bluuebunny/crossref_metadata_2025_split huggingface dataset:
EMBIO trial study protocol: left gastric artery embolisation for weight loss in patients living with obesity with a BMI 35–50 kg/m2
Authors: Patel Prashant , Thomas Robert , Hamady Mohamad , Hague Julian , Raja Jowad , Tan Tricia , Bloom Stephen , Richards Toby , Weiss Clifford R , Prechtl Christina Gabriele , Smith Claire , Sasikaran Thiagarajah , Hesketh Richard , Bourmpaki Elli , Johnson Nicholas Andrew , Fiorentino Francesca , Ahmed Ahmed R 
Published: September 2023

IntroductionLeft gastric artery embolisation (LGAE) is a well-established treatment for major upper gastrointestinal (GI) bleeding when control is not established via upper GI endoscopy and recently has shown promising results for weight loss in small single arm studies. LGAE could be a treatment option in between our current tier-3 and tier-4 services for obesity. EMBIO is a National Institute for Health Research funded trial, a multicentre double-blinded randomised controlled trial between Imperial College National Health Service Trust and University College London Hospital, comparing LGAE versus Placebo procedure. The key aims of the trial is to evaluate LGAE efficacy on weight loss, its mechanism of action, safety profile and obesity-related comorbidities.Methods and analysis76 participants will be recruited from the existing tier-3 database after providing informed consent. Key inclusion criteria include adults aged 18–70 with a body mass index 35–50 kg/m2and appropriate anatomy of the left gastric artery and coeliac plexus on CT Angiogram. Key exclusion criteria included previous major abdominal and bariatric surgery, weight >150 kg, type 2 diabetes on any medications other than metformin and the use of weight modifying medications. Participants will undergo mechanistic visits 1 week prior to the intervention and 3, 6 and 12 months postintervention. Informed consent will be received from each participant and they will be randomised in a 1:1 ratio to left gastric artery embolisation and placebo treatment. Blinding strategies include the use of moderate doses of sedation, visual and auditory isolation. All participants will enter a tier-3 weight management programme postintervention. The primary analysis will estimate the difference between the groups in the mean per cent weight loss at 12 months.Ethics and disseminationThis trial shall be conducted in full conformity with the 1964 Declaration of Helsinki and all subsequent revisions. Local research ethics approval was granted by London-Central Research Ethics Committee, (Reference 19/LO/0509) on 11 October 2019. The Medicines and Healthcare products Regulatory Agency (MHRA) issued the Letter of No Objection on 8 April 2022 (Reference CI/2022/0008/GB). The trial’s development and progress are monitored by an independent trial steering committee and data monitoring and ethics committee. The researchers plan to disseminate results at conferences, in peer- reviewed journals as well as lay media and to patient organisations.Trial registration numberISRCTN16158402.
Systematic review and meta-synthesis protocol for examining policies mitigating the determinants of African nurses’ and midwives’ migration
Authors: Osei Stephanopoulos Kofi Junior , Owusu Michael Barfi , Frimpong Sandra , Dela Bosro Dorinda , Asamoah Christopher Fosu , Owusu Daniel , Ntriwaa Amoako-Mensah Deborah , Barimah Sammy Kwantwi , Agbavor Jerry Kofi Esinu , Agbesi Bertha Delanyo Awo 
Published: September 2023

