Isopp 2023

The proceedings contain 109 papers. The topics discussed include: dose intensity of palbociclib and initial body weight dosage: implications on progression free survival in 220 patients with ER+/HER2-negative metastatic breast cancer;characteristics of Nirmatrelvir/Ritonavir (Paxlovid) recipients and clinical interventions by oncology pharmacists at a tertiary outpatient cancer center;safe handling of non-carcinogenic drugs in the Ghent University Hospital: development, implementation and communication of hospital-specific guidelines;case series: use of olaparib in uncommon locations in patients with impaired homologous recombination;real-world data evaluation of medicines used in special situations in oncohematology: a retrospective study from a comprehensive cancer institution;Dostarlimab in the treatment of recurrent endometrial cancer: real life experience;medication-related osteonecrosis of the jaws and CDK4/6 inhibitors in breast cancer;and efficacy and safety outcomes of generic imatinib in adults with chronic myeloid leukemia (CML) following the switch from branded imatinib.

Following Guidelines During a Crisis

The guidance states, "These preventative measures can include steps to prepare personnel such as: * "Educating employees on topics such as, in the case of a pandemic, personal hygiene (hand washing and coughing and sneezing etiquette), social distancing, and appropriate use of sick leave * "Encouraging employees to get immunized as appropriate by providing information on local vaccination services or by offering on-site vaccination services, if reasonable * "Providing information for and encouraging employees to develop family emergency preparedness plans * "Reviewing CGMP [current good manufacturing practice] regulations regarding appropriate sanitation practices and restriction of ill or sick employees from production areas (see 21 CFR [Code of Federal Regulations] 211.28)" (2). Examples include: * "Production equipment routine maintenance * "Utility system performance checks and maintenance (e.g., air temperature, lighting, compressed air) * "Environmental monitoring of facilities such as cell culture, harvesting, and purification rooms during production * "Stability testing for certain drug products and components * "Periodic examinations of data and of reserve samples" (2). EMA, Guidance on the Format of the Risk Management Plan (RMP) in the EU-in Integrated Format, EMA/164014/2018 Rev.2.0.1 accompanying GVP Module V Rev.2 Human Medicines Evaluation (EMA, 31 October 2018).

Percutaneous Tracheostomy With a Demistifier Canopy in the COVID-19 Era: A Safe Technique in the Intensive Care Unit.

BACKGROUND: Endoscopic percutaneous tracheostomy (PT) is a safe technique that is performed frequently by otolaryngologists and intensivists. New challenges have been identified in order to maintain the safety of this procedure during the COVID-19 pandemic. A novel approach, using a modified demistifier canopy, was developed during the first wave of the pandemic and implemented for 17 consecutive percutaneous tracheostomies in order to enhance procedural safety. METHODS: A protocol was developed after performing a literature review of tracheostomy in COVID-19 patients. A multidisciplinary tracheostomy team was established, including the departments of otolaryngology, critical care, and respiratory therapy. Simulation was performed prior to each PT, and postoperative debriefings were done. RESULTS: A protocol and technical description of PT using a modified demistifier canopy covering was written and video documented. Data were collected on 17 patients who underwent this procedure safely in our tertiary care hospital. There were no procedure-related complications, and no evidence of COVID-19 transmission to any member of the health care team during the study period. CONCLUSION: As patients continue to recover from COVID-19, their need for tracheostomy will increase. The technique described provides a safe, multidisciplinary method of performing PT in COVID-19 patients.

Safety and efficacy of vitamin B in cancer treatments: A systematic review.

