A randomised controlled trial to compare the clinical and cost-effectiveness of prism glasses, visual search training and standard care in patients with hemianopia following stroke: a protocol

INTRODUCTION: Homonymous hemianopia is a common and disabling visual problem after stroke. Currently, prism glasses and visual scanning training are proposed to improve it. The aim of this trial is to determine the effectiveness of these interventions compared to standard care. METHODS AND ANALYSIS: The trial will be a multicentre three arm individually randomised controlled trial with independent assessment at 6 week, 12 week and 26 week post-randomisation. Recruitment will occur in hospital, outpatient and primary care settings in UK hospital trusts. A total of 105 patients with homonymous hemianopia and without ocular motility impairment, visual inattention or pre-existent visual field impairment will be randomised to one of three balanced groups. Randomisation lists will be stratified by site and hemianopia level (partial or complete) and created using simple block randomisation by an independent statistician. Allocations will be disclosed to patients by the treating clinician, maintaining blinding for outcome assessment. The primary outcome will be change in visual field assessment from baseline to 26 weeks. Secondary measures will include the Rivermead Mobility Index, Visual Function Questionnaire 25/10, Nottingham Extended Activities of Daily Living, Euro Qual-5D and Short Form-12 questionnaires. Analysis will be by intention to treat. ETHICS AND DISSEMINATION: This study has been developed and supported by the UK Stroke Research Network Clinical Studies Group working with service users. Multicentre ethical approval was obtained through the North West 6 Research ethics committee (Reference 10/H1003/119). The trial is funded by the UK Stroke Association. Trial Registration: Current Controlled Trials ISRCTN05956042. Dissemination will consider usual scholarly options of conference presentation and journal publication in addition to patient and public dissemination with lay summaries and articles. TRIAL REGISTRATION: Current Controlled Trials ISRCTN05956042

Medical Leadership and Management in the United Kingdom

Objective: This article aims to outline the historical development of medical leadership in the United Kingdom (UK), present recent advances, discuss professional development and future prospects. Conclusions: With increasing involvement of medical professionals in top managerial roles in the UK over the last 30 years, leadership development initiatives have been growing steadily and there is increasing recognition of the need for leadership and management skills for doctors. Such skills can help to greatly improve patient care as well as enhance organisational effectiveness and productivity. The central involvement of professional bodies such as the UK Faculty of Medical Leadership and Management, and the establishment of medical fellowship schemes, have provided a solid foundation for a new generation of aspiring medical leaders but there is still a long way to go to achieve a higher degree of professionalism for clinical leadership in the UK. The evidence base is weak such that integrated efforts by clinicians and management academics have much to offer in achieving the vision of socially responsible, clinically relevant and research-informed medical leadership training

Oxygen therapy: time to move on?

This analysis examines the roots of clinical practice regarding oxygen therapy and finds that some aspects have changed very little over the past 200 years. Oxygen is commonly prescribed and administered as a therapy across all healthcare settings, particularly for the treatment and management of respiratory conditions, both acute and chronic. Yet despite its widespread use and recent advances in understanding and guidance, poor practice and controversies regarding its use persist. This historical analysis highlights origins in practice that may suggest where the roots of these fallacies lie, highlighting potential ambiguities and myths that have permeated clinical and social contexts. It can be considered that based on clinical presumptions and speculation the prolific and injudicious use of oxygen was encouraged and the legacy for today’s practice seeded. The conjectures proposed here may enable modern day erroneous beliefs to be confronted and clinical practice to move on

