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.

Development of a behaviour change intervention to increase upper limb exercise in stroke rehabilitation.

BACKGROUND: Two thirds of survivors will achieve independent ambulation after a stroke, but less than half will recover upper limb function. There is strong evidence to support intensive repetitive task-oriented training for recovery after stroke. The number of repetitions needed is suggested to be in the order of hundreds, but this is not currently being achieved in clinical practice. In an effort to bridge this evidence-practice gap, we have developed a behaviour change intervention that aims to increase provision of upper limb repetitive task-oriented training in stroke rehabilitation. This paper aims to describe the systematic processes that took place in collaboratively developing the behaviour change intervention. METHODS: The methods used in this study were not defined a priori but were guided by the Behaviour Change Wheel. The process was collaborative and iterative with four stages of development emerging (i) establishing an intervention development group; (ii) structured discussions to understand the problem, prioritise target behaviours and analyse target behaviours; (iii) collaborative design of theoretically underpinned intervention components and (iv) piloting and refining of intervention components. RESULTS: The intervention development group consisted of the research team and stroke therapy team at a local stroke rehabilitation unit. The group prioritised four target behaviours at the therapist level: (i) identifying suitable patients for exercises, (ii) provision of exercises, (iii) communicating exercises to family/visitors and (iv) monitoring and reviewing exercises. It also provides a method for self-monitoring performance in order to measure fidelity. The developed intervention, PRACTISE (Promoting Recovery of the Arm: Clinical Tools for Intensive Stroke Exercise), consists of team meetings and the PRACTISE Toolkit (screening tool and upper limb exercise plan, PRACTISE exercise pack and an audit tool). CONCLUSIONS: This paper provides an example of how the Behaviour Change Wheel may be applied in the collaborative development of a behaviour change intervention for health professionals. The process involved was resource-intensive, and the iterative process was difficult to capture. The use of a published behaviour change framework and taxonomy will assist replication in future research and clinical use. The feasibility and acceptability of PRACTISE is currently being explored in two other stroke rehabilitation units.

Self-reported long-term needs after stroke.

BACKGROUND AND PURPOSE: Development of interventions to manage patients with stroke after discharge from the hospital requires estimates of need. This study estimates the prevalence of self-reported need in community-dwelling stroke survivors across the United Kingdom. METHODS: We conducted a survey of stroke survivors 1 to 5 years poststroke recruited through Medical Research Council General Practice Research Framework general practices and 2 population-based stroke registers. Levels and type of need were calculated with comparisons among sociodemographic groups, disability level, and cognitive status using the χ2 test or Fisher exact test, as appropriate. RESULTS: From 1251 participants, response rates were 60% (national sample) and 78% (population registers sample) with few differences in levels of reported need between the 2 samples. Over half (51%) reported no unmet needs; among the remainder, the median number of unmet needs was 3 (range, 1 to 13). Proportions reporting unmet clinical needs ranged from 15% to 59%; 54% reported an unmet need for stroke information; 52% reported reduction in or loss of work activities, significantly more from black ethnic groups (P=0.006); 18% reported a loss in income and 31% an increase in expenses with differences by age, ethnic group, and deprivation score. In multivariable analysis, ethnicity (P=0.032) and disability (P=0.014) were associated with total number of unmet needs. CONCLUSIONS: Multiple long-term clinical and social needs remain unmet long after incident stroke. Higher levels of unmet need were reported by people with disabilities, from ethnic minority groups, and from those living in the most deprived areas. Development and testing of novel methods to meet unmet needs are required.

Cluster randomized controlled trial of a patient and general practitioner intervention to improve the management of multiple risk factors after stroke: stop stroke.

BACKGROUND AND PURPOSE: Stroke is a major public health concern worldwide and survivors remain at high risk of recurrence. Secondary prevention requires management of multiple risk factors but current management is suboptimal. Evidence of the effectiveness of interventions to improve poststroke risk factor management from well-designed trials is limited. We assessed the effectiveness of a patient and general practitioner systematic follow-up intervention to improve risk factor management after stroke. METHODS: We undertook a pragmatic cluster trial involving 523 consecutive incident stroke survivors identified using the population South London Stroke Register and registered with general practices in inner-city London. Practices were randomized to receive the intervention or usual care. The intervention entailed systematically identifying stroke survivors' risk factors for recurrence and providing tailored evidence-based management advice to general practitioners, patients, and caregivers at 10 weeks, 5 months, and 8 months poststroke. The primary outcome was management of key modifiable risk factors for stroke at 1 year with 3 end points: treatment with antihypertensive therapy, treatment with antiplatelet therapy, and smoking cessation. Hierarchical testing was used to adjust for multiple endpoints. Analysis was by intention to treat. This study is registered as number ISRCTN10730637. RESULTS: The absolute risk reduction (and 95% CI) for each outcome was -3.7% (-13.0% to 5.6%) for treatment with antihypertensives; -2.3% (-12.0% to 7.6%) for treatment with antiplatelets; and -0.6% (-14.5% to 13.5%) for smoking cessation. Treatment effects were confirmed in the generalized linear model adjusting for clustering and predefined confounders. CONCLUSIONS: No improvement in risk factor management was demonstrated as a result of this patient, caregiver, and healthcare professional systematic follow-up system. Further evidence of how to effectively alter behavior of patients/caregivers and professionals is required if tailored information on risk and its treatment is to be of any clinical benefit.

