Adam John Noble

Background: Statins are the UK’s most prescribed medicine and are used more in deprived populations. Patient Information Leaflets (PILs) included in medication packaging may support safe, effective use, but only if they are understandable. Guidance states PILs should have a reading age of ≤13 years, and regulators require that ≥80% of patients answer comprehension questions correctly on them when ‘user tested’. Aim: To provide the first independent evaluation of the readability and comprehension of UK statin PILs. Design & setting: Study 1: Cross-sectional analysis of the reading age of 39/40 of the UK’s approved statin PILs. Study 2: Cross-sectional survey with a representative sample of 517 UK adults aged 40–74. Methods: Study 1: Reading age was assessed using four readability formulas, with additional scores calculated after adjusting for potentially familiar technical terms. Study 2: Two PILs (atorvastatin [MSN] and rosuvastatin [Ranbaxy]) were randomly selected and user-tested with participants. They answered eight comprehension questions per PIL; responses were double-scored. Results: Study 1: No PIL met the recommended reading age. Median reading age was 15.9 years (15.0 after adjustment). Atorvastatin PILs were least readable. Study 2: Key messages were poorly understood; for atorvastatin, 5/8 items met the≥80% criterion; for rosuvastatin, 2/8 met it. Key safety and use messages were frequently misunderstood. Conclusion: UK statin PILs do not meet recommended readability or comprehension standards and are likely to be difficult to understand for many users. Improving clarity and usability is essential to support equitable understanding and safe, informed long-term statin use.

Objective: Different causes of transient loss of consciousness (TLOC) carry distinct risks and require different management. Early accurate diagnosis is essential to guide counseling, investigation, and referral. In routine practice, frontline clinicians and specialists often rely on eyewitness accounts, yet the reliability of witness testimony for functional/dissociative seizures (FDSs) is unknown. We, for the first time, evaluated eyewitness recall of a single FDS immediately and after clinically relevant delays of 2 and 7 weeks, reflecting waiting times for specialist assessment in the United Kingdom (UK) and elsewhere. We also examined the relationship between confidence and accuracy, and whether early structured questioning improves later recall. Methods: In this UK‐based experimental study, general population adults (≥18) viewed a video of an FDS and were randomized to four conditions: A (immediate free recall + 2‐week follow‐up), B (immediate free recall + 7‐week follow‐up), C (immediate systematic questioning + 2‐week follow‐up), and D (immediate systematic questioning + 7‐week follow‐up). The primary outcome was accuracy on 15 standardized semiology questions, scored against consensus ratings from five neurologists. Results: Of 300 participants, 286 (95.3%) viewed the video in full; 90% completed follow‐up. Immediately afterward, participants answered only 67.0% of questions correctly. Accuracy declined to 58.8% at 2 weeks and was a further 5.4% lower at 7 weeks (95% confidence interval [CI] = 2.07–8.73). Features sometimes considered diagnostically informative—asynchronous limb movements, head movements, ictal eye closure—were prone to decay. Confidence was weakly associated with accuracy. Immediate systematic questioning did not improve follow‐up recall compared with free recall (−2.9, 95% CI = −6.3 to .5). Significance: Eyewitness recall of FDSs is modest and declines over clinically relevant intervals, and confidence poorly reflects accuracy. Early structured questioning did not improve retention. These findings highlight a key constraint on diagnostic accuracy in TLOC. Strategies to support differentiation in routine care are needed.

Objective: A key diagnostic challenge at “first seizure” clinic appointments is determining whether the reported event was epileptic. Witness accounts are often critical, yet such appointments typically occur weeks after the event. Guidelines recommend review within 2 weeks. Wait times are however often longer, with a median of 7 weeks in countries such as the UK. The accuracy of witness recall at these clinically relevant intervals and whether their confidence predicts accuracy have never been determined. This study addressed these fundamental questions. It also piloted a potential intervention: whether asking witnesses a set of systematic questions immediately after viewing a suspected seizure improves recall at follow‐up, compared to the usual free recall approach used by first responders. Methods: In this UK‐based experimental study, adults (≥18 years old) viewed a video of an epileptic seizure and were randomized into four conditions: A (immediate free recall + 2‐week follow‐up), B (immediate free recall + 7‐week follow‐up), C (immediate systematic questions + 2‐week follow‐up), and D (immediate systematic questions + 7‐week follow‐up). The primary outcome was accuracy on 15 standardized questions addressing key semiological features, scored against consensus ratings from five neurologists. Results: Of a representative sample of 304 participants, 295 (97%) fully viewed the video, and 94.7% completed follow‐up. At 2 weeks, participants answered 54.4% of questions correctly—only 3.9% (95% confidence interval [CI] = .52–7.3) more than those at 7 weeks. Confidence was poorly correlated with accuracy. Immediate systematic questioning improved later recall by 6.7% (95% CI = 3.3–10.0). A definitive trial of this intervention would require 926 participants. Significance: This is the first evidence on the accuracy of witness recall at clinically relevant intervals. Recall is modest even within recommended timeframes and declines only slightly by 7 weeks. Witness confidence does not predict accuracy. Immediate structured questioning may enhance later recall and thus support seizure diagnoses.

