Research Protocol Research Articles

Nursing assessment of mental health issues in the general clinical environment: A descriptive study.

To evaluate the effectiveness of a mental health screening form for early identification and care escalation of mental health issues in general settings. A secondary aim was to explore general nurses' use of the form and their confidence to discuss mental health issues with patients. A cross-sectional design comprising a review of clinical records to determine use of the form, instances of missed care and escalation to the mental health team. The survey focused on nurses' confidence in general settings to engage in discussions with patients about mental health. Data were collected from April to December 2022. The Strengthening the Reporting of Observational Studies in Epidemiology Statement guided this study. Of 400 patient records, 397 were analysed; 293 (73.8%) of those had mental health screening by nurses. Age was a significant factor, with younger patients more likely to be screened although concerns were typically recognized in older patients. Of the 20 patients identified with mental health concerns, 9 (45%) were referred for further evaluation by the Clinical Liaison Team. While nurses were proactive in assessing physical risks, assessing risk factors that required deeper conversations with patients, including psychiatric history, was lacking. The survey highlighted fewer than half of the respondents (46%, n = 10) felt competent to engage in discussions about mental health; however, most (59%, n = 13) knew when to seek a mental health referral. General nurses have a role in the early identification and referral of patients with mental health challenges. However, training is imperative to facilitate deeper patient interactions concerning mental health. Integrating mental health checks within general settings is crucial for early detection and intervention, aligning with global quality care standards. STROBE guidelines. We received feedback that shaped the research protocol from a consumer representative.

RELATIONSHIP AMONG EXPERIENTIAL AVOIDANCE, COGNITIVE EMOTION REGULATION STRATEGIES, AND DEPRESSION

Depression is a prevalent psychiatric illness and a leading cause of disability worldwide. Experiential Avoidance (EA) and maladaptive cognitive emotion regulation (CER) strategies are significant predictors of depression, yet their interaction remains poorly understood. This study aimed to investigate the relationship between experiential avoidance, CER strategies, and depression, while examining the arbitrating role of maladaptive CER strategies in the association between EA and depression. A purposive sample of N= 354 patients diagnosed with Major Depressive Disorder was recruited from three teaching hospitals. Following research and clinical ethics protocols, measures were administered. Results revealed that participants in the treatment group N=38 demonstrated statistically significant improvement in depression, general health, and quality of life, with sustained effects observed at 9 months post-baseline. Additionally, participants in the treatment group reported higher treatment satisfaction compared to the control group N=38. Spiritual-integrated cognitive-behavioral therapy (CBT) shows promise in alleviating post-partum depression when compared to treatment as usual. Future research should explore the generalizability of these findings and investigate potential mechanisms underlying the effectiveness of spirituality-integrated CBT in treating depression.

Increasing coverage and uptake of voluntary family planning in Uganda's emerging municipalities and secondary cities: An implementation research study protocol.

While urban areas are often perceived to have better access to healthcare services, including modern family planning (FP) services, urban dwellers including those with better socioeconomic status are faced with multidimensional challenges that shape their access to appropriate FP services. In Uganda's urban spaces, there is currently a lack of understanding among service providers, civil society organizations, and individuals/communities regarding the implementation of interventions that promote informed choice and voluntary use of family planning services. This knowledge gap has profound implications for reproductive rights. This study seeks to enhance existing efforts towards increasing coverage and uptake of Voluntary Family Planning (VFP) in Jinja City and Iganga Municipality, central eastern Uganda. Our primary question is, "What interventions can effectively be packaged and delivered to increase the uptake of VFP among different segments of urban residents?" We propose to use the Human-Centered Design (HCD) approach to understand the needs and challenges of users and community capabilities in ensuring access to VFP services. Co-creating with stakeholders' engagement and a data-driven-centric approach will steer design and adaptation that respond to the different population segments within the urban space. As such, the study will be implemented in three phases: formative assessment, design and implementation, and implementation monitoring and evaluation. The implementation process will incorporate robust monitoring, learning, and adaptation mechanisms. The primary focus of these mechanisms will be to utilize gathered information effectively to inform the design of the implementation and facilitate continuous learning throughout the process. The study will apply a process monitoring and evaluation approach to address questions related to what package of FP interventions work, for whom, under what circumstances and why. Guided by strong learning and implementation flexibility, we hypothesize that our implementation will provide segmentation-specific high-impact interventions in an urban context. This implementation research protocol has been registered on the Open Science Framework (OSF) repository Registries (https://osf.io/vqxu9; DOI: 10.17605/OSF.IO/VQXU9).

