Background Although the preferred management approach for patients with infected necrotising pancreatitis is endoscopic transluminal stenting followed by endoscopic necrosectomy as step-up treatment if there is no clinical improvement, the optimal timing of necrosectomy is unclear. Therefore, we aimed to compare outcomes between performing upfront necrosectomy at the index intervention versus as a step-up measure in patients with infected necrotising pancreatitis. Methods This single-blinded, multicentre, randomised trial (DESTIN) was done at six tertiary care hospitals (five hospitals in the USA and one hospital in India). We enrolled patients (aged >= 18 years) with confirmed or suspected infected necrotising pancreatitis with a necrosis extent of at least 33% who were amenable to endoscopic ultrasound-guided drainage. By use of computer-generated permuted block randomisation (block size four), eligible patients were randomly assigned (1:1) to receive either upfront endoscopic necrosectomy or endoscopic step-up treatment. Endoscopists were not masked to treatment allocation, but participants, research coordinators, and the statistician were. Lumen-apposing metal stents (20 mm diameter; 10 mm saddle length) were used for drainage in both groups. In the upfront group, direct necrosectomy was performed immediately after stenting in the same treatment session. In the step-up group, direct necrosectomy or additional drainage was done at a subsequent treatment session if there was no clinical improvement (resolution of any criteria of systemic inflammatory response syndrome or sepsis or one or more organ failure and at least a 25% percentage decrease in necrotic collection size) 72 h after stenting. The primary outcome was the number of reinterventions per patient to achieve treatment success from index intervention to 6 months' follow-up, which was defined as symptom relief in conjunction with disease resolution on CT. Reinterventions included any endoscopic or radiological procedures performed for necrosectomy or additional drainage after the index intervention, excluding the follow-up procedure at 4 weeks for stent removal. All endpoints and safety were analysed by intention-to-treat. This study is registered with ClinicalTrials.gov, NCT05043415 and NCT04113499, and recruitment and follow-up have been completed. Findings Between Nov 27, 2019, and Oct 26, 2022, 183 patients were assessed for eligibility and 70 patients (24 [34%] women and 46 [66%] men) were randomly assigned to receive upfront necrosectomy (n=37) or step-up treatment (n=33) and included in the intention-to-treat population. At the time of index intervention, seven (10%) of 70 patients had organ failure and 64 (91%) patients had walled-off necrosis. The median number of reinterventions was significantly lower for upfront necrosectomy (1 [IQR 0 to 1] than for the step-up approach (2 [1 to 4], difference -1 [95% CI -2 to 0]; p=0 center dot 0027). Mortality did not differ between groups (zero patients in the upfront necrosectomy group vs two [6%] in the step-up group, difference -6 center dot 1 percentage points [95% CI -16 center dot 5 to 4 center dot 5]; p=0 center dot 22), nor did overall disease-related adverse events (12 [32%] patients in the upfront necrosectomy group vs 16 [48%] patients in the step-up group, difference -16 center dot 1 percentage points [-37 center dot 4 to 7 center dot 0]; p=0 center dot 17), nor procedurerelated adverse events (four [11%] patients in the upfront necrosectomy group vs eight [24%] patients in the step-up group, difference -13 center dot 4 percentage points [-30 center dot 8 to 5 center dot 0]; p=0 center dot 14). Interpretation In stabilised patients with infected necrotising pancreatitis and fully encapsulated collections, an approach incorporating upfront necrosectomy at the index intervention rather than as a step-up measure could safely reduce the number of reinterventions required to achieve treatment success. Funding None. Copyright (c) 2023 Elsevier Ltd. All rights reserved

Introduction: Clinical research has consistently established mental health conditions (MHCs) as frequent comorbidities of epilepsy. However, the extent of economic burden of comorbid MHC in patients with focal seizures has not been systematically investigated. This retrospective cohort analysis of health plan claims compared healthcare use and costs among adult patients with focal seizures with and without comorbid MHC. Methods: We utilized the lnovalon Medical Outcomes Research for Effectiveness and Economics (MORE2) Registry, longitudinal data from over 150 commercial, Medicare Advantage, and managed Medicaid health plans for the analysis, and identified a cohort of patients with focal (partial-onset) seizure with relevant ICD9/10 diagnosis codes with and without MHC. Mental health conditions were defined as diagnoses for anxiety, bipolar condition/mania, attention-deficit conduct condition, major depression, schizophrenia, and other psychotic conditions, and patients without MHC were propensity score-matched to patients with preexisting MHC on baseline patient characteristics. The assessment examined a series of outcomes, including 1) direct healthcare resource utilization and 2) total provider reimbursement. Results: Patients with preexisting MHC were more likely to receive adjunctive epilepsy therapy as well as broadspectrum antiepileptic drugs/antiseizure medications (ASMs). Additionally, patients with focal seizures and MHC were significantly more likely to utilize high-cost healthcare services. The presence of MHC was associated with approximately 50% greater utilization of emergency department (ED), physician, and inpatient services. Consequently, healthcare expenditures were significantly higher among patients with MHC ($17,596 vs. $10,857; 62% higher, p < 0.001), with the trend consistent across all care settings. Conclusions: This analysis illustrates the health service utilization and cost implications of MHC among patients with focal seizures. The data suggest that patients with MHC have a greater overall clinical burden, which may be associated with higher healthcare resource use and expenditures. Because of the potential burden and costs associated with MHC, neurologists should consider screening patients with focal seizures for mental health disorders to identify and initiate treatment for comorbid mental health disorders. (C) 2020 Elsevier Inc. All rights reserved.

BACKGROUND & AIMS:Although single-operator cholangioscopy (SOC)-guided lithotripsy and large balloon sphincteroplasty (LBS)-based techniques are effective rescue measures, the ideal approach to management of difficult bile duct stones is unclear. We conducted a randomized trial to compare the effectiveness of SOC-guided lithotripsy and LBS-based approaches for endoscopic management of difficult bile duct stones. METHODS:Patients with difficult bile duct stones who failed retrieval using balloon or basket were randomly assigned to groups that received SOC-guided laser lithotripsy (SOC-LL, n = 33) or LBS (n = 33), from June 2016 through August 2018. When assigned treatment was unsuccessful, patients underwent mechanical lithotripsy before crossing over to the other group. The main outcome was treatment success, defined as ability to clear the duct in 1 session. Secondary outcomes were adverse events and treatment costs. RESULTS:A higher proportion of patients in the SOC-LL group had treatment success (93.9%) than in the LBS group (72.7%; P = .021). On multiple logistic regression analysis, treatment success was significantly associated with use of SOC-LL (odds ratio [OR], 8.7; 95% CI, 1.3-59.3; P = .026), stone to extrahepatic bile duct ratio of 1 or less (OR, 28.8; 95% CI, 1.2-687.6; P = .038), and lack of a tapered bile duct (OR, 26.9; 95% CI, 1.3-558.2; P = .034). There was no significant difference between groups in adverse events (9.1% in the SOC-LL group vs 3.0% in the LBS group, P = .61) or overall treatment cost ($16,684 in the SOC-LL group vs $10,626 in the LBS group; P = .097). CONCLUSIONS:In a randomized trial of patients with difficult bile stones that cannot be cleared by standard maneuvers, SOC-guided lithotripsy leads to duct clearance in a significantly higher proportion of patients than LBS-particularly when stone size exceeds the diameter of the extrahepatic bile duct. Adjunct lithotripsy might be required in patients with tapered distal bile duct, because LBS alone is less likely to be successful. ClinicalTrials.gov no: NCT00852072.

