Precision rehabilitation for aphasia by patient age, sex, aphasia severity, and time since stroke? A prespecified, systematic review-based, individual participant data, network, subgroup meta-analysis.

BACKGROUND: Stroke rehabilitation interventions are routinely personalized to address individuals' needs, goals, and challenges based on evidence from aggregated randomized controlled trials (RCT) data and meta-syntheses. Individual participant data (IPD) meta-analyses may better inform the development of precision rehabilitation approaches, quantifying treatment responses while adjusting for confounders and reducing ecological bias. AIM: We explored associations between speech and language therapy (SLT) interventions frequency (days/week), intensity (h/week), and dosage (total SLT-hours) and language outcomes for different age, sex, aphasia severity, and chronicity subgroups by undertaking prespecified subgroup network meta-analyses of the RELEASE database. METHODS: MEDLINE, EMBASE, and trial registrations were systematically searched (inception-Sept2015) for RCTs, including ⩾ 10 IPD on stroke-related aphasia. We extracted demographic, stroke, aphasia, SLT, and risk of bias data. Overall-language ability, auditory comprehension, and functional communication outcomes were standardized. A one-stage, random effects, network meta-analysis approach filtered IPD into a single optimal model, examining SLT regimen and language recovery from baseline to first post-intervention follow-up, adjusting for covariates identified a-priori. Data were dichotomized by age (⩽/> 65 years), aphasia severity (mild-moderate/ moderate-severe based on language outcomes' median value), chronicity (⩽/> 3 months), and sex subgroups. We reported estimates of means and 95% confidence intervals. Where relative variance was high (> 50%), results were reported for completeness. RESULTS: 959 IPD (25 RCTs) were analyzed. For working-age participants, greatest language gains from baseline occurred alongside moderate to high-intensity SLT (functional communication 3-to-4 h/week; overall-language and comprehension > 9 h/week); older participants' greatest gains occurred alongside low-intensity SLT (⩽ 2 h/week) except for auditory comprehension (> 9 h/week). For both age-groups, SLT-frequency and dosage associated with best language gains were similar. Participants ⩽ 3 months post-onset demonstrated greatest overall-language gains for SLT at low intensity/moderate dosage (⩽ 2 SLT-h/week; 20-to-50 h); for those > 3 months, post-stroke greatest gains were associated with moderate-intensity/high-dosage SLT (3-4 SLT-h/week; ⩾ 50 hours). For moderate-severe participants, 4 SLT-days/week conferred the greatest language gains across outcomes, with auditory comprehension gains only observed for ⩾ 4 SLT-days/week; mild-moderate participants' greatest functional communication gains were associated with similar frequency (⩾ 4 SLT-days/week) and greatest overall-language gains with higher frequency SLT (⩾ 6 days/weekly). Males' greatest gains were associated with SLT of moderate (functional communication; 3-to-4 h/weekly) or high intensity (overall-language and auditory comprehension; (> 9 h/weekly) compared to females for whom the greatest gains were associated with lower-intensity SLT (< 2 SLT-h/weekly). Consistencies across subgroups were also evident; greatest overall-language gains were associated with 20-to-50 SLT-h in total; auditory comprehension gains were generally observed when SLT > 9 h over ⩾ 4 days/week. CONCLUSIONS: We observed a treatment response in most subgroups' overall-language, auditory comprehension, and functional communication language gains. For some, the maximum treatment response varied in association with different SLT-frequency, intensity, and dosage. Where differences were observed, working-aged, chronic, mild-moderate, and male subgroups experienced their greatest language gains alongside high-frequency/intensity SLT. In contrast, older, moderate-severely impaired, and female subgroups within 3 months of aphasia onset made their greatest gains for lower-intensity SLT. The acceptability, clinical, and cost effectiveness of precision aphasia rehabilitation approaches based on age, sex, aphasia severity, and chronicity should be evaluated in future clinical RCTs.