Streamlined research governance: are we there yet?

Despite the promise of a new streamlined process for gaining research ethics and governance approval, Nina Fudge, Judith Redfern, Charles Wolfe, and Christopher McKevitt argue that the process is still dogged by delay and arbitrary decisions.

Patterns of smoking cessation in the first 3 years after stroke: the South London Stroke Register.

BACKGROUND: Stroke survivors are at high risk of recurrent strokes and other vascular events. Smoking is an established risk factor for stroke, with cessation recommended for secondary prevention. Little is known about patterns of smoking cessation after stroke. DESIGN: A prospective cohort of patients was identified. METHODS: Data were derived from the population-based South London Stroke Register. Self-reported smoking status was measured at the time of stroke, at 3 months, and at 1 and 3 years after stroke. Stroke survivors, who were smoking at the time of stroke and were alive 3 years later, were included. Logistic regression was used to examine associations between age, sex, ethnicity, socioeconomic status, risk factors, stroke subtype, disability, and probability of attempting and maintaining smoking cessation. RESULTS: Complete smoking data were available for 363 survivors with strokes between 1995 and 2003. In all, 71% of the smokers had attempted to quit within 3 years; 30% had quit and maintained cessation at 1 and 3 years; 10% had quit immediately after stroke, but had subsequently relapsed (smoking again at 1 and 3 years); and 25% of the smokers had quit after 3 months. Black ethnicity [odds ratio (OR): 6.20; confidence interval (CI): 2.39-16.10] and more severe disability (P=0.035) were predictors of attempts to quit. Older age (OR: 0.30; CI: 0.13-0.71) and black ethnicity (OR: 0.30; CI: 0.15-0.60) reduced the likelihood of smoking at 3 years. Among those attempting cessation, being older predicted maintenance (OR: 4.50; CI: 1.50-13.51). CONCLUSION: The majority of smokers had attempted to quit after stroke; however, a minority achieved sustained cessation in the longer term. Cessation patterns are complex, and interventions should be targeted at multiple time points.

Stop Stroke: development of an innovative intervention to improve risk factor management after stroke.

OBJECTIVE: Stroke survivors are at high risk of stroke recurrence yet current strategies to reduce recurrence risk are sub-optimal. The UK Medical Research Council (MRC) have proposed a framework for developing and evaluating complex interventions, such as community management of stroke secondary prevention. The Framework outlines a five-phased approach from theory through to implementation of effective interventions. This paper reports Phases I-III of the development of a novel intervention to improve risk factor management after stroke. METHODS: The pre-clinical/theoretical phase entailed reviewing the literature and undertaking quantitative and qualitative studies to identify current practices and barriers to secondary prevention. In Phase I (modelling), findings were used to design an intervention with the potential to overcome barriers to effective stroke secondary prevention management. The feasibility of delivering the intervention and its acceptability were tested in the Phase II exploratory trial involving 25 stroke survivors and their general practitioners. RESULTS: This led to the development of the definitive risk factor management intervention. This comprises multiple components and involves using an on-going population stroke register to target patients, carers and health care professionals with tailored secondary prevention advice. Clinical, socio-demographic and service use data collected by the stroke register are transformed to provide an individualised secondary prevention package for patients, carers and health care professionals at three time points: within 10 weeks, 3 and 6 months post-stroke. CONCLUSION: The intervention is currently being evaluated in a randomised controlled trial. Further research is needed to test generalisability to other aspects of stroke management and for other chronic diseases. PRACTICE IMPLICATIONS: The MRC Framework for complex interventions provides a structured approach to guide the development of novel interventions in public health. Implications for practice in stroke secondary prevention will emerge when the results of our randomised controlled trial are published.

Development of complex interventions in stroke care: a systematic review.

