Caesarean section in critically unwell peri-partum patients with COVID-19: A tertiary centre's experience

Introduction: The COVID-19 pandemic has required clinical teams to function with an unprecedented amount of uncertainty, balancing complex risks and benefits in a highly fluid environment. This is especially the case when considering the delivery of a pregnant woman critically unwell with COVID-19. This is one maternal critical care team's reflections on establishing best practice and a shared mental model when undertaking a Caesarean section in critically unwell patients with COVID-19. Objective(s): We describe our experience of balancing the risks and streamlining the process of this high-risk intervention. Method(s): We used our standard clinical governance forums across four specialties (Obstetrics, Intensive care, Anaesthetics and Neonatology) to identify key challenges and learning points. We developed a working group to combine our learning and develop a shared mental model across the involved teams. Result(s): 1. The decision to deliver must be multidisciplinary involving Obstetrics, Intensive care, Anaesthetics, Neonatology and the patient according to their capacity to participate. The existing structure of twice daily ITU ward rounds could be leveraged as a 'pause' moment to consider the need for imminent delivery and review the risk-benefit balance of continued enhanced pharmacological thromboprophylaxis. 2. We identified a range of scenarios that our teams might be exposed to: 3. Perimortem Caesarean section 4. Critically unwell - unsafe to move to theatre 5. Critically unwell - safe to move to theatre 6. Recreating an obstetric theatre in the ICU Advantages Avoids moving a critically unstable patient, although our experience is increasing moving patients for ECMO. Some forms of maximal non-invasive therapy such as High Flow Nasal Oxygen may require interruption to move to theatre with resultant risk of harm or be difficult to continue in transport mode through a bulky ICU ventilator e.g. CPAP Disadvantages Significant logistics and coordination burden: multiple items of specialist equipment needing to be brought to the ICU. Human factors burden: performing a caesarean section in an unfamiliar environment is a significant increase in cognitive load for participating teams. Environmental factors: ICU side rooms may offer limited space vs the need to control the space if performed on an open unit. Delivering a Neonate into a COVID bubble. Conclusion(s): Developing a shared mental model across the key teams involved in delivering an emergency caesarean section in this cohort of critically unwell patients has enabled our group to own a common understanding of the key decisions and risks involved. We recommend a patient centred MDT decision making model, with a structure for regular reassessment by senior members of the teams involved. In most circumstances the human factors and logistical burden of recreating an operating theatre in the ICU outweighs the risk of transport to theatre. Pre-defined checklists and action cards mitigate the cognitive and logistical burden when multiple teams do perform an operative delivery in ICU. Action cards highlight key aspects of routine obstetric care to be replicated in the ICU environment.

The inspiratory activity of respiratory center and respiratory muscles strength after COVID-19.

The respiratory pump that provides pulmonary ventilation includes the respiratory center, peripheral nervous system, chest and respiratory muscles. The aim of this study was to evaluate the activity of the respiratory center and the respiratory muscles strength after COVID-19 (COronaVIrus Disease 2019). Methods. The observational retrospective cross-sectional study included 74 post-COVID-19 patients (56 (76%) men, median age - 48 years). Spirometry, body plethysmography, measurement of lung diffusing capacity (DLCO), maximal inspiratory and expiratory pressures (MIP and MEP), and airway occlusion pressure after 0.1 sec (P0.1) were performed. In addition, dyspnea was assessed in 31 patients using the mMRC scale and muscle strength was assessed in 27 of those patients using MRC Weakness scale. Results. The median time from the COVID-19 onset to pulmonary function tests (PFTs) was 120 days. The total sample was divided into 2 subgroups: 1 - P0.1 <= 0.15 kPa (norm), 2 - > 0.15 kPa. The lung volumes, airway resistance, MIP, and MEP were within normal values in most patients, whereas DLCO was reduced in 59% of cases in both the total sample and the subgroups. Mild dyspnea and a slight decrease in muscle strength were also detected. Statistically significant differences between the subgroups were found in the lung volumes (lower) and airway resistance (higher) in subgroup 2. Correlation analysis revealed moderate negative correlations between P0.1 and ventilation parameters. Conclusion. Measurement of P0.1 is a simple and non-invasive method for assessing pulmonary function. In our study, an increase in P0.1 was detected in 45% of post-COVID-19 cases, possibly due to impaired pulmonary mechanics despite the preserved pulmonary ventilation as well as normal MIP and MEP values.Copyright © Savushkina O.I. et al., 2023.

