bluuebunny/crossref_metadata_2025_split huggingface dataset:
Establishing the reference interval for pulse oxygen saturation in neonates at high altitudes: protocol for a multicentre, open, cross-sectional study
Authors: Wang Bo , Liu Chongde , Yao Yanli , Lu Zhihui , Yu Rong , CaiRen Zhuoma , Wang Zhixiu , Liu Runwu , Wu Yazhen , Yu Zhangbin 
Published: May 2022

IntroductionEstablishing the reference interval for pulse oxygen saturation (SpO2) is essential for sensitively identifying neonatal hypoxaemia due to various causes. However, the reference interval for high altitudes has not yet been established, and existing studies have many limitations. This study will aim to establish the reference interval for various high altitudes and determine whether preductal and postductal measurements at the same altitude vary.Methods and analysisThis is a multicentre, open, cross-sectional study, which will begin in February 2022. Approximately 2000 healthy full-term singleton neonates will be recruited from six hospitals (altitude ≥2000 m) in Qinghai Province, China. The participating hospitals will use a uniform pulse oximeter type. The measurements will be performed between 24 hours after birth and discharge. During the measurement, the neonate will be awake and quiet. Preductal and postductal measurements will be performed. The measurement time, site and results will be recorded and input, along with the collected basic information, into the perinatal cloud database. We will carry out strict quality control for basic information collection, measurement and data filing. We will perform descriptive statistics on the distribution range of the collected data, determine the lower limit value of the reference interval for each hospital and the corresponding altitude, perform curve fitting for the lower limit value, use the altitude as a covariate for the function corresponding to the fitted curve, establish the prediction equation and ultimately determine the reference intervals of each high altitude location.Ethics and disseminationOur protocol has been approved by the Medical Ethics Committee of all participating hospitals. We will publish our study results in academic conferences and peer-reviewed public journals.Trial registration numberNCT05115721.
Advance care planning in amyotrophic lateral sclerosis (ALS): study protocol for a qualitative longitudinal study with persons with ALS and their family carers
Authors: Vandenbogaerde Isabel , Miranda Rose , De Bleecker Jan L , Carduff Emma , van der Heide Agnes , Van den Block Lieve , Deliens Luc , De Vleminck Aline 
Published: May 2022

IntroductionAmyotrophic lateral sclerosis (ALS) is an incurable motor neuron degenerative disease that has rapid progression and is associated with cognitive impairment. For people with ALS (pALS) and their family carers, advance care planning (ACP) is beneficial, as it can lead to feelings of control/relief and refusal of unwanted treatments. However, evidence concerning the experiences and preferences regarding ACP of pALS and their family carers, especially when their symptoms progress, is scarce. This article describes the protocol for a qualitative longitudinal study that aims to explore: (1) the experiences with ACP and the preferences for future care and treatment of pALS and their family carers and (2) how these experiences and preferences change over time.Methods and analysisA qualitative, longitudinal, multiperspective design. A total of eight to nine dyads (pALS and their family carers) will be recruited, and semistructured interviews administered every 3 months over a 9-month period. Qualitative longitudinal analysis involves content analysis via in-depth reading, followed by a two-step timeline method to describe changes in experiences and preferences within and across participants.Ethics and disseminationThis protocol has been approved by the central ethical committee of the University Hospital of Brussels, and local ethical committees of the other participating hospitals (B.U.N. B1432020000128). The results will be disseminated via the research group’s (endoflifecare.be) website, social media and newsletter and via presentations at national and international scientific conferences.
Treatment of Hidradenitis Suppurativa Evaluation Study (THESEUS): protocol for a prospective cohort study
Authors: Bates Janine , Stanton Helen , Cannings-John Rebecca , Thomas Kim Suzanne , Leighton Paul , Howells Laura M , Rodrigues Jeremy , Howes Rachel , Collier Fiona , Harris Ceri , Gibbons Angela , Thomas-Jones Emma , Hood Kerenza , Ingram John R 
Published: May 2022