BackgroundThere has been a notable rise in the number of African nurses and midwives migrating to high-income countries despite varying policies and restrictions to promote retention. The need to comprehensively evaluate existing policies addressing the exodus is crucial to future policy formulation and steps in addressing drivers of nurses and midwives brain drain in Africa.AimTo explore the existence of migration policies that address the drivers of nurse and midwives’ migration outside Africa and determine the characteristics and implementation of these policies.MethodsThe review would be guided by the JBI methodology for systematic reviews of text and non-research evidence. Databases including CINAHL, PubMed, Academic Search Complete via Ebscohost and ISI Web of Science will be searched using a PICOS selection criteria framework. Grey literature would be gathered from Google Scholar, government and organisational websites. Two independent reviewers would be involved in searching, study selection, data extraction and data analysis. A third reviewer would provide an arbitrary judgement during conflicts when disagreements persist after discussion. A meta-synthesis would be used to identify and report emerging themes in the literature.Ethics and disseminationThe study does not require ethical approval. The findings would be published in peer-review journals and presented at research conferences.PROSPERO registration numberCRD42023395013.
Predictive accuracy of risk prediction models for recurrence, metastasis and survival for early-stage cutaneous melanoma: a systematic review
Authors: Kunonga Tafadzwa Patience , Kenny R P W , Astin Margaret , Bryant Andrew , Kontogiannis Vasileios , Coughlan Diarmuid , Richmond Catherine , Eastaugh Claire H , Beyer Fiona R , Pearson Fiona , Craig Dawn , Lovat Penny , Vale Luke , Ellis Robert 
Published: September 2023

ObjectivesTo identify prognostic models for melanoma survival, recurrence and metastasis among American Joint Committee on Cancer stage I and II patients postsurgery; and evaluate model performance, including overall survival (OS) prediction.DesignSystematic review and narrative synthesis.Data sourcesSearched MEDLINE, Embase, CINAHL, Cochrane Library, Science Citation Index and grey literature sources including cancer and guideline websites from 2000 to September 2021.Eligibility criteriaIncluded studies on risk prediction models for stage I and II melanoma in adults ≥18 years. Outcomes included OS, recurrence, metastases and model performance. No language or country of publication restrictions were applied.Data extraction and synthesisTwo pairs of reviewers independently screened studies, extracted data and assessed the risk of bias using the CHecklist for critical Appraisal and data extraction for systematic Reviews of prediction Modelling Studies checklist and the Prediction study Risk of Bias Assessment Tool. Heterogeneous predictors prevented statistical synthesis.ResultsFrom 28 967 records, 15 studies reporting 20 models were included; 8 (stage I), 2 (stage II), 7 (stages I–II) and 7 (stages not reported), but were clearly applicable to early stages. Clinicopathological predictors per model ranged from 3–10. The most common were: ulceration, Breslow thickness/depth, sociodemographic status and site. Where reported, discriminatory values were ≥0.7. Calibration measures showed good matches between predicted and observed rates. None of the studies assessed clinical usefulness of the models. Risk of bias was high in eight models, unclear in nine and low in three. Seven models were internally and externally cross-validated, six models were externally validated and eight models were internally validated.ConclusionsAll models are effective in their predictive performance, however the low quality of the evidence raises concern as to whether current follow-up recommendations following surgical treatment is adequate. Future models should incorporate biomarkers for improved accuracy.PROSPERO registration numberCRD42018086784.
Peri-Operative Wearables in Elder Recover after Surgery (POWERS) study: a protocol for a multicentre, prospective cohort study to evaluate perioperative activity with postoperative disability in older adults after non-cardiac surgery
Authors: Ladha Karim S , Lu Justin , McIsaac Daniel I , van Vlymen Janet M , Lebovic Gerald , Ehtesham Sahar , Pazmino-Canizares Janneth , Clarke Hance , Parotto Matteo , Lorello Gianni R , Wijeysundera Duminda Nalaka 
Published: September 2023

