bluuebunny/crossref_metadata_2025_split huggingface dataset:
Characteristics and outcomes associated with fidelity in the Family-Nurse Partnership in England: a data linkage cohort study
Authors: Clery Amanda , Cavallaro Francesca , Kennedy Eilis , Gilbert Ruth , Harron Katie L 
Published: January 2025

ObjectivesTo determine (1) which maternal and area characteristics are associated with reaching fidelity targets (the expected number of visits mothers should receive at each stage of the programme) in the Family-Nurse Partnership (FNP), and (2) whether achieving these fidelity targets affects outcomes.Design, setting and populationCohort study of mothers enrolled in the FNP, aged 13–19 years, giving birth between April 2010 and January 2018 in England. Mothers were linked to their Hospital Episode Statistics and National Pupil Database records.OutcomesWe described whether mothers reached fidelity targets for each programme stage (pregnancy, infancy and toddlerhood) and explored the characteristics associated with reaching targets. We used generalised linear models to compare child and maternal outcomes between mothers who did and did not reach fidelity targets.ResultsOf the 28 155 mothers enrolled, 58% completed the programme. Fidelity targets were met by 59% of mothers in pregnancy, 65% in infancy and 61% in toddlerhood. The median number of visits was 38 (median 43 hours contact time). Younger mothers, those with a history of unplanned hospital admissions for adversity and those with social care involvement received a greater number of visits. Meeting fidelity targets was associated with a reduction in subsequent births within 18 months and an increase in the number of children with unplanned hospital admissions for maltreatment or injury up to age 2.ConclusionsAchieving fidelity to the FNP is challenging, but family nurses are able to engage the most vulnerable mothers in the programme. More research is needed to understand whether fidelity to programme targets is a useful measure of mothers’ experiences of intensive home visiting.
Mount Fuji sign in invasive fungal rhinosinusitis
Authors: Viskens Karolien , van Gerven Laura , Devos Johannes , Vos Robin 
Published: January 2025

We report on a fatal case of invasive fungal rhinosinusitis withAspergillus fumigatusafter lung transplantation. After endoscopic treatment and adjuvant medical therapy with isavuconazole, caspofungin and an investigational antifungal drug, there was a good clinical response with absence of endoscopic and radiographic disease. However, the patient developed disease recurrence, with signs of intracranial involvement on MRI, for which urgent endoscopic sinus surgery was performed and isavuconazole was restarted. In the days following the surgery, the patient suffered from increasing headache and confusion, with CT scan displaying a Mount Fuji sign (tension pneumocephalus). Best supportive care was provided, but the patient succumbed shortly after. Autopsy demonstrated a perforation at the skull base due to locally invasive fungal infection.Invasive fungal rhinosinusitis is uncommon, mainly occurs in subjects with altered host defence, requires multimodal treatment and has a poor prognosis, with tension pneumocephalus as a rare, life-threatening complication.
Analytical approaches to evaluate risk factors of multimorbidity: a systematic scoping review protocol
Authors: Song Wenbo , Birk Nick , Matsuzaki Mika , Lieber Judith , Yamanashi Hirotomo , Rogers Elliott , Aramrat Chanchanok , Wiwatkunupakarn Nutchar , Angkurawaranon Chaisiri , Lewin Alex , Kinra Sanjay , Mallinson Poppy Alice Carson 
Published: January 2025

IntroductionUnderstanding causal risk factors that contribute to the development of multimorbidity is essential for designing and targeting effective preventive strategies. Despite a large body of research in this field, there has been little critical discussion about the appropriateness of the various analytical approaches used. This proposed scoping review aims to summarise and appraise the analytical approaches used in the published literature that evaluated risk factors of multimorbidity and to provide guidance for researchers conducting analyses in this field.Methods and analysisWe will systematically search three electronic databases—Embase, Global Health and MEDLINE, as well as the reference lists of identified relevant review articles, from inception to September 2024. We will screen titles and abstracts using the artificial intelligence-aided software ASReview, followed by screening for eligible articles in full text and extracting data. We will then categorise the analytical approaches used across studies, provide a comprehensive overview of the methodology and discuss the potential strengths and limitations of each analytical approach.Ethics and disseminationWe will undertake a secondary analysis of published literature; therefore, ethical approval is not required. The results will be disseminated through an open-access, peer-reviewed publication. This systematic scoping review will serve as a guide for researchers in selecting analytical approaches for aetiological multimorbidity research, thereby improving the quality and comparability of research in this field.
Comparison of the effectiveness of intra-infrapatellar fat pad and intra-articular glucocorticoid injection in knee osteoarthritis patients with Hoffa’s synovitis: protocol for a multicentre randomised controlled trial
Authors: Chen Yiwei , Lin Junqing , Lin Jiali , Gao Tao , Cai Qianying , Zhang Changqing , Zhu Hongyi , Shen Longxiang , Wang Qiuke 
Published: January 2025

