bluuebunny/crossref_metadata_2025_split huggingface dataset:
Randomised controlled trial of the effects of kefir on behaviour, sleep and the microbiome in children with ADHD: a study protocol
Authors: Lawrence Kate , Fibert Philippa , Hobbs Jemima , Myrissa Kyriaki , Toribio-Mateas Miguel A , Quadt Frits , Cotter Paul D , Gregory Alice M 
Published: December 2023

IntroductionCurrent interventions for children with attention-deficit/hyperactivity disorder (ADHD) are primarily medication, behavioural therapy and parent training. However, research suggests dietary manipulations may provide therapeutic benefit for some. There is accumulating evidence that the gut microbiome may be atypical in ADHD, and therefore, manipulating gut bacteria in such individuals may help alleviate some of the symptoms of this condition. The aim of this study is to explore the effects of supplementation with kefir (a fermented dairy drink) on ADHD symptomatology, sleep, attention and the gut microbiome in children diagnosed with ADHD.Methods and analysisA 6-week randomised, double-blind, placebo-controlled trial in 70 children aged 8–13 years diagnosed with ADHD. Participants will be recruited throughout the UK, through support groups, community groups, schools, social media and word of mouth. Children will be randomised to consume daily either dairy kefir or a placebo dairy drink for 6 weeks. The primary outcome, ADHD symptomatology, will be measured by The Strengths and Weakness of ADHD-symptoms and Normal-behaviour scale. Secondary outcomes will include gut microbiota composition (using shotgun metagenomic microbiome sequencing), gut symptomatology (The Gastrointestinal Severity Index questionnaire), sleep (using 7-day actigraphy recordings, The Child’s Sleep Habits Questionnaire and Sleep Self Report questionnaire), inattention and impulsivity (with a computerised Go/NoGo test). Assessments will be conducted prior to the intervention and at the end of the intervention. Interaction between time (preintervention/postintervention) and group (probiotic/placebo) is to be analysed using a Mixed Model Analysis of Variances.Ethics and disseminationEthical approval for the study was granted by St Mary’s University Ethics Committee. Results will be disseminated through peer-reviewed publications, presentations to the scientific community and support groups.Trial registration numberNCT05155696.
Experiences and management needs of endocrine therapy-related symptoms in patients with breast cancer: a systematic review and qualitative evidence synthesis protocol
Authors: Wang Lijie , Wei Tao , Liu Jiahui , Peng Siyi , Chen Jiejun , Hu Meihong , Li Xuying 
Published: December 2023

IntroductionPatients with breast cancer and endocrine therapy-related symptoms often experience pain, self-denial, anxiety, fear of recurrence and despair, which can be extremely physically and psychologically traumatising for the patients. Failure to receive effective support and management reduces adherence to medications, leading to a higher risk of relapse and mortality. Clearly, it is paramount to identify what support these patients may need and how to meet their symptom management needs. This paper outlines a protocol to synthesise qualitative evidence on endocrine therapy symptom experiences, management expectations and preferences of patients with breast cancer.Methods and analysisThe following databases were searched in November 2023 with no date restriction applied: The Cochrane Library, PubMed, Embase, Web of Science, Scopus, CINAHL and OpenGrey. Published studies on qualitative or mixed-method on symptom experiences and management needs during endocrine therapy in patients with breast cancer will be retrieved. We will also search for reference lists and perform a forward citation search. Before inclusion in this review, two reviewers will independently apply the Joanna Briggs Institute (JBI) Critical Appraisal Checklist for Qualitative Research to ensure methodological validity. Any disagreements regarding the evaluation of the articles will be resolved through discussion with or by a third reviewer. Data will be extracted using the standardised data extraction tool EndNote20 for unified management, assessment, and review of information. The common sense model of self-regulation will guide data extraction and synthesis. The final synthesised findings will be graded according to the GRADE-CERQual approach to establish confidence.Ethics and disseminationThis systematic review addressed previously published studies without personally identifiable participant information. Ethical approval from the research committee was not required. The findings of this systematic review will be disseminated to various key stakeholders and published in peer-reviewed journals.PROSPERO registration numberCRD42023406987
Factors guiding gastrostomy tube decision-making for caregivers of children with cystic fibrosis: a scoping review protocol
Authors: Zientek Emily , Rane Sanika , Godfrey Chelsea , Sisson Amy , Dickinson Kimberly M. 
Published: December 2023

