Flow Cytometry and Automated Microscopy Integration for Phagocytic Analysis of Hypervirulent Klebsiella pneumoniae in Dictyostelium discoideum.

This chapter introduces protocols for culturing and maintaining Dictyostelium discoideum and methods for conducting virulence assays in this organism to study bacterial pathogenicity. It outlines advanced techniques, such as automated microscopy and flow cytometry, for detailed cellular analysis and traditional microbiological approaches. These comprehensive protocols will enable researchers to probe the virulence factors of pathogens like Klebsiella pneumoniae and to elucidate the details of host-pathogen interactions within a cost-effective and adaptable laboratory framework.

Results of a brief online group application of the unified protocol for the prevention of emotional disorders in university students: a pilot study with multiple baseline experimental design / Resultados de una aplicación grupal breve en línea del protocolo unificado para la prevención de trastornos emocionales en estudiantes universitarios: un estudio piloto con diseño experimental de línea base múltiple

Los trastornos emocionales (TEs) son los trastornos más comunes entre la población joven. El desarrollo de programas preventivos de los TEs es fundamental para evitar su posible aparición. Los programas de prevención transdiagnósticos podrían presentar una ventaja sobre los existentes para mejorar las estrategias de regulación emocional. Así, el objetivo de este estudio ha sido determinar la viabilidad y eficacia preliminar de un programa breve basado en el Protocolo Unificado (PU). El proyecto consistió en un estudio piloto utilizando un diseño experimental de línea base múltiple. Nueve estudiantes universitarios recibieron un programa de 5 sesiones basado en el PU en formato grupal online. Se encontraron diferencias significativas después de la intervención en la regulación de las emociones, el apoyo social percibido y la evitación, con tamaños del efecto moderados-grandes (r de Cohen = .49 - .59). Estas mejoras mostraron aumentos en los seguimientos al mes y a los 3 meses. Esos resultados están en línea con los que muestran que los programas preventivos transdiagnósticos breves podrían ser útiles para la prevención de los TEs en población universitaria.(AU)

Emotional disorders (EDs) are the most common disorders among the young population. The development of preventive programs for EDs is essential to avoid their possible appearance. Transdiagnostic prevention programs could present an advantage over existing ones to im-prove emotional regulation strategies. Thus, the objective of this study has been to determine the preliminary feasibility and effectiveness of a brief program based on the Unified Protocol (UP). The project consisted of a pilot study using a multiple baseline experimental design. Nine university students received a 5-session program based on the UP in online-group format. Significant differences were found after the intervention for emo-tion regulation, perceived social support and avoidance, with moderate-large effect sizes (Cohen's r= .49-.59). These improvements showed in-creases at 1-month and 3-month follow-ups. Those results are in line with those showing that brief transdiagnostic preventive programs could be use-ful for the prevention of EDs in the university population.(AU)

A smartphone app-based mindfulness intervention to enhance recovery from substance use disorders: Protocol for a pilot feasibility randomized controlled trial.

Background: Poor long-term recovery outcomes after treatment (e.g., readmission to inpatient treatment) are common among individuals with substance use disorders (SUDs). In-person mindfulness-based treatments (MBTs) are efficacious for SUDs and may improve recovery outcomes. However, existing MBTs for SUD have limited public health reach, and thus scalable delivery methods are needed. A digitally-delivered MBT for SUDs may hold promise. Methods: We recently developed Mindful Journey, a smartphone app-based adjunctive MBT for improving long-term recovery outcomes. In this paper, we present details on the app and describe the protocol for a single-site pilot feasibility randomized controlled trial of Mindful Journey. In this trial, individuals (n = 34) in an early phase of outpatient treatment for SUDs will be randomized to either treatment-as-usual (TAU) plus Mindful Journey, or TAU only. The trial will focus on testing the feasibility (e.g., engagement) and acceptability of the app (e.g., perceived usability and helpfulness for recovery), as well as feasibility of study procedures (e.g., assessment completion). The trial will incorporate ecological momentary assessment before and after treatment to assess mechanisms in real-time, including mindfulness, craving, difficulties with negative emotion regulation, and savoring. To examine the sensitivity to change of outcomes (substance use, substance-related problems, and psychological distress) and mechanism variables (noted above), we will test within-treatment-condition changes over time. Discussion: The proposed pilot trial will provide important preliminary data on whether Mindful Journey is feasible and acceptable among individuals with SUDs. Trial registration: ClinicalTrials.gov NCT05109507.

