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Background Hematopoietic cell transplantation (HCT) is a potentially curative therapy as well as a costly procedure. Published studies have examined the cost of HCT in the US and the complications that follow but little is known about the cancer-related healthcare costs and resource utilization prior to the procedure and none of the studies have examined the variability in cost based on the type of hematologic malignancy involved. The aim of this study was to estimate mean cancer-related costs and resources incurred before the HCT is performed from the time the hematologic malignancy first develops. Methods The IBM® MarketScan® Research Databases were used to identify adult patients ≥18 years of age with commercial or Medicare supplemental insurance who had undergone allogeneic HCT for hematologic malignancies from January 1, 2008 to December 31, 2017. Healthcare utilization and costs were assessed during the 6 months prior to diagnosis (pre-diagnostic period) and the follow-up period from diagnosis just prior to the HCT (pre-HCT period). Multivariable regression models were constructed to estimate total all-cause costs and cancer-related costs as well as healthcare utilization by type in each time period. Results A total of 2663 commercially insured patients and 266 with Medicare supplemental insurance were included in the study population. The mean-adjusted incremental cancer-related costs for commercially insured patients was $399,011 in the overall observation period including the pre-diagnostic and pre-HCT periods combined, 9% of which was incurred in the pre-diagnostic period. The corresponding mean-adjusted incremental cancer-related costs for Medicare supplemental patients was $195,575 for the same time period but the patterns of healthcare utilization were similar to the commercially insured population. Inpatient care accounted for approximately one-half the cost in both patient populations. By type of hematologic malignancy, costs were lowest for myeloproliferative disorders ($211,561) and highest for acute lymphocytic leukemia ($462,072) in the commercially insured population. Conclusion This study demonstrates that overall patients with hematologic malignancies requiring HCT have considerable cancer-related healthcare resource utilization and costs leading up to HCT compared to the period of time prior to developing cancer.

BACKGROUND: Atopic dermatitis is considered a childhood illness, and the direct and indirect health care burden of atopic dermatitis in adults is not fully understood. OBJECTIVE: To measure the dir...

Purpose: To determine the efficacy of an educational intervention on patient adoption and attitudes toward selective laser trabeculoplasty (SLT) as first-line treatment for glaucoma. Methods: This study is a randomized controlled trial. Subjects include 33 patients within 1-year diagnosis of either primary open-angle glaucoma, ocular hypertension, or pseudoexfoliation syndrome. After informed consent, subjects were randomly assigned to a Usual Care or Educational Intervention group. All subjects completed a pre-intervention questionnaire. The Educational Intervention group was shown a slideshow presentation and a 3-min video and given a post-intervention questionnaire. Follow-up examinations were reviewed for 6 months to determine subject completion of SLT, the primary outcome. Secondary outcomes include assessment of attitude toward SLT before and after intervention. Results: Age, gender, and baseline characteristics between the groups did not differ. The Usual Care group had a higher proportion of African Americans (77% vs 31%, p = 0.04). At 6 months following the intervention, 63% of subjects underwent SLT compared to 35% of Usual Care subjects ( p = 0.12). Older age was associated with decreased SLT uptake (OR 0.90, 95% CI 0.82–0.99, p = 0.03). Prior to the intervention, there were no differences in attitudes of both groups regarding SLT therapy. Nineteen percent of Educational Intervention subjects changed positively toward SLT ( p = 0.08) and 50% scheduled an SLT appointment after intervention ( p = 0.005). Conclusions: A slideshow and video-based educational intervention may positively enhance patient adoption of SLT. Clinical trial registration name, number, URL: Educational Intervention to Adopt SLT as First-Line Glaucoma Treatment, NCT03365778, https://clinicaltrials.gov/ct2/show/NCT03365778