Objective: To estimate the net monetary benefit of an individual placement and support-based supported employment program for Veterans with spinal cord injuries. Design: Economic evaluation comparing a supported employment program to treatment as usual, using cost and quality-of-life data from a longitudinal study of Veterans with spinal cord injuries. Setting: Spinal cord injury centers in the Veterans Health Administration. Participants: Subjects (N = 213) who participated in a 24-month supported employment program at seven spinal cord injury centers. Supported employment participants were compared with a group of spinal cord injury Veterans who received treatment as usual in a prior study. Main outcome measures: Costs and quality-adjusted life years using the Veterans Rand-6 Dimension, estimated from the Veterans Rand 36-Item Health Survey. Results: The supported employment program was more effective at both 1- and 2-year periods compared with treatment as usual. Outpatient costs were significantly higher for supported employment, but inpatient costs were not significantly different from treatment as usual. When cost and effectiveness were compared jointly using net monetary benefit, a supported employment program following the core principles of Individual Placement and Supported employment was more effective but not cost-effective at standard willingness to pay thresholds. When we considered a sub-group of the supported employment participants who more closely resemble the treatment as usual group from a randomized trial, there was no significant difference in the cost-effectiveness of supported employment when compared to treatment as usual. Conclusions: With higher effectiveness and similar costs, supported employment for spinal cord injury Veterans has the potential to be cost-effective. Future studies need to randomize participants or carefully match participants based on observable patient characteristics to improve cost-effectiveness evaluations of this population.

