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1.
Biomater Adv ; 163: 213934, 2024 Jun 28.
Artigo em Inglês | MEDLINE | ID: mdl-38954877

RESUMO

Sample partitioning is a crucial step towards digitization of biological assays on polymer microfluidic platforms. However, effective liquid filling into microwells and long-term hydrophilicity remain a challenge in polymeric microfluidic devices, impeding the applicability in diagnostic and cell culture studies. To overcome this, a method to produce permanent superhydrophilic 3-dimensional microwells using cyclic olefin copolymer (COC) microfluidic chips is presented. The COC substrate is oxidized using UV treatment followed by ultrasonic spray coating of polyvinyl alcohol solution, offering uniform and long-term coating of high-aspect ratio microfeatures. The coated COC surfaces are UV-cured before bonding with a hydrophobic pressure-sensitive adhesive to drive selective filling into the wells. The surface hydrophilicity achieved using this method remains unchanged (water contact angle of 9°) for up to 6 months and the modified surface is characterized for physical (contact angle & surface energy, morphology, integrity of microfeatures and roughness), chemical composition (FTIR, Raman spectroscopy) and coating stability (pH, temperature, time). To establish the feasibility of the modified surface in biological applications, PVA-coated COC microfluidic chips are tested for DNA sensing (digital LAMP detection of CMV), and biocompatibility through protein adsorption and cell culture studies (cell adhesion, viability, and metabolic activity). Kidney and breast cells remained viable for the duration of testing (7 days) on this modified surface, and the coating did not affect the protein content, morphology or quality of the cultured cells. The ultrasonic spray coated system, coating with 0.25 % PVA for 15 cycles with 0.12 A current after UV oxidation, increased the surface energy of the COC (naturally hydrophobic) from 22.04 to 112.89 mJ/m2 and improved the filling efficiency from 40 % (native untreated COC) to 94 % in the microwells without interfering with the biocompatibility of the surface, proving to be an efficient, high-throughput and scalable method of microfluidic surface treatment for diagnostic and cell growth applications.

2.
BMJ Open ; 14(6): e081557, 2024 Jul 01.
Artigo em Inglês | MEDLINE | ID: mdl-38951006

RESUMO

PURPOSE: The global burden of mental health difficulties among children underscores the importance of early prevention. This study aims to assess the efficacy, feasibility and acceptability of the Strong Families programme in enhancing child behaviour and family functioning in low-resource settings in Gilgit-Baltistan, Pakistan. METHODS AND ANALYSIS: This is a two-arm, multisite feasibility randomised controlled trial with an embedded process evaluation in three districts of Gilgit-Baltistan, namely Gilgit, Hunza and Skardu. 90 families living in these challenged settings, comprising a female primary caregiver aged 18 or above, and at least one child aged 8-15 years, will participate. Participants will be randomly assigned to either receive the Strong Families programme or to the waitlist group. Strong Families is a 7-hour family skills group intervention programme attended by children and their primary caregivers over 3 weeks. The waitlist group will be offered the intervention after their outcome assessment. Three raters will conduct blind assessments at baseline, 2 and 6 weeks postintervention. The primary outcome measures include the feasibility of Strong Families, as determined by families' recruitment and attendance rates, and programme completeness (mean number of sessions attended, attrition rates). The secondary outcomes include assessment of child behaviour, parenting practices, parental adjustment and child resilience. Purposefully selected participants, including up to five caregivers from each site, researchers and facilitators delivering the intervention, will be interviewed. Descriptive statistics will be used to analyse primary and secondary outcomes. The process evaluation will be conducted in terms of programme context, reach, fidelity, dose delivered and received, implementation, and recruitment. ETHICS AND DISSEMINATION: This study has been approved by the UNODC Drug Prevention and Health Branch in the Headquarters office of Vienna and the National Bioethics Committee of Pakistan. Findings will be disseminated through publication in reputable journals, newsletters and presentations at conferences. TRIAL REGISTRATION NUMBER: NCT05933850.


