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Background: Disease prevalence and distribution by patient characteristics data are needed to guide "representative" patient enrollment in clinical trials and assess relevance of results to patient populations. Our objective was to describe disease prevalence, and age/sex distribution of patients with common chronic conditions from a large population sample., Methods: A cross-sectional study of all members of Clalit Health Services, alive on January 1, 2020. Included were 26 chronic diseases, and 21 types of malignancies regarded as active by being diagnosed between January 1, 2018- to January 1, 2020, or by prescription of oncologic treatment medications January 1, 2018 and January 1, 2020., Results: Data from 4,627,183 individuals, 2,274,349 males and 2,352,834 females from newborn to 110 years. Obesity (19%), hypertension (13%), diabetes mellitus (9%), esophagitis-gastritis (5.5%), thyroid disease (5.3%), asthma (5.1%), ischemic heart disease (4.5%), depression (4.5%), osteoporosis (3.8%), and atopic dermatitis (3.6%) were the ten most prevalent conditions. Proportions of age groups varied between conditions (67% of hypertensives were ≥65 years old, 24% ≥80 years; 73% with ischemic heart disease were ≥65 years, 29% ≥80 years; 59% of diabetics were ≥65 years, 17% ≥80 years; 42% of atrial fibrillation patients were ≥80 years; 40% of heart failure patients were ≥80 years). Proportions of males and females for most conditions paralleled prevalence except proportions of women increased after age 80 for cardiovascular diseases, and for diabetes after age 75. The five most frequent active cancers were breast, prostate, colon/rectal, lymphoma and melanoma. The prevalence of cancers increased with age beginning in the middle-aged groups and peaking at very old ages. Women had lower prevalence of lung cancers and accounted for lower percentages of patients with lung cancers (45 vs 55%) but similar percentages for women and men were seen in the patients with colon and rectal cancer (50.4 vs. 49.6% in women) and lymphoma (50.7 vs. 49.3% in women)., Conclusions: Prevalence of medical conditions and distributions differ by age and sex. This information serves as an example and resource for data needed to describe a "representative" clinical population., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Gronich et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background: Coronavirus disease (COVID-19) negatively impacted tuberculosis (TB) programs which were already struggling to meet End-TB targets globally. We aimed to quantify and compare diagnosis, treatment initiation, treatment success, and losses along this TB care cascade for drug-susceptible TB in Cape Town, South Africa, prior to and during COVID-19., Methods: This observational study used routine TB data within two predefined cohorts: pre-COVID-19 (1 October 2018-30 September 2019) and during-COVID-19 (1 April 2020-31 March 2021). The numbers of people diagnosed, treated for TB and successfully treated were received from the Western Cape Provincial Health Data Centre. Pre and post treatment loss to follow up and cascade success rates (proportion of individuals diagnosed with an outcome of treatment success) were calculated and compared across cohorts, disaggregated by sex, age, HIV status, TB treatment history and mode of diagnosis., Results: There were 27,481 and 19,800 individuals diagnosed with drug-susceptible TB in the pre- and during-COVID-19 cohorts respectively, a relative reduction of 28% (95% CI [27.4% - 28.5%]). Initial loss to follow up increased from 13.4% to 15.2% (p<0.001), while post treatment loss increased from 25.2% to 26.1% (p < 0.033). The overall cascade success rate dropped by 2.1%, from 64.8% to 62.7% (p< 0.001). Pre- and during-COVID-19 cascade success rates were negatively associated with living with HIV and having recurrent TB., Conclusions: An already poorly performing TB program in Cape Town was negatively impacted by the COVID-19 pandemic. There was a substantial reduction in the number of individuals diagnosed with drug-susceptible. Increases in pre-and post-treatment losses resulted in a decline in TB cascade success rates. Strengthened implementation of TB recovery plans is vital, as health services now face an even greater gap between achievements and targets and will need to become more resilient to possible future public health disruptions., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Jennings et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Introduction: Epithelioid hemangioendothelioma (EHE) is an ultra-rare sarcoma, marked by distinctive molecular and pathological features and with a variable clinical behavior. Its natural history is still partially understood, reliable prognostic and predictive factors are lacking and many questions are still open on the optimal management. In the context of EURACAN, a prospective registry specifically dedicated to EHE was developed and launched with the aim of providing, through high-quality prospective data collection, a better understanding of this disease., Study Design: Registry-based cohort study including only new cases of patients with a pathological and molecularly confirmed diagnosis of EHE., Objectives: To improve the understanding of EHE natural history, validate and identify new prognostic and predictive factors, clarify the activity and efficacy of currently available treatment options, describe treatment pattern., Methods: Settings and participantsIt is an hospital-based registry established in centers with expertise in EHE including adult patients with a new pathological and molecularly confirmed diagnosis of EHE starting from the 1st December 2023. The characteristics of each patient in the facility who meets the above-mentioned inclusion criteria will be collected prospectively and longitudinally with follow-up at cancer progression and / or cancer relapse or patient death. It is a secondary use of data which will be collected from the clinical records. The data collected for the registry will not entail further examinations or admissions to the facility and/or additional appointments to those normally provided for routine patient follow-up. VariablesFull details on patients and disease features, treatment and outcome will be collected, according to common clinical practice guidelines developed and shared with all the contributing centers. In addition, data on potential confounders (e.g. comorbidity; functional status etc.) will also be collected. Statistical methodsThe data analyses will include descriptive statistics and analytical analyses. Multivariable Cox's proportional hazards model and Hazard ratios (HR) for all-cause or cause-specific mortality will be used to determine independent predictors of overall survival, recurrence and progression., Results: The registry has been joined by 21 sarcoma reference centers across EU and UK, covering 10 countries. Patients' recruitment started in December 2023. The estimated completion date is December 2033 upon agreement on the achievement of all the registry objectives. The already established collaboration and participation of EHE patient's associations involved in the project will help in promoting the registry and fostering accrual., Competing Interests: Anna Maria Frezza declares institutional research funding from Advenchen Laboratories, Amgen Dompé, AROG Pharmaceuticals, Ayala Pharmaceuticals, Bayer, Blueprint Medicines, Boehriger Ingelheim, Daiichi Sankyo, Deciphera, Eisai, Eli Lilly, Epizyme Inc, Foghorn Therapeutics Inc., Glaxo, Hutchison MediPharma Limited, Inhibrx, Inc., Karyopharm Pharmaceuticals, Novartis, Pfizer, PharmaMar, PTC Therapeutics, Rain Oncology, SpringWorks Therapeutics. Alexia Bertuzzi declares support for attending meeting and/or travels from Pharmamar and Istituto Gentili; support for scientific activities from Istituto Gentili. Antonella Brunello declares consulting fees or serving on advisory boards for Eli Lilly, Roche, GSK, Eisai, Pharmamar, Boehringer Ingelheim, Deciphera; payment or honoraria for educational events by GSK and Pharmamar; travel grants by Pharmamar, Istituto Gentili. Giacomo G. Baldi declares consulting fees from Eli Lilly, Pharmamar, AboutEvents; honoraria from Pharmamar, Eli Lilly, Glaxo Smith Kline, Merck Sharp & Dome, Eisai, IstitutoGentili; support for attending meetings and/or travels from Novartis, Pharmamar, Eli Lilly; participation on the advisory board from Pharmamar, Eli Lilly, Glaxo Smith Kline, Merck Sharp & Dome, Eisai. Paolo G. Casali declares institutional research funding from Advenchen Laboratories, Amgen Dompé, AROG Pharmaceuticals, Ayala Pharmaceuticals, Bayer, Blueprint Medicines, Boehriger Ingelheim, Daiichi Sankyo, Deciphera, Eisai, Eli Lilly, Epizyme Inc, Foghorn Therapeutics Inc., Glaxo, Hutchison MediPharma Limited, Inhibrx, Inc., Karyopharm Pharmaceuticals, Novartis, Pfizer, PharmaMar, PTC Therapeutics, Rain Oncology, SpringWorks Therapeutics. Virginia Ferraresi declares consultancy fees or honoraria from PharmaMar, Boehringer Ingelheim, Gentili e Serb Pharmaceuticals. Matilde Ingrosso reports institutional research funding from Advenchen Laboratories, Amgen Dompé, AROG Pharmaceuticals, Ayala Pharmaceuticals, Bayer, Blueprint Medicines, Boehriger Ingelheim, Daiichi Sankyo, Deciphera, Eisai, Eli Lilly, Epizyme Inc, Foghorn Therapeutics Inc., Glaxo, Hutchison MediPharma Limited, Inhibrx, Inc., Karyopharm Pharmaceuticals, Novartis, Pfizer, PharmaMar, PTC Therapeutics, Rain Oncology, SpringWorks Therapeutics. Laura Monteleone reports institutional research funding from Advenchen Laboratories, Amgen Dompé, AROG Pharmaceuticals, Ayala Pharmaceuticals, Bayer, Blueprint Medicines, Boehriger Ingelheim, Daiichi Sankyo, Deciphera, Eisai, Eli Lilly, Epizyme Inc, Foghorn Therapeutics Inc., Glaxo, Hutchison MediPharma Limited, Inhibrx, Inc., Karyopharm Pharmaceuticals, Novartis, Pfizer, PharmaMar, PTC Therapeutics, Rain Oncology, SpringWorks Therapeutics. Johanna Szkandera reports participation in advisory boards or invited speaker fees for PharmaMar, Bayer, Roche, Lilly, Amgen; travel expenses coverage from PharmaMar, Roche, Lilly, Amgen, Bristol Myers Squibb; research funding from PharmaMar, Roche, Eisai. Bruno Vincenzi reports consulting fees from Eisai, Lilly, Bayer, Deciphera, PharmaMar, Blueprint, Pfizer, GSK, Accord, Abbott and research support from PharmaMar, Novartis, Lilly Silvia Stacchiotti declares advisory board roles with Bayer, Boehringer, Daiichi, Ikena, Nec Oncology, Pharma Essentia, Regeneron, Servier; invited speaker roles for Bayer, Boehringer, Gentili, Pharmamar; institutional research funding from Advenchen Laboratories, Amgen Dompé, AROG Pharmaceuticals, Ayala Pharmaceuticals, Bayer, Blueprint Medicines, Boehriger Ingelheim, Daiichi Sankyo, Deciphera, Eisai, Eli Lilly, Epizyme Inc, Foghorn Therapeutics Inc., Glaxo, Hutchison MediPharma Limited, Inhibrx, Inc., Karyopharm Pharmaceuticals, Novartis, Pfizer, PharmaMar, PTC Therapeutics, Rain Oncology, SpringWorks Therapeutics. Carlo Cicala, Lorenzo D’Ambrosio, Angelo Paolo Dei Tos, Alessandro Gronchi, Nadia Hindi, Robin Jones, Iwona Lugowska, Julia Ketzer, Anna Mariuk-Jarema, Andrea Napolitano, Andri Papakonstantinou, Sandro Pasquali, Marta Sbaraglia, Federico Scolari, Elisa Crotti, Irene Benzonelli, Jean-Yves Blay, Christophe Bouvier, Javier Martin Broto, Hugh Leonard, Ninna Aggerholm-Pedersen, Andri Papakonstantinou, Giuseppe Bianchi, Federica Zuccheri, Paolo Baili, Simone Bonfarnuzzo, Domenico Campanacci, Armelle Dufresne, Sebastian Bauer, Serena Bazzurri, Stefano Gabellini, Claudia Giani, Vincenzo Giannusa, Melissa Gil-Sanjines, Teresa Grassani, Paolo Lasalvia, Stefan Lindskog, Salvatore Vizzaccaro, Nils Dieckmann, Alessandro Mazzocca, Andrei Ivanescu, Giuseppe Badalamenti, Carlo Morosi, Stephanie Elston, Kyetil Boye, Francesca Nardozza, Elisabetta Neri, Maria Nilsson and Annalisa Trama declares no conflict of interest., (Copyright: © 2024 Frezza et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Introduction: Mothers of very premature infants often have difficulties expressing breastmilk, which can cause distress and potential negative impact on infant health. Clinical recommendations on breastmilk expression are extrapolated from term infants' breastfeeding patterns. This study's objective was to analyse the association of expressing pattern with lactation outcomes after very premature birth., Methods: 132 participants were recruited after birth between 23+0 and 31+6 weeks' gestation. Participants recorded the milk expressed in several 24-hour periods in the three weeks after birth., Results: Expressing frequency was positively associated with 24-hour milk yield, with an adjusted 30.5g increase per expressing session on day four (95% CI 15.7 to 45.3) and 94.4g on day 21 (95% CI 62.7 to 126.2). Expressing ≥8 times per day was associated with higher adjusted milk yield than expressing <6 times (on day four, 146.8g, 95% CI 47.4 to 246.1), but not in comparison to expressing 6-7 times (on day four, 82.1g, 95% CI -25.9 to 190.1). Participants with six months or more prior breastmilk feeding experience had a higher adjusted milk yield than others (on day four, 204.3g, 95% CI 125.2 to 283.3). Night-time (2300-0700 hours) expressing sessions were not associated with increased milk yield after adjustment for time since the prior session. On average, participants who had a longest gap between expressions of less than six hours achieved the UK target of 750g breastmilk, whereas those with a longer gap did not., Conclusion: Expressing frequency was an important determinant of milk yield. Clinical recommendations to express ≥8 times per day were supported but for some, 6-7 times was sufficient. This was particularly likely for those with six months or more of prior breastmilk feeding experience. A need to express during the night-time hours appeared to be related to