SHIFTING FROM PAPER TO DIGITAL PATIENT CONSENT

[...]we want to ensure that the potential participant understands the study, especially the risks and benefits. [...]paper consent increases the patient burden of participating in trials, requiring more time and travel. [...]our team is now better prepared to review documents, ensure accuracy, and seamlessly file a patient's information.

Dynamic modelling of changes in emotional and behavioural problems in children and adolescents during the COVID-19 pandemic

Aims: Children and adolescents were affected in various ways by the measures due to COVID-19 pandemic. The aims of this study were to investigate and compare the effects on mental health across age, to identify latent class trajectories of emotional and behavioural problems over 12-months and to examine the association of classes of trajectories with baseline demographic and clinical predictors. Method(s): Children (n = 1854) and adolescents (n = 1243) from the general population were assessed baseline, at 6-, 9-, and 12-month follow-up. They were eligible if they were residents in Austria, Germany, or Switzerland, were parents/caregivers of a child aged between 7 and 10 years or adolescents >=11 years, had sufficient German language skills and provided informed consent. Results and Conclusion(s): Significant age-effects were found regarding type and frequency of problems. While children had the largest increase in aggressive behaviours, adolescents reported the largest increase in emotional problems. Sociodemographic variables, exposure to and appraisal of COVID-19, psychotherapy before COVID-19 and parental mental health significantly predicted change in problemscores (F >= 3.69, p <= .001). Using growth mixture modelling, a oneclass solution was detected for the trajectory of aggressive behaviours and a two- and three-class solution for withdrawn/depression and anxiety/depression. A substantial proportion of children and adolescents experienced age-related mental health problems during the different stages of the COVID-19 pandemic. These results suggest that psychological problems of specific sub-groups should be monitored over the longer-term and interventions to improve communication, emotion regulation, and appraisal style should be offered to risk groups.

Management of cardiovascular complications of BTKis: Are we complying with the good practice guidelines?

Bruton tyrosine kinase inhibitors (BTKis) were approved for use at the end of 2013 and have since been used for indications including chronic lymphocytic leukaemia (CLL), Waldenstrom's macroglobulinaemia and mantle cell lymphoma. The use of BTKis has increased significantly in the UK since they achieved NICE (National Institute for Health and Care Excellence) approval for frontline treatment of CLL in 2021. However, they are associated with significant adverse cardiovascular events. In September 2021 the British Journal of Haematology published good practice guidelines for the management of cardiovascular complications of BTKis. Our aim was to see whether these guidelines had been adhered to for patients taking BTKis. Method(s): Data was collected for all patients being prescribed BTKis (ibrutinib and acalabrutinib) in the South Tees NHS Trust in July 2022. Patients' medical records were used to assess whether their management adhered to the good practice guidelines. Data was collated for 67 patients in total. Result(s): The data showed that although all patients were consented for the risk of atrial fibrillation only 6% were consented for hypertension and only 1.5% for ventricular arrhythmias and sudden cardiac death. The guidelines recommend a baseline ECG (electrocardiogram) on commencement of treatment;however, only 7% had this completed and 0% had the minimum monitoring recommendation of 6-monthly ECGs. Thirty patients (45%) had an indication for a baseline echocardiogram;however, only one had this completed. For patients reporting symptoms of syncope, dizziness or palpitations only 50% had an ECG completed. Three patients developed worsening heart failure. The recommendations suggest referral to a cardio-oncologist;however, due to lack of availability of this service the referrals were instead made to the usual cardiologist. Conclusion(s): Although there was a lack of compliance with guideline recommendations, it should be considered that most usual checks were affected by COVID-19 outbreaks and a drop in face-to- face clinics, which were replaced by phone clinics and home delivery of medications. However, the premade consent forms for BTKis need to be updated to include consent for ventricular arrhythmias and sudden cardiac death. There also needs to be routine procedures in place to ensure that regular blood pressure testing and ECG monitoring occurs and that there is prompt recognition of cardiovascular complications. Action and implementation: To ensure improved compliance with these guidelines we plan to update our consent forms and create a proforma for clinic use to ensure that clinicians are aware of the various monitoring criteria required.