IntroductionWhile ensuring appropriate growth is essential for all children, optimising nutritional status in children with cystic fibrosis (CF) is critical for improving health outcomes. Nutritional challenges in CF are multifactorial and malnutrition is common. While gastrostomy tubes (G-tubes) can improve weight status in individuals with CF, they also have common and chronic complications resulting in clinical equipoise. To date, factors influencing G-tube decision-making among caregivers of children with CF have not been systematically explored. This review aims to chart existing knowledge about caregivers’ decisional needs related to G-tube placement, with a focus on caregivers of children with CF, as well as known medical and psychosocial benefits and risks of G-tube feedings in paediatric care.Methods and analysisThis scoping review will follow the JBI methodological framework. We will include articles published between 1 January 1985 and 1 November 2023 in English and Spanish from MEDLINE (Ovid), Embase, CINAHL, PsycInfo, Cochrane Database of Systematic Reviews and Web of Science related to G-tube decision-making. Articles published in languages besides English and Spanish will be excluded. Articles will be screened for final eligibility and inclusion according to title and abstract, followed by full texts. Articles will be independently reviewed by two reviewers and any disagreements discussed with a third reviewer for consensus. We will map themes and concepts, and data extracted will be presented in tabular, diagrams and descriptive summaries.Ethics and disseminationAs a form of secondary analysis, scoping reviews do not require ethics approval. This review will inform future research with caregivers involved in G-tube decision-making for children with CF. The final review will be submitted to a peer-reviewed scientific journal, disseminated at relevant academic conferences and will be shared with patients and clinicians.Trial registration numberCenter for Open Science.https://osf.io/g4pdb.
ARCHERY: a prospective observational study of artificial intelligence-based radiotherapy treatment planning for cervical, head and neck and prostate cancer – study protocol
Authors: Aggarwal Ajay , Court Laurence Edward , Hoskin Peter , Jacques Isabella , Kroiss Mariana , Laskar Sarbani , Lievens Yolande , Mallick Indranil , Abdul Malik Rozita , Miles Elizabeth , Mohamad Issa , Murphy Claire , Nankivell Matthew , Parkes Jeannette , Parmar Mahesh , Roach Carol , Simonds Hannah , Torode Julie , Vanderstraeten Barbara , Langley Ruth 
Published: December 2023

IntroductionFifty per cent of patients with cancer require radiotherapy during their disease course, however, only 10%–40% of patients in low-income and middle-income countries (LMICs) have access to it. A shortfall in specialised workforce has been identified as the most significant barrier to expanding radiotherapy capacity. Artificial intelligence (AI)-based software has been developed to automate both the delineation of anatomical target structures and the definition of the position, size and shape of the radiation beams. Proposed advantages include improved treatment accuracy, as well as a reduction in the time (from weeks to minutes) and human resources needed to deliver radiotherapy.MethodsARCHERY is a non-randomised prospective study to evaluate the quality and economic impact of AI-based automated radiotherapy treatment planning for cervical, head and neck, and prostate cancers, which are endemic in LMICs, and for which radiotherapy is the primary curative treatment modality. The sample size of 990 patients (330 for each cancer type) has been calculated based on an estimated 95% treatment plan acceptability rate. Time and cost savings will be analysed as secondary outcome measures using the time-driven activity-based costing model. The 48-month study will take place in six public sector cancer hospitals in India (n=2), Jordan (n=1), Malaysia (n=1) and South Africa (n=2) to support implementation of the software in LMICs.Ethics and disseminationThe study has received ethical approval from University College London (UCL) and each of the six study sites. If the study objectives are met, the AI-based software will be offered as a not-for-profit web service to public sector state hospitals in LMICs to support expansion of high quality radiotherapy capacity, improving access to and affordability of this key modality of cancer cure and control. Public and policy engagement plans will involve patients as key partners.
Economic evaluation of serplulimab plus chemotherapy as the first-line treatment of oesophageal squamous cell carcinoma in China
Authors: Chen Fang , Long Yunchun , Yang Jiayong , Zhong Kailong , Liu Bili 
Published: December 2023