How Does the Proportion of Child-Specific Content of Pre-Registration Nursing Programmes in Higher Education Institutions Impact Upon Newly Qualified Registered Nurses' Perceptions of Preparedness to Care for Children, Young People, and Their Families? A Narrative Review Protocol.

This paper presents a narrative review protocol to explore how the proportion of child-specific content of pre-registration programmes in universities impact upon newly qualified nurses' perceptions of preparedness to care for children, young people (CYP), and their families. The preparation and education to become a nurse who cares for children and young people differs from country to country. Providers of pre-registration nurse education offer routes into nursing from diploma to degree and in some countries post-graduate routes. The United Kingdom offers pre-registration programmes leading to qualifying as a children's nurse whereas programmes in countries such as the USA and Canada lead to a professional registration as a registered nurse with postgraduate study to specialize in areas such as pediatrics. The role of pre-registration nursing programmes is to facilitate preparedness for practice. Preparation for practice can include theoretical teaching and practice learning through simulation and face-to-face experience with countries requiring different numbers of practice hours to be completed. Although practice hours are central to nursing education, there is limited evidence on the impact and portion of child-specific content, including clinical learning in preparation of newly qualified nurses to care for CYP and their families. A preliminary search of Prospero, CINAHL, Medline and Cochrane Database indicates that there are no current or in progress reviews identified. The Population of interest, Exposure of interest, and Outcome framework were used to define the research question and inform the eligibility criteria. The review will consider different research designs if related to the research question. The search strategy will conform to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines for systematic reviews. Two independent reviewers will be involved in the screening progress to determine the final studies for inclusion. Eligible studies will be assessed for methodological quality using the Joanna Briggs Institute critical appraisal tools. Extraction of study characteristics and data related to the research question will be extracted into a predefined table. Data synthesis will be conducted using a descriptive analytical approach to summarize extracted data.

Longitudinal study for the early detection of autism in children with very preterm birth.

INTRODUCTION: Very preterm birth is an important risk factor for autism spectrum disorder (ASD). The aim of this study is the early detection of ASD risk, using a follow-up protocol, in children weighing less than 1500 g at birth or born before 32 weeks of gestation. METHODS: This is a prospective longitudinal study in which a total of 133 very premature babies were monitored to the age of 2 years with the M-CHAT autism screening test and, in the event of a positive result, the Autism Diagnostic Observation Schedule (ADOS-2). RESULTS: 53 cases (4 out of 10) screened positive, and the rest negative. Among the positives, the ADOS-2 was administered in 50 cases, of which 24 scored above the ASD cutoff point. The average age of detection was 25.39 months. The results suggest an estimated prevalence of ASD in the very premature population of 18.46 %. CONCLUSIONS: The application of the follow-up protocol in the very premature population is effective for early detection of ASD.

Adopting a Framework for Rapid Real-World Data Analyses in Safety Signal Assessment.

The expanding availability of real-world data (RWD) has led to an increase in both the interest and possibilities for using this information in postmarketing safety analyses and signal management. While there is enormous potential value from the safety insights generated through RWD, the analysis preparation, execution, and communication required to reliably deliver the evidence can be time consuming. Since the safety signal assessment process is a regulated and timebound process, any supporting RWD analyses require a rapid turnaround of well-designed and informative results. To address this challenge, a TransCelerate BioPharma working group was formed and developed a framework to help teams responsible for safety signal assessment overcome the challenges of working with RWD rapidly to deliver analyses within regulatory timelines. Here, a previously performed safety assessment was evaluated within the context of the developed framework to illustrate how the framework may be adopted in practice.

Estimating dengue disease and economic burden to inform municipal-level policymakers: Method for a pragmatic city-level observational cohort study.

