Real-world cost- effectiveness analysis: Tumor Treating Fields for newly diagnosed glioblastoma in China.

BACKGROUND: Glioblastoma (GBM) stands as the most aggressive and prevalent primary brain malignancy. Tumor Treating Fields (TTFields), an innovative therapy complementing chemotherapy for GBM treatment, which can significantly enhance overall survival, disease progression-free survival, and patient's quality of life. However, there is a dearth of health economics evaluation on TTFields therapy both domestically and internationally. OBJECTIVE: The study aims to assess the cost-effectiveness of TTFields + temozolomide (TMZ) in comparison to TMZ alone for newly diagnosed GBM patients. The intent is to provide robust economic evidence to serve as a foundation for policymaking and decision-making processes in GBM treatment. METHODS: We estimated outcomes for newly diagnosed GBM patients over a lifetime horizon using a partitioned survival model with three states: Progression-Free Survival, Progression Disease, and Death. The survival model was derived from a real-world study in China, with long-term survival data drawn from GBM epidemiology literature. Adverse event rates were sourced from the EF-14 trial data. Cost data, validated by expert consultation, was obtained from public literature and databases. Utility values were extracted from published literature. Using Microsoft Excel, we calculated expected costs and quality-adjusted life years (QALYs) over 15 years from a health system perspective. The willingness-to-pay threshold was set at three times the Chinese per capita Gross Domestic Product (GDP) in 2022, amounting to CN¥242,928 (US$37,655) /QALY. A 5% discount rate was applied to costs and utilities. Results underwent analysis through single factor and probability sensitivity analyses. RESULTS: TTFields + TMZ demonstrated a mean increase in cost by CN¥389,326 (US$57,859) and an increase of 2.46 QALYs compared to TMZ alone. The incremental cost-effectiveness ratio (ICER) was CN¥157,979 (US$23,474) per QALY gained. The model exhibited heightened sensitivity to changes in the discount rate. Probability sensitivity analysis indicates that, under the existing threshold, the probability of TTFields + TMZ being economical is 95.60%. CONCLUSIONS: This cost-effectiveness analysis affirms that incorporating TTFields into TMZ treatment proves to be cost-effective, given a threshold three times the Chinese per capita GDP.

Effectiveness, safety and cost-effectiveness of sacral neuromodulation for idiopathic slow-transit constipation: a systematic review.

AIM: Sacral neuromodulation (SNM) is a minimally invasive treatment option for functional constipation. Evidence regarding its effectiveness is contradictory, driven by heterogeneous study populations and designs. The aim of this study was to assess the effectiveness, safety and cost-effectiveness of SNM in children and adults with refractory idiopathic slow-transit constipation (STC). METHOD: OVID Medline, OVID Embase, Cochrane Library, the KSR Evidence Database, the NHS Economic Evaluation Database and the International HTA Database were searched up to 25 May 2023. For effectiveness outcomes, randomized controlled trials (RCTs) were selected. For safety outcomes, all study designs were selected. For cost-effectiveness outcomes, trial- and model-based economic evaluations were selected for review. Study selection, risk of bias and quality assessment, and data extraction were independently performed by two reviewers. For the intervention 'sacral neuromodulation' effectiveness outcomes included defaecation frequency and constipation severity. Safety and cost-effectiveness outcomes were, respectively, adverse events and incremental cost-effectiveness ratios. RESULTS: Of 1390 records reviewed, 67 studies were selected for full-text screening. For effectiveness, one cross-over and one parallel-group RCT was included, showing contradictory results. Eleven studies on safety were included (four RCTs, three prospective cohort studies and four retrospective cohort studies). Overall infection rates varied between 0% and 22%, whereas reoperation rates varied between 0% and 29%. One trial-based economic evaluation was included, which concluded that SNM was not cost-effective compared with personalized conservative treatment at a time horizon of 6 months. The review findings are limited by the small number of available studies and the heterogeneity in terms of study populations, definitions of refractory idiopathic STC and study designs. CONCLUSION: Evidence for the (cost-)effectiveness of SNM in children and adults with refractory idiopathic STC is inconclusive. Reoperation rates of up to 29% were reported.

Nutritional Assessment in Patients after Gastric Electrical Stimulation (GES).