minimising the gap between expressions rather than an inherent value of night-time expression., Competing Interests: I have read the journal’s policy and the authors of this manuscript have the following competing interests: MF receives an unrestricted research donation from Philips for research in infant nutrition, unrelated to this work., (Copyright: © 2024 Levene et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background: To assess factors associated with perceived changes in physical and mental health and with delays in seeking healthcare during the second and third COVID-19 lockdowns in England (2020-2021)., Methods: An online survey of Million Women Study participants collected data on 44,523 women, mean age 76 (SD = 4), October 2020-May 2021. These data were linked to data collected prospectively on Million Women Study participants at recruitment in median year 1998 and at re-surveys in 2011-2013, as well as to hospital admission data from 2017-2019., Results: Of 40,821 participants with complete data on the outcomes of interest, 28% reported worse physical health and 26% worse mental health. After adjustment for age, region, education and survey period, poor/fair self-rated health (adjusted OR 2.71, 95% CI 2.52-2.91), having been told to shield (1.92, 1.79-2.05), obesity (2.17, 2.04-2.31) and other measures of poor health prior to the outbreak were all strongly related to worse physical health, as was being an informal carer (1.47, 1.38-1.56) and having a COVID-19 infection (1.64, 1.53-1.77). Depression (2.31, 2.06-2.58), poor/fair self-rated health (1.98, 1.84-2.13) and being an informal carer (1.69, 95% CI 1.58-1.80) were the factors most strongly related to worse mental health. Having poor/fair self-rated health (2.22, 2.05-2.40), obesity (1.58, 1.47-1.70) and being an informal carer (1.45, 1.34-1.56) were all strongly related to delaying seeking medical care. These associations remained essentially unchanged after exclusion of participants who had a COVID-19 infection., Conclusions: In a large sample of older women in England, just over a quarter reported a deterioration in their physical and mental health during the national lockdowns. In addition to the expected effect of a COVID-19 infection on physical health, the groups who were most likely to report such a deterioration were those with pre-existing morbidity and those who were caring for others as informal carers., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Floud et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Introduction: The COVID-19 pandemic led to a significant reorganization of health services, potentially affecting the quality of care for major public health concerns such as proximal femoral fractures. This study aimed to investigate potential changes in the timing of various steps in the patient journey after a hip fracture during the pandemic in Piedmont, a region in Northern Italy., Methods: A retrospective study was conducted on the discharge records of patients aged 65 or older who were admitted for hip surgery following a femur fracture in 2019 and 2020. The study examined four-time steps: duration from hospital admission to surgery, length of hospital stay, interval between hospital discharge and admission to the rehabilitation facility, and duration of stay at the rehabilitation facility. To mitigate biases linked to sex and age factors, groups well-balanced across 2019 and 2020 were created using propensity score estimation., Results: The dataset consisted of two cohorts of 583 patients each for the years 2019 and 2020. The average duration from admission to surgery was approximately 1.9 days in both years, with 75% of patients undergoing surgery within 2 days of hospital admission. The average hospital stay reduced from 13.49 days in 2019 to 11.34 days in 2020. The gap between hospital discharge and admission to rehabilitation was approximately 10-12 days, and the average duration of stay at the rehabilitation facility was about 31.6 days., Discussion: The study indicates that healthcare systems can exhibit resilience and adaptability, even during a global pandemic, to ensure high-quality and safe standards of care. However, further long-term studies are needed to fully understand the pandemic's impact on primary health outcomes following hip replacement surgery and subsequent rehabilitation. The potential role of telemedicine in reducing the time between steps also warrants further investigation., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Elhadidy et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background and Objective: This cross-sectional study aimed to provide a scale to assess different aspects of the will based on Roberto Assagioli's theory., Methods and Results: The scale development followed three steps. Step 1 focused on operationalizing the construct and developing the items. It was carried out through several phases of item generation and refinement, resulting in a pool of 38 items. At Step 2 we tested the psychometric properties of the initial 38-item scale with the goal of excluding the items that weakened the structural validity and reliability of the scale. Descriptive, internal consistency, and exploratory factor analyses statistics were computed on a large sample (Sample 1: N = 587; age: M = 21.55, SD = 4.14, 66% female) and they led to a five-dimension model (Strong, Skillful, Good toward Self and Other, and Transpersonal Will) and the exclusion of 15 items. Analyses conducted at Step 3 on a different sample (Sample 2: N = 683; age: M = 34.09, SD = 16.27, 54% female) allowed for further refinement of the scale. Confirmatory factor analysis conducted on the resulting 19-item scale showed a good fit for the five-factor model (χ2 (142) = 507.63, p< .001, TLI = .91; CFI = .93; RMSEA = .06 [90%CI: .06‒.07]), and evidence of its invariance across genders and ages was provided. Reliability indices (internal consistency and intraclass correlation coefficients) were adequate (ranging from .66 to .83) and correlations with measures of related constructs supported the external validity of the scale., Conclusion: This study provides researchers, therapists, and counselors with an efficient measurement tool to assess Assagioli's construct of will., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Bonacchi et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Objectives: To study informed consent to midwifery practices and interventions during the second stage of labor and to investigate the association between informed consent and experiences of these practices and interventions and women's experiences of the second stage of labor., Methods: This study uses an observational design with data from a follow-up questionnaire sent to women one month after giving birth spontaneously in the Oneplus trial, a study aimed at evaluating collegial midwifery assistance to reduce severe perineal trauma. The trial was conducted between 2018-2020 at five Swedish maternity wards and trial registered at clinicaltrials.gov, no NCT03770962. The follow-up questionnaire contained questions about experiences of the second stage of labor, practices and interventions used and whether the women had provided informed consent. Evaluated practices and interventions were the use of warm compresses held at the perineum, manual perineal protection, vaginal examinations, perineal massage, levator pressure, intermittent catheterization of the bladder, fundal pressure, and episiotomy. Associations between informed consent and women's experiences were assessed by univariate and multivariable logistic regression., Findings: Of the 3049 women participating in the trial, 2849 consented to receive the questionnaire. Informed consent was reported by less than one in five women and was associated with feelings of being safe, strong, and in control. Informed consent was further associated with more positive experiences of clinical practices and interventions, and with less discomfort and pain from interventions involving physical penetration of the genital area., Conclusion: The findings indicate that informed consent during the second stage is associated with feelings of safety and of being in control. With less than one in five women reporting informed consent to all practices and interventions performed by midwives, the results emphasize the need for further action to enhance midwives' knowledge and motivation in obtaining informed consent prior to performance of interventions., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Häggsgård et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Introduction: Workers with occupational exposure to respirable silica dust, such as casual labourers at road construction sites (RCSs), are known to be at high risk of developing pulmonary tuberculosis (TB). There is limited literature about the burden of PTB among this subpopulation with high occupational exposure to silica dust at road construction sites. We aimed to determine the prevalence of PTB among casual labourers working at road construction sites in central Uganda., Methods: We enrolled 297 participants via consecutive sampling in a cross-sectional study between September 1st and September 30th, 2022, at four road construction sites in four districts in central Uganda. A structured questionnaire was administered, and the PTB patients were identified by using GeneXpert and/or computer-aided detection for TB (CAD4TB). The data were analysed with STATA version 17.0. Descriptive statistics adjusted for clustering were used to summarize the data, and the relationships between PTB and independent variables were assessed by using a mixed effects modified Poisson regression model to estimate the adjusted prevalence ratios., Results: Most participants were males (95.6% [284/297]), and the median age was 29 years (interquartile range [IQR]: 25-33). The prevalence of PTB among casual labourers was 2.4% (95% CI: 1.9, 2.8). Not being vaccinated with BCG (3.45, 95% CI: 1.02, 11.61), alcohol use (2.70, 95% CI: 1.52, 4.80) and staying in shared rooms (8.13, 95% CI: 4.37, 15.12) were positively associated with having PTB., Conclusion: There is a high prevalence of PTB among casual labourers working at road construction sites in central Uganda. Individuals who had never been vaccinated with BCG, alcohol users and those staying in shared rooms were at an increased risk of having PTB. We recommend routine screening of casual labourers at road construction sites to optimize active TB case finding., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Ahimbisibwe et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background: In April 2018, the UK government implemented a levy on soft drinks importers and manufacturers, tiered according to the amount of sugar in drinks. The stated aim was to encourage manufacturers to reduce sugar and portion sizes. Previous evidence suggests that the policy has been successful in reducing sugar in drinks in the short-term since implementation, but their sustained effects have not been explored. This study aimed to assess the impact of the soft drink industry levy (SDIL) on sugar levels, price, portion size and use of non-sugar sweeteners in the medium-term., Methods and Findings: Product data from 30 November 2017 to 14 March 2020 from one major UK retail supermarket were analysed (112,452 observations, 126 weekly time points). We used interrupted time series analysis, to assess the impact of the soft-drink industry levy (SDIL) on levy-eligible soft drinks, with exempt drinks (i.e. 100% fruit juices, milks, flavoured milks) acting as a comparator series. At the point of implementation of the SDIL (April 2018) there was a step change in the proportion of eligible drinks with sugar content below the SDIL levy threshold (5g per 100ml) (+0.08, 95%CI: +0.04, +0.12), with a similar sized decrease in the proportion in the highest levy category (> = 8g sugar per 100ml) (-0.06, 95%CI: -0.10, -0.03). Between April 2018 and March 2020, the proportion of eligible drinks below the SDIL levy threshold continued to gradually increase (p = 0.003), while those in the highest levy category decreased (p = 0.007). There was a step change in price of eligible drinks in the higher levy category at the point of implementation of +£0.049 (95%CI: +£0.034, +£0.065) per 100mL (for comparison, the levy is set at £0.024 per 100mL for this group). Trends in price for the high levy category were not altered by the SDIL. In the no levy category, there was a step change in price at the implementation (+£0.012 per 100mL, 95%CI: +£0.008, +£0.023), followed by a second step change in October 2018 (-£0.018p per 100mL, 95%CI: -£0.033, -£0.001p). The volume of products in the higher levy group decreased at the time of the implementation (-305mL on average including multipacks, 95%CI: -511, -99). The change in trend for the product volume of drinks in the higher levy group between April 2018 and March 2020 was in the increasing direction (+704mL per year, 95%CI: -95, 1504), but it did not meet our threshold for statistical significance (p = 0.084). There were no changes observed in the volume of lower levy drinks or no levy drinks. There was a step change in the proportion of drinks with non-sugar sweeteners at the implementation of the SDIL (+0.04, 95%CI: +0.02, +0.06)., Conclusion: These results suggest that the SDIL was successful in [1] producing reductions in sugar levels that were maintained over the medium term up to March 2020 and [2] a reduction in product volume for higher tier drinks that may be diminishing over time. Our results also show that the SDIL was associated with a maintained price differential between high and low sugar drinks., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Luick et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Objectives: Rates of severe maternal morbidity have highlighted persistent and growing racial disparities in the United States (US). We