IntroductionThe infrapatellar fat pad and synovium are the sites of immune cell infiltration and the origin of proinflammation. Studies have shown that Hoffa’s synovitis may be a sign of early-stage osteoarthritis (OA). However, there have been no effective interventions specifically for Hoffa’s synovitis.Methods and analysisWe will conduct a multicentre, multi-blind (participant, physician, outcome assessor and data analyst blinded) randomised controlled trial to compare the effectiveness of an intra-infrapatellar fat glucocorticoid versus an intra-articular injection for Hoffa’s synovitis in patients with knee OA. We will recruit 236 knee OA patients with Hoffa’s synovitis at outpatient clinics in three centres. We will randomly allocate them to two groups in a 1:1 ratio. One group will receive ultrasound-guided injection of 40 mg (1 mL) triamcinolone acetonide into the infrapatellar fat pad; the other group will receive ultrasound-guided injection of 40 mg (1 mL) triamcinolone acetonide into the knee joint cavity. All patients will be followed up at 2, 4, 8, 12 and 24 weeks after the injection. Primary outcomes are (1) Hoffa’s synovitis improvement rate, measured with the MRI Osteoarthritis Knee Score system (superiority outcome) at 24 weeks and (2) pain intensity, measured with the Western Ontario and McMasters University Osteoarthritis Index (WOMAC) at 2 weeks post-injection. Secondary outcomes include Hoffa’s synovitis score at 2 weeks post-injection, pain intensity with the numerical rating scale, WOMAC questionnaire score improvements (function, joint stiffness and total score), improvement rates in effusion synovitis at 2 and 24 weeks, articular cartilage thickness changes at 2 and 24 weeks, Intermittent and Constant Osteoarthritis Pain score, quality of life measured with the EuroQol-5D, OARSI-OMERACT response indicators, co-interventions and side effects at 2, 4, 8, 12 and 24 weeks.Ethics and disseminationEthical approval has been granted by the Medical Ethics Committee of the Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine (2023–178). Written informed consent will be obtained from all patients prior to data collection. The findings of this research will be shared through presentations at academic conferences and publications in peer-reviewed journals.Trial registration numberChiCTR2400080474.
How do multiple deprivations in nuanced urban and rural settings affect health differently in South Africa? Evidence from NIDS data, 2017
Authors: Dlamini Msawenkosi , Mbonigaba Josue 
Published: January 2025