BACKGROUND: Gastric electrical stimulation (GES) is used for patients with drug-refractory gastroparesis (Gp) symptoms. Approximately two-thirds of patients with Gp symptoms are either overweight or obese. We aimed to assess symptoms and nutritional status pre-GES and post-GES placement in a large sample of drug-refractory Gp patients. METHODS: We conducted a chart review of 282 patients with drug-refractory Gp who received temporary followed by permanent GES at an academic medical center. Gastrointestinal symptoms were collected by a traditional standardized PRO (0-4, 0 being asymptomatic and 4 being worst symptoms), baseline nutritional status by BMI plus subjective global assessment (SGA score A, B, C, for mild, moderate, and severe nutritional deficits), ability to tolerate diet, enteral tube access, and parenteral therapy were assessed at baseline and after permanent GES placement. RESULTS: Comparing baseline with permanent, GES was found to significantly improve upper GI symptoms in all quartiles. Of the 282 patients with baseline body mass index (BMI) information, 112 (40%) patients were severely malnourished at baseline, of which 36 (32%) patients' nutritional status improved after GES. Among all patients, 76 (68%) patients' nutritional status remained unchanged. Many patients with high BMI were malnourished by SGA. CONCLUSION: We conclude that symptomatic patients of different BMIs showed improvement in their GI symptoms irrespective of baseline nutritional status. Severely malnourished patients were found to have an improvement in their nutritional status after GES therapy. We conclude that BMI, even if high, is not by itself a contraindication for GES therapy for symptomatic patients.

Long-Term Cost Analysis of Third-Line Treatment Options for Overactive Bladder.

INTRODUCTION: We aimed to analyze the long-term cost of overactive bladder third-line treatments. METHODS: This insurance claims review analyzed the 2015 to 2020 MarketScan (MKS) claims data set subjects age ≥ 18, diagnosis of overactive bladder (OAB) using ICD-9/ICD-10 codes and receipt of treatment for percutaneous tibial nerve stimulation, sacral neuromodulation (SNM), or botulinum A. Age, gender, treatment types, and cost were extracted. Treatment costs were aggregated at the level of patient and treatment type for total payment and patient contribution by combining copay, coinsurance, and deductible. We used the Wilcoxon rank-sum test for continuous and chi-square test for categorical variables. SAS v9.4 was used for analyses. Significance was set at P < .05. RESULTS: We identified 17,755 patients from the commercial claims MKS and 10,912 patients from the Medicare supplemental (MDC) database with mean age 50.7±11.1 and 75.5±7.6 years, respectively, who underwent ≥ 1 third-line OAB treatment. Patients receiving third-line treatment were predominantly female (84.9%, MKS, 74.8%, MDC). Long-term costs over a 15-year period were estimated. Percutaneous tibial nerve stimulation is the most expensive in terms of total net payment ($105,337.50 MKS, $94,102.50 MDC) and patient contribution ($9177.60 MKS, $3921.00 MDC). Total net payment for botulinum A was $67,968 (MSK), $54,261 (MDC), and patient contribution cost was $2850 (MSK), $1110 (MDC). The most cost-effective option was SNM in terms of both total net payment ($5179.10 MKS, $6099.00 MDC) and patient contribution ($59.10 MKS, $60.00 MDC). CONCLUSIONS: SNM was the most cost-effective third-line treatment for OAB looking over a 15-year period in terms of both total net payment and patient contribution.

Retrospective study of sacral neuromodulator implantations in a French hospital center: Lifespan and hospital costs assessment.

PURPOSE: Sacral nerve neuromodulation (SNM) is a safe and effective therapy for the management of fecal and/or urinary incontinence. The generators InterStim™ and InterStim™ II (Medtronic™) are non-rechargeable active implantable medical devices with a limited lifespan. The aims of this study were to assess the generators' median lifespan for all indications and the long-term hospital costs of the therapy. METHODS: This was a retrospective monocentric study that included 215 patients aged over 18 years who were treated by SNM for fecal incontinence and/or urinary incontinence. Lifespan was considered as the amount of time between definitive implantation and observed battery depletion by the surgeon and was assessed by the Kaplan-Meier method. Costs were assessed according to the activity-based pricing of the French public health care system. RESULTS: The median observed lifetime of stimulators implanted in our center was 7.29 years and 5.9 years for InterStim™ and InterStim™ II, respectively. The difference observed between the two generations was statistically significant. The modelling of primary implantation and renewal costs allowed us to observe that the decrease in the lifetime of Interstim™ II is associated with an increase in hospital costs over time. The retrospective study design is one limitation and we did not take into consideration stimulation's settings. CONCLUSIONS: The InterStim™ II lifespan is shorter than the first-generation device. This is associated with an increase of the long-term hospital costs. Additional information about the new neuromodulator will be required to choose the most appropriate IPG for the patient while optimizing the costs.

