W. Henry Smithson

Practice Guideline Summary: Sudden Unexpected Death in Epilepsy Incidence Rates and Risk Factors: Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology and the American Epilepsy Society

Objective: To determine the incidence rates of sudden unexpected death in epilepsy (SUDEP) in different epilepsy populations and address the question of whether risk factors for SUDEP have been identified. Methods: Systematic review of evidence; modified Grading Recommendations Assessment, Development, and Evaluation process for developing conclusions; recommendations developed by consensus. Results: Findings for incidence rates based on 12 Class I studies include the following: SUDEP risk in children with epilepsy (aged 0–17 years) is 0.22/1,000 patient-years (95% confidence interval [CI] 0.16–0.31) (moderate confidence in evidence). SUDEP risk increases in adults to 1.2/1,000 patient-years (95% CI 0.64–2.32) (low confidence in evidence). The major risk factor for SUDEP is the occurrence of generalized tonic-clonic seizures (GTCS); the SUDEP risk increases in association with increasing frequency of GTCS occurrence (high confidence in evidence). Recommendations: Level B: Clinicians caring for young children with epilepsy should inform parents/guardians that in 1 year, SUDEP typically affects 1 in 4,500 children; therefore, 4,499 of 4,500 children will not be affected. Clinicians should inform adult patients with epilepsy that SUDEP typically affects 1 in 1,000 adults with epilepsy per year; therefore, annually 999 of 1,000 adults will not be affected. For persons with epilepsy who continue to experience GTCS, clinicians should continue to actively manage epilepsy therapies to reduce seizures and SUDEP risk while incorporating patient preferences and weighing the risks and benefits of any new approach. Clinicians should inform persons with epilepsy that seizure freedom, particularly freedom from GTCS, is strongly associated with decreased SUDEP risk.

“We’re certainly not in our comfort zone”: a qualitative study of GPs’ dementia-care educational needs

BackgroundRising dementia prevalence rates rise combined with the policy objective of enabling people with dementia to remain living at home, means that there will be a growing demand for dementia care in the community setting. However, GPs are challenged by dementia care and have identified it as an area in which further training is needed. Previous studies of GPs dementia care educational needs have explored the views of GPs alone, without taking the perspectives of people with dementia and family carers into account. The aim of the study was to explore GPs’ dementia care educational needs, as viewed from multiple perspectives, in order to inform the design and delivery of an educational programme for GPs.MethodsA qualitative study of GPs, people with dementia and family carers in a community setting was undertaken. Face-to-face interviews were performed with GPs, people with dementia and with family carers. Interviews were audio-recorded, transcribed verbatim and thematically analysed.ResultsThirty-one people were interviewed, consisting of fourteen GPs, twelve family carers and five people with dementia. GPs expressed a wish for further education, preferentially through small group workshops. Five distinct educational needs emerged from the interviews, namely, diagnosis, disclosure, signposting of local services, counselling and the management of behavioural and psychological symptoms (BPSD). While GPs focused on diagnosis, disclosure and BPSD in particular, people with dementia and family carers emphasised the need for GPs to engage in counselling and signposting of local services.ConclusionsThe triangulation of data from multiple relevant sources revealed a broader range of GPs’ educational needs, incorporating both medical and social aspects of dementia care. The findings of this study will inform the content and delivery of a dementia educational programme for GPs that is practice-relevant, by ensuring that the curriculum meets the needs of GPs, patients and their families.

Sudden Unexpected Death in Epilepsy: Addressing the Challenges

Epilepsy is associated with a higher rate of premature death than the general population, and the commonest cause of epilepsy mortality is sudden unexpected death in epilepsy (SUDEP). It is difficult to quantify because of the variable reporting of this cause of death. Death occurs due to autonomic deregulation of cardio-respiratory pathways as a result of seizures. Measures to reduce cardio-respiratory dysfunction are discussed together with the importance of seizure control in preventing SUDEP. The role of seizure detection devices, antiepileptic drugs and the importance of providing information about SUDEP to people with epilepsy are highlighted. There is increasing interest in SUDEP and some current initiatives are discussed.

