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Aims: This study aims to investigate the safety, tolerability, efficacy, and pharmacokinetics of Pynegabine as an add‐on therapy in the treatment of focal epilepsy. Methodology: This is a protocol phase‐IIa, randomized, double‐blinded, placebo‐controlled, multicenter study in patients with focal epilepsy from multiple centers in China who have been treated with at least 2 ASMs without effective control. The study involves an 8‐week run‐in period with stable use of previous medications. Patients are then randomized to receive either Pynegabine or a placebo. Sentinel administration is performed initially, and subsequent patients are randomized based on safety assessments. Three dose cohorts (15, 20, and 25 mg/d) are established. Efficacy is assessed through various measures, including seizure frequency, CGI score, PGI score, HAMA score, HAMD score, MoCA scale score, QOLIE‐31 scale score, and 12 h‐EEG score. Safety evaluations, PK blood samples, concomitant medications, and adverse events are also recorded. Conclusion: Data from the study will be used to evaluate the safety, tolerability, efficacy, and pharmacokinetics of Pynegabine tablets as add‐on therapy for focal epilepsy. [ABSTRACT FROM AUTHOR]

Background and Objectives: Current national or regional guidelines for the pathology reporting on invasive breast cancer differ in certain aspects, resulting in divergent reporting practice and a lack of comparability of data. Here we report on a new international dataset for the pathology reporting of resection specimens with invasive cancer of the breast. The dataset was produced under the auspices of the International Collaboration on Cancer Reporting (ICCR), a global alliance of major (inter‐)national pathology and cancer organizations. Methods and Results: The established ICCR process for dataset development was followed. An international expert panel consisting of breast pathologists, a surgeon, and an oncologist prepared a draft set of core and noncore data items based on a critical review and discussion of current evidence. Commentary was provided for each data item to explain the rationale for selecting it as a core or noncore element, its clinical relevance, and to highlight potential areas of disagreement or lack of evidence, in which case a consensus position was formulated. Following international public consultation, the document was finalized and ratified, and the dataset, which includes a synoptic reporting guide, was published on the ICCR website. Conclusions: This first international dataset for invasive cancer of the breast is intended to promote high‐quality, standardized pathology reporting. Its widespread adoption will improve consistency of reporting, facilitate multidisciplinary communication, and enhance comparability of data, all of which will help to improve the management of invasive breast cancer patients. [ABSTRACT FROM AUTHOR]

Background: Populations are ageing, making the quality of old age a crucial issue. Some adversity in old age, such as loss of loved one or loss of physical function, is often experienced, as is the need for recovery from such adversity. Resilience in later life has become an important topic and has accumulated much empirical research. However, the research has mainly centred on individual factors, such as personality, rather than social factors, such as family relationships or community engagement. There is no systematic review of the social dimensions of resilience in old age, a focus that should be especially important for policy and practice seeking to create supporting environments. Methods: Our review comprises quantitative and qualitative empirical original English language studies, published 2013–2023, using predefined search phrases including 'resilience' and various terms for old age and social dimensions. Titles and abstracts are screened by the first two authors using registered exclusion criteria. Final inclusion, based on full‐text reading, is decided using registered inclusion criteria, and verified by co‐authors. Qualitative articles are read by authors specialized in qualitative research and quantitative articles by authors specialized in quantitative research. Due to large expected heterogeneity, meta‐analysis is not conducted, but weighted effect sizes or funnel plots may be prepared if parallel quantitative studies are encountered. Qualitative studies are synthesized using meta‐aggregation. The risk of bias is evaluated with applicable Joanna Briggs Institute checklists for each study design. A narrative synthesis brings together the qualitative and quantitative studies. Conclusion: Methodological strengths and weaknesses of the included studies are reported to assess the quality of the research. Summary of the most significant social dimensions of resilience in old age is prepared, emphasizing interactions between contexts, stressors, mechanisms and outcomes; and research gaps are identified. Systematic Review Registration: Protocol is registered in PROSPERO (CRD42023412532). [ABSTRACT FROM AUTHOR]

Introduction: The pathogenesis and clinical profiles of patients with pulmonary hypertension (PH) associated with interstitial lung disease (ILD-PH) are poorly understood. Whether and to what extent pulmonary arterial hypertension (PAH)-specific therapy improves hemodynamic and outcome in ILD-PH are also unknown. Study Objective: This study aims to clarify the characteristics, clinical course and response to PAH-specific therapy of ILD and/or PH by enrolling three unique subsets: PAH, ILD-PH, and ILD. Methods: The proposed study is a retrospective and prospective, multi-centre, observational cohort study of patients treated at any of three university hospitals in the Hokkaido region of Japan who have any one of the following: PAH; ILD-PH with or without PAH features; or ILD without PH. We aim to enrol 250 patients in total. For the retrospective observation period, data obtained after 1 January 2010, will be analysed, and the prospective observation period will be 1 year. We will compare the clinical data of patients with ILD-PH with those of patients with PAH and those of patients with ILD without PH in the real-world clinical setting. In addition, within the cohort of patients with ILD-PH, we will explore the subset with "ILD-PH with PAH features" and compare the response to PAH-specific therapy with that of PAH. The primary outcome will be the change in pulmonary vascular resistance from first treatment to follow-up in patients with PAH and ILD-PH with PAH features (excluding ILD-PH without PAH feature and ILD-no-PH for the primary outcome). The exploratory outcomes will include analyses of PH-associated biomarkers, right ventricular function and patient-reported outcomes. Results: This is a protocol article and the results will be presented after data collection is completed. Conclusion: The POPLAR study will provide data that help better understand the pathophysiology of ILD-PH and improve the quality of life and outcome of patients with PH and/or ILD. Trial Registration: Japan Registry of Clinical Trials: jRCT1010230018. [ABSTRACT FROM AUTHOR]

Background: The European Society of Anesthesiology and Intensive Care recommends the use of neuromuscular blocking agents (NMBA) in adults, to facilitate tracheal intubation and reduce its associated complications. Children who undergo tracheal intubation may suffer some of the same complications, however, no consensus exists regarding the use of NMBA for tracheal intubation in the pediatric population. We will explore the existing evidence assessing the effects of avoidance versus the use of NMBA for the facilitation of tracheal intubation in children and infants. Methods: This protocol follows the preferred reporting items for systematic reviews and meta‐analyses protocols recommendations. We will include all randomized controlled clinical trials assessing the effects of avoidance versus the use of NMBA for facilitation of tracheal intubation (oral or nasal) using direct laryngoscopy or video laryngoscopy in pediatric participants (<18 years). Our primary outcome is incidence of difficult tracheal intubation. Secondary outcomes include incidence of serious adverse events, failed intubation, events of upper airway discomfort or injury, and difficult laryngoscopy. We will conduct a thorough database search to identify relevant trials, including CENTRAL, MEDLINE, EMBASE, BIOSIS, Web of Science, CINAHL, and trial registries. Two review authors will independently handle the screening of literature and data extraction. Each trial will be evaluated for major sources of bias with the "classic risk of bias tool" used in the Cochrane Collaboration tool from 2011. We will use Review manager (RevMan) or R with the meta package to perform the meta‐analysis. We will perform a trial sequential analysis on the meta‐analysis of our primary outcome, providing an estimate of statistical reliability. Two review authors will independently assess the quality of the body of evidence using the grading of recommendations assessment, development, and evaluation (GRADE) approach. We will use GRADEpro software to conduct the GRADE assessments and to create "Summary of the findings" tables. [ABSTRACT FROM AUTHOR]

Background: In Germany, the nutritional situation of adults and children living in households at risk of poverty has been insufficiently studied so far. Aim: The aim of the mixed-methods study MEGA_kids is to gain a deeper understanding of the nutritional situation including socioeconomic, behavioral, and attitudinal factors and health characteristics among persons living in families at risk of poverty. Method: MEGA_kids is a mixed-methods cross-sectional study consisting of four modules combining quantitative and qualitative methods. The first module (A) applies self-administered questionnaires to assess the individual's diet, household food insecurity, and several other factors among adults and children of 500 households. Cash receipts are used to assess household's food expenses. For the second module (B), a semistructured interview guide is used to identify factors influencing food security and nutritional quality from the perspective of a subsample of module A (n = 20). The third module (C) applies the participatory World Café technique to explore experiences and generate ideas for tailored support measures for a healthy diet from the perspective of 40 parents participating in module A. Finally, the fourth module (D) investigates the knowledge and usage of existing nutrition-related preventive measures among 200 parents at risk of poverty by using an online questionnaire. Conclusion: By providing a comprehensive picture of nutritional aspects of families living at risk of poverty, MEGA_kids will guide officials to target and prioritize public health nutrition measures, inform policy makers to implement and improve healthy policies and, finally, identify research gaps to be prioritized. [ABSTRACT FROM AUTHOR]

Wireless sensor networks contain of many sensors that can serve as powerful tools for data collection in environments. A key challenge in these networks is the limited lifetime of sensor batteries. Ideally, all nodes would exhaust their energy simultaneously or through regular scheduling, maximizing the lifetime. Consequently, the primary concern is achieving optimal energy utilization to extend the network's lifetime over a logical duration. Depleting the batteries of the sensors means stopping the operation of the network, because it is practically impossible to replace the batteries of thousands of nodes. To address this issue, the low energy adaptive clustering hierarchical (LEACH) protocol has been widely recognized as one of the prominent solutions for clustering WSNs. However, the random selection of cluster heads in each round under the LEACH protocol fails to guarantee proper convergence. To overcome this limitation, this paper proposes a refined approach by utilizing a genetic algorithm and a novel objective function that incorporates various factors, including energy level and distance. The algorithm employs chromosomes to represent CHs and facilitates the selection of cluster nodes. Notably, the proposed algorithm dynamically performs clustering, meaning that clustering is conducted iteratively, considering identifying dead nodes. By leveraging this approach, the algorithm significantly enhances the clustering quality, ultimately leading to an increased network lifetime. To validate its effectiveness, it is compared with LEACH, LEACH_E and LEACH_EX algorithms, demonstrating its superior capabilities. On average, the proposed algorithm has more alive nodes in the network, and the remaining energy is at least 11% higher than the best other algorithms. [ABSTRACT FROM AUTHOR]

