Work package 2: Outcome Adjudication
Leader: Prof. Kennedy Lees, University of Glasgow
- Establish a web-based platform for the handling of mRS Scale video assessments; the Centralised Adjudication of Rankin Scores (CARS) portal.
- To train the investigators participating in the trial in the use of the mRS and provide certification that they have successfully completed this training.
- WP2 will also develop instructional materials for the investigators in the use of the mRS, in video recording of patient assessments and use of the CARS portal for assessment upload and scoring.
- The management of independent scoring for mRS assessments across all participating sites to provide reliable and blinded mRS scores in the PRECIOUS trial.
Description of the tasks
The University of Glasgow will provide an internet-based platform to let expert, independent clinicians 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 doctors 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, we ask doctors who are not involved in the patient’s care to assess their recovery.
We do this by making a short video recording of an interview with the patient, then we invite several independent doctors to watch the video and assign a grading according to a well-established method called the modified Rankin Scale or ‘mRS’. To let the doctors view video, even from a different hospital or country, we send these recordings to an internet-based but very secure storage area that we call the Central Adjudication of Rankin Scores, or ‘CARS’, system. This internet-based platform notifies the independent doctors that a video is ready for scoring, it keeps track of their results, lets them record reasons for their scores and it monitors their workload etc. It even allows for translation of the interview when necessary.
WP 2 run by the University of Glasgow will also oversee training of our 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 is all done via an online system of instruction and testing before we issue certificates to confirm that staff are qualified to the required standard.