aimed to contrast temporal trends in peripartum hysterectomy by race/ethnicity and quantify the contribution of changes in maternal and obstetric factors to temporal variations in hysterectomy rates., Methods: We conducted a population-based, retrospective study of 5,739,569 US residents with a previous cesarean delivery, using National Vital Statistics System's Natality Files (2011-2021). Individuals were stratified by self-identified race/ethnicity and classified into four periods based on year of delivery. Temporal changes in hysterectomy rates were estimated using odds ratios (ORs) and 95% confidence intervals (CIs). We used sequential logistic regression models to quantify the contribution of maternal and obstetric factors to temporal variations in hysterectomy rates., Results: Over the study period, the peripartum hysterectomy rate increased from 1.23 (2011-2013) to 1.44 (2019-2021) per 1,000 deliveries (OR 2019-2021 vs. 2011-2013 = 1.17, 95% CI 1.10 to 1.25). Hysterectomy rates varied by race/ethnicity with the highest rates among Native Hawaiian and Other Pacific Islander (NHOPI; 2.73 per 1,000 deliveries) and American Indian or Alaskan Native (AIAN; 2.67 per 1,000 deliveries) populations in 2019-2021. Unadjusted models showed a temporal increase in hysterectomy rates among AIAN (2011-2013 rate = 1.43 per 1,000 deliveries; OR 2019-2021 vs. 2011-2013 = 1.87, 95% CI 1.02 to 3.45) and White (2011-2013 rate = 1.13 per 1,000 deliveries; OR 2019-2021 vs. 2011-2013 = 1.21, 95% CI 1.11 to 1.33) populations. Adjustment ranged from having no effect among NHOPI individuals to explaining 14.0% of the observed 21.0% increase in hysterectomy rates among White individuals., Conclusion: Nationally, racial disparities in peripartum hysterectomy are evident. Between 2011-2021, the rate of hysterectomy increased; however, this increase was confined to AIAN and White individuals., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Rajasingham et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background: Benfotiamine provides an important novel therapeutic direction in Alzheimer's disease (AD) with possible additive or synergistic effects to amyloid targeting therapeutic approaches., Objective: To conduct a seamless phase 2A-2B proof of concept trial investigating tolerability, safety, and efficacy of benfotiamine, a prodrug of thiamine, as a first-in-class small molecule oral treatment for early AD., Methods: This is the protocol for a randomized, double-blind, placebo-controlled 72-week clinical trial of benfotiamine in 406 participants with early AD. Phase 2A determines the highest safe and well-tolerated dose of benfotiamine to be carried forward to phase 2B. During phase 2A, real-time monitoring of pre-defined safety stopping criteria in the first approximately 150 enrollees will help determine which dose (600 mg or 1200 mg) will be carried forward into phase 2B. The phase 2A primary analysis will test whether the rate of tolerability events (TEs) is unacceptably high in the high-dose arm compared to placebo. The primary safety endpoint in phase 2A is the rate of TEs compared between active and placebo arms, at each dose. The completion of phase 2A will seamlessly transition to phase 2B without pausing or stopping the trial. Phase 2B will assess efficacy and longer-term safety of benfotiamine in a larger group of participants through 72 weeks of treatment, at the selected dose. The co-primary efficacy endpoints in phase 2B are CDR-Sum of Boxes and ADAS-Cog13. Secondary endpoints include safety and tolerability measures; pharmacokinetic measures of thiamine and its esters, erythrocyte transketolase activity as blood markers of efficacy of drug delivery; ADCS-ADL-MCI; and MoCA., Conclusion: The BenfoTeam trial utilizes an innovative seamless phase 2A-2B design to achieve proof of concept. It includes an adaptive dose decision rule, thus optimizing exposure to the highest and best-tolerated dose., Trial Registration: ClinicalTrials.gov identifier: NCT06223360, registered on January 25, 2024. https://classic.clinicaltrials.gov/ct2/show/NCT06223360., Competing Interests: I have read the journal’s policy and the authors of this manuscript have the following competing interests: SDE is a Data Safety Monitoring Board statistician for clinical trials performed by Janssen Research & Development LLC and Suven. For this manuscript, HHF reports grant funding from the National Institute of Aging (R01AG076634) with no personal funds received and all payments to UC San Diego. HHF also discloses grant funding from Annovis (QR Pharma), Vivoryon (Probiodrug), Biohaven Pharmaceuticals, AC Immune, and LuMind Foundation; service agreements for consulting activities with LuMind, Genentech (DSMB), Roche/Banner (DMC), Tau Consortium (SAB), Axon Neuroscience, Biosplice Therapeutics, Janssen Research & Development LLC (DMC), Arrowhead Pharmaceuticals, Samus Therapeutics; Advisory Board activities: Translating Research in Elder Care (TREC), Association for Frontotemporal Dementia, Tau Consortium and Rainwater Charitable Foundation; support for travel from Novo Nordisk, Royal Society of Canada, Tau Consortium, Canadian Consortium for Neurodegeneration in Aging (CCNA), Translating Research in Elder Care (TREC), World Events Forum (ADDF); and a philanthropic donation for the Epstein Family Alzheimer Research Collaboration. For these activities, no personal funds have been received with all payments to UC San Diego. HHF personally receives royalties for patent: Feldman HH (filed November 26, 2008). Detecting and Treating Dementia Serial Number 12/3-2691 U.S. Patent No. PCT/US2007/07008. Washington, DC: U.S. Patent and Trademark Office. DMJ reports support from grants to UC San Diego from NIH/NIA, Vivoryon Therapeutics, Biohaven Pharmaceuticals, and the Epstein Family Foundation. SAF reports grant funding from the NIH. GEG reports a pending patent. KJ received funding from BBSRC and the National Institute for Health and Care Research (NIHR) Cambridge Biomedical Research Centre. AK receives funding from the UKRI (MRC & BBSRC), the Wellcome Trust, and the National Institute for Health and Care Research (NIHR) Cambridge Biomedical Research Centre and is a paid consultant for the company Juvenescence. JAL was a consultant for Merck KGaA in 2022 (no longer active); receives drug/placebo from EMD Serono, Merck Subsidiary, for another clinical trial; and receives a stipend from Wolters Kluwer as Editor In Chief of the journal Alzheimer’s Disease and Associated Disorders. KEY, PBV, and VV are employed by and have equity interests in C2N Diagnostics. C2N Diagnostics has received support from the NIH (grant No. R44 AG059489), BrightFocus Foundation (grant No. CA2016636), The Gerald and Henrietta Rauenhorst Foundation, and the Alzheimer’s Drug Discovery Foundation (grant No. GC-201711-2013978). HZ has served at scientific advisory boards and/or as a consultant for Abbvie, Acumen, Alector, Alzinova, ALZPath, Amylyx, Annexon, Apellis, Artery Therapeutics, AZTherapies, Cognito Therapeutics, CogRx, Denali, Eisai, Merry Life, Nervgen, Novo Nordisk, Optoceutics, Passage Bio, Pinteon Therapeutics, Prothena, Red Abbey Labs, reMYND, Roche, Samumed, Siemens Healthineers, Triplet Therapeutics, and Wave, has given lectures in symposia sponsored by Alzecure, Biogen, Cellectricon, Fujirebio, Lilly, Novo Nordisk, and Roche, and is a co-founder of Brain Biomarker Solutions in Gothenburg AB (BBS), which is a part of the GU Ventures Incubator Program (outside submitted work)., (Copyright: © 2024 Feldman et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background: The symptom profiles of acute SARS-CoV-2 infection and long-COVID in children and young people (CYP), risk factors, and associated healthcare needs, are poorly defined. The Schools Infection Survey 1 (SIS-1) was a nationwide study of SARS-CoV-2 infection in primary and secondary schools in England during the 2020/21 school year. The Covid-19 Mapping and Mitigation in Schools (CoMMinS) study was conducted in schools in the Bristol area over a similar period. Both studies conducted testing to identify current and previous SARS-CoV-2 infection, and recorded symptoms and school attendance. These research data have been linked to routine electronic health record (EHR) data., Aims: To better understand the short- and long-term consequences of SARS-CoV-2 infection, and their risk factors, in CYP., Methods: Retrospective cohort and nested case-control analyses will be conducted for SIS-1 and CoMMinS data linked to EHR data for the association between (1) acute symptomatic SARS-CoV-2 infection and risk factors; (2) SARS-CoV-2 infection and long-term effects on health: (a) persistent symptoms; (b) any new diagnosis; (c) a new prescription in primary care; (d) health service attendance; (e) a high rate of school absence., Results: Our study will improve understanding of long-COVID in CYP by characterising the trajectory of long-COVID in CYP in terms of things like symptoms and diagnoses of conditions. The research will inform which groups of CYP are more likely to get acute- and long-term outcomes of SARS-CoV-2 infection, and patterns of related healthcare-seeking behaviour, relevant for healthcare service planning. Digested information will be produced for affected families, doctors, schools, and the public, as appropriate., Conclusion: Linked SIS-1 and CoMMinS data represent a unique and rich resource for understanding the impact of SARS-CoV-2 infection on children's health, benefiting from enhanced SARS-CoV-2 testing and ability to assess a wide range of outcomes., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Looker et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Livestock excrement is composted and applied to agricultural soils. If composts contain antimicrobial-resistant bacteria (ARB), they may spread to the soil and contaminate cultivated crops. Therefore, we investigated the degree of transmission of ARB and related antimicrobial resistance genes (ARGs) and, as well as clonal transmission of ARB from livestock to soil and crops through composting. This study was conducted at Rakuno Gakuen University farm in Hokkaido, Japan. Samples of cattle feces, solid and liquid composts, agricultural soil, and crops were collected. The abundance of Escherichia coli, coliforms, β-lactam-resistant E. coli, and β-lactam-resistant coliforms, as well as the copy numbers of ARG (specifically the bla gene related to β-lactam-resistant bacteria), were assessed using qPCR through colony counts on CHROMagar ECC with or without ampicillin, respectively, 160 days after compost application. After the application of the compost to the soil, there was an initial increase in E. coli and coliform numbers, followed by a subsequent decrease over time. This trend was also observed in the copy numbers of the bla gene. In the soil, 5.0 CFU g-1 E. coli was detected on day 0 (the day post-compost application), and then, E. coli was not quantified on 60 days post-application. Through phylogenetic analysis involving single nucleotide polymorphisms (SNPs) and using whole-genome sequencing, it was discovered that clonal blaCTX-M-positive E. coli and blaTEM-positive Escherichia fergusonii were present in cattle feces, liquid compost, and soil on day 0 as well as 7 days post-application. This showed that livestock-derived ARB were transmitted from compost to soil and persisted for at least 7 days in soil. These findings indicate a potential low-level transmission of livestock-associated bacteria to agricultural soil through composts was observed at low frequency, dissemination was detected. Therefore, decreasing ARB abundance during composting is important for public health., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Fukuda et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Adolescents with HIV (AWH) face the double burden of dealing with challenges presented by their developmental phase while coping with stigma related to HIV, affecting their mental health. Poor mental health complicates adherence to daily treatment regimens, requiring innovative psychosocial support strategies for use with adolescents. We assessed the effectiveness of a mindfulness and acceptance-based intervention on the mental health of AWH in Uganda. One hundred and twenty-two AWH, mean age 17 ±1.59 (range 15 to 19 years), 57% female, receiving care at a public health facility in Kampala were enrolled in an open-label randomized trial (ClinicalTrials.gov: NCT05010317) with assessments at pre-and post-intervention. The mindfulness and acceptance-based intervention involved weekly 90-minute group sessions for four consecutive weeks facilitated by two experienced trainers. Sessions involved clarifying values, skillfully relating to thoughts, allowing and becoming aware of experiences non-judgmentally, and exploring life through trial and error. The control group received the current standard of care. Three mental health domains (depression, anxiety, and internalized stigma) were compared between the intervention and control groups. A linear mixed effects regression was used to analyze the effect of the intervention across the two time points. Results showed that the intervention was associated with a statistically significant reduction in symptoms of depression (β = -10.72, 95%CI: 6.25, -15.20; p < .0001), anxiety (β = -7.55, 95%CI: 2.66, -12.43; p = .0003) and stigma (β = -1.40, 95%CI: 0.66 to -2.15; p = .0004) over time. Results suggest that mindfulness and acceptance-based interventions have the potential to improve the mental health of AWH., Competing Interests: The authors have declared that no competing interests exist., (Copyright: This is an open access article, free of all copyright, and may be freely reproduced, distributed, transmitted, modified, built upon, or otherwise used by anyone for any lawful purpose. The work is made available under the Creative Commons CC0 public domain dedication.)