EFFICACY AND SAFETY OF NICORANDIL FOR PERIPROCEDURAL MYOCARDIAL INJURY IN PATIENTS UNDERGOING PCI

Coronary artery disease (CAD) remains a leading cause of morbidity and mortality globally, with percutaneous coronary intervention (PCI) being a typical therapeutic approach. Objectives: In this comparative study, we aimed to investigate the efficacy and safety of nicorandil for periprocedural myocardial injury in patients undergoing PCI. Methods: This comparative study was conducted at Ayub Teaching Hospital from September 2023 to December 2023. Data from 90 patients was recruited for the research using inclusion and exclusion screening standards. Our study was performed on 90 patients treated with percutaneous coronary intervention (PCI). Patients from Group 1 were different from those in Group 2. Group A: the critical study parameters will switch between those patients who received nicorandil and Group B: non-nicorandil patients. Baseline demographic data, past medical history, and relevant laboratory values and clinical characteristics were documented for all patients. In addition, an intraoperative laboratory investigation was conducted, including cardiac biomarkers. Results: Research data were drawn from 90 patients whose gender wasn't a factor based on the research protocol. In Group A, the mean age of the patients was 62 years. Players in group A played for 4 ± 8.5 years. In team B, the players had a slightly longer experience and played for 63. Humans on Earth could do the same, and it could significantly impact future generations: ± 7. 9 years. Of 58 men and 32 women in the control group, there were two persons and persons in the experimental group, respectively. Only one stent differed between the two groups; however, the number was similar. 8 ± 0. 6 mmol/l in the tricorandil group and 1. +9 ± 0 in Case 1. Patients in the Nicorandil group displayed the lowest level of heart problem-causing protein (troponin) at the peak (5. There is a statistically significant 1.8-fold (2 ng/mL versus seven ng/mL) decline in serum lysozyme levels in the group administered rhG-CSF. The treatment group exhibited a substantial increase in haemoglobin levels (t(12) = 3. 74, p-value <0.005) with a mean difference of 0. 5 ± 2 ng/mL. 001, 95% CI: 2. 1 to 3. 5). Conclusion: It is concluded that nicorandil shows positive results for the efficacy (the ability of a drug to bring the desired effect) and safety of the drug in reducing myocardial injury and in maintaining the function of myocardial during percutaneous coronary intervention in patients.

Clinical Subsets of Central Cord Syndrome: Is It a Distinct Entity from Other Forms of Incomplete Tetraplegia for Research?

Central cord syndrome (CCS) is the most prevalent and debated incomplete spinal cord injury (SCI) syndrome, with its hallmark feature being more pronounced weakness of the upper extremities than of the lower extremities. Varying definitions encapsulate multiple clinical features under the single umbrella term of CCS, complicating evaluation of its frequency, prognosis discussions, and outcomes research. Often, people with CCS are excluded from research protocols, as it is thought to have a favorable prognosis, but the vague nature of CCS raises doubts about the validity of this practice. The objective of this study was to categorize CCS into specific subsets with clear quantifiable differences, to assess whether this would enhance the ability to determine if individuals with CCS or its subsets exhibit distinct neurological and functional outcomes relative to others with incomplete tetraplegia. This study retrospectively reviewed individuals with new motor incomplete tetraplegia from traumatic SCI who enrolled in the Spinal Cord Injury Model Systems (SCIMS) database from 2010 to 2020. Through an assessment of the prevailing criteria for CCS, coupled with data analysis, we used two key criteria, including the severity of distal upper extremity weakness (i.e., hands and fingers) and extent of symmetry, to delineate three CCS subsets: full CCS, unilateral CCS, and borderline CCS. Of the 1490 participants in our sample, 17.5% had full, 25.6% had unilateral, and 9% had borderline CCS, together encompassing >50% of motor incomplete tetraplegia cases. Despite the increased sensitivity and specificity of these subsets compared with existing quantifiable criteria, substantial variability in clinical presentation was still observed. Overall, individuals meeting CCS subset criteria showed a higher likelihood of American Spinal Injury Association (ASIA) Impairment Scale (AIS) D grade than those with motor incomplete tetraplegia without CCS. Upper Extremity Motor Score (UEMS) for those with CCS was lower on admission, a difference that diminished by discharge, whereas their Lower Extremity Motor Score (LEMS) consistently remained higher than for those without CCS. However, these neurological distinctions did not result in significant functional differences, as lower and upper extremity functional outcomes at discharge were mostly similar, with some differences observed within those with AIS D grade. The AIS grade, rather than the diagnosis of CCS, remains the foremost determinant influencing neurological and functional outcomes. We recommend that future studies consider incorporating motor incomplete tetraplegia into their inclusion/exclusion criteria, instead of relying on criteria specific to CCS. Although there remains clinical value in characterizing an injury pattern as CCS and perhaps using the different subsets to better characterize the impairments, it does not appear to be a useful research criterion.

