Research Ethics Committee Research Articles

Body transformations: An opportunity to work on the ethical perspective through photovoice and bodymapping

BackgroundBody transformations are alterations of the body due to symbolic, aesthetic, religious or cultural reasons. The increase in frequency, especially among young people, raises ethical questions. Future nurses must understand the ethical implications of social phenomena. AimThe aim was to find out how nursing students perceive bodily transformations from the perspective of Foulcauldian self-care and to determine the ethical value and health consequences of these transformations. Research designA qualitative study based on the socio-critical paradigm and based on the theory's principles of the Technologies of the self (Foucault). Photovoice and bodymapping were used for the reflection process. The participants were 267 first-year nursing students from two Spanish universities. A content analysis was conducted. Ethical considerationsThe Research Ethics Committee of both universities approved this study. FindingsThe body transformations most photographed by the students were piercing, tattoos and surgical interventions. Two main categories emerged: 1. Body modifications as constructions of the self with two subcategories, the pursuit of bodily aesthetics and the pursuit of spiritual aesthetics. 2. Health consequences.The need to build an identity of their own, as well as to be integrated into their environment by helping to improve not only their external appearance but also their inner side were the main inputs. The major ethical dilemmas are evident when body modifications are influenced by social and cultural values. The debate and reflection of the students through photovoice and its symbolic representation in bodymapping highlighted its health consequences. For the students, nursing should accompany them throughout the entire process, highlighting the importance of ethical values. ConclusionThe ethical value attributed to the different body modifications has been shown, revealing how they have a common origin, the improvement of their corporal and spiritual aesthetics. Nursing has a role as an active carer of the health of these people and must act in accordance with the ethical principles of this profession.

POSIÇÕES NÃO-SUPINAS E AUTONOMIA MATERNA NA ASSISTÊNCIA AO PARTO POR EQUIPE DE FISIOTERAPIA EM SAÚDE DA MULHER

Introduction: Childbirth in supine positions centralizes interventions instead of maternal autonomy, physiology and biomechanics of birth which are facilitated by non-supine positions. Objective: To quantitatively describe the prevalence of maternal positioning choice and non-supine positions in childbirth through assistance conducted by a Women's health physiotherapy team. Methods: Quantitative and descriptive cross-sectional study through retrospective secondary data available on the Assistance Database of the Women's health physiotherapy service of a public maternity hospital in Salvador from 2015 to 2019. initiated after approval by the Research Ethics Committee and waiver of the informed consent form. Results: Out of the total patients assisted by a multidisciplinary team with Women’s Health physiotherapists during childbirth from 2015 to 2019, 35.1% delivered in the supine position and 61% in non-supine positions. 65.4% chose the position they give birth in and 34.3% didn’t. Conclusion: Delivery assistance by a multidisciplinary team with a physical therapist promotes deliveries in non-supine positions and maternal autonomy during childbirth.

The effect of viral anxiety experienced by nurses working in pediatric service on psychological factors during Covid-19 period

During the Covid-19 period, nurses, as healthcare professionals, have been under a great workload, and their anxiety levels have also increased their psychological effects. Therefore, this study was conducted to examine the effect of viral anxiety experienced by nurses working in the pediatric ward during the Covid-19 period on psychological factors. This is a descriptive study. Permission was obtained from Hakkari University Scientific Research and Publication Ethics Committee for research permission. Sociodemographic data were collected online from 1200 nurses working in the pediatric service who voluntarily participated in the study between October 13, 2023 and December 25, 2023 using the sociodemographic data collection form and the stress and anxiety scale for health workers due to virus epidemic-9 items (SAVE-9), Patient health questionnaire-9 (PHQ-9), Obsession with Covid-19 Scale (OCS), Reassurance-seeking behavior scale against coronavirus (CRBS). In order to compare SAVE, PHQ, OCS and CRBS scale scores according to sociodemographic information and vaccination status variables, independent groups t test one-way variance analysis Levene's F test was applied and data were analyzed using a statistical package program. It is understood that 59.9% of the participants are male and 40.1% are female. The proportion of married participants was 95.4%. The results of the scores obtained from the SAVE and PHQ scales show that the stress and anxiety related to the virus epidemic are above the middle level, the result of the OCS scale score shows that the dysfunctional thoughts associated with the coronavirus, and the scores obtained from the CRBS Total scale show that the assurance-seeking behavior is exhibited according to the results. The effect of viral anxiety on the psychological factor according to sociodemographic characteristics (gender, age, marital status, socioeconomic status, educational status, working area in pediatric service, vaccination status) showed significant and different results according to scale scores. It was concluded that the viral anxiety experienced by the nurses working in the pediatric service during the Covid-19 period showed different characteristics in terms of psychological factors and sociodemographic characteristics, and the nurses were not very effective due to the decrease in the effect of Covid-19.