Assuntos
Estudos de Viabilidade , Humanos , Paquistão , Criança , Adolescente , Feminino , Comportamento Infantil , Ensaios Clínicos Controlados Aleatórios como Assunto , Masculino , Terapia Familiar/métodos , Avaliação de Programas e Projetos de Saúde , Poder Familiar
3.
J Burn Care Res ; 2024 Jul 10.
Artigo em Inglês | MEDLINE | ID: mdl-38984771

RESUMO

Soft casts have been introduced as an efficacious strategy to manage hand burns that simplifies wound care for families. We hypothesized that the outpatient use of soft casts in pediatric hand burns would be viewed as acceptable by patient caregivers and providers, logistically feasible, and result in satisfactory clinical outcomes. A review was performed of pediatric clinic patients managed with soft casts since implementation (9/2022 - 9/2023). Patient caregivers and providers were surveyed. The primary outcome was acceptability of soft casts as a management strategy (questions targeted care burden, overall satisfaction, comfort, pragmatism, and healing concerns). Secondary outcome was feasibility (effect on clinic workflow, efficiency). Survey responses were collected from 70% of caregivers and 95% of providers. Responses overwhelmingly favored soft cast acceptability. Among providers, 84% agreed that "the soft cast method simplified the hand burn care experience in our clinic" and 100% indicated "the soft cast was easy for parents to manage at home" (Likert range 7-10, mode 10). Thirty-three English-speaking patients with partial and full thickness hand burns were managed with soft casts. A mean of 1.8 reapplications (mode 1, range 1-5) were required with median healing time of 13 days. No infections were attributed to the use of soft casting, and only one patient ultimately required grafting. Overall, the introduction of soft casts as a management strategy for pediatric hand burns was acceptable and feasible. The clinical outcomes assessed suggest soft casts are associated with good wound healing with minimal wound care responsibilities for patient and family.

4.
J Clin Exp Neuropsychol ; : 1-15, 2024 Jul 10.
Artigo em Inglês | MEDLINE | ID: mdl-38984860

RESUMO

OBJECTIVES: Interest in teleneuropsychology services increased considerably after the COVID-19 pandemic. However, the utility of unsupervised administration of computerized tests remains largely unexplored. In the present study, we developed a brief computerized battery that assesses self-reported cognitive abilities and performances on executive functioning and verbal memory. We investigated the equivalence of the self-administration online (SAO) procedure and the face-to-face (FTF) administration. Preliminary normative data were developed and the acceptance of the SAO procedure was explored. METHODS: A community sample of 169 Greek adults [94 women; mean age: 41.95 (SD = 13.40) years, mean years of education: 15.10 (SD = 2.65)] completed the SAO assessment. A subgroup of 40 participants was tested in a counterbalanced way both with SAO and FTF. Participants' performances were compared with paired sample t-tests and the agreement between the two methods was estimated with intraclass correlation coefficients (ICCs). Multiple linear regression analyses were applied to investigate the effect of demographic characteristics on SAO measures. RESULTS: No difference between SAO and FTF scores was observed. ICCs indicated moderate to good agreement (.418-.848) for most measures. Age was positively associated with self-reported cognitive state and negatively with neuropsychological performances and the level of acceptance of the SAO procedure. Approximately 80% of participants reported satisfaction from the SAO assessment, 69% good compliance with the instructions, but less than 30% belief that the FTF assessment could be adequately replaced. CONCLUSION: SAO testing is feasible and well accepted among Greek adults yielding equivalent results with FTF testing. Despite the wide satisfaction, though, notable reluctance was noted for the substitution of FTF with SAO procedures.

5.
ChemSusChem ; : e202401025, 2024 Jul 10.
Artigo em Inglês | MEDLINE | ID: mdl-38984900

RESUMO

The rampant exploitation of fossil fuels has led to the significant energy scarcity and environmental disruption, affecting the sound momentum of development and progress of human civilization. To build a closed-loop anthropogenic carbon cycle, development of biofuels employing sustainable biomass feedstocks stands at the forefront of advancing carbon neutrality, yet its widespread adoption is mainly hampered by the high production costs. Montmorillonite, however, has garnered considerable attention serving as an efficient heterogeneous catalyst of ideal economic feasibility for biofuel production, primarily due to its affordability, accessibility, stability, and excellent plasticity. Up to now, nevertheless, it has merely received finite concerns and interests in production of various biofuels using montmorillonite-based catalysts. There is no timely and comprehensive review that addresses this latest relevant progress. This review fills the gap by providing a systematically review and summary in controllable synthesis, performance enhancement, and applications related to different kinds of biofuels including biodiesel, biohydrogenated diesel, levulinate, γ-valerolactone, 5-ethoxymethylfurfural, gaseous biofuels (CO, H2), and cycloalkane, by using montmorillonite catalysts and its modified forms. Particularly, this review critically depicts the design strategies for montmorillonite, illustrates the relevant reaction mechanisms, and assesses their economic viability, realizing sustainable biofuels production via efficient biomass valorization.

