Motivational interviewing for low mood and adjustment early after stroke: a feasibility randomised trial.

BACKGROUND: Management of psychological adjustment and low mood after stroke can result in positive health outcomes. We have adapted a talk-based therapy, motivational interviewing (MI), and shown it to be potentially effective for managing low mood and supporting psychological adjustment post-stroke in a single-centre trial. In the current study, we aimed to explore the feasibility of delivering MI using clinical stroke team members, and using an attention control (AC), to inform the protocol for a future definitive trial. METHODS: This parallel two-arm feasibility trial took place in north-west England. Recruitment occurred between December 2012 and November 2013. Participants were stroke patients aged 18 years or over, who were medically stable, had no severe communication problems, and were residents of the hospital catchment. Randomisation was to MI or AC, and was conducted by a researcher not involved in recruitment using opaque sealed envelopes. The main outcome measures were descriptions of study feasibility (recruitment/retention rates, MI delivery by clinical staff, use of AC) and acceptability (through qualitative interviews and completion of study measures), and fidelity to MI and AC (through review of session audio-recordings). Information was also collected on participants' mood, quality of life, adjustment, and resource-use. RESULTS: Over 12 months, 461 patients were screened, 124 were screened eligible, and 49 were randomised: 23 to MI, 26 to AC. At 3 months, 13 MI and 18 AC participants completed the follow-up assessment (63% retention). This was less than expected based on our original trial. An AC was successfully implemented. Alternative approaches would be required to ensure the feasibility of clinical staff delivering MI. The study measures, MI, and AC interventions were considered acceptable, and there was good fidelity to the interventions. There were no adverse events related to study participation. CONCLUSIONS: It was possible to recruit and retain participants, train clinical staff to deliver MI, and implement an appropriate AC. Changes would be necessary to conduct a future multi-centre trial, including: assuming a recruitment rate lower than that in the current study; implementing more strategies to increase participant retention; and considering alternative clinical staff groups to undertake the delivery of MI and AC. TRIAL REGISTRATION: ISRCTN study ID: ISRCTN55624892. TRIAL FUNDING: Northern Stroke Research Fund.

Do studies of the weekend effect really allow for differences in illness severity? An analysis of 14 years of stroke admissions.

Background: An increased mortality rate among patients admitted to hospital at weekends has been found in many studies, and this 'weekend effect' has been used to justify major health service reorganisation. Most studies have used routine administrative data to adjust for potential confounding factors, and are unable to measure differences in illness severity due to the tendency of patients with milder symptoms to stay home at weekends. We set out to estimate the importance of such unmeasured 'confounding by severity', using data from a hospital stroke register. Methods: All suspected acute stroke admissions in Gateshead were prospectively registered over a period of 14.3 years, including information on premorbid factors, measures of stroke severity and survival to hospital discharge. We examined whether each factor differed between weekday and weekend admissions, then used logistic regression to estimate the main contributors to variation in mortality rates. Results: Stroke severity, measured by the Scandinavian Stroke Scale (SSS), was significantly greater among weekend admissions and strongly associated with mortality, and after adjustment for SSS score in logistic regression, the weekend effect completely disappeared. By contrast, most indicators of pre-stroke function, comorbidity or stroke type did not differ between weekday and weekend admissions, although some of them had prognostic significance. Conclusions: The sorts of factors measurable in administrative databases only account for a small part of the prognostically important differences in case-mix between weekday and weekend stroke admissions. While increasing weekend staffing might improve adherence to care standards, evidence that it could save lives is unreliable.

Thrombolytic Treatment for Ischaemic Stroke: Could the Crisis of Confidence Have Been Avoided by Better Analysis of Trial Data?