Acute Coronary Syndrome during the Pandemic New Coronavirus Infection.

The experience of managing patients with COVID-19 around the world has shown that, although respiratory symptoms predominate during the manifestation of infection, then many patients can develop serious damage to the cardiovascular system. However, coronary artery disease (CHD) remains the leading cause of death worldwide. The purpose of the review is to clarify the possible pathogenetic links between COVID-19 and acute coronary syndrome (ACS), taking into account which will help to optimize the management of patients with comorbid pathology. Among the body's responses to SARS-CoV-2 infection, which increase the likelihood of developing ACS, the role of systemic inflammation, the quintessence of which is a "cytokine storm" that can destabilize an atherosclerotic plaque is discussed. Coagulopathy, typical for patients with Covid-19, is based on immunothrombosis, caused by a complex interaction between neutrophilic extracellular traps and von Willebrandt factor in conditions of systemic inflammation. The implementation of a modern strategy for managing patients with ACS, focused on the priority of percutaneous interventions (PCI), during a pandemic is experiencing great difficulties due to the formation of time delays before the start of invasive procedures due to the epidemiological situation. Despite this, the current European, American and Russian recommendations for the management of infected patients with ACS confirm the inviolability of the position of PCI as the first choice for treating patients with ACS and the undesirability of replacing invasive treatment with thrombolysis.Copyright © 2023 Stolichnaya Izdatelskaya Kompaniya. All rights reserved.

Tuberculosis and Hiv Infection - So Many Questions Pending

Since the early days of HIV infection, back in the eighties, TB - particularly extrapulmonary TB emerged as one of the opportunistic infections affecting these patients, specifically as a reactivation of latent TB infections. A diagnosis of TB in the context of HIV infection was then considered as an 'AIDS defining condition' according to classification systems used at that time. It has been recognized for a long time that there are many interactions between HIV and Mycobacterium tuberculosis, which lead to further immune deterioration and to worsening of both conditions due to complex biological and mechanistic interactions between these two agents. Many methods and techniques have been proposed in order to improve diagnosis of TB in HIV-infected subjects, knowing that TB is the most frequent opportunistic infection;and, if not treated in a timely fashion, it may easily take the lives of affected patients. It is not easy to have a diagnosis of TB in HIV-infected subjects, because of the difficulties for obtaining adequate sputum samples, or because of lack of adequate facilities for making a timely diagnosis, particularly in the so-called developing world. On the other hand, extrapulmonary TB is most frequently found in HIV-infected individuals compared to non-infected subjects, and its diagnosis poses significant difficulties, since so many times invasive procedures must be performed in order to obtain an adequate tissue sample and then be able to identify the pathological characteristics of tuberculous disease. In the first days of HIV infection when no antiretroviral therapy was available, a diagnosis of TB was made on clinical grounds, considering a history of contact or some characteristics of the disease, and those of us who are old (or experienced) enough offered antituberculosis therapy for these subjects, obtaining an adequate response many times, but in all cases, the natural history of HIV infection took place, and ultimately these patients died because of the occurrence of another opportunistic infection (or malignancy). With the advent of antiretroviral therapy in the late nineties, another problem occurred. The possibility of drug-drug interactions, taking into account hepatic metabolism of rifampin and the alterations of antiretroviral drug blood - or tissue - concentrations. On top of this, the occurrence of IRIS became another problem, and strategies and protocols have been designed in order to establish the adequate timing of antituberculosis therapy and sometime later antiretroviral therapy. A last point to be considered is the COVID-19 pandemic. The question to be asked is what the influence of the pandemic has been for affecting TB and HIV diagnosis and therapy strategies and programs, particularly in the developing world, knowing that health systems in these countries have many limitations, and that - scant - resources had to be dedicated for the fight against the pandemic.Copyright © 2023

Is It Cancer Hepatic Inflammatory Pseudotumor: An Important Hepatic Mass Differential

