The ESCAPS study: a feasibility randomized controlled trial of early electrical stimulation to the wrist extensors and flexors to prevent post-stroke complications of pain and contractures in the paretic arm.

OBJECTIVE: To establish feasibility of initiating electrical stimulation treatment of wrist extensors and flexors in patients early after stroke to prevent muscle contractures and pain. DESIGN: Feasibility randomized controlled trial with economic evaluation. SETTING: A specialist stroke unit in Nottinghamshire. SUBJECTS: A total of 40 patients recruited within 72 hours post-stroke with arm hemiparesis. INTERVENTIONS: Participants were randomized to receive usual care or usual care and electrical stimulation to wrist flexors and extensors for 30 minutes, twice a day, five days a week for three months. Initial treatment was delivered by an occupational therapist or physiotherapist who trained participants to self-manage subsequent treatments. MEASURES: Measures of feasibility included recruitment and attrition rates, completion of treatment, and successful data collection. Outcome data on wrist range of motion, pain, arm function, independence, quality of life, and resource use were measured at 3-, 6-, and 12-months post-randomization. RESULTS: A total of 40 participants (of 215 potentially eligible) were recruited in 15 months (20 men; mean age: 72 (SD: 13.0)). Half the participants lacked mental capacity and were recruited by consultee consent. Attrition at three-month follow-up was 12.5% (death (n = 2), end-of-life care (n = 2), and unable to contact (n = 1)). Compliance varied (mean: 65 (SD: 53)) and ranged from 10 to 166 treatments per patient (target dosage was 120). Data for a valid economic analysis can be adequately collected. CONCLUSION: Early initiation of electrical stimulation was acceptable and feasible. Data collection methods used were feasible and acceptable to participants. A large definitive study is needed to determine if electrical stimulation is efficacious and cost effective.

Systematic review of interventions for treating or preventing antipsychotic-induced tardive dyskinesia.

BACKGROUND: Antipsychotic medication can cause tardive dyskinesia (TD) - late-onset, involuntary, repetitive movements, often involving the face and tongue. TD occurs in > 20% of adults taking antipsychotic medication (first-generation antipsychotics for > 3 months), with this proportion increasing by 5% per year among those who continue to use these drugs. The incidence of TD among those taking newer antipsychotics is not different from the rate in people who have used older-generation drugs in moderate doses. Studies of TD have previously been found to be limited, with no treatment approach shown to be effective. OBJECTIVES: To summarise the clinical effectiveness and safety of treatments for TD by updating past Cochrane reviews with new evidence and improved methods; to undertake public consultation to gauge the importance of the topic for people living with TD/the risk of TD; and to make available all data from relevant trials. DATA SOURCES: All relevant randomised controlled trials (RCTs) and observational studies. REVIEW METHODS: Cochrane review methods, network meta-analysis (NMA). DESIGN: Systematic reviews, patient and public involvement consultation and NMA. SETTING: Any setting, inpatient or outpatient. PARTICIPANTS: For systematic reviews, adults with TD who have been taking a stable antipsychotic drug dose for > 3 months. INTERVENTIONS: Any, with emphasis on those relevant to UK NHS practice. MAIN OUTCOME MEASURES: Any measure of TD, global assessments and adverse effects/events. RESULTS: We included 112 studies (nine Cochrane reviews). Overall, risk of bias showed little sign of improvement over two decades. Taking the outcome of 'TD symptoms improved to a clinically important extent', we identified two trials investigating reduction of antipsychotic dose [n = 17, risk ratio (RR) 0.42, 95% confidence interval (CI) 0.17 to 1.04; very low quality]. Switching was investigated twice in trials that could not be combined (switching to risperidone vs. antipsychotic withdrawal: one RCT, n = 42, RR 0.45, 95% CI 0.23 to 0.89; low quality; switching to quetiapine vs. haloperidol: one RCT, n = 45, RR 0.80, 95% CI 0.52 to 1.22; low quality). In addition to RCTs, six observational studies compared antipsychotic discontinuation with decreased or increased dosage, and there was no clear evidence that any of these strategies had a beneficial effect on TD symptoms (very low-quality evidence). We evaluated the addition to standard antipsychotic care of several treatments, but not anticholinergic treatments, for which we identified no trials. We found no clear effect of the addition of either benzodiazepines (two RCTs, n = 32, RR 1.12, 95% CI 0.6 to 2.09; very low quality) or vitamin E (six RCTs, n = 264, RR 0.95, 95% CI 0.89 to 1.01; low quality). Buspirone as an adjunctive treatment did have some effect in one small study (n = 42, RR 0.53, 95% CI 0.33 to 0.84; low quality), as did hypnosis and relaxation (one RCT, n = 15, RR 0.45, 95% CI 0.21 to 0.94; very low quality). We identified no studies focusing on TD in people with dementia. The NMA model found indirect estimates to be imprecise and failed to produce useful summaries on relative effects of interventions or interpretable results for decision-making. Consultation with people with/at risk of TD highlighted that management of TD remains a concern, and found that people are deeply disappointed at the length of time it has taken researchers to address the issue. LIMITATIONS: Most studies remain small and poorly reported. CONCLUSIONS: Clinicians, policy-makers and people with/at risk of TD are little better informed than they were decades ago. Underpowered trials of limited quality repeatedly fail to provide answers. FUTURE WORK: TD reviews have data from current trials extracted, tabulated and traceable to source. The NMA highlights one context in which support for this technique is ill advised. All relevant trials, even if not primarily addressing the issue of TD, should report appropriate binary outcomes on groups of people with this problem. Randomised trials of treatments for people with established TD are indicated. These should be large (> 800 participants), necessitating accrual through accurate local/national registers, including an intervention with acceptable treatments and recording outcomes used in clinical practice. STUDY REGISTRATION: This study is registered as PROSPERO CRD4201502045. FUNDING: The National Institute for Health Research Health Technology Assessment programme.

