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 well-being and patient-reported satisfaction/impact of treatment, were identified through three international consensus studies. Constructs were paired with outcome measurement instruments (OMIs) during an inter-national consensus meeting (ROMA-1). Before 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. Before 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). A total of 20 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 (TST) and the Communication Activities of Daily Living—3 (CADL-3). TST received 72% (n=21) of ‘yes’ votes and theCADL-3 received 28% (n=8) of ‘yes’ votes.
Conclusions & Implications: Consensus was achieved that TST was the preferred communication OMI for inclusion in the ROMA COS. It is currently available in the original Dutch version and has been adapted into 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 ROMACOS would improve research outcome measurement and the quality, relevance, transparency, replicability and efficiency of aphasia treatment research.

Aim

To establish consensus on a communication Outcome measurement instruments for inclusion in the ROMA COS.

Contributors

Sarah J. Wallace, Linda Worrall, Tanya A. Rose, Reem S. W. Alyahya, Edna Babbitt, Suzanne Beeke, Carola de Beer, Arpita Bose, Audrey Bowen, Marian C. Brady, Caterina Breitenstein, Stefanie Bruehl, Lucy Bryant, Bonnie B. Y. Cheng, Leora R. Cherney, Paul Conroy, David A. Copland, Clare Croteau, Madeline Cruice, Lucy Dipper, Katerina Hilari, Tami Howe, Helen Kelly, Swathi Kiran, Ann-Charlotte Laska, Jane Marshall, Laura L. Murray, Janet Patterson, Gill Pearl, Jana Quinting, Elizabeth Rochon, Miranda L. Rose, Ilona Rubi-Fessen, Karen Sage, Nina Simmons-Mackie, Evy Visch-Brink, Anna Volkmer, Janet Webster, Anne Whitworth, Guylaine Le Dorze

Publication

Journal: International Journal of Language & Communication Disorders
Volume:
Issue:
Pages: -
Year: 2022
DOI: 10.1111/1460-6984.12840

Further Study Information

Current Stage: Completed
Date:
Funding source(s): National Health and Medical Research Council, Grant/Award Number: 1175821;University of Manchester; A. Bowen is supported by National Institute for Health and Care Research (NIHR),Stroke Association and University of Manchester grants.; A. Volkmer is funded byan NIHR Advanced Fellowship


Health Area

Disease Category: Neurology

Disease Name: Aphasia

Target Population

Age Range: Unknown

Sex: Either

Nature of Intervention:

Stakeholders Involved

- Researchers

Study Type

- Recommendations for outcome measures (measurement/how)

Method(s)

- Consensus meeting
- Semi structured discussion
- Systematic review

Four main steps when selecting OMIs for outcomes (i.e., constructs)r included in a COS: (1)conceptual considerations; (2) finding existing OMIs; (3)quality assessment of OMIs; and (4) generic recommendations on the selection of OMIs for a COS (i.e., select only one OMI; apply minimum requirements for accept-able content validity, internal consistency (if applicable),and feasibility; use a consensus procedure to obtain final agreement).