Malaria in the Republic of Ireland; A retrospective review of the clinical epidemiology of malaria between 2016 and 2020

ObjectivesMalaria is a parasitic infection that continues to present significant morbidity and mortality figures throughout the world. In the Republic of Ireland (Ireland), malaria is an imported infection linked most frequently to travel routes from West Africa. There is a paucity of data on the clinical epidemiology and hospital service utilization of malaria in non-endemic setting to inform physician practice. This study aims to fill that gap, providing a clinical context to the national picture of both adult and pediatric cases. MethodsA retrospective review of data from all public Irish hospitals was performed from 2016 to 2020, inclusive. Ethical approval was granted following review by the Social Research Ethics Committee (SREC) of University College Cork. Results and ConclusionsDuring the study period, there were 337 cases of malaria presenting to Irish hospitals, 15.1% (51/337) in the pediatric age category. Presentations occurred nationwide with a predictable seasonality. The majority (77.45%; 261/337) were Plasmodium falciparum and 6% (20/337) required critical care admission. Interestingly, females had a higher likelihood of admission to critical care (odds ratio 2.75, 95% confidence interval 1.1-6.86). The COVID-19 pandemic saw a 78% reduction in malaria presentations in 2020. A total of 1,166 bed days were utilized by cases of malaria.

A prospective cohort study on the role of surgical mentorship on medical students’ surgical experience and attitudes towards surgery

BackgroundExposure to surgery during medical school is limited. We ran a mentorship scheme pairing students at a medical school with local surgeons to improve undergraduate insight. We evaluated the effectiveness of mentorship in increasing surgical exposure and drivers for students seeking surgical mentorship.Methods35 surgeons across 7 specialties were recruited and matched with 37 students in years 2–4 for 7 months. Quantitative and qualitative evaluation was done with pre-, mid- and post-scheme questionnaires. Students rated confidence across pursuing a career in surgery, surgical exposure, career insight, understanding the application process, contacts, portfolio development, research knowledge and pursuing extra-curricular activities related to surgery using a 5-point Likert scale. Paired t-tests were performed to measure students’ confidence before and after the scheme.ResultsOf students that completed all 3 questionnaires (n = 21), conducting research/audit was most frequently selected as a main goal (81.0%), followed by theatre experience (66.7%) and career progression support (28.6%). The number of students that had assisted in theatre increased by 50.0%. Confidence ratings across all domains increased with 7/8 (87.5%) exhibiting a statistically significant improvement (p < 0.05). The greatest improvement was seen in having adequate contacts in surgery from 2.05 to 3.33 (p = 0.00). 95.2% would recommend the scheme.ConclusionsStudents gained significantly more surgical experience and were better equipped with the knowledge required to pursue a surgical career. Mentorship schemes are invaluable in supplementing the undergraduate curriculum and empowering students.Trial registrationEthical clearance granted by King’s College London Research Ethics Committee, Reference Number MRSU-22/23-34530. .

Correlation of the treatment sensitivity of patient-derived organoids with treatment outcomes in patients with head and neck cancer (SOTO): protocol for a prospective observational study

IntroductionOrganoids have been successfully used in several areas of cancer research and large living biobanks of patient-derived organoids (PDOs) have been developed from various malignancies. The characteristics of the original...

Abrasive challenge effects on enamel and dentin from irradiated human teeth: an in vitro study.

