study highlights the importance of terminal cleaning and indicates room for improvement in cleaning practices to reduce surface contamination throughout hospital rooms.

Clinical Impact of Telomere Length Testing for Interstitial Lung Disease.

BACKGROUND: Shortened telomere length (TL) is a genomic risk factor for fibrotic interstitial lung disease (ILD), but its role in clinical management is unknown. RESEARCH QUESTION: What is the clinical impact of TL testing on the management of ILD? STUDY DESIGN AND METHODS: Patients were evaluated in the Columbia University ILD clinic and underwent Clinical Laboratory Improvement Amendments-certified TL testing by flow cytometry and fluorescence in situ hybridization (FlowFISH) as part of clinical treatment. Short TL was defined as below the 10th age-adjusted percentile for either granulocytes or lymphocytes by FlowFISH. Patients were offered genetic counseling and testing if they had short TL or a family history of ILD. FlowFISH TL was compared with research quantitative polymerase chain reaction (qPCR) TL measurement. RESULTS: A total of 108 patients underwent TL testing, including those with clinical features of short telomere syndrome such as familial pulmonary fibrosis (50%) or extrapulmonary manifestations in the patient (25%) or a relative (41%). The overall prevalence of short TL was 46% and was similar across clinical ILD diagnoses. The number of short telomere clinical features was independently associated with detecting short TL (OR, 2.00; 95% CI, 1.27-3.32). TL testing led to clinical treatment changes for 35 patients (32%), most commonly resulting in reduction or avoidance of immunosuppression. Of the patients who underwent genetic testing (n = 34), a positive or candidate diagnostic finding in telomere-related genes was identified in 10 patients (29%). Inclusion of TL testing below the 1st percentile helped reclassify eight of nine variants of uncertain significance into actionable findings. The quantitative polymerase chain reaction test correlated with FlowFISH, but age-adjusted percentile cutoffs may not be equivalent between the two assays. INTERPRETATION: Incorporating TL testing in ILD impacted clinical management and led to the discovery of new actionable genetic variants.

A thematic analysis of the perceptions of reversible inhibition of sperm under guidance as a potential family planning method in the United Kingdom.

BACKGROUND: This exploratory study aimed to look into public perceptions of Reversible Inhibition of Sperm Under Guidance (RISUG) as a family planning method in the United Kingdom (UK). It also aimed to discover if there were any sex differences in perceptions between males and females. DESIGN: Twelve semi-structured interviews were conducted, six with males and six with females, all residents of the UK. METHODS: The audio data from the interviews then was transcribed for analysis. An inductive and a semantic thematic analysis was conducted on the data set. RESULTS: Three main themes were constructed, including: (i) RISUG Hesitancy, (ii) Females perceived benefits of RISUG and (iii) Males perceived concerns regarding RISUG. Hesitancy was related to vaccination hesitancy, females wanted males to have more reproductive autonomy and males placed their concerns through the lens of 'other' males that their may be unintended side effects. Together these three themes represent both perceived risk and overall benefits of the method. However, while randomized control trails have been completed to standard for RISUG, males perceived concerns, suggesting a disconnect between the public's perceptions and professionals understanding of trails. CONCLUSION: RISUG was perceived as a viable option for family planning in the future, however trust of the new contraceptive method will need to be fostered among the public in order to effectively transfer knowledge on the potential side effects and the standard of pre-market testing for these. Effective public health messages can result in better education of people concerning the new contraceptive method, including the risks and benefits. By using perceptions to inform health messages around RISUG, researchers and practitioners can learn from potential users how to best address misinformation or concerns, while at the same time building an evidence base for when new male methods reach the contraceptive market.

The influence of the severity of gender dysphoria on anxiety, depression, suicidal ideation, and non-suicidal self-injury in Chinese transgender, nonbinary, and gender-diverse youth.