Health expenditures in the United States are substantial, accounting for 17.8% of gross domestic product (GDP) in 2015. These expenditures are expected to increase to nearly 20% of GDP by 2025. National health spending in the US is projected to grow at an average rate of 5.6% per year between 2016 and 2025 and a 4.7% rate annually on a per capita basis.1 The economic impact of lower-limb amputation (LLA) is variable, with estimated lifetime prosthetic costs for those who use them ranging from $0.5 to $1.8 million, depending upon the number and type of prostheses received, the number and type of limb amputations, and other factors.2 Collectively, Medicare reimbursed $655 million worth of lower-limb prosthetic services in 2009.3 However, prosthetic costs only constitute a portion of the full economic impact, with reported cumulative societal costs (United States) of an estimated $4.3 billion for persons with amputations of dysvascular etiology.4 Comparative health economic literature in prosthetic rehabilitation literature is relatively scarce and has been summarized.5 Given the dearth of comparative health economic literature, there is a need to expand the search for it within the larger body of prosthetic rehabilitation science including trends, insights, and practice guidance within these areas. A previous review of prosthetic health economic science recommended review of descriptive economic literature, citing a lack of comparative economic literature. Therefore, the purpose of this project was to systematically review the descriptive literature to determine if further economic observations in rehabilitative care for persons with LLA are available. Specifically, this review sought to formulate evidence-based economic observations (EBEOs) related to prosthetic interventions for persons with LLA from an economic evaluation perspective based solely on descriptive studies. METHODS On November 18, 2015, three databases—Medline (PubMed), CINAHL (Ovid), and the Cochrane Database of Systematic Reviews—were systematically searched for the following terms: Primary Search Terms: (prosthe* OR “Prostheses and Implants” OR prosthesis OR prostheses OR preprosthe* OR pre-prosthe*) AND (((transtibial OR trans-tibial OR trans tibial OR below knee OR bka OR tta OR Leg[Mesh] OR leg OR legs OR lower limb OR lower limbs OR lower extremity OR lower extremit* OR “Lower Extremity”[Mesh]))) Primary search terms were combined systematically with the following secondary search terms: Cost OR Econ* OR Efficacy OR “Cost Benefit” OR “Cost Effectiveness” OR “Cost Utility” OR “Health care Econ*” The following date limits were implemented as part of the database search parameters: January 1, 1997, through November 15, 2015. Resulting articles’ reference lists were searched for potentially relevant articles. ARTICLE SCREENING Resulting references were exported to EndNote (vX6; Thompson, CA, USA) reference management software for stage 1 screening. This involved screening title and abstract and the elimination of duplicate references. Remaining prosthetic economic articles were sorted by topic. Exclusion criteria were applied starting at stage 1 to eliminate comparative studies as these have been previously reviewed. Articles published in a non-English language were eliminated relative to prohibitive translation fees. Articles were screened for exclusion using the following criteria within EndNote: Foreign language (i.e., non-English language) Economic evaluation or cost-comparison studies After stage 1 screening, stage 2 screening was applied as outlined here. Remaining economic manuscripts were reviewed by two raters and screened independently to verify inclusion/exclusion and for classification as either: 1) pertinent, 2) not pertinent, or 3) uncertain pertinence. Full-text articles were reviewed for citations classified as pertinent or uncertain pertinence. Disagreements regarding citations of uncertain pertinence were resolved by discussion with a third rater. Review of full-text articles and associated discussion led to group consensus and ultimate inclusion/exclusion. To be included, the article had to be a descriptive manuscript including persons with lower extremity amputation or prosthetic care as a topic.6 DATA EXTRACTION The following data were extracted: population, inclusive costs, reported costs, reported currency, and equivalent in 2017 US dollars (USD). Reported costs were converted to USD by dividing the local currency unit with the purchasing power parity rates for the mentioned price year and subsequently inflated to 2017 year dollars as defined by the World Bank Group.7,8 If the price-year was not stated in the study, cost in the publication year was used. Final costs displayed were rounded to the nearest whole number. SORTING BY TOPIC After screening for eligibility determination and data extraction, articles were sorted for pertinence into available topical areas. SYNTHESIS OF EVIDENCE-BASED ECONOMIC OBSERVATIONS Based on results from the included publications, EBEOs were developed that described LLA-related interventions economically. Reviewers rated the level of confidence of each EBEO as “low,” given the source manuscripts were descriptive or qualitative designs. RESULTS LITERATURE SEARCH The search yielded 292 manuscripts (Figure 1). Stage 1 screening eliminated 263 manuscripts, and stage 2 screening eliminated an additional 13 manuscripts, leaving 16 articles meeting eligibility criteria. The remaining articles were published from 1996 to 2015 where most were published in 2013 (four manuscripts) and 2014 (three manuscripts). These were divided into the following three topical areas describing costs related to:Figure 1: Flow diagram of literature search. Amputations resulting from diabetes mellitus (DM), peripheral arterial disease (PAD), and critical limb ischemia (CLI) (n = 6) Amputations in veterans related to military trauma (n = 3) Other miscellaneous prosthetic care issues including economic considerations in episodes of care where amputation represents one open care pathway, economic considerations in discrete treatment populations of persons with amputation, prosthetic componentry, and the financial impact when the wage earner loses a limb in resource-limited settings (n = 7). Articles were published in multiple different journals including Prosthetics and Orthotics International, Journal of Rehabilitation Research & Development, Disability and Rehabilitation, and numerous others. From an economic evaluation type, all included articles were descriptive. Some used epidemiologic methods where others were purely narrative. FUNDING Twelve of the 16 manuscripts included a statement disclosing whether or not the study was funded. Eleven of these 12 were funded. Four were funded by the US Department of Veterans Affairs, one by the National Institutes of Health, one by the US Department of Education, three by nonprofit organizations (i.e., foundations, professional associations), and three were supported by their respective governments. Four of the 16 included studies did not indicate whether or not the studies were funded. Given that there was no industry funding and that all reported funding was governmental or nonprofit, the likelihood of funding bias was regarded to be low. SOCIODEMOGRAPHIC AND ECONOMIC DATA Key economic data regarding amputations resulting from DM, PAD, and CLI were extracted into Table 1. Values were listed as directly reported in the manuscript and as converted per the methods aforementioned to current values in USD. Observations were reported from the United States, Australia, Germany, and Sweden. Aggregation of economic data was precluded by the variability of reported information. Sample sizes were diverse, with some studies reporting amputation data in conjunction with data observed with other surgical procedures. Among defined populations that were clearly limited to those with LLA, sample sizes ranged from 95 to 9066 with a mean sample size of 2,124. Among studies that reported the variable, mean cohort ages ranged from 62 to 77 years.Table 1: Economic reports of amputation-related health care costs for patients with DM, PAD, and CLIKey economic data regarding amputations resulting from military trauma in both the veteran and service member populations were extracted into Table 2. Values were listed as directly reported in the manuscript and as converted per the methods aforementioned to current values in USD. The divergence of sample sizes and reported variables preclude meaningful aggregate analysis. Maynard et al.15 reported upon the largest sample size of 2,690 injured veterans. Blough et al.2 reported upon 245 veterans with amputation from the Vietnam conflict and 226 veterans with amputation from the Operation Iraqi Freedom and Operation Enduring Freedom (OIF/OEF) conflict that presented with either unilateral major LLA (350 subjects) or multiple major amputations (121 subjects) excluding bilateral upper-limb amputation. Edwards et al.16 reported upon 265 individuals with 416 amputations, but the reported data did not include the number of subjects with unilateral or bilateral LLA.Table 2: Economic data of amputation-related health care costs for patients who sustained traumatic amputations during military conflictThe remaining seven studies were too divergent to allow for meaningful aggregation. Two of these reported upon the niche populations of pediatric lawn mower injury17 and farmers,18 although with very different economic considerations. Two reported economic considerations as they relate to divergent care pathways in which amputation represents a route of care. These include the management of nonhealing tibial fractures19 and the management of the diabetic at-risk foot.20 The remaining 3 studies were highly divergent in their content and include socket fabrication methods,21 a low-cost suspension alternative,22 and financial constraints in a resource-limited practice environment.23 EVIDENCE-BASED ECONOMIC OBSERVATIONS Thirteen EBEOs were synthesized from the results within the three topical areas previously identified and are listed below. Of these, 12 were only supported by a single study with the remaining statement supported by two articles. AMPUTATIONS RESULTING FROM DIABETES MELLITUS, PERIPHERAL ARTERIAL DISEASE, AND CRITICAL LIMB ISCHEMIA Mean inpatient costs associated with LLA due to DM, PAD, or both range from $20,000 to $46,000 (2017 USD) depending upon the level of amputation and comorbid health conditions.9,10 Average inpatient costs among patients with PAD are higher with major amputations and with comorbid DM.10 The mean cumulative health care costs incurred during the 90-day acute stage of associated with DM averaged $65,000 (2017 USD) and increased with more proximal amputation levels.11 i. Those associated with transtibial amputation were approximately 60% higher than those observed with toe amputation and 20% less that those observed with transfemoral amputation.11 ii. After accounting for inflation, these costs increased 16% to 25% between 2004 and 2010.11 For those undergoing LLA with comorbid DM, the cumulative health care costs incurred during the 24 weeks of acute postamputation rehabilitation are comparable to those incurred by individuals undergoing LLA without comorbid DM.12 i. The cumulative health care costs 1 year before LLA are approximately 30% higher among those with DM than among those without DM.13 ii. The cumulative health care costs in the first 3 years after amputation are 25% higher among those with DM than among those without DM.12 Among patients with CLI, amputation surgeries are less expensive than either reconstructive or restorative vascular surgeries. However, in the Swedish health care system, amputation was associated with a longer hospital stay, such that cumulative surgical/hospital costs for those with primary amputation exceeded those observed with primary reconstructive or restorative vascular procedures.13 Approximately 60% of the prostheses and 26% of the socket replacements provided within 8 years of unilateral transtibial amputation due to vascular disease are provided within the first year postamputation. Prosthetic maintenance costs are approximately 20% of primary prosthetic costs within the Swedish health care system.14 Among those who undergo unilateral transtibial amputation due to vascular disease, approximately 40% will likely require subsequent amputation in the form of proximal revision amputation to the ipsilateral limb or contralateral amputation, with attendant impact on total health care costs.14 AMPUTATIONS IN VETERANS RELATED TO MILITARY TRAUMA 8. The anticipated costs for prostheses and assistive devices for Vietnam-era veterans are roughly 60% higher for those with multiple amputations compared with those with unilateral LLA.2 9. The anticipated costs for prostheses and assistive devices for OIF/OEF-era veterans are approximately 97% higher for those with multiple amputations compared with those with unilateral LLA.2 10. Veterans who sustained LLA in Vietnam tend to have reduced prosthetic costs compared with those who sustained LLA in OIF/OEF due to their collective use of fewer, less technologically advanced prosthetic devices.2 i. Among veterans with major unilateral LLAs sustained in combat, the mean anticipated costs for prostheses and assistive devices are 178% to 327% higher for those sustained in OIF/OEF than those sustained in Vietnam.2 ii.Among veterans with multiple limb amputations sustained in combat, the mean anticipated costs for prostheses and assistive devices are 246% to 409% higher for those sustained in OIF/OEF than those sustained in Vietnam.2 11. Among British war veterans who sustained major limb amputations, the anticipated 40-year health costs of an individual with unilateral transtibial amputation (US $1.4 million in 2017 currency) are 25% less than those associated with unilateral transfemoral amputation and 16% less than those associated with bilateral transtibial amputation.16 OTHER MISCELLANEOUS PROSTHETIC CARE CONSIDERATIONS 12. The lifetime costs associated with amputation secondary to severe tibial fracture may be more than twice those associated with limb salvage due to the ongoing replacement costs associated with prostheses. This disparity reduces with advancing age at the time of amputation.19 13. The costs associated with multidisciplinary foot protection clinics appear to be offset by the health care savings that accompany reduced rates of amputation and associated prosthetic care.20 DISCUSSION IMPACT OF DIABETES MELLITUS, PERIPHERAL ARTERIAL DISEASE, AND CRITICAL LIMB ISCHEMIA ON AMPUTATION-RELATED HEALTH CARE COST An area of prosthetic rehabilitation receiving a large amount of descriptive consideration related to health care costs associated with LLA was in individuals with the common predisposing conditions of DM, PAD, and/or CLI. Unfortunately, the economic data reported in these publications are difficult to aggregate and compare due to variation in specific costs included in each analysis. These ranged from operative costs only to inpatient costs, to aggregate health care costs across extended postamputation timelines. Although these articles include both US and international economic observations over the past 20 years, their respective findings have been converted to 2017 USD in Table 1. Yin et al.9 reported inpatient costs of LLA among patients with DM in the United States. Their data, taken from the 2007 National Inpatient Sample of the Healthcare Cost and Utilization Project, reports on 9066 LLAs from DM from 39 states. The average inpatient cost was reported at $17,103 (2007 USD) of which 55.3% of the variance could be explained by the following patient and hospital factors: age, race, length of hospital stay, amputation level, in-patient mortality, primary payer, comorbidities, and type of hospital (i.e., rural, urban nonteaching, and urban teaching). Unfortunately, the directionality of the effects of these variables was not reported. By contrast, the variables of sex, hospital size, and a hospital’s volume of LLAs were nonsignificant in their contributions. This implies that nearly half of the variability in inpatient costs for LLAs from DM was not explained by these variables. After accounting for the known influences identified previously, the highest unexplained costs were observed in California, Oregon, and Washington, whereas the lowest amounts of unexplained costs were observed in Kentucky, Tennessee, and Arkansas. Some directionality is suggested by Malone et al.,10 reporting on the length of hospital stay and associated costs among Australian patients with and without DM undergoing vascular surgeries secondary to PAD. Increased inpatient costs were reported for both minor (toe) and major (proximal to the toe) amputations when DM was comorbid with PAD. For minor amputations, the average inpatient costs rose from $21,849 (USD) among patients with PAD only to $27,068 for patients with PAD as well as DM. Similarly, for major amputations the associated inpatient costs were reported at $40,195 and $42,236, respectively. Notably, patients with both PAD and DM were three times more likely to require an amputation than those with PAD only. The comorbid patients in both groups (minor and major amputations) had increased lengths of stay and inpatient costs than their peers with PAD only, but these increases were not significantly different. A broader view of the comprehensive costs associated with LLAs among patients with DM is found in the work of Franklin et al.11 in their analysis of the subpopulation of US veterans meeting this description in fiscal years 2004 and 2010. Their analysis aggregated inpatient medical, inpatient surgical, outpatient care, and medication-related costs incurred between 30 days before and 60 days after LLA. The mean health care costs (2012 USD) for veterans who underwent LLAs in 2004 were $33,205, $53,261, and $69,726 at the toe, transtibial, and transfemoral amputation levels, respectively. These mean costs in 2010 were $41,484, $71,067, and $82,758, respectively. The mean cost of all amputations levels increased 20% during this interval, from $50,351 to $60,647. A related study from Germany reported the impact of DM on health care costs before and after lower-limb surgery. As with the US veteran study described previously, Hoffmann et al.12 aggregated comprehensive health care costs including hospitalization, rehabilitation, outpatient care, pharmaceutical prescriptions, nonphysician services, durable medical equipment, and long-term care. These costs for those with and without DM were retrospectively aggregated for the year before amputation and then at defined intervals postamputation. During the year before amputation, health care costs were higher for those with DM ($37,427 vs. $28,961 2017 USD). Health care costs from the time of amputation through the first 24 weeks after amputation were similar between the two cohorts (approximately $55,000 2017 USD). Thereafter, the health care costs of those with DM began to exceed those of their peers with amputation that did not have DM. Three years postamputation, the average cumulative health care costs for those with DM exceeded those for patients without DM ($176,681 and $141,835, respectively, 2017 USD). The economic implications of PAD in its advanced form of CLI can be inferred by a study of 321 Swedish patients managed surgically via reconstructive, restorative, or amputative procedures.13 Of note, these vascular procedures rarely occurred in isolation, evidenced by the fact that the 321 subjects ultimately underwent 978 surgical procedures. Major LLA was the primary operation in 36% of the reported cases and ultimately accounted for 38% of the reported procedures. Thus, it was also frequently indicated among those with reconstructive and restorative procedures as their primary operation. Among the former, 34% required amputation ipsilateral to the reconstruction procedure with an additional 20% requiring amputation contralateral to the reconstruction procedures. Among the latter, 48% required amputation ipsilateral to the restorative procedure and 14% required amputation to the contralateral limb. Ultimately, the surgical costs for reconstructive procedures were twice those reported for restorative procedures and more than three times higher than those reported for amputation. The average costs for major and minor amputation surgeries were reported at $1,500 and $984, respectively (in 1996 USD). Patients with amputation as their primary operation underwent fewer surgical procedures, but had longer length of stay in the hospital (152 days) compared with those undergoing primary reconstructive (101 days) or restorative vascular procedures (96 days). Ultimately, the mean surgical and hospital costs reported in patients undergoing primary amputation was $54,000 (in 1996 USD), compared with $46,000 in patients undergoing primary reconstructive vascular procedures and $41,000 in patients undergoing primary restorative vascular procedures. A second Swedish study from the same period reported prosthetic costs incurred by patients with unilateral transtibial amputation due to vascular disease.14 This effort reported on 112 patients treated with unilateral transtibial amputation. At 6 and 12 months postamputation, 50% (n = 56) and 63% (n = 71), respectively, had been fitted with a prosthesis. Eight years postamputation, this fitting rate was unchanged (71 of 112 subjects). By this point, with an 8-year mortality rate of 92%, only 9 subjects were still alive. During the 8-year period, 137 prostheses and 54 socket replacements had been provided, facilitating the determination that 59% of the prostheses and 26% of the socket replacements provided within 8 years of an amputation were provided within the first year postamputation. Ultimately, nine of those subjects ultimately fitted with a prosthesis (13%) required revision amputation to the through-knee/transfemoral level and 20 subjects (28%) required contralateral major LLA. During this same 8-year period, the median cost of prosthetic care was $1,582 (in 1997 USD). Median costs for prostheses were reported at $898 for transtibial prostheses, $1,251 for through-knee prostheses, and $2,409 for transfemoral prostheses. Median costs for socket replacements were reported for transtibial ($733) and through-knee/transfemoral ($1,202) sockets. Reported maintenance costs during this period represented 20% of the total primary costs for prostheses and socket replacements. The authors also determined the functional level for patients who had received prostheses and reported that there was no difference in median prosthetic costs between the two groups. HEALTH CARE COSTS OBSERVED AMONG VETERANS WITH MILITARY TRAUMA-RELATED AMPUTATIONS Blough et al.2 surveyed 581 service members with major traumatic amputations acquired in the Vietnam War and OIF/OEF to determine prosthetic utilization. Then, establishing the associated prosthetic costs in 2005 USD, they attempted to project future prosthetic costs for these wounded veterans at 5 years, 10 years, 20 years, and lifetime projections. Their findings are summarized in Table 2. Those veterans who sustained amputations in Vietnam had reduced prosthetic costs due to their collective use of fewer, less technologically advanced prosthetic devices, and higher rates of prosthetic abandonment. In addition to the costs of prostheses, when amputations occur in the line of duty, the military also provides financial compensation, which is tied to the level of disability. Maynard et al.15 reported the monthly compensations paid to veterans with amputations sustained during the Vietnam, Desert Shield/Desert Storm, and OIF/OEF conflicts. Notably, 94% of those veterans studied had disabilities beyond their amputations with posttraumatic stress disorder being the most frequently observed. Monthly mean compensation values, reported in 2007 USD, were similar for veterans from all three military operations, reported at just over $3,000 for the half of all veterans with a 100% disability rating and just under $2,000 for their peers with disability ratings less than 100%. These are summarized in Table 2. In a final article, Edwards et al.16 report on their efforts to project the lifetime health care costs of British veterans who sustained at least one major amputation in Afghanistan. Utilizing a systematic review of existing literature on care costs for persons with amputation, the authors determined and reported the anticipated health care costs for these veterans based on amputation level. These ranged from $1.34 million for unilateral transtibial amputation to $2.47 million for bilateral transfemoral amputation. These are shown in Table 2. OTHER MISCELLANEOUS PROSTHETIC CARE CONSIDERATIONS HEALTH CARE COSTS ASSOCIATED WITH OTHER DISCRETE TREATMENT POPULATIONS In addition to DM, PAD, CLI, and traumatic military amputations, two additional niche populations, children with traumatic amputations secondary to lawnmower injury and farmers and ranchers who have sustained major amputations, have been reported in the literature. Loder et al.17 attempted to project the long-term lower-limb prosthetic costs in the United States among children who sustain traumatic lawnmower amputation. They determined that the prosthetic costs from the time of injury to the age of 18 ranged from $73,140 to $116,040 (2003 USD). Using amputation prevalence data, they estimated the annual burden for prosthetic costs due to lawnmower amputation to range from $43.88 to $75.42 million (2003 USD). Waldera et al.18 reported a set of structured interviews that took place with 40 farms and 26 prosthetists. Cost was among the common themes identified through this effort. The authors provided generic cost-related summarizing statements from these interviews. For example, most farmers do not receive workers’ compensation benefits because they are small business owners. Farmers and clinicians agreed that insurance coverage is often inadequate for this population with high deductibles and low lifetime coverage limits. Poor durability trends observed in this vocation constituted another cost-related concern. Finally, because of their rural living environments, several farmers reported long travel distances to see their prosthetist and receive prosthetic care. However, outside of these general trends and concerns, no actual costs were reported. COST CONSIDERATIONS WHERE AMPUTATION REPRESENTS ONE OPTION ACROSS A SPECTRUM OF CARE Two common causes of LLA are severe tibial fractures and nonhealing ulceration. In both cases, amputation represents one course of intervention. When selecting between treatment options, health care costs are reasonably considered. Chung et al.19 reported the comparative costs observed between limb salvage and amputation in the management of severe, open tibial fractures. They assert that the average lifetime cost of limb salvage in such cases is $163,282 (2002 USD). By contrast, the average lifetime cost of limb amputation was reported at $509,275 (2002 USD). Within this figure, they assert that prostheses will be replaced every 2.3 years with annual maintenance costs of 20%. Using an average prosthetic cost of $10,232, this equates to $181,500 in prosthetic costs over 40 years. The cost differential between limb salvage and amputation decreases with increasing age at the time of the event and life expectancy after injury. At the institutional level, Nason et al.20 examined the 2-year costs at an Irish university hospital setting before and immediately after the implementation of a multidisciplinary foot protection clinic. Their findings are reported in Euros, presumably in 2010 currency, but for the sake of this review, they are presented as percentages of baseline costs. The authors report that the implementation of the clinic resulted in a decrease in both hospital and prosthesis costs of 13.6%. These health care savings were partially offset by the addition of multidisciplinary human resources (i.e., consultant, administrators, nurses) and total contact footwear, casts, and other orthoses. Ultimately, the number of amputations reduced from 12 cases before the clinic implementation to seven cases after the establishment of the clinic. Total costs (i.e., hospital, prostheses, staff, and footwear) ultimately decreased by 9% in the 2 years following the implementation of the multidisciplinary foot clinic. ADDITIONAL PROSTHETIC-RELATED ECONOMIC CONSIDERATIONS Beyond the articles cited previously, three additional publications were identified that included economic considerations relative to lower-limb prosthetic intervention. Rogers et al.,21 in their description of transtibial socket fabrication using selective laser sintering, refer to the potential scale economies that would increase the viability of additive manufacturing by reducing fabrication costs. Authors were unable to find evidence of widespread adoption of this technique in current practice. In a separate Malaysian publication, Gholizadeh et al. describe the HOLO suspension system. This Velcro-based suspensions system is described and evaluated in terms of mechanical testing and patient questionnaire.22 In addition, the authors describe the associated economic considerations by pointing out that the cost of the HOLO system at US $5 is 1/35th the cost relative to widely used pin lock systems, a consideration of substantial importance in resource-limited practice settings. Finally, Paul et al.23 reported upon the rehabilitation of persons with bilateral LLAs in India including the impact of severe resource limitations on outcomes. They report on 25 individuals with bilateral amputations of whom 11 (44%) attained successful prosthetic ambulation. Six of the subjects were not fitted with prostheses due to the extremely short nature of their bilateral transfemoral amputation. An additional 5 subjects (20%) failed to attain prosthetic ambulation because they simply could not afford prostheses. These were day laborers and unskilled workers who had been the primary wage earners in their homes and could no longer work. Their wives attempted to supplement the resultant financial deficits, but were able to earn just enough income to feed immediate family members. These individuals attained wheelchair mobility, not because of physical limitation, but due to simple financial constraint. LIMITATIONS The EBEOs derived from this narrative review of descriptive literature are inherently limited by the scarcity of existing economic literature associated with prosthetic rehabilitation. Thus, the aim of this review was not to provide a comprehensive overview of such economics, but rather, to summarize existing resources. CONCLUSIONS This project systematically reviewed the narrative literature related to transtibial and lower-limb prosthetic health economics and produced 13 EBEOs. Specifically, the review indicates a broad range of expected inpatient costs associated with LLA associated with DM, PAD, or both, as well as those health care costs associated with the 90-day acute stage beginning 30 days before LLA associated with DM. Although comorbid DM appears to increase health care costs before amputation and during chronic prosthetic rehabilitation, during the first 24 weeks after amputation, cumulative health care costs are comparable to those experienced by patients without DM. Among patients with CLI, amputation surgery is less expensive than reconstructive or restorative vascular surgeries, but has been associated with longer hospitalization and increased overall health care costs. The majority of primary prosthetic costs are experienced in the first year after unilateral amputation due to vascular disease. However, revision amputation and amputation of the contralateral limb are not uncommon and include additional economic impact. Among US veterans who sustained a major amputation in conflict, those injured in Vietnam have lower projected prosthetic costs than those injured in OIF/OEF due to the use of fewer, less advanced prosthetic technologies. Among British veterans injured in combat, the lifetime costs following unilateral transtibial amputation are 25% less than those associated with unilateral transfemoral amputation and 16% less than those associated with bilateral transtibial amputation. With exclusive regard to economic implications, limb salvage has been associated with reduced lifetime health care costs relative to amputation and the costs of wound care/foot protection clinics appear to be offset by reduced health care expenses associated with amputation and subsequent prosthetic rehabilitation.