Preventing and Lessening Exacerbations of Asthma in School-aged children Associated with a New Term (PLEASANT): Recruiting Primary Care Research Sites-the PLEASANT experience

Background:Recruitment of general practices and their patients into research studies is frequently reported as a challenge. The Preventing and Lessening Exacerbations of Asthma in School-aged children Associated with a New Term (PLEASANT) trial recruited 142 general practices, across England and Wales and delivered the study intervention to time and target.Aims:To describe the process of recruitment used within the cluster randomised PLEASANT trial and present results on factors that influenced recruitment.Methods:Data were collected on the number of and types of contact used to gain expression of interest and subsequent randomisation into the PLEASANT trial. Practice size and previous research experience were also collected.Results:The mean number of contacts required to gain expression of interest were m=3.01 (s.d. 1.6) and total number of contacts from initial invitation to randomisation m=6.8 (s.d. 3.5). Previous randomised controlled trial involvement (hazard ratio (HR)=1.81 (confidence interval (CI) 95%, 1.55–2.11) P<0.001) and number of studies a practice had previously engaged in (odds ratio (OR) 1.91 (CI 95%, (1.52–2.42)) P<0.001), significantly influenced whether a practice would participate in PLEASANT. Practice size was not a significant deciding factor (OR=1.04 (95% CI 0.99–1.08) P=0.137).Conclusions:Recruitment to time and target can be achieved in general practice. The amount of resource required for site recruitment should not, however, be underestimated and multiple strategies for contacting practices should be considered. General practitioners with more research experience are more likely to participate in studies.

PLEASANT: Preventing and Lessening Exacerbations of Asthma in School-age children Associated with a New Term - a cluster randomised controlled trial and economic evaluation

BACKGROUND Asthma episodes and deaths are known to be seasonal. A number of reports have shown peaks in asthma episodes in school-aged children associated with the return to school following the summer vacation. A fall in prescription collection in the month of August has been observed, and was associated with an increase in the number of unscheduled contacts after the return to school in September. OBJECTIVE The primary objective of the study was to assess whether or not a NHS-delivered public health intervention reduces the September peak in unscheduled medical contacts. DESIGN Cluster randomised trial, with the unit of randomisation being 142 NHS general practices, and trial-based economic evaluation. SETTING Primary care. INTERVENTION A letter sent (n = 70 practices) in July from their general practitioner (GP) to parents/carers of school-aged children with asthma to remind them of the importance of taking their medication, and to ensure that they have sufficient medication prior to the start of the new school year in September. The control group received usual care. MAIN OUTCOME MEASURES The primary outcome measure was the proportion of children aged 5-16 years who had an unscheduled medical contact in September 2013. Supporting end points included the proportion of children who collected prescriptions in August 2013 and unscheduled contacts through the following 12 months. Economic end points were quality-adjusted life-years (QALYs) gained and costs from an NHS and Personal Social Services perspective. RESULTS There is no evidence of effect in terms of unscheduled contacts in September. Among children aged 5-16 years, the odds ratio (OR) was 1.09 [95% confidence interval (CI) 0.96 to 1.25] against the intervention. The intervention did increase the proportion of children collecting a prescription in August (OR 1.43, 95% CI 1.24 to 1.64) as well as scheduled contacts in the same month (OR 1.13, 95% CI 0.84 to 1.52). For the wider time intervals (September-December 2013 and September-August 2014), there is weak evidence of the intervention reducing unscheduled contacts. The intervention did not reduce unscheduled care in September, although it succeeded in increasing the proportion of children collecting prescriptions in August as well as having scheduled contacts in the same month. These unscheduled contacts in September could be a result of the intervention, as GPs may have wanted to see patients before issuing a prescription. The economic analysis estimated a high probability that the intervention was cost-saving, for baseline-adjusted costs, across both base-case and sensitivity analyses. There was no increase in QALYs. LIMITATION The use of routine data led to uncertainty in the coding of medical contacts. The uncertainty was mitigated by advice from a GP adjudication panel. CONCLUSIONS The intervention did not reduce unscheduled care in September, although it succeeded in increasing the proportion of children both collecting prescriptions and having scheduled contacts in August. After September there is weak evidence in favour of the intervention. The intervention had a favourable impact on costs but did not demonstrate any impact on QALYs. The results of the trial indicate that further work is required on assessing and understanding adherence, both in terms of using routine data to make quantitative assessments, and through additional qualitative interviews with key stakeholders such as practice nurses, GPs and a wider group of children with asthma. TRIAL REGISTRATION Current Controlled Trials ISRCTN03000938. FUNDING DETAILS This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 20, No. 93. See the HTA programme website for further project information.