Complexity of case mix in a regional allergy service

<p>Abstract</p> <p>Background</p> <p>Currently in the United Kingdom (UK), there is a mismatch between limited financial resources and the large proportion of patients with suspected allergies actually being referred to specialist allergy clinics. To better understand the case mix of patients being referred, we audited referrals to a regional allergy service over an 8 year period.</p> <p>The main source of data was consultant letters to General Practitioners (GP) summarising the diagnosis of patients, archived from January 2002 to September 2009. Letters were reviewed, extracting the clinic date, doctor seen, gender, date of birth, postcode, GP, and diagnoses. Diagnoses were classified into seven groups and illustrative cases for each group noted.</p> <p>Findings</p> <p>Data from 2,028 new referrals with suspected allergy were analysed. The largest group of patients (43%) were diagnosed with a type I hypersensitivity. The other diagnostic groups were chronic idiopathic (spontaneous) urticaria (35%), suspected type I hypersensitivity but no allergen identified (8%), idiopathic (spontaneous) angioedema (8%), physical urticaria (2.5%), non-allergic symptoms (1.6%), type IV hypersensitivity (0.8%) and ACE inhibitor sensitivity (0.5%). Two thirds of patients seen were female with a higher percentage of female patients in the non type-I hypersensitivity group (71%) than the type 1 hypersensitivity (66%) (χ²= 5.1, 1df, <it>p = 0.024</it>). The type 1 hypersensitivity patients were younger than other patients (38 Vs 46 years, t = -10.8, <it>p < 0.001</it>)</p> <p>Conclusions</p> <p>This study highlights the complexity of specialist allergy practice and the large proportion of patients referred with non-type I hypersensitivities, chronic idiopathic (spontaneous) urticaria being by far the largest group. Such information is critical to inform commissioning decisions, define referral pathways and in primary care education.</p

Reporting interventions in communication partner training: a critical review and narrative synthesis of the literature

Background: Communication partner training (CPT) is an umbrella term for a complex behavioural intervention for communications partners (CPs) of people with aphasia (PWA) and possibly PWA themselves, with many interacting components, deployed in flexible ways. Recent systematic reviews (Simmons-Mackie, Raymer, Armstrong, Holland, & Cherney, 2010; Simmons-Mackie, Raymer, & Cherney, 2016) have highlighted the effectiveness of CPT in addressing the skills of conversation partners and the communicative participation of people with aphasia but have suggested that CPT has been variably delivered, with no clear picture of what the essential elements of CPT are and how CPT is expected to achieve its results through hypothesised mechanisms of change (Coster, 2013). Aim: This paper aims broadly to consider specification of CPT and describes how CPT has been conducted overall and in relation to treatment recipients. Recommendations for CPT and areas for future research are considered. Methods & Procedures: A critical review and narrative synthesis was carried out through: (i) the systematic application of the 12-item TIDieR checklist (Hoffmann et al., 2014) to the 56 studies appraised in the Simmons-Mackie et al. (2010, 2016)) reviews, providing a quantitative overview of the completeness of CPT intervention reporting; and (ii) a qualitative synthesis of the reviewed CPT literature according to TIDieR items. Outcomes & Results: Half of the TIDieR checklist items were reported by 71% or more of the studies, and the rest of the items were reported by 0–63% of studies. TIDieR items relating to the treatment (goal, rationale or theory of essential elements, materials and procedures) and provision (provider, mode, timing, dose) were more frequently reported; however, the level of detail provided was often inadequate or incomplete. The interventions were insufficiently specified to enable replication for most of the studies considered. The most infrequently reported items were: name, location, intervention tailoring and modification, and planned and actual intervention adherence/fidelity. Conclusion: For a better understanding of an intervention, it is necessary to identify and describe potentially central elements and perhaps especially in complex interventions as CPT, where it is likely also more difficult. Whilst the reviewed CPT studies are on average reporting on slightly more than half of the TIDieR items, they are overall insufficiently detailed. Some items appear easier to report on, whereas other items have not been attended to, are too complex in nature to give a full report on, or simply have not been relevant for the individual study to include

Why do patients with stroke not receive the recommended amount of active therapy (ReAcT)? Study protocol for a multisite case study investigation