BACKGROUND: With rising rates of complementary and alternative medicine use, the exploration of complementary and alternative medicine integration into oncology treatments is becoming increasingly prevalent. Vitamin B compounds including B1, B2, B3, B5, B6, B9, and B12, have all been proposed as potentially beneficial in cancer prevention and treatment as well as side effect management; however, many studies contain contradicting evidence regarding the utility of B vitamins within oncology. Thus, the aim of this study was to evaluate the safety and efficacy of Vitamin B supplementation in the oncology setting. DESIGN: A systematic review was conducted following The Preferred Reporting Items for Systematic Reviews and Meta-Analyses-Scoping Reviews guidelines, using pre-specified search terms in PubMed to include randomized control trials, clinical trials, and case studies. Two reviewers independently reviewed titles, abstracts, and full-text articles for inclusion, with a third reviewer resolving conflicts, before the included articles underwent data extraction and quality appraisal. Data extraction was conducted through COVIDENCE, which was used to manage and track the data during the search process. RESULTS: Out of 694 articles initially identified, 25 articles met the inclusion criteria and were included in the review. Designs of the studies varied, including randomized control trials, clinical trials, and case/cohort studies. The impact of vitamin supplementation on cancer risk varied. Several studies found that certain B vitamin supplementation lowered cancer risk: B9 and B6 in nasopharyngeal carcinoma (n = 1200 patients) and in pancreatic cancer (n = 258 patients); B3 in hepatocellular carcinoma (n = 494,860 patients); B6 in breast cancer (n = 27,853 patients); and B9 in BRCA1-positive breast cancer (n = 400 patients). However, some studies found that certain B vitamin supplementation increased the risk or negative outcomes of cancer: B6 during nasopharyngeal carcinoma treatment (n = 592 patients); B6 in risk of hepatocellular carcinoma (n = 494,860 patients); and B9 plasma levels in breast cancer (n = 164 patients). Due to the many adverse effects that occur in cancer treatment, the effectiveness of Vitamin B supplementation in alleviating adverse effects was evaluated. In two separate studies, Vitamin B6 and Vitamin B12 supplementation with acupuncture was found to be effective as adjunct therapies aimed to reduce chemotherapy-induced peripheral neuropathy (n = 23 patients and n = 104 patients, respectively). No significant findings were established regarding B vitamin supplementation in chemotherapy-induced hand-foot syndrome. CONCLUSIONS: In this systematic review we concluded that B vitamin supplements have varying data regarding safety and efficacy in cancer. Taking into account the etiology of the cancer, the specific B-vitamin, and the presence of any side effects could help guide utilization of the data found in this review. Large, randomized controlled trials are needed to confirm these findings among various cancer diagnoses and stages. Given the widespread utilization of supplements, healthcare providers should understand the safety and efficacy of vitamin B supplementation to address questions that arise in caring for those with cancer.

Safety of Nurse-Managed Inhaled Nitric Oxide During Critical Care Interfacility Transport.

Inhaled nitric oxide (iNO) is an advanced therapy typically managed by physicians and respiratory therapists in order to increase arterial oxygenation and decrease pulmonary arterial pressure. The Johns Hopkins Lifeline Critical Care Transportation Program (Lifeline) initiated a novel nurse-managed iNO protocol in order to optimize the oxygenation of critically ill patients during interfacility transport. This study was a retrospective chart review of adverse events associated with iNO initiation or continuation by Lifeline on patients transported from March 1, 2020, to August 1, 2022. Basic demographic data and adverse events were recorded. Recorded adverse events included hypotension defined as a mean arterial pressure (MAP) < 65 mm Hg, hypoxemia defined as a decrease of ≥ 10% arterial oxygenation saturation measured by pulse oximetry, new bradycardia or tachyarrhythmia, nitrogen dioxide (NO2) levels greater than 1.0 ppm, methemoglobinemia, and cardiac arrest. Fifteen patients were diagnosed with SARS-CoV-2 infection, of which one also had pulmonary emboli, 2 had bacterial pneumonia, 1 suffered cardiogenic shock from occlusive myocardial infarction and were on VA-ECMO, and 2 had significant thoracic trauma resulting in pulmonary contusions and hemopneumothorax. iNO was continued on 10 patients and initiated on 8 patients, 2 of whom were transitioned from inhaled epoprostenol. Hypotension occurred in 3 (16.7%) patients and one (5.56%) of the hypotensive patients subsequently went on to experience new atrial fibrillation with vasopressor titration. No patients developed worsening hypoxemia, elevated NO2 levels, methemoglobinemia, or suffered cardiac arrest. All 3 patients who experienced hypotension were already on vasopressor support and the hypotension resolved with medication titration. This study shows that iNO administration can be safely managed by appropriately trained nurses.