6.
Gland Surg ; 13(6): 952-968, 2024 Jun 30.
Artigo em Inglês | MEDLINE | ID: mdl-39015701

RESUMO

Background: Laparoscopic adrenalectomy (LA) has emerged as the primary treatment for adrenal masses. This systematic review and meta-analysis assessed LA's feasibility, safety, effectiveness, and complications for adrenal masses exceeding 5 cm. Methods: The study was conducted using PRISMA guidelines with PROSPERO registration No. CRD42023462901. Adults with unilateral adrenal masses >5 cm who underwent unilateral LA were included. Intraoperative and postoperative measurements and complications were assessed. A systematic literature review employed a comprehensive search strategy which was last searched on September 8, 2023, through PubMed, Google Scholar, Web of Science, and ProQuest databases. Meta-analysis was utilized to analyze the outcomes. Risk of bias was assessed using the Newcastle-Ottawa scale. Results: This systematic review encompassed 25 studies involving 963 patients who underwent LA. Tumor size varied 7.05 cm [95% confidence interval (CI): 6.24-7.70], with 50% on the right and 45% on the left. The subgroup meta-analysis comparing the transperitoneal and retroperitoneal approaches revealed the transperitoneal approach h was utilized for the largest tumor size with a mean of 12.10 cm (95% CI: 11.30-12.96), compared to the retroperitoneal approach 5.83 cm (95% CI: 5.52-6.14). Notably, the mean operative time across studies was 137.4 minutes (95% CI: 113.36-150.94), bleeding prevalence was 0.02% (95% CI: 0.01-0.03%), and average blood loss was 110.6 mL (95% CI: 78.2-156.3). Postoperative complications such as pulmonary edema, pulmonary embolism, gastric dysfunction, and wound infection were very low, ranging from 0.03% to 0.4%. Out of 963 patients, only 49 were converted to open surgery. Patient hospital stay averaged 3.72 days (95% CI: 2.97-4.66); blood transfusion was required in 1.3% (95% CI: 0.30-8.88%). Conclusions: The feasibility and safety of LA for tumors exceeding 5 cm in size have notable implications for intraoperative and postoperative outcomes. Underreporting in the included studies may impact the generalizability of findings.

7.
BMC Public Health ; 24(1): 1830, 2024 Jul 09.
Artigo em Inglês | MEDLINE | ID: mdl-38982408

RESUMO

BACKGROUND: Lack of physical activity is a concern for children across diverse backgrounds, particularly affecting those in rural areas who face distinct challenges compared to their urban counterparts. Community-derived interventions are needed that consider the unique context and additional physical activity barriers in under-resourced rural settings. Therefore, a prospective pre-post pilot/feasibility study of Hoosier Sport was conducted over 8-weeks with 6th and 7th grade children in a low-socioeconomic rural middle school setting. The primary objective of the present study was to assess trial- and intervention-related feasibility indicators; and the secondary objective was to collect preliminary assessment data for physical activity levels, fitness, psychological needs satisfaction, and knowledge of physical activity and nutrition among participating youth. METHODS: This prospective 8-week pilot/feasibility study took place in the rural Midwestern United States where twenty-four middle school students participated in a mixed-methods pre-post intervention during physical education classes. The intervention included elements like sport-based youth development, individualized goal setting, physical activity monitoring, pedometer usage, and health education. Data were collected at baseline (T1) and post-intervention (T3), with intermediate measures during the intervention (T2). Qualitative data were integrated through semi-structured interviews. Analytical methods encompassed descriptive statistics, correlations, repeated measures ANOVA, and thematic analysis. RESULTS: Key findings indicate robust feasibility, with intervention-related scores (FIM, AIM, and IAM) consistently surpassing the "good" threshold and 100% retention and recruitment success. Additionally, participants showed significant physical performance improvement, shifting from the 25th to the 50th percentile in the 6-minute walk test (p < 0.05). Autonomy and competence remained high, reflecting positive perceptions of program practicality. Nutrition knowledge, initially low, significantly improved at post-intervention (p < 0.01), highlighting the efficacy of targeted nutritional education in Hoosier Sport. CONCLUSIONS: This study pioneers a community-engaged model for physical activity intervention in under-resourced rural settings. Positive participant feedback, coupled with improvements in physical fitness and psychosocial factors, highlights the potential of the co-design approach. The findings offer valuable insights and a practical template for future community-based research, signaling the promising impact of such interventions on holistic well-being. This research lays the foundation for subsequent phases of the ORBIT model, emphasizing collaborative, community-driven approaches to address the complex issue of declining physical activity levels among adolescents.


