Professor Linda Worrall & Dr Tanya Rose

Professor Guylaine Le Dorze

Australian Postgraduate Award

Initiatives in Aphasia Seed Grants

COS consensus meeting support

WHY A CORE OUTCOME SET FORRESEARCH?1. We use too many different outcome measures

WHY A CORE OUTCOME SET FORRESEARCH?

2. Are we measuring what matters?

CORE OUTCOME SETS

• Agreed standardised set of outcomes and outcome measures7

• Do not restrict the measurement of study specific outcomes

• Facilitate data combination, cross-study comparisons, deterrent to selective reporting7-9

• Used in many health areas. See http://www.comet-initiative.org/

• Use encouraged by funding bodies e.g. NHS National Institute for Health Research & European Commission Horizon 2020

Our project:

What matters?

How can we measure it?

Can we agree on it?

Wallace, S.J., Worrall, L., Rose, T., Le Dorze, G., Cruice, M., Isaksen, J., Pak HinKong, A., Simmons-Mackie, N., Scarinci, N. & Alary Gauvreau, C. (2016). Disability and Rehabilitation, 1-16. doi:10.1080/09638288.2016.1194899

Which outcomes are most important to people with aphasia and their families? An international nominal group technique study framed within the ICF

Study 1

WHAT WE DID

• Seven international locations

• Two participant groups: • (1) people with aphasia

(n= 39)

• (2) the family of people with aphasia (n = 29)

• Aphasia severity: mild to severe

• Time post-onset: 4 months to 17 years

THE NOMINAL GROUP TECHNIQUE

• What would you most like to change about your communication and the way aphasia affects your life?

• Outcomes prioritised by participants and assigned a number value

• Numbers tallied to give a prioritised list of outcomes

• Analysed using qualitative content analysis and ICF coding

WHAT WE LEARNED

Important outcomes for both people with aphasia and their families span the ICF

WHAT WE LEARNED

WHAT WE LEARNED

• Important outcomes for people with aphasia and their families span all components of the ICF.

→ The relevancy and translation of research may be increased by measuring and reporting research outcomes which are important to people living with aphasia.

→ A broad role for clinicians working in aphasia rehabilitation.

→ The categories of identified outcomes may be used clinically as a starting point in goal-setting discussions.

Wallace, S.J., Worrall, L., Rose, T., Le Dorze, G. (2016). Aphasiology, 1-31. doi:10.1080/02687038.2016.1186265

Which outcomes are most important to aphasia clinicians and managers? An international e-Delphi consensus study.

Study 2

WHAT WE DID

• Three-round, international web-based Delphi exercise

• Two participant groups : Clinicians (n= 265) & managers (n=53) from 25 countries

• Advertisement through national and international speech pathology and aphasia networks & snowball sampling.

The question: “In your opinion, what are the most important outcomes (results) from aphasia treatment.”

1709 codes

90 sub-categories

25 categories 4 themes

WHAT WE LEARNED - TOP 101. Family/carers/significant others understand how to communicate with people with

aphasia – 99% consensus

2. The PWA can communicate with relevant communication partners – 97% consensus

3. The PWA is able to communicate in daily life activities (96%)

4. The PWA is able to communicate their basic needs (95%)

5. The PWA experiences successful communication (95%)

6. Family/carers/significant others understand the nature and extent of the PWA's communication impairment (94%)

7. The PWA is able to participate in life (94%)

8. The PWA has a positive & supportive communication environment and environmental barriers are reduced (94%)

9. Strategies/ techniques used by the PWA generalise from therapy to real-life (94%)

10. The PWA has effective communication (93%)

WHAT WE LEARNED

• Clinicians and managers identified a broad role for themselves in aphasia treatment

• Important outcomes identified for both people with aphasia and their significant others.

• Top 2 outcomes both related to communication between the PWA and their communication partner: the dyad

Wallace, S.J., Worrall, L., Rose, T., Le Dorze, G. (In press). American Journal of Speech-Language Pathology.

Core outcomes in aphasia treatment research: An e-Delphi consensus study of international aphasia researchers.

Study 3

WHAT WE DID

• Three-round, international web-based Delphi exercise

• Carried out between March 2014 and February 2015

• Purposive sampling

• We asked, “What constructs do you believe should be measured as outcomes in all aphasia treatment research?".

WHAT WE DID

• 80 researchers commenced round 1, with 72 completing the entire survey. High response rates (≥85%) were achieved in subsequent rounds

• 564 codes, 49 sub-categories, 13 categories, 2 themes

WHAT WE LEARNED

Consensus was reached for 6 outcomes:

1. Language functioning in modalities relevant to study aims;

2. Impact of treatment from the perspective of the person with aphasia (PWA);

3. Communication-related quality of life;

4. Satisfaction with intervention from the perspective of the PWA;

5. Satisfaction with ability to communicate from the perspective of the PWA; and

6. Satisfaction with participation in activities from the perspective of the PWA.

WHAT WE LEARNED

• Language matters

• The patient perspective matters

→ While measures of language function are

frequently included in aphasia treatment

trials, PROs are infrequently measured.

SYNTHESIS OF STAKEHOLDERPERSPECTIVES

ICF coding used to identify similarities across stakeholder groups.

A COS for aphasia treatment research should include measures relating to: language; psychological wellbeing; communication; health services; and quality of life

Wallace, S.J., Worrall, L., Rose, T., Le Dorze, G. (In preparation).

A Systematic Review of Studies Reporting the Measurement Properties of Standardised Outcome Instruments for People with Aphasia.

Study 4

WHAT WE DID

• Scoping systematic review of all studies reporting the measurement properties of outcome instruments which have been validated with people with aphasia.