CAPAbility: comparison of the JOURNEY II Bi-Cruciate Stabilised and GENESIS II total knee arthroplasty in performance and functional ability: protocol of a randomised controlled trial.

BACKGROUND: Osteoarthritis of the knee is a common condition that is expected to rise in the next two decades leading to an associated increase in total knee replacement (TKR) surgery. Although there is little debate regarding the safety and efficacy of modern TKR, up to 20% of patients report poor functional outcomes following surgery. This study will investigate the functional outcome of two TKRs; the JOURNEY II Bi-Cruciate Stabilised knee arthroplasty, a newer knee prosthesis designed to provide guided motion and improve knee kinematics by more closely approximating a normal knee, and the GENESIS II, a proven existing design. AIM: To compare the change in Patient-reported Outcome Measures (PROMs) scores of the JOURNEY II BCS and the GENESIS II from pre-operation to 6 months post operation. METHODS: CAPAbility is a pragmatic, blinded, two-arm parallel, randomised controlled trial recruiting patients with primary osteoarthritis due to have unilateral TKR surgery across two UK hospitals. Eligible participants (n = 80) will be randomly allocated to receive either the JOURNEY II or the GENESIS II BCS knee prosthesis. Baseline measures will be taken prior to surgery. Patients will be followed at 1 week, 6 to 8 weeks and 6 months post-operatively. The primary outcome is the Oxford Knee Score (OKS) at 6 months post-operatively. Secondary outcomes include: other PROMs, biomechanical, radiological (computerised tomography, (CT)), clinical efficacy and safety outcomes. An embedded qualitative study will also investigate patients' perspectives via interview pre and post surgery on variables known to affect the outcome of TKR surgery. A sub-sample (n = 30) will have additional in-depth interviews to explore the themes identified. The surgeons' perspectives on the operation will be investigated by a group interview after all participants have undergone surgery. DISCUSSION: This trial will evaluate two generations of TKR using PROMS, kinematic and radiological analyses and qualitative outcomes from the patient perspective. TRIAL REGISTRATION: International Standard Randomised Controlled Trials Number Registration, ID: ISRCTN32315753. Registered on 12 December 2017.

RELEASE: a protocol for a systematic review based, individual participant data, meta- and network meta-analysis, of complex speech-language therapy interventions for stroke-related aphasia.

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).

Cognitive profile and determinants of poor cognition in people without dementia in Parkinson's disease.

Background: The Montreal Cognitive Assessment (MoCA) has been recommended as a cognitive screening tool for clinical practice and research in Parkinson's disease (PD), yet no normative data have been published for MoCA in PD without dementia. Methods: We undertook a pooled secondary analysis of data from two studies (one cross-sectional design and one clinical trial) conducted in the East of England region. All participants were aged 18 years or over, met UK Brain Bank criteria for PD and did not have clinical dementia. Cognitive status was assessed using MoCA at baseline in both studies. The influences of age, gender, disease duration, medication load (LEDD) and mood (HADS) on cognition were examined using regression analysis. Results: Data from 101 people with PD without dementia were available (mean age 71 years, 66% men). Median (IQR) MoCA was 25(22, 27). Age was found as the only predictor of MoCA in this sample. People aged over 71 had poorer MoCA (Beta=0.6 (95%CI 0.44, 0.82)) and an increased odds of MoCA <26 (Beta=0.29 (95%CI 0.12, 0.70)) as well as poorer scores on several MoCA sub-domains. Conclusion: We present the normative data for MoCA in people with PD without clinical dementia. Age appeared to be the only associated factor for lower level of cognition, suggestive of Mild cognitive impairment in PD (PD-MCI) in PD without clinical diagnosis of dementia.

On the character and production of 'active participation' in neuro-rehabilitation: an Actor-Network perspective.

