BACKGROUND:Animal data suggest teratogenic effects with zonisamide use and risk of pregnancy losses. Human data following zonisamide exposure are presently limited, but suggest low risk of malformation with elevated risk of low birth weight.OBJECTIVE:To calculate the major congenital malformation (MCM) rate of zonisamide in human pregnancy and assess for a signal of any specific malformation pattern and associations with birth weight.METHODS AND MATERIALS:Data were obtained from the UK and Ireland Epilepsy and Pregnancy register (UKIEPR) which is an observational, registration, and follow up study from December 1996 to July 2020. Eligibility criteria were use of zonisamide and to have been referred to the UKIEPR before the outcome of the pregnancy was known. Primary outcome was evidence of MCM.RESULTS:From December 1996 through July 2020 there were 112 cases of first trimester exposure to zonisamide, including 26 monotherapy cases. There were 3 MCM for monotherapy cases (MCM rate 13.0% (95% confidence interval 4.5-32.1)), and 5 MCM for polytherapy cases (MCM rate 6.9% (95% confidence interval 3.0-15.2)). While the median birth weight was on 71st and 44th centile for monotherapy and polytherapy cases respectively, there was a high rate of infants born small for gestational age (21% for both).CONCLUSION:These data raise concerns about a signal for potential teratogenicity with zonisamide in human pregnancy. Given the low numbers reported, further data will be required to adequately counsel women who use zonisamide in pregnancy.

ObjectivesAfter 20 years of data collection, pregnancy registers have informed prescribing practice. Various populations show trends for a reduction in valproate prescribing, which is associated with an increased risk of anatomical teratogenesis and neurodevelopmental effects in those exposed in utero. Our aim was to determine if any shifts in prescribing trends have occurred in the UK and Ireland Epilepsy and Pregnancy Register cohort and to assess if there had been any change in the overall major congenital malformation (MCM) rate over time.MethodsThe UK and Ireland Epilepsy and Pregnancy Register, a prospective, observational, registration and follow-up study established in 1996, was used to determine the changes in antiepileptic drugs (AEDs) utilised during pregnancy and the MCM rate between 1996 and 2016. Linear regression analysis was used to assess changes in AED utilisation, and Poisson regression was used for the analysis of trends in the MCM rates.ResultsOutcome data for 9247 pregnancies showed a stable percentage of monotherapy to polytherapy prescribing habits over time. After Bonferroni correction, statistically significant (p<0.003) changes were found in monotherapy prescribing with increases in lamotrigine and levetiracetam and decreases in valproate and carbamazepine use. Between 1996 and 2016, the total MCM rate showed a 2.1% reduction per year (incidence risk ratio 0.979 (95% CIs 0.956 to 1.002) but Poisson regression analysis showed that this was not statistically significant p=0.08).ConclusionSignificant changes are seen in the prescribing habits in this cohort over 20 years, but a statistically significant change in the MCM rate was not detected. This work should be replicated on a larger scale to determine if significant changes are occurring in the MCM rate, which would allow a robust economic estimate of the benefits of improvements in prescribing practice and the personal effect of such changes.

BACKGROUND:Asthma is seasonal with peaks in exacerbation rates in school-age children associated with the return to school following the summer vacation. A drop in prescription collection in August is associated with an increase in the number of unscheduled contacts after the school return. OBJECTIVE:To assess whether a public health intervention delivered in general practice reduced unscheduled medical contacts in children with asthma. DESIGN:Cluster randomised trial with trial-based economic evaluation. Randomisation was at general practice level, stratified by size of practice. The intervention group received a letter from their general practitioner (GP) in late July outlining the importance of (re)taking asthma medication before the return to school. The control group was usual care. SETTING:General practices in England and Wales. PARTICIPANTS:12 179 school-age children in 142 general practices (70 randomised to intervention). MAIN OUTCOME:Proportion of children aged 5-16 years who had an unscheduled contact in September. Secondary endpoints included collection of prescriptions in August and medical contacts over 12 months (September-August). Economic endpoints were quality-adjusted life-years gained and health service costs. RESULTS:There was no evidence of effect (OR 1.09; 95% CI 0.96 to 1.25 against treatment) on unscheduled contacts in September. The intervention increased the proportion of children collecting a prescription in August by 4% (OR 1.43; 95% CI 1.24 to 1.64). The intervention also reduced the total number of medical contacts between September-August by 5% (incidence ratio 0.95; 95% CI 0.91 to 0.99).The mean reduction in medical contacts informed the health economics analyses. The intervention was estimated to save £36.07 per patient, with a high probability (96.3%) of being cost-saving. CONCLUSIONS:The intervention succeeded in increasing children collecting prescriptions. It did not reduce unscheduled care in September (the primary outcome), but in the year following the intervention, it reduced the total number of medical contacts. TRIAL REGISTRATION NUMBER:ISRCTN03000938; Results.