Purpose: To describe a patient who presented with right unilateral white-eyed posteriorly-draining carotid-cavernous fistulas (CCF) causing an isolated, acute-onset trochlear nerve palsy with atypical progression to a contralateral left red-eyed anteriorly-draining CCF associated with orbital congestion.Observation: A 74-year-old female presented with an acute onset incomitant right hypertropia consistent with the clinical diagnosis of a superior oblique palsy. Initial workup including MRI was normal. During a several-week course, she progressed to a comitant deviation. Six-weeks later she developed an episode of severe headache followed by worsening of her diplopia, reverse left hypertropia and left orbital congestive signs. CTA revealed mild opacification of the left cavernous sinus without a concomitantly present superior ophthalmic vein dilatation. A diagnostic angiogram was obtained which revealed a posterior-draining indirect CCF of the right internal carotid artery (ICA) and an anterior-draining indirect CCF of the left ICA. Transvenous Coil embolization resulted in immediate resolution of diplopia, orbital congestion, and headaches.Conclusion: Although it is atypical for a CCF - or other vascular pathology - to present with an isolated fourth nerve palsy, this case illustrates that vascular imaging should be considered in cases of acquired ocular motor paresis associated with headaches and cases with atypical progression despite normal initial cranial imaging.

Fundus manifestations of primary hyperoxaluria include crystalline deposits, focal or diffuse macular hyperpigmentation, and subretinal fibrosis. Choroidal neovascularization has been hypothesized to underlie the pathogenesis of subretinal fibrosis, yet its manifestations are rarely observed. We report a case of infantile primary hyperoxaluria type 1 in a 17-month-old infant with macular subretinal fluid and subretinal hemorrhage that was associated with leakage on fluorescein angiography and responded to bevacizumab treatment, consistent with choroidal neovascularization. This case suggests that choroidal neovascularization may contribute to subretinal fibrosis and subsequent vision loss in infantile primary hyperoxaluria and may benefit from anti-vascular endothelial growth factor therapy.

Purpose An International Classification of Disease (ICD‐10) Charlson Comorbidity Index (CCI) adaptation had not been previously developed and validated for United States (US) healthcare claims data. Many researchers use the Canadian adaption by Quan et al (2005), not validated in US data. We sought to evaluate the predictive validity of a US ICD‐10 CCI adaptation in US claims and compare it with the Canadian standard. Methods Diverse patient cohorts (rheumatoid arthritis, hip/knee replacement, lumbar spine surgery, acute myocardial infarction [AMI], stroke, pneumonia) in the IBM® MarketScan® Research Databases were linked with the IBM MarketScan Mortality file. Predictive performance was measured using c‐statistics for binary outcomes (1‐year and postoperative mortality, in‐hospital complications) and root mean square prediction error (RMSE) for continuous outcomes (1‐year all‐cause medical costs, index hospitalization costs, length of stay [LOS]), after adjusting for age and sex. C‐statistics were compared by the method of DeLong and colleagues (1988); RMSEs, by resampling. Results C‐statistics were generally high (≥ ~ 0.8) for mortality but lower for in‐hospital complications (~0.6–0.7). RMSEs for costs and hospitalization LOS were relatively large and comparable to standard deviations. Results were similar overall between the US and Canadian adaptations, with relative differences typically

Summary The study examined long-term direct and indirect economic burden of osteoporotic fractures among postmenopausal women. Healthcare costs among fracture patients were substantial in first year after fracture and remained higher than fracture-free controls for 5 years which highlight needs for early detection of high-risk patients and continued management for osteoporosis. Introduction This study compared direct and indirect healthcare costs between postmenopausal women and demographically matched controls in the 5 years after incident non-traumatic fracture, and by fracture type in commercially insured and Medicare populations. Methods Two hundred twenty-six thousand one hundred ninety women (91,925 aged 50–64 years; 134,265 aged ≥ 65 years) with incident non-traumatic fracture (hip, vertebral, and non-hip non-vertebral (NHNV)) from 2008 to 2017 were identified. Patients with fracture were directly matched (1:1) to non-fracture controls based on demographic characteristics. Direct healthcare costs were assessed using general linear models, adjusting for baseline costs, comorbidities, osteoporosis diagnosis, and treatment. Indirect costs associated with work loss due to absenteeism and short-term disability (STD) were assessed among commercially insured patients. Costs were standardized to 2019 US dollars. Results Osteoporosis diagnosis and treatment rates prior to fracture were low. Patients with fracture incurred higher direct costs across 5-year post-index compared with non-fracture controls, regardless of fracture type or insurance. For commercially insured hip fracture patients, the mean adjusted incremental direct healthcare costs in years 1, 3, and 5 were $59,327, $6885, and $3241, respectively. Incremental costs were lower, but trends were similar for vertebral and NHNV fracture types and Medicare-insured patients. Commercially insured patients with fracture had higher unadjusted indirect costs due to absenteeism and STD in year 1 and higher adjusted indirect costs due to STD at year 1 (incremental cost $5848, $2748, and $2596 for hip, vertebral, and NHNV fracture). Conclusions A considerable and sustained economic burden after a non-traumatic fracture underscores the need for early patient identification and continued management. Supplementary Information The online version contains supplementary material available at 10.1007/s00198-020-05769-3.

