'A Meaningful Difference, but Not Ultimately the Difference I Would Want': A Mixed-Methods Approach to Explore and Benchmark Clinically Meaningful Changes in Aphasia Recovery.

ABSTRACT

INTRODUCTION: Outcome measurement instruments (OMIs) are used to gauge the effects of treatment. In post-stroke aphasia rehabilitation, benchmarks for meaningful change are needed to support the interpretation of patient outcomes. This study is part of a research programme to establish minimal important change (MIC) values (the smallest change above which patients perceive themselves as importantly changed) for core OMIs. As a first step in this process, the views of people with aphasia and clinicians were explored, and consensus was sought on a threshold for clinically meaningful change. METHODS: Sequential mixed-methods design was employed. Participants included people with post-stroke aphasia and speech pathologists. People with aphasia were purposively sampled based on time post-stroke, age and gender, whereas speech pathologists were sampled according to their work setting (hospital or community). Each participant attended a focus group followed by a consensus workshop with a survey component. Within the focus groups, experiences and methods for measuring meaningful change during aphasia recovery were explored. Qualitative data were transcribed and analysed using reflexive thematic analysis. In the consensus workshop, participants voted on thresholds for meaningful change in core outcome constructs of language, communication, emotional well-being and quality of life, using a six-point rating scale (much worse, slightly worse, no change, slightly improved, much improved and completely recovered). Consensus was defined a priori as 70% agreement. Voting results were reported using descriptive statistics. RESULTS: Five people with aphasia (n = 4, > 6 months after stroke; n = 5, < 65 years; n = 3, males) and eight speech pathologists (n = 4, hospital setting; n = 4, community setting) participated in one of four focus groups (duration 92-112 min). Four themes were identified describing meaningful change as follows (1) different for every single person; (2) small continuous improvements; (3) measured by progress towards personally relevant goals; and (4) influenced by personal factors. 'Slightly improved' was agreed as the threshold of MIC on the anchor-rating scale (75%-92%) within 6 months of stroke, whereas after 6 months there was a trend towards supporting 'much improved' (36%-66%). CONCLUSION: Our mixed-methods research with people with aphasia and speech pathologists provides novel evidence to inform the definition of MIC in aphasia rehabilitation. Future research will aim to establish MIC values for core OMIs. PATIENT OR PUBLIC CONTRIBUTION This work is the result of engagement between people with lived experience of post-stroke aphasia, including people with aphasia, family members, clinicians and researchers. Engagement across the research cycle was sought to ensure that the research tasks were acceptable and easily understood by participants and that the outcomes of the study were relevant to the aphasia community. This engagement included the co-development of a plain English summary of the results. Advisors were remunerated in accordance with Health Consumers Queensland guidelines. Interview guides for clinicians were piloted by speech pathologists working in aphasia rehabilitation.