BackgroundStroke often results in upper limb motor impairment and activity limitation, however terminology to describe severity levels vary. This hinders data pooling from clinical trials to inform practice. There are no reviews that have synthesized severity levels of stroke-related upper limb motor impairment or activity limitation.ObjectiveTo systematically review published literature on descriptors of severity levels for post-stroke upper limb motor impairment and activity limitation.MethodsFollowing the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, we searched eight major databases. Inclusion criteria: primary research studies, adults post-stroke, severity of upper limb motor impairment and/or activity limitation described. We classified included papers by assessing descriptor precision: 'green' (studies including descriptors that used recommended outcome measures, cut-offs or central tendency and dispersion), 'red' (descriptors only), and 'amber' (remaining studies). Of the 'green' studies, we identified the most commonly reported descriptors and measures, and computed cut-off scores using non-parametric statistics.ResultsFrom 17,273 records, 750 studies were included. The most commonly used severity descriptors were 'mild, and/or moderate, and/or severe,' used in 580 (77%) of studies. For the Fugl-Meyer Assessment (Upper Extremity) (57 studies, 8% of the total number of studies included), 'severe' ranged from 0 to 25, 'moderate' from 26 to 50, and 'mild' from 51 to 66. Limited data from the remaining studies prevented further analysis.ConclusionsOur review highlights a lack of standardization of the operationalization of 'severity' of post-stroke upper limb motor impairment and activity limitation. It provides a foundation for developing a standardized clinical language to describe severity levels to improve research and clinical practice.

Background:Identifying and addressing long-term health and societal challenges after COVID-19 is a research priority. Objectives:To create an international, multidisciplinary COVID-19 database, and synthesise long-term outcomes, predictors and costs. Design:Systematic identification of COVID-19 data sets and meta-analysis of individual participant data on long-term outcomes after COVID-19. Setting:Contributed data were collected in clinical, community and research settings. Interventions:Interventions from original studies were included as covariates in models. Data sources:MEDLINE, Cochrane Central Register of Controlled Trials, EMBASE, Web of Science, PsycInfo® (American Psychological Association, Washington, DC, USA), Cumulative Index to Nursing and Allied Health Literature, World Health Organization Global Index Medicus, Epistemonikos, LitCOVID; World Health Organization International Clinical Trials Registry Platform; ClinicalTrials.gov and supplementary searches for studies (November 2019-November 2021) were searched for studies on > 10 people from cohort, case-control, survey or randomised controlled trial studies, across any setting, describing validated assessment instruments, symptoms, hospitalisation, discharge destination or mortality beyond 28-days after COVID-19 onset. Data were extracted by two independent reviewers. Methods:Principal investigators contributed fully anonymised individual participant data. Demography, equity and symptoms were described. Assessment instruments were mapped to the International Classification of Functioning, Disability and Health. Factors associated with outcomes at 3-6 months, 9-12 months and beyond 12 months of index infection, for n > 500 individual participant data and > 1 data set were described using ratio of difference, point estimates, odds ratio and 95% confidence interval, as appropriate. The Mixed Methods Appraisal Tool described study quality; models were appraised using a Grading of Recommendations Assessment, Development and Evaluation-informed approach; heterogeneity was described using I2. Outcome measures:Included overall perception of health, multidomain cognitive function, anxiety, depression, stress, post-traumatic stress disorder, fatigue, strength, walking ability, mobility, coping with daily life, breathlessness, mortality, later hospitalisation and health-related quality of life. Results:PRECIOUS collated 116 data sets from 40 countries (individual participant data = 62,849), comprising 20 randomised controlled trials, 13 case-control, 60 cohort 2 longitudinal, 1 survey and 20 other study types. Participants' median age was 58 years interquartile range (45-68); 34,185 (54.4%) were female; 158 unique symptoms and 137 unique assessment instruments were captured, predominantly describing International Classification of Function, Disability and Health-body functions. Women had poorer outcomes across 30/37 models, compared with men. In 15/37 models, pre-existing lung disease and increasing age were associated with poorer outcomes; hospitalisation, diabetes and chronic kidney disease were each associated with poorer outcomes in 8/37 models. Initial hospitalisation resulted in lower health-related quality of life that did not recover for up to 2 years after initial infection. Heterogeneity was low in 34/37 models; 22/37 models were of moderate and 11/37 were of low quality. Limitations:Use of secondary data limits available covariates, outcomes and time points to those included in primary data sets; evidence was primarily based on high-income countries. There was a lack of data on longer-term healthcare resource use to estimate the costs to the healthcare system. Conclusions:PRECIOUS contributes to the overall picture of long-term COVID-19 outcomes beyond the long-COVID condition and highlights poorer long-term outcomes in women and people with pre-existing comorbidities. Future work:Evidence gaps included healthcare resource use, isolation, loneliness, societal participation and return to work outcomes. Data are needed on the role of health inequity on long-term outcomes. Study registration:This study is registered as PROSPERO (CRD42020224323, IRAS ID: 293578). Funding:This award was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme (NIHR award ref: NIHR132895) and is published in full in Health and Social Care Delivery Research; Vol. 14, No. 29. See the NIHR Funding and Awards website for further award information.

