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Introduction of the Concept of Diagnostic Sensitivity and Specificity of Normothermic Perfusion Protocols to Assess High-Risk Donor Livers.
No full textNormothermic machine perfusion (NMP) allows objective assessment of donor liver transplantability. Several viability evaluation protocols have been established, consisting of parameters such as perfusate lactate clearance, pH, transaminase levels, and the production and composition of bile. The aims of this study were to assess 3 such protocols, namely, those introduced by the teams from Birmingham (BP), Cambridge (CP), and Groningen (GP), using a cohort of high-risk marginal livers that had initially been deemed unsuitable for transplantation and to introduce the concept of the viability assessment sensitivity and specificity. To demonstrate and quantify the diagnostic accuracy of these protocols, we used a composite outcome of organ use and 24-month graft survival as a surrogate endpoint. The effects of assessment modifications, including the removal of the most stringent components of the protocols, were also assessed. Of the 31 organs, 22 were transplanted after a period of NMP, of which 18 achieved the outcome of 24-month graft survival. The BP yielded 94% sensitivity and 50% specificity when predicting this outcome. The GP and CP both seemed overly conservative, with 1 and 0 organs, respectively, meeting these protocols. Modification of the GP and CP to exclude their most stringent components increased this to 11 and 8 organs, respectively, and resulted in moderate sensitivity (56% and 44%) but high specificity (92% and 100%, respectively) with respect to the composite outcome. This study shows that the normothermic assessment protocols can be useful in identifying potentially viable organs but that the balance of risk of underuse and overuse varies by protocol
Effect of BMI on safety of bariatric surgery during the COVID-19 pandemic, procedure choice, and safety protocols - An analysis from the GENEVA Study.
No full textBACKGROUND
It has been suggested that patients with a Body Mass Index (BMI) of > 60 kg/m should be offered expedited Bariatric Surgery (BS) during the Coronavirus Disease-2019 (COVID-19) pandemic. The main objective of this study was to assess the safety of this approach.
METHODS
We conducted a global study of patients who underwent BS between 1/05/2020 and 31/10/2020. Patients were divided into three groups according to their preoperative BMI - Group I (BMI60 kg/m). The effect of preoperative BMI on 30-day morbidity and mortality, procedure choice, COVID-19 specific safety protocols, and comorbidities was assessed.
RESULTS
This study included 7084 patients (5197;73.4 % females). The mean preoperative weight and BMI were 119.49 ± 24.4 Kgs and 43.03 ± 6.9 Kg/m respectively. Group I included 6024 (85 %) patients, whereas Groups II and III included 905 (13 %) and 155 (2 %) patients, respectively. The 30-day mortality rate was higher in Group III (p = 0.001). The complication rate and COVID-19 infection were not different. Comorbidities were significantly more likely in Group III (p = 70 kg/m had a 30-day mortality of 7.7 % (2/26). None of these patients underwent a Roux-en-Y Gastric Bypass.
CONCLUSION
The 30-day mortality rate was significantly higher in patients with BMI > 60 kg/m. There was, however, no significant difference in complications rates in different BMI groups, probably due to differences in procedure selection
Benefit-risk evaluation of COVID-19 vaccination in special population groups of interest.
No full textSeveral population groups display an increased risk of severe disease and mortality following SARS-CoV-2 infection. These include those who are immunocompromised (IC), have a cancer diagnosis, human immunodeficiency virus (HIV) infection or chronic inflammatory disease including autoimmune disease, primary immunodeficiencies, and those with kidney or liver disease. As such, improved understanding of the course of COVID-19 disease, as well as the efficacy, safety, and benefit-risk profiles of COVID-19 vaccines in these vulnerable groups is paramount in order to inform health policy makers and identify evidence-based vaccination strategies. In this review, we seek to summarize current data, including recommendations by national health authorities, on the impact and benefit-risk profiles of COVID-19 vaccination in these populations. Moving forward, although significant efforts have been made to elucidate and characterize COVID-19 disease course and vaccine responses in these groups, further larger-scale and longer-term evaluation will be instrumental to help further guide management and vaccination strategies, particularly given concerns about waning of vaccine-induced immunity and the recent surge of transmission with SARS-CoV-2 variants of concern
PICaSSO virtual electronic chromendoscopy accurately reflects combined endoscopic and histological assessment for prediction of clinical outcomes in ulcerative colitis.
No full textBACKGROUND AND AIMS
A composite endoscopic-histologic remission is increasingly explored as an important endpoint in ulcerative colitis (UC). We investigated combined endoscopic-histologic remission for predicting clinical outcomes at 12 months compared with endoscopic remission alone using the high definition virtual chromoendoscopy (VCE) Paddington International virtual ChromoendoScopy ScOre (PICaSSO) and histology scores.