Introduction/objectivePrevious research on socioeconomic factors influencing health outcomes has often centred on the urban–rural divide, overlooking the nuanced variations within these categories. This study enhances our understanding by moving beyond traditional comparisons to examine the specific impacts of multiple deprivations on self-rated health across traditional authority areas, rural formal areas, urban informal areas and urban formal areas. By doing so, it captures the unique challenges and health implications associated with varying deprivation levels within these diverse contexts.MethodsWe first constructed the Provincial Index of Multiple Deprivation for each selected region using Wave 5 data from the National Income Dynamics Study, enabling an assessment of the health impacts of multiple deprivations across South Africa. During the estimation of the ordered probit model, collinearity issues emerged. To address this, we applied Principal Component Analysis (PCA) to create independent components which were then incorporated into the model. Self-reported health (SRH) was used as the dependent variable, allowing us to gain valuable insights into the relationship between health and multiple deprivation within these four contexts.ResultsThe study uncovers significant disparities in deprivations, with the most deprived areas being rural formal areas and traditional authorities’ areas and the least deprived being the urban formal areas. The PCA variables in the ordered probit model suggest that traditional and rural formal areas soften the effect of multiple deprivations on SRH relative to urban areas. In contrast, informal urban areas enhance the negative effect of multiple deprivation SRH relative to urban formal areas.Conclusion/recommendationsThe interaction between multiple deprivation variables and the specific areas examined in this study reveals varying impacts on health. Greater attention should be given to finer geographical characteristics in residential contexts to ensure that interventions are tailored effectively to the specific needs of each area. This focus is particularly important, as the local context may significantly impact health—a fundamental component of life and well-being.
Rehabilitation using virtual gaming for Hospital and hOMe-Based training for the Upper limb in acute and subacute Stroke (RHOMBUS II): results of a feasibility randomised controlled trial
Authors: Butcher Tom , Warland Alyson , Stewart Victoria , Aweid Basaam , Samiyappan Arul , Kal Elmar , Ryan Jennifer , Athanasiou Dimitrios A , Baker Karen , Singla-Buxarrais Guillem , Anokye Nana , Pound Carole , Gowing Francesca , Norris Meriel , Kilbride Cherry 
Published: January 2025

ObjectiveTo investigate the safety, feasibility and acceptability of the Neurofenix platform for upper-limb rehabilitation in acute and subacute stroke.DesignA feasibility randomised controlled trial with a parallel process evaluation.SettingAcute Stroke Unit and participants’ homes (London, UK).Participants24 adults (>18 years), acute and subacute poststroke, new unilateral weakness, scoring 9–25 on the Motricity Index (elbow and shoulder), with sufficient cognitive and communicative abilities to participate.InterventionsParticipants randomised to the intervention or control group on a 2:1 ratio. The intervention group (n=16) received usual care plus the Neurofenix platform for 7 weeks. The control group (n=8) received usual care only.OutcomesSafety was assessed through adverse events (AEs), pain, spasticity and fatigue. Feasibility was assessed through training and support requirements and intervention fidelity. Acceptability was assessed through a satisfaction questionnaire. Impairment, activity and participation outcomes were also collected at baseline and 7 weeks to assess their suitability for use in a definitive trial.RandomisationComputer-generated, allocation sequence concealed by opaque, sealed envelopes.BlindingParticipants and assessors were not blinded; statistician blinded for data processing and analysis.Results192 stroke survivors were screened for eligibility, and 24 were recruited and randomised. Intervention group: n=16, mean age 66.5 years; median 9.5 days post stroke. Control group: n=8, mean age 64.6 years; median 17.5 days post stroke. Three participants withdrew before the 7-week assessment, n=21 included in the analysis (intervention group n=15; control group n=6). No significant group differences in fatigue, spasticity, pain scores or total number of AEs. The median (IQR) time to train participants was 98 (64) min over 1–3 sessions. Participants trained with the platform for a median (range) of 11 (1-58) hours, equating to 94 min extra per week. The mean satisfaction score was 34.9 out of 40.ConclusionThe Neurofenix platform is safe, feasible and well accepted as an adjunct to usual care in acute and subacute stroke rehabilitation. There was a wide range of engagement with the platform in a cohort of stroke survivors which was varied in age and level of impairment. Recruitment, training and support were manageable and completion of data was good, indicating that a future randomised controlled trial would be feasible.Trial registration numberISRCTN11440079.
Successful open defecation-free intervention in low- and middle-income countries: a qualitative synthesis systematic review protocol
Authors: Yulyani Vera , Iswanto Iswanto , Daniel Daniel , Kusumaningrum Fitrina Mahardani , Tetra Dewi Fatwa Sari 
Published: January 2025