Long-term cost-effectiveness analysis of sacral neuromodulation in the treatment of severe faecal incontinence.

AIM: The aim of this study was to evaluate the long-term cost-effectiveness of sacral neuromodulation in the treatment of severe faecal incontinence as compared with symptomatic management. METHODS: In the public health field, a micro-costing evaluation method was conducted from the perspectives of the health system and the society. The incremental cost-effectiveness ratio was used as a decision index, and we considered various scenarios to evaluate the impact of the cost of symptomatic management and percutaneous nerve evaluation success rate in its calculation. Clinical data were retrieved from a consecutive cohort of 93 patients with severe faecal incontinence undergoing sacral neuromodulation after a failure of conservative (pharmacological and biofeedback) and/or surgical (sphincteroplasty) first-line treatments were considered. RESULTS: The long-term incremental cost-effectiveness ratio comparing sacral neuromodulation versus symptomatic management was 14347€/QALY and 28523€/QALY from the societal and health service provider's perspectives, respectively. If the definitive pulse generator implant success rate was 100%, incremental cost-effectiveness would correspond to 6831€/QALY and 16761€/QALY, respectively. CONCLUSIONS: Sacral neuromodulation may be considered a cost-effective technique in the long-term treatment of severe faecal incontinence from the societal and health care sector perspectives. Improving patient selection and determining the predictive outcome factors for successful sacral neuromodulation in the treatment of faecal incontinence would improve cost-effectiveness.

Patient-reported outcomes with hypoglossal nerve stimulation for treatment of obstructive sleep apnea: a systematic review and meta-analysis.

INTRODUCTION: Hypoglossal nerve stimulation (HNS) has recently been introduced as an alternative treatment for patients with OSA. A large number of studies have demonstrated substantial changes in OSA with this therapy by reducing respiratory events and improving symptoms such as daytime sleepiness and quality of life. The objective of this review was to conduct a systematic review and meta-analysis to evaluate patient-reported outcomes and experience with HNS therapy. METHODS: A systematic literature search of MEDLINE, Cochrane, and Web of Science was performed to identify randomized controlled and observational studies reporting subjective outcomes with different HNS systems in patients with OSA. Abstracts of 406 articles were screened and a subset of 55 articles were reviewed for eligibility. Risk of bias was assessed using the ROBINS-I tool. Meta-analysis using RevMan was performed when > 2 studies were identified that reported data on a specific outcome. RESULTS: Thirty-four publications reporting data on 3785 patients with a mean follow-up of 11.8 ± 12.2 months were identified and included in the meta-analysis. The analysis revealed a pooled effect of 4.59 points improvement in daytime sleepiness as measured by the ESS questionnaire (Z = 42.82, p < .001), 2.84 points improvement in daytime functioning as measured by the FOSQ score (Z = 28.38, p < .001), and 1.77 points improvement in sleep quality as measured by the PSQI questionnaire (Z = 2.53, p = .010). Patient-reported experience was consistently positive and revealed additional relevant aspects from this perspective. CONCLUSION: HNS therapy significantly improves quality of life in patients with OSA and reliably produces clinically meaningful effects on daytime sleepiness, daytime functioning, and sleep quality. Treatment regularly meets or exceeds the minimum clinically important differences defined for the respective instruments. Additional research is needed to further investigate effects on quality of life beyond improvements in daytime sleepiness and daytime functioning.

ICEP: An Instrumented Cycling Ergometer Platform for the Assessment of Advanced FES Strategies.

BACKGROUND: Functional electrical stimulation (FES) cycling has seen an upsurge in interest over the last decade. The present study describes the novel instrumented cycling ergometer platform designed to assess the efficiency of electrical stimulation strategies. The capabilities of the platform are showcased in an example determining the adequate stimulation patterns for reproducing a cycling movement of the paralyzed legs of a spinal cord injury (SCI) subject. METHODS: Two procedures have been followed to determine the stimulation patterns: (1) using the EMG recordings of the able-bodied subject; (2) using the recordings of the forces produced by the SCI subject's stimulated muscles. RESULTS: the stimulation pattern derived from the SCI subject's force output was found to produce 14% more power than the EMG-derived stimulation pattern. CONCLUSIONS: the cycling platform proved useful for determining and assessing stimulation patterns, and it can be used to further investigate advanced stimulation strategies.

Assessment of Stress Urinary Incontinence-Related Podcasts on Stitcher.

