bluuebunny/crossref_metadata_2025 huggingface dataset:
Twisted epitaxy of gold nanodisks grown between twisted substrate layers of molybdenum disulfide
Authors: Cui Yi , Wang Jingyang , Li Yanbin , Wu Yecun , Been Emily , Zhang Zewen , Zhou Jiawei , Zhang Wenbo , Hwang Harold Y. , Sinclair Robert , Cui Yi
Published: January 2024

We expand the concept of epitaxy to a regime of “twisted epitaxy” with the epilayer crystal orientation between two substrates influenced by their relative orientation. We annealed nanometer-thick gold (Au) nanoparticles between two substrates of exfoliated hexagonal molybdenum disulfide (MoS
2
) with varying orientation of their basal planes with a mutual twist angle ranging from 0° to 60°. Transmission electron microscopy studies show that Au aligns midway between the top and bottom MoS
2
when the twist angle of the bilayer is small (<~7°). For larger twist angles, Au has only a small misorientation with the bottom MoS
2
that varies approximately sinusoidally with twist angle of the bilayer MoS
2
. Four-dimensional scanning transmission electron microscopy analysis further reveals a periodic strain variation (<|±0.5%|) in the Au nanodisks associated with the twisted epitaxy, consistent with the Moiré registry of the two MoS
2
twisted layers.
Rapid-acting antidepressant drugs modulate affective bias in rats
Authors: Hinchcliffe Justyna K. , Stuart Sarah A. , Wood Christian M. , Bartlett Julia , Kamenish Katie , Arban Roberto , Thomas Christopher W. , Selimbeyoglu Aslihan , Hurley Shaun , Hengerer Bastian , Gilmour Gary , Robinson Emma S. J.
Published: January 2024

How rapid-acting antidepressants (RAADs), such as ketamine, induce immediate and sustained improvements in mood in patients with major depressive disorder (MDD) is poorly understood. A core feature of MDD is the prevalence of cognitive processing biases associated with negative affective states, and the alleviation of negative affective biases may be an index of response to drug treatment. Here, we used an affective bias behavioral test in rats, based on an associative learning task, to investigate the effects of RAADs. To generate an affective bias, animals learned to associate two different digging substrates with a food reward in the presence or absence of an affective state manipulation. A choice between the two reward-associated digging substrates was used to quantify the affective bias generated. Acute treatment with the RAADs ketamine, scopolamine, or psilocybin selectively attenuated a negative affective bias in the affective bias test. Low, but not high, doses of ketamine and psilocybin reversed the valence of the negative affective bias 24 hours after RAAD treatment. Only treatment with psilocybin, but not ketamine or scopolamine, led to a positive affective bias that was dependent on new learning and memory formation. The relearning effects of ketamine were dependent on protein synthesis localized to the rat medial prefrontal cortex and could be modulated by cue reactivation, consistent with experience-dependent neural plasticity. These findings suggest a neuropsychological mechanism that may explain both the acute and sustained effects of RAADs, potentially linking their effects on neural plasticity with affective bias modulation in a rodent model.
Nitric oxide-releasing prodrug for the treatment of complex
Mycobacterium abscessus
infections
Authors: McDonald Rebecca A. , Nagy Sarah G. , Chambers Madyson , Broberg Chris A. , Ahonen Mona J. R. , Schoenfisch Mark H.
Published: January 2024

Non-tuberculosis mycobacteria (NTM) can cause severe respiratory infection in patients with underlying pulmonary conditions, and these infections are extremely difficult to treat. In this report, we evaluate a nitric oxide (NO)-releasing prodrug [methyl tris diazeniumdiolate (MD3)] against a panel of NTM clinical isolates and as a treatment for acute and chronic NTM infections
in vivo
. Its efficacy in inhibiting growth or killing mycobacteria was explored
in vitro
alongside evaluation of the impact to primary human airway epithelial tissue. Airway epithelial tissues remained viable after exposure at concentrations of MD3 needed to kill mycobacteria, with no inherent toxic effect from drug scaffold after NO liberation. Resistance studies conducted via serial passage with representative
Mycobacterium abscessus
isolates demonstrated no resistance to MD3. When administered directly into the lung via intra-tracheal administration in mice, MD3 demonstrated significant reduction in
M. abscessus
bacterial load in both acute and chronic models of
M. abscessus
lung infection. In summary, MD3 is a promising treatment for complex NTM pulmonary infection, specifically those caused by
M. abscessus
, and warrants further exploration as a therapeutic.
The fatty acid 2-hydroxylase CsSCS7 is a key hyphal growth factor and potential control target in
Colletotrichum siamense
Authors: Xi Yitao , Long Xiping , Song Miao , Liu Yu , Yan Jingting , Lv Yanyun , Yang Hong , Zhang Yu , Miao Weiguo , Lin Chunhua
Published: January 2024