IntroductionThe results of open defecation-free (ODF) programmes vary greatly, especially in low- and middle-income countries (LMICs). This study will systematically investigate available qualitative research to identify the elements contributing to open defecation programmes’ effectiveness in various situations across LMICs. Furthermore, this review seeks to identify gaps in the available literature and areas that require additional investigation and action.Methods and analysisInclusion criteria were developed considering issues related to open defecation in LMICs, sanitation interventions and behavioural change. Research examining sanitation interventions in schools, shelters, disability communities and virtual communities was excluded, as the review focused exclusively on community-based interventions. Studies published in English and Indonesian were included without limitation of the initial year until 31 January 2025. Systematic research will be carried out using ScienceDirect, PubMed, ProQuest and Scopus databases. Information from grey literature, including conference proceedings and reports from relevant organisations, will be systematically searched using Google Scholar and the websites of leading institutions, such as the WHO, UNICEF and WaterAid. This systematic review did not impose any restrictions on the place and date of publication. Two reviewers followed Joanna Briggs Institute guidelines in selecting studies, conducting critical appraisal using confidential tools and extracting data using a structured approach. Data synthesis will be performed using meta-aggregate methods to identify the themes. A ConQual Summary will be used to assess confidence in the findings.Ethics and disseminationThe findings of the systematic review will be disseminated through a publication in a peer-reviewed journal and presented at a relevant conference. Since the data used will not contain individual patient information, ethical approval is unnecessary.PROSPERO registration numberCRD42023408851.
Efficacy of the Foodbot Factory digital curriculum-based nutrition education intervention in improving children’s nutrition knowledge, attitudes and behaviours in elementary school classrooms: protocol for a cluster randomised controlled trial
Authors: Brown Jacqueline Marie , Tahir Saman , Franco-Arellano Beatriz , LeSage Ann , Hughes Janette , Kapralos Bill , Lou Wendy , Vogel Ellen , Farkouh Michael , Tugault-Lafleur Claire , Arcand JoAnne 
Published: January 2025

IntroductionSchools are an important setting for supporting children’s development of food literacy, but minimal research has assessed which strategies are most suitable for school nutrition education. The Foodbot Factory intervention, consisting of serious game (ie, a digital game designed for education) and curriculum-based lesson plans, was developed to support teachers and children ages 8–12 with nutrition education. Pilot data have demonstrated that Foodbot Factory can significantly improve children’s nutrition knowledge, but it has not yet been evaluated in classrooms.Methods and analysisA single-blinded cluster randomised controlled trial was designed in 2022 by a research team based at Ontario Tech University to determine the efficacy of the Foodbot Factory intervention in improving children’s nutrition knowledge, attitudes and behaviours. 32 grade 4 and 4/5 classrooms in Ontario will be randomised to receive (1) the Foodbot Factory intervention or (2) a control nutrition education intervention using conventional materials (eg, activity sheets). The study’s primary outcome is to determine the overall nutrition knowledge acquired from the intervention. Secondary outcomes include nutrition knowledge subscores (ie, knowledge of specific food groups), nutrition attitudes, dietary intake, general nutrition behaviours (eg, eating breakfast) and intervention acceptability. An Ontario-certified teacher will deliver the intervention to both groups for 35–40 min/day for five consecutive days. Outcomes will be assessed at baseline, immediately postintervention, and 4 weeks and 3 months postintervention using the Nutrition Attitudes and Knowledge questionnaire, the Block Kids Food Screener, a modified Family Nutrition and Physical Activity screener and an acceptability questionnaire. Generalised linear mixed models will assess changes in outcomes between groups.Ethics and disseminationThe study protocol is approved by research ethics boards at Ontario Tech University and participating school boards. Results of the trial will be published in peer-reviewed journals and lay summaries will be available to stakeholders.Trial registration numberNCT05979259.
Remote symptom monitoring with patient-reported outcomes and nudges during lung cancer immunotherapy in China (PRO-NET): protocol for a randomised controlled trial
Authors: Xia Yiqi , Guan Xiaolong , Shi Zhenyu , Luo Yanan , He Ping 
Published: January 2025