In many countries, thrombolysis with intravenous alteplase has become a central part of acute stroke care in recent years, requiring radical restructuring of services. However, a significant minority of emergency and stroke physicians have always had serious doubts about the safety and efficacy of thrombolytic treatment, and in 2015 these prompted a major review of the licensing status of alteplase by the UK regulatory authorities. Subsequent dramatic headlines and media stories have called into question the integrity of researchers and clinicians and undermined public faith in medical research. How did this situation arise and what should be done to prevent a repetition as we enter the era of intra-arterial treatment for stroke?Early intravenous alteplase increases the chances both of good recovery and of severe haemorrhage, so the risk/benefit balance must be assessed for individual patients according to stroke severity. For older patients and those with bigger strokes, the 'good recovery' criterion is an inefficient way of assessing treatment effects since few achieve full independence and differences between levels of functional impairment are ignored. This waste of information can be reduced by applying different criteria for 'good' and 'poor' outcomes in different prognostic groups (as clinicians do intuitively), hence increasing the number of patients contributing useful data. Such 'three-way prognosis-based outcome' analysis of existing and future trials could greatly increase the amount of relevant evidence to guide clinical decisions for individual patients across the range of stroke severity.

Effects of diagnostic uncertainty and misclassification on hospital performance indicators for acute stroke care.

The Stroke Improvement National Audit Programme (SINAP), now replaced by the Sentinel Stroke National Audit Programme, was established to provide comparative data on hospital performance indicators for stroke, but comparisons are only valid if case ascertainment is complete. In Gateshead we compared initial results from SINAP with those from a pre-existing hospital stroke register, which ran independently for 11 months after SINAP's introduction in 2010, as well as with Hospital Episode Statistics (HES) data. Of 315 confirmed acute stroke cases identified from the three combined data sources, 96 (30%) were omitted from SINAP and 51 (16%) were missed by HES. Of 478 suspected strokes in the combined datasets, 214 were either misclassified by HES or remained with uncertain diagnosis. These patients had much lower mortality and shorter hospital stays than those with confirmed stroke. This diagnostic uncertainty could be an important source of uncontrolled variation in, or even a potential target for manipulation of, hospital performance indicators for stroke.

Rehabilitation aimed at improving outdoor mobility for people after stroke: a multicentre randomised controlled study (the Getting out of the House Study).

