Determining the sample size for a cluster-randomised trial using knowledge elicitation: Bayesian hierarchical modelling of the intracluster correlation coefficient.

BACKGROUND: The intracluster correlation coefficient is a key input parameter for sample size determination in cluster-randomised trials. Sample size is very sensitive to small differences in the intracluster correlation coefficient, so it is vital to have a robust intracluster correlation coefficient estimate. This is often problematic because either a relevant intracluster correlation coefficient estimate is not available or the available estimate is imprecise due to being based on small-scale studies with low numbers of clusters. Misspecification may lead to an underpowered or inefficiently large and potentially unethical trial. METHODS: We apply a Bayesian approach to produce an intracluster correlation coefficient estimate and hence propose sample size for a planned cluster-randomised trial of the effectiveness of a systematic voiding programme for post-stroke incontinence. A Bayesian hierarchical model is used to combine intracluster correlation coefficient estimates from other relevant trials making use of the wealth of intracluster correlation coefficient information available in published research. We employ knowledge elicitation process to assess the relevance of each intracluster correlation coefficient estimate to the planned trial setting. The team of expert reviewers assigned relevance weights to each study, and each outcome within the study, hence informing parameters of Bayesian modelling. To measure the performance of experts, agreement and reliability methods were applied. RESULTS: The 34 intracluster correlation coefficient estimates extracted from 16 previously published trials were combined in the Bayesian hierarchical model using aggregated relevance weights elicited from the experts. The intracluster correlation coefficients available from external sources were used to construct a posterior distribution of the targeted intracluster correlation coefficient which was summarised as a posterior median with a 95% credible interval informing researchers about the range of plausible sample size values. The estimated intracluster correlation coefficient determined a sample size of between 450 (25 clusters) and 480 (20 clusters), compared to 500-600 from a classical approach. The use of quantiles, and other parameters, from the estimated posterior distribution is illustrated and the impact on sample size described. CONCLUSION: Accounting for uncertainty in an unknown intracluster correlation coefficient, trials can be designed with a more robust sample size. The approach presented provides the possibility of incorporating intracluster correlation coefficients from various cluster-randomised trial settings which can differ from the planned study, with the difference being accounted for in the modelling. By using expert knowledge to elicit relevance weights and synthesising the externally available intracluster correlation coefficient estimates, information is used more efficiently than in a classical approach, where the intracluster correlation coefficient estimates tend to be less robust and overly conservative. The intracluster correlation coefficient estimate constructed is likely to produce a smaller sample size on average than the conventional strategy of choosing a conservative intracluster correlation coefficient estimate. This may therefore result in substantial time and resources savings.

How is hydration assessed and managed in acute stroke? A qualitative study of healthcare staff's knowledge, attitudes and experiences.

AIMS AND OBJECTIVES: To explore healthcare staff's experiences of how dehydration is identified and managed in hospitalised patients after acute stroke, and facilitators and challenges to optimising hydration. BACKGROUND: Optimal hydration post-stroke reduces the risk of neurological deterioration and other complications. Patients are at risk of dehydration in acute stroke, particularly those with dysphagia. DESIGN: A descriptive qualitative study reported following the COREQ guidelines. METHODS: Semi-structured interviews, utilising patient vignettes, were conducted in 2018 (Apr-Oct) with a purposive sample of 30 multidisciplinary staff members from two UK stroke units. Interviews were digitally recorded and transcribed verbatim. Content analysis identified common themes which were mapped to the Theoretical Domains Framework and the Behaviour Change Wheel. RESULTS: The themes were mapped to twelve of the fourteen domains in the Theoretical Domains Framework. Participants believed that inadequate hydration management had potentially serious consequences, and described complex knowledge, skills and cognitive elements to effective hydration care. Participants felt that maintaining hydration was a multidisciplinary responsibility requiring good communication. Although the performance of initial dysphagia screening was reinforced by external audit, other areas of post-stroke hydration management were not; notably, there was no established method of assessing hydration. Barriers to maintaining good hydration included lack of staff, out-of-hours working patterns, low priority given to hydration, patients' comorbidities and complex post-stroke disabilities such as dysphagia, aphasia, inattention and hemiparesis. CONCLUSION: Findings highlighted the importance of assessing and maintaining hydration but identified barriers to, and variation in, clinical practice. To provide optimal care, barriers to the prevention and treatment of dehydration after stroke must be further understood and addressed. RELEVANCE TO CLINICAL PRACTICE: Multidisciplinary teamwork is important in hydration care after stroke, but clarity is required about the specific contributions of each team member. Without this, hydration care becomes 'everybody's and nobody's job'.

Development of the stroke patient concerns inventory: A modified Delphi study.

