The Experts below are selected from a list of 360 Experts worldwide ranked by ideXlab platform
Christopher M Degiorgio - One of the best experts on this subject based on the ideXlab platform.
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fish oil n 3 fatty acids in Drug Resistant Epilepsy a randomised placebo controlled crossover study
Journal of Neurology Neurosurgery and Psychiatry, 2015Co-Authors: Christopher M Degiorgio, Patrick Miller, Ronald M Harper, Jeffrey Gornbein, Lara M Schrader, Jason Soss, Sheba MeymandiAbstract:Background n-3 fatty acids inhibit neuronal excitability and reduce seizures in animal models. High-dose fish oil has been explored in two randomised trials in Drug Resistant Epilepsy with negative results. We performed a phase II randomised controlled crossover trial of lowdose and high-dose fish oil in participants with Drug Resistant Epilepsy to explore whether low-dose or highdose fish oil reduces seizures or improves cardiovascular health. Methods Randomised placebo-controlled trial of lowdose and high-dose fish oil versus placebo (corn oil, linoleic acid) in 24 participants with Drug Resistant Epilepsy. A three-period crossover design was utilised lasting 42 weeks, with three 10-week treatment periods and two 6-week washout periods. All participants were randomised in double-blind fashion to receive placebo, high dose or low dose in different sequences. The primary outcome was per cent change in total seizure frequency. Findings Low-dose fish oil (3 capsules/day, 1080 mg eicosapentaenoic acid+docosahexaenoic acid) was associated with a 33.6% reduction in seizure frequency compared with placebo. Low-dose fish oil was also associated with a mild but significant reduction in blood pressure. High-dose fish oil was no different than placebo in reducing seizures or improving cardiac risk factors. Interpretation In this phase II randomised crossover trial, low-dose fish oil was effective in reducing seizures compared with placebo. The magnitude of improvement is similar to that of recent antiepileptic Drug trials in Drug Resistant Epilepsy (DRE). The results indicate that low-dose fish oil may reduce seizures and improve the health of people with Epilepsy. These findings justify a large multicentre randomised trial of low-dose fish oil (n-3 fatty acids <1080 mg/day) in Drug Resistant Epilepsy. Trial registration number NCT00871377.
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fish oil n 3 fatty acids in Drug Resistant Epilepsy a randomised placebo controlled crossover study
Journal of Neurology Neurosurgery and Psychiatry, 2015Co-Authors: Christopher M Degiorgio, Ronald M Harper, Jeffrey Gornbein, Lara M Schrader, Jason Soss, Patrick R Miller, Sheba MeymandiAbstract:Background n-3 fatty acids inhibit neuronal excitability and reduce seizures in animal models. High-dose fish oil has been explored in two randomised trials in Drug Resistant Epilepsy with negative results. We performed a phase II randomised controlled crossover trial of lowdose and high-dose fish oil in participants with Drug Resistant Epilepsy to explore whether low-dose or highdose fish oil reduces seizures or improves cardiovascular health. Methods Randomised placebo-controlled trial of lowdose and high-dose fish oil versus placebo (corn oil, linoleic acid) in 24 participants with Drug Resistant Epilepsy. A three-period crossover design was utilised lasting 42 weeks, with three 10-week treatment periods and two 6-week washout periods. All participants were randomised in double-blind fashion to receive placebo, high dose or low dose in different sequences. The primary outcome was per cent change in total seizure frequency. Findings Low-dose fish oil (3 capsules/day, 1080 mg eicosapentaenoic acid+docosahexaenoic acid) was associated with a 33.6% reduction in seizure frequency compared with placebo. Low-dose fish oil was also associated with a mild but significant reduction in blood pressure. High-dose fish oil was no different than placebo in reducing seizures or improving cardiac risk factors. Interpretation In this phase II randomised crossover trial, low-dose fish oil was effective in reducing seizures compared with placebo. The magnitude of improvement is similar to that of recent antiepileptic Drug trials in Drug Resistant Epilepsy (DRE). The results indicate that low-dose fish oil may reduce seizures and improve the health of people with Epilepsy. These findings justify a large multicentre randomised trial of low-dose fish oil (n-3 fatty acids <1080 mg/day) in Drug Resistant Epilepsy. Trial registration number NCT00871377.
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a prospective long term study of external trigeminal nerve stimulation for Drug Resistant Epilepsy
Epilepsy & Behavior, 2015Co-Authors: Jason Soss, Christi N Heck, Diana Murray, Daniela Markovic, Sandra Oviedo, Guadalupe Corraleleyva, Steven Gordon, Colin Kealey, Christopher M DegiorgioAbstract:Abstract Background External trigeminal nerve stimulation (eTNS) is an emerging noninvasive therapy for Drug-Resistant Epilepsy (DRE). We report the long-term safety and efficacy of eTNS after completion of a phase II randomized controlled clinical trial for Drug-Resistant Epilepsy. Methods This was a prospective open-label long-term study. Subjects who completed the phase II randomized controlled trial of eTNS for DRE were offered long-term follow-up for 1 year. Subjects who were originally randomized to control settings were crossed over to effective device parameters (30 s on, 30 s off, pulse duration of 250 s, frequency of 120 Hz). Efficacy was assessed using last observation carried forward or parametric imputation methods for missing data points. Outcomes included change in median seizure frequency, RRATIO, and 50% responder rate. Results Thirty-five of 50 subjects from the acute double-blind randomized controlled study continued in the long-term study. External trigeminal nerve stimulation was well tolerated. No serious device-related adverse events occurred through 12 months of long-term treatment. At six and twelve months, the median seizure frequency for the original treatment group decreased by -2.39 seizures per month at 6 months (-27.4%) and -3.03 seizures per month at 12 months (-34.8%), respectively, from the initial baseline (p Conclusion The results provide long-term evidence that external trigeminal nerve stimulation is a safe and promising long-term treatment for Drug-Resistant Epilepsy.