Aims We aimed at investigating the relationship between particulate matter (PM) and daily admissions for cardiovascular diseases (CVDs) at national level in Italy. Methods and results Daily numbers of cardiovascular hospitalizations were collected for all 8084 municipalities of Italy, in the period 2013–2015. A satellite-based spatiotemporal model was used to estimate daily PM10 (inhalable particles) and PM2.5 (fine particles) concentrations at 1-km2 resolution. Multivariate Poisson regression models were fit to estimate the association between daily PM and cardiovascular admissions. Flexible functions were estimated to explore the shape of the associations at low PM concentrations, also in non-urban areas. We analysed 2 154 810 acute hospitalizations for CVDs (25% stroke, 24% ischaemic heart diseases, 22% heart failure, and 5% atrial fibrillation). Relative increases of total cardiovascular admissions, per 10 µg/m3 variation in PM10 and PM2.5 at lag 0–5 (average of last 6 days since admission), were 0.55% (95% confidence intervals: 0.32%, 0.77%) and 0.97% (0.67%, 1.27%), respectively. The corresponding estimates for heart failure were 1.70% (1.28%, 2.13%) and 2.66% (2.09%, 3.23%). We estimated significant effects of PM10 and PM2.5 also on ischaemic heart diseases, myocardial infarction, atrial fibrillation, and ischaemic stroke. Associations were similar between less and more urbanized areas, and persisted even at low concentrations, e.g. below WHO guidelines. Conclusion PM was robustly associated with peaks in daily cardiovascular admissions, especially for heart failure, both in large cities and in less urbanized areas of Italy. Current WHO Air Quality Guidelines for PM10 and PM2.5 are not sufficient to protect public health.

Objectives The aim of this study was to examine the indirect burden of employed multiple sclerosis (MS) patients initiating disease-modifying therapies (DMTs) in the US. Methods DMT-treated MS patients (DMT users) and direct-matched controls without MS (1:3) were captured using the IBM MarketScan Commercial Claims and Encounters Database and the Health and Productivity Management Database between 1 January 2009 and 1 January 2017. DMT users were also stratified by route of administration. Time loss and costs from absenteeism, short-term disability, and long-term disability were assessed for DMT users and matched controls. Results A total of 3022 DMT users were matched to 9066 controls. Compared with injectable DMT users, oral DMT users took twice as long to initiate therapy but had numerically lower absenteeism costs and significantly lower long-term disability costs in the first year after DMT initiation. The mean (standard deviation) indirect costs of absenteeism, short-term disability, and long-term disability were US$6474 (US$6779), US$2368 (US$5777), and US$280 (US$2578), respectively, for DMT users and US$4468 (US$3814), US$328 (US$1950), and US$36 (US$938), respectively, for controls in the first year (all p