Background: Gender dysphoria (GD) is frequently reported among transgender, nonbinary, and gender-diverse (TNG) populations, and is closely related to anxiety, depression, suicidal ideation, and non-suicidal self-injury (NSSI). This study aimed to understand how GD influences the four mental health disparities among TNG youth, and to compare these outcomes depending on the severity of GD. Methods: 96,218 College students participated in the survey, of which the analysis was run on an extracted sub-set data of 2,315 (2.40%) TNG youth, with a mean age of 19.46 (SD = 1.52). Self-reported inventories measured sociodemographic factors, the severity of GD (Utrecht Gender Dysphoria Scale-Gender Spectrum), anxiety (seven-item Generalized Anxiety Disorder Questionnaire), depression (nine-item Patient Health Questionnaire), suicidal ideation (Suicidal Behaviors Questionnaire-Revised), and NSSI (Clinician-Rated Severity of Non-Suicidal Self-Injury Scale). Binary logistic regression assessed the association between significant GD and the four psychiatric disorders. Adjusted multiple logistic regression, and directed acyclic graph (DAG) analyses were conducted to explore the activating relationship among GD, sociodemographic factors, and psychiatric disorders. Results: 1,582 (68.30%) TNG youth who experienced significant levels of GD (total scores cutoff >= 46) were entered into the analyses. Binary logistic regression displayed significantly positive associations between significant GD and anxiety, depression, suicidal ideation, and NSSI. Multiple regression models showed risk factors included poor relationship with one's father/mother, tobacco smoking, alcohol consumption, and having a lower subjective social status. While family harmony, a higher father's educational level, and partaking in exercise were protective factors that exerted distinct impacts on these four psychiatric disorders. DAG findings showed a poor relationship with one's father with significant GD via other socio-demographic characteristics, activated psychiatric disorders. Conclusions: TNG youth with higher levels of GD also exhibited more severe anxiety, depression, suicidal ideation, and NSSI. Tailored interventions should be provided to prioritize relieving those with severe GD to protect TNG youth from psychiatric outcomes further.

Do the teaching, practice and assessment of clinical communication skills align?

BACKGROUND: Evidence indicates that communication skills teaching learnt in the classroom are not often readily transferable to the assessment methods that are applied nor to the clinical environment. An observational study was conducted to objectively evaluate students' communication skills in different learning environments. The study sought to investigate the extent to which the communication skills demonstrated by students in classroom, clinical, and assessment settings align. METHOD: A mixed methods study was conducted to observe and evaluate students during the fourth year of a five-year medical program. Participants were videorecorded during structured classroom 'interactional skills' sessions, as well as clinical encounters with real patients and an OSCE station calling upon communication skills. The Calgary Cambridge Observational Guides was used to evaluate students at different settings. RESULT: This study observed 28 students and findings revealed that while in the classroom students were able to practise a broad range of communication skills, in contrast in the clinical environment, information-gathering and relationship-building with patients became the focus of their encounters with patients. In the OSCEs, limited time and high-pressure scenarios caused the students to rush to complete the task which focussed solely on information-gathering and/or explanation, diminishing opportunity for rapport-building with the patient. CONCLUSION: These findings indicate a poor alignment that can develop between the skills practiced across learning environments. Further research is needed to investigate the development and application of students' skills over the long term to understand supports for and barriers to effective teaching and learning of communication skills in different learning environments.

Quantitative microbial risk assessment (QMRA) tool for modelling pathogen infection risk to wastewater treatment plant workers.

Wastewater treatment plants (WWTPs) provide vital services to the public by removing contaminants from wastewater prior to environmental discharge or reuse for beneficial purposes. WWTP workers occupationally exposed to wastewater can be at risk of respiratory or gastrointestinal diseases. The study objectives were to: (1) quantify pathogens and pathogen indicators in wastewater aerosols near different WWTP processes/unit operations, (2) develop a QMRA model for multi-pathogen and multi-exposure pathway risks, and (3) create a web-based application to perform and communicate risk calculations for wastewater workers. Case studies for seven different WWTP job tasks were performed investigating infection risk across nine different enteric and respiratory pathogens. It was observed that the ingestion risk among job tasks was highest for "walking the WWTP," which involved exposure from splashing, bioaerosols, and hand-to-mouth contact from touching contaminated surfaces. There was also a notable difference in exposure risk during peak (5:00am-9:00am) and non-peak hours (9:00am- 5:00am), with risks during the peak flow hours of the early morning assumed to be 5 times greater than non-peak hours. N95 respirator usage reduced median respiratory risks by 77 %. The developed tool performs multiple QMRA calculations to estimate WWTP workers' infection risks from accidental ingestion or inhalation of wastewater from multiple pathogens and exposure scenarios, which can inform risk management strategies to protect occupational health. However, more data are needed to reduce uncertainty in model estimates, including comparative data for pathogen concentrations in wastewater during peak and non-peak hours. QMRA tools will increase accessibility of risk models for utilization in decision-making.

Biodistribution of lipid nanoparticle, eGFP mRNA and translated protein following subcutaneous administration in mouse.

