bluuebunny/crossref_metadata_2025_split huggingface dataset:
Mental Imagery to Reduce Alcohol-related harm in patients with alcohol dependence and alcohol-related liver damaGE: the MIRAGE pilot trial protocol
Authors: Dhanda Ashwin D , Allende Hannah , Allgar Victoria , Andrade Jackie , Bailey Matthew Peter , Callaghan Lynne , Cocking Laura , Goodwin Elizabeth , Hawton Annie , Hayward Christopher , Hudson Ben , Jeffery Alison , King Angela , Lavers Victoria , Lomax Joe , McCune C Anne , Parker Richard , Rollinson Christopher , Wilks Jonny , Creanor E Siobhan 
Published: November 2022

Introduction
In the UK, alcohol use is the main driver of chronic liver disease and each year results in over 1 million unplanned hospital admissions and over 25 000 deaths from alcohol-related liver disease (ArLD). The only effective treatment to prevent progression of liver damage is reducing or ceasing alcohol consumption. Psychological and pharmacological therapies for alcohol misuse are ineffective in patients with ArLD. Functional imagery training (FIT) is a novel psychological therapy that builds on motivational interviewing techniques with multisensory imagery. This pilot trial aims to test the feasibility of training alcohol liaison nurses to deliver FIT therapy and of recruiting and retaining patients with ArLD and alcohol dependence to a randomised trial of FIT and treatment as usual (TAU) versus TAU alone.

Methods and analysis
This is a randomised pilot trial of FIT and TAU versus TAU alone in 90 patients with ArLD and alcohol dependence admitted to one of four UK centres. The primary objectives are to estimate rates of screening, recruitment, randomisation, retention, adherence to FIT/TAU and a preliminary assessment of the FIT intervention in the ArLD population. Data from the pilot study will be used to finalise the design of a definitive randomised controlled trial to assess the effectiveness and cost-effectiveness of FIT. The proposed primary outcome measure for the definitive trial is self-reported alcohol use assessed using timeline follow-back.

Ethics and dissemination
Research ethics approval was given by the Yorkshire and Humber–Bradford Leeds Research Ethics Committee (reference: 21/YH/0044). Eligible patients will be approached and written informed consent obtained prior to participation. Results will be disseminated through peer-reviewed open access journals, international conferences and a lay summary published on the Trials Unit website and made available to patient groups.

Trial registration number

NCT41353774.
Women’s EmotionS, Trauma and EmpowErMent (W-ES.T.EEM) study protocol: a psychoeducational support intervention for victims of domestic violence – a randomised controlled trial
Authors: Taccini Federica , Rossi Alessandro Alberto , Mannarini Stefania 
Published: November 2022

IntroductionIntimate partner violence (IPV) is a widespread phenomenon that affects the physical and mental well-being of victims. Several barriers prevented sufferers from receiving face-to-face interventions. These obstacles increased with the advent of the COVID-19 pandemic, and online psychological intervention can represent a valid solution to increase the well-being of IPV victims. This manuscript describes the study protocol for a single blind randomised controlled trial that examines the efficacy of a web-based psychoeducational intervention for IPV victims that integrates dialectical behavioural therapy and the empowerment approach.Methods and analysisEighty-six women who were victims of IPV during the COVID-19 outbreak will be recruited by the Interdepartmental Center for Family Research (CIRF) staff from the several antiviolence centres located in Italy. Participants will be randomly allocated to the Women’s EmotionS, Trauma and EmpowErMent experimental group or the treatment as usual control condition. Both interventions will be administered individually to each woman.Ethics and disseminationThe study protocol was approved by the Ethics Committee of the University of Padua (protocol no 4300). Written informed consent will be obtained from all research participants before study entry. Study results will be published as peer-reviewed articles. Any relevant protocol changes will be reported in the published articles. The results will be reported anonymously.Trial registration numberNCT12880309.
Vitamin D status in children and its association with glucose metabolism in northern China: a combination of a cross-sectional and retrospective study
Authors: Liu Junyi , Fu Liqun , Jin Shanshan , Jia Yubing , Zhang Jingyi , Sun Changhao , Na Lixin 
Published: November 2022

