Seizures and Driving: A Systematic Review of the Evidence Dr Carol Hawley Warwick Medical School and Professor Jane Hutton Department of Statistics Clerical Assistance: Lynda Mason Warwick Medical School. Contact: c.a.hawley@warwick.ac.uk Background Seizures affect up to 10% of the population at some point during their lifetime. Cumulative incidence of epilepsy worldwide is at least 4% (Hauser, 1996) Driving Licensing authorities throughout the world apply restrictions on those who have seizures, but the seizure-free period required before a driving licence is restored varies between countries. Restrictions are based on judgements of the risk of further seizures which could affect road safety. The European Working Group (1996) states that rules must be liberal, simple, clear and based on calculated risk. The European Directive sets out standards for driving and epilepsy. EU member states can be more restrictive but not more liberal. In the UK an unprovoked seizure triggers a 12 month driving ban (up until 1994 it was a 2 year ban). Study Aims To conduct a systematic review of the existing literature (academic papers and 'grey' literature and research in progress) relating to the probability of further seizures occurring at various time intervals after an initial seizure or seizure provoking incident such as head injury, neurosurgery, tumour or stroke. UK Medical Standards Group 1 drivers: after a ‘first epileptic seizure or solitary fit’, Cease driving for one year and then be submitted for medical review before restarting driving. The licence may then be restored until age 70 provided that there is no further attack and the driver is otherwise medically well. Seizure Legislation Around the World Seizure free period before return of driver's licence INDIA (proposed) PORTUGAL CROATIA SWEDEN AUSTRALIA JAPAN USA SWITZERLAND BELGIUM GERMANY UK USA: WISCONSIN 0 6 12 18 24 30 Unprovoked Seizures The Way Forward? The overall risk of recurrence of seizures by one year after a first unprovoked seizure ranged from 16% to 67% depending on the duration of follow-up, method of case ascertainment, definition of seizure, and population studied. No reliable estimates of risk can be given by type of seizure. Different rules for different seizures. Proposed by 2nd European Working Group on Epilepsy and Driving; (2005). 36 Systematic review of the literature from 1966 to present, including foreign language articles. Seizures of all causes and all risk factors were included and co-morbidities (including alcohol related health issues) were considered. Anonymised abstracts screened by 4 independent researchers. Data were extracted relating to the probabilities of recurrent seizures over varying time periods. Data synthesised and risk estimates calculated. Broad eligibility criteria were applied at the abstract screening stage: 1. Studies of seizures in previously seizure free individuals 2. Studies of predominantly adults 3. Studies which reported numerical data 4. Studies which appeared to assess risk of subsequent seizures after an initial seizure Post-traumatic seizure: An initial or recurrent seizure episode not attributable to another obvious cause after penetrating or nonpenetrating TBI. Late post-traumatic seizure: Occurring after the first week of injury. Epilepsy: A condition characterised by recurrent seizures. TBI accounts for 5% of all cases of epilepsy (Hauser et al, 1991). 21 studies of TBI met inclusion criteria for the review, only 13 provided data in a form suitable for meta-analysis. Risk of seizures per person per year declines with increasing time without seizures after injury. Mild TBI is associated with a low risk of seizures. Conservative estimate: 8% of people with severe TBI will have a seizure in the first year after their injury (Hawley & Hutton, 2010). Evidence suggests that drivers with a history of epilepsy are no more likely to have an accident whilst driving than drivers without a history of epilepsy (Chadwick, 1996). But the at-risk group of non-reporters are young drivers who are 10 times more likely to be involved in a serious collision than more experienced drivers. (RoSPA). Most accidents occur to 17 – 24 year olds, mostly males (DfT Road Casualties GB 2007). (Jennett, 1995) Conclusions 35 35 30 25 25 17 yes no 15 10 5 3 4 5 0 Early seizures Depressed Skull Fracture Intercranial haematoma Risk of Accidents and Seizures Compliance with Seizure Laws Drivers don’t always report their seizures to physicians or to the licensing authorities. Non-reporters more likely to be young, male, inexperienced drivers with increased accident risk than those who DO report (e.g. Taylor et al, 1995). Norfolk study (Dalrymple and Appleby, 2000): 1/6th of patients had not reported recent seizures to their GP. 40% of patients who anonymously reported seizures to researchers also held a current driving licence, but only 1/4 had told their GP. Berg et al (2000): 1/3 epilepsy patients drove regularly despite frequent seizures. Compliance can only be increased if we can give an explanation of the risk-increase in terms that are understandable and convincing for the patient.’ (2nd European Working Group on Epilepsy and Driving; 2005). The QUOROM statement flow diagram Quality of Evidence The standard of reporting was poor in many of the studies reviewed. The majority of studies had research objectives which differed from the research question being addressed in this systematic review. Few studies specifically addressed seizure recurrence in a systematic manner. Of the 343 full-text papers reviewed, seizure recurrence was the main focus of the research for only 39 papers. Different follow-up periods, patient groups. Patients have a legal duty to notify DVLA about any condition that may affect his or her ability to drive. Doctors (and other health professionals (HP)) should advise their patients that they should notify DVLA and must cease driving. (General Medical Council). If patient refuses, then doctor (or HP) may disclose medical information to DVLA in confidence and write to patient informing them of this. www.dvla.gov.uk EU Working Group: Physician should not be obliged to report patient to authorities as it: •increases non-compliance with regulations •increases nonreporting of seizures to the physician •interferes with medical treatment. Risk factors for late seizures post-TBI 20 Results Notification to Licensing Authorities Are people with epilepsy high risk drivers? % Group 2 drivers: After a first unprovoked seizure, Group 2 drivers must demonstrate 10 years freedom from further seizures, without the aid of anticonvulsant medication in that time. Epilepsy: Grp.1:12 month seizure free period. Grp.2:10 years seizure free without AED Risk of Seizures after TBI months Methods First unprovoked seizure: Grp.1: 6 month seizure free period & appropriate medical assessment. Grp.2: 5 years seizure free without aid of AED 700 / million population have a 1st seizure (Jallon, 2001). In 1st year after 1st Seizure: 55% of people not taking anti-epileptic drugs (AEDs) will have a second seizure (Elwes et al, 1985; FIRST, 1993). 33% of people taking AEDs will have a second seizure (FIRST, 1993). Car drivers spend an average of 1 hr/day driving (4% of lifetime). Seizures can occur at any time in 24 hrs therefore for car drivers there is a 1 in 24 chance that a seizure will occur whilst driving. Professional drivers spend up to 8 hrs/day driving (20% of lifetime). Therefore they have a 1 in 3 chance of a seizure whilst driving. About 50 - 60% of seizures behind the wheel result in an accident (Sonnen, 1993). Extrapolating from the 700/million population who have an initial seizure: half (350 people) will have a second seizure and 15 of these will be driving when they have that seizure. For 60% that seizure will cause an accident. Therefore: 8.8 people / million population will suffer a seizure which will cause an accident in the first year after their first seizure. Despite this low risk most countries impose a minimum of a 12 month driving ban after an initial seizure. The wide variation in the seizure free interval after a first seizure before driving can resume, applied by licensing agencies throughout the world, reflects the limited scientific data available on driving with seizures or epilepsy. This variation may also relate to the politics of road safety or to historic decisions that are difficult to change without clear evidence. This review found no new evidence for revision of the DfT current estimates of seizure risk. New studies are needed to obtain better information on risks of seizures in those with predisposing factors. Such studies must have very clearly specified questions and intensive follow-up of patients. Latest Research A large MRC funded Multi-centre trial for early Epilepsy and Single Seizures (MESS) was published in 2005 (Marson et al. 2005, Lancet). More seizures patients had prior to randomisation = higher the risk of recurrent seizures. MESS data is being used to generate estimates of risk of seizure recurrence for individual patients and should provide good estimates of the probability of future seizures after an initial seizure. (Hutton, Johnson & Marson). References •Chadwick D. (1996) Risk of accidents in drivers with epilepsy. Journal of Neurology, Neurosurgery and Psychiatry, 60(6): 621-627. •Department for Transport (2008) Road Casualties Great Britain: 2007. London. •Darymple, J and Appleby J. (2000) Cross sectional study of reporting of epileptic seizures to general practitioners. British Medical Journal, 320: 94-97. •Elwes RDC et al (1985) Prognosis after a first untreated tonic-clonic seizure. Lancet 326 (8458):752-753. •First Seizure Trial Group (FIRST Group) (1993) Randomized clinical trial on the efficacy of antiepileptic drugs in reducing the risk of relapse after a first unprovoked tonic clonic seizure. Neurology 43:478–483. •General Medical Council. A-Z of Ethical Guidance. 2010. •Hauser, WA, Annegers, JF, Kurland, LT. (1991) Prevalence of epilepsy in Rochester, Minnesota: 1940-1980. Epilepsia, 32: 429-445. •Hauser, WA, Annegers, JF, Rocca, WA. (1996) Descriptive epidemiology of epilepsy: contributions of population-based studies from Rochester, Minnesota. Mayo Clinic Proceedings, 71: 578-586. •Hawley C and Hutton J. Road Safety Web Publication No.5: Systematic review of the probability of future seizures after an initial seizure or other event creating an increased future risk. January 2010. Department for Transport, London. •Jallon, P et al (2001) Newly Diagnosed Unprovoked Epileptic Seizures: Presentation at Diagnosis in CAROLE Study Epilepsia, 42(4):464-475. •Jennett, B. (1995) Epilepsy and neurosurgical disorders. In Epilepsy: Hopkins, A., Ed. 2nd Edn. London: Chapman and Hall. •Marson A, Jacoby A, Johnson A, Kim L, Gamble C, Chadwick D, on behalf of the Medical Research Council MESS Study Group (2005) Immediate versus deferred antiepileptic drug treatment for early epilepsy and single seizures: a randomised controlled trial. Lancet, 365: 200713. •Second European Working Group on Epilepsy and Driving. Epilepsy and Driving in Europe. 2005. •Sonnen, AEH (1993) The risk of epilepsy in daily life. In: C. M. Cornaggia CM, et al. Eds, Epilepsy and Risks: A First-step Evaluation, Ghedini Editore, Milano.101–112. •Taylor, J. (1995) The older driver. In Taylor JF (ed.) Medical Aspects of Fitness to Drive. A Guide for Medical Practitioners. London: The Medical Commission on Accident Prevention 1995.