Aim: Increased knowledge of biodistribution and pharmacokinetics of lipid nanoparticle (LNP)-encapsulated mRNA drug components may aid efficacy and safety evaluation.Methods: Mice were subcutaneously administrated LNP encapsulated enhanced green fluorescent protein mRNA and sampled up to 72 h after dosing. LNP, mRNA and translated protein were quantified by LC-MS, branched DNA and ELISA.Results: Highest levels of LNP and mRNA were detected in skin, followed by spleen, but also rapidly distributed to circulation. Translated protein showed high concentration in skin and spleen, but also in liver and kidney across 24 h where the LNP was cleared at 4 h.Conclusion: Subcutaneously dosing LNP encapsulated mRNA in mice resulted in a nonlinear relationship of LNP, mRNA and protein concentration across multiple tissues.

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Preliminary Analysis of Fall Concern Among Family Caregivers of Older Adults Discharged From the Hospital: A Psychometric Evaluation of the Carers' Fall Concern Instrument.

PURPOSE: To provide a preliminary descriptive analysis of the change in fall concern among family caregiver-care recipient dyads during hospitalization and after discharge as part of a prospective study exploring the psychometric properties of the Carers' Fall Concern Instrument. METHOD: Using a prospective cohort design, an interviewer-administered survey was completed by dyads at 48 hours before discharge and 1 week and 30 days after discharge. RESULTS: Of family caregivers, 76.9% thought their care recipient was at risk of falling and 61.5% were afraid of them falling. However, only 34.6% of older adults thought that they were at risk of falling and only 42.3% were afraid of falling. Family caregivers reported significantly less concern about falls after their care recipients were discharged. CONCLUSION: This study provided greater insight into caregiver-care recipient dyads' fall concern during their transition from hospital to home that may guide post-discharge fall prevention education on falls. [Journal of Gerontological Nursing, 50(5), 14-18.].

Anticholinergic deprescribing: A case report demonstrating improved cognition and function with minimal adverse withdrawal effects.

Anticholinergic-induced cognitive impairment may be partially reversible upon cessation. A barrier to deprescribing of anticholinergics is the unknown risk of anticholinergic adverse drug withdrawal events (ADWE), with only limited information available on the incidence, timing and severity of anticholinergic ADWE. We report the case of a 76-year-old woman who experienced significant cognitive improvement following deprescribing long-term use of a strong anticholinergic drug, doxepin, and dose reduction of another possible anticholinergic agent. The patient decided to abruptly stop taking doxepin, despite a planned careful taper with twice weekly monitoring, but did not experience any severe anticholinergic ADWE and subsequently had significantly improved cognitive function. Future research should focus on better understanding the risk of anticholinergic ADWE so that anticholinergic deprescribing decisions, including how often and by how much to taper, can be made confidently and safely.

Research gaps and priorities for quantitative microbial risk assessment (QMRA).

The coronavirus disease 2019 pandemic highlighted the need for more rapid and routine application of modeling approaches such as quantitative microbial risk assessment (QMRA) for protecting public health. QMRA is a transdisciplinary science dedicated to understanding, predicting, and mitigating infectious disease risks. To better equip QMRA researchers to inform policy and public health management, an Advances in Research for QMRA workshop was held to synthesize a path forward for QMRA research. We summarize insights from 41 QMRA researchers and experts to clarify the role of QMRA in risk analysis by (1) identifying key research needs, (2) highlighting emerging applications of QMRA; and (3) describing data needs and key scientific efforts to improve the science of QMRA. Key identified research priorities included using molecular tools in QMRA, advancing dose-response methodology, addressing needed exposure assessments, harmonizing environmental monitoring for QMRA, unifying a divide between disease transmission and QMRA models, calibrating and/or validating QMRA models, modeling co-exposures and mixtures, and standardizing practices for incorporating variability and uncertainty throughout the source-to-outcome continuum. Cross-cutting needs identified were to: develop a community of research and practice, integrate QMRA with other scientific approaches, increase QMRA translation and impacts, build communication strategies, and encourage sustainable funding mechanisms. Ultimately, a vision for advancing the science of QMRA is outlined for informing national to global health assessments, controls, and policies.

Experiences of community pharmacists in the United Kingdom on the provision of travel health services and associated educational requirements.

BACKGROUND: Travel health services play a critical role in public health. Previously, travel services were provided solely through GPs or private specialist clinics. In recent years, they have been available from community pharmacists in the UK. This study sought to understand the types of travel health services provided by community pharmacists and to establish the educational needs. METHOD: Qualitative interviews and focus groups explored current practices and educational needs in travel medicine. Thematic analysis of transcribed interviews and focus groups was conducted to understand how travel services are provided and the training undertaken by community pharmacists in delivering these services. RESULTS: Nine individual interviews and one focus group of seven additional pharmacists was conducted. Pharmacists considered that they provided a comprehensive service and undertook the necessary training for safe delivery. Pharmacists described a 'vaccine centric' approach to travel services, with aspects, such as management of chronic conditions, fitness/preparedness for travel, prevention and self-management of travel-related conditions considered to be of lower priority. This was reflected in the travel medicine education that they had received and their perception of future requirements. CONCLUSION: Whilst vaccination is a critical aspect of travel health medicine, taking a 'vaccine centric' approach represents a missed opportunity in public health. Future educational opportunities for pharmacists could include training that encourages a broader approach to travel health consultations, to include a co-created, structured, and holistic risk assessment for travellers and recommendations for appropriate prevention and management strategies for travellers prior to, during and after travel.

