Validation of general pain scores from multidomain assessment tools in stroke.

Purpose: We describe how well general pain reported in multidomain assessment tools correlated with pain-specific assessment tools; associations between general pain, activities of daily living and independence after stroke. Materials and methods: Analyses of individual participant data (IPD) from the Virtual International Stroke Trials Archive (VISTA) described correlation coefficients examining (i) direct comparisons of assessments from pain-specific and multidomain assessment tools that included pain, (ii) indirect comparisons of pain assessments with the Barthel Index (BI) and modified Rankin Scale (mRS), and (iii) whether pain identification could be enhanced by accounting for reported usual activities, self-care, mobility and anxiety/depression; factors associated with pain. Results: European Quality of Life 3- and 5-Level (EQ-5D-3L and EQ-5D-5L), RAND 36 Item Health Survey 1.0 (SF-36) or the 0-10 Numeric Pain Rating Scale (NPRS) were available from 10/94 studies (IPD = 10,002). The 0-10 NPRS was the only available pain-specific assessment tool and was a reference for comparison with other tools. Pearson correlation coefficients between the 0-10 NPRS and (A) the EQ-5D-3L and (B) EQ5D-5 L were r = 0.572 (n = 436) and r = 0.305 (n = 1,134), respectively. mRS was better aligned with pain by EQ-5D-3L (n = 8,966; r = 0.340) than by SF-36 (n = 623; r = 0.318). BI aligned better with pain by SF-36 (n = 623; r = -0.320). Creating a composite score using the EQ-5D 3 L and 5 L comprising pain, mobility, usual-activities, self-care and anxiety/depression did not improve correlation with the 0-10 NPRS. Discussion: The EQ-5D-3L pain domain aligned better than the EQ-5D-5L with the 0-10 NPRS and may inform general pain description where resources and assessment burden hinder use of additional, pain-specific assessments.

Prevalence, Trajectory, and Predictors of Poststroke Pain: Retrospective Analysis of Pooled Clinical Trial Data Set.

BACKGROUND: Poststroke pain remains underdiagnosed and inadequately managed. To inform the optimum time to initiate interventions, we examined prevalence, trajectory, and participant factors associated with poststroke pain. METHODS: Eligible studies from the VISTA (Virtual International Stroke Trials Archives) included an assessment of pain. Analyses of individual participant data examined demography, pain, mobility, independence, language, anxiety/depression, and vitality. Pain assessments were standardized to the European Quality of Life Scale (European Quality of Life 5 Dimensions 3 Level) pain domain, describing no, moderate, or extreme pain. We described pain prevalence, associations between participant characteristics, and pain using multivariable models. RESULTS: From 94 studies (n>48 000 individual participant data) in VISTA, 10 (n=10 002 individual participant data) included a pain assessment. Median age was 70.0 years (interquartile range [59.0-77.1]), 5560 (55.6%) were male, baseline stroke severity was National Institutes of Health Stroke Scale score 10 (interquartile range [7-15]). Reports of extreme pain ranged between 3% and 9.5% and were highest beyond 2 years poststroke (31/328 [9.5%]); pain trajectory varied by study. Poorer independence was significantly associated with presence of moderate or extreme pain (5 weeks-3 months odds ratio [OR], 1.5 [95% CI, 1.4-1.6]; 4-6 months OR, 1.7 [95% CI, 1.3-2.1]; >6 months OR, 1.5 [95% CI, 1.2-2.0]), and increased severity of pain (5 weeks-3 months: OR, 1.2 [95% CI, 1.1-1.2]; 4-6 months OR, 1.1 [95% CI, 1.1-1.2]; >6 months, OR, 1.2 [95% CI, 1.1-1.2]), after adjusting for covariates. Anxiety/depression and lower vitality were each associated with pain severity. CONCLUSIONS: Between 3% and 9.5% of participants reported extreme poststroke pain; the presence and severity of pain were independently associated with dependence at each time point. Future studies could determine whether and when interventions may reduce the prevalence and severity of poststroke pain.

Data mining versus manual screening to select papers for inclusion in systematic reviews: a novel method to increase efficiency.

