A core outcome set for aphasia treatment research: the ROMA consensus statement

Sarah J. Wallace*, Linda Worrall, Tanya Rose, Guylaine LeDorze, Caterina Breitenstein, Katerina Hilari, Edna Babbitt, Arpita Bose, Marian Brady, Leora R. Cherney, David Copland, Madeline Cruice, Pamela Enderby, Deborah Hersh, Tami Howe, Helen Kelly, Swathi Kiran, Ann-Charlotte Laska, Jane Marshall, Marjorie NicholasJanet Patterson, Gill Pearl, Elizabeth Rochon, Miranda Rose, Karen Sage, Steven Small, Janet Webster

*Corresponding author for this work

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Abstract

Background: A core outcome set (COS; an agreed, minimum set of outcomes) was needed to address the heterogeneous measurement of outcomes in aphasia treatment research and to facilitate the production of transparent, meaningful and efficient outcome data.
Objective: The Research Outcome Measurement in Aphasia (ROMA) consensus statement provides evidence-based recommendations for the measurement of outcomes for adults with post-stroke aphasia within phase I-IV aphasia treatment studies.
Methods: This statement was informed by a four-year program of research which comprised investigation of stakeholder-important outcomes using consensus processes, a scoping review of aphasia outcome measurement instruments, and an international consensus meeting. This paper provides an overview of this process and presents the results and recommendations arising from the international consensus meeting.
Results: Five essential outcome constructs were identified: Language, communication, patient-reported satisfaction with treatment and impact of treatment, emotional wellbeing, and quality of life. Consensus was reached for the following measurement instruments: Language: The Western Aphasia Battery Revised (WAB-R) (74% consensus); emotional well-being: General Health Questionnaire (GHQ)-12 (83% consensus); quality of life: Stroke and Aphasia Quality of Life Scale (SAQOL-39) (96% consensus). Consensus was unable to be reached for measures of communication (where multiple measures exist) or patient-reported satisfaction with treatment or impact of treatment (where no measures exist).
Discussion: Harmonisation of the ROMA COS with other core outcome initiatives in stroke rehabilitation is discussed. Ongoing research and consensus processes are outlined.
Conclusion: The WAB-R, GHQ, and SAQOL-39 are recommended to be routinely included within phase I-IV aphasia treatment studies. This consensus statement has been endorsed by the Collaboration of Aphasia Trialists, the British Aphasiology Society, the German Society for Aphasia Research and Therapy, and the Royal College of Speech Language Therapists.
Original languageEnglish
Pages (from-to)180-185
Number of pages6
JournalInternational Journal of Stroke
Volume14
Issue number2
Early online date10 Oct 2018
DOIs
Publication statusPublished - 1 Feb 2019

Keywords

  • aphasia treatment
  • core outcome set
  • stroke patients
  • consensus
  • methodology

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    Wallace, S. J., Worrall, L., Rose, T., LeDorze, G., Breitenstein, C., Hilari, K., Babbitt, E., Bose, A., Brady, M., Cherney, L. R., Copland, D., Cruice, M., Enderby, P., Hersh, D., Howe, T., Kelly, H., Kiran, S., Laska, A-C., Marshall, J., ... Webster, J. (2019). A core outcome set for aphasia treatment research: the ROMA consensus statement. International Journal of Stroke, 14(2), 180-185. https://doi.org/10.1177/1747493018806200