Background Meaningful engagement with families who have lived experience of traumatic brain injury (TBI) is essential if interventions are to more closely align with their needs. The aim of this study was to co-design a family project-based intervention including people with lived experience of TBI and explore participant experience. Methods People with cognitive-communication disorders following severe TBI, and their family members, were recruited from three Scottish brain injury services. The co-design teams participated in Microsoft Teams focus groups (October 2022 to January 2023). A range of adapted communication tools were developed to facilitate the co-design process, and e-surveys about the co-design experience were completed. Qualitative data arising from the focus groups were analysed thematically, and survey data were analysed descriptively. Results Thirteen participants (6 people following TBI and 7 family members) attended the co-design groups. The concept of a family project-based intervention was positively received and adaptions to content identified: inclusion of real-life examples, family support resources and a toolkit of strategies. A range of perceived personal benefits of being involved in the co-design groups was also reported; peer support, feeling heard and helping others. Conclusion People with cognitive-communication disorders following severe TBI, and their families, can make a valuable contribution to co-design research and benefit from the process. Following development of the adapted content, progression to the next design stage will involve feasibility testing of the co-designed family project-based intervention.

PURPOSE:Aphasia information provision to family members (FMs) is often lacking or delayed, prolonging adjustment and management of the severe consequences of aphasia. We explored FMs' response to the communication changes when a family member acquires aphasia (PwA) in Türkiye. Specifically, we explored their experiences of navigating the healthcare system in Türkiye, aphasia information provision and communicating with PwA. MATERIAL AND METHODS:Online semi-structured interviews with FMs (n = 12) were conducted. Data were analysed using reflexive thematic analysis. RESULTS:The findings revealed four themes (11 subthemes): Communication changes (challenges, strategies), information and training (unmet needs, sources, aphasia training), access to and availability of health services (interdisciplinary management, speech-language therapists, referrals), rehabilitation roles and responsibilities (cooperating with therapists, providing speech and language therapy, navigating rehabilitation programmes). The FMs described unmet information needs and unrecognised potential contribution to aphasia rehabilitation. Consequently, they described predominantly navigating this journey using their own resources. CONCLUSIONS:Healthcare professionals in Türkiye need to be aware of FMs' aphasia information needs and consider whether current service delivery approaches should be revised beyond a medical model and impairment-based approaches in terms of assessment and treatment to include programmes based on Life Participation Approach to Aphasia.

PurposeWe 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 methodsAnalyses 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.ResultsEuropean 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.DiscussionThe 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.

