bluuebunny/crossref_metadata_2025_split huggingface dataset:
Development and validation of predictive models for mortality of cases with COVID-19 (Omicron BA.5.2.48 and B.7.14): a retrospective study
Authors: Li Peifang , Yang Huiliang , Wu Jinyu , Ma Yanfei , Hou Ailin , Chen Jiali , Ning Ning 
Published: October 2024

ObjectivesWith the emergence of new COVID-19 variants (Omicron BA.5.2.48 and B.7.14), predicting the mortality of infected patients has become increasingly challenging due to the continuous mutation of the virus. Existing models have shown poor performance and limited clinical utility. This study aims to identify the independent risk factors and develop practical predictive models for mortality among patients infected with new COVID-19 variants.DesignA retrospective study.Setting and participantsWe extracted data from 1029 COVID-19 patients in the respiratory disease wards of a general hospital in China between 22 December 2022 and 15 February 2023.Outcome measuresMortality within 15 days after hospital discharge.ResultsA total of 987 cases with new COVID-19 variants (Omicron BA.5.2.48 and B.7.14) were eventually included, among them, 153 (15.5%) died. Non-invasive ventilation, intubation, myoglobin, international normalised ratio, age, number of diagnoses, respiratory rate, pulse, neutrophil count and albumin were the most important predictors of mortality among new COVID-19 variants. The area under the curve of logistic regression (LR), decision tree (DT) and Extreme Gradient Boosting (XGBoost) models were 0.959, 0.883 and 0.993, respectively. The diagnostic accuracy was 0.926 for LR, 0.918 for DT and 0.977 for XGBoost. XGBoost model had the highest sensitivity (0.908) and specificity (0.989).ConclusionOur study developed and validated three practical models for predicting mortality in patients with new COVID-19 variants. All models performed well, and XGBoost was the best-performing model.
Influence of temperament on early neurodevelopmental disorders: a systematic review protocol
Authors: Ponce Rodriguez Lucia , Fuentes Rueda Carmen M , Rojo Franconetti Maria , Esteban Laura , Ibáñez-Alfonso Joaquín A 
Published: October 2024

IntroductionSeveral studies have highlighted the role of temperament as a relevant construct to understand the wide variability observed in neurodevelopmental disorders (NDDs) such as autism spectrum disorder and attention deficit hyperactivity disorder. Some studies have pointed to temperamental traits such as strained control as possible precursors to the development of these disorders. In addition, how temperament influences high-risk populations, as well as intervention programmes aimed at families, has been investigated.Methods and analysisThis paper presents the protocol that will be followed to carry out a systematic review, the objective of which is to know how child temperament is related to the different domains of development in children with NDD or the risk of suffering from it. The search strategy will be implemented in Web of Science (WoS Core Collection), PubMed, ERIC, PsycINFO and Cochrane databases. The risk of bias will be measured by the Newcastle-Ottawa Scale to carry out the integration of the results obtained to synthesis without meta-analysis will be used. This systematic review aims to improve scientific evidence for institutions and professionals and enhance the effectiveness of early care programmes for children with NDD and their families.Ethics and disseminationNo express approval has been sought from any ethics committee because there is no primary data involved and no access to confidential patient information.PROSPERO registration numberCRD42023445173.
Oxford Vaccine Hesitancy Scale (OVHS): a UK-based and US-based online mixed-methods psychometric development and validation study of an instrument to assess vaccine hesitancy
Authors: Kantor Jonathan , Carlisle Robert C , Morrison Michael , Pollard Andrew J , Vanderslott Samantha 
Published: October 2024