The effects of electronic nursing handover on patient safety in the general (non-COVID-19) and COVID-19 intensive care units: a quasi-experimental study.

BACKGROUND: The unprecedented increase in the nurses' workload is one of the issues affecting the quality and safety of patient care in the Intensive Care Units (ICUs). The electronic nursing handover can share sufficient, relevant, and necessary data about patients with greater efficiency and accuracy and prevent their information from being deleted. Therefore, this study aimed to determine and compare the effect of the Electronic Nursing Handover System (ENHS) on patient safety in General ICU and COVID-19 ICU. METHOD: This is a quasi-experimental study conducted during an 8-month period from 22 to 2021 to 26 June 2022 using a test-retest design. A total of 29 nurses working in the General and COVID-19 ICUs participated in this study. Data were collected using a five-part questionnaire consisting of demographic information, handover quality, handover efficiency, error reduction, and handover time. Data analysis was conducted in IBM SPSS Statistics for Windows, version 26 (IBM Corp., Armonk, N.Y., USA) using the chi-squared test, paired t-test, and Analysis of Covariance (ANCOVA). RESULTS: The results showed that the mean scores of handover quality and efficiency, reduction of clinical error, and handover time in the electronic handover were significantly higher than those obtained in the paper-based method. The results showed that the mean score of patient safety in the COVID-19 ICU was 177.40 ± 30.416 for the paper-based handover and 251.40 ± 29.049 for the electronic handover (p = .0001). Moreover, the mean score of patient safety in the general ICU was 209.21 ± 23.072 for the paper-based handover and 251.93 ± 23.381 for the electronic one (p = .0001). CONCLUSION: The use of ENHS significantly improved the quality and efficiency of shift handover, reduced the possibility of clinical error, saved handover time, and finally increased patient safety compared to the paper-based method. The results also showed the positive perspectives of ICU nurses toward the positive effect of ENHS on the patient safety improvement.

[Use of thoracic and lung ultrasound in general anesthesia]. / A mellkas és a tüdo ultrahangvizsgálatának szerepe az általános érzéstelenítés során.

The use of ultrasound became an essential tool in the everyday practice of anesthesiology and intensive care as an indispensable prerequisite for the precise guidance of invasive procedures and also as a point-of-care diagnostic method. Despite the limitations of imaging the lung and thoracic structures, the COVID-19 pandemic and recent advances made this technology an evolving field. The intensive therapy applies these methods with important experience for differential diagnosis and assessment of disease severity or prognosis. Minor modifications of these results make the method beneficial for anesthesia and perioperative medicine. In the present review, the authors accentuate the most important imaging artefacts of lung ultrasonography and the principles of lung ultrasound diagnostic steps. Methods and artefacts of high importance supported by evidence for the assessment of airway management, attuning of intraoperative mechanical ventilation, respiratory disorders during surgery, and postoperative prognosis are articulated. This review intends to focus on evolving subfields in which technological or scientific novelties are expected. Orv Hetil. 2023; 164(22): 864-870.

COVID-19 Education and Resource Development for Punjabi-Speaking Sikh Farmworkers in California.

OBJECTIVE: While the vast majority of farmworkers in California are Latinx, a small proportion of the farmworkers are Asian Indian who primarily speak Punjabi. To date, there are few COVID-19 resources developed that specifically target Punjabi-speaking farmworkers. This study examines the COVID-19 educational needs of Punjabi-speaking farmworkers in California and aims to inform future development of educational materials for Punjabi-speaking farmworkers. METHODS: During early 2021, a two-phase qualitative study was conducted. In Phase 1, five key informant interviews were conducted using a semi-structured interview guide to assess the content, visual, and cultural relevance of current COVID-19 educational resources. Based on informant feedback, new agriculture-specific COVID-19 educational resources were developed in Punjabi. In Phase 2, three focus groups were conducted (in Fresno and Yuba Counties) with five participants in each group to evaluate the newly developed COVID-19 resources. RESULTS: Informant interviews showed that Punjabi-speaking farmworkers preferred printed handouts, videos, and radio messages to receive COVID-19 related information. Participants preferred 8-1/2"x11" sized printed handouts that were colorful and had culturally relevant photographs. Participant video preferences included live action videos that were short (1-3 mins) with characters representing the Punjabi community. A substantial majority of focus group participants approved the newly developed COVID-19 educational and safety resources. CONCLUSION: Current COVID-19 resources are not meeting the educational needs of Punjabi-speaking farmworkers. This community needs COVID-19 educational and safety materials that are culturally relevant and linguistically appropriate to be available in different formats: handouts, videos, and radio messages.