Crowdfunding: an innovative way to fund your project.

Background Getting research funded is extremely difficult, with research councils rejecting more than 70% of grant applications ( Else 2014 ). It is even more difficult if you are a junior researcher who doesn't have a track record of being awarded grant money or leading a research project. Crowdfunding may offer a solution. It is a method of raising funds from members of the public online and can offer an alternative to the more formal methods of research funding. Aim To outline how this model works and provide tips on designing a campaign. Discussion The authors provide an overview of the literature regarding this model, as well as a set of resources for future reference when designing a campaign. Conclusion Crowdfunding can provide small amounts of money for your first project. Implications for practice It is expected that clinicians practice evidence based medicine, and research in health environments is commonplace. Crowdfunding can offer you support in becoming more engaged in research.

ESCAPS study protocol: a feasibility randomised controlled trial of 'Early electrical stimulation to the wrist extensors and wrist flexors to prevent the post-stroke complications of pain and contractures in the paretic arm'.

INTRODUCTION: Approximately 70% of patients with stroke experience impaired arm function, which is persistent and disabling for an estimated 40%. Loss of function reduces independence in daily activities and impacts on quality of life. Muscles in those who do not recover functional movement in the stroke affected arm are at risk of atrophy and contractures, which can be established as early as 6 weeks following stroke. Pain is also common. This study aims to evaluate the feasibility of a randomised controlled trial to test the efficacy and cost-effectiveness of delivering early intensive electrical stimulation (ES) to prevent post-stroke complications in the paretic upper limb. METHODS AND ANALYSIS: This is a feasibility randomised controlled trial (n=40) with embedded qualitative studies (patient/carer interviews and therapist focus groups) and feasibility economic evaluation. Patients will be recruited from the Stroke Unit at the Nottingham University Hospitals National Health Service (NHS) Trust within 72 h after stroke. Participants will be randomised to receive usual care or usual care and early ES to the wrist flexors and extensors for 30 min twice a day, 5 days a week for 3 months. The initial treatment(s) will be delivered by an occupational therapist or physiotherapist who will then train the patient and/or their nominated carer to self-manage subsequent treatments. ETHICS AND DISSEMINATION: This study has been granted ethical approval by the National Research Ethics Service, East Midlands Nottingham1 Research Ethics Committee (ref: 15/EM/0006). To our knowledge, this is the first study of its kind of the early application (within 72 h post-stroke) of ES to both the wrist extensors and wrist flexors of stroke survivors with upper limb impairment. The results will inform the design of a definitive randomised controlled trial. Dissemination will include 2 peer-reviewed journal publications and presentations at national conferences. TRIAL REGISTRATION NUMBER: ISRCTN1648908; Pre-results. Clinicaltrials.gov ID: NCT02324634.

Can research development bursaries for patient and public involvement have a positive impact on grant applications? A UK-based, small-scale service evaluation.

BACKGROUND: Increasingly, research grant awarding bodies are regarding involvement at all stages of research, including prior to funding, as good practice. However, it is unclear how researchers should pay for this. Therefore, a pre-funding bursary scheme was designed. Up to £500 could be requested for involvement to develop a grant application for which user involvement is a key requisite for the funding body concerned. As the bursary scheme had run for 2 years, an evaluation was conducted to ascertain whether the scheme was effective for incorporating early involvement and in developing the grant proposal. RESULTS: Twelve applications were made of which all were funded. The mean amount requested was £432.91; with the mean amount awarded £308.72. The involvement activities conducted all used qualitative methodology. Feedback regarding the bursaries was positive: enabling refinement of the research question and design; developing dialogue between the service users and the researchers; and helping with team building, with service users sometimes becoming co-applicants or members of the steering groups. The bursaries provided a learning opportunity ­ about involvement for the researchers and about research for the service users. The ultimate aim of the scheme was to enhance the research grant. Regarding this, the involvement paid for by the bursary meant that applicants could complete the involvement sections with in-depth information and clarity. CONCLUSION: For a relatively small financial outlay, appropriate involvement was made possible at an important part of the research process which is usually neglected due to lack of funding. Recommendations for implementation made.