Board Diversity and Governance Outcomes of State Corporations in Kenya

Boards play a critical leadership role in good governance of Kenya’s state corporations, which exit by law to deliver effectual services to the citizenry. The sector has since independence undergone various reforms aimed at continuous improvement, mitigating inherent challenges and to deliver efficient service. In 2015, the Government of Kenya upscaled its governance architecture by sanctioning a governance code. Despite this endeavour, the state corporation’s ecosystem has recorded unimpressive outcomes on the corporate governance front. This study sought to establish the relationship between board diversity and governance outcomes of state corporations in Kenya. A descriptive survey design was used on a target population of 138 state corporations and a simple random sampling technique used to draw a 20% study sample, amounting to 28 state corporations. The study collected primary data using a structured questionnaire. A drop and pick method were used to administer the questionnaire to three respondents from each sampled state corporation upon consideration and application of accruing research protocols. The data collection instrument was pretested prior to the actual data collection to check reliability and validity upon which the emergent issues were corrected and instrumentation enhanced. The collected data was analysed using simple regression analysis vide SPSS version 21. The findings have been presented using tables. The study established a significant positive relationship between board diversity and inclusion and governance outcomes of state corporations in Kenya and concluded that board diversity and inclusion is a key driver of corporate governance outcomes. The study recommended that firms should mainstream diversity and inclusion in order to drive sustainable advantage in boards as a tool to effective leadership and governance. Future studies may be undertaken in the private sector for contextual comparability

Frequency and immediate neonatal prognosis of low birth weight neonates in Parakou (Benin) in 2018

Introduction: Infant and child mortality remains high in Benin and is sustained by neonatal mortality which has stagnated for decades. Low birth weight (LBW) is recognized to be an important risk factor for neonatal death worldwide and serves as an indicator of perinatal death. Objective: The objective is to establish the relationship between LBW and immediate neonatal prognosis in the city of Parakou (Benin). Patients and methods: This was a cross-sectional study with a descriptive and analytical aim. A prospective collection of data on neonates born from pregnancies with a gestational age of at least 22 weeks of amenorrhea was carried out. It was conducted in three health structures drawn randomly from ten structures in the city of Parakou from May 15 to July 14, 2018. The study included all live neonates. The recruitment of neonates was subject to an oral informed consent of their mothers. We excluded from this study any malformed neonate, any neonate who died in utero and any neonate born from a multiple pregnancy. The data collected were processed and analyzed using Epi Data 3.1, Microsoft Excel 2007 and Epi Info version 7.1.5.0 software. Statistical inferences (Chi-Square test, Person test, Yates correction, Ficher's exact test and their confidence intervals) were used to check the level of association between LBW and morbid situations and then immediate mortality. The research protocol was submitted to the local ethics committee of the University of Parakou and obtained its approval under the reference 0121/CLERB-UP/P/SP/R/SA of May 5, 2018. Results: The frequency of LBW was 16.9%. LBW was associated with poor adaptation to extrauterine life (p=0.000), neonatal resuscitation (p=0.000) and early neonatal mortality (p=0.000). Birth weight in neonates with LBW was inversely related to the risk of death within 24 hours of life. Conclusion: One in six neonates had LBW in the city of Parakou in 2018. LBW at birth was a state at risk of neonatal resuscitation and early death. Reducing neonatal mortality requires preventing low birth weight.