Experiences of Sex Workers in Chicago during COVID-19: A Qualitative Study.

COVID-19 exacerbated health disparities, financial insecurity, and occupational safety for many within marginalized populations. This study, which took place between 2019 and 2022, aimed to explore the way in which sex workers (n = 36) in Chicago were impacted by COVID-19. We analyzed the transcripts of 36 individual interviews with a diverse group of sex workers using thematic analysis. Five general themes emerged regarding the detrimental impact of COVID-19 on sex workers: (1) the impact of COVID-19 on physical health; (2) the economic impact of COVID-19; (3) the impact of COVID-19 on safety; (4) the impact of COVID-19 on mental health; and (5) adaptive strategies for working during COVID-19. Participants reported that their physical and mental health, economic stability, and safety worsened due to COVID-19 and that adaptive strategies did not serve to improve working conditions. Findings highlight the ways in which sex workers are particularly vulnerable during a public health crisis, such as COVID-19. In response to these findings, targeted resources, an increased access to funding, community-empowered interventions and policy changes are needed to protect the health and safety of sex workers in Chicago.

A phase 1, randomized, placebo-controlled, dose-ranging study to evaluate the safety and immunogenicity of an mRNA-based chikungunya virus vaccine in healthy adults.

BACKGROUND: Chikungunya, a mosquito-borne viral disease caused by the chikungunya virus (CHIKV), causes a significant global health burden, and there is currently no approved vaccine to prevent chikungunya disease. In this study, the safety and immunogenicity of a CHIKV mRNA vaccine candidate (mRNA-1388) were evaluated in healthy participants in a CHIKV-nonendemic region. METHODS: This phase 1, first-in-human, randomized, placebo-controlled, dose-ranging study enrolled healthy adults (ages 18-49 years) between July 2017 and March 2019 in the United States. Participants were randomly assigned (3:1) to receive 2 intramuscular injections 28 days apart with mRNA-1388 in 3 dose-level groups (25 µg, 50 µg, and 100 µg) or placebo and were followed for up to 1 year. Safety (unsolicited adverse events [AEs]), tolerability (local and systemic reactogenicity; solicited AEs), and immunogenicity (geometric mean titers [GMTs] of CHIKV neutralizing and binding antibodies) of mRNA-1388 versus placebo were evaluated. RESULTS: Sixty participants were randomized and received ≥ 1 vaccination; 54 (90 %) completed the study. mRNA-1388 demonstrated favorable safety and reactogenicity profiles at all dose levels. Immunization with mRNA-1388 induced substantial and persistent humoral responses. Dose-dependent increases in neutralizing antibody titers were observed; GMTs (95 % confidence intervals [CIs]) at 28 days after dose 2 were 6.2 (5.1-7.6) for mRNA-1388 25 µg, 53.8 (26.8-108.1) for mRNA-1388 50 µg, 92.8 (43.6-197.6) for mRNA-1388 100 µg, and 5.0 (not estimable) for placebo. Persistent humoral responses were observed up to 1 year after vaccination and remained higher than placebo in the 2 higher mRNA-1388 dose groups. The development of CHIKV-binding antibodies followed a similar trend as that observed with neutralizing antibodies. CONCLUSIONS: mRNA-1388, the first mRNA vaccine against CHIKV, was well tolerated and elicited substantial and long-lasting neutralizing antibody responses in healthy adult participants in a nonendemic region. CLINICALTRIALS: gov: NCT03325075.

Uneventful Coadministration of Seasonal Influenza and COVID-19 BNT162b2 Vaccines Two Weeks Post-Influenza Vaccination in an Egg-Allergic Subject: A Case Report.