Background: Recent trials have confirmed the effectiveness of promising dengue control technologies - two vaccines and Wolbachia. These would generally be applied at the municipal level. To help local officials decide which, if any, control strategy to implement, they need affordable, timely, and accurate data on dengue burden. Building on our previous work in Mexico, Indonesia, and Thailand, we developed a streamlined prospective method to estimate dengue burden at the municipal level quickly, accurately, and efficiently. Methods: The method entails enrolling and repeatedly interviewing 100 patients with laboratory-confirmed dengue. They will be selected after screening and testing about 1,000 patients with clinical dengue. The method will capture both acute and chronic effects relating to disease, economic burden, and psychological impacts (presenteeism). The total time requirements are 1.5 years, comprised of 0.25 years for planning and approvals, 1 year for data collection (a full dengue cycle), and 0 .25 years for data cleaning and analysis. A collaboration with municipal and academic colleagues in the city of Semarang, Central Java, Indonesia shows how the method could be readily applied in Indonesia's eighth largest city (population 1.8 million). Conclusions: Many surveillance studies gather only information on numbers of cases. This proposed method will provide a comprehensive picture of the dengue burden to the health system, payers, and households at the local level.

Identifications of Similarity Metrics for Patients With Cancer: Protocol for a Scoping Review.

BACKGROUND: Understanding the similarities of patients with cancer is essential to advancing personalized medicine, improving patient outcomes, and developing more effective and individualized treatments. It enables researchers to discover important patterns, biomarkers, and treatment strategies that can have a significant impact on cancer research and oncology. In addition, the identification of previously successfully treated patients supports oncologists in making treatment decisions for a new patient who is clinically or molecularly similar to the previous patient. OBJECTIVE: The planned review aims to systematically summarize, map, and describe existing evidence to understand how patient similarity is defined and used in cancer research and clinical care. METHODS: To systematically identify relevant studies and to ensure reproducibility and transparency of the review process, a comprehensive literature search will be conducted in several bibliographic databases, including Web of Science, PubMed, LIVIVIVO, and MEDLINE, covering the period from 1998 to February 2024. After the initial duplicate deletion phase, a study selection phase will be applied using Rayyan, which consists of 3 distinct steps: title and abstract screening, disagreement resolution, and full-text screening. To ensure the integrity and quality of the selection process, each of these steps is preceded by a pilot testing phase. This methodological process will culminate in the presentation of the final research results in a structured form according to the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) flowchart. The protocol has been registered in the Journal of Medical Internet Research. RESULTS: This protocol outlines the methodologies used in conducting the scoping review. A search of the specified electronic databases and after removing duplicates resulted in 1183 unique records. As of March 2024, the review process has moved to the full-text evaluation phase. At this stage, data extraction will be conducted using a pretested chart template. CONCLUSIONS: The scoping review protocol, centered on these main concepts, aims to systematically map the available evidence on patient similarity among patients with cancer. By defining the types of data sources, approaches, and methods used in the field, and aligning these with the research questions, the review will provide a foundation for future research and clinical application in personalized cancer care. This protocol will guide the literature search, data extraction, and synthesis of findings to achieve the review's objectives. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/58705.

Impact of the COVID-19 Pandemic on Cancer Clinical Trials: Alliance for Clinical Trials in Oncology Experience (Alliance A152022).

Objective: The COVID-19 pandemic led to immediate changes in cancer clinical trial conduct. The primary aims of this study were to summarize the impact of the pandemic on Alliance for Clinical Trials in Oncology (Alliance) enrollment, protocol deviations, COVID-19 events (positive or presumptive-positive COVID test), and premature study discontinuation rates. Methods: Enrollment trends were examined from January 2019 (pre COVID-19 pandemic) through 2022. Data were captured for protocol deviations and premature treatment and study discontinuation events across all Alliance protocols using a centralized Medidata Rave database, and summarized from January 1, 2020, through June 30, 2022. Descriptive statistics and graphical techniques are used to summarize observed trends. Results: Overall enrollment across Alliance trials decreased during the COVID-19 pandemic and remained below pre-pandemic levels in 2022. Racial and ethnic demographics of enrolled patients did not change substantially. 4805 protocol deviations were reported on 2745 unique patients, with at least one protocol deviation reported by 618 sites and 77 unique trials. Commonly reported deviations were telemedicine visits (n=2167, 45%) and late/missed study procedures (n=2150, 45%). A total of 826 COVID-19 events were reported in 659 unique patients. Of an estimated 18,000 enrolled patients, only 68 withdrew from treatment and 45 withdrew from study due to COVID-19. Conclusion: A centralized COVID-19 database enabled a comprehensive assessment of the impact of the pandemic across Alliance trials. COVID-19 led to an immediate decline in enrollment across all patient populations. While the number of trials open to patient accrual remained stable, several large, adjuvant studies completed accrual during this period, which contributed to accrual decline. Telemedicine usage was notable, and both COVID-19 events and study discontinuation due to COVID-19 were rare.