Participation in COVID-19 clinical trials, willingness to participate, and trust in sources of information among persons with and without cancer in Puerto Rico

Introduction: Cancer patients have a high risk of severe COVID-19 and complications from it. Although the COVID-19 pandemic has led to an increase in the conduction of clinical trials (CTs), there is a scarcity of data on CT participation among cancer patients. We aimed to describe the level of participation in a COVID-19 CT, willingness to participate, as well as trust in sources of information for CTs among persons with and without a previous cancer diagnosis in Puerto Rico. Method(s): Data collected from November 2021 to March 2022 from two cross-sectional studies were merged and used for analysis. Informed consent, telephone, face-to-face, and online interviews were conducted among participants >=18 years old living in Puerto Rico (n=987). Descriptive statistics and bivariate analysis (Fisher's exact text and chi-squared test) was done to describe the outcomes of interest, overall and by cancer status. Result(s): Mean age of participants was 41+/-15.5 years. Most participants were women (71.3%), with an educational level greater than high school (89.5%) and with an annual family income below $20,000 (75.1%). Overall, 4.4% of participants (n=43) reported history of cancer diagnosis. Only 1.8% of the population reported to have participated in a COVID-19 CT to receive either a treatment or vaccine;stratifying by cancer, none of the cancer patients had participated in a COVID-19 CT, and only 1.9% of non-cancer patients participated. While 37.0% of the participants indicated being very willing to sign up for a CT assessing COVID-19 treatment, willingness was higher in cancer patients (55.8%) than among participants without cancer (36.1%). Regarding trust in sources of information for CTs, the level of trust ("a great deal/a fair amount") was higher for their physicians (87.6%), researchers (87.0%), the National Institute of Health (86.7%), their local clinics (82.9%), and a university hospital (82.7%), while it was lower for a pharmaceutical company (64.0%), and for friend, relative, or community leader (37.6%);no differences were observed by cancer status. Conclusion(s): While participation in COVID-19 CTs was extremely low in the study population, the willingness to participate was higher among cancer patients. Education on CTs and their availability are necessary to increase participation in this understudied group. Such efforts will enhance the representation of Hispanic and vulnerable populations, such as cancer patients, on COVID-19 CTs, and thus proper generalizability of study findings in the future.

Implementing the Yorkshire Cancer Research funded Prehabilitation Radiotherapy Exercise smoking Habit cessation And Balanced diet Study (PREHABS): a therapeutic radiographer's perspective

Introduction: Lung cancer patients often have a number of comorbidities which impacts patient mortality and morbidity rates. Lifestyle changes for this group of patients have the potential to positively impact both quality of life and longevity. The Yorkshire Cancer Research funded Prehabilitation Radiotherapy Exercise smoking Habit cessation And Balanced diet Study (PREHABS) was designed to determine if it is feasible to embed interventions promoting a healthier lifestyle into the radical lung radiotherapy pathway. Method(s): The PREHABS study was led by therapeutic radiographers trained in smoking cessation provision, motivational interviewing, informed consent and good clinical practice and a dietitian. Radiographers screened and consented study participants, delivered the exercise intervention and up to 12-weeks of smoking cessation support, whilst dietary advice was provided by the dietitian. Patients diagnosed with chronic obstructive pulmonary disease (COPD), were referred to a community based pulmonary rehabilitation service rather than the PREHABS exercise intervention. Ethical and regulatory approvals were secured in September 2021. Result(s): 61 patients were recruited between September 2021 and October 2022. The majority were female (n=42), mean age 73.1 years (SD 9.36 years). Discussion(s): In addition to the training requirements detailed above and the challenges of COVID-19, the radiographers had to become adept in a number of study-specific aspects including writing the study standard operating procedures (SOPs), creating a study organisational workflow and patient recruitment. The PREHABS study has broadened the radiographer's perspective beyond the radiotherapy department, by further understanding the complex comorbidities that lung cancer patients present with, how to motivate patients to positively change their lifestyle, and how the side effects caused by cancer treatment can affect a patient's ability to change their lifestyle. Conclusion(s): Therapeutic radiographers, after appropriate training, are capable of delivering lifestyle intervention support within a radical lung cancer radiotherapy pathway. Disclosure: No significant relationships.Copyright © 2023 Elsevier B.V.