Clinical and radiographic outcomes of a novel technique for socket healing: a protocol for a split-mouth randomized controlled trial

Abstract Tooth extraction is one of the most common routine procedures in the dental clinic. Tooth extraction is followed by an inevitable bone resorption that leads to alveolar ridge reduction in the horizontal and vertical directions. The dimensions of alveolar ridge after socket healing are the result of a balance between the resorption and remodeling mechanisms that occur naturally after tooth extraction. The aim of this study is to evaluate the clinical and radiographic outcomes of the socket decortication technique for socket healing through a split-mouth randomized controlled trial. The proposed research protocol will investigate the effectiveness of this technique in promoting optimal healing and reducing bone loss following tooth extraction. By comparing radiographic data from the intervention side with the control side within the same individual, the study seeks to provide valuable insights into the potential benefits of the novel approach. The findings of this study have the potential to advance current knowledge in the field of dentistry and contribute to improved clinical practices for socket healing.

Impacts of Involving Young Learners in Mind, Brain, and Education Research

AbstractAs the field of Mind, Brain, and Education (MBE) continues to grow, MBE researchers have begun expanding the scope of their investigations and approaches. One such development is the establishment of collaborative partnership with young learners, both to inform research practices and to develop student‐researchers. We explore how middle school students (ages 12 to 14 years) engage in MBE research through an assistantship program, initiated through a unique research‐practice partnership that embeds MBE researchers and an electrophysiology laboratory into a school. In this program, student‐researchers learn about experimental methods, assist with university research protocols, and drive independent projects. Here, we detail this program and report on its impact from both the teacher and student‐researcher perspectives. Overall, we find that daily involvement in scientific research aids the holistic development of student‐researchers by fostering academic and nonacademic skills that may transcend formal learning environments.

Lifestyle management and brain MRI metrics in female Australian adults living with multiple sclerosis: a feasibility and acceptability study

BackgroundLimited studies of multiple sclerosis (MS) exist whereby magnetic resonance imaging (MRI) of the brain with consistent imaging protocols occurs at the same time points as collection of healthy lifestyle measures. The aim of this study was to test the feasibility, acceptability and preliminary efficacy of acquiring MRI data as an objective, diagnostic and prognostic marker of MS, at the same time point as brain-healthy lifestyle measures including diet.MethodsParticipants living with relapsing remitting MS partook in one structural MRI scanning session of the brain, completed two online 24-hour dietary recalls and demographic and self-reported lifestyle questionnaires (e.g. self-reported disability, comorbidities, physical activity, smoking status, body mass index (BMI), stress). Measures of central tenancy and level of dispersion were calculated for feasibility and acceptability of the research protocols. Lesion count was determined by one radiologist and volumetric analyses by a data analysis pipeline based on FreeSurfer software suite. Correlations between white matter lesion count, whole brain volume analyses and lifestyle measures were assessed using Spearman’s rank-order correlation coefficient.ResultsThirteen female participants were included in the study: eligibility rate 90.6% (29/32), recruitment rate 46.9% (15/32) and compliance rate 87% (13/15). The mean time to complete all required tasks, including MRI acquisition was 115.86 minutes (\\documentclass[12pt]{minimal} \\usepackage{amsmath} \\usepackage{wasysym} \\usepackage{amsfonts} \\usepackage{amssymb} \\usepackage{amsbsy} \\usepackage{mathrsfs} \\usepackage{upgreek} \\setlength{\\oddsidemargin}{-69pt} \\begin{document}$$($$\\end{document}± 23.04), over 4 days. Conversion to usual dietary intake was limited by the small sample. There was one strong, negative correlation between BMI and brain volume (rs = −0.643, p = 0.018) and one strong, positive correlation between physical activity and brain volume (rs = 0.670, p = 0.012) that were both statistically significant.ConclusionsAcquiring MRI brain scans at the same time point as lifestyle profiles in adults with MS is both feasible and accepted among adult females living with MS. Quantification of volumetric MRI data support further investigations using semi-automated pipelines among people living with MS, with pre-processing steps identified to increase automated feasibility. This protocol may be used to determine relationships between elements of a brain-healthy lifestyle, including dietary intake, and measures of disease burden and brain health, as assessed by T1-weighted and T2-weighted lesion count and whole brain volume, in an adequately powered sample.Trial registrationThe study protocol was retrospectively registered in the Australia New Zealand Clinical Trials Registry (ACTRN12624000296538).

