Regulatory Science Perspective on the Analysis of Microplastics and Nanoplastics in Human Food.

Microplastics are increasingly reported, not only in the environment but also in a wide range of food commodities. While studies on microplastics in food abound, the current state of science is limited in its application to regulatory risk assessment by a continued lack of standardized definitions, reference materials, sample collection and preparation procedures, fit-for purpose analytical methods for real-world and environmentally relevant plastic mixtures, and appropriate quality controls. This is particularly the case for nanoplastics. These methodological challenges hinder robust, quantitative exposure assessments of microplastic and nanoplastic mixtures from food consumption. Furthermore, limited toxicological studies on whether microplastics and nanoplastics adversely impact human health are also impeded by methodology challenges. Food safety regulatory agencies must consider both the exposure and the risk of contaminants of emerging concern to ascertain potential harm. Foundational to this effort is access to and application of analytical methods with the capability to quantify and characterize micro- and nanoscale sized polymers in complex food matrices. However, the early stages of method development and application of early stage methods to study the distribution and potential health effects of microplastics and nanoplastics in food have largely been done without consideration of the stringent requirements of methods to inform regulatory activities. We provide regulatory science perspectives on the state of knowledge regarding the occurrence of microplastics and nanoplastics in food and present our general approach for developing, validating, and implementing analytical methods for regulatory purposes.

Rotavirus trends and distribution of genotypes before and during COVID-19 pandemic era: Bangladesh, 2017-2021.

Rotavirus gastroenteritis is accountable for an estimated 128 500 deaths among children younger than 5 years worldwide, and the majority occur in low-income countries. Although the clinical trials of rotavirus vaccines in Bangladesh revealed a significant reduction of severe rotavirus disease by around 50%, the vaccines are not yet included in the routine immunization program. The present study was designed to provide data on rotavirus diarrhea with clinical profiles and genotypes before (2017-2019) and during the COVID-19 pandemic period (2020-2021). Fecal samples were collected from 2% of the diarrheal patients at icddr,b Dhaka hospital of all ages between January 2017 and December 2021 and were tested for VP6 rotavirus antigen using ELISA. The clinical manifestations such as fever, duration of diarrhea and hospitalization, number of stools, and dehydration and so on were collected from the surveillance database (n = 3127). Of the positive samples, 10% were randomly selected for genotyping using Sanger sequencing method. A total of 12 705 fecal samples were screened for rotavirus A antigen by enzyme immunoassay. Overall, 3369 (27%) were rotavirus antigen-positive, of whom children <2 years had the highest prevalence (88.6%). The risk of rotavirus A infection was 4.2 times higher in winter than in summer. Overall, G3P[8] was the most prominent genotype (45.3%), followed by G1P[8] (32.1%), G9P[8] (6.8%), and G2P[4] (6.1%). The other unusual combinations, such as G1P[4], G1P[6], G2P[6], G3P[4], G3P[6], and G9P[6], were also present. Genetic analysis on Bangladeshi strains revealed that the selection pressure (dN/dS) was estimated as <1. The number of hospital visits showed a 37% drop during the COVID-19 pandemic relative to the years before the pandemic. Conversely, there was a notable increase in the rate of rotavirus positivity during the pandemic (34%, p < 0.00) compared to the period before COVID-19 (23%). Among the various clinical symptoms, only the occurrence of watery stool significantly increased during the pandemic. The G2P[4] strain showed a sudden rise (19%) in 2020, which then declined in 2021. In the same year, G1P[8] was more prevalent than G3P[8] (40% vs. 38%, respectively). The remaining genotypes were negligible and did not exhibit much fluctuation. This study reveals that the rotavirus burden remained high during the COVID-19 prepandemic and pandemic in Bangladesh. Considering the lack of antigenic variations between the circulating and vaccine-targeted strains, integrating the vaccine into the national immunization program could reduce the prevalence of the disease, the number of hospitalizations, and the severity of cases.

The Clinical Utility of a 7-Gene Biosignature on Radiation Therapy Decision Making in Patients with Ductal Carcinoma In Situ Following Breast-Conserving Surgery: An Updated Analysis of the DCISionRT® PREDICT Study.

