bluuebunny/crossref_metadata_2025 huggingface dataset:
A comprehensive review of Pseudocercospora fruit and leaf spot (angular leaf spot): Current status, advances and future directions for sustainable citrus production
Authors: Dofuor Aboagye Kwarteng , Obeng Joshua , Sossah Frederick Leo , Osabutey Angelina Fathia , Lutuf Hanif , Osei‐Owusu Jonathan , Ablormeti Fred Kormla , Duker Rahmat Quaigrane , Loh Seyram Kofi , Honger Joseph Okani , Opoku Maxwell Jnr , Aidoo Owusu Fordjour
Published: June 2024

Pseudocercospora fruit and leaf spot (PFLS), also known as angular leaf spot of citrus, is a devastating fungal disease that poses a significant threat to citrus production, profitability and food security in sub‐Saharan Africa and the Arabian Peninsula. In the present review, we explore current knowledge regarding PFLS management initiatives, including cultural practices, chemical control strategies and biological interventions. Furthermore, this review highlights the challenges faced in controlling PFLS and emphasizes the urgent need for sustainable and cost‐effective solutions to combat the disease. We discuss recent advancements and emerging prospects in understanding PFLS, including novel approaches for disease management and the potential for developing resistant citrus cultivars through breeding programmes or genetic modification. By synthesizing existing research findings and identifying gaps in knowledge, this review aims to provide a comprehensive understanding of PFLS and its impact on food security. We emphasize the importance of collaborative efforts, knowledge exchange and developing integrated disease management strategies to control PFLS and mitigate its detrimental effects on citrus production and farmers' livelihoods in affected regions.
Development of a severity scale and an RT‐qPCR assay for screening resistance levels in rice genotypes against rice stripe necrosis virus and its vector
Authors: do Nascimento Samara Campos , Scheuermann Klaus Konrad , Pereira Fernando Sartori , Gorayeb Eduardo Silva , Albuquerque Matheus Rodrigues Magalhães , Mendes Giselle Camargo , de Mello Raquel Neves , Lau Douglas , da Silva Fabio Nascimento
Published: June 2024

Rice stripe necrosis virus (RSNV) is the causal agent of the disease ‘rice crinkling’ and is transmitted by the protozoan Polymyxa graminis. Although genetic resistance has been explored, no resistant commercial cultivars are currently available. Oryza glaberrima has been identified as a promising source of resistance. However, it remains unclear whether this resistance is effective against the virus, the vector, or both, as well as whether it can be transferred to Oryza sativa cultivars. Disease‐resistant genotypes are primarily selected through visual observations of symptom expression. The absence of a severity scale for RSNV makes this process difficult, and relying solely on visual assessments can introduce subjectivity. We developed a severity scale and a reverse transcripiton‐quantitative PCR (RT‐qPCR) assay for screening resistance levels in rice genotypes against RSNV and its vector and to analyse the genetic variability of RSNV isolates. To achieve absolute quantification, experiments were conducted using O. glaberrima and three O. sativa cultivars. Inoculation occurred naturally using soil from an area with a history of the disease. Visual symptoms were recorded and disease intensity was evaluated. Subsequently, total nucleic acid extraction was performed on the samples and viral and vector loads were quantified through RT‐qPCR and qPCR, respectively. To characterize the virus variability, symptomatic rice samples were collected in the 2021/2022 crop season. RT‐PCR was conducted to amplify the coat protein gene of RSNV, and molecular variability descriptors were analysed.
Preliminary validation of the Norwegian version of the Berlin Misophonia Questionnaire Revised (BMQ‐R‐NOR)
Authors: Krog Eirin , Falck Andreas , Nielsen Guri Engernes
Published: June 2024

Objective

To perform a psychometric evaluation of a Norwegian version of the Berlin Misophonia Questionnaire Revised (BMQ‐R‐NOR).

Design

Participants completed online versions of the self‐report questionnaire BMQ‐R‐NOR on two occasions and MQ‐NOR on one occasion. Convergent validity was assessed through Spearman's correlation between BMQ‐R‐NOR and MQ‐NOR. Internal consistency was evaluated with McDonald's omega and Cronbach's alpha. Test–retest reliability was evaluated using Cohen's weighted kappa and intraclass correlation.

Study sample

82 participants with self‐reported misophonia took part in the study at T1, and 53 of these participated at T2. However, only 41 of them were included in the test–retest analyses due to 12 participants being in treatment between T1 and T2.

Results

Subscales from the BMQ‐R‐NOR and MQ‐NOR were significantly positively correlated, indicating evidence of convergent validity (rs = 0.22*–0.74**). The BMQ‐R‐NOR showed overall good internal consistency (omega = 0.72–0.93; alpha = 0.70–0.93) and satisfactory test–retest reliability (ICC = 0.35–0.92).

Conclusion

The psychometric properties of the BMQ‐R‐NOR are considered satisfactory. However, it is advised to exercise caution when using it until further comprehensive validation studies are conducted to ensure robustness and reliability in clinical practice.
Comparison of prophylaxis and preemptive strategy as cytomegalovirus prevention in liver transplant recipients
Authors: Camus Christophe , Poinot Mélanie , Pronier Charlotte , Rayar Michel , Neillon Anne Le , Latournerie Marianne , Lagathu Gisèle , Revest Matthieu
Published: June 2024

Objectives

Prophylaxis (P) or pre‐emptive strategy (PS) in high‐risk liver transplant recipients (LTRs) are either recommended. We compared the results of each strategy.