Research Protocol and Recruitment Redesign of a Study of Pregnant Women and Their Infants During the COVID-19 Pandemic: Childhood Allergy and the NeOnatal Environment (CANOE)

BackgroundRecruitment for research studies is a challenging endeavor that was further complicated by the COVID-19 pandemic. We launched a new NIH-supported multi-center birth cohort, “Childhood Allergy and the NeOnatal Environment” (CANOE) in January 2020 across four sites. While the pandemic temporarily halted clinical research, we restructured the study and instituted novel recruitment methods that we hypothesized would enable brisk enrollment when research activities resumed. ObjectiveDevelop protocol modifications and recruitment methods that promote successful recruitment of diverse populations in clinical research despite a global pandemic. MethodsWhile study activities were suspended, we modified recruitment strategies to limit in-person contact, shifting toward alternative HIPAA-compliant methods like clinician referrals, institutional social media, and telemedicine screening and consent procedures. Protocol changes included reducing the frequency of in-person visits, leveraging clinical care visits to collect biospecimens, expanded self-collection of samples at home, and making study materials available online. ResultsRemote methods, including targeted social media posts, mailed letters, and email, combined with in-clinic recruitment with modifications for social distancing led to successful recruitment at all sites. Rates of consent have been similar across recruitment sites, with the highest rates of enrollment of mother-infant dyads realized by sites that implemented multiple recruitment strategies. ConclusionsStudy procedures that prioritize health and safety measures such as social distancing, study participant convenience, and diverse recruitment strategies enable successful enrollment of pregnant women and their newborns into clinical research while adhering to public health restrictions during a global pandemic.

Monogamous hybridization of Nile tilapia (Oreochromis niloticus) with Mozambique tilapia (O. mossambicus) results in unprecedented all-female F1 hybrid

Tilapiine breeding success is season-dependent, with very rare exceptions. The female (f) to male (m) ratio differences showed significant variations in fruitful breeding. Furthermore, the female-to-male ratio in any hybridization protocol involving reciprocal crosses may be the most influential factor in determining breeding seasonality. The innate genetic traits of tilapia, a prominent contributor to global aquaculture production, enable them to easily adapt to a wide range of aquatic environments, rendering them suitable for domestication. The study aimed to determine the breeding timeframe of Nile tilapia (Oreochromis niloticus, N) through interspecific monogamous/two-parent reciprocal crossing with Mozambique tilapia (O. mossambicus, M). Considering preselected genotypic characteristics by PrlLK microsatellite marker, different combinations of hybrid reciprocal crosses were performed in breeding hapa (3 × 3 × 3 cubic feet) inside an indoor plastered cemented tank and then in an outdoor earthen pond facility. Total 11 parental pairs were attempted to propagate inside a cemented tank with (9 pairs) and without (2 pairs) hapa during early April to mid-June. Unfortunately, the trials failed to produce any successful breeding within the schedule. Among those 11 pairs, 6 pairs were Nf × Mm and 5 pairs were Mf × Nm cross. In the earthen pond inside hapa, a total of 18 pairs were attempted where seven breeding successes were reported without demonstrating any dependency for hybridizations over cross types or genotypes and for individuals over sex or species. Successful breeding were reported from the month of May to November. There were few overlapping months of successful breeding for different grouping categories. During the successful breeding period, there were no successful outcomes in both August and October. An inadvertent all-female F1 generation was observed for Mf × Nm crosses, while the reciprocal cross Nf × Mm produced an F1 generation with a nearly 1:1 female to male ratio. The F1 sex ratios exhibited a significant reliance on parental genotypic combinations (p = 5.4e-11). The success stories from different cross combinations would help to frame the breeding protocol for future research. More precisely, for arranging a breeding schedule in freshwater earthen ponds inside hapa for a monogamous/two-parent hybrid cross the study light a close insight.

Time to Therapy and Safety of Testicular Tissue Cryopreservation in Children Undergoing Gonadotoxic Treatment or Hematopoietic Stem Cell Transplant