Background: Nephrotic syndrome (NS) is considered a significant health issue in Egypt, with an increased percentage of those with steroid-resistant courses. Gaining a comprehensive understanding of the health-related quality of life for those children with SRNS (steroid-resistant nephrotic syndrome) can contribute to improved healthcare management strategies for them. Methods: This case control study consisted of a total of 160 participants, categorized into 3 distinct cohorts: 60 individuals with SRNS, and two control groups that were matched accordingly. The healthy control group included healthy children and a diseased control group with steroid-sensitive nephrotic syndrome (SSNS) children. We use The Pediatric Quality of Life Inventory (PedsQLTM 4.0 Generic Core Scales) for the assessment of quality of life (QoL) in all the study participants. Results: The mean scores of PedsQL domains in the SRNS group were found to be significantly lower compared to the SSNS group (P < 0.05) as well as the healthy control group (P = 0.01). The findings of the regression analysis revealed that duration of illness, active disease at enrolment, number of relapses, number of hospital admissions, cushingoid facies, obesity, and receiving cyclosporine, rituximab, and cyclophosphamide were found to be correlated with decreased total PedsQL scores (P < 0.05). Conclusion: The study concluded that we need integrated efforts, including both pediatric nephrologists and psychiatrists, to properly evaluate and improve QoL in Egyptian children suffering from SRNS. The PedsQL™ 4.0 Generic Core Scales is a straightforward and convenient tool that can be utilized as a preliminary evaluation to assess the QoL in NS children.

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 ± 0.26 min per abstract. Computer output screening took 0.43 ± 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.

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 www.virtualtrialsarchives.org.

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.

Coordination of international aphasia research would minimise duplication of effort, support synergistic international activities across languages and multidisciplinary perspectives, and promote high-quality conduct and reporting of aphasia research, thereby increasing the relevance, transparency, and implementation of findings. The Collaboration of Aphasia Trialists (CATs) sought to develop an aphasia research agenda to direct future research activities, based on priorities shared by people with aphasia, family members, and healthcare professionals. Our established international research network spanning 33 countries contributed to this activity. Research literature reporting the priorities of stakeholders was reviewed and synthesized (phase 1). Representatives from Working Groups on Aphasia Assessment & Outcomes, Prognosis & Predictors of Recovery, Effectiveness of Interventions, and Societal Impact & Reintegration participated in a two-day research agenda-setting meeting. The CATs expert panel refined research objectives and identified constituent components of research and methodological developments required to address these research components. The objectives and research components were grouped into overarching themes (phase 2). The resultant list was then circulated to more than 180 CATs members for review, revision, and approval. Consensus on the final aphasia research agenda and roadmap was reached by CATs executive committee (phase 3). The expert panel identified five overarching research themes: (i) evidence-based interventions for people with aphasia, (ii) effective interventions to support those communicating with people with aphasia, (iii) cross-linguistic assessment and core outcomes for aphasia research, (iv) predictors of language recovery, and (v) clinical implementation of research findings. Within these broad themes, 30 research objectives and 91 individual aphasia research components were identified and sequentially ordered. This agenda builds on research priorities identified by people with aphasia and their families, and includes priorities of healthcare professionals and researchers, and will support the rehabilitation and recovery of people with aphasia. Our internationally relevant research agenda promotes rigor in methodology, considers international applicability, synergistic activities, and sharing of resources and expertise.