• Full text journal articles were identified through searches of PUBMED, EMBASE, and CINAHL databases and through hand searching of journals.

• Secondary searches were performed for outcome instruments identified in the initial search.

• PRISMA guidelines and COSMIN recommendations for systematic reviews of health measurement instruments.

WHAT WE LEARNED (ORCONFIRMED…)

• We have a lot of outcome measures.

• In total, 184 references for 79 outcome instruments were ultimately included in this review.

• When considered in reference to the ICF, the instruments identified in the current review predominately measured Body Functions (n=49; 62%).

COS meeting participants (In preparation).

An international consensus meeting to develop a core outcome set for aphasia treatment research.

Study 5

WHAT WE DID

•Participants in the researcher e-Delphi invited to participate in an international consensus meeting in London on Tuesday.

•We reduced the number of measures using pre-defined criteria

•We considered each remaining outcome measure in terms of its psychometric properties and feasibility (in alignment with published COS guidelines)

•Voted for inclusion in COS.

WHAT WE LEARNED…

WHAT WE AGREED ON

Language

The Western Aphasia Battery (WAB-R) (AQ+LQ)

Psychological

General Health Questionnaire (GHQ) 12-item

Communication

The Scenario Test

Quality of Life

Stroke and Aphasia Quality of Life Scale (SAQOL-39)Participation

Outcome measure to be discussed further

FUTURE DIRECTIONS

•Gaps in measures – treatment satisfaction/patient reported impact of treatment

•Need for a participation measure

•A report on the outcomes of the meeting•Implementation of the Core Outcome Set

QUESTIONS?

For further informationSarah Wallace

s.wallace3@uq.edu.au

@SarahJWallace

REFERENCES

1. Elsner, B., Kugler, J., Pohl, M., & Mehrholz, J. (2015). Transcranial direct current stimulation (tDCS) for improving aphasia in patients with aphasia after stroke. Cochrane Database of Systematic Reviews (5). doi:10.1002/14651858.CD009760.pub3

2. Cherney, L. R., Patterson, J. P., Raymer, A., Frymark, T., & Schooling, T. (2008). Evidence-based systematic review: Effects of intensity of treatment and constraint-induced language therapy for individuals with stroke-induced aphasia. Journal of Speech Language and Hearing Research, 51(5), 1282-1299. doi:10.1044/1092-4388(2008/07-0206)

3. Simmons-Mackie, N., Raymer, A., & Cherney, L. R. (2016). Communication partner training in aphasia: An updated systematic review. Archives of Physical Medicine and Rehabilitation. doi:10.1016/j.apmr.2016.03.023Treatment for bilingual individuals (Faroqi-Shah et al., 2010);

4. Lanyon, L.E., Rose, M.L., & Worrall, L. (2013). The efficacy of outpatient and community-based aphasia group interventions: A systematic review. International Journal of Speech Language Pathology, 15(4), 359-374. doi: 10.3109/17549507.2012.752865Maddy, K. M., Capilouto, G. J., & McComas, K. L. (2014). The effectiveness of semantic feature analysis: An evidence-based systematic review. Annals of Physical and Rehabilitation Medicine, 57(4), 254-267. doi:10.1016/j.rehab.2014.03.002Computer therapy for aphasia

5. Zheng, C., Lynch, L., & Taylor, N. (2016). Effect of computer therapy in aphasia: A systematic review. Aphasiology, 30(2-3), 211-244. doi:10.1080/02687038.2014.996521

REFERENCES6. PCORI Methodology Committee. (2013). The PCORI (Patient-Centred Outcomes Research Institute) methodology

report. Retrieved from www.pcori.org/research-we-support/research-methodology-standards

7. Williamson, P. R., Altman, D. G., Blazeby, J. M., Clarke, M., Devane, D., Gargon, E., & Tugwell, P. (2012). Developing core outcome sets for clinical trials: Issues to consider. Trials, 13, 132. doi:10.1186/1745-6215-13-132

8. Clarke, M. (2007). Standardising outcomes for clinical trials and systematic reviews. Trials, 8, 39. doi: 10.1186/1745-6215-8-39

9. Schmitt, J., Langan, S., Stamm, T., Williams, H. C., & Harmonizing Outcome Measurements in Eczema Delphi panel. (2011). Core outcome domains for controlled trials and clinical recordkeeping in eczema: International multiperspective Delphi consensus process. Journal of Investigative Dermatology, 131(3), 623-630. doi: 10.1038/jid.2010.303

10. Wallace, S. J., Worrall, L., Rose, T., Le Dorze, G., Cruice, M., Isaksen, J., . . . Gauvreau, C. A. (2016). Which outcomes are most important to people with aphasia and their families? An international nominal group technique study framed within the ICF. Disability and Rehabilitation, 1-16. doi:10.1080/09638288.2016.1194899

11. Wallace, S. J., Worrall, L., Rose, T., & Le Dorze, G. (2016). Which treatment outcomes are most important to aphasia clinicians and managers? An international e-Delphi consensus study. Aphasiology, 1-31. doi:10.1080/02687038.2016.1186265

12. Wallace, S. J., Worrall, L., Rose, T., & Le Dorze, G. (In press). Core outcomes in aphasia treatment research: An e-Delphi consensus study of international aphasia researchers. American Journal of Speech-Language-Pathology.

13. Brady, M. C., Kelly, H., Godwin, J., & Enderby, P. (2012). Speech and language therapy for aphasia following stroke. Cochrane Database of Systematic Reviews, 16(5). doi: 10.1002/14651858.CD000425.pub3