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randomized controlled trial of trigeminal nerve stimulation for Drug Resistant Epilepsy
Neurology, 2013Co-Authors: Christopher M Degiorgio, Jeffrey Gornbein, Jason Soss, Diana Murray, Daniela Markovic, Sandra Oviedo, Steven Gordon, Ian A Cook, Guadalupe Corralleleyva, Colin KealeyAbstract:Objective: To explore the safety and efficacy of external trigeminal nerve stimulation (eTNS) in patients with Drug-Resistant Epilepsy (DRE) using a double-blind randomized controlled trial design, and to test the suitability of treatment and control parameters in preparation for a phase III multicenter clinical trial. Methods: This is a double-blind randomized active-control trial in DRE. Fifty subjects with 2 or more partial onset seizures per month (complex partial or tonic-clonic) entered a 6-week baseline period, and then were evaluated at 6, 12, and 18 weeks during the acute treatment period. Subjects were randomized to treatment (eTNS 120 Hz) or control (eTNS 2 Hz) parameters. Results: At entry, subjects were highly Drug-Resistant, averaging 8.7 seizures per month (treatment group) and 4.8 seizures per month (active controls). On average, subjects failed 3.35 antiepileptic Drugs prior to enrollment, with an average duration of Epilepsy of 21.5 years (treatment group) and 23.7 years (active control group), respectively. eTNS was well-tolerated. Side effects included anxiety (4%), headache (4%), and skin irritation (14%). The responder rate, defined as >50% reduction in seizure frequency, was 30.2% for the treatment group vs 21.1% for the active control group for the 18-week treatment period (not significant, p = 0.31, generalized estimating equation [GEE] model). The treatment group experienced a significant within-group improvement in responder rate over the 18-week treatment period (from 17.8% at 6 weeks to 40.5% at 18 weeks, p = 0.01, GEE). Subjects in the treatment group were more likely to respond than patients randomized to control (odds ratio 1.73, confidence interval 0.59–0.51). eTNS was associated with reductions in seizure frequency as measured by the response ratio ( p = 0.04, analysis of variance [ANOVA]), and improvements in mood on the Beck Depression Inventory ( p = 0.02, ANOVA). Conclusions: This study provides preliminary evidence that eTNS is safe and may be effective in subjects with DRE. Side effects were primarily limited to anxiety, headache, and skin irritation. These results will serve as a basis to inform and power a larger multicenter phase III clinical trial. Classification of evidence: This phase II study provides Class II evidence that trigeminal nerve stimulation may be safe and effective in reducing seizures in people with DRE.
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acute and long term safety of external trigeminal nerve stimulation for Drug Resistant Epilepsy
Epilepsy & Behavior, 2011Co-Authors: Juliana Pop, Daniela Markovic, Diana Murray, Christopher M DegiorgioAbstract:Trigeminal nerve stimulation (TNS) is a novel therapy for Drug-Resistant Epilepsy. We report in detail the safety of external TNS (eTNS), focusing on acute and long-term heart rate and systolic and diastolic blood pressure in response to TNS from the pilot feasibility study. The data indicate that eTNS of the infraorbital and supraorbital branches of the trigeminal nerve is safe and well tolerated.
Jason Soss - One of the best experts on this subject based on the ideXlab platform.
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fish oil n 3 fatty acids in Drug Resistant Epilepsy a randomised placebo controlled crossover study
Journal of Neurology Neurosurgery and Psychiatry, 2015Co-Authors: Christopher M Degiorgio, Patrick Miller, Ronald M Harper, Jeffrey Gornbein, Lara M Schrader, Jason Soss, Sheba MeymandiAbstract:Background n-3 fatty acids inhibit neuronal excitability and reduce seizures in animal models. High-dose fish oil has been explored in two randomised trials in Drug Resistant Epilepsy with negative results. We performed a phase II randomised controlled crossover trial of lowdose and high-dose fish oil in participants with Drug Resistant Epilepsy to explore whether low-dose or highdose fish oil reduces seizures or improves cardiovascular health. Methods Randomised placebo-controlled trial of lowdose and high-dose fish oil versus placebo (corn oil, linoleic acid) in 24 participants with Drug Resistant Epilepsy. A three-period crossover design was utilised lasting 42 weeks, with three 10-week treatment periods and two 6-week washout periods. All participants were randomised in double-blind fashion to receive placebo, high dose or low dose in different sequences. The primary outcome was per cent change in total seizure frequency. Findings Low-dose fish oil (3 capsules/day, 1080 mg eicosapentaenoic acid+docosahexaenoic acid) was associated with a 33.6% reduction in seizure frequency compared with placebo. Low-dose fish oil was also associated with a mild but significant reduction in blood pressure. High-dose fish oil was no different than placebo in reducing seizures or improving cardiac risk factors. Interpretation In this phase II randomised crossover trial, low-dose fish oil was effective in reducing seizures compared with placebo. The magnitude of improvement is similar to that of recent antiepileptic Drug trials in Drug Resistant Epilepsy (DRE). The results indicate that low-dose fish oil may reduce seizures and improve the health of people with Epilepsy. These findings justify a large multicentre randomised trial of low-dose fish oil (n-3 fatty acids <1080 mg/day) in Drug Resistant Epilepsy. Trial registration number NCT00871377.
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fish oil n 3 fatty acids in Drug Resistant Epilepsy a randomised placebo controlled crossover study
Journal of Neurology Neurosurgery and Psychiatry, 2015Co-Authors: Christopher M Degiorgio, Ronald M Harper, Jeffrey Gornbein, Lara M Schrader, Jason Soss, Patrick R Miller, Sheba MeymandiAbstract:Background n-3 fatty acids inhibit neuronal excitability and reduce seizures in animal models. High-dose fish oil has been explored in two randomised trials in Drug Resistant Epilepsy with negative results. We performed a phase II randomised controlled crossover trial of lowdose and high-dose fish oil in participants with Drug Resistant Epilepsy to explore whether low-dose or highdose fish oil reduces seizures or improves cardiovascular health. Methods Randomised placebo-controlled trial of lowdose and high-dose fish oil versus placebo (corn oil, linoleic acid) in 24 participants with Drug Resistant Epilepsy. A three-period crossover design was utilised lasting 42 weeks, with three 10-week treatment periods and two 6-week washout periods. All participants were randomised in double-blind fashion to receive placebo, high dose or low dose in different sequences. The primary outcome was per cent change in total seizure frequency. Findings Low-dose fish oil (3 capsules/day, 1080 mg eicosapentaenoic acid+docosahexaenoic acid) was associated with a 33.6% reduction in seizure frequency compared with placebo. Low-dose fish oil was also associated with a mild but significant reduction in blood pressure. High-dose fish oil was no different than placebo in reducing seizures or improving cardiac risk factors. Interpretation In this phase II randomised crossover trial, low-dose fish oil was effective in reducing seizures compared with placebo. The magnitude of improvement is similar to that of recent antiepileptic Drug trials in Drug Resistant Epilepsy (DRE). The results indicate that low-dose fish oil may reduce seizures and improve the health of people with Epilepsy. These findings justify a large multicentre randomised trial of low-dose fish oil (n-3 fatty acids <1080 mg/day) in Drug Resistant Epilepsy. Trial registration number NCT00871377.
