bluuebunny/crossref_metadata_2025_split huggingface dataset:
Trends and differences in sexual practices and sexually transmitted infections in men who have sex with men only (MSMO) and men who have sex with men and women (MSMW): a repeated cross-sectional study in Melbourne, Australia
Authors: Martín-Sánchez Mario , Case Richard , Fairley Christopher , Hocking Jane S , Bradshaw Catriona , Ong Jason , Chen Marcus Y , Chow Eric P F 
Published: November 2020

ObjectivesIn the 2010s, there has been an increase in sexually transmitted infections (STI) in men who have sex with men (MSM) in Australia, and since 2015 also in urban heterosexuals. Men who have sex with both men and women (MSMW) have characteristics that may differ from both men who have sex with men only (MSMO) and heterosexual men. We aimed to compare the sexual practices and the trends in HIV/STI positivity between MSMO and MSMW.DesignRepeated cross-sectional study.SettingA sexual health centre in Melbourne, Australia.ParticipantsMSM aged 18 years and above who attended the Melbourne Sexual Health Centre for the first time between 2011 and 2018. This includes 12 795 MSMO and 1979 MSMW.Primary outcome measuresDemographic characterics, sexual practices and HIV/STI positivity.ResultsCompared with MSMW, MSMO were more likely to practice anal sex and to have condomless receptive anal sex with casual male partners, and less likely to have a current regular relationship. Over the 8-year period, there was an increase in condomless receptive anal sex with casual male partners for both groups (MSMO: from 46.2% to 63.3%, ptrend <0.001; MSMW: from 41.3% to 57.9%, ptrend=0.011). Syphilis positivity increased in MSMO (from 5.5% to 7.9%, ptrend=0.012) and MSMW (from 0.9% to 6.4%, ptrend=0.004) and HIV remained stable. Gonorrhoea increased among MSMO from 2011 to 2014 (from 6.7% to 9.6%, ptrend=0.002), and remained stable from 2015 to 2018. MSMO had higher odds of testing positive for gonorrhoea (adjusted OR (aOR) 1.36, 95% CI 1.13 to 1.64), chlamydia (aOR 1.39, 95% CI 1.16 to 1.67), syphilis (aOR 1.74, 95% CI 1.37 to 2.22) and HIV (aOR 4.60, 95% CI 2.43 to 8.70) than MSMW.ConclusionsMSMW have overall lower condomless sex and lower HIV/STI positivity. In the last years, changes in sexual practices in MSM have affected both MSMW and MSMO leading to an increased STI risk.
Laying the foundation for an International Classification of Functioning, Disability and Health Core Set for community-dwelling elderly adults in primary care: the clinical perspective identified in a cross-sectional study
Authors: Book Stephanie , Ulbrecht Gudrun , Tomandl Johanna , Kuehlein Thomas , Gotthardt Susann , Freiberger Ellen , Graessel Elmar 
Published: November 2020

ObjectivesHaving more information about the biopsychosocial functioning of their geriatric patients might help physicians better balance medical interventions according to patients’ needs. For this reason, we aimed to develop an easy-to-handle International Classification of Functioning, Disability and Health (ICF) Core Set for community-dwelling geriatric patients aged 75 and older in primary care. In this empirical study, we describe the functioning and health of community-dwelling patients aged 75 and older in primary care in Germany and identify the most common problems encountered by these individuals when using the ICF.DesignIn this exploratory, cross-sectional study, a health professional conducted semi-structured interviews.SettingCommunity-dwelling older adults aged 75 and older in Germany.Participants65 participants (mean age=80.2, SD=3.6).Outcome measuresExtended ICF Checklist V.2.1a, patients prioritised chapters of the ‘activities and participation’ component.ResultsThe three most common impairments for ‘body functions’ were visual system functions (ICF-code b210; 89%), blood pressure functions (b420; 80%) and sensations associated with hearing and vestibular functions (b240; 59%). For ‘body structures’, they were eyes, ears and related structures (s2; 81%), structure of mouth (s320; 74%) and structures related to the digestive, metabolic and endocrine systems (s5; 49%). For the ‘activities and participation’ component, adequate aids compensated for activity limitations to a certain degree. Still, after having adequate aids, the category in which the participants had the most difficulty was walking (d450; 35%). Participants rated the ‘mobility’ chapter as the most important of all chapters. ‘Environmental factors’ were facilitators of participants’ functioning.ConclusionsThis empirical study provides a list of ICF categories relevant to older adults from the clinical perspective. Along with lists from the other three preparatory studies, it will form the basis for the development of an ICF Core Set for community-dwelling older adults in primary care.Trial registration detailsThe trial is registered in ClinicalTrials.gov (NCT03384732).
Informing prevention of stillbirth and preterm birth in Malawi: development of a minimum dataset for health facilities participating in the DIPLOMATIC collaboration
Authors: von Wissmann Beatrix , Wastnedge Elizabeth , Waters Donald , Gadama Luis A , Dube Queen , Masesa Clemens , Chodzaza Elizabeth , Stock Sarah Jane , Reynolds Rebecca M , Norrie John , Makwakwa Enita , Freyne Bridget , Campbell Harry , Norman Jane E , Wood Rachael 
Published: November 2020

