bluuebunny/crossref_metadata_2025_split huggingface dataset:
Development of a hoRizontal data intEgration classifier for NOn-invasive early diAgnosis of breasT cancEr: the RENOVATE study protocol
Authors: Ravera Francesco , Cirmena Gabriella , Dameri Martina , Gallo Maurizio , Vellone Valerio Gaetano , Fregatti Piero , Friedman Daniele , Calabrese Massimo , Ballestrero Alberto , Tagliafico Alberto , Ferrando Lorenzo , Zoppoli Gabriele 
Published: December 2021

IntroductionStandard procedures aimed at the early diagnosis of breast cancer (BC) present suboptimal accuracy and imply the execution of invasive and sometimes unnecessary tissue biopsies. The assessment of circulating biomarkers for diagnostic purposes, together with radiomics, is of great potential in BC management.Methods and analysisThis is a prospective translational study investigating the accuracy of the combined assessment of multiple circulating analytes together with radiomic variables for early BC diagnosis. Up to 750 patients will be recruited at their presentation at the Diagnostic Senology Unit of Ospedale Policlinico San Martino (Genoa, IT) for the execution of a diagnostic biopsy after the detection of a suspect breast lesion (t0). Each recruited patient will be asked to donate peripheral blood and urine before undergoing breast biopsy. Blood and urine samples will also be collected from a cohort of 100 patients with negative mammography. For cases with histological diagnosis of invasive BC, a second sample of blood and urine will be collected after breast surgery. Circulating tumour DNA, cell-free methylated DNA and circulating proteins will be assessed in samples collected at t0 from patients with stage I–IIA BC at surgery together with those collected from patients with histologically confirmed benign lesions of similar size and from healthy controls with negative mammography. These analyses will be combined with radiomic variables extracted with freeware algorithms applied to cases and matched controls for which digital mammography is available. The overall goal of the present study is to develop a horizontal data integration classifier for the early diagnosis of BC.Ethics and disseminationThis research protocol has been approved by Regione Liguria Ethics Committee (reference number: 2019/75, study ID: 4452). Patients will be required to provide written informed consent. Results will be published in international peer-reviewed scientific journals.Trial registration numberNCT04781062.
Trends in energy and nutrient content of menu items served by large UK chain restaurants from 2018 to 2020: an observational study
Authors: Huang Yuru , Theis Dolly R Z , Burgoine Thomas , Adams Jean 
Published: December 2021

ObjectiveThe objective of this study was to evaluate the change in energy and nutrient content of menu items sold in large UK chain restaurants (eg, fast food, full service) from 2018 to 2020.DesignObservational study.SettingEnergy and nutritional information of menu items served by 29 large UK chain restaurants that consistently provided this information online in all three years. Data were collected in 2018 (March–April), 2019 (April) and 2020 (October–November) from restaurant websites.Primary and secondary outcome measuresThe per-item energy and nutrient (saturated fat, sugar and salt) changes in all items available on menus (‘all menu items’) and recurring items that were consistently available on menus in all three years (‘core menu items’), overall and in 12 different food categories.ResultsOur study included 7770, 9213 and 6928 menu items served by 29 large UK chain restaurants in 2018, 2019 and 2020, respectively. Our results showed that sugar content declined from 2018 to 2020 among all menu items (per-item: −0.43 g/year, 95% CI −0.66 to –0.21). This reduction in sugar was evident in beverages, sandwiches and desserts. Among core menu items (N=1855), sugar content reduced significantly from 2018 to 2020 (per-item: −0.31 g/year, 95% CI −0.45 to –0.17), especially in beverages. Energy, salt and saturated fat content in menu items remained constant overall, in both all menu items and core menu items. Fewer food categories had significant changes in energy, sugar, salt and saturated fat content among core menu items than among all menu items.ConclusionsFrom 2018 to 2020, sugar content declined in restaurant menu items, which may reflect a response to the sugar reduction strategy and the effects of the soft drinks industry levy. In contrast, there was little change in other nutrients. Future policies addressing the overall nutritional quality of restaurant foods, rather than single nutrients, may help the restaurant sector move towards offering healthier foods.
Cohort profile: Japanese human milk study, a prospective birth cohort: baseline data for lactating women, infants and human milk macronutrients
Authors: Nojiri Keisuke , Higurashi Satoshi , Takahashi Tomoki , Tsujimori Yuta , Kobayashi Shunjiro , Toba Yasuhiro , Yamamura Jun-ichi , Nomura Kyoko , Ueno Hiroshi M 
Published: December 2021