COVID-19 Vaccination and the Role of Informed Consent: England as a Case Study

Informed consent (IC), following the Supreme Court judgment in Montgomery v Lanarkshire Health Board, [2015] UKSC 11, constitutes a key patients' right. There is a vast literature exploring the significance of this right, while an analysis of the role that this has played in England during the COVID-19 vaccine distribution has been under-explored. Using England as a case study, this paper argues that IC has received limited protection in the COVID-19 vaccination context of the adult population, upholding at its best only a minimalistic approach where mere ‘consent' has been safeguarded. It suggests that new approaches should be brainstormed so as to more properly safeguard IC in a Montgomery-compliant-approach, namely in a way that enhances patients' autonomy and medical partnership, and also to better prepare and respond to future pandemics. [ FROM AUTHOR] Copyright of European Journal of Health Law is the property of Brill Academic Publishers and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full . (Copyright applies to all s.)

Comprensión, confianza y ética en las entrevistas con personas migrantes

Qualitative social research on the lives of migrants in Chile involves investigating the social suffering that arises from the "migratory condition" that is produced. The progressive recrudescence of migration policies both at national and international level since the end of the 20th century has further deepened the effects of the COVID 19 pandemic, generating a complex scenario for research in this area for two reasons: the online modality assumed by the interviewing exercise, and the increase of frictions in the relationship between Chileans and migrants. In this text we ask ourselves how to investigate someone who suffers, for which we stop, on the one hand, in the interview as an exercise that should be vigilant of the structural conditions in which it occurs and that can produce symbolic violence, while it should tend to the understanding of the social from the singularity of a life that the interview attends. This implies considering that the ethics of research runs through the very exercise of, in this case, the interview, so that it is not an external constraint to the method, but an integral part of its deployment. Informed consents play a fundamental role in the achievement of the above, however, they often turn out to be standardized protocols that fail to protect or inform the participating subjects, given their technical language and the little reflection on the social relationship they establish, with the result that Informed Consent ends up being installed in the distance between the researcher and the research participant. This is why it is necessary to stop and consider what is understood by ethics, in order to make the interview a fair institution that is built on the recognition of the other as part of the research exercise. Thus, ethics in qualitative social research must be recognized as both situated and, therefore, as reflexive and non-standardized. Thus, we conclude by arguing that in qualitative social research, understanding and ethics are imbricated in a single exercise.

Discussion on feasibility of electronic informed consent in drug clinical trials.

With the development of science and technology, electronic information technology has penetrated into many aspects of society now. Electronic informed consent is an effective way to adapt to development clinical trial. China is still at an early stage in this field. Affected by the outbreak of COVID-19 in 2020, the demand for electronic informed consent in clinical trial has become more urgent. Based on my own work experience, the author wants to analyze the problems in the traditional informed consent process and the current situations of electronic informed consent in China and explores the feasibility of electronic informed consent in clinical trials.Copyright © 2021 Drug Evaluation Research. All rights reserved.

Observational study of peripheral skin temperature changes following spinal anaesthesia for caesarean delivery