Background and Aims: Although EUS-guided celiac plexus neurolysis (EUS-CPN) is frequently performed, its efficacy for palliation of pain in pancreatic cancer is suboptimal. Recently, EUS-guided radiofrequency ablation (EUS-RFA) has been proposed as a palliative treatment option for pancreatic neoplasms. We performed a single-blind, randomized trial to compare the effectiveness of EUS-CPN and EUS-RFA for palliation of pain in pancreatic cancer. Methods: Patients with abdominal pain because of locally advanced or metastatic pancreatic cancer underwent EUS-CPN (n = 14) or EUS-RFA (n = 12). EUS-RFA was performed using a 1F monopolar probe passed via a 19-gauge FNA needle, by targeting the area of celiac plexus or visualized ganglia. Primary outcome was pain severity as measured by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire pancreatic cancer module (PAN26) administered pretreatment and at 2 and 4 weeks post-treatment. Secondary outcome measures were comparison of quality of life as determined by the PAN26 and EORTC Quality of Life Questionnaire core questionnaire (C30) and opioid analgesia use between the 2 groups. Results: Both the PAN26 (49.0 vs 57.0, P<.001) and C30 (51.9 vs 64.4, P=.032) revealed less pain for EUS-RFA than for EUS-CPN. Also, the EUS-RFA cohort experienced significantly less-severe GI symptoms, were able to plan more for the future, and had better emotional functioning compared with the EUS-CPN group. Conclusions: Compared with EUS-CPN, EUS-RFA provided more pain relief and improved the quality of life for patients with pancreatic cancer. (Clinical trials registration number: NCT03152487.)

