Research reportMeasuring the impact of epilepsy: the development of a novel scale
Abstract
The impact of a chronic illness is experienced not only through its physical symptoms, but also as a result of its effect on psychosocial functioning. In the case of an illness such as epilepsy, where the physical manifestations are transient, the psychosocial consequences may, with time, come to be of greater concern. We have been involved in developing a quality of life model for epilepsy. As part of the refinement of the initial model, we have devised a novel scale to measure the impact of the condition on a number of different aspects of daily life. The scale was administered to 75 patients attending an epilepsy out-patient clinic. Initial analysis of its psychometric properties is encouraging, although the inclusion of an item relating to employment reduced the scale's reliability. As a result, the wording of the existing item has been amended and an additional item has been incorporated. We hope the scale will be useful in investigations of treatment for epilepsy and of its psychosocial aspects.
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Cited by (135)
Clinical outcome assessment in patients with epilepsy: The value of health-related quality of life measurements
2024, Epilepsy ResearchThis narrative review provides an overview of the current knowledge on health-related quality of life (HRQOL), a relevant clinical outcome in patients with epilepsy. It shows that the most important factor determining HRQOL in this patient group is seizure frequency. In particular, seizure-freedom is associated with better HRQOL scores. Many other factors may impact perceived HRQOL aspects, but their interrelation is complex and requires further research. Novel analytical approaches, such as hierarchical cluster and symptom network analyses might shed further light on this, and may result in recommendations for interventions on the most ‘central’ factors influencing different aspects of HRQOL in patients with epilepsy. Next, an overview of the HRQOL tools and analytical methods currently used in epilepsy care, with a focus on clinical trials, is provided. The QOLIE-31 is the most frequently applied and best validated tool. Several other questionnaires focusing on specific aspects of HRQOL (e.g., mood, social impact) are less frequently used. We show some pitfalls that should be taken into account when designing study protocols including HRQOL endpoints. This includes standardized statistical analysis approaches and predefined reporting methods for HRQOL in epilepsy populations. It has been shown in other patient groups that the lack of such standardisation negatively impacts the quality and comparability of results. We conclude with a number of recommendations for future research.
Development and Validation of an Instrument to Measure Health-Related Out-of-Pocket Costs: The Cost for Patients Questionnaire
2021, Value in HealthThe growth of healthcare spending is a major concern for insurers and governments but also for patients whose health problems may result in costs going beyond direct medical costs. To develop a comprehensive tool to measure direct and indirect costs of a health condition for patients and their families to various outpatient contexts.
We conducted a content and face validation including results of a systematic review to identify the items related to direct and indirect costs for patients or their families and an online Delphi to determine the cost items to retain. We conducted a pilot test-retest with 18 naive participants and analyzed data calculating intraclass correlation and kappa coefficients.
An initial list of 34 items was established from the systematic review. Each round of the Delphi panel incorporated feedback from the previous round until a strong consensus was achieved. After 4 rounds of the Delphi to reach consensus on items to be included and wording, the questionnaire had a total of 32 cost items. For the test-retest, kappa coefficients ranged from −0.11 to 1.00 (median = 0.86), and intraclass correlation ranged from −0.02 to 0.99 (median = 0.62).
A rigorous process of content and face development was implemented for the Cost for Patients Questionnaire, and this study allowed to set a list of cost elements to be considered from the patient’s perspective. Additional research including a test-retest with a larger sample will be part of a subsequent validation strategy.
Levetiracetam and zonisamide are licensed as monotherapy for patients with focal epilepsy, but there is uncertainty as to whether they should be recommended as first-line treatments because of insufficient evidence of clinical effectiveness and cost-effectiveness. We aimed to assess the long-term clinical effectiveness and cost-effectiveness of levetiracetam and zonisamide compared with lamotrigine in people with newly diagnosed focal epilepsy.
This randomised, open-label, controlled trial compared levetiracetam and zonisamide with lamotrigine as first-line treatment for patients with newly diagnosed focal epilepsy. Adult and paediatric neurology services across the UK recruited participants aged 5 years or older (with no upper age limit) with two or more unprovoked focal seizures. Participants were randomly allocated (1:1:1) using a minimisation programme with a random element utilising factor to receive lamotrigine, levetiracetam, or zonisamide. Participants and investigators were not masked and were aware of treatment allocation. SANAD II was designed to assess non-inferiority of both levetiracetam and zonisamide to lamotrigine for the primary outcome of time to 12-month remission. Anti-seizure medications were taken orally and for participants aged 12 years or older the initial advised maintenance doses were lamotrigine 50 mg (morning) and 100 mg (evening), levetiracetam 500 mg twice per day, and zonisamide 100 mg twice per day. For children aged between 5 and 12 years the initial daily maintenance doses advised were lamotrigine 1·5 mg/kg twice per day, levetiracetam 20 mg/kg twice per day, and zonisamide 2·5 mg/kg twice per day. All participants were included in the intention-to-treat (ITT) analysis. The per-protocol (PP) analysis excluded participants with major protocol deviations and those who were subsequently diagnosed as not having epilepsy. Safety analysis included all participants who received one dose of any study drug. The non-inferiority limit was a hazard ratio (HR) of 1·329, which equates to an absolute difference of 10%. A HR greater than 1 indicated that an event was more likely on lamotrigine. The trial is registered with the ISRCTN registry, 30294119 (EudraCt number: 2012-001884-64).