ObjectiveThe ASTRUM-007 study confirmed the significant efficacy and safety of serplulimab plus chemotherapy for patients with locally advanced/metastatic, programmed cell death-ligand 1 positive oesophageal squamous cell carcinoma (OSCC). The economics of this regimen, however, is unclear. Therefore, this study aimed to evaluate the cost-effectiveness of adding serplulimab to chemotherapy for the treatment of advanced OSCC from the perspective of the Chinese healthcare system.DesignA partitioned survival model was established to simulate the costs and outcomes of chemotherapy versus serplulimab plus chemotherapy. The survival data came from the ASTRUM-007 study. Only direct medical costs were considered, and utility values were referred to the literature. Sensitivity analysis was performed to assess the effect of parameter uncertainty on the model.Outcome measuresTotal costs, incremental costs, life years, quality-adjusted life years (QALYs), incremental QALYs and incremental cost-effectiveness ratio (ICER).ResultsThe base case analysis showed that the cost of serplulimab plus chemotherapy (US$69 356) was US$41 607 higher than that of chemotherapy (US$27 749), but it also gained 0.38 QALYs more (1.38 vs 1 QALYs), with an ICER of US$110 744.36/QALY, which was higher than the willingness to pay. The factors that most influenced the ICER were the price of serplulimab, weight and utility value of the progression-free survival stage. The subgroup analysis and scenario analysis also demonstrated that serplulimab plus chemotherapy was not economical.ConclusionsCompared with chemotherapy, serplulimab coupled with chemotherapy was not cost-effective for the treatment of advanced OSCC in China.
Willingness to vaccinate against herpes zoster in Chinese urban population: a mixed-methods study
Authors: Wang Ming , Hu Mingzheng , Wang Yanshang , Long Chao , Xia Yiqi , Zhu Dawei , Zhao Weiying , Yuan Beibei , He Ping 
Published: December 2023

ObjectiveAlthough the herpes zoster vaccine has been available in mainland China since June 2020, residents’ knowledge of herpes zoster and the herpes zoster vaccine is poor, and vaccination rates are low, especially among the elderly, who are at high risk for herpes zoster. This study assessed willingness to be vaccinated against herpes zoster and factors associated with vaccination among urban residents in China.MethodsA mixed-methods study was conducted in community health centres from August 2022 to September 2022. We used convenience sampling to select 2864 residents from 9 Chinese cities for the quantitative study and 67 adults for the qualitative study. A structured questionnaire was used for the quantitative study, and data were collected through face-to-face interviews. Multinomial logistic regression was used to analyse factors associated with willingness to vaccinate. Qualitative data were analysed using thematic analysis of barriers to herpes zoster vaccination.ResultsA total of 2864 eligible respondents were included in the study. Of these, 42.67% intended to receive the herpes zoster vaccine, 21.44% refused and 35.89% were hesitant. The results of the quantitative and qualitative analyses showed that the factors associated with respondents’ willingness to be vaccinated against herpes zoster included: personal characteristics such as gender, age and income; knowledge and attitudes about herpes zoster and the vaccine; vaccine characteristics such as efficacy, safety and price; and other factors such as pain tolerance and accessibility to vaccination.ConclusionThe low willingness to vaccinate, especially among the elderly, is mainly related to their poor knowledge and negative attitude towards the infection and vaccination. Therefore, health education about herpes zoster, immunisation promotion, and improvement of accessibility and affordability would be valuable in China.
Access, Relationships, Quality and Safety (ARQS): a qualitative study to cocreate an Indigenous patient experience tool for virtual primary care
Authors: Roach Pamela , Campbell Paige , Ody Meagan , Scott Melissa , Barnabe Cheryl , Montesanti Stephanie , Kennedy Andrea , Murry Adam , Tailfeathers Esther , Crowshoe Lynden 
Published: December 2023