Background: Emerging disease-modifying therapies (DMTs) have evolved as an alternative treatment for patients with multiple sclerosis (MS). The efficacy and safety of established DMTs (interferons, glatiramer acetate, natalizumab, fingolimod and mitoxantrone) have been well studied and clinical trials with small sample sizes have suggested that emerging DMTs (iteriflunomide, dimethyl fumarate/BG-12, alemtuzumab and pegylated IFN) may have distinct advantages relative to established DMTs including better outcomes and reduced healthcare resource utilization. However, there is limited real-world information regarding which DMTs (established vs. emerging) provide the best clinical response and outcomes in managed care populations of patients with MS. Aims: To compare MS related healthcare use within one year of initiating emergent and established DMTs among Managed Medicaid individuals diagnosed with MS in the US. Methods: A large national sample of patient-level administrative healthcare claims data was used for this analysis. MS patients aged 18 years and over with a new prescription fill for an established or emergent DMT between 2013 and 2016 were evaluated. Patients were eligible if they were continuously enrolled in a health plan with pharmacy and medical coverage for at least 6 months before and 1 year after initiation of therapy. Four types of healthcare use were examined: MS-related hospitalizations, emergency room (ER) visits and relapse events (inpatient and outpatient). Multivariate negative binomial models with robust standard errors were used to estimate the association between MS related healthcare use and type of DMT. All models adjusted for age, gender, Charlson index and geographic region. Results: During the study period, 6981 Managed Medicaid individuals with a MS diagnosis initiated a DMT. Of those, 79.8% were female, 50.4% were aged 40–64 years and 21.5% were on emergent DMTs. Emergent DMT users had fewer hospitalizations compared to first generation DMT users within one year of initiating therapy (adjusted risk ratio [ARR] = 0.64, 95% confidence interval [CI]: 0.46–0.88) and fewer outpatient relapses (ARR = 0.86%, CI: 0.79–0.95). Differences in inpatient relapses and ER visits were not observed by DMT type. Conclusions: This study suggests emergent DMTs are associated with reduced MS-related hospitalizations and outpatient relapses within one year of initiating therapy. Studies examining a longer treatment time frame and additional outcomes are warranted to confirm these findings.