ObjectivesTo describe the development, validation and reliability of the Oxford Vaccine Hesitancy Scale (OVHS), a new instrument to assess vaccine hesitancy in the general population.DesignCross-sectional validation study.SettingInternet-based study with participants in the UK and USA.ParticipantsDemographically representative (stratified by age, sex and race) samples from the UK and USA recruited through the Prolific Academic platform.Main outcome measuresTo demonstrate OVHS development, exploratory factor analysis with categorical variables and a polychoric correlation matrix followed by promax oblique rotation on the UK sample was performed. Confirmatory factor analysis with a Satorra-Bentler scaled test statistic evaluating goodness of fit statistics including the root mean squared error of approximation (RMSEA), standardised root mean squared residual (SRMR) and comparative fit index (CFI) was performed on the US sample. Reliability as internal consistency was assessed using McDonald’s omega. Evidence in support of the predictive, convergent and discriminant validity of the scale was assessed using logistic regression ORs of association (OR) or Pearson correlation coefficients.ResultsData for factor analysis were obtained from 1004 respondents, 504 in the UK and 500 in the USA. A scree plot, minimum average partial correlation analysis and parallel analysis suggested a three-factor 13-item scale with domains of vaccine beliefs (seven items), pain (three items) and personal deliberation (three items). Responses were recorded on a Likert scale ranging from disagree completely to agree completely, with higher score reflecting greater hesitancy. Potential total scores ranged from 13 to 65. Goodness of fit was excellent, with RMSEA=0.044, SRMR=0.041 and CFI=0.977. Predictive validity for COVID-19 vaccination status was excellent, with logistic regression ORs of association (95% CI) of 0.07 (0.04, 0.13), p<0.0001 for the UK sample for each SD increase in OVHS score, suggesting a 93% decrease in the odds of being vaccinated against COVID-19 for each SD increase in OVHS score. Convergent validity between the OVHS score and the 5C short version scale demonstrated a correlation coefficient of 0.32 (p<0.0001). Discriminant validity with an unrelated desire to perform outdoor activities demonstrated an OR (95% CI) of 1.06 (0.88, 1.29), p=0.523 for the UK sample for each SD increase in OVHS score. McDonald’s omega was 0.86 and 0.87 in the UK and US samples, respectively.ConclusionsThe OVHS is a feasible, valid and reliable scale for assessing vaccine hesitancy; further testing is warranted.
Quality and completeness of, and spin in reporting of, pilot and feasibility studies in hip and knee arthroplasty: a protocol for a methodological survey
Authors: Chung Zinnia , Mbuagbaw Lawrence , Mokete Lipalo , Bhandari Mohit , Thabane Lehana 
Published: October 2024

IntroductionPilot or feasibility trials examine the feasibility, viability and recruitment potential of larger, main trials. Specifically, a pilot trial can be instrumental in identifying methodological issues essential to the development of an effective research protocol. However, numerous studies published as pilot or feasibility studies have demonstrated notable inconsistencies in the nature of information reported, resulting in poor-quality and incomplete reporting. It is unclear whether such low quality or incompleteness of reporting is also prevalent in arthroplasty pilot trials.Methods and analysisThis protocol outlines a methodological survey examining the completeness of reporting among hip and knee arthroplasty pilot trials in accordance with the Consolidated Standards of Reporting Trials (CONSORT) 2010 extension to pilot trials. Secondary objectives include: (1) determining the prevalence of ‘spin’ practices, defined as: (a) placing a focus on statistical significance rather than feasibility, (b) presenting results that show the trial to be non-feasible as feasible or (c) emphasising the effectiveness or potential intervention benefits rather than feasibility; (2) determining factors associated with incomplete reporting, and ‘spin’. A search of PubMed will be conducted for pilot trials in hip or knee arthroplasty published between 01 January 2017 and 31 December 2023. Following screening, appropriate data will be extracted from eligible publications and reported as descriptive statistics, encompassing elements of the CONSORT checklist associated with completeness of reporting. Logistic regression analysis and Poisson regression will be used to analyse factors associated with completeness of reporting and spin.Ethics and disseminationThis methodological review does not require formal ethical approval, as it will solely involve the use of published and publicly reported literature. The results of this study will be disseminated through submission to peer-reviewed journals and academic conference presentations. Study details will be sent to McMaster University’s media coordinators to be shared through the institution’s research-focused platforms.
Prevalence of and factors associated with pre-diabetes among adolescents in Eastern Sudan: a community-based cross-sectional study
Authors: Alsafi Walaa Mamoun , Al Eed Ashwaq , Hassan Ahmed Ali , Al-Nafeesah Abdullah , Alfaifi Jaber , Adam Ishag 
Published: October 2024