Targeted immunomodulators (TIMs) are used for the treatment of moderate to severe rheumatoid arthritis (RA) and include biologic and nonbiologic medications with different mechanisms of action. Data describing disease activity levels in RA are not directly available in claims databases but can be determined using a claims-based effectiveness algorithm. Rheumatology has benefited from the recent introduction of new drugs, many with new mechanisms of action. We provide an analysis of this broader range of medications.To (a) describe and summarize the effectiveness of available TIMs for the treatment of moderate to severe RA and (b) determine the RA-related health care costs per effectively treated patient, using recent data.This was a retrospective analysis using data from the IBM MarketScan Commercial Claims and Encounters Database from July 1, 2012, through December 31, 2016. Index date was the new prescription claim for a TIM (abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, tocilizumab, or tofacitinib). A 6-month pre-index baseline period was used to determine demographic and clinical characteristics. Patients without a TIM claim during the baseline period were considered naive; patients with a TIM claim in the baseline period that was different than the index TIM were assessed as receiving second-line therapy. A claims-based algorithm was used to assess 12-month treatment effectiveness and total RA-related costs. Costs included RA-related pharmacy costs and medical costs.Data from 14,775 patients were analyzed, including patients prescribed abatacept (n = 1,250), adalimumab (n = 4,986), certolizumab pegol (n = 387), etanercept (n = 5,266), golimumab (n = 577), infliximab (n = 969), tocilizumab (n = 451), and tofacitinib (n = 889). Of these, 705 were receiving second-line therapy. TIM effectiveness by first-line and second-line therapy, respectively, were abatacept 27.1%, 18.1%; adalimumab 30.9%, 22.1%; certolizumab pegol 20.9%, 14.3%; etanercept 31.4%, 31.5%; golimumab 32.7%, 22.2%; infliximab 21.9%, 21.3%; tocilizumab 30.9%, 30.6%; and tofacitinib 26.0%, 21.6%. The main reason for failing effectiveness was not achieving an 80% medication possession ratio or being nonadherent. The 1-year total RA-related cost per effectively treated patient for first-line and second-line therapies, respectively, were abatacept $121,835, $174,090; adalimumab $112,708, $154,540; certolizumab pegol $149,946, $236,743; etanercept $102,058, $94,821; golimumab $108,802, $140,651; infliximab $155,123, $185,369; tocilizumab $93,333, $109,351; and tofacitinib $100,306, $130,501.The effectiveness of TIMs from this real-world experience showed that the range of patients who were effectively treated with first-line therapy was higher for certain tumor necrosis factor inhibitors and tocilizumab. The percentages of effectively treated patients were generally lower in second-line treatment compared with first-line except for etanercept, which had the same percentage between lines of therapy. Etanercept had the lowest RA-related cost per effectively treated patient among tumor necrosis factor inhibitors in first-line use and the lowest RA-related cost per effectively treated patient compared with all second-line treatments.This study was sponsored by Amgen. Amgen employees contributed to study design, analysis of the data, and the decision to publish the results. Maksabedian Hernandez and Stolshek are employees and shareholders of Amgen; Gharaibeh was employed by Amgen at the time of this study. Bonafede was employed by IBM Watson Health, at the time of this study, and McMorrow is employed by IBM Watson Health, which received funding from Amgen to conduct this study. Data from this study were presented at AMCP Nexus, October 22-25, 2018, in Orlando, FL.

Objective Disease-modifying therapies (DMTs) can reduce multiple sclerosis (MS) relapse rates; however, effectiveness of treatments may vary. It is important to understand real-world treatment patterns in the context of MS relapses. We describe MS relapses related to treatment patterns among patients who switch treatment after their first DMT. Methods IBM MarketScan research databases were used to identify adult patients with MS who switched DMTs (index-first switch) after being newly treated with a DMT from January 2009 through March 2017, with 12 months of continuous enrollment pre- and post-index. Non-persistence was defined as discontinuing (at least 60 days without DMT) or switching DMTs. MS relapses were defined using a validated claims-based algorithm. Multivariable analysis was used to examine odds of 12-month persistence, odds of post-index relapse, and number of relapses. Results In total, 4121 patients with MS met all inclusion criteria (mean age 46.4 years; female 76.2%). Overall, 49.6% switched to an oral DMT, 36.5% to an injectable DMT, and 13.9% to an infusion DMT. Switching DMTs resulted in a 32.4% reduction in relapses between pre- and post-index. Only 54.6% of patients were persistent throughout the first year. Patients who switched to oral DMTs had 95% higher adjusted odds of persistence and 18% lower adjusted odds of a post-index period relapse than patients who switched to injectable DMTs. The number of baseline relapses was not associated with persistence but with 68% higher odds of a post-index relapse, with each additional baseline relapse associated with a 44% increase in number of post-index relapses. Conclusions Among patients with MS who switched DMTs, persistence was consistently low regardless of treatment. Although persistence with oral DMTs was slightly higher than with injectable DMTs, overall results indicate poor persistence to second-line therapy and highlight the need to improve long-term persistence with DMTs. Electronic supplementary material The online version of this article (10.1007/s12325-020-01367-1) contains supplementary material, which is available to authorized users.

