Work package 2
Provide a robust and validated blinded outcome assessment platform and use it to deliver reliable modified Rankin Scale (mRS) scores of all patients
Establish an online platform for handling the mRS (modified Rankin Scale) video assessments:
Centralised Adjudication of Rankin Scores (CARS) portal
Provide training and certification in mRS assessment for the investigators participating in the trial
Develop instructional materials for the investigators for recording, upload, and handling of mRS assessments within CARS Portal
Manage independent scoring of mRS assessments across all participating sites to provide reliable and blinded mRS scores in the PRECIOUS trial
Description of tasks
The University of Glasgow provided an online platform for independent clinicians to review and assign a score to the degree of recovery that is achieved by each patient in the trial. It is impractical to conceal from patients and their physicians which treatment the patient has been given. Yet, knowledge of treatment can prejudice our perception of recovery, particularly in a condition as variable and chronic as stroke. To avoid this prejudice from harming the trial results, physicians who were not involved in the patient’s care, were asked to assess their recovery.
Therefore, video recordings documented short interviews with the patient, which have been uploaded in the established, secure CARS portal. The recordings were then evaluated by several independent physicians, who assigned a grading according to a well-established method called the modified Rankin Scale or ‘mRS’.
As soon as a video has been uploaded a physician has been notified by the system that a video is ready for scoring. The CARS portal kept track of their results, were able to record reasons for their scores and monitored their workload. To translate the interviews, if necessary, was possible as well.
Another task of WP 2 was to conduct the training for investigators and expert adjudicators in recording interviews for mRS, in using the CARS platform to view mRS videos and in applying scores on the mRS. This was all done via an online system of instruction and testing before certificates were issued to confirm that staff is qualified to the required standard.
PRECIOUS: List of Work Packages
WP 1: Trial Management
WP 2: Outcome Adjudication
WP 3: Infections and Antimicrobial Resistance
WP 4: Monitoring
WP 5: Health Economics
WP 6: Safety Monitoring
WP 7: Statistical Analysis
WP 8: Dissemination, Exploitation and Communication
WP 9: Project Management