Rethink analgo-sedation in digestive endoscopy: the role of scientific societies in tracing training path.

OBJECTIVE: The Italian Society of Anesthesia, Analgesia, Reanimation and Intensive Care Medicine (SIAARTI) and the Italian Society of Digestive Endoscopy (SIED) worked together to produce a joint Good Clinical Practice (GCP) on analgo-sedation in digestive endoscopy and launched a survey to support the document. The aim was to identify and describe the actual clinical practice of sedation in Italian digestive endoscopy units and offer material for a wider and more widespread discussion among anesthetists and endoscopists. SUBJECTS AND METHODS: A national survey was planned, in order to support the statements of the GCP. Twelve thousand and five hundred questionnaires were sent to the members of SIAARTI and SIED in June 2020. RESULTS: A total of 662 forms (5.3%) returned completed. Highly complex procedures are performed according to 70% of respondents; daily anesthesiologist's assistance is guaranteed in 26%, for scheduled sessions in 14.5% and as needed in 8%. 69% of respondents declared not to have a dedicated team of anesthesiologists, while just 5% reported an anesthesiologist in charge. A complete monitoring system was assured by 70% of respondents. Dedicated pathways for COVID-19-positive patients were confirmed in <40% of the answers. With regard to moderate/deep sedation, 90% of respondents stated that an anesthetist decides timing and doses. Propofol was exclusively administered by anesthetists according to 94% of answers, and for 6% of respondents the endoscopist is allowed to administer propofol in presence of a dedicated nurse, but with a readily available anesthetist. Only 32.8% of respondents reported institutional training courses on procedural analgo-sedation. CONCLUSIONS: The need to provide patients scheduled for endoscopy procedures with an adequate analgo-sedation is becoming an increasing concern, well-known in almost all countries, but many factors compromise the quality of patient care. Results of a national survey would give strength to the need for a shared GCP in gastrointestinal endoscopy. Training and certification of non-anesthetist professionals should be one of the main ways to center the objective.

Exploring patient experiences with a telehealth approach for the PRO-ACTIVE trial intervention in head and neck cancer patients.

INTRODUCTION: Following the COVID-19 directive to cease non-essential services, a rapid shift was made in the delivery of Speech Language Pathology (SLP) dysphagia management in the 3-arm, randomized PRO-ACTIVE trial. To inform future programs, this study explored patients' experiences with telehealth when the planned in-person SLP intervention was moved to a telehealth modality. METHODS: A theory-guided qualitative descriptive approach was used. Willing participants who had received at least one telehealth swallowing therapy session participated in a one-time semi-structured interview. Interview transcripts were subjected to a standard qualitative content/theme analysis. Researchers reviewed all transcripts and used a multi-step analysis process to build a coding framework through consensus discussion. Summaries and key messages were generated for each code. RESULTS: Eleven participants recounted their telehealth experiences and reported feeling satisfied, comfortable and confident with the session(s). They identified that previous experience with teleconferencing, access to optimal technical equipment, clinician skill, and caregiver assistance facilitated their telehealth participation. Participants highlighted that telehealth was beneficial as it reduced commuting time, COVID-19 exposure and fatigue from travel; and also allowed caregiver participation particularly during COVID. In comparing their in-person SLP sessions to telehealth sessions, limitations were also identified, including: lack of previous experience with and/or poor access to technology, and less opportunity for personalization. Participants indicated that use of phone alone was less preferred than an audio/video platform. DISCUSSION: Patients reported that overall, telehealth sessions did not compromise their learning experience when compared to in-person sessions. Patients benefited from use of telehealth in several ways despite some limitations of the use of technology. Patient feedback about telehealth provides an important perspective that may be critical to inform best practices for care delivery.

EXPLORING PATIENT EXPERIENCES WITH A TELEHEALTH BEHAVIOURAL SWALLOWING INTERVENTION FOR THE PRO-ACTIVE TRIAL IN PATIENTS WITH HEAD AND NECK CANCER

Introduction In response to COVID-19, a rapid shift was made to deliver behavioural swallowing therapy in the PRO-ACTIVE trial via a TeleHealth (TH) approach. Patient experiences with TH were explored. Methods A theory-guided qualitative approach explored the perspective of consenting participants who received at least one TH swallowing therapy session. Patients participated in a one-time semi-structured interview. Interview transcripts were analyzed for content and theme using a multi-step consensus process to build a coding framework and key messages. Results Eleven participants recounted their TH experiences and reported feeling satisfied, comfortable and confident with the session(s). Facilitating factors included: previous experience with teleconferencing, access to optimal equipment, clinician skill, and caregiver assistance. TH was considered beneficial to reduce commuting time, potential exposure to COVID19, energy expenditure and also allow caregiver participation. Limitations were also identified, including lack or poor previous experience with technology, and less opportunity for personalization. Participants indicated that use of audio alone was less preferred than an audio/video platform. Conclusions Patients reported overall that TH sessions did not compromise their clinical learning experience when compared to in-person sessions. Patient feedback about TH provides an important perspective to inform best practices for care delivery.