Methods

Two groups of LTR transplanted during two consecutive periods were compared. Only cytomegalovirus (CMV)‐mismatched LTR (Donor +/ Recipient ‐) were included. The primary endpoints were: the onset of polymerase chain reaction‐based DNAemia and the proportion of patients with CMV disease. A number of episodes of CMV infection, antiviral therapy, ganciclovir resistance, infectious or immunological complications, cost of both strategies, and survival (1, 5, and 10 years) were also compared.

Results

Forty‐eight and 60 patients were respectively included in the P and PS groups. Eighteen (38%) in the P group and 56 (93%) in the PS group had CMV DNAemia (p<.0001) with a similar CMV disease rate (16.7% and 15%). Duration of curative therapy was longer in the PS group: 91 days versus 16 (p<.0001). Acute rejection was less frequent (p = .04) and more patients experienced a ganciclovir‐resistant CMV infection in the PS group (10% vs. 0,p = .03). The drug‐associated cost of PS was higher (10 004 vs. 4804€) and the median number of rehospitalization days tended to be higher (6 vs. 4,p = .06). Survival at any time was similar.

Conclusion

We reported more CMV DNAemias and ganciclovir‐resistant CMV events with PS. The cost of the PS strategy was higher.

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The BEL1‐like homeodomain protein OsBLH4 regulates rice plant height, grain number, and heading date by repressing the expression of OsGA2ox1
Authors: Cao Chengjuan , Guo Shuaiqiang , Deng Ping , Yang Shiyi , Xu Jing , Hu Tengfei , Hu Zhijuan , Chen Di , Zhang Hongsheng , Navea Ian Paul , Chin Joong Hyoun , Zhang Wenhua , Jing Wen
Published: June 2024

Gibberellins (GAs) play crucial roles in regulating plant architecture and grain yield of crops. In rice, the inactivation of endogenous bioactive GAs and their precursors by GA 2‐oxidases (GA2oxs) regulates stem elongation and reproductive development. However, the regulatory mechanisms of GA2ox gene expression, especially in rice reproductive organs, are unknown. The BEL1‐like homeodomain protein OsBLH4, a negative regulatory factor for the rice OsGA2ox1 gene, was identified in this study. Loss of OsBLH4 function results in decreased bioactive GA levels and pleiotropic phenotypes, including reduced plant height, decreased grain number per panicle, and delayed heading date, as also observed in OsGA2ox1‐overexpressing plants. Consistent with the mutant phenotype, OsBLH4 was predominantly expressed in shoots and young spikelets; its encoded protein was exclusively localized in the nucleus. Molecular analysis demonstrated that OsBLH4 directly bound to the promoter region of OsGA2ox1 to repress its expression. Genetic assays revealed that OsBLH4 acts upstream of OsGA2ox1 to control rice plant height, grain number, and heading date. Taken together, these results indicate a crucial role for OsBLH4 in regulating rice plant architecture and yield potential via regulation of bioactive GA levels, and provide a potential strategy for genetic improvements of rice.
Lateral canthal reconstruction for the treatment of macroblepharon/diamond eye conformation in dogs
Authors: Kecova Helga , Miller William W. , Lindley Denise M.
Published: June 2024

Purpose

To introduce a novel surgical technique for treatment of macroblepharon and diamond eye conformation in dogs.

Methods

Lateral canthal reconstruction was used in dogs with prominent eyelid malformations resulting in ocular surface disease. Lateral canthus was resected and new lateral canthus was created using a two‐layer closure. This technique was performed either alone or in combination with additional procedure(s). Additionally, this technique was used to resect lateral canthal dermoid.

Results

One hundred and fifty‐three eyes of 85 dogs were included in the study. Procedure was done for macroblepharon and/or lateral canthal entropion (149 eyes of 81 dogs) or for lateral canthal dermoid (four eyes of four dogs). Procedure was done either alone (n = 68 eyes) or in combination with additional procedure (n = 85 eyes). Favorable cosmetic outcome and client satisfaction was achieved in all dogs. Good to excellent functional outcome was recorded in all but 6 eyes of 4 dogs, which required additional surgery. Most common complications included slight undercorrection or overcorrection.

Conclusions

Lateral canthal reconstruction is a simple yet effective surgical procedure for macroblepharon and/or lateral canthal entropion. If done early, it prevents development of secondary eyelid malformation (“pagoda defect”) in giant breed dogs. If done after severe eyelid malformation has developed, combining this technique with concurrent pagoda resection is recommended to achieve ideal eyelid conformation. None.
Ngalaksa Traditional Ceremony as a Local Wisdom to Maintain Community Social Interaction
Authors: Kartika Nyai , Dienaputra Reiza D. , Machdalena Susi , Nugraha Awaludin , Suryadimulya Agus S. , Yuliawati Susi , Hidayat Rony
Published: June 2024