Systematic reviews rely on identification of studies, initially through electronic searches yielding potentially thousands of studies, and then reviewer-led screening studies for inclusion. This standard method is time- and resource-intensive. We designed and applied an algorithm written in Python involving computer-aided identification of keywords within each paper for an exemplar systematic review of arm impairment after stroke. The standard method involved reading each abstract searching for these keywords. We compared the methods in terms of accuracy in identification of keywords, abstracts' eligibility, and time taken to make a decision about eligibility. For external validation, we adapted the algorithm for a different systematic review, and compared eligible studies using the algorithm with those included in that review. For the exemplar systematic review, the algorithm failed on 72 out of 2,789 documents retrieved (2.6%). Both methods identified the same 610 studies for inclusion. Based on a sample of 21 randomly selected abstracts, the standard screening took 1.58 ±â€…0.26 min per abstract. Computer output screening took 0.43 ±â€…0.14 min per abstract. The mean difference between the two methods was 1.15 min ( P  < 0.0001), saving 73% per abstract. For the other systematic review, use of the algorithm resulted in the same studies being identified. One study was excluded based on the interpretation of the comparison intervention. Our purpose-built software was an accurate and significantly time-saving method for identifying eligible abstracts for inclusion in systematic reviews. This novel method could be adapted for other systematic reviews in future for the benefit of authors, reviewers and editors.

Establishing reporting standards for participant characteristics in post-stroke aphasia research: An international e-Delphi exercise and consensus meeting.

OBJECTIVE: To establish international, multidisciplinary expert consensus on minimum participant characteristic reporting standards in aphasia research (DESCRIBE project). METHODS: An international, three-round e-Delphi exercise and consensus meeting, involving multidisciplinary researchers, clinicians and journal editors working academically or clinically in the field of aphasia. RESULTS: Round 1 of the DESCRIBE e-Delphi exercise (n = 156) generated 113 items, 20 of which reached consensus by round 3. The final consensus meeting (n = 19 participants) established DESCRIBE's 14 participant characteristics that should be reported in aphasia studies: age; years of education; biological sex; language of treatment/testing; primary language; languages used; history of condition(s) known to impact communication/cognition; history of previous stroke; lesion hemisphere; time since onset of aphasia; conditions arising from the neurological event; and, for communication partner participants, age, biological sex and relationship to person with aphasia. Each characteristic has been defined and matched with standard response options to enable consistent reporting. CONCLUSION: Aphasia research studies should report the 14 DESCRIBE participant characteristics as a minimum. Consistent adherence to the DESCRIBE minimum reporting standard will reduce research wastage and facilitate evidence-based aphasia management by enabling replication and collation of research findings, and translation of evidence into practice.

Data resource profile: the virtual international care homes trials archive (VICHTA).

Introduction: Randomised controlled trials (RCTs) conducted in care home settings address a range of health conditions impacting older people, but often include a common core of data about residents and the care home environment. These data can be used to inform service provision, but accessing these data can be challenging. Methods: The Virtual International Care Home Trials Archive (VICHTA) collates care home RCTs conducted since 2010, with >100 participants, across multiple conditions, with documented eligibility criteria, initially identified from a scoping review. A Steering Committee comprising contributing trialists oversees proposed uses of fully anonymised data. We characterised available demography and outcomes to inform potential analyses. Data are accessible via application to the Virtual Trials Archives, through a secure online analysis platform. Trial recruitment is ongoing and future expansion will include international studies. Results: The first phase of VICHTA includes data from six UK RCTs, with individual participant data (IPD) on 5,674 residents across 308 care homes. IPD include age, sex, dementia status, length of stay, quality of life, clinical outcome measures, medications, resource use, and care home characteristics, such as funding, case mix, and occupancy. Follow-up ranges between four and sixteen months. Conclusions: VICHTA collates and makes accessible data on a complex and under-represented research population for novel analyses, and to inform design of future studies. Planned expansion to international care home RCTs will facilitate a wider range of research questions. Interested collaborators can submit trial data or request data at http://www.virtualtrialsarchives.org.

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.

Using the Barthel Index and modified Rankin Scale as Outcome Measures for Stroke Rehabilitation Trials; A Comparison of Minimum Sample Size Requirements.