CsSCS7, which is homologous to yeast fatty acid 2-hydroxylase SCS7, was confirmed to play a key role in the hyphal growth of
Colletotrichum siamense
and affect its virulence. The CsSCS7 gene is involved in the synthesis and metabolism of fatty acids. Homologs from the filamentous fungi
Magnaporthe oryzae
and
Fusarium graminearum
can recover the retarded growth and virulence of
C. siamense
ΔCsSCS7. The spraying of double-stranded RNAs targeting CsSCS7 can inhibit hyphal growth and reduce the disease lesion area to some extent. After using nano material Mg-Al layered double hydroxide as carrier, the inhibition rates were significantly increased. We demonstrated that CsSCS7 is an important factor for hyphal growth and affects virulence and may be a potential control target in
C. siamense
and even in filamentous plant pathogenic fungi.
Linking human milk oligosaccharide metabolism and early life gut microbiota: bifidobacteria and beyond
Authors: Lordan Cathy , Roche Aoife K. , Delsing Dianne , Nauta Arjen , Groeneveld Andre , MacSharry John , Cotter Paul D. , van Sinderen Douwe
Published: January 2024

Human milk oligosaccharides (HMOs) are complex, multi-functional glycans present in human breast milk. They represent an intricate mix of heterogeneous structures which reach the infant intestine in an intact form as they resist gastrointestinal digestion. Therefore, they confer a multitude of benefits, directly and/or indirectly, to the developing neonate. Certain bifidobacterial species, being among the earliest gut colonizers of breast-fed infants, have an adapted functional capacity to metabolize various HMO structures. This ability is typically observed in infant-associated bifidobacteria, as opposed to bifidobacteria associated with a mature microbiota. In recent years, information has been gleaned regarding how these infant-associated bifidobacteria as well as certain other taxa are able to assimilate HMOs, including the mechanistic strategies enabling their acquisition and consumption. Additionally, complex metabolic interactions occur between microbes facilitated by HMOs, including the utilization of breakdown products released from HMO degradation. Interest in HMO-mediated changes in microbial composition and function has been the focal point of numerous studies, in recent times fueled by the availability of individual biosynthetic HMOs, some of which are now commonly included in infant formula. In this review, we outline the main HMO assimilatory and catabolic strategies employed by infant-associated bifidobacteria, discuss other taxa that exhibit breast milk glycan degradation capacity, and cover HMO-supported cross-feeding interactions and related metabolites that have been described thus far.
Application of bacteriophage φPaP11-13 attenuates rat
Cutibacterium acnes
infection lesions by promoting keratinocytes apoptosis via inhibiting PI3K/Akt pathway
Authors: Liu Yuanyuan , Zhen Ni , Liao Danxi , Niu Jiahui , Liu Ruolan , Li Zijiao , Lei Zeyuan , Yang Zichen
Published: January 2024

Acne vulgaris caused by antibiotic-resistant
Cutibacterium acnes
(
C. acnes
) infection is difficult to treat conventionally. Phages have been suggested as a potential solution, but research on the mechanism of phage treatment is inadequate. This research investigates the underlying molecular mechanisms of phage φPaP11-13 attenuating
C. acnes
-induced inflammation in rat models. We found that rats infected with
C. acnes
had higher average ear thickness, greater enrichment of inflammatory cells as shown by hematoxylin–eosin (HE) staining, and fewer TUNEL (TdT-mediated dUTP Nick-End Labeling)-positive keratinocytes visualized by IF staining. Moreover, an increase of IGF-1 and IGF-1 receptor (IGF-1r) was detected using the immunohistochemical (IHC) staining method, Western blot (WB), and quantitative real-time PCR (qRT-PCR) when infected with
C. acnes
, which was decreased after the application of phage φPaP11-13. By applying the IGF-1 antibody, it was demonstrated that the severity of
C. acnes
-induced inflammation was relevant to the expression of IGF-1. Through WB and qRT-PCR, activation of the PI3K/Akt pathway and a down-regulation of the BAD-mediated apoptosis pathway were discovered after
C. acnes
infection. Subsequently, it was shown that the activation of the PI3K/Akt pathway against BAD-mediated apoptosis pathway was alleviated after applying phage φPaP11-13. Furthermore, applying the IGF-1r inhibitor, Pan-PI3K inhibitor, and Akt inhibitor reversed the changing trends of BAD induced by
C. acnes
and phage φPaP11-13. This study demonstrates that one of the critical mechanisms underlying the attenuation of acne vulgaris by phage φPaP11-13 is lysing
C. acnes
and regulating keratinocyte apoptosis via the PI3K/Akt signaling pathway.

IMPORTANCE

Cutibacterium acnes
infection-induced acne vulgaris may cause severe physical and psychological prognosis. However, the overuse of antibiotics develops drug resistance, bringing challenges in treating
Cutibacterium acnes
. Bacteriophages are currently proven effective in MDR (multiple drug-resistant)
Cutibacterium acnes
, but there is a significant lack of understanding of phage therapy. This study demonstrated a novel way of curing acne vulgaris by using phages through promoting cell death of excessive keratinocytes in acne lesions by lysing
Cutibacterium acnes
. However, the regulation of this cell cycle has not been proven to be directly mediated by phages. The hint of ternary relation among "phage–bacteria–host" inspires huge interest in future phage therapy studies.
Quantum Chemical Investigations of the Mechanisms of Carbo- and Heterocycles Assemblies Based on Acetylenes Reactions in Superbasic Media
Authors: Vitkovskaya N. M. , Orel V. B. , Kobychev V. B. , Bobkov A. S.
Published: January 2024

