ABSTRACT
Background: Clinical Trial Recruitment Support Systems can booster patient inclusion of clinical trials by automatically analyzing eligibility criteria based on electronic health records. However, missing interoperability has hindered introduction of those systems on a broader scale. Purpose(s): Our aim was to develop a recruitment support system based on FHIR R4 and evaluate its usage and features in a cardiology department. Methods/Implementation: Clinical conditions, anamnesis, examinations, allergies, medication, laboratory data and echocardiography results were imported as FHIR resources. Trial study nurses and physicians were enabled to add new and edit trial information and input inclusion and exclusion criteria using a web-browser user interface in the hospital intranet. All information were recorded on the server side as the FHIR resources ResearchStudy and Group . Eligibility criteria linked by the logical operation OR were represented by using multiple FHIR Group resources for enrollment. On the client side, eligibility criteria were transformed to a tree-like structure (see Figure 1). Upon user demand, all hospitalized and ambulatory patients in the cardiology department were instantly screened for trial eligibility using the FHIR eligibility criteria on the existing patients' FHIR resources. Furthermore, study personal was able to manually edit trial status (i.e. ineligible, on-study, ..) of patients, which was implemented using the FHIR resource ResearchSubject . Result(s): This implementation of a CTRSS based on FHIR R4 was evaluated in clinical practice: Beginning from 1st April 2021 the application was used as an additional patient screening tool for the four trials CLOSUREAF, FAIR-HF2, SPRIRIT-HF and TORCH-PLUS of the German Centre for Cardiovascular Research. As the COVID-19 pandemic is prohibiting any proper comparison of patient inclusion rates, efficacy of the recruitment support system was tested by comparing the numbers of patients identified by the recruitment support system and enrolled in a trial to the actual number of enrolled patients irrespective of the screening method from 1st April 2021 to 23rd November 2021. The system was able to identify 52 of 55 patients included in those four clinical trials. Conclusion(s): Use of FHIR for defining eligibility criteria of clinical trials may facilitate interoperability and allow automatic screening for eligible patients at multiple sites of different healthcare providers in the future. Upcoming changes in FHIR should allow easier description of OR -linked eligibility criteria. (Figure Presented).
ABSTRACT
Background: Clinical Trial Recruitment Support Systems can booster patient inclusion of clinical trials by automatically analyzing eligibility criteria based on electronic health records. However, missing interoperability has hindered introduction of those systems on a broader scale. Purpose: Our aim was to develop a recruitment support system based on FHIR R4 and evaluate its usage and features in a cardiology department. Methods/Implementation: Clinical conditions, anamnesis, examinations, allergies, medication, laboratory data and echocardiography results were imported as FHIR resources. Trial study nurses and physicians were enabled to add new and edit trial information and input inclusion and exclusion criteria using a web-browser user interface in the hospital intranet. All information were recorded on the server side as the FHIR resources "ResearchStudy” and "Group”. Eligibility criteria linked by the logical operation "OR” were represented by using multiple FHIR Group resources for enrollment. On the client side, eligibility criteria were transformed to a tree-like structure (see Figure 1). Upon user demand, all hospitalized and ambulatory patients in the cardiology department were instantly screened for trial eligibility using the FHIR eligibility criteria on the existing patients' FHIR resources. Furthermore, study personal was able to manually edit trial status (i.e. ineligible, on-study, ...) of patients, which was implemented using the FHIR resource "ResearchSubject”. Results: This implementation of a CTRSS based on FHIR R4 was evaluated in clinical practice: Beginning from 1st April 2021 the application was used as an additional patient screening tool for the four trials CLOSURE-AF, FAIR-HF2, SPRIRIT-HF and TORCH-PLUS of the German Centre for Cardiovascular Research. As the COVID-19 pandemic is prohibiting any proper comparison of patient inclusion rates, efficacy of the recruitment support system was tested by comparing the numbers of patients identified by the recruitment support system and enrolled in a trial to the actual number of enrolled patients irrespective of the screening method from 1st April 2021 to 23rd November 2021. The system was able to identify 52 of 55 patients included in those four clinical trials. Conclusion: Use of FHIR for defining eligibility criteria of clinical trials may facilitate interoperability and allow automatic screening for eligible patients at multiple sites of different healthcare providers in the future. Upcoming changes in FHIR should allow easier description of "OR”-linked eligibility criteria. Funding Acknowledgement: Type of funding sources: Public grant(s) – National budget only. Main funding source(s): Deutsche ForschungsgemeinschaftFigure 1
ABSTRACT
The current pandemic of the SARS-CoV-2 virus requires measures to reduce the risk of infection. In addition to the usual hygiene measures, air cleaners are a recommended solution to decrease the viral load in rooms. Suitable technologies range from pure filters to inactivating units, such as cold plasma or UVC irradiation. Such inactivating air cleaners, partly combined with filter technology, are available on the market in various designs, dimensions and technical specifications. Since it is not always clear whether they may produce undesirable by-products, and the suitability for particular applications cannot be assessed on the basis of the principle of operation, the effectivity of six inactivating devices was investigated in a near-real environment. The investigations were based on a standard method published by the VDI. The procedure was extended in such a way that a permanent virus source was simulated, which corresponds to the presence of a person suffering from COVID-19 in a room. The study addresses the difference of the mere presence of viruses to the determination of the virulence. As a result, a deep understanding is provided between the behavior of a virus as a pure aerosolized particle and its real infectivity in order to enable the assessment of suitable air cleaners.