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a prospective long term study of external trigeminal nerve stimulation for Drug Resistant Epilepsy
Epilepsy & Behavior, 2015Co-Authors: Jason Soss, Christi N Heck, Diana Murray, Daniela Markovic, Sandra Oviedo, Guadalupe Corraleleyva, Steven Gordon, Colin Kealey, Christopher M DegiorgioAbstract:Abstract Background External trigeminal nerve stimulation (eTNS) is an emerging noninvasive therapy for Drug-Resistant Epilepsy (DRE). We report the long-term safety and efficacy of eTNS after completion of a phase II randomized controlled clinical trial for Drug-Resistant Epilepsy. Methods This was a prospective open-label long-term study. Subjects who completed the phase II randomized controlled trial of eTNS for DRE were offered long-term follow-up for 1 year. Subjects who were originally randomized to control settings were crossed over to effective device parameters (30 s on, 30 s off, pulse duration of 250 s, frequency of 120 Hz). Efficacy was assessed using last observation carried forward or parametric imputation methods for missing data points. Outcomes included change in median seizure frequency, RRATIO, and 50% responder rate. Results Thirty-five of 50 subjects from the acute double-blind randomized controlled study continued in the long-term study. External trigeminal nerve stimulation was well tolerated. No serious device-related adverse events occurred through 12 months of long-term treatment. At six and twelve months, the median seizure frequency for the original treatment group decreased by -2.39 seizures per month at 6 months (-27.4%) and -3.03 seizures per month at 12 months (-34.8%), respectively, from the initial baseline (p Conclusion The results provide long-term evidence that external trigeminal nerve stimulation is a safe and promising long-term treatment for Drug-Resistant Epilepsy.
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randomized controlled trial of trigeminal nerve stimulation for Drug Resistant Epilepsy
Neurology, 2013Co-Authors: Christopher M Degiorgio, Jeffrey Gornbein, Jason Soss, Diana Murray, Daniela Markovic, Sandra Oviedo, Steven Gordon, Ian A Cook, Guadalupe Corralleleyva, Colin KealeyAbstract:Objective: To explore the safety and efficacy of external trigeminal nerve stimulation (eTNS) in patients with Drug-Resistant Epilepsy (DRE) using a double-blind randomized controlled trial design, and to test the suitability of treatment and control parameters in preparation for a phase III multicenter clinical trial. Methods: This is a double-blind randomized active-control trial in DRE. Fifty subjects with 2 or more partial onset seizures per month (complex partial or tonic-clonic) entered a 6-week baseline period, and then were evaluated at 6, 12, and 18 weeks during the acute treatment period. Subjects were randomized to treatment (eTNS 120 Hz) or control (eTNS 2 Hz) parameters. Results: At entry, subjects were highly Drug-Resistant, averaging 8.7 seizures per month (treatment group) and 4.8 seizures per month (active controls). On average, subjects failed 3.35 antiepileptic Drugs prior to enrollment, with an average duration of Epilepsy of 21.5 years (treatment group) and 23.7 years (active control group), respectively. eTNS was well-tolerated. Side effects included anxiety (4%), headache (4%), and skin irritation (14%). The responder rate, defined as >50% reduction in seizure frequency, was 30.2% for the treatment group vs 21.1% for the active control group for the 18-week treatment period (not significant, p = 0.31, generalized estimating equation [GEE] model). The treatment group experienced a significant within-group improvement in responder rate over the 18-week treatment period (from 17.8% at 6 weeks to 40.5% at 18 weeks, p = 0.01, GEE). Subjects in the treatment group were more likely to respond than patients randomized to control (odds ratio 1.73, confidence interval 0.59–0.51). eTNS was associated with reductions in seizure frequency as measured by the response ratio ( p = 0.04, analysis of variance [ANOVA]), and improvements in mood on the Beck Depression Inventory ( p = 0.02, ANOVA). Conclusions: This study provides preliminary evidence that eTNS is safe and may be effective in subjects with DRE. Side effects were primarily limited to anxiety, headache, and skin irritation. These results will serve as a basis to inform and power a larger multicenter phase III clinical trial. Classification of evidence: This phase II study provides Class II evidence that trigeminal nerve stimulation may be safe and effective in reducing seizures in people with DRE.
Doug Coyle - One of the best experts on this subject based on the ideXlab platform.
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barriers in accessing medical cannabis for children with Drug Resistant Epilepsy in canada a qualitative study
Epilepsy & Behavior, 2020Co-Authors: Jesse Elliott, Deirdre Dejean, Beth K Potter, Blathnaid Mccoy, Tammy Clifford, Doug Coyle, George A WellsAbstract:Abstract Introduction The use of medical cannabis to treat Drug-Resistant Epilepsy in children is increasing; however, there has been limited study of the experiences of parents with the current system of accessing medical cannabis for their children. Methods In this qualitative study, we used a patient-centered access to care framework to explore the barriers faced by parents of children with Drug-Resistant Epilepsy when trying to access medical cannabis in Canada. We conducted semistructured interviews with 19 parents to elicit their experiences with medical cannabis. We analyzed the data according to five dimensions of access, namely approachability, acceptability, availability, affordability, and appropriateness. Results Parents sought medical cannabis as a treatment because of a perceived unmet need stemming from the failure of antiepileptic Drugs to control their children's seizures. Medical cannabis was viewed as an acceptable treatment, especially compared with adding additional antiepileptic Drugs. After learning about medical cannabis from the media, friends and family, or other parents, participants sought authorization for medical use. However, most encountered resistance from their child's neurologist to discuss and/or authorize medical cannabis, and many parents experienced difficulty in obtaining authorization from a member of the child's existing care team, leading them to seek authorization from a cannabis clinic. Participants described spending up to $2000 per month on medical cannabis, and most were frustrated that it was not eligible for reimbursement through public or private insurance programs. Conclusions Parents pursue medical cannabis as a treatment for their children's Drug-Resistant Epilepsy because of a perceived unmet need. However, parents encounter barriers in accessing medical cannabis in Canada, and strategies are needed to ensure that children using medical cannabis receive proper care from healthcare professionals with training in Epilepsy care, antiepileptic Drugs, and medical cannabis.