This study aimed to evaluate the effects of radiotherapy (RT) and chemoradiotherapy (CRT) on the wear and surface roughness of in vitro irradiated human enamel and dentin subjected to abrasive challenge. Enamel and dentin specimens (n = 42) were prepared from teeth donated by healthy patients and those with head and neck cancer who had received radiotherapy (RT) or chemoradiotherapy (CRT). The specimens were categorized into three groups: control, RT, and CRT (n = 14 per group for both enamel and dentin). These samples were subjected to an in vitro abrasive experiment using a brushing machine, followed by wear and surface roughness assessments with a confocal laser scanning microscope conducted before and after the abrasive challenge, considering both exposed and non-exposed areas. Statistical analysis used Shapiro-Wilk tests for normality, Wilcoxon tests for comparing two means, and Kruskal-Wallis tests. A significance level of 5% was adopted. In enamel specimens, wear profile values ​​of CRT and RT groups were not different from the control (p > 0.05). The RT group presents lower step values than the CRT and control groups (p < 0.001). No significant difference in final surface roughness was observed in all groups (p > 0.05). In dentin specimens, no significant difference in wear profile and step was observed in all groups (p > 0.05). However, CRT and RT groups present higher values in final surface roughness (p < 0.001). The exposure to ionizing radiation (associated or not to chemotherapy) influenced the surface roughness of dentin and the wear (step) of enamel after the in vitro abrasive challenge.Trial registration: Ethical procedures were approved by the FORP/USP Research Ethics Committee (CAAE: 61308416.4.0000.5419), and Hospital do Câncer de Barretos/Fundação Pio XII (CAAE: 61308416.4.3001.5437).

Percepção do transtorno disfórico pré-menstrual entre universitários de medicina de Curitiba/PR

Introduction: Premenstrual Dysphoric Disorder (PMDD) is a severe form of Premenstrual Syndrome (PMS) characterized by psychological or behavioral symptoms that significantly impact a woman’s quality of life. Due to its recent recognition as a mental health disorder, many healthcare professionals remain unfamiliar with PMDD, complicating its diagnosis and management. Objective: To evaluate the perception of medical students in Curitiba, Paraná, regarding premenstrualdysphoric disorder. Methods: This descriptive cross-sectional study was approved by the Research Ethics Committee (CAAE: 47635921.4.0000.0093). Data were collected between August 2021 and April 2022 through an online questionnaire administered to 593 medical students from institutions in Curitiba, Paraná. The questionnaire assessed knowledge about PMDD, its teaching during medical training, differentiation from PMS, and the medical approach towards affected women. Results: Of the participants, 83.6% were women and 16.4% were men. A total of 51.9% had studied Gynecology and Obstetrics and/or Psychiatry. Regarding PMDD, 40.8% had never heard of it, and only 28.8% had acquired knowledge about it during their university education. Among those who had studied Gynecology and/or Psychiatry, 86.7% did not feel qualified to diagnose the disorder and were unaware of the differences between PMDD and PMS (52.4%), with a higher frequency of men (68.4%) compared to women (51%, p=0.017). While 55.2% of students correctly defined PMDD, the majority (53.2%) were unclear about its signs and symptoms. Among female students, 82.9% felt that the medical approach was superficial during consultations, while only 10.1% reported a thorough investigation of symptoms.Conclusions: PMDD is a condition that is poorly understood and inadequately addressed in the training of general practitioners. Increasing awareness and education on this subject in universities would better equip professionals to recognize and manage this disorder, ultimately improving women’s quality of life.

Linfoma não Hodgkin da Zona Marginal Extranodal Tipo MALT com Acometimento da Coluna Torácica: revisão Sistemática da Literatura e Relato de Caso em um Hospital Universitário no Brasil

Background: Primary bone lymphomas are rare, accounting for less than 1% of non-Hodgkin's lymphomas (NHL). Extranodal marginal zone non-Hodgkin lymphoma of mucosa-associated lymphoid tissue (MALT) arising in the vertebral spine is extremely rare, with only seven cases reported. Methodology: A systematic literature review was conducted on cases from 2012 to 2022 of extranodal marginal zone MALT lymphoma involving the vertebral spine and associated with spinal cord compression. Additionally, a case report from a university hospital in Rio de Janeiro is described. The study was approved by the Research Ethics Committee (approval number: 5.818.416). Searches were performed in SciELO, PubMed, and LILACS databases, using the Health Sciences Descriptors: ("Vertebral Body" OR Spine) AND ("Lymphoma B-Cell Marginal Zone" OR "MALT Lymphoma" OR "Lymphoma of Mucosa Associated Lymphoid Tissue" OR "Mucosa Associated Lymphoid Tissue Lymphoma"). Articles with full texts available in English or Portuguese were selected. Case Description: A 56-year-old female presented with right-sided back pain, progressing to right flank irradiation, lower limb weakness (LLLL), and constitutional symptoms. MRI revealed a solid extradural mass occupying two-thirds of the vertebral canal's diameter, displacing and compressing the dorsal cord to the left. A bone marrow biopsy confirmed infiltration. Laminectomy was performed, and histopathology identified stage IVB extranodal marginal zone MALT lymphoma. Adjuvant chemotherapy led to complete remission. Results and Discussion: The literature review uncovered two relevant case reports. The thoracic spine was the most commonly affected region, and LLLL weakness was the most frequent symptom, with normal laboratory results. Treatment typically involved surgical tumor removal combined with radiotherapy or chemotherapy. Recurrence occurred in both cases, but follow-up showed no evidence of disease. The clinical presentation and exam findings of the current patient were similar to those in the literature, though with bone marrow infiltration. Treatment was consistent with cases in the review, with no recurrence to date. Conclusion: This case represents an uncommon manifestation of primary extranodal marginal zone MALT lymphoma with spinal cord compression, distinguished by bone marrow infiltration—a feature not previously reported in the two cases found in the literature. The case may be considered within the same group of cases reviewed.