METHODS
Ulcerative colitis patients, prospectively enrolled from 11 international centres, underwent VCE with targeted biopsies and followed up for 12 months. Endoscopic activity was assessed by Mayo Endoscopic Score (MES), Ulcerative Colitis Endoscopic Index Severity (UCEIS) followed by VCE-PICaSSO. Robarts Histopathological Index|Robarts Histological index≤3 without neutrophils in mucosa, and Nancy Histological index (NHI)≤ 1 were used to define histologic remission. Combined endoscopic-histologic remission was compared with endoscopic remission alone by Cox proportional hazards model and by two- and three-proportion analysis using pre-specified clinical outcomes.
RESULTS
307 patients were recruited and 302 analysed. There was no difference in survival without specified clinical outcomes between PICaSSO defined endoscopic remission alone and endoscopic plus histologic remission in the rectum (HR 0.42, 95%CI 0.16-1.11 and HR 1.03, 95%CI 0.42-2.52 for Robarts Histological index and NHI respectively) at 12 months. There was however a significant survival advantage without specified clinical outcome events for UCEIS combined with histology compared with UCEIS alone (HR 0.30, 95%CI 0.12-0.75, p = 0.02) at 12 months (but not combined with NHI). For MES there was no advantage for predicting specified clinical outcomes at 12 months for endoscopy alone versus endoscopy plus histology, but there were differences in two and three proportion analysis at 6 months.
CONCLUSION
Endoscopic remission by VCE-PICaSSO alone was similar to combined endoscopic and histologic remission for predicting specified clinical outcomes at 12 months. Larger studies with specific therapeutic interventions are required to further confirm the findings
Exacerbation Profile and Risk Factors in a T2-Low Severe Asthma Population.
No full textAlthough present in a minority of severe asthmatics, very little is known about the mechanisms underlying T2-low asthma, making it a significant unmet need in asthma research.
METHODS
Exacerbation assessment was a pre-specified secondary analysis of data from a RCT comparing the use of biomarkers & symptoms to adjust steroid treatment in a T2-low severe asthma-enriched cohort. Participants were phenotyped as T2LOW(fractional exhaled nitric oxide [FeNO] ≤20 ppb & blood eosinophil count [PBE] ≤150 cells/µL) or T2HIGH ( FeNO>20 or PBE>150) at study enrolment & at each exacerbation. We report comparison of exacerbators & non-exacerbators, physiological changes at exacerbation in T2LOW & T2HIGH ,& stability of inflammatory phenotypes.
RESULTS
60.8% (183/301) ≥1 self-reported exacerbations (total of 390). Exacerbators were more likely to be female, have a higher BMI & more exacerbations requiring oral corticosteroid (OCS) & unscheduled primary care attendances for exacerbations. At enrolment, 23.6% (71/301) were T2LOW, & 76.4% (230/301) T2HIGH. The T2LOW group had more asthma primary care attendances, were more likely to have a previous admission to HDU/ICU & to be receiving maintenance OCS. At exacerbation the T2LOW events were indistinguishable from T2HIGH exacerbations in terms of lung function & symptom increase, with no increase in T2 biomarkers from stable to exacerbation state in the T2LOW exacerbations.
CONCLUSION
Asthma exacerbations demonstrating a T2LOW phenotype were physiologically & symptomatically similar to T2HIGHexacerbations. The clinically significant T2LOW exacerbations highlights the unmet & pressing need to further understand the mechanisms at play in non-T2 asthma
Why are some ReSPECT conversations left incomplete? A qualitative case study analysis.
No full textBackground
As an emergency care and treatment planning process (ECTP), a key feature of the Recommended Summary Plan for Emergency Care and Treatment (ReSPECT) is the engagement of patients and/or their representatives in conversations about treatment options including, but not limited to, cardiopulmonary resuscitation (CPR). However, qualitative research suggests that some ReSPECT conversations lead to partial or no decision-making about treatment recommendations. This paper explores why some ReSPECT conversations are left incomplete.
Methods
Drawing on observation and interview data collected in four National Health Service (NHS) hospital sites in England, this paper offers an in-depth exploration of six case studies in which ReSPECT conversations were incomplete. Using thematic analysis, we triangulate fieldnote data documenting these conversations with interview data in which the doctors who conducted these conversations shared their perceptions and reflected on their decision-making processes.