ObjectivesThere is an increasing trend of pre-diabetes and diabetes mellitus (DM) among adolescents, and sub-Saharan Africa is no exception. However, few published data on pre-diabetes among adolescents in Sudan exist. We aimed to investigate the prevalence of and factors associated with pre-diabetes among adolescents in Eastern Sudan.DesignA community-based cross-sectional study was conducted from August to October 2023.SettingsThis community-based study was conducted in Gadarif city, the capital of Gadarif state, Eastern Sudan.ParticipantsAdolescents (within the ages of 10–19 years).Main outcome measuresA questionnaire was used to collect socio-demographic information. Anthropometric and glycated haemoglobin (HbA1c) measurements were performed in accordance with standard procedures. Multivariate logistic regression analysis was performed.ResultsOf the 387 enrolled adolescents, 207 (53.5%) were female and 180 (46.5%) were male. The median (IQR) age was 14.0 (12.0–16.0) years. 39.5% of the participants’ fathers were employed. The median (IQR) HbA1c was 5.5% (5.2%–5.8%). One-third (32.6%) of the adolescents had pre-diabetes or DM. Of the participants, 67.4%, 30.0% and 2.6% had no DM, pre-diabetes or type 2 DM, respectively. In the univariate analysis, the father’s employment (OR=1.60, 95% CI=1.03 to 2.50) was associated with increased odds of pre-diabetes; age, sex, parents’ education, the mother’s occupation, body mass index z-score, cigarette smoking and a family history of DM were not associated with pre-diabetes. In the multivariate analysis, the father’s employment (adjusted OR=1.70, 95% CI=1.03 to 2.50) was associated with increased odds of pre-diabetes.ConclusionPre-diabetes is a significant public health problem among adolescents in Eastern Sudan. The introduction of early screening programmes for pre-diabetes at the community level is recommended to halt the progression of pre-diabetes to DM and to deal with existing DM among adolescents.
Cohort profile: a nationwide study in DutchCHEK2c.1100delC families using the infrastructure of the HEreditary Breast and Ovarian cancer study Netherlands – Hebon-CHEK2
Authors: Schreurs Maartje A.C. , Adank Muriel A , Hollestelle Antoinette , de Groot Rosa , Stommel-Jenner Denise J , Van Asperen Christi J. , Ausems Margreet G.E.M. , Berger Lieke P V , Blok Marinus J , van Engelen Klaartje , Hogervorst Frans B L , Geurts-Giele Willemina , Gille Johan J P , Wevers Marijke R , Schmidt Marjanka K , Hooning Maartje J. 
Published: October 2024

PurposeCHEK2c.1100delC is associated with an increased breast cancer risk in women. While this variant is prevalent in the Netherlands (1% in the general population), knowledge of aetiology and prognosis of breast cancer and other tumours inCHEK2c.1100delC carriers is lacking. The nationwide HEreditary Breast and Ovarian cancer study the Netherlands (Hebon) cohort aims to answer study questions in families with an increased risk of breast cancer and ovarian cancer. While initially focusing onBRCA1/2-variant families, Hebon gradually expanded to include pathogenic variants in other genes associated with breast and/or ovarian cancer over time. This provides an excellent setting to establish a cohort to ultimately study the impact ofCHEK2c.1100delC on cancer risk prediction and surveillance, breast cancer treatment and prognosis.ParticipantsWe invited all heterozygous and homozygousCHEK2c.1100delC indexes and tested female relatives. 1802 women were included, of whom 1374 were heterozygotes and 938 were breast cancer cases. Pedigrees were collected from all clinical genetic departments. Furthermore, participants completed a detailed questionnaire on hormonal and lifestyle factors, family history, cancer diagnosis and treatment.Findings to dateMean age at study inclusion was 53 years. Linkage with the Netherlands Cancer Registry showed a younger age at diagnosis in homozygotes (mean age 41.7 years) and heterozygotes (47.9 years) than non-carriers (51.2 years). Furthermore, carriers were more often diagnosed with grade 2, oestrogen receptor-positive breast cancer and more often developed contralateral breast cancer than non-carriers. Most women consumed alcohol regularly and about half never smoked.Future plansFurther data linkages with the Netherlands Cancer Registry will allow prospective follow-up and breast cancer risk assessment in unaffected women at the time of genetic testing, risk of contralateral breast cancer and survival in patients with breast cancer. Also, linkage with the nationwide network and registry of histopathology and cytopathology in The Netherlands (PALGA) allows us to retrieve tumour samples to study tumourigenesis.
Decline in and recovery of fertility rates after COVID-19-related state of emergency in Japan
Authors: Mitoma Tomohiro , Maki Jota , Ooba Hikaru , Masuyama Hisashi 
Published: October 2024