BackgroundPerspectives from Indigenous peoples and their primary care providers about the quality and impacts of virtual primary care for Indigenous patients are currently limited. This study engaged Indigenous patients and their primary care providers, resulting in four domains being established for an Indigenous patient experience tool for use in virtual primary care. In this paper, we explore the development and finalisation of the Access, Relationships, Quality and Safety (ARQS) tool.MethodsWe re-engaged five Indigenous patient participants who had been involved in the semistructured interviews that established the ARQS tool domains. Through cognitive interviews, we tested the tool statements, leading to modifications. To finalise the tool statements, an Indigenous advisory group was consulted.ResultsThe ARQS tool statements were revised and finalised with twelve statements that reflect the experiences and perspectives of Indigenous patients.DiscussionThe ARQS tool statements assess the four domains that reflect high-quality virtual care for Indigenous patients. By centring Indigenous peoples and their lived experience with primary care at every stage in the tool’s development, it captures Indigenous-centred understandings of high-quality virtual primary care and has validity for use in virtual primary care settings.ConclusionThe ARQS tool offers a promising way for Indigenous patients to provide feedback and for clinics to measure the quality and safety of virtual primary care practice on the provider and/or clinic level. This is important, as such feedback may help to promote improvements in virtual primary care delivery for Indigenous patients and more widely, may help advance Indigenous health equity.
A realist review of medication optimisation of community dwelling service users with serious mental illness
Authors: Howe Jo , MacPhee Maura , Duddy Claire , Habib Hafsah , Wong Geoff , Jacklin Simon , Oduola Sheri , Upthegrove Rachel , Carlish Max , Allen Katherine , Patterson Emma , Maidment Ian 
Published: December 2023

BackgroundSevere mental illness (SMI) incorporates schizophrenia, bipolar disorder, non-organic psychosis, personality disorder or any other severe and enduring mental health illness. Medication, particularly antipsychotics and mood stabilisers are the main treatment options. Medication optimisation is a hallmark of medication safety, characterised by the use of collaborative, person-centred approaches. There is very little published research describing medication optimisation with people living with SMI.ObjectivePublished literature and two stakeholder groups were employed to answer: What works for whom and in what circumstances to optimise medication use with people living with SMI in the community?MethodsA five-stage realist review was co-conducted with a lived experience group of individuals living with SMI and a practitioner group caring for individuals with SMI. An initial programme theory was developed. A formal literature search was conducted across eight bibliographic databases, and literature were screened for relevance to programme theory refinement. In total 60 papers contributed to the review. 42 papers were from the original database search with 18 papers identified from additional database searches and citation searches conducted based on stakeholder recommendations.ResultsOur programme theory represents a continuum from a service user’s initial diagnosis of SMI to therapeutic alliance development with practitioners, followed by mutual exchange of information, shared decision-making and medication optimisation. Accompanying the programme theory are 11 context-mechanism-outcome configurations that propose evidence-informed contextual factors and mechanisms that either facilitate or impede medication optimisation. Two mid-range theories highlighted in this review are supported decision-making and trust formation.ConclusionsSupported decision-making and trust are foundational to overcoming stigma and establishing ‘safety’ and comfort between service users and practitioners. Avenues for future research include the influence of stigma and equity across cultural and ethnic groups with individuals with SMI; and use of trained supports, such as peer support workers.PROSPERO registration numberCRD42021280980.
Risk factors for injury complaints leading to restricted participation in Athletics (Track and Field): a secondary analysis of data from 320 athletes over one season
Authors: Edouard Pascal , Tondut Jeanne , Hollander Karsten , Dandrieux Pierre-Eddy , Navarro Laurent , Bruneau Antoine , Junge Astrid , Blanco David 
Published: December 2023