Smokers report poorer sleep quality than non-smokers and sleep quality deteriorates further during cessation, increasing risk of smoking relapse. Despite the use of cognitive behavioural therapy for insomnia (CBT-I) to aid quit attempts emerging in the area, little is known about smokers and ex smoker's experiences of sleep during a quit attempt or their perceptions of CBT-I. This study addresses this gap by exploring smoker's and ex-smoker's experiences of the link between smoking and sleep and how this may change as a function of smoking/smoking abstinence. It also explores views of traditional CBT-I components (i.e., perceived feasibility, effectiveness, barriers of use). We conducted semi-structured interviews with current and recently quit smokers (n = 17) between January and September 2022. The framework method was used for analysis. Four themes addressing research questions were described. These included: 1) A viscous cycle; poor sleep quality and negative psychological state during cessation; 2) Perceived engagement and effectiveness; the importance of feasibility, experience, value, identity and psychological state in assessing CBT-I as a cessation tool; 3) Striking a balance; tailoring CBT-I to reduce psychological overload in a time of lifestyle transition; and 4) Personalisation and digital delivery helping overcome psychological barriers during cessation. The analysis suggested during quit attempts smokers experienced a range of sleep problems that could increase risk of relapse due to a negative impact on psychological state. It also revealed participants thought that CBT-I is something they would use during a quit attempt but suggested changes and additions that would improve engagement and be better tailored to quitting smokers. Key additions included the integration of smoking-based cognitive restructuring, starting the intervention prior to a quit attempt, and the need for personalisation and tailoring., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Matthews et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background: Mendelian randomisation (MR) is the use of genetic variants as instrumental variables. Mode-based estimators (MBE) are one of the most popular types of estimators used in univariable-MR studies and is often used as a sensitivity analysis for pleiotropy. However, because there are no plurality valid regression estimators, modal estimators for multivariable-MR have been under-explored., Methods: We use the residual framework for multivariable-MR to introduce two multivariable modal estimators: multivariable-MBE, which uses IVW to create residuals fed into a traditional plurality valid estimator, and an estimator which instead has the residuals fed into the contamination mixture method (CM), multivariable-CM. We then use Monte-Carlo simulations to explore the performance of these estimators when compared to existing ones and re-analyse the data used by Grant and Burgess (2021) looking at the causal effect of intelligence, education, and household income on Alzheimer's disease as an applied example., Results: In our simulation, we found that multivariable-MBE was generally too variable to be much use. Multivariable-CM produced more precise estimates on the other hand. Multivariable-CM performed better than MR-Egger in almost all settings, and Weighted Median under balanced pleiotropy. However, it underperformed Weighted Median when there was a moderate amount of directional pleiotropy. Our re-analysis supported the conclusion of Grant and Burgess (2021), that intelligence had a protective effect on Alzheimer's disease, while education, and household income do not have a causal effect., Conclusions: Here we introduced two, non-regression-based, plurality valid estimators for multivariable MR. Of these, "multivariable-CM" which uses IVW to create residuals fed into a contamination-mixture model, performed the best. This estimator uses a plurality of variants valid assumption, and appears to provide precise and unbiased estimates in the presence of balanced pleiotropy and small amounts of directional pleiotropy., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Woolf et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Inflamm-aging refers to the chronic low-grade inflammation that occurs with aging and cellular senescence, and it is linked to various diseases. Understanding the markers involved in inflammation and aging, as well as their interaction with environmental factors and bodily control mechanisms, can provide crucial tools for assessing the resilience (i.e. the ability to adapt and improve) of the human body, particularly in the presence of chronic degenerative conditions or vulnerable life stages, that place the individual and the community to which he belongs in a state of potential fragility. HEBE focuses on physical exercise, along with nutritional and lifestyle recommendations, to reduce systemic inflammation and promote healthy aging. HEBE encompasses multiple research lines (LR). In the ongoing LR1 ("proof of concept"), healthy lifestyle recommendations were provided to University of Milan employees, and changes in quality of life and well-being were assessed using a specialized questionnaire. The first 100 eligible subjects, who expressed their willingness to participate, underwent a personalized physical exercise protocol based on clinical and objective assessments. Biomedical samples were collected at baseline (T0) and follow-up (T1) to establish a shared biobank and identify non-invasive biomarkers that monitor the impact of physical exercise on individual characteristics such as cardiovascular and metabolic health. Subsequently (LR2-LR10), the proof of concept findings will be expanded to include various conditions of vulnerability such as obesity, cancer, endocrine disorders, cardiovascular diseases, infertility, functional syndromes, respiratory disorders, neurodegenerative diseases, and autoimmune conditions. The research lines will leverage the expertise of the 94 participating investigators to form a collaborative network that maximizes the potential for investigation and knowledge exchange. This approach fosters a culture of health promotion and disease prevention. ClinicalTrials.gov Identifier: NCT05815732., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Bianchi et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Objective: To assess the impact of diabetes on physical and mental health status, as well as patient satisfaction, one-year following knee and hip total joint arthroplasty (TJA) for osteoarthritis (OA)., Methods: Participants were 626 hip and 754 knee TJA patients. Pre-surgery data were collected on socio-demographics and health status. The 12-item Short Form Health Survey (SF-12) was collected pre- and one year post-surgery, and physical (PCS) and mental component (MCS) summary scores computed. One-year patient satisfaction was also recorded. Four regression models tested the effect of diabetes on: 1) PCS change score; 2) MCS change score; 3) achieving minimal clinically important improvement (MCII) on PCS; and 4) patient satisfaction ('Somewhat or Very Satisfied' vs. 'Somewhat or Very Dissatisfied'). An interaction between surgical joint and diabetes was tested in each model., Results: Self-reported diabetes prevalence was 13.0% (95% CI: 11.2%-14.7%) and was more common in knee 16.1% (95% CI: 13.4%-18.7%) than hip 9.3% (95% CI: 7.0%-11.5%) patients. In adjusted analyses, change scores were 2.3 units less on the PCS for those with diabetes compared to those without (p = 0.005). Patients with diabetes were about half as likely to achieve MCII as patients without diabetes (p = 0.004). Diabetes was not significantly associated with satisfaction or changes in MCS scores. Diabetes effects did not differ by surgical joint., Conclusions: Findings support that diabetes has a negative impact on improvements in physical health after TJA. Considering the growing prevalence of OA and diabetes in the population, our findings support the importance of perioperative screening and management of diabetes in patients undergoing TJA., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Power et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Screen time, social media, and weight-related bullying are ubiquitous among adolescents. However, little research has been conducted among international samples. Therefore, the aim of this study was to determine the association between screen time, social media use, and weight-related bullying victimization among an international sample of adolescents from six countries. Data from the 2020 International Food Policy Study Youth Survey were analyzed (N = 12,031). Multiple modified Poisson regression models were estimated to determine the associations between weekday hours of five forms of screen time, and total screen time, and use of six contemporary social media platforms and weight-related bullying victimization. Analyses were conducted among the overall sample, and stratified by country (Australia, Canada, Chile, Mexico, United Kingdom, United States). Greater hours of weekday screen time and use of each of the six social media platforms were associated with weight-related bullying victimization among the sample. Each additional hour of social media use was equivalent to a 13% (confidence interval [CI] 1.10-1.16) increase in the prevalence of weight-related bullying victimization. The use of Twitter was associated with a 69% (CI 1.53-1.84) increase in the prevalence of weight-related bullying victimization. Associations between hours of weekday screen time, use of six social media, and weight-related bullying victimization differed by country. Findings underscore the associations between screen time, social media, and weight-related bullying among a sample of adolescents from six medium- and high-income countries. Country-specific and global public health and technology efforts are needed to address this burgeoning social problem., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Ganson et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background: Neonatal jaundice (NNJ) is a major contributor to childhood morbidity and mortality. As many infants are discharged by 24 hours of age, mothers are key in detecting severe forms of jaundice. Mothers with limited knowledge of NNJ have a hard time identifying these infants who could go on to have the worst outcomes. This study aimed to determine the effect of a jaundice education package delivered to mothers prior to hospital discharge on maternal knowledge after discharge., Methods: This was a before and after interventional study involving an education package delivered through a video message and informational voucher. At 10-14 days after discharge, participants were followed up via telephone to assess their post-intervention knowledge. A paired t-test was used to determine the effectiveness of the intervention on knowledge improvement. Linear regression was used to determine predictors of baseline knowledge and of change in knowledge score., Results: Of the 250 mothers recruited, 188 were fit for analysis. The mean knowledge score was 10.02 before and 14.61 after the intervention, a significant difference (p<0.001). Factors determining higher baseline knowledge included attendance of 4 or more antenatal visits (p < 0.001), having heard about NNJ previously (p < 0.001), having experienced an antepartum illness (p = 0.019) and higher maternal age (p = 0.015). Participants with poor baseline knowledge (β = 7.523) and moderate baseline knowledge (β = 3.114) had much more to gain from the intervention relative to those with high baseline knowledge (p < 0.001)., Conclusion: Maternal knowledge of jaundice can be increased using a simple educational intervention, especially in settings where the burden of detection often falls on the mother. Further study is needed to determine the impact of this intervention on care seeking and infant outcomes., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Alinaitwe et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Objective: In osteoarthritis (OA) research, disability is largely studied within the context of activities of daily living. Broader consequences for social participation are often overlooked. In prior work, instrumental supports received and their perceived availability were shown to play a role in the maintenance of social participation. Two indicators of social participation were identified, diversity and intensity. The current study extends the findings from this prior cross-sectional work by examining these relationships longitudinally., Methods: Data are from the baseline and 3-year follow-up questionnaires of the Canadian Longitudinal Study on Aging, a population-based study of people ages 45-85 years at baseline. The sample was restricted to those who at baseline reported a doctor diagnosis of OA (n = 4104). Using structural equation modeling, latent variables were derived at each time point for activity limitations, instrumental supports perceived and received, and social participation diversity and intensity. Longitudinal factorial invariance was assessed. Model covariates included age, sex, education, income, marital status, smoking status, obesity, and number of chronic conditions., Results: For all latent variables, strong factorial longitudinal invariance was found. Activity limitations increased over time. Greater baseline social participation intensity was associated with increases in later intensity and diversity. Increasing activity limitations were associated with decreases in social participation and with increasing receipt of instrumental supports; they were not associated with changes in perceived availability of supports. However, increasing perceived availability was positively associated with social participation intensity., Conclusions: With a goal of increasing social participation, findings suggest a focus on interventions to reduce activity limitations in OA is necessary. Findings additionally highlight an important role for perceived availability of instrumental supports in maintaining or improving social participation in OA, in addition to current social participation, particularly intensity, for future social participation status., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Perruccio et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Introduction: Reversing malnutrition-induced impairment of cognition and emotional regulation is a critical global