Infrastructuring Readability: Framing and Overflowing in Writing Assistant Software for Biomedical Research Informed Consent Forms

This article analyzes the development process of a software solution designed to assist researchers in writing biomedical research–informed consent forms. Funded by a Swiss ethics committee, the purpose of the software is to enhance the readability of such documents to improve biomedical research participants’ understanding of the information disclosed therein and to reduce the editing work of research ethics committees. Drawing on an embedded ethnographic research, we show how concerns that emerge in ethics reviews shape ethics committee IT infrastructure and how, in turn, this infrastructure contributes to redefining research ethics. We demonstrate that while the software reinforces the biomedical framing of research ethics, it also generates unexpected overflows. By forming new collectives, this infrastructuring process furthers expertise on informed consent forms while giving rise to new areas of inquiry and redefining the issue of readability in biomedical research. Thus, we provide insights into the complex entanglements between research ethic, computer programs, and writing practices. We conclude by reflecting on the role played by our research team during the software's development and outline proposals on how ethnographic methods can contribute to make research ethics review accountable.

Effects of Combined Visual-Motor Response Training on Cognitive Function and Brain Plasticity Mechanisms in Various Populations: Protocol for a Single-Center, Open-Label, Controlled Clinical Trial.

Cognitive impairment is one of the major diseases facing the aging population. The progressive decline of cognitive function can lead to declining health or even the loss of life, work, and social ability. Exercise and behavioral stimulation can increase neurotransmitters in the brain and improve overall health and cognitive function. Reactivity training can mobilize neuromuscular function and induce changes in brain plasticity, which may effectively improve cognitive dysfunction and delay the occurrence and development of Alzheimer disease; however, the evidence supporting its effectiveness is still limited. This study aims to explore the effectiveness and reliability of visual-motor reaction training in improving cognitive function, thereby promoting the application of novel nonpharmacological therapies. This study is a single-center, open-label, controlled clinical trial. A total of 78 participants will be recruited for the study, including an equal number of athletes, ordinary healthy college students, and ordinary older adults in the community. Participants will receive 2 weeks of visual-motor response training. The primary outcome of this study is to assess differences in functional magnetic resonance imaging (fMRI) at 2 weeks. The secondary outcomes were the following: acousto-optic response time, Hamilton Depression Rating Scale (HAM-D), Hamilton Anxiety Rating Scale (HAM-A), Mini Mental State Examination (MMSE), Activity of Daily Living (ADL) Scale, Subjective Cognitive Decline Questionnaire-9 (SCD-Q9), a 10-word memory test, and safety. The study was approved by the Shanghai Clinical Research Ethics Committee on January 2, 2024 (SECCR/2023-162-01). As of September 11, 2024, we have completed the recruitment of all 3 groups of volunteers. We expect to complete data collection and analysis by February 2025. The purpose of this study is to compare improvements in brain perceptual motor functions and cognitive levels across different populations through response ability training and to explore the efficacy and safety of exercise-based nonpharmacological therapies in improving cognitive function. Other potential benefits include understanding the functional differences and perceptual characteristics of the brain's perceptual-motor system between athletes and the general population and exploring the adaptability of the brain in acquiring skills during competitive sports training. This could provide an evidence base for early sports talent development and broader youth development. Chinese Clinical Trial Registry ChiCTR2400079602; https://tinyurl.com/23fbbndw. DERR1-10.2196/56424.