ObjectivesThis study aimed to explore the vitamin D status of children in northern China and the association between vitamin D and glucose metabolism.DesignCross-sectional study was conducted among child participants and retrospective study designs were conducted among adult participants.Setting and participantsBoth studies were recruited from Harbin, 326 children were included in children’s study, 8469 adults were included in adult study.Primary and secondary outcome measuresPhysical examination, lifestyle and dietary habit data were recorded in all the participants. Serum insulin, glucose, 25(OH)D3concentrations in children and serum glucose and lipids levels in adults were measured. Rickets history was also investigated in adults, which was used to define vitamin D deficiency in childhood. The associations were tested by linear regression and binary logistic regression.ResultIn the children’s study, only 10.7% of participants were vitamin D sufficient (≥30 ng/mL). Inverse correlations between serum 25(OH)D3concentration and fasting insulin and homeostasis model assessment - insulin resistance (HOMA-IR) were found, and children with lower serum 25(OH)D3concentrations were likely to have insulin resistance (IR) (OR: 0.955, 95% CI: 0.917 to 0.995, p value: 0.027). In an adult study, rickets in childhood increased the risk of type 2 diabetes in male participants (OR=1.414, 95% CI=1.013 to 1.972; p value=0.042), but this result was not observed in female participants.ConclusionOur findings suggest that vitamin D deficiency is widespread in northern China. Vitamin D deficiency in childhood was associated with IR and increased the risk of type 2 diabetes in male adults.
Gestational diabetes mellitus and offspring’s carotid intima–media thickness at birth: MySweetHeart Cohort study
Authors: Epure Adina Mihaela , Di Bernardo Stefano , Mivelaz Yvan , Estoppey Younes Sandrine , Chiolero Arnaud , Sekarski Nicole 
Published: November 2022

Objective
Hyperglycaemia during pregnancy is associated with cardiometabolic risks for the mother and the offspring. Mothers with gestational diabetes mellitus (GDM) have signs of subclinical atherosclerosis, including increased carotid intima–media thickness (CIMT). We assessed whether GDM is associated with increased CIMT in the offspring at birth.

Design and setting
MySweetHeart Cohort is a prospective cohort study conducted in Switzerland.

Participants, exposure and outcome measures
This work included pregnant women with and without GDM at 24–32 weeks of gestation and their singleton live-born offspring with data on the primary outcome of CIMT. GDM was diagnosed based on the criteria of the International Association of Diabetes and Pregnancy Study Groups. Offspring’s CIMT was measured by ultrasonography after birth (range 1–19 days).

Results
Data on CIMT were available for 99 offspring of women without GDM and 101 offspring of women with GDM. Maternal age ranged from 18 to 47 years. Some 16% of women with GDM and 6% of women without GDM were obese. Smoking during pregnancy was more frequent among women with GDM (18%) than among those without GDM (4%). Neonatal characteristics were comparable between the two groups. The difference in CIMT between offspring of women with and without GDM was of 0.00 mm (95% CI −0.01 to 0.01; p=0.96) and remained similar on adjustment for potential confounding factors, such as maternal prepregnancy body mass index, maternal education, smoking during pregnancy, family history of diabetes, as well as offspring’s sex, age, and body surface area (0.00 mm (95% CI −0.02 to 0.01; p=0.45)).

Conclusions
We found no evidence of increased CIMT in neonates exposed to GDM. A longer-term follow-up that includes additional vascular measures, such as endothelial function or arterial stiffness, may shed further light on the cardiovascular health trajectories in children born to mothers with GDM.

Trial registration number

NCT02872974; Pre-results.
Effect of lifting COVID-19 restrictions on utilisation of primary care services in Nepal: a difference-in-differences analysis
Authors: Kapoor Neena R , Aryal Amit , Mehata Suresh , Dulal Mahesh , Kruk Margaret E , Bauhoff Sebastian , Arsenault Catherine 
Published: November 2022