The development and evaluation of peer-facilitated dementia workshops in general practice

Abstract Background: Rising dementia prevalence rates, combined with the policy objectives of integrated care in the community, means that general practitioners (GPs) are playing an increasing and pivotal role in dementia care. However, GPs are challenged by dementia care and have identified it as an area of learning need. We describe the development, roll-out and evaluation of peer-facilitated workshops for GPs, as part of a national programme to support GPs in their delivery of dementia care. Method: Informed by a triangulated educational needs analysis, small-group case-based workshops were designed. Five GPs were trained as facilitators and delivered workshops in GP practices within their own locality. A mixed-methods evaluation was undertaken, incorporating participant completion of post-workshop questionnaires along with the collection and analysis of qualitative data obtained from a focus group with workshop facilitators. Results: 104 GPs attended 39 workshops (median attendance number 3, range 2–9). The majority of participants reported an improvement in their knowledge and confidence in dementia care. In particular, participants felt that workshop content was relevant and they liked peer-facilitation within their own practices. Facilitators emphasised the importance of skilful facilitation of sensitive topics and described the tension between being regarded as a facilitator and a subject expert. Conclusions: The findings of this study indicate that practice-based, peer-facilitated, small-group workshops improve self-reported knowledge and confidence in dementia care and are well-received by GPs. Findings further suggest that similar educational approaches may be effective in supporting GPs in other areas of complex chronic care in general practice.

PPI in the PLEASANT trial: involving children with asthma and their parents in designing an intervention for a randomised controlled trial based within primary care.

Aims We describe how patient and public involvement (PPI) was integrated into the design of an intervention for a randomised controlled trial (RCT) based within primary care. The RCT, known as the PLEASANT trial, aimed to reduce unscheduled medical contacts in children with asthma associated with start of the new school year in September with a simple postal intervention, highlighting the importance of maintaining asthma medication for helping to prevent increased asthma exacerbations. BACKGROUND PPI is a key feature of UK health research policy, and is often a requirement of funding from the National Institute for Health Research. There are few detailed accounts of PPI in the design and conduct of clinical trials in the PPI literature for researchers to learn from. METHODS We held PPI consultation events to determine whether the proposed intervention for the trial was acceptable to children with asthma and their parents, and to ascertain whether enhancements should be made. Two PPI consultation events were held with children with asthma and their parents, prior to the research commencing. Detailed field notes were taken by the research team at each consultation event. Findings At the first consultation event, parents and children endorsed the trials rationale, made suggestions to the wording of the trial intervention letter, and made recommendations about to whom the letter should be sent out. At the second consultation event, parents discussed the timing of the intervention, commented on the lay summary of the Research Ethics Application, and were invited to join the trials steering committee, while the children selected a logo for the study. PPI has resulted in enhancements to the PLEASANT studys intervention. A further PPI consultation event is scheduled for the end of the trial, in order for children with asthma and their parents to contribute to the trials dissemination strategy.