Medication errors are a major source of preventable morbidity, mortality and cost and many occur at the times of hospital admission and discharge. Novel interventions (such as new methods of recording medication information and conducting medication reconciliation) are required to facilitate accurate transfer of medication information. With existing evidence supporting the use of information technology and the patient representing the one constant in the care process, an electronic patient held medication record may provide a solution. This study will assess the feasibility of introducing a patient held electronic medication record in primary and secondary care using the Consolidated Framework for Implementation Research (CFIR).This feasibility study is a mixed method study of community dwelling older adult patients admitted to an urban secondary care facility comprising a non-randomised intervention and qualitative interviews with key stakeholders. Outcomes of interest include clinical outcomes and process evaluation.This study will yield insights pertaining to feasibility, acceptability and participation for a more definitive evaluation of the intervention. The study also has the potential to contribute to knowledge of implementation of technology in a healthcare context and to the broader area of implementation science.

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.

Introduction: Social media developments have completely changed how information is accessed and communicated. While great potential exists with these platforms, recent reports of online unprofessional behavior by doctors has threatened the medical professional identity; a matter of critical importance for clinicians and medical educators. This paper outlines a role for social media in facilitating support for clinicians and medical teachers; it will raise awareness of pitfalls and explain ethical and legal guidelines.Methods: An analysis of inappropriate behaviors and conflicting attitudes regarding what is acceptable in online posts, including the inter-generational contrast in online presence and perceptions of where the boundaries lie.Results and discussion: Guidance documents are analyzed and potentially confusing and conflicting statements are identified and clarified. The authors believe that clinicians and medical students must follow ethical imperatives in both personal and professional spheres.Conclusions: It is essential that medical educational and professional bodies encourage clinicians to support one another and share information online while providing clear legal and ethical advice on maintaining standards and avoiding common pitfalls. Education on the responsible use of social media and associated risk awareness should be a priority for medical school curricula.

Electronic healthcare data have several advantages over prospective observational studies, but the sensitivity of data on neurodevelopmental outcomes and its comparability with data generated through other methodologies is unknown.

Background: While there is an increasing consensus that clinical trial results should be shared with trial participants, there is a lack of evidence on the most appropriate methods. The aim of this study is to use a patient and public involvement (PPI) approach to identify, develop and evaluate a patient-preferred method of receiving results of the Thyroid Hormone Replacement for Subclinical Hypo-Thyroidism Trial (TRUST). Methods: This is a mixed methods study with three consecutive phases. Phase 1 iteratively developed a patient-preferred result method using semi-structured focus groups and a consensus-orientated-decision model, a PPI group to refine the method and adult literacy review for plain English assessment. Phase 2 was a single-blind parallel group trial. Irish TRUST participants were randomised to the intervention (patient-preferred method) and control group (standard method developed by lead study site). Phase 3 used a patient understanding questionnaire to compare patient understanding of results between the two methods. Results: Patients want to receive results of clinical trials, with qualitative findings indicating three key themes including ‘acknowledgement of individual contribution’, ‘contributing for a collective benefit’ and ‘receiving accessible and easy to understand results’. Building on these findings, a patient-preferred method of receiving results was developed as described above. TRUST participants (n=101) were randomised to the intervention. The questionnaire response rate was 74% for the intervention group and 62% for the control group. There were no differences in patient understanding between the two methods. Conclusions: We have demonstrated that it is feasible to conduct PPI with regard to the dissemination of results. The study identified and developed a patient-preferred method of receiving clinical trial results for older adults over 65 years. Although, in this study PPI did not influence patients’ final understanding of results, it provides a record of the process of conducting PPI within the clinical trial setting.