As policymakers look to encourage value-driven, cost-effective, quality care delivery models, there is growing interest in comparing traditional Fee-for-Service (FFS) Medicare and Medicare Advantage (MA). To date, there is little comprehensive information on the performance of MA compared to FFS due in part to a lack of access to comparable MA encounter data. The objective of this study was to compare healthcare utilization, cost, and quality outcomes across 2 large national samples of dual eligible MA and FFS Medicare beneficiaries. A descriptive cross-sectional cohort design was used to analyze 1,581,822 MA beneficiaries from a large national claims database and 1,212,698 FFS beneficiaries from Medicare Standard Analytic Files (SAF). Beneficiaries were required to be continuously enrolled with medical and pharmacy benefit coverage for the 12-month reporting year 2015. Dual eligible MA beneficiaries had 32.9% fewer inpatient stays and 42.1% fewer ER visits than FFS Medicare. Total cost of care for duals was 16.7% higher in FFS Medicare ($13,398 versus $11,159 in MA). MA duals experienced a 24.1% lower rate of potentially avoidable hospitalizations (19.2% versus 25.3% of FFS Medicare). Despite having a higher percentage of beneficiaries with clinical and social risk factors, the MA population had lower utilization of costly healthcare services. These findings support the notion that the flexibility MA plans have to provide coordinated care and additional benefits results in improved outcomes and lower costs. Starting in 2019, regulatory changes will expand the scope of supplemental benefits that MA plans can offer, including benefits that are not primarily health related. A better understanding of high-cost, high-need patients is essential to developing targeted and innovative benefit programs aimed at reducing costs and improving outcomes in this growing population.