OBJECTIVES: Stroke survivors often have unmet physical, psychological and/or social concerns. Patient Concerns Inventories (PCIs) have been developed for other health conditions to address concerns. Our objective was to develop a PCI for stroke care. METHODS: This was a development study, including Modified Delphi study design, with academic and healthcare professionals with stroke care expertise. In Stage 1, a draft Stroke PCI (Version 1a) was created through identifying patient-reported concerns post-stroke from three previous studies and through expert panel discussions using Nominal Group Technique. In Stage 2, Version 1a was sent to 92 academic and healthcare professionals with stroke care expertise. Participants ranked their top 20 Stroke PCI items in order of importance and provided feedback. Rankings were converted into scores, and, with the feedback, used to amend the Stroke PCI. Two further rounds of feedback followed until consensus was reached between participants. A final draft of the Stroke PCI was created. RESULTS: In stage 1, 64 potential Stroke PCI items were generated. In Stage 2, 38 participants (41.3%) responded to the request to rank Stroke PCI items. The three highest ranked items were 'Risk of another stroke', 'Walking', 'Recovery'. After three rounds of feedback and amendments, the final draft of the Stroke PCI consisted of 53 items. CONCLUSIONS: A Stroke PCI has been developed using patient-reported concerns in previous studies and input from academic and healthcare professionals. Future work will involve gathering further feedback on the tool and exploring its acceptability and usability in a pilot study.

Hydration and nutrition care practices in stroke: findings from the UK and Australia.

BACKGROUND: Dehydration and malnutrition are common in hospitalised patients following stroke leading to poor outcomes including increased mortality. Little is known about hydration and nutrition care practices in hospital to avoid dehydration or malnutrition, and how these practices vary in different countries. This study sought to capture how the hydration and nutrition needs of patients' post-stroke are assessed and managed in the United Kingdom (UK) and Australia (AUS). AIM: To examine and compare current in-hospital hydration and nutrition care practice for patients with stroke in the UK and Australia. METHODS: A cross-sectional survey was conducted between April and November 2019. Questionnaires were mailed to stroke specialist nurses in UK and Australian hospitals providing post-stroke inpatient acute care or rehabilitation. Non-respondents were contacted up to five times. RESULTS: We received 150/174 (86%) completed surveys from hospitals in the UK, and 120/162 (74%) in Australia. Of the 270 responding hospitals, 96% reported undertaking assessment of hydration status during an admission, with nurses most likely to complete assessments (85%). The most common methods of admission assessment were visual assessment of the patient (UK 62%; AUS 58%), weight (UK 52%; AUS 52%), and body mass index (UK 47%; AUS 42%). Almost all (99%) sites reported that nutrition status was assessed at some point during admission, and these were mainly completed by nurses (91%). Use of standardised nutrition screening tools were more common in the UK (91%) than Australia (60%). Similar proportions of hydration management decisions were made by physicians (UK 84%; AUS 83%), and nutrition management decisions by dietitians (UK 98%; AUS 97%). CONCLUSION: Despite broadly similar hydration and nutrition care practices after stroke in the UK and Australia, some variability was identified. Although nutrition assessment was more often informed by structured screening tools, the routine assessment of hydration was generally not. Nurses were responsible for assessment and monitoring, while dietitians and physicians undertook decision-making regarding management. Hydration care could be improved through the development of standardised assessment tools. This study highlights the need for increased implementation and use of evidence-based protocols in stroke hydration and nutrition care to improve patient outcomes.

Influence of Including Patients with Premorbid Disability in Acute Stroke Trials: The HeadPoST Experience.

BACKGROUND: Patients with premorbid functional impairment are generally excluded from acute stroke trials. We aimed to determine the impact of including such patients in the Head Positioning in acute Stroke Trial (HeadPoST) and early additional impairment on outcomes. METHODS: Post hoc analyses of HeadPoST, an international, cluster-randomized crossover trial of lying-flat versus sitting-up head positioning in acute stroke. Associations of early additional impairment, defined as change in modified Rankin scale (mRS) scores from premorbid levels (estimated at baseline) to Day 7 ("early ΔmRS"), and poor outcome (mRS score 3-6) at Day 90 were determined with generalized linear mixed model. Heterogeneity of the trial treatment effect was tested according to premorbid mRS scores 0-1 versus 2-5. RESULTS: Of 8,285 patients (38.9% female, mean age 68 ± 13 years) with complete data, there were 1,984 (23.9%) with premorbid functional impairment (mRS 2-5). A significant linear association was evident for early ∆mRS and poor outcome (per 1-point increase in ΔmRS, adjusted odds ratio 1.20, 95% confidence interval 1.14-1.27; p < 0.0001). Patients with greater premorbid functional impairment were less likely to develop additional impairment, but their risk of poor 90-day outcome significantly increased with increasing (worse) premorbid mRS scores (linear trend p < 0.0001). There was no heterogeneity of the trial treatment effect by level of premorbid function. CONCLUSIONS: Early poststroke functional impairment that exceeded premorbid levels was associated with worse 90-day outcome, and this association increased with greater premorbid functional impairment. Yet, including premorbid impaired patients in the HeadPoST did not materially affect the subsequent treatment effect. CLINICAL TRIAL REGISTRATION: HeadPoST is registered at http://www.ClinicalTrials.gov (NCT02162017).

Screening for aspiration risk associated with dysphagia in acute stroke.