Introduction: Hepatic inflammatory pseudotumor (HIP), albeit rare, is an important pathology to be included in differentials for hepatic masses. The benign nature and treatment of this disease process should be considered especially in comparison to malignant hepatic processes. Case Description/Methods: A 66-year-old male with pre-existing history of compensated Hepatitis C cirrhosis status post direct-acting antivirals with sustained virologic response presented in shock after a syncopal episode. Initial work up revealed leukocytosis, thrombocytopenia, acute renal injury, elevated liver enzymes, and COVID-19 positive test. Patient underwent initial liver ultrasound revealing intrahepatic and extrahepatic biliary ductal dilation. Subsequent MRCP demonstrated diffuse thickening of intra and extra hepatic bile ducts suggestive of cholangitis and several hepatic masses concerning for abscesses versus possible metastatic cholangiocarcinoma. Patient improved symptomatically with antibiotics and supportive care. A liver biopsy was performed with pathology showing lymphoplasmacytic inflammation and fibroblastic infiltration suggestive of hepatic inflammatory pseudotumor. A repeat MRCP one week later showed interval decrease in size of liver lesions and repeat liver function tests also showed improvement. Patient was discharged on a course of ciprofloxacin and metronidazole. Patient had repeat MRCP 3 months after discharge, with further significant improvement in size of liver lesions. After multi-disciplinary discussion the plan was for further surveillance with imaging and labs in 2 months. Discussion(s): Inflammatory pseudotumors are benign and non-neoplastic lesions that can occur in any organ. They can appear as a malignant lesion when they arise in the liver and an accurate identification can allow for conservative management and prevent unnecessary invasive procedures. Hepatic inflammatory pseudotumors are often seen with concomitant infection or inflammatory processes. Liver biopsies distinguish these tumors from other malignant processes as they demonstrate a characteristic dense inflammatory infiltrate interspersed in stroma of interlacing bundles of myofibroblasts. This case highlights the importance of maintaining HIP on the differential diagnosis. (Figure Presented).

The inspiratory activity of respiratory center and respiratory muscles strength after COVID-19.

The respiratory pump that provides pulmonary ventilation includes the respiratory center, peripheral nervous system, chest and respiratory muscles. The aim of this study was to evaluate the activity of the respiratory center and the respiratory muscles strength after COVID-19 (COronaVIrus Disease 2019). Methods. The observational retrospective cross-sectional study included 74 post-COVID-19 patients (56 (76%) men, median age - 48 years). Spirometry, body plethysmography, measurement of lung diffusing capacity (DLCO), maximal inspiratory and expiratory pressures (MIP and MEP), and airway occlusion pressure after 0.1 sec (P0.1) were performed. In addition, dyspnea was assessed in 31 patients using the mMRC scale and muscle strength was assessed in 27 of those patients using MRC Weakness scale. Results. The median time from the COVID-19 onset to pulmonary function tests (PFTs) was 120 days. The total sample was divided into 2 subgroups: 1 - P0.1 <= 0.15 kPa (norm), 2 - > 0.15 kPa. The lung volumes, airway resistance, MIP, and MEP were within normal values in most patients, whereas DLCO was reduced in 59% of cases in both the total sample and the subgroups. Mild dyspnea and a slight decrease in muscle strength were also detected. Statistically significant differences between the subgroups were found in the lung volumes (lower) and airway resistance (higher) in subgroup 2. Correlation analysis revealed moderate negative correlations between P0.1 and ventilation parameters. Conclusion. Measurement of P0.1 is a simple and non-invasive method for assessing pulmonary function. In our study, an increase in P0.1 was detected in 45% of post-COVID-19 cases, possibly due to impaired pulmonary mechanics despite the preserved pulmonary ventilation as well as normal MIP and MEP values.Copyright © Savushkina O.I. et al., 2023.

Acute Coronary Syndrome during the Pandemic New Coronavirus Infection.