Introduction Increased frequency and intensity of inpatient therapy contributes to improved outcomes for stroke survivors. Differences exist in the amount of therapy provided internationally. In England, Wales and Northern Ireland it is recommended that a minimum of 45 min of each active therapy should be provided at least 5 days a week provided the therapy is appropriate and that the patient can tolerate this. Sentinel Stroke National Audit Programme (2014) data demonstrate this standard is not being achieved for most patients. No research been undertaken to explore how therapists in England manage their practice to meet time-specific therapy recommendations. The ReAcT study aims to develop an in-depth understanding of stroke therapy provision, including how the guideline of 45 min a day of each relevant therapy, is interpreted and implemented by therapists, and how it is experienced by stroke-survivors and their families. Methods and analysis A multisite ethnographic case study design in a minimum of six stroke units will include modified process mapping, observations of service organisation, therapy delivery and documentary analysis. Semistructured interviews with therapists and service managers (n=90), and with patients and informal carers (n=60 pairs) will be conducted. Data will be analysed using the Framework approach. Ethics and dissemination The study received a favourable ethical opinion via the National Research Ethics Service (reference number: 14/NW/0266). Participants will provide written informed consent or, where stroke-survivors lack capacity, a consultee declaration will be sought. ReAcT is designed to generate insights into the organisational, professional, social, practical and patient-related factors acting as facilitators or barriers to providing the recommended amount of therapy. Provisional recommendations will be debated in consensus meetings with stakeholders who have not participated in ReAcT case studies or interviews. Final recommendations will be disseminated to therapists, service managers, clinical guideline developers and policymakers and stroke-survivors and informal carers

An occupational therapy intervention for residents with stroke-related disabilities in UK care homes (OTCH):Cluster randomised controlled trial with economic evaluation

Background: Care home residents with stroke-related disabilities have significant activity limitations. Phase II trial results suggested a potential benefit of occupational therapy (OT) in maintaining residents’ capacity to engage in functional activity. Objective: Evaluate clinical and cost effectiveness of a targeted course of OT in maintaining functional activity and reducing further health risks from inactivity for UK care home residents living with stroke-related disabilities. Design: Pragmatic, parallel-group, cluster randomised controlled trial with economic evaluation. Cluster randomisation occurred at the care home level. Homes were stratified according to trial administrative centre, and type of care provided (nursing or residential) and randomised 1:1 to either the intervention or control arm. Setting: 228 care homes local to 11 trial administrative centres across England and Wales. Participants: 1042 care home residents with a history of stroke or transient ischaemic attack, including residents with communication and cognitive impairments, not receiving end of life care. 114 care homes (n=568 residents) were allocated to the intervention arm; 114 homes (n=474 residents) to the control arm. Randomisation of participating homes occurred between May 2010 and March 2012. Intervention: Personalised three-month course of OT delivered by qualified therapists. Care workers participated in training workshops to support personal activities of daily living. The control condition consisted of usual care for residents. Main outcome measures: Primary outcome at the participant level: Barthel Index of Activities of Daily Living at three months. Secondary outcomes at the participant level: Barthel Index scores at six and twelve months post-randomisation, and the Rivermead Mobility Index, Geriatric Depression Scale-15, and EuroQol EQ-5D-3L questionnaire at all time-points. An economic evaluation examined the incremental cost per quality-adjusted life year (QALY) gain, costs were estimated from the perspective of the NHS and personal social services. Results: Participants mean age= 82.9 years, 665/1042 (64%) were female. 2538 OT sessions were delivered to 498 participants in the intervention group (mean visits/participant =5.1, SD=3.0). No adverse events attributable to the intervention were recorded. The primary outcome showed no significant differences between groups. The adjusted mean difference in the Barthel Index score between groups was 0.19 points higher in the intervention arm (95% CI -0.33 to 0.70, p=0.48, adjusted ICC 0.09). Secondary outcome measures showed no significant differences at all time-points. Mean incremental cost of the OTCH intervention was £438.78 (CI £-360.89 to £1238.46), and the incremental QALY gain was 0.009 (CI -0.030 to 0.048). Conclusion: A three-month individualised course of OT, showed no benefit in maintaining functional activity in an older care home population with stroke-related disabilities. Limitations: A high proportion of participants with very severe activity-based limitations and cognitive impairment have limited capacity to engage in therapy. Future work: There is an urgent need to reduce health-related complications caused by inactivity, and create more of an enabling built environment within care homes. Trial registration: Current controlled trials ISRCTN00757750

Accuracy and clinical utility of comprehensive dysphagia screening assessments in acute stroke: A systematic review and meta‐analysis