OBJECTIVE: To assess the quality, understandability, actionability, accuracy and commercial bias of podcasts regarding stress urinary incontinence (SUI). METHODS: The first 100 Stitcher podcasts from the search, "Stress urinary incontinence" were evaluated using the validated DISCERN criteria, PEMAT tool, and a Misinformation Likert Scale. The accuracy of information was assessed by comparison to the American Urological Association (AUA) SUI Guidelines. RESULTS: Common publisher types included health/wellness channels (66%). Low-moderate quality, poor understandability and misinformation was seen in 67% (DISCERN ≤3), 69% (PEMAT understandability ≤75%) and 17% of podcasts, respectively. Treatments discussed included pelvic floor muscle training (PFMT) (89%) and surgery (47%). Health and wellness channels had the most evidence of commercial bias (44%). Podcasts that discussed surgery more often emphasized shared decision-making (DISCERN15). CONCLUSION: SUI-related podcasts on Stitcher are mostly published by health/wellness channels and skewed toward discussing PFMT. Podcasts are often low-moderate quality, poorly understandable and often have commercial bias.

Diaphragm Pacing: A Safety, Appropriateness, Financial Neutrality, and Efficacy Analysis of Treating Chronic Respiratory Insufficiency.

OBJECTIVES: This study aimed to evaluate the safety and applicability of treating chronic respiratory insufficiency with diaphragm pacing relative to mechanical ventilation. MATERIALS AND METHODS: A literature review and analysis were conducted using the safety, appropriateness, financial neutrality, and efficacy principles. RESULTS: Although mechanical ventilation is clearly indicated in acute respiratory failure, diaphragm pacing improves life expectancy, increases quality of life, and reduces complications in patients with chronic respiratory insufficiency. CONCLUSION: Diaphragm pacing should be given more consideration in appropriately selected patients with chronic respiratory insufficiency.

Clinical Longevity of 106,462 Rechargeable and Primary Cell Spinal Cord Stimulators: Real World Study in the Medicare Population.

INTRODUCTION: Spinal cord stimulators (SCS) are available with either primary cell (PC) or rechargeable cell (RC) batteries. Although RC systems are proposed to have a battery longevity upward of nine years, in comparison with four years for PC systems, there are few studies of longevity of SCS in the real world. MATERIALS AND METHODS: This was an observational, nonrandomized, retrospective study of Medicare beneficiaries who received neurostimulator implants in the outpatient hospital. This study used Medicare fee-for-service claims data from 2013 to 2020. The clinical longevity of the implantable pulse generator (IPG), defined as the duration from implant until removal for any reason, was compared between PC and RC devices. Life distribution analysis was used to approximate device lifespan. The secondary analysis separated removals into explant or replacements. The statistics were adjusted for relevant clinical covariates. RESULTS: A total of 25,856 PC and 79,606 RC systems were included in the study. At seven years after implant, 53.8% of PC IPGs and 55.0% of RC IPGs remained in use. The life distribution modeling analysis projected a median lifespan of 8.2 years for PC and 9.0 years for RC devices. The rate of explant was lower for PC devices (19.2%) than for RC devices (22.0%, hazard ratio (HR) = 0.96, p = 0.082), whereas the rate of replacements was higher for PC devices (33.7%) than for RC devices (29.5%, HR = 1.31, p < 0.001). An analysis of the battery type used in device replacements showed an increasing adoption of PC devices over time. CONCLUSIONS: This large, retrospective, real-world analysis of Medicare claims data demonstrated that the clinical longevity of neurostimulator devices is similar for PC and RC batteries. In the past, clinicians may have defaulted to RC devices based on the assumption that they provided extended battery life. Considering this longevity data, clinicians should now consider the choice between PC and RC devices based on other individual factors pertinent to the patient experience and not on purported longevity claims.

Optimization of Protocols Using Neuromuscular Electrical Stimulation for Paralyzed Lower-Limb Muscles to Increase Energy Expenditure in People With Spinal Cord Injury.

OBJECTIVE: The aim of this study was to evaluate whether using surface neuromuscular electrical stimulation (NMES) for paralyzed lower-limb muscles results in an increase in energy expenditure and whether the number of activated muscles and duty cycle affect the potential increase. DESIGN: This was a cross-sectional study. RESULTS: Energy expenditure during all NMES protocols was significantly higher than the condition without NMES (1.2 ± 0.2 kcal/min), with the highest increase (+51%; +0.7 kcal/min, 95% confidence interval, 0.3-1.2) for the protocol with more muscles activated and the duty cycle with a shorter rest period. A significant decrease in muscle contraction size during NMES was found with a longer stimulation time, more muscles activated, or the duty cycle with a shorter rest period. CONCLUSION: Using NMES for paralyzed lower-limb muscles can significantly increase energy expenditure compared with sitting without NMES, with the highest increase for the protocol with more muscles activated and the duty cycle with a shorter rest period. Muscle fatigue occurred significantly with the more intense NMES protocols, which might cause a lower energy expenditure in a longer protocol. Future studies should further optimize the NMES parameters and investigate the long-term effects of NMES on weight management in people with SCI.