Efficacy of arch contouring foot orthoses for midfoot osteoarthritis: Protocol for a randomised controlled trial.

INTRODUCTION: Midfoot osteoarthritis (OA) is a painful and disabling condition. Arch contouring foot orthoses have been recommended for midfoot OA, yet there is no high-quality evidence from randomised controlled trials to support their use. This clinical trial aims to evaluate the efficacy of arch contouring foot orthoses for midfoot OA. METHODS: This will be a parallel-group randomised controlled superiority trial. One-hundred and forty community-dwelling people with painful midfoot OA will be randomised to receive either arch contouring foot orthoses or flat sham inserts. Outcome measures will be obtained at baseline, 4, 8 and 12 weeks; the primary endpoint for assessing efficacy being 12 weeks. The primary outcome measure will be average midfoot pain whilst walking over the last 7 days on an 11-point numerical rating scale. Secondary outcome measures include function (walking/standing subscale of the Manchester-Oxford Foot Questionnaire), participants' perception of overall treatment effect (self-reported global rating of change on a 15-point Likert scale), physical activity (Incidental and Planned Exercise Questionnaire), general health-related quality of life (Short Form-12 Version® 2.0), use of co-interventions and adverse events. DISCUSSION: This trial will evaluate the efficacy of arch contouring foot orthoses for relieving pain and improving function, physical activity and health-related quality of life in people with midfoot OA. The findings will provide high-quality evidence as to whether arch contouring foot orthoses are efficacious and will help to inform clinical guidelines about the use of foot orthoses for midfoot OA. TRIAL REGISTRATION: Australian and New Zealand Clinical Trial Registry (ACTRN12623000953639).

Piloting the Inclusion of the Key Populations Unique Identifier Code in the South African Routine Health Information Management System: Protocol for a Multiphased Study.

BACKGROUND: The global community has set an ambitious goal to end HIV/AIDS as a public health threat by 2030. Significant progress has been achieved in pursuing these objectives; however, concerns remain regarding the lack of disaggregated routine data for key populations (KPs) for a targeted HIV response. KPs include female sex workers, transgender populations, gay men and other men who have sex with men, people who are incarcerated, and people who use drugs. From an epidemiological perspective, KPs play a fundamental role in shaping the dynamics of HIV transmission due to specific behaviors. In South Africa, routine health information management systems (RHIMS) do not include a unique identifier code (UIC) for KPs. The purpose of this protocol is to develop the framework for improved HIV monitoring and programming through piloting the inclusion of KPs UIC in the South African RHIMS. OBJECTIVE: This paper aims to describe the protocol for a multiphased study to pilot the inclusion of KPs UIC in RHIMS. METHODS: We will conduct a multiphased study to pilot the framework for the inclusion of KPs UIC in the RHIMS. The study has attained the University of Johannesburg Research Ethics Committee approval (REC-2518-2023). This study has four objectives, including a systematic review, according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines (objective 1). Second, policy document review and in-depth stakeholder interviews using semistructured questionnaires (objective 2). Third, exploratory data analysis of deidentified HIV data sets (objective 3), and finally, piloting the framework to assess the feasibility of incorporating KPs UIC in RHIMS using findings from objectives 1, 2, and 3 (objective 4). Qualitative and quantitative data will be analyzed using ATLAS.ti (version 6; ATLAS.ti Scientific Software Development GmbH) and Python (version 3.8; Python Software Foundation) programming language, respectively. RESULTS: The results will encompass a systematic review of literature, qualitative interviews, and document reviews, along with exploratory analysis of deidentified routine program data and findings from the pilot study. The systematic review has been registered in PROSPERO (International Prospective Register of Systematic Reviews; CRD42023440656). Data collection is planned to commence in September 2024 and expected results for all objectives will be published by December 2025. CONCLUSIONS: The study will produce a framework to be recommended for the inclusion of the KP UIC national rollout. The study results will contribute to the knowledge base around the inclusion of KPs UIC in RHIMS data. TRIAL REGISTRATION: PROSPERO CRD42023440656; https://tinyurl.com/msnppany. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/55092.