IntroductionThe COVID-19 pandemic led to a decline in fertility rates worldwide. Although many regions have experienced a temporary drop in fertility rates with the spread of the infection, subsequent recovery has varied across countries. This study aimed to evaluate the impact of COVID-19 infection rates and regional sociodemographic factors on the recovery of fertility rates in Japan following the state of emergency.MethodsThis study examined prefectural fertility data from before the COVID-19 pandemic to forecast fertility rates up to 2022 using a seasonal autoregressive integrated moving average model. A regression analysis was conducted on fertility rates during the first state of emergency and the subsequent recovery rate with respect to the number of new COVID-19 cases and sociodemographic factors specific to each prefecture.ResultsDuring the first state of emergency, the monthly fertility rate decreased by an average of −13.8% (SD: 6.26, min: −28.78, max: 0.15) compared with the previous year. Over the following 22 months, the average fertility recovery rate was +2.31% (SD: 3.57; min: −8.55, max: 19.54). Multivariate analysis of the impact of the pandemic on fertility changes during the first emergency indicated a negative correlation between new COVID-19 cases per capita and the proportion of nuclear households. No significant correlation was found between fertility recovery rate and new COVID-19 cases or emergency duration. When classifying fertility rate fluctuation patterns before and after the emergency into four clusters, variations were noted in the proportion of the elderly population, marriage divorce rate and the number of internet searches related to pregnancy intentions across the clusters.ConclusionsNo association was found between pregnancy intentions related to the spread of infection, such as the number of new cases and the fertility recovery rate following the first state of emergency. Differences in the patterns of decline and recovery during the pandemic were observed based on population composition and internet searches for infection and pregnancy across different prefectures.
Objectively measured daily steps and health outcomes: an umbrella review of the systematic review and meta-analysis of observational studies
Authors: Xu Chunlan , Jia Jinli , Zhao Binbin , Yuan Man , Luo Nan , Zhang Fan , Wang Hui 
Published: October 2024

ObjectivesThe purpose of this review is to summarise the evidence from a systematic review and meta-analysis of observational studies that objectively measure daily steps and health outcomes.DesignThis is an umbrella review.Data sourcesPubMed, Embase, Scopus, the Cochrane Library and Web of Science databases were searched through 31 January 2024.EligibilityWe included systematic reviews of observational studies (with or without meta-analysis) that assessed the association of objectively measured daily steps with human health-related outcomes. Methodological quality was assessed using ‘A MeaSurement Tool to Assess systematic Reviews 2’.ResultsA total of 10 systematic reviews and 6 health outcomes were included after excluding irrelevant and duplicate studies. Higher daily steps were associated with more benefits than harms for a range of health-related outcomes, including all-cause mortality, cardiovascular event, skeletal muscle lesions, metabolic diseases and respiratory disease. A dose-response analysis showed that an increase of 500–1000 steps per day was associated with lower all-cause mortality and cardiovascular events. Beneficial associations were also found in patients with asthma and acutely hospitalised older adults. Conversely, one study within a systematic review suggested that higher daily steps (≥10 000) might be associated with an increased 52% risk of meniscal pathologies in individuals without knee osteoarthritis. However, one study within a systematic review suggested a potential increased risk of meniscal pathologies in individuals without knee osteoarthritis. Specifically, those exceeding 10 000 steps per day showed a 52% increase in risk.ConclusionThe results of this study suggest that daily steps are associated with a lower risk of all-cause mortality and cardiovascular events. Future research could focus on identifying specific populations that may benefit most from increased daily steps and exploring potential mechanisms to enhance our understanding of how daily steps contribute to improved health outcomes.PROSPERO registration numberCRD42022347055.
Semaglutide treatment for PRevention Of Toxicity in high-dosE Chemotherapy with autologous haematopoietic stem-cell Transplantation (PROTECT): study protocol for a randomised, double-blind, placebo-controlled, investigator-initiated study
Authors: Sørum Maria Ebbesen , Gang Anne Ortved , Tholstrup Dorte Maegaard , Gudbrandsdottir Sif , Kissow Hannelouise , Kornblit Brian , Müller Klaus , Knop Filip K 
Published: October 2024