Assuntos
Exercício Físico , Estudos de Viabilidade , População Rural , Humanos , Projetos Piloto , Masculino , Exercício Físico/psicologia , Criança , Feminino , Adolescente , Estudos Prospectivos , Promoção da Saúde/métodos , Meio-Oeste dos Estados Unidos , Avaliação de Programas e Projetos de Saúde , Educação Física e Treinamento
8.
Am J Epidemiol ; 2024 Jul 16.
Artigo em Inglês | MEDLINE | ID: mdl-39010744

RESUMO

Over three million patients are admitted to hospitals annually with high-acuity conditions mandating emergency abdominal or skin/soft-tissue operation. Patients with these high-acuity emergency general surgery (HA-EGS) diseases experience significant morbidity/mortality, yet the quality of life (QOL) impact on survivors is not well studied. Acuity, transfer patterns, and adverse social determinants of health (SDOH) documented in epidemiologic studies are cited reasons for inability to measure patient-reported outcomes (PROs) among HA-EGS survivors. We conducted a feasibility study to understand facilitators and barriers of conducting a prospective study of changes in QOL after surviving HA-EGS. From September 2019 to April 2021, we collected baseline (pre-admission) and 30/60-days post-surgery data on activities of daily living, depression, self-efficacy, resilience, pain, work limitations, social support, and substance use from patients who enrolled during index hospitalization. 100 patients were consented to participate in the study (71.9% enrollment rate). The retention rate was 65.9% for 30-day calls and 53.8% for 60-day calls. Median time to complete each time point remained under 25 minutes. Patients with a longer length of stay and nicotine users didn't complete their 30-day interview while those with systemic complications didn't complete their 60-day interview. These results set the foundation for future PRO studies.

9.
J Hum Nutr Diet ; 2024 Jul 14.
Artigo em Inglês | MEDLINE | ID: mdl-39004917

RESUMO

BACKGROUND: A sleeve gastrectomy (SG) is a lifelong treatment that improves health and better outcomes are associated with follow-up. However, there is lack of access or high attrition to aftercare. This potentially contributes to sub-optimal dietary intake and a lack of evidence for nutrition interventions. The present study assessed the feasibility and preliminary efficacy of a nutrition intervention to improve diet quality in Australian adults living with a SG. METHODS: Adults (n = 96) post-SG were recruited into a cross-sectional diet quality study, with 68 eligible for randomisation to an intervention or wait-list control group. Over 10 weeks, a Facebook group was used to post daily nutrition education. Feasibility outcomes included participant recruitment, engagement, retention and acceptability. Preliminary efficacy was assessed using change in Australian Recommended Food Score (ARFS). Linear mixed models were used to measure differences in mean outcome between the experimental groups over time. RESULTS: Sixty-eight participants (97% female) aged 48.2 ± 9.8 years, body mass index 33.1 ± 5.8 kg/m2, and mean ± SD ARFS 39 ± 9 points were randomised to the intervention, with 66% retention at 10 weeks. At follow-up, diet quality increased for the intervention group (mean ARFS, 95% confidence interval = 0.2 [-1.5 to 1.9]) and decreased for the control group (mean ARFS, 95% confidence interval= -2.0 [-5.2 to 1.2]) with no between group difference (p = 0.2). Participants (n = 30) rated the intervention positively. CONCLUSIONS: Recruiting and retaining adults post-SG into a nutrition intervention is feasible. Low-cost recruitment attracted strong interest from women to identify greater support to know what to eat following SG. A future fully powered trial to assess intervention efficacy is warranted.

10.
J Hum Nutr Diet ; 2024 Jul 14.
Artigo em Inglês | MEDLINE | ID: mdl-39004937

RESUMO

BACKGROUND: Breast cancer is the most frequent female malignancy in the UK. Around 20% of cases are linked to weight gain, excess weight and health behaviours. We designed a weight gain prevention, health behaviour intervention for young women at increased risk. METHODS: The study comprised a single arm observational study over 2 months testing acceptability and usability of the intervention: online group welcome event, app and private Facebook group. Females aged 18-35 years at moderate or high risk of breast cancer (>17% lifetime risk) were recruited via invite letters and social media posts. The app included behaviour change techniques and education content. Online questionnaires were completed at baseline, as well as at 1 and 2 months. We also assessed feasibility of study procedures. RESULTS: Both recruitment methods were successful. Thirty-five women were recruited, 26% via social media posts. Median age was 33 (interquartile range = 28.2-34.5) years, the majority (94.1%) were of White ethnicity. Thirty-four participants were included in the analyses, of which 94% downloaded the app. Median self-monitoring logs per participant during the study period was 10.0 (interquartile range = 4.8-28.8). App quality mean (SD) score was 3.7 (0.6) at 1 and 2 months (scale: 1-5). Eighty-nine per cent rated the app at average or above at 1 month and 75.0% at 2 months. Nineteen women (55.9%) joined the Facebook group and there were 61 comments and 83 reactions and votes from participants during the study period. CONCLUSIONS: This first iteration of the app and intervention was well received and is suitable to progress to the next stage of refining and further testing.

