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

Bibliographic Details
Title: 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
Authors: Ursula Marschall, S Fatima Faqar-Uz-Zaman, Natalie Filmann, Dora Mahkovic, Michael von Wagner, Charlotte Detemble, Ulf Kippke, Luxia Anantharajah, Philipp Baumartz, Paula Sobotta, Wolf O Bechstein, Andreas A Schnitzbauer
Source: BMJ Open, Vol 11, Iss 1 (2021)
Publisher Information: BMJ Publishing Group, 2021.
Publication Year: 2021
Collection: LCC:Medicine
Subject Terms: Medicine
More Details: 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.
Document Type: article
File Description: electronic resource
Language: English
ISSN: 2044-6055
Relation: https://bmjopen.bmj.com/content/11/1/e041396.full; https://doaj.org/toc/2044-6055
DOI: 10.1136/bmjopen-2020-041396
Access URL: https://doaj.org/article/76b6636926744dd2997e23e11a4a1230
Accession Number: edsdoj.76b6636926744dd2997e23e11a4a1230
Database: Directory of Open Access Journals
More Details
ISSN:20446055
DOI:10.1136/bmjopen-2020-041396
Published in:BMJ Open
Language:English