Introduction
Cancer treatment with high-dose chemotherapy damages the mucosal barrier of the gastrointestinal (GI) tract and is associated with severe toxicity involving mucositis, severe inflammation and organ dysfunction. Currently, there is no effective prophylaxis against this. Glucagon-like peptide 1 (GLP-1), a well-known regulator of blood glucose, has been suggested in mouse studies to possess trophic effects on gut epithelial cells as well as anti-inflammatory properties. In line with this, endogenous GLP-1 levels have been shown to be inversely correlated with toxicities after haematopoietic stem cell transplantation (HSCT) and treatment with a GLP-1 receptor agonist (GLP-1RA) was shown to limit chemotherapy-induced mucositis in rodents. This present study investigates the effects of the GLP-1RA semaglutide on GI mucositis severity score in patients with lymphoma undergoing high-dose chemotherapy followed by autologous (auto) HSCT.

Methods and analysis
This is a randomised, double-blind, placebo-controlled, two-centre investigator-initiated clinical study. Forty adult patients with malignant lymphoma referred for auto-HSCT will be randomised in a 1:1 manner to receive either semaglutide or placebo once-weekly for 8 weeks. This includes a run-in period of 3–4 weeks with semaglutide 0.25 mg prior to high-dose chemotherapy treatment followed by a period of 4–5 weeks with semaglutide 0.5 mg including the 1 week of high-dose chemotherapy treatment. Clinical assessment of endpoint measurements and safety will be performed weekly during treatment and in a follow-up period of 10 weeks. The primary endpoint is GI mucositis severity (mean severity grade (0–II) during week 1–4 after auto-HSCT). Secondary endpoints include C-reactive protein increment, quality of life and safety. Fever, bacteraemia, antibiotic use, weight loss, morphine consumption, duration of hospitalisation, use of parenteral nutrition, change in muscle mass and clinical and laboratory evidence of organ toxicities will also be assessed.

Ethics and dissemination
The study complies with Danish and European Union legislation and is approved by the Danish Medicines Agency, the Danish National Medical Research Ethics Committee (EU CT #2022-502139-20-00) and the Danish Data Protection Agency. The study is monitored by the Capital Region of Denmark’s good clinical practice unit. All results, positive, negative and inconclusive, will be disseminated at national and international scientific meetings and in peer-reviewed scientific journals.

Trial registration number

NCT06449625
Exploring the early experiences of assisted dying in Aotearoa New Zealand: a qualitative study protocol
Authors: Young Jessica , Dehkhoda Aida , Ahuriri-Driscoll Annabel , Cheung Gary , Diesfeld Kate , Egan Richard , Karaka-Clarke Te Hurinui , Moeke-Maxwell Tess , Reid Kate , Robinson Jackie , Snelling Jeanne , White Ben , Winters Janine 
Published: October 2024

IntroductionIncreasing numbers of jurisdictions are legalising assisted dying (AD). Developing research protocols to study the experiences and outcomes of legislation is imperative. AD is a topic that, by nature of its complexity and inherent ethical issues, lends itself to qualitative research. Using the objectives of the statutory framework, this qualitative study aims to provide a robust review of the newly formed AD service in New Zealand and the extent to which it is safe, people-centred, dignity-enhancing, accessible and available equitably to all eligible people.Methods and analysisThe research uses an appreciative inquiry design to focus on what is working well, what could be improved, what constitutes the ‘ideal’ and how to enable people to achieve that ideal. We are using online semi-structured interviews and face-to-face focus groups to explore the experiences of key stakeholders: eligible/ineligible service users; eligible/ineligible service users with impairments; families of service users; AD providers; non-providers (providers who object to AD and others who are not directly involved in providing AD but are not opposed in principle); health service leaders; and Māori community members. An estimated 110 participants will be interviewed. We will conduct thematic and regulatory analyses of data.Ethics and disseminationThe ethical aspects of this study have been approved by the Northern A Health and Disability Ethics Committee through the full review pathway (2023 EXP 18493). To disseminate the findings, we will draft resources to support interviewee groups, to be developed with feedback from stakeholder meetings. We will submit evidence-based recommendations to inform the government review of the End of Life Choice Act 2019. Findings will be disseminated in peer-reviewed publications, conferences, webinars, media, stakeholder feedback sessions and accessible research briefings.