11.
J Clin Neurosci ; 126: 294-306, 2024 Jul 12.
Artigo em Inglês | MEDLINE | ID: mdl-39002303

RESUMO

OBJECTIVE: To evaluate the feasibility and durability of coil embolization for MCAB aneurysms by analyzing clinical and radiological results. METHODS: From January of 2008 to June of 2018, we treated a total of 1785 aneurysms using coil embolization. The aneurysms were treated by both coiling and stent-assisted coiling. Among these cases, 223 MCAB aneurysms were analyzed retrospectively. Clinical and radiological assessments were conducted at admission, after treatment, at discharge, and at last clinical follow-up. RESULTS: Coil embolization was performed on 223 MCAB aneurysms in 217 patients. Peri-procedural ischemic, hemorrhagic, and other complications within 30 days after coil embolization occurred at rates of 8.0 %, 8.0 %, and 2.0 %, respectively, in the ruptured group and at 2.9 %, 1.2 %, and 0 %, respectively, in the unruptured group. The overall morbidity and mortality rates associated with complications were 2.3 % and 2.0 %. The cumulative major recurrence rates were 5.1 % at 12 months, 7.1 % at 18 months, and 11.9 % at three years after coil embolization. The mean follow-up period was 33.27 ± 25.48 months. Independent risk factors for major recurrence after coil embolization for MCAB aneurysms were a ruptured aneurysm, initial incomplete occlusion, the aneurysm size, and the neck size. CONCLUSION: Coil embolization is a good alternative treatment option for MCAB aneurysms compared to surgical clipping. Considering the risk factors for major recurrence, the follow-up angiography should continue up to three years after coil embolization.

12.
Comput Biol Med ; 179: 108839, 2024 Jul 12.
Artigo em Inglês | MEDLINE | ID: mdl-39002320

RESUMO

BACKGROUND: Although early rehabilitation is important following a stroke, severely affected patients have limited options for intensive rehabilitation as they are often bedridden. To create a system for early rehabilitation of lower extremities in these patients, we combined the robotic manipulator ROBERT® with electromyography (EMG)-triggered functional electrical stimulation (FES) and developed a novel user-driven Assist-As-Needed (AAN) control. The method is based on a state machine able to detect user movement capability, assessed by the presence of an EMG-trigger and the movement velocity, and provide different levels of assistance as required by the patient (no support, FES only, and simultaneous FES and mechanical assistance). METHODS: To technically validate the system, we tested 10 able-bodied participants who were instructed to perform specific behaviors to test the system states while conducting knee extension and ankle dorsal flexion exercises. The system was also tested on two stroke patients to establish its clinical feasibility. RESULTS: The technical validation showed that the state machine correctly detected the participants' behavior and activated the target AAN state in more than 96% of the exercise repetitions. The clinical feasibility test showed that the system successfully recognized the patients' movement capacity and activated assistive states according to their needs providing the minimal level of support required to exercise successfully. CONCLUSIONS: The system was technically validated and preliminarily proved clinically feasible. The present study shows that the novel system can be used to deliver exercises with a high number of repetitions while engaging the participants' residual capabilities through the AAN strategy.

13.
Data Brief ; 55: 110586, 2024 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-38993232

RESUMO

Floating solar photovoltaic has emerged as a highly sustainable and environmentally friendly solution worldwide from the various clean energy generation technologies. However, the installation of floating solar differs from rooftop or ground-mounted solar due to the significant consideration of the availability of water bodies and suitable climatic conditions. Therefore, conducting a feasibility analysis of the suitable climate is essential for installing a floating solar plant on water bodies. These data are evaluated for the viability of installing a 6.7 MW floating solar power plant on Hatirjheel Lake in Dhaka, Bangladesh. The feasibility analysis incorporated various climatic data, such as temperature, humidity, rainfall, sunshine hours, solar radiation, and windspeed, obtained from Meteonorm 8.1 software and the archive of the Bangladesh Meteorological Department. Besides, this study gathered and analyzed the energy demands of the local grid substation operated by Dhaka Power Distribution Company, to determine the appropriate capacity and architecture of the power plant. The power plant design was conducted using the PVsyst 7.3 software, which determined the necessary equipment quantities, DC energy generation capacity, and the energy injected into the grid in MWh. The study also calculated the Levelized Cost of Energy per kilowatt-hour and the payback period for the system, which indicates the economic viability of installing the system. Furthermore, the acquired dataset possesses significant potential and can be utilized for the establishment of all sorts of solar power plants, including floating solar plants, in any location or body of water within the Dhaka Metropolitan area.