The experience of managing patients with COVID-19 around the world has shown that, although respiratory symptoms predominate during the manifestation of infection, then many patients can develop serious damage to the cardiovascular system. However, coronary artery disease (CHD) remains the leading cause of death worldwide. The purpose of the review is to clarify the possible pathogenetic links between COVID-19 and acute coronary syndrome (ACS), taking into account which will help to optimize the management of patients with comorbid pathology. Among the body's responses to SARS-CoV-2 infection, which increase the likelihood of developing ACS, the role of systemic inflammation, the quintessence of which is a "cytokine storm" that can destabilize an atherosclerotic plaque is discussed. Coagulopathy, typical for patients with Covid-19, is based on immunothrombosis, caused by a complex interaction between neutrophilic extracellular traps and von Willebrandt factor in conditions of systemic inflammation. The implementation of a modern strategy for managing patients with ACS, focused on the priority of percutaneous interventions (PCI), during a pandemic is experiencing great difficulties due to the formation of time delays before the start of invasive procedures due to the epidemiological situation. Despite this, the current European, American and Russian recommendations for the management of infected patients with ACS confirm the inviolability of the position of PCI as the first choice for treating patients with ACS and the undesirability of replacing invasive treatment with thrombolysis.Copyright © 2023 Stolichnaya Izdatelskaya Kompaniya. All rights reserved.

COVID-19 screening in asymptomatic patients scheduled for surgery. What is the role of rt-PCR in elective procedures during the pandemic?

Background: COVID-19 has changed medical practice nowadays. One of the biggest concerns has been establishing when invasive procedures such as surgery, GI endoscopy or bone marrow transplant are safe;and if it is necessary to consider screening for asymptomatic patients. Method(s): We identified asymptomatic patients that were scheduled for invasive procedures from May 2020 to April 2021 at Clinica de Marly. Patients were asked to fill a questionnaire about GI and upper respiratory symptoms and contact with possible/confirmed cases of COVID- 19 in the last 15 days. Patients taken to emergency procedures, who had symptoms or contact with probable/confirmed cases in the last 15 days were excluded. rt-PCR was performed to screen COVID-19. Result(s): A total of 1837 patients were included. 104 rt-PCRs tested positive for SARS-CoV-2, leading to a 5.66% of identified asymptomatic patients. Patients were followed-up on the 30th day after the procedure. 1733 negative patients responded to our follow-up, in which only 1 death and 2 complications were detected. 102 positive patients were followed-up and no complications or deaths were reported. Conclusion(s): We found the presence of 5.66% of asymptomatic patients with positive rt-PCR for COVID-19. Safe screening will decide if these invasive interventions can be postponed, or, if the benefit outweighs the risks.Copyright © 2022 Asociacion Colombiana de Infectologia. All rights reserved.

Shunt fraction in Covid-19 related Acute Respiratory Failure

Background: Failing autoregulation of pulmonary vessels and higher shunt have been described in Covid-19 related Acute respiratory failure (ARF). The aim was to investigate shunt fraction in patients with Covid-19-ARF compared to patients with other causes of ARF. Method(s): Observational study of hospitalized patients with Covid-19-ARF and other causes of ARF at Papa Giovanni XXIII Hospital, Bergamo, Italy between June 2020 and November 2021. Shunt fraction was measured by a non-invasive system during spontaneous breathing (BeaconCaresystem). Result(s): We enrolled 51 adult patients (8 female), mean age (+/-SD) 65+/-13 years and mean BMI 28,3+/-5,3 Kg/m2. Covid-19-ARF patients represented 71% (36/51). Community acquired pneumonia was the most common cause of other ARF (11/15). No differences in terms of age and BMI were described between the two groups. Pulmonary gas exchange impairment was similar, median PaO2/FIO2 ratio was 254 [IQR 162,297] in Covid-19-ARF and 269 [IQR 201,296] in other causes of ARF patients (p=0.41). Nevertheless, mean shunt fraction resulted significantly increased in Covid-19-ARF (18+/-6%) than other causes of ARF patients (12+/-9%;p=0.03) Fig. 1. Conclusion(s): Shunt fraction appears to be increased in Covid-19-ARF if compared to patients with other causes of ARF. However, this is the first study proposing this non-invasive method to measure shunt fraction in ARF and further investigations are needed to validate this technique.