BACKGROUND: Stroke can affect people's ability to swallow, resulting in passage of some food and drink into the airway. This can cause choking, chest infection, malnutrition and dehydration, reduced rehabilitation, increased risk of anxiety and depression, longer hospital stay, increased likelihood of discharge to a care home, and increased risk of death. Early identification and management of disordered swallowing reduces risk of these difficulties. OBJECTIVES: Primary objective • To determine the diagnostic accuracy and the sensitivity and specificity of bedside screening tests for detecting risk of aspiration associated with dysphagia in people with acute stroke Secondary objectives • To assess the influence of the following sources of heterogeneity on the diagnostic accuracy of bedside screening tools for dysphagia - Patient demographics (e.g. age, gender) - Time post stroke that the study was conducted (from admission to 48 hours) to ensure only hyperacute and acute stroke swallow screening tools are identified - Definition of dysphagia used by the study - Level of training of nursing staff (both grade and training in the screening tool) - Low-quality studies identified from the methodological quality checklist - Type and threshold of index test - Type of reference test SEARCH METHODS: In June 2017 and December 2019, we searched CENTRAL, MEDLINE, Embase, CINAHL, and the Health Technology Assessment (HTA) database via the Centre for Reviews and Dissemination; the reference lists of included studies; and grey literature sources. We contacted experts in the field to identify any ongoing studies and those potentially missed by the search strategy. SELECTION CRITERIA: We included studies that were single-gate or two-gate studies comparing a bedside screening tool administered by nurses or other healthcare professionals (HCPs) with expert or instrumental assessment for detection of aspiration associated with dysphagia in adults with acute stroke admitted to hospital. DATA COLLECTION AND ANALYSIS: Two review authors independently screened each study using the eligibility criteria and then extracted data, including the sensitivity and specificity of each index test against the reference test. A third review author was available at each stage to settle disagreements. The methodological quality of each study was assessed using the Quality Assessment of Studies of Diagnostic Accuracy (QUADAS-2) tool. We identified insufficient studies for each index test, so we performed no meta-analysis. Diagnostic accuracy data were presented as sensitivities and specificities for the index tests. MAIN RESULTS: Overall, we included 25 studies in the review, four of which we included as narratives (with no accuracy statistics reported). The included studies involved 3953 participants and 37 screening tests. Of these, 24 screening tests used water only, six used water and other consistencies, and seven used other methods. For index tests using water only, sensitivity and specificity ranged from 46% to 100% and from 43% to 100%, respectively; for those using water and other consistencies, sensitivity and specificity ranged from 75% to 100% and from 69% to 90%, respectively; and for those using other methods, sensitivity and specificity ranged from 29% to 100% and from 39% to 86%, respectively. Twenty screening tests used expert assessment or the Mann Assessment of Swallowing Ability (MASA) as the reference, six used fibreoptic endoscopic evaluation of swallowing (FEES), and 11 used videofluoroscopy (VF). Fifteen screening tools had an outcome of aspiration risk, 20 screening tools had an outcome of dysphagia, and two narrative papers did not report the outcome. Twenty-one screening tests were carried out by nurses, and 16 were carried out by other HCPs (not including speech and language therapists (SLTs)). We assessed a total of six studies as low risk across all four QUADAS-2 risk of bias domains, and we rated 15 studies as low concern across all three applicability domains. No single study demonstrated 100% sensitivity and specificity with low risk of bias for all domains. The best performing combined water swallow and instrumental tool was the Bedside Aspiration test (n = 50), the best performing water plus other consistencies tool was the Gugging Swallowing Screen (GUSS; n = 30), and the best water only swallow screening tool was the Toronto Bedside Swallowing Screening Test (TOR-BSST; n = 24). All tools demonstrated combined highest sensitivity and specificity and low risk of bias for all domains. However, clinicians should be cautious in their interpretation of these findings, as these tests are based on single studies with small sample sizes, which limits the estimates of reliability of screening tests. AUTHORS' CONCLUSIONS: We were unable to identify a single swallow screening tool with high and precisely estimated sensitivity and specificity based on at least one trial with low risk of bias. However, we were able to offer recommendations for further high-quality studies that are needed to improve the accuracy and clinical utility of bedside screening tools.

Characteristics of patients who had a stroke not initially identified during emergency prehospital assessment: a systematic review.

BACKGROUND: Around 25% of patients who had a stroke do not present with typical 'face, arm, speech' symptoms at onset, and are challenging for emergency medical services (EMS) to identify. The aim of this systematic review was to identify the characteristics of acute stroke presentations associated with inaccurate EMS identification (false negatives). METHOD: We performed a systematic search of MEDLINE, EMBASE, CINAHL and PubMed from 1995 to August 2020 using key terms: stroke, EMS, paramedics, identification and assessment. Studies included: patients who had a stroke or patient records; ≥18 years; any stroke type; prehospital assessment undertaken by health professionals including paramedics or technicians; data reported on prehospital diagnostic accuracy and/or presenting symptoms. Data were extracted and study quality assessed by two researchers using the Quality Assessment of Diagnostic Accuracy Studies V.2 tool. RESULTS: Of 845 studies initially identified, 21 observational studies met the inclusion criteria. Of the 6934 stroke and Transient Ischaemic Attack patients included, there were 1774 (26%) false negative patients (range from 4 (2%) to 247 (52%)). Commonly documented symptoms in false negative cases were speech problems (n=107; 13%-28%), nausea/vomiting (n=94; 8%-38%), dizziness (n=86; 23%-27%), changes in mental status (n=51; 8%-25%) and visual disturbance/impairment (n=43; 13%-28%). CONCLUSION: Speech problems and posterior circulation symptoms were the most commonly documented symptoms among stroke presentations that were not correctly identified by EMS (false negatives). However, the addition of further symptoms to stroke screening tools requires valuation of subsequent sensitivity and specificity, training needs and possible overuse of high priority resources.

Oral care practices in stroke: findings from the UK and Australia.