gap. We hypothesize that brain-targeted micronutrient supplemented nutritional rehabilitation in children with moderate acute malnutrition, followed by 2 years micronutrient supplementation will impact on the cognition and emotion regulation of these children., Methods: The primary outcome of this prospective, randomized controlled trial is to study the development of executive functions (EFs) and emotion regulation (ER) in this cohort. Moderate acute malnourished (MAM; WLZ/WHZ <-2 and ≥-3 z-score, and/or 11.5 cm ≤ MUAC < 12.5cm; n = 140)children aged around one year (11m-13m) in Mirpur, Dhaka, Bangladesh will be randomized (1:1) to receive either locally produced Ready to Use Supplementary Food (RUSF) or Enhanced Ready to Use Supplementary Food (E-RUSF) until anthropometric recovery (WLZ/WHZ > -1SD), or for 3 months after enrollment (whichever is earlier). The randomized MAMs groups will be given either Small Quantity Lipid Based Nutrient Supplement (SQLNS) or Enhanced Small Quantity Lipid Based Nutrient Supplement (E-SQLNS), respectively until the end of the 2-year follow up period. Standard psychosocial stimulation will be provided to the MAMs intervention groups. Biological samples will be collected, anthropometric and neurocognitive assessments will be performed at 2 (22m-26m) and 3 (34m-38m) years of age. Two control groups will be recruited: 1), non-malnourished one-year (11m-13m) old children (WLZ/WHZ score>-1SD; n = 70); and 2) three-year (34m-38m) old children (n = 70) with untreated MAM (WHZ <-2 and ≥-3 z-score, and/or 11.5≤MUAC<12.5 cm). The 3-year-old MAM reference group will be assessed once and provided with 2 months of nutritional rehabilitation support (RUSF Nutriset's Plumpy'Sup™)., Competing Interests: We have read the journal’s policy and the authors of this manuscript have the following competing interests: M. Zeilani is employed by Nutriset, who collaborated and produced the enhanced E-RUSF, SQ-NLS and E-SQLNS feed and supplements. This does not alter our adherence to PLOS ONE policies on sharing data and materials., (Copyright: © 2024 Shama et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Although research has demonstrated that transport infrastructure development can have positive and negative health-related impacts, most of this research has not considered mental health and wellbeing separately from physical health. There is also limited understanding of whether and how any effects might be experienced differently across population groups, whether this differs according to the stage of development (e.g. planning, construction), and how changes to planned infrastructure may affect mental health and wellbeing. This paper presents a protocol for the Wellbeing Impact Study of HS2 (WISH2), which seeks to address these questions using a high-speed rail development in the UK as an applied example. WISH2 is a 10-year, integrated, longitudinal, mixed-methods project using general practices (primary medical care providers in the UK) as an avenue for participant recruitment and for providing a geographically defined population for which aggregated data on mental health indicators are available. The research comprises: (i) a combined longitudinal and repeated cross-sectional cohort study involving multiple waves of survey data collection and data from medical records; (ii) longitudinal, semi-structured interviews and focus groups with residents and community stakeholders from exposed areas; (iii) analysis of administrative data aggregated at the general practice population level; and (iv) health economic analysis of mental health and wellbeing impacts. The study findings will support the development of strategies to reduce negative impacts and/or enhance positive mental health and wellbeing impacts of high-speed rail developments and other large-scale infrastructure projects., Competing Interests: I have read the journal’s policy and the authors of this manuscript have the following competing interests: Roger Mackett is a member of Disabled Persons Transport Advisory Committee which advises the government on the transport needs of disabled people., (Copyright: © 2024 Morley et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background: Colistin serves as the last line of defense against multidrug resistant Gram-negative bacterial infections in both human and veterinary medicine. This study aimed to investigate the occurrence and spread of colistin-resistant Enterobacterales (ColR-E) using a One Health approach in Belgium and in the Netherlands., Methods: In a transnational research project, a total of 998 hospitalized patients, 1430 long-term care facility (LTCF) residents, 947 children attending day care centres, 1597 pigs and 1691 broilers were sampled for the presence of ColR-E in 2017 and 2018, followed by a second round twelve months later for hospitalized patients and animals. Colistin treatment incidence in livestock farms was used to determine the association between colistin use and resistance. Selective cultures and colistin minimum inhibitory concentrations (MIC) were employed to identify ColR-E. A combination of short-read and long-read sequencing was utilized to investigate the molecular characteristics of 562 colistin-resistant isolates. Core genome multi-locus sequence typing (cgMLST) was applied to examine potential transmission events., Results: The presence of ColR-E was observed in all One Health sectors. In Dutch hospitalized patients, ColR-E proportions (11.3 and 11.8% in both measurements) were higher than in Belgian patients (4.4 and 7.9% in both measurements), while the occurrence of ColR-E in Belgian LTCF residents (10.2%) and children in day care centres (17.6%) was higher than in their Dutch counterparts (5.6% and 12.8%, respectively). Colistin use in pig farms was associated with the occurrence of colistin resistance. The percentage of pigs carrying ColR-E was 21.8 and 23.3% in Belgium and 14.6% and 8.9% in the Netherlands during both measurements. The proportion of broilers carrying ColR-E in the Netherlands (5.3 and 1.5%) was higher compared to Belgium (1.5 and 0.7%) in both measurements. mcr-harboring E. coli were detected in 17.4% (31/178) of the screened pigs from 7 Belgian pig farms. Concurrently, four human-related Enterobacter spp. isolates harbored mcr-9.1 and mcr-10 genes. The majority of colistin-resistant isolates (419/473, 88.6% E. coli; 126/166, 75.9% Klebsiella spp.; 50/75, 66.7% Enterobacter spp.) were susceptible to the critically important antibiotics (extended-spectrum cephalosporins, fluoroquinolones, carbapenems and aminoglycosides). Chromosomal colistin resistance mutations have been identified in globally prevalent high-risk clonal lineages, including E. coli ST131 (n = 17) and ST1193 (n = 4). Clonally related isolates were detected in different patients, healthy individuals and livestock animals of the same site suggesting local transmission. Clonal clustering of E. coli ST10 and K. pneumoniae ST45 was identified in different sites from both countries suggesting that these clones have the potential to spread colistin resistance through the human population or were acquired by exposure to a common (food) source. In pig farms, the continuous circulation of related isolates was observed over time. Inter-host transmission between humans and livestock animals was not detected., Conclusions: The findings of this study contribute to a broader understanding of ColR-E prevalence and the possible pathways of transmission, offering insights valuable to both academic research and public health policy development., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 De Koster et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background: Two accepted designs exist for parallel-group cluster-randomised trials (CRTs). Closed-cohort designs follow the same individuals over time with a single recruitment period before randomisation, but face challenges in settings with high attrition. (Repeated) cross-sectional designs recruit at one or more timepoints before and/or after randomisation, collecting data from different individuals present in the cluster at these timepoints, but are unsuitable for assessment of individual change over time. An 'open-cohort' design allows individual follow-up with recruitment before and after cluster-randomisation, but little literature exists on acceptability to inform their use in CRTs., Aim: To document the views and experiences of expert trialists to identify: a) Design and conduct challenges with established parallel-group CRT designs,b) Perceptions of potential benefits and barriers to implementation of open-cohort CRTs,c) Methods for minimising, and investigating the impact of, bias in open-cohort CRTs., Methods: Qualitative consultation via two expert workshops including triallists (n = 24) who had worked on CRTs over a range of settings. Workshop transcripts were analysed using Descriptive Thematic Analysis utilising inductive and deductive coding., Results: Two central organising concepts were developed. Design and conduct challenges with established CRT designs confirmed that current CRT designs are unable to deal with many of the complex research and intervention circumstances found in some trial settings (e.g. care homes). Perceptions of potential benefits and barriers of open cohort designs included themes on: approaches to recruitment; data collection; analysis; minimising/investigating the impact of bias; and how open-cohort designs might address or present CRT design challenges. Open-cohort designs were felt to provide a solution for some of the challenges current CRT designs present in some settings., Conclusions: Open-cohort CRT designs hold promise for addressing the challenges associated with standard CRT designs. Research is needed to provide clarity around definition and guidance on application., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Surr et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background: Quantifying movement behaviours over 24-hours enables the combined effects of and inter-relations between sleep, sedentary time and physical activity (PA) to be understood. This is the first study describing 24-hour movement behaviours in school-aged children and adolescents in South-East Asia. Further aims were to investigate between-participant differences in movement behaviours by demographic characteristics and timing of data collection during Ramadan and COVID-19 restrictions., Methods: Data came from the South-East Asia Community Observatory health surveillance cohort, 2021-2022. Children aged 7-18 years within selected households in Segamat, Malaysia wore an Axivity AX6 accelerometer on their wrist for 24 hours/day over 7 days, completed the PAQ-C questionnaire, and demographic information was obtained. Accelerometer data was processed using GGIR to determine time spent asleep, inactive, in light-intensity PA (LPA) and moderate-to-vigorous PA (MVPA). Differences in accelerometer-measured PA by demographic characteristics (sex, age, ethnicity, socioeconomic group) were explored using univariate linear regression. Differences between data collected during vs outside Ramadan or during vs after COVID-19 restrictions, were investigated through univariate and multiple linear regressions, adjusted for age, sex and ethnicity., Results: The 491 participants providing accelerometer data spent 8.2 (95% confidence interval (CI) = 7.9-8.4) hours/day asleep, 12.4 (95% CI = 12.2-12.7) hours/day inactive, 2.8 (95% CI = 2.7-2.9) hours/day in LPA, and 33.0 (95% CI = 31.0-35.1) minutes/day in MVPA. Greater PA and less time inactive were observed in boys vs girls, children vs adolescents, Indian and Chinese vs Malay children and higher income vs lower income households. Data collection during Ramadan or during COVID-19 restrictions were not associated with MVPA engagement after adjustment for demographic characteristics., Conclusions: Demographic characteristics remained the strongest correlates of accelerometer-measured 24-hour movement behaviours in Malaysian children and adolescents. Future studies should seek to understand why predominantly girls, adolescents and children from Malay ethnicities have particularly low movement behaviours within Malaysia., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Brady et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Objective: This study aims to test the association of rest-activity rhythm (intradaily variability and interdaily stability) with all-cause mortality in an older adult cohort in Brazil. It also assesses whether the amount of time spent at each intensity level (i.e., physical activity and nocturnal sleep) interferes with this association., Methods: This cohort study started in 2014 with older adults (≥60 years). We investigated deaths from all causes that occurred until April 2017. Rest-activity rhythm variables were obtained using accelerometry at baseline. Intradaily variability indicates higher rhythm fragmentation, while interdaily stability indicates higher rhythm stability. Cox proportional-hazard models were used to test the associations controlling for confounders., Results: Among the 1451 older adults interviewed in 2014, 965 presented valid accelerometry data. During the follow-up period, 80 individuals died. After adjusting the analysis for sociodemographic, smoking, morbidity score, and number of medicines, an increase of one standard deviation in interdaily stability decreased 26% the risk of death. The adjustment for total sleep time and inactivity did not change this association. On the other hand, the association was no longer significant after adjusting for overall physical activity and moderate to vigorous physical activity., Conclusion: Rest-activity rhythm pattern was not associated with mortality when physical activity was considered, possibly because this pattern could be driven by regular exercise. Promoting physical activity remains a relevant strategy to improve population health., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Wendt et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background: Globally, tuberculosis (TB) remains a significant cause of morbidity and mortality having caused 1.6 million deaths in 2021. Uganda is a high TB burden country with a large private sector that serves close to 60% of the urban population. However, private for-profit health facilities' involvement with the National TB and Leprosy Program (NTLP) activities remains poor. This study evaluated the practices of