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Developing, monitoring, and reporting of fidelity are essential and integral components to the design of randomised controlled trials (RCTs) in stroke and aphasia. Treatment fidelity refers to the degree to which an intervention is delivered as intended and is directly related to the quality of the evidence generated by RCTs. Clear documentation of treatment fidelity in trials assists in the evaluation of the clinical implications of potential benefits attributed to the intervention. Consideration of the implementation requirements of a research-based intervention as intended in a clinical context is necessary to achieve similar outcomes for a clinical population. Despite this, treatment fidelity is rarely reported in RCTs of aphasia intervention. To describe fidelity strategies and develop core recommendations for developing, monitoring, and reporting of fidelity in aphasia intervention RCTs. Relevant conceptual frameworks were considered. The Behaviour Change Consortium comprehensive framework of fidelity was adopted. It includes five areas: study design, training providers, delivery of treatment, treatment receipt, and treatment enactment. We explored fidelity in RCTs with a range of complex aphasia interventions (e.g., ASK, Big CACTUS, COMPARE, FCET2EC, POLAR, SUPERB, and VERSE) and described how different trial design factors (e.g., phase of trial, explanatory vs. pragmatic, number and location of sites, and number and type of treatment providers) influenced the fidelity strategies chosen. Strategies were mapped onto the five areas of the fidelity framework with a detailed exploration of how fidelity criteria were developed, measured, and monitored throughout each trial. This information was synthesised into a set of core recommendations to guide aphasia researchers towards the adequate measurement, capture, and reporting of fidelity within future aphasia intervention studies. Treatment fidelity should be a core consideration in planning an intervention trial, a concept that goes beyond treatment adherence alone. A range of strategies should be selected depending on the phase and design of the trial being undertaken and appropriate investment of time and costs should be considered. [ABSTRACT FROM AUTHOR]

Treatment success is the desired outcome in aphasia rehabilitation. However, to date, there is a lack of consensus on what defines a 'successful' result on a given aphasia outcome measurement instrument (OMI). In this methodological paper, we present strategies for how to define and measure treatment success on a given OMI at the group-level, as well as for an individual person with aphasia. The latter is particularly important when research findings from group studies are clinically implemented for individuals in rehabilitation. We start by presenting methods to calculate the average statistically significant change across several (group) studies (e.g., standardised mean difference, raw unstandardised mean difference) for a given OMI. Such metrics are useful to summarise the overall effect of the intervention of interest, particularly in meta-analyses. However, benchmarks based on group effects are not feasible for assessing an individual participant's treatment success and thus for determining the proportion of patients who had a beneficial response to therapy (overall response rate of an intervention). We therefore recommend a distribution-based approach to determine benchmarks of a statistically significant treatment response at the individual level, i.e., the 'smallest detectable change' for a given OMI, which refers to the smallest change that can be detected by the OMI beyond measurement error. However, the statistical significance of an individual treatment effect does not necessarily correspond to its clinical impact. This requires an additional indicator. The benchmark to determine a clinically relevant improvement on a given OMI is the 'minimal important change'. The minimally important change is defined as the smallest OMI change score perceived as important by the relevant stakeholder group (i.e., people with aphasia, their relatives/caregivers, clinicians). It therefore requires relating the individual OMI change scores to 'anchors', i.e., meaningful external criteria, preferably based on patient-perceived therapy success. Currently, there is no consensus regarding the optimal 'anchors' and their respective definition of clinically important change in aphasia outcome research. Operationalising individual treatment success based on both statistically significant and (patient-reported) clinically meaningful benchmarks is a key priority in aphasia rehabilitation. Availability of such measures will (a) facilitate estimates of therapy response rate in intervention studies and thus optimise therapeutic decisions and (b) provide stakeholder groups (e.g., the society, the stroke team, people with aphasia, family, clinicians, healthcare professionals) with objective, statistically reliable and meaningful feedback on individual treatment response in the clinical setting. [ABSTRACT FROM AUTHOR]