AIMS: To examine current practice, perceptions of healthcare professionals and factors affecting provision for oral care post-stroke in the UK and Australia. BACKGROUND: Poor oral care has negative health consequences for people post-stroke. Little is known about oral care practice in hospital for people post-stroke and factors affecting provision in different countries. DESIGN: A cross-sectional survey. METHODS: Questionnaires were mailed to stroke specialist nurses in UK and Australian hospitals providing inpatient acute or rehabilitation care post-stroke. The survey was conducted between April and November 2019. Non-respondents were contacted up to five times. RESULTS: Completed questionnaires were received from 150/174 (86%) hospitals in the UK, and 120/162 (74%) in Australia. A total of 52% of UK hospitals and 30% of Australian hospitals reported having a general oral care protocol, with 53% of UK and only 13% of Australian hospitals reporting using oral care assessment tools. Of those using oral care assessment tools, 50% of UK and 38% of Australian hospitals used local hospital-specific tools. Oral care assessments were undertaken on admission in 73% of UK and 57% of Australian hospitals. Staff had received oral care training in the last year in 55% of UK and 30% of Australian hospitals. Inadequate training and education on oral care for pre-registration nurses were reported by 63% of UK and 53% of Australian respondents. CONCLUSION: Unacceptable variability exists in oral care practices in hospital stroke care settings. Oral care could be improved by increasing training, performing individual assessments on admission, and using standardised assessment tools and protocols to guide high quality care. The study highlights the need for incorporating staff training and the use of oral care standardised assessments and protocols in stroke care in order to improve patient outcomes.

Etiologic Workup in Cases of Cryptogenic Stroke: A Systematic Review of International Clinical Practice Guidelines.

Background and Purpose- Identifying the etiology of acute ischemic stroke is essential for effective secondary prevention. However, in at least one third of ischemic strokes, existing investigative protocols fail to determine the underlying cause. Establishing etiology is complicated by variation in clinical practice, often reflecting preferences of treating clinicians and variable availability of investigative techniques. In this review, we systematically assess the extent to which there exists consensus, disagreement, and gaps in clinical practice recommendations on etiologic workup in acute ischemic stroke. Methods- We identified clinical practice guidelines/consensus statements through searches of 4 electronic databases and hand-searching of websites/reference lists. Two reviewers independently assessed reports for eligibility. We extracted data on report characteristics and recommendations relating to etiologic workup in acute ischemic stroke and in cases of cryptogenic stroke. Quality was assessed using the AGREE II tool (Appraisal of Guidelines for Research & Evaluation). Recommendations were synthesized according to a published algorithm for diagnostic evaluation in cryptogenic stroke. Results- We retrieved 16 clinical practice guidelines and 7 consensus statements addressing acute stroke management (n=12), atrial fibrillation (n=5), imaging (n=5), and secondary prevention (n=1). Five reports were of overall high quality. For all patients, guidelines recommended routine brain imaging, noninvasive vascular imaging, a 12-lead ECG, and routine blood tests/laboratory investigations. Additionally, ECG monitoring (>24 hours) was recommended for patients with suspected embolic stroke and echocardiography for patients with suspected cardiac source. Three reports recommended investigations for rarer causes of stroke. None of the reports provided guidance on the extent of investigation needed before classifying a stroke as cryptogenic. Conclusions- While consensus exists surrounding standard etiologic workup, there is little agreement on more advanced investigations for rarer causes of acute ischemic stroke. This gap in guidance, and in the underpinning evidence, demonstrates missed opportunities to better understand and protect against ongoing stroke risk. Registration- URL: https://www.crd.york.ac.uk/PROSPERO/; Unique identifier: CRD42019127822.

Mobile health applications for managing atrial fibrillation for healthcare professionals and patients: a systematic review.

AIMS: A plethora of mobile health applications (m-health apps) to support healthcare are available for both patients and healthcare professionals (HCPs) but content and quality vary considerably and few have undergone formal assessment. The aim is to systematically review the literature on m-health apps for managing atrial fibrillation (AF) that examine the impact on knowledge of AF, patient and HCP behaviour, patients' quality-of-life, and user engagement. METHODS AND RESULTS: MEDLINE, EMBASE, CINAHL, and PsychInfo were searched from 1 January 2005 to 5 September 2019, with hand-searching of clinical trial registers and grey literature. Studies were eligible for inclusion if they reported changes in any of the following: (i) knowledge of AF; (ii) provider behaviour (e.g. guideline adherence); (iii) patient behaviour (e.g. medication adherence); (iv) patient quality-of-life; and (v) user engagement. Two reviewers independently assessed articles for eligibility. A narrative review was undertaken as included studies varied widely in their design, interventions, comparators, and outcomes. Seven studies were included; six m-health apps aimed at patients and one at HCPs. Mobile health apps ranged widely in design, features, and method of delivery. Four studies reported patient knowledge of AF; three demonstrated significant knowledge improvement post-intervention or compared to usual care. One study reported greater HCP adherence to oral anticoagulation guidelines after m-health app implementation. Two studies reported on patient medication adherence and quality-of-life; both showed improved quality-of-life post-intervention but only one observed increased adherence. Regarding user engagement, five studies reported patient perspectives on usability, three on acceptability, and one on feasibility; overall all m-health apps were rated positively. CONCLUSION: Mobile health apps demonstrate improvements in patient knowledge, behaviour, and quality of life. Studies formally evaluating the impact of m-health on HCP behaviour are scarce and larger-scale studies with representative patient cohorts, appropriate comparators, and longer-term assessment of the impact of m-health apps are warranted.