BACKGROUND: Breast-conserving surgery (BCS) followed by adjuvant radiotherapy (RT) is a standard treatment for ductal carcinoma in situ (DCIS). A low-risk patient subset that does not benefit from RT has not yet been clearly identified. The DCISionRT test provides a clinically validated decision score (DS), which is prognostic of 10-year in-breast recurrence rates (invasive and non-invasive) and is also predictive of RT benefit. This analysis presents final outcomes from the PREDICT prospective registry trial aiming to determine how often the DCISionRT test changes radiation treatment recommendations. METHODS: Overall, 2496 patients were enrolled from February 2018 to January 2022 at 63 academic and community practice sites and received DCISionRT as part of their care plan. Treating physicians reported their treatment recommendations pre- and post-test as well as the patient's preference. The primary endpoint was to identify the percentage of patients where testing led to a change in RT recommendation. The impact of the test on RT treatment recommendation was physician specialty, treatment settings, individual clinical/pathological features and RTOG 9804 like criteria. Multivariate logisitc regression analysis was used to estimate the odds ratio (ORs) for factors associated with the post-test RT recommendations. RESULTS: RT recommendation changed 38% of women, resulting in a 20% decrease in the overall recommendation of RT (p < 0.001). Of those women initially recommended no RT (n = 583), 31% were recommended RT post-test. The recommendation for RT post-test increased with increasing DS, from 29% to 66% to 91% for DS <2, DS 2-4, and DS >4, respectively. On multivariable analysis, DS had the strongest influence on final RT recommendation (odds ratio 22.2, 95% confidence interval 16.3-30.7), which was eightfold greater than clinicopathologic features. Furthermore, there was an overall change in the recommendation to receive RT in 42% of those patients meeting RTOG 9804-like low-risk criteria. CONCLUSIONS: The test results provided information that changes treatment recommendations both for and against RT use in large population of women with DCIS treated in a variety of clinical settings. Overall, clinicians changed their recommendations to include or omit RT for 38% of women based on the test results. Based on published clinical validations and the results from current study, DCISionRT may aid in preventing the over- and undertreatment of clinicopathological 'low-risk' and 'high-risk' DCIS patients. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03448926 ( https://clinicaltrials.gov/study/NCT03448926 ).

Experiences of cardiac care nurses related to the management and delayed removal of trans-radial band of patients at a private tertiary care hospital, Islamabad.

Objectives: To explore the experiences of cardiac care nurses in managing transradial band of patients in a tertiary care setting. METHODS: The exploratory, descriptive, qualitative study was conducted at a private-sector tertiary care hospital in Islamabad, Pakistan, from March to September 2021, and comprised registered cardiac care nurses with >6 months of relevant experience. Data was collected through face-to-face interviews using a semi-structured interview guide. Data was analysed qualitatively using the Creswell and Creswell framework. RESULTS: Of the 10 nurses, 5(50%) were males and 5(50%) were females. In terms of age, 5(50%) were aged <25 years. Cardiac specialisation had been done by 2(20%) nurses, and none of the subjects had formal training related to transradial band. The main theme that emerged from the data was nurses' management of patients with transradial band, and the three categories were nurses' knowledge and practices about transradial band, reasons for delayed transradial band removal, and strategies to minimise complications. CONCLUSIONS: To minimise transradial band-related complications, in-service training of nurses and ensuring a safe nursepatient ratio are necessary.

Non-Pharmacological approach for the management of gastroesophageal reflux disease.

Treatment of Gastro-Esophageal Reflux Disease (GERD) is becoming a challenge. Proton pump inhibitors (PPIs) are commonly prescribed but have many risks, particularly in long-term use. In an earlier pilot study, we have reported benefits of short-term practice of a new life-style, two meals a day with only liquids in between, for management of GERD. Present case report demonstrates benefits of long-term practice of this dietary regimen. A 61 year old patient complaining of night refluxes was diagnosed to have severe GERD with ulcerations at gastroesophageal junction and was advised to take two meals a day with only water, fruit juice, tea, or milk in intervening period. His reflux symptoms improved within fortnight and he remained well for long-time. Endoscopy done after seven years revealed competent and clear gastroesophageal junction. It is concluded that suggested life-style, "Akram's life-style", for GERD is a useful alternate to risky medical and surgical interventions.