Introduction: Effective spinal anaesthesia for caesarean delivery (CD) is assumed to cause bilateral sympathetic blockade with increased feet skin temperature due to vasodilatation [1]. There has been no published study of peripheral skin temperature measurements during spinal anaesthesia for CD. Our study investigated foot skin temperature changes as spinal anaesthesia was established. Method(s): A single centre, prospective observational study with ethics committee approval (IRAS No. 263967). With informed consent, 60 healthy parturients, 37-42 weeks' gestation with singleton pregnancy scheduled for category 4 CD with spinal anaesthesia were recruited. Standard spinal anaesthesia used 0.5% hyperbaric bupivacaine and diamorphine with IV Phenylephrine and fluids. Skin temperature was measured on the dorsum of both feet with Covidien Mon-a-Therm© skin thermistor sensors prior to intrathecal injection and every minute after until completion of surgery. Theatre room temperature and ambient temperature under surgical drapes were recorded. Two controls were recruited. Result(s): All participants had successful spinal anaesthesia. The Figure shows mean (95% CI) skin temperature changes of both feet of participants during spinal anaesthesia and for controls. The maximum rate of skin temperature increase occurred 5-12 minutes after spinal injection with temperature change plateauing after 30 mins. The mean temperature range was 5.54degreeC (min = 29.7degreeC;max = 35.2degreeC). Discussion(s): This study characterises for the first time the peripheral temperature changes in the feet that occur with sympathetic block after spinal anaesthesia in parturients. Increased bilateral foot skin temperatures occur within 10 minutes of spinal injection. This may be useful for determining successful spinal anaesthesia for CD in addition to other assessments [2]. The insights may be useful for assessing epidural analgesia. The study was supported by an OAA research grant. Data collected by ROAR group.Copyright © 2023 Elsevier Ltd

Past, present and future of RTT training in mainland China: Evaluation of trainee perspectives

Objective: The radiation therapy technologist fundamentals training program (RFTP) facilitates knowledge and skills development of newly employed radiation therapy technologists (RTTs) within our China network. Since its initial implementation in 2019, the RFTP has evolved to address the diversity of RTTs' education and experience, as well as changing local clinical contexts. In particular, a shift to remote delivery and assessment has been required during the COVID-19 pandemic. This quality improvement initiative aimed to evaluate the impact of the RFTP on learning engagement and outcomes, from trainee perspectives. Method(s): Online pre-interview surveys and semi-structured interviews were conducted with 16 RTTs from five China sites in July and August 2022.1 Participants provided verbal informed consent regarding the survey and interview recordings for subsequent analysis. Surveys were reported with descriptive statistics, and interview themes were developed using direct content analysis.2 Results: 15/16 participants qualified in a non-RTT field of study, with most practiced in medical imaging (N = 7);12/12 participants with previous RTT experience reported differences in practice standards. All participants rated the RFTP highly (see Figure), with IGRT (13/16), ARIA (14/16), and SimCT (7/16) most frequently identified as new areas of learning;14 participants who completed the RFTP reported the preparation for IGRT standard workflow was most valuable. Discussion/Conclusion: Results show that the RFTP is an essential on-boarding program that advances RTTs' knowledge and reduces the skills gap to perform our network's established workflows. Additional feedback gained through this initiative will be considered for future development of the RFTP.

