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Conventional and tablet-supported physical training to reduce falls and fall-related injuries in community-dwelling older adults: protocol of the randomised SURE-footed into the future Fall Intervention Trial (SURE-FIT)

Por: Schoene · D. · Gross · M. · Finger · B. · Lahmann · N. A. · Raeder · K. · Vorwerg-Gall · S. · König · H.-H. · Grochtdreis · T. · Stöger · D. · Handschuh · A. · Unseld · T. · Rothenbacher · D. · Büchele · G. · Rapp · K.
Introduction

Exercise-based interventions are well-established in reducing falls and fall-related injuries, but adherence and accessibility remain key challenges, particularly in rural areas. While conventional in-person training is widely used, digital interventions may offer scalable solutions to enhance engagement and reach. However, pragmatic trials evaluating the real-world effectiveness of conventional and digitally supported fall prevention interventions are lacking, limiting the evidence base for their implementation in routine healthcare settings. The SURE-Footed into the Future Fall Intervention Trial (SURE-FIT) aims to compare the effectiveness of two structured fall prevention interventions—a conventional centre-based exercise programme and a hybrid telemedical programme combining in-person and tablet-supported training—against a wait-list control group in reducing falls and fall-related injuries among community-dwelling older adults.

Methods and analysis

This study is a pragmatic three-arm, parallel-group, randomised controlled superiority trial with a 1:1:1 allocation ratio. Participants (≥65 years, community-dwelling, planned n=2778) will be randomly assigned to (1) conventional centre-based training supplemented with printed materials for home-based continuation (conventional group), (2) a hybrid model integrating centre-based and tablet-supported training for continuation (tablet group) or (3) a wait-list control group. The intervention includes a 9-week supervised phase followed by 43 weeks of independent home-based training. The primary outcomes are the incidence rate of falls and fall-related injuries over 12 months. Secondary outcomes include physical functioning, physical activity, concerns about falling, loneliness and the risk of low protein intake. A process evaluation will assess intervention feasibility and implementation. Additionally, qualitative interviews will be conducted with participants, course instructors and municipal stakeholders to explore experiences, facilitators and challenges related to programme participation and implementation. A health-economic evaluation will be conducted to assess the cost-effectiveness of the structured fall prevention interventions. Data collection will take place at baseline and every 3 months via standardised questionnaires, with a subgroup undergoing physical performance testing and sensor-based activity monitoring. Analyses will follow an intention-to-treat approach.

Ethics and dissemination

Ethical approval has been granted by the Ethics Committee of Ulm University (271/23). Written informed consent will be obtained from all participants before enrolment. Study findings will be disseminated through peer-reviewed publications, scientific conferences and national fall prevention initiatives. Additionally, results will be shared with key municipal representatives, and the German National Association of Senior Citizens’ Organisations (BAGSO). A publicly accessible website will provide ongoing access to study information and findings in plain language.

Trial registration number

DRKS00032878, German Clinical Trials Register

Safety and efficacy of quick-soluble gelatin microparticles for transarterial embolization of the lower urinary tract: Preclinical study in a rabbit urinary bladder embolization model

by Sunghoon Jeon, Keunho Kim, Cheolwon Choe, Juil Choi, Gun Lee, Chung-Do Lee, Hyeon-Jeong Moon, Jun-Gyu Park, Jin-kyung Kim, Namsoon Lee, Dongwoo Chang

Quick-soluble gelatin microparticles (QS-GMP) are emerging embolic agents under investigation for temporary vascular occlusion, offering reduced ischemic risk compared to permanent materials. The aim of this preclinical study was to evaluate the safety and efficacy of QS-GMP for transarterial embolization in a rabbit model of urinary bladder embolization. Twelve male New Zealand White rabbits underwent bilateral umbilical artery embolization using QS-GMP. Animals were assigned to four time-points (immediately, 3, 7, and 14 days post-embolization), with comprehensive assessments including clinical observations, hematologic and serum biochemical analysis, angiography, and histopathology. The procedure was technically feasible in all animals without intraoperative complications. Temporary hematuria and a transient decrease in body weight were observed post-procedure, both of which resolved spontaneously. Complete occlusion of the cranial vesical artery and absence of bladder wall perfusion were achieved immediately after embolization, followed by full recanalization at 3 days. Angiographic imaging at 7 and 14 days revealed transient hypervascularization of the bladder wall. Histopathological analysis showed marked edema, epithelial necrosis, and inflammatory infiltration at 3 and 7 days, with full urothelial regeneration observed at 14 days. No signs of ureteral or renal injury, or adverse systemic responses were detected. These findings suggest that QS-GMP may serve as a feasible option for temporary arterial occlusion in future veterinary lower urinary tract applications, although further long-term evaluation is warranted.