Risk-Adapted Intraoperative Radiation Therapy (IORT) for Breast Cancer: A Novel Analysis.

BACKGROUND: Randomized trials have shown that risk-adapted intraoperative radiation therapy (IORT) after breast-conserving surgery for low-risk breast cancer patients is a safe alternative to whole-breast radiation therapy (WBRT). The risk-adapted strategy allows additional WBRT for predefined high-risk pathologic characteristics discovered on final histopathology. The greater the percentage of patients receiving WBRT, the lower the recurrence rate. The risk-adapted strategy, although important and necessary, can make IORT appear better than it actually is. METHODS: Risk-adapted IORT was used to treat 1600 breast cancers. They were analyzed by the intention-to-treat method and per protocol to better understand the contribution of IORT with and without additional whole-breast treatment. Any ipsilateral breast tumor event was considered a local recurrence. RESULTS: During a median follow-up period of 63 months, local recurrence differed significantly between the patients who received local treatment and those who received whole-breast treatment. For 1393 patients the treatment was local treatment alone. These patients experienced 79 local recurrences and a 5-year local recurrence probability of 5.95 %. For 207 patients with high-risk final histopathology, additional whole-breast treatment was administered. They experienced two local recurrences and a 5-year local recurrence probability of 0.5 % (p = 0.0009). CONCLUSIONS: Whole-breast treatment works well at reducing local recurrence, and it is a totally acceptable and necessary addition to IORT as part of a risk-adapted program. However, the more whole-breast treatment that is given, the more it dilutes the original plan of simplifying local treatment and the less we understand exactly what IORT contributes to local control as a stand-alone treatment.

Non-surgical treatment of mild to moderate peri-implantitis with an oscillating chitosan brush or a titanium curette-12-month follow-up of a multicenter randomized clinical trial.

OBJECTIVES: To study clinical and radiographic outcomes after non-surgical treatment of peri-implantitis using either an oscillating chitosan brush (OCB) or titanium curette (TC) and to observe changes in clinical signs of inflammation after repeated treatment. METHODS: Thirty-nine patients with dental implants (n = 39) presented with radiographic bone level (RBL) of 2-4 mm, bleeding index (BI) ≥ 2, and probing pocket depth (PPD) ≥ 4 mm were randomly assigned to mechanical debridement with OCB (test) or TC (control). Treatment was performed at baseline and repeated at 3, 6, and 9 months in cases with > 1 implant site with BI ≥ 1 and PPD≥4 mm. Blinded examiners recorded PPD, BI, pus, and plaque. The radiographic bone level change between baseline and 12 months was calculated. A multistate model was used to calculate transitions of BI. RESULTS: Thirty-one patients completed the study. Both groups exhibited a significant reduction in PPD, BI, and pus at 12 months compared to baseline. Radiographic analysis showed stable mean RBL in both groups at 12 months. There was no statistically significant difference in any of the parameters between the groups. CONCLUSIONS: Within the limitations of this 12-month multicenter randomized clinical trial, non-surgical treatment of peri-implantitis with OCB or TC showed no statistically significant differences between the groups. Clinical improvements and, in some cases, disease resolution, was observed in both groups. However, persistent inflammation was a common finding which further puts emphasis on the need for further treatment.

Cognitive biases regarding utilization of emergency severity index among emergency nurses.