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neurologists perspectives on medical cannabis for pediatric Drug Resistant Epilepsy in canada a qualitative interview study
Seizure-european Journal of Epilepsy, 2020Co-Authors: Jesse Elliott, Deirdre Dejean, Beth K Potter, Blathnaid Mccoy, Tammy Clifford, Doug Coyle, George A WellsAbstract:Abstract Purpose To understand the experiences with and perspectives of neurologists about the use of medical cannabis in the treatment of pediatric Drug-Resistant Epilepsy. Methods In this qualitative study, we interviewed neurologists who provide care to children with Drug-Resistant Epilepsy in Canada. Through semi-structured telephone interviews, we sought participants’ views about and experiences with medical cannabis for the treatment of Drug-Resistant Epilepsy in children. Here we present a thematic summary of the interviews. Results The 12 interviewed neurologists generally perceived medical cannabis as a viable treatment option for children with Drug-Resistant Epilepsy; however, participants identified important gaps in the evidence and implications for their practices. Six themes were generated from the content of the interviews: learning about medical cannabis; perceptions about medical cannabis; discussing medical cannabis with parents; experiences with medical cannabis authorization; barriers to authorizing medical cannabis; and the impact of medical cannabis on clinical care. Of note, while some neurologists took on all aspects of the children’s care, including medical cannabis, others referred interested families to non-neurology health care professionals. Conclusion Our findings highlight the diverse opinions and experiences of neurologists in Canada with medical cannabis for the treatment of Drug-Resistant Epilepsy in children, including with the authorization process and caring for children using medical cannabis. Additional education about medical cannabis may be warranted, in order to better prepare neurologists to have informed and open conversations with parents about this treatment option and to provide care for children using medical cannabis.
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decision models for assessing the cost effectiveness of treatments for pediatric Drug Resistant Epilepsy a systematic review of economic evaluations
PharmacoEconomics, 2019Co-Authors: Jesse Elliott, Beth K Potter, Blathnaid Mccoy, Tammy Clifford, George A Wells, Becky Skidmore, Sasha Van Katwyk, Doug CoyleAbstract:Drug-Resistant Epilepsy affects about one-third of children with Epilepsy and is associated with high costs to the healthcare system, yet the cost effectiveness of most treatments is unclear. Use of cannabis-based products for Epilepsy is increasing, and the cost effectiveness of such strategies relative to conventional pharmacologic treatments must be considered. The objective of this systematic review was to identify economic evaluations of cannabis-based treatments for pediatric Drug-Resistant Epilepsy. We also sought to identify and appraise decision models that have been used in economic evaluations of pharmacologic treatments (i.e., antiepileptic Drugs) in this population. Electronic searches of MEDLINE, EMBASE, and the Cochrane library, as well as a targeted grey literature search, were undertaken (11 June 2018). Model-based full economic evaluations involving cannabis-based treatments or pharmacologic treatments for Drug-Resistant Epilepsy in children were eligible for inclusion. Two independent reviewers selected studies for inclusion, and study quality was assessed by use of the Drummond and Consolidated Health Economic Evaluation Reporting Standards (CHEERS) checklists. Study findings, as well as model characteristics, are narratively summarized. Nine economic evaluations involving children with Drug-Resistant Epilepsy were identified; however, none involved cannabis-based treatments. All studies involved pharmacologic treatments compared with other pharmacologic treatments or non-pharmacologic treatments (i.e., ketogenic diet, Epilepsy surgery, vagus nerve stimulation). Few studies have assessed the cost effectiveness of pharmacologic treatments in specific Drug-Resistant Epilepsy syndromes, including Dravet and Lennox-Gastaut syndromes. Five included studies involved use of Markov models with a similar structure (i.e., health states based on seizure frequency relative to baseline). There was a wide range of methodological quality, and few studies fully addressed context-specific issues such as weight gain and treatment switching. Whether cannabis-based treatments for pediatric Drug-Resistant Epilepsy represent good value for money has yet to be investigated. Economic evaluations of such treatments are needed and should address issues of particular importance in pediatric Epilepsy, including weight gain over time, switching or discontinuation of treatments, effectiveness of interventions and comparators, and long-term effectiveness beyond the duration of available clinical studies. CRD42018099591.