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Discrepant sample processing remains a significant challenge within blood metabolomics research, introducing non-biological variation into the measured metabolome and biasing downstream results. Inconsistency during the pre-analytical phase can influence experimental processes, producing metabolome measurements that are non-representative of in vivo composition. To minimize variation, there is a need to create and adhere to standardized pre-analytical protocols for blood samples intended for use in metabolomics analyses. This will allow for reliable and reproducible findings within blood metabolomics research. In this review article, we provide an overview of the existing literature pertaining to pre-analytical factors that influence blood metabolite measurements. Pre-analytical factors including blood tube selection, pre- and post-processing time and temperature conditions, centrifugation conditions, freeze–thaw cycles, and long-term storage conditions are specifically discussed, with recommendations provided for best practices at each stage. [ABSTRACT FROM AUTHOR]

Abstract As plastic pollution exists in aquatic ecosystems globally, monitoring its abundance and distribution has become crucial for understanding transport pathways, sources, sinks, and impacts. Riverbanks are accumulation zones for plastic, but the selection of monitoring methods is constrained by research goals, available resources, and site-specific conditions. This diversity in approaches has led to disparate datasets, highlighting the need for standardized monitoring protocols. Here, we study the spatial distribution of plastic at the riverbank scale, quantify the uncertainty of existing riverbank methods, and provide recommendations for improved monitoring based on the balance between uncertainty loss and increase in effort. We measured riverbank plastic abundance at eight Dutch riverbanks, categorizing the items using 108 item categories (River-OSPAR). For every riverbank, an area of 100 by 25 meters was subdivided into five-by-five-meter squares, resulting in 100 individual monitored sub-areas. We found riverbank plastic exhibited high spatial variability, with deposition patterns ranging from parallel to the waterline to clustered, random, or uniform (Moran’s I between -0.050 and 0.301). Individual measurements from diverse sampling protocols are 5-49 times less accurate than estimates derived from extensive sampling, highlighting the diminishing impact of specific methods with increased data collection. Lastly, our findings suggest that increasing the sampling area quickly reaches diminishing returns in terms of accuracy. Reducing the sampled area by 80% only increases the uncertainty in estimating the true plastic density by 20%. While standardized protocols are essential for data comparability, a rigid, uniform sampling approach may be less efficient and resource-intensive than a flexible (step-wise) strategy that adapts to local conditions. By demonstrating that extensive sampling can mitigate the differences between unique sampling protocols, this study promotes a shift towards flexible and efficient riverbank plastic monitoring, ultimately accelerating global efforts to combat plastic pollution.

Background: The ulnar collateral ligament (UCL) is frequently injured in overhead throwing athletes, leading to elbow instability, pain and decreased performance, and requiring surgical intervention. Augmenting with suture tape provides a novel approach to UCL repair, offering stability while preserving native anatomy, proprioception, and minimizing bone loss, with the added benefit of an expected faster rehabilitation and return to sport (RTS) compared to traditional UCL reconstruction. The purpose of this study is to assess the variability of the current publicly available rehabilitation protocols for elbow UCL repair with suture tape augmentation. Methods: A systematic review of Google and PubMed was performed to find rehabilitation protocols for UCL repair with suture tape augmentation. Two hundred nine orthopedic surgery residency programs were identified using the Fellowship and Residency Electronic Interactive Database Access. The programs were searched on Google, a broad nonspecific Google search, and a systematic literature search of journal databases for UCL repair with suture tape augmentation rehabilitation protocols was conducted. Results: Thirteen rehabilitation protocols met the inclusion criteria for analysis. Of these, 12 protocols outlined the use of an articulating brace at varying range of motion settings for the first 4-6 weeks following surgery. Return to throwing was included in all 13 protocols and began between 10 and 12 weeks following surgery. RTS was included in 11 protocols and expected athletes competing as early as 16 weeks with a mean recommended RTS at 21.5 weeks. Conclusion: Rehabilitation protocols for UCL repair with suture tape augmentation were often structured around a 5-phase program with RTS approaching 20 weeks. They utilized immobilization and range of motion restriction as well as strengthening and gradual RTS procedures. Overall, the included protocols had mild variability with initiation of throwing and RTS 12 to 24 weeks faster than traditional UCL reconstruction.

Tongzuo Liu,1,2,&ast; Jingyi Zhang,1,2,&ast; Zhiqiang Zhao,1 Yingfei Bi,1 Ying Zheng,1 Shuai Wang,1 Xiaohua Dai,3 Jun Li,4 Qian Lin,5 Daimei Ni,6 Chenglong Wang,7 Jianguang Wu,8 Yitao Xue,9 Mingjun Zhu,10 Xianliang Wang,1,&ast; Jingyuan Mao1,&ast; 1Cardiovascular Department, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine/National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, Tianjin, People’s Republic of China; 2Graduate School, Tianjin University of Traditional Chinese Medicine, Tianjin, People’s Republic of China; 3Cardiovascular Department, The First Affiliated Hospital of Anhui University of Chinese Medicine, Anhui, People’s Republic of China; 4Cardiovascular Department, Guang’anmen Hospital of China Academy of Chinese Medicine Science, Beijing, People’s Republic of China; 5Cardiovascular Department, Dongzhimen Hospital of Beijing University of Chinese Medicine, Beijing, People’s Republic of China; 6Cardiovascular Department, Taihe Hospital of Traditional Chinese Medicine Affiliated to Anhui University of Chinese Medicine, Anhui, People’s Republic of China; 7Cardiovascular Department, Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing, People’s Republic of China; 8Cardiovascular Department, Affiliated Hospital of Jiangxi University of Chinese Medicine, Jiangxi, People’s Republic of China; 9Cardiovascular Department, Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Shandong, People’s Republic of China; 10Cardiovascular Department, The First Affiliated Hospital of He’nan University of Traditional Chinese Medicine, Henan, People’s Republic of China&ast;These authors contributed equally to this workCorrespondence: Jingyuan Mao; Xianliang Wang, Cardiovascular Department, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine/National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, Tianjin, People’s Republic of China, Tel +86-13820498886 ; +86-13920007825, Email jymao@126.com; xlwang1981@126.comBackground: Stable angina pectoris (SAP), as a common type of coronary heart disease (CHD), is characterized by transient retrosternal squeezing pain or suffocation induced by exercise, mood swings, or other stress. Most patients with stable angina pectoris do not benefit from interventional therapy and medication, so optimizing treatment plans has important clinical significance. Jiuxin pill is a Chinese patent medicine developed by Huatuo Chinese Medicine Co. Ltd. (Bozhou, China) to relieve the symptoms of stable angina pectoris (SAP). However, there is a lack of evidence support from high-quality clinical studies.Methods: In this randomized, double-blind, placebo-controlled, multicenter clinical trial, 170 patients with SAP were recruited from 11 centers in China. The patients were randomized to either the treatment group (Jiuxin pill, 2 pills, bid) or the control group (Jiuxin pill simulant, 2 pills, bid) without changing the original conventional western medicine. The trial was set up with a run-in period of 7 days, a treatment period of 28 ± 2 days, and a follow-up period of 28 ± 2 days. Total exercise time (TED) in the treadmill test and Seattle Angina Questionnaire (SAQ) scores were set as the main efficacy outcomes, and the 1-minute heart rate recovery (HRR1), metabolic equivalents (METs), maximum ST segment depression, Borg perceived exertion after exercise, the average number of angina attacks per week, usage of nitroglycerin, drug withdrawal and reduction rate, information scoring of four diagnostic methods in traditional Chinese medicine and incidence of major adverse cardiovascular events were set as the secondary efficacy outcomes. Adverse events were monitored throughout the trial.Discussion: In China, the use of Chinese patent medicine in the treatment of stable angina pectoris is more common. This trial evaluated the efficacy and safety of the Jiuxin pill in the treatment of patients with SAP, and the trial results provide high-quality research evidence for its clinical application.Trial Registration: This trial has been registered in the China Clinical Trial Registry on 11 June 2022 (Registration No.: ChiCTR2200060780, https://www.chictr.org.cn/showproj.html?proj=172352).Keywords: traditional Chinese medicine, Jiuxin pill, stable angina pectoris, protocol, randomized controlled trial

Abstract Background Despite receiving adequate treatment, many tuberculosis (TB) survivors are left with post-tuberculosis complications, possibly due to lung tissue damage incurred during the active period of the disease. Current TB programs worldwide deliver quality care throughout the course of active TB treatment, yet often fail to provide organized follow-up once treatment ends. Post-tuberculosis lung disease (PTLD) is a prominent, yet underrecognized cause of chronic lung disease, managed similarly to chronic respiratory diseases with pharmacotherapy and/or personalized pulmonary rehabilitation interventions. Basic pulmonary rehabilitation packages for people finishing TB treatment are still lacking in low- and middle-income countries (LMICs). We offer a study protocol to evaluate the implementation of spirometry and symptom screening for PTLD among people who have completed TB treatment in a rural district in Mozambique. Methods The overall objective of this study is to evaluate the introduction of a new screening program that utilizes symptom screening and spirometry for diagnosing PTLD among adolescents and adults that have completed TB treatment. This research protocol consists of three complementary components: 1) assessing the prevalence of PTLD among patients enrolled in the National TB Control Program (NTCP) at Carmelo Hospital (CHC) in Chókwè District, Mozambique; 2) evaluating anticipated implementation outcomes through the identification of the site-, provider-, and individual-level determinants that either facilitate or hinder the successful adoption, implementation, and maintenance of the spirometry screening program, and 3) evaluating the real-time implementation outcomes/processes in order to provide practical evidence-based key indicators of successful implementation of the spirometry screening program. Discussion Providing well-organized, evidence-based care for individuals with a history of TB who are experiencing symptoms of PTLD can relieve chronic respiratory issues, enhance quality of life, and potentially lower the risk of further pulmonary infections, including recurrent TB. However, there is a significant gap in the literature regarding the implementation of best practices of HIV and TB health services delivery. Addressing this gap could assist Mozambique in improving diagnosis, treatment, and continuity of care for people formerly living with TB. The insights from this study will help decision-makers improve spirometry screening coverage, enhance intervention effectiveness, and translate our findings to evidence-based programming. Trial registration ISRCTN92021748 retrospectively registered.