Cognitive Dysfunction in the Addictions (CDiA): A Neuron to Neighbourhood Collaborative Research Program on Executive Dysfunction and Functional Outcomes in Outpatients Seeking Treatment for Addiction.

Background: Substance use disorders (SUDs) are pressing global public health problems. Executive functions (EFs) are prominently featured in mechanistic models of addiction. However, there remain significant gaps in our understanding of EFs in SUDs, including the dimensional relationships of EFs to underlying neural circuits, molecular biomarkers, disorder heterogeneity, and functional ability. To improve health outcomes for people with SUDs, interdisciplinary clinical, preclinical and health services research is needed to inform policies and interventions aligned with biopsychosocial models of addiction. Here, we introduce Cognitive Dysfunction in the Addictions (CDiA), an integrative team-science and translational research program, which aims to fill these knowledge gaps and facilitate research discoveries to enhance treatments for people living with SUDs. Methods: The CDiA Program comprises seven complementary interdisciplinary projects that aim to progress understanding of EF in SUDs and investigate new biological treatment approaches. The projects draw on a diverse sample of adults aged 18-60 (target N=400) seeking treatment for addiction, who are followed prospectively over one year to identify EF domains crucial to recovery. Projects 1-3 investigate SUD symptoms, brain circuits, and blood biomarkers and their associations with both EF domains (inhibition, working memory, and set-shifting) and functional outcomes (disability, quality of life). Projects 4 and 5 evaluate interventions for addiction and their impacts on EF: a clinical trial of repetitive transcranial magnetic stimulation and a preclinical study of potential new pharmacological treatments in rodents. Project 6 links EF to healthcare utilization and is supplemented with a qualitative investigation of EF-related barriers to treatment engagement for those with substance use concerns. Project 7 uses innovative whole-person modeling to integrate the multi-modal data generated across projects, applying clustering and deep learning methods to identify patient subtypes and drive future cross-disciplinary initiatives. Discussion: The CDiA program has promise to bring scientific domains together to uncover the diverse ways in which EFs are linked to SUD severity and functional recovery. These findings, supported by emerging clinical, preclinical, health service, and whole-person modeling investigations, will facilitate future discoveries about cognitive dysfunction in addiction and could enhance the future clinical care of individuals seeking treatment for SUDs.

Ten-year follow-up of outcomes, patterns of care, and psychosocial burden in adolescent and young adult (AYA) patients with bone sarcomas from a large cohort in a low-income and middle-income country (LMIC).

BACKGROUND: The care of adolescents and young adults (AYAs) with bone sarcomas involves unique challenges. The objectives of this study were to identify challenges and evaluate long-term outcomes of these patients from India who received treatment with novel protocols. METHODS: This prospective cohort study included AYA patients (aged 15-39 years) with osteosarcoma and Ewing sarcoma (ES), who were treated uniformly at the authors' institute using unique protocols (OGS-12 and EFT-2001) from 2011 to 2021 and from 2013 to 2018, respectively. RESULTS: The cohorts included 688 of 748 (91.9%) treatment-naive AYA patients with osteosarcoma and 126 of 142 (88.7%) treatment-naive AYA patients with ES. Among 481 of 561 patients (85.7%) who had nonmetastatic osteosarcoma treated according to protocol, at a median follow-up of 59.7 months, the 5-year event-free survival (5-EFS) rate was 58.6% (95% confidence interval, 54.1%-63.5%) and for 142 patients (20.6%) who had metastatic osteosarcoma, the 5-EFS rate was 18.7%. The 5-EFS rate was 66.4% and 21.9% for 104 patients (73%) with nonmetastatic ES and 38 patients (27%) with metastatic ES, respectively. Treatment-naive patients had better outcomes, similar to compliance in the form of protocol completion (hazard ratio, 1.93 [p = .0043] and 2.66 [p < .0001], respectively. Only 230 of 377 (61.0%) male patients and 10 of 134 (7.4%) female patients reached out to fertility specialists. In addition, 17 of 161 (10.6%) eligible male survivors and 14 of 61 (22.9%) eligible female survivors got married posttreatment. Furthermore, 14 of 17 (82.4%) males and 14 of 14 (100%) females conceived. Among 311 patients who were working or attending school during diagnosis, greater than 90% had interruptions. CONCLUSIONS: Homogenous treatment with the OGS-12 and EFT-2001 protocols resulted in internationally comparable long-term outcomes in the cohorts with nonmetastatic and metastatic AYA bone sarcomas. Treatment compliance, timely referral to sarcoma reference centers (avoiding prior inadvertent treatment), and streamlining fertility-preservation practices constitute unmet needs that demand prioritization.