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cost effectiveness of cannabinoids for pediatric Drug Resistant Epilepsy protocol for a systematic review of economic evaluations
Systematic Reviews, 2019Co-Authors: Jesse Elliott, Beth K Potter, Blathnaid Mccoy, Tammy Clifford, George A Wells, Becky Skidmore, Doug CoyleAbstract:Drug-Resistant Epilepsy negatively impacts the quality of life and is associated with increased morbidity and mortality and high costs to the healthcare system. Cannabis-based treatments may be effective in reducing seizures in this population, but whether they are cost-effective is unclear. In this systematic review, we will search for cost-effectiveness analyses involving the treatment of pediatric Drug-Resistant Epilepsy with cannabis-based products to inform decision-making by public healthcare payers about reimbursement of such products. We will also search for cost-effectiveness analyses of other pharmacologic treatments for pediatric Drug-Resistant Epilepsy, as well as estimates of healthcare resource use, costs, and utilities, for use in a subsequent cost-utility analysis to address this decision problem. We will search the published and gray literature for economic evaluations of cannabis-based products and other pharmacologic treatments for pediatric Drug-Resistant Epilepsy, as well as resource utilization and utility studies. Two independent reviewers will screen the title and abstract of each identified record and the full-text version of any study deemed potentially relevant. Study and population characteristics, the incremental cost-effectiveness ratio (ICER), as well as total costs and benefits, will be extracted, and quality will be assessed by use of the Drummond and CHEERS checklists; context-specific issues will also be considered. From model-based cost-utility and cost-effectiveness analyses, we will extract and summarize the model structure, including health states, time horizon, and cycle length. From resource utilization studies, we will extract data about the frequency of resource use (e.g., neurology visits, emergency department visits, admissions to hospital). From utility studies, we will extract the utility for each health state, the source of the preferences (e.g., child, parent, patient, general public), and the method of elicitation. Drug-Resistant Epilepsy in children is associated with important costs to the healthcare system, and decision-makers require high-quality evidence on which to base reimbursement decisions. The results of this review will be useful to both decision-makers considering the decision problem of whether to reimburse cannabis-based products through public formularies and to analysts conducting studies in this area. PROSPERO no.: CRD42018099591 .
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Cost-effectiveness of cannabinoids for pediatric Drug-Resistant Epilepsy: protocol for a systematic review of economic evaluations
BMC, 2019Co-Authors: Jesse Elliott, Beth K Potter, Blathnaid Mccoy, Tammy Clifford, George A Wells, Becky Skidmore, Doug CoyleAbstract:Abstract Background Drug-Resistant Epilepsy negatively impacts the quality of life and is associated with increased morbidity and mortality and high costs to the healthcare system. Cannabis-based treatments may be effective in reducing seizures in this population, but whether they are cost-effective is unclear. In this systematic review, we will search for cost-effectiveness analyses involving the treatment of pediatric Drug-Resistant Epilepsy with cannabis-based products to inform decision-making by public healthcare payers about reimbursement of such products. We will also search for cost-effectiveness analyses of other pharmacologic treatments for pediatric Drug-Resistant Epilepsy, as well as estimates of healthcare resource use, costs, and utilities, for use in a subsequent cost-utility analysis to address this decision problem. Methods We will search the published and gray literature for economic evaluations of cannabis-based products and other pharmacologic treatments for pediatric Drug-Resistant Epilepsy, as well as resource utilization and utility studies. Two independent reviewers will screen the title and abstract of each identified record and the full-text version of any study deemed potentially relevant. Study and population characteristics, the incremental cost-effectiveness ratio (ICER), as well as total costs and benefits, will be extracted, and quality will be assessed by use of the Drummond and CHEERS checklists; context-specific issues will also be considered. From model-based cost-utility and cost-effectiveness analyses, we will extract and summarize the model structure, including health states, time horizon, and cycle length. From resource utilization studies, we will extract data about the frequency of resource use (e.g., neurology visits, emergency department visits, admissions to hospital). From utility studies, we will extract the utility for each health state, the source of the preferences (e.g., child, parent, patient, general public), and the method of elicitation. Discussion Drug-Resistant Epilepsy in children is associated with important costs to the healthcare system, and decision-makers require high-quality evidence on which to base reimbursement decisions. The results of this review will be useful to both decision-makers considering the decision problem of whether to reimburse cannabis-based products through public formularies and to analysts conducting studies in this area. Systematic review registration PROSPERO no.: CRD42018099591
Jesse Elliott - One of the best experts on this subject based on the ideXlab platform.
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barriers in accessing medical cannabis for children with Drug Resistant Epilepsy in canada a qualitative study
Epilepsy & Behavior, 2020Co-Authors: Jesse Elliott, Deirdre Dejean, Beth K Potter, Blathnaid Mccoy, Tammy Clifford, Doug Coyle, George A WellsAbstract:Abstract Introduction The use of medical cannabis to treat Drug-Resistant Epilepsy in children is increasing; however, there has been limited study of the experiences of parents with the current system of accessing medical cannabis for their children. Methods In this qualitative study, we used a patient-centered access to care framework to explore the barriers faced by parents of children with Drug-Resistant Epilepsy when trying to access medical cannabis in Canada. We conducted semistructured interviews with 19 parents to elicit their experiences with medical cannabis. We analyzed the data according to five dimensions of access, namely approachability, acceptability, availability, affordability, and appropriateness. Results Parents sought medical cannabis as a treatment because of a perceived unmet need stemming from the failure of antiepileptic Drugs to control their children's seizures. Medical cannabis was viewed as an acceptable treatment, especially compared with adding additional antiepileptic Drugs. After learning about medical cannabis from the media, friends and family, or other parents, participants sought authorization for medical use. However, most encountered resistance from their child's neurologist to discuss and/or authorize medical cannabis, and many parents experienced difficulty in obtaining authorization from a member of the child's existing care team, leading them to seek authorization from a cannabis clinic. Participants described spending up to $2000 per month on medical cannabis, and most were frustrated that it was not eligible for reimbursement through public or private insurance programs. Conclusions Parents pursue medical cannabis as a treatment for their children's Drug-Resistant Epilepsy because of a perceived unmet need. However, parents encounter barriers in accessing medical cannabis in Canada, and strategies are needed to ensure that children using medical cannabis receive proper care from healthcare professionals with training in Epilepsy care, antiepileptic Drugs, and medical cannabis.