ABSTRACT
CASE: 66yo woman with a past medical history of hypertension and monoclonal gammopathy of undetermined significance was sent from clinic in winter for 4 days of worsening fevers and sinus congestion unrelieved by over-the- counter medications. COVID and flu negative. Patient has had no sick contacts or recent travel and has pet cats but no recent scratches. Initial chest x-ray showed no acute processes, but patient was continuing to have fevers up to 103 with mild dyspnea and chills so a CT chest was completed which showed ground glass opacities in the right middle lobe. Blood and sputum cultures were obtained, and patient was started on ceftriaxone and azithromycin for community acquired pneumonia. Urine strep and legionella antigens were also acquired, both negative. Over the next two days, she continued to have high fevers and chills at nights with leukocytosis, thrombocytopenia, hyponatremia, and notable worsening of mild elevation of liver enzymes on admission. Cultures were negative and patient had no other indication of an infection aside from the cyclical fevers therefore empiric doxycycline was added for coverage of atypical infections. Over the next two days, she continued to have nightly fevers up to 103 so ID was consulted for fever of unknown origin. On repeat exposure assessment, patient revealed that she lived with multiple animals including cats, dogs, parakeets, chickens, geese and a pony. Patient was continued on doxycycline while additional lab tests were sent for atypical infections including Rickettsia typhi, Coxiella brunetti (Q fever), and Brucella spp given patient's history of exposure to multiple animals at home. Patient was discharged on doxycycline after being afebrile for 48hrs with declining white count and liver enzymes. Lab results confirmed the diagnosis with high titers for Rickettsia typhi IgG and IgM. IMPACT/DISCUSSION: This case illustrates an atypical presentation of murine typhus with pneumonia in winter. There are several key teaching points in this case: 1. Ricketssia typhi infections have largely nonspecific symptoms therefore it should should be included in differential diagnoses of febrile illnesses with thrombocytopenia and elevated liver enzymes 2. Although a complete history is acquired on admission, it is important to revisit and review information again when a clinical diagnosis has not been established 3. Defeverscence after starting doxycycline can take anywhere from 4 to 66hrs so fevers during this timeframe is not an indication of failure of therapy CONCLUSION: Murine typhus presents with non-specific symptoms so it should be included in the differential diagnosis of patients with fevers of unknown origin with potential exposure to flea-bearing animals. The optimal therapy is doxycycline 100mg twice a day for seven days. Patients should also be advised to treat their animals for fleas to prevent recurrent infections.
ABSTRACT
Objective Liver injury has frequently been reported in COVID-19 patients. The clinical relevance of liver injury related to SARS-CoV-2 infection remains unclear with a need for prospective studies on the impact of liver function test (LFT) abnormalities at baseline. Design Data of 217 patients without pre-existing liver disease prospectively included in the COVID-19 registry of the LMU university hospital were analysed in order to assess the association of abnormal LFT at admission and course of the disease. Severe course was defined as admission to the intensive care unit (ICU) or as COVID-19-related death. Results Abnormal LFT at baseline was present in 58% of patients, with a predominant elevation of aspartate aminotransferase (AST) (42%), gamma-glutamyltransferase (GGT) (37%) and alanine aminotransferase (ALT) (27%), hypoalbuminaemia was observed in 33%. Elevation of ALT and GGT, as well as hypoalbuminaemia, was associated with higher proportions of patients requiring ICU treatment and mechanical ventilation. After adjusting for age, gender and comorbidities, hypoalbuminaemia combined with abnormal AST or GGT at hospital admission was a highly significant independent risk factor for ICU admission (OR 46.22 and 38.8, respectively) and for a composite endpoint of ICU admission and/or COVID-19-related death (OR 42.0 and 26.9, respectively). Conclusion Abnormal LFTs at hospital admission, in particular GGT and albumin, are associated with a severe course of SARS-CoV-2 infection.