The importance of patients' active involvement in neuro-rehabilitation after acquired brain injury has been consistently emphasised in recent years. However, most approaches fail to show how 'active participation' is practically enacted, focusing on individualised explanations of patient choice and behaviours, or notions of inherent patient traits. Using actor-network theory (ANT) as a sensitising concept, we investigated neuro-rehabilitation practices, asking how participation is shaped through biological and socio-material specificities, how rights to knowledge and expertise are constructed, and how a body acclimatises and adjusts within an order of participation and transformation. We analysed video-recorded fieldwork extracts, examining the work of adjusting, testing and transforming; the construction of competence and incompetence; and material and social processes involved in the division of the body and its re-composition. Our findings show how an ANT-sensitised approach provides a critical understanding and context-specific characterisation of 'active participation', produced through the association of heterogeneous actors at any one time. Such specificity and the distribution of work suggest that efforts to account for optimum therapy 'dosages', and clinical attention to establishing individually-located levels of 'self-efficacy' or 'motivation' are misdirected. The performance of 'active participation', rather, should be re-imagined as a product of diverse, mutually attuned entities. A Virtual Abstract of this paper can be viewed at: https://www.youtube.com/channel/UC_979cmCmR9rLrKuD7z0ycA.

Speech and communication in Parkinson's disease: a cross-sectional exploratory study in the UK.

OBJECTIVE: To assess associations between cognitive status, intelligibility, acoustics and functional communication in PD. DESIGN: Cross-sectional exploratory study of functional communication, including a within-participants experimental design for listener assessment. SETTING: A major academic medical centre in the East of England, UK. PARTICIPANTS: Questionnaire data were assessed for 45 people with Parkinson's disease (PD), who had self-reported speech or communication difficulties and did not have clinical dementia. Acoustic and listener analyses were conducted on read and conversational speech for 20 people with PD and 20 familiar conversation partner controls without speech, language or cognitive difficulties. MAIN OUTCOME MEASURES: Functional communication assessed by the Communicative Participation Item Bank (CPIB) and Communicative Effectiveness Survey (CES). RESULTS: People with PD had lower intelligibility than controls for both the read (mean difference 13.7%, p=0.009) and conversational (mean difference 16.2%, p=0.04) sentences. Intensity and pause were statistically significant predictors of intelligibility in read sentences. Listeners were less accurate identifying the intended emotion in the speech of people with PD (14.8% point difference across conditions, p=0.02) and this was associated with worse speaker cognitive status (16.7% point difference, p=0.04). Cognitive status was a significant predictor of functional communication using CPIB (F=8.99, p=0.005, η2 = 0.15) but not CES. Intelligibility in conversation sentences was a statistically significant predictor of CPIB (F=4.96, p=0.04, η2 = 0.19) and CES (F=13.65, p=0.002, η2 = 0.43). Read sentence intelligibility was not a significant predictor of either outcome. CONCLUSIONS: Cognitive status was an important predictor of functional communication-the role of intelligibility was modest and limited to conversational and not read speech. Our results highlight the importance of focusing on functional communication as well as physical speech impairment in speech and language therapy (SLT) for PD. Our results could inform future trials of SLT techniques for PD.

Methodological issues in the design and evaluation of supported communication for aphasia training: a cluster-controlled feasibility study.