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neurologists perspectives on medical cannabis for pediatric Drug Resistant Epilepsy in canada a qualitative interview study
Seizure-european Journal of Epilepsy, 2020Co-Authors: Jesse Elliott, Deirdre Dejean, Beth K Potter, Blathnaid Mccoy, Tammy Clifford, Doug Coyle, George A WellsAbstract:Abstract Purpose To understand the experiences with and perspectives of neurologists about the use of medical cannabis in the treatment of pediatric Drug-Resistant Epilepsy. Methods In this qualitative study, we interviewed neurologists who provide care to children with Drug-Resistant Epilepsy in Canada. Through semi-structured telephone interviews, we sought participants’ views about and experiences with medical cannabis for the treatment of Drug-Resistant Epilepsy in children. Here we present a thematic summary of the interviews. Results The 12 interviewed neurologists generally perceived medical cannabis as a viable treatment option for children with Drug-Resistant Epilepsy; however, participants identified important gaps in the evidence and implications for their practices. Six themes were generated from the content of the interviews: learning about medical cannabis; perceptions about medical cannabis; discussing medical cannabis with parents; experiences with medical cannabis authorization; barriers to authorizing medical cannabis; and the impact of medical cannabis on clinical care. Of note, while some neurologists took on all aspects of the children’s care, including medical cannabis, others referred interested families to non-neurology health care professionals. Conclusion Our findings highlight the diverse opinions and experiences of neurologists in Canada with medical cannabis for the treatment of Drug-Resistant Epilepsy in children, including with the authorization process and caring for children using medical cannabis. Additional education about medical cannabis may be warranted, in order to better prepare neurologists to have informed and open conversations with parents about this treatment option and to provide care for children using medical cannabis.
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decision models for assessing the cost effectiveness of treatments for pediatric Drug Resistant Epilepsy a systematic review of economic evaluations
PharmacoEconomics, 2019Co-Authors: Jesse Elliott, Beth K Potter, Blathnaid Mccoy, Tammy Clifford, George A Wells, Becky Skidmore, Sasha Van Katwyk, Doug CoyleAbstract:Drug-Resistant Epilepsy affects about one-third of children with Epilepsy and is associated with high costs to the healthcare system, yet the cost effectiveness of most treatments is unclear. Use of cannabis-based products for Epilepsy is increasing, and the cost effectiveness of such strategies relative to conventional pharmacologic treatments must be considered. The objective of this systematic review was to identify economic evaluations of cannabis-based treatments for pediatric Drug-Resistant Epilepsy. We also sought to identify and appraise decision models that have been used in economic evaluations of pharmacologic treatments (i.e., antiepileptic Drugs) in this population. Electronic searches of MEDLINE, EMBASE, and the Cochrane library, as well as a targeted grey literature search, were undertaken (11 June 2018). Model-based full economic evaluations involving cannabis-based treatments or pharmacologic treatments for Drug-Resistant Epilepsy in children were eligible for inclusion. Two independent reviewers selected studies for inclusion, and study quality was assessed by use of the Drummond and Consolidated Health Economic Evaluation Reporting Standards (CHEERS) checklists. Study findings, as well as model characteristics, are narratively summarized. Nine economic evaluations involving children with Drug-Resistant Epilepsy were identified; however, none involved cannabis-based treatments. All studies involved pharmacologic treatments compared with other pharmacologic treatments or non-pharmacologic treatments (i.e., ketogenic diet, Epilepsy surgery, vagus nerve stimulation). Few studies have assessed the cost effectiveness of pharmacologic treatments in specific Drug-Resistant Epilepsy syndromes, including Dravet and Lennox-Gastaut syndromes. Five included studies involved use of Markov models with a similar structure (i.e., health states based on seizure frequency relative to baseline). There was a wide range of methodological quality, and few studies fully addressed context-specific issues such as weight gain and treatment switching. Whether cannabis-based treatments for pediatric Drug-Resistant Epilepsy represent good value for money has yet to be investigated. Economic evaluations of such treatments are needed and should address issues of particular importance in pediatric Epilepsy, including weight gain over time, switching or discontinuation of treatments, effectiveness of interventions and comparators, and long-term effectiveness beyond the duration of available clinical studies. CRD42018099591.
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cost effectiveness of cannabinoids for pediatric Drug Resistant Epilepsy protocol for a systematic review of economic evaluations
Systematic Reviews, 2019Co-Authors: Jesse Elliott, Beth K Potter, Blathnaid Mccoy, Tammy Clifford, George A Wells, Becky Skidmore, Doug CoyleAbstract:Drug-Resistant Epilepsy negatively impacts the quality of life and is associated with increased morbidity and mortality and high costs to the healthcare system. Cannabis-based treatments may be effective in reducing seizures in this population, but whether they are cost-effective is unclear. In this systematic review, we will search for cost-effectiveness analyses involving the treatment of pediatric Drug-Resistant Epilepsy with cannabis-based products to inform decision-making by public healthcare payers about reimbursement of such products. We will also search for cost-effectiveness analyses of other pharmacologic treatments for pediatric Drug-Resistant Epilepsy, as well as estimates of healthcare resource use, costs, and utilities, for use in a subsequent cost-utility analysis to address this decision problem. We will search the published and gray literature for economic evaluations of cannabis-based products and other pharmacologic treatments for pediatric Drug-Resistant Epilepsy, as well as resource utilization and utility studies. Two independent reviewers will screen the title and abstract of each identified record and the full-text version of any study deemed potentially relevant. Study and population characteristics, the incremental cost-effectiveness ratio (ICER), as well as total costs and benefits, will be extracted, and quality will be assessed by use of the Drummond and CHEERS checklists; context-specific issues will also be considered. From model-based cost-utility and cost-effectiveness analyses, we will extract and summarize the model structure, including health states, time horizon, and cycle length. From resource utilization studies, we will extract data about the frequency of resource use (e.g., neurology visits, emergency department visits, admissions to hospital). From utility studies, we will extract the utility for each health state, the source of the preferences (e.g., child, parent, patient, general public), and the method of elicitation. Drug-Resistant Epilepsy in children is associated with important costs to the healthcare system, and decision-makers require high-quality evidence on which to base reimbursement decisions. The results of this review will be useful to both decision-makers considering the decision problem of whether to reimburse cannabis-based products through public formularies and to analysts conducting studies in this area. PROSPERO no.: CRD42018099591 .