PurposeThe Japanese Human Milk Study, a longitudinal prospective cohort study, was set up to clarify how maternal health, nutritional status, lifestyle and sociodemographic and economic factors affect breastfeeding practices and human milk composition. This would eventually determine factors affecting the growth and development of infants and children.ParticipantsA total of 1210 Japanese lactating women who satisfied the inclusion criteria, were invited across the country at various participating sites, between 2014 and 2019. Finally a total of 1122 women were enrolled in this study.Findings to dateAmong 1122 eligible participants, mean age at delivery was 31.2 (SD 4.4) years and mean prepregnancy BMI was 20.8 (SD 2.7). Among these women, 35% were previously nulliparous and 77.7% had college, university or higher education. The mean gestational period was 39.0 (SD 1.3) weeks. Caesarean section was reported among 11.9%; mean infant birth weight was 3082 (SD 360) g. Of the infants, 53.7% were male. Overall, our participants appeared to be healthier than the general population in Japan. Analyses of the 1079 eligible human milk samples obtained at the first and second months postpartum showed the following composition: carbohydrate, 8.13 (SD 0.32) g/100 mL; fat, 3.77 (SD 1.29) g/100 mL; and crude protein, 1.20 (SD 0.23) g/100 mL. We also analysed osteopontin, fatty acid, vitamin D and phospholipid levels in limited subcohorts of the samples.Future plansFollow-up surveys will be conducted to obtain milk samples every 2 months for 12 months and to investigate mother and child health until the children reach 5 years of age. These will be completed in 2024. We plan to longitudinally analyse the composition of macronutrients and various bioactive factors in human milk and investigate the lifestyle and environmental factors that influence breastfeeding practices, maternal and child health, and child development.Trial registration numberUMIN000015494; pre-results.
Early development of primary care networks in the NHS in England: a qualitative mixed-methods evaluation
Authors: Parkinson Sarah , Smith Judith , Sidhu Manbinder 
Published: December 2021

ObjectivesPrimary care networks (PCNs) were introduced in the National Health Service (NHS) in England in 2019 to improve integrated care for patients and help address financial and workforce sustainability issues in general practice. The purpose of this study was to collect early evidence on their implementation and development, including motivations to participate and what enables or inhibits progress. This paper considers the core characteristics of PCNs, and how this informs their management.DesignA qualitative mixed-methods rapid evaluation was conducted across four case study sites in England, informed by a literature review and stakeholder workshop. Data collection comprised interviews, non-participant observation of meetings, an online survey and documentary review.ResultsGeneral practitioners (GPs) are motivated to participate in PCNs for their potential to improve patient care, enable better coordinated services and enhance financial and workforce sustainability within primary care. However, PCNs also have an almost mandatory feel, based on the national policy context and significant financial incentives associated with joining them. PCNs offer potential to bring GPs together to work towards common goals, deliver national priorities and respond rapidly to local needs.ConclusionsPCNs face similar challenges to other meso-level primary care organisations internationally, as they respond to local and national priorities and operate in a context of multiple goals and interests. In managing these organisations, it is important to find a balance between local and national autonomy, decision making and control.
Cohort profile: the Spanish Early-onset Colorectal Cancer (SECOC) cohort: a multicentre cohort study on the molecular basis of colorectal cancer among young individuals in Spain
Authors: Perea Jose , Marti Marc , Espin Eloy , Hernandez-Villafranca Sergio , Orihuela Pilar , Vidal Tocino Rosario , Alcazar Jose Antonio , Vivas Alfredo , Narvaez Cristina , Prieto Isabel , Asensio Luis , López Rojo Irene , Encinas Garcia Sara , Hurtado Elena , Jiménez Luis M , Jiménez Fernando , Cavero Adriana , Alvaro Edurne , Fuenmayor Maria Luisa , Jiménez Toscano Marta , Iglesias Comas Mar , Balaguer Francesc , Daca Maria , Ballestero Araceli , Die Trill Javier , Sanz Gonzalo , Sanz López Rodrigo , Melone Sirio , Rueda Jose A , Brandariz Lorena , Valverde Ignacio , Arredondo Jorge , Pastor Carlos , Garcia-Olmo Damian , Malats Nuria , Urioste Miguel , Gonzalez-Sarmiento Rogelio , Spinelli Antonino , Holowatyj Andreana N 
Published: December 2021

