Evaluating Efficacy Of Functional Luminal Imaging Probe In Preoperative Evaluation For Antireflux Procedures

Introduction: The COVID-19 pandemic caused significant decreases in outpatient procedures, many of which are required before to antireflux operation (ARS). The purpose of this study was to add functional luminal imaging probe (FLIP) to esophagogastroduodenoscopy (EGD) and esophageal pH monitoring to assess its utility in decreasing the need for follow up studies in patients being evaluated for ARS. Method(s): Retrospective observational study was performed on 81 patients being evaluated for GERD who underwent EGD, pH monitoring, and FLIP. Data collected included average distensibility index (DI) at 60 mL, presence of repetitive anterograde or retrograde contractions, hiatal hernia dimensions, pathology results, pH data, and need for follow-up testing. Result(s): Based on FLIP results, HRM was recommended in 35 patients (43.2%). This included 14 patients with DI suggestive of significant esophagogastric junction outflow obstruction, eight of whom completed HRM with four confirmed as achalasia. FLIP results were suspicious for eosinophilic esophagitis (EoE) in four patients of which one was confirmed as EoE on biopsy. Gastric emptying study was felt to be necessary for 11 patients before to ARS. Conclusion(s): FLIP identified patients with possible alternative pathologies including achalasia and EoE that would otherwise be a contraindication to ARS. FLIP at the time of EGD and pH monitoring is useful as it guides the clinical decision on need for additional outpatient procedures, which may be difficult to obtain in pandemic conditions. FLIP was effective at reducing the requirements for further follow-up testing in the majority of patients being evaluated for potential ARS.

Design Probes in a Pandemic: Two Tales of Hybrid Radical Placemaking from Ireland and Australia

Design probes, an essential research tool during the COVID-19 pandemic, are ancillary "personal"data gathering tools that enable researchers to enter the private world of research participants. This paper compares two case studies of design probes used during the pandemic for radical placemaking in hybrid digital-physical environments: Digital Art Summer School in Northrock, Ireland, with eleven participants, and Chatty Bench Project in Brisbane, Australia, with sixteen participants. The paper further expands on the design methodology of the probes and their deployment during the online radical placemaking projects. From the participant responses to the probes' activities and interviews, both studies demonstrated that the probes fostered placemaking in digital environments during the pandemic. The paper concludes with three lessons on the potential of probes as a critical research instrument to enable creativity, build social capital and create bonds between people and places during uncertain and turbulent times. © 2022 Owner/Author.

Tell Me About It: Adolescent Self-Disclosure with an Online Robot for Mental Health

Self-disclosure to a social robot is a mental health intervention that can decrease stress for adolescents. Online digital robots provide the potential to scale this intervention especially in COVID-19 social distancing situations. However, self-disclosure interactions with digital social robots remain relatively unexplored. We conducted two online self-disclosure studies with adolescents (13-19 years old): our Active Listening Study compared experiences sharing positive, negative, and neutral feelings with a social robot, while our Journaling Study explored differences in sharing stressors by speaking with and without a social robot and by writing. We found that positive prompt tone improved mood while neutral prompt decreased stress, and less negative attitudes toward robots correlate with more qualitatively positive experiences with robot interactions.We also found robot disclosure interactions hold promising potential as a preferred method of self-disclosure over solo speaking, moderated by negative attitudes toward robots. This paper outlines limitations and future work from these studies. © 2023 IEEE Computer Society. All rights reserved.