OBJECTIVE: To assess the feasibility and acceptability of training stroke service staff to provide supported communication for people with moderate-severe aphasia in the acute phase; assess the suitability of outcome measures; collect data to inform sample size and Health Economic evaluation in a definitive trial. DESIGN: Phase II cluster-controlled, observer-blinded feasibility study. SETTINGS: In-patient stroke rehabilitation units in the UK matched for bed numbers and staffing were assigned to control and intervention conditions. PARTICIPANTS: 70 stroke rehabilitation staff from all professional groups, excluding doctors, were recruited. 20 patients with moderate-severe aphasia were recruited. INTERVENTION: Supported communication for aphasia training, adapted to the stroke unit context versus usual care. Training was supplemented by a staff learning log, refresher sessions and provision of communication resources. MAIN OUTCOME MEASURES: Feasibility of recruitment and acceptability of the intervention and of measures required to assess outcomes and Health Economic evaluation in a definitive trial. Staff outcomes: Measure of Support in Conversation; patient outcomes: Stroke and Aphasia Quality of Life Scale; Communicative Access Measure for Stroke; Therapy Outcome Measures for aphasia; EQ-5D-3L was used to assess health outcomes. RESULTS: Feasibility of staff recruitment was demonstrated. Training in the intervention was carried out with 28 staff and was found to be acceptable in qualitative reports. 20 patients consented to take part, 6 withdrew. 18 underwent all measures at baseline; 16 at discharge; and 14 at 6-month follow-up. Of 175 patients screened 71% were deemed to be ineligible, either lacking capacity or too unwell to participate. Poor completion rates impacted on assessment of patient outcomes. We were able to collect sufficient data at baseline, discharge and follow-up for economic evaluation. CONCLUSIONS: The feasibility study informed components of the intervention and implementation in day-to-day practice. Modifications to the design are needed before a definitive cluster-randomised trial can be undertaken. TRIAL REGISTRATION NUMBER: ISRCTN37002304; Results.

Roles of Cognitive Status and Intelligibility in Everyday Communication in People with Parkinson's Disease: A Systematic Review.

BACKGROUND: Communication is fundamental to human interaction and the development and maintenance of human relationships and is frequently affected in Parkinson's disease (PD). However, research and clinical practice have both tended to focus on impairment rather than participation aspects of communicative deficit in PD. In contrast, people with PD have reported that it is these participation aspects of communication that are of greatest concern to them rather than physical speech impairment. OBJECTIVE: To systematically review the existing body of evidence regarding the association between cognitive status and/or intelligibility and everyday communication in PD. METHODS: Five online databases were systematically searched in May 2015 (Medline Ovid, EMBASE, AMED, PsycINFO and CINAHL) and supplementary searches were also conducted. Two reviewers independently evaluated retrieved records for inclusion and then performed data extraction and quality assessment using standardised forms. Articles were eligible for inclusion if they were English-language original peer-reviewed research articles, book chapters or doctoral theses investigating the associations between at least one of cognitive status and level of intelligibility impairment and an everyday communication outcome in human participants with PD. RESULTS: 4816 unique records were identified through database searches with 16 additional records identified through supplementary searches. 41 articles were suitable for full-text screening and 15 articles (12 studies) met the eligibility criteria. 10 studies assessed the role of cognitive status and 9 found that participants with greater cognitive impairment had greater everyday communication difficulties. 4 studies assessed the role of intelligibility and all found that participants with greater intelligibility impairment had greater everyday communication difficulties, although effects were often weak and not consistent. CONCLUSIONS: Both cognitive status and intelligibility may be associated with everyday communicative outcomes in PD. The contribution of intelligibility to everyday communication appears to be of small magnitude, suggesting that other factors beyond predominantly motor-driven impairment-level changes in intelligibility may play an important role in everyday communication difficulties in PD.

Systematic overview of economic evaluations of health-related rehabilitation.

BACKGROUND: Health related rehabilitation is instrumental in improving functioning and promoting participation by people with disabilities. To make clinical and policy decisions about health-related rehabilitation, resource allocation and cost issues need to be considered. OBJECTIVES: To provide an overview of systematic reviews (SRs) on economic evaluations of health-related rehabilitation. METHODS: We searched multiple databases to identify relevant SRs of economic evaluations of health-related rehabilitation. Review quality was assessed by AMSTAR checklist. RESULTS: We included 64 SRs, most of which included economic evaluations alongside randomized controlled trials (RCTs). The review quality was low to moderate (AMSTAR score 5-8) in 35, and high (score 9-11) in 29 of the included SRs. The included SRs addressed various health conditions, including spinal or other pain conditions (n = 14), age-related problems (11), stroke (7), musculoskeletal disorders (6), heart diseases (4), pulmonary (3), mental health problems (3), and injury (3). Physiotherapy was the most commonly evaluated rehabilitation intervention in the included SRs (n = 24). Other commonly evaluated interventions included multidisciplinary programmes (14); behavioral, educational or psychological interventions (11); home-based interventions (11); complementary therapy (6); self-management (6); and occupational therapy (4). CONCLUSIONS: Although the available evidence is often described as limited, inconsistent or inconclusive, some rehabilitation interventions were cost-effective or showed cost-saving in a variety of disability conditions. Available evidence comes predominantly from high income countries, therefore economic evaluations of health-related rehabilitation are urgently required in less resourced settings.