Short-term and long-term effects of skin-to-skin contact in healthy term infants: study protocol for a parallel-group double-blind randomised controlled trial

Por: Cho · H. · Park · J. · Choe · S.-A. · Lee · J.
Introduction

Mother-infant skin-to-skin contact (SSC) improves developmental and cognitive outcomes in preterm infants. However, the effects of SSC on healthy term infants remain unclear. We aim to investigate the short-term and long-term impacts of SSC in full-term infants to provide supporting data emphasising the importance of mother-infant SSC in South Korea.

Methods and analysis

This study is a prospective, double-blind, randomised controlled trial. A total of 130 mothers and their healthy term infants will be recruited after birth. Participants will be randomised to the intervention (SSC) or control groups. Participants in both groups will be instructed on general newborn care guidance and requested to record the same in a mobile diary app daily for 2 weeks after hospital discharge. The intervention group will be educated on the importance and clinical advantages of mother-infant SSC and provided with practical guidance, along with an informational pamphlet. They will also be informed to engage in a minimum of 6 hours of SSC per day with the infant’s and mother’s chests exposed and in contact for at least 15 min per session and to keep a record of the contact time. Breastfeeding rate, time spent on SSC and holding clothed infant, maternal depression, anxiety and bonding scores will be measured. Infants’ growth, temperament and neurodevelopmental outcomes will be assessed. In addition, artificial intelligence algorithms will be developed to analyse infant movements captured in videos.

Ethics and dissemination

This study was approved by the institutional review board of the Korea University Anam Hospital (2024AN0613), and the results will be disseminated through scientific conferences and publications.

Trial registration number

NCT06777524, registered on 14 January 2025.

The leishmaniases in Kenya: a scoping review sub-analysis of diagnostics

Por: OBrien · K. · Grifferty · G. · Shirley · H. · George · S. · Binkley · A. · Orriols · A. M. · Espinola Coombs · P. · Williams · A. L. · Wong · M. G. · Roe · S. · Wallace · F. · Tschoepe · K. · Hirsch · J. L. · Wamai · R.
Objectives

Leishmaniasis poses a significant public health problem in Kenya, where effective case management and treatment rely on accurate diagnosis. This review aims to summarise the research landscape on leishmaniasis diagnostics in Kenya and identify gaps.

Design

This scoping review expands a previously published scoping review on leishmaniasis in Kenya to further analyse studies focusing on diagnostics. The field of diagnostics was chosen because of recent pushes for novel tools and because of the role timely diagnosis plays in disease elimination. A comprehensive search of PubMed, Embase via Embase.com, Web of Science Core Collection, the Cochrane Library, ClinicalTrials.gov, WHO ICTRP and the Pan African Clinical Trials Registry was conducted, covering studies up to 5 January 2024.

Results

After dual, blind screening with conflict resolution by a third reviewer, 41 studies were included in the review. These studies examined a range of diagnostic tools; however most were assessed in one or few studies, and none evaluated real-time PCR. Additional gaps in the research landscape include a lack of diagnostics for cutaneous leishmaniasis and post-kala-azar dermal leishmaniasis in Kenya, outdated literature surrounding the Direct Agglutination Test and randomised trials for any diagnostic tool.

Conclusions

Future research should focus on solidifying the validity and reliability of diagnostic tools in the Kenyan context and updating previous work.