Abstract Background The Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet is a plant-based and anti-inflammatory diet that has the ability to protect and manage cardiovascular and nervous system diseases. Regarding that insomnia and cardiovascular problems are x`common in type 2 diabetes mellitus (T2DM), the present study will assess the effectiveness of the MIND dietary pattern on sleep quality, cardiometabolic indicators, and other psychological indicators. Methods Forty-four overweight/obese T2DM women with insomnia, aged 30–65 years, will voluntarily participate in this randomized controlled trial and will be randomized to receive either a MIND low-calorie diet (MLCD) or a low-calorie diet (LCD) over a 3-month period. Before and after the study, sleep quality, some biochemical and cardiometabolic indices, cortisol, brain-derived neurotrophic factor (BDNF), high-sensitivity C-reactive protein (hs-CRP), and oxidative stress indicators will be assessed. Discussion The use of dietary interventions in the management of T2DM complications is practical and safe. This research seeks to investigate the capacity of the MIND diet in the management of insomnia and cardiovascular problems of DM. It is expected that the results of this research will provide new perspectives on using an ideal dietary regimen to treat these health conditions. Trial registration IRCT20181111041611N8. Registered on August 7, 2023. https://www.irct.ir/trial/71772

Yongkang Zhang,&ast; Jiarui Liu,&ast; Yuzhen Wang, Yuan Zong, Kangli Yin, Fang Cao, Xinyu Liang, Yemin Cao Diagnosis and Treatment Center of Vascular Disease, Shanghai TCM-Integrated Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, People’s Republic of China&ast;These authors contributed equally to this workCorrespondence: Yemin Cao; Yongkang Zhang, Diagnosis and Treatment Center of Vascular Disease, Shanghai TCM-Integrated Hospital, No. 230 Baoding Road, Hongkou District, Shanghai, People’s Republic of China, Tel +8613361831119 ; +8613761921568, Email caoyemin@shutcm.edu.cn; zhangyongkang_tcm@163.comPurpose: Peripheral arterial disease (PAD) is a chronic ischemic disease caused by atherosclerosis of the lower extremities, with early clinical symptoms manifesting mainly as intermittent claudication. Current treatment of PAD is based on the control of cardiovascular risk factors. However, even vasoactive drugs are not ideal for improving ischemic symptoms in the lower limbs of PAD patients. Ruanjian Qingmai granules, derived from the classic formula of the late Professor Jiuyi Xi, a famous traditional Chinese medicine doctor in Shanghai, have good clinical efficacy in the treatment of the pattern of blood vessel stasis and obstruction of PAD and have been used by more than 600,000 PAD patients over the past three decades. This study aims to evaluate the efficacy and safety of Ruanjian Qingmai granules in patients with symptomatic PAD.Patients and methods: A prospective, center-randomized, double-blind, placebo-controlled clinical trial will be conducted at 9 grade A tertiary hospitals in Shanghai. It is anticipated that 250 patients with early symptomatic PAD will be recruited and randomized to the control and intervention groups (1:1 ratio of central randomization). Subjects will be treated with Ruanjian Qingmai granules or placebo at 6 g twice daily for 16 weeks. The primary efficacy indicators are the pain-free walking distance and maximum walking distance. The secondary efficacy indicators are the ankle-brachial index, walking impairment questionnaire, quality of life score, and Chinese medicine syndrome score.Conclusion: Positive results from this study will demonstrate the efficacy and safety of Ruanjian Qingmai granules in improving ischemic symptoms in patients with symptomatic PAD.Clinical Registration: This study has been registered with the Chinese Clinical Trials Registry (ChiCTR2200056109, Date: 02/01/2022, https://www.chictr.org.cn/showproj.html?proj=150982).Keywords: peripheral arterial disease, Ruanjian Qingmai granules, intermittent claudication, efficacy, randomized controlled trial, protocol

Abstract Objectives This study aimed to assess the feasibility and acceptability of using EMA questionnaires and physiological data via wristbands to measure day-to-day occupational stress, musculoskeletal pain, and mental health among university employees (N = 23), across 10 work days. Adherence to the study protocol as well as participant experiences (via semi-structured interviews) with the protocol were used to assess feasibility and acceptability of the method. Results Adherence to the study protocol was excellent. Participants wore the wristband for a mean of 9.7 days. Participants completed a mean of 24.5 EMAs (out of 30). Semi-structured interviews with participants revealed that a small number of participants had difficulties uploading data from the wristband. The timing of EMAs was challenging for some participants, resulting in missed EMAs, raising questions about whether EMA frequency and timing could be changed to improve adherence. Some EMA items were difficult to answer due to the nature of participants’ roles and the work undertaken. Overall, the protocol was feasible and acceptable but highlighted future potential changes including using a different physiological data collection tool, reducing the number of EMAs, adjusting EMA timings, and reviewing EMA items.

Abstract Background Chuna manual therapy (CMT), a Korean manual therapy technique predominantly used for treating low back pain (LBP) and related disorders, lacks well-conceived research focusing on its comparative effectiveness, safety, and economic evaluation, particularly with respect to complex CMT with established CMT diagnostic algorithms. This study aims to illustrate a protocol for a randomized clinical study for comparative effectiveness and cost-effectiveness of complex CMT with simple CMT and usual care. Methods This is a protocol for a three-armed, multicenter, assessor-blinded, pragmatic, randomized controlled trial study. A total of 81 patients suffering from non-acute LBP with pelvic biomechanical lesions (PBL), characterized by a pain duration of at least two weeks and a Numeric Rating Scale (NRS) score of 5 or higher, will be recruited from two Korean medicine hospitals. These participants will be randomly assigned to one of three groups: complex CMT plus usual care (UC; n = 27), simple CMT plus UC (n = 27), or UC groups (n = 27). They will undergo treatment for 4 weeks, and follow-up assessments will be performed 8 weeks after treatment completion. The primary outcome will be the NRS score of LBP, and secondary outcomes will include the Oswestry Disability Index, Patient Global Impression of Change, credibility and expectancy questionnaire, three-dimensional posture analysis indicators, quality of life assessment, economic evaluation, and safety assessments. Discussion This will be the first study to assess the comparative effectiveness, safety, and cost-effectiveness of complex CMT compared to UC and simple/complex CMT in patients with LBP and PBL. We will also analyze useful diagnostic methods to help in clinical practice for CMT diagnosis. Trial registration Clinical Research Information Service (CRIS), KCT0009210. Registered on February 28, 2024.

Understanding the health culture of tribal community is important as health problems among tribal communities and their care is influenced by sociocultural factors, which will help in the implementation of health services. The conventional way of improving the access for the general populations may not suit the tribal populations owing to their distinct culture and owing to health systems factors as well. A stepwise process was followed for the development of a protocol to study to strengthen the implementation of National Programme for Prevention and Control of Non-Communicable Diseases. The study was planned to be carried out across six tribal districts of India. A detailed protocol was built around Implementation Research Logic Model, primarily as a method for planning, executing, reporting, and synthesizing the implementation.

Abstract Background Rotator cuff calcific tendinitis (RCCT) is a common shoulder disease whose main symptoms include shoulder pain, limited mobility, and calcification deposits in the shoulder. Traditional treatment methods have certain limitations, so finding new treatment methods has become the focus of research. Extracorporeal shock wave (ESW) and platelet-rich plasma (PRP) treatments have attracted much attention due to their non-invasive and tissue repair-promoting properties; however, the efficacy of their combined treatment in RCCT remains unclear. Methods This study is designed as a single-center, assessment-blind, randomized controlled clinical trial with three parallel groups. Sixty subjects will be recruited and randomly divided into the ESW group, PRP group, and ESW combined with PRP group, in a 1:1:1 ratio. The entire intervention period is 4 weeks, and the follow-up period is 4 weeks. Outcomes will be measured at baseline (T0), after 1 week of intervention (T1), after 2 weeks of intervention (T2), after 4 weeks of intervention (T3), and after an additional 4 weeks of follow-up period (T4). The primary endpoint is the VAS score. Secondary endpoints are ASES, CMS, UCLA, and the location and size of calcified areas. Discussion This study aims to evaluate the efficacy of ESW therapy combined with PRP in treating RCCT. We compare the effects of single and combined treatments to explore their impact on disease symptoms, functional improvement, and calcification regression. This provides a scientific basis for identifying more effective treatment options. Trial registration ClinicalTrials.gov NCT06372600. Registered on April 17, 2024; version 1.

Abstract Background Improving the quality of midwifery education to international standards is critical to prepare competent midwives. Despite the recognised impact of competent midwives, little is known concerning the implementation of Competency-Based Education (CBE), especially in Africa, where poor investment in quality midwifery education has been reported. Objective The aim of this study is to scope and synthesize the existing literature on the implementation of CBE for midwifery programmes and its sustainability in Africa. Methods The scoping review methodology outlined by Arksey and O’Malley framework was adopted to explore the extent of the literature on the implementation of CBE for midwifery programmes and its sustainability in Africa. This framework directed the scoping review methodology, with reference to PRISMA-ScR guidelines. Results A total sample of 72 studies were finally included in this scoping review. Reporting of the scoping review findings follows the PRISMA- ScR format. The study showed that of the 54 African countries as per the World Bank classification, after review of the full articles following the eligibility criteria for inclusion, literature on midwifery education programmes only spanned 17 African countries as at the time of this report. Of which, 11 are implementing CBE, 5 are still using Traditionally Based Approaches (TBA) while Problem-Based Learning (PBL) is the main teaching pedagogy used in Botswana. This review revealed that for the successful implementation of CBE, a CBE curriculum implementation process must be strictly observed. Evidence from the literature confirmed that CBE has not been sustained in Africa. There is still a struggle to fully integrate the major components of the competency-based midwifery programme due to inadequate support and an inadequate monitoring system. Conclusions It is expedient that CBE implementation should be planned concurrently with its sustainability for it to be effective. Adequate training and support should be continuously provided to faculties, institutions, policy makers, professional bodies, students and other stakeholders for successful implementation and sustainability. International Registered Report Identifier (IRRID) PRR1- https://doi.org/10.2196/47603 .

