Person:

Kressel, Herbert

Incomplete reporting has been identified as a major source of avoidable waste in biomedical research. Essential information is often not provided in study reports, impeding the identification, critical appraisal, and replication of studies. To improve the quality of reporting of diagnostic accuracy studies, the Standards for Reporting Diagnostic Accuracy (STARD) statement was developed. Here we present STARD 2015, an updated list of 30 essential items that should be included in every report of a diagnostic accuracy study. This update incorporates recent evidence about sources of bias and variability in diagnostic accuracy and is intended to facilitate the use of STARD. As such, STARD 2015 may help to improve completeness and transparency in reporting of diagnostic accuracy studies.

Artificial intelligence (AI) is projected to substantially influence clinical practice in the foreseeable future. However, despite the excitement around the technologies, it is yet rare to see examples of robust clinical validation of the technologies and, as a result, very few are currently in clinical use. A thorough, systematic validation of AI technologies using adequately designed clinical research studies before their integration into clinical practice is critical to ensure patient benefit and safety while avoiding any inadvertent harms. We would like to suggest several specific points regarding the role that peer-reviewed medical journals can play, in terms of study design, registration, and reporting, to help achieve proper and meaningful clinical validation of AI technologies designed to make medical diagnosis and prediction, focusing on the evaluation of diagnostic accuracy efficacy. Peer-reviewed medical journals can encourage investigators who wish to validate the performance of AI systems for medical diagnosis and prediction to pay closer attention to the factors listed in this article by emphasizing their importance. Thereby, peer-reviewed medical journals can ultimately facilitate translating the technological innovations into real-world practice while securing patient safety and benefit.