diagnosis and treatment of pulmonary tuberculosis (PTB) and associated factors among practitioners in private for-profit (PFP) healthcare facilities in Kampala, Uganda., Methods: We conducted a cross-sectional study among randomly selected private practitioners in Uganda's largest city, Kampala. A structured questionnaire was used for data collection. Descriptive statistics and generalized linear models with log Poisson link were used to analyze data. Practices were graded as standard or substandard., Results: Of the 630 private practitioners studied, 46.2% (95% confidence interval (CI): 26.6 to 67.1) had overall standard practices. Being a laboratory technician (prevalence ratio (PR) = 2.7, p< 0.001) or doctor (PR = 1.2, p< 0.001), a bachelor's degree level of qualification (PR = 1.1, p = 0.021), quarterly supervision by the national TB program (PR = 1.3, p = 0.023), and acceptable knowledge of the practitioner about TB (PR = 1.8, p<0.001) were significantly associated with standard practices., Conclusions: The practices of TB management for practitioners from the PFP facilities in Kampala are suboptimal and this poses a challenge for the fight against TB given that these practitioners are a major source of primary health care in the city., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Ssemasaazi et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Since December 2019, the World Health Organization (WHO) has encouraged National Tuberculosis Programs to deprioritize the use of injectable-containing regimens and roll-out all-oral bedaquiline-containing regimens for rifampicin-resistant tuberculosis (RR-TB) treatment. Consequently, Iraq gradually replaced the injectable-containing regimen with an all-oral regimen, including bedaquiline. To assess treatment enrolment and outcomes of both regimens during a transitioning phase in Iraq, where health system services are recovering from decades of war, we conducted a nationwide retrospective cohort study using routinely collected programmatic data for patients enrolled between 2019-2021. We describe treatment enrolment and use logistic regression to identify predictors of unfavorable treatment outcomes (failure, death, or lost to follow-up), including regimen type. Nationwide, a total of 301 RR-TB patients started treatment, of whom 167 concluded treatment. The proportion of patients enrolled on the all-oral regimen increased from 53.2% (50/94) in 2020, to 75.5% (80/106) in 2021. Successful treatment was achieved in 82.1% (32/39) and 63.3% (81/128), for all-oral and injectable-containing regimens respectively. Moreover, the proportion of lost to follow-up was lower among those treated with the all-oral versus the long injectable-containing regimen; respectively 2.6% (1/39) versus 17.9% (23/128: p = 0.02). Unfavorable treatment outcome was associated with male gender (aOR 2.12, 95%CI:1.02-4.43) and age <15 years (vs 30-49 years, aOR 5.80, 95%CI:1.30-25.86). Regimen type (aOR 2.37, 95%CI: 0.91-6.13) was not significantly associated with having an unfavorable treatment outcome. In Iraq, the use of bedaquiline-containing all-oral regimen resulted in a high treatment success and reduced lost to follow-up., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Tesfahun et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background: Poor mental health is associated with obesity, but existing studies are either cross-sectional or have long time periods between measurements of mental health and weight. It is, therefore, unclear how small fluctuations in mental wellbeing within individuals predict bodyweight over short time periods, e.g. within the next month. Studying this could identify modifiable determinants of weight changes and highlight opportunities for early intervention., Methods: 2,133 UK adults from a population-based cohort completed monthly mental health and weight measurements using a mobile app over a period of 6-9 months. We used random intercept regression models to examine longitudinal associations of depressive symptoms, anxiety symptoms and stress with subsequent weight. In sub-group analyses, we included interaction terms of mental health variables with baseline characteristics. Mental health variables were split into "between-individual" measurements (= the participant's median score across all timepoints) and "within-individual" measurements (at each timepoint, the difference between the participant's current score and their median)., Results: Within-individual variation in depressive symptoms predicted subsequent weight (0.045kg per unit of depressive symptom severity, 95% CI 0.021-0.069). We found evidence of a moderation effect of baseline BMI on the association between within-individual fluctuation in depressive symptoms and subsequent weight: The association was only apparent in those with overweight/obesity, and it was stronger in those with obesity than those with overweight (BMI<25kg/m2: 0.011kg per unit of depressive symptom severity [95% CI -0.017 to 0.039]; BMI 25-29.9kg/m2: 0.052kg per unit of depressive symptom severity [95%CI 0.010-0.094kg]; BMI≥30kg/m2: 0.071kg per unit of depressive symptom severity [95%CI 0.013-0.129kg]). We found no evidence for other interactions, associations of stress and anxiety with weight, or for a reverse direction of association., Conclusion: In this exploratory study, individuals with overweight or obesity were more vulnerable to weight gain following higher-than-usual (for that individual) depressive symptoms than individuals with a BMI<25kg/m2., Competing Interests: JM is a trustee for the Association for the Study of Obesity (unpaid role). GMK receives royalties from Cambridge University Press (Editor of Textbook of Immunopsychiatry). ALA is the chief investigator on two publicly funded (MRC, NIHR) trials where the intervention is provided by WW (formerly Weight Watchers) at no cost outside the submitted work. ALA is on the Scientific Advisory Board for WW (payment to institution). The views expressed are those of the author(s) and not necessarily those of the NIHR, MRC or other funders. Huma Therapeutics Ltd. developed, validated and tested the app at no charge. This does not alter our adherence to PLOS ONE policies on sharing data and materials., (Copyright: © 2024 Mueller et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background: Blood pressure, grip strength and lung function are frequently assessed in longitudinal population studies, but the measurement devices used differ between studies and within studies over time. We aimed to compare measurements ascertained from different commonly used devices., Methods: We used a randomised cross-over study. Participants were 118 men and women aged 45-74 years whose blood pressure, grip strength and lung function were assessed using two sphygmomanometers (Omron 705-CP and Omron HEM-907), four handheld dynamometers (Jamar Hydraulic, Jamar Plus+ Digital, Nottingham Electronic and Smedley) and two spirometers (Micro Medical Plus turbine and ndd Easy on-PC ultrasonic flow-sensor) with multiple measurements taken on each device. Mean differences between pairs of devices were estimated along with limits of agreement from Bland-Altman plots. Sensitivity analyses were carried out using alternative exclusion criteria and summary measures, and using multilevel models to estimate mean differences., Results: The mean difference between sphygmomanometers was 3.9mmHg for systolic blood pressure (95% Confidence Interval (CI):2.5,5.2) and 1.4mmHg for diastolic blood pressure (95% CI:0.3,2.4), with the Omron HEM-907 measuring higher. For maximum grip strength, the mean difference when either one of the electronic dynamometers was compared with either the hydraulic or spring-gauge device was 4-5kg, with the electronic devices measuring higher. The differences were small when comparing the two electronic devices (difference = 0.3kg, 95% CI:-0.9,1.4), and when comparing the hydraulic and spring-gauge devices (difference = 0.2kg, 95% CI:-0.8,1.3). In all cases limits of agreement were wide. The mean difference in FEV1 between spirometers was close to zero (95% CI:-0.03,0.03), limits of agreement were reasonably narrow, but a difference of 0.47l was observed for FVC (95% CI:0.53,0.42), with the ndd Easy on-PC measuring higher., Conclusion: Our study highlights potentially important differences in measurement of key functions when different devices are used. These differences need to be considered when interpreting results from modelling intra-individual changes in function and when carrying out cross-study comparisons, and sensitivity analyses using correction factors may be helpful., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2023 Lessof et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background and Aims: This paper assesses the impact of estimation methods for general and education-specific trends in alcohol-attributable mortality (AAM), and develops an alternative method that can be used when the data available for study is limited., Methods: We calculated yearly adult (30+) age-standardised and age-specific AAM rates by sex for the general population and by educational level (low, middle, high) in Finland and Turin (Italy) from 1972 to 2017. Furthermore the slope index of inequality and relative inequality index were computed by country and sex. We compared trends, levels, age distributions, and educational inequalities in AAM according to three existing estimation methods: (1) Underlying COD (UCOD), (2) Multiple COD (MCOD) method, and (3) the population attributable fractions (PAF)-method. An alternative method is developed based on the pros and cons of these methods and the outcomes of the comparison., Results: The UCOD and MCOD approaches revealed mainly increasing trends in AAM compared to the declining trends according to the PAF approach. These differences are more pronounced when examining AAM trends by educational groups, particularly for Finnish men. Until age 65, age patterns are similar for all methods, and levels nearly identical for MCOD and PAF in Finland. Our novel method assumes a similar trend and age pattern as observed in UCOD, but adjusts its level upwards so that it matches the level of the PAF approach for ages 30-64. Our new method yields levels in-between UCOD and PAF for Turin (Italy), and resembles the MCOD rates in Finland for females. Relative inequalities deviate for the PAF-method (lower levels) compared to other methods, whereas absolute inequalities are generally lower for UCOD than all three methods that combine wholly and partly AAM., Conclusions: The choice of method to estimate AAM affects not only levels, but also general and education-specific trends and inequalities. Our newly developed method constitutes a better alternative for multiple-country studies by educational level than the currently used UCOD-method when the data available for study is limited to underlying causes of death., Competing Interests: The authors have declared that they have no competing interests., (Copyright: © 2023 Van Hemelrijck et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

To investigate the association between biochemical and blood parameters collected before the pandemic in a large cohort of Italian blood donors with the risk of infection and severe disease. We also focused on the differences between the pre- and post-Omicron spread in Italy (i.e., pre- and post-January 01, 2022) on the observed associations. We conducted an observational cohort study on 13750 blood donors was conducted using data archived up to 5 years before the pandemic. A t-test or chi-squared test was used to compare differences between groups. Hazard ratios with 95% confidence intervals for SARS-CoV-2 infection and severe disease were estimated using Cox proportional hazards models. Subgroup analyses stratified by sex, age and epidemic phase of first infection (pre- and post-Omicron spread) were examined. We confirmed a protective effect of groups B and O, while groups A and AB had a higher likelihood of infection and severe disease. However, these associations were only significant in the pre-Omicron period. We found an opposite behavior after Omicron spread, with the O phenotype having a higher probability of infection. When stratified by variant, A antigen appeared to protect against Omicron infection, whereas it was associated with an increased risk of infection by earlier variants. We were able to stratify for the SARS CoV-2 dominant variant, which revealed a causal association between blood group and probability of infection, as evidenced by the strong effect modification observed between the pre- and post-Omicron spread. The mechanism by which group A acts on the probability of infection should consider this strong effect modification., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2023 Marraccini et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Introduction: The practice of creating large databases has become increasingly common by combining research participants' data into larger repositories. Funders now require that data sharing be considered in newly funded research project, unless there are justifiable reasons not to do so. Access to genomic data brings along a host of ethical concerns as well as fairness and equity in the conduct of collaborative research between researchers from high- income and low-and middle-income countries., Materials and Methods: This systematic review protocol will be developed in line with PRISMA -guidelines which refers to Open Science Framework, registered in PROSPERO (https://www.crd.york.ac.uk/prospero/) record CRD42022297984 and published in a peer reviewed journal. Data sources will include PubMed, google scholar, EMBASE, Web of science and MEDLINE. Both published and grey literature will be searched. Subject matter experts including bioethicists, principal investigators of genomic research projects and research administrators will be contacted. After de-duplication, titles and abstracts will be screened for eligibility. Data extraction will be undertaken using a piloted form designed in EPPI-Reviewer software before conducting risk of bias assessments by a pair of reviewers, acting independently. Any discrepancies will be resolved by consensus. Analysis will be done using a structured narrative synthesis and where feasible metanalysis. This review will attempt to highlight the context of data sharing practices in the global North-South and South-South collaborative human genomic research in