Developing and piloting a resource for training assessors in use of the Mini-CEX (mini clinical evaluation exercise)

The assessment of undergraduate medical students in the clinical setting has become a key priority for medical educators. Facilitating the successful translation of undergraduate theoretical knowledge into safe and appropriate postgraduate clinical practice represents a challenge in medical education [1]. Poor clinical performance of newly qualified doctors has been highlighted as a major issue relating to patient safety [2]. Performance based assessment in the undergraduate setting may assist in addressing this issue by assessing ‘doing’ rather than ‘knowing’. The mini clinical evaluation exercise (Mini-CEX) is a formative assessment used to assess the performance of medical students in a clinical context. It incorporates assessment by, and feedback from, an assessor, based on the direct observation of a student–patient consultation [3]. Conducted in a series of stages, the Mini-CEX allows focused assessment of key competencies (see Box 1) [3]. While widely employed in both undergraduate and postgraduate settings as an assessment tool the MiniCEX has been criticised for lacking standardisation [4,5]. Ideally, the Mini-CEX assessment should be conducted on a number of occasions and assessors should receive formal training in the technique [6]. The Mini-CEX is used currently to assess third and final year undergraduate medical students in University College Cork (UCC). However, in previous work, we identified that local assessors lacked both formal training and confidence in use of the Mini-CEX [7]. Additionally, an audio-visual recording of a Mini-CEX encounter was identified by the assessors as a potentially useful resource for supporting training in use of the Mini-CEX [7]. Our aim was to develop and evaluate a training workshop for Mini-CEX assessors using an audio-visual recording of a Mini-CEX encounter with the aim of improving confidence in use of the Mini-CEX and standardising student assessment.

187Participants’ Perspectives and Preferences on Clinical Trial Result Dissemination: The TRUST Thyroid Trial Experience

Introduction: Dissemination of results of randomised controlled trials is traditionally limited to academic and professional groups rather than clinical trial participants. While there is increasing consensus that results should be communicated to trial participants, there is a lack of evidence on the most appropriate methods of dissemination. This study within a trial (SWAT) aims to address this gap by using a public and patient involvement (PPI) approach to identify, develop and evaluate a patient-preferred method of receiving trial results of the Thyroid Hormone Replacement for Subclinical Hypothyroidism Trial (TRUST). Methods: An experimental (intervention) study will be conducted using mixed methods to inform the development of and evaluation of a patient-preferred method of communication of trial results. The study will involve three consecutive phases. In the first phase, focus groups of trial participants will be conducted to identify a patient-preferred method of receiving trial results. The method will be developed and then assessed and refined by a patient and public expert group. In the second phase participants will be randomly assigned to the intervention (patient-preferred method) and comparison groups (standard dissemination method as developed by the lead study site in Glasgow, Scotland). In the third phase, a quantitative questionnaire will be used to measure and compare patient understanding of trial results between the two groups. Discussion: This protocol provides a template for other trialists who wish to enhance patient and public involvement and additionally, will provide empirical evidence on how trialists should best disseminate study results to their participants.

A study of the impact of VNS on health care utilisation in England.

PURPOSE To compare hospital service use before and after VNS therapy implantation in a sample of drug-resistant people with epilepsy. METHOD The before and after study was performed using anonymised Hospital Episode Statistics (HES) data from one year before to 3 years after implantation in 321 patients from data collected between April 2009 to July 2011. Episodes relating to out-patient clinic, Accident and Emergency (A&E) department attendance, hospital admissions and length of stay were collected and compared. Descriptive statistics are used to summarise patient demographics, patient pathways and resource usage before and after VNS implantation. Means and proportions were reported on continuous variables, proportion and frequency on categorical variables. Trends of activity over time were determined using before and after VNS comparisons and tested with the Wilcoxon Signed-rank (WSR) test. RESULTS The summary statistics indicate a drop in resource use in terms of in-patient bed-days (21% decrease), elective in-patient episodes (7% decrease) and non-elective in-patient episodes (14% decrease). There was an increase in the quarterly average out-patient appointments by 12%. The A&E attendance outcome recorded a mean increase in quarterly attendances of 9% but a slight decrease when subject to a signed rank test. These contradictory results should therefore be treated with caution. CONCLUSION VNS Therapy may be associated with an overall reduction in health service resource use.