8812 Incidence And Clinical Experience Of Immune Checkpoint Inhibitors-Induced Endocrine Side Effects Among Filipino Cancer Patients: A Single-Center Retrospective Study

Abstract Disclosure: N.B. Luna: None. E. Mendoza: None. S.A. Kho: None. Incidence And Clinical Experience Of Immune Checkpoint Inhibitors-Induced Endocrine Side Effects Among Filipino Cancer Patients: A Single-Center, Retrospective Study Immune checkpoint inhibitors (ICIs) serve as immunomodulatory antibodies, which enhance the immune system and substantially improve the prognosis for patients with advanced malignancies [1]. Referral to endocrinology have been increasing because ICIs were associated with endocrine-related adverse effects including hypothyroidism, hyperthyroidism, diabetes, hypophysitis and adrenalitis. Hence, the study aimed to retrospectively determine the local prevalence and profile of Filipino patients who developed endocrinopathies during ICI therapy at the University of Santo Tomas Hospital (USTH), Manila, Philippines from 2013-2019. A single-center retrospective study of ICI-treated cancer patients with serial biochemical and/or radiologic monitoring of endocrine adverse effects was done upon approval by the Research Ethics Committee. A total of 27 subjects were included with a median age of 60 years and male predominance. Pembrolizumab consisted 93% of the ICIs given. The incidence of thyroid dysfunction was 36% (18% overt hypothyroidism, 9% subclinical hypothyroidism, and 9% subclinical hyperthyroidism). The median time at risk for development of overt hypothyroidism is 4 weeks with median TSH level of 9.05 uIU/mL from baseline level of 3.77 uIU/mL. All patients who had baseline hypothyroidism worsened with increase from baseline levothyroxine dose by 50 to 230% in order to achieve euthyroidism (p 0.037). Serial monitoring was done every 2 weeks until euthyroidism. ICIs were temporarily put on hold in 75%. Diabetes (p 0.05), renal carcinoma (p 0.001) and dose of 200mg (p 0.42) were associated to developing overt hypothyroidism. Checking of glycemic levels was not routine among non-diabetic patients. Fifteen percent of diabetic patients had worsening of control (median HbA1c 8.5% [8-9] and 23% were newly diagnosed pre-diabetes (median fasting glucose 114mg/dL [104-120]). With the available imaging results, there were no abnormal adrenal metabolic uptake on PET scan and no evidence of hypophysitis in pituitary MRI. In conclusion, overt hypothyroidism is a common occurrence during ICI therapy (18%). Worsening occurred among all patients with hypothyroidism at baseline. New-onset pre-diabetes and worsening of glycemic control were seen in 15 and 23%, respectively. Serial clinical and biochemical monitoring is important and referral to endocrinology should be made if deemed necessary. [1] L Agrawal, A Bacal, S Jain, V Singh, N Emanuele, Ma Emanuele &amp; F Meah (2020) Immune checkpoint inhibitors and endocrine side effects, a narrative review, Postgraduate Medicine, 132:2, 206-214, DOI: 10.1080/00325481. 2019. 1709344 Presentation: 6/1/2024

Active Ingredient Prescribing in Australia: exploring pharmacists' experiences

AbstractBackgroundThe Active Ingredient Prescribing (AIP) mandate was introduced Australia‐wide on 1 February 2021. The AIP legislation makes the pharmacist a stakeholder who can provide valuable information to customers and patients.AimTo explore the experiences of community pharmacists with AIP legislation with a focus on attitude, health literacy, and medication safety.MethodSemi‐structured, in‐depth interviews were conducted and guided by the Theoretical Domains Framework (TDF). Transcripts were analysed using a deductive approach to categorise data and inductive thematic analysis to identify concepts and themes. Ethical approval was granted by the Griffith University Human Research Ethics Committee (Reference no: 2021/878) and the study conforms to the Australian National Statement on Ethical Conduct in Human Research. Informed consent from all participants was obtained via a study information sheet distributed to all potential participants and completion of written consent forms prior to participation in the study. Participants received gift cards as compensation for their time.ResultsSix pharmacists participated, and thematic analysis of collected data revealed three main themes. These included education, integration, and trust. Insights on patients' acceptance of their prescriptions and the expanded patient‐facing opportunities were highlighted. Participants' opinions leaned towards enhancing the smooth integration into the AIP process of other stakeholders like prescribers and regulatory bodies. Establishing multilevel communication between stakeholders and customers was pivotal to improving health literacy and medication safety. Pharmacists' views on process integration provided unique insight into the practical challenges with the AIP mandate. In addition, ‘trust’ in the prescriber enhanced patient acceptance of generic medicines.ConclusionThe study provided baseline evidence to show that the AIP mandate enhances health literacy and empowers patients to know the active ingredients in their medicines, which in turn supports medication safety. Examining the implementation of the AIP legislation facilitated a nuanced understanding of the effect that these AIP changes have on patients.