Abstract Background Music therapy is the clinical use of musical interventions to improve mental and physical health across multiple domains, including social communication. Autistic children, who have difficulties in social communication and often increased anxiety, tend to show a strong preference for music, because it can be structured and systematic, and therefore more predictable than social interaction. This makes music therapy a promising medium for therapeutic support and intervention. Previous clinical trials of music therapy compared to traditional therapy for autistic children have shown encouraging but nevertheless mixed results. Key aims The primary aim is to conduct a randomised controlled trial (RCT) of improvisational music therapy for autistic children and test its effectiveness in at improving social communication and wellbeing, and to reduce anxiety. Research plan The RCT will be conducted with 200 autistic children in the UK aged 7 to 11 years old. Participants will be randomly assigned to either improvisational music therapy or support as usual. The trial will be an assessor-blind, pragmatic two-arm cluster RCT comparing the impact of 12-weeks of improvisational music therapy in addition to support as usual, vs. support as usual for autistic children. Methods Researchers who are blind to which arm the children are in will conduct assessments and obtain data via caregiver reports. The primary outcome will be the absolute change in the total score of the Brief Observation of Social Communication Change (BOSCC) assessed at baseline, T1 (13 weeks) and T2 (39 weeks) follow-ups. The BOSCC consists of specific items that were developed to identify changes in social-communication behaviours. Secondary outcome measures include: (1) Parent reported anxiety scale for youth with ASD (Note that we do not use the term ‘ASD’ or Autism Spectrum Disorder, because many autistic people feel it is stigmatising. Instead, we use the term ‘autism’) (PRAS-ASD) (2) Young Child Outcome Rating Scale, for wellbeing (YCORS), (3) Strengths and Difficulties Questionnaire (SDQ); and (4) Vineland Adaptive Behaviour Scale (VABS). (5) The Children’s Communication Checklist-2 (CCC-2) will be completed to evaluate pragmatic speech with fluent speakers only; (6) The Music Engagement Scale (MES); and (7) Assessment of the Quality of Relationship (AQR) will be used to evaluate the child-therapist relationships using video-analysis of music therapy sessions. Additional data will be collected by administering the Wechsler Abbreviated Scale of Intelligence (WASI-II), Music at Home Questionnaire (M@H), and children’s versions of the Empathy Quotient (EQ) and Systemizing Quotient (SQ). Audio and video data from the therapy sessions will be collected and analysed (using both human and computer-based feature-coding, e.g., machine learning and AI-driven methods) to identify how music and non-musical interactions foster change throughout the therapy. Discussion This study aims to observe if the interactions, engagement, and therapeutic modalities fostered during music therapy sessions can translate to non-musical contexts and improve autistic children’s social communication skills, identifying possible mediating factors contributing to the effectiveness of music therapy, potentially informing policy making and governance. Trial registration This randomised control trial is registered with the NIH U.S. National Library of Medicine: https://clinicaltrials.gov/search?term=NCT06016621 , clinicalTrials.gov Identifier: NCT0601662, Registration Date 19th August 2023.

Abstract Background Suicide is a major public health problem, especially among individuals over 50 years old. Despite the suitability of this life stage for prevention, research on the efficacy of psychological interventions is scarce and methodologically limited, affecting their clinical utility and efficacy. Brief, flexible interventions that can be applied both in-person and remotely are needed. This study aims to evaluate the efficacy of a brief problem-solving-based suicide prevention program applied through various modalities to individuals over 50 years old. Methods A randomized controlled trial will be conducted. A sample of 212 adults aged 50 or older with suicidal ideation will be randomly assigned to a problem-solving-based psychological intervention administered face-to-face (PSPI-P; n = 53), by telephone multiconference (PSPI-M; n = 53), via a smartphone app (PSPI-A; n = 53), or to a usual care control group (UCCG; n = 53). The intervention will be delivered in 7 sessions or modules of 90 min each. Blind trained evaluators will conduct assessments at pre-intervention, post-intervention, and follow-ups at 3, 6, and 12 months. The primary outcome will be suicidal ideation evaluated using the Suicidal Ideation Scale (SSI) and the Columbia Suicide Severity Rating Scale (C-SSRS). Secondary outcomes will include hopelessness, anxiety and depression symptoms, reasons for living, impulsivity, problem-solving skills, social support, anger syndrome, gratitude, personality, dropouts, treatment adherence, and satisfaction with the intervention. Discussion This study will provide evidence of the efficacy of a brief problem-solving-based intervention for suicide prevention in individuals over 50 years old, administered face-to-face, by telephone multiconference, and via a smartphone app. If results are favorable, it will indicate that an effective, accessible, clinically and socially useful suicide prevention intervention has been developed for affected individuals, families, and communities. Trial registration ClinicalTrials.gov NCT06338904. Registered April 1, 2024.

Abstract Background [18F]MK-6240 is a neurofibrillary tangles PET radiotracer that has been broadly used in aging and Alzheimer’s disease (AD) studies. Majority of [18F]MK-6240 PET studies use dynamic acquisitions longer than 60 min to assess the tracer kinetic parameters. As of today, no consensus has been established on the optimum dynamic PET scan time. In this study, we assess the reproducibility of [18F]MK-6240 quantitative metrics using shortest dynamic PET protocols in cognitively normal subjects. PET metrics were measured through two-tissue compartment model (2TCM) and Logan model to estimate VT and DVR, as well as SUVR from 90 to 120 min (SUVR90 − 120 min) post-tracer injection for brain regions. 2TCM was carried out using the 120 min dynamic coffee break dataset (first scan from 0 to 60 min p.i., second scan from 90 to 120 min p.i.) and then repeated after stepwise shortening it by 5 min. The dynamic scan length that reproduced the 120 min dynamic scans-based VT to within 10% error was defined as the shortest acquisition time (SAT). The SAT SUVR90 − 120 min was deduced from the SAT dataset by extrapolation of each image pixel time-activity curve to 120 min. The reproducibility of the 120 min dynamic scans-based VT2TCM, DVR2TCM, DVRLogan, and SUVR using the SAT was assessed using Passing-Bablock analysis. The limits of reproducibility of each PET metrics were determined using Bland-Altman analysis. Results A dynamic SAT of 40 min yielded

Abstract Background Enhancing social participation is not only the main goal of stroke survivors' community rehabilitation but also a protective factor affecting their physical and emotional health. The current state of stroke survivors' social participation is not encouraging due to the high disability incidence of stroke. Spouses may play a facilitating role in the social participation of patients by providing them with support and assistance. However, there remains a lack of evidence specifically regarding dyadic coping interventions of social participation for stroke survivors, and the intervention strategies are still underdeveloped without clear theoretical frameworks. Therefore, this proposed study aims to develop and evaluate the effectiveness of the Dyadic Coping Intervention of Social Participation (DCISP) for survivors of first-episode homebound stroke. Methods A single-blind (assessor-blinded), randomized controlled trial will be conducted to verify the effectiveness of DCISP. The randomized controlled trial will be preceded by a feasibility study (N = 20) of DCISP in stroke survivors. Stroke survivors will be randomly classified (1:1) into either a control (N = 50) or an experimental group (N = 50). In addition to routine care, participants in the experimental group will receive six 40 ~ 45 min sessions of guidance, once every two weeks. The primary outcome is social participation of stroke survivors, measured using Impact on Participation and Autonomy Questionnaire (IPA) and Utrecht Scale for Evaluation of Rehabilitation-Participation (USER-P), and the secondary outcomes will be measured by Knowledge Questionnaire for Stroke Patients (SPKQ), Stroke-specific Quality of Life Scale (SS-QOL), Dyadic Coping Inventory (DCI), Modified Rankin Scale (mRS) and Zarit Caregiver Burden Interview (ZBI-22). These will be measured at baseline(T0), during the intervention (T1 = 1 month), and after intervention completion (T2 = 3 months, T3 = 6 months). Discussion Findings from the study will provide evidence of the effects of DCISP on improving the social participation of first-episode homebound stroke survivors. The results of this study may support the implementation of survivor–spouse dyads care support in stroke survivors and provide a reference for clinical rehabilitation nursing practice, offering new insights into nursing interventions for stroke patients. Trial registration Chinese Clinical Trial Registry (ChiCTR) ChiCTR2400083072. Registered on 20 July 2023.

Zhihan Jiang,1,&ast; Yingying Dai,2,&ast; Jing Chang,2 Pingchao Xiang,3 Zhenyu Liang,4 Yan Yin,5 Yongchun Shen,6 Ruiying Wang,7 Bianba Qiongda,8 Hongling Chu,9 Nan Li,9 Xiaoyan Gai,1,10 Ying Liang,1,10 Yongchang Sun1,10 1Department of Respiratory and Critical Care Medicine, Peking University Third Hospital, Beijing, People’s Republic of China; 2School of Basic Medical Sciences, Peking University, Beijing, People’s Republic of China; 3Department of Respiratory and Critical Care Medicine, Peking University Shougang Hospital, Beijing, People’s Republic of China; 4Department of Respiratory and Critical Care Medicine, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou Institute of Respiratory Health, GuangZhou, People’s Republic of China; 5Department of Respiratory and Critical Care Medicine, The First Hospital of China Medical University, Shenyang, People’s Republic of China; 6Department of Respiratory and Critical Care Medicine, West China Hospital of Sichuan University, Chengdu, People’s Republic of China; 7Department of Respiratory and Critical Care Medicine, Shanxi Bethune Hospital, Taiyuan, People’s Republic of China; 8Department of Respiratory and Critical Care Medicine, Tibet Autonomous Region People’s Hospital, Lhasa, People’s Republic of China; 9Clinical Epidemiology Research Center, Peking University Third Hospital, Beijing, People’s Republic of China; 10Research Center for Chronic Airway Diseases, Peking University Health Science Center, Beijing, People’s Republic of China&ast;These authors contributed equally to this workCorrespondence: Ying Liang; Yongchang Sun, Department of Respiratory and Critical Care Medicine, Peking University Third Hospital, North Garden Road 49, Haidian District, Beijing, People’s Republic of China, Tel +86 13810964766 ; +86 13910979132, Fax +86 108 226 6989, Email bysyliangying@126.com; suny@bjmu.edu.cnBackground: Tuberculosis and chronic obstructive pulmonary disease (COPD) are significant public health challenges, with pulmonary tuberculosis recognized as a pivotal risk factor for the development of COPD. Tuberculosis-associated COPD is increasingly recognized as a distinct phenotype of COPD that potentially exhibits unique clinical features. A thorough understanding of the precise definition, clinical manifestations, prognosis, and most effective pharmacological strategies for tuberculosis-associated COPD warrants further investigation.Methods: This prospective, observational cohort study aims to enroll over 135 patients with tuberculosis-associated COPD and 405 patients with non-tuberculosis-associated COPD, across seven tertiary hospitals in mainland China. The diagnosis of tuberculosis-associated COPD will be established based on the following criteria: (1) history of pulmonary tuberculosis with standard antituberculosis treatment; (2) suspected pulmonary tuberculosis with radiological evidence indicative of tuberculosis sequelae; (3) no definitive history of pulmonary tuberculosis but with positive interferon-gamma release assay results and radiological signs suggestive of tuberculosis. At baseline, demographic information, medical history, respiratory questionnaires, complete blood count, interferon-gamma release assays, medications, spirometry, and chest computed tomography (CT) scans will be recorded. Participants will be followed for one year, with evaluations at six-month intervals to track the longitudinal changes in symptoms, treatment, lung function, and frequencies of COPD exacerbations and hospitalizations. At the final outpatient visit, additional assessments will include chest CT scans and total medical costs incurred.Discussion: The findings of this study are expected to delineate the specific characteristics of tuberculosis-associated COPD and may propose potential treatment options for this particular phenotype, potentially leading to improved clinical management and patient outcomes.Keywords: chronic obstructive pulmonary disease, COPD, pulmonary tuberculosis, tuberculosis-associated COPD, protocol