Dispositif OptuneMC pour le traitement des patients adultes atteints d'un glioblastome nouvellement diagnostiqué / Optune™ for the treatment of adult patients with newly diagnosed glioblastoma

MANDAT: L'Institut national d'excellence en santé et en services sociaux (INESSS) a reçu le mandat du Bureau de l'innovation d'estimer la valeur de la technologie OptuneMC et la pertinence de sa couverture par le régime public en tant que dispositif de traitement des patients adultes souffrant d'un glioblastome nouvellement diagnostiqué avec et après la chimiothérapie d'entretien standard au témozolomide. DESCRIPTION: Pour l'indication demandée, le dispositif requiert la pose de matrices de transducteurs fixées sur le crâne rasé des patients afin de délivrer un champ électrique alternatif antitumoral via le générateur de champ OptuneMC. Les champs antitumoraux visent à stopper la progression des tumeurs en ciblant les étapes de la mitose des cellules cancéreuses et ils doivent agir en continu. Le dispositif OptuneMC est donc proposé avec des accessoires permettant un traitement ambulatoire et constant des patients. DÉMARCHE D'ÉVALUATION: Une revue des donn

MANDATE: L'Institut national d'excellence en santé et en services sociaux (INESSS) was mandated by the Bureau de l'innovation to assess the value of OptuneTM technology and the relevance of its coverage by the public plan as a treatment device for adult patients with newly diagnosed glioblastoma with and after standard temozolomide maintenance chemotherapy. DESCRIPTION: For the requested indication, the device requires the placement of transducer arrays to patients' shaved scalp to deliver to deliver a tumour-treating field through the OptuneTM field generator. Tumour treating fields aim to halt tumour progression by targeting the mitosis stages of cancer cells and must act continuously. The OptuneTM device is therefore provided with accessories for constant ambulatory treatment of patients. EVALUATION PROCESS: A review of data from the literature and those provided by the manufacturer was carried out to assess the scientific evidence regarding the application of tumour treating fields provided by Novocure's OptuneTM device for the treatment of newly diagnosed glioblastoma. Contextual and experiential stakeholder data were also collected through an expert advisory committee and one-on-one interviews with caregivers and patients who have used the OptuneTM device. SOCIO-CULTURAL DIMENSION: Despite the media visibility of the OptuneTM device and the enthusiasm for new therapeutic options, the acceptability of the device by Quebec patients is difficult to predict, as several factors need to be taken into consideration - e.g., aesthetic considerations, portability of the device and usage requirements. According to advisory committee members, the maximum acceptability rate could be as high as 50% of eligible patients offered the treatment. Some health technology assessment agencies have assessed OptuneTM and issued divergent recommendations, some favourable from the Haute Autorité de Santé (HAS, France), other unfavourable from the National Institute for Health and Care Excellence (NICE, UK). For their part, publications by listed oncology learned societies have chosen to recommend the OptuneTM device as a complementary treatment option to temozolomide in patients under 70 years of age. POPULATION DIMENSION: Glioblastoma is a heterogeneous cancer, with some subtypes more aggressive than others, affecting an estimated 150 new patient/year in Quebec. Median survival is around 8 months, with a 1-year survival rate of 25%. The disease is both cognitively and physically disabling, and family caregivers play an important role in its management. Current management is mainly based on diagnosis with magnetic resonance imaging (MRI), followed by tumour resection, when possible, combined radiotherapy with temozolomide, and maintenance chemotherapy with temozolomide (Stupp protocol). Despite treatment, 90% of patients will experience a recurrence of their cancer within 7 months. At this stage, there is no recognized standard of care. Glioblastoma is therefore an incurable pathology with limited treatment options, and with high unmet medical needs related to the development of new treatment options to prolong life and reduce the risk of recurrence. CLINICAL DIMENSION: The efficacy of the OptuneTM device is supported by the EF-14 study, an open-label, multicenter, randomized Phase 3 clinical trial conducted in 14 countries, including Canada. This study compared the efficacy of the OptuneTM device / temozolomide combination versus temozolomide alone in adult patients with supratentorial glioblastoma. The EF-14 study is judged to be of good methodological quality, despite the presence