COVID-19 in Children Following Hematopoietic Cell Transplantation: A Multinational Study of the European Bone Marrow Transplantation Society (EBMT) and the Spanish Group of Hematopoietic Stem Cell Transplantation (GETH)

Introduction COVID-19 is usually a mild disease in immunocompetent children, with ~1% requiring intensive care unit (ICU) admission and <0.1% mortality. Data on its course in children following hematopoietic cell transplantation (HCT) is limited. Methods Data on children following HCT who developed COVID-19 (diagnosed by positive SARS-CoV-2 PCR on respiratory tract samples) during 3.2020-4.2021 were prospectively collected by EBMT and GETH, including demography, HCT data, COVID-related manifestations, ICU admission and mortality. Factors associated with worse outcomes (ICU admission or mortality) were characterized. Results Sixty-two children (34 boys;median age 9;min-max;0.7-17 years) were reported from 27 centers, 16 countries;57 (92%) following allogeneic and 5 (8%) following autologous HCT. Underlying diseases were acute leukemia (23;37%), inherited disorders (9;15%), hemoglobinopathies (7;11%), solid tumor (6;10%), bone marrow failure (5;8%), other malignant (8;13%) and non-malignant (4;6%) diseases. Five (8%) children had high blood pressure;6 (10%) had underlying lung pathology. The median time from the most recent HCT to COVID was 5 months (min-max;0-169). The stem cell source was bone marrow (33);peripheral (22) or cord blood (1). Among the patients with information available, 34 (62%) underwent in-vivo T cell depletion, 20 (33%) received corticosteroids, and 36 (60%) other immunosuppressant drugs(s) within two months prior to and after the COVID-19 episode. The presence of acute grade 2-4 or chronic graft versus host disease (GVHD) was reported in 12/54 (23%) and 8/51 (16%) children, respectively. Clinical presentation (n=57) included fever (28;49%), cough (18;32%), diarrhea (8;14%), upper respiratory tract disease (as rhinorrhea, sinusitis, otitis, or pharyngitis;12;21%);six (10%) required oxygen to maintain oxygen saturation above 92%;20 children (35%) were asymptomatic. The median time from symptoms onset to COVID diagnosis was 1 day (-43-40). Sixty-three percent of patients were hospitalized;43% due to COVID. The proportion of children with neutropenia or lymphocytopenia (<500 cells/mm 3) was 75% and 73%, respectively. Sixteen children (26%) had evidence of viral (n=10), bacterial (n=6) or fungal (n=2) coinfections. The median time from COVID diagnosis to the last follow-up in alive patients was 69 days (min-max;2 - 294). Six (10%) children who developed COVID at a median 6.5 (min-max;2- 16) months following allo-HCT (median age 6 years;5 boys) required ICU care within a median 6 (min-max;-5-15) days after diagnosis. All of them were neutropenic, received steroids, and other immunosuppressive drugs at COVID diagnosis;5 had undergone in-vivo T cell depletion;5 were lymphocytopenic, 5 had GVHD (2 acute and 3 chronic);3 received non-invasive and 2 invasive ventilation. Three children had viral or bacterial coinfections. Three children died. Six (10%) children (5 boys, median age 10.5 years;min-max;4-13) who developed COVID at median 2 (min-max;0-147) months following allo-HCT died within median 35 days (min-max;5-54) after diagnosis. One had high blood pressure, and none suffered from underlying lung pathology. At the time of COVID, 3 were neutropenic, 2 lymphocytopenic;4 had GVHD (2 acute, 2 chronic);3 received steroids and 4 immunosuppressive drugs. Two had viral or bacterial coinfections. Five had positive SARS-CoV-2 PCR at the time of death. In 3, COVID was the primary cause of death. We compared nine children with the worse outcomes to 53 children with benign course. Among patients alive at 100-day post HCT, the probability of worse outcomes was higher in patients with vs. without chronic GVHD (Figure). No other significant differences were observed in demographic, underlying disease, and HCT-related characteristics. Compared to adults following HCT (Ljungman, Leukemia 2021), children had: - Shorter median time from HCT to COVID diagnosis, 5 vs 18 months;- Higher proportion of asymptomatic infections, 35% vs 9%;- Lower proportion of those who required oxygen, 10% vs 35%;- Lower all-cause mortality, 10% vs 29%. Conclusions Children following HCT with COVID-19 have a higher risk of ICU admission and mortality compared to immune competent children. The presence of chronic GVHD at COVID diagnosis was associated with worse outcomes. COVID course following HCT is milder in children compared to adults. [Formula presented] Disclosures: Averbuch: Takeda: Consultancy;Pfizer: Consultancy;GSK: Speakers Bureau. De La Camara: Roche: Consultancy;IQONE: Consultancy. Corbacioglu: Gentium/Jazz Pharmaceuticals: Consultancy, Honoraria. Mikulska: Pfizer: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau;Gilead: Speakers Bureau;MSD: Speakers Bureau;Janssen: Speakers Bureau;Biotest: Speakers Bureau. Kulagin: Roche: Speakers Bureau;Sanofi: Speakers Bureau;Generium: Speakers Bureau;Biocad: Research Funding;Apellis: Research Funding;Alexion: Research Funding;X4 Pharmaceuticals: Research Funding;Novartis: Speakers Bureau;Johnson & Johnson: Speakers Bureau;Pfizer: Speakers Bureau. Cesaro: Sobi: Membership on an entity's Board of Directors or advisory committees;Gilead: Speakers Bureau. Lawson: Alexion: Honoraria. Kroeger: Neovii: Honoraria, Research Funding;Sanofi: Honoraria;Jazz: Honoraria, Research Funding;Celgene: Honoraria, Research Funding;Riemser: Honoraria, Research Funding;Gilead/Kite: Honoraria;AOP Pharma: Honoraria;Novartis: Honoraria. Styczynski: MSD, Pfizer, Giled, TEVA, Jazz, Novartis: Honoraria, Speakers Bureau. Ljungman: Takeda: Consultancy, Other: Endpoint committee, speaker;Enanta: Other: DSMB;Janssen: Other: Investigator;OctaPharma: Other: DSMB;Merck: Other: Investigator, speaker;AiCuris: Consultancy.