IntroductionThe ageing population has led to an increasing proportion of surgical patients with greater frailty and comorbidity. Complications and mortality within 30 days of a surgical procedure are often used to evaluate success in the perioperative period however these measures can potentially underestimate a substantial level of morbidity associated with surgery. Personal wearable technologies are now readily available and can offer detailed information on activity intensity, sedentary behaviour and sleeping patterns. These devices may provide important information perioperatively by acting as a non-invasive, and cost-efficient means to risk stratify patients.Methods and analysisThe Peri-Operative Wearables in Elder Recover After Surgery (POWERS) study is a multicentre observational study of 200 older adults (≥65 years) having major elective non-cardiac surgery. The objectives are to characterise the association between preoperative and postoperative activity monitor measurements with postoperative disability and recovery, as well as characterise trajectories of activity and sleep in the perioperative period. Activity will be monitored with the ActiGraph GT3X device and measured for 7-day increments, preoperatively, and at 1 week, 1 month and 3 months postoperatively. Disability will be assessed using the WHO Disability Assessment Schedule 2.0 assessed at 1 week, 1 month and 3 months postoperatively.Ethics and disseminationThe POWERS study received research ethics board approval at all participating sites on 1 August 2019 (REB # 19-121 (CTO 1849)). Renewal was granted on 19 May 2022.
Providing the basis for a patient-centred and effective screening for cancer-related fatigue (MERLIN study): design of a longitudinal observational study
Authors: Blickle Patricia , Haussmann Alexander , Holzner Bernhard , Berger Anne Katrin , Steindorf Karen , Schmidt Martina E 
Published: September 2023

IntroductionCancer-related fatigue (CRF) is a frequent and burdensome sequela of cancer and cancer therapies. It can persist from months to years and has a substantial impact on patients’ quality of life and functioning. CRF is often still not adequately diagnosed and insufficiently treated. According to guideline recommendations, patients should be routinely screened for CRF from cancer diagnosis onwards. We will investigate how an effective screening should be designed regarding timing, frequency, screening type and cut-off points.Methods and analysisMERLIN is a longitudinal observational study that will include 300 patients with cancer at the beginning of cancer therapy. The main study centre is the National Center for Tumour Diseases Heidelberg, Germany. Patients answer five items to shortly screen for CRF at high frequency during their therapy and at lower frequency during the post-treatment phase for 18 months. Further, CRF is assessed at wider intervals based on the Cella criteria, the Brief Fatigue Inventory impact scale, the quality of life fatigue questionnaire (QLQ-FA12) and the fatigue and cognitive items of the quality of life core questionnaire (QLQ-C30), both of the European Organisation for Research and Treatment of Cancer. Important psychological, socio-demographical or medical factors, which may exacerbate CRF are assessed. All assessments are performed online. Receiver operating curves, areas under the curve, sensitivity, specificity, positive and negative predictive values and likelihood ratios will be calculated to determine optimal short screening modalities.Ethics and disseminationThe study was approved by the ethics committee of the Medical Faculty of the Heidelberg University, Germany (approval number: S-336/2022). Written informed consent is obtained from all participants. The study is conducted in full conformance with the principles of the Declaration of Helsinki. Results will be published in peer-reviewed scientific journals, presented at conferences and communicated to clinical stakeholders to foster the implementation of an effective CRF management.Trial registration numberClinicalTrials.gov; registration number:NCT05448573.
How does participatory research work: protocol for a realist synthesis
Authors: Belaid Loubna , Sarmiento Ivàn , Dion Anna , Pimentel Juan Pablo , Rojas-Cárdenas Andrés , Cockcroft Anne , Andersson Neil 
Published: September 2023

