The University of Glasgow is a leading UK university, a member of the prestigous Russell Group, undertaking internationally-competitive research and generating a research income of £181m annually. The stroke team at the UGLA have extensive expertise in trial conduct and outcomes assessment. This team developed internationally accepted training and certification for the modified Rankin Scale (mRS) and more recently led the European Stroke Outcomes working party in the recommendation of the ordinal mRS as the optimal outcomes measure in stroke clinical trials. Supported by a Scottish government grant the UGLA stroke team created a centralised adjudication system for scoring of the modified Rankin Scale which has been used in several international trials including the NIH-funded CLEAR-3 trial of intraventricular haemorrhage, the MISTIE-3 trial of intracerebral haemorrhage, the EU-FP7 funded EuroHYP trial and the investigator-driven SITS-OPEN trial of endovascular treatment.
In any clinical trial, after enrolment of suitable patients and appropriate delivery of the investigational treatment, it is essential to collect valid, unbiased and reliable outcome assessments which can be used in assessing efficacy of the treatment. To ensure that the outcome measures that are collected in the PRECIOUS trial are reliable, valid and unbiased the UGLA will lead WP2 (Outcomes adjudication) using their centralised adjudication system. The interventions in the PRECIOUS trial cannot be blinded to investigators and knowledge of treatment may generate bias in scoring of functional outcomes, using central adjudication of patients’ functional outcomes based on video-recorded patient interviews this bias can be circumvented and allows for source data verification. This method also carries a statistical advantage through increased reliability.
The WP2 and stroke research team at UGLA is led by Prof Lees who was chief investigator for several of the largest acute stroke trials (IMAGES, GAIN, SAINT) and has extensive experience in designing, coordinating, analysing, reporting and interpreting stroke trials.
Prof Lees and the WP2 team will be responsible for:
- The training of investigators in the assessments and methods of collection for the centralised adjudcation of the mRS.
- The provision of a secure web-based system for the handling of the video recorded assessment compliant with the ISO 9001:2005, Tickit and ISO27001:2008 regulations for data management.
- Co-ordinating a team of independent experts for the scoring of the modified Rankin assessments.
- Provide technical assisstance and training to other work packages in the use of centralised adjudication and the modified Rankin Scale.
UGLA staff will also contribute to design, ethics, conduct, analysis and reporting of the trial using expertise in each of these areas to assist other work packages to deliver their tasks.