AIM: The study aimed to measure emergency nurses' prevalence of cognitive biases when utilizing Emergency Severity Index (ESI). Moreover, the study aimed to measure the differences between cognitive biases and demographic variables. BACKGROUND: Nurses use Emergency Severity Index (ESI) to prioritize the patients. Cognitive biases could compromise the clinical decisions of nurses in triage. Consequently, this hinders the delivery of safe and quality patient care. METHODS: A cross-sectional analytical approach invited 208 emergency nurses from four tertiary care hospitals. Institutional review board approval and permission from institutional heads were obtained. Informed consent was attained before data collection. Data was collected through a structured scenario-based questionnaire to measure cognitive biases at five levels of ESI. Descriptive and inferential statistics were obtained through v25.0 of SPSS. RESULTS: Among the 86.6% response rate, 56.2% of nurses were male. 62.90% had nursing diplomas. Cognitive biases were present at all ESI levels one to five, in order 51%, 45%, 90%, 89%, and 91% among nurses. Premature closure 22%, tolerance to risk 12%, satisfying bias 25%, framing effect 22%, and blind obedience 34% from level one to five consecutively. Demographic variables, including males, experience between 2 and 5 years, general nursing as qualification, and without emergency severity index certification, were identified to encounter more cognitive biases when making triage decisions. CONCLUSION: Numerous cognitive biases are considerably existing among emergency nurses when prioritizing patients. Cognitive de-biasing measures can improve triage decisions among nurses that could enhance quality care and patient safety.

Armatenols A-C, new antioxidant isoflavanols from Colutea armata.

Armatenols A-C (1-3), new isoflavan-4-ols, have been isolated from the CHCl3-soluble sub-fraction of Colutea armata Hemsl. & Lace, along with two known compounds namely 8-methoxyvestitol (4) and colutequinone (5), reported for the first time from this species. Their structures have been elucidated through spectroscopic techniques including MS, IR, UV, CD, 1 D and 2 D NMR. Compounds 1-2 invariably showed significant antioxidant activity using the methods of 1,1-diphenyl-2-picrylhydrazyl radical scavenging activity (DPPH), Fe3+ reducing antioxidant power (FRAP) assay and 2,2'-azinobis(3-ethylbenzothiazoline-6-sulfonate) radical scavenging activity (ABTS).

Metallic Nanoparticles: A Promising Arsenal against Antimicrobial Resistance-Unraveling Mechanisms and Enhancing Medication Efficacy.

The misuse of antibiotics and antimycotics accelerates the emergence of antimicrobial resistance, prompting the need for novel strategies to combat this global issue. Metallic nanoparticles have emerged as effective tools for combating various resistant microbes. Numerous studies have highlighted their potential in addressing antibiotic-resistant fungi and bacterial strains. Understanding the mechanisms of action of these nanoparticles, including iron-oxide, gold, zinc oxide, and silver is a central focus of research within the life science community. Various hypotheses have been proposed regarding how nanoparticles exert their effects. Some suggest direct targeting of microbial cell membranes, while others emphasize the release of ions from nanoparticles. The most compelling proposed antimicrobial mechanism of nanoparticles involves oxidative damage caused by nanoparticles-generated reactive oxygen species. This review aims to consolidate knowledge, discuss the properties and mechanisms of action of metallic nanoparticles, and underscore their potential as alternatives to enhance the efficacy of existing medications against infections caused by antimicrobial-resistant pathogens.

Patient perceptions and experiences of dental fear of different dental specialties: a mixed-method study.

OBJECTIVE: The primary objective of this study was to validate an Urdu translation of Kleinknecht's Dental Fear Survey (DFS) for use in Pakistan and to explore which items contribute the most to the variance in dental fear scores based on patient perceptions and lived experiences during dental care. METHODOLOGY: This mixed-method study was conducted at Dow Dental Hospital from February 2022 to June 2022. For quantitative analysis, a total of 273 participants were enrolled through convenience sampling. After obtaining signed consent, participants were asked to self-report their dental fear. In-depth interviews with 25 patients displaying moderate to high dental fear were conducted to clarify the elements of dental fear scores through the lens of individual perceptions and experiences. RESULTS: The prevalence of moderate dental fear was significantly higher among female participants than males. The mean dental fear score was higher among females (39.47 ± 14.23) as compared to males (30.83 ± 10.50). Most of the female participants reported an increase in breathing rate and heartbeat during dental treatment. The highest mean fear score was reported by participants who underwent oral surgical treatment (42.98 ± 14.21), followed by participants who received restorative care (36.20 ± 12.60). Approaching the dentist's office was the significant factor that contributed the most to the variance in dental fear scores. Four themes were generated through the content analysis of the interviews: physical reactions to dental procedures, perceptions and fears about surgical and restorative procedures, and gender and environmental factors in dental fear and interaction with dentists. CONCLUSION: The Urdu translation of DFS is a reliable and valid instrument for assessing dental fears in Pakistan based on the findings of this study. Patients perceive surgical and restorative procedures as unpleasant and threatening. It was noted that "the heart beats faster" and "the breathing rate increases." were the top two physiological responses.