COVID Challenges for Trials in Low-to-Middle-Income Countries

While the substantial majority of clinical trials still take place in countries classified by the World Bank as high income, a review of clinical trial registrations on the World Health Organization (WHO) International Clinical Trials Registry Platform and clinicaltrials.gov shows that a significant and growing number are being conducted in LMICs, with major centers in Eastern Europe, the Middle East, Brazil, China, India, and South Africa. COVID-19 will likely have a longlasting effect on global supply chains.11 The U.S. and more than 50 other countries are restricting or considering restrictions on exports of supplies that are needed to mitigate the effects of COVID-19 locally.12 Internationally, the World Trade Organization and the World Customs Organization issued a joint statement noting the disruptive impact of the virus on global supply chains and pledged to cooperate to facilitate trade in essential goods.13 LMICs are struggling to obtain limited hospital supplies in the global market in competition with the U.S., the European Union, Japan, and similar high-income buyers, as recent reporting about the COVID-19 outbreak in Nigeria shows.14 Clinical trial sites in LMICs that cannot obtain needed supplies in-country could obtain them from a study sponsor, assuming the products can be legally imported and shipments to that country are not cost-prohibitive in light of global freight and logistic disruptions. [...]informed consent forms and study institutional review board (IRB) and independent ethics committee (IEC) approvals may need to be revisited in light of local conditions. Clint D. Hermes is an attorney at Bass, Berry & Sims References 1. https://main.icmr.nic.in/sites/default/files/guidelines/EC_Guidance_ COVID19_06_05_2020.pdf 2. http://www.sahpra.org.za/wp-content/uploads/2020/03/SAHPRACommunication_COVID_19-Final-25032020.pdf 3. https://pharmacyboardkenya.org/files/?file=Clinical_Trials_During_ COVID-19_Pandemic.pdf 4. http://portal.anvisa.gov.br/documents/219201/4340788/SEI_ ANVISA+-+0989653+-+Nota+Técnica14.pdf/6b48273f-550f-47618ba1-4e731a87b526 5. https://www.gob.mx/cofepris/articulos/medidas-extraordinarias-enrelacion-a-estudios-clinicos-ante-la-pandemia-de-covid-19 6. https://ensayosclinicos-repec.ins.gob.pe/images/Nueva_actualización_12.12.19/Actualización_2020/Comunicado_N_002-2020.pdf 7. https://www.imf.org/en/Topics/imf-and-covid19/Policy-Responsesto-COVID-19 8. https://www.bsg.ox.ac.uk/research/research-projects/coronavirusgovernment-response-tracker 9. https://covidtracker.bsg.ox.ac.uk/stringency-map 10.https://www.who.int/news-room/commentaries/detail/immunitypassports-in-the-context-of-covid-19 11. https://www.weforum.org/agenda/2020/04/supply-chains-leadership-business-economics-trade-coronavirus-covid19/ 12. https://www.weforum.org/agenda/2020/03/covid-19-coronaviruslessons-past-supply-chain-disruptions/ 13.http://www.wcoomd.org/en/media/newsroom/2020/april/wco-wtojoint-statement-on-covid-19-related-trade-measures.aspx 14.https://www.nytimes.com/2020/05/17/world/africa/coronaviruskano-nigeria-hotspot.html 15. https://mp.weixin.qq.com/s/amB7fBxLw8KSR9DcUsbTWg

Unique vascular complication following extended VV-ECMO support

Objectives: To present an unusual complication related to prolonged ECMO support in a patient with COVID19 induced acute respiratory syndrome (ARDS). Method(s): Clinical chart review of the care process after obtaining the informed consent from the patient. Result(s): A 48-year-old female with COVID-19 infection during second wave of pandemic in August 2021 progressed to severe ARDS. She was put on VV-ECMO support after failing conventional therapy for refractory hypoxemia. Her cannulation configuration included a 25 F venous drainage cannula in the right femoral vein and a 21 F venous return cannula in the right Internal Jugular (IJ) vein. Cannulations were performed using the ;Seldinger technique;under USG guidance, and no difficulties or complications were reported. Her hospital course was notable for delirium, and intermittent bleeding from the cannula sites. After 80 days of support, she showed adequate respiratory improvement which allowed ECMO decannulation. She continued to show improvement, and was eventually discharged after 102 days of total hospital stay. During her 6 weeks follow-up clinic visit a palpable thrill was noted at the jugular ECMO cannula site. A CT angiogram of the neck demonstrated a large venous varix connecting the right IJ and the left common carotid artery with filling from the left common carotid artery. ECMO cannulation site complications such as aneurysm, clots, infections and stenosis are well known. What was unusual in this case is the nature of the aneurysm given that there were no arterial procedures performed on the left side of the neck. She was managed by an ;Amplatzer plug;to the carotid artery at the level of the connection to the varix without any complications. Conclusion(s): Longer duration of ECMO support needs careful follow-up for timely recognition and management of vascular complications. (Figure Presented).

Carving a Path Toward Global Implementation of eConsent in Clinical Trials

[...]countries do not always recognize and allow electronic signatures. In many cases, this calls for a complete revision of existing laws and regulations;it has already been done in the past for some technologies, including the regulation of electronic signatures, but much more important revisions, such as the third revision of International Conference on Harmonization Good Clinical Practice (ICH GCP), are underway for the complete integration of the various aspects of emerging technologies.7 In the scope of our research project, titled "Toward a Global Implementation of eConsent in Clinical Trials," a survey was conducted to understand how eConsent is perceived and experienced by clinical research experts, how it can improve patient comprehension and reduce site burden, as well as to identify areas of opportunities and challenges for further adoption. [...]when stakeholders were asked what the main barrier limiting the implementation of eConsent at their organization is, many sponsors explained that the fragmented guidelines and regulations had considerably hindered their use of eConsent. [...]it requires staff training and adaptation and, here again, the fragmented or-in some cases-even lack of regulation around eConsent makes it difficult to implement on sites.