Introduction Infection with SARS-CoV-2 is typically compared with influenza to contextualize its health risks. SARS-CoV-2 has been linked with coagulation disturbances including arterial thrombosis, leading to considerable interest in antithrombotic therapy for Coronavirus Disease 2019 (COVID-19). However, the independent thromboembolic risk of SARS-CoV-2 infection compared with influenza remains incompletely understood. We evaluated the adjusted risks of thromboembolic events after a diagnosis of COVID-19 compared with influenza in a large retrospective cohort. Methods We used a US-based electronic health record (EHR) dataset linked with insurance claims to identify adults diagnosed with COVID-19 between April 1, 2020 and October 31, 2020. We identified influenza patients diagnosed between October 1, 2018 and April 31, 2019. Primary outcomes [venous composite of pulmonary embolism (PE) and acute deep vein thrombosis (DVT); arterial composite of ischemic stroke and myocardial infarction (MI)] and secondary outcomes were assessed 90 days post-diagnosis. Propensity scores (PS) were calculated using demographic, clinical, and medication variables. PS-adjusted hazard ratios (HRs) were calculated using Cox proportional hazards regression. Results There were 417,975 COVID-19 patients (median age 57y, 61% women), and 345,934 influenza patients (median age 47y, 66% women). Compared with influenza, patients with COVID-19 had higher venous thromboembolic risk (HR 1.53, 95% CI 1.38–1.70), but not arterial thromboembolic risk (HR 1.02, 95% CI 0.95–1.10). Secondary analyses demonstrated similar risk for ischemic stroke (HR 1.11, 95% CI 0.98–1.25) and MI (HR 0.93, 95% CI 0.85–1.03) and higher risk for DVT (HR 1.36, 95% CI 1.19–1.56) and PE (HR 1.82, 95% CI 1.57–2.10) in patients with COVID-19. Conclusion In a large retrospective US cohort, COVID-19 was independently associated with higher 90-day risk for venous thrombosis, but not arterial thrombosis, as compared with influenza. These findings may inform crucial knowledge gaps regarding the specific thromboembolic risks of COVID-19.

Since its emergence, the novel coronavirus disease of 2019 (COVID-19) has had enormous physical, social, and psychological impacts worldwide. The aim of this article was to identify elements of our knowledge on asbestos exposure and malignant mesothelioma (MM) that can provide insight into the psychological impact of the COVID-19 pandemic and be used to develop adequate interventions. Although the etiology of Covid-19 and MM differs, their psychological impacts have common characteristics: in both diseases, there is a feeling of being exposed through aerial contagion to an “invisible killer” without boundaries that can strike even the strongest individuals. In both cases, affected persons can experience personality dysfunction, anxiety, depression, and posttraumatic symptoms; helplessness, hopelessness, and projection of destructive thoughts onto external forces often emerge, while defense mechanisms such as denial, splitting, repression, and reduced emotional expression are used by individuals to contain their overwhelming anxieties. We believe that in both diseases, an integrated multidimensional intervention offered by hospitals and other public health services is the most effective approach to alleviating patients’ and caregivers’ psychological distress. In particular, we emphasize that in the context of both MM and COVID-19, Brief Psychoanalytic Group therapy can help patients and caregivers attribute meaning to the significant changes in their lives related to the experience of the disease and identify adaptive strategies and more realistic relational modalities to deal with what has happened to them. We also highlight the importance of developing a surveillance system that includes individual anamnestic evaluation of occupational risk factors for COVID-19 disease.