The COVID-19 pandemic took the world by storm, and although it has taken the world's attention, it did not stop the spread of other communicable diseases. Seasonal influenza is a viral infection that could cause severe disease; therefore, annual influenza vaccination is highly recommended, especially among patients with a weakened immune system. However, such vaccination is contraindicated for people with hypersensitivity to the vaccine or any of its components, e.g., eggs. This paper describes a case of an egg-allergic individual who received an influenza vaccine containing egg protein, which only caused mild tenderness at the site of injection. Two weeks later, the subject received a double vaccination of a second booster dose of Pfizer-BioNTech and the seasonal influenza vaccine. The patient reported no local or systemic adverse reactions to the vaccine. This case report suggests vaccination safety for subjects with mild allergies to vaccine components.

Assessment of long-term adverse events regarding different COVID-19 vaccine regimens within an 18-month follow-up study.

Early reports on coronavirus disease 2019 (COVID-19) vaccines presented the short-term adverse events (AEs). This follow-up study investigated a standard regimen based on protein subunit vaccines, PastoCovac and PastoCovac Plus, and the combinational vaccine regimens including AstraZeneca/PastoCovac Plus and Sinopharm/PastoCovac Plus. The participants were followed up to 6 months post the booster shot. All the AEs were collected through in-depth interviews using a valid researcher-made questionnaire and were evaluated regarding the association with the vaccines. Of the 509 individuals, 6.2% of the combinational vaccine participants had late AEs, of whom 3.3% suffered from cutaneous manifestations, followed by 1.1% arthralgia complaints, 1.1% with neurologic disorders, 0.3% ocular problems and 0.3% metabolic complications, with no significant difference between the vaccine regimens. For the standard regimen, 2% of the individuals experienced late AEs as (1%), neurological disorders (0.3%), metabolic problems (0.3%) and involvement of joints (0.3%). Notably, 75% of the AEs were persistent up to the end of the study. A low number of late AEs were captured in 18 months as 12 improbable, 5 unclassifiable, 4 possible and 3 probable associated AEs with the vaccine regimens. The benefits of COVID-19 vaccination far exceed the potential risks and late AEs seem to be uncommon.

Triage and Diagnostic Accuracy of Online Symptom Checkers: Systematic Review.

BACKGROUND: In the context of a deepening global shortage of health workers and, in particular, the COVID-19 pandemic, there is growing international interest in, and use of, online symptom checkers (OSCs). However, the evidence surrounding the triage and diagnostic accuracy of these tools remains inconclusive. OBJECTIVE: This systematic review aimed to summarize the existing peer-reviewed literature evaluating the triage accuracy (directing users to appropriate services based on their presenting symptoms) and diagnostic accuracy of OSCs aimed at lay users for general health concerns. METHODS: Searches were conducted in MEDLINE, Embase, CINAHL, Health Management Information Consortium (HMIC), and Web of Science, as well as the citations of the studies selected for full-text screening. We included peer-reviewed studies published in English between January 1, 2010, and February 16, 2022, with a controlled and quantitative assessment of either or both triage and diagnostic accuracy of OSCs directed at lay users. We excluded tools supporting health care professionals, as well as disease- or specialty-specific OSCs. Screening and data extraction were carried out independently by 2 reviewers for each study. We performed a descriptive narrative synthesis. RESULTS: A total of 21,296 studies were identified, of which 14 (0.07%) were included. The included studies used clinical vignettes, medical records, or direct input by patients. Of the 14 studies, 6 (43%) reported on triage and diagnostic accuracy, 7 (50%) focused on triage accuracy, and 1 (7%) focused on diagnostic accuracy. These outcomes were assessed based on the diagnostic and triage recommendations attached to the vignette in the case of vignette studies or on those provided by nurses or general practitioners, including through face-to-face and telephone consultations. Both diagnostic accuracy and triage accuracy varied greatly among OSCs. Overall diagnostic accuracy was deemed to be low and was almost always lower than that of the comparator. Similarly, most of the studies (9/13, 69 %) showed suboptimal triage accuracy overall, with a few exceptions (4/13, 31%). The main variables affecting the levels of diagnostic and triage accuracy were the severity and urgency of the condition, the use of artificial intelligence algorithms, and demographic questions. However, the impact of each variable differed across tools and studies, making it difficult to draw any solid conclusions. All included studies had at least one area with unclear risk of bias according to the revised Quality Assessment of Diagnostic Accuracy Studies-2 tool. CONCLUSIONS: Although OSCs have potential to provide accessible and accurate health advice and triage recommendations to users, more research is needed to validate their triage and diagnostic accuracy before widescale adoption in community and health care settings. Future studies should aim to use a common methodology and agreed standard for evaluation to facilitate objective benchmarking and validation. TRIAL REGISTRATION: PROSPERO CRD42020215210; https://tinyurl.com/3949zw83.