Characteristics and Clinical Implications of Anti-IFN-alpha cytokine antibodies in partial Recombinase Activating Gene Deficiency patients before and during the COVID-19 Pandemic

Introduction: With the onset of the COVID-19 pandemic, there was increased attention on anti- IFN-alpha autoantibodies and its correlation with severe clinical outcomes in a large group of patients. However, this correlation has not been extensively investigated in patients with partial Recombinase Activating Gene Deficiency (pRD) who are known to have increased prevalence of anti- IFN-alpha autoantibodies. Therefore, there is a need to assess the presence of anti- IFN-alpha antibodies in pRD patients before and after the COVID-19 pandemic and explore the relationship between anti- IFN-alpha antibody presence and clinical outcomes. Method(s): Sera was collected from the whole blood after informed consent and Enzyme-Linked Immunosorbent Assay was conducted to confirm the presence of IgG-specific anti- IFN-alpha autoantibodies. Positive samples were determined as OD values above 3 standard deviations of the healthy donor OD mean. Result(s): Our cohort included both adult (n = 13) and pediatric (n = 9) patients with variants in RAG1 and RAG2. Eleven patients (50%) out of the 22 showed elevated anti- IFN-alpha autoantibodies levels. Five patients (23%) were defined as low positive for anti- IFN-alpha autoantibodies, and 6 patients had no autoantibody titers. Of the 22 patients, 16 were symptomatic with infectious and non-infectious complications including recurrent viral and/or bacterial infections, autoimmune cytopenias, and lymphoproliferation. Ten (63%) of the symptomatic patients demonstrated high anti-IFN-alpha autoantibodies titers. Of the 11 patients with no or low neutralizing anti- IFN-alpha autoantibodies levels, 5 were asymptomatic. In temporal comparison, 16 samples were collected pre-COVID-19 pandemic;8 samples were collected during the pandemic, 2 of which belonged to patients with samples collected before and during the pandemic. In the pre-pandemic cohort, 66% had anti- IFN-alpha autoantibodies. Conversely, during the COVID-19 pandemic, 89% had anti- IFN-alpha autoantibodies. Of note, one patient who had neutralizing anti- IFN-alpha autoantibodies remained positive both before and during the pandemic despite HSCT. Patient also had a SARS-CoV-2 infection in summer of 2022 with a mild clinical course. Conclusions & Next Steps: We observed persistence of anti-IFN-alpha autoantibodies in our cohort post-pandemic and even post-HSCT. It is unclear whether the presence of anti-cytokine antibodies are risk factor for severe COVID-19.Copyright © 2023 Elsevier Inc.

Mild COVID-19 outcomes in adults with inborn errors of immunity: a single-center experience

Currently, 640 million cases of coronavirus disease 2019 (COVID-19) and 6.6 million deaths have been reported world-wide. Risk factors for severe COVID-19 are known, including those with compromised immunity. Among patients with inborn errors of immunity (IEI), early reports of severe outcomes lead to strict masking and social distancing measures. While this resulted in relatively low infection rates among those with IEI, real-world data describing the clinical course of COVID-19 in this patient population have remained limited. We performed a retrospective study of adult IEI patients followed by our center in which a positive test (rapid antigen or PCR) for COVID-19 was determined between November 2021-November 2022. Medical charts were reviewed, and patient interviews conducted. All patients provided informed consent. Twenty-nine patients were enrolled (22 females, 7 males), aged between 18-69 years (median: 20-29 years). The cohort included those with antibody deficiencies (41.37%), combined immunodeficiencies (34.48%;HIES, CARD11, STAT1-GOF), immune dysregulation disorders (20.69%;LRBA deficiency, AIRE deficiency) and phagocyte defect (3.45%;CGD). The duration of symptoms ranged between 3 days-4 weeks (median: < 1 week). Upper respiratory symptoms (including sore throat, congestion) were reported in 97% while fever was present in 41% of patients. Prior to infection, 14 (48%) patients had underlying asthma or bronchiectasis - 2 subsequently experienced shortness of breath and were treated with inhalers or Sotrovimab, respectively. No treatment was required in 65.5% of cases. The remaining received Paxlovid (10.3%), Sotrovimab (13.79%), or antibiotics (10.3%). Of the 2 patients with STAT1-GOF, one tested positive during a repeat episode of febrile neutropenia which required hospitalization. No other patients were hospitalized or needed ICU admission. No deaths were recorded. In light of these favourable outcomes, patients with IEI can gradually and safely return to normal activities.Copyright © 2023 Elsevier Inc.