The Ngalaksa traditional ceremony is a legacy of the Rancakalong people's ancestors through their traditional arts. It is carried out as a form of gratitude for the harvest. This cultural activity can positively impact the community and the local government. It can be an event that can foster noble values in society, such as strengthening family relationships between communities. However, the potential of Ngalaksa traditional ceremony has not been exploited optimally. If managed wellit can become a cultural tourist attraction with the concept of cultural advancement. This research aims to reveal the values of local wisdom in the community through the traditional Ngalaksa ceremony. Using a qualitative descriptive method with a case study, this research was conducted in Nagarawangi Village, Rancakalong District, Sumedang Regency. The data were collected using in-depth interviews and observations to explain the research object factually. In addition, literature studies, document searches and field notes were also carried out. The data were validated using triangulation techniques. This research reveals the values of the Ngalaksa tradition, which presents the concept of interaction between humans, nature, and God, wrapped in a traditional ceremony. Hopefully, this research will be a conservation effort through community cultural customs activities to become a tourism potential and improve community welfare.
Exploration of TIK TOK's Contribution to the Communication of Huangmei Opera: An Analysis Based on the 5W Model
Authors: Yang Jian , Amirrul Azrul Azizi
Published: June 2024

This study discusses the communication and inheritance of Huangmei Opera on TikTok. Adopting the 5W model comprehensively analyses five aspects: communication subject, content, object, medium, and effect. Huangmei opera, as a part of Chinese traditional opera, faces the challenge of a shrinking audience and market. However, TIK TOK, as a short video platform with wide influence, provides new opportunities for the dissemination of Huangmei opera.The study shows that vloggers at different levels play an important role on TIK TOK, especially high-influence professional actors and theatre troupes, who have effectively promoted Huangmei Opera by leveraging their large fan bases and high-quality content. Medium- to low-impact and emerging vloggers have also attracted a large number of viewers to Huangmei Opera through their diverse and interactive content. The findings show a significant positive correlation between viewers' interactive behaviours (e.g., liking, commenting, sharing) and viewing duration, suggesting that improving content quality and viewer engagement is crucial for communication effectiveness.This paper also explores the features of the TIK TOK, such as fragmented communication, interactive communication, precise pushing and community effect, which help Huangmei opera expand its influence among young audiences. Despite challenges such as differences in content quality and the short attention span of young audiences, the communication effect of Huangmei Opera on TikTok has been significantly improved through cooperation and innovation. The research in this paper provides new perspectives and practical suggestions for the communication strategy of Huangmei Opera in the digital era and further enriches the modern communication path of traditional art.
How far can reformulation participate in improving the nutritional quality of diets at population level? A modelling study using real food market data in France
Authors: Sarda Barthélémy , Kesse-Guyot Emmanuelle , Srour Bernard , Deschasaux-Tanguy Mélanie , Fialon Morgane , Fezeu Léopold K , Galan Pilar , Hercberg Serge , Touvier Mathilde , Julia Chantal
Published: June 2024

Background

Food reformulation is promoted as a tool to improve the nutritional quality of population diets. However, the potential impact of industry-wide reformulation on dietary intake has been investigated minimally.

Objectives

The aim was to estimate the impact on the French population nutrient intakes of industry-wide reformulation towards healthier products using the updated nutrient profiling system underpinning the front-of-pack nutrition label Nutri-Score (uNS-NPS).

Methods

Dietary data were retrieved from the Nutrinet-Santé cohort at baseline (N=100 418), providing detailed information regarding participants’ food choices (N>3000 generic food items). Each individual food from 24 hours dietary record was matched with French food market data from OpenFoodFacts database (N=119 073 products). Three scenarios were constructed using nutrient content of currently existing food products: (1) all products available (baseline situation); (2) only existing products of better nutritional quality were available as potential substitutes and (3) only existing products of poorer quality were available. The assessment of the nutritional quality was based on the uNS-NPS score. Finally, dietary intakes were calculated for each scenario after random attribution of healthier/less healthy products as dietary choices. Monte-Carlo iterations (n=300) were conducted to generate uncertainty intervals.

Results

After simulation of reformulation using scenario 2, reduction in daily intake in comparison with the baseline situation was observed for energy (–55 kcal/day, –2.9%), saturated fat (–2.4g/day, –7.6%), sugar (–4.8g/day, –5.3%) and salt (–0.54g/day, –8.3%) and increase was observed for fibre (+1.0g/day, +4.9%). Improvements in diet quality were observed regardless of the overall quality of diet. The most important contributors to diet improvement were the followings: (1) sugars: sugary products, sweet bakery products and dairy products; (2) saturated fat: sweet bakery products, dairy products and prepared dishes and (3) salt: bread, prepared dishes, vegetable preparations and soups.

Conclusion

Widespread reformulation of food offer appeared to be an opportunity for improving nutritional status at population level in France.
Bidirectional associations between mental disorders, antidepressants and cardiovascular disease
Authors: Cao Hongbao , Baranova Ancha , Zhao Qian , Zhang Fuquan
Published: June 2024

Background

Mental disorders have a high comorbidity with cardiovascular disease (CVD), but the causality between them has not been fully appreciated.

Objective

This study aimed to systematically explore the bidirectional causality between the two broad categories of diseases.

Methods

We conducted Mendelian randomisation (MR) and multivariable MR (MVMR) analyses to evaluate potential causal links between 10 mental disorders, the use of antidepressants and 7 CVDs.

Findings

We discovered that major depressive disorder (MDD), attention-deficit/hyperactivity disorder (ADHD) and insomnia exhibit connections with elevated risks of two or more CVDs. Moreover, the use of antidepressants is linked to heightened risks of each CVD. Each distinct CVD is correlated with a greater probability of taking antidepressants. Our MVMR analysis demonstrated that the use of antidepressants is correlated with the elevation of respective risks across all cardiovascular conditions. This includes arrhythmias (OR: 1.28), atrial fibrillation (OR: 1.44), coronary artery disease (OR: 1.16), hypertension (OR: 1.16), heart failure (OR: 1.16), stroke (OR: 1.44) and entire CVD group (OR: 1.35). However, MDD itself was not linked to a heightened risk of any CVD.