OBJECTIVES: Underpowered trials risk inaccurate results. Recruitment to stroke rehabilitation randomised controlled trials (RCTs) is often a challenge. Statistical simulations offer an important opportunity to explore the adequacy of sample sizes in the context of specific outcome measures. We aimed to examine and compare the adequacy of stroke rehabilitation RCT sample sizes using the Barthel Index (BI) or modified Rankin Scale (mRS) as primary outcomes. METHODS: We conducted computer simulations using typical experimental event rates (EER) and control event rates (CER) based on individual participant data (IPD) from stroke rehabilitation RCTs. Event rates are the proportion of participants who experienced clinically relevant improvements in the RCT experimental and control groups. We examined minimum sample size requirements and estimated the number of participants required to achieve a number needed to treat within clinically acceptable boundaries for the BI and mRS. RESULTS: We secured 2350 IPD (18 RCTs). For a 90% chance of statistical accuracy on the BI a rehabilitation RCT would require 273 participants per randomised group. Accurate interpretation of effect sizes would require 1000s of participants per group. Simulations for the mRS were not possible as a clinically relevant improvement was not detected when using this outcome measure. CONCLUSIONS: Stroke rehabilitation RCTs with large sample sizes are required for accurate interpretation of effect sizes based on the BI. The mRS lacked sensitivity to detect change and thus may be unsuitable as a primary outcome in stroke rehabilitation trials.

Protocol for the development of a repository of individual participant data from randomised controlled trials conducted in adult care homes (the Virtual International Care Homes Trials Archive (VICHTA)).

BACKGROUND: Approximately 418,000 people live in care homes in the UK, yet accessible, robust data on care home populations and organisation are lacking. This hampers our ability to plan, allocate resources or prevent risk. Large randomised controlled trials (RCTs) conducted in care homes offer a potential solution. The value of detailed data on residents' demographics, outcomes and contextual information captured in RCTs has yet to be fully realised. Irrespective of the intervention tested, much of the trial data collected overlaps in terms of structured assessments and descriptive information. Given the time and costs required to prospectively collect data in these populations, pooling anonymised RCT data into a structured repository offers benefit; secondary analyses of pooled RCT data can improve understanding of this under-researched population and enhance the future trial design. This protocol describes the creation of a project-specific repository of individual participant data (IPD) from trials conducted in care homes and subsequent expansion into a legacy dataset for wider use, to address the need for accurate, high-quality IPD on this vulnerable population. METHODS: Informed by scoping of relevant literature, the principal investigators of RCTs conducted in adult care homes in the UK since 2010 will be invited to contribute trial IPD. Contributing trialists will form a Steering Committee who will oversee data sharing and remain gatekeepers of their own trial's data. IPD will be cleaned and standardised in consultation with the Steering Committee for accuracy. Planned analyses include a comparison of pooled IPD with point estimates from administrative sources, to assess generalisability of RCT data to the wider care home population. We will also identify key resident characteristics and outcomes from within the trial repository, which will inform the development of a national minimum dataset for care homes. Following project completion, management will migrate to the Virtual Trials Archives, forming a legacy dataset which will be expanded to include international RCTs, and will be accessible to the wider research community for analyses. DISCUSSION: Analysis of pooled IPD has the potential to inform and direct future practice, research and policy at low cost, enhancing the value of existing data and reducing research waste. We aim to create a permanent archive for care home trial data and welcome the contribution of emerging trial datasets.

The impact of cognitive-communication difficulties following traumatic brain injury on the family; a qualitative, focus group study.

Primary Objective: To identify how families experience cognitive-communication difficulties following Traumatic Brain Injury (TBI). Experiences of information, training and support for managing communication changes were also explored. Research Design: Qualitative focus group methodology using thematic analysis. Method: 15 family members of individuals with cognitive-communication difficulties following severe TBI participated in the study; four parents, six spouses, three siblings and two offspring. The majority of participants were female (80%, n = 12), with a mean age of 51 (range 19-71). Four focus groups were held with family members at 0-12 months, 12-36 months and 36+ months post-injury. The data were transcribed verbatim and analyzed using NVIVO 12.Results: Cognitive-communication difficulties were found to impact upon family functioning and psychological wellbeing for several years post-injury. Changes to social cognition, insight and the "filter switch" of the person following TBI were key areas of distress. Participants highlighted the need for information about communication changes to be provided at several time points post-injury. The need for peer support from other families with experience of cognitive-communication difficulties was also identified.Conclusion: Cognitive-communication difficulties impact upon family functioning for many years following injury with families continuing to have support needs for communication well beyond the acute rehabilitation stage.

International consensus recommendations for outcome measurement in post-stroke arm rehabilitation trials.