Results
We identified two themes, both focused on 'mismatch': (1) Mismatch between the doctor's clinical priorities and the patient's/family's immediate needs; and (2) mismatch between the doctor's conversation scripts, which included patient autonomy, the feasibility of CPR, and what medicine can and should do to prolong a patient's life, and the patient's/family's understandings of these concepts.
Conclusions
This case study analysis of six ReSPECT conversations found that mismatch between doctors' priorities and understandings and those of patients and/or their relatives led to incomplete ReSPECT conversations. Future research should explore methods to overcome these mismatches
Chest wall perforator flap to partially reconstruct central mound of breast tissue - evolution of the technique.
No full textWe describe the use of chest wall perforator flap (CWPF) to reconstruct the central mound of breast tissue in women presenting with central/retro areolar breast cancer. We describe the results of seven patients (median age, 59 years) with a median follow-up of 9 months. We were able to conserve the breast in all except one woman who was found to have extensive DCIS. Two patients were taken back to theatre, one for a washout of infected seroma and second for a wound debridement. There was no flap loss or donor site complications in our series. We were able to conserve the breast, maintain aesthetic contour of the central mound along with projection and achieve excellent cosmetic outcome for our patients. Partial breast reconstruction using CWPF provides an oncologically safe and cosmetically superior alternative in selected women with breast cancer needing central wide local excision
Feasibility study of a randomised controlled trial of preoperative and postoperative nutritional supplementation in major lung surgery.
No full textOBJECTIVES
Malnutrition and weight loss are important risk factors for complications after lung surgery. However, it is uncertain whether modifying or optimising perioperative nutritional state with oral supplements results in a reduction in malnutrition, complications or quality of life.
DESIGN
A randomised, open label, controlled feasibility study was conducted to assess the feasibility of carrying out a large multicentre randomised trial of nutritional intervention. The intervention involved preoperative carbohydrate-loading drinks (4×200 mL evening before surgery and 2×200 mL the morning of surgery) and early postoperative nutritional protein supplement drinks two times per day for 14 days compared with the control group receiving an equivalent volume of water.
SETTING
Single adult thoracic centre in the UK.
PARTICIPANTS
All adult patients admitted for major lung surgery. Patients were included if were able to take nutritional drinks prior to surgery and give written informed consent. Patients were excluded if they were likely unable to complete the study questionnaires, they had a body mass index <18.5 kg/m, were receiving parenteral nutrition or known pregnancy.
RESULTS
All patients presenting for major lung surgery were screened over a 6-month period, with 163 patients screened, 99 excluded and 64 (41%) patients randomised. Feasibility criteria were met and the study completed recruitment 5 months ahead of target. The two groups were well balanced and tools used to measure outcomes were robust. Compliance with nutritional drinks was 97% preoperatively and 89% postoperatively; 89% of the questionnaires at 3 months were returned fully completed. The qualitative interviews demonstrated that the trial and the intervention were acceptable to patients. Patients felt the questionnaires captured their experience of recovery from surgery well.
CONCLUSION
A large multicentre randomised controlled trial of nutritional intervention in major lung surgery is feasible and required to test clinical efficacy in improving outcomes after surgery.
TRIAL REGISTRATION NUMBER
ISRCTN16535341
Acute SARS-CoV-2-Induced Psychosis in an Adolescents.
No full textSevere SARS-CoV-2COVID-19 illness in pediatrics is less common in children than in adults. Here we report an unvaccinated 16-year-old male, normally fit and well with no previous personal or family history of mental illness who developed moderate respiratory illness related to SARS-CoV-2 infection that was followed by acute psychosis. Neuropsychiatric manifestations are well documented in adults with SARS-CoV-2 infections; however, there are few reports in the pediatric population. This case illustrates that acute psychosis is a possible complication in children with mild SARS-CoV-2 illness and highlights the need for vigilance
Clinical pathways for patients with giant cell arteritis during the COVID-19 pandemic: an international perspective.
No full textGiant cell arteritis, a common primary systemic vasculitis affecting older people, presents acutely as a medical emergency and requires rapid specialist assessment and treatment to prevent irreversible vision loss. Disruption of the health-care system caused by the COVID-19 pandemic exposed weak points in clinical pathways for diagnosis and treatment of giant cell arteritis, but has also permitted innovative solutions. The essential roles played by all professionals, including general practitioners and surgeons, in treating these patients have become evident. Patients must also be involved in the reshaping of clinical services. As an international group of authors involved in the care of patients with giant cell arteritis, we reflect in this Viewpoint on rapid service adaptations during the first peak of COVID-19, evaluate challenges, and consider implications for the future