Although most postendoscopic retrograde cholangiopancreatography (ERCP) biliary tract infections are attributed to suboptimal ductal drainage, transmission of infection by contaminated reusable duodenoscopes has been reported. To overcome this limitation, a disposable duodenoscope has been recently developed. However, given the widespread use and large volume of ERCPs being performed worldwide, the financial viability of this novel concept is unclear. Utilising an activity-based costing and financial model, we estimated that the per-procedure cost of a disposable duodenoscope in the United States can vary from $797 to $1547 for centres performing at the 75th percentile of ERCP procedure volume and from $1318 to $2068 for centres performing at the 25th percentile of procedure volume, based on infection rates of 0.4% to 1%, respectively. However, when infection was not factored, the per-procedure cost decreased to $818 and $297 for centres performing at the 25th and 75th percentiles, respectively. Given the recent reports on infection outbreaks, including carbapenem-resistant Enterobacteriaceae (CRE), caused by contaminated duodenoscopes used at ERCP,1–4 a disposable duodenoscope (ExaltTM, Single-Use Duodenoscope, Boston Scientific Corporation, Natick, Massachusetts, USA) has been developed to circumvent this problem.5 To determine the adaptability of this innovation in clinical practice, we estimated the per-procedure cost of ERCP using a reusable duodenoscope in order to assess the break-even costs for transitioning to disposable duodenoscopes. An activity-based costing and financial model was constructed based on the current clinical practice of ERCP at a tertiary medical centre in the USA. The annual procedure volume was 1752 ERCPs in 2018. Nine duodenoscopes with lifetime usage of 3 years and a reprocessing turn-over time of 40 min per scope were required to meet the clinical needs. The cost of an individual duodenoscope was $35 000 ($11 667/year) with annual maintenance and repair costs of $1451 per scope. The annual cost …

BACKGROUND & AIMS:Although single-operator cholangioscopy is considered to be the most sensitive method for tissue acquisition in patients with indeterminate bile duct strictures (IBDS), methods are needed to optimize the specimen collection and processing techniques. We aimed to determine the optimal method for specimen processing and identify the number of biopsies required to establish a definitive diagnosis. METHODS:Patients with IBDS were randomly assigned to groups that underwent specimen processing using the onsite (n = 32) or offsite (n = 30) method. The primary outcome was to compare operating characteristics of onsite vs offsite specimen processing techniques. The secondary outcome was number of biopsies needed to establish definitive diagnosis. A final diagnosis was established at surgery or after a minimum clinical follow-up period of 18 months RESULTS: The final diagnosis was benign disease in 33 patients and malignancy in 29 patients. There were no significant differences between the offsite and onsite groups in diagnostic accuracy (90% vs 87.5%; P=.99), sensitivity (76.9% vs 75%; P=.99), specificity (100% vs 100%; P=.99), positive predictive value (100% vs 100%; P=.99), or negative predictive value (85% vs 80%; P=.99). Although diagnoses were established by analysis of a median of 1 biopsy in the onsite cohort (interquartile range, 1-1.5), the diagnostic accuracy was identical (90%) in each group, regardless of whether 3 or 4 biopsies were collected from each patient in the offsite cohort. CONCLUSIONS:In a prospective comparative study, we found that centers without onsite cytopathology support that analyze 3 single-operator cholangioscopy-guided biopsies of a biliary stricture and process the specimens offsite make the correct diagnosis for 90% of cases. ClinicalTrials.gov, Number: NCT01815619.

Although frequently performed, the efficacy of celiac plexus neurolysis (EUS-CPN) for palliation of pain in pancreatic cancer is suboptimal. Recently, EUS-guided radiofrequency ablation (EUS-RFA) has been proposed as a palliative treatment modality for pancreatic neoplasms. We performed a single-blind, randomized trial to compare the effectiveness of EUS-CPN and EUS-RFA for palliation of pain in pancreatic cancer. Patients with abdominal pain due to locally advanced or metastatic pancreatic cancer underwent EUS-CPN (n=14) or EUS-RFA (n=12). EUS-RFA was performed using a 1mm monopolar (Habib EndoHPB) probe passed via a 19G FNA needle and by targeting the area of celiac plexus or visualized ganglia. The primary endpoint was quality of life (QOL) as measured by the European Organization for Research and Treatment of Cancer (EORTC) core cancer (QLQ-C30) and pancreatic cancer-specific (QLQ-PAN26) questionnaires that were administered pre-treatment and at 2 and 4-weeks post-treatment. The core cancer (QLQ-C30) assessment revealed less pain (51.9 vs. 64.4, P=0.032) for EUS-RFA over EUS-CPN cohort. Likewise, when compared to EUS-CPN, the pancreatic cancer specific (QLQ-PAN26) questionnaire revealed less pain (49 vs. 57, P<0.001), fewer digestive symptoms (39.1 vs. 53.5, P=0.031), less alteration in bowel habits (16.9 vs. 24.8, P=0.029), less indigestion (20.6 vs. 51, P<0.001), less fear of future health (56.8 vs. 69.3, P=0.001) and better ability to plan for future (50.1 vs. 68.5, P=0.003) for the EUS-RFA cohort. Compared to EUS-CPN, EUS-guided RFA provided more pain relief and improved quality of life.

BACKGROUND & AIMSInfected necrotizing pancreatitis is a highly morbid disease with poor outcomes. Intervention strategies have progressed from open necrosectomy to minimally invasive approaches. We compared outcomes of minimally invasive surgery vs endoscopic approaches for patients with infected necrotizing pancreatitis.METHODSWe performed a single-center, randomized trial of 66 patients with confirmed or suspected infected necrotizing pancreatitis who required intervention from May 12, 2014, through March 24, 2017. Patients were randomly assigned to groups that received minimally invasive surgery (laparoscopic or video-assisted retroperitoneal debridement, depending on location of collection, n = 32) or an endoscopic step-up approach (transluminal drainage with or without necrosectomy, n = 34). The primary endpoint was a composite of major complications (new-onset multiple organ failure, new-onset systemic dysfunction, enteral or pancreatic-cutaneous fistula, bleeding and perforation of a visceral organ) or death during 6 months of follow-up.RESULTSThe primary endpoint occurred in 11.8% of patients who received the endoscopic procedure and 40.6% of patients who received the minimally invasive surgery (risk ratio 0.29; 95% confidence interval 0.11-0.80; P = .007). Although there was no significant difference in mortality (endoscopy 8.8% vs surgery 6.3%; P = .999), none of the patients assigned to the endoscopic approach developed enteral or pancreatic-cutaneous fistulae compared with 28.1% of the patients who underwent surgery (P = .001). The mean number of major complications per patient was significantly higher in the surgery group (0.69 ± 1.03) compared with the endoscopy group (0.15 ± 0.44) (P = .007). The physical health scores for quality of life at 3 months was better with the endoscopic approach (P = .039) and mean total cost was lower ($75,830) compared with $117,492 for surgery (P = .039).CONCLUSIONSIn a randomized trial of 66 patients, an endoscopic transluminal approach for infected necrotizing pancreatitis, compared with minimally invasive surgery, significantly reduced major complications, lowered costs, and increased quality of life. Clinicaltrials.gov no: NCT02084537.

OBJECTIVE:Although lumen-apposing metal stents (LAMS) are increasingly used for drainage of walled-off necrosis (WON), their advantage over plastic stents is unclear. We compared efficacy of LAMS and plastic stents for WON drainage. DESIGN:Patients with WON were randomised to endoscopic ultrasound-guided drainage using LAMS or plastic stents. Primary outcome was comparing total number of procedures to achieve treatment success defined as symptom relief in conjunction with WON resolution on CT at 6 months. Secondary outcomes were treatment success, procedure duration, clinical/stent-related adverse events, readmissions, length of hospital stay (LOS) and costs. RESULTS:60 patients underwent LAMS (n=31) or plastic stent (n=29) placement. There was no significant difference in total number of procedures performed (median 2 (range 2-7) LAMS vs 3 (range 2-7) plastic, p=0.192), treatment success, clinical adverse events, readmissions, LOS and overall treatment costs between cohorts. Although procedure duration was shorter (15 vs 40 min, p<0.001), stent-related adverse events (32.3% vs 6.9%, p=0.01) and procedure costs (US$12 155 vs US$6609, p<0.001) were higher with LAMS. Significant stent-related adverse events were observed ≥3 weeks postintervention in LAMS cohort. Interim audit resulted in protocol amendment where CT scan was obtained at 3 weeks postintervention followed by LAMS removal if WON had resolved. After protocol amendment, there was no significant difference in adverse events between cohorts. CONCLUSION:Except for procedure duration, there was no significant difference in treatment outcomes between LAMS and plastic stents. To minimise adverse events with LAMS, patients should undergo follow-up imaging and stent removal at 3 weeks if WON has resolved. TRIAL REGISTRATION NUMBER:NCT02685865.