Qualitative Study to Explore the Occupational and Reproductive Health Challenges among Women Tobacco Farm Laborers in Mysore District, India.

Tobacco farm laborers are primarily women and children working for very low wages. The aim of this study was to explore occupational and reproductive health challenges faced by women tobacco farm laborers in Mysore District, India. We conducted interviews and six focus group discussions among 41 women tobacco farm laborers. Codes and themes were generated based on deductive and inductive approaches using the socioecological model. Participants reported symptoms of green tobacco sickness including headaches, back pain, gastric problems, weakness, and allergies during menstruation, pre-natal, and post-natal periods. Participants had poor awareness about the health effects of tobacco farming, and there were gender inequalities in wages and the use of personal protective equipment. Participants received support from family and community health workers during their pregnancy and post-natal period. Women reported wanting maternity benefits from the tobacco board, as well as monetary support and nutritional supplements. There is a need for health education about the environmental dangers of tobacco among farm laborers, and more supportive policies for women farmworkers during pregnancy and post-natal periods.

Occupational exposures among women beedi workers in Mysore District, India: A mixed-methods study protocol.

Beedi is the most common smoking form of tobacco used in India. The rolling of beedis is performed primarily by women in settings that lack occupational safeguards. The aims of this protocol are to establish methods for the study of occupational exposures among women beedi workers and their experiences and challenges working with unburnt tobacco. This protocol employs a convergent parallel mixed-methods approach. Qualitatively, we plan to explore the experiences and challenges faced by women beedi workers using photovoice, a community based participatory method. Occupational exposures to pesticides will be assessed through the use of silicone wristbands worn for seven days by workers, and exposure to toxic metals and metalloids will be assessed in dust samples collected in the homes of workers. The outcomes will be analyzed to form policy recommendations to improve the occupational health of women beedi workers.

Potential impact of annual vaccination with reformulated COVID-19 vaccines: Lessons from the US COVID-19 scenario modeling hub.

BACKGROUND: Coronavirus Disease 2019 (COVID-19) continues to cause significant hospitalizations and deaths in the United States. Its continued burden and the impact of annually reformulated vaccines remain unclear. Here, we present projections of COVID-19 hospitalizations and deaths in the United States for the next 2 years under 2 plausible assumptions about immune escape (20% per year and 50% per year) and 3 possible CDC recommendations for the use of annually reformulated vaccines (no recommendation, vaccination for those aged 65 years and over, vaccination for all eligible age groups based on FDA approval). METHODS AND FINDINGS: The COVID-19 Scenario Modeling Hub solicited projections of COVID-19 hospitalization and deaths between April 15, 2023 and April 15, 2025 under 6 scenarios representing the intersection of considered levels of immune escape and vaccination. Annually reformulated vaccines are assumed to be 65% effective against symptomatic infection with strains circulating on June 15 of each year and to become available on September 1. Age- and state-specific coverage in recommended groups was assumed to match that seen for the first (fall 2021) COVID-19 booster. State and national projections from 8 modeling teams were ensembled to produce projections for each scenario and expected reductions in disease outcomes due to vaccination over the projection period. From April 15, 2023 to April 15, 2025, COVID-19 is projected to cause annual epidemics peaking November to January. In the most pessimistic scenario (high immune escape, no vaccination recommendation), we project 2.1 million (90% projection interval (PI) [1,438,000, 4,270,000]) hospitalizations and 209,000 (90% PI [139,000, 461,000]) deaths, exceeding pre-pandemic mortality of influenza and pneumonia. In high immune escape scenarios, vaccination of those aged 65+ results in 230,000 (95% confidence interval (CI) [104,000, 355,000]) fewer hospitalizations and 33,000 (95% CI [12,000, 54,000]) fewer deaths, while vaccination of all eligible individuals results in 431,000 (95% CI: 264,000-598,000) fewer hospitalizations and 49,000 (95% CI [29,000, 69,000]) fewer deaths. CONCLUSIONS: COVID-19 is projected to be a significant public health threat over the coming 2 years. Broad vaccination has the potential to substantially reduce the burden of this disease, saving tens of thousands of lives each year.