Immunogenicity and safety of COVID-19 BNT162b2 booster vaccine in end-stage kidney disease patients receiving haemodialysis in Yogyakarta, Indonesia: a cohort prospective study.

BACKGROUND: A significant decrease in antibody titres several months after COVID-19 primary vaccination in end-stage kidney disease (ESKD) patients receiving maintenance haemodialysis has recently been reported. The waning in antibody titres has led to the recommendations for a booster dose to increase the antibody titres after vaccination. Consequently, it is crucial to analyse the long-term humoral immune responses after COVID-19 primary vaccination and assess the immunogenicity and safety of booster doses in haemodialysis (HD) patients. METHODS: Patients on maintenance haemodialysis who received the primary vaccine of CoronaVac (Sinovac) vaccine were administered with BNT162b2 (Pfizer-BioNTech) as the booster dose. The immunogenicity was assessed before (V1), one month (V2) and eight months (V3) after the primary vaccination, as well as one month after the booster dose (V4). Patients were followed up one month after the booster dose to assess the adverse events (AEs). RESULTS: The geometric mean titre (GMT) of anti-SARS-CoV-2 S-RBD IgG antibody at 8 months after the primary vaccination increased significantly to 5,296.63 (95%CI: 2,930.89-9,571.94) U/mL (p = < 0.0001) compared to before the primary vaccination. The GMT also increased significantly to 19,142.56 (95% CI: 13,489.63-27,227.01) U/mL (p < 0.0001) 1 month after the booster vaccine. Meanwhile, the median inhibition rate of neutralizing antibodies (NAbs) at 8 months after the primary vaccine and 1 month after the booster dose were not significantly different (p > 0.9999). The most common AEs after the booster dose included mild pain at the injection site (55.26%), mild fatigue (10.53%), and swelling at the injection site (10.53%). No serious AEs were reported. CONCLUSIONS: The majority of ESKD patients on haemodialysis mounted a good antibody response to the BNT162b2 booster vaccination with tolerable adverse events.

Implementation of medication reconciliation in outpatient cancer care.

BACKGROUND: Medication reconciliation (MedRec) is a process where providers work with patients to document and communicate comprehensive medication information by creating a complete medication list (best possible medication history (BPMH)) then reconciling it against what patient is actually taking to identify potential issues such as drug-drug interactions. We undertook an environmental scan of current MedRec practices in outpatient cancer care to inform a quality improvement project at our centre with the aim of 30% of patients having a BPMH or MedRec within 30 days of initiating treatment with systemic therapy. METHODS: We conducted semi-structured interviews with key stakeholders from 21 cancer centres across Canada, probing on current policies, and barriers and facilitators to MedRec. Guided by the findings of the scan, we then undertook a quality improvement project at our cancer centre, comprising six iterative improvement cycles. RESULTS: Most institutions interviewed had a process in place for collecting a BPMH (81%) and targeted patients initiating systemic therapy (59%); however, considerable practice variation was noted and completion of full MedRec was uncommon. Lack of resources, high patient volumes, lack of a common medical record spanning institutions and settings which limits access to medication records from external institutions and community pharmacies were identified as significant barriers. Despite navigating challenges related to the COVID-19 pandemic, we achieved 26.6% of eligible patients with a documented BPMH. However, uptake of full MedRec remained low whereby 4.7% of patients had a documented MedRec. CONCLUSIONS: Realising improvements to completion of MedRec in outpatient cancer care is possible but takes considerable time and iteration as the process is complex. Resource allocation and information sharing remain major barriers which need to be addressed in order to observe meaningful improvements in MedRec.