Goal setting is an essential rehabilitation activity. However, multidisciplinary rehabilitation staff goal-setting practice with stroke survivors with aphasia and associated training needs are not well understood. We designed, piloted, and conducted a survey of stroke rehabilitation staff in the UK, Australia, Aotearoa New Zealand, Canada, Ireland. Analysis included descriptive statistics, chi-square and Fisher's exact tests, and qualitative content analysis. We received 251 responses from 118 SLTs and 133 non-SLTs. Most reported setting goals with most or all people with aphasia (78%, 197/251); 57% (138/244) rarely or never provided an accessible copy of goals. All disciplines reported significantly less confidence setting goals with people with aphasia than without aphasia (p = 0.012, n = 119). Barriers to goal setting included the communication impairment (especially severe aphasia) and poor insight. Staff described feeling ill-equipped to support people with aphasia in goal setting; only 27% (67/251) had accessed training to do so. Rehabilitation staff described involving stroke survivors with aphasia in goal setting but lacked confidence doing so and receive inadequate training and support. Training should target multidisciplinary staff confidence and communication support strategies and resources so that people with aphasia and families are supported as goal-setting partners. [ABSTRACT FROM AUTHOR]

Background: Guidelines to support accessible goal setting with stroke survivors with aphasia are lacking. Aims: This review aimed to (i) determine the communication barriers and facilitators relevant to accessible goal setting for stroke survivors with aphasia and (ii) propose recommendations for accessible goal setting practice. Design: We conducted a narrative literature review incorporating a systematic search strategy. Methods & procedures: An electronic database search of abstracts was conducted from January 2003 to March 2018 in CINAHL, MEDLINE, AMED, ProQuest Central, and PsychINFO. We sought peer-reviewed articles including stroke survivors with aphasia, carers, or healthcare professionals that addressed (i) communication partner skills and behaviours and/or (ii) the physical environment. Study quality was appraised using the Mixed Methods Appraisal Tool (MMAT). Thematic analysis was conducted on key findings. Outcomes & results: 647 articles were identified. 70 full-text articles were screened for eligibility; 34 of which were included. We propose a model and recommendations to support accessible goal setting, including supportive conversation strategies and a modified physical environment. Conclusions: Specific evidence for accessible goal setting with stroke survivors with aphasia is lacking. Staff training and ongoing support is required for successful use of communication strategies and resources. Further research is needed to develop and evaluate accessible goal setting resources and training. [ABSTRACT FROM AUTHOR]

Background: Speech and language therapy (SLT) benefits people with aphasia following stroke. Group level summary statistics from randomised controlled trials hinder exploration of highly complex SLT interventions and a clinically relevant heterogeneous population. Creating a database of individual participant data (IPD) for people with aphasia aims to allow exploration of individual and therapy-related predictors of recovery and prognosis. Aim: To explore the contribution that individual participant characteristics (including stroke and aphasia profiles) and SLT intervention components make to language recovery following stroke. Methods and procedures: We will identify eligible IPD datasets (including randomised controlled trials, non-randomised comparison studies, observational studies and registries) and invite their contribution to the database. Where possible, we will use meta- and network meta-analysis to explore language performance after stroke and predictors of recovery as it relates to participants who had no SLT, historical SLT or SLT in the primary research study. We will also examine the components of effective SLT interventions. Outcomes and results: Outcomes include changes in measures of functional communication, overall severity of language impairment, auditory comprehension, spoken language (including naming), reading and writing from baseline. Data captured on assessment tools will be collated and transformed to a standardised measure for each of the outcome domains. Conclusion: Our planned systematic-review-based IPD meta- and network meta-analysis is a large scale, international, multidisciplinary and methodologically complex endeavour. It will enable hypotheses to be generated and tested to optimise and inform development of interventions for people with aphasia after stroke. Systematic review registration: The protocol has been registered at the International Prospective Register of Systematic Reviews (PROSPERO; registration number: CRD42018110947) [ABSTRACT FROM AUTHOR]