The chemistry of acetylenes has gained significant development in the context of using superbasic media in organic synthesis. Studies of reaction mechanisms require a combination of chemical, physicochemical, and theoretical methods to be applied. The review discusses the results of recent quantum chemical studies on the mechanisms of assemblies of complex highly functionalized molecular structures based on reactions of acetylene and its derivatives in superbasic media performed at the Favorsky Irkutsk Institute of Chemistry (Siberian Branch, Russian Academy of Sciences).
A Procedure of Comparative Analysis of Recursive Nonlinear Filtering Algorithms in Navigation Data Processing Based on Predictive Simulation
Authors: Stepanov O. A. , Isaev A. M.
Published: January 2024

The paper describes a procedure based on predictive simulation for comparing the recursive suboptimal algorithms developed for nonlinear filtering problems including navigation data processing problems. The algorithms are compared in terms of accuracy, consistency, and computational complexity. The provided examples explain the procedure and illustrate its application.
Polyethylene bags before cord clamping in very preterm infants: a randomised controlled trial
Authors: Dunne Emma A , Ni Chathasaigh Caitriona M , Geraghty Lucy E , O'Donnell Colm PF , McCarthy Lisa K
Published: January 2024

Objective

Hypothermia on admission to the neonatal intensive care unit (NICU) is associated with an increased risk of death in preterm infants. There are currently no evidence-based recommendations for thermal care before cord clamping (CC). We wished to determine whether placing very preterm infants in a polyethylene bag (PB) before CC, compared with after CC, results in more infants with a temperature in the normal range on NICU admission.

Design

Randomised controlled trial.

Setting

Tertiary maternity hospital.

Patients

Inborn infants<32 weeks’ gestational age (GA).

Interventions

Infants were randomly assigned to have a PB placed before or after CC.

Main outcome

Rectal temperature within the normal range (36.5°C–37.5°C) on NICU admission.

Results

Between July 2020 and September 2022, 198/220 (90%) eligible infants were enrolled in this study; 99 (44 (44%) girls) were randomly assigned to BEFORE and 99 (53 (54%) girls) to AFTER. Median (IQR) GA 29 (27–31) vs 29 (27–31) weeks, mean (SD) birth weight 1206 (429) vs 1138 (419) g, respectively. The proportion of infants who had normal temperature on NICU admission did not differ between the groups (BEFORE 54/99 (55%) vs AFTER 55/98 (56%), p 0.824). The proportion of infants with a temperature outside of the normal range was similar between the groups; hypothermia (BEFORE 34/99 (34%) vs AFTER 33/98 (34%), hyperthermia (BEFORE 10/99 (10%) vs AFTER 10/98 (10%)).

Conclusions

Placing a PB before CC did not increase the proportion of preterm infants with normal temperature on NICU admission. A large proportion of preterm infants had abnormal temperature. Further studies on thermoregulation before CC are needed.

Trial registration number

NCT04463511
Scoping review of interventions to improve continuity of postdischarge care for newborns in LMICs
Authors: Grewal Gulraj , Fuller Sebastian S , Rababeh Asma , Maina Michuki , English Mike , Paton Chris , Papoutsi Chrysanthi
Published: January 2024

Introduction

Neonatal mortality remains significant in low-income and middle-income countries (LMICs) with in-hospital mortality rates similar to those following discharge from healthcare facilities. Care continuity interventions have been suggested as a way of reducing postdischarge mortality by better linking care between facilities and communities. This scoping review aims to map and describe interventions used in LMICs to improve care continuity for newborns after discharge and examine assumptions underpinning the design and delivery of continuity.

Methods

We searched seven databases (MEDLINE, CINAHL, Scopus, Web of Science, EMBASE, Cochrane library and (Ovid) Global health). Publications with primary data on interventions focused on continuity of care for newborns in LMICs were included. Extracted data included year of publication, study location, study design and type of intervention. Drawing on relevant theoretical frameworks and classifications, we assessed the extent to which interventions adopted participatory methods and how they attempted to establish continuity.

Results

A total of 65 papers were included in this review; 28 core articles with rich descriptions were prioritised for more in-depth analysis. Most articles adopted quantitative designs. Interventions focused on improving continuity and flow of information via education sessions led by community health workers during home visits. Extending previous frameworks, our findings highlight the importance of interpersonal continuity in LMICs where communication and relationships between family members, healthcare workers and members of the wider community play a vital role in creating support systems for postdischarge care. Only a small proportion of studies focused on high-risk babies. Some studies used participatory methods, although often without meaningful engagement in problem definition and intervention implementation.

Conclusion

Efforts to reduce neonatal mortality and morbidity should draw across multiple continuity logics (informational, relational, interpersonal and managerial) to strengthen care after hospital discharge in LMIC settings and further focus on high-risk neonates, as they often have the worst outcomes.
Individual journeys to tuberculosis care in Nigeria’s private sector during the COVID-19 pandemic
Authors: Oga-Omenka Charity , Rosapep Lauren , Baruwa Elaine , Huria Lavanya , Vasquez Nathaly Aquilera , Faleye Bolanle Olusola , Kafi Md.Abdullah Heel , Sassi Angelina , Nwosu Chimdi , Johns Benjamin , Adamu Abdu , Chijioke-Akaniro Obioma , Anyaike Chukwuma , Pai Madhukar
Published: January 2024

Background

Pre-COVID-19, individuals with tuberculosis (TB) in Nigeria were often underdiagnosed and untreated. TB services were mostly in the public sector with only 15% of new cases in 2019 reported from the private sector. Reports highlighted challenges in accessing care in the private sector, which accounted for 67% of all initial care-seeking. Our study examined patients’ health seeking pathways for TB in Nigeria’s private sector and explored any changes to care pathways during COVID-19.