ObjectiveThe global research group, DIPLOMATIC (Using eviDence, Implementation science, and a clinical trial PLatform to Optimise MATernal and newborn health in low Income Countries), aims to reduce stillbirths and preterm births and optimise outcomes for babies born preterm. Minimum datasets for routine data collection in healthcare facilities participating in DIPLOMATIC (initially in Malawi) were designed to assist understanding of baseline maternal and neonatal care processes and outcomes, and facilitate evaluation of improvement interventions and pragmatic clinical trials.DesignPublished and grey literature was reviewed alongside extensive in-country consultation to define relevant clinical best practice guidance, and the existing local data and reporting infrastructure, to identify requirements for the minimum datasets. Data elements were subjected to iterative rounds of consultation with topic experts in Malawi and Scotland, the relevant Malawian professional bodies and the Ministry of Health in Malawi to ensure relevance, validity and feasibility.SettingAntenatal, maternity and specialist neonatal care in Malawi.ResultsThe resulting three minimum datasets cover the maternal and neonatal healthcare journey for antenatal, maternity and specialist neonatal care, with provision for effective linkage of records for mother/baby pairs. They can facilitate consistent, precise recording of relevant outcomes (stillbirths, preterm births, neonatal deaths), risk factors and key care processes.ConclusionsPoor quality routine data on care processes and outcomes constrain healthcare system improvement. The datasets developed for implementation in DIPLOMATIC partner facilities reflect, and hence support delivery of, internationally agreed best practice for maternal and newborn care in low-income settings. Informed by extensive consultation, they are designed to integrate with existing local data infrastructure and reporting as well as meeting research data needs. This work provides a transferable example of strengthening data infrastructure to underpin a learning healthcare system approach in low-income settings.DIPLOMATIC is funded by the UK National Institute for Health Research.
Impact of allergic rhinitis on the day-to-day lives of children: insights from an Australian cross-sectional study
Authors: Bosnic-Anticevich Sinthia , Smith Peter , Abramson Michael , Hespe Charlotte Mary , Johnson Menai , Stosic Rodney , Price David B 
Published: November 2020