IntroductionParticipatory research science deals with partnerships underlying research, governance and ownership of research products. It is concerned with relationships behind research objectives and methods. Participatory research has gained significant traction in design of health interventions, contextualising these to local settings and stakeholder groups. Despite a massive increase in participatory research exercises, the field remains undertheorised, and the mechanisms for improving health outcomes remain unclear. This realist review seeks to understand how and under what circumstances participatory research impacts health and social outcomes.Methods and analysisThe review will follow four steps: (1) searching for and selecting evidence, (2) assessing the quality of evidence, (3) extracting and categorising data and (4) synthesising the data in the form of context–mechanism–outcomes configurations. The review will follow the Realist And Meta Narrative Evidence Syntheses: Evolving Standards (RAMESES) II guidelines for reporting realist evaluations. We categorise and synthesise data in four steps: (1) identifying outcomes, (2) identifying contextual components of outcomes, (3) theoretical redescription (abduction) and (4) identifying mechanisms. A retroductive analysis will identify mechanisms by moving between empirical data and theories, using inductive and deductive reasoning to explain the outcomes–context matches. The output will generate middle-range theories on how participatory research works, for whom and under what circumstances.Ethics and disseminationThis study is a review of a published literature. It does not involve human participants. We will convene a workshop to share and discuss the preliminary results with partners and key stakeholders involved in participatory health research. We will publish the review results in peer-reviewed journals and academic conferences.
Experiences of work for people living with a grade 2/3 oligodendroglioma: a qualitative analysis within the Ways Ahead study
Authors: Walker Hayley , Rimmer Ben , Dutton Lizzie , Finch Tracy , Gallagher Pamela , Lewis Joanne , Burns Richéal , Araújo-Soares Vera , Williams Sophie , Sharp Linda 
Published: September 2023

ObjectivesThis study aimed to explore the work experiences of people living with an oligodendroglioma.DesignThis was a descriptive qualitative study. One-time semi-structured interviews exploring supportive care needs were conducted; work was discussed at various points throughout each interview. An inductive thematic analysis was undertaken.SettingParticipants were recruited across the UK through four National Health Service hospitals and the Brain Tumour Charity research involvement networks.Participants19 people with grade 2 or 3 oligodendroglioma (mean age 52 years; male n=11). At diagnosis, 16 participants were working, 2 studying and 1 retired. At the interview (mean time since diagnosis 9.6 years; range 1–18 years), seven participants were working, eight retired (four on medical grounds) and four unable to work due to illness.ResultsSeven themes were constructed: (1) physical and cognitive limitations; (2) work ability and productivity; (3) work accommodations; (4) changing roles; (5) attitudes of clients and coworkers; (6) feelings and ambitions; and (7) financial implications. Fatigue, seizures and cognitive deficits influenced work ability. A stressful work environment could exacerbate symptoms. Changes in job roles and work environment were often required. Employer and coworker support were integral to positive experiences. Work changes could result in financial stress and strain.ConclusionsThis study has highlighted, for the first time, influences on work experiences in this understudied population. These findings have implications for clinicians and employers, when considering the importance of work in rehabilitation for people with oligodendrogliomas, and the individually assessed adjustments required to accommodate them, should employment be desired.
Implementing a package of essential non-communicable diseases interventions in low- and middle-income countries: a realist review protocol
Authors: Vaidya Anju , Simkhada Padam , Lee Andrew , Jones Susan , Mukumbang Ferdinand C 
Published: September 2023

IntroductionThe burden of non-communicable diseases (NCDs) is increasing rapidly, particularly in low- and middle-income countries (LMIC), accounting for 85% of premature deaths in the region. LMICs have been facing an increasing trend of a double burden of disease (infectious diseases and NCDs) that has led to multiple challenges in prioritising strategies for NCDs control amidst limited resources. Evidence indicates that measures such as the WHO’s package of essential non-communicable (PEN) diseases interventions can prevent and control NCDs. However, because of the complexity of such health interventions, there is limited evidence that explains how the intervention works, for whom and in what context. We aim to unpack the causal mechanisms explaining how, why, for whom and in what context PEN prevents and controls NCDs.Methods and analysisWe propose a realist review to understand how, why, for whom and under what circumstances PEN works or does not work. The review process includes five steps applied iteratively throughout the study: clarification of review scope, searching for evidence, appraising and extracting data, synthesising evidence and drawing conclusions, and disseminating the findings. Programme theories will be developed using the realist logic for theory formulation—Retroductive Theorising. The context-mechanism-outcome (CMO) heuristic tool will be used to develop the programme theories. Portions of the reviewed documents describing constructs of context, mechanism and outcomes will be coded inductively and extracted. These extracted constructs will then be linked abductively to formulate CMO configurations.Ethics and disseminationFormal ethical approval is not required for this review. Study findings will be disseminated through publications in peer-reviewed journals, conference presentations and formal and informal reports.
Observational cohort study to validate SEARCH, a novel hierarchical algorithm to define long-term outcomes after pulmonary embolism
Authors: Morris Timothy A , Fernandes Timothy M , Chung Jina , Vintch Janine R E , McGuire W Cameron , Thapamagar Suman , Alotaibi Mona , Aries Savannah , Dakaeva Khadizhat 
Published: September 2023