The last decade has seen an increase in the development, conduct and publication of high-quality aphasia studies including well-powered randomised controlled trials (Breitenstein et al., 2017; Godecke et al., 2020; Kristinsson et al., 2021; Nouwens et al., 2017; Palmer et al., 2019; Rose et al., 2019). Within this period, we have seen an increase in coordinated and collaborative aphasia research, exemplified by the establishment of international aphasia research collaborations, such as the Collaboration of Aphasia Trialists (CATs; www.aphasiatrials.org) and the international individual participant data (IPD) meta-analysis group RELEASE (REhabilitation and recovery of peopLE with Aphasia after StrokE) (Brady et al., 2020). This is demonstrative of a change in the way aphasia research is being conducted, moving beyond addressing historically region and discipline-specific aphasia activities, to improving international standards to achieve parity between and amongst studies conducted in different regions. Increasing the scale of aphasia research means that investigators are better placed to address the highly heterogenous nature of aphasia. This special issue describes such coordinated activities, each addressing different stages of the aphasia research pathway: generating consensus on definitions and interventions, adapting tools to facilitate international use, building on the existing evidence base, as well as planning coordinated international research. Defining health conditions is an essential step in framing diagnostic categories, developing targeted and effective interventions, and enabling potential communities of people with the condition to form. There has been no universal agreement about the definition of aphasia and historical definitions do not encompass the broad domains of the International Classification of Functioning, Disability and Health (ICF) (World Health Organization Geneva, 2001) known to be impacted by aphasia. To tackle this challenge Berg et al. (2021) undertook an e-Delphi consensus study of more than 117 international aphasia researchers from 31 countries to attempt to establish consensus on an expanded definition of aphasia. Their results highlight consensus for an expanded definition that includes the broader ICF domains, but differences in opinion concerning the nature of the brain injuries underpinning aphasia and application of the key constructs of impairment versus disability. This expanded definition offers a platform for further consensus work involving people with lived experience of aphasia. Valid and reliable outcome measurements are crucial for investigating the effects of aphasia interventions. Wallace et al. (2021) carried out a scoping review to identify all the available standardised measurement instruments validated with people with aphasia and to examine their aims, constructs, structure, and possible cultural adaptations. They found 146 outcome measures, the majority focusing on body functions, and none on patientreported treatment impact or satisfaction. The work provides an excellent resource for clinicians and researchers seeking validated outcome measures suited to their particular aims and contexts. APHASIOLOGY 2022, VOL. 36, NO. 4, 381–384 https://doi.org/10.1080/02687038.2021.1985350

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.

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.

Background: Collation of aphasia research data across settings, countries and study designs using big data principles will support analyses across different language modalities, levels of impairment, and therapy interventions in this heterogeneous population. Big data approaches in aphasia research may support vital analyses, which are unachievable within individual trial datasets. However, we lack insight into the requirements for a systematically created database, the feasibility and challenges and potential utility of the type of data collated. Aim: To report the development, preparation and establishment of an internationally agreed aphasia after stroke research database of individual participant data (IPD) to facilitate planned aphasia research analyses. Methods: Data were collated by systematically identifying existing, eligible studies in any language (>= 10 IPD, data on time since stroke, and language performance) and included sourcing from relevant aphasia research networks. We invited electronic contributions and also extracted IPD from the public domain. Data were assessed for completeness, validity of value-ranges within variables, and described according to pre-defined categories of demographic data, therapy descriptions, and language domain measurements. We cleaned, clarified, imputed and standardised relevant data in collaboration with the original study investigators. We presented participant, language, stroke, and therapy data characteristics of the final database using summary statistics. Results: From 5256 screened records, 698 datasets were potentially eligible for inclusion; 174 datasets (5928 IPD) from 28 countries were included, 47/174 RCT datasets (1778 IPD) and 91/174 (2834 IPD) included a speech and language therapy (SLT) intervention. Participants' median age was 63 years (interquartile range [53, 72]), 3407 (61.4%) were male and median recruitment time was 321 days (IQR 30, 1156) after stroke. IPD were available for aphasia severity or ability overall (n = 2699; 80 datasets), naming (n = 2886; 75 datasets), auditory comprehension (n = 2750; 71 datasets), functional communication (n = 1591; 29 datasets), reading (n = 770; 12 datasets) and writing (n = 724; 13 datasets). Information on SLT interventions were described by theoretical approach, therapy target, mode of delivery, setting and provider. Therapy regimen was described according to intensity (1882 IPD; 60 datasets), frequency (2057 IPD; 66 datasets), duration (1960 IPD; 64 datasets) and dosage (1978 IPD; 62 datasets). Discussion: Our international IPD archive demonstrates the application of big data principles in the context of aphasia research; our rigorous methodology for data acquisition and cleaning can serve as a template for the establishment of similar databases in other research areas.