ABSTRACT As modern health care systems transition from fee-for-service to fee-for-value structures, it is increasingly relevant for the field of prosthetic rehabilitation to understand modern economic science. Health care economics can be approached through a range of analyses in which the costs of health care services are compared against subsequent cost savings, consequences observed with the intervention, the effectiveness of the intervention with regard to a range of outcomes valued by the patient, payer, and provider, or widely used global utility measures. Although examples of economic science are limited in current prosthetic literature, available examples are cited to describe various approaches to economic analysis. An understanding of economic science clarifies the need for the continued identification, creation, and adoption of outcome measures sensitive enough to discriminate between prosthetic interventions and valued collectively by patients, payers, and providers. Future clinical trials should collect and report upon the associated costs as well as meaningful outcome measures to expand the current body of economic evidence in the prosthetic literature.

To compare multiple sclerosis (MS) related healthcare use within one year of initiating first and second generation disease modifying therapies (DMTs) among individuals diagnosed with MS in the U.S. A large national sample of patient-level administrative healthcare claims data were used for this analysis. MS patients aged 18 years and over with a new prescription fill for a first or second generation DMT between 2013 and 2015 were evaluated. First generation DMTs included interferon beta-1b and glatiramer acetate (GA). Second generation DMTs included teriflunomide, dimethyl fumarate, natalizumab, novantrone, interferon beta-1a, peginterferon beta-1b, and fingolimod. Patients were eligible if they were continuously enrolled in a health plan with pharmacy and medical coverage for at least 6 months before and 1 year after initiation of therapy. Three types of healthcare use were examined: MS-related hospitalizations and relapse events (inpatient and outpatient). Multivariate Poisson and Zero-inflated Poisson models with robust standard errors were used to estimate the association between MS-related healthcare use and type of DMT. All models adjusted for age, gender, Charlson index, geographic region and payer type. During the study period, 18,946 individuals with a MS diagnosis initiated a DMT. Of those, 77.3% were female, 66.3% were ages 40-64 years, and 53.3% had commercial health insurance. Almost two-thirds (62.9%) were on second generation DMTs. Second generation DMT users were found to have fewer MS-related hospitalizations compared to first generation DMT users within one year of initiating therapy (adjusted risk ratio (ARR)= 0.91 (95% confidence interval (CI): 0.88-0.97)). Differences in inpatient and outpatient relapses were not observed by DMT type. This study suggests that second generation DMTs are associated with reduced MS-related hospitalizations within one year of initiating therapy. Studies examining a longer treatment timeframe and additional healthcare outcomes are warranted to confirm these findings.

Although lumen‐apposing metal stents (LAMS) are increasingly being used for drainage of pancreatic fluid collections (PFC), their advantage over plastic stents is unclear.

Objective: To determine the relationship between medical and mental health comorbidities in a large cohort of veterans with spinal cord injury (SCI). Methods: Data were collected from interviews and electronic medical records of veterans with SCI (N = 1,047) who received care at 7 geographically diverse SCI centers within the Department of Veterans Affairs across the country (https://clinicaltrials.gov/ct2/show/NCT01141647). Employment, medical, functional, and psychosocial data underwent cross-sectional analysis. Results: Lack of any documented mental health diagnosis correlated strongly with being employed at the time of enrollment. No single comorbidity was associated with employment at enrollment, but an increased number of medical and/or mental health comorbidities ("health burden") were associated with a decreased likelihood of employment at the time of enrollment. Conclusion: Further investigation is needed to clarify whether comorbidity severity or combinations of specific comorbidities predict rehabilitation outcome, including employment.

Compared to non-microprocessor knees, the C-Leg microprocessor knee (MPK) is bioenergentically and economically more efficient and safer for transfemoral amputation (TFA) patients. The Genium MPK has demonstrated improvements in perceived function, knee kinematics, and physical functional performance compared to C-Leg. Clinical and health economic analyses have not been conducted with the Genium knee system. The purpose of this study was to determine if laboratory determined benefits of Genium are detectable using common clinical assessments and if there are economic benefits associated with its use. This study utilized a randomized AB crossover study with 60 d follow-up including cost-effectiveness analysis. Twenty TFA patients tested with both knees in mobility and preference measures. Incremental cost-effectiveness ratios (ICER) were calculated based on performance measures. Stair Assessment Index scores improved with Genium. Mean stair completion times and descent stepping rate were not different between knees. Stair ascent stepping rate for C-Leg was greater compared with Genium (p = 0.04). Genium use decreased Four square step test completion time and increased functional level and step activity (p ≤ 0.05). Further, Genium use improved (p ≤ 0.05) function and safety in three out of five Activities of Daily Living (ADL) survey domains. Finally, more subjects preferred Genium following testing. Functional measures were used to calculate ICERs. ICER values for Genium fall within established likely-to-accept value ranges. Compared with C-Leg, Genium use improved stair walking performance, multi-directional stepping, functional level, and perceived function. In this group of community ambulators with TFA, Genium was preferred, and, while more costly, it may be worth funding due to significant improvements in functional performance with ADLs.

The objectives were to determine whether and by what amounts the US Department of Veterans Affairs (VA) use of Medical Foster Homes (MFH) rather than Community Living Centers (CLC) reduced budget impacts to the VA. This was a retrospective, matched, case-control study of veterans residing in MFH or CLC in the VA health care system from 2008 to 2012. Administrative data sets, nearest neighbor matching, generalized linear models, and a secondary analysis were used to capture and analyze budget impacts by veterans who used MFH or CLC exclusively in 2008-2012. Controls of 1483 veterans in CLC were matched to 203 cases of veterans in MFH. Use of MFH instead of CLC reduced budget impacts to the VA by at least $2645 per veteran per month. A secondary analysis of the data using different matching criteria and statistical methods produced similar results, demonstrating the robustness of the estimates of budget impact. When the average out-of-pocket payments made by MFH residents, not made by CLC residents, were included in the analysis, the net reduction of budget impact ranged from $145 to $2814 per veteran per month or a savings of $1740 to $33,768 per veteran per year. Even though outpatient costs of MFH are higher, much of the reduced budget impact of MFH use arises from lower inpatient or hospital costs. Reduced budget impacts on the VA system indicate that expansion of the MFH program may be cost-effective. Implications for further research are suggested.