bestätigt durch einen (externen) zentralen Facharzt (der die scores auswertet). In diesem Fall vielleicht durch einen Facharzt für Gastroenterologie.

Man könnte auch den Begriff unübersetzt lassen und eine Erklärung in Klammern hinzufügen. Anmerkung des Übersetzers.

Endoscopic images were reviewed by a single expert central reader. The primary outcome was clinical remission (UCDAI, stool frequency and bleeding scores of 0, and no fecal urgency) at week 6.

Thirty-one percent of participants, all of whom had a UCDAI sigmoidoscopy score ≥2 as read by the site investigator, were considered ineligible by the central reader.

https://www.researchgate.net/publication/236080369_The_Role_...

Knowledge and utilization of the two scores were investigated. Inter-observer agreement and agreement with an IBD-expert gastroenterologist of the same center (central reader) , and correlation between the two scores, was calculated. Among the endoscopists, MES was much more known and currently used than UCEIS. Both the scores displayed a similar good performance.

Agreement with central reader was moderate for MES and UCEIS, and interobserver agreement was good, for both MES and UCEIS. Correlation between the two scores was very good both for central reader and for the hospital endoscopist.

https://www.researchgate.net/publication/351424443_Mayo_Endo...

A blinded read ─ defined as a Blinded Independent Central Review (BICR) ─ is the practice of collecting all study images acquired at the investigative sites and presenting these data to separate groups of readers for evaluations. In most cases, end point clinical trial images are read by radiologists, but depending on the therapeutic area, and read requirements for subspecialty trained experts, the images may also be read by cardiologists, oncologists, orthopedic surgeons, nuclear medicine physicians or other experts as required. Hence the term ‘reader’ has become the all-encompassing term used to describe these individuals, and this is the term the FDA uses in their guidance documents.

https://www.ert.com/blog/understanding-the-blinded-read-clin...