BACKGROUND AND PURPOSE: Stroke care is complex, requiring input from professionals, patients and carers. Identifying and developing appropriate intervention components to meet these complex needs is difficult. The Medical Research Council (MRC) Framework for developing and evaluating 'complex' (nonpharmacological) interventions aims to improve intervention development. This study uses the Framework to review complex interventions in stroke care. METHODS: Systematic review with multiple search strategies (electronic databases, recent journals, gray literature) was used. The MRC Framework was used to guide the search strategy and assess study quality. 'Complex interventions' were defined as educational/psychosocial interventions to change knowledge, beliefs or behaviors. RESULTS: Sixty-seven studies were included: 39 randomized controlled trials (RCT) and 28 other designs. Complex interventions targeted healthcare professionals (17), and patients, carers and the general population (21 targeting primary or secondary prevention; 30 targeting adjustment and recovery after stroke). Compared with recovery studies, primary and secondary prevention studies were significantly less likely to have been evaluated in RCTs. Interventions evaluated in RCTs were significantly less likely to influence primary outcomes (26%) compared with other designs (44%). Theoretical grounding to support intervention choice was reported in 40 studies but only 14 were theoretically 'well developed'; 21 RCTs listed multiple primary outcome measures, with 10 listing 5 or more. Of these only 3 reported considering statistical power before recruitment and none was sufficiently powered. CONCLUSIONS: Few complex interventions in stroke care have been adequately developed or evaluated. This may explain failures to demonstrate efficacy. In future, greater attention is needed to theoretical development and methodological quality.

Qualitative studies of stroke: a systematic review.

BACKGROUND AND PURPOSE: Qualitative studies are increasingly used to investigate social processes and phenomena influencing health behaviors and service provision. We aimed to identify the scope of published qualitative studies of stroke, consider their relevance to development and delivery of services for people with stroke, and make recommendations for future work. METHODS: Literature review of published articles was identified by systematically searching online literature databases using keywords from the start of each database until 2002. Articles were reviewed by 2 authors, using a standardized matrix for data extraction. The 2003 European Stroke Initiative recommendations for stroke management were used to categorize the literature for consideration of its contribution to stroke research. RESULTS: We included 95 articles. Their empirical contribution includes an emphasis on recording the "human" experience of stroke; identification of needs as perceived by patients and their families, differences in priorities between patients and professionals, and barriers to best-quality care. We identified 12 papers that were specifically undertaken to develop or evaluate interventions. CONCLUSIONS: Qualitative studies have addressed a wide range of issues related to the impact of stroke on individuals and caregivers, and to the organization and delivery of services. Significant problems remain in ensuring the delivery of best-quality stroke care, which such studies have the potential to address. Maximizing this potential requires greater collaboration between nonclinical and clinical scientists, service providers, and users to formulate research questions of interest as well as new research strategies, such as meta-analysis, to pool qualitative research findings and multisited investigations.

Health care follow-up after stroke: opportunities for secondary prevention.

BACKGROUND: Stroke patients have a 15-fold increased risk of a recurrence, but management of risk factors following stroke has been found to be unsatisfactory. Little is known about health service follow-up of patients after stroke or, consequently, the opportunities for providing secondary prevention to patients. OBJECTIVE: The aim of the present study was to investigate the relationship between health service follow-up and management of risk factors after stroke. METHODS: The study used data from the population-based South London Stroke Register, collected prospectively between 1995 and 1998. Main measures included risk factor change and follow-up by hospital physicians, GPs and district nurses. Logistic regression was used to determine relationships between these measures. RESULTS: Seven hundred and seventeen stroke survivors were registered with first stroke between 1995 and 1998. Most patients were followed-up on at least one occasion by at least one service within the first 3 months after stroke: 51% saw a hospital specialist; 72% saw a GP; and 14% saw a community nurse. However, 14% of patients did not see a doctor at all. Disabled patients were less likely to see a doctor, only 17% of severely disabled patients seeing a hospital specialist [odds ratio (OR) 0.17; 95% confidence interval (CI) 0.07-0.41]. Doctor-led follow-up was related to treatment of physiological risk factors (e.g. 73% of hypertensive patients who had seen a GP were treated compared with 59% who had seen only a hospital specialist and 47% who had seen neither). Contact with health services was not associated with behavioural risk factor change. CONCLUSIONS: Opportunities for delivering secondary prevention existed through a range of services, but problems of continuity and effectiveness of care are evident. Further investigation is needed to determine how best to intervene to address these issues. In other words, whether interventions should concentrate on improving access and availability of current services, or whether the focus should be on making current strategies more effective.