Protocol for preparing metabolically reprogrammed human CAR T cells and evaluating their in vitro effects.

Chimeric antigen receptor (CAR) T cell therapy represents a cutting-edge cancer treatment, making the development and testing of CAR T cells crucial for advancing this therapeutic strategy. We present a protocol for creating and characterizing human epidermal growth factor receptor 2 (HER2)- and glypican-3 (GPC3)-metabolic reprogramming (MR)-CAR T cells by overexpressing adenosine deaminase 1 (ADA1) and CD26 (also known as dipeptidylpeptidase-4 or DPP4). This approach effectively converts immunosuppressive adenosine into inosine, which supports T cell survival in glucose-deficient tumor microenvironments. The protocol includes producing retroviral vectors, generating CAR T cells, and conducting ecto-ADA1 activity, cytotoxicity, cell migration, and RNA sequencing assays. For complete details on the use and execution of this protocol, please refer to Hu et al.1.

Reducing amplification cycles to improve the coverage of influenza A virus genome sequencing in heterosubtypic co-infection.

This study delineates the enhancement of a Reverse Transcription Polymerase Chain Reaction (RT-PCR) method for the amplification of the complete genome of the influenza A virus during heterosubtypic co-infection, relying on the amplification of intact gene segments. The precision of the method was assessed using all amplicons, which underwent both capillary electrophoresis and DNA sequencing. Five samples featuring co-infection of Influenza A viruses with H1N1 and H3N2 subtypes were evaluated. The improved strategy successfully amplified all eight segments of H3N2 strains in four samples, and the entire genome of H1N1 strains in three samples.

Effect of extracorporeal shock wave combined with autologous platelet-rich plasma injection on rotator cuff calcific tendinitis: study protocol for a randomized controlled trial.

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.

The neural effects of acupuncture for stroke: a protocol for systematic review and meta-analysis based on fMRI.

Background: Stroke is one of the most common causes of death and is the main cause of persistent and acquired disability in adults worldwide. Acupuncture is recommended by the World Health Organization as an alternative and complementary strategy for stroke treatment. However, the mechanism of the neural effects of acupuncture on stroke is still lacking a uniform conclusion. The purpose of this study is to clarify the neural effects of acupuncture for stroke from the perspective of neuroimaging. Methods: Seven databases, including PubMed, Embase, Cochrane Library, Chinese National Knowledge Infrastructure, VIP Database, Wan-Fang Data, and Chinese Biomedical Database, will be searched comprehensively according to the search strategy. All of them will be retrieved from the date of database establishment to December 31, 2023. All randomized controlled trials and observational studies will be considered for inclusion. The risk of bias will be assessed by the Cochrane Risk of Bias tool. Functional imaging of the whole brain in the resting functional state will be the primary outcome. A meta-analysis of primary outcome will be performed using Seed-based D Mapping with Permutation of Subject Images software. The data will be synthesized using a random effects model. Meta-analysis of other clinical data will be performed using RevMan 5.3 software. Publication bias will be assessed through funnel plots. Reports will adhere to the Preferred Reporting Items for Systematic Review and Meta-Analysis. Conclusion: This study will aggregate the results of independent studies to provide overall evidence for the neural effects of acupuncture for stroke. Clinical Trial Registration: https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=500306, Identifier CRD42024500306.

Acupuncture for Residual Dizziness After Successful Repositioning Maneuvers in Patients with Benign Paroxysmal Positional Vertigo: Study Protocol for a Randomized Noninferiority Trial.