of a selection bias favouring the inclusion of individuals with a better prognosis. Moreover, the study population is also younger, has a higher performance index and contains a higher proportion of individuals with MGMT (6-O-Methylguanine-DNA methyltransferase) promoter methylation than the Quebec glioblastoma patient population. The main results of the study showed clinically significant gains in progression-free survival of 2.7 months and overall survival of 4.9 months. A dose-response effect was also observed according to patients' level of adherence to treatment, with a minimum use threshold of 50% to obtain a benefit, i.e., 12 hours per day. Secondary analyses failed to identify a sub-population that might benefit more from treatment and showed that all subgroups treated with the OptuneTM device benefited. The main adverse events attributable to this device were skin reactions and irritations. The results of the quality-of-life assessment indicate that the device is well tolerated by patients, as illustrated by the fact that the 75% adherence threshold was reached by 75% of the cohort. Skin irritation was the main cause of reduced quality of life in the cohort studied. Other results are subject to uncertainty due to the open design of the study, the low response of patients to the quality-of-life questionnaires, and the design of the device used, which was heavier, bulkier, and noisier than the model currently available. ORGANIZATIONAL DIMENSION: The OptuneTM device does not replace current care, but it is added to the standard maintenance treatment. GBM patients' diagnosis MRI images are transmitted to the manufacturer for array creation. Once the healthcare professional has assessed the patient's eligibility and transmitted the prescription to the manufacturer, the latter charges a monthly fee for unlimited array replacement, equipment delivery, patient service (technical assistance and training), and healthcare professional service, which includes training and reporting on patient compliance. This rental model is not common in Quebec, and the real involvement of healthcare network professionals and resources in monitoring patient use of the device is also uncertain, for example regarding skin effects, array repositioning and technical problems. However, Quebec centres participated in the EF-14 study and therefore have some experience with the device and the manufacturer. The OptuneTM device requires the help of a third party to place the electrode arrays, which may represent an issue for patients who have no family caregiver and/or for whom resources from the healthcare network could be solicited. Members of the advisory committee consulted are therefore of the opinion that, without access to such a resource, patients may be unable to use the device. In addition, there is uncertainty as to the optimal discontinuation criteria for patients treated with the OptuneTM device. Indeed, according to the members of the advisory committee consulted, there is no clinical advantage to continuing treatment after a first recurrence. Because of the organizational issues, several uncertainties remain as to whether the results of the clinical study can be reproduced in a real healthcare setting. ECONOMIC DIMENSION: The use of the OptuneTM device to treat patients with newly diagnosed glioblastoma concomitantly with temozolomide versus temozolomide alone is not cost-effective. Public coverage could generate additional costs of $ XX million over 5 years for the treatment of 308 patients. The real costs of adding the OptuneTM device, particularly those associated with its implementation in the health and social services network and with the involvement of healthcare personnel in patient follow-up, are uncertain. Market share for the OptuneTM device is also uncertain, since it depends on the quality of the manufacturer's service offering in Quebec, the organizational capacity of the Quebec healthcare network, and real patient acceptability. INESSS'S RECOMMENDATION: Based on the information available to date, and given the importance of the uncertainties raised, INESSS considers that it would not be fair and equitable to provide public coverage for the OptuneTM device for the treatment of adult patients with newly diagnosed supratentorial glioblastoma following maximal reduction surgery and completion of radiotherapy with and after standard maintenance chemotherapy. INESSS may reassess the OptuneTM device, at the request of the ministère de la Santé et des Services sociaux (MSSS), when more information becomes available, including data in reallife settings that will better reduce uncertainties and mitigate associated risks.

Recent Trends in Medicare Utilization and Reimbursement for Spinal Cord Stimulators: 2000-2019.

