Evaluation of Clinical and Pathological Characteristics and Routine Treatment of Patients with Prostate Cancer in Six Referral Centers in Iran: A Pilot Non-interventional, Multicenter Study

Background: Prostate cancer is the second most common malignancy among Iranian men after stomach cancer. To understand the nature of the disease and plan and develop a population-based cancer registry, it is essential to recognize the clinical and pathological characteristics of the tumors, as well as treatment results. Objectives: The present study aimed to evaluate the clinical and pathological characteristics of prostate cancer and evaluate the routine practice, including treatment outline and results of treatment in six referral centers in Iran. Methods: This prospective observational pilot study recruited patients with prostate cancer between April 2015 and October 2015 at six referral centers in Iran. The participating physicians included consecutive patients according to inclusion criteria. Demographic, clinicopathologic, and treatment data were collected by the physicians using an electronic case report form (eCRF). The patients were followed for 18 months, and during this period, four visits were scheduled for each patient to collect the data. Results: A total number of 102 patients from six centers in five different cities of Iran were included in the study. Sixty-seven (65.7%) patients were diagnosed by needle biopsy as the first diagnostic method, 23 (22.5%) by radical prostatectomy, and 12 (11.8%) by open prostatectomy. Total at-risk times of patients for overall survival (OS) and progression-free survival (PFS) were 1480.9 and 1437 months, respectively. Median (IQR) values of OS and PFS were 18.2 (9.2 - 20.5) and 18.2 (6.8 - 20.4) months, respectively. Forty (39.2%) patients underwent surgery, 58 (56.8%) underwent radiotherapy, and 13 (12.7%) received chemotherapy. Twenty-nine (28.4%) patients experienced adverse events over the follow-up period. Eight deaths were reported that were unrelated to treatment adverse effects. Conclusions: This pilot registry could serve as a valuable tool for the development of a comprehensive nationwide registry for patients with prostate cancer in Iran.

O1 Admission avoidance in tonsillitis and peritonsillar abscess: a prospective national audit during the initial peak of the COVID-19 pandemic

Introduction During the COVID-19 outbreak, the collaborative network for ENT trainees in the UK (INTEGRATE), conducted a multi-centre prospective audit on the management of Tonsillitis and Quinsy. This was in response to the implementation of new COVID-19 specific guidelines released by ENT UK and to explore factors relating to unscheduled re-presentations discharges direct from the Emergency Department (ED). Methods Consecutive patients with suspected tonsillitis or quinsy, aged 18 or over, and referred to ENT in secondary care were eligible for inclusion. Data was collected, using a standardised electronic case report form, relating to patient demographics, COVID-19 status, clinicians’ grade, assessment and interventions. Each case was followed-up for 10 days to assess predictors of unscheduled re-presentation after discharge direct from the ED. Results 83 centres submitted 765 tonsillitis and 416 quinsy cases. 54.4% of tonsillitis cases and 45.3% of quinsy were discharged directly from the ED. 9.6% of tonsillitis and 10.3% of quinsy discharges re-presented within 10 days, compared to 9.7% and 10.6% for those initially admitted. IV steroids were given to 67.0% of tonsillitis patients and 73.6% of quinsy. 77.2% of quinsy patients underwent drainage during their initial presentation, but there was no significant difference in re-presentation rate in those drained vs not-drained (p = 0.85). Univariable logistic regression showed no significant predictors of re-presentation within 10 days. Conclusion Management of tonsillitis and quinsy was affected during the initial peak of the pandemic, with a shift towards outpatient care. Some patients who may previously have been admitted to hospital may be safely discharged from the ED.

Development and design of the Hantavirus registry - HantaReg - for epidemiological studies, outbreaks and clinical studies on hantavirus disease

Background Frequent outbreaks around the globe and endemic appearance in different parts of the world emphasize the substantial risk of hantavirus diseases. Increasing incidence rates, trends of changing distribution of hantavirus species and new insights into clinical courses of hantavirus diseases call for multinational surveillance. Furthermore, evidence-based guidelines for the management of hantavirus diseases and scoring systems, which allow stratification of patients into risk categories, are lacking. Methods Hantavirus registry (HantaReg) is a novel registry platform facilitating multinational research of hantavirus-caused diseases, such as haemorrhagic fever with renal syndrome (HFRS) and hantavirus cardiopulmonary syndrome (HCPS). HantaReg provides an electronic case report form and uses the General Data Protection Regulation compliant platform clinicalsurveys.net, which can be accessed from any internet browser in the world. Having a modular structure, the registry platform is designed to display or hide questions and items according to the documented case (e.g. patient with HFRS versus HCPS) to facilitate fast, but standardized, data entry. Information categories documented in HantaReg are demographics, pre-existing diseases, clinical presentation, diagnostic and therapeutic approaches, as well as outcome. Conclusions HantaReg is a novel, ready-to-use platform for clinical and epidemiological studies on hantavirus diseases and facilitates the documentation of the disease course associated with hantavirus infections. HantaReg is expected to promote international collaboration and contributes to improving patient care through the analysis of diagnostic and treatment pathways for hantavirus diseases, providing evidence for robust treatment recommendations. Moreover, HantaReg enables the development of prognosis-indicating scoring systems for patients with hantavirus disease.