Lung transplant and COVID-19: A single centre experience in Ireland

As of April 2022, the Mater Hospital serves 190 patients who have been the recipient of a lung transplant in Ireland. During the COVID-19 pandemic, solid organ transplant was recognised as a risk factor for progression to severe disease. In January 2022, the European Medicines Agency (EMA) approved the use of Sotrovimab for high risk patients. Sotrovimab is a monoclonal antibody which neutralises SARS-CoV-2 with recent data showing efficacy in reducing the risk of progression to severe disease in high risk patients . We aim to describe our patient cohort and the rates of COVID-19 infection seen before and after the introduction of monoclonal antibody therapy. While likely reflecting emerging variants resulting in less severe disease, we observe variation in morbidity and mortality in this time. From March 2020 to April 2022, 116 post-lung transplant patients tested positive for COVID-19 infection. This represents 61% of our overall population. Since January 2022, coinciding with the surge of the omicron variant, 57 patients contracted COVID-19. 47 were deemed to be suitable for treatment with 10 presenting outside the window for therapeutic intervention. 3.5% (n=2) required ICU admission and 2 died directly as a result of COVID-19. Prior to this, 58 patients contracted COVID-19, 31 of which (53.5%) required hospital admission with 18 (58%) requiring ICU admission. Overall we saw 13 deaths representing 22.4% of this group and 6.8% of the overall population.

Demand for hospital-based telemedicine services among outpatients during the Covid-19 outbreak

Background: In response to the COVID-19 outbreak in China, we opened the hospital-based video consultation service that allows virtual visits for outpatients with any illness. Although telemedicine used widely during the pandemic, there is lack of data to estimate the demand and effect in an outbreak. Here we retrospectively evaluate the effect of virtual service in a tertiary hospital and breakdown the whole volume data. Method(s): Between Jan30,2020 and Mar12,2020, the video-consultation station was set up in the hospital and specialists staffed the service equivalent to previous in-person care service for outpatients. The service fielded calls for fever triage and other complaints to a total of 122 specialists from 34 branches of medicine, each consultation was recorded. Result(s): Over 41 days, 570 called to report fever, 16 (3%) of whom were asked to the facility for further care. None was addmited to hospital. The remaining 554 (97%) were followed up at home by telemedicine. Among the 4811 patients who called for other illnesses, 568(11.8%) were asked to visit the clinic for further care. Among these present to hospital after calling, 35.6% got further care in Reproductive medicine, 11.8% in Obstetrics, 6.5% in Endocrinology, 5.6% in Gynecology, 40.5% in other divisions. The remained 4243(88.2%) were followed up at home through the telemedicine service. The average recovery course was 3.2 days by self-report. Conclusion(s): We found the telemedicine service reduced the potential in-person visits volume by 90%. Adjusting the panel of hybrid specialists scheduel to meet different volume demand of branches is needed to rebuild a more resilient hospital strategy for outpatient care in the pandemic.

Work-related experiences of mental health professionals during COVID-19 pandemic: a qualitative study

The imposition of nation-wide lockdowns and sporadic transition to remote work produced unforeseen psychological challenges likely to impact the medium of care and workload of mental health professionals. The present study explored the lived occupational experiences of clinical psychologists, counsellors, and psychotherapists working in the National Health Service (NHS) and private practice in the UK during COVID-19 pandemic. Nineteen professionals (11 employed in the NHS and 8 working in independent settings) were interviewed about their professional experiences during first and second waves of the pandemic. Data were analysed using interpretative phenomenological analysis. Three main themes emerged from the analysis: (i) transition from face to face to online therapy;(ii) novel changes and wellbeing;and (iii) uncertain professional support in uncertain times. The findings suggest that lack of experience in providing online or telephonic psychotherapeutic services from home negatively impacted professionals' physical and psychological health and wellbeing. Thus, to cope with it, they availed psychological and structural support from colleagues, co-workers, clinical supervisors, managers, organisations, and professional bodies. This study adds to the existing body of research on the impact of the pandemic on UK-based mental health professionals and from an applied perspective, it highlights the need for skill-upgradation of professionals. © 2023 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group.