OBJECTIVE: Spinal cord stimulators (SCS) allow spine surgeons to provide relief for patients who suffer from chronic pain due to several disorders, such as failed back surgery syndrome, complex regional pain syndrome, and neuropathy. Despite this, there remains a paucity of data regarding the utilization and reimbursement of SCS. Therefore, the purpose of this study is to evaluate the monetary and procedural trends of spinal cord stimulators among the Medicare database from 2000 to 2019. METHODS: Medicare Part B National Summary Data files, which are publicly available, were used. These files contain data from the years 2000-2019 on all services billed to Medicare within that time frame. Each service is given a Current Procedural Terminology (CPT) code and the number of times that service was performed, as well as the total physician Medicare charges and reimbursements for each service annually are included in that data set. The CPT codes for percutaneous and open placement of spinal cord stimulators were identified: 63650 and 63655, respectively. The total allowed services allowed charges and actual payments were isolated from the data set for each year for each CPT code. The total allowed charges and actual payments for the year were then divided by the total allowed services to find and trend the allowed charges and actual payment for each individual service performed for both percutaneous and open placement of spinal cord stimulators. RESULTS: There were 992,372 Medicare-approved total percutaneous spinal cord stimulator operations and 99,736 Medicare-approved total open spinal cord stimulator operations from 2000 to 2019. Medicare paid $1.02 billion (2019 U.S. dollars) in reimbursement to physicians for percutaneous spinal cord stimulator operations and nearly $145 million (2019 U.S. dollars) in reimbursement to physicians for open spinal cord stimulator operations. From the years 2000 to 2019, there was an average 21.9% increase annually in Medicare-approved percutaneous spinal stimulator placement operations and a 18.4% increase annually in Medicare-approved open spinal stimulator placement operations. During this time, there was also an average 8.7% increase annually in Medicare reimbursement per each percutaneous spinal stimulator placement operation and a 9.1% increase annually in Medicare reimbursement per each open spinal stimulator placement operation. CONCLUSIONS: The results of this study show that the number of percutaneous and open procedures have steadily increased from 2000 to 2019. Reimbursement per procedure has also increased steadily over this time. Identifying these trends is important to promote research into costs of these surgeries and ensure adequate resource allocation.

Physiotherapy for pain and disability in adults with complex regional pain syndrome (CRPS) types I and II.

BACKGROUND: Complex regional pain syndrome (CRPS) is a painful and disabling condition that usually manifests in response to trauma or surgery and is associated with significant pain and disability. CRPS can be classified into two types: type I (CRPS I) in which a specific nerve lesion has not been identified and type II (CRPS II) where there is an identifiable nerve lesion. Guidelines recommend the inclusion of a variety of physiotherapy interventions as part of the multimodal treatment of people with CRPS. This is the first update of the review originally published in Issue 2, 2016. OBJECTIVES: To determine the effectiveness of physiotherapy interventions for treating pain and disability associated with CRPS types I and II in adults. SEARCH METHODS: For this update we searched CENTRAL (the Cochrane Library), MEDLINE, Embase, CINAHL, PsycINFO, LILACS, PEDro, Web of Science, DARE and Health Technology Assessments from February 2015 to July 2021 without language restrictions, we searched the reference lists of included studies and we contacted an expert in the field. We also searched additional online sources for unpublished trials and trials in progress. SELECTION CRITERIA: We included randomised controlled trials (RCTs) of physiotherapy interventions compared with placebo, no treatment, another intervention or usual care, or other physiotherapy interventions in adults with CRPS I and II. Primary outcomes were pain intensity and disability. Secondary outcomes were composite scores for CRPS symptoms, health-related quality of life (HRQoL), patient global impression of change (PGIC) scales and adverse effects. DATA COLLECTION AND ANALYSIS: Two review authors independently screened database searches for eligibility, extracted data, evaluated risk of bias and assessed the certainty of evidence using the GRADE system. MAIN RESULTS: We included 16 new trials (600 participants) along with the 18 trials from the original review totalling 34 RCTs (1339 participants). Thirty-three trials included participants with CRPS I and one trial included participants with CRPS II. Included trials compared a diverse range of interventions including physical rehabilitation, electrotherapy modalities, cortically directed rehabilitation, electroacupuncture and exposure-based approaches. Most interventions were tested in small, single trials. Most were at high risk of bias overall (27 trials) and the remainder were at 'unclear' risk of bias (seven trials). For all comparisons and outcomes where we found evidence, we graded the certainty of the evidence as very low, downgraded due to serious study limitations, imprecision and inconsistency. Included trials rarely reported adverse effects. Physiotherapy compared with minimal care for adults with CRPS I One trial (135 participants) of multimodal physiotherapy, for which pain data were unavailable, found no between-group differences in pain intensity at 12-month follow-up. Multimodal physiotherapy demonstrated a small between-group improvement in disability at 12 months follow-up compared to an attention control (Impairment Level Sum score, 5 to 50 scale; mean difference (MD) -3.7, 95% confidence interval (CI) -7.13 to -0.27) (very low-certainty evidence). Equivalent data for pain were not available. Details regarding adverse events were not reported. Physiotherapy compared with minimal care for adults with CRPS II We did not find any trials of physiotherapy compared with minimal care for adults with CRPS II. AUTHORS' CONCLUSIONS: The evidence is very uncertain about the effects of physiotherapy interventions on pain and disability in CRPS. This conclusion is similar to our 2016 review. Large-scale, high-quality RCTs with longer-term follow-up are required to test the effectiveness of physiotherapy-based interventions for treating pain and disability in adults with CRPS I and II.

