WP 05: Outcome Adjudication

It is impossible to mask from patients and clinicians which treatment the patient is given. To assure a robust assessment of outcome, with minimal potential for bias, the functional status of the patients will be assessed by at least 4 independent experts, who will be blinded to treatment and geographically remote from the hospital.

This work programme describes the methodology used to train the investigators and implement a method for recording and adjudicating interviews with patients, and in handling the entire scoring system in a rigorous but economic manner. Digital video cameras linked to a web-based communication system will be used.

Objectives

  1. Establish a robust, blinded outcome measurement platform via video-recorded outcome assessment interviews – coordinate and monitor the adjudication effort. (T1-7)
  2. Provide validated mRS outcomes on all patients surviving to 3 months. (T7)

Work package Description

This work will be carried out under the supervision of Prof. Kennedy Lees (UGLA). Crucial to the process is the effort of the adjudicators, who will all be experienced and bilingual, mRS certified, members of the international team, based in the main participating centres.

A lead adjudicator for each country will check every outcome video clip for technical quality, anonymisation and blinding to treatment allocation; will communicate to the investigator any request for additional outcome information; and will serve on the central adjudication committee (CAC) where s/he will contribute to the CAC review for quality control and to scoring decisions on misclassified cases arising from any country.

Other adjudicators will receive outcome video clips from investigator sites in their own country and will score these, adding a comment in English to justify their decision. These scores will be provided in timely fashion, within 5 working days. At least four adjudicators will rate every outcome interview; adjudicators will not review clips arising from their own investigative site.

Adjudicators will be monitored for their performance, according to timeliness of review and consistency with the group mean scores, ie accuracy and precision. Video clips may first be translated into English by the lead adjudicator to facilitate committee review.

Participating Partners

University Of Glasgow

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