BACKGROUND: Existing randomized controlled trials (RCTs) of arm rehabilitation interventions after stroke use a wide range of outcome measures, limiting ability to pool data to determine efficacy. Published recommendations also lack stroke survivor, carer and clinician involvement specifically about perceived relevance and importance of outcomes and measures. AIM: To generate international consensus recommendations for selection of outcome measures for use in future stroke RCTs in arm rehabilitation, considering outcomes important to stroke survivors, carers and clinicians. The recommendations are the Standardizing Measurement in Arm Rehabilitation Trials (SMART) Toolbox. DESIGN: Two-round international e-Delphi Survey and consensus meeting. SETTING: Online and University. POPULATION: Fifty-five researchers and clinicians with expertise in stroke upper limb rehabilitation from 18 countries (e-Delphi); N.=13 researchers and clinicians, N.=2 stroke survivors, N.=1 carer (consensus meeting). METHODS: Using systematically identified outcome measures from published RCTs, we conducted a two-round international e-Delphi Survey with researchers and clinicians to identify the most important measures for inclusion in the toolbox. Measures that achieved ≥60% consensus were categorized using the International Classification of Functioning, Disability and Health Framework (ICF); psychometric properties were ascertained from literature and research resources. At a final consensus meeting, expert stakeholders selected measures for inclusion in the toolbox. RESULTS: e-Delphi participants recommended 28/170 measures for discussion at the final consensus meeting. Expert stakeholders (N.=16) selected the Visual Analogue Scale for pain/0-10 Numeric Pain Rating Scale, dynamometry, Action Research Arm Test, Wolf Motor Function Test, Barthel Index, Motricity Index and Fugl-Meyer Assessment (upper limb section of each), Box and Block Test, Motor Activity Log 14, Nine Hole Peg Test, Functional Independence Measure, EQ-5D, Canadian Occupational Performance Measure and Modified Rankin Scale for inclusion in the toolbox. CONCLUSIONS: The SMART Toolbox provides a refined selection of measures that capture outcomes considered important by stakeholders for each ICF domain. CLINICAL REHABILITATION IMPACT: The toolbox will facilitate data aggregation for efficacy analyses thereby strengthening evidence to inform clinical practice. Clinicians can also use the toolbox to guide selection of measures ensuring a patient-centered focus.

Improving economic evaluations in stroke: A report from the ESO Health Economics Working Group.

INTRODUCTION: Approaches to economic evaluations of stroke therapies are varied and inconsistently described. An objective of the European Stroke Organisation (ESO) Health Economics Working Group is to standardise and improve the economic evaluations of interventions for stroke. METHODS: The ESO Health Economics Working Group and additional experts were contacted to develop a protocol and a guidance document for data collection for economic evaluations of stroke therapies. A modified Delphi approach, including a survey and consensus processes, was used to agree on content. We also asked the participants about resources that could be shared to improve economic evaluations of interventions for stroke. RESULTS: Of 28 experts invited, 16 (57%) completed the initial survey, with representation from universities, government, and industry. More than half of the survey respondents endorsed 13 specific items to include in a standard resource use questionnaire. Preferred functional/quality of life outcome measures to use for economic evaluations were the modified Rankin Scale (14 respondents, 88%) and the EQ-5D instrument (11 respondents, 69%). Of the 12 respondents who had access to data used in economic evaluations, 10 (83%) indicated a willingness to share data. A protocol template and a guidance document for data collection were developed and are presented in this article. CONCLUSION: The protocol template and guidance document for data collection will support a more standardised and transparent approach for economic evaluations of stroke care.

A survey of cognitive-communication difficulties following TBI: are families receiving the training and support they need?

