Determining the sample size for a cluster-randomised trial: Bayesian hierarchical modelling of the ICC estimate

In common with many cluster-randomised trials, it was difficult to determine the appropriate sample size for the planned trial of the effectiveness of a systematic voiding programme for post-stroke incontinence due to the lack of a robust estimate of the intra-cluster correlation coefficient (ICC). One approach to overcome this problem is a method of combining ICC values in the Bayesian framework (Turner et al. 2005). We adopted this approach and used Bayesian hierarchical modelling to estimate the ICC

Men’s health – the impact of stroke

Stroke is a leading cause of adult death and the most common cause of complex disability in the UK. This article discusses the incidence and impact of stroke, focusing on a range of issues from a male perspective, including stroke prevention, psychological needs, sexuality and return to work. There are some gender differences in modifiable risk factors for stroke, and women have better knowledge of stroke symptomatology. For men, the development of post-stroke depression is associated with greater physical disability. (c) Sherborne Gibbs Limite

Evaluation of a rehabilitation support service after acute stroke: Feasibility and patient/carer benefit

Background: Stroke survivors returning home after discharge from hospital and their carers require support to meet their rehabilitation needs (independence in Activities of Daily Living, exercise, psychosocial support). Voluntary or charitable care providers may be able to address some of these needs. Objective: To explore the feasibility of delivering and evaluating enhanced support to stroke survivors and their carers, with a Rehabilitation Support Worker (RSW). Methods: 16 consecutive stroke survivors and their carers were included. All participants received usual hospital care. Seven of these patients and their carers were also allocated an RSW from a charitable care provider. The RSW accompanied therapy training sessions with the patient, carer and therapist in hospital. On discharge, the RSW visited the patient and carer at home over the initial 6 week post-discharge period to support them in practising rehabilitation skills. Patient function (Barthel Index) and patient/carer confidence were independently assessed at discharge (Week 0). The above assessments and patient/carer mood (GHQ-12) and Carer Giver Strain were also assessed at Weeks 1, 6 and 12. RSWs were interviewed for their views about the service. Results: Participants’ functional ability at Week 1 post-discharge was significantly higher in the RSW group. At 6 and 12 weeks post-discharge, functional ability was not significantly different between groups. Carers in the intervention group were less confident at all time points, however, this was not significant. There was no significant effect on carer strain or well-being. Interviews with RSWs highlighted areas of their training that could be enhanced and the need for greater clarity as to their role. Conclusions: The results showed that a definitive trial of rehabilitation support is feasible. A number of obstacles however would need to be overcome including: difficulty in identifying suitable patients, clarity of the RSW role, and appropriate training content

Does repetitive task training improve functional activity after stroke? A Cochrane systematic review and meta-analysis.

Repetitive task training resulted in modest improvement across a range of lower limb outcome measures, but not upper limb outcome measures. Training may be sufficient to have a small impact on activities of daily living. Interventions involving elements of repetition and task training are diverse and difficult to classify: the results presented are specific to trials where both elements are clearly present in the intervention, without major confounding by other potential mechanisms of action

Factors affecting thrombolysis in acute stroke: longer door-to-needle (DTN) time in younger people? [Abstract No. 53]

Introduction: Shortening the time to delivery of IV thrombolysis improves patient outcomes and reduces adverse events. This research aimed to explore patient and service delivery factors that increase or decrease DTN time for thrombolysis. Method: We conducted a Service Evaluation from July 2011 to March 2013, using stroke data from SINAP and DASH databases. Data was provided by 6 acute trusts in Lancashire and Cumbria which used telemedicine, and 11 stroke services within the North East of England which instead used face-to-face. Our investigation concentrates on admissions to hospital occurring out of routine working hours, when resources are particularly constrained. Descriptive and inferential analyses, focusing on multivariate Cox regressions models selected using a forward stepwise approach, were then carried out to determine which factors impacted on DTN time, our main outcome variable. Results: After testing alternative specifications, our final model included these potential risk factors: mode of thrombolysis decision-making (either face-to-face or telemedicine); hospital; age; sex. Our results show that DTN time was strongly influenced by patient’s age (p<0.01), with older people receiving thrombolysis more quickly. Among the statistically significant variables, type of hospital (p<0.001) appeared to affect DTN times, together with patient’s sex (p¼0.01), suggesting that males had shorter DTN times. Conclusion: Older age was associated with shorter DTN times, with this effect being independent of other factors. Therefore, our research suggests that age played a predominant role in the delivery of thrombolysis, rather than solely through the choice of assessing acute strokethrough face-to-face or telemedicine

A systematic review of repetitive task training with modelling of resource use, costs and effectiveness