Efficacy of multiple Biomarkers: NGAL, KIM1, Cystatin C and IL18 in predicting pregnancy related acute kidney injury.

Objective: Several biomarkers like NGAL, KIM-1, IL-18, and Cystatin C has been previously reported as reliable marker to predict AKI. However, their predictive accuracy varies widely. We aim to observe the efficacy of multiple markers, NGAL, KIM-1, Cystatin C and IL-18, in obstetric population who are at risk of developing AKI. Methods: This prospective study was carried out between June 2021 to March 2022 at Department of Obstetrics & Gynecology Unit II, Ruth Pfau KM Civil Hospital and Sindh Institute of Urology & Transplant (SIUT), Karachi Pakistan. On women brought to OBGYN-ER with the diagnosis of hemorrhage (antepartum and postpartum), hypertension (pre-eclampsia and eclampsia) and sepsis. The urine samples and 3cc blood was collected at the time of admission, blood sample processed for biochemistry at time of admission and repeat blood samples for serum creatinine at 24 and 48 hours. Urine was stored at -80ºC and later evaluated for NGAL, KIM-1, Cystatin C and IL-18. Serum Cystatin C was also processed for the time zero sample. The biomarkers were tested using ELISA assays. Results: A total of 149 women were included in the study, 83% of these women were non-booked. Twenty-six (17%) women developed AKI. Serum Cystatin C, urinary Cystatin C and urinary NGAL were found significantly raised in women who developed AKI. While KIM-1 and IL-18 were not raised to statistical significance in this population. However, urinary KIM-1 along with urinary Cystatin C were significantly raised in women with positive quick sequential organ failure assessment (qSOFA). Conclusion: This study validates the use of serum and urinary Cystatin C and urinary NGAL as highly predictable biomarkers for the development of AKI and nullifies urinary IL-18 and KIM-1 in this regard.

Recurrence and Survival Rates for 1400 Early Breast Tumors Treated with Intraoperative Radiation Therapy (IORT).

INTRODUCTION: Intraoperative radiotherapy (IORT) permits accurate delivery of radiation therapy directly to the tumor bed. We report local, regional, and distant recurrence data along with overall and breast cancer-specific survival for 1400 tumors treated with x-ray IORT. METHODS: A total of 1367 patients with 1400 distinct tumors were enrolled in a registry trial. All received breast conservation surgery and low-energy 50 kV x-ray IORT. To be eligible for excision plus IORT as the only local treatment, histopathology had to confirm tumor size ≤30 mm, margins ≥2 mm, negative lymph nodes, and no extensive lymphovascular invasion. Patients who failed any parameters were referred for additional surgery and/or whole breast radiation therapy (WBRT). RESULTS: There were 64 ipsilateral local recurrences, 60 were in the IORT only group, 7 axillary recurrences, and 7 distant recurrences. Forty-one local recurrences were within the same quadrant as the index cancer. Twenty-three were in different quadrants. With 62 months of median follow-up, the 5-year Kaplan-Meier probability of any event for all 1400 tumors was 5.27%. For 1175 patients who received IORT only, it was 5.98%. For favorable subtypes, it ranged from 2.41 to 4.31%. Multivariate analysis revealed that biologic subtype luminal A and the addition of WBRT significantly reduced the risk of local recurrence. CONCLUSIONS: The local, regional, and distant recurrence rates observed were comparable to those reported in the literature for IORT but higher than those reported for standard forms of WBRT, hypofractionated treatment, or APBI. IORT benefits include convenience, decreased exposure to medical environments, and low complication rates.