BackgroundWith the use of multimodal treatments and hematopoietic stem cell transplant, the majority of children diagnosed with malignancies and hematologic diseases are now surviving into adulthood. Due to the gonadotoxic effects and potential for future infertility associated with many of these treatments, fertility counseling with sperm cryopreservation prior to starting therapy is the standard of care for post-pubertal males. Unfortunately, the options are limited for pre-pubertal patients or those unable to provide a specimen. Testicular tissue cryopreservation (TTC) is an investigational method to surgically obtain germ cells from testicular tissue and potentially restore future spermatogenesis. While TTC has been shown to be safe, little is reported on the time to treatment following the procedure to ensure adequate wound healing and avoid delays in definitive therapy. ObjectivesThe primary outcome was the time to initiation of treatment following TTC. Secondary outcomes were complication rates, delays in treatment due to TTC, and presence of germ cells. MethodsWe conducted a single-institution retrospective cohort study of patients undergoing TTC between 2017-2023. Patients at significant risk for treatment related infertility based on established criteria were eligible for TTC. Patients were excluded if they received their oncology or hematology care elsewhere. All patients were enrolled in an IRB approved research protocol with 75% of the tissue submitted for cryopreservation and 25% for research purposes. Time to therapy was defined as the first receipt of gonadotoxic treatment following TTC. ResultsA total of 122 patients (53=malignant, 69=non-malignant) underwent TTC with a median age of 5.9 years (IQR 2.3-9.35). Germ cells were identified in 115 (94%) specimens. A total of 109 (89%) patients underwent concomitant procedures. The median time to initiation of therapy was 5 (IQR 1.0-7.0) and 7 days (IQR 6.0-13.0) for malignant and non-malignant disease, respectively. The 30-day surgical complication rate was 2.5% and was similar between malignant vs non-malignant diagnoses (p=0.58). All surgical complications were managed non-operatively. No patients had a delay in definitive treatment due to concern for wound healing or complications. DiscussionOur surgical complication rates are similar to previous studies and are not affected by the time to treatment following TTC. Limitations of the study are its retrospective design, single institution, and short-term follow up. ConclusionTTC can be performed safely, efficiently, and in conjunction with other necessary procedures without resulting in delays of definitive treatment . TTC affords the opportunity for fertility preservation in children who have no other options.

Barriers to Clinical Trial Implementation Among Community Care Centers

While an overwhelming majority of patients diagnosed with cancer express willingness to participate in clinical trials, only a fraction will enroll onto a research protocol. To identify critical barriers to trial enrollment to translate findings into actionable practice changes that increase cancer clinical trial enrollment. This survey study included designated site contacts at oncology practices with teams who were highly involved with the Association of Community Cancer Centers (ACCC) Community Oncology Research Institute (ACORI) clinical trials activities, all American Society of Clinical Oncology (ASCO)-ACCC collaboration pilot sites, and/or sites providing care to at least 25% African American and Hispanic residents. To determine participation trends among health care practices in oncology-focused research, identify barriers to clinical trial implementation and operation, and establish unmet needs for cancer clinics interested in trial participation, a 34-question survey was designed. Survey questions were defined within 3 categories: cancer center demographic characteristics, clinical trial characteristics, and referral practices. The survey was distributed through email and was open from June 20 through October 5, 2022. Participation in and barriers to conducting oncology trials in different community oncology settings. The survey was distributed to 100 cancer centers, with completion by 58 centers (58%) across 25 states. Fifty-two centers (88%) reported that they conduct therapeutic clinical trials, of which 33 (63%) were from urban settings, 11 (21%) were from suburban settings, and 8 (15%) were from rural settings. Only 25% of rural practices (2 of 8) offered phase 1 trials, compared with 67% of urban practices (22 of 33) (P = .01). Respondents noted challenges in conducting research, including patient recruitment (27 respondents [52%]), limited staffing (27 [52%]), and nonrelevant trials for their patient population (25 [48%]). Among sites not offering therapeutic trials, barriers to research conduct included limited infrastructure, funding, and staffing. Most centers (46 of 58 [79%]) referred patients to outside centers for clinical trial enrollment, particularly in the context of late-stage disease and/or disease progression. Only 17 of these sites (37%) had established protocols for patient follow-up subsequent to outside referral. In this national survey study of barriers to clinical trial implementation, most sites offered therapeutic trials, but there were significant disparities in trial availability across care settings. Furthermore, fundamental deficiencies in trial support infrastructure limited research activity, including within programs currently conducting research as well as at sites interested in future clinical research opportunities. These results identify crucial unmet needs for oncology clinics to effectively offer clinical trials to patients seeking care.

Humane Endpoints in Swiss Webster Mice Infected with Toxoplasma gondii RH Strain.