OBJECTIVES: To determine whether repetitive functional task practice (RFTP) after stroke improves limb-specific or global function or activities of daily living and whether treatment effects are dependent on the amount of practice, or the type or timing of the intervention. Also to provide estimates of the cost-effectiveness of RFTP. DATA SOURCES: The main electronic databases were searched from inception to week 4, September 2006. Searches were also carried out on non-English-language databases and for unpublished trials up to May 2006. REVIEW METHODS: Standard quantitative methods were used to conduct the systematic review. The measures of efficacy of RFTP from the data synthesis were used to inform an economic model. The model used a pre-existing data set and tested the potential impact of RFTP on cost. An incremental cost per quality-adjusted life-year (QALY) gained for RFTP was estimated from the model. Sensitivity analyses around the assumptions made for the model were used to test the robustness of the estimates. RESULTS: Thirty-one trials with 34 intervention-control pairs and 1078 participants were included. Overall, it was found that some forms of RFTP resulted in improvement in global function, and in both arm and lower limb function. Overall standardised mean difference in data suitable for pooling was 0.38 [95% confidence interval (CI) 0.09 to 0.68] for global motor function, 0.24 (95% CI 0.06 to 0.42) for arm function and 0.28 (95% CI 0.05 to 0.51) for functional ambulation. Results suggest that training may be sufficient to have an impact on activities of daily living. Retention effects of training persist for up to 6 months, but whether they persist beyond this is unclear. There was little or no evidence that treatment effects overall were modified by time since stroke or dosage of task practice, but results for upper limb function were modified by type of intervention. The economic modelling suggested that RFTP was cost-effective. Given a threshold for cost-effectiveness of 20,000 pounds per QALY gained, RFTP is cost-effective so long as the net cost per patient is less than 1963 pounds. This result showed some sensitivity to the assumptions made for the model. The cost-effectiveness of RFTP tends to stem from the relatively modest cost associated with this intervention. CONCLUSIONS: The evidence suggests that some form of RFTP can be effective in improving lower limb function at any time after stroke, but that the duration of intervention effect is unclear. There is as yet insufficient good-quality evidence to make any firm recommendations for upper limb interventions. If task-specific training is used, adverse effects should be monitored. While the effectiveness of RFTP is relatively modest, this sort of intervention appears to be cost-effective. Owing to the large number of ongoing trials, this review should be updated within 2 years and any future review should include a comparison against alternative treatments. Further research should evaluate RFTP upper limb interventions and in particular constraint-induced movement therapy, address practical ways of delivering RFTP interventions, be directed towards the evaluation of suitable methods to maintain functional gain, and be powered to detect whether RFTP interventions are cost-effective

Assessing fidelity to complex interventions: the icons experience

Background Assessing fidelity to complex healthcare interventions in clinical trials is a challenging area. ‘ICONS' is a cluster randomised controlled feasibility trial of a systematic voiding programme (SVP), incorporating bladder training and prompted voiding, to promote post-stroke continence. Here we describe feasibility of one aspect of fidelity assessment: the day-to-day implementation of the SVP through analysis of clinical logs. Methods Nurses completed clinical logs daily, which included documenting: the toileting interval, proposed toileting times and times toileted. Clinical logs were sampled across trial sites. The original intention was to assess fidelity by exploring the degree of concordance between proposed times and times toileted. Initial analysis revealed the unfeasibility of this method due to documentation errors in toileting intervals and proposed times. Consequently, the planned method was changed to identification of key ‘quality indicators' (QIs) for documentation of practice. Results The need to revise the method of measurement demonstrates the difficulty in assessing fidelity. Assessment of clinical logs revealed low levels of adherence to key quality indicators. However, it is unclear whether this indicates poor fidelity or an imprecise method of fidelity assessment. Conclusion This study highlights challenges of assessing fidelity to complex interventions. Lessons learned will inform the measurement of fidelity in a future trial. Researchers should be aware that the practical implementation of complex healthcare interventions may not be exactly as intended. For ICONS, clinical logs constituted a proxy measure of day-to-day fidelity to the intervention: identification of alternative methods could be considered

Stroke patients' experiences of being admitted to and nursed within a mixed sex environment: a qualitative study

Abstract Objectives: Explore, from a consumer’s perspective, experiences of being admitted to, and nursed within, a mixed sex environment (MSE). Design: Structured and semi-structured interviews. Setting: An acute stroke unit (ASU) in a UK teaching hospital, which includes a MSE, stroke monitoring bay (SMB). Subjects: Consecutive males (15) and females (15) admitted to the ASU, without severe cognitive and/or communication problems. Methods: For consenting patients, basic demographic details were collected and structured questionnaires and semi-structured interviews performed. Answers to structured questionnaires were collated. Interviews were tape-recorded, transcribed verbatim and content analysed to reveal themes. Results: 30 patients were included (median age 68 years, inter-quartile range 60–73). Only 21(70%) patients were informed that the SMB was a MSE before admission, with 6(20%) being offered an alternative. Patients were generally happy with staffs’ attention to their privacy and dignity. Overall, 21(70%) expressed their willingness to be readmitted to the SMB. Knowing they would be in the MSE for only 72 hours was important to 27(90%) patients. The semi-structured interviews revealed three main themes: information/knowledge, procedure for communication, and experiences. Conclusions: Few patients objected to being nursed in a MSE in the acute stage of stroke. Care pathways should ensure adequate and timely information. Staff were respectful of privacy and dignity issues