14.
Front Cell Dev Biol ; 12: 1422764, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38966426

RESUMO

Purpose: Extraocular electrical stimulation is known to provide neuroprotection for retinal cells in retinal and optic nerve diseases. Currently, the treatment approach requires patients to set up extraocular electrodes and stimulate potentially weekly due to the lack of an implantable stimulation device. Hence, a minimally-invasive implant was developed to provide chronic electrical stimulation to the retina, potentially improving patient compliance for long-term use. The aim of the present study was to determine the surgical and stimulation safety of this novel device designed for neuroprotective stimulation. Methods: Eight normally sighted adult feline subjects were monocularly implanted in the suprachoroidal space in the peripheral retina for 9-39 weeks. Charge balanced, biphasic, current pulses (100 µA, 500 µs pulse width and 50 pulses/s) were delivered continuously to platinum electrodes for 3-34 weeks. Electrode impedances were measured hourly. Retinal structure and function were assessed at 1-, 2-, 4-, 6- and 8-month using electroretinography, optical coherence tomography and fundus photography. Retina and fibrotic thickness were measured from histological sections. Randomized, blinded histopathological assessments of stimulated and non-stimulated retina were performed. Results: All subjects tolerated the surgical and stimulation procedure with no evidence of discomfort or unexpected adverse outcomes. The device position was stable after a post-surgery settling period. Median electrode impedance remained within a consistent range (5-10 kΩ) over time. There was no change in retinal thickness or function relative to baseline and fellow eyes. Fibrotic capsule thickness was equivalent between stimulated and non-stimulated tissue and helps to hold the device in place. There was no scarring, insertion trauma, necrosis, retinal damage or fibroblastic response in any retinal samples from implanted eyes, whilst 19% had a minimal histiocytic response, 19% had minimal to mild acute inflammation and 28% had minimal to mild chronic inflammation. Conclusion: Chronic suprathreshold electrical stimulation of the retina using a minimally invasive device evoked a mild tissue response and no adverse clinical findings. Peripheral suprachoroidal electrical stimulation with an implanted device could potentially be an alternative approach to transcorneal electrical stimulation for delivering neuroprotective stimulation.

15.
Acta Med Philipp ; 58(4): 26-39, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38966608

RESUMO

Objectives: The Bioavailability/Bioequivalence Unit (BA/BE Unit) of the Department of Pharmacology and Toxicology, College of Medicine, University of the Philippines Manila which has not been operational since 2012, is due for renewal of its accreditation. To date, there are only three Philippine Food and Drug Administration-accredited laboratories that perform bioequivalence studies in the Philippines. One of the prerequisites of registering specific generic medicines is the conduct of Bioequivalence (BE) studies which are performed to ensure that the generic drug is at par with the innovator drug. Thus, this study aimed to determine the feasibility of re-establishing the BA/BE Unit as a bioequivalence testing center. Methods: The feasibility study done is a qualitative descriptive analysis based on expansive literature review and performance of SWOT analysis within the BA/BE unit. Literatures were selected based on its assessed relevance to the study. The databases checked were PubMed and Google Scholar. The terms used were from the Medical Subject Heading (MeSH) including feasibility studies, therapeutic equivalency, and generic drugs. Literature review was performed on the factors affecting the four types of feasibility studies (market, technical, financial, and organizational). A SWOT analysis of the BA/BE Unit was done through the review of records and documents of previous BE studies and focus group discussion among the BA/BE Unit team members. Results: The BA/BE Unit conducted 24 bioequivalence studies from 2006-2009 and still receives inquiries from drug companies. It implements its QMS throughout the pre-analytical, analytical, and post-analytical stages of the workflow. Its organizational structure consists of qualified professionals with updated GCP and GLP certificates. Because of the adequately equipped facility, lower honoraria for government-employed personnel, and lower expenses for laboratories and in-patient admissions, the cost of conducting a bioequivalence study in the BA/BE Unit will be lower than in other BE centers. Conclusion: Based on the SWOT analysis and market, technical, financial, and organizational considerations, re-establishing the BA/BE Unit as a bioequivalence testing center is feasible.