Non-surgical treatment of mild to moderate peri-implantitis using an oscillating chitosan brush or a titanium curette-A randomized multicentre controlled clinical trial.

OBJECTIVES: This prospective, parallel-group, examiner-blinded, multicentre, randomized, controlled clinical trial aimed to assess the efficacy of an oscillating chitosan brush (OCB) versus titanium curettes (TC) on clinical parameters in the non-surgical treatment of peri-implantitis. MATERIAL AND METHODS: In five dental specialist clinics, 39 patients with one implant with mild to moderate peri-implantitis, defined as 2-4 mm radiographic reduced bone level, bleeding index (BI) ≥ 2, and probing pocket depth (PPD) ≥ 4 mm were randomly allocated to test and control groups, receiving OCB or TC debridement, respectively. Treatment was performed at baseline and three months. PPD, BI, and Plaque index (PI) were measured at six sites per implant and recorded by five blinded examiners at baseline, one, three, and six month(s). Pus was recorded as present/not present. Changes in PPD and BI were compared between groups and analysed using multilevel partial ordinal and linear regression. RESULTS: Thirty-eight patients completed the study. Both groups showed significant reductions in PPD and BI at six months compared with baseline (p < .05). There was no statistically significant difference in PPD and BI changes between the groups. Eradication of peri-implant disease as defined was observed in 9.5% of cases in the OCB group and 5.9% in the TC group. CONCLUSIONS: Within the limitations of this six-month multicentre clinical trial, non-surgical treatment of peri-implantitis with OCB and TC showed no difference between the interventions. Eradication of disease was not predictable for any of the groups.

Unmediated connection of mental health decline and suicide among medical and nonmedical undergraduates during the pandemic of COVID-19: A cross-sectional comparative study.

Background and Objectives: All medicine and healthcare undergraduates were encountered with terminations and delays of professional examinations. These alterations were on topmost of other tasks the COVID-19 pandemic carried out for instance not roaming, covered faces with masks and specifically segregation. This interruption of normal life was a major cause of mental health disaster and it is no surprise that medicine and healthcare undergraduate has had high rates of psychological effects including hopelessness, stress and suicidal thoughts. This study aimed to investigate the unmediated connection of anxiety and stress related mental health decline and suicide among medical and nonmedical undergraduates during the pandemic of covid-19. Methods: A multidiscipline online cross-sectional comparative study design was chosen for this study conducted from November 2020 to January 2021 with a pre-validated questionnaire to collect responses from sample size 1290. SPSS- 21 used for descriptive analysis of means, S.D, ANOVA and spearman's correlations. Forward step-wise model of linear regression applies for true significant bivariate relationship (p<.001). Results: The result shows that all three cohorts were affected. Among the non-medical cohorts, B-Pharmacy students had the high level (p<.001) of anxiety with suicide ideation response (n=200; 39.2%), along with lowest level of envisions care (19.5%; p<.001) in pandemic. Control and independent variable had a strong negative effects on B-Pharmacy and medical students with p<.000. Conclusions: This study offered more data that the concerns, anxieties and uncertainties caused by pandemic COVID-19, don't roll out alone but remain as long-lasting problems demanding ongoing attention.

Retrospective observational study to compare Xpert MTB/RIF assay with other diagnostic tests in lymph node tuberculosis.

