Key Factors Associated With Pulmonary Sequelae in the Follow-Up of Critically Ill COVID-19 Patients

Introduction: Critical COVID-19 survivors have a high risk of respiratory sequelae. Therefore, we aimed to identify key factors associated with altered lung function and CT scan abnormalities at a follow-up visit in a cohort of critical COVID-19 survivors. Methods: Multicenter ambispective observational study in 52 Spanish intensive care units. Up to 1327 PCR-confirmed critical COVID-19 patients had sociodemographic, anthropometric, comorbidity and lifestyle characteristics collected at hospital admission; clinical and biological parameters throughout hospital stay; and, lung function and CT scan at a follow-up visit. Results: The median [p25–p75] time from discharge to follow-up was 3.57 [2.77–4.92] months. Median age was 60 [53–67] years, 27.8% women. The mean (SD) percentage of predicted diffusing lung capacity for carbon monoxide (DLCO) at follow-up was 72.02 (18.33)% predicted, with 66% of patients having DLCO < 80% and 24% having DLCO < 60%. CT scan showed persistent pulmonary infiltrates, fibrotic lesions, and emphysema in 33%, 25% and 6% of patients, respectively. Key variables associated with DLCO < 60% were chronic lung disease (CLD) (OR: 1.86 (1.18–2.92)), duration of invasive mechanical ventilation (IMV) (OR: 1.56 (1.37–1.77)), age (OR [per-1-SD] (95%CI): 1.39 (1.18–1.63)), urea (OR: 1.16 (0.97–1.39)) and estimated glomerular filtration rate at ICU admission (OR: 0.88 (0.73–1.06)). Bacterial pneumonia (1.62 (1.11–2.35)) and duration of ventilation (NIMV (1.23 (1.06–1.42), IMV (1.21 (1.01–1.45)) and prone positioning (1.17 (0.98–1.39)) were associated with fibrotic lesions. Conclusion: Age and CLD, reflecting patients’ baseline vulnerability, and markers of COVID-19 severity, such as duration of IMV and renal failure, were key factors associated with impaired DLCO and CT abnormalities

Mortality and pulmonary complications in patients undergoing surgery with perioperative sars-cov-2 infection: An international cohort study

Background The impact of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) on postoperative recovery needs to be understood to inform clinical decision making during and after the COVID-19 pandemic. This study reports 30-day mortality and pulmonary complication rates in patients with perioperative SARS-CoV-2 infection. Methods This international, multicentre, cohort study at 235 hospitals in 24 countries included all patients undergoing surgery who had SARS-CoV-2 infection confirmed within 7 days before or 30 days after surgery. The primary outcome measure was 30-day postoperative mortality and was assessed in all enrolled patients. The main secondary outcome measure was pulmonary complications, defined as pneumonia, acute respiratory distress syndrome, or unexpected postoperative ventilation. Findings This analysis includes 1128 patients who had surgery between Jan 1 and March 31, 2020, of whom 835 (740%) had emergency surgery and 280 (248%) had elective surgery. SARS-CoV-2 infection was confirmed preoperatively in 294 (261%) patients. 30-day mortality was 238% (268 of 1128). Pulmonary complications occurred in 577 (512%) of 1128 patients; 30-day mortality in these patients was 380% (219 of 577), accounting for 817% (219 of 268) of all deaths. In adjusted analyses, 30-day mortality was associated with male sex (odds ratio 175 [95% CI 128-240], p&lt;00001), age 70 years or older versus younger than 70 years (230 [165-322], p&lt;00001), American Society of Anesthesiologists grades 3-5 versus grades 1-2 (235 [157-353], p&lt;00001), malignant versus benign or obstetric diagnosis (155 [101-239], p=0046), emergency versus elective surgery (167 [106-263], p=0026), and major versus minor surgery (152 [101-231], p=0047). Interpretation Postoperative pulmonary complications occur in half of patients with perioperative SARS-CoV-2 infection and are associated with high mortality. Thresholds for surgery during the COVID-19 pandemic should be higher than during normal practice, particularly in men aged 70 years and older. Consideration should be given for postponing non-urgent procedures and promoting non-operative treatment to delay or avoid the need for surgery. Funding National Institute for Health Research (NIHR), Association of Coloproctology of Great Britain and Ireland, Bowel and Cancer Research, Bowel Disease Research Foundation, Association of Upper Gastrointestinal Surgeons, British Association of Surgical Oncology, British Gynaecological Cancer Society, European Society of Coloproctology, NIHR Academy, Sarcoma UK, Vascular Society for Great Britain and Ireland, and Yorkshire Cancer Research