An International Perspective on Quality of Life in Aphasia: A Survey of Clinician Views and Practices from Sixteen Countries.

OBJECTIVE: To gain an insight into speech and language therapists' perspectives on and practices in quality of life in aphasia. PARTICIPANTS AND METHODS: The International Association of Logopedics and Phoniatrics Aphasia Committee developed a survey questionnaire, which was delivered online, anonymously, through SurveyMonkey (November 2012 to April 2013) to clinicians working with people with aphasia in 16 countries across the world. RESULTS: A large number of speech and language therapists responded to the survey, with 19/21 questions answered by 385-579 participants. Clinicians were well informed on what constitutes quality of life and viewed it as a complex construct influenced by health, participation, in/dependence, communication, personal factors, and environmental factors. In their clinical practice, they considered quality of life as important, used informal approaches to explore it and aimed to address quality of life goals; yet, the majority did not evaluate quality of life in a systematic way. CONCLUSION: There is a need for training on quality of life to help speech and language therapists incorporate quality of life outcome measures in their interventions. There is also a need for further research on which interventions improve quality of life in aphasia.

Assessing and comparing the outcome measures for the rehabilitation of adults with communication disorders in randomised controlled trials: an International Classification of Functioning, Disability and Health approach.

PURPOSE: To identify the assessment instruments and relevant outcome measures used in randomised clinical trials (RCTs) relating to interventions for adults with communication disorders, and then examine and compare the domains of the outcome measures using the International Classification of Functioning, Disability and Health (ICF) as a reference tool. METHOD: Published RCTs with primary focus on the effectiveness of rehabilitation for adults with communication disorders were systematically reviewed. Identified RCTs were examined for all the assessments used as outcome measures. Distinctions were made between the use of standardised assessment tools and non-standardised empirical measures. The key concepts examined by the outcome measures were then linked to the ICF using the established ICF linking rules. RESULTS: The systematic review included 24 RCTs in which 11 trials used non-standardised empirical assessment as the outcome measure, and 18 trials included standardised instruments as the outcome measure. It is clear that all the identified items and meaningful concepts from the assessment used in the included studies can be linked to the ICF categories. Of the 108 linked level-two ICF categories, 53% were linked to 'body functions', 36% to 'activity and participation' and 9% to 'environmental factors'. CONCLUSIONS: A wide range of outcome measures have been used in RCTs of interventions for adults with communications disorders. The ICF provides a clarifying framework for systematically gathering and examining the information about the content of outcome measures and then can be used as a common reference to identify and compare the domains of the outcome measures. The high proportion of elements relating to body functions raises some questions about the purpose and aims of the interventions.

Engagement and learning: an exploratory study of situated practice in multi-disciplinary stroke rehabilitation.

PURPOSE: Active participation is considered to be a key factor in stroke rehabilitation. Patient engagement in learning is an important part of this process. This study sets out to explore how active participation and engagement are 'produced' in the course of day-to-day multi-disciplinary stroke rehabilitation. METHOD: Ethnographic observation, analytic concepts drawn from discourse analysis (DA) and the perspective and methods of conversation analysis (CA) were applied to videotaped data from three sessions of rehabilitation therapy each for two patients with communication impairments (dysarthria, aphasia). FINDINGS: Engagement was facilitated (and hindered) through the interactional work of patients and healthcare professionals. An institutional ethos of 'right practice' was evidenced in the working practices of therapists and aligned with or resisted by patients; therapeutic activity type (impairment, activity or functional focus) impacted on the ways in which patient engagement was developed and sustained. CONCLUSIONS: This exploration of multi-disciplinary rehabilitation practice adds a new dimension to our understanding of the barriers and facilitators to patient engagement in the learning process and provides scope for further research. Harmonising the rehabilitation process across disciplines through more focused attention to ways in which patient participation is enhanced may help improve the consistency and quality of patient engagement.

Chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) in adults: a qualitative study of perspectives from professional practice.

BACKGROUND: Chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) can cause profound and prolonged illness and disability, and poses significant problems of uncertainty for healthcare professionals in its diagnosis and management. The aim of this qualitative study was to explore the nature of professional 'best practice' in working with people with CFS/ME. METHODS: The views and experiences of health care practitioners (HCPs) were sought, who had been judged by people with CFS/ME themselves to have been particularly helpful and effective. Qualitative semi-structured interviews following a topic guide were carried out with six health care practitioners. Interviews were audio-recorded, transcribed and subject to thematic analysis. RESULTS: Five main themes were developed: 1) Diagnosis; 2) Professional perspectives on living with CFS/ME; 3) Interventions for treatment and management; 4) Professional values and support for people with CFS/ME and their families; 5) Health professional roles and working practices. Key findings related to: the diagnostic process, especially the degree of uncertainty which may be shared by primary care physicians and patients alike; the continued denial in some quarters of the existence of CFS/ME as a condition; the variability, complexity, and serious impact of the condition on life and living; the onus on the person with CFS/ME to manage their condition, supported by HCPs; the wealth of often conflicting and confusing information on the condition and options for treatment; and the vital role of extended listening and trustful relationships with patients. CONCLUSIONS: While professional frustrations were clearly expressed about the variability of services both in primary and specialist care and continuing equivocal attitudes to CFS/ME as a condition, there were also strong positive messages for people with CFS/ME where the right services are in place. Many of the findings from these practitioners seen by their patients as helping them more effectively, accord with the existing literature identifying the particular importance of listening skills, respect and trust for establishing a therapeutic relationship which recognises key features of the patient trajectory and promotes effective person-centred management of this complex condition. These findings indicate the need to build such skills and knowledge more systematically into professional training informed by the experience of specialist services and those living with the condition.

Development and preliminary validation of a measure for assessing staff perspectives on the quality of clinical group supervision.

BACKGROUND: In the UK clinical supervision is regarded as an essential process supporting quality improvement within the clinical governance framework, and the Royal College of Speech and Language Therapists regards it as a tool for promoting critical reflective practice. There is limited evidence of the impact on practice or improvements in healthcare quality, and the need for an evaluation instrument specifically tailored to group supervision. AIMS: To develop a measure for assessing staff perspectives on the quality of clinical group supervision and its impact on the quality of care. METHODS & PROCEDURES: A self-completion questionnaire was devised to measure staff perceptions of purpose, process and impact of clinical group supervision. Items were developed through an inductive process of consultation, peer and literature review. The questionnaire's content validity was assessed. The questionnaire was then administered to 57 subjects who had received approximately 1 year of clinical supervision to evaluate acceptability, factor structure and convergent validity. OUTCOMES & RESULTS: Response rates were 91% (52/57). Principal component factor analysis suggested a three-factor structure, the first three factors accounting for 72.4% of the total variance. Items loaded appropriately onto purpose, process and impact. These three dimensions were positively and moderately correlated. Internal consistency reliability (Cronbach's alpha = 0.86) indicated that the 14 items could be regarded as a scale. The overall CSEQ score was positively correlated with a single question assessing 'general opinion' about the CS program (Spearman's rho = 0.79, p < 0.001) giving evidence for convergent validity. CONCLUSIONS: The questionnaire is concise, easy to complete and simple to analyse, and appears to be a reliable and valid measure of staff perceptions of quality of clinical group supervision. Further studies with larger sample sizes and including other groups of health professionals are needed to confirm the validity and reliability of the CSEQ.