BACKGROUND: Whilst research into the wide-ranging needs of family members following traumatic brain injury (TBI) is well established, investigation into the specific needs of families in relation to supporting cognitive-communication difficulties, relationships and social participation is limited. AIMS: To identify the family needs for cognitive-communication difficulties following TBI and to explore whether current services are meeting these needs. METHODS & PROCEDURES: Following a successful pilot, family members from the UK and Australia were invited via posters, social media and e-mail to take part in an anonymous, communication needs survey. Data arising from the thirty two closed questions (six eligibility, nine demographic and seventeen needs questions) were analysed using SPSS descriptive statistics. Data arising from one open question were analysed using qualitative content analysis. OUTCOMES & RESULTS: A total of 102 family members from the UK (n = 89, 87%) and Australia (n = 13, 13%) completed the survey. The majority of respondents were female (n = 76; 75%), between the ages of 30 and 69 (n = 88; 87%), and either a parent or a partner of the person following TBI (n = 78;76%). Respondents rated information about expected recovery from cognitive-communication difficulties and training in helpful strategies as their most important needs. The majority of respondents (more than 60%) were not satisfied that any of their cognitive-communication needs had been fully met and high levels of unmet need remained evident at three years or more post-injury. Written information, communication partner training and counselling were identified as key supports. CONCLUSIONS & IMPLICATIONS: Families report high levels of unmet need for managing cognitive-communication difficulties following TBI. Access to written information and communication partner training should be available to families at various time points following TBI and not just in the early stages. What this paper adds What is already known on this subject Attempting to support a person who has cognitive-communication difficulties following TBI has been found to be highly burdensome for family members. However, few studies have asked how families perceive their needs in relation to cognitive-communication difficulties or measured how well current services are meeting their needs. What this paper adds to existing knowledge This study demonstrates that current speech and language therapy services are not yet meeting the needs of the relatives of individuals with cognitive-communication difficulties following TBI. Important insights into the information, training and support families' rate as important are identified in addition to how these needs develop over time. What are the potential or actual clinical implications of this work? Speech and language therapy service design requires to reflect the ongoing nature of familial needs for cognitive-communication difficulties following TBI. Families require access to appropriate literature, speech and language therapy support, and communication partner training in the longer term, not just in the acute phase.

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).

Accuracy of the short-form Montreal Cognitive Assessment: Systematic review and validation.

INTRODUCTION: Short-form versions of the Montreal Cognitive Assessment (SF-MoCA) are increasingly used to screen for dementia in research and practice. We sought to collate evidence on the accuracy of SF-MoCAs and to externally validate these assessment tools. METHODS: We performed systematic literature searching across multidisciplinary electronic literature databases, collating information on the content and accuracy of all published SF-MoCAs. We then validated all the SF-MoCAs against clinical diagnosis using independent stroke (n = 787) and memory clinic (n = 410) data sets. RESULTS: We identified 13 different SF-MoCAs (21 studies, n = 6477 participants) with differing test content and properties. There was a pattern of high sensitivity across the range of SF-MoCA tests. In the published literature, for detection of post stroke cognitive impairment, median sensitivity across included studies: 0.88 (range: 0.70-1.00); specificity: 0.70 (0.39-0.92). In our independent validation using stroke data, median sensitivity: 0.99 (0.80-1.00); specificity: 0.40 (0.14-0.87). To detect dementia in older adults, median sensitivity: 0.88 (0.62-0.98); median specificity: 0.87 (0.07-0.98) in the literature and median sensitivity: 0.96 (range: 0.72-1.00); median specificity: 0.36 (0.14-0.86) in our validation. Horton's SF-MoCA (delayed recall, serial subtraction, and orientation) had the most favorable properties in stroke (sensitivity: 0.90, specificity: 0.87, positive predictive value [PPV]: 0.55, and negative predictive value [NPV]: 0.93), whereas Cecato's "MoCA reduced" (clock draw, animal naming, delayed recall, and orientation) performed better in the memory clinic (sensitivity: 0.72, specificity: 0.86, PPV: 0.55, and NPV: 0.93). CONCLUSIONS: There are many published SF-MoCAs. Clinicians and researchers using a SF-MoCA should be explicit about the content. For all SF-MoCA, sensitivity is high and similar to the full scale suggesting potential utility as an initial cognitive screening tool. However, choice of SF-MoCA should be informed by the clinical population to be studied.

Outcome measures in post-stroke arm rehabilitation trials: do existing measures capture outcomes that are important to stroke survivors, carers, and clinicians?