The effectiveness of disinfection protocols in medical school osteopathic manipulative medicine labs.

CONTEXT: In light of the COVID-19 pandemic, healthcare-associated infections have taken center stage. Healthcare has adjusted workflows to accommodate for more robust disinfecting regiments to help protect the community. This has resulted in the need for medical institutions to reevaluate the current disinfection protocols down to the student level. The osteopathic manipulative medicine (OMM) laboratory provides an optimal avenue for assessing the effectiveness of medical students' ability to clean examination tables. With OMM laboratories having a high level of interaction, adequate disinfection is important for the health and safety of students and teaching faculties. OBJECTIVES: This study will evaluate the effectiveness of the current disinfection protocols in the medical school OMM labs. METHODS: A cross-sectional, nonrandomized study was performed on 20 OMM examination tables utilized for osteopathic training. Tables were chosen based on their close proximity to the podium. Close proximity was utilized as a criteria to increase the probability of utilization by students. The sampled tables were observed to ensure their use by students during class. Initial samples were collected in the morning after disinfection by Environmental Services. Terminal samples were collected after Osteopathic medical students utilized and disinfected the OMM examination tables. Samples were collected from the face-cradle and midtorso regions and analyzed utilizing adenosine triphosphate (ATP) bioluminescence assays with an AccuPoint Advanced HC Reader. This reader provides a digital readout of the quantity of light measured in relative light units (RLUs), which is directly correlated to the amount of ATP present in the sample, providing an estimated pathogen count. For statistical analysis, a Wilcoxon signed-rank test was utilized to find statistical differences in RLUs in samples after initial and terminal disinfection. RESULTS: The face cradle showed a 40 % increase in failure rate in samples after terminal disinfection when samples were compared after initial disinfection. A Wilcoxon signed-rank test revealed an estimated pathogen level for face cradle that was significantly higher after terminal disinfection (median, 4,295 RLUs; range, 2,269-12919 RLUs; n=20) compared to initial disinfection (median, 769 RLUs; range, 29-2,422 RLUs; n=20), z=-3.8, p=0.00008, with a large effect size, d=2.2. The midtorso region showed a 75 % increase in samples after terminal disinfection when samples were compared after initial disinfection. A Wilcoxon signed-rank test revealed that the estimated pathogen levels for midtorso were significantly higher after terminal disinfecting (median, 656 RLUs; range, 112-1,922 RLUs; n=20) compared to initial disinfecting (median, 128 RLUs; range, 1-335 RLUs; n=20), z=-3.9, p=0.00012, with a large effect size, d=1.8. CONCLUSIONS: This study suggests that medical students frequently failed to disinfect high-touch regions on examination tables, such as the midtorso and the face cradle. It is recommended that the current OMM lab disinfection protocol be modified to include the disinfection of high-touch regions in order to reduce the possibility of pathogen transmission. Further research should explore the effectiveness of disinfection protocols in clinical settings such as outpatient offices.

Assessing food safety risks based on a geospatial analysis: toward a cross-regional food safety management.

BACKGROUND: Food safety risks (FSRs) are increasingly characterized by geographical complexity along with rapid urbanization, changing dietary pattern, and the modernization of the food industry. These factors pose challenges for food risk control in developing economies, more so during the global COVID-19 pandemic. The accurate assessment of risk source and transfer path is a crucial step toward enhancing cross-regional food safety management. This study aims to examine the spatial distribution, transfer path and driving factors of FSRs in China, provided with a national food safety database collected from 8.63 million batches of food sampling inspections for 33 different types of foods across 30 provinces. RESULTS: The findings reveal significant regional disparities in FSRs, which is the highest in the west with small-scale sampling inspection and the lowest in the east with intensive sampling inspection. Catering and processed foods with higher daily consumption suffer more profound FSR than agricultural products. As evidenced by the shrinking low-low agglomeration areas, the local FSRs have been effectively controlled. The high-high agglomeration areas playing positive impacts on risk control are expanding while distributed discretely. CONCLUSION: The spatial transfer of FSRs is significantly driven by multiple drivers: regulatory capacity and intensity, information disclosure, food industry, regional economy, and food consumption. Assessing FSRs based on a geospatial analysis contributes to identifying risk sources, optimizing risk management, and constructing a sustainable food safety system. © 2023 Society of Chemical Industry.