Design and rationale of the COVID-19 Critical Care Consortium international, multicentre, observational study

IntroductionThere is a paucity of data that can be used to guide the management of critically ill patients with COVID-19. In response, a research and data-sharing collaborative—The COVID-19 Critical Care Consortium—has been assembled to harness the cumulative experience of intensive care units (ICUs) worldwide. The resulting observational study provides a platform to rapidly disseminate detailed data and insights crucial to improving outcomes.Methods and analysisThis is an international, multicentre, observational study of patients with confirmed or suspected SARS-CoV-2 infection admitted to ICUs. This is an evolving, open-ended study that commenced on 1 January 2020 and currently includes >350 sites in over 48 countries. The study enrols patients at the time of ICU admission and follows them to the time of death, hospital discharge or 28 days post-ICU admission, whichever occurs last. Key data, collected via an electronic case report form devised in collaboration with the International Severe Acute Respiratory and Emerging Infection Consortium/Short Period Incidence Study of Severe Acute Respiratory Illness networks, include: patient demographic data and risk factors, clinical features, severity of illness and respiratory failure, need for non-invasive and/or mechanical ventilation and/or extracorporeal membrane oxygenation and associated complications, as well as data on adjunctive therapies.Ethics and disseminationLocal principal investigators will ensure that the study adheres to all relevant national regulations, and that the necessary approvals are in place before a site may contribute data. In jurisdictions where a waiver of consent is deemed insufficient, prospective, representative or retrospective consent will be obtained, as appropriate. A web-based dashboard has been developed to provide relevant data and descriptive statistics to international collaborators in real-time. It is anticipated that, following study completion, all de-identified data will be made open access.Trial registration numberACTRN12620000421932 (http://anzctr.org.au/ACTRN12620000421932.aspx).

546. Capturing Clinician’s Experiences Repurposing Drugs to Inform Future Studies During COVID-19

Background CURE ID is an internet-based repository developed collaboratively by FDA and NCATS/NIH, with the support of WHO and IDSA. It encourages clinicians globally to share novel uses of existing drugs for patients with difficult-to-treat infections. It is designed to serve as a rapid communication platform for healthcare providers during an outbreak, providing for systematic case-sharing, discussion, and the latest literature. Besides case reports, CURE ID offers a discussion platform for clinicians, disease-specific clinical trials curated from clincialtrials.gov, and a newsfeed that shows relevant journal articles and news related to COVID-19 and other infectious diseases. Methods The CURE ID team extracted individual case reports on patient-level treatments and outcomes of COVID-19 infection from the published literature and gathered clinician-submitted cases through the electronic case report form. Additionally, CURE ID partnered with the University of Pennsylvania’s CORONA database to further populate the CURE ID database with published cases. Results As of submission, lopinavir-Ritonavir (n=51) was the most commonly reported drug used. The following were also reported: hydroxychloroquine (n=31), azithromycin (n=28), arbidol (n=22), interferon alfa-2B (n=18), moxifloxacin (n=18), methylprednisolone (n=17), ivermectin (n=14), lopinavir (n=12), oseltamivir (n=12). The other drugs reported were danoprevir-ritonavir, intravenous immunoglobulins, interferon, interferon alfa, and tocilizumab. CURE ID currently includes more than 150 detailed COVID case reports of 65 repurposed drugs. We expect case reporting for specific drugs to be dynamic and additional data to accrue. Updated results will be presented. Conclusion Several drugs are being repurposed to treat COVID-19. CURE ID gives clinicians an opportunity to share their treatment experiences and discuss their questions with a global community of healthcare providers. By utilizing the CURE ID platform, in conjunction with data gathered from other registries, observational studies and clinical trials, hypotheses can be generated that may inform future clinical trials and ultimately, potentially find safe and effective treatments for this deadly disease. Disclosures All Authors: No reported disclosures