Marginal bone loss and soft tissue health around two-implant mandibular overdenture retained with milled versus selective laser melted cobalt chromium bar: a randomized clinical trial

BackgroundTo assess marginal bone loss and soft tissue health around two-implant mandibular overdenture retained with milled versus selective laser-melted cobalt chromium (Co-Cr) bars.MethodThis research was set to be a parallel, triple-blinded, randomised controlled trial. Twenty completely edentulous patients received new conventional complete dentures according to conventional techniques. Two implants were placed at mandibular canine areas bilaterally, and patients were randomly allocated into two equal groups: the milled Co-Cr bar group and the selective laser melted (SLM) Co-Cr bar group. Marginal bone loss (MBL), modified plaque index (mPI), modified gingival index (mGI), and probing depth (PD) were evaluated at 0-month (baseline), 6-month, and 12-month follow-up visits. Repeated measures ANOVA test and Bonferroni’s post-hoc test were used for parametric data as PD, while for non-parametric data as MBL, mGI, and mPI, Mann-Whitney U test and Friedman’s test were used. A P-value ≤ 0.05 was set as the statistical level of significance. The study protocol was approved by the Faculty Research Ethics Committee at Minia University (636 4/10/2022). Registration for the clinical trial was made retrospectively on clinicaltrials.gov with ID NCT06401200 at 04/30/2024.ResultsThe follow-up period (one year) was completed without a dropout. Regarding MBL, no statistically significant difference was found between the two groups throughout the study. However, the milled group showed significantly increased MBL from 0- to 6-month follow up period. In both groups, mPI increased significantly from 0- to 6-months post-loading. On the other hand, no statistically significant difference between the two groups was found regarding mPI and mGI throughout the study follow-up periods. The PD was significantly lower in the milled compared to the SLM group at the 6- and 12-month follow up period.ConclusionTwo-implant mandibular overdenture retained with milled or SLM Co-Cr bar can provide an acceptable treatment option for completely edentulous patients regarding marginal bone loss and soft tissue outcomes.

Calcium carbonate supplementation for the prevention of preeclampsia in high-risk pregnant women: a randomized clinical trial protocol

BackgroundPreeclampsia (PE) is a significant cause of maternal mortality worldwide, affecting 2% to 8% of pregnancies. The World Health Organization recommends the use of low-dose acetylsalicylic acid (100 mg of aspirin) and 1.5 to 2 g of calcium carbonate during pregnancy to prevent PE. However, robust evidence supporting the efficacy of calcium supplementation is still needed. This study aims to assess the efficacy of calcium carbonate in preventing preeclampsia in high-risk pregnant women.MethodsA triple-blind, randomized clinical trial will be conducted at an outpatient clinic in Brazil between May 2024 and March 2026. Pregnant women at high risk of developing preeclampsia and with low dietary calcium intake will be randomly assigned to one of three groups: one group will receive calcium carbonate capsules (commercially available in Brazil) along with 100 mg of aspirin; the second group will receive calcium carbonate derived from Crassostrea sp. along with 100 mg of aspirin; and the control group will receive a placebo alongside 100 mg of aspirin. The primary outcome is the diagnosis of preeclampsia during pregnancy, while secondary outcomes evaluate maternal and fetal health indicators.DiscussionThis trial seeks to generate evidence on the efficacy of calcium carbonate in preeclampsia prevention, with a focus on comparing industrial calcium carbonate with calcium carbonate sourced from Crassostrea sp., a more sustainable alternative.Trial registrationThe study was approved by the Research Ethics Committee of the Federal University of Sergipe and registered in the Brazilian Registry of Clinical Trials (ReBEC), under the ID RBR-7hqhj3y. Registered on November 16, 2023.

Safety and efficacy of high thoracic epidural analgesia for chest wall surgery in young adolescents: A retrospective cohort analysis and a new standardised definition for success rate.