IntroductionAn increasing number of studies have reported disruptions in health service utilisation due to the COVID-19 pandemic and its associated restrictions. However, little is known about the effect of lifting COVID-19 restrictions on health service utilisation. The objective of this study was to estimate the effect of lifting COVID-19 restrictions on primary care service utilisation in Nepal.MethodsData on utilisation of 10 primary care services were extracted from the Health Management Information System across all health facilities in Nepal. We used a difference-in-differences design and linear fixed effects regressions to estimate the effect of lifting COVID-19 restrictions. The treatment group included palikas that had lifted restrictions in place from 17 August 2020 to 16 September 2020 (Bhadra 2077) and the control group included palikas that had maintained restrictions during that period. The pre-period included the 4 months of national lockdown from 24 March 2020 to 22 July 2020 (Chaitra 2076 to Ashar 2077). Models included month and palika fixed effects and controlled for COVID-19 incidence.ResultsWe found that lifting COVID-19 restrictions was associated with an average increase per palika of 57.5 contraceptive users (95% CI 14.6 to 100.5), 15.6 antenatal care visits (95% CI 5.3 to 25.9) and 1.6 child pneumonia visits (95% CI 0.2 to 2.9). This corresponded to a 9.4% increase in contraceptive users, 34.2% increase in antenatal care visits and 15.6% increase in child pneumonia visits. Utilisation of most other primary care services also increased after lifting restrictions, but coefficients were not statistically significant.ConclusionsDespite the ongoing pandemic, lifting restrictions can lead to an increase in some primary care services. Our results point to a causal link between restrictions and health service utilisation and call for policy makers in low- and middle-income countries to carefully consider the trade-offs of strict lockdowns during future COVID-19 waves or future pandemics.
Effects of air pollution on clinical pregnancy rates after in vitro fertilisation (IVF): a retrospective cohort study
Authors: Tartaglia Marie , Chansel-Debordeaux Lucie , Rondeau Virginie , Hulin Agnès , Levy Alexandre , Jimenez Clément , Bourquin Patrick , Delva Fleur , Papaxanthos-Roche Aline 
Published: November 2022

ObjectiveTo evaluate the effect of air pollution, from oocyte retrieval to embryo transfer, on the results of in vitro fertilisation (IVF) in terms of clinical pregnancy rates, at two fertility centres, from 2013 to 2019.DesignExploratory retrospective cohort study.SettingThis retrospective cohort study was performed in the Reproductive Biology Department of Bordeaux University Hospital localised in Bordeaux, France and the Jean Villar Fertility Center localised in Bruges, France.ParticipantsThis study included 10 763 IVF attempts occurring between January 2013 and December 2019, 2194 of which resulted in a clinical pregnancy.Primary and secondary outcome measuresThe outcome of the IVF attempt was recorded as the presence or absence of a clinical pregnancy; exposure to air pollution was assessed by calculating the cumulative exposure of suspended particulate matter, fine particulate matter, black carbon, nitrogen dioxide and ozone (O3), over the period from oocyte retrieval to embryo transfer, together with secondary exposure due to the presence of the biomass boiler room, which was installed in 2016, close to the Bordeaux University Hospital laboratory. The association between air pollution and IVF outcome was evaluated by a random-effects logistic regression analysis.ResultsWe found negative associations between cumulative O3exposure and clinical pregnancy rate (OR=0.92, 95% CI = (0.86 to 0.98)), and between biomass boiler room exposure and clinical pregnancy rate (OR=0.75, 95% CI = (0.61 to 0.91)), after adjustment for potential confounders.ConclusionAir pollution could have a negative effect on assisted reproductive technology results and therefore precautions should be taken to minimise the impact of outdoor air on embryo culture.
Clinical and cost-effectiveness of Knee Arthroplasty versus Joint Distraction for Osteoarthritis (KARDS): protocol for a multicentre, phase III, randomised control trial
Authors: Tassinari Cerys Joyce , Higham Ruchi , Smith Isabelle Louise , Arnold Susanne , Mujica-Mota Ruben , Metcalfe Andrew , Simpson Hamish , Murray David , McGonagle Dennis G , Sharma Hemant , Hamilton Thomas William , Ellard David R , Fernandez Catherine , Reynolds Catherine , Harwood Paul , Croft Julie , Stocken Deborah D , Pandit Hemant 
Published: November 2022

Introduction
Knee replacement (KR) is a clinically proven procedure typically offered to patients with severe knee osteoarthritis (OA) to relieve pain and improve quality of life. However, artificial joints fail over time, requiring revision associated with higher mortality and inferior outcomes. With more young people presenting with knee OA and increasing life expectancy, there is an unmet need to postpone time to first KR. Knee joint distraction (KJD), the practice of using external fixators to open up knee joint space, is proposed as potentially effective to preserve the joint following initial studies in the Netherlands, however, has not been researched within an NHS setting. The KARDS trial will investigate whether KJD is non-inferior to KR in terms of patient-reported postoperative pain 12 months post-surgery.