Aim: The atherogenic dyslipidemia index (triglycerides [TG] / high density lipoprotein cholesterol [HDL-C]), has been confirmed as a strong predictor of coronary heart disease (CHD) risk. However it has not been examined in primary care populations. Therefore we aimed to explore correlations between TG/HDL-C - and CHD and type 2 diabetes mellitus (T2DM) in primary care patients.

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.

INTRODUCTION In the recent years, alterations in the carbohydrate metabolism, including insulin resistance, are considered as risk factors in the development of hypertension and its complications in young age. Hypertension is associated with significant cardiovascular morbidity and mortality. The onset of pathology responsible for the development of hypertension, as well as levels of biomarkers specific for early stages of atherosclerosis are poorly understood. AIM To compare a group of children whose parents have a history of hypertension (study group) with a group of children with normotensive parents (reference group), with consideration of typical risk factors for atherosclerosis, parameters of lipid and carbohydrate metabolism, anthropometric data and new biomarkers of early cardiovascular disease (hsCRP, adiponectin, sICAM-1). MATERIAL AND METHODS The study population consists of 84 children. Of these, 40 children (mean age 13.6±2.7 years) had a parental history of hypertension, and 44 aged 13.1±3.7 yrs were children of normotensive parents. Anthropometric measurements were taken, and measurements of blood pressure, lipid profile, glucose and insulin levels were carried out. The insulin resistance index (HOMA IR) was calculated. Levels of hsCRP, soluble cell adhesion molecules (sICAM) and adiponectin were measured. RESULTS There were no statistically significant differences in anthropometric parameters (body mass, SDS BMI, skin folds) between groups. Values of systolic blood pressure were statistically significantly higher in the study group (Me 108 vs. 100 mmHg, p= 0.031), as were glycaemia (Me 80 vs. 67 mg/dl p<0.001) and insulinaemia levels (Me 8.89 vs. 5.34 µIU/ml, p=0.024). Higher, statistically significant values of HOMA IR were found in the study group (children of hypertensive parents) (Me 1.68 vs. 0.80 mmol/l × mU/l, p=0.007). Lower adiponectin levels (Me 13959.45 vs. 16822 ng/ml, p=0.020) were found in children with a family history of hypertension. No significant differences were found in the levels of sICAM, hsCRP, and parameters of lipid metabolism. CONCLUSIONS Family history of hypertension is correlated with higher values of systolic blood pressure and higher values of parameters for carbohydrate metabolism in children. Hypertension in parents is a risk factor for cardiovascular disease in their children.

BACKGROUND:Rising 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.METHODS:A 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.RESULTS:Thirty-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.CONCLUSIONS:The 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.

Introduction: Hospitals have increasing numbers of emergency department attendances each year. We need to treat these patients more quickly and avoid emergency over-crowding thus allowing patients to flow freely through the acute hospital. Hospitals require timely and efficient discharge processes to achieve adequate patient flow. In a previous quality improvement project to reduce readmissions, we had highlighted the importance of supporting patients with complex discharge needs at the time of discharge. Achieving safe, timely and person-centred discharge from hospital to home is an important indicator of quality and a measure of effective integrated care. At a time when building new acute beds is not feasible innovative new ideas are required to attain this goal.Practice change: We planned and commissioned a new off-site 18-bedded transitional care unit (TCU). The nursing and therapy team of the TCU are part of our acute hospital nursing service. The medical model is a unique hybrid with a local general practice providing day-to-day medical input supported by the consultant geriatricians from the acute hospital. Active daily discharge planning and creating links with community is a primary goal of the TCU. There is a weekly multidisciplinary meeting including the GPs and geriatricians with the unit team. Aim: Our TCU was developed to support the smooth flow of patients with complex discharge needs from the acute hospital back to home in a safe and timely manner. The goal of the TCU is to reduce the patients’ stay in acute care and provide effective discharge planning.Targeted population: The TCU is designed to care for patients who no longer require active acute hospital facilities but are not yet ready to discharge directly home. Patients requiring multidisciplinary assessment, a short reablement programme or social care set-up before discharge are suitable. All patients come directly from our acute hospital. Highlights: The TCU opened in September 2016 after nine-months of planning and refurbishment. The TCU is now admitting about 50 patients per month with an average length of stay of 9.1 days. The identification of appropriate patients for the TCU is sustained by a daily “discharge support meeting” and senior staff assessment in the acute hospital. The TCU has developed increasingly close links with other community discharge support servicesDiscussion & Conclusions: Our TCU has been successfully opened and is achieving its goals. Successful discharge involves far more than a move from hospital to home. Appropriate discharge planning emphasises patient support and communication. Success and sustainability of the TCU is possible with a dynamic nursing and therapy team. Acute hospital identification and assessment of appropriate patients is vital for the TCU. The hybrid model of medical care has been a positive innovation that could be replicated elsewhere. Lessons learned:Social & non-clinical problems are often involved in complex dischargesDischarge planning is not started early enough in acute hospitalsCommunication and information transfer between acute wards and TCU is criticalComplex operational issues emerge is organising and running an off-site unit