Elective cancer surgery in COVID-19-free surgical pathways during the SARS-CoV-2 pandemic: An international, multicenter, comparative cohort study

PURPOSE As cancer surgery restarts after the first COVID-19 wave, health care providers urgently require data to determine where elective surgery is best performed. This study aimed to determine whether COVID-19–free surgical pathways were associated with lower postoperative pulmonary complication rates compared with hospitals with no defined pathway. PATIENTS AND METHODS This international, multicenter cohort study included patients who underwent elective surgery for 10 solid cancer types without preoperative suspicion of SARS-CoV-2. Participating hospitals included patients from local emergence of SARS-CoV-2 until April 19, 2020. At the time of surgery, hospitals were defined as having a COVID-19–free surgical pathway (complete segregation of the operating theater, critical care, and inpatient ward areas) or no defined pathway (incomplete or no segregation, areas shared with patients with COVID-19). The primary outcome was 30-day postoperative pulmonary complications (pneumonia, acute respiratory distress syndrome, unexpected ventilation). RESULTS Of 9,171 patients from 447 hospitals in 55 countries, 2,481 were operated on in COVID-19–free surgical pathways. Patients who underwent surgery within COVID-19–free surgical pathways were younger with fewer comorbidities than those in hospitals with no defined pathway but with similar proportions of major surgery. After adjustment, pulmonary complication rates were lower with COVID-19–free surgical pathways (2.2% v 4.9%; adjusted odds ratio [aOR], 0.62; 95% CI, 0.44 to 0.86). This was consistent in sensitivity analyses for low-risk patients (American Society of Anesthesiologists grade 1/2), propensity score–matched models, and patients with negative SARS-CoV-2 preoperative tests. The postoperative SARS-CoV-2 infection rate was also lower in COVID-19–free surgical pathways (2.1% v 3.6%; aOR, 0.53; 95% CI, 0.36 to 0.76). CONCLUSION Within available resources, dedicated COVID-19–free surgical pathways should be established to provide safe elective cancer surgery during current and before future SARS-CoV-2 outbreaks

Elective Cancer Surgery in COVID-19-Free Surgical Pathways During the SARS-CoV-2 Pandemic: An International, Multicenter, Comparative Cohort Study.

PURPOSE: As cancer surgery restarts after the first COVID-19 wave, health care providers urgently require data to determine where elective surgery is best performed. This study aimed to determine whether COVID-19-free surgical pathways were associated with lower postoperative pulmonary complication rates compared with hospitals with no defined pathway. PATIENTS AND METHODS: This international, multicenter cohort study included patients who underwent elective surgery for 10 solid cancer types without preoperative suspicion of SARS-CoV-2. Participating hospitals included patients from local emergence of SARS-CoV-2 until April 19, 2020. At the time of surgery, hospitals were defined as having a COVID-19-free surgical pathway (complete segregation of the operating theater, critical care, and inpatient ward areas) or no defined pathway (incomplete or no segregation, areas shared with patients with COVID-19). The primary outcome was 30-day postoperative pulmonary complications (pneumonia, acute respiratory distress syndrome, unexpected ventilation). RESULTS: Of 9,171 patients from 447 hospitals in 55 countries, 2,481 were operated on in COVID-19-free surgical pathways. Patients who underwent surgery within COVID-19-free surgical pathways were younger with fewer comorbidities than those in hospitals with no defined pathway but with similar proportions of major surgery. After adjustment, pulmonary complication rates were lower with COVID-19-free surgical pathways (2.2% v 4.9%; adjusted odds ratio [aOR], 0.62; 95% CI, 0.44 to 0.86). This was consistent in sensitivity analyses for low-risk patients (American Society of Anesthesiologists grade 1/2), propensity score-matched models, and patients with negative SARS-CoV-2 preoperative tests. The postoperative SARS-CoV-2 infection rate was also lower in COVID-19-free surgical pathways (2.1% v 3.6%; aOR, 0.53; 95% CI, 0.36 to 0.76). CONCLUSION: Within available resources, dedicated COVID-19-free surgical pathways should be established to provide safe elective cancer surgery during current and before future SARS-CoV-2 outbreaks

The impact of surgical delay on resectability of colorectal cancer: An international prospective cohort study