Methods and analysis
KARDS is a phase III, multicentre, pragmatic, open-label, individually randomised controlled non-inferiority trial comparing KJD with KR in patients with severe knee OA, employing a hybrid-expertise design, with internal pilot phase and process evaluation. 344 participants will be randomised (1:1) to KJD or KR. The primary outcome measure is the Knee Injury and Osteoarthritis Outcomes Score (KOOS) pain domain score at 12 months post-operation. Secondary outcome measures include patient-reported overall KOOS, Pain Visual Analogue Scale and Oxford Knee Scores, knee function assessments, joint space width, complications and further interventions over 24 months post-operation. Per patient cost difference between KR and KJD and cost per quality-adjusted life year (QALY) gained over 24 months will be estimated within trial, and incremental cost per QALY gained over 20 years by KJD relative to KR predicted using decision analytic modelling.

Ethics and dissemination
Ethics approval was obtained from the Research Ethics Committee (REC) and Health Research Authority (HRA). Trial results will be disseminated at clinical conferences, through relevant patient groups and published in peer-reviewed journals.

Trial registration number

NCT14879004;recruitment opened April 2021.
Thirst in adult patients in the intensive care unit: protocol for a scoping review
Authors: Flim Marleen , Rustøen Tone , Blackwood Bronagh , Spronk Peter 
Published: November 2022

IntroductionThirst is one of the most bothersome symptoms experienced by intensive care unit (ICU) patients. Effective diagnosis and management of thirst in the ICU is essential, particularly as patients are less sedated than previously and more aware of this problem. Currently, no overview of publications on thirst identification and management in ICU patients exists. The scoping review will address the broad question ‘What is known about thirst as a symptom in adult critically ill patients?’ It aims to provide an overview of the causes and risk factors, diagnosis and measurement, the symptom dimensions and its interaction with other symptoms, and thirst management.Methods and analysisThe review will follow the Joanna Briggs Institute methodology framework to guide the process and will be reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews. Methods include: defining the review questions, eligibility criteria, concepts of interest and context; and outlining the search strategy, study selection process, data extraction and analysis. PubMed, MEDLINE, EMBASE and CINAHL will be searched from inception to April 2022.Ethics and disseminationEthical approval is not required, as the scoping review will synthesise information from available publications. The scoping review will be submitted for publication to a scientific journal, presented at relevant conferences and disseminated as part of future workshops with ICU support groups and the critical care professional community.
Enablers and barriers to implementing obesity assessments in clinical practice: a rapid mixed-methods systematic review
Authors: Atlantis Evan , Chimoriya Ritesh , Seifu Canaan Negash , Peters Kath , Murphy Gill , Carr Bernadette , Lim David , Fahey P 
Published: November 2022

ObjectivesThis systematic review aims to improve our knowledge of enablers and barriers to implementing obesity-related anthropometric assessments in clinical practice.DesignA mixed-methods systematic review.Data sourcesMedline, Embase and CINAHL to November 2021.Eligibility criteriaQuantitative studies that reported patient factors associated with obesity assessments in clinical practice (general practice or primary care); and qualitative studies that reported views of healthcare professionals about enablers and barriers to their implementation.Data extraction and synthesisWe used random-effects meta-analysis to pool ratios for categorical predictors reported in ≥3 studies expressed as pooled risk ratio (RR) with 95% CI, applied inverse variance weights, and investigated statistical heterogeneity (I2), publication bias (Egger’s test), and sensitivity analyses. We used reflexive thematic analysis for qualitative data and applied a convergent integrated approach to synthesis.ResultsWe reviewed 22 quantitative (observational) and 3 qualitative studies published between 2004 and 2020. All had ≥50% of the quality items for risk of bias assessments. Obesity assessment in clinical practice was positively associated with patient factors: female sex (RR 1.28, 95% CI 1.10 to 1.50, I299.8%, mostly UK/USA), socioeconomic deprivation (RR 1.21, 95% CI 1.18 to 1.24, I273.9%, UK studies), non-white race/ethnicity (RR 1.27, 95% CI 1.03 to 1.57, I299.6%) and comorbidities (RR 2.11, 95% CI 1.60 to 2.79, I299.6%, consistent across most countries). Obesity assessment was also most common in the heaviest body mass index group (RR 1.55, 95% CI 0.99 to 2.45, I299.6%). Views of healthcare professionals were positive about obesity assessments when linked to patient health (convergent with meta-analysis for comorbidities) and if part of routine practice, but negative about their role, training, time, resources and incentives in the healthcare system.ConclusionsOur evidence synthesis revealed several important enablers and barriers to obesity assessments that should inform healthcare professionals and relevant stakeholders to encourage adherence to clinical practice guideline recommendations.
Reasons for dropout in the transition from hospital to municipality during exercise-based cardiac rehabilitation in a Danish cross-sectorial setting: a qualitative study
Authors: Damlund Anders Ravnholt Schüsler , Jørgensen Lars Bo , Blume Birgitte , Skou Søren T , Tang Lars H , Møller Tom 
Published: November 2022