Vaccination in pregnancy.

The evidence indicates that pregnancy is associated with increased severity of some infectious diseases. Given the high maternal morbidity associated with influenza in pregnancy and the high neonatal morbidity and mortality associated with pertussis, the traditionally two recommended vaccines during pregnancy were those against influenza and Tdap (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis) vaccines. The recent COVID-19 pandemic introduced a third vaccine that after much debate is now recommended for all pregnant women. Other vaccines can be offered based for high-risk pregnant women, and only when the benefits of receiving them outweigh the risks. The soon expected vaccines against group B streptococcus infection and respiratory syncytial virus infection will be a breakthrough in reducing perinatal mortality. In this paper, the recommendations for administration of each vaccine during pregnancy are discussed.

Safety and efficacy of Sinopharm vaccine (BBIBP-CorV) in elderly population of Faisalabad district of Pakistan.

INTRODUCTION: The first case of novel SARS-COV-2 (COVID-19) in Pakistan was detected on 26 February 2020. Pharmacological and non-pharmacological strategies have been tried to lessen the mortality and morbidity burden. Various vaccines have been approved. The Drug Regulatory Authority of Pakistan gave emergency approval for Sinopharm (BBIBP-CorV) COVID-19 vaccine in December 2021. The phase 3 trial of BBIBP-CorV included only 612 participants aged 60 years and above. The primary aim of this study was to assess the safety and efficacy of BBIBPP-CorV (Sinopharm) vaccine within the Pakistani adult population aged 60 or above. The study was carried out in the Faisalabad district of Pakistan. METHODS: A test negative case-control study design was used to assess safety and efficacy of BBIBP-CorV in individuals aged 60 and above against symptomatic infection, hospitalisations and mortality due to SARS-CoV-2 among vaccinated and unvaccinated individuals. ORs were calculated using logistic regression model at 95% CI. ORs were used to calculate the vaccine efficacy (VE) by using the following formula.VE= (1-OR) ×100. RESULTS: 3426 individuals with symptoms of COVID-19 were PCR tested between 5 May 2021 and 31 July 2021. The results showed that Sinopharm vaccine 14 days after the second dose was efficient in reducing the risk of symptomatic COVID-19 infection, hospitalisations and mortality by 94.3%, 60.5% and 98.6%, respectively, among vaccinated individuals with a significant p value of 0.001. CONCLUSION: Our study showed that BBIBP-CorV vaccine is highly effective in preventing infection, hospitalisations and mortality due to COVID-19.

Studying how administration route and dose regulates antibody generation against LNPs for mRNA delivery with single-particle resolution.

Following the recent approval of both siRNA- and mRNA-based therapeutics, nucleic acid therapies are considered a game changer in medicine. Their envisioned widespread use for many therapeutic applications with an array of cellular target sites means that various administration routes will be employed. Concerns exist regarding adverse reactions against the lipid nanoparticles (LNPs) used for mRNA delivery, as PEG coatings on nanoparticles can induce severe antibody-mediated immune reactions, potentially being boosted by the inherently immunogenic nucleic acid cargo. While exhaustive information is available on how physicochemical features of nanoparticles affects immunogenicity, it remains unexplored how the fundamental choice of administration route regulates anti-particle immunity. Here, we directly compared antibody generation against PEGylated mRNA-carrying LNPs administered by the intravenous, intramuscular, or subcutaneous route, using a novel sophisticated assay capable of measuring antibody binding to authentic LNP surfaces with single-particle resolution. Intramuscular injections in mice were found to generate overall low and dose-independent levels of anti-LNP antibodies, while both intravenous and subcutaneous LNP injections generated substantial and highly dose-dependent levels. These findings demonstrate that before LNP-based mRNA medicines can be safely applied to new therapeutic applications, it will be crucial to carefully consider the choice of administration route.