BACKGROUND: One-third of stroke patients are dependent on others to get outside their homes. This can cause people to become housebound, leading to increased immobility, poor health, isolation and misery. There is some evidence that outdoor mobility rehabilitation can reduce these limitations. OBJECTIVE: To test the clinical effectiveness and cost-effectiveness of an outdoor mobility rehabilitation intervention for stroke patients. DESIGN: Multicentre, parallel-group randomised controlled trial, with two groups allocated at a 1 : 1 ratio plus qualitative participant interviews. SETTING: Fifteen UK NHS stroke services throughout England, Scotland and Wales. PARTICIPANTS: A total of 568 stroke patients who wished to get out of the house more often, mean age of 71 years: 508 reached the 6-month follow-up and 10 were interviewed. INTERVENTION: Control was delivered prior to randomisation to all participants, and consisted of verbal advice and transport and outdoor mobility leaflets. Intervention was a targeted outdoor mobility rehabilitation programme delivered by 29 NHS therapists to 287 randomly chosen participants for up to 12 sessions over 4 months. MAIN OUTCOME MEASURES: Primary outcome was participant health-related quality of life, measured by the Short Form questionnaire-36 items, version 2 (Social Function domain), 6 months after baseline. Secondary outcomes were functional ability, mobility, number of journeys (from monthly travel diaries), satisfaction with outdoor mobility (SWOM), psychological well-being and resource use [health care and Personal Social Services (PSS)] 6 months after baseline. Carer well-being was recorded. All outcome measures were collected by post and repeated 12 months after baseline. Outcomes for the groups were compared using statistical significance testing and adjusted for multiple membership to account for the effect of multiple therapists at different sites. Interviews were analysed using interpretive phenomenology to explore confidence. RESULTS: A median of seven intervention sessions [interquartile range (IQR) 3-7 sessions], median duration of 369 minutes (IQR 170-691.5 minutes) per participant was delivered. There was no significant difference between the groups on health-related quality of life (social function). There were no significant differences between groups in functional ability, psychological well-being or SWOM at 6- or 12-month follow-ups. There was a significant difference observed for travel journeys with the intervention group being 42% more likely to make a journey compared with the control group [rate ratio 1.42, 95% confidence interval (95% CI) 1.14 to 1.67] at 6 months and 76% more likely (rate ratio 1.76, 95% CI 1.36 to 1.95) at 12 months. The number of journeys was affected by the therapist effect. The mean incremental cost (total NHS and PSS cost) of the intervention was £3413.75 (95% CI -£448.43 to £7121.00), with an incremental quality-adjusted life-year gain of -0.027 (95% CI -0.060 to 0.007) according to the European Quality of Life-5 Dimensions and -0.003 (95% CI -0.016 to 0.006) according to the Short Form questionnaire-6 Dimensions. At baseline, 259 out of 281 (92.2%) participants in the control group were dissatisfied with outdoor mobility but at the 6-month assessment this had reduced to 77.7% (181/233), a 15% reduction. The corresponding reduction in the intervention group was slightly greater (21%) than 268 out of 287 (93.4%) participants dissatisfied with outdoor mobility at baseline to 189 out of 261 (72.4%) at 6 months. Participants described losing confidence after stroke as being detrimental to outdoor mobility. Recruitment and retention rates were high. The intervention was deliverable by the NHS but had a neutral effect in all areas apart from potentially increasing the number of journeys. This was dependent on the therapist effect, meaning that some therapists were more successful than others. The control appeared to affect change. CONCLUSIONS: The outdoor mobility intervention provided in this study to these stroke patients was not clinically effective or cost-effective. However, the provision of personalised information and monthly diaries should be considered for all people who wish to get out more. TRIAL REGISTRATION: Current Controlled Trials ISRCTN58683841. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 18, No. 29. See the NIHR Journals Library website for further project information.

A multi-centre randomised controlled trial of rehabilitation aimed at improving outdoor mobility for people after stroke: study protocol for a randomised controlled trial.

BACKGROUND: Up to 42% of all stroke patients do not get out of the house as much as they would like. This can impede a person's quality of life. This study is testing the clinical effectiveness and cost effectiveness of a new outdoor mobility rehabilitation intervention by comparing it to usual care. METHODS/DESIGN: This is a multi-centre parallel group individually randomised, controlled trial. At least 506 participants will be recruited through 15 primary and secondary care settings and will be eligible if they are over 18 years of age, have had a stroke and wish to get out of the house more often. Participants are being randomly allocated to either the intervention group or the control group. Intervention group participants receive up to 12 rehabilitation outdoor mobility sessions over up to four months. The main component of the intervention is repeated practice of outdoor mobility with a therapist. Control group participants are receiving the usual intervention for outdoor mobility limitations: verbal advice and provision of leaflets provided over one session.Outcome measures are being collected using postal questionnaires, travel calendars and by independent assessors. The primary outcome measure is the Social Function domain of the SF36v2 quality of life assessment six months after recruitment. The secondary outcome measures include: functional ability, mobility, the number of journeys (monthly travel diaries), satisfaction with outdoor mobility, mood, health-related quality of life, resource use of health and social care. Carer mood information is also being collected.The mean Social Function score of the SF-36v2 will be compared between treatment arms using a multiple membership form of mixed effects multiple regression analysis adjusting for centre (as a fixed effect), age and baseline Social Function score as covariates and therapist as a multiple membership random effect. Regression coefficients and 95% confidence intervals will be presented. DISCUSSION: This study protocol describes a pragmatic randomised controlled trial that will hopefully provide robust evidence of the benefit of outdoor mobility interventions after stroke for clinicians working in the community. The results will be available towards the end of 2012. TRIAL REGISTRATION: ISRCTN58683841.