OBJECTIVE:: We sought to (1) identify the outcome measures currently used across stroke arm rehabilitation randomized trials, (2) identify and compare outcomes important to stroke survivors, carers and clinicians and (3) describe where existing research outcome measures capture outcomes that matter the most to stroke survivors, carers and clinicians and where there may be discrepancies. METHODS:: First, we systematically identified and extracted data on outcome measures used in trials within a Cochrane overview of arm rehabilitation interventions. Second, we conducted 16 focus groups with stroke survivors, carers and clinicians using nominal group technique, supplemented with eight semi-structured interviews, to identify these stakeholders' most important outcomes following post-stroke arm impairment. Finally, we described the constructs of each outcome measure and indicated where stakeholders' important outcomes were captured by each measure. RESULTS:: We extracted 144 outcome measures from 243 post-stroke arm rehabilitation trials. The Fugl-Meyer Assessment Upper Extremity section (used in 79/243 trials; 33%), Action Research Arm Test (56/243; 23%), and modified Ashworth Scale (53/243; 22%) were most frequently used. Stroke survivors ( n = 43), carers ( n = 10) and clinicians ( n = 58) identified 66 unique, important outcomes related to arm impairment following stroke. Between one and three outcomes considered important by the stakeholders were captured by the three most commonly used assessments in research. CONCLUSION:: Post-stroke arm rehabilitation research would benefit from a reduction in the number of outcome measures currently used, and better alignment between what is measured and what is important to stroke survivors, carers and clinicians.

Lack of Early Improvement Predicts Poor Outcome Following Acute Intracerebral Hemorrhage.

OBJECTIVES: There are limited data as to what degree of early neurologic change best relates to outcome in acute intracerebral hemorrhage. We aimed to derive and validate a threshold for early postintracerebral hemorrhage change that best predicts 90-day outcomes. DESIGN: Derivation: retrospective analysis of collated clinical stroke trial data (Virtual International Stroke Trials Archive). VALIDATION: retrospective analysis of a prospective multicenter cohort study (Prediction of haematoma growth and outcome in patients with intracerebral haemorrhage using the CT-angiography spot sign [PREDICT]). SETTING: Neurocritical and ICUs. PATIENTS: Patients with acute intracerebral hemorrhage presenting less than 6 hours. Derivation: 552 patients; validation: 275 patients. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: We generated a receiver operating characteristic curve for the association between 24-hour National Institutes of Health Stroke Scale change and clinical outcome. The primary outcome was a modified Rankin Scale score of 4-6 at 90 days; secondary outcomes were other modified Rankin Scale score ranges (modified Rankin Scale, 2-6, 3-6, 5-6, 6). We employed Youden's J Index to select optimal cut points and calculated sensitivity, specificity, and predictive values. We determined independent predictors via multivariable logistic regression. The derived definitions were validated in the PREDICT cohort. Twenty-four-hour National Institutes of Health Stroke Scale change was strongly associated with 90-day outcome with an area under the receiver operating characteristic curve of 0.75. Youden's method showed an optimum cut point at -0.5, corresponding to National Institutes of Health Stroke Scale change of greater than or equal to 0 (a lack of clinical improvement), which was seen in 46%. Early neurologic change accurately predicted poor outcome when defined as greater than or equal to 0 (sensitivity, 65%; specificity, 73%; positive predictive value, 70%; adjusted odds ratio, 5.05 [CI, 3.25-7.85]) or greater than or equal to 4 (sensitivity, 19%; specificity, 98%; positive predictive value, 91%; adjusted odds ratio, 12.24 [CI, 4.08-36.66]). All definitions reproduced well in the validation cohort. CONCLUSIONS: Lack of clinical improvement at 24 hours robustly predicted poor outcome and showed good discrimination for individual patients who would do poorly. These findings are useful for prognostication and may also present as a potential early surrogate outcome for future intracerebral hemorrhage treatment trials.

Enlarged perivascular spaces and cognitive impairment after stroke and transient ischemic attack.

Background Previous studies suggested that enlarged perivascular spaces are neuroimaging markers of cerebral small vessel disease. However, it is not clear whether enlarged perivascular spaces are associated with cognitive impairment. We aimed to determine the cross-sectional relationship between enlarged perivascular spaces and small vessel disease, and to investigate the relationship between enlarged perivascular spaces and subsequent cognitive impairment in patients with recent cerebral ischemic event. Methods Anonymized data were accessed from the virtual international stroke trial archive. We rated number of lacunes, white matter hyperintensities, brain atrophy, and enlarged perivascular spaces with validated scales on magnetic resonance brain images after the index stroke. We defined cognitive impairment as a mini mental state examination score of ≤26, recorded at one year post stroke. We examined the associations between enlarged perivascular spaces and clinical and imaging markers of small vessel disease at presentation and clinical evidence of cognitive impairment at one year using linear and logistic regression models. Results We analyzed data on 430 patients with mean (±SD) age 64.7 (±12.7) years, 276 (64%) males. In linear regression analysis, age (ß = 0.24; p < 0.001), hypertension (ß = 0.09; p = 0.025), and deep white matter hyperintensities (ß = 0.31; p < 0.001) were associated with enlarged perivascular spaces. In logistic regression analysis, basal ganglia enlarged perivascular spaces were independently associated with cognitive impairment at one year after adjusting for clinical confounders (OR = 1.72, 95% CI = 1.22-2.42) and for clinical and imaging confounders (OR = 1.54; 95% CI = 1.03-2.31). Conclusions Our data show that in patients with ischemic cerebral events, enlarged perivascular spaces are cross-sectionally associated with age, hypertension, and white matter hyperintensities and suggest that enlarged perivascular spaces in the basal ganglia are associated with cognitive impairment after one year.