16.
BMJ Open ; 14(7): e081823, 2024 Jul 11.
Artigo em Inglês | MEDLINE | ID: mdl-38991689

RESUMO

OBJECTIVES: In our study, we aimed to characterise adult childhood cancer survivors (ACCS), assess their health issues, gauge health-related quality of life (HRQOL) and evaluate visit satisfaction. DESIGN: Prospective cohort study using data from clinical visits and questionnaires. SETTING: Interdisciplinary follow-up programme for ACCS based on the long-term follow-up (LTFU) guidelines of the Children's Oncology Group and overseen by internists in two Swiss hospitals. PARTICIPANTS: ACCS attending our LTFU clinics between April 2017 and January 2022 were eligible. INTERVENTIONS: We documented medical history, current health status and assessed HRQOL using Short Form-36 V.2, comparing it with Swiss general population (SGP) norms (T mean=50, SD=10; age stratified). 3 months post visit, a feedback questionnaire was distributed. MAIN RESULTS: Among 102 ACCS (mean age: 32 years (range: 18-62 years), 68% women), 43 had no prior follow-up (36 ACCS>28 years, 7 ACCS≤28 years). A notable 94% had health issues, affecting an average of 6.1 (SD=3.3) organ systems. HRQOL was lower in ACCS>28 years than the SGP>28 years (physical: 44.8 (SD=11.65) vs 49.3 (SD=10.29), p=0.016; mental: 44.4 (SD=13.78) vs 50.53 (SD=9.92), p=0.004). Older ACCS (>28 years) reported inferior physical (44.8 vs 50.1 (SD=9.30), p=0.017) and mental HRQOL (44.4 vs 50.3 (SD=7.20), p=0.009) than younger ACCS. The majority of respondents reported high levels of satisfaction with the consultation, exceeding 90%. CONCLUSION: ACCS attending LTFU clinics face diverse health issues impacting multiple organ systems and exhibit lower HRQOL compared with the SGP. Thus, internist-led LTFU clinics are crucial for optimising follow-up care.


Assuntos
Sobreviventes de Câncer , Neoplasias , Qualidade de Vida , Humanos , Feminino , Masculino , Sobreviventes de Câncer/psicologia , Estudos Prospectivos , Adulto , Suíça , Pessoa de Meia-Idade , Adolescente , Adulto Jovem , Neoplasias/psicologia , Neoplasias/terapia , Inquéritos e Questionários , Satisfação do Paciente , Seguimentos , Nível de Saúde
17.
Resusc Plus ; 19: 100688, 2024 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-38974930

RESUMO

Background: Fewer than one in ten out-of-hospital cardiac arrest (OHCA) patients survive to hospital discharge in the UK. For prehospital teams to improve outcomes in patients who remain in refractory OHCA despite advanced life support (ALS); novel strategies that increase the likelihood of return of spontaneous circulation, whilst preserving cerebral circulation, should be investigated. Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) has been shown to improve coronary and cerebral perfusion during cardiopulmonary resuscitation. Early, prehospital initiation of REBOA may improve outcomes in patients who do not respond to standard ALS. However, there are significant clinical, technical, and logistical challenges with rapidly delivering prehospital REBOA in OHCA; and the feasibility of delivering this intervention in the UK urban-rural setting has not been evaluated. Methods: The Emergency Resuscitative Endovascular Balloon Occlusion of the Aorta in Out-of-Hospital Cardiac Arrest (ERICA-ARREST) study is a prospective, single-arm, interventional feasibility study. The trial will enrol 20 adult patients with non-traumatic OHCA. The primary objective is to assess the feasibility of performing Zone I (supra-coeliac) aortic occlusion in patients who remain in OHCA despite standard ALS in the UK prehospital setting. The trial's secondary objectives are to describe the hemodynamic and physiological responses to aortic occlusion; to report key time intervals; and to document adverse events when performing REBOA in this context. Discussion: Using compressed geography, and targeted dispatch, alongside a well-established femoral arterial access programme, the ERICA-ARREST study will assess the feasibility of deploying REBOA in OHCA in a mixed UK urban and rural setting.Trial registration.ClinicalTrials.gov (NCT06071910), registration date October 10, 2023, https://classic.clinicaltrials.gov/ct2/show/NCT06071910.