BackgroundChronic dyspnoea and exercise impairment are common after acute pulmonary embolism (PE) but are not defined and quantified sufficiently to serve as outcomes in clinical trials. The planned project will clinically validate a novel method to determine discrete, clinically meaningful diagnoses after acute PE. The method uses an algorithm entitled SEARCH, forsymptom screen,exercise testing,arterial perfusion,resting echocardiography,confirmatory imaging andhaemodynamic measurements. SEARCH is a stepwise algorithm that sorts patients by a hierarchical series of dichotomous tests into discreet categories of long-term outcomes after PE: asymptomatic, post-PE deconditioning, symptoms from other causes, chronic thromboembolism with ventilatory inefficiency, chronic thromboembolism with small stroke volume augmentation, chronic thromboembolic disease and chronic thromboembolic pulmonary hypertension.MethodsThe project will test the inter-rater reliability of the SEARCH algorithm by determining whether it will yield concordant post-PE diagnoses when six independent reviewers review the same diagnostic data on 150 patients evaluated at two time points after PE. The project will also determine whether the post-PE diagnoses are stable, according to the SEARCH algorithm, between the first evaluation and the subsequent one 6 months later.ImplicationsValidation of the SEARCH algorithm would offer clinicians a straightforward method to diagnose post-PE conditions that are rarely distinguished clinically. Their categorisation and definition will allow post-PE conditions to be used as endpoints in clinical trials of acute PE treatment.Trial registration numberNCT05568927.
Measuring the prevalence of autistic traits in a cohort of adults living with HIV or taking HIV pre-exposure prophylaxis and mapping safer-sex barriers and facilitators: a study protocol
Authors: Huyst Veerle , Dewinter Jeroen , Noens Ilse , Platteau Tom , Tsoumanis Achilleas 
Published: September 2023

IntroductionAutistic individuals identify with a wider range of sexual orientations than non-autistic individuals, including higher rates of bisexual orientation in autistic men. Gay, bisexual and other men who have sex with men are at greater risk for HIV. Prevalence data of autistic traits in people living with HIV or using Pre-Exposure Prophylaxis (PrEP) for HIV are lacking so far. Such data, combined with insights in barriers and facilitators for safer sex in autistic people living with HIV or using PrEP, are a first step to improve health support for autistic people in HIV clinics. This support is crucial since autistic individuals have worse physical and mental health outcomes. The objective of this research is to determine the prevalence of autistic traits within the group of people living with HIV or using PrEP in Belgium and to describe specific facilitators and barriers for sexual safer behaviour in people living with HIV and PrEP users with autistic traits.Methods and analysisThe research is a cross-sectional, observational and multicentre study with recruitment of individual participants. The research consists of two phases. In phase 1, adults coming for HIV/AIDS care or HIV PrEP in participating Belgian HIV Reference Centres will be invited to fill in the validated Autism Spectrum Quotient questionnaire. In phase 2, participants with a score above the predefined cut-off for autistic traits (>26), who agreed to be informed about this score, will be invited to complete an additional survey, inquiring facilitators and barriers for sexual safer behaviour.Ethics and dissemination of resultsInstitutional Review Board Institute of Tropical Medicine Antwerp, 25 July 2022, REF 1601/22 and University Hospital of Antwerp, 12 September 2022, Project ID 3679: BUN B3002022000111. Study results will be published in peer-reviewed journals and presented to Belgian HIV Reference Centres and at conferences.