BackgroundHidradenitis suppurativa (HS) is a chronic, painful, inflammatory skin disease with estimates of prevalence in the European population of 1%–2%. Despite being a relatively common condition, the evidence base for management of HS is limited. European and North American management guidelines rely on consensus for many aspects of treatment and within the UK variations in management of HS have been identified. The HS James Lind Alliance Priority Setting Partnership (PSP) published a top 10 list of future HS research priorities including both medical and surgical interventions. The aims of the THESEUS study are to inform the design of future HS randomised controlled trials (RCTs) and to understand how HS treatments are currently used. THESEUS incorporates several HS PSP research priorities, including investigation of oral and surgical treatments. Core outcome domains have been established by the HIdradenitis SuppuraTiva cORe outcomes set International Collaboration (HISTORIC) and THESEUS is designed to validate instruments to measure the domains.Methods and analysisThe THESEUS study is a prospective observational cohort study. Participants, adults with active HS of any severity, will be asked to select one of five HS treatment options that is appropriate for their HS care. Participants will be allocated to their chosen treatment intervention and followed for a period of up to 12 months. Outcomes will be assessed at 3-monthly intervals using HISTORIC core outcome instruments. Video recordings of the surgical and laser operations will provide informational and training videos for future trials. Nested mixed-methods studies will characterise the interventions in clinical practice, understand facilitators and barriers to recruitment into future HS RCTs and examine patients’ and clinicians’ perspectives on HS treatment choices.Trial registration numberISRCTN69985145.
Uncovering the effects of gender affirming hormone therapy on skeletal muscle and epigenetics: protocol for a prospective matched cohort study in transgender individuals (the GAME study)
Authors: Jones Patrice R , Voisin Sarah , Nolan Brendan J , Landen Shanie , Jacques Macsue , Newell Beau , Zwickl Sav , Cook Teddy , Wong Alex , Ginger Ariel , Palmer Andrew , Garnham Andrew , Alvarez-Romero Javier , Mohandas Namitha , Seale Kirsten , Cheung Ada , Eynon Nir 
Published: May 2022

IntroductionGender affirming hormone therapy (GAHT) is increasingly used by transgender individuals and leads to shifts in sex hormone levels. Skeletal muscle is highly responsive to hormone activity, with limited data on the effects of GAHT on different human tissues. Here, we present the protocol for the GAME study (the effects ofGenderAffirming hormone therapy on skeletalMuscle training andEpigenetics), which aims to uncover the effects of GAHT on skeletal muscle ‘omic’ profiles (methylomics, transcriptomics, proteomics, metabolomics) and markers of skeletal muscle health and fitness.Methods and analysisThis study is a prospective age-matched cohort study in transgender adults commencing GAHT (n=80) and age-matched individuals not commencing GAHT (n=80), conducted at Austin Health and Victoria University in Victoria, Australia. Assessments will take place prior to beginning GAHT and 6 and 12 months into therapies in adults commencing GAHT. Age-matched individuals will be assessed at the same time points. Assessments will be divided over three examination days, involving (1) aerobic fitness tests, (2) muscle strength assessments and (3) collection of blood and muscle samples, as well as body composition measurements. Standardised diets, fitness watches and questionnaires will be used to control for key confounders in analyses. Primary outcomes are changes in aerobic fitness and muscle strength, as well as changes in skeletal muscle DNA methylation and gene expression profiles. Secondary outcomes include changes in skeletal muscle characteristics, proteomics, body composition and blood markers. Linear mixed models will be used to assess changes in outcomes, while accounting for repeated measures within participants and adjusting for known confounders.Ethics and disseminationThe Austin Health Human Research Ethics Committee (HREC) and Victoria University HREC granted approval for this study (HREC/77146/Austin-2021). Findings from this project will be published in open-access, peer-reviewed journals and presented to scientific and public audiences.Trial registration numberACTRN12621001415897; Pre-results.
Genetics Adviser: a protocol for a mixed-methods randomised controlled trial evaluating a digital platform for genetics service delivery
Authors: Shickh Salma , Hirjikaka Daena , Clausen Marc , Kodida Rita , Mighton Chloe , Reble Emma , Sam Jordan , Panchal Seema , Aronson Melyssa , Graham Tracy , Armel Susan Randall , Glogowski Emily , Elser Christine , Eisen Andrea , Carroll June C , Shuman Cheryl , Seto Emily , Baxter Nancy N , Scheer Adena , Shastri-Estrada Serena , Feldman Geoff , Thorpe Kevin E , Schrader Kasmintan A , Lerner-Ellis Jordan , Kim Raymond H , Faghfoury Hanna , Bombard Yvonne 
Published: May 2022