Methods

We conducted 180 cross-sectional surveys and 20 in-depth interviews with individuals having chest symptoms attending 18 high-volume private clinics and hospitals in Kano and Lagos States. Questions focused on sociodemographic characteristics, health-seeking behaviour, and pathways to care during the COVID-19 pandemic. All surveys and interviews were conducted in May 2021.

Results

Most participants were male (111/180), with an average age of 37. Half (96/180) sought healthcare within a week of symptoms, while few (20/180) waited over 2 months. Individuals testing positive for TB had more health-seeking delays, and those testing negative for TB had more provider delays. On average, participants visited two providers in Kano and 1.69 in Lagos, with 61 of 180 in Kano and 48 of 180 in Lagos visiting other providers before the recruitment facility. Private providers were the initial encounters for most participants (60/180 in Kano, 83/180 in Lagos). Most respondents (164/180) experienced short-lived pandemic-related restrictions, affecting access to transportation, and closed facilities.

Conclusions

This study showed a few challenges in accessing TB care, necessitating continued investment in healthcare infrastructure and resources, particularly in the private sector. Understanding the different care pathways and delays in care provides opportunities for targeted interventions to improve deployment of services closer to where patients first seek care.
Estimating the smallest worthwhile difference of antidepressants: a cross-sectional survey
Authors: Sahker Ethan , Furukawa Toshi A , Luo Yan , Ferreira Manuela L , Okazaki Kaori , Chevance Astrid , Markham Sarah , Ede Roger , Leucht Stefan , Cipriani Andrea , Salanti Georgia
Published: January 2024

Background

Approximately 30% of patients experience substantial improvement in depression after 2 months without treatment, and 45% with antidepressants. The smallest worthwhile difference (SWD) refers to an intervention’s smallest beneficial effect over a comparison patients deem worthwhile given treatment burdens (harms, expenses and inconveniences), but is undetermined for antidepressants.

Objective

Estimating the SWD of commonly prescribed antidepressants for depression compared to no treatment.

Methods

The SWD was estimated as a patient-required difference in response rates between antidepressants and no treatment after 2 months. An online cross-sectional survey using Prolific, MQ Mental Health and Amazon Mechanical Turk crowdsourcing services in the UK and USA between October 2022 and January 2023 garnered participants (N=935) that were a mean age of 44.1 (SD=13.9) and 66% women (n=617).

Findings

Of 935 participants, 124 reported moderate-to-severe depressive symptoms but were not in treatment, 390 were in treatment and 495 reported absent-to-mild symptoms with or without treatment experiences. The median SWD was a 20% (IQR=10–30%) difference in response rates for people with moderate-to-severe depressive symptoms, not in treatment, and willing to consider antidepressants, and 25% (IQR=10–35%) for the full sample.

Conclusions

Our observed SWDs mean that the current 15% antidepressant benefit over no treatment was sufficient for one in three people to accept antidepressants given the burdens, but two in three expected greater treatment benefits.

Implications

While a minority may be satisfied with the best currently available antidepressants, more effective and/or less burdensome medications are needed, with more attention given to patient perspectives.
Novel proteomics-based plasma test for early detection of multiple cancers in the general population
Authors: Budnik Bogdan , Amirkhani Hossein , Forouzanfar Mohammad H , Afshin Ashkan
Published: January 2024

Objective

Early detection of cancer is crucial for reducing the global burden of cancer, but effective screening tests for many cancers do not exist. This study aimed to develop a novel proteome-based multi-cancer screening test that can detect early-stage cancers with high accuracy.

Methods and analysis

We collected plasma samples from 440 individuals, healthy and diagnosed with 18 early-stage solid tumours. Using proximity extension assay, we measured more than 3000 high-abundance and low-abundance proteins in each sample. Then, using a multi-step statistical approach, we identified a limited set of sex-specific proteins that could detect early-stage cancers and their tissue of origin with high accuracy.

Results

Our sex-specific cancer detection panels consisting of 10 proteins showed high accuracy for both males (area under the curve (AUC): 0.98, 95% CI 0.96, 1) and females (AUC: 0.983, 95% CI 0.95, 1.00). At stage I and at the specificity of 99%, our panels were able to identify 93% (95% CI 79%, 100%) of cancers among males and 84% (95% CI 68%, 100%) of cancers among females. Our sex-specific localisation panels consisted of 150 proteins and were able to identify the tissue of origin of most cancers in more than 80% of cases. The analysis of the plasma concentrations of proteins selected showed that almost all the proteins were in the low-concentration part of the human plasma proteome.

Conclusion

The proteome-based screening test showed promising performance compared with other technologies and could be a starting point for developing a new generation of screening tests for the early detection of cancer.
Primary care system-level training and support programme for the secondary prevention of domestic violence and abuse: a cost-effectiveness feasibility model
Authors: Cochrane Madeleine , Szilassy Eszter , Coope Caroline , Emsley Elizabeth , Johnson Medina , Feder Gene , Barbosa Estela Capelas
Published: January 2024

Objectives

This study aimed to evaluate the prospective cost-effectiveness of the Identification and Referral to Improve Safety plus (IRIS+) intervention compared with usual care using feasibility data derived from seven UK general practice sites.