Interventions for treating urinary incontinence after stroke in adults.

BACKGROUND: Urinary incontinence can affect 40% to 60% of people admitted to hospital after a stroke, with 25% still having problems when discharged from hospital and 15% remaining incontinent after one year.This is an update of a review published in 2005 and updated in 2008. OBJECTIVES: To assess the effects of interventions for treating urinary incontinence after stroke in adults at least one-month post-stroke. SEARCH METHODS: We searched the Cochrane Incontinence and Cochrane Stroke Specialised Registers (searched 30 October 2017 and 1 November 2017 respectively), which contain trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE In-Process, MEDLINE Epub Ahead of Print, CINAHL, ClinicalTrials.gov, WHO ICTRP and handsearched journals and conference proceedings. SELECTION CRITERIA: We included randomised or quasi-randomised controlled trials. DATA COLLECTION AND ANALYSIS: Two review authors independently undertook data extraction, risk of bias assessment and implemented GRADE. MAIN RESULTS: We included 20 trials (reporting 21 comparisons) with 1338 participants. Data for prespecified outcomes were not available except where reported below.Intervention versus no intervention/usual careBehavioural interventions: Low-quality evidence suggests behavioural interventions may reduce the mean number of incontinent episodes in 24 hours (mean difference (MD) -1.00, 95% confidence interval (CI) -2.74 to 0.74; 1 trial; 18 participants; P = 0.26). Further, low-quality evidence from two trials suggests that behavioural interventions may make little or no difference to quality of life (SMD -0.99, 95% CI -2.83 to 0.86; 55 participants).Specialised professional input interventions: One trial of moderate-quality suggested structured assessment and management by continence nurse practitioners probably made little or no difference to the number of people continent three months after treatment (risk ratio (RR) 1.28, 95% CI 0.81 to 2.02; 121 participants; equivalent to an increase from 354 to 453 per 1000, 95% CI 287 to 715).Complementary therapy: Five trials assessed complementary therapy using traditional acupuncture, electroacupuncture and ginger-salt-partitioned moxibustion plus routine acupuncture. Low-quality evidence from five trials suggested that complementary therapy may increase the number of participants continent after treatment; participants in the treatment group were three times more likely to be continent (RR 2.82, 95% CI 1.57 to 5.07; 524 participants; equivalent to an increase from 193 to 544 per 1000, 95% CI 303 to 978). Adverse events were reported narratively in one study of electroacupuncture, reporting on bruising and postacupuncture abdominal pain in the intervention group.Physical therapy: Two trials reporting three comparisons suggest that physical therapy using transcutaneous electrical nerve stimulation (TENS) may reduce the mean number of incontinent episodes in 24 hours (MD -4.76, 95% CI -8.10 to -1.41; 142 participants; low-quality evidence). One trial of TENS reporting two comparisons found that the intervention probably improves overall functional ability (MD 8.97, 95% CI 1.27 to 16.68; 81 participants; moderate-quality evidence).Intervention versus placeboPhysical therapy: One trial of physical therapy suggests TPTNS may make little or no difference to the number of participants continent after treatment (RR 0.75, 95% CI 0.19 to 3.04; 54 participants) or number of incontinent episodes (MD -1.10, 95% CI -3.99 to 1.79; 39 participants). One trial suggested improvement in the TPTNS group at 26-weeks (OR 0.04, 95% CI 0.004 to 0.41) but there was no evidence of a difference in perceived bladder condition at six weeks (OR 2.33, 95% CI 0.63 to 8.65) or 12 weeks (OR 1.22, 95% CI 0.29 to 5.17). Data from one trial provided no evidence that TPTNS made a difference to quality of life measured with the ICIQLUTSqol (MD 3.90, 95% CI -4.25 to 12.05; 30 participants). Minor adverse events, such as minor skin irritation and ankle cramping, were reported in one study.Pharmacotherapy interventions: There was no evidence from one study that oestrogen therapy made a difference to the mean number of incontinent episodes per week in mild incontinence (paired samples, MD -1.71, 95% CI -3.51 to 0.09) or severe incontinence (paired samples, MD -6.40, 95% CI -9.47 to -3.33). One study reported no adverse events.Specific intervention versus another interventionBehavioural interventions: One trial comparing a behavioural intervention (timed voiding) with a pharmacotherapy intervention (oxybutynin) contained no useable data.Complementary therapy: One trial comparing different acupuncture needles and depth of needle insertion to assess the effect on incontinence reported that, after four courses of treatment, 78.1% participants in the elongated needle group had no incontinent episodes versus 40% in the filiform needle group (57 participants). This trial was assessed as unclear or high for all types of bias apart from incomplete outcome data.Combined intervention versus single interventionOne trial compared a combined intervention (sensory motor biofeedback plus timed prompted voiding) against a single intervention (timed voiding). The combined intervention may make little or no difference to the number of participants continent after treatment (RR 0.55, 95% CI 0.06 to 5.21; 23 participants; equivalent to a decrease from 167 to 92 per 1000, 95% CI 10 to 868) or to the number of incontinent episodes (MD 2.20, 95% CI 0.12 to 4.28; 23 participants).Specific intervention versus attention controlPhysical therapy interventions: One study found TPTNS may make little or no difference to the number of participants continent after treatment compared to an attention control group undertaking stretching exercises (RR 1.33, 95% CI 0.38 to 4.72; 24 participants; equivalent to an increase from 250 to 333 per 1000, 95% CI 95 to 1000). AUTHORS' CONCLUSIONS: There is insufficient evidence to guide continence care of adults in the rehabilitative phase after stroke. As few trials tested the same intervention, conclusions are drawn from few, usually small, trials. CIs were wide, making it difficult to ascertain if there were clinically important differences. Only four trials had adequate allocation concealment and many were limited by poor reporting, making it impossible to judge the extent to which they were prone to bias. More appropriately powered, multicentre trials of interventions are required to provide robust evidence for interventions to improve urinary incontinence after stroke.