Study design and objectiveCross-sectional, observational survey to describe the impact of allergic rhinitis (AR) on Australian children (2 to 15 years).MethodsParticipants (n=1541), parents of children aged 2 to 15 years, provided information on behalf of themselves and one eligible child in their household using a custom-built online questionnaire. Children were allocated to case (AR) or control (No AR) analysis groups based on a validated screening questionnaire.Statistical methodsThe study sample was stratified on age: primary analysis population (6 to 15 years, n=1111; AR=797, No AR=314); exploratory population (2 to 5 years). The primary endpoint, parent-perceived burden, was quantified using a validated measure of health status and analysed via comparison of means.ResultsThe majority of AR cases were treated (730/797; 90.3%) and classified as having moderate-severe, intermittent AR (549/797; 68.9%). Half reported adequate symptom control in the prior 2 weeks (389/797; 48.8%; OR=4.04; 95% CI (CI) 2.24 to 7.31). Having AR was associated with worse overall health status (7.4 vs 8.4, mean difference (least squares mean difference (LSMD))=−0.99; 95% CI −1.18 to −0.79), fewer days being happy (22.2 vs 25.9, LSMD=−3.68; 95% CI −4.82 to −2.54) and more days of poor physical (2.82 vs 0.78, LSMD=2.04; 95% CI 1.61 to 2.47) and emotional (2.14 vs 0.67, LSMD=1.47; 95% CI 1.02 to −1.92) health compared with not having AR. All of these outcomes were significantly (p<0.05) worse in children who reported inadequate symptom control. Having AR negatively impacted on schoolwork, sleep and other activities, and increased the likelihood of having comorbidities.ConclusionThe parent-perceived burden of AR in Australian children is high and it impacts many areas of day-to-day living. Inadequate symptom control is a key driver of the extent of this impact. Opportunities to optimise the management of AR in children include the adoption of self-assessment tools to gauge and monitor adequacy of symptom control.
Protocol for measuring indoor exposure to coal fly ash and heavy metals, and neurobehavioural symptoms in children aged 6 to 14 years old
Authors: Zierold Kristina M , Sears Clara G , Hagemeyer Abby N , Brock Guy N , Polivka Barbara J , Zhang Charlie H , Sears Lonnie 
Published: November 2020

IntroductionFly ash is a waste product generated from burning coal for electricity. It is comprised of spherical particles ranging in size from 0.1 µm to over 100 µm in diameter that contain trace levels of heavy metals. Large countries such as China and India generate over 100 million tons per year while smaller countries like Italy and France generate 2 to 3 million tons per year. The USA generates over 36 million tons of ash, making it one of the largest industrial waste streams in the nation. Fly ash is stored in landfills and surface impoundments exposing communities to fugitive dust and heavy metals that leach into the groundwater. Limited information exists on the health impact of exposure to fly ash. This protocol represents the first research to assess children’s exposure to coal fly ash and neurobehavioural outcomes.MethodsWe measure indoor exposure to fly ash and heavy metals, and neurobehavioural symptoms in children aged 6 to 14 years old. Using air pollution samplers and lift tape samples, we collect particulate matter ≤10 µm that is analysed for fly ash and heavy metals. Toenails and fingernails are collected to assess body burden for 72 chemical elements. Using the Behavioural Assessment and Research System and the Child Behaviour Checklist, we collect information on neurobehavioural outcomes. Data collection began in September 2015 and will continue until February 2021.Ethics and disseminationThis study was approved by the Institutional Review Boards of the University of Louisville (#14.1069) and the University of Alabama at Birmingham (#300003807). We have collected data from 267 children who live within 10 miles of two power plants. Children are at a greater risk for environmental exposure which justifies the rationale for this study. Results of this study will be distributed at conferences, in peer-reviewed journals and to the participants of the study.
Randomised, double-blind, multicentre, phase Ⅰ/Ⅱ dose escalation and expansion trial of GR1501 in patients with plaque psoriasis: study protocol
Authors: Dong Wenliang , Nie Xiaoyan , Wang Jiaxue , Xia Lin , Cai Lin , Wang Qian , Wang Wei , Fu Weixing , Wang Qi , Shen Tiantian , Fan Huaying , Niu Suping , Cui Yimin , Zheng Qingshan , Zhang Jianzhong , Fang Yi 
Published: November 2020

IntroductionPsoriasis is a life-long, immune-mediated disease that greatly reduces the quality of life of patients. Plaque psoriasis is the most common form of psoriasis. Treatment options for plaque psoriasis with good tolerance and sufficient response remain profoundly limited. Based on mechanistic findings that suggest the key pathogenic role of interleukin (IL)-17 in plaque psoriasis, we hypothesise that GR1501, a new monoclonal antibody (IL-17A targeted), will be an efficacious treatment for plaque psoriasis. This phase I/II trial aims to evaluate the safety, tolerability, pharmacokinetics, immunogenicity and preliminary efficacy of GR1501.Methods and analysisA multicentre, randomised, double-blind, phase I/II dose escalation and expansion trial will be conducted at four hospitals in China. In total, 226 patients with plaque psoriasis will be enrolled in the study, with 46 cases in the dose-escalation stage and 180 cases randomised to GR1501 or the placebo in a 3:1 ratio in the expansion cohort. The primary outcomes are safety and tolerability; the secondary outcomes include pharmacokinetics, immunogenicity and efficacy.Ethics and disseminationThe study is in accordance with the Declaration of Helsinki, and the ethics approvals of the protocol have been obtained from the ethics committees of all participating centres, including Peking University People’s Hospital, Chinese PLA General Hospital, The First Affiliated Hospital, College of Medicine, Zhejiang University and the Second Xiangya Hospital of Central South University. The findings of the study will be presented in published journals or at scientific conferences or meetings.Trial registration numberChiCTR1800017956.
Theory-based digital intervention to promote weight loss and weight loss maintenance (Choosing Health): protocol for a randomised controlled trial
Authors: Kwasnicka Dominika , Luszczynska Aleksandra , Hagger Martin S , Quested Eleanor , Pagoto Sherry L , Verboon Peter , Robinson Suzanne , Januszewicz Anna , Idziak Paulina , Palacz-Poborczyk Iga , Naughton Felix 
Published: November 2020