Leishmaniases in Kenya: a scoping review subanalysis of vectors

Por: OBrien · K. · Grifferty · G. · Shirley · H. · Wanjiku · C. · Binkley · A. · Williams · A. L. · Espinola Coombs · P. · Wong · M. G. · Roe · S. · Wallace · F. · Tschoepe · K. · Orriols · A. M. · Hirsch · J. L. · Wamai · R.
Objectives

Vector control is imperative for eliminating leishmaniasis as a public health problem in Kenya. As elimination efforts expand in East Africa, it is crucial to understand the current research landscape. To address that need and identify gaps, a scoping review was conducted to characterise the landscape of leishmaniasis vector research in Kenya.

Design

Building on a previously published scoping review by this team, we updated database searches in PubMed, Embase via Embase.com, Web of Science Core Collection, the Cochrane Library, ClinicalTrials.gov, WHO International Clinical Trials Registry Platform (ICTRP) and the Pan African Clinical Trials Registry to incorporate literature up to 4 January 2024 and focused on vector-related papers. Studies classified as ‘prevention’ in the original scoping review were included due to overlapping definitions.

Results

A total of 95 studies were included in the analysis. Although a wide range of sandfly species have been documented, most of the research is outdated, having taken place 20–40 years ago. Existing studies are mostly epidemiological with little focus on basic and clinical research. There are also no studies on post-kala-azar dermal leishmaniasis despite its potential contribution to the disease transmission cycle. The geographical scope of the research is largely limited to traditional transmission foci with little attention to new disease hotspots such as North Eastern Kenya.

Conclusions

These research gaps need to be addressed to better inform the country’s leishmaniasis prevention and vector control strategy.

Side effect profile and comparative tolerability of newer generation antidepressants in the acute treatment of major depressive disorder in children and adolescents: protocol for a systematic review and network meta-analysis

Por: Türkmen · C. · Sacu · S. · Furukawa · Y. · de Cates · A. N. · Schoevers · R. A. · Kamphuis · J. · Chevance · A. · Weisz · J. R. · Emslie · G. J. · Strawn · J. R. · Hetrick · S. E. · Efthimiou · O. · Salanti · G. · van Dalfsen · J. H. · Furukawa · T. A. · Cipriani · A.
Introduction

Major depressive disorder (MDD) is among the most common psychiatric disorders in children and adolescents. While previous meta-analyses have synthesised evidence on the efficacy and acceptability of newer-generation antidepressants in this population, specific adverse events (AEs) remain poorly characterised. This is of high clinical importance, as AEs are burdensome for patients, can reduce treatment adherence and lead to discontinuation. Here, we present a protocol for a network meta-analysis designed to evaluate the specific AE profile and comparative tolerability of newer-generation antidepressants in children and adolescents with MDD.

Methods and analysis

The planned study will include double-blind randomised controlled trials that compared one active drug with another and/or placebo for the acute treatment of MDD in children and adolescents. The following antidepressants will be considered: agomelatine, alaproclate, bupropion, citalopram, desvenlafaxine, duloxetine, edivoxetine, escitalopram, fluoxetine, fluvoxamine, levomilnacipran, milnacipran, mirtazapine, paroxetine, reboxetine, sertraline, venlafaxine, vilazodone and vortioxetine. The primary outcomes will include the number of patients experiencing at least one AE, specific non-serious AEs, serious AEs (eg, suicidal ideation) and AEs leading to treatment discontinuation. Published and unpublished studies will be retrieved through a systematic search in the following databases: PubMed, Embase, Cochrane Library (including the Cochrane Central Register of Controlled Trials), Web of Science Core Collection, PsycInfo and regulatory agencies’ registries. Study selection and data extraction will be performed independently by two reviewers. For each outcome, a network meta-analysis will be performed to synthesise all evidence. Consistency will be assessed through local and global methods, and the confidence in the evidence will be evaluated using the Confidence in Network Meta-Analysis web application. All analyses will be conducted in the R software.

Ethics and dissemination

The planned review does not require ethical approval. The findings will be published in a peer-reviewed journal and may be presented at international conferences.

PROSPERO registration number

CRD420251011399.

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