Study protocol for a prospective, double-blinded, observational study investigating the diagnostic accuracy of an app-based diagnostic health care application in an emergency room setting: the eRadaR trial.

INTRODUCTION: Occurrence of inaccurate or delayed diagnoses is a significant concern in patient care, particularly in emergency medicine, where decision making is often constrained by high throughput and inaccurate admission diagnoses. Artificial intelligence-based diagnostic decision support system have been developed to enhance clinical performance by suggesting differential diagnoses to a given case, based on an integrated medical knowledge base and machine learning techniques. The purpose of the study is to evaluate the diagnostic accuracy of Ada, an app-based diagnostic tool and the impact on patient outcome. METHODS AND ANALYSIS: The eRadaR trial is a prospective, double-blinded study with patients presenting to the emergency room (ER) with abdominal pain. At initial contact in the ER, a structured interview will be performed using the Ada-App and both, patients and attending physicians, will be blinded to the proposed diagnosis lists until trial completion. Throughout the study, clinical data relating to diagnostic findings and types of therapy will be obtained and the follow-up until day 90 will comprise occurrence of complications and overall survival of patients. The primary efficacy of the trial is defined by the percentage of correct diagnoses suggested by Ada compared with the final discharge diagnosis. Further, accuracy and timing of diagnosis will be compared with decision making of classical doctor-patient interaction. Secondary objectives are complications, length of hospital stay and overall survival. ETHICS AND DISSEMINATION: Ethical approval was received by the independent ethics committee (IEC) of the Goethe-University Frankfurt on 9 April 2020 including the patient information material and informed consent form. All protocol amendments must be reported to and adapted by the IEC. The results from this study will be submitted to peer-reviewed journals and reported at suitable national and international meetings. TRIAL REGISTRATION NUMBER: DRKS00019098.

[SARS-CoV-2/COVID-19: systematic review of requirements for personal protective equipment in primary patient contact and organization of the operating area]. / SARS-CoV-2/COVID-19: Systematischer Review zu Anforderungen an die persönliche Schutzausrüstung bei primärem Patientenkontakt und Strukturierung des Operationsbereiches.

BACKGROUND: The SARS-CoV-2/COVID-19 pandemic necessitates a rapid reorganization of the hospital procedures. The establishment of centers dedicated to COVID-19 treatment and care also necessitates preparation of the surgical departments for the forthcoming emergency interventions for infected patients and patients with an unclear infection status. This article summarizes the evidence on standards for personal protective equipment for personnel in the central emergency admission department and in the operations area as well as restructuring measures for the procedures in the operations area in a COVID-plus area. METHOD: A systematic literature search was carried out. RESULTS: The grey area of unknown infected and potential transmitters of SARS-CoV-2/COVID-19 is high. Patients with an unclear infection status or who are highly suspected of having an infection should be classified as infectious until the contrary can be proven. The protection of personnel in healthcare professions against infections is of particular importance. The supply of adequate personal protective equipment in a risk-stratified form can substantially influence the success of combating the pandemic. Most operations must be assessed as aerosol-forming procedures and necessitate the maximum protection of personnel working directly on the patient. Particular attention should be paid to obligatory hygiene regulatory measures for protection against contamination during the reorganization in the operations area and on the transport routes between the wards. CONCLUSION: The correct personal protective equipment considering the occupational safety helps to sustainably protect personnel from infections. Reorganizational measures in the operating room are urgently indicated for potential aerosol-forming procedures in infected patients or patients with an unclear infection status. The current dynamic situation necessitates a high level of flexibility as well as reassessment and adaptation of the measures at short intervals.