Aim The SARS-CoV-2 pandemic has provided a unique opportunity to explore the impact of surgical delays on cancer resectability. This study aimed to compare resectability for colorectal cancer patients undergoing delayed versus non-delayed surgery. Methods This was an international prospective cohort study of consecutive colorectal cancer patients with a decision for curative surgery (January-April 2020). Surgical delay was defined as an operation taking place more than 4 weeks after treatment decision, in a patient who did not receive neoadjuvant therapy. A subgroup analysis explored the effects of delay in elective patients only. The impact of longer delays was explored in a sensitivity analysis. The primary outcome was complete resection, defined as curative resection with an R0 margin. Results Overall, 5453 patients from 304 hospitals in 47 countries were included, of whom 6.6% (358/5453) did not receive their planned operation. Of the 4304 operated patients without neoadjuvant therapy, 40.5% (1744/4304) were delayed beyond 4 weeks. Delayed patients were more likely to be older, men, more comorbid, have higher body mass index and have rectal cancer and early stage disease. Delayed patients had higher unadjusted rates of complete resection (93.7% vs. 91.9%, P = 0.032) and lower rates of emergency surgery (4.5% vs. 22.5%, P &lt; 0.001). After adjustment, delay was not associated with a lower rate of complete resection (OR 1.18, 95% CI 0.90-1.55, P = 0.224), which was consistent in elective patients only (OR 0.94, 95% CI 0.69-1.27, P = 0.672). Longer delays were not associated with poorer outcomes. Conclusion One in 15 colorectal cancer patients did not receive their planned operation during the first wave of COVID-19. Surgical delay did not appear to compromise resectability, raising the hypothesis that any reduction in long-term survival attributable to delays is likely to be due to micro-metastatic disease

Expert Perspectives on Next Generation Health Guidelines: How to Integrate RWE in EBM