Method

A cost–utility analysis was conducted to assess the potential cost-effectiveness of IRIS+, an enhanced model of the UK’s usual care. IRIS+ assisted primary care staff in identifying, documenting and referring not only women, but also men and children who may have experienced domestic violence/abuse as victims, perpetrators or both. A perpetrator group programme was not part of the intervention per se but was linked to the IRIS+ intervention via a referral pathway and signposting. A Markov model was constructed from a societal perspective to estimate mean incremental costs and quality-adjusted life years (QALYs) of IRIS+ compared with to usual care over a 10-year time horizon.

Results

The IRIS+ intervention saved £92 per patient and produced QALY gains of 0.003. The incremental net monetary benefit was positive (£145) and the IRIS+ intervention was cost-effective in 55% of simulations at a cost-effectiveness threshold of £20 000 per QALY.

Conclusion

The IRIS+ intervention could be cost-effective or even cost saving from a societal perspective in the UK, though there are large uncertainties, reflected in the confidence intervals and simulation results.
Integrated health system intervention aimed at reducing type 2 diabetes risk in women after gestational diabetes in South Africa (IINDIAGO): a randomised controlled trial protocol
Authors: Norris Shane A , Zarowsky Christina , Murphy Katherine , Ware Lisa Jayne , Lombard Carl , Matjila Mushi , Chivese Tawanda , Muhwava Lorrein Shamiso , Mutabazi Jean Claude , Harbron Janetta , Fairall Lara R , Lambert Estelle , Levitt Naomi
Published: January 2024

Introduction

South Africa has a high prevalence of gestational diabetes mellitus (GDM; 15%) and many of these women (48%) progress to type 2 diabetes mellitus (T2DM) within 5 years post partum. A significant proportion (47%) of the women are not aware of their diabetes status after the index pregnancy, which may be in part to low postnatal diabetes screening rates. Therefore, we aim to evaluate a intervention that reduces the subsequent risk of developing T2DM among women with recent GDM. Our objectives are fourfold: (1) compare the completion of the nationally recommended 6-week postpartum oral glucose tolerance test (OGTT) between intervention and control groups; (2) compare the diabetes risk reduction between control and intervention groups at 12 months’ post partum; (3) assess the process of implementation; and (4) assess the cost-effectiveness of the proposed intervention package.

Methods and analyses

Convergent parallel mixed-methods study with the main component being a pragmatic, 2-arm individually randomised controlled trial, which will be carried out at five major referral centres and up to 26 well-baby clinics in the Western Cape and Gauteng provinces of South Africa. Participants (n=370) with GDM (with no prior history of either type 1 or type 2 diabetes) will be recruited into the study at 24–36 weeks’ gestational age, at which stage first data collection will take place. Subsequent data collection will take place at 6–8 weeks after delivery and again at 12 months. The primary outcome for the trial is twofold: first, the completion of the recommended 2-hour OGTT at the well-baby clinics 6–8 weeks post partum, and second, a composite diabetes risk reduction indicator at 12 months. Process evaluation will assess fidelity, acceptability, and dose of the intervention.

Ethics and dissemination

Ethics approval has been granted from University of Cape Town (829/2016), University of the Witwatersrand, Johannesburg (M170228), University of Stellenbosch (N17/04/032) and the University of Montreal (2019-794). The results of the trial will be disseminated through publication in peer-reviewed journals and presentations to key South African Government stakeholders and health service providers.

Protocol version

1 December 2022 (version #2). Any protocol amendments will be communicated to investigators, Human Ethics Research Committees, trial participants, and trial registries.

Trial registration number

PAN African Clinical Trials Registry (https://pactr.samrc.ac.za) on 11 June 2018 (identifier PACTR201805003336174).
Baduanjin exercise intervention trial: research protocol of a randomised controlled trial for frail kidney transplant recipients
Authors: Lin Keke , Fang Jiaxin , Zhang Shuping , Ding Zhenshan , Hu Yanbin , Zhang Bei , Guo Xuejie , Liu Hongxia , Zhao Peiyu
Published: January 2024

Introduction

Frailty is one of the most common comorbidities in kidney transplant recipients (KTRs). Physical, psychological and social frailty could be improved by exercise intervention. Baduanjin, also known as Eight-section Brocades, is a type of traditional Chinese medicine exercise characterised by the interplay between physical postures and movements, breathing and mind. It can help frail patients strengthen their upper and lower body muscles, improve their mood, quality of life and frailty. However, the effectiveness of Baduanjin on frail KTRs remains unknown. Therefore, we will conduct a randomised controlled trial (RCT) to evaluate the effectiveness of Baduanjin on frail KTRs.

Methods and analysis

This protocol describes an assessor and analyst blinded, parallel RCT for frail KTRs comparing Baduanjin group (n=72) with care-as-usual group (n=72). The primary outcomes are frailty assessed by Frailty Phenotype scale and Tilburg Frailty Indicator scale, and muscle strength assessed by a grip strength metre. The secondary outcomes are quality of life assessed by Medical Outcomes Study 36-Item Short-Form Health Survey (MOS SF-36) and depression assessed by the Hospital Anxiety and Depression Scale. All these data will be collected at the baseline, after 3, 6, 9 and 12 months, respectively. Two-way mixed analysis of variance (ANOVA) will be used to test the effectiveness of Baduanjin exercise. Qualitative interviews with participants in the intervention group will also be performed after 6 months. Themes will be extracted from interview transcripts using NVivo software.