ObjectivesDespite documented benefits of cardiac rehabilitation (CR), attrition rates remain relatively high. Insights on patient perspectives concerning dropout during transition phases are deficient. This deeper understanding may help to inform on the perceived benefits and barriers in CR. This qualitative study explores the reasons why patients’ dropout during the transition from a hospital-based CR programme to local healthcare facilities.SettingA Danish hospital and seven local healthcare centres.ParticipantsTwelve patients, who had dropped out of exercise-based cardiac rehabilitation (exCR) during the transition from hospital-based rehabilitation to local healthcare centres, were recruited to semistructured interviews based on a purposeful sampling.ResultsImportant patient needs during rehabilitation was the ability to identify and reflect oneself in a group of peers in a safe, specialised hospital-based environment. At the transition point, the meaningfulness of continuation of CR was revaluated. Findings showed that reasons for discontinuation varied within individuals. It encompassed on a balanced choice of reassessing benefits against competing agendas as work demands versus expectations of benefits in a changed exercise environment and own exercise capabilities.ConclusionThe study indicated that patient needs as timely relevance, a specialised safe environment and peer support are significant for participation in exCR. These needs may change during the transition stage due to competing agendas as work obligations and assessment of own ability to take control themselves. Perceived meaningfulness may be a major motivational driver for both initiating and making a judiciously choice of leaving an exCR programme.
Bi-atrial versus left atrial ablation for patients with rheumatic mitral valve disease and non-paroxysmal atrial fibrillation (ABLATION): rationale, design and study protocol for a multicentre randomised controlled trial
Authors: Yu Chunyu , Li Haojie , Wang Yang , Chen Sipeng , Zhao Yan , Zheng Zhe 
Published: November 2022

IntroductionAtrial fibrillation (AF) is common in patients with rheumatic mitral valve disease (RMVD) and increase the risk of stroke and death. Bi-atrial or left atrial ablation remains controversial for treatment of AF during mitral valve surgery. The study aims to compare the efficacy and safety of bi-atrial ablation with those of left atrial ablation among patients with RMVD and persistent or long-standing persistent AF.Methods and analysisThe ABLATION trial (Bi-atrial vs Left Atrial Ablation for Patients with RMVD and Non-paroxysmal AF) is a prospective, multicentre, randomised controlled study. The trial will randomly assign 320 patients with RMVD and persistent or long-standing persistent AF to bi-atrial ablation procedure or left atrial ablation procedure in a 1:1 randomisation. The primary end point is freedom from documented AF, atrial flutter or atrial tachycardia of >30 s at 12 months after surgery off antiarrhythmic drugs. Key secondary end point is the probability of freedom from permanent pacemaker implantation at 12 months after surgery. Secondary outcomes include the probability of freedom from any recurrence of atrial tachyarrhythmias with antiarrhythmic drugs, AF burden, incidence of adverse events and cardiac function documented by echocardiography at 12 months after operation.Ethics and disseminationThe central ethics committee at Fuwai Hospital approved the ABLATION trial. The results of this study will be disseminated through publications in peer-reviewed journals and conference presentations.Trial registration numberNCT05021601.