A 2-month-old boy developed a protuberant, blue nodule inferomedial to the left medial canthus. It was unresponsive to oral and intramuscular antibiotics. After developing difficulty breathing, he was admitted, with the diagnosis of a dacryocele, and, after an inconclusive ultrasound, underwent probing and irrigation with nasal endoscopy. Intraoperatively, the lesion appeared discontinuous with the nasolacrimal system and could not be decompressed. Postoperative magnetic resonance imaging suggested a hemangioma or possible collapsed dacryocele. Doppler ultrasound confirmed a perinasolacrimal duct hemangioma. Systemic propranolol treatment was initiated.

Objective: The impact of cytomegalovirus (CMV) infection on healthcare resource utilization (HCRU) and costs post-allogeneic hematopoietic stem cell transplant (allo-HSCT) has not been well studied...

Aim: We evaluated treatment patterns and healthcare costs of initiating psoriatic arthritis (PsA) treatment with oral apremilast versus biologics. Methods: Claims data identified biologic-naive adults with PsA who initiated either apremilast or a biologic from 2013 to 2016. Results: Medication adherence was similar at 12 months (76.9 vs 73.4%; p = 0.175) between apremilast (n = 381) and matched biologic (n = 761) patients. Apremilast users had $12,715 lower total costs per-patient-per-month (p Conclusion: Commercially insured patients with PsA initiating apremilast had adherence similar to those initiating biologics but lower total healthcare costs.

Purpose: To describe health care resource utilization (HCRU) and costs among patients with juvenile idiopathic arthritis (JIA) compared to patients without JIA and to describe treatment patterns among JIA patients who initiated biologic and non-biologic disease-modifying antirheumatic drugs (DMARDs). Patients and methods: The IBM MarketScan® Commercial Database was used to identify patients aged 2-17 years with a new JIA diagnosis (index date) and 12 months continuous enrollment pre- and post-diagnosis from 2008 to 2016. JIA patients were matched to non-JIA patients on age, gender, region, and health plan type. Patients with other rheumatic or autoimmune conditions were excluded. Receipt of a biologic and/or non-biologic was evaluated on or after the new JIA diagnosis. Results: A total of 3,815 JIA patients were matched to 11,535 non-JIA patients (mean age 10.0 [SD=4.5], 69% female). Average total costs were greater for JIA patients than non-JIA controls ($18,611 [SD=$42,104; median=$8,189] versus $2,203 [SD=$9,309; median=$649], p

Eric T Wittbrodt,1 Lauren A Millette,1 Kristin A Evans,2 Machaon Bonafede,2 Joseph Tkacz,2 Gary T Ferguson3 1Medical Affairs, AstraZeneca, Wilmington, DE, USA; 2Life Sciences, Value-Based Care, IBM Watson Health, Cambridge, MA, USA; 3Pulmonary Research Institute of Southeast Michigan, Farmington Hills, MI, USA Purpose: The aim of this study was to examine real-world differences in health care resource use (HRU) and costs among COPD patients in the USA treated with a dry powder inhaler (DPI) or pressurized metered-dose inhaler (pMDI) following a COPD-related hospitalization. Methods: This retrospective analysis used the Truven MarketScan® databases. Eligibility criteria included 1) age ≥40years, 2) COPD diagnosis, 3) inpatient admission with a diagnosis of COPD exacerbation, 4) inhaled corticosteroid (ICS)/long-acting β2-agonist (LABA) prescription within 10days of hospital discharge (index date), and 5) continuous enrollment for 12months preindex and 90days postindex. Outcomes included pre- and postindex HRU and costs. DPI and pMDI groups were compared on postindex outcomes via multivariate models controlling for demographic and baseline characteristics. Results: The sample included 1,960 DPI and 1,086 pMDI ICS/LABA patients. During the preindex period, pMDI patients were significantly more likely to be prescribed a short-acting β-agonist, experienced more COPD exacerbation-related hospital days, and had a greater number of pulmonologist visits compared to DPI patients (P