Abstract Background Recreational water activities at beaches are popular among Canadians. However, these activities can increase the risk of recreational water illnesses (RWI) among beachgoers. Few studies have been conducted in Canada to determine the risk of these illnesses. This protocol describes the methodology for a study to determine the risk and burden of RWI due to exposure to fecal pollution at beaches in Canada. Methods This study will use a mixed-methods approach, consisting of a prospective cohort study of beachgoers with embedded qualitative research. The cohort study involves recruiting and enrolling participants at public beaches across Canada, ascertaining their water and sand contact exposure status, then following-up after seven days to determine the incidence of acute RWI outcomes. We will test beach water samples each recruitment day for culture-based E. coli, enterococci using rapid molecular methods, and microbial source tracking biomarkers. The study started in 2023 and will continue to 2025 at beaches in British Columbia, Manitoba, Ontario, and Nova Scotia. The target enrollment is 5000 beachgoers. Multilevel logistic regression models will be fitted to examine the relationships between water and sand contact and RWI among beachgoers. We will also examine differences in risks by beachgoer age, gender, and beach location and the influence of fecal indicator bacteria and other water quality parameters on these relationships. Sensitivity analyses will be conducted to examine the impact of various alternative exposure and outcome definitions on these associations. The qualitative research phase will include focus groups with beachgoers and key informant interviews to provide additional contextual insights into the study findings. The study will use an integrated knowledge translation approach. Discussion Initial implementation of the study at two Toronto, Ontario, beaches in 2023 confirmed that recruitment is feasible and that a high completion rate (80%) can be achieved for the follow-up survey. While recall bias could be a concern for the self-reported RWI outcomes, we will examine the impact of this bias in a negative control analysis. Study findings will inform future recreational water quality guidelines, policies, and risk communication strategies in Canada.

In this paper, we provide guidance for the organization and implementation of EEG studies. This work was inspired by our experience conducting a large-scale, multi-site study, but many elements could be applied to any EEG project. Section 1 focuses on study activities that take place before data collection begins. Topics covered include: establishing and training study teams, considerations for task design and piloting, setting up equipment and software, development of formal protocol documents, and planning communication strategy with all study team members. Section 2 focuses on what to do once data collection has already begun. Topics covered include: (1) how to effectively monitor and maintain EEG data quality, (2) how to ensure consistent implementation of experimental protocols, and (3) how to develop rigorous preprocessing procedures that are feasible for use in a large-scale study. Links to resources are also provided, including sample protocols, sample equipment and software tracking forms, sample code, and tutorial videos (to access resources, please visit: https://osf.io/wdrj3/).

Microbial infections of the brain can lead to dementia, and for many decades microbial infections have been implicated in Alzheimers disease (AD) pathology. However, a causal role for infection in AD remains contentious, and the lack of standardized detection methodologies has led to inconsistent detection/identification of microbes in AD brains. There is a need for a consensus methodology; the Alzheimers Pathobiome Initiative aims to perform comparative molecular analyses of microbes in post mortem brains versus cerebrospinal fluid, blood, olfactory neuroepithelium, oral/nasopharyngeal tissue, bronchoalveolar, urinary, and gut/stool samples. Diverse extraction methodologies, polymerase chain reaction and sequencing techniques, and bioinformatic tools will be evaluated, in addition to direct microbial culture and metabolomic techniques. The goal is to provide a roadmap for detecting infectious agents in patients with mild cognitive impairment or AD. Positive findings would then prompt tailoring of antimicrobial treatments that might attenuate or remit mounting clinical deficits in a subset of patients.

Introduction Introducing proper nutrition interventions to critically ill patients has been proven effective in mitigating the metabolic stress response and positively influencing immune reactions. Providing nutritional support to critically ill patients helps prevent further metabolic decline and preserves lean body mass.Material and Methods This study was conducted in Critical Care Units 1, 2, 3 and 4 at our Main Hospital included 316 patients divided into 2 groups, 155 patient (control group) and 161 patient (interventional group), where the interventional group was subjected to local nutritional protocol; which is based on various existing guidelines, meta-analyses, and randomized controlled trials (RCTs). The comprehensive study focuses on the impact of the local nutritional protocol on length of ICU stay, length of hospital stay, survival at 30 days, and at 90 days.Results There is statistically significant difference between interventional group ICU stay and control group ICU stay with P-value

Abstract Introduction Primary total elbow replacement (TER) services in England are being restructured with the goal of centralising care to specialised centres. It is important to monitor the impact of this service redesign. This protocol outlines an intended analysis to provide detailed descriptions of the patients who are receiving primary TER, where and by whom TER is being performed, and what the current surgical practices for TER are in England before the reconfiguration. Methods This analysis will use the National Joint Registry (NJR) elbow dataset and link it with NHS England Hospital Episode Statistics-Admitted Patient Care (HES-APC). It will include eligible patients from the start of the NJR elbow dataset in April 2012 to December 2022. The main objective is to determine the incidence of TER in England. Age-sex standardised rates will be calculated for groups including different ethnicities, and socioeconomic backgrounds, using the mid-year population data provided by the Office for National Statistics. This planned analysis will summarise patient characteristics such as age, sex, body mass index (BMI), hand dominance, American Society of Anaesthesiologists (ASA) grade, indication for TER, socioeconomic status, and patient co-morbidities. It will also examine implant fixation type, classification, brand/type, and changes over time in implant types used in England. Additionally, it will explore the characteristics and volume of the surgeons and hospitals providing primary TER services, including the grade of the primary surgeons, funding source for surgery, and admission type. The analysis will cover the number of procedures performed by surgeons and hospitals annually in England and in each region of England. Finally, the planned analysis will summarise the elective wait time, postoperative length of stay, and any serious adverse events or re-admissions within 30 and 90 days after the TER. Discussion This protocol describes the first deep dive analysis into the NJR elbow dataset to describe the incidence of TER surgery in England and the characteristics of patients who are receiving it. This analysis will summarise current primary TER practices in England before service reconfigurations. The impact of reconfiguration can be monitored by comparing future practice to the outcomes from this study. Trial registration ClinicalTrials.gov, NCT06355011. Registered 02 April 2024, https://clinicaltrials.gov/ct2/show/NCT06355011 .

Objective (s): In a situation where the vaccine was not completely accurate and up-to-date against different strains of the virus in all people of the world, compliance with health guidelines was the main key to prevent transmission. But what is clear is that compliance with health protocols is not the same among all communities and depends on factors. This article examines the effects and attitudes of health protocols. Methods: This research was a descriptive-quantitative cross-sectional study, which was conducted among 385 students of Shahid Beheshti University of Medical Sciences, Iran in the last week of May 2022. Factors affecting the adherence to water hygiene behaviors due to covid-19 were investigated using a questionnaire and the results were analyzed and reported in ordinal regression with SPSS 25 software. Results: The ratio of the average score of compliance (19.08) from the total of eight health behaviors to the maximum score (25) was reported as 76%. It was reported that the score of awareness was very high, 94%, and the average score of attitude was about 75%. In the ordinal regression, it was found that having knowledge was not effective in following all health protocols and only two behaviors of avoiding attending gatherings and avoiding losing when meeting acquaintances showed a statistically significant relationship. In other words, with the increase of each score of awareness, the chance of having higher compliance scores in these two behaviors increased by about 1.5 times. On the other hand, the attitude score had a statistically significant relationship with most of the behaviors, except the compliance of coughing and sneezing into a handkerchief or the corner of the arm, and it had a positive simultaneous effect on the compliance of the behaviors. Conclusion: The high level of awareness among the studied community can partially indicate the effectiveness of interventions in increasing awareness, but the gap between awareness, attitude and behavior indicates the need to pay attention to other factors affecting attitude and behavior.

In the quotidian, people perform voluntary whole-body movements requiring dynamic body balance. However, the literature is scarce of dynamic balance evaluations employing standardized voluntary movements. In this investigation, we aimed to analyze the sensitivity of balance evaluation between gymnasts and athletes from other sports in the performance of balance tasks. Participants were evaluated in upright quiet standing and the performance of cyclic dynamic tasks of hip flexion-extension and squat-lift movements. Movements were individually standardized in amplitude, while the rhythm was externally paced at the frequency of 0.5 Hz. Tasks were performed on a force plate, with dynamic balance measured through the center of pressure displacement. Results showed that in quiet standing and the dynamic hip flexion-extension task, no significant differences were found between the groups. Conversely, results for the squat-lift task revealed a better balance of the gymnasts over controls, as indicated by the reduced amplitude and velocity of the center of pressure displacement during the task execution. The superior balance performance of gymnasts in the squat-lift task was also observed when vision was suppressed. These findings suggest the employed squat-lift task protocol is a potentially sensitive procedure for the evaluation of voluntary dynamic balance.