Background: Lymph node tuberculosis (TB) is the most common form of extrapulmonary TB in India. Standards for TB care in India recommend microscopy/culture/CBNAAT/molecular test/histopathology examination and drug sensitivity testing on appropriate specimens from the presumed sites of involvement for all patients with presumptive extrapulmonary TB. Objectives: To analyze the utility of Xpert MTB/Rif assay in lymph node TB. Methods: All patients who underwent lymph node sampling between July 2014 and June 2017 and for whom Xpert MTB/Rif assay was done were included. Demographic profile, Xpert MTB/Rif assay result, histopathology/cytology findings, smear acid-fast bacillus (AFB), and AFB culture results were noted. A composite reference score (CRS) was made. Results: Xpert MTB/Rif assay was positive in 63 of the 81 patients. Xpert had a sensitivity of 82.14% and specificity of 86.18%when compared against AFB culture and 75.61% and 98.97% when compared against CRS. Conclusion: Xpert MTB/Rif assay is a valuable test for rapid diagnosis of lymph node TB.

The Clinical Utility of DCISionRT® on Radiation Therapy Decision Making in Patients with Ductal Carcinoma In Situ Following Breast-Conserving Surgery.

BACKGROUND: The role of radiation therapy (RT) following breast-conserving surgery (BCS) in ductal carcinoma in situ (DCIS) remains controversial. Trials have not identified a low-risk cohort, based on clinicopathologic features, who do not benefit from RT. A biosignature (DCISionRT®) that evaluates recurrence risk has been developed and validated. We evaluated the impact of DCISionRT on clinicians' recommendations for adjuvant RT. METHODS: The PREDICT study is a prospective, multi-institutional, observational registry in which patients underwent DCISionRT testing. The primary endpoint was to identify the percentage of patients where testing led to a change in RT recommendations. RESULTS: Overall, 539 women were included in this study. Pre DCISionRT testing, RT was recommended to 69% of patients; however, post-testing, a change in the RT recommendation was made for 42% of patients compared with the pre-testing recommendation; the percentage of women who were recommended RT decreased by 20%. For women initially recommended not to receive an RT pre-test, 35% had their recommendation changed to add RT following testing, while post-test, 46% of patients had their recommendation changed to omit RT after an initial recommendation for RT. When considered in conjunction with other clinicopathologic factors, the elevated DCISionRT score risk group (DS > 3) had the strongest association with an RT recommendation (odds ratio 43.4) compared with age, grade, size, margin status, and other factors. CONCLUSIONS: DCISionRT provided information that significantly changed the recommendations to add or omit RT. Compared with traditional clinicopathologic features used to determine recommendations for or against RT, the factor most strongly associated with RT recommendations was the DCISionRT result, with other factors of importance being patient preference, tumor size, and grade.

The pilot, proof of concept REMOTE-COVID trial: remote monitoring use in suspected cases of COVID-19 (SARS-CoV 2).

BACKGROUND: SARS-CoV-2 has ever-increasing attributed deaths. Vital sign trends are routinely used to monitor patients with changes in these parameters preceding an adverse event. Wearable sensors can measure vital signs continuously and remotely, outside of hospital facilities, recognising early clinical deterioration. We aim to determine the feasibility & acceptability of remote monitoring systems for quarantined individuals in a hotel suspected of COVID-19. METHODS: A pilot, proof-of-concept, feasibility trial was conducted in engineered hotels near London airports (May-June 2020). Individuals arriving to London with mild suspected COVID-19 symptoms requiring quarantine, as recommended by Public Health England, or healthcare professionals with COVID-19 symptoms unable to isolate at home were eligible. The SensiumVitals™ patch, measuring temperature, heart & respiratory rates, was applied on arrival for the duration of their stay. Alerts were generated when pre-established thresholds were breeched; trained nursing staff could consequently intervene. RESULTS: Fourteen individuals (M = 7, F = 7) were recruited; the mean age was 34.9 (SD 11) years. Mean length of stay was 3 (SD 1.8) days. In total, 10 vital alerts were generated across 4 participants, resulting in telephone contact, reassurance, or adjustment of the sensor. No individuals required hospitalisation or virtual general practitioner review. DISCUSSION: This proof-of-concept trial demonstrated the feasibility of a rapidly implemented model of healthcare delivery through remote monitoring during a pandemic at a hotel, acting as an extension to a healthcare trust. Benefits included reduced viral exposure to healthcare staff, with recognition of clinical deterioration through ambulatory, continuous, remote monitoring using a discrete wearable sensor. CONCLUSION: Remote monitoring systems can be applied to hotels to deliver healthcare safely in individuals suspected of COVID-19. Further work is required to evaluate this model on a larger scale. TRIAL REGISTRATION: Clinical trials registration information: ClinicalTrials.gov Identifier: NCT04337489 (07/04/2020).