Conclusions

The findings of our study indicate that MDD, insomnia and ADHD may increase the risk of CVD. Our findings highlight the utilisation of antidepressants as an independent risk factor for CVD, thus explaining the influence of MDD on CVD through the mediating effects of antidepressants.

Clinical implications

When treating patients with antidepressants, it is necessary to take into consideration the potential beneficial and detrimental effects of antidepressants.
Multicentre randomised trial of screening with sFlt1/PlGF and planned delivery to prevent pre-eclampsia at term: protocol of the PE37 study
Authors: Llurba Elisa , Crispi Fatima , Crovetto Francesca , Youssef Lina , Delgado Juan Luis , Puig Isabel , Mora Josefina , Krofta Ladislav , Mackova Katerina , Martinez-Varea Alicia , Tubau Albert , Ruiz Aina , Paya Antoni , Prat Maria , Chantraine Frederic , Comas Carmina , Kajdy Anna , Lopez-Tinajero Maria Fernanda , Figueras Francesc , Gratacos Eduard
Published: June 2024

Introduction

Pre-eclampsia affects ~5%–7% of pregnancies. Although improved obstetric care has significantly diminished its associated maternal mortality, it remains a leading cause of maternal morbidity and mortality in the world. Term pre-eclampsia accounts for 70% of all cases and a large proportion of maternal–fetal morbidity related to this condition. Unlike in preterm pre-eclampsia, the prediction and prevention of term pre-eclampsia remain unsolved. Previously proposed approaches are based on combined third-trimester screening and/or prophylactic drugs, but these policies are unlikely to be widely implementable in many world settings. Recent evidence shows that the soluble fms-like tyrosine kinase-1 (s-Flt-1) to placental growth factor (PlGF) ratio measured at 35–37 weeks’ gestation predicts term pre-eclampsia with an 80% detection rate. Likewise, recent studies demonstrate that induction of labour beyond 37 weeks is safe and well accepted by women. We hypothesise that a single-step universal screening for term pre-eclampsia based on sFlt1/PlGF ratio at 35–37 weeks followed by planned delivery beyond 37 weeks reduces the prevalence of term pre-eclampsia without increasing the caesarean section rates or worsening the neonatal outcomes.

Methods and analysis

We propose an open-label randomised clinical trial to evaluate the impact of a screening of term pre-eclampsia with the sFlt-1/PlGF ratio followed by planned delivery in asymptomatic nulliparous women at 35–37 weeks. Women will be assigned 1:1 to revealed (sFlt-1/PlGF known to clinicians) versus concealed (unknown) arms. A cut-off of >90th centile is used to define the high risk of subsequent pre-eclampsia and offer planned delivery from 37 weeks. The efficacy variables will be analysed and compared between groups primarily following an intention-to-treat approach, by ORs and their 95% CI. This value will be computed using a Generalised Linear Mixed Model for binary response (study group as fixed effect and the centre as intercept random effect).

Ethics and dissemination

The study is conducted under the principles of Good Clinical Practice. This study was accepted by the Clinical Research Ethics Committee of Hospital Clinic Barcelona on 20 November 2020. Subsequent approval by individual ethical committees and competent authorities was granted. The study results will be published in peer-reviewed journals and disseminated at international conferences.

Trial registration number

NCT04766866.
Finerenone cardiovascular and kidney outcomes by age and sex: FIDELITY post hoc analysis of two phase 3, multicentre, double-blind trials
Authors: Bansal Shweta , Canziani Maria E F , Birne Rita , Anker Stefan D , Bakris George L , Filippatos Gerasimos , Rossing Peter , Ruilope Luis M , Farjat Alfredo E , Kolkhof Peter , Lage Andrea , Brinker Meike , Pitt Bertram
Published: June 2024

Objectives

This study aimed to evaluate the efficacy and safety of finerenone, a selective, non-steroidal mineralocorticoid receptor antagonist, on cardiovascular and kidney outcomes by age and/or sex.

Design

FIDELITY post hoc analysis; median follow-up of 3 years.

Setting

FIDELITY: a prespecified analysis of the FIDELIO-DKD and FIGARO-DKD trials.

Participants

Adults with type 2 diabetes and chronic kidney disease receiving optimised renin–angiotensin system inhibitors (N=13 026).

Interventions

Randomised 1:1; finerenone or placebo.

Primary and secondary outcome measures

Cardiovascular (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke or hospitalisation for heart failure (HHF)) and kidney (kidney failure, sustained ≥57% estimated glomerular filtration rate (eGFR) decline or renal death) composite outcomes.