The highly virulent Toxoplasma gondii RH strain is maintained through successive passages in mice, but there is still a lack of studies that refine these procedures from a 3Rs perspective, where humanitarian ideals aim to minimize the stress, pain, or suffering of the animals used in the research without the loss of results. The aim of this study was to establish humane endpoints in Swiss Webster mice inoculated with the T. gondii RH strain. A total of 52 mice were infected with 5 × 106 tachyzoites/mL and monitored for periods of up to 5 days. The parameters body weight; hair condition; higher than normal body temperature; hypothermia; respiratory function; pain; soft stools or diarrhea; bloody diarrhea; tense, nervous, or in distress during handling; and ascites were recorded daily in score tables. The results showed that prominent piloerection, respiratory function, pain parameters, and ascites are important clinical signs to be used as a cut-off point for implementing euthanasia. The application of this refinement method helped to avoid animal suffering and pain without compromising the number of parasites recovered. We therefore suggest adopting these parameters in research protocols that require the maintenance of the T. gondii RH strain in murine models to avoid and reduce animal suffering.

Isolated REM Sleep without Atonia Is Not Equivalent to REM Sleep Behavior Disorder in Early-Stage Parkinson's Disease.

In early-stage Parkinson's disease (PD), rapid eye movement (REM) sleep behavior disorder (RBD) predicts poor cognitive and motor outcome. However, the baseline significance and disease evolution associated with isolated REM sleep without atonia (iRWA, ie, enhanced muscle tone during 8.7% of REM sleep, but no violent behavior) are not well understood. The objective is to determine whether iRWA was a mild form of RBD and progressed similarly over time. Participants with early PD (<4 years from medical diagnosis) were included from 2014 to 2021 in a longitudinal study. They underwent interviews and examinations in the motor, cognitive, autonomous, psychiatric, sensory, and sleep domains every year for 4 years along with a video polysomnography and magnetic resonance imaging examination of the locus coeruleus/subcoeruleus complex (LC/LsC) at baseline. The clinical characteristics were compared between groups with normal REM sleep, with iRWA and with RBD, at baseline and for 4 years. Among 159 PD participants, 25% had RBD, 25% had iRWA, and 50% had normal REM sleep. At baseline, the non-motor symptoms were less prevalent and the LC/LsC signal intensity was more intense in participants with iRWA than with RBD. Over 4 years, participants with normal REM sleep and with iRWA had a similar cognitive and motor trajectory, whereas participants with RBD had greater cognitive and motor decline. We demonstrated that iRWA is frequent in early PD, but is not a milder form of RBD. Both groups have distinct baseline characteristics and clinical trajectories. They should be distinguished in clinical routine and research protocols. © 2024 The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.

An advanced netnographic framework for analyzing brand community overlap conflicts in the phygital brand community (PBC) environment

Purpose This study aims to introduce and define the concept of phygital brand community (PBC). It discusses the potential conflicts that can arise from engaging in multiple PBCs and propose an enriched netnographic methodological approach to explore the role of PBC engagement overlap and its influence on the phygital experience. Design/methodology/approach Following a critical analysis of the inherent limitations of netnographic methodological approaches in the context of PBCs, this study develops an enriched netnographic research protocol that accounts for the challenges of engagement overlap among PBCs. Findings This study proposes two methods of analysis, namely, “participatory netnography” and “witness netnography,” which are derived from a mixed-methodology approach that integrates elements of netnography. Research limitations/implications The findings of this study underscore the requisite methodological refinements imperative for enhancing netnographic analysis, particularly in its application for a better comprehension of individual behaviors within the realm of PBCs. In pursuit of this objective, the identified adjustments encompass ethical considerations, evaluation methods and their application in a digital milieu, where intricate mechanics and technologies frequently elude conventional methodologies. Originality/value In this study, the authors present a novel conceptualization of PBCs, highlighting their role and development, as well as the challenges they pose. To adequately capture the impact of PBC engagement overlap, the authors propose the need for an enriched mixed-methodological approach.