Contactless non-invasive method to identify abnormal tongue area using K-mean and problem identification in COVID-19 scenario

Due to the spread of COVID-19 all around the world, there is a need of automatic system for primary tongue ulcer cancerous cell detection since everyone do not go to hospital due to the panic and fear of virus spread. These diseases if avoided may spread soon. So, in such a situation, there is global need of improvement in disease sensing through remote devices using non-invasive methods. Automatic tongue analysis supports the examiner to identify the problem which can be finally verified using invasive methods. In automated tongue analysis image quality, segmentation of the affected region plays an important role for disease identification. This paper proposes mobile-based image sensing and sending the image to the examiner, if examiner finds an issue in the image, the examiner may guide the user to go for further treatment. For segmentation of abnormal area, K-mean clustering is used by varying its parameters.Copyright © 2022 Inderscience Enterprises Ltd.

SMALL: Open Surgery versus Minimally invasive vacuum-Assisted excision for smaLL screendetected breast cancer - a UK phase III randomised multicentre trial

Background: Mammographic screening programmes reduce breast cancer mortality, but detect many small tumours with favourable biological features which may not progress during a woman's lifetime. Screen-detected cancers are treated with standard surgery and adjuvant therapies, with associated morbidities. There is a need to reduce overtreatment of good prognosis tumours and numerous studies have evaluated the omission of radiotherapy in this context. However, there is little evidence to support surgical de-escalation, although percutaneous minimally invasive treatment approaches have been described. Vacuum-assisted excision (VAE) is in widespread use for management of benign lesions and lesions of uncertain malignant potential. SMALL (ISRCTN 12240119) is designed to determine the feasibility of using this approach for treatment of small invasive tumours detected within the UK NHS Breast Screening Programme (BSP). Method(s): SMALL is a phase III multicentre randomised trial comparing standard surgery with VAE for screendetected good prognosis cancers. The main eligibility criteria are age >=47 years, unifocal grade 1 tumours with maximum diameter 15mm, which are strongly ER/PR+ve and HER2-ve, with negative clinical/radiological axillary staging. Patients are randomised 2:1 in favour of VAE or surgery;with no axillary surgery in the VAE arm. Completeness of excision is assessed radiologically, and if excision is incomplete, patients undergo open surgery. Adjuvant radiotherapy and endocrine therapy are mandated in the VAE arm but may be omitted following surgery. Co-primary end-points are: 1. Noninferiority comparison of the requirement for a second procedure following excision 2. Single arm analysis of local recurrence (LR) at 5 years following VAE Recruitment of 800 patients will permit demonstration of 10% non-inferiority of VAE for requirement of a second procedure. This ensures sufficient patients for single arm analysis of LR rates, where expected LR free survival is 99% at 5 years, with an undesirable survival probability after VAE of 97%. To ensure that the trial as a whole only has 5% alpha, the significance level for each co-primary outcome is set at 2.5% with 90% power. The Data Monitoring Committee will monitor LR events to ensure these do not exceed 3% per year. Secondary outcome measures include time to ipsilateral recurrence, overall survival, complications, quality of life and health economic analysis. A novel feature of SMALL is the integration of a QuinteT Recruitment Intervention (QRI), which aims to optimise recruitment to the study. Recruitment challenges are identified by analysing recruiter/patient interviews and audiorecordings of trial discussions, and by review of trial screening logs, eligibility and recruitment data and study documentation. Solutions to address these are developed collaboratively, including individual/group recruiter feedback and recruitment tips documents. Result(s): SMALL opened in December 2019, but recruitment halted in 2020 for 5 months due to COVID-19. At 7st July 2022, 142 patients had been randomised from 26 centres, with a randomisation rate of approximately 45%, and a per site recruitment rate of 0.4-0.5 patients/month, approaching the feasibility recruitment target of 144 patients. Drawing from preliminary QRI findings and insights from patient representatives, a recruitment tips document has been circulated (on providing balanced information about treatments, encouraging recruiters to engage with patient preferences, and explaining randomisation). Individual recruiter feedback has commenced, with wider feedback delivered across sites via recruitment training workshops. Conclusion(s): Despite pandemic-related challenges, SMALL has an excellent recruitment rate to date and is expected to have a global impact on treatment of breast cancer within mammographic screening programmes.