IntroductionDigital behavioural weight loss interventions have the potential to improve public health; however, these interventions are often not adequately tailored to the needs of the participants. This is the protocol for a trial that aims to determine the effectiveness and cost-effectiveness of the Choosing Health programme as a means to promote weight loss and weight loss maintenance among overweight/obese adults.Methods and analysisThe proposed study is a two-group randomised controlled trial with a nested interrupted time series (ITS) within-person design. Participants (n=285) will be randomly assigned to either the Choosing Health digital intervention or a control group. For intervention participants, ecological momentary assessment will be used to identify behavioural determinants for each individual in order to tailor evidence-based behaviour change techniques and intervention content.Control group participants will receive non-tailored weight loss advice via e-book and generic emails. The primary outcome is the mean difference in weight loss between groups at 6 months controlled for baseline. Secondary outcomes include blood pressure and percentage of body fat; self-reported measures of physical activity, sitting time, quality of life, cost and theory-derived correlates of weight loss. Secondary outcomes will be measured at baseline, 3, 6 and 12 months. The primary outcome for ITS will be daily weight loss plan adherence. Data will be analysed using regression and time series analyses.Ethics and disseminationEthics approval was granted by Faculty of Psychology, SWPS University of Social Sciences and Humanities, Wroclaw, Poland, approval number 03/P/12/2019. The project results will be disseminated through structured strategy implemented in collaboration with the Ministry of Health.Trial registration detailsThis trial was registered with www.clinicaltrials.gov; registration number NCT04291482.
Rapid review of available evidence on the serial interval and generation
time of COVID-19
Authors: Griffin John , Casey Miriam , Collins Áine , Hunt Kevin , McEvoy David , Byrne Andrew , McAloon Conor , Barber Ann , Lane Elizabeth Ann , More SImon 
Published: November 2020

The serial interval is the time between symptom onsets in an
infector–infectee pair. The generation time, also known as the generation
interval, is the time between infection events in an infector–infectee pair.
The serial interval and the generation time are key parameters for assessing
the dynamics of a disease. A number of scientific papers reported
information pertaining to the serial interval and/or generation time for
COVID-19.

Objective
Conduct a review of available evidence to advise on appropriate
parameter values for serial interval and generation time in national
COVID-19 transmission models for Ireland and on methodological issues
relating to those parameters.

Methods
We conducted a rapid review of the literature covering the period 1
January 2020 and 21 August 2020, following predefined eligibility
criteria. Forty scientific papers met our inclusion criteria and were
included in the review.

Results
The mean of the serial interval ranged from 3.03 to 7.6 days, based
on 38 estimates, and the median from 1.0 to 6.0 days (based on 15
estimates). Only three estimates were provided for the mean of the
generation time. These ranged from 3.95 to 5.20 days. One estimate of
5.0 days was provided for the median of the generation time.