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Cost-effectiveness of cannabinoids for pediatric Drug-Resistant Epilepsy: protocol for a systematic review of economic evaluations
BMC, 2019Co-Authors: Jesse Elliott, Beth K Potter, Blathnaid Mccoy, Tammy Clifford, George A Wells, Becky Skidmore, Doug CoyleAbstract:Abstract Background Drug-Resistant Epilepsy negatively impacts the quality of life and is associated with increased morbidity and mortality and high costs to the healthcare system. Cannabis-based treatments may be effective in reducing seizures in this population, but whether they are cost-effective is unclear. In this systematic review, we will search for cost-effectiveness analyses involving the treatment of pediatric Drug-Resistant Epilepsy with cannabis-based products to inform decision-making by public healthcare payers about reimbursement of such products. We will also search for cost-effectiveness analyses of other pharmacologic treatments for pediatric Drug-Resistant Epilepsy, as well as estimates of healthcare resource use, costs, and utilities, for use in a subsequent cost-utility analysis to address this decision problem. Methods We will search the published and gray literature for economic evaluations of cannabis-based products and other pharmacologic treatments for pediatric Drug-Resistant Epilepsy, as well as resource utilization and utility studies. Two independent reviewers will screen the title and abstract of each identified record and the full-text version of any study deemed potentially relevant. Study and population characteristics, the incremental cost-effectiveness ratio (ICER), as well as total costs and benefits, will be extracted, and quality will be assessed by use of the Drummond and CHEERS checklists; context-specific issues will also be considered. From model-based cost-utility and cost-effectiveness analyses, we will extract and summarize the model structure, including health states, time horizon, and cycle length. From resource utilization studies, we will extract data about the frequency of resource use (e.g., neurology visits, emergency department visits, admissions to hospital). From utility studies, we will extract the utility for each health state, the source of the preferences (e.g., child, parent, patient, general public), and the method of elicitation. Discussion Drug-Resistant Epilepsy in children is associated with important costs to the healthcare system, and decision-makers require high-quality evidence on which to base reimbursement decisions. The results of this review will be useful to both decision-makers considering the decision problem of whether to reimburse cannabis-based products through public formularies and to analysts conducting studies in this area. Systematic review registration PROSPERO no.: CRD42018099591
George A Wells - One of the best experts on this subject based on the ideXlab platform.
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barriers in accessing medical cannabis for children with Drug Resistant Epilepsy in canada a qualitative study
Epilepsy & Behavior, 2020Co-Authors: Jesse Elliott, Deirdre Dejean, Beth K Potter, Blathnaid Mccoy, Tammy Clifford, Doug Coyle, George A WellsAbstract:Abstract Introduction The use of medical cannabis to treat Drug-Resistant Epilepsy in children is increasing; however, there has been limited study of the experiences of parents with the current system of accessing medical cannabis for their children. Methods In this qualitative study, we used a patient-centered access to care framework to explore the barriers faced by parents of children with Drug-Resistant Epilepsy when trying to access medical cannabis in Canada. We conducted semistructured interviews with 19 parents to elicit their experiences with medical cannabis. We analyzed the data according to five dimensions of access, namely approachability, acceptability, availability, affordability, and appropriateness. Results Parents sought medical cannabis as a treatment because of a perceived unmet need stemming from the failure of antiepileptic Drugs to control their children's seizures. Medical cannabis was viewed as an acceptable treatment, especially compared with adding additional antiepileptic Drugs. After learning about medical cannabis from the media, friends and family, or other parents, participants sought authorization for medical use. However, most encountered resistance from their child's neurologist to discuss and/or authorize medical cannabis, and many parents experienced difficulty in obtaining authorization from a member of the child's existing care team, leading them to seek authorization from a cannabis clinic. Participants described spending up to $2000 per month on medical cannabis, and most were frustrated that it was not eligible for reimbursement through public or private insurance programs. Conclusions Parents pursue medical cannabis as a treatment for their children's Drug-Resistant Epilepsy because of a perceived unmet need. However, parents encounter barriers in accessing medical cannabis in Canada, and strategies are needed to ensure that children using medical cannabis receive proper care from healthcare professionals with training in Epilepsy care, antiepileptic Drugs, and medical cannabis.
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neurologists perspectives on medical cannabis for pediatric Drug Resistant Epilepsy in canada a qualitative interview study
Seizure-european Journal of Epilepsy, 2020Co-Authors: Jesse Elliott, Deirdre Dejean, Beth K Potter, Blathnaid Mccoy, Tammy Clifford, Doug Coyle, George A WellsAbstract:Abstract Purpose To understand the experiences with and perspectives of neurologists about the use of medical cannabis in the treatment of pediatric Drug-Resistant Epilepsy. Methods In this qualitative study, we interviewed neurologists who provide care to children with Drug-Resistant Epilepsy in Canada. Through semi-structured telephone interviews, we sought participants’ views about and experiences with medical cannabis for the treatment of Drug-Resistant Epilepsy in children. Here we present a thematic summary of the interviews. Results The 12 interviewed neurologists generally perceived medical cannabis as a viable treatment option for children with Drug-Resistant Epilepsy; however, participants identified important gaps in the evidence and implications for their practices. Six themes were generated from the content of the interviews: learning about medical cannabis; perceptions about medical cannabis; discussing medical cannabis with parents; experiences with medical cannabis authorization; barriers to authorizing medical cannabis; and the impact of medical cannabis on clinical care. Of note, while some neurologists took on all aspects of the children’s care, including medical cannabis, others referred interested families to non-neurology health care professionals. Conclusion Our findings highlight the diverse opinions and experiences of neurologists in Canada with medical cannabis for the treatment of Drug-Resistant Epilepsy in children, including with the authorization process and caring for children using medical cannabis. Additional education about medical cannabis may be warranted, in order to better prepare neurologists to have informed and open conversations with parents about this treatment option and to provide care for children using medical cannabis.