Chest wall surgery for the correction of pectus excavatum or pectus carinatum has gained increased interest in recent years. Adequate pain treatment, respiratory physiotherapy and early ambulation are key to improving the outcomes. Although thoracic epidural analgesia is highly effective, its safety is controversial, leading to extensive scrutiny and questioning of its role. We hypothesise that thoracic epidural analgesia is effective and well tolerated to use in adolescents, with a high success rate and low pain scores. Observational retrospective cohort study. All adolescent cases in a high-volume academic tertiary chest wall surgery centre between March 1993 and December 2017 were included. A total of 1117 patients aged from 12 to 19 years of age and receiving either Ravvitch, Nuss or Abramson chest wall reconstruction for pectus excavatum were identified in our institutional chest wall surgery database. After applying selection and exclusion criteria, 532 patients were included in the current analysis. The primary endpoint of this study was the safety of epidural analgesia, assessed by the incidence of acute adverse events. Secondary endpoints were block success rates using a specific novel definition, and analgesic efficacy using recorded postoperative pain scores. More than 60% of patients experienced one or more adverse events. However, all events were minor and without consequences. No serious or long-term adverse events were detected. The success rate of thoracic epidural placement was 81%. Low postoperative pain scores were observed. Thoracic epidural analgesia is an extremely effective pain control technique, with a surprisingly high number of minor adverse events but safe with regard to serious adverse events. The local research ethics committee approved and registered this study on 16 May 2022 (registration number: S66594).

B-318 Serum PSA in Extracellular Vesicles: Immunoreactivity to Commercial Kits and Elimination Kinetics

Abstract Background Prostate Specific Antigen (PSA) also circulates in blood bound to extracellular vesicles (EVs), and observed higher ratio of PSA in EVs respect total serum PSA when serum concentrations are &amp;lt;4 μg/L, and can represent up to 59% of total circulating PSA. Moreover, this molecular form of PSA (ev-PSA) is recognized and can be quantified with commercial methodologies designed for serum quantification. We aimed to characterize ev-PSA studying its immunoreactivity to different commercial assays and analyzing its presence in international standards used for assays standardization. Serum half-life and elimination kinetics of ev-PSA were also studied. Methods Serum EVs from 32 prostate cancer (PCa) patients were isolated by ultracentrifugation (100,000xg, 90 minutes). PSA was assessed in serum (srm-), serum supernatant free of EVs (sn-) and EVs (ev-) with total PSA (T-PSA) commercial immunoassays (Elecsys® from Roche Diagnostics and Immulite® 2000 from Siemens Healthineers), and Immulite/Elecsys ratio was calculated in all samples. The analysis of the differences between methods was performed with Bland-Altman test, representing the percentage of the difference respect the mean. WHO 96/670 PSA Standard was ultracentrifuged and analyzed by Nanoparticle Tracking Analysis (NTA) in a NanoSight LM20.For half-life estimation, serum samples from 10 localized PCa patients were collected basal and 2 days after radical prostatectomy, and EVs were isolated by Size Exclusion Chromatography using Exo-spinTM kit (Cell Guidance System). The Research Ethic Committee approved the study. Results Significant differences were observed between Elecsys and Immulite immunoassays in ev-T-PSA (p&amp;lt;0.001) concentrations. ev-T-PSA was quantified in all samples with Elecsys (median: 0.134 μg/L; Q1-Q3: 0.033-0.391 μg/L), but only in 22 patients (68.75%) with Immulite (median: 0.206 μg/L; Q1-Q3: 0.074-0.340 μg/L). In those 22 quantifiable patients, the median Immulite/Elecsys ratio was similar (p=0.057) between sn-T-PSA and srm-T-PSA (0.96 and 0.92, respectively), but much lower for ev-T-PSA (0.77; p&amp;lt;0.001). Bland-Altman graphical analysis showed that Elecsys overestimates the concentrations of T-PSA in all samples compared to Immulite, being this overestimation more marked in the case of PSA contained in EVs, and amplified at lower PSA concentrations. Besides, NTA analysis of WHO 96/670 PSA Standard showed that it does not contain EVs, and therefore, ev-PSA. The percentage of remnant PSA calculated in samples obtained post-surgery respect to baseline concentration in prostatectomized patients, was significantly higher for ev-T-PSA compared to soluble srm-T-PSA (p=0.014) and srm-F-PSA (p=0.002). The elimination half-life of ev-T-PSA was 3.99 days, much higher than those estimated for serum T-PSA and F-PSA, that were 1.76 days and 0.64 days, respectively. Conclusions The quantification of ev-PSA is affected by the different immunoreactivity of the diverse commercial assays. Thus, Elecsys T-PSA immunoassay shows higher immunoreactivity compared to Immulite technique, being this different reactivity more marked at lower PSA concentrations. ev-PSA is not considered in the International WHO 96/670 PSA Standard used for methods standardization. PSA bound to EVs remains longer in circulation than soluble serum PSA.