18.
Cureus ; 16(6): e61764, 2024 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-38975453

RESUMO

When considering dental restorations, the use of fixed partial dentures is one of the most widely accepted treatment options. In the past, fabrication was done using traditional techniques and the conventional workflow was by far the popular method; however, nowadays digital workflows are being used as a means to produce the prosthesis. This systematic review aims to compare the workflows by considering their respective qualities, such as precision, efficiency, cost-effectiveness, and clinical performance. A complete search has been carried out to incorporate any relevant studies published between the years 2012 and 2023 in databases such as Scopus, Web of Science, PubMed, ScienceDirect, and Cochrane Library. Two independent reviewers screened articles for inclusion and assessed the studies' methodological quality rating via the NIH Tool. A total of 22 relevant articles were reviewed after a systematic search strategy. The main outcome of the review was digital workflows were found to reduce working time, eliminate the selection of trays, minimize material consumption, and enhance patient comfort and acceptance. The studies also showed that digital workflows resulted in greater patient satisfaction and higher success rates than conventional workflows. Workflows for digital dentistry demonstrated to be better than traditional ones due to the cost-effectiveness, accuracy, and time optimization for the fabrication of fixed prostheses.

19.
Front Psychol ; 15: 1395990, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38979066

RESUMO

Introduction: The increase in school violence following the COVID-19 pandemic underscores the need for schools to adopt a multilevel whole-school approach. This study examines a national program designed by the Chilean Ministry of Education, in collaboration with universities, as part of the Ministry's Educational Reactivation Plan, aimed at improving school climate management across Chile. Methods: The "Learning to Live Together Program" (LLT) was implemented across all 16 regions of Chile, focusing on establishing school climate networks, providing direct intensive university technical assistance, and enhancing professional development and training. The feasibility, acceptability, and appropriability of the LLT program were assessed through a survey distributed to 1,561 staff members from 783 schools. Participants responded to a comprehensive set of instruments measuring acceptability, appropriability, feasibility, attitudes toward implementation, fidelity, and initial perceived results. Results: The results indicate high initial adoption rates and significant improvements in the assessed dimensions. The enhancement of school climate practices and strengthening school collaboration networks were of considerable relevance. Discussion: These findings support the efficacy of the multilevel whole-school approach as a viable strategy for Latin American countries, providing critical data for educational and governmental decision-making. Furthermore, this study provides evidence that these outcomes may be applicable to the implementation of similar policies in different contexts and countries.

20.
BMJ Open ; 14(7): e088992, 2024 Jul 09.
Artigo em Inglês | MEDLINE | ID: mdl-38986556

RESUMO

INTRODUCTION: Adolescents living with HIV (ALHIV) are an extremely vulnerable population, with the burden of mental health problems carefully documented together with the constraints for receiving timely and adequate management of the problems, especially in rural settings. Problem Management Plus (PM+) is a scalable psychological intervention for individuals impaired by distress in communities exposed to adversity. Initially developed for adult populations, few studies have assessed its potential to address adolescent distress. This study aims to co-adapt PM+ with an adherence component (PM+Adherence) for ALHIV and to evaluate its acceptability and feasibility in rural Kwa-Zulu Natal Province, South Africa. METHODS AND ANALYSIS: We will use a mixed-methods approach over three phases. The first phase will include a realist synthesis and collection of formative data from up to 60 ALHIV, caregivers and healthcare providers to inform the adaptation of WHO PM+, including the components of an adherence module. During the second phase, we will undertake the cultural adaptation of the PM+Adherence intervention. The third phase will involve a hybrid type 3 implementation strategy among ALHIV aged 16-19 years (n=50) to implement and evaluate the feasibility of the culturally co-adapted PM+Adherence. The feasibility indicators to be evaluated include reach, adoption, attrition, implementation and acceptability of the adapted intervention, which will be assessed qualitatively and quantitatively. In addition, we will assess preliminary effectiveness using an intention-to-treat approach on HIV-related indicators and mental health outcomes at baseline, end intervention, 2-month follow-up during the 6-month implementation. DISCUSSION: We expect that the PM+Adherence will be acceptable and can feasibly be delivered by lay counsellors in resource-limited rural KwaZulu-Natal. ETHICS AND DISSEMINATION: Ethical clearance has been obtained from the University of KwaZulu-Natal Biomedical Research Ethics Committee, (BREC/00005743/2023). Dissemination plans include presentations at scientific conferences, peer-reviewed publications and community level.


Assuntos
Estudos de Viabilidade , Infecções por HIV , Humanos , Adolescente , África do Sul , Infecções por HIV/psicologia , Adulto Jovem , Masculino , Feminino , População Rural , Intervenção Psicossocial/métodos
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