IntroductionThe high demand for genetic tests and limited supply of genetics professionals has created a need for alternative service delivery models. Digital tools are increasingly being used to support multiple points in the genetic testing journey; however, none are transferable across multiple clinical specialties and settings nor do they encompass the entire trajectory of the journey. We aim to evaluate the effectiveness of the Genetics Adviser, an interactive, patient-facing, online digital health tool that delivers pre-test counselling, provides support during the waiting period for results, and returns results with post-test counselling, encompassing the entire patient genetic testing journey.Methods and analysisWe will compare the Genetics Adviser paired with a brief genetic counselling session to genetic counselling alone in a randomised controlled trial. One hundred and forty patients who previously received uninformative genetic test results for their personal and family history of cancer will be recruited from familial cancer clinics in Toronto and offered all clinically significant results from genomic sequencing. Participants randomised into the intervention arm will use the Genetics Adviser to learn about genomic sequencing, receive pre-test counselling, support during the waiting period and results, supplemented with brief counselling from a genetic counsellor. Participants in the control arm will receive standard pre-test and post-test counselling for genomic sequencing from a genetic counsellor. Our primary outcome is decisional conflict following pre-test counselling from the Genetics Adviser+genetic counsellor or counsellor alone. Secondary outcomes include: knowledge, satisfaction with decision-making, anxiety, quality of life, psychological impact of results, empowerment, acceptability and economic impact for patients and the health system. A subset of patients will be interviewed to assess user experience.Ethics and disseminationThis study has been approved by Clinical Trials Ontario Streamlined Research Ethics Review System (REB#20–035). Results will be shared through stakeholder workshops, national and international conferences and peer-reviewed journals.Trial registration numberNCT04725565.
Atrial cardiomyopathy in patients with ischaemic stroke: a cross-sectional and prospective cohort study—the COAST study
Authors: Larsen Bjørn Strøier , Aplin Mark , Høst Nis , Dominguez Helena , Christensen Hanne , Christensen Louisa Marguerite , Havsteen Inger , Prescott Eva , Jensen Gorm Boje , Vejlstrup Niels , Bertelsen Litten , Sajadieh Ahmad 
Published: May 2022

IntroductionDespite workup for the aetiology of ischaemic stroke, about 25% of cases remain unexplained. Paroxysmal atrial fibrillation is typically suspected but often not detected. Even if atrial fibrillation (AF) is detected, the quantitative threshold of clinically relevant AF remains unclear. Emerging evidence suggests that left atrial (LA) functional and structural abnormalities may convey a risk of ischaemic stroke in which AF is only one of several features. These abnormalities have been termed ‘atrial cardiomyopathy’. This study uses cardiac magnetic resonance (CMR) to evaluate atrial cardiomyopathy among patients with stroke of undetermined aetiology compared with those with an attributable mechanism and controls without established cardiovascular disease.Methods and analysisThis cross-sectional and prospective cohort study included 100 patients with recent ischaemic stroke and 50 controls with no established cardiovascular disease. The study will assess LA structural and functional abnormalities with CMR. Inclusion began in March 2019, and follow-up is planned to be complete in January 2023. There are two scheduled follow-ups: (1) 18 months after individual inclusion, counting from the index diagnostic MRI of the brain, (2) end of study follow-up at 18 months after inclusion of the last patient, assessing the incidence of recurrent ischaemic stroke, AF and cardiovascular death. The primary endpoint is the extent of CMR-assessed atrial fibrosis in the LA at baseline. The study is powered to detect a difference of 6% fibrosis between stroke of undetermined aetiology and stroke of known mechanism with a SD of 9%, a significance level of 0.05, and power of 80%.Ethics and disseminationThis study has been approved by the Danish National Committee on Health Research Ethics (H-18055313). All participants in the study signed informed consent. Results from the study will be published in peer-reviewed journals regardless of the outcome.Trial registration numberNCT03830983.
Cross-sectional study of the relationship between women’s representation among editors and peer reviewers in journals of the British Medical Journal Publishing Group
Authors: Pinho-Gomes Ana-Catarina , Vassallo Amy , Woodward Mark , Peters Sanne 
Published: May 2022