LANGERHANS CELL HISTIOCYTOSIS IN A CHILD WITH MULTISYSTEMIC LESIONS ASSOCIATED WITH INFECTED POLIOMYELITIS AND SARS-COV-2, FEATURES OF DIAGNOSTICS. CLINICAL CASE.

Langerhans cell histiocytosis (LCH) is an abnormal clonal proliferation of Langerhans cells. The prognosis varies depending on the form of the disease and organ damage. Any organs and systems can be involved in the pathological process in various combinations. A poor response to standard therapy and an unfavorable prognosis are characteristic of patients with a multisystem form of LCH and involvement of organs at risk. Skin lesions are a classic sign of LCH. Purpose - to describe the complexity and duration of diagnosis of LCH with multisystem damage in a boy aged 2 years and 2 months, infected with poliomyelitis and coronavirus. Clinical case. The first clinical manifestations of LCH in the child debuted with an eczematous-seborrheic rash on the scalp with spread to the limbs and trunk. The child was treated for toxicoderma, hemorrhagic vasculitis at the place of residence for 6 months. The boy lost 1.5 kg of body weight in 1 month. At the time of hospitalization, seborrheic-eczematous rashes on the skin with a hemorrhagic component, trophic-inflammatory changes in the nails of the hands, signs of protein-energy deficiency, stomatitis, gingivitis, hepatosplenomegaly, polyserositis, diabetes insipidus, osteolytic foci of the frontal bones were found. Results of the tests: anemia, thrombocytopenia, hypoproteinemia and hypoalbuminemia, coagulation disorders. The patient had the onset of lower flaccid paraparesis, muscle hypotonia. The boy was diagnosed with a number of infectious complications, including poliomyelitis (a derivative of vaccine poliovirus type 2), COVID-19. The child received LCH-III cytostatic therapy with a positive effect. The research was carried out in accordance with the principles of the Helsinki Declaration. The informed consent of the patient was obtained for conducting the studies.Copyright © 2023 Institute of Physics of the Russian Academy of Sciences. All rights reserved.

What impact did the COVID-19 pandemic have on psychosis and the delivery of early intervention psychosis (EIP) services in Australia?

Background: The COVID-19 pandemic had a catastrophic impact worldwide, the significance of which continues to be explored. For EIP services the implications were two fold. First, that the pandemic and associated psychosocial stressors would lead to an increased incidence of psychosis and secondly, social distancing measures would negatively impact the detection and treatment of people with psychosis. 18 months on and we now have the data to explore these questions. Method(s): Participants included in this study are young people who attended one of the six headspace Early Psychosis (hEP) services across Australia and met the criteria for being at Ultra High Risk (UHR) of psychosis or experiencing a First Episode of Psychosis (FEP), were aged between 12 and 25 years, and provided informed consent for their data to be used. We will analyse the following routinely collected data from young people accessing EIP services and compared outcomes collected the year before the COVID-19 pandemic occurred (March 2019-February 2020) with data collected during the pandemic (March 2020 onwards): a. Clinical and functional outcomes of young people at UHR or with FEP, b. Duration of untreated psychosis (DUP), c. patterns of substance use, and d. source and rates of referrals. Results and Conclusion(s): I will present the differences in the above outcomes for those young people accessing treatment pre and during COVID-19 pandemic. Confounding factors such as age, gender, sexuality, ATSI status, CALD background will be controlled for. Discussion of the results ad implication for clinical practice will follow.