Early Use of Aprv in Critically Ill Adults with Moderate-to-Severe Ards: A Pilot Feasibility Trial

INTRODUCTION: Airway pressure release ventilation (APRV) may be an alternative to low tidal volume ventilation for patients with acute respiratory distress syndrome (ARDS). We conducted an investigator-initiated, pilot feasibility randomized controlled study (RCT) comparing APRV to low tidal volume ventilation in critically ill adults with ARDS (ClinicalTrials.gov identifier NCT 04156438). METHOD(S): Participants with moderate-to-severe ARDS admitted to an intensive care unit (ICU) in Regina, Saskatchewan, were randomized on an open-label basis to APRV or low tidal volume ventilation, over a one-year period. The primary feasibility outcomes were the informed consent rate, recruitment rate, and protocol adherence rate. A successful informed consent rate was defined as at least 70% of eligible patients approached for study participation consenting to participation. Enrollment of at least 15 participants during the one-year recruitment period was considered a successful recruitment rate. Protocol adherence was defined as the number of patient-days of complete adherence to the study protocol, with a rate of at least 80% considered successful. The secondary efficacy outcomes were 28-day mortality, in-hospital mortality, ICU length of stay, hospital length of stay, length of mechanical ventilation, and incidence of tracheostomy. RESULT(S): Due to interruptions in study recruitment from the COVID-19 pandemic, this study took place between July 1, 2020 to December 31, 2021 to ensure a one-year recruitment window. Of the 165 ARDS patients admitted to the ICU during this period, 42 (25.5%) were screened for eligibility, with 17/42 patients (40.5%) meeting the eligibility criteria. 13/17 (76.5%) secondary decision makers were approached for informed consent, with only one (7.7%) giving consent for participation. Clinical documentation limited ability to assess protocol adherence. Efficacy outcomes were not analyzed due to low recruitment. No adverse events associated with trial participation were identified. CONCLUSION(S): Our study did not meet the pre-specified feasibility outcomes for recruitment, informed consent, or protocol adherence. Future studies of ventilation strategies for ARDS at our center may need to consider the impacts of COVID-19 pandemic on recruitment strategies, institutional resources and policies.

Mortality Risk in Pediatric Sepsis Based on C-reactive Protein and Ferritin Levels.

OBJECTIVES: Interest in using bedside C-reactive protein (CRP) and ferritin levels to identify patients with hyperinflammatory sepsis who might benefit from anti-inflammatory therapies has piqued with the COVID-19 pandemic experience. Our first objective was to identify patterns in CRP and ferritin trajectory among critically ill pediatric sepsis patients. We then examined the association between these different groups of patients in their inflammatory cytokine responses, systemic inflammation, and mortality risks. DATA SOURCES: A prospective, observational cohort study. STUDY SELECTION: Children with sepsis and organ failure in nine pediatric intensive care units in the United States. DATA EXTRACTION: Two hundred and fifty-five children were enrolled. Five distinct clinical multi-trajectory groups were identified. Plasma CRP (mg/dL), ferritin (ng/mL), and 31 cytokine levels were measured at two timepoints during sepsis (median Day 2 and Day 5). Group-based multi-trajectory models (GBMTM) identified groups of children with distinct patterns of CRP and ferritin. DATA SYNTHESIS: Group 1 had normal CRP and ferritin levels ( n = 8; 0% mortality); Group 2 had high CRP levels that became normal, with normal ferritin levels throughout ( n = 80; 5% mortality); Group 3 had high ferritin levels alone ( n = 16; 6% mortality); Group 4 had very high CRP levels, and high ferritin levels ( n = 121; 11% mortality); and Group 5 had very high CRP and very high ferritin levels ( n = 30; 40% mortality). Cytokine responses differed across the five groups, with ferritin levels correlated with macrophage inflammatory protein 1α levels and CRP levels reflective of many cytokines. CONCLUSIONS: Bedside CRP and ferritin levels can be used together to distinguish groups of children with sepsis who have different systemic inflammation cytokine responses and mortality risks. These data suggest future potential value in personalized clinical trials with specific targets for anti-inflammatory therapies.

The Temporal Association of the COVID-19 Pandemic and Pediatric Cardiopulmonary Resuscitation Quality and Outcomes.