Ethics and dissemination

The Ethics Committees of Beijing University of Chinese Medicine (2022BZYLL1018) and China-Japan Friendship Hospital (2022-KY-250) had approved the study. The organ donors were all from China-Japan Friendship Hospital. They provided informed consent and they were not executed prisoners. We have providedBMJ Openwith documentation from the hospital that indicates that the organs will be harvested ethically. The findings of this study will be disseminated through peer-reviewed journals, international conferences, media reports and briefings.

Trial registration number

ChiCTR2100041730
Biophysical and nutritional combination treatment for myosteatosis in patients with sarcopenia: a study protocol for single-blinded randomised controlled trial
Authors: Li Meng Chen Michelle , Cheng Yu Kin , Cui Can , Chow Simon Kwoon Ho , Wong Ronald Man Yeung , Kwok Timothy CY , Siu Parco M , Yang Minghui , Tian Maoyi , Rubin Clinton , Welch A A , Qin Ling , Law Sheung Wai , Cheung Wing Hoi
Published: January 2024

Introduction

Sarcopenia is characterised by age-related loss of skeletal muscle and function and is associated with risks of adverse outcomes. The prevalence of sarcopenia increases due to ageing population and effective interventions is in need. Previous studies showed that β-hydroxy β-methylbutyrate (HMB) supplement and vibration treatment (VT) enhanced muscle quality, while the coapplication of the two interventions had further improved muscle mass and function in sarcopenic mice model. This study aims to investigate the efficacy of this combination treatment in combating sarcopenia in older people. The findings of this study will demonstrate the effect of combination treatment as an alternative for managing sarcopenia.

Methods and analysis

In this single-blinded randomised controlled trial, subjects will be screened based on the Asian Working Group for Sarcopenia (AWGS) 2019 definition. 200 subjects who are aged 65 or above and identified sarcopenic according to the AWGS algorithm will be recruited. They will be randomised to one of the following four groups: (1) Control+ONS; (2) HMB+ONS; (3) VT+ONS and (4) HMB+VT + ONS, where ONS stands for oral nutritional supplement. ONS will be taken in the form of protein formular once/day; HMB supplements will be 3 g/day; VT (35 Hz, 0.3 g, where g=gravitational acceleration) will be received for 20 mins/day and at least 3 days/week. The primary outcome assessments are muscle strength and function. Subjects will be assessed at baseline, 3-month and 6-month post treatment.

Ethics and dissemination

This study was approved by Joint CUHK-NTEC (The Chinese University of Hong Kong and New Territories East Cluster) Clinical Research Management Office (Ref: CRE-2022.223-T) and conformed to the Declaration of Helsinki. Trial results will be published in peer-reviewed journals and disseminated at academic conferences.

Trial registration number

NCT05525039.
Non-operative versus operative treatment of suprasyndesmotic ankle fractures: protocol for a prospective, multicentre, randomised controlled trial
Authors: Saatvedt Ola , Riiser Martin , Frihagen Frede , Figved Wender , Madsen Jan Erik , Molund Marius , Furunes Håvard
Published: January 2024

Introduction

Surgery is widely recognised as the treatment of choice for suprasyndesmotic ankle fractures, because of the assumption that these injuries yield instability of the ankle joint. Stability assessment of ankle fractures using weightbearing radiographs is now used regularly to guide the treatment of transsyndesmotic and infrasyndesmotic ankle fractures. Patients with a congruent ankle joint on weightbearing radiographs can be treated non-operatively with excellent results. Weightbearing radiographs are, however, rarely performed on suprasyndesmotic fractures due to the assumed unstable nature of these fractures. If weightbearing radiographs can be used to identify suprasyndesmotic fractures suitable for non-operative treatment, we may save patients from the potential burdens of surgery.

Our aim is to compare the efficacy of operative and non-operative treatment of patients with suprasyndesmotic ankle fractures that reduce on weightbearing radiographs.

Methods and analysis

A non-inferiority randomised controlled trial involving 120 patients will be conducted. A total of 120 patients with suprasyndesmotic ankle fractures with an initial radiographic medial clear space of <7 mm will be subjected to weightbearing radiographs. If the tibio-talar joint is completely reduced, we will randomise in a 1:1 ratio to either operative treatment including reduction and fixation of the syndesmosis or non-operative treatment with an orthosis. The primary study outcome is patient-reported ankle function and symptoms as measured by the Olerud-Molander Ankle Score at 2-year follow-up. Secondary outcomes include the Manchester-Oxford Foot Questionnaire, range of motion, radiographic results and rates of adverse events.

Ethics and dissemination

The Regional Committee for Medical and Health Research South East, group A (permission number: 169307), has granted ethics approval. The results of this study will provide valuable insights for developing future diagnostic and treatment strategies for a common fracture type. The findings will be shared through publication in peer-reviewed journals and presentations at conferences.

Trial registration number

NCT04615650.
Comparison of healthcare quality for uninsured and underinsured children through community health centres in Canada and the USA: a scoping review protocol
Authors: Suleman Shazeen , Calleja Sabine , Parmar Puneet Kaur , Cohen Eyal
Published: January 2024

Introduction

Children and youth who are uninsured or underinsured in Canada and the USA have limited options where they can receive healthcare. In both countries, community health centres (CHCs) have been established as a solution to provide quality care to children without adequate insurance, including those who are newcomers or refugees. However, little is known about how well these models deliver paediatric care. Cross-country analysis provides an important viewpoint to identify areas of success and growth. The purpose of this scoping review is to compare quality of care for uninsured and underinsured children through CHCs in the USA and Canada.