BACKGROUND:Insulin is generally administered to people with type 1 diabetes mellitus (T1DM) using multiple daily injections (MDIs), but can also be delivered using infusion pumps. In the UK, pumps are recommended for patients with the greatest need and adult use is less than in comparable countries. Previous trials have been small, of short duration and have failed to control for training in insulin adjustment. OBJECTIVE:To assess the clinical effectiveness and cost-effectiveness of pump therapy compared with MDI for adults with T1DM, with both groups receiving equivalent structured training in flexible insulin therapy. DESIGN:Pragmatic, multicentre, open-label, parallel-group cluster randomised controlled trial, including economic and psychosocial evaluations. After participants were assigned a group training course, courses were randomly allocated in pairs to either pump or MDI. SETTING:Eight secondary care diabetes centres in the UK. PARTICIPANTS:Adults with T1DM for > 12 months, willing to undertake intensive insulin therapy, with no preference for pump or MDI, or a clinical indication for pumps. INTERVENTIONS:Pump or MDI structured training in flexible insulin therapy, followed up for 2 years. MDI participants used insulin analogues. Pump participants used a Medtronic Paradigm® VeoTM (Medtronic, Watford, UK) with insulin aspart (NovoRapid, Novo Nordisk, Gatwick, UK). MAIN OUTCOME MEASURES:Primary outcome - change in glycated haemoglobin (HbA1c) at 2 years in participants whose baseline HbA1c was ≥ 7.5% (58 mmol/mol). Key secondary outcome - proportion of participants with HbA1c ≤ 7.5% at 2 years. Other outcomes at 6, 12 and 24 months - moderate and severe hypoglycaemia; insulin dose; body weight; proteinuria; diabetic ketoacidosis; quality of life (QoL); fear of hypoglycaemia; treatment satisfaction; emotional well-being; qualitative interviews with participants and staff (2 weeks), and participants (6 months); and ICERs in trial and modelled estimates of cost-effectiveness. RESULTS:We randomised 46 courses comprising 317 participants: 267 attended a Dose Adjustment For Normal Eating course (132 pump; 135 MDI); 260 were included in the intention-to-treat analysis, of which 235 (119 pump; 116 MDI) had baseline HbA1c of ≥ 7.5%. HbA1c and severe hypoglycaemia improved in both groups. The drop in HbA1c% at 2 years was 0.85 on pump and 0.42 on MDI. The mean difference (MD) in HbA1c change at 2 years, at which the baseline HbA1c was ≥ 7.5%, was -0.24% [95% confidence interval (CI) -0.53% to 0.05%] in favour of the pump (p = 0.098). The per-protocol analysis showed a MD in change of -0.36% (95% CI -0.64% to -0.07%) favouring pumps (p = 0.015). Pumps were not cost-effective in the base case and all of the sensitivity analyses. The pump group had greater improvement in diabetes-specific QoL diet restrictions, daily hassle plus treatment satisfaction, statistically significant at 12 and 24 months and supported by qualitative interviews. LIMITATION:Blinding of pump therapy was not possible, although an objective primary outcome was used. CONCLUSION:Adding pump therapy to structured training in flexible insulin therapy did not significantly enhance glycaemic control or psychosocial outcomes in adults with T1DM. RESEARCH PRIORITY:To understand why few patients achieve a HbA1c of < 7.5%, particularly as glycaemic control is worse in the UK than in other European countries. TRIAL REGISTRATION:Current Controlled Trials ISRCTN61215213. FUNDING:This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 20. See the NIHR Journals Library website for further project information.

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.