ObjectiveTo investigate if several potential risk factors were associated with time to injury complaints leading to participation restriction in Athletics (ICPR).MethodsWe performed a secondary analysis of data collected during 39 weeks of the 2017–2018 Athletics season in a cluster-randomised controlled trial (‘PREVATHLE’). Univariate and multivariable analyses using Cox regression models were performed to analyse the association between the time to first ICPR and potential risk factors collected (1) at baseline: sex, age, height, body mass, discipline, the usual duration of Athletics training and non-specific sports training, ICPR in the preceding season (yes/no), ICPR at baseline (yes/no); (2) weekly during the season: duration and intensity of Athletics training and competition, and non-specific sports training, fitness subjective state, sleep duration and illness (yes/no); and (3) combined.ResultsData from 320 athletes were included; 138 (43.1%) athletes reported at least one ICPR during the study follow-up. The combined multivariable analyses revealed that the risk of ICPR at any given time was significantly higher in athletes with a pre-existing ICPR (hazard rate ratio, HRR 1.90, 95% CI 1.15 to 3.15; p=0.012) and lower in athletes with a higher fitness subjective state (HRR 0.63, 95% CI 0.55 to 0.73; p<0.001) and who had had at least one illness during the season (HRR 0.42, 95% CI 0.29 to 0.62; p<0.001).ConclusionsOur results provide new insights into injury risk factors in Athletics that could help with potential injury risk reduction strategies. These could be to explore the pre-existing injury presence at the season’s beginning and to monitor the fitness subjective state and illnesses occurrence during the season.Trial registrationClinicalTrials.gov Identifier:NCT03307434
Facility-based approach for the management of acute ST segment elevation myocardial infarction with cardiogenic shock in a rural medical centre: the Durango model
Authors: Carter Andrew Joseph , Raffoul Jad , Lane Linden , LeSage Leah , Langenhorst Shelley , Smolin Matthew , Dempsey Michael , Hughes David , Gleason Michael , Weiss Steven , Anderson William D 
Published: December 2023

IntroductionCardiogenic shock (CS) complicates 5%–15% of cases of acute myocardial infarction (AMI) with inpatient mortality greater than 40%. The implementation of standardised protocols may improve clinical outcomes in patients with AMI-CS.Methods and analysisThe Durango model is a prospective single-centre registry designed to enable early identification of patients with STEMI-CS to facilitate primary reperfusion therapy with a shock team management algorithm in a rural level II heart attack centre. This prospective registry includes all patients >18 years of age presenting with STEMI with or without CS beginning on 1 February 2023. The primary outcome measures are adherence to model-based documentation of SCAI shock Classification prehospital and in the ED with appropriate STEMI shock alert for AMI and stages C, D, E shock; use of mechanical circulatory support Pre-PCI and door to support time <90 min.Ethics and disseminationThis study was approved by the Institutional Review Board with a waiver of informed consent. The findings will be submitted for publication in a peer-review open access journal on completion of the study.ConclusionsThe Durango model will demonstrate that the implementation of a STEMI shock team can be feasible in a rural medical centre through comprehensive education of a diverse group providers with different levels of experience, continuous model/device proficiency training and performance feedback.
Diffusing capacity of lungs for carbon monoxide associated with subclinical myocardial impairment in systemic sclerosis: A cardiac MR study
Authors: He Huilin , Tong Xinyu , Ning Zihan , Zhou Jiaxin , Du Chenlin , Wang Yuhua , Wang Qian , Xu Dong , Zeng Xiaofeng , He Zuo-Xiang , Zhao Xihai 
Published: December 2023

BackgroundSystemic sclerosis (SSc) is characterised by microvascular and fibrotic lesions, which are located not only in skin but also in lungs and heart.ObjectiveThis study aimed to investigate the association between lung function and myocardial T1 values using cardiac MR (CMR) imaging in patients with SSc without cardiovascular symptoms.MethodsThe SSc patients and age- and sex-matched healthy subjects underwent CMR. The cardiac function and native T1 values of myocardium and lung function were measured. Spearman’s rank correlations and linear regression analyses were performed to determine the association between lung function and myocardial T1.ResultsForty-five SSc patients (aged 47.7±13.2 years, 40 females) and 23 (aged 46.0±14.4 years, 20 females) healthy subjects were enrolled. SSc patients exhibited considerably higher native T1 values compared with healthy subjects (1305.9±49.8 ms vs 1272.6±37.6 ms, p=0.006). Linear regression analysis revealed that decrease of diffusing capacity of lungs for carbon monoxide (DLCO) in SSc patients was notably associated with myocardial native T1 value before (β –1.017; 95% CI –1.883 to –0.151; p=0.022) and after adjusting for confounding factors (β –1.108; 95% CI −2.053 to –0.164; p=0.023). Moderate-to-severe decrease of DLCO was found to be significantly associated with myocardial native T1 value (β 48.006; 95% CI 17.822 to 78.190; p=0.003) after adjusting for confounding factors.ConclusionDLCO inversely correlates with myocardial native T1 values in SSc patients, particularly moderate-to-severely decreased DLCO, suggesting that DLCO might be a potential indicator for subclinical myocardial impairment in SSc patients.