At present, the outcomes measured and reported in clinical trials for adults with epilepsy are heterogenous and have often not been selected in consultation with people living with epilepsy. As part of a wider project developing a core outcome set for clinical trials for adults with epilepsy (the EPSET Project), a rapid review of the published qualitative literature was performed. MEDLINE was searched using an established qualitative methodological search filter to identify studies discussing the views of adults with epilepsy and their representatives. Eligible articles included published free‐text verbatim quotations from adults with epilepsy or their representatives discussing potential health outcomes. Data were coded and categorized in line with an established health outcome taxonomy. A total of 614 eligible articles were identified, of which 74 were included as they met the inclusion criteria. In total, the views of more than 2474 adults with epilepsy and 658 caregivers were included from six continents. Of the included studies, 77% used in‐depth interviews and 12% used focus groups. A total of 140 individual health outcomes were identified in the included studies across nine outcome domains: seizure‐related, cognitive–behavioral–neuropsychological, physical functioning–disability, emotional functioning, social role functioning, global quality of life, side effects and adverse events, fertility–pregnancy–offspring, and death. This is the first review of qualitative studies focusing on health outcomes for adults with epilepsy. The findings confirm that living with epilepsy represents more than living with seizures and highlight the impact of neuropsychiatric symptoms in these populations. Importantly, many outcomes identified from this review are not measured and reported in studies assessing the effectiveness and safety of treatments for epilepsy, supporting the development of a lived experience‐informed core outcome set for future effectiveness studies. Furthermore, the findings could be used to inform clinical practice and noninterventional studies across broad geographic, societal, and cultural settings.

Objectives With a projected rise in care home residency and the disproportionate impact of epilepsy and seizures on older adults, understanding seizure-related needs in this population is crucial. Data silos and inconsistent recording of residence status make this challenging. We thus leveraged ambulance data to investigate seizure call-out incidence, characteristics, management and costs in care homes compared with the wider community. Design Retrospective analysis of dispatch data from a regional English ambulance service over four 9-month periods between 2014/2015 and 2021/2022. Suspected seizures in adults (≥16 years) were identified, with data on location, patient age, severity and management extracted. Incidence rates, trends over time and case characteristics were compared. Costs of ambulance response were estimated, and factors influencing emergency department (ED) conveyance were analysed using logistic regression. Setting North West Ambulance Service National Health Service Trust, serving an adult population of ~5.5 million. Participants Dispatch data for 98 752 suspected seizure cases. Results Care homes, accommodating ~0.8% of the regional population, accounted for 7.2% of seizure call-outs. Incidence was higher in care homes than the wider community (55.71 vs 5.97 per 1000 person/year in 2021/2022) and increased over time. Care home cases peaked around 8:00–9:00. Despite similar or lower severity, they had a higher ED conveyance rate (78.3% vs 70.6%). Conveyance likelihood was influenced by factors beyond severity: reduced in homes specialising in learning disabilities (adjusted OR=0.649) and increased in homes with nursing provision (adjusted OR=1.226). Care homes accounted for 7.26% of the £24 million cost. Conclusions This study highlights the growing seizure-related needs in care homes. Despite similar severity, most cases result in ED conveyance. Future research should examine the appropriateness and implications of these transfers, ensuring specialist services support the care home population effectively.

Background: Calls have been made for paramedics to have some form of care pathway that they could use to safely divert adults with epilepsy away from emergency departments and instigate ambulatory care improvements. Different configurations are possible. To know which to prioritise for implementation/evaluation, there is a need to determine which are acceptable to service users and likely National Health Service-feasible. Objective(s): (1) Identify configurations being considered, (2) understand service users’ views of them and current provision, (3) identify what sort of care service users want and (4) determine which configuration(s) is considered to achieve optimal balance in meeting users’ preference and being National Health Service-feasible. Design: Service providers were surveyed to address objective 1. Interviews with service users addressed objective 2. Objective 3 was addressed by completing discrete choice experiments. These determined users’ care preferences for different seizure scenarios. Objective 4 was addressed by completing ‘knowledge exchange’ workshops. At these, stakeholders considered the findings on users’ stated preferences and judged different pathway configurations against Michie’s ‘acceptability, practicability, effectiveness, affordability, side-effects and equity’ feasibility criteria. Setting: This project took place in England. The survey recruited representatives from neurology and neuroscience centres and from urgent and emergency care providers. For the interviews, recruitment occurred via third-sector support groups. Recruitment for discrete choice experiments occurred via the North West Ambulance Service NHS Trust and public advert. Workshop participants were recruited from neurology and neuroscience centres, urgent and emergency care providers, support groups and commissioning networks. Participants: Seventy-two services completed the survey. Interviews were conducted with 25 adults with epilepsy (and 5 relatives) who had emergency service contact in the prior 12 months. Discrete choice experiments were completed by 427 adults with epilepsy (and 167 relatives) who had ambulance service contact in the prior 12 months. Workshops were completed with 27 stakeholders. Results: The survey identified a range of pathway configurations. They differed in where they would take the patient and their potential to instigate ambulatory care improvements. Users had been rarely consulted in designing them. The discrete choice experiments found that users want a configuration of care markedly different to that offered. Across the seizure scenarios, users wanted their paramedic to have access to their medical records; for an epilepsy specialist (e.g. an epilepsy nurse, neurologist) to be available to advise; for their general practitioner to receive a report; for the incident to generate an appointment with an epilepsy specialist; for the care episode to last < 6 hours; and there was a pattern of preference to avoid conveyance to emergency departments and stay where they were. Stakeholders judged this configuration to be National Health Service-feasible within 5–10 years, with some elements being immediately deployable. Limitations: The discrete choice experiment sample was broadly representative, but those reporting recent contact with an epilepsy specialist were over-represented. Conclusions: Users state they want a configuration of care that is markedly different to current provision. The configuration they prefer was, with support and investment, judged to likely be National Health Service-feasible. The preferred configuration should now be developed and evaluated to determine its actual deliverability and efficacy. Study registration: The study is registered as researchregistry4723. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme (NIHR award ref: 17/05/62) and is published in full in Health and Social Care Delivery Research; Vol. 12, No. 24. See the NIHR Funding and Awards website for further award information.