PurposeThe Spanish Early-onset Colorectal Cancer (SECOC) study is a multicentre prospective cohort established in Spain to investigate the molecular basis of early-onset colorectal cancer (EOCRC), including metabolic alterations.Participants220 patients with EOCRC have been enrolled since January 2019 through 18 centres across Spain. Individual-level data were collected by questionnaire, including lifestyle and other colorectal cancer-related factors. Medical record review was performed to capture clinical, histopathological and familial cancer history data. Biospecimen collection (blood, stool, tissue) at diagnosis and at various time points across treatment, as applicable, is also completed.Findings to dateParticipants had a median age of 44 years (range 14–49), and the majority are men (60%), with individuals age 40–49 years at EOCRC diagnosis being over-represented. Forty-three per cent of participants were diagnosed with a tumour in the rectosigmoid junction/rectum. Nearly two-thirds of EOCRC cases (64%) were diagnosed with advanced stage (III–IV) disease, and 28% of cases had no reported familial history of cancer.Future plansWe are actively recruiting and observing participants; we plan to administer follow-up questionnaires and perform additional biospecimen collection. This prospective cohort offers a unique, rich resource for research on EOCRC aetiologies and will contribute to larger international efforts to disentangle the rising disease burden.
Durham University students’ experiences of asymptomatic COVID-19 testing: a qualitative study
Authors: Jones Leah Ffion , Batteux Eleonore , Bonfield Stefanie , Bhogal Jaskiran Kaur , Taylor Jo , Caiado Camila , Ramagge Jacqui , Weston Dale 
Published: December 2021

ObjectivesTo evaluate the asymptomatic coronavirus testing programme at Durham University by exploring students’ barriers and facilitators to taking part and provide recommendations to improve the programme.DesignQualitative interviews.SettingOnline.Participants30 students enrolled at Durham University were interviewed in March 2021.Main outcome measuresAttitudes towards testing, experiences of testing and barriers and facilitators to engaging in testing at Durham University.ResultsKey motivations for testing included protecting oneself and others and accessing facilities and events. The process of booking, accessing and doing a test was mostly easy and convenient, although some may prefer home testing. There were concerns about the accuracy of tests and the implications of a positive result. Some highlighted they might be less likely to engage in testing if vaccinated. A negative test result provided confidence to engage in their daily activities, while encouraging some to socialise more.ConclusionsThe findings show that the testing programme at Durham University is convenient and well organised, with testing as a potential requirement to access social events, and self-isolation support being key contributor to uptake. These findings provide insights into young adults’ attitudes towards testing and can inform testing programmes in other universities and settings with asymptomatic testing programmes.
Disparities in HIV/STI burden and care coverage among men and transgender persons who have sex with men in Nairobi, Kenya: a cross-sectional study
Authors: Smith Adrian D , Fearon Elizabeth , Kabuti Rhoda , Irungu Erastus , Kungu Mary , Babu Hellen , Nyabuto Chrispo , Muthoga Peter , Weatherburn Peter , Bourne Adam , Kimani Joshua 
Published: December 2021