Results

Mean age was 64.8 years; 45.2%, 40.1% and 14.7% were aged <65, 65–74 and ≥75 years, respectively; 69.8% were male. Cardiovascular benefits of finerenone versus placebo were consistent across age (HR 0.94 (95% CI 0.81 to 1.10) (<65 years), HR 0.84 (95% CI 0.73 to 0.98) (65–74 years), HR 0.80 (95% CI 0.65 to 0.99) (≥75 years); Pinteraction=0.42) and sex categories (HR 0.86 (95% CI 0.77 to 0.96) (male), HR 0.89 (95% CI 0.35 to 2.27) (premenopausal female), HR 0.87 (95% CI 0.73 to 1.05) (postmenopausal female); Pinteraction=0.99). Effects on HHF reduction were not modified by age (Pinteraction=0.70) but appeared more pronounced in males (Pinteraction=0.02). Kidney events were reduced with finerenone versus placebo in age groups <65 and 65–74 but not ≥75; no heterogeneity in treatment effect was observed (Pinteraction=0.51). In sex subgroups, finerenone consistently reduced kidney events (Pinteraction=0.85). Finerenone reduced albuminuria and eGFR decline regardless of age and sex. Hyperkalaemia increased with finerenone, but discontinuation rates were <3% across subgroups. Gynaecomastia in males was uncommon across age subgroups and identical between treatment groups.

Conclusions

Finerenone improved cardiovascular and kidney composite outcomes with no significant heterogeneity between age and sex subgroups; however, the effect on HHF appeared more pronounced in males. Finerenone demonstrated a similar safety profile across age and sex subgroups.

Trial registration numbers

NCT02540993,NCT02545049.
A study protocol to investigate if acipimox improves muscle function and sarcopenia: an open-label, uncontrolled, before-and-after experimental medicine feasibility study in community-dwelling older adults
Authors: McDonald Claire , Alderson Craig , Birkbeck Matthew G , Brown Laura , Del Din Silvia , Gorman Grainne G , Hollingsworth Kieren , Massarella Clare , Rehman Rana , Rochester Lynn , Sayer Avan AP , Su Huizhong , Tuppen Helen , Warren Charlotte , Witham Miles D
Published: June 2024

Introduction

Sarcopenia is the age-associated loss of muscle mass and strength. Nicotinamide adenine dinucleotide (NAD) plays a central role in both mitochondrial function and cellular ageing processes implicated in sarcopenia. NAD concentrations are low in older people with sarcopenia, and increasing skeletal muscle NAD concentrations may offer a novel therapy for this condition. Acipimox is a licensed lipid-lowering agent known to act as an NAD precursor. This open-label, uncontrolled, before-and-after proof-of-concept experimental medicine study will test whether daily supplementation with acipimox improves skeletal muscle NAD concentrations.

Methods and analysis

Sixteen participants aged 65 and over with probable sarcopenia will receive acipimox 250 mg and aspirin 75 mg orally daily for 4 weeks, with the frequency of acipimox administration being dependent on renal function. Muscle biopsy of the vastus lateralis and MRI scanning of the lower leg will be performed at baseline before starting acipimox and after 3 weeks of treatment. Adverse events will be recorded for the duration of the trial. The primary outcome, analysed in a per-protocol population, is the change in skeletal muscle NAD concentration between baseline and follow-up. Secondary outcomes include changes in phosphocreatine recovery rate by31P magnetic resonance spectroscopy, changes in physical performance and daily activity (handgrip strength, 4 m walk and 7-day accelerometry), changes in skeletal muscle mitochondrial respiratory function, changes in skeletal muscle mitochondrial DNA copy number and changes in NAD concentrations in whole blood as a putative biomarker for future participant selection.

Ethics and dissemination

The trial is approved by the UK Medicines and Healthcare Products Regulatory Agency (EuDRACT 2021-000993-28) and UK Health Research Authority and Northeast – Tyne and Wear South Research Ethics Committee (IRAS 293565). Results will be made available to participants, their families, patients with sarcopenia, the public, regional and national clinical teams, and the international scientific community.

Protocol

Acipimox feasibility study Clinical Trial Protocol V.2 2/11/21.

Trial registration number

The ISRCTN trial database (ISRCTN87404878).
Evaluating a rehabilitative intervention for substance-dependent patients with and without their accompanying children in Germany (KontextSucht): study protocol for a non-randomised trial
Authors: Stullich Ananda , Hoffmann Laura , Stephan Johannes , Gehrmann Jan , Richter Matthias
Published: June 2024

Introduction

People suffering from substance use disorders often live in social contexts with children or are parents themselves. Addicted parents show specific substance-related problems while raising their children, which often leads to various lifelong consequences for the children. The German rehabilitative treatment system allows bringing children to inpatient treatment centres. This mixed-methods study evaluates a newly developed intervention, called ‘KontextSucht’ or ‘AddictionContext’, for parents in rehabilitation treatment centres concerning the effectiveness of the intervention in parenting and abstinence outcome.

Methods and analysis

The study uses a two-stage parallel mixed-methods design. A feasibility study (stage 1) and a benefit assessment (stage 2) will be conducted to evaluate the intervention. Both parts of the study will be carried out with qualitative and quantitative work packages. German-speaking parents of children 0–14 years will be included in this study. Qualitative data will be analysed using qualitative content analyses, whereas quantitative data will be analysed descriptively using regression analysis as well as linear mixed models.

Ethics and dissemination

All participants will receive detailed information on the study and sign informed consent before data collection. The research team has obtained the approval of the Ethical Review Committee at the Technical University of Munich in Germany and will follow all legislation rules regarding data protection. The study results will be published in peer-reviewed national and international journals. Furthermore, the study results will be included in an intervention manual distributed to treatment centres.