Background/aim The relationship between air pollution and respiratory morbidity has been widely addressed in urban and metropolitan areas but little is known about the effects in non-urban settings. Our aim was to assess the short-term effects of PM10 and PM2.5 on respiratory admissions in the whole country of Italy during 2006–2015. Methods We estimated daily PM concentrations at the municipality level using satellite data and spatiotemporal predictors. We collected daily counts of respiratory hospital admissions for each Italian municipality. We considered five different outcomes: all respiratory diseases, asthma, chronic obstructive pulmonary disease (COPD), lower and upper respiratory tract infections (LRTI and URTI). Meta-analysis of province-specific estimates obtained by time-series models, adjusting for temperature, humidity and other confounders, was applied to extrapolate national estimates for each outcome. At last, we tested for effect modification by sex, age, period, and urbanization score. Analyses for PM2.5 were restricted to 2013–2015 cause the goodness of fit of exposure estimation. Results A total of 4,154,887 respiratory admission were registered during 2006–2015, of which 29% for LRTI, 12% for COPD, 6% for URTI, and 3% for asthma. Daily mean PM10 and PM2.5 concentrations over the study period were 23.3 and 17 μg/m3, respectively. For each 10 μg/m3 increases in PM10 and PM2.5 at lag 0–5 days, we found excess risks of total respiratory diseases equal to 1.20% (95% confidence intervals, 0.92, 1.49) and 1.22% (0.76, 1.68), respectively. The effects for the specific diseases were similar, with the strongest ones for asthma and COPD. Higher effects were found in the elderly and in less urbanized areas. Conclusions Short-term exposure to PM is harmful for the respiratory system throughout an entire country, especially in elderly patients. Strong effects can be found also in less urbanized areas.

Angela V Bedenbaugh,1 Machaon Bonafede,2 Elizabeth H Marchlewicz,3 Vinson Lee,4 Jeyanesh Tambiah1 1Biosplice Therapeutics, Inc., San Diego, CA, USA; 2Veradigm Life Sciences, Chicago, IL, USA; 3IBM Watson Health, Cambridge, MA, USA; 4The Kinetix Group, New York, NY, USACorrespondence: Angela V BedenbaughBiosplice Therapeutics, Inc., San Diego, CA, USATel +1 404 272 8139Email angela.bedenbaugh@biosplice.comPurpose: To determine the prevalence, healthcare resource utilization and costs (HCRU&C) of knee osteoarthritis (OA) patients versus controls.Patients and Methods: Retrospective, matched-cohort administrative claims analysis using IBM MarketScan databases (2011– 2017). Newly diagnosed, adult (18+ yrs) knee OA patients identified by ICD9/10 code were matched 1:1 to controls by age, sex, payer, and geography; alpha level set to 0.05. Prevalence was estimated for 2017. All-cause and knee OA-related HCRU&C reported per-patient-per-year (PPPY) over follow-up period up to 4 years.Results: Overall 2017 knee OA prevalence was 4% (615,514 knee OA/15.4M adults). A total of 510,605 patients meeting inclusion criteria were matched 1:1 with controls. The knee OA cohort had mean age 60 years and was 58% female. Versus controls, knee OA patients had significantly more PPPY outpatient (84.5 versus 45.0) and pharmacy (29.8 versus 19.8) claims, and significantly higher PPPY outpatient costs ($12,571 versus $6,465), and pharmacy costs ($3,655 versus $2,038). Knee OA patients incurred $7,707 more PPPY total healthcare costs than controls, of which $4,674 (60.6%) were knee OA-related medical claims and $1,926 (25%) were knee OA-related medications of interest. PPPY costs for nonselective NSAIDs, cyclooxygenase-2 (COX-2) inhibitors, intraarticular hyaluronic acid, non-acute opioids, and knee replacement were higher for knee OA patients than controls. Using median and mean all-cause total cost ($9,330 and $24,550, respectively), the estimated sum cost of knee OA patients in MarketScan ranged from $5.7B to $15B annually.Conclusion: This retrospective analysis demonstrated an annual 2017 prevalence of 4.0% (≥ 18 years) and 13.2% (≥ 65 years) for newly diagnosed knee OA patients. Compared with controls, all-cause costs were significantly higher for knee OA patients, nearly double that of matched controls, attributable to increased medical and treatment costs and comorbidity treatment burden. Additionally, the estimated annual cost of knee OA treatment was substantial, ranging between $5.7 billion and $15 billion.Keywords: administrative claims, economic burden, arthritis, pharmacy costs