Feasibility, acceptability and costs of nurse-led Alpha-Stim cranial electrostimulation to treat anxiety and depression in university students.

BACKGROUND: Only a relatively low proportion of university students seek help for anxiety and depression disorders, partly because they dislike current drug and psychological treatment options and would prefer home-based care. The aim of this study is to determine the feasibility, acceptability and cost utility of Alpha-Stim cranial electrostimulation (CES) delivered through a nurse led primary care clinic as a daily treatment for anxiety and depression symptoms by the student at home in contrast to usual primary care. METHOD: Feasibility and acceptability of a nurse led clinic offering Alpha-Stim CES in terms of the take up and completion of the six-week course of Alpha-Stim CES. Change in score on the GAD-7 and PHQ-9 as measures of anxiety and depression symptoms at baseline and at 8 weeks following a course of Alpha-Stim CES. Similar evaluation in a non-randomised control group attending a family doctor over the same period. Cost-utility analysis of the nurse led Alpha-Stim CES and family doctor pathways with participants failing to improve following further NICE Guideline clinical care (facilitated self-help and cognitive behaviour therapy). RESULTS: Of 47 students (mean age 22.1, years, 79% female opting for Alpha-Stim CES at the nurse-led clinic 46 (97.9%) completed a 6-week daily course. Forty-seven (47) students comprised a comparison group receiving usual family doctor care. Both Alpha-Stim CES and usual family doctor care were associated with large effect size reductions in GAD-7 and PHQ-9 scores from baseline to 8 weeks. There were no adverse effects and only one participant showed a clinically important deterioration in the Alpha-Stim group. In the cost utility analysis, Alpha-Stim CES was a cheaper option than usual family doctor care under all deterministic or probabilistic assumptions. CONCLUSION: Nurse delivered Alpha-Stim CES may be a feasible, acceptable and cheaper way of providing greater choice and home-based care for some university students seeking help from primary care with new presentations of anxiety and depression.

A randomised controlled trial investigating the clinical and cost-effectiveness of Alpha-Stim AID cranial electrotherapy stimulation (CES) in patients seeking treatment for moderate severity depression in primary care (Alpha-Stim-D Trial).

BACKGROUND: Major depression is the second leading cause of years lost to disability worldwide and is a leading contributor to suicide. However, first-line antidepressants are only fully effective for 33%, and only 40% of those offered psychological treatment attend for two sessions or more. Views gained from patients and primary care professionals are that greater treatment uptake might be achieved if people with depression could be offered alternative and more accessible treatment options. Although there is evidence that the Alpha-Stim Anxiety Insomnia and Depression (AID) device is safe and effective for anxiety and depression symptoms in people with anxiety disorders, there is much less evidence of efficacy in major depression without anxiety. This study investigates the effectiveness of the Alpha-Stim AID device, a cranial electrotherapy stimulation (CES) treatment that people can safely use independently at home. The device provides CES which has been shown to increase alpha oscillatory brain activity, associated with relaxation. METHODS: The aim of this study is to investigate the clinical and cost-effectiveness of Alpha-Stim AID in treatment-seeking patients (aged 16 years upwards) with moderate to moderately severe depressive symptoms in primary care. The study is a multi-centre parallel-group, double-blind, non-commercial, randomised controlled superiority trial. The primary objective of the study is to examine the clinical efficacy of active daily use of 8 weeks of Alpha-Stim AID versus sham Alpha-Stim AID on depression symptoms at 16 weeks (8 weeks after the end of treatment) in people with moderate severity depression. The primary outcome is the 17-item Hamilton Depression Rating Scale at 16 weeks. All trial and treatment procedures are carried out remotely using videoconferencing, telephone and postal delivery considering the COVID-19 pandemic restrictions. DISCUSSION: This study is investigating whether participants using the Alpha-Stim AID device display a reduction in depressive symptoms that can be maintained over 8 weeks post-treatment. The findings will help to determine whether Alpha-Stim AID should be recommended, including being made available in the NHS for patients with depressive symptoms. TRIAL REGISTRATION: ISRTCN ISRCTN11853110 . Registered on 14 August 2020.