Ethical review of preclinical research

The main goal of medicine has been and remains the desire to preserve the health of the population, increase human life expectancy and its quality. For those purposes, it is necessary to constantly improve treatment measures, create and introduce into medical practice new methods of therapy, innovative medicines, guided by strict rules of evidence of their high effectiveness and safety, study the mechanisms of physiological processes of a living organism in normal conditions and in pathology, the possibilities of correction and prevention of disease processes, and this means the need to conduct research, including those involving animals. The modern ethical and legal framework for research involving animals contains a requirement for mandatory examination of a research project by an ethical committee, monitoring its implementation, and analysis of the results. An ethics committee is a structure implemented into the research process to help researchers navigate the complex network of guidelines, rules and best practices, as well as the existing legal framework for conducting scientific research that guarantees quality results of work that do not violate these principles and restrictions. The local ethics committee is responsible for ensuring that research conducted in the territory under its supervision complies with modern ethical standards. This article presents the experience of the local ethics committee of the Kazan State Medical University in the ethical review of research projects involving animals, and substantiates the list and content of the requirements for documents submitted by the researcher for ethical review. The shortcomings identified in the preclinical research protocols submitted for examination were separately analyzed, and references were provided to the ethical and legal framework existing in the Russian Federation.

A network of care to improve the continuity and quality of maternal and perinatal services in Makueni County, Kenya: study protocol

Background Kenya’s high maternal and perinatal mortality rates exceeds its recommended 2030 targets. The lack of effective collaboration between health facilities and workers contributes to delays and uncoordinated provision of care, leading to negative maternal and neonatal health (MNH) outcomes. Network of Care (NOC) is an effective strategy to improve health facility network efficiencies and MNH outcomes. Utilizing NOC to improve health system coordination and MNH outcomes in Kenya has not been studied. We present a study protocol for implementation research to investigate the feasibility and acceptability of establishing a county-level NOC on relationships among health facilities and workers, the feasibility of NOC for the Makueni county health system, and the impact of NOC on the quality of MNH services and emergency referrals within the county health system. Levels of communication, collaboration, and trust between NOC health facilities and levels of preparedness for management of MNH complications are also evaluated. Methods The study employed a mixed methods design with quantitative data from health worker self-administered phone surveys, health facility referral forms, and facility registers collected at baseline, then every three months from September 2021 to July 2023. Health worker focus group discussions and county management key informant interviews were conducted at baseline, midline, and endline. The study purposively selected 60 public and private health facilities in Makueni. These facilities were a sub-sample of 344 facilities with the highest maternity caseloads. A descriptive and thematic analysis of communication, collaboration, and trust between NOC health facilities and workers, and referral system changes will take place. Trend analysis of MNH indicators for Makueni from the Kenya Health Information System will be done. Conclusion This study aims at informing decision-makers locally and globally on whether NOC is feasible and acceptable as a county-level model of care in Kenya with application to similar LMIC settings.

Trends and hotspots in acupuncture treatment of rat models of stroke: a bibliometric analysis from 2004 to 2023.

Acupuncture is a widely used clinical treatment method, and studies have confirmed its therapeutic effects on stroke patients. It can also reduce the burden on patients and society. Acupuncture treatment is a complementary and preventive treatment for stroke. However, there has yet to be a visual bibliometric analysis of the field of acupuncture for stroke rat models. This study explores future trends, research hotspots, and frontiers in acupuncture for stroke rat models over the past 20 years through investigation and visualization. We collected literature data on acupuncture treatment of stroke in rats from the Web of Science Core Collection (WOSCC) database from January 1, 2004, to December 31, 2023. Import into CiteSpace (version 6.2.R4) and RStudio for analysis by author, country/region, affiliation, annual publication, keywords, and journal visualization. A total of 379 articles were retrieved, including articles from 16 countries, 258 research institutions, and 123 academic journals. The countries and institutions with the most publications were the People's Republic of China (338) and the Fujian University of Traditional Chinese Medicine (43). Tao, Jing had the highest number of co-citations (144). The keywords and co-citation clustering show the main research directions in the field, including "artery occlusion," "neural regeneration," "stimulation," "rapid tolerance," "receptor," "signaling pathway," "apoptosis," "oxidative stress," "inflammatory response," "endogenous neurogenesis," "tolerance of local cerebral ischemic tissues," "proliferation of reactive astrocytes" and "neuroprotective effect." The intervention combines classical acupuncture treatment and modern technology (electricity) with electroacupuncture as a new intervention modality. This study demonstrates the increasing research on acupuncture for treating stroke in rat models. The country/region with the most publications is the People's Republic of China. However, international cooperation still needs to be improved, and future researchers must strengthen international cooperation. In addition, in future studies, researchers should improve the overall quality of research results in this area and enhance research protocols.