Introduction: Benign paroxysmal positional vertigo (BPPV) is the most common cause of peripheral vertigo among adults. Successful treatment often requires an appropriate canalith repositioning procedure (CRP), which has proven effective in the treatment of BPPV. However, some patients experience residual dizziness (RD) after CRP, affecting their daily activities and quality of life. Although oral betahistine is a common clinical treatment for RD, some patients may discontinue this medication due to adverse effects. Conversely, acupuncture has demonstrated efficacy in treating dizziness with minimal adverse effects. However, to date, no trials have directly compared the efficacy of acupuncture and betahistine in treating RD. Our goal was to assess the noninferiority of acupuncture in treating RD compared with the commonly used oral betahistine treatment. Methods and Analysis: A randomized, controlled, non-inferiority trial was conducted to compare the effectiveness of acupuncture and betahistine in patients with BPPV who experience RD after a successful CRP. Eighty-four participants were randomly assigned to two treatment groups, each receiving either acupuncture or betahistine. The assessors and statisticians were blinded to treatment allocation. The primary outcomes were the response rate and change in vertigo level, and secondary outcomes included Visual Analog Scores and the presence and change in depressive symptoms among patients. Scale measures were recorded at baseline, 2, 4, and 12 weeks after randomization. This trial aims to provide causal evidence supporting the non-inferiority of acupuncture therapy relative to oral betahistine, offering an alternative treatment avenue for patients intolerant to betahistine. Ethics and Dissemination: Ethics approval was obtained from the Affiliated Hospital of Shandong University of Traditional Chinese Medicine, with permission number 2023-095-KY. Written informed consent was obtained from the enrolled patients.

Physical Rehabilitation Using Oromotor Stimulation, Manual Airway Clearance Technique, Positioning, and Tactile and Kinaesthetic Stimulation (PROMPT) Protocol in Low-Birth-Weight Triplets With Neonatal Respiratory Distress: A Case Series.

Neonatal respiratory distress syndrome (RDS), a severe respiratory illness that is likely to affect preterm newborns especially those who were born preterm with low birth weight (LBW) or multiple births, is one of the complications that preterm babies are likely to develop. Physical Rehabilitation using Oromotor Stimulation, Manual Airway Clearance Technique, Positioning, and Tactile and Kinaesthetic Stimulations (PROMPT) is the intervention followed in this study to determine its effectiveness in the treatment of RDS in LBW triplets. The PROMPT protocol involves interventions such as manually promoting the airway, positioning, oral motor stimulation, and tactile and kinesthetic stimulation. The study examined triplets of similar weight, 1.23g, 1.36g, and 1.18g, at birth. Thus, all known triplets were suffering from the symptoms of RDS like fast breathing and grunting. They were born via premature delivery at 30+5 weeks of pregnancy. Chest X-rays were used as a diagnostic tool for assessing RDS. At the same time, the PROMPT protocol was administered and significant improvements were seen in respiratory health and there was reduced use of mechanical ventilation. The PROMPT protocol shows how effectively an organized method can be applied to treat RDS in LBW triplets.

Development and Feasibility Evaluation of a Family-Centred Neonatal End-of-Life Care Protocol.

AIM: To develop a family-centred end-of-life care protocol and evaluate its feasibility. DESIGN: The draft protocol was created by integrating literature review results and existing protocols and interviewing bereaved parents. A Delphi study and an experts' review were conducted to refine the draft, followed by feasibility testing with neonatal intensive care unit nurses. RESULTS: A 71-item protocol based on an integrated end-of-life care model and the family-centred care concept was developed, comprising three sections: principal guidelines, communication during end-of-life care and five substeps (4, 17 and 71 items, respectively) according to changes in an infant's condition. The feasibility was confirmed by an increase in competency and a positive attitude towards infant end-of-life care participants who completed the protocol education. CONCLUSION: The protocol was feasible and improved nurses' competency and attitude in providing end-of-life care for infants and parents requiring support due to the loss of their infants. It can positively impact the well-being of parents who have experienced the loss of their infants in neonatal intensive care units and enhance family-centred care within the units. IMPLICATIONS FOR THE PROFESSION AND/OR PATIENT CARE: Application of the family-cantered end-of-life care could support infants' dying process and improve bereaved parents' quality of life in neonatal intensive care units. IMPACT: This study increased neonatal end-of-life nursing needs' awareness among nurses and parents during bereavement. It offered preliminary evidence regarding the feasibility of a neonatal end-of-life care protocol developed in this study. REPORTING METHOD: AGREE Reporting Checklist 2016. PATIENT OR PUBLIC CONTRIBUTION: We interviewed bereaved parents to develop the draft protocol and involved neonatal care experts for the Delphi study and neonatal nurses (who would use the protocol) as feasibility test subjects. TRIAL REGISTRATION: This was a doctoral dissertation and did not require protocol registration as the feasibility test involved a single neonatal intensive care unit.