Hongxia Xin,1,2,&ast; Shuoshuo Wei,1,3,&ast; Hao Zheng,4,&ast; Yanchao Qi,5,&ast; Shuping Xu,6,&ast; Bei Wang,2 Wangshu Jiang,7 Ning Deng,7,&ast; Juan Chen1,2,&ast; 1Department of Key Laboratory of Ningxia Stem Cell and Regenerative Medicine, Institute of Medical Sciences, General Hospital of Ningxia Medical University, Yinchuan, Ningxia, People’s Republic of China; 2Department of Pulmonary and Critical Care Medicine, General Hospital of Ningxia Medical University, Yinchuan, Ningxia, People’s Republic of China; 3Department of Pulmonary and Critical Care Medicine, Affiliated Yijishan Hospital, Wannan Medical College, Wuhu, Anhui, People’s Republic of China; 4Department of Pulmonary and Critical Care Medicine, Yanchi County People’s Hospital, Wuzhong, Ningxia, People’s Republic of China; 5Department of Pulmonary and Critical Care Medicine, Second People’s Hospital of Shizuishan, Shizuishan, Ningxia, People’s Republic of China; 6Department of Pulmonary and Critical Care Medicine II, Wuzhong People’s Hospital, WuZhong, Ningxia, People’s Republic of China; 7Ministry of Education Key Laboratory of Biomedical Engineering, College of Biomedical Engineering and Instrument Science, Zhejiang University, Hangzhou, People’s Republic of China&ast;These authors contributed equally to this workCorrespondence: Ning Deng, Ministry of Education Key Laboratory of Biomedical Engineering, College of Biomedical Engineering and Instrument Science, Zhejiang University, Hangzhou, 310058, People’s Republic of China, Email zju.dengning@gmail.com Juan Chen, Department of Pulmonary and Critical Care Medicine, General Hospital of Ningxia Medical University, Yongan Lane, Xingqing District, Yinchuan, Ningxia, 750004, People’s Republic of China, Email chenjuan7419@163.comBackground: Pulmonary rehabilitation (PR) is an effective intervention for people with chronic obstructive pulmonary disease (COPD). However, fewer than 5% of eligible individuals receive pulmonary rehabilitation, largely due to limited by the accessibility of rehabilitation and difficulties associated with travel and transport. Supervised home-based tele-rehabilitation (SHTR) is an alternative model to center-based pulmonary rehabilitation. We will determine whether supervised home-based tele-rehabilitation is non-inferior to center-based pulmonary rehabilitation.Methods: The participants will undergo an 8-week rehabilitation program. Pulmonary rehabilitation comprises four main modules: exercise training, education, nutritional support, and psychological and behavioral interventions. We mainly focus on the module of exercise training and education. The education module includes information on exercise training, nutrition, and psychology, which are presented in an educational booklet provided to each participant. Blinded assessors will evaluate the outcomes at baseline, post-intervention, and 6 months after the intervention. The primary outcome is the change in the 6-minute walking distance. Secondary outcomes will assess changes in the patients’ 1-minute sit-to-stand test, maximal inspiratory pressure (MIP), scales (CAT, mMRC, HAD), diaphragm ultrasound (TD, DE, DIF), changes in extrathoracic muscle volume and mass, completion rate of patient exercise prescriptions, occurrence of adverse events, as well as disease exacerbation and rehospitalization rates after rehabilitation and during the 6-month follow-up.Discussion: In order to improve the accessibility of pulmonary rehabilitation and patient-related outcomes, it is necessary to propose an alternative model of pulmonary rehabilitation. This trial will establish whether a supervised home-based tele-rehabilitation is not inferior to traditional center-based pulmonary rehabilitation.Trial Registration: Chinese Clinical Trial Registry ChiCTR2300076969. Registered on October 25, 2023. Keywords: COPD, tele-rehabilitation, protocol, randomized non-inferiority trial

Introduction: International societies recommend microbiological surveillance of endoscopes to reduce the incidence of endoscope-associated infections, particularly for duodenoscopes. However, surveillance protocols are not internationally standardized, both regarding sample collection, processing, and culture. This study aims to provide a framework protocol encompassing the experience of a tertiary large volume endoscopy center and the microbiology laboratory for collecting and culturing of endoscope samples for microbiological surveillance. Methods: A sample collection and processing protocol was designed as a result of a cooperation between the Endoscopy Center of the Gastroenterology Department and the Microbiology Laboratory of the Department of Clinical Pathology. This protocol reflects international recommendations in this topic and the human and technological resources of the involved departments. Results: The established protocol for collecting samples varies according to the type and model of endoscope. The specimens are collected as sterile saline liquid samples, as well as swabs (with and without transport media). Together with the collection of samples from the endoscope, samples from the final rinse water as well as the water bottle are also collected. For duodenoscopes and curvilinear echoendoscopes, we perform microbiological surveillance every 3 months; for gastroscopes and colonoscopes, at least, once a year; and for specific endoscopes, such as the pediatric or dual-channel therapeutic endoscopes, enteroscopes, or radial echoendoscopes, every 6 months. Conclusion: Endoscopy units should have detailed protocols for microbiological surveillance of endoscopes. These protocols should be drawn up by a multidisciplinary team that includes endoscopy nurses, gastroenterologists, microbiologists, and the antimicrobial stewardship team, following international recommendations, adapted to each institution resources.

Abstract Background Plant-parasitic nematodes are economically important pests responsible for substantial losses in agriculture. Researchers focusing on plant-parasitic nematodes, especially on finding new ways of their control, often need to assess basic parameters such as their motility, viability, and reproduction. Traditionally, these assays involve visually counting juveniles and eggs under a dissecting microscope, making this investigation time-consuming and laborious. Results In this study, we established a procedure to efficiently determine the motility of two plant-parasitic nematode species, Heterodera schachtii and Ditylenchus destructor, using the WMicrotracker ONE platform. Additionally, we demonstrated that hatching of the cyst nematode H. schachtii can be evaluated using both the WMicrotracker ONE and by assessing the enzymatic activity of chitinase produced during hatching. Conclusions We present fast and straightforward protocols for studying nematode motility and hatching that allow us to draw conclusions about viability and survival. Thus, these methods are useful tools for facilitating fast and efficient evaluation in various fields of research focused on plant-parasitic nematodes.

Abstract Background Antibiotics are globally overprescribed for the treatment of upper respiratory tract infections (URTI), especially in persons living with HIV. However, most URTIs are caused by viruses, and antibiotics are not indicated. De-implementation is perceived as an important area of research that can lead to reductions in unnecessary, wasteful, or harmful practices, such as excessive or inappropriate antibiotic use for URTI, through the employment of evidence-based interventions to reduce these practices. Research into strategies that lead to successful de-implementation of unnecessary antibiotic prescriptions within the primary health care setting is limited in Mozambique. In this study, we propose a protocol designed to evaluate the use of a clinical decision support algorithm (CDSA) for promoting the de-implementation of unnecessary antibiotic prescriptions for URTI among ambulatory HIV-infected adult patients in primary healthcare settings. Methods This study is a multicenter, two-arm, cluster randomized controlled trial, involving six primary health care facilities in Maputo and Matola municipalities in Mozambique, guided by an innovative implementation science framework, the Dynamic Adaption Process. In total, 380 HIV-infected patients with URTI symptoms will be enrolled, with 190 patients assigned to both the intervention and control arms. For intervention sites, the CDSAs will be posted on either the exam room wall or on the clinician´s exam room desk for ease of reference during clinical visits. Our sample size is powered to detect a reduction in antibiotic use by 15%. We will evaluate the effectiveness and implementation outcomes and examine the effect of multi-level (sites and patients) factors in promoting the de-implementation of unnecessary antibiotic prescriptions. The effectiveness and implementation of our antibiotic de-implementation strategy are the primary outcomes, whereas the clinical endpoints are the secondary outcomes. Discussion This research will provide evidence on the effectiveness of the use of the CDSA in promoting the de-implementation of unnecessary antibiotic prescribing in treating acute URTI, among ambulatory HIV-infected patients. Findings will bring evidence for the need to scale up strategies for the de-implementation of unnecessary antibiotic prescription practices in additional healthcare sites within the country. Trial registration ISRCTN, ISRCTN88272350. Registered 16 May 2024, https://www.isrctn.com/ISRCTN88272350

Abstract Background Allergic rhinitis (AR) is a common inflammatory disease of the nasal mucosa that is characterized by symptoms such as sneezing, nasal congestion, nasal itching, and rhinorrhoea. In recent years, acupoint herbal patching (AHP) therapy has gained a growing interest as a potential management option for AR. This systematic review and meta-analysis will evaluate the clinical research evidence on the effectiveness and safety of AHP as a treatment option for AR outside of the Sanfu or Sanjiu days (summer or winter solstice). The results of this review will provide up-to-date evidence-based guidance for healthcare providers and individuals seeking alternative treatments for AR. Methods A comprehensive search of electronic databases (PubMed, Cochrane Central Register of Controlled Trials (CENTRAL), EMBASE, China National Knowledge Infrastructure (CNKI), CQVIP, Sino-Med, and Wanfang Databases) will be conducted from their inception to June 2023. The inclusion criteria will be limited to randomized controlled trials that evaluate the effectiveness or efficacy of non-Sanfu or non-Sanjiu AHP for AR. The primary outcome measure will be the total nasal symptom score. The methodological quality of included studies will be assessed using the Revised Cochrane risk-of-bias tool for randomized trials (RoB 2), and meta-analyses will be performed using RevMan (V.5.3) statistical software. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach will be used to determine the certainty of evidence. Discussion This systematic review and meta-analysis will provide valuable insights into the effectiveness and safety of non-Sanfu or non-Sanjiu AHP as a treatment option for AR. The study aims to produce a high-quality review by adhering to PRISMA-P guidelines and using clinical guideline recommended outcome measures. The results of this review may offer additional treatment options for AR patients who seek complementary and alternative therapies, and hold significant implications for future research in this field. Overall, this study has the potential to inform clinical practice and improve patient outcomes. Systematic review registration PROSPERO CRD42022181322.