990 participants were recruited between May 2, 2013, and June 20, 2017, and followed up for a further 2 years. Patients were randomly assigned to receive lamotrigine (n=330), levetiracetam (n=332), or zonisamide (n=328). The ITT analysis included all participants and the PP analysis included 324 participants randomly assigned to lamotrigine, 320 participants randomly assigned to levetiracetam, and 315 participants randomly assigned to zonisamide. Levetiracetam did not meet the criteria for non-inferiority in the ITT analysis of time to 12-month remission versus lamotrigine (HR 1·18; 97·5% CI 0·95–1·47) but zonisamide did meet the criteria for non-inferiority in the ITT analysis versus lamotrigine (1·03; 0·83–1·28). The PP analysis showed that 12-month remission was superior with lamotrigine than both levetiracetam (HR 1·32 [97·5% CI 1·05 to 1·66]) and zonisamide (HR 1·37 [1·08–1·73]). There were 37 deaths during the trial. Adverse reactions were reported by 108 (33%) participants who started lamotrigine, 144 (44%) participants who started levetiracetam, and 146 (45%) participants who started zonisamide. Lamotrigine was superior in the cost-utility analysis, with a higher net health benefit of 1·403 QALYs (97·5% central range 1·319–1·458) compared with 1·222 (1·110–1·283) for levetiracetam and 1·232 (1·112, 1·307) for zonisamide at a cost-effectiveness threshold of £20 000 per QALY. Cost-effectiveness was based on differences between treatment groups in costs and QALYs.
These findings do not support the use of levetiracetam or zonisamide as first-line treatments for patients with focal epilepsy. Lamotrigine should remain a first-line treatment for patients with focal epilepsy and should be the standard treatment in future trials.
National Institute for Health Research Health Technology Assessment programme.
Valproate is a first-line treatment for patients with newly diagnosed idiopathic generalised or difficult to classify epilepsy, but not for women of child-bearing potential because of teratogenicity. Levetiracetam is increasingly prescribed for these patient populations despite scarcity of evidence of clinical effectiveness or cost-effectiveness. We aimed to compare the long-term clinical effectiveness and cost-effectiveness of levetiracetam compared with valproate in participants with newly diagnosed generalised or unclassifiable epilepsy.
We did an open-label, randomised controlled trial to compare levetiracetam with valproate as first-line treatment for patients with generalised or unclassified epilepsy. Adult and paediatric neurology services (69 centres overall) across the UK recruited participants aged 5 years or older (with no upper age limit) with two or more unprovoked generalised or unclassifiable seizures. Participants were randomly allocated (1:1) to receive either levetiracetam or valproate, using a minimisation programme with a random element utilising factors. Participants and investigators were aware of treatment allocation. For participants aged 12 years or older, the initial advised maintenance doses were 500 mg twice per day for levetiracetam and valproate, and for children aged 5–12 years, the initial daily maintenance doses advised were 25 mg/kg for valproate and 40 mg/kg for levetiracetam. All drugs were administered orally. SANAD II was designed to assess the non-inferiority of levetiracetam compared with valproate for the primary outcome time to 12-month remission. The non-inferiority limit was a hazard ratio (HR) of 1·314, which equates to an absolute difference of 10%. A HR greater than 1 indicated that an event was more likely on valproate. All participants were included in the intention-to-treat (ITT) analysis. Per-protocol (PP) analyses excluded participants with major protocol deviations and those who were subsequently diagnosed as not having epilepsy. Safety analyses included all participants who received one dose of any study drug. This trial is registered with the ISRCTN registry, 30294119 (EudraCt number: 2012-001884-64).