IntroductionNurses and other nonspecialists in dysphagia are often trained to screen swallowing poststroke. There are many basic tools that test water only, they are usually conservative, and patients that fail the test remain nil by mouth until a speech and language therapy assessment. More comprehensive tests also allow nonspecialists to recommend modified oral intake. Little is known about the accuracy, clinical utility and cost‐effectiveness of these tests.MethodsFollowing PRISMA guidelines, a systematic review was conducted to describe comprehensive swallowing tests that are available for use in acute stroke by nurses or other nonspecialists in dysphagia. A meta‐analysis was performed to evaluate accuracy and the clinical utility of the tests was considered. Searches and analyses, conducted by two reviewers, included MEDLINE, Embase, trial registries and grey literature up to December 2018. Validated studies were assessed for quality and risk of bias using QUADAS‐2.ResultsTwenty studies were included, describing five different tests, three of which had undergone validation. The tests varied in content, recommendations and use. There was no test superior in accuracy and clinical utility. Three studies validating the Gugging Swallow Screen provided sufficient data for meta‐analysis, demonstrating high sensitivity; 96% (95% CI 0.90–0.99), but low specificity, 65% (95% CI 0.47–0.79), in line with many water swallow tests. Results should be interpreted with caution as study quality and applicability to the acute stroke population was poor.ConclusionsThere is no comprehensive nurse dysphagia assessment tool that has robustly demonstrated good accuracy, clinical utility and cost‐effectiveness in acute stroke.Relevance to Clinical PracticeNurses and other clinicians can develop competencies in screening swallowing and assessing for safe oral intake in those with poststroke dysphagia. It is important to use a validated assessment tool that demonstrates good accuracy, clinical utility and cost‐effectiveness

Implementing biomarkers to predict motor recovery after stroke

BACKGROUND: There is growing interest in using biomarkers to predict motor recovery and outcomes after stroke. The PREP2 algorithm combines clinical assessment with biomarkers in an algorithm, to predict upper limb functional outcomes for individual patients. To date, PREP2 is the first algorithm to be tested in clinical practice, and other biomarker-based algorithms are likely to follow. PURPOSE: This review considers how algorithms to predict motor recovery and outcomes after stroke might be implemented in clinical practice. FINDINGS: There are two tasks: first the prediction information needs to be obtained, and then it needs to be used. The barriers and facilitators of implementation are likely to differ for these tasks. We identify specific elements of the Consolidated Framework for Implementation Research that are relevant to each of these two tasks, using the PREP2 algorithm as an example. These include the characteristics of the predictors and algorithm, the clinical setting and its staff, and the healthcare environment. CONCLUSIONS: Active, theoretically underpinned implementation strategies are needed to ensure that biomarkers are successfully used in clinical practice for predicting motor outcomes after stroke, and should be considered in parallel with biomarker developmen

Biopsychosocial intervention for stroke carers (BISC): results of a feasibility randomised controlled trial and nested qualitative interview study

Objective: To determine the feasibility of recruiting to and delivering a biopsychosocial intervention for carers of stroke survivors. Design: Feasibility randomised controlled study with nested qualitative interview study. Setting: The intervention was delivered in the community in either a group or one-to-one format. Subjects: Carers and stroke survivors within one year of stroke onset. Interventions: A carer targeted intervention delivered by a research psychologist in six structured two-hour sessions or usual care control. The intervention combined education about the biological, psychological and social effects of stroke with strategies and techniques focussing on adjustment to stroke and caregiving. Stroke survivors in both groups received baseline and follow-up assessment but no intervention. Main Outcome: Recruitment rate, study attrition, fidelity of intervention delivery, acceptability and sensitivity of outcome measures used (health related quality of life, anxiety and depression and carer burden six months after randomisation). Results: Of the 257 carers approached, 41 consented. Six withdrew before randomisation. Eighteen participants were randomised to receive the intervention and 17 to usual care. Attendance at sessions was greater when treated one-to-one. Feedback interviews suggested that participants found the intervention acceptable and peer support particularly helpful in normalising their feelings. Thirty participants were assessed at follow-up with improvements from baseline on all health measures for both groups. Conclusions: Our results suggest that a biopsychosocial intervention was acceptable to carers and can be delivered in group and one-to-one formats. Timing of approach and mode of intervention delivery is critical and requires tailoring to the carers individual needs