Changing Attitudes about Online Continuing Education and Training: A Singapore Case Study

The COVID-19 pandemic has precipitated an unprecedented education crisis, causing severe disruption to global education systems. One consequence has been an increased demand for online educational platforms, leading to a shift from face-to-face to online teaching. This was the case in Singapore where online educational provisions were quickly adopted and implemented by institutions providing continuing education and training to adult learners. This paper reports on the data from a survey of 258 participants on the accessibility and effectiveness of the different modes of learning (i.e. online learning, face-to-face learning, and a combination of both) based on comparisons prior to and after the onset of COVID-19. The findings indicate that familiarity with online platforms enhances the potential efficacy of online provisions of continuing education and training, but also illuminate issues concerning the kinds of experiences required for effective continuing education and training, with implications for providers and educators in and beyond Singapore.

Impact of COVID-19 on longitudinal breast cancer research studies involving TNBC patients

Background Triple-negative breast cancer (TNBC) accounts for ~15% of breast cancer diagnoses but is linked to worse outcomes and comprises a disproportionate number of breast cancer deaths. The TNBC pilot study is a prospective longitudinal study to provide a critical resource for understanding TNBC disease. However, the pandemic impacted the collection of samples. Objective To highlight the impacts of COVID-19 on this longitudinal cancer translational research study including the patient's perspective and to develop recommendations to avoid future disruptions. Methods 389 participants were enrolled in the prospective longitudinal cohort, which collected serial blood samples for up to 5 years. Due to the pandemic, research was curtailed for 6 months due to concerns about patient safety, halting the collection of blood samples. Missed samples and data gaps were documented. To complement this, we initiated a survey capturing the patient perspective on their experience of the study disruption due to COVID. Results 217 enrolled participants missed a blood draw or had a collection outside the study window. 158 patients missed 1 time-point collection, and 59 patients missed >= 2 collections. Of the 217 participants who missed a collection, 6 disease recurrence diagnoses and 3 deaths occurred during research curtailment. The collection of survey responses from participants is ongoing and will be presented at the AACR Annual Meeting. Conclusion Missed samples resulted in irreplaceable data gaps critical to monitoring patient outcomes, and reduced cohort sampling during the pandemic. Our current knowledge of the risks suggests that with proper informed consent, collections could have continued. To mitigate disruption in future clinical studies, clear plans should be part of study design to provide continuity. The participants' experience to be reported will also help researchers understand their issues and help develop policies. (Table Presented).

Extracorporeal membrane oxygenation for airway emergencies

Objectives: Extracorporeal membrane oxygenation (ECMO) is well established in cardiorespiratory failure. Here we report the use of ECMO in an airway emergency to provide respiratory support. Method(s): Informed consent was obtained from patient at the time of admission. Result(s): A 48-year-old with COVID-19 requiring venovenous ECMO (VVECMO) for 32 days and tracheostomy for 47 days had developed tracheal stenosis three months after tracheostomy removal, and undergone tracheal resection and reconstruction. He presented two weeks later with acute dyspnea, bloody drainage and a bulge in his neck with coughing. A computerized tomography (CT) of the cervical spine and chest showed dehiscence of the tracheal wound and a gap in the trachea. He was managed with High Flow Nasal Canula and supported on VVECMO support using 25 Fr. right femoral drainage cannula and 23 Fr. left IJ return cannula. A covered stent was placed, neck wound was irrigated and debrided. Patient was decannulated after 10 days on ECMO. Future therapeutic considerations include mediastinal tracheostomy, aortic homograft interposition of the disrupted segment of trachea with stent placement and permanent self-expandable stent with internal silicone stent. Conclusion(s): ECMO is increasingly used in complex thoracic surgery as well as in the perioperative period as salvage support. One of the areas where it has shown promising results is traumatic main bronchial rupture, airway tumor leading to severe airway stenosis, and other complex airway problems. The ease of cannulation, the technological advances and growing confidence in the management of ECMO patients are the main reasons for the expansion of ECMO use beyond conventional indications. The case described above is an example of the use of ECMO in the perioperative management of impending respiratory failure due to airway obstruction or disconnection. (Figure Presented).