Comparison of management options for specific antibody deficiency.

Background: Specific antibody deficiency is a primary immunodeficiency characterized by normal immunoglobulins with an inadequate response to polysaccharide antigen vaccination. This disease can result in recurrent infections, the most common being sinopulmonary infections. Treatment options include clinical observation, prophylactic antibiotic therapy, and immunoglobulin supplementation therapy, each with limited clinical data about their efficacy. Objective: This study aimed to identify whether there was a statistically significant difference in the rate of infections for patients who were managed with clinical observation, prophylactic antibiotics, or immunoglobulin supplementation therapy. Methods: A retrospective chart review was conducted. Patients were eligible for the study if they had normal immunoglobulin levels, an inadequate antibody response to polysaccharide antigen-based vaccination, and no other known causes of immunodeficiency. Results: A total of 26 patients with specific antibody deficiency were identified. Eleven patients were managed with immunoglobulin supplementation, ten with clinical observation, and five with prophylactic antibiotic therapy. The frequency of antibiotic prescriptions was assessed for the first year after intervention. A statistically significant rate of decreased antibiotic prescriptions after intervention was found for patients treated with immunoglobulin supplementation (n = 11; p = 0.0004) and for patients on prophylactic antibiotics (n = 5; p = 0.01). There was no statistical difference in antibiotic prescriptions for those patients treated with immunoglobulin supplementation versus prophylactic antibiotics (p = 0.21). Conclusion: Prophylactic antibiotics seemed to be equally effective as immunoglobin supplementation therapy for the treatment of specific antibody deficiency. Further studies are needed in this area.

Efficacy of pedagogical framework in neonatal resuscitation skill learning in a resource-limited setting: a randomized controlled trial.

BACKGROUND: The educational efficacy in neonatal resuscitation relies on the subject and teaching strategies. Therefore, it is imperative to test diverse educational methods if they are more instructive to engage students in active learning and practicing knowledge. Hence, the present study aims to investigate the efficacy of a pedagogical framework in neonatal resuscitation skill learning among nursing students in a resource-limited setting. METHODS: A single-blind randomized controlled trial was conducted between October 2020 to March 2021. Sixty nursing students in the 3rd and 4th year of professional training were randomly allocated to the pedagogy and the traditional group. The pedagogy group learned via 6-step LSPPDM (Learn, See, Practice, Prove, Do, Maintain) pedagogy including lectures, video, clinical observation, skill sessions under supervision, and self-directed practice. The traditional group learned through 2-step (Learn, Practice) method that included lectures and skill sessions under supervision. The outcomes measured included technical and non-technical skills in neonatal resuscitation. The technical skill deals with steps such as stimulation, ventilation, oxygenation, intubation, chest compression, medications, and reporting. Non-technical skills refer to teamwork skills that focus on the interaction between leader and helper. Both skills were measured through previously published validated tools two times before and after the intervention by blinded assessors in a simulated delivery room. RESULTS: Overall, the skill was significantly improved in both groups after intervention. Yet, the results showed that the mean difference of technical skill score in the pedagogy group (24.3 ± 3.5) was significantly higher (p <  0.001) compared to the traditional group (16.2 ± 2.4). Likewise, the mean difference of non-technical skill score in the pedagogy (36.9 ± 1.9) was highly significant (p <  0.001) compared to the traditional group (31.2 ± 1.7). CONCLUSIONS: The LSPPDM pedagogy was found more effective in enhancing technical and non-technical skills in neonatal resuscitation compared to the traditional method. The results of this study support the efficacy of the 6-step LSPPDM pedagogy in the education of nursing students regarding neonatal resuscitation in a resource-limited setting. TRIAL REGISTRATION: Prospectively registered at ClinicalTrials.gov ( NCT04748341 ).