A Veneto Institute of Oncology-IRCCS Survey on the measures implemented to contain the spread of SARS-CoV-2 and on the anti-COVID vaccination during the COVID-19 pandemic: Lesson from cancer patients

Introduction: The SARS-CoV-2 spread has led to a revolution in the healthcare. Veneto Institute of Oncology has adopted contagion containment measures to guarantee a greater level of protection to cancer patients. The anti- COVID vaccination for cancer patients has been a priority for the national health system and the institute has implemented a vaccination campaign to ensure coverage for patients. A survey was developed to assess the impact of the COVID-19 pandemic on patients' perceptions about the measures taken to limit the risk of SARS-CoV-2 infections and their concern about their cancer care. A questionnaire on the degree of satisfaction with vaccination was administered after anti-COVID vaccination. Methods: The Survey was distributed to all patients who entered in hospital during analysis period and it was divided into 3 items: characteristics of patients, concerns about the pandemic on their cancer path, perception of the measures adopted by the institute to limit the spread of the infection. The vaccination questionnaire was distributed to a cohort of vaccinated patients and explored the degree of satisfaction with the vaccination campaign. Results: From May18th until June15th, 3238 questionnaires were completed. Most of the responders said they were concerned about SARS-CoV-2 pandemic while keeping the concern for oncological disease as a priority. All measures (triage for hospital access, restrictions for caregivers, use of personal protective equipment, sanitization of environments) have been appreciated by patients. Telemedicine was positively evaluated by the responders while, the absence of the caregiver during visit, does not seem to have determined discomfort in about two thirds of patients. From April26th until May14th 2021, 356 vaccination questionnaires were completed. 60% of responders were female;90% were on active cancer treatment and 33% of the patients reported adverse events related to the anti-COVID vaccination. Patients expressed a high degree of satisfaction with the vaccination campaign (99% were satisfied/very satisfied) Conclusions: This survey reported the point of view of cancer patients regarding the impact of the COVID-19 pandemic on the oncological activities of which they are protagonists and patients' perceptions of the anti-COVID vaccination campaign. We believe that the perspective of patients can be crucial to help the reorganization of the health system, especially in this period of medical emergency.

Intranasal gene therapy to prevent infection by SARS-CoV-2 variants.

SARS-CoV-2 variants have emerged with enhanced pathogenicity and transmissibility, and escape from pre-existing immunity, suggesting first-generation vaccines and monoclonal antibodies may now be less effective. Here we present an approach for preventing clinical sequelae and the spread of SARS-CoV-2 variants. First, we affinity matured an angiotensin-converting enzyme 2 (ACE2) decoy protein, achieving 1000-fold binding improvements that extend across a wide range of SARS-CoV-2 variants and distantly related, ACE2-dependent coronaviruses. Next, we demonstrated the expression of this decoy in proximal airway when delivered via intranasal administration of an AAV vector. This intervention significantly diminished clinical and pathologic consequences of SARS-CoV-2 challenge in a mouse model and achieved therapeutic levels of decoy expression at the surface of proximal airways when delivered intranasally to nonhuman primates. Importantly, this long-lasting, passive protection approach is applicable in vulnerable populations such as the elderly and immune-compromised that do not respond well to traditional vaccination. This approach could be useful in combating COVID-19 surges caused by SARS-CoV-2 variants and should be considered as a countermeasure to future pandemics caused by one of the many pre-emergent, ACE2-dependent CoVs that are poised for zoonosis.