SUDEP – are we as safe as we can be?
[Part 3: Challenges; Shankar R]
Epilepsy is ranked as the fifth highest cause of years of life lost in the UK (Wheller et al., 2007) and UK clinical guidelines (NICE, 2012) strongly advocate discussion of SUDEP with people who are newly diagnosed with the condition. Unfortunately, evidence shows that the guideline has rarely been followed (Morton et al., 2006) and until recently only 4% of people with epilepsy (Waddell et al., 2013) had a discussion of SUDEP recorded in their medical record. It seems that the decision to discuss SUDEP and to assess SUDEP risk is often arbitrary. The risk of death associated with epilepsy appears to be discussed infrequently with patients or their families and there is also little documented evidence of contact with bereaved relatives after death. Failure to discuss risks can contribute to the distress that the family experience following a case of SUDEP.
One argument that physicians use to justify failure to discuss SUDEP with patients and families is the lack of evidence for any protective interventions. However, there is growing evidence of clearly identifiable risk factors for SUDEP, although large-scale trials of interventions are still lacking. There has been no structured, evidenced mechanism to estimate the person-centered risk of SUDEP and no method or template available to facilitate this discussion with the person who has epilepsy and their family. However, an evidence-based checklist identifying the major risk factors could help both clinicians and patients to focus on minimizing certain risk factors. It could promote safety by highlighting the modifiable factors and guiding treatment. It could also be a tool to open a person-centered discussion with patients that outlines how individual behaviors might impact on risk (for example, lack of compliance, alcohol misuse etc.) (Brown et al., 2013).
Research and advocacy on this issue has been led in Cornwall UK by a partnership between local researchers and clinicians of Cornwall Partnership NHS Foundation Trust (CFT) and the Royal Cornwall Hospital Trust (RCHT), the Cornwall coroner and SUDEP Action. The funding was raised by Katie’s Fund, which was set up after the sudden unexpected death of a young nurse.
A detailed review of the literature was undertaken to determine the contributory risk factors of SUDEP. A total of 18 factors were identified of which 11 were modifiable and therefore had the potential to influence the risk of SUDEP. A safety checklist for SUDEP (Shankar et al., 2013) that could help communicate and quantify risk was postulated taking into account the epilepsy factors (duration of epilepsy, seizure increase in frequency and intensity), psychological factors (depression and anxiety), social factors (alcohol intake, compliance, lack of nocturnal surveillance), and biological factors (sleep disturbances, recent medication changes, co-morbidity and diagnosis of new medical conditions). These are useful to assess and proactively manage in clinical practice to reduce an individual patient’s risk of SUDEP.
A retrospective study completed in Cornwall with the Coroner, looking at the risk factors of all deaths linked to epilepsy 2003 -2012 (Shankar et al., 2014) helped confirm and improve aspects of the tool to make it more patient-focused. The study underlined risk factors for worsening of epilepsy control and SUDEP. It highlighted the presence of modifiable risk factors identifiable 3-6 months prior to the demise of the individual that, when not corrected, had a potential cumulative effect on the individual’s seizure control and risk. There was correlation of this evidence to SUDEP. Most of those who died of SUDEP had a worsening of seizure intensity or frequency, or both, 3-6 months prior to their untimely demise.
In addition to the coroner’s study the checklist was used as routine practice with 200 epilepsy patients and/or their carers. Ninety eight percent responded positively and 2% were neutral. Feedback was reviewed and assimilated. Patients said that the checklist made them think about issues to address and modify, especially lifestyle choices. Patients who were previously aware of SUDEP, or where risk factors were well controlled, said it was reassuring to have the discussion. Interestingly, this challenges the popular preconception that it would upset patients to discuss SUDEP. It appears that a structured approach pays dividends in focusing individuals on items within their locus of control.
The checklist consists of an Excel spreadsheet listing the factors of interest with drop down boxes for the responses to each factor. An initial risk assessment is conducted with the patient during their first consultation to provide an individual baseline SUDEP risk rating for the patient. The checklist can be repeated at the annual review, when the patient with unstable epilepsy or identified high risk returns for follow up, or when there is a change of treatment. Epilepsy clinicians have found the tool simple and quick to use (5-10 minutes in clinic). The assessment can be filed in the patient’s medical notes.
To refine the checklist, a group of epilepsy experts has reviewed the content and presentation of the tool which is now known as the ‘SUDEP and Seizure Safety Check List’. It can be accessed in the UK, after registration, from SUDEP Action. Having a single registration point to access the checklist gives assurance to the public and health professionals that the checklist is governed by the framework of good practice and that it is linked to regular reviews by an expert panel. The website also facilitates feedback from health professionals about their experience with the checklist and the response of patients. A demonstration video on how it can be used in clinical practice is also available.
The evidence-based checklist identifying the major risk factors helps both clinicians and patients to focus on minimizing risk and promotes safety by focusing on the modifiable factors and guiding treatment. It is a tool to open person-centered discussion with patients and to outline how individual behaviors could impact on risk. It can provide documentary evidence for the clinician about the impact the treatment plan is having on risk over a period of time.
Health care is a risky business and preventable mistakes are common (Pearson et al., 2010). Regulators set standards which healthcare organizations strive to attain in order to provide assurances to the public and patients that clinical risks are minimized. Clinical risk should not only be contained through risk management initiatives such as the safety checklist implemented at the level of the individual but also at the clinical and corporate governance levels of the healthcare organization (Verbano & Turra, 2010). From a governance perspective, according to Rudkin 2009, knowing how people feel about risk is more than useful; it is an essential aspect of effective regulation. Initiatives such as the safety checklist satisfy the need for organisations to put in place evidence-based effective management systems for patient safety. They can also protect the clinical staff from potential litigation by demonstrating that they have discharged their ‘duty of care’. The safety checklist can be used to demonstrate effective clinical and corporate governance while enhancing patient safety.
It is said that health care is slow to adopt technological advances (Shankar et al., 2015a; Shankar et al., 2015b). The SUDEP and Seizure Safety Check List, due to its strong evidence base, was an easy conversion to a mobile application known as EpsMon. A partnership of CFT, RCHT, Plymouth University and SUDEP Action converted the checklist to a digital format to promote engagement between patients and their medical teams. EpsMon is the first app of its kind which allows self-risk monitoring based on an evidence-based framework. It is a novel venture into the world of patient-led self-care using current technology. It has had good reviews and a positive response by patient communities. More information can be found at www.epsmon.com and https://www.sudep.org/epilepsy-self-monitor.
Consultant Neuropsychiatrist, Cornwall Partnership NHS Foundation Trust, UK
Hon. Associate Professor, Exeter Medical School, UK
Updated May 2016; Original Dec 2014
How to cite:
Shankar R. SUDEP – are we as safe as we can be? In: Hanna J, Panelli R, Jeffs T, Chapman D, editors. Continuing the global conversation [online]. SUDEP Action, SUDEP Aware & Epilepsy Australia; 2014 [retrieved day/month/year]. Available from: www.sudepglobalconversation.com.