ObjectivesThe study aimed to estimate the prevalence of, and associations, with HIV and metrics of HIV care engagement in a representative population of gay, bisexual and other men who have sex with men (GBMSM) and transgender persons (TP) who have sex with men (GBMSM/TP)SettingUrban districts of Nairobi, Kenya.DesignCross-sectional.Participants608 eligible participants were identified through respondent-driven sampling over 19 waves of recruitment arising from ten seeds between May and December 2017. Inclusion criteria were: age >18 years; Nairobi residence; male sex assignment at birth or current identification as male, and recent consensual sex with male partners. Exclusion criteria were: missing or invalid recruitment coupon; repeat registration; intoxication at study visit.Primary and secondary outcome measuresHIV status measured using Determine Alere HIV 1/2 and First Response HIV 1–2.0 and GeneXpert HIV-1 Qual. Self-reported metrics of HIV status awareness, antiretroviral use and objective quantification of viral suppression using GeneXpert HIV-1 VL.Results26.4% (286/618) were HIV positive of whom 76.6% were status aware, 65.3% were on antiretroviral therapy (ART), and 47.4% were virally suppressed (<50 copies/mL). Participants 18–22 years were less likely to be status aware, be receiving ART or to have achieved viral suppression. Mean log viral load was 3.14 log higher in 18–22 years compared with older participants. Bacterial sexually transmitted infections were common at both urethral and rectal sites and most infections were asymptomatic by self-report (rectal 82.2%, urethral 82.3%).ConclusionsEngagement in the HIV diagnosis and care cascade among GBMSM/TP in Nairobi is markedly better than in most sub-Saharan African countries, yet falls short of achievements for the general population in Kenya and for GBMSM in high income settings. Young GBMSM/TP are least well served by the current configuration of adult key population services, and programmes should identify and address the sexual, social and developmental needs of adolescent and young key populations.
Facilitators and barriers to implement nurse-led physical activities for people with dementia in nursing homes: a protocol for a mixed-methods systematic review
Authors: Hirt Julian , Vetsch Janine , Heinrich Steffen 
Published: December 2021

IntroductionDementia is a major neurocognitive disorder and accounts for a great proportion of nursing home residents. Bodily symptoms such as gait, balance difficulties and muscle weakness are common in people with dementia. Physical activities are important to maintain and promote physical functioning and activities of daily living.Nurses are a prone stakeholder to deliver physical activity interventions in nursing homes. However, several barriers have been reported for implementing nurse-led physical activity programmes. Also synthesised strategies for sustainable implementation in nursing homes are lacking. We, therefore, aim to synthesise the evidence on physical activity interventions which can be led by nurses and to identify facilitators and barriers of sustainable implementation of physical activity for people with dementia.Methods and analysisWe will conduct a mixed-methods systematic review to (1) describe the characteristics of nurse-led physical activities for people with dementia living in nursing homes and to (2) determine facilitators and barriers for sustainable implementation of nurse-led physical activities for people with dementia in nursing homes. We will search four different electronic databases, do forward and backward citation tracking and will web-search additionally. We will also search through guideline databases. Two reviewers will independently screen the identified studies for their eligibility. Data extraction and critical appraisal of included studies will be performed by one reviewer and double-checked by another reviewer. We will analyse the data using an integrative mixed-method synthesis and we will summarise the findings narratively.Ethics and disseminationNo ethics approval is needed to perform this systematic review. We will publish our review results as scientific and non-scientific journal articles and we will hold an oral or a poster conference presentation. The review results will inform the development of structured and easy to understand guidance for nurses to initiate tailored physical activities for people with dementia in nursing homes.
Heterogeneity in outcome assessment for inflammatory bowel disease in routine clinical practice: a mixed-methods study in a sample of English hospitals
Authors: Razanskaite Violeta , Kallis Constantinos , Young Bridget , Williamson Paula R , Bodger Keith 
Published: December 2021