520 participants were recruited between April 30, 2013, and Aug 2, 2016, and followed up for a further 2 years. 260 participants were randomly allocated to receive levetiracetam and 260 participants to receive valproate. The ITT analysis included all participants and the PP analysis included 255 participants randomly allocated to valproate and 254 randomly allocated to levetiracetam. Median age of participants was 13·9 years (range 5·0–94·4), 65% were male and 35% were female, 397 participants had generalised epilepsy, and 123 unclassified epilepsy. Levetiracetam did not meet the criteria for non-inferiority in the ITT analysis of time to 12-month remission (HR 1·19 [95% CI 0·96–1·47]); non-inferiority margin 1·314. The PP analysis showed that the 12-month remission was superior with valproate than with levetiracetam. There were two deaths, one in each group, that were unrelated to trial treatments. Adverse reactions were reported by 96 (37%) participants randomly assigned to valproate and 107 (42%) participants randomly assigned to levetiracetam. Levetiracetam was dominated by valproate in the cost-utility analysis, with a negative incremental net health benefit of −0·040 (95% central range −0·175 to 0·037) and a probability of 0·17 of being cost-effectiveness at a threshold of £20 000 per quality-adjusted life-year. Cost-effectiveness was based on differences between treatment groups in costs and quality-adjusted life-years.
Compared with valproate, levetiracetam was found to be neither clinically effective nor cost-effective. For girls and women of child-bearing potential, these results inform discussions about benefit and harm of avoiding valproate.
National Institute for Health Research Health Technology Assessment Programme.
Seizure severity in children with epilepsy is associated with their parents' perception of stigma
2016, Epilepsy and BehaviorTo develop and implement interventions to improve the quality of life (QOL) in children with epilepsy, it is important for clinicians and researchers to understand the effects of the children's parents' perception of stigma. The purpose of this study was to identify a relationship between patient clinical characteristics and perception of stigma in the parents of children with epilepsy.
Parents of children with epilepsy were recruited from our university hospital between April 1, 2005 and March 31, 2012. Items for the Parent Stigma Scale were developed from the literature and open-ended interviews with parents of children with epilepsy about their concerns and fears, including those related to stigma. Parents were asked to respond to five items, each on a 5-point scale from 1 (strongly disagree) to 5 (strongly agree). Assessments were performed for each clinical characteristic, such as child's sex, age at seizure onset, family history of epilepsy, seizure frequency, presence of status epilepticus (SE), presence of treatment-related adverse events, and the scores of each scale.
A total of 52 parents of children with epilepsy and 10 parents of healthy children were enrolled in the study. Parents of children with epilepsy showed significantly higher scores on the questionnaire than parents of healthy children. In multiple regression analysis, greater perceptions of stigma were associated with a seizure frequency of more than one per month (p = 0.0036, B = 1.104, β = 0.402). In contrast, the presence of prior febrile seizures (p = 0.0034, B = − 1.297, β = − 0.308) and family history of epilepsy (p = 0.0066, B = − 1.613, β = − 0.277) were associated with lower perceptions of stigma. Greater parental perceptions of stigma were seen with the presence of monthly seizures.
Parents of children with epilepsy are at risk of significant perceptions of stigma. Seizure severity, indicated by the presence of monthly seizures, was associated with greater perceptions of stigma in parents. In addition, the presence of prior febrile seizures and family history of epilepsy were associated with fewer perceptions of stigma. The findings of this study emphasize the importance of acknowledging and addressing parental perceptions of stigma.
Correlation between perceived stigma and EEG paroxysmal abnormality in childhood epilepsy
2015, Epilepsy and BehaviorWe investigated the relationship between abnormal electroencephalogram (EEG) findings such as localized EEG paroxysmal abnormality (PA) and the perception of stigma to determine EEG factors associated with perceived stigma in childhood epilepsy.
Participants comprised 40 patients (21 boys, 19 girls; mean age, 14.6 years) with epilepsy at enrollment. The criteria for inclusion were as follows: 1) age of 12–18 years, inclusive; 2) ≥ 6 months after epilepsy onset; 3) the ability to read and speak Japanese; and 4) the presence of EEG PA. Fifteen healthy seizure-free children were included as a control group. Participants were asked to rate how often they felt or acted in the ways described in the items of the Child Stigma Scale using a 5-point scale. Electroencephalogram paroxysms were classified based on the presence of spikes, sharp waves, or spike–wave complexes, whether focal or generalized.
Participants showed significantly higher stigma scores than healthy subjects (p < 0.01). A higher score reflects a greater perception of stigma. The average total scores of patients presenting with EEG PA at generalized, frontal, RD, midtemporal, and occipital regions were 2.3, 4.0, 2.4, 3.2, and 2.2, respectively. The scores of all questions were higher in the frontal group than those in other regions (p < 0.01). Children presenting with frontal EEG PA perceived a greater stigma than children presenting with nonfrontal EEG PA (p < 0.01).
A relationship was identified between frontal EEG PA and a greater perception of stigma. Further studies are needed to confirm whether frontal EEG PA may function as a mediator of emotional responses such as perceived stigma in childhood epilepsy.