"Inside out" - An exceptional intussusception

Introduction: We present the first case of appendiceal intussusception associated with myeloid sarcoma in a young patient. Minimally invasive techniques used along the clinical course are highlighted. Case description: A 2.5-year-old boy was admitted after three weeks of COVID-19 infection with ongoing symptoms of MIS-C. Due to constipation, distended belly and vomiting, US was done which showed ileocolic intussusception. After unsuccessful hydrostatic reduction laparoscopic exploration was performed, where the vermiform appendix was found to be thickened and partially intussuscepted into the coecum. The ileocecal region was exteriorized transumbilically. After manual reduction of the intussusception, a long, thickened, fragile appendix was removed. Histopathology revealed myeloid sarcoma. Bone marrow investigation identified acute myeloid leukemia. During the oncological treatment, laparoscopic cholecystectomy was necessary due to cholecystitis and cholelithiasis. The child recovered uneventfully in terms of surgical complications, with good cosmetic result. Conclusion(s): No similar case in childhood was found in the English literature. Unusual symptoms and radiological findings of intussusception can conceal unexpected disorders. Minimally invasive technique offered advantages in the treatment of the presented patient and can be recommended to treat intussusception or cholelithiasis, if applicable, during an ongoing oncological treatment as well.Copyright © 2023 The Authors

The Impact of the Covid19 Pandemic on Patients with Peripheral Artery Disease

Background The impact of COVID-19 on major adverse lower extremity (MALE) and cardiovascular events (MACE) in patients with peripheral artery disease (PAD) is unknown. Methods Using the VA Corporate Data Warehouse, Veterans with PAD were identified. Rates of MALE (amputation or lower extremity revascularization [LER]), and MACE (death, MI, or coronary revascularization) were assessed in pre-pandemic (3/11/2019-3/10/2020), early-pandemic (3/11/2020-3/10/2021), and late-pandemic (3/11/2021-3/10/2022) periods. Outcomes were compared using Kaplan-Meier method. Results Of 418,042 Veterans (mean age 72 yrs) with PAD, 76.7% were white and 96.8% male. Furthermore, 89.2% had HTN, 60.4% diabetes, 49.3% CAD, 21.6% heart failure, and 20.5% atrial fibrillation. From 3/11/2019 to 3/10/2022, 3,100 had amputation, 8,187 had LER, & 2,229 had MACE. Amputation rates declined and continued to decline in early- and late-pandemic period (306 to 268 to 235;p<0.001;rates per 100k). Rates of LER declined initially and stabilized in late-pandemic period (951 to 587 to 609;p < 0.001;rates per 100k). MACE did not change significantly. (215 to 168 to 202;p<0.001;rates per 100k). Conclusion Amputation rates in Veterans with PAD did not increase despite a clinically significant decline in LER. Given the known efficacy of noninvasive therapies in PAD, these data suggest that there is a need to re-evaluate appropriate indications for LER and amputation. [Formula presented]Copyright © 2023 American College of Cardiology Foundation