Trial registration number

DRKS00030950.
Selecting an e-cigarette for use in smoking cessation interventions and healthcare services: findings from patient and public consultation for the COSTED trial
Authors: Belderson Pippa , Ward Emma , Pope Ian , Notley Caitlin
Published: June 2024

Objectives

The Cessation of Smoking Trial in the Emergency Department (COSTED) trial aims to ascertain whether brief advice, the provision of an e-cigarette starter kit and referral to stop smoking services (SSS), increases smoking cessation in people attending the emergency department. Patient and public involvement (PPI) and scoping work were undertaken to select an appropriate e-cigarette for the trial.

Design and setting

PPI consultation and feasibility scoping about potential devices with a professional and lay panel, all based in England. Consultation was via email, telephone or video interview. This work took place between April and July 2021, prior to recruitment commencing for the COSTED trial.

Participants

A professional panel (n=7) including representatives from academia, SSS and the independent vaping industry, and a PPI lay panel (n=3) who smoke or vape.

Results

The professional panel recommended a shortlist of devices which were tested by the PPI lay panel. Key criteria for selecting an appropriate e-cigarette for smoking cessation intervention include satisfaction, usability, affordability and availability. Simplicity of use was highlighted by the PPI lay panel, who found refillable devices complex, and availability of consumables was highlighted as more important than price by both panels. The pod device selected for inclusion was rated highly for satisfaction and usability and had mid-price range and consumables which were widely available.

Conclusions

To select the most appropriate device for the COSTED trial, each criterion required assessment to ensure the best fit to the intervention context and needs of the target population. There is a need for guidance to help enable decision-making about choice of vape products, tailored to service users’ needs. We propose a bespoke checklist template, based on our findings, to assist with this process. This has applicability to the recent government announcement of a ‘Swap to Stop’ programme, offering a vaping starter kit to smokers across England, allowing services flexibility to shape their own programmes and models of delivery.

Trial registration number

Clinical trial numberISRCTN04854616; pre-results.
Sociological determinants of adherence to continuous positive airway pressure in the management of sleep apnoea syndrome: protocol for a transdisciplinary, prospective observational study
Authors: Bailly Sebastien , Foote Alison , Mendelson Monique , Rakotovao Andry , Borel Jean Christian , Pepin Jean Louis , Tamisier Renaud , Revil Helena
Published: June 2024

Introduction

Obstructive sleep apnoea syndrome (OSAS) is a chronic multiorgan pathology that has a negative impact on quality of life. Continuous positive airway pressure (CPAP) is the first-line treatment for OSAS. However, CPAP termination rates remain very high, and adherence to therapy is a major issue. To date, studies targeting predictive factors of CPAP adherence by OSAS patients mainly include clinical data. The social, socioeconomic, psychological, and home environment aspects have been far less studied and largely underestimated. This study aims to obtain solid quantitative results examining the relationship between the determinants of refusal, non-adherence, or termination of CPAP treatment, and in particular the pivotal role played by health literacy.

Methods and analysis

This is a prospective, multicentre, observational study recruiting patients attending the sleep clinic of the Grenoble Alpes University Hospital, France. Consecutive adults (>18 years) recently diagnosed with OSAS and prescribed CPAP treatment with telemonitoring will be enrolled in the present study. They will benefit from home visits by a CPAP technician or nurse at CPAP initiation. Patients will then be followed up for 6 months through the telemonitoring platform of a home-care provider. The primary objective is to evaluate the impact of health literacy (health literacy, measured by the European Health Literacy Survey questionnaire (HLS-EU-16) on the refusal, non-adherence or termination of CPAP treatment in newly diagnosed OSAS patients, during the first 6 months after diagnosis. The target sample size is 250 participants.

Ethics and dissemination

The study protocol, patient information, and the non-opposition form were approved by the French national ethics committee (CPP 2021-92, January 2022). All patients are required to have signed a written informed consent form permitting their anonymised personal and medical data to be used for clinical research purposes. We will publish the results in a peer-reviewed medical journal and on our institutional websites.

Trial registration number

NCT05385302.
Fibre-rich Foods to Treat Obesity and Prevent Colon Cancer trial study protocol: a randomised clinical trial of fibre-rich legumes targeting the gut microbiome, metabolome and gut transit time of overweight and obese patients with a history of noncancerous adenomatous polyps
Authors: Hartman Terryl J , Christie Jennifer , Wilson Annette , Ziegler Thomas R , Methe Barbara , Flanders William Dana , Rolls Barbara J , Loye Eberhart Blaine , Li Jia V , Huneault Helaina , Cousineau Ben , Perez Miriam R , O'Keefe Stephen J D
Published: June 2024

Introduction

Recently published studies support the beneficial effects of consuming fibre-rich legumes, such as cooked dry beans, to improve metabolic health and reduce cancer risk. In participants with overweight/obesity and a history of colorectal polyps, the Fibre-rich Foods to Treat Obesity and Prevent Colon Cancer randomised clinical trial will test whether a high-fibre diet featuring legumes will simultaneously facilitate weight reduction and suppress colonic mucosal biomarkers of colorectal cancer (CRC).