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.

Background: We require high-quality information on the current burden, the types of therapy and resources available, methods of delivery, care pathways and long-term outcomes for people with aphasia. Aim: To document and inform international delivery of post-stroke aphasia treatment, to optimise recovery and reintegration of people with aphasia. Methods & Procedures: Multi-centre, prospective, non-randomised, open study, employing blinded outcome assessment, where appropriate, including people with post-stroke aphasia, able to attend for 30 minutes during the initial language assessment, at first contact with a speech and language therapist for assessment of aphasia at participating sites. There is no study-mandated intervention. Assessments will occur at baseline (first contact with a speech and language therapist for aphasia assessment), discharge from Speech and Language Therapy (SLT), 6 and 12-months post-stroke. Our primary outcome is changed from baseline in the Amsterdam Nijmegen Everyday Language Test (ANELT/Scenario Test for participants with severe verbal impairments) at 12-months post-stroke. Secondary outcomes at 6 and 12 months include the Therapy Outcome Measure (TOMS), Subjective Index of Physical and Social Outcome (SIPSO), Aphasia Severity Rating Scale (ASRS), Western Aphasia Battery Aphasia Quotient (WAB-AQ), stroke and aphasia quality of life scale (SAQoL-39), European Quality of Life Scale (EQ-5D), lesion description, General Health Questionnaire (GHQ-12), resource use, and satisfaction with therapy provision and success. We will collect demography, clinical data, and therapy content. Routine neuroimaging and medication administration records will be accessed where possible; imaging will be pseudonymised and transferred to a central reading centre. Data will be collected in a central registry. We will describe demography, stroke and aphasia profiles and therapies available. International individual participant data (IPD) meta-analyses will examine treatment responder rates based on minimal detectable change & clinically important changes from baseline for primary and secondary outcomes at 6 and 12 months. Multivariable meta-analyses will examine associations between demography, therapy, medication use and outcomes, considering service characteristics. Where feasible, costs associated with treatment will be reported. Where available, we will detail brain lesion size and site, and examine correlations with SLT and language outcome at 12 months. Conclusion: International differences in care, resource utilisation and outcomes will highlight avenues for further aphasia research, promote knowledge sharing and optimise aphasia rehabilitation delivery. IPD meta-analyses will enhance and expand understanding, identifying cost-effective and promising approaches to optimise rehabilitation to benefit people with aphasia.

Background: The long-term burden of self-management in type 2 diabetes can impact quality of life. Aims: To examine associations between demographic and clinical factors, anxiety/depression and perception of health in people with type 2 diabetes. Methods: Retrospective analyses of anonymised data from completed clinical trials provided by the diabetes subsection of Virtual International Cardiovascular and Cognitive Trials Archive (VICCTA). Data on demographics, polypharmacy, HbA1c, anxiety/depression (EQ-5D-3L) and perception of health (EQ-5D-3L VAS) were extracted. Regression analyses explored associations amongst polypharmacy, HbA1c and quality of life (anxiety/depression and health perception) at baseline. Results: In 2783 participants with type 2 diabetes (median age 66 years (IQR 61–70), n=1,595 (57%) male), female sex and Caucasian/European ethnicity were each associated with increased anxiety/depression and lower EQ-5D-3L VAS scores. Following adjustment for covariates, each additional prescribed medication was associated with increased anxiety/depression: OR 1.09 (95% CI 1.04 to 1.14; p<0.001) and lower VAS scores: B= −1.06 (95% CI −1.37 to −0.75, p<0.001)). Conclusion: Demographic factors and polypharmacy are associated with anxiety/depression and lower health perception.

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.