OBJECTIVES: The COVID-19 pandemic resulted in adaptations to pediatric resuscitation systems of care. The objective of this study was to determine the temporal association between the pandemic and pediatric in-hospital cardiac arrest (IHCA) process of care metrics, cardiopulmonary resuscitation (cardiopulmonary resuscitation) quality, and patient outcomes. DESIGN: Multicenter retrospective analysis of a dataset comprising observations of IHCA outcomes pre pandemic (March 1, 2019 to February 29, 2020) versus pandemic (March 1, 2020 to February 28, 2021). SETTING: Data source was the ICU-RESUScitation Project ("ICU-RESUS;" NCT028374497), a prospective, multicenter, cluster randomized interventional trial. PATIENTS: Children (≤ 18 yr) who received cardiopulmonary resuscitation while admitted to the ICU and were enrolled in ICU-RESUS. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Among 429 IHCAs meeting inclusion criteria, occurrence during the pandemic period was associated with higher frequency of hypotension as the immediate cause of arrest. Cardiac arrest physiology, cardiopulmonary resuscitation quality metrics, and postarrest physiologic and quality of care metrics were similar between the two periods. Survival with favorable neurologic outcome (Pediatric Cerebral Performance Category score 1-3 or unchanged from baseline) occurred in 102 of 195 subjects (52%) during the pandemic compared with 140 of 234 (60%) pre pandemic ( p = 0.12). Among survivors, occurrence of IHCA during the pandemic period was associated with a greater increase in Functional Status Scale (FSS) (i.e., worsening) from baseline (1 [0-3] vs 0 [0-2]; p = 0.01). After adjustment for confounders, IHCA survival during the pandemic period was associated with a greater increase in FSS from baseline (+1.19 [95% CI, 0.35-2.04] FSS points; p = 0.006) and higher odds of a new FSS-defined morbidity (adjusted odds ratio, 1.88 [95% CI, 1.03-3.46]; p = 0.04). CONCLUSIONS: Using the ICU-RESUS dataset, we found that relative to the year prior, pediatric IHCA during the first year of the COVID-19 pandemic was associated with greater worsening of functional status and higher odds of new functional morbidity among survivors.

The impact of Covid-19 on research into work and health.

BACKGROUND: The global coronavirus (Covid-19) pandemic created a profound disruption to the delivery of planned scientific research with unknown immediate and potentially longer-term impacts. AIMS: We explored researchers' experiences of the impact of the pandemic on the continued development and delivery of research into work and health, and on research infrastructure in this field. METHODS: A cross-sectional study. RESULTS: Thirty-three questionnaires were completed, representing a response rate of 15%. Sixty-one per cent of respondents were female, the majority (78%) had over 11 years of research experience and 76% worked mainly in academia. Most respondents (88%) were able to progress with research during the pandemic. A small proportion (4%) had studies paused or suspended due to the pandemic, while a larger proportion (19%) had research staff redeployed to assist with other studies or furloughed. Respondents described a range of emerging practical and logistical issues for research into work and health during the pandemic. Some benefited from increased opportunities to collaborate on new multidisciplinary studies, opportunities to engage participants in work and health research, and more flexible and inclusive work practices. Others experienced challenges that had an adverse impact, such as hampering research delivery (e.g. barriers to participant screening and intervention delivery), poor (home) working environments, reduced team cohesion and isolation. A range of future priorities for research was highlighted. CONCLUSIONS: We describe lessons learned and opportunities that can be used to support or further research activities in the field of work and health research in the future.

Transparency practices at the FDA: A barrier to global health.

Data sharing among regulators must be "business as usual".