Evolution of pancreatic ductal adenocarcinoma diagnosis during the last decade

Background: Pancreatic Ductal Adenocarcinoma (PDAC) has historically been an important diagnostic and therapeutic challenge. The multidisciplinary approach and new diagnostic techniques' implementation have modified this process. Method(s): We conducted a retrospective analysis based on clinical data of patients with PDAC between the years 2010 to 2021, analyzing the diagnosis and initial treatment evolution. Result(s): 673 patients between 2010-2021 with a suspected diagnosis of pancreatic adenocarcinoma were reviewed. Most of them were metastatic (n=362;53.8%), followed by locally advanced unresectable (n=166;24.7%) and resectable or borderline resectable (n=145;21.5%). Regarding the pathological diagnosis, it was not possible in 62 patients (9.2%), varying over time from 21.2%in 2010-2012 to 1% in 2019-2021 (p<0,0001). Moreover, the number of biopsies has decreased with a mean number of biopsies to obtain a pathological diagnosis of 1.55 (2010-2012) vs 1.31 (2019-2021). During this last period, most of the diagnoses were made by cytological analysis (61.4%;n=121). Specifically in the 2019-2021 patients subgroup, we found that 18 NGS (9,1%) were performed in this period (solid tumor), with 4 patients having actionable mutations (22.2%;3 KRAS G12C). Germline (g) mutational panels were carried out in 89 patients, finding only 9 positive cases (10.1%), being 3 of them gBRCA1/2 mutated (3,4%). In our study, a decrease in palliative management was evidenced over time. In 2010-2012, 28,8% of patients received exclusively palliative care against 9,6% in 2019-21 (p, 0.0001). An increase in PDAC diagnosis was observed since 2010, 44 patients/year in 2010-12 vs. 66 patients/year in 2019-21 (including COVID-19 pandemic period). All previous results are summarized. Conclusion(s): The diagnosis of PDAC has changed throughout the last decade, increasing the percentage of patients with a pathological diagnosis without increasing the number of invasive procedures. The number of patients suitable for anti-cancer therapy has also increased among time. In our cohort, the implementation of molecular testing would change the therapeutic approach in more than 20% of patients.

A review of infection prevention and control guidelines for dental offices during the COVID-19 pandemic in mid-2020

Background: The COVID-19 pandemic was a challenge for all dental professionals who had to rapidly update infection prevention and control (IPAC) guidelines and protocols due to increased risk of SARS-CoV-2 transmission during common aerosol-generating procedures (AGPs), and a lack of consensus on how best to mitigate the risk of transmission in a dental office. Thus, the purpose of this descriptive study was to compare the variance in IPAC guidelines for dental offices that emerged, and to assess practice consistency from early to mid-2020. Methods: A comprehensive literature search was conducted from May 26 to July 8, 2020 for IPAC documentation specific to the dental office during the COVID-19 pandemic. Documents that met the inclusion criteria were independently reviewed. Data was extracted using a framework based on the following IPAC domains: pre-appointment, waiting room, personal protective equipment (PPE) selection, treatment room, and post-dismissal. Results: A total of 67 IPAC documents specific to dental offices were reviewed in this study. Included documents originated from 22 dental associations, 17 peer-reviewed articles, 13 dental regulators, 11 government bodies, two public health units, and two dental corporations. There was a great degree of variance with IPAC guidelines from the pre-appointment stage, during treatment, and post-treatment. Recommendations that emerged with some level of consistency involved pre-screening patients for COVID-19 symptoms (97%), staggering appointments (84%), social distancing, minimizing occupants in the waiting room, wearing a face shield over protective eyewear for AGPs (92%), and preprocedural rinses (84%). There was less consistency with recommendations for consolidating multiple appointments (36%), waiting room ventilation (46%), N95 masks (47%) versus FFP2/FFP3 masks (30%) use for AGPs, fit-testing respirators (37%), enclosing open operatories for AGPs (28%), prioritizing minimally invasive procedures (30%), and using third-party laundry companies (32%). Conclusions: The risk of SARS-CoV-2 transmission, lack of consensus on mode of spread, and need for rapid action resulted in a significant variation in most downstream IPAC interventions in the hierarchy of controls, including choice of PPE, treatment room, and post-dismissal domains. Upstream interventions, including pre-appointment and waiting room domains, were relatively consistent in practices in early to mid-2020.

Challenges and strategies with international recruitment in early phase gene therapy trials

The Children's NIHR Clinical Research Facility at Royal Manchester Children's Hospital has been involved in numerous early phase gene therapy trials for diseases such as GM1 gangliosidosis, Gaucher disease, MPSIIIA and MPSII. These trials have necessitated international recruitment which brings challenges for both site and families. In addition, we also actively recruited participants during the Covid-19 global pandemic, amplifying these challenges. A typical patient journey on one of these trials would involve being approached soon after diagnosis due to the rapid progression of these diseases and the need for early intervention. The family would then relocate to the UK with relatively short notice and commence an intensive period of screening involving a lot of extensive information for them to retain and invasive procedures for the patient. Some of these families will speak no English at all which is an additional barrier to managing the parental anxiety and expectations of the trial and its outcome. Once eligibility is confirmed the families are then faced with an extended stay in the UK without the support of their extended family/community. This impacts parent's employment and other siblings who may or may not be with them and who may also be affected by the same disease. Following administration of the gene therapy, participants then commence intensive follow up often associated with immunosuppressants. Close working with the local clinicians is essential for patient safety and trial integrity. Good engagement with families once they have returned to their home country is vital in obtaining continuing trial data and ensuring retention and compliance with attending future visits. Follow up visits are essential for safety and efficacy data for the progression of gene therapy trials. Travel restrictions brought about by the covid 19 pandemic exacerbated these challenges but with good communication and engagement we have mostly overcome them.