Abstract Background Rural African people living with HIV face significant challenges in entering and remaining in HIV care. In rural Uganda, for example, there is a threefold higher prevalence of HIV compared to the national average and lower engagement throughout the HIV continuum of care. There is an urgent need for appropriate interventions to improve entry and retention in HIV care for rural Ugandans with HIV. Though many adults living with HIV in rural areas prioritize seeking care services from traditional healers over formal clinical services, healers have not been integrated into HIV care programs. The Omuyambi trial is investigating the effectiveness of psychosocial support delivered by traditional healers as an adjunct to standard HIV care versus standard clinic-based HIV care alone. Additionally, we are evaluating the implementation process and outcomes, following the Consolidated Framework for Implementation Research. Methods This cluster randomized hybrid type 1 effectiveness-implementation trial will be conducted among 44 traditional healers in two districts of southwestern Uganda. Healers were randomized 1:1 into study arms, where healers in the intervention arm will provide 12 months of psychosocial support to adults with unsuppressed HIV viral loads receiving care at their practices. A total of 650 adults with unsuppressed HIV viral loads will be recruited from healer clusters in the Mbarara and Rwampara districts. The primary study outcome is HIV viral load measured at 12 months after enrollment, which will be analyzed by intention-to-treat. Secondary clinical outcome measures include (re)initiation of HIV care, antiretroviral therapy adherence, and retention in care. The implementation outcomes of adoption, fidelity, appropriateness, and acceptability will be evaluated through key informant interviews and structured surveys at baseline, 3, 9, 12, and 24 months. Sustainability will be measured through HIV viral load measurements at 24 months following enrollment. Discussion The Omuyambi trial is evaluating an approach that could improve HIV outcomes by incorporating previously overlooked community lay supporters into the HIV cascade of care. These findings could provide effectiveness and implementation evidence to guide the development of policies and programs aimed at improving HIV outcomes in rural Uganda and other countries where healers play an essential role in community health. Trial registration ClinicalTrials.gov NCT05943548. Registered on July 5, 2023. The current protocol version is 4.0 (September 29, 2023).

Abstract Background Public involvement and engagement (PI&E) is increasingly recognised as an important component of research. It can offer valuable insights from those with experiential knowledge to improve research quality, relevance, and reach. Similarly, schools are ever more common sites for health research and, more recently, PI&E. However, ‘gold-standard’ practice is yet to be established, and activities/approaches remain underreported. As a result, knowledge can remain localised or lost. Diversity and inclusion also remains a challenge. Methods This protocol has been informed by UK national guidance, evidence-based frameworks and available implementation literature. It describes both rationale and approach to conducting PI&E activities within a secondary school context. Activities are designed to be engaging, safe and accessible to young people with diverse experiences, with scope to be iteratively developed in line with public collaborator preference. Discussion Young people should be architects of their involvement and engagement. Ongoing appraisal and transparency of approaches to PI&E in school settings is crucial. Expected challenges of implementing this protocol include facilitating a safe space for the discussion of sensitive topics, absence and attrition, recruiting students with a diverse range of experiences, and potential knowledge and capacity barriers of both facilitator and contributors. Activities to mitigate these risks are suggested and explored.

Abstract Introduction The pathogenesis and clinical profiles of patients with pulmonary hypertension (PH) associated with interstitial lung disease (ILD-PH) are poorly understood. Whether and to what extent pulmonary arterial hypertension (PAH)-specific therapy improves hemodynamic and outcome in ILD-PH are also unknown. Study Objective This study aims to clarify the characteristics, clinical course and response to PAH-specific therapy of ILD and/or PH by enrolling three unique subsets: PAH, ILD-PH, and ILD. Methods The proposed study is a retrospective and prospective, multi-centre, observational cohort study of patients treated at any of three university hospitals in the Hokkaido region of Japan who have any one of the following: PAH; ILD-PH with or without PAH features; or ILD without PH. We aim to enrol 250 patients in total. For the retrospective observation period, data obtained after 1 January 2010, will be analysed, and the prospective observation period will be 1 year. We will compare the clinical data of patients with ILD-PH with those of patients with PAH and those of patients with ILD without PH in the real-world clinical setting. In addition, within the cohort of patients with ILD-PH, we will explore the subset with “ILD-PH with PAH features” and compare the response to PAH-specific therapy with that of PAH. The primary outcome will be the change in pulmonary vascular resistance from first treatment to follow-up in patients with PAH and ILD-PH with PAH features (excluding ILD-PH without PAH feature and ILD-no-PH for the primary outcome). The exploratory outcomes will include analyses of PH-associated biomarkers, right ventricular function and patient-reported outcomes. Results This is a protocol article and the results will be presented after data collection is completed. Conclusion The POPLAR study will provide data that help better understand the pathophysiology of ILD-PH and improve the quality of life and outcome of patients with PH and/or ILD. Trial Registration Japan Registry of Clinical Trials: jRCT1010230018.

The lack of robust water quality data in drinking water services in many low-income settings can be attributed to inadequate funding for regular monitoring using analytical equipment. Turbidity is an indicator that is relatively quick and easy to measure; however, it still requires a turbidimeter and a trained operator. This study developed an entire smartphone camera-based application to measure turbidity in drinking water, removing both the need for external equipment and skilled labour. The application was created using a convolutional neural network, able to classify water samples into eight turbidity bins ranging from 0 to 40 NTU. The turbidity of the samples was created using formazine and kaolin clay suspensions. The in-built camera of a smartphone was used to capture images of water samples with known turbidity values. This algorithm was then embedded in a smartphone application, thereby providing an easy-to-use tool for users to estimate turbidity. Specifically, the protocol for using this application was developed with the intention that it will be used in low-resource settings by laypersons. Formazine samples achieved a turbidity classification accuracy of 98.7%, while kaolin clay samples achieved 90.9% accuracy using this method, which provides an encouraging proof of concept, as justification for further testing and improvements. HIGHLIGHTS An algorithm and accompanying protocol for estimating drinking water turbidity using only a smartphone camera were developed. The protocol is designed for use in low-resource settings by laypersons.; A correct turbidity bin classification accuracy of 98.7% was obtained for formazine samples between 0 and 40 NTU in the laboratory.;

The densification of the vehicle fleet leads to numerous challenges in road safety management. Wireless Sensor Networks (WSN) helps to manage vehicle-vehicle-infrastructure interactivity, in particular to predict dangers and avoid accidents, detect and penalize traffic violations. This requires a massive deployment of communicating nodes embedded in vehicles and in road infrastructure. The reliability of the systems built on these nodes lies in the accuracy of the ranging. In order to improve the factors that impact accuracy, various ranging protocols have been developed, but their implementations most often involve the use of expensive and specialized transceivers, which incorporate a dedicated IEEE 802.15.4a ranging layer. Our approach implements the basic and advanced functions integrated into low-cost transceivers and microcontrollers. As result, in two or three links according to the case, our protocol performs simultaneously the ranging and the data exchange, against a specific ranging session with a minimum of three exchanges for the other protocols. Moreover, each node knows the ranging data and has its clock frequency adapted to the controlled process. So, we meet the challenges of large-scale low-cost node deployment, while ensuring high reliability and performance of ranging.

Abstract Background Hemiplegic shoulder pain (HSP) is a common complication after stroke. It severely affects the recovery of upper limb motor function. Early shoulder pain in hemiplegic patients is mainly neuropathic caused by central nerve injury or neuroplasticity. Commonly used corticosteroid injections in the shoulder joint can reduce shoulder pain; however, the side effects also include soft tissue degeneration or increased tendon fragility, and the long-term effects remain controversial. Botulinum toxin injections are relatively new and are thought to block the transmission of pain receptors in the shoulder joint cavity and inhibit the production of neuropathogenic substances to reduce neurogenic inflammation. Some studies suggest that the shoulder pain of hemiplegia after stroke is caused by changes in the central system related to shoulder joint pain, and persistent pain may induce the reorganization of the cortical sensory center or motor center. However, there is no conclusive evidence as to whether or not the amelioration of pain by botulinum toxin affects brain function. In previous studies of botulinum toxin versus glucocorticoids (triamcinolone acetonide injection) in the treatment of shoulder pain, there is a lack of observation of differences in changes in brain function. As the content of previous assessments of pain improvement was predominantly subjective, objective quantitative assessment indicators were lacking. Functional near-infrared imaging (fNIRS) can remedy this problem. Methods This study protocol is designed for a double-blind, randomized controlled clinical trial of patients with post-stroke HSP without biceps longus tenosynovitis or acromion bursitis. Seventy-eight patients will be randomly assigned to either the botulinum toxin type A or glucocorticoid group. At baseline, patients in each group will receive shoulder cavity injections of either botulinum toxin or glucocorticoids and will be followed for 1 and 4 weeks. The primary outcome is change in shoulder pain on the visual analog scale (VAS). The secondary outcome is the assessment of changes in oxyhemoglobin levels in the corresponding brain regions by fNIRS imaging, shoulder flexion, external rotation range of motion, upper extremity Fugl-Meyer, and modified Ashworth score. Discussion Ultrasound-guided botulinum toxin type A shoulder joint cavity injections may provide evidence of pain improvement in patients with HSP. The results of this trial are also help to analyze the correlation between changes in shoulder pain and changes in cerebral hemodynamics and shoulder joint motor function. Trial registration Chinese clinical Trial Registry, ChiCTR2300070132. Registered 03 April 2023, https://www.chictr.org.cn/showproj.html?proj=193722 .