The pharmaceutical industry in action: 2021 clinical research diversity and inclusion survey

Development of medicines and vaccines for COVID-19 amplified the need for all US communities to participate in research. This recognition spurred interest in adopting inclusive and equitable research practices across industry and the clinical research ecosystem in general. Between 2018-2021, regulatory bodies, professional organizations, and working groups issued policy and/or recommendations outlining measures that support the conduct of inclusive and equitable clinical trials. We applied previously published multi-themed strategies, multi-stakeholder recommendations, and calls to action by surveying industry to document baseline practices towards equitable clinical trial representation in the US. Research Question: What strategies are industry leaders deploying to increase diversity in clinical trials? Methods: Using a 4-staged approach, we first identified 48 success factors sourced from 12 documents. This analysis included previously documented measures that are both inclusive of diverse populations as well as practices that facilitate insights from diverse communities. Second, a survey tool was developed that organized the individual success factors into 6 categories with one open-ended question on ecosystem changes;survey measures and 4 choices for each factor were “Actively implementing,” “Recommended to be implemented,” “No plans to implement,” and “No answer.” Third, the survey was administered between April 10-30, 2021, to 12 pharmaceutical companies all having a proven external commitment to health equity in oncology and all are represented on the 2021 1Q Biopharma top 25 by Market Cap report. Fourth, responses were anonymized and aggregated;results were provided to respondents. Results: The response rate was 67% (8/12). Responders indicated success factors across two major implementation categories as follows: “actively implemented” (51%);“recommended/planned for implementation” (44%). No responders added any additional success factors via free text. Being “actively implemented” was highest for the 3 categories “site selection” (78%), “general capabilities” (72%), “leadership” (53%). “Recommended/planned for implementation” was highest for the 3 categories “participant focused” (50%), “other factors” (50%), “racial and ethnic minority group data (REMG)” (48%). Conclusions: Pharmaceutical companies reported active implementation of success factors sourced from public documents across all categories. As an example, stakeholders have generally considered thoughtful site selection an important measure to enroll diverse representation in clinical trials as it may mitigate access barriers to participation. In the site selection category, the survey reported 7/8 companies were actively implementing three measures and 5/8 were actively implementing two measures. An approach and analysis should be considered for expansion to more biotech companies and include a process devised for annual fielding and transparently reporting results.

Timeline for site onboarding for an nih funded clinical trial in pediatric gastroenterology & nutrition: Ikaneat

Prospective multicenter center studies are needed to develop inter-institutional clinical pathways and improve health care practices. Multicenter studies are encouraged by the National Institutes of Health and desired by investigators. However, investigator-initiated, randomized, controlled, multi-site trials face many challenges1, one of which is the timeline involved in contracting, regulatory and human subjects' requirements. These steps must be finalized prior to each site's activation to engage in any study-related activities. Research indicates these timelines can be especially challenging for pediatric trials, and trials involving medically complex patients.2,3 Given the typical investigator-initiated funding cycle of five years or less, understanding the timeline necessary to achieve multi-site activation is key to the conduct of multi-site trials, especially trials that are complex. Therefore, the purpose of the current analysis is to present the timeline for site activation across nine sites in the United States participating in the iKanEat trial (NCT03815019;NIH R01 HD093933) from October 2018 thru present. iKanEat is a prospective randomized controlled trial conducted across 10 sites in the United States focused on the use of megesterol as part of a pediatric tube weaning program. Data were collected from the regulatory system at the primary site regarding the variables of: expressing interest, IRB approval, contract approval, site activation, and first subject recruited. Data indicate that time from expressing interest in the study to full IRB approval averaged 230 days (range = 70-396) and time to full contract approval averaged 190 days (range = 88-190). The time for clearing all administrative hurdles and moving to full site activation for subject recruitment averaged 288 days (range = 253-350) and the time from site activation to consenting a first patient to the study averaged 463 days (range = 314-669). Reasons for delays collected from each site included coordination with the investigational pharmacy, site accounting set up, and scheduling site trainings with the investigative team at the primary site. It is also likely that the outbreak of SARS COV-2, and subsequent pauses in site activities, impacted these timelines, especially from March 2020-March 2021. These longer than anticipated timelines have put subject recruitment goals at risk and also increased cost for the current study. These findings indicate that at least one year should be built into study timelines prior to subject recruitment. This information should be helpful to other investigators planning multi-site investigator-initiated pediatric trials. Future research should examine specific methods for decreasing these timelines, with an emphasis on those trials that involve medically complex children.