Stroke survivors' and carers' experiences of a systematic voiding programme to treat urinary incontinence after stroke.

AIMS AND OBJECTIVES: To explore the views and experiences of stroke survivors and carers about a systematic voiding programme for poststroke incontinence. BACKGROUND: Urinary incontinence after stroke is common and associated with poorer functional outcome. Structured assessment and management are potentially effective interventions, but it is important that there is a good understanding of stroke survivors' and carers' views of their acceptability and implementation. DESIGN: A qualitative study within a feasibility trial. METHODS: Sixteen participants (12 stroke survivors and four carers) were interviewed using a structured schedule shortly before discharge from one of six inpatient stroke units across six hospitals. Interviews were audio-recorded and transcribed verbatim, and thematic analysis was conducted. FINDINGS: Participants included seven male and five female stroke survivors (mean age 76 years) and four female carers (two wives and two daughters). Themes relating to the preliminary (assessment) phase of the programme were as follows: physical impact, psychological impact, beliefs about incontinence, and the assessment process itself. Main themes relating to the implementation of the programme included the following: timed voiding decisions, adapting the programme or the timed voiding schedule, and urinary incontinence management techniques. Participants felt that the programme helped them to re-establish a regular pattern of micturition and to regain autonomy. CONCLUSIONS: The effectiveness of a systematic voiding programme may partly lie in its educational component, challenging patients' and carers' assumptions that poststroke incontinence is inevitable. Individual adaptation of the programme and the ability to incorporate it alongside other aspects of care are likely to be key factors influencing implementation. RELEVANCE TO CLINICAL PRACTICE: Urinary incontinence is common after stroke. To maximise benefits from a systematic voiding programme, nurses should support stroke survivors to overturn erroneous beliefs, to participate in tailoring of the programme, and in self-management where appropriate.

Interventions for treating anxiety after stroke.

BACKGROUND: Approximately 20% of stroke patients experience clinically significant levels of anxiety at some point after stroke. Physicians can treat these patients with antidepressants or other anxiety-reducing drugs, or both, or they can provide psychological therapy. This review looks at available evidence for these interventions. This is an update of the review first published in October 2011. OBJECTIVES: The primary objective was to assess the effectiveness of pharmaceutical, psychological, complementary, or alternative therapeutic interventions in treating stroke patients with anxiety disorders or symptoms. The secondary objective was to identify whether any of these interventions for anxiety had an effect on quality of life, disability, depression, social participation, caregiver burden, or risk of death. SEARCH METHODS: We searched the trials register of the Cochrane Stroke Group (January 2017). We also searched the Cochrane Central Register of Controlled Trials (CENTRAL; the Cochrane Library; 2017, Issue 1: searched January 2017); MEDLINE (1966 to January 2017) in Ovid; Embase (1980 to January 2017) in Ovid; the Cumulative Index to Nursing and Allied Health Literature (CINAHL; 1937 to January 2017) in EBSCO; and PsycINFO (1800 to January 2017) in Ovid. We conducted backward citation searches of reviews identified through database searches and forward citation searches of included studies. We contacted researchers known to be involved in related trials, and we searched clinical trials registers for ongoing studies. SELECTION CRITERIA: We included randomised trials including participants with a diagnosis of both stroke and anxiety for which treatment was intended to reduce anxiety. Two review authors independently screened and selected titles and abstracts for inclusion. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data and assessed risk of bias. We performed a narrative review. We planned to do a meta-analysis but were unable to do so as included studies were not sufficiently comparable. MAIN RESULTS: We included three trials (four interventions) involving 196 participants with stroke and co-morbid anxiety. One trial (described as a 'pilot study') randomised 21 community-dwelling stroke survivors to four-week use of a relaxation CD or to wait list control. This trial assessed anxiety using the Hospital Anxiety and Depression Scale and reported a reduction in anxiety at three months among participants who had used the relaxation CD (mean (standard deviation (SD) 6.9 (± 4.9) and 11.0 (± 3.9)), Cohen's d = 0.926, P value = 0.001; 19 participants analysed).The second trial randomised 81 participants with co-morbid anxiety and depression to paroxetine, paroxetine plus psychotherapy, or standard care. Mean levels of anxiety severity scores based on the Hamilton Anxiety Scale (HAM-A) at follow-up were 5.4 (SD ± 1.7), 3.8 (SD ± 1.8), and 12.8 (SD ± 1.9), respectively (P value < 0.01).The third trial randomised 94 stroke patients, also with co-morbid anxiety and depression, to receive buspirone hydrochloride or standard care. At follow-up, the mean levels of anxiety based on the HAM-A were 6.5 (SD ± 3.1) and 12.6 (SD ± 3.4) in the two groups, respectively, which represents a significant difference (P value < 0.01). Half of the participants receiving paroxetine experienced adverse events that included nausea, vomiting, or dizziness; however, only 14% of those receiving buspirone experienced nausea or palpitations. Trial authors provided no information about the duration of symptoms associated with adverse events. The trial of relaxation therapy reported no adverse events.The quality of the evidence was very low. Each study included a small number of participants, particularly the study of relaxation therapy. Studies of pharmacological agents presented details too limited to allow judgement of selection, performance, and detection bias and lack of placebo treatment in control groups. Although the study of relaxation therapy had allocated participants to treatment using an adequate method of randomisation, study recruitment methods might have introduced bias, and drop-outs in the intervention group may have influenced results. AUTHORS' CONCLUSIONS: Evidence is insufficient to guide the treatment of anxiety after stroke. Further well-conducted randomised controlled trials (using placebo or attention controls) are required to assess pharmacological agents and psychological therapies.