IntroductionLung cancer is the leading cause of cancer-related mortality globally, with non-small cell lung cancer (NSCLC) comprising the majority of cases. For advanced NSCLC, immunotherapy offers substantial survival benefits but is often accompanied by severe immune-related adverse events symptoms, significantly affecting health-related quality of life (HRQoL). Routinely collection of patient-reported outcomes (PROs) followed by automated alerts has been shown to improve overall survival and HRQoL for cancers. However, there is limited evidence for PRO-based symptom monitoring on advanced NSCLC during immunotherapy. This study proposes an electronic PRO-based symptom tracking intervention, integrated with reactive alerts and nudges (PRO-NET) to improve HRQoL for advanced NSCLC patients receiving immunotherapy in China. Secondary objectives include assessing the effect of PRO-symptom monitoring on survival, physical function, symptom control, mental health, cost-effectiveness and implementation fidelity.Methods and analysisThe PRO-NET study is a two-arm, parallel randomised controlled trial. The study will enrol at least 300 advanced NSCLC patients undergoing immunotherapy in China. Participants will be randomly assigned to either the intervention or control group in a ratio of 1:1 via PRO-NET programme. The intervention involves weekly electronic collection of immune-related PROs and reactive alerts sent directly to patients, combined with nudges over a 6-month period. Patients in the control group will follow usual care and will not trigger the alerts. Both the intervention and control groups will receive outcome assessments at baseline, 3 months and 6 months. Primary outcome focuses on HRQoL, while secondary outcomes include survival, physical function, symptom burden, mental health, cost-effectiveness and implementation fidelity. Differences in HRQoL between the groups will be compared using general linear mixed model, accounting for potential confounding.Ethics and disseminationThe study was approved by the Institutional Review Board of the Peking University protocol on 21 July 2024 (No. IRB 00001052-24066). This protocol is based on V2.0, 6 July 2024 of the protocol. The results of this study will be disseminated through peer-reviewed publications and academic conferences.Trials registration numberChiCTR2400088408.
The Protocol for the Multi-Ethnic, multi-centre raNdomised controlled trial of a low-energy Diet for improving functional status in heart failure with Preserved ejection fraction (AMEND Preserved)
Authors: Bilak Joanna M , Squire Iain , Wormleighton Joanne V , Brown Rachel L , Hadjiconstantinou Michelle , Robertson Noelle , Davies Melanie J , Yates Thomas , Asad Mehak , Levelt Eylem , Pan Jiliu , Rider Oliver , Soltani Fardad , Miller Christopher , Gulsin Gaurav Singh , Brady Emer M , McCann Gerry P 
Published: January 2025

IntroductionHeart failure with preserved ejection fraction (HFpEF) is characterised by severe exercise intolerance, particularly in those living with obesity. Low-energy meal-replacement plans (MRPs) have shown significant weight loss and potential cardiac remodelling benefits. This pragmatic randomised trial aims to evaluate the efficacy of MRP-directed weight loss on exercise intolerance, symptoms, quality of life and cardiovascular remodelling in a multiethnic cohort with obesity and HFpEF.Methods and analysisProspective multicentre, open-label, blinded endpoint randomised controlled trial comparing low-energy MRP with guideline-driven care plus health coaching. Participants (n=110, age ≥18 years) with HFpEF and clinical stability for at least 3 months will be randomised to receive either MRP (810 kcal/day) or guideline-driven care for 12 weeks. Randomisation is stratified by sex, ethnicity, and baseline Sodium Glucose Cotransporter-2 inhibitor (SGLT2-i) use, using the electronic database RedCap with allocation concealment. Key exclusion criteria include severe valvular, lung or renal disease, infiltrative cardiomyopathies, symptomatic biliary disease or history of an eating disorder. Participants will undergo glycometabolic profiling, echocardiography, MRI for cardiovascular structure and function, body composition analysis (including visceral and subcutaneous adiposity quantification), Kansas City Cardiomyopathy Questionnaire (KCCQ) and Six-Minute Walk Test (6MWT), at baseline and 12 weeks. An optional 24-week assessment will include non-contrast CMR, 6MWT, KCCQ score. Optional substudies include a qualitative study assessing participants’ experiences and barriers to adopting MRP, and skeletal muscle imaging and cardiac energetics using 31Phosphorus MR spectroscopy.Statistical analysisComplete case analysis will be conducted with adjustment for baseline randomisation factors including sex, ethnicity and baseline SGLT2-i use. The primary outcome is the change in distance walked during the 6MWT. The primary imaging endpoint is the change in left atrial volume indexed to height on cardiac MRI. Key secondary endpoints include symptoms and quality of life measured by the KCCQ score.Ethics and disseminationThe Health Research Authority Ethics Committee (REC reference 22/EM/0215) has approved the study. The findings of this study will be published in peer-reviewed journals.Trial registration numberNCT05887271.