ObjectivesTo investigate whether there is an association between women’s representation as peer reviewers and editors of medical journals.MethodsIn this cross-sectional study, the gender of editors and peer reviewers of journals of the British Medical Journal Publishing Group (BMJ-PG) in 2020 was determined based on given names. Trends over time were analysed for the BMJ between 2009 and 2017.ResultsOverall, this study included 47 of the 74 journals in the BMJ-PG. Women accounted for 30.2% of the 42 539 peer reviewers, with marked variation from 8% to 50%. Women represented 33.4% of the 555 editors, including 19.2% of the 52 editors-in-chief. There was a moderate positive correlation between the percentage of women as editors and as reviewers (Spearman correlation coefficient 0.590; p<0.0001). The percentage of women as editors, excluding editors-in-chief, was higher when the editor-in-chief was a woman than a man (53.3% vs 29.2%, respectively; p<0.0001). Likewise, the percentage of women as peer reviewers was higher in journals that had a woman as editor-in-chief in comparison with a man (32.0% vs 26.4%, respectively; p<0.0001). There was a slight increase in the percentage of women as peer reviewers from 27.3% in 2009 to 29.7% in 2017 in the BMJ.ConclusionsWomen account for less than one in three peer reviewers of medical journals. Women’s representation as peer reviewers is higher in journals with higher percentage of women as editors or with a woman as editor-in-chief. It is, thus, imperative to address the persisting gender gap at all levels of the publishing system.
Online synchronous chat counselling for young people aged 12–25: a mixed methods systematic review protocol
Authors: Tibbs Maria , O'Reilly Aileen , Dwan O'Reilly Maeve , Fitzgerald Amanda 
Published: May 2022

IntroductionYouth mental health is a global issue, with 75% of many serious mental health difficulties emerging before the age of 25. An increase in the popularity of online counselling for young people’s mental health has been seen in recent years, due to their accessibility, cost-effectiveness and reduced stigmatising effects. Online synchronous chat counselling consists of real-time, text-based, one-to-one chats with a mental health professional and/or trained volunteer. Literature to date examining the effectiveness of these interventions has been limited, and little is known about their design features, their acceptance, effectiveness and the therapeutic processes that contribute to their working.Methods and analysisA mixed-methods systematic review of the literature will be conducted. PsycINFO MEDLINE, CINAHL, Web of Science and relevant grey literature will be searched for peer-reviewed, English language studies between January 1995 and June 2021. Backward and forward reference checking will be conducted. Quality of included articles will be examined using the Mixed Methods Appraisal Tool and a combination of the TIDieR checklist and a prepopulated data table will be used for extraction. A mixed methods review adopting a convergent-integrated design will be employed. Quantitative data will be transformed and analysed simultaneously alongside qualitative data using narrative synthesis.Ethics and disseminationThe research does not require ethical approval. Findings will be disseminated through peer-reviewed publications, academic conference presentations, academic social media and invited workshops, webinars and seminars.PROSPERO registration numberCRD42021256016.
Protocol of a mixed-method randomised controlled pilot study evaluating a wilderness programme for adolescent and young adult cancer survivors: the WAYA study
Authors: Jong Miek C , Mulder Eric , Kristoffersen Agnete E , Stub Trine , Dahlqvist Heléne , Viitasara Eija , Lown E Anne , Schats Winnie , Jong Mats 
Published: May 2022