Integrating acute stroke telemedicine consultations into specialists' usual practice: a qualitative analysis comparing the experience of Australia and the United Kingdom.

BACKGROUND: Stroke telemedicine can reduce healthcare inequities by increasing access to specialists. Successful telemedicine networks require specialists adapting clinical practice to provide remote consultations. Variation in experiences of specialists between different countries is unknown. To support future implementation, we compared perceptions of Australian and United Kingdom specialists providing remote acute stroke consultations. METHODS: Specialist participants were identified using purposive sampling from two new services: Australia's Victorian Stroke Telemedicine Program (n = 6; 2010-13) and the United Kingdom's Cumbria and Lancashire telestroke network (n = 5; 2010-2012). Semi-structured interviews were conducted pre- and post-implementation, recorded and transcribed verbatim. Deductive thematic and content analysis (NVivo) was undertaken by two independent coders using Normalisation Process Theory to explore integration of telemedicine into practice. Agreement between coders was M = 91%, SD = 9 and weighted average κ = 0.70. RESULTS: Cross-cultural similarities and differences were found. In both countries, specialists described old and new consulting practices, the purpose and value of telemedicine systems, and concerns regarding confidence in the assessment and diagnostic skills of unknown colleagues requesting telemedicine support. Australian specialists discussed how remote consultations impacted on usual roles and suggested future improvements, while United Kingdom specialists discussed system governance, policy and procedures. CONCLUSION: Australian and United Kingdom specialists reported telemedicine required changes in work practice and development of new skills. Both groups described potential for improvements in stroke telemedicine systems with Australian specialists more focused on role change and the United Kingdom on system governance issues. Future research should examine if cross-cultural variation reflects different models of care and extends to other networks.

Client and clinical staff perceptions of barriers to and enablers of the uptake and delivery of behavioural interventions for urinary incontinence: qualitative evidence synthesis.

AIM: To evaluate factors influencing uptake and delivery of behavioural interventions for urinary incontinence from the perspective of clients and clinical staff. BACKGROUND: Behavioural interventions are recommended as first-line therapy for the management of urinary incontinence. Barriers to and enablers of uptake and delivery of behavioural interventions have not been reviewed. DESIGN: Qualitative evidence synthesis. DATA SOURCES: MEDLINE, EMBASE, CINAHL, PsychInfo, AMED (inception to May 2013); Proceedings of the International Continence Society (ICS) (2006-2013). REVIEW METHODS: Studies where data were collected from clients or staff about their experiences or perceptions of behavioural interventions were included. Two reviewers independently screened records on title and abstract. Full-text papers were obtained for records identified as potentially relevant by either reviewer. Two reviewers independently filtered all full-text papers for inclusion, extracted findings and critically appraised studies. We used an approach akin to Framework, using a matrix of pre-specified themes to classify the data and facilitate its presentation and synthesis. RESULTS: Seven studies involving 200 participants identified clients' views. Findings identified from at least one study of moderate quality included increased fear of accidents and convenience of treatment. Factors enabling participation included realistic goals and gaining control. Six studies involving 427 participants identified staff views. Findings identified from at least one study of moderate quality included staff education and perceptions of treatment effectiveness. Enabling factors included teamwork and experience of success. CONCLUSION: There is little detailed exploration of clients' experiences of, and responses to, behavioural interventions. Evidence for staff relates predominantly to prompted voiding in long-term residential care. Studies of the uptake and delivery of other behavioural interventions in other settings are warranted.

Repetitive task training for improving functional ability after stroke.

