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

Author:

Wallace Sarah J1ORCID,Worrall Linda1,Rose Tanya1,Le Dorze Guylaine2,Breitenstein Caterina3,Hilari Katerina4,Babbitt Edna5,Bose Arpita6,Brady Marian7ORCID,Cherney Leora R.5,Copland David1,Cruice Madeline4,Enderby Pam8,Hersh Deborah9,Howe Tami10ORCID,Kelly Helen11ORCID,Kiran Swathi12,Laska Ann-Charlotte13,Marshall Jane4,Nicholas Marjorie14,Patterson Janet15,Pearl Gill16,Rochon Elizabeth17,Rose Miranda18,Sage Karen1,Small Steven19,Webster Janet20

Affiliation:

1. School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Australia

2. School of Speech-Language Pathology and Audiology, University of Montreal, Montreal, Canada

3. Department of General Neurology with Institute of Translational Neurology, University of Münster, Münster, Germany

4. School of Health Sciences, City University of London, London, UK

5. Department of Physical Medicine and Rehabilitation, Feinberg School of Medicine, Northwestern University, Chicago, USA & Shirley Ryan AbilityLab, Chicago, USA

6. School of Psychology and Clinical Language Sciences, University of Reading, Reading, UK

7. Nursing, Midwifery and Allied Health Professionals Research Unit, Glasgow Caledonian University, Glasgow, UK

8. School of Health and Related Research, University of Sheffield, Sheffield, UK

9. School of Psychology and Social Science, Edith Cowan University, Perth, Australia

10. School of Audiology and Speech Sciences, University of British Columbia, Vancouver, Canada

11. School of Clinical Therapies, University College Cork, Cork, Republic of Ireland

12. Department of Speech, Language, and Hearing Sciences, Boston University, Boston, USA

13. Karolinska Institutet, Department of Clinical Sciences, Danderyd Hospital, Division of Internal Medicine, Stockholm, Sweden

14. School of Health and Rehabilitation Sciences, MGH Institute of Health Professions, Boston, USA

15. California State University East Bay, Hayward, USA

16. Speakeasy, UK

17. Department of Speech-Language Pathology, University of Toronto, Toronto, Canada

18. School of Allied Health, La Trobe University, Bundoora, Australia

19. Department of Neurology, University of California, Irvine, USA

20. School of Education, Communication and Language Sciences, Newcastle University, Newcastle Upon Tyne, UK

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 phases 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 wellbeing: 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 Harmonization 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-12, and SAQOL-39 are recommended to be routinely included within phases 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.

Funder

British Aphasiology Society

Publisher

SAGE Publications

Subject

Neurology

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