Measuring communication as a core outcome in aphasia trials: results of the ROMA-2 international core outcome set development meeting

Background: Evidence-based recommendations for a Core Outcome Set (COS; minimum set of outcomes) for aphasia treatment research have been developed (the Research Outcome Measurement in Aphasia, ROMA, COS). Five recommended core outcome constructs: communication, language, quality of life, emotional wellbeing, and patient reported satisfaction/impact of treatment, were identified through three international consensus studies. Constructs were paired with outcome measurement instruments (OMIs) during an international consensus meeting (ROMA-1). Prior to the current study (ROMA-2), agreement had not been reached on OMIs for the constructs of communication or patient reported satisfaction/impact of treatment.
Aim: To establish consensus on a communication OMI for inclusion in the ROMA COS.
Methods & Procedures: Research methods were based on recommendations from the Core Outcome Measures in Effectiveness Trials (COMET) Initiative. Participants with expertise in design and conduct of aphasia trials, measurement instrument development/testing, and/or communication outcome measurement were recruited through an open call. Prior to the consensus meeting, participants agreed on a definition of communication, identified appropriate OMIs, extracted their measurement properties, and established criteria for their quality assessment. During the consensus meeting, they short-listed OMIs and participants without conflicts of interest voted on the two most highly ranked instruments. Consensus was defined a priori as agreement by ≥70% of participants.
Outcomes & Results: In total, 40 researchers from nine countries participated in ROMA-2 (including four facilitators and three panel members who participated in pre-meeting activities only). Twenty OMIs were identified and evaluated. Eight short-listed communication measures were further evaluated for their measurement properties and ranked. Participants in the consensus meeting (n=33) who did not have conflicts of interest (n=29) voted on the top two ranked OMIs: The Scenario Test and the Communication Activities of Daily Living-3 (CADL-3). The Scenario Test received 72% (n=21) of ‘yes’ votes, and the CADL-3 received 28% (n=8) of ‘yes’ votes.
Conclusions & Implications: Consensus was achieved that The Scenario Test was the preferred communication OMI for inclusion in the ROMA COS. It is currently available in the original Dutch version and has been adapted to English, German, and Greek. Further consideration must be given to the best way to measure communication in people with mild aphasia. Development of a patient-reported measure for satisfaction with/impact of treatment and multilingual versions of all OMIs of the COS is still required. Implementation of the ROMA COS would improve research outcome measurement and the quality, relevance, transparency, replicability, and efficiency of aphasia treatment research.