ObjectivesKnowledge of the extent of variation in outcome assessment for inflammatory bowel disease (IBD) in routine practice is limited. We aimed to describe and quantify variation in outcome coverage and to explore patient, clinician and practitioner factors associated with it.DesignProspective exploratory mixed-methods study.SettingIBD clinics at six hospitals in North West England with differing electronic health record (EHR) systems.MethodsMixed-methods study comprising: (a) structured observations of outcomes elicited during consultations (102 patients consulting 24 clinicians); (b) retrospective analysis of outcomes recorded in the EHR (909 consultations; 127 clinicians) and (c) semistructured interviews with the 24 observed clinicians. We determined whether specific outcome ‘sets’ were elicited or recorded, including: (1) a minimum set of symptom pairs (‘PRO-2’); (2) symptom sets from disease activity indices and (3) a reference list of 37 symptoms, signs and impacts. Factors associated with variation were explored in univariate and multivariate binary logistic regression analyses and from clinician interviews.ResultsPRO-2 coverage was not invariable (elicited during 81% of observed consultations; recorded in 56% of EHR) and infrequent for complete activity indices (all domains from Harvey-Bradshaw Index: elicited, 18%; recorded, 5%). The median number of outcomes from the reference list elicited per consultation was 12 (13-fold variation) and recorded in EHR was 7 (>20-fold variation). Symptom quantification (PRO-2) seldom adhered closely to standardised descriptors and an explicit timeframe was defined rarely. PRO-2 recording in EHR was associated with a diagnosis of ulcerative colitis (OR: 2.09 (95% CI 1.15 to 3.80)) and nurse-led consultations (OR: 6.98 (95% CI 3.28 to 14.83)) and a three-way model suggested 26% of total variability lay between clinicians, 17% between patients but the remainder was unexplained. Most clinicians expressed preference for individualised health status evaluations versus standardised outcome assessments.ConclusionsThere was little evidence for standardised assessment and recording of IBD outcomes and substantial intra-clinician and inter-clinician variation from one consultation to another. Nurses demonstrated a greater tendency to standardised practice.
Healthcare workers’ perception of gender and work roles during the COVID-19 pandemic: a mixed-methods study
Authors: Mele Bria Scriven , Holroyd-Leduc Jayna M , Harasym Patricia , Dumanski Sandra M , Fiest Kirsten , Graham Ian D , Nerenberg Kara , Norris Colleen , Parsons Leigh Jeanna , Pilote Louise , Pruden Harlan , Raparelli Valeria , Rabi Doreen , Ruzycki Shannon M , Somayaji Ranjani , Stelfox Henry Thomas , Ahmed Sofia B 
Published: December 2021

ObjectivesA high functioning healthcare workforce is a key priority during the COVID-19 pandemic. We sought to determine how work and mental health for healthcare workers changed during the COVID-19 pandemic in a universal healthcare system, stratified by gender factors.DesignA mixed-methods study was employed. Phase 1 was an anonymous, internet-based survey (7 May–15 July 2020). Phase 2 was semistructured interviews offered to all respondents upon survey completion to describe how experiences may have differed by gender identity, roles and relations.SettingNational universal healthcare system (Canada).Participants2058 Canadian healthcare worker survey respondents (87% women, 11% men, 1% transgender or Two-Spirit), including 783 health professionals, 673 allied health professionals, 557 health support staff. Of the 63 unique healthcare worker types reported, registered nurses (11.5%), physicians (9.9%) and pharmacists (4.5%) were most common. Forty-six healthcare workers were interviewed.Main outcome measuresReported pandemic-induced changes to occupational leadership roles and responsibilities, household and caregiving responsibilities, and anxiety levels by gender identity.ResultsMen (19.8%) were more likely to hold pandemic leadership roles compared with women (13.4%). Women (57.5%) were more likely to report increased domestic responsibilities than men (45%). Women and those with dependents under the age of 10 years reported the greatest levels of anxiety during the pandemic. Interviews with healthcare workers further revealed a perceived imbalance in leadership opportunities based on gender identity, a lack of workplace supports disproportionately affecting women and an increase in domestic responsibilities influenced by gender roles.ConclusionsThe COVID-19 pandemic response has important gendered effects on the healthcare workforce. Healthcare workers are central to effective pandemic control, highlighting an urgent need for a gender-transformative pandemic response strategy.