Discussion
Estimates of the serial interval and the generation time are very
dependent on the specific factors that apply at the time that the data
are collected, including the level of social contact. Consequently, the
estimates may not be entirely relevant to other environments. Therefore,
local estimates should be obtained as soon as possible. Careful
consideration should be given to the methodology that is used. Real-time
estimations of the serial interval/generation time, allowing for
variations over time, may provide more accurate estimates of
reproduction numbers than using conventionally fixed serial
interval/generation time distributions.
Community psychosocial music intervention (CHIME) to reduce antenatal common mental disorder symptoms in The Gambia: a feasibility trial
Authors: Sanfilippo Katie Rose M , McConnell Bonnie , Cornelius Victoria , Darboe Buba , Huma Hajara B , Gaye Malick , Ceesay Hassoum , Ramchandani Paul , Cross Ian , Glover Vivette , Stewart Lauren 
Published: November 2020

ObjectivesExamine the feasibility of a Community Health Intervention through Musical Engagement (CHIME) in The Gambia to reduce common mental disorder (CMD) symptoms in pregnant women.DesignFeasibility trial testing a randomised stepped-wedge cluster design.SettingFour local antenatal clinics.ParticipantsWomen who were 14–24 weeks pregnant and spoke Mandinka or Wolof were recruited into the intervention (n=50) or control group (n=74).InterventionMusic-based psychosocial support sessions designed and delivered by all-female fertility societies. Sessions lasted 1 hour and were held weekly for 6 weeks. Delivered to groups of women with no preselection. Sessions were designed to lift mood, build social connection and provide health messaging through participatory music making. The control group received standard antenatal care.OutcomesDemographic, feasibility, acceptability outcomes and the appropriateness of the study design were assessed. Translated measurement tools (Self-Reporting Questionnaire (SRQ-20); Edinburgh Postnatal Depression Scale (EPDS)) were used to assess CMD symptoms at baseline, post-intervention and 4-week follow-up.ResultsAll clinics and 82% of women approached consented to take part. A 33% attrition rate across all time points was observed. 72% in the intervention group attended at least three sessions. Audio and video analysis confirmed fidelity of the intervention and a thematic analysis of participant interviews demonstrated acceptability and positive evaluation. Results showed a potential beneficial effect with a reduction of 2.13 points (95% CI (0.89 to 3.38), p<0.01, n=99) on the SRQ-20 and 1.98 points (95% CI (1.06 to 2.90), p<0.01, n=99) on the EPDS at the post-intervention time point for the intervention group compared with standard care.ConclusionResults demonstrate that CHIME is acceptable and feasible in The Gambia. To our knowledge, CHIME is the first example of a music-based psychosocial intervention to be applied to perinatal mental health in a low- and middle-income country context.Trial registration numberPan African Clinical Trials Registry (PACTR201901917619299).
Associations between gestational diabetes mellitus and the neurodevelopment of offspring from 1 month to 72 months: study protocol for a cohort study
Authors: Li Chao , Zhou Ping , Cai Yixi , Peng Bin , Liu Yongfang , Yang Ting , Li Yinying , Hu Yirong , Fu Yajun , Wang Zhenming , Peng Hong , Zhang Yue , Chen Jie , Li Tingyu , Chen Li 
Published: November 2020

IntroductionGestational diabetes mellitus (GDM) is a common gestational disease and an important global public health problem. GDM may affect the short-term and long-term health of offspring, but the associations between GDM and the neurodevelopment of offspring of mothers with GDM (OGDM) are still unclear, and studies based on the Chinese population are lacking. We aim to determine the associations between GDM and the neurodevelopment of OGDM by studying a cohort of OGDM and offspring of non-GDM mothers.Methods and analysisThe single-centre prospective cohort study is being conducted in China over 7 years. A total of 490 OGDM (GDM group) and 490 fromof healthy mothers (control group) will be enrolled during the same period. Baseline characteristics, neuropsychological development scores and clinical data at specific time points (at 0, 1, 3, 6, 12, 24, 36, 48, 60 and 72 months old) will be collected from the children in both groups until the age of 6 years. The associations between GDM and the neurodevelopment of OGDM from infancy to preschool age will be analysed using a multiple linear regression model adjusted for confounders. In addition, we will compare longitudinal data to further assess the effects of GDM on neurodevelopmental trajectories.Ethics and disseminationThe study has been approved by the Ethics Committee of the Children’s Hospital of Chongqing Medical University (Approval Number: (2019) Institutional Review Board (IRB) (STUDY) No. 85). The findings of this study will be disseminated through open access journals, peer-reviewed journals and scientific meetings.Trial registration numberNCT03997396.