low- and middle-income countries. This review will enhance the body of evidence on ethical, legal and social implications of data sharing in international collaborative genomic research setting criteria for data sharing. The full report will be shared with relevant stakeholders including universities, civil society, funders, and departments of genomic research to ensure an adequate reach in low-and middle-income countries (LMICs)., Competing Interests: The authors have declared that no competing interest exists., (Copyright: © 2023 Ekusai-Sebatta et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background: Few studies have compared breastfeeding rates before and during the pandemic using comparable data across time. We used data from two national maternity surveys (NMS) to compare breastfeeding rates in England before and during the pandemic., Methods: Analysis was conducted using the NMS from 2018 (pre-pandemic; n = 4,509) and 2020 (during the pandemic; n = 4,611). The prevalence of breastfeeding initiation, and 'any' breastfeeding and exclusive breastfeeding (EBF) at 6 weeks and 6 months were compared between these surveys. Data were interpreted in the context of underlying trends in these prevalences from previous NMS (from 2010 and 2014), and annual routine data for England (from 2009-10 to 2020-21). Modified Poisson regression was used to estimate adjusted risk ratios (aRR) for the effect of birth during the pandemic (2020 versus 2018) on breastfeeding, with adjustment for sociodemographic and birth-related factors., Results: Breastfeeding initiation and any breastfeeding at 6 weeks remained relatively constant in the NMS and the routine data. Birth during the pandemic was associated with a 3 percentage point decrease in EBF at 6 weeks in the NMS (aRR 0.92, 95%CI: 0.87, 0.98 for pandemic versus pre-pandemic), but a smaller decrease in the routine data. Birth during the pandemic was associated with a 3 percentage point increase in any breastfeeding at 6 months in the NMS (aRR 1.05, 95%CI: 1.00, 1.10). Breastfeeding varied across different groups of women in the NMS (i.e. marked inequalities), but the small changes observed between the pandemic and pre-pandemic NMS were broadly similar across the sociodemographic and birth-related factors examined (i.e. no change in inequalities)., Conclusion: Breastfeeding initiation and any breastfeeding at 6 weeks in England were unaffected by the pandemic, and the persistent inequalities in breastfeeding did not widen. Services should aim to reduce these inequalities in breastfeeding which have been documented since the 1970s., Competing Interests: IL chairs the Hospital Infant Feeding Network, a knowledge sharing and advocacy organisation. IL is a trustee for a local breastfeeding support charity. The other authors have declared that they have no competing interests. This does not alter our adherence to PLOS ONE policies on sharing data and materials., (Copyright: © 2023 Quigley et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Objectives: To estimate the incidence of, and investigate risk factors for, postpartum haemorrhage (PPH) requiring transfer to obstetric care following birth in midwifery units (MU) in the UK; to describe outcomes for women who experience PPH requiring transfer to obstetric care., Methods: We conducted a national population-based case-control study in all MUs in the UK using the UK Midwifery Study System (UKMidSS). Between September 2019 and February 2020, 1501 women with PPH requiring transfer to obstetric care following birth in an MU, and 1475 control women were identified. We used multivariable logistic regression, generating adjusted odds ratios (aORs) and 95% confidence intervals (CIs) to investigate risk factors for PPH requiring transfer to obstetric care., Results: The incidence of PPH requiring transfer to obstetric care following birth in an MU was 3.7% (95% CI 3.6%-3.9%). Factors independently associated with PPH requiring transfer to obstetric care were smoking during pregnancy (aOR = 0.73; 95% CI 0.56-0.94), nulliparity (aOR = 1.96; 95% CI 1.66-2.30), previous PPH (aOR = 2.67; 95% CI 1.67-4.25), complications in a previous pregnancy other than PPH (aOR = 2.40; 95% CI 1.25-4.60), gestational age ≥41 weeks (aOR = 1.36; 95% CI 1.10-1.69), instrumental birth (aOR = 2.69; 95% CI 1.53-4.72), third stage of labour ≥60 minutes (aOR = 5.56; 95% CI 3.93-7.88), perineal trauma (aOR = 4.67; 95% CI 3.16-6.90), and birthweight 3500-3999g (aOR = 1.71; 95% CI 1.42-2.07) or ≥4000g (aOR = 2.31; 95% CI 1.78-3.00). One in ten (10.6%) cases received a blood transfusion and one in five (21.0%) were admitted to higher level care., Conclusions: The risk factors identified in this study align with those identified in previous research and with current guidelines for women planning birth in an MU in the UK. Maternal outcomes after PPH were broadly reassuring and indicative of appropriate management. NHS organisations should ensure that robust guidelines are in place to support management of PPH in MUs., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2023 Elkington et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Objective: To provide quantitative evidence for systematically prioritising individuals for full formal cardiovascular disease (CVD) risk assessment using primary care records with a novel tool (eHEART) with age- and sex- specific risk thresholds., Methods and Analysis: eHEART was derived using landmark Cox models for incident CVD with repeated measures of conventional CVD risk predictors in 1,642,498 individuals from the Clinical Practice Research Datalink. Using 119,137 individuals from UK Biobank, we modelled the implications of initiating guideline-recommended statin therapy using eHEART with age- and sex-specific prioritisation thresholds corresponding to 5% false negative rates to prioritise adults aged 40-69 years in a population in England for invitation to a formal CVD risk assessment., Results: Formal CVD risk assessment on all adults would identify 76% and 49% of future CVD events amongst men and women respectively, and 93 (95% CI: 90, 95) men and 279 (95% CI: 259, 297) women would need to be screened (NNS) to prevent one CVD event. In contrast, if eHEART was first used to prioritise individuals for formal CVD risk assessment, we would identify 73% and 47% of future events amongst men and women respectively, and a NNS of 75 (95% CI: 72, 77) men and 162 (95% CI: 150, 172) women. Replacing the age- and sex-specific prioritisation thresholds with a 10% threshold identify around 10% less events., Conclusions: The use of prioritisation tools with age- and sex-specific thresholds could lead to more efficient CVD assessment programmes with only small reductions in effectiveness at preventing new CVD events., Competing Interests: During the drafting of the manuscript, M.A. became an employee of AstraZeneca. This does not alter our adherence to PLOS ONE policies on sharing data and materials., (Copyright: © 2023 Chung et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

The term Headache Disorders (HD) refers to a number of nervous system pathologies characterised by recurrent headaches. Despite the serious impact HD have on the health system, society, and the economy, these are an underestimated, underdiagnosed, and, hence, undertreated phenomenon. Triptans are the first-line therapy for the acute treatment of moderate to severe migraine but their utilization is still inadequate, perhaps also because in Italy no triptan can be bought without a medical prescription. In this article, the data from a 2016-2017 study has been further analysed with the aim of evaluating any associations between the use of triptans and the other series of variables identified in the questionnaire. This further analysis has been connected to the role that community pharmacies could play on this issue. The questionnaire was administered to 4,424 pharmacy users by 610 purposely trained pharmacists working in 514 pharmacies. The survey was carried out in 19 of the 20 Italian regions. The data shows that only 25% of patients suffering from HDs are prescribed triptans. Older patients, those with definite migraines, and those with a chronic disorder resort more frequently to this class of pharmaceuticals, as do those patients in care at a specialist headache centre. The multivariable analysis also confirmed these results. Our study, which performed a direct detection, in real life, on patients requesting pharmacological treatment for a migraine headache, therefore confirmed the need to investigate the reasons behind the low use and prescription of triptans in the Italian population. Moreover, any future studies should take advantage of community pharmacies, plan actions that would allow a series of evaluations over time of the requirements of migraineurs, and establish a process to put these patients under the care of the pharmacy to ensure adherence to therapy., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2023 Baratta et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Biochemical remission of type 2 diabetes is achievable through dietary changes, physical activity and subsequent weight loss. We aim to identify distinct diabetes remission trajectories in a large population-based cohort over seven-years follow-up and to examine associations between remission trajectories and diabetes complications. Group-based trajectory modelling examined longitudinal patterns of HbA1c level (adjusting for remission status) over time. Multivariable Cox models quantified the association between each remission trajectory and microvascular complications, macrovascular complications, cardiovascular (CVD) events and all-cause mortality. Four groups were assigned. Group 1 (8,112 [13.5%]; achieving HbA1c <48 mmol/mol (6.5%) followed by increasing HbA1c levels); Group 2 (6,369 [10.6%]; decreasing HbA1c levels >48 mmol/mol (6.5%)); Group 3 (36,557 [60.6%]; stable high HbA1c levels); Group 4 (9,249 [15.3%]; stable low HbA1c levels (<48mmol/mol or <6.5%)). Compared to Group 3, Groups 1 and 4 had lower risk of microvascular complications (aHRs (95% CI): 0.65 (0.61-0.70), p-value <0.001;0.59 (0.55-0.64) p-value<0.001, respectively)), macrovascular complications (aHRs (95% CI): 0.83 (0.75-0.92), p-value<0.001; 0.66 (0.61-0.71), p-value<0.001) and CVD events (aHRs (95% CI): 0.74(0.67-0.83), p-value<0.001; 0.67(0.61-0.73), p-vlaue<0.001). Risk of CVD outcomes were similar for Groups 2 and 3. Compared to Group 3, Group 1 (aHR: 0.82(95% CI: 0.76-0.89)) had lower risk of mortality, but Group 4 had higher risk of mortality (aHR: 1.11(95% CI: 1.03-1.19)). Risk of CVD outcomes vary by pattern of remission over time, with lowest risk for those in remission longer. People who achieve remission, even for shorter periods of time, continue to benefit from this lower exposure to hyperglycaemia, which may, in turn, lower the risk of CVD outcomes including mortality., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2023 Dambha-Miller et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Soon after the beginning of the COVID-19 pandemic in early 2020, the Betacoronavirus SARS-CoV-2 infection of several mink farms breeding American minks (Neovison vison) for fur was detected in various European countries. The risk of a new reservoir being formed and of a reverse zoonosis from minks quickly became a major concern. The aim of this study was to investigate the four French mink farms to see whether SARS-CoV-2 was circulating there in late 2020. The investigations took place during the slaughtering period, thus facilitating different types of sampling (swabs and blood). On one of the four mink farms, 96.6% of serum samples were positive when tested with a SARS-CoV-2 ELISA coated with purified N protein recombinant antigen, and 54 out of 162 (33%) pharyngo-tracheal swabs were positive by RT-qPCR. The genetic variability among 12 SARS-CoV-2 genomes sequenced from this farm indicated the co-circulation of several lineages at the time of sampling. All the SARS-CoV-2 genomes detected were nested within the 20A clade (Nextclade), together with SARS-CoV-2 genomes from humans sampled during the same period. The percentage of SARS-CoV-2 seropositivity by ELISA varied between 0.3 and 1.1% on the other three farms. Interestingly, among these three farms, 11 pharyngo-tracheal swabs and 3 fecal pools from two farms were positive by end-point RT-PCR for an Alphacoronavirus very similar to a mink coronavirus sequence observed on Danish farms in 2015. In addition, a mink Caliciviridae was identified on one of the two farms positive for Alphacoronavirus. The clinical impact of these inapparent viral infections is not known. The co-infection of SARS-CoV-2 with other viruses on mink farms could help explain the diversity of clinical symptoms noted on different infected farms in Europe. In addition, the co-circulation of an Alphacoronavirus and SARS-CoV-2 on a mink farm would potentially increase the risk of viral recombination between alpha and betacoronaviruses as already suggested in wild and domestic animals, as well as in humans., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2023 Wasniewski et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background & Aims: Studies have determined that people with genetically defined lactase non-persistence have lower dairy intake that may lead to an increase risk of various non-communicable diseases. Furthermore, lactase non-persistence itself has been associated with insulin resistance. However, data on lactase non-persistence status and dairy intake in developing countries are sparse. We therefore aimed to define 1) the prevalence of lactase non-persistence among individuals with diabetes and non-diabetes in Thai population and 2) the links between lactase non-persistence, milk consumption, and risk of diabetes mellitus., Methods: We conducted a case-control study from participants of the National Health Examination Survey. DNA was isolated from the blood for LCT -13910C>T (rs4988235) polymorphism and processed using the Bio-rad c1000 touch thermal cycler and MALDI-TOF Mass Spectrometry MassARRAY Typer v4.0 (Agena Bioscience, San Diego, CA, USA) at the Center for Medical Genomics, Faculty of Medicine Ramathibodi Hospital. Cases were participants with previously diagnosed diabetes mellitus or fasting plasma glucose ≥126 mg/dL (n = 1,756) vs. the controls (n = 2,380)., Results: We included 4,136 participants, 62% female, and 98.8% were > 30 years old. Homozygous CC genotype (i.e., lactase non-persistence) was noted in 98.6% and only 1.4% carried heterozygous CT. Most (76%) consumed milk <1 portion/month. Participants with either CC or CT genotype had comparable milk consumption and the risk of diabetes mellitus. Males, older adults, and lower education had a lower chance of consuming milk at least one portion per month. Besides various baseline variables, we found that higher milk consumption was associated with a lower DM risk (P = .01)., Conclusion: The prevalence of lactase non-persistence in Thai population is very high. A significant difference in milk consumption frequency in relation to the lactase non-persistence status was not found. However, higher milk consumption is associated with a lower risk of diabetes mellitus., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2023 Tanpowpong et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