Strain Echocardiography and Myocardial Dysfunction in Critically Ill Children With Multisystem Inflammatory Syndrome Unrecognized by Conventional Echocardiography: A Retrospective Cohort Analysis.

OBJECTIVES: Multisystem inflammatory syndrome in children is a newly defined complication of severe acute respiratory syndrome coronavirus 2 infection that can result in cardiogenic shock in the pediatric population. Early detection of cardiac dysfunction is imperative in directing therapy and identifying patients at highest risk for deterioration. This study compares the strengths of conventional and strain echocardiography in identifying cardiac dysfunction in critically ill children with multisystem inflammatory syndrome in children and their association with ICU therapeutic needs and clinical outcomes. DESIGN: Retrospective, observational cohort study. SETTING: A large, quaternary care PICU. PATIENTS: Sixty-five pediatric patients admitted to the PICU with the diagnosis of multisystem inflammatory syndrome in children from March 2020 to March 2021. INTERVENTIONS: Global longitudinal strain four chamber was measured retrospectively by strain echocardiography and compared with conventional echocardiography. Cardiac dysfunction was defined by left ventricular ejection fraction less than 55% and global longitudinal strain four chamber greater than or equal to -17.2%. Clinical variables examined included cardiac biomarkers, immune therapies, and ICU interventions and outcomes. MEASUREMENTS AND MAIN RESULTS: Twenty-four patients (37%) had abnormal left ventricular ejection fraction and 56 (86%) had abnormal global longitudinal strain four chamber. Between patients with normal and abnormal left ventricular ejection fraction, we failed to identify a difference in cardiac biomarker levels, vasoactive use, respiratory support needs, or ICU length of stay. Global longitudinal strain four chamber was associated with maximum cardiac biomarker levels. Abnormal global longitudinal strain four chamber was associated with greater odds of any vasoactive use (odds ratio, 5.8; 95% CI, 1.3-25.3; z-statistic, 2.3; p = 0.021). The number of days of vasoactive infusion was correlated with global longitudinal strain four chamber (r = 0.400; 95% CI, 2.4-3.9; p < 0.001). Children with abnormal strain had longer ICU length of stay (4.5 d vs 2 d; p = 0.014). CONCLUSIONS: Our findings suggest strain echocardiography can detect abnormalities in cardiac function in multisystem inflammatory syndrome in children patients unrecognized by conventional echocardiography. These abnormalities are associated with increased use of intensive care therapies. Evaluation of these patients with strain echocardiography may better identify those with myocardial dysfunction and need for more intensive therapy.

Defining the boundaries of disability: Critical perspectives

This ground-breaking volume considers what it means to make claims of disability membership in view of the robust Disability Rights movement, the rich areas of academic inquiry into disability, increased philosophical attention to the nature and significance of disability, a vibrant disability culture and disability arts movement, and advances in biomedical science and technology. By focusing on the statement, "We are all disabled", the book explores the following questions: What are the philosophical, political, and practical implications of making this claim? What conceptions of disability underlie it? When, if ever, is this claim justified, and when or why might it be problematic or harmful? What are the implications of claiming "we are all disabled" amidst this global COVID-19 pandemic? These critical reflections on the boundaries of disability include perspectives from the humanities, social sciences, law, and the arts. In exploring the boundaries of disability, and the ways in which these lines are drawn theoretically, legally, medically, socially, and culturally, the authors in this volume challenge particular conceptions of disability, expand the meaning and significance of the term, and consider the implications of claiming disability as an identity. It will be of interest to a broad audience, including disability scholars, advocates and activists, philosophers and historians of disability, moral theorists, clinicians, legal scholars, and artists. © 2021 selection and editorial matter, Licia Carlson and Matthew C. Murray;individual chapters, the contributors.