A-041 Metoclopramide Stimulation Test can Rule Out Prolactinoma in Patients with Moderate Hyperprolactinemia

Abstract Background Prolactinoma is the main cause of hyperprolactinemia once physiological and pharmacological causes are excluded. Prolactin (PRL) and thyrotropin (TSH) response to dopaminergic antagonists has been previously used in prolactinoma diagnosis. Current guidelines only recommend baseline PRL concentration in diagnosis, considering values exceeding 250 ng/mL highly suggestive of prolactinoma. However, subtler hyperprolactinemia is much more frequent, and magnetic resonance imaging (MRI) studies are necessary to detect potential prolactinomas. Our aim was to examine the utility of a metoclopramide (MCP) stimulation test as a screening tool to evaluate the need for pituitary MRI studies in patients with moderate hyperprolactinemia. Methods We retrospectively selected 67 moderate hyperprolactinemia patients (&amp;lt;250 ng/mL), with a MCP test and a pituitary MRI within the same assistance. We excluded patients with pharmacological treatments affecting dopaminergic axis. According MRI results we classified them in patients with microadenoma (&amp;lt;10 mm; n=23), with macroadenoma (≥10 mm; n=5) or without adenoma (n=39). Maximum relative increases over baseline concentrations were calculated for PRL (ΔPRLMax) and TSH (ΔTSHMax). The Research Ethic Committee approved the study. Results ΔPRLMax exceeds baseline PRL capability to identify patients with an adenoma (AUC=0.8718 vs 0.7756). ΔPRLMax below 220% identifies 100% of these patients with 71% of specificity (Table 1). Screening with MCP test would have avoided 42% of MRI, resulting in 34% costs saving. Analysis of TSH response only slightly increased the specificity when considered as a secondary criterion. Test length can be reduced from 60 to 30 minutes without losing screening capability. Conclusions A shortened MCP test is a useful and cost-effective screening tool to avoid unnecessary MRI. Its simplicity allows its performance in almost any clinical facility, allowing to easily rule out prolactinoma in an important percentage of patients, something of upmost importance specially in regions were MRI facilities are scarce.

B-199 Rapid Molecular Detection of Meningitis Agents in Diverse Brazilian Regions (2019-2023): A Multicenter Study

Abstract Background Meningitis, caused by viral and bacterial agents, is a significant public health issue globally, with a substantial economic impact. In Brazil, the incidence of meningitis varies by region, making the identification of the causative agent crucial for effective treatment. This study aims to evaluate the epidemiology of meningitis agents diagnosed using a rapid molecular detection panel in samples from various hospital units of a nationwide diagnostic and healthcare company. Methods Samples from several hospitals across different regions of Brazil were analyzed using the FilmArray® rapid molecular panel for meningitis and encephalitis, capable of identifying up to 14 agents, including bacteria, viruses, and fungi/yeasts. Gender, age group, regional distribution, and agent prevalence from January 2019 to April 2023, were retrieved from the database ensuring compliance with the Brazilian Data Privacy and Protection (LGPD) and local Research Ethics Committee guidelines. Results The study included 485 patients from 41 cities across 11 Brazilian states. The age range was 0 to 96 years, with an average age of 45 years, and a majority of female participants (59%). The highest number of test requests occurred in 2022 (17.5%), followed by 2021 (10%), with 2019, 2020, and 2023 accounting for less than 5% of requests each. The overall positivity rate was 10.5% (51/485), with 92.8% (13/14) of the possible agents identified. Viral agents were detected in 60.7% of positive cases, bacterial agents in 39.2%, and one mixed infection (human herpesvirus 6 and Escherichia coli K1) in a 2-year-old child. No fungal/yeast infections were detected. The most common agents were varicella-zoster virus (18.2%), Haemophilus influenzae (12.7%), herpes simplex viruses type 1 and 2 (12.7% each), and enterovirus (12.7%). Conclusions The study highlights the importance of rapid molecular diagnostic methods in Brazilian clinical-laboratory practice, offering fast, safe, and sensitive detection of meningitis-causing agents, which can contribute to improved patient outcomes.

Effectiveness of a supervised group-based walking program on physical, psychological and social outcomes among older adults: a randomised controlled trial protocol

IntroductionTo minimise adverse health events among older adults, physical activity (PA) is considered one of the most fundamental and effective forms of lifestyle. Therefore, an urgent effort to promote a...