School-based physical activity interventions are considered ideal given their potential to reach most children. They can help children achieve the recommended guidelines of 60 minutes of moderate-to-vigorous physical activity per day. The Daily Mile is a popular school-based active mile intervention with a global reach. It recommends ten core principles for successful implementation, three of which are key for effectiveness: that it is quick (15 minutes), the whole school participates, and that it takes place in the school day during lessons (excluding physical education lessons and scheduled breaks). Studies assessing the impacts of The Daily Mile do not often report implementation of the ten core principles which is crucial to identifying the potential impact and feasibility of scalable interventions in real-world settings. Our aim was to assess adherence to The Daily Mile's ten core principles in Greater London primary schools. We created and distributed a survey to 1717 primary schools during September 2020 and achieved a 21% (n = 369/1717) response rate by September 2021. Our sample was representative of Greater London primary schools with responses from every London borough. A total of 196/369 (53%) schools reported implementing The Daily Mile but none of them reported adherence to all ten core principles. Adherence to at least 6/10 principles in various combinations was reported by 54/196 (28%) schools. Only 19/196 (10%) schools that reported implementing The Daily Mile reported adherence to the three key principles recommended for effectiveness. Despite its popularity and global reach, our findings suggest that an implementation gap exists when The Daily Mile is adopted in real-world settings which is likely to challenge its intended purpose. Further research in school settings is needed to understand factors that can improve adherence to increase the potential public health impact of The Daily Mile and other similar interventions., Competing Interests: SS and BR received funding from The Daily Mile Foundation. All other authors declare no competing interests., (Copyright: © 2023 Ram et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Importance: The mechanisms underlying the association between chronic stress and higher mortality among individuals with cancer remain incompletely understood., Objective: To test the hypotheses that among individuals with active head and neck cancer, that higher stress-associated neural activity (ie. metabolic amygdalar activity [AmygA]) at cancer staging associates with survival., Design: Retrospective cohort study., Setting: Academic Medical Center (Massachusetts General Hospital, Boston)., Participants: 240 patients with head and neck cancer (HNCA) who underwent 18F-FDG-PET/CT imaging as part of initial cancer staging., Measurements: 18F-FDG uptake in the amygdala was determined by placing circular regions of interest in the right and left amygdalae and measuring the mean tracer accumulation (i.e., standardized uptake value [SUV]) in each region of interest. Amygdalar uptake was corrected for background cerebral activity (mean temporal lobe SUV)., Results: Among individuals with HNCA (age 59±13 years; 30% female), 67 died over a median follow-up period of 3 years (IQR: 1.7-5.1). AmygA associated with heightened bone marrow activity, leukocytosis, and C-reactive protein (P<0.05 each). In adjusted and unadjusted analyses, AmygA associated with subsequent mortality (HR [95% CI]: 1.35, [1.07-1.70], P = 0.009); the association persisted in stratified subset analyses restricted to patients with advanced cancer stage (P<0.001). Individuals within the highest tertile of AmygA experienced a 2-fold higher mortality rate compared to others (P = 0.01). The median progression-free survival was 25 months in patients with higher AmygA (upper tertile) as compared with 36.5 months in other individuals (HR for progression or death [95%CI], 1.83 [1.24-2.68], P = 0.001)., Conclusions and Relevance: AmygA, quantified on routine 18F-FDG-PET/CT images obtained at cancer staging, independently and robustly predicts mortality and cancer progression among patients with HNCA. Future studies should test whether strategies that attenuate AmygA (or its downstream biological consequences) may improve cancer survival., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2023 Hassan et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

The Eating Disorders In weight-related Therapy (EDIT) Collaboration brings together data from randomised controlled trials of behavioural weight management interventions to identify individual participant risk factors and intervention strategies that contribute to eating disorder risk. We present a protocol for a systematic review and individual participant data (IPD) meta-analysis which aims to identify participants at risk of developing eating disorders, or related symptoms, during or after weight management interventions conducted in adolescents or adults with overweight or obesity. We systematically searched four databases up to March 2022 and clinical trials registries to May 2022 to identify randomised controlled trials of weight management interventions conducted in adolescents or adults with overweight or obesity that measured eating disorder risk at pre- and post-intervention or follow-up. Authors from eligible trials have been invited to share their deidentified IPD. Two IPD meta-analyses will be conducted. The first IPD meta-analysis aims to examine participant level factors associated with a change in eating disorder scores during and following a weight management intervention. To do this we will examine baseline variables that predict change in eating disorder risk within intervention arms. The second IPD meta-analysis aims to assess whether there are participant level factors that predict whether participation in an intervention is more or less likely than no intervention to lead to a change in eating disorder risk. To do this, we will examine if there are differences in predictors of eating disorder risk between intervention and no-treatment control arms. The primary outcome will be a standardised mean difference in global eating disorder score from baseline to immediately post-intervention and at 6- and 12- months follow-up. Identifying participant level risk factors predicting eating disorder risk will inform screening and monitoring protocols to allow early identification and intervention for those at risk., Competing Interests: I have read the journal’s policy and the authors of this manuscript have the following competing interests: AS owns 50% of the shares in Zuman International, which receives royalties for books AS has written and payments for presentations. AS additionally reports receiving presentation fees and travel reimbursements from Eli Lilly and Co, the Pharmacy Guild of Australia, Novo Nordisk, the Dietitians Association of Australia, Shoalhaven Family Medical Centres, the Pharmaceutical Society of Australia, and Metagenics, and serving on the Nestlé Health Science Optifast VLCD advisory board from 2016 to 2018. ALA is Principal Investigator on two publicly funded trials where the intervention is provided by WW (formerly Weight Watchers) at no cost. KS has received in kind support as meals from ‘Lite and Easy’ for a clinical trial of weight stigma in young women in the last 5 years. ER has previously received research funding from Unilever and the American Beverage Association for unrelated work. JAY reports unrelated grant funds to NICHD supporting his research from Soleno Therapeutics, Rhythm Pharmaceuticals, and Hikma Pharmaceuticals. HFS has previously received a salary from Novo Nordisk unrelated to the present work. YSD has previously received a salary from Novo Nordisk unrelated to the present work. HAR has received funding from the National Institutes of Health in the area of adult and pediatric weight management. HAR is a committee member for the evidence-based practice guidelines for pediatric weight management for the American Psychological Association and for the Evidence Analysis Library for the Academy of Nutrition and Dietetics for the topic of adult weight management and the prevention of type 2 diabetes. MIC is an employee and shareholder at WW International, Inc. TKK has received professional fees from Novo Nordisk, Nutrisystem, Gelesis and Johnson & Johnson. CKM has received research grants and research agreements from Commission on Dietetic Registration, Academy of Nutrition and Dietetics, Ohio State University (InFACT), Novartis, University of Michigan’s Michigan Institute for Clinical and Health Research, Elizabeth Blackwell Institute for Health Research, Egg Board, PCORI, Department of Defense, Access Business Group International LLC, IDEA Public Schools, Louisiana LIFT Fund, WW, Pack Health, American Society for Nutrition, RAND Corporation, Richard King Mellon Foundation (RKMF), The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc., Evidation Health, Leona M. and Harry B. Helmsley Charitable Trust, State of Louisiana- Federal American Rescue Plan (ARP), United States Department of Agriculture (USDA), National Institute for Health Research (NIHR), National Science Foundation (NSF), Lilly, National Institutes of Health (NIH). CKM has served on advisory boards for EHE Health, Wondr Health, and the Nutrition Obesity Research Center at the University of Alabama Birmingham and consulted to Kitchry, Metagenics, WW, Florida Hospital, Gila Therapeutics, Zafgen, OpenFit/MXCXM Health Inc. CKM developed intellectual property (IP) to quantify dietary adherence and his institution has licensed this IP, resulting in receiving royalties via the institution from the licensing fees. CKM is part of US and European patent applications for a weight loss approach called the Body weight Management and activity tracking system and also occasionally gives lectures and talks where he is provided with an honorarium, including talks to the Obesity Action Coalition and Indiana University Bloomington. Finally, CKM serves as a developer and facilitator for continuing education events sponsored by the Commission on Dietetic Registration, and is a Planning Committee Member for the Bray Course. The opinions and assertions expressed herein are those of the authors and are not to be construed as reflecting the views of the Public Health Service, the Department of Health and Human Services, USUHS, or the U.S. Department of Defense., (Copyright: © 2023 Jebeile et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Introduction: Caesarean section (C-section) is a life-saving procedure when medically indicated but unmet need and overuse can add to avoidable morbidity and mortality. It is not clear whether C-section has a negative impact on breastfeeding and there is limited data available on rates of C-section or breastfeeding from Northern Cyprus, an emerging region in Europe. This study aimed to investigate prevalence, trends and associations of C-section and breastfeeding in this population., Methods: Using self-reported data from the representative Cyprus Women's Health Research (COHERE) Initiative, we used 2,836 first pregnancies to describe trends in C-section and breastfeeding between 1981 and 2017. Using modified Poisson regression, we examined the relationship between year of pregnancy and C-section and breastfeeding, as well as the association between C-section and breastfeeding prevalence and duration., Results: C-section prevalence in first pregnancies increased from 11.1% in 1981 to 72.5% in 2017 with a relative risk of 2.60 (95%CI; 2.14-2.15) of babies being delivered by C-section after 2005 compared to before 1995, after full adjustment for demographic and maternal medical and pregnancy related factors. Prevalence of ever breastfeeding remained steady throughout the years at 88.7% and there was no significant association between breastfeeding initiation and the year of pregnancy, or demographic and maternal medical and pregnancy related variables. After full adjustment, women who gave birth after 2005 were 1.24 (95%CI; 1.06-1.45) times more likely to breastfeed for >12 weeks compared to women who gave birth before 1995. There was no association between C-section and breastfeeding prevalence or length., Conclusion: Prevalence of C-section in this population is much higher than WHO recommendations. Public awareness campaigns surrounding choice during pregnancy and change in legal framework to allow for midwife-led continuity models of birthing care should be implemented. Further research is required to understand the reasons and drivers behind this high rate., Competing Interests: CMB declares that he is part of a scientific collaboration between Oxford University and Bayer Healthcare Ltd. for the purpose of drug target identification in endometriosis. He holds/has held research grants from Bayer Healthcare, MDNA Life Sciences and Roche Diagnostics and has in recent years been a consultant for Abbvie Inc., Roche Diagnostics, Myovant and ObsEva. KTZ declares that she has scientific collaborations outside the submitted work with Bayer Healthcare, MDNA Life Sciences, Roche Diagnostics Inc., and Volition Rx and is a Board member (Secretary) of the World Endometriosis Society, Research Advisory Board member of Wellbeing of Women, UK (research charity) and Chair of the Research Directions Working Group, World Endometriosis Society. NR declares that she is the founding president of Cyprus Women’s Health Research Society in Northern Cyprus (CoHERS)., (Copyright: © 2023 Swift et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)