Stefano Del Giacco,1,&amp;ast; Giorgio Walter Canonica,2,&amp;ast; Ioana Agache,3 David Price,4,5 Nicolas Roche,6 Holger Schunemann,7,8 Keith Allan,9 Ignacio Ansotegui,10 Simona Barbaglia,11 Jonathan A Bernstein,12 Matteo Bonini,13,14 Sinthia Bosnic-Anticevich,15,16 Jean Bousquet,17,18 Fulvio Braido,19,20 Victoria Carter,21 Herberto Jose Chong-Neto,22 Danilo Di Bona,23 Kirsty Fletton,5 Sandra Gonzalez Diaz,24 Vandana Ayyar Gupta,25 Richard Hubbard,26 Jonathan Iaccarino,27 Ibon Eguiluz-Gracia,28 Cristina Jacomelli,5 Janwillem Kocks,4,29– 31 Jerry Krishnan,3 Vera Mahler,32 Mario Morais-Almeida,33 Daniel Moreles,34 Paola Muti,35,36 Susanna Palkonen,37 Nikolaos G Papadopoulos,38,39 Ruby Pawankar,40 Christina Reeb,32 Helen Reddel,41 Isabel Rojo,42 Dermot Ryan,43 Lydia Sodhi,4 Maria Torres,28,44 Tonya Winders,45 Kevin C Wilson46 1Department of Medical Sciences and Public Health, University of Cagliari, Monserrato, Cagliari, Italy; 2Personalized Medicine, Asthma and Allergy, Humanitas Clinical and Research Hospital IRCCS, Rozzano, Milan, Italy; Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy; 3Faculty of Medicine, Transylvania University, Brasov, Romania; 4Observational and Pragmatic Research Institute, Singapore; 5Centre of Academic Primary Care, Division of Applied Health Sciences, University of Aberdeen, Aberdeen, UK; 6Respiratory Medicine Department, Hôpitaux Universitaires Paris Centre, Hôpital Cochin, AP-HP and Université Paris Cité, Paris, France; 7Department of Health Research Methods, Evidence, and Impact, and of Medicine, McMaster University, Hamilton, ON, Canada; 8McMaster GRADE Centre &amp; Department of Biomedical Sciences, Humanitas University, Milan, Italy; 9Department of Patient and Community Engagement, University Hospitals of Leicester, Leicester, UK; 10Department of Allergy and Immunology, Hospital Quironsalud Bizkaia, Bilbao, Spain; 11Leadership Team, Respiriamo Insieme Association, Padova, Italy; 12Division of Immunology/Allergy Section, Department of Internal Medicine, University of Cincinnati College of Medicine, Cincinnati, OH, USA; 13Department of Public Health and Infectious Diseases, Sapienza University, Rome, Italy; 14National Health and Lung Institute (NHLI), Imperial College London, London, UK; 15Macquarie Medical School, Faculty of Medicine, Health and Human Sciences, Macquarie University, Sydney, Australia; 16Woolcock Institute of Medical Research, Glebe, MSW, 2037, Australia; 17Institute of Allergology, Charité – Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany; 18Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Allergology and Immunology, Berlin, Germany; 19Respiratory Clinic, Department of Internal Medicine, University of Genoa, Genoa, Italy; 20IRCCS Ospedale Policlinico San Martino, Genoa, Italy; 21Optimum Patient Care Global, Cambridge, United Kingdom; Observational and Pragmatic Research Institute, Singapore; 22Division of Allergy and Immunology-Complexo Hospital de Clinicas-Department of Pediatrics-Federal University of Paraná, Curitiba, Brazil; 23Department of Medical and Surgical Sciences, University of Foggia, Foggia, Italy; 24Universidad Autónoma de Nuevo León, Faculty of Medicine and Hospital Universitario “Dr. José Eleuterio González”, Regional Center of Allergy and Clinical Immunology, Gonzalitos y Madero s/n Colonia Mitras Centro, Monterrey, Nuevo León, CP 64460, Mexico; 25Data &amp; Analytics, NICE, Manchester, UK; 26School of Medicine, University of Nottingham, Nottingham, UK; 27American College of Chest Physicians, Glenview, IL, USA; 28Medicine Department and Allergy Unit, University of Malaga, Malaga, Spain; 29General Practitioners Research Institute, Groningen, the Netherlands; 30Groningen Research Institute Asthma and COPD (GRIAC), University of Groningen, University Medical Center Groningen, Groningen, the Netherlands; 31Department of Pulmonology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands; 32Paul-Ehrlich-Institut, Langen, Germany; 33Allergy Center, CUF Descobertas Hospital, Lisbon, Portugal; 34Data Analytics Taskforce, EMA – European Medicine Agency, Amsterdam, the Netherlands; 35Department of Biomedical, Surgical and Dental Health Sciences, University of Milan, Milan, Italy; 36IRCCS Multimedica, Milan, Italy; 37Secretariat EFA- European Federation of Allergy and Airways Diseases, Brussels, Belgium; 38Allergy and Clinical Immunology Unit, Second Pediatric Clinic, National and Kapodistrian University of Athens, Athens, Greece; 39University of Manchester, Manchester, UK; 40Asia Pacific Association of AllergyAsthma Clinical Immunology, Nippon Medical School, Tokio, Japan; 41The Woolcock Institute of Medical Research and Macquarie University, Sydney, New South Wales, Australia; Faculty of Medicine and Health, The University of Sydney; Sydney Local Health District, Sydney, Australia; 42Hospital Juárez de México, CMICA y SLAAI, Ciudad de México, Mexico; 43Centre for Population Health Sciences, Usher Institute, University of Edinburgh, Edinburgh, UK; 44Regional University Hospital, IBIMA-BIONAND, Malaga, Spain; 45Leadership Team, GAAPP – Global Allergy and Airways Patient Platform, Hendersonville, TN, USA; 46Department of Medicine, Boston University School of Medicine Boston, Boston, MA, USA&amp;ast;These authors contributed equally to this workCorrespondence: Stefano Del Giacco, Department of Medical Sciences and Public Health, Asse didattico “E1”, Cittadella Universitaria, Monserrato, Cagliari, 09042, Italy, Email [email protected]: Integrating real-world evidence (RWE) into evidence-based medicine (EBM) enhances healthcare decision-making. RWE provides insights into the real-world effectiveness and safety of therapies and health technologies, filling gaps that clinical trials may leave. EBM, which concentrates on therapeutic issues, depends on rigorous evaluation of evidence, including data from randomized controlled trials (RCTs) and RWE. Combining evidence from RCTs and RWE when forming recommendations offers a comprehensive understanding of benefits and risks by considering their strengths, limitations, and standardized methods. The 2nd European Academy of Allergy &amp; Clinical Immunology/Respiratory Effectiveness Group (EAACI/REG) Workshop, held in Rome, Italy, on October 4th, 2023, discussed integrating RWE and EBM. The goals were to develop recommendations for high-quality RWE and its inclusion in evidence syntheses, with a particular focus on airway diseases. During the discussion, key topics emerged. An “action plan” is needed to share these topics in various formats. RCTs are currently seen as providing the strongest evidence, so how to incorporate Non-Randomized Studies of Interventions (NRSI) requires careful consideration. An educational plan and collaboration with patients’ organizations are also very important. A collaborative approach involving patients, clinicians, and regulators is essential for achieving meaningful results and can be adapted as needed for cultural differences. A “glossary” of terms used in this context will be created to improve understanding. Setting benchmarks for data quality and reliability, such as quality thresholds, in disease-specific studies requires collaboration with research method experts. Managing and recording registries according to standardized protocols and quality standards from well-designed registries will ensure the data is valid and accurate.Keywords: real world evidence, evidence-based medicine, real world data, registrie