Methods/design

This study is designed to characterise changes in (1) body weight; (2) biomarkers of insulin resistance and systemic inflammation; (3) compositional and functional profiles of the faecal microbiome and metabolome; (4) mucosal biomarkers of CRC risk and (5) gut transit. Approximately 60 overweight or obese adults with a history of noncancerous adenomatous polyps within the previous 3 years will be recruited and randomised to one of two weight-loss diets. Following a 1-week run-in, participants in the intervention arm will receive preportioned high-fibre legume-rich entrées for two meals/day in months 1–3 and one meal/day in months 4–6. In the control arm, entrées will replace legumes with lean protein sources (eg, chicken). Both groups will receive in-person and written guidance to include nutritionally balanced sides with energy intake to lose 1–2 pounds per week.

Ethics and dissemination

The National Institutes of Health fund this ongoing 5-year study through a National Cancer Institute grant (5R01CA245063) awarded to Emory University with a subaward to the University of Pittsburgh. The study protocol was approved by the Emory Institutional Review Board (IRB approval number: 00000563).

Trial registration number

NCT04780477.
Epicardial left atrial appendage clipping versus direct oral anticoagulant to reduce stroke risk in non-paroxysmal atrial fibrillation (LAA-CLIP): rationale, design and study protocol for a multicentre randomised controlled trial
Authors: Yu Chunyu , Li Haojie , Lei Chuxiang , Wang Yang , Chen Sipeng , Zhao Yan , Zheng Zhe
Published: June 2024

Introduction

The prevalence of atrial fibrillation (AF) is increasing globally, and stroke prevention is the key to reduce the morbidity and mortality related to AF. Currently, direct oral anticoagulants (DOACs) are the primary options for stroke prevention, while it increases risk of bleeding. Left atrial appendage (LAA) is suspected as a vital source of cerebral emboli and may lead to ischaemic stroke, and thoracoscopic LAA clipping procedure provides an alternative option for stroke prevention in high-risk patients. However, high-quality evidence comparing LAA clipping to DOACs in terms of stroke prevention is lacking. This trial is designed to assess whether the efficacy of thoracoscopic LAA clipping is superior to DOACs for stroke prevention in AF patients at high risk of thrombosis (CHA2DS2-VASc≥2 in men and ≥3 in women)[CHA2DS2-VASc stands for "congestive heart failure, hypertension, age ≥75 (doubled), diabetes, stroke (doubled), vascular disease, age 65 to 74 and sex category (female)”].

Methods and analysis

This is a prospective, multicentre, open-labelled, randomised controlled study. This trial will randomly assign 290 patients with non-paroxysmal AF to thoracoscopic LAA clipping group or DOAC therapy group in a 1:1 randomisation. The primary endpoint is defined as a composite endpoint event consisting of stroke, systemic embolism, all-cause mortality, major bleeding events and clinically relevant non-major bleeding events at 24 months after randomisation. The secondary endpoints consist of the components of the primary composite endpoint, surgery-related adverse events and minor bleeding events.

Ethics and dissemination

The central ethics committee at Fuwai Hospital approved the trial entitled “Epicardial left atrial appendage clipping versus direct oral anticoagulant to reduce stroke risk in non-paroxysmal atrial fibrillation (LAA-CLIP trial)”. The results of this study will be disseminated through publications in peer-reviewed journals and conference presentations.

Trial registration number

NCT06021808.
Couples motivational interviewing with mobile breathalysers to reduce alcohol use in South Africa: a pilot randomised controlled trial of Masibambisane
Authors: Msimango Lindani , Butterfield Rita , Starks Tyrel J , van Heerden Alastair , Neilands Torsten B , Hahn Judy A , Chibi Buyisile , Humphries Hilton , Conroy Amy A
Published: June 2024

Introduction

Heavy alcohol use among people living with HIV in sub-Saharan Africa can hinder the success of HIV treatment programmes, impacting progress towards United Nations Programme on HIV/AIDS goals. Primary partners can provide critical forms of social support to reduce heavy drinking and could be included in motivational interviewing (MI) interventions to address heavy drinking; however, few studies have evaluated MI interventions for couples living with HIV in sub-Saharan Africa. We aim to evaluate the feasibility and acceptability of a couple-based MI intervention with mobile breathalyser technology to reduce heavy alcohol use and improve HIV treatment outcomes among HIV-affected couples in South Africa.

Methods and analysis

We will employ a three-arm randomised controlled trial to assess the efficacy of couple-based MI (MI-only arm) and in conjunction with mobile breathalysers (MI-plus arm) to address alcohol use and HIV outcomes, as compared with enhanced usual care (control arm). We will enrol heterosexual couples aged 18–49 in a primary relationship for at least 6 months who have at least one partner reporting hazardous alcohol use and on antiretroviral therapy for 6 months. Participants in both MI arms will attend three manualised counselling sessions and those in the MI-plus arm will receive real-time feedback on blood alcohol concentration levels using a mobile breathalyser. Couples randomised in the control arm will receive enhanced usual care based on the South African ART Clinical Guidelines. Feasibility and acceptability indicators will be analysed descriptively, and exploratory hypotheses will be examined through regression models considering time points and treatment arms.

Ethics and dissemination

The study was approved by the University of California, San Francisco (HRPP; protocol number 21-35034) and Human Sciences Research Council Research Ethics Committee (REC: protocol number 1/27/20/21). We will disseminate the results at local community meetings, community-level health gatherings and conferences focused on HIV and alcohol use.