Abstract Context According to the World Health Organization, alcohol is a major global public health problem, leading to a significant increase in illness and death. To treat alcohol use disorders, new therapeutic tools are being promoted, among which virtual reality (VR) shows promise. Previous research has demonstrated the efficacy of VR in reducing alcohol cravings in patients, but there is a lack of data on its effectiveness in maintaining abstinence or reducing consumption in recently abstinent individuals. The E-Reva study aims to compare the efficacy of a treatment strategy combining virtual reality cue exposure therapy (VR-CET) and cognitive behavioral therapy (CBT) with conventional CBT in reducing alcohol consumption and craving in patients with alcohol use disorder (AUD). In addition to this primary objective, the study will compare the effects of VR-CET combined with CBT on anxiety, depression, rumination, and feelings of self-efficacy versus conventional CBT. Methods This prospective randomized controlled trial will be conducted over 8 months in four addiction departments in France. It includes two parallel groups: i) the VR-CET + CBT group, and ii) the CBT-only group, which serves as a control group. Participants will be recruited by the investigating doctor in the addiction centers. The sample will consist of 156 patients diagnosed with AUD and abstinent for at least 15 days. Both treatment groups will participate in four group CBT sessions followed by four individual sessions: i) the VR-CET group will be exposed to virtual environments associated with alcohol-related stimuli, ii) the CBT-only group will receive traditional CBT sessions. After completion of the 8 sessions, patients will be followed up for 6 months. The primary outcome is the cumulative number of standard drinks consumed at 8 months, assessed using the TLFB method. Discussion Despite the promise of VR-CET to reduce the desire to drink, the effect on alcohol consumption remains uncertain in the existing literature. Our protocol aims to address the limitations of previous research by increasing sample size, targeting consumption reduction, and incorporating neutral environments. E-Reva aims to enrich the literature on the use of VR in the treatment of AUD and open new perspectives for future interventions. Trial registration ClinicalTrials.gov ID NCT06104176, Registered 2023/11/13 ( https://clinicaltrials.gov/study/NCT06104176?id=NCT06104176&rank=1 ). N° IDRCB: 2022-A02797-36. Protocol version 1.0, 12/05/2023.

Delays in construction projects are common and persistent. Frequent disputes also make work time inefficient and result in significant cost increases. Therefore, it is necessary to study or investigate events that are useful as a solution to delay claims and have the potential to be used in litigation. This research has been conducted to maximize reliable data sources. The Source Validation Protocol guides the process for ensuring the validity of the source data based on the Forensic Schedule Analysis methodology. According to the Critical Path Method (CPM) schedule analysis, the construction time of the Rusunawa Building (Rent Simple Flat) of the Health Polytechnic of the Ministry of Health Yogyakarta is 73.2 weeks or 511 calendar days. The 2 data source validation protocols, including Validation of Baseline Schedule Selection, Validation and Rectification, and Validation of As-Built Schedule Sources, Reconstruction, and Validation, greatly influenced the project delays.

Background Knee osteoarthritis affects the performance of daily activities, independence, and quality of life. The etiopathogenesis of this condition considers the mechanisms of activation of metalloproteinase and reactive oxygen species production pathways. Metalloproteinases-3 (MMP-3) and Glutathione Peroxidase (GPx) may be responsible for cartilage destruction. Aquatic physiotherapy promotes a positive impact on the clinical picture of osteoarthritis, and this study presents an intervention protocol that aims to evaluate the effects of a single session of different aquatic physiotherapy modalities on the biochemical and functional behavior of patients with knee osteoarthritis. Methods This will be a crossover randomized controlled trial in which 15 individuals will be submitted to three aquatic physiotherapy modalities with a minimum 15-day wash-out period in patients over 50 years old and diagnosed with OA in at least one knee, presence of pain and at least one functional dysfunction for at least 6 months, absence of physical limitation that prevents the exercise protocol from being performed, Kellgren and Lawrence ranking between I and IV, walk independently and without auxiliary device. Variations in the concentrations of MMP-3 and GPx in peripheral blood, pain, edema, and flexibility resulting from the three aquatic physiotherapeutic interventions will be evaluated both pre- and immediate post-intervention. The reference group will be submitted to the same aquatic physiotherapy protocols, however, only the biochemical parameters and the self-perception questionnaires will be evaluated. Registration ClinicalTrials.gov ( NCT05610696, 18/01/2023).

Introduction: Primary total elbow replacement (TER) services in England are being restructured with the goal of centralising care to specialised centres. It is important to monitor the impact of this service redesign. This protocol outlines an intended analysis to provide detailed descriptions of the patients who are receiving primary TER, where and by whom TER is being performed, and what the current surgical practices for TER are in England before the reconfiguration. Methods: This analysis will use the National Joint Registry (NJR) elbow dataset and link it with NHS England Hospital Episode Statistics-Admitted Patient Care (HES-APC). It will include eligible patients from the start of the NJR elbow dataset in April 2012 to December 2022. The main objective is to determine the incidence of TER in England. Age-sex standardised rates will be calculated for groups including different ethnicities, and socioeconomic backgrounds, using the mid-year population data provided by the Office for National Statistics. This planned analysis will summarise patient characteristics such as age, sex, body mass index (BMI), hand dominance, American Society of Anaesthesiologists (ASA) grade, indication for TER, socioeconomic status, and patient co-morbidities. It will also examine implant fixation type, classification, brand/type, and changes over time in implant types used in England. Additionally, it will explore the characteristics and volume of the surgeons and hospitals providing primary TER services, including the grade of the primary surgeons, funding source for surgery, and admission type. The analysis will cover the number of procedures performed by surgeons and hospitals annually in England and in each region of England. Finally, the planned analysis will summarise the elective wait time, postoperative length of stay, and any serious adverse events or re-admissions within 30 and 90 days after the TER. Discussion: This protocol describes the first deep dive analysis into the NJR elbow dataset to describe the incidence of TER surgery in England and the characteristics of patients who are receiving it. This analysis will summarise current primary TER practices in England before service reconfigurations. The impact of reconfiguration can be monitored by comparing future practice to the outcomes from this study. Trial registration ClinicalTrials.gov, NCT06355011. Registered 02 April 2024, https://clinicaltrials.gov/ct2/show/NCT06355011. [ABSTRACT FROM AUTHOR]

Introduction: In patients with acute ischemic stroke (AIS) secondary to intracranial large vessel occlusion, optimal blood pressure (BP) management following endovascular treatment (EVT) has not yet been established. The randomized trial on Hemodynamic Optimization of Cerebral Perfusion after Successful Endovascular Therapy in Patients with Acute Ischemic Stroke (HOPE) (clinicaltrials.gov id: NCT04892511) aims to demonstrate whether hemodynamic optimization using different systolic BP targets following EVT according to the degree of final recanalization, is more effective than currently recommended BP management in improving functional outcomes of patients with AIS. Methods: HOPE is an investigator-initiated multicenter clinical trial with randomized allocation, open-label treatment, and blinded endpoint evaluation (PROBE). Patients with an anterior circulation AIS within 24 h of symptom onset, treated with EVT, and showing successful recanalization (mTICI ≥2b) at the end of the procedure, are equally allocated (1:1) to hemodynamic optimization according to the study protocol versus BP management according to current guidelines (≤180/105 mm Hg). The protocol includes two different targets of systolic BP depending on the recanalization status (mTICI = 2b: 140–160 mm Hg; mTICI = 2c/3: 100–140 mm Hg). The protocol is applied within the first 72 h and includes BP lowering as well as vasopressor therapies when needed. The primary outcome is the proportion of favorable outcome (modified Rankin Scale [mRS] 0–2) at 90 days. Secondary outcomes include the shift on the mRS score, neurological deterioration, symptomatic intracerebral hemorrhage, and mortality. Conclusion: The HOPE trial will provide new information on the safety and efficacy of different BP targets following EVT according to the degree of final recanalization in patients with AIS. [ABSTRACT FROM AUTHOR]

Background: Poverty-related diseases (PRD) remain amongst the leading causes of death in children under-5 years in sub-Saharan Africa (SSA). Clinical practice guidelines (CPGs) based on the best available evidence are key to strengthening health systems and helping to enhance equitable health access for children under five. However, the CPG development process is complex and resource-intensive, with substantial scope for improving the process in SSA, which is the goal of the Global Evidence, Local Adaptation (GELA) project. The impact of research on PRD will be maximized through enhancing researchers and decision makers' capacity to use global research to develop locally relevant CPGs in the field of newborn and child health. The project will be implemented in three SSA countries, Malawi, South Africa and Nigeria, over a 3-year period. This research protocol is for the monitoring and evaluation work package of the project. The aim of this work package is to monitor the various GELA project activities and evaluate the influence these may have on evidence-informed decision-making and guideline adaptation capacities and processes. The specific project activities we will monitor include (1) our ongoing engagement with local stakeholders, (2) their capacity needs and development, (3) their understanding and use of evidence from reviews of qualitative research and, (4) their overall views and experiences of the project. Methods: We will use a longitudinal, mixed-methods study design, informed by an overarching project Theory of Change. A series of interconnected qualitative and quantitative data collections methods will be used, including knowledge translation tracking sheets and case studies, capacity assessment online surveys, user testing and in-depth interviews, and non-participant observations of project activities. Participants will comprise of project staff, members of the CPG panels and steering committees in Malawi, South Africa and Nigeria, as well as other local stakeholders in these three African countries. Discussion: Ongoing monitoring and evaluation will help ensure the relationship between researchers and stakeholders is supported from the project start. This can facilitate achievement of common goals and enable researchers in South Africa, Malawi and Nigeria to make adjustments to project activities to maximize stakeholder engagement and research utilization. Ethical approval has been provided by South African Medical Research Council Human Research Ethics Committee (EC015-7/2022); The College of Medicine Research and Ethics Committee, Malawi (P.07/22/3687); National Health Research Ethics Committee of Nigeria (01/01/2007). [ABSTRACT FROM AUTHOR]

Purpose: Severe pilonidal diseases have refractory symptoms despite multiple surgeries and optimal therapy remains unclear. We hypothesized that standardized minimally invasive protocol could be an effective rescue treatment. Methods: We prospectively collected data from symptomatic patients who underwent ≥ 1 pilonidal excision prior to presentation at our clinic 2019–2023. We treated these patients with standardized protocol incorporating local wound care, regular manual/laser epilation, and selective debridement/pit trephination. Results: We treated 34 refractory patients (23 males) with median follow-up 405 days. Median age of first symptoms was 17.1 years; presentation to our clinic 20.0 years. Prior to our clinic, 27 received one surgery (cleft lift-2, excision no closure-1, excision primary closure-18, wound vac after excision-3, excision flap closure-3); 7 had two surgeries (excision without closure + cleft lift-1, primary closure after excision twice-3, flap closure after excision twice-2, excision primary closure + excision without closure-1). We treated all patients with regular epilation ± local wound care. 14 (41%) underwent trephination ± debridement. All patients achieved complete resolution after median 52 days. Five (14.7%) recurred and were treated with trephination + debridement-2 or wound care alone-3. Symptom length had no correlation with resolution time, skin type, hair amount. Conclusions: Standardized minimally invasive protocol requiring only selective surgical intervention can treat refractory pilonidal disease with low recurrence rate. [ABSTRACT FROM AUTHOR]