Outcomes from elective colorectal cancer surgery during the SARS-CoV-2 pandemic

This study aimed to describe the change in surgical practice and the impact of SARS-CoV-2 on mortality after surgical resection of colorectal cancer during the initial phases of the SARS-CoV-2 pandemic

Mortality and pulmonary complications in patients undergoing surgery with perioperative SARS-CoV-2 infection: an international cohort study

Background: The impact of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) on postoperative recovery needs to be understood to inform clinical decision making during and after the COVID-19 pandemic. This study reports 30-day mortality and pulmonary complication rates in patients with perioperative SARS-CoV-2 infection. Methods: This international, multicentre, cohort study at 235 hospitals in 24 countries included all patients undergoing surgery who had SARS-CoV-2 infection confirmed within 7 days before or 30 days after surgery. The primary outcome measure was 30-day postoperative mortality and was assessed in all enrolled patients. The main secondary outcome measure was pulmonary complications, defined as pneumonia, acute respiratory distress syndrome, or unexpected postoperative ventilation. Findings: This analysis includes 1128 patients who had surgery between Jan 1 and March 31, 2020, of whom 835 (74·0%) had emergency surgery and 280 (24·8%) had elective surgery. SARS-CoV-2 infection was confirmed preoperatively in 294 (26·1%) patients. 30-day mortality was 23·8% (268 of 1128). Pulmonary complications occurred in 577 (51·2%) of 1128 patients; 30-day mortality in these patients was 38·0% (219 of 577), accounting for 81·7% (219 of 268) of all deaths. In adjusted analyses, 30-day mortality was associated with male sex (odds ratio 1·75 [95% CI 1·28–2·40], p\textless0·0001), age 70 years or older versus younger than 70 years (2·30 [1·65–3·22], p\textless0·0001), American Society of Anesthesiologists grades 3–5 versus grades 1–2 (2·35 [1·57–3·53], p\textless0·0001), malignant versus benign or obstetric diagnosis (1·55 [1·01–2·39], p=0·046), emergency versus elective surgery (1·67 [1·06–2·63], p=0·026), and major versus minor surgery (1·52 [1·01–2·31], p=0·047). Interpretation: Postoperative pulmonary complications occur in half of patients with perioperative SARS-CoV-2 infection and are associated with high mortality. Thresholds for surgery during the COVID-19 pandemic should be higher than during normal practice, particularly in men aged 70 years and older. Consideration should be given for postponing non-urgent procedures and promoting non-operative treatment to delay or avoid the need for surgery. Funding: National Institute for Health Research (NIHR), Association of Coloproctology of Great Britain and Ireland, Bowel and Cancer Research, Bowel Disease Research Foundation, Association of Upper Gastrointestinal Surgeons, British Association of Surgical Oncology, British Gynaecological Cancer Society, European Society of Coloproctology, NIHR Academy, Sarcoma UK, Vascular Society for Great Britain and Ireland, and Yorkshire Cancer Research

BiosecurID: a multimodal biometric database

A new multimodal biometric database, acquired in the framework of the BiosecurID project funded by the Spanish MEC, is presented together with a brief description of the acquisition setup and protocol. The database includes 7 unimodal biometric traits, namely: speech, iris, face (photographs and talking faces), signature and handwriting (online and off-line), fingerprints (acquired with two different sensors), hand (palmprint and contour-geometry) and keystroking. The database comprises 400 subjects and presents features such as: realistic acquisition scenario, balanced gender and population distributions, availability of information about particular demographic groups (age, gender, handedness), acquisition of skilled forgeries, and compatibility with other existing databases. All these characteristics make it very useful in research and development of multimodal biometric systems