Theme 4

Outcomes in RCTs: assessment, reporting and integration in decision-making

This theme builds on previous Hub work to improve clinical and patient-reported outcome assessment and reporting in RCTs, and establish new methods to communicate data from RCTs in practice.

Theme members are conducting research in three main areas:

    • Identification of outcomes to be measured in trials: a) improving methods to facilitate development of core outcome sets for different clinical areas; b) development and validation of new outcome measures.
    • Communication of clinical and patient-reported outcomes from RCTs in practice: a) interpretability and acceptability of different methods of data presentation to clinicians and patients; b) evaluation of the effectiveness of such methods, including identification of appropriate outcome measures with which to determine effectiveness; c) extension of these methods to data provision for informed consent for surgery and trial participation.
    • Unbiased outcome assessment: a) exploring novel methods of blinding and b) masking outcome data collection in surgical trials.

Theme 4 specific collaborators:

Core Outcome Measures in Effectiveness Trials (COMET)

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