Methods

This scoping review follows the methodological guidelines from the Joanna Briggs Institute Evidence synthesis. The protocol has been registered with the Open Science Framework Registries and can be accessed online. A search will be conducted in electronic databases of peer-reviewed literature (Ovid MEDLINE ALL, CINAHL Complete via EbscoHost, Scopus; Health Business Elite via EbscoHost and Sociological Abstracts via ProQuest) as well as the grey literature. Two reviewers will review all titles and abstracts for inclusion in full-text review. Studies that meet inclusion criteria will be included in full-text review. Data will be extracted into Covidence, using the Donabedian model as a conceptual framework. Findings will be synthesised in a narrative format.

Ethics and dissemination

As this study only uses publicly available data, ethics approval is not required. Findings will be shared at national and international conferences and published in a peer-reviewed journal. In addition, findings will be prepared into a policy brief or white paper to be shared with relevant policy stakeholders to advocate for a better model of care for marginalised children and youth.
Elements of organisation of integrated maternity care and their associations with outcomes: a scoping review protocol
Authors: Liebregts Jolanda , Goodarzi Bahareh , Valentijn Pim P , Downe Soo , Erwich Jan Jaap , Burchell George , Batenburg Ronald , de Vries Eline F , de Jonge Ank , Verhoeven Corine J M
Published: January 2024

Introduction

Integrated care is seen as an enabling strategy in organising healthcare to improve quality, finances, personnel and sustainability. Developments in the organisation of maternity care follow this trend. The way care is organised should support the general aims and outcomes of healthcare systems. Organisation itself consists of a variety of smaller ‘elements of organisation’. Various elements of organisation are implemented in different organisations and networks. We will examine which elements of integrated maternity care are associated with maternal and neonatal health outcomes, experiences of women and professionals, healthcare spending and care processes.

Methods and analysis

We will conduct this review using the JBI methodology for scoping reviews and the reporting guideline PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analysis extension for Scoping Reviews). We will undertake a systematic search in the databases PubMed, Scopus, Cochrane and PsycINFO. A machine learning tool, ASReview, will be used to select relevant papers. These papers will be analysed and classified thematically using the framework of the Rainbow Model of Integrated Care (RMIC). The Population Concept Context framework for scoping reviews will be used in which ‘Population’ is defined as elements of the organisation of integrated maternity care, ‘Context’ as high-income countries and ‘Concepts’ as outcomes stated in the objective of this review. We will include papers from 2012 onwards, in Dutch or English language, which describe both ‘how the care is organised’ (elements) and ‘outcomes’.

Ethics and dissemination

Since this is a scoping review of previously published summary data, ethical approval for this study is not needed. Findings will be published in a peer-reviewed international journal, discussed in a webinar and presented at (inter)national conferences and meetings of professional associations.

The findings of this scoping review will give insight into the nature and effectiveness of elements of integrated care and will generate hypotheses for further research.
Early detection of clinically significant prostate cancer: protocol summary and statistical analysis plan for the ProScreen randomised trial
Authors: Nevalainen Jaakko , Raitanen Jani , Natunen Kari , Kilpeläinen Tuomas , Rannikko Antti , Tammela Teuvo , Auvinen Anssi
Published: January 2024

Introduction

Evidence on the effectiveness of prostate cancer screening based on prostate-specific antigen is inconclusive and suggests a questionable balance between benefits and harms due to overdiagnosis, and complications from biopsies and overtreatment. However, diagnostic accuracy studies have shown that detection of clinically insignificant prostate cancer can be reduced by MRI combined with targeted biopsies.

The aim of the paper is to describe the analysis of the ProScreen randomised trial to assess the performance of the novel screening algorithm in terms of the primary outcome, prostate cancer mortality and secondary outcomes as intermediate indicators of screening benefits and harms of screening.

Methods

The trial aims to recruit at least 111 000 men to achieve sufficient statistical power for the primary outcome. Men will be allocated in a 1:3 ratio to the screening and control arms. Interim analysis is planned at 10 years of follow-up, and the final analysis at 15 years. Difference between the trial arms in prostate cancer mortality will be assessed by Gray’s test using intention-to-screen analysis of randomised men. Secondary outcomes will be the incidence of prostate cancer by disease aggressiveness, progression to advanced prostate cancer, death due to any cause and cost-effectiveness of screening.

Ethics and dissemination

The trial protocol was reviewed by the ethical committee of the Helsinki University Hospital (2910/2017). Results will be disseminated through publications in international peer-reviewed journals and at scientific meetings.

Trial registration number

NCT03423303
Examining age, period and cohort effects in attitude change to childhood vaccinations in a representative New Zealand survey: a multiyear cohort-sequential growth modelling study
Authors: Hayes Emily , Yogeeswaran Kumar , Zubielevitch Elena , Lee Carol H J , Cording Jacinta , Sibley Chris G
Published: January 2024

Objectives

Vaccinations are an important preventative measure in reducing the spread of infectious diseases worldwide. However, concerns of undervaccination during childhood have become increasingly common. The current study aims to investigate changes in attitudes towards childhood vaccinations prior to the COVID-19 pandemic using a national sample from New Zealand.

Design

Age-based, period-based, and cohort-based changes were assessed using cohort-sequential latent growth modelling in 11 overlapping birth cohorts, which spanned the ages of 23–79 years.