IntroductionThe majority of childhood, adolescent and young adult (AYA) cancer survivors suffer from long-term and late effects such as fatigue, psychological distress or comorbid diseases. Effective health promotion strategies are needed to support the health of this vulnerable group. This protocol provides a methodological description of a study that aims to examine the feasibility and safety of performing a randomised clinical trial (RCT) on a wilderness programme that is developed to support the health of AYA cancer survivors.Methods and analysisThe pilot RCT study has a mixed-method design, including quantitative and qualitative evaluations. Participants are AYAs, aged 16–39 years, that have been diagnosed with cancer during childhood, adolescence or young adulthood. A total of 40 participants will be randomly assigned to a wilderness programme (n=20) or a holiday programme (n=20). Both arms include participation in an 8-day summer programme, followed by a 4-day programme 3 months later. Primary outcomes are feasibility and safety parameters such as time to recruitment, willingness to be randomised, programme adherence and adverse effects. Secondary outcomes include self-reported health such as self-esteem, quality of life, self-efficacy and lived experiences. Descriptive statistics will be used to analyse outcomes and explore indications of differences between the programmes. Interviews are analysed by directed content analysis and hermeneutic phenomenology. A convergent parallel mixed-method analysis design will be applied to integrate quantitative and qualitative data. Results of this feasibility study will inform the preparation for a larger RCT with AYA cancer survivors.Ethics and disseminationThe study protocol is approved by the Swedish Ethical Review Authority (reference: 2020-00239). This study will be performed between January 2021 and December 2023. Results will be published in international peer-reviewed journals, presented at conferences and disseminated to participants, cancer societies, healthcare professionals and outdoor instructors.Trial registration numberNCT04761042.
Study protocol for CELLAR (COVID-related Eating Limitations and Latent dietary effects in the Atlantic Region): population-based observational study to monitor dietary intakes and purchasing during COVID-19 in four Atlantic Canadian provinces
Authors: Mah Catherine L , Foster Karen , Jago Emily , Hajizadeh Mohammad , Luongo Gabriella , Taylor Nathan , Fuller Daniel , Yi Yanqing , Esan Olukorede T , Lukic Ryan , Clarke Maria , Wranik Wiesława Dominika , Brimblecombe Julie Kay , Peeters Anna 
Published: May 2022

IntroductionPoor diet is a leading preventable risk for the global burden of non-communicable disease. Robust measurement is needed to determine the effect of COVID-19 on dietary intakes and consumer purchasing, given the widespread changes to consumer food environments and economic precarity. The research objectives are as follows: (1) describe dietary intakes of foods, beverages and nutrients of concern during the COVID-19 pandemic; (2) quantify change in diet during COVID-19 as compared with prepandemic, previously captured in the provincial samples of the population-representative 2015 Canadian Community Health Survey-Nutrition and (3) examine how household purchasing practices predict dietary intakes during COVID-19.Methods and analysesObservational study of diet, using a population-based stratified probability sampling strategy allocated via dual-frame (landline and cellphone) calls to random-digit dialled numbers, followed by age-sex group quotas. The base population comprises the four provinces of the Atlantic region of Canada, jurisdictions with an excess burden of pre-existing dietary risk, compared with the rest of Canada. Our aim is n=1000 to obtain reliable estimates at a regional level to describe intakes and compare with prepandemic baseline. Data collection entails 12 weeks participation: (1) enrolment with sociodemographics (key dietary risk predictors such as age, sex, gender, pre-COVID-19 income, employment, household composition, receipt of economic relief, rural residence); (2) two 24hour diet recalls using the online ASA-24 Canada 2018 tool; and (3) online uploads of household food purchase receipts over the 12 weeks enrolled. Participation incentives will be offered.Ethics and disseminationThis research protocol received funding from the Canadian Institutes of Health Research (FRN VR5 172691) and ethics review approval from the Dalhousie University Research Ethics Board. Study protocol and instruments and a de-identified dataset will be made publicly available. We will submit the findings to peer-reviewed journals, as well as conferences geared towards scientific and decision-maker audiences.