Trial registration number

ISRCTN05756790.
Effectiveness of an online intervention for parents/guardians of children aged 4–7 years who are concerned about their child’s emotional and behavioural development: protocol for an online randomised controlled trial (EMERGENT study)
Authors: Frings Daniel , Reavey Paula , Chew Jowinn , Leahy Michael , Allabyrne Clare , Herteliu Claudiu
Published: June 2024

Introduction

The demand for resources to support emotional and behavioural development in early childhood is ever increasing. However, conventional interventions are lacking in resources and have significant barriers. The Embers the Dragon programme helps address the growing unmet need of children requiring support. The delivery of the current project seeks to help support parents, reduce the burden placed on pressed services (eg, Child and Adolescent Mental Health Services) and to help improve the emotional and behavioural development of children.

Methods and analysis

This project aims to investigate the efficacy and acceptability of Embers on parenting and children’s psychosocial outcomes. 364 parents/guardians of children aged between 4 and 7 will be recruited via the internet, schools and general practitioners (GPs). This is an online waitlist-controlled trial with three arms: (1) control arm, (2) access to Embers arm and (3) access to Embers+school. Participants will be randomised (1:1) into (1) or (2) to evaluate the use of Embers at home. To evaluate scalability in schools, (3) will be compared with (2), and (1) to test efficacy against treatment as usual (not receiving the intervention). Qualitative interviews will also be conducted. Primary outcomes are the Parental Self-efficacy Scale, Strengths and Difficulties Questionnaire and qualitative interviews. Outcomes will be compared between the three groups at baseline, 8, 16 and 24 weeks.

Ethics and dissemination

Ethical approval has been granted by the London South Bank University ethics panel (ETH2324-0004). To recruit via GPs, NHS ethical approval has been applied for, and the IRAS (331410) application is under consideration by the Central Bristol REC. The results of the project will be submitted for publication in a peer-reviewed journal. Parents/guardians will provide informed consent online prior to taking part in the study. For the interviews, assent will be taken from children by the researchers on the day.

Trial registration number

ISRCTN58327872
Potential health and economic impact of achieving Kenya’s overweight and obesity reduction target: a modelling study
Authors: Wanjau Mary Njeri , Aminde Leopold Ndemnge , Veerman J Lennert
Published: June 2024

Introduction

Kenya has adopted the WHO target of halting the rise of overweight, including obesity, by 2025. This paper assesses the potential impact of achieving the set target on health, healthcare cost and productivity.

Methods

We used a proportional multistate life table model (
Kenya Obesity Model
) to simulate the 2019 population of Kenya over their lifetime. We compared a scenario in which body mass index (BMI) distributions stabilise in 2025 against one whose BMI distributions stabilise in 2044, and quantified changes in disease-specific health outcomes, healthcare costs and productivity. We searched the literature to identify the best estimates of the total and disease-specific healthcare costs in Kenya. We used the Human Capital Approach to estimate productivity gains.

Results

If BMI distributions stabilised in 2025, an estimated 6.8 million health-adjusted life years (HALYs) (95% uncertainty interval (UI) 5.8–7.9 million) would be saved over the lifetime of the 2019 Kenyan population (135 HALYs per 1000 persons). A total of US$755 million in body mass-related healthcare costs could be saved by 2044 (US$15 per capita). For context, this equates to 16% of Kenya’s annual healthcare expenditure. Over the lifetime, ~US$3 billion healthcare costs could be saved (US$62 per capita). By 2044, the total productivity gain resulting from a reduction in high BMI-related mortality and morbidity (combined) was ~US$5.8 billion (~US$237 per capita).

Conclusion

Achieving Kenya’s overweight and obesity reduction target could improve health outcomes and also yield substantial healthcare cost savings and productivity gains.
Exploring the attitudes of solid organ transplant recipients towards COVID-19 shielding communications and the language of ‘clinically extremely vulnerable’: a qualitative study investigating lessons for the future
Authors: Greig Abbie E , Rennie Kirsten L , Ali Jason , Summers Dominic
Published: June 2024

Introduction

Solid organ transplant (SOT) recipients were among the first individuals in the UK identified as ‘clinically extremely vulnerable’ (CEV) to COVID-19 and asked to ‘shield’ at the beginning of the pandemic in March 2020. This qualitative study explores the attitudes of SOT recipients towards COVID-19 shielding communications and the language used.

Methods

Semistructured interviews were conducted with 43 adult heart, liver and kidney transplant recipients in England between January 2022 and May 2023. Open-ended questions enabled participants to fully explore their experiences of the pandemic and how they felt towards the shielding advice they received. Interviews were transcribed, anonymised and thematically analysed and coded using NVivo V.12.

Results

Communications about shielding evoked significant fear and anxiety among participants. These communications were perceived as implying that death was probable, or even inevitable, should they leave their home or fail to follow the official advice. Participants expressed widespread dislike for the term ‘CEV’, with the word ‘vulnerable’ being particularly difficult for participants to accept owing to its connotations of weakness and the reminder that participants were not as ‘normal’ as they typically felt. While shielding restrictions have come to an end, longer term impacts were highlighted by participants who expressed ongoing anxiety, with many still choosing to shield and wear a mask if in public.

Conclusions

This study suggests that governments and health authorities should carefully consider how they communicate with individuals with underlying health conditions in future public health emergencies. We have developed recommendations for how to improve shielding communications in the future, including replacing the phrase ‘CEV’ with that of ‘higher risk’, avoiding using those at higher risk as a national benchmark for risk of illness and death and providing more balanced and engaged communication and advice that takes into consideration the importance of mental well-being.