A Cohort of Patients with COVID-19 in a Major Teaching Hospital in Europe

Background: Since the confirmation of the first patient infected with SARS-CoV-2 in Spain in January 2020, the epidemic has grown rapidly, with the greatest impact on the region of Madrid. This article describes the first 2226 adult patients with COVID-19, consecutively admitted to La Paz University Hospital in Madrid. Methods: Our cohort included all patients consecutively hospitalized who had a final outcome (death or discharge) in a 1286-bed hospital of Madrid (Spain) from 25 February (first case admitted) to 19 April 2020. The data were manually entered into an electronic case report form, which was monitored prior to the analysis. Results: We consecutively included 2226 adult patients admitted to the hospital who either died (460) or were discharged (1766). The patients’ median age was 61 years, and 51.8% were women. The most common comorbidity was arterial hypertension (41.3%), and the most common symptom on admission was fever (71.2%). The median time from disease onset to hospital admission was 6 days. The overall mortality was 20.7% and was higher in men (26.6% vs. 15.1%). Seventy-five patients with a final outcome were transferred to the intensive care unit (ICU) (3.4%). Most patients admitted to the ICU were men, and the median age was 64 years. Baseline laboratory values on admission were consistent with an impaired immune-inflammatory profile. Conclusions: We provide a description of the first large cohort of hospitalized patients with COVID-19 in Europe. Advanced age, male sex, the presence of comorbidities and abnormal laboratory values were more common among the patients with fatal outcomes.

A cohort of patients with COVID-19 in a major teaching hospital in Europe

ABSTRACTBACKGROUNDSince the confirmation of the first patient infected with SARS-CoV-2 in Spain in January 2020, the epidemic has grown rapidly, with the greatest impact on the Madrid region. This article describes the first 2226 consecutive adult patients with COVID-19 admitted to the La Paz University Hospital in Madrid.METHODSOur cohort included all consecutively admitted patients who were hospitalized and who had a final outcome (death or discharge) in a 1286-bed hospital of Madrid (Spain) from February 25th (first case admitted) to April 19th, 2020. Data was entered manually into an electronic case report form, which was monitored prior to the analysis.RESULTSWe consecutively included 2226 adult patients admitted to the hospital who either died (460) or were discharged (1766). The patients’ median age was 61 years; 51.8% were women. The most common comorbidity was arterial hypertension (41.3%). The most common symptom on admission were fever (71.2%). The median time from disease onset to hospital admission was 6 days. Overall mortality was 20.7% and was higher in men (26.6% vs 15.1%). Seventy-five patients with a final outcome were transferred to the ICU (3.4%). Most patients admitted to the ICU were men, and the median age was 64 years. Baseline laboratory values on admission were consistent with an impaired immune-inflammatory profile.CONCLUSIONSWe provide a description of the first large cohort of hospitalized patients with COVID-19 in Europe. Advanced age, male gender, the presence of comorbidities and abnormal laboratory values were more common among the patients with fatal outcomes.

The iCRF Generator: Generating interoperable electronic case report forms using online codebooks

Semantic interoperability of clinical data is essential to preserve its meaning and intent when the data is exchanged, re-used or integrated with other data. Achieving semantic operability requires the use of a communication standard, such as HL7, as well as (functional) information standards. Manually mapping clinical data to a medical thesaurus, such as SNOMED CT, is complicated and requires expert knowledge of both the dataset, including its context, and the thesaurus. As an alternative, the (re-)use of codebooks, data definitions which may already have been mapped to a thesaurus, can be a viable approach. We’ve developed the iCRF Generator, a Java program that can generate the core of an interoperable electronic case report form (iCRF) for several of the major electronic data capture systems (EDCs). To build their CRFs, users can select one or more items from established codebooks, available from an online system called ART-DECOR. By providing an easy to use method to create CRFs for multiple EDCs based on the same codebooks, interoperability can be more easily attained.

The iCRF Generator: Generating interoperable electronic case report forms using online codebooks

Semantic interoperability of clinical data is essential to preserve its meaning and intent when the data is exchanged, re-used or integrated with other data. Achieving semantic operability requires the use of a communication standard, such as HL7, as well as (functional) information standards. Manually mapping clinical data to a medical thesaurus, such as SNOMED CT, is complicated and requires expert knowledge of both the dataset, including its context, and the thesaurus. As an alternative, the (re-)use of codebooks, data definitions which may already have been mapped to a thesaurus, can be a viable approach. We’ve developed the iCRF Generator, a Java program that can generate the core of an interoperable electronic case report form (iCRF) for several of the major electronic data capture systems (EDCs). To build their CRFs, users can select one or more items from established codebooks, available from an online system called ART-DECOR. By providing an easy to use method to create CRFs for multiple EDCs based on the same codebooks, interoperability can be more easily attained.