Setting and participants

Data were taken from the New Zealand Attitudes and Values Study where 58 654 adults completed at least one wave across a 7-year period (2013 and 2015–2019).

Results

The period-based and cohort-based models fit the data equally well (χ2(282)=8547.93, p<0.001, comparative fit index, CFI=0.894, root mean square error of approximation, (RMSEA)=0.074, standardised root mean square residual, SRMR=0.105; χ2(273)=8514.87, p<0.001, CFI=0.894, RMSEA=0.075, SRMR=0.105, respectively) suggesting societal factors contribute to childhood vaccination attitudes. Additionally, the findings suggest attitudes towards childhood vaccinations were becoming increasingly more positive in all birth cohorts (ps<0.001), with younger and older birth cohorts exhibiting even positive attitudes compared with middle-aged cohorts.

Conclusion

Overall, both the cohort-based and period-based models reveal changes in vaccination attitudes suggesting that even prior to the COVID-19 pandemic, societal influences had an impact on attitudes towards childhood vaccination.
Evaluation of a codesigned group cognitive–behavioural therapy intervention for trans young people (TAG TEAM): protocol for a feasibility trial and a subsequent pilot RCT
Authors: Chinsen Alessandra , Cronin Tim J , Pace Carmen C , Tollit Michelle A , Pang Ken C
Published: January 2024

Introduction

Trans young people are at a higher risk of mental health difficulties such as depression, anxiety and suicidality than their cisgender peers, due in part to their experiences of minority stress. This protocol describes a feasibility trial and subsequent pilot randomised controlled trial (RCT) of a codesigned group cognitive–behavioural therapy intervention for trans young people, named Trans Adolescent Group ThErapy for Alleviating Minority stress (TAG TEAM).

Methods and analysis

To evaluate TAG TEAM, we will conduct a feasibility trial followed by a pilot RCT with trans young people aged 14–16 years who have been referred to the Royal Children’s Hospital Gender Service in Melbourne, Australia. In the feasibility trial, we aim to enrol 32 participants who will be randomised at a 1:1 ratio to either in-person or online intervention arms. Participants will be assessed at baseline and post-treatment, with a nested qualitative evaluation post-treatment. Primary outcomes are the feasibility and acceptability of the intervention and the study design and associated procedures, including comparison of the in-person and online delivery modes. In the subsequent pilot RCT, we aim to enrol 64 participants who will be randomised at a 1:1 ratio to an intervention or waitlist control arm, with delivery mode determined by the feasibility trial. Participants will complete assessments at baseline, post-treatment and 3-month follow-up. Primary outcomes are the feasibility and acceptability of the RCT study design. In both the feasibility trial and pilot RCT, participants will complete assessments related to mood, anxiety, suicidality, quality of life, minority stress, family support and social transition. Quantitative data will be analysed using descriptive statistics. Qualitative data will be analysed using thematic and interpretive analysis.

Ethics and dissemination

The Royal Children’s Hospital Human Research Ethics Committee has approved this study (#91162). Informed consent will be obtained in writing from all participants and a legal guardian. Findings will inform the development of a full-scale RCT to evaluate the efficacy of TAG TEAM and will be disseminated through conferences and peer-reviewed journals.

Trial registration number

ACTRN12623000302651, ACTRN12623000318684.
Availability of evidence and comparative effectiveness for surgical versus drug interventions: an overview of systematic reviews and meta-analyses
Authors: Zavalis Emmanuel A , Rameau Anaïs , Saraswathula Anirudh , Vist Joachim , Schuit Ewoud , Ioannidis John P
Published: January 2024

Objectives

This study aims to examine the prevalence of comparisons of surgery to drug regimens, the strength of evidence of such comparisons and whether surgery or the drug intervention was favoured.

Design

Systematic review of systematic reviews (umbrella review).

Data sources

Cochrane Database of Systematic Reviews.

Eligibility criteria

Systematic reviews attempt to compare surgical to drug interventions.

Data extraction

We extracted whether the review found any randomised controlled trials (RCTs) for eligible comparisons. Individual trial results were extracted directly from the systematic review.

Synthesis

The outcomes of each meta-analysis were resynthesised into random-effects meta-analyses. Egger’s test and excess significance were assessed.

Results

Overall, 188 systematic reviews intended to compare surgery versus drugs. Only 41 included data from at least one RCT (total, 165 RCTs) and covered a total of 103 different outcomes of various comparisons of surgery versus drugs. A GRADE assessment was performed by the Cochrane reviewers for 87 (83%) outcomes in the reviews, indicating the strength of evidence was high in 4 outcomes (4%), moderate in 22 (21%), low in 27 (26%) and very low in 33 (32%). Based on 95% CIs, the surgical intervention was favoured in 38/103 (37%), and the drugs were favoured in 13/103 (13%) outcomes. Of the outcomes with high GRADE rating, only one showed conclusive superiority in our reanalysis (sphincterotomy was better than medical therapy for anal fissure). Of the 22 outcomes with moderate GRADE rating, 6 (27%) were inconclusive, 14 (64%) were in favour of surgery and 2 (9%) were in favour of drugs. There was no evidence of excess significance.

Conclusions

Though the relative merits of surgical versus drug interventions are important to know for many diseases, high strength randomised evidence is rare. More randomised trials comparing surgery to drug interventions are needed.