The cost-effectiveness of seizure dogs for persons living with severe refractory epilepsy: results from the EPISODE study.

OBJECTIVES: The EPISODE study was commissioned by the Dutch Ministry of Health, Welfare and Sports to inform a reimbursement decision on seizure dogs. The randomized trial found that seizure dogs reduce seizure frequency and improve health-related quality of life of persons with severe refractory epilepsy (PSREs). This paper examines the cost-effectiveness of adding seizure dogs to usual care for PSREs in the Netherlands. METHODS: A microsimulation model was developed, informed by generalized linear mixed models using patient level trial data from the EPISODE study. The model adopted a 10-year time horizon and took a societal perspective. Seizure frequency was predicted as a function of time with the seizure dog. Patient utilities, caregiver utilities and costs were predicted as a function of seizure frequency and time with the seizure dog. RESULTS: Quality-adjusted life years (QALYs) of PSREs with a seizure dog and usual care alone were estimated at 6.28 and 5.65 respectively (Δ 0.63). For caregivers, estimated QALYs were 6.94 and 6.52, respectively (Δ 0.42). Total costs were respectively €228,691 and €226,261 (Δ €2,430). Intervention costs were largely offset by savings in informal care and healthcare. The incremental cost-effectiveness ratio (ICER) was €2,314/QALY. Probabilistic sensitivity analysis indicated a 91% probability of seizure dogs being cost-effective at the €50,000/QALY threshold. The ICER fell well below this threshold in scenario analyses. CONCLUSIONS: Seizure dogs are likely to be a cost-effective addition to usual care for PSREs in the Netherlands.

Effectiveness of Seizure Dogs for People With Severe Refractory Epilepsy: Results From the EPISODE Study.

BACKGROUND AND OBJECTIVES: The aim of this study was to evaluate whether people living with severe medically refractory epilepsy (PSRE) benefit from a seizure dog. METHODS: An individual-level stepped-wedge randomized controlled trial was conducted. The study was conducted in the Netherlands among adults with daily to weekly seizures. All participants were included simultaneously (on June 1, 2019) while receiving usual care. Then, during the 36-month follow-up, they received a seizure dog in a randomized sequence. Participants kept a seizure diary and completed 3-monthly surveys. Seizure frequency was the primary outcome. Secondary outcomes included seizure-free days, seizure severity, health-related quality of life (HRQoL), and well-being. Data were analyzed using generalized linear mixed modeling (GLMM). The models assumed a delayed intervention effect, starting when the seizure dog reached an advanced stage of training. Effects were calculated as changes per 28-day period with the intervention. RESULTS: Data were collected from 25 participants, of whom 20 crossed over to the intervention condition. The median follow-up was 19 months with usual care and 12 months with the intervention. On average, participants experienced 115 (SD 164) seizures per 28-day period in the usual care condition and 73 (SD 131) seizures in the intervention condition. Seven participants achieved a reduction of 50% or more at the end of follow-up. GLMM indicated a 3.1% decrease in seizure frequency for each consecutive 28-day period with the intervention (0.969, 95% CI 0.960-0.977). Furthermore, an increase in the number of seizure-free days was observed (1.012, 95% CI 1.009, 1.015), but no effect on seizure severity measured with the NHS3. Generic HRQoL scores improved, as reflected in the decrease in EQ-5D-5L utility decrement (0.975, 95% CI 0.954-0.997). Smaller improvements were observed on overall self-rated HRQoL, epilepsy-specific HRQoL, and well-being, measured with the EQ VAS, QOLIE-31-P, and ICECAP-A, respectively. DISCUSSION: Seizure dogs reduce seizure frequency, increase the number of seizure-free days, and improve the quality of life of PSRE. The magnitude of the effect on generic HRQoL indicates that seizure dogs benefit PSRE beyond the impact on seizure frequency alone. Early discontinuation of seizure dog partnerships suggests that this intervention is not suitable for all PSRE and requires further study. TRIAL REGISTRATION INFORMATION: This study was registered in the Dutch Trial Register (NL6682) on November 28, 2017. Participants were enrolled on June 1, 2019. CLASSIFICATION OF EVIDENCE: This study provides Class III evidence that seizure dogs are associated with a decrease in seizure frequency in adult patients with medically refractory epilepsy.

Caregiver Burden and Quality of Life Across Alzheimer's Disease Severity Stages.

INTRODUCTION: The objective is to estimate the caregiver burden in terms of informal care time, health-related quality of life (HRQoL), and societal costs by disease severity (mild, moderate, or severe) and living situation (community-dwelling or institutionalized) of persons with AD (PwAD); and PwAD HRQoL. METHODS: Caregivers were recruited through an online panel provider in the Netherlands. The survey used validated instruments, including iMTA Valuation of Informal Care Questionnaire, CarerQoL, and EQ-5D-5L. RESULTS: One hundred two caregivers participated. PwADs received, on average, 26 hours of informal care per week. Informal care costs were higher for community-dwelling PwADs compared with institutionalized PwADs (€480 and €278, respectively). On the EQ-5D-5L, caregivers scored on average 0.797, reflecting a utility decrement of 0.065 compared with an age-matched population. Proxy-rated utility scores for PwADs decreased with increasing disease severity (0.455, 0.314, and 0.212 for mild, moderate, and severe AD, respectively). Institutionalised PwADs had lower utility scores than community-dwelling PwADs (0.590 vs. 0.421). There was no difference in informal care time, societal costs, CarerQol scores, and caregiver EQ-5D-5L scores between disease severities. CONCLUSION: The burden of AD extends to caregivers in terms of HRQoL and time investment, regardless of the disease severity of the target population. These impacts should be incorporated into the evaluation of new AD interventions.

Burden of illness in people with medically refractory epilepsy who suffer from daily to weekly seizures: 12-month follow-up of participants in the EPISODE study.

Background: A small group of people with epilepsy suffers from frequent seizures despite the available pharmacological and non-pharmacological interventions. The impact of epilepsy on these people extends beyond health-related quality of life (HRQoL), impacting a person's broader well-being and ability to participate in society. This study describes the burden of medically refractory epilepsy in people who suffer from daily to weekly seizures, in terms of HRQoL, well-being, and societal costs. Methods: Data from the EPISODE study on (cost-) effectiveness of seizure dogs for adults with severe medically refractory epilepsy were used, collected in 25 patients during the first 12 months before they were partnered with a certified seizure dog. Data comprised seizure diaries covering 365 days and five three-monthly surveys, including the EQ-5D-5L, QOLIE-31-P, and ICECAP-A to measure HRQoL and well-being. A societal perspective was applied to estimate costs using the iMCQ and iPCQ questionnaires about healthcare use, informal care, and productivity losses. Results: Daily seizure frequency and survey data were collected in 25 patients. A minimum of 114 observations was available for each instrument included in the survey. A total of 80% of participants experienced seizures on three or more days per week, with a median ranging from 1 to 17 seizures per seizure day. The mean EQ-5D-5L utility score was 0.682 (SD 0.235), which is considerably lower than the age-adjusted general population average. The mean QOLIE-31-P and ICECAP-A scores were 55.8 (SD 14.0) and 0.746 (SD 0.172), respectively. The average annual total cost amounted to €39,956 (range €3,804-€132,64). Informal care accounted for the largest share of costs (50%); those who received informal care reported, on average, 26 h per week (SD 30). Conclusions: Severe medically refractory epilepsy is associated with a considerable burden of illness at the patient and societal level. People with this condition have significantly reduced HRQoL and well-being and are limited in their ability to work while having substantial medical costs and a strong dependency on informal care.