The impact of telesensors on neurosurgical service demand: A cohort cost-effectiveness analysis from institutional and patient perspectives

Introduction: Implantable telemetric intracranial pressure sensors (telesensors) enable routine, non-invasive ICP feedback which can assist with clinical decision-making and attribution of pressure-related symptoms in patients with CSF shunt systems. Here, we aim to characterise telesensor cost-effectiveness and impact on service demand. Methods: A single-centre, retrospective, cohort study and costeffectiveness analysis of 80 patients (78% Female;30% IIH, 22% Chiari malformation, 48% other) with MScio® (Christoph Miethke) telemetric ICP monitors. Service demand in the two years before and after implantation were retrieved from the centre's electronic patient record system. Intentionally, data did not overlap with the COVID-19 pandemic period. The frequencies of hydrocephalusrelated neurosurgical admissions, outpatient clinics, and scans were recorded along with A&E, neurology, and ophthalmology encounters. Tariffs were used to compare expenditure before and after implantation. Results: Significant reductions were seen in the frequencies of neurosurgical admissions (1.9/year to 0.6;p < 0.001), ICP monitoring (0.4 to 0.01;p < 0.001), and CT scans (0.5 to 0.3;p = 0.013) following implantation. There were also significant reductions in the proportion of patients requiring admissions (91% to 45%;p < 0.001) and ICP monitoring (30% to 3%;p < 0.001). There were non-significant reductions in other invasive procedures, neurology encounters, and A&E admissions. Overall, there was a £341 (SD = 1069) per patient per year saving (22% reduction in included costs). Conclusions: From an institutional perspective, the implantation of telesensors contributes to a reduction in service demand and a net financial saving. From a patient perspective, fewer appointments, invasive procedures, and radiation exposures suggest an improvement in patient experience and safety.

The impact of telesensors on neurosurgical service demand: A cohort cost-effectiveness analysis from institutional and patient perspectives

Introduction: Implantable telemetric intracranial pressure sensors (telesensors) enable routine, non-invasive ICP feedback which can assist with clinical decision-making and attribution of pressure-related symptoms in patients with CSF shunt systems. Here, we aim to characterise telesensor cost-effectiveness and impact on service demand. Method(s): A single-centre, retrospective, cohort study and costeffectiveness analysis of 80 patients (78% Female;30% IIH, 22% Chiari malformation, 48% other) with MScio (Christoph Miethke) telemetric ICP monitors. Service demand in the two years before and after implantation were retrieved from the centre's electronic patient record system. Intentionally, data did not overlap with the COVID-19 pandemic period. The frequencies of hydrocephalusrelated neurosurgical admissions, outpatient clinics, and scans were recorded along with A&E, neurology, and ophthalmology encounters. Tariffs were used to compare expenditure before and after implantation. Result(s): Significant reductions were seen in the frequencies of neurosurgical admissions (1.9/year to 0.6;p < 0.001), ICP monitoring (0.4 to 0.01;p < 0.001), and CT scans (0.5 to 0.3;p = 0.013) following implantation. There were also significant reductions in the proportion of patients requiring admissions (91% to 45%;p < 0.001) and ICP monitoring (30% to 3%;p < 0.001). There were non-significant reductions in other invasive procedures, neurology encounters, and A&E admissions. Overall, there was a 341 (SD = 1069) per patient per year saving (22% reduction in included costs). Conclusion(s): From an institutional perspective, the implantation of telesensors contributes to a reduction in service demand and a net financial saving. From a patient perspective, fewer appointments, invasive procedures, and radiation exposures suggest an improvement in patient experience and safety.