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decision models for assessing the cost effectiveness of treatments for pediatric Drug Resistant Epilepsy a systematic review of economic evaluations
PharmacoEconomics, 2019Co-Authors: Jesse Elliott, Beth K Potter, Blathnaid Mccoy, Tammy Clifford, George A Wells, Becky Skidmore, Sasha Van Katwyk, Doug CoyleAbstract:Drug-Resistant Epilepsy affects about one-third of children with Epilepsy and is associated with high costs to the healthcare system, yet the cost effectiveness of most treatments is unclear. Use of cannabis-based products for Epilepsy is increasing, and the cost effectiveness of such strategies relative to conventional pharmacologic treatments must be considered. The objective of this systematic review was to identify economic evaluations of cannabis-based treatments for pediatric Drug-Resistant Epilepsy. We also sought to identify and appraise decision models that have been used in economic evaluations of pharmacologic treatments (i.e., antiepileptic Drugs) in this population. Electronic searches of MEDLINE, EMBASE, and the Cochrane library, as well as a targeted grey literature search, were undertaken (11 June 2018). Model-based full economic evaluations involving cannabis-based treatments or pharmacologic treatments for Drug-Resistant Epilepsy in children were eligible for inclusion. Two independent reviewers selected studies for inclusion, and study quality was assessed by use of the Drummond and Consolidated Health Economic Evaluation Reporting Standards (CHEERS) checklists. Study findings, as well as model characteristics, are narratively summarized. Nine economic evaluations involving children with Drug-Resistant Epilepsy were identified; however, none involved cannabis-based treatments. All studies involved pharmacologic treatments compared with other pharmacologic treatments or non-pharmacologic treatments (i.e., ketogenic diet, Epilepsy surgery, vagus nerve stimulation). Few studies have assessed the cost effectiveness of pharmacologic treatments in specific Drug-Resistant Epilepsy syndromes, including Dravet and Lennox-Gastaut syndromes. Five included studies involved use of Markov models with a similar structure (i.e., health states based on seizure frequency relative to baseline). There was a wide range of methodological quality, and few studies fully addressed context-specific issues such as weight gain and treatment switching. Whether cannabis-based treatments for pediatric Drug-Resistant Epilepsy represent good value for money has yet to be investigated. Economic evaluations of such treatments are needed and should address issues of particular importance in pediatric Epilepsy, including weight gain over time, switching or discontinuation of treatments, effectiveness of interventions and comparators, and long-term effectiveness beyond the duration of available clinical studies. CRD42018099591.
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cost effectiveness of cannabinoids for pediatric Drug Resistant Epilepsy protocol for a systematic review of economic evaluations
Systematic Reviews, 2019Co-Authors: Jesse Elliott, Beth K Potter, Blathnaid Mccoy, Tammy Clifford, George A Wells, Becky Skidmore, Doug CoyleAbstract:Drug-Resistant Epilepsy negatively impacts the quality of life and is associated with increased morbidity and mortality and high costs to the healthcare system. Cannabis-based treatments may be effective in reducing seizures in this population, but whether they are cost-effective is unclear. In this systematic review, we will search for cost-effectiveness analyses involving the treatment of pediatric Drug-Resistant Epilepsy with cannabis-based products to inform decision-making by public healthcare payers about reimbursement of such products. We will also search for cost-effectiveness analyses of other pharmacologic treatments for pediatric Drug-Resistant Epilepsy, as well as estimates of healthcare resource use, costs, and utilities, for use in a subsequent cost-utility analysis to address this decision problem. We will search the published and gray literature for economic evaluations of cannabis-based products and other pharmacologic treatments for pediatric Drug-Resistant Epilepsy, as well as resource utilization and utility studies. Two independent reviewers will screen the title and abstract of each identified record and the full-text version of any study deemed potentially relevant. Study and population characteristics, the incremental cost-effectiveness ratio (ICER), as well as total costs and benefits, will be extracted, and quality will be assessed by use of the Drummond and CHEERS checklists; context-specific issues will also be considered. From model-based cost-utility and cost-effectiveness analyses, we will extract and summarize the model structure, including health states, time horizon, and cycle length. From resource utilization studies, we will extract data about the frequency of resource use (e.g., neurology visits, emergency department visits, admissions to hospital). From utility studies, we will extract the utility for each health state, the source of the preferences (e.g., child, parent, patient, general public), and the method of elicitation. Drug-Resistant Epilepsy in children is associated with important costs to the healthcare system, and decision-makers require high-quality evidence on which to base reimbursement decisions. The results of this review will be useful to both decision-makers considering the decision problem of whether to reimburse cannabis-based products through public formularies and to analysts conducting studies in this area. PROSPERO no.: CRD42018099591 .
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Cost-effectiveness of cannabinoids for pediatric Drug-Resistant Epilepsy: protocol for a systematic review of economic evaluations
BMC, 2019Co-Authors: Jesse Elliott, Beth K Potter, Blathnaid Mccoy, Tammy Clifford, George A Wells, Becky Skidmore, Doug CoyleAbstract:Abstract Background Drug-Resistant Epilepsy negatively impacts the quality of life and is associated with increased morbidity and mortality and high costs to the healthcare system. Cannabis-based treatments may be effective in reducing seizures in this population, but whether they are cost-effective is unclear. In this systematic review, we will search for cost-effectiveness analyses involving the treatment of pediatric Drug-Resistant Epilepsy with cannabis-based products to inform decision-making by public healthcare payers about reimbursement of such products. We will also search for cost-effectiveness analyses of other pharmacologic treatments for pediatric Drug-Resistant Epilepsy, as well as estimates of healthcare resource use, costs, and utilities, for use in a subsequent cost-utility analysis to address this decision problem. Methods We will search the published and gray literature for economic evaluations of cannabis-based products and other pharmacologic treatments for pediatric Drug-Resistant Epilepsy, as well as resource utilization and utility studies. Two independent reviewers will screen the title and abstract of each identified record and the full-text version of any study deemed potentially relevant. Study and population characteristics, the incremental cost-effectiveness ratio (ICER), as well as total costs and benefits, will be extracted, and quality will be assessed by use of the Drummond and CHEERS checklists; context-specific issues will also be considered. From model-based cost-utility and cost-effectiveness analyses, we will extract and summarize the model structure, including health states, time horizon, and cycle length. From resource utilization studies, we will extract data about the frequency of resource use (e.g., neurology visits, emergency department visits, admissions to hospital). From utility studies, we will extract the utility for each health state, the source of the preferences (e.g., child, parent, patient, general public), and the method of elicitation. Discussion Drug-Resistant Epilepsy in children is associated with important costs to the healthcare system, and decision-makers require high-quality evidence on which to base reimbursement decisions. The results of this review will be useful to both decision-makers considering the decision problem of whether to reimburse cannabis-based products through public formularies and to analysts conducting studies in this area. Systematic review registration PROSPERO no.: CRD42018099591