BACKGROUND: Repetitive task training (RTT) involves the active practice of task-specific motor activities and is a component of current therapy approaches in stroke rehabilitation. OBJECTIVES: Primary objective: To determine if RTT improves upper limb function/reach and lower limb function/balance in adults after stroke. Secondary objectives: 1) To determine the effect of RTT on secondary outcome measures including activities of daily living, global motor function, quality of life/health status and adverse events. 2) To determine the factors that could influence primary and secondary outcome measures, including the effect of 'dose' of task practice; type of task (whole therapy, mixed or single task); timing of the intervention and type of intervention. SEARCH METHODS: We searched the Cochrane Stroke Group Trials Register (4 March 2016); the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library 2016, Issue 5: 1 October 2006 to 24 June 2016); MEDLINE (1 October 2006 to 8 March 2016); Embase (1 October 2006 to 8 March 2016); CINAHL (2006 to 23 June 2016); AMED (2006 to 21 June 2016) and SPORTSDiscus (2006 to 21 June 2016). SELECTION CRITERIA: Randomised/quasi-randomised trials in adults after stroke, where the intervention was an active motor sequence performed repetitively within a single training session, aimed towards a clear functional goal. DATA COLLECTION AND ANALYSIS: Two review authors independently screened abstracts, extracted data and appraised trials. We determined the quality of evidence within each study and outcome group using the Cochrane 'Risk of bias' tool and GRADE (Grades of Recommendation, Assessment, Development and Evaluation) criteria. We did not assess follow-up outcome data using GRADE. We contacted trial authors for additional information. MAIN RESULTS: We included 33 trials with 36 intervention-control pairs and 1853 participants. The risk of bias present in many studies was unclear due to poor reporting; the evidence has therefore been rated 'moderate' or 'low' when using the GRADE system. There is low-quality evidence that RTT improves arm function (standardised mean difference (SMD) 0.25, 95% confidence interval (CI) 0.01 to 0.49; 11 studies, number of participants analysed = 749), hand function (SMD 0.25, 95% CI 0.00 to 0.51; eight studies, number of participants analysed = 619), and lower limb functional measures (SMD 0.29, 95% CI 0.10 to 0.48; five trials, number of participants analysed = 419). There is moderate-quality evidence that RTT improves walking distance (mean difference (MD) 34.80, 95% CI 18.19 to 51.41; nine studies, number of participants analysed = 610) and functional ambulation (SMD 0.35, 95% CI 0.04 to 0.66; eight studies, number of participants analysed = 525). We found significant differences between groups for both upper-limb (SMD 0.92, 95% CI 0.58 to 1.26; three studies, number of participants analysed = 153) and lower-limb (SMD 0.34, 95% CI 0.16 to 0.52; eight studies, number of participants analysed = 471) outcomes up to six months post treatment but not after six months. Effects were not modified by intervention type, dosage of task practice or time since stroke for upper or lower limb. There was insufficient evidence to be certain about the risk of adverse events. AUTHORS' CONCLUSIONS: There is low- to moderate-quality evidence that RTT improves upper and lower limb function; improvements were sustained up to six months post treatment. Further research should focus on the type and amount of training, including ways of measuring the number of repetitions actually performed by participants. The definition of RTT will need revisiting prior to further updates of this review in order to ensure it remains clinically meaningful and distinguishable from other interventions.

Mechanisms of action of an implementation intervention in stroke rehabilitation: a qualitative interview study.

BACKGROUND: Despite best evidence demonstrating the effectiveness of increased intensity of exercise after stroke, current levels of therapy continue to be below those required to optimise motor recovery. We developed and tested an implementation intervention that aims to increase arm exercise in stroke rehabilitation. The aim of this study was to illustrate the use of a behaviour change framework, the Behaviour Change Wheel, to identify the mechanisms of action that explain how the intervention produced change. METHODS: We implemented the intervention at three stroke rehabilitation units in the United Kingdom. A purposive sample of therapy team members were recruited to participate in semi-structured interviews to explore their perceptions of how the intervention produced change at their work place. Audio recordings were transcribed and imported into NVivo 10 for content analysis. Two coders separately analysed the transcripts and coded emergent mechanisms. Mechanisms were categorised using the Theoretical Domains Framework (TDF) (an extension of the Capability, Opportunity, Motivation and Behaviour model (COM-B) at the hub of the Behaviour Change Wheel). RESULTS: We identified five main mechanisms of action: 'social/professional role and identity', 'intentions', 'reinforcement', 'behavioural regulation' and 'beliefs about consequences'. At the outset, participants viewed the research team as an external influence for whom they endeavoured to complete the study activities. The study design, with a focus on implementation in real world settings, influenced participants' intentions to implement the intervention components. Monthly meetings between the research and therapy teams were central to the intervention and acted as prompt or reminder to sustain implementation. The phased approach to introducing and implementing intervention components influenced participants' beliefs about the feasibility of implementation. CONCLUSIONS: The Behaviour Change Wheel, and in particular the Theoretical Domains Framework, were used to investigate mechanisms of action of an implementation intervention. This approach allowed for consideration of a range of possible mechanisms, and allowed us to categorise these mechanisms using an established behaviour change framework. Identification of the mechanisms of action, following testing of the intervention in a number of settings, has resulted in a refined and more robust intervention programme theory for future testing.

Parallel-Serial Memoing: A Novel Approach to Analyzing Qualitative Data.

The mechanisms by which talking therapies exert their beneficial effects are largely unknown. In exploring the process of a talking therapy, motivational interviewing (MI), when used to treat and prevent low mood in stroke survivors, we developed, what we believe to be, a novel approach to analyzing transcripts. We illustrate the method using qualitative data from MI sessions with 10 stroke survivors. The approach, drawing on grounded theory, incorporated processes of parallel and serial memoing among a team of researchers to allow a process of validation. This enabled us to describe session content and to develop theoretical interpretations of what was occurring in and across MI sessions. We found that this process can be used to integrate different perspectives in theory building, allowing for a richer description and more robust theoretical interpretation. Others can use and adapt this approach to develop insights into their own inquiry.