Standardized Measurement of Sensorimotor Recovery in Stroke Trials: Consensus-Based Core Recommendations from the Stroke Recovery and Rehabilitation Roundtable.

Finding, testing and demonstrating efficacy of new treatments for stroke recovery is a multifaceted challenge. We believe that to advance the field, neurorehabilitation trials need a conceptually rigorous starting framework. An essential first step is to agree on definitions of sensorimotor recovery and on measures consistent with these definitions. Such standardization would allow pooling of participant data across studies and institutions aiding meta-analyses of completed trials, more detailed exploration of recovery profiles of our patients and the generation of new hypotheses. Here, we present the results of a consensus meeting about measurement standards and patient characteristics that we suggest should be collected in all future stroke recovery trials. Recommendations are made considering time post stroke and are aligned with the international classification of functioning and disability. A strong case is made for addition of kinematic and kinetic movement quantification. Further work is being undertaken by our group to form consensus on clinical predictors and pre-stroke clinical data that should be collected, as well as recommendations for additional outcome measurement tools. To improve stroke recovery trials, we urge the research community to consider adopting our recommendations in their trial design.

Standardized measurement of sensorimotor recovery in stroke trials: Consensus-based core recommendations from the Stroke Recovery and Rehabilitation Roundtable.

Finding, testing and demonstrating efficacy of new treatments for stroke recovery is a multifaceted challenge. We believe that to advance the field, neurorehabilitation trials need a conceptually rigorous starting framework. An essential first step is to agree on definitions of sensorimotor recovery and on measures consistent with these definitions. Such standardization would allow pooling of participant data across studies and institutions aiding meta-analyses of completed trials, more detailed exploration of recovery profiles of our patients and the generation of new hypotheses. Here, we present the results of a consensus meeting about measurement standards and patient characteristics that we suggest should be collected in all future stroke recovery trials. Recommendations are made considering time post stroke and are aligned with the international classification of functioning and disability. A strong case is made for addition of kinematic and kinetic movement quantification. Further work is being undertaken by our group to form consensus on clinical predictors and pre-stroke clinical data that should be collected, as well as recommendations for additional outcome measurement tools. To improve stroke recovery trials, we urge the research community to consider adopting our recommendations in their trial design.

Big data and data repurposing - using existing data to answer new questions in vascular dementia research.

INTRODUCTION: Traditional approaches to clinical research have, as yet, failed to provide effective treatments for vascular dementia (VaD). Novel approaches to collation and synthesis of data may allow for time and cost efficient hypothesis generating and testing. These approaches may have particular utility in helping us understand and treat a complex condition such as VaD. METHODS: We present an overview of new uses for existing data to progress VaD research. The overview is the result of consultation with various stakeholders, focused literature review and learning from the group's experience of successful approaches to data repurposing. In particular, we benefitted from the expert discussion and input of delegates at the 9th International Congress on Vascular Dementia (Ljubljana, 16-18th October 2015). RESULTS: We agreed on key areas that could be of relevance to VaD research: systematic review of existing studies; individual patient level analyses of existing trials and cohorts and linking electronic health record data to other datasets. We illustrated each theme with a case-study of an existing project that has utilised this approach. CONCLUSIONS: There are many opportunities for the VaD research community to make better use of existing data. The volume of potentially available data is increasing and the opportunities for using these resources to progress the VaD research agenda are exciting. Of course, these approaches come with inherent limitations and biases, as bigger datasets are not necessarily better datasets and maintaining rigour and critical analysis will be key to optimising data use.