Background Adverse health impacts of cystic fibrosis (CF) can be present in children before respiratory complications are observed. Children with CF show progressive health decline, with increasing lung function decline in adolescence. This study aims to quantify the healthcare resource utilization (HCRU) and costs attributable to CF by comparing children with CF with the general pediatric population. Methods This retrospective, cross‐sectional, observational study compared HCRU and costs among children with CF in the US with demographically similar children without CF (comparison group) over a 12‐month period using administrative claims data spanning 2010–2017. Analyses were conducted by insurance type (commercially insured [COM] and Medicaid insured [MED]) and stratified by age (

Introduction Ivacaftor was first approved in 2012 for the treatment of a select population of individuals with cystic fibrosis (CF), a rare, life-shortening genetic disease. Reductions in healthcare resource utilization (HCRU) associated with ivacaftor have been observed during limited follow-up and for selected outcomes in real-world studies. This study aimed to further describe the long-term impact of ivacaftor treatment on multiple measures of HCRU among people with CF (pwCF). Methods This retrospective study used US commercial and Medicaid claims data from 2011–2018. We included pwCF ≥ 6 years of age with ≥ 1 claim for ivacaftor and 12 months of continuous health plan enrollment before ivacaftor initiation (“pre-ivacaftor” period) who also had 36 months of continuous enrollment and persistent ivacaftor use (i.e., no gap ≥ 90 days between refills) following initiation (“post-ivacaftor” period). We compared comorbidities occurring pre-ivacaftor versus the last 12 months post-ivacaftor. HCRU outcomes included medication use, inpatient admissions, and outpatient office visits. We compared medication use pre-ivacaftor versus the last 12 months post-ivacaftor and inpatient admissions and outpatient office visits pre-ivacaftor versus the post-ivacaftor period annualized across 36 months. Results Seventy-nine pwCF met all criteria, including persistent ivacaftor use during the post-ivacaftor period. Ivacaftor treatment was associated with a significant reduction in pneumonia prevalence (10.1% vs. 26.6%; p

IntroductionThe epidemiology of gender differences for mesothelioma incidence has been rarely discussed in national case lists. In Italy an epidemiological surveillance system (ReNaM) is working by the means of a national register.MethodsIncident malignant mesothelioma (MM) cases in the period 1993 to 2012 were retrieved from ReNaM. Gender ratio by age class, period of diagnosis, diagnostic certainty, morphology and modalities of asbestos exposure has been analysed using exact tests for proportion. Economic activity sectors, jobs and territorial distribution of mesothelioma cases in women have been described and discussed. To perform international comparative analyses, the gender ratio of mesothelioma deaths was calculated by country from the WHO database and the correlation with the mortality rates estimated.ResultsIn the period of study a case list of 21 463 MMs has been registered and the modalities of asbestos exposure have been investigated for 16 458 (76.7%) of them. The gender ratio (F/M) was 0.38 and 0.70 (0.14 and 0.30 for occupationally exposed subjects only) for pleural and peritoneal cases respectively. Occupational exposures for female MM cases occurred in the chemical and plastic industry, and mainly in the non-asbestos textile sector. Gender ratio proved to be inversely correlated with mortality rate among countries.ConclusionsThe consistent proportion of mesothelioma cases in women in Italy is mainly due to the relevant role of non-occupational asbestos exposures and the historical presence of the female workforce in several industrial settings. Enhancing the awareness of mesothelioma aetiology in women could support the effectiveness of welfare system and prevention policies.

Toxoplasmosis is a worldwide zoonotic infectious disease caused by Toxoplasma gondii. This infection is estimated to affect about a third of the world's population. The aim of this study was to evaluate the knowledge of Italian women about toxoplasmosis and its forms of transmission, clinical manifestations, diagnosis and prevention through two different modalities (e-research and traditional research). In a cross-sectional study, 808 Italian women were interviewed, using a self-administered questionnaire, through two different modalities: an e-research or web survey and a traditional paper research and 84% reported to have heard about toxoplasmosis, but from most of the sample, it resulted that the knowledge of the protozoan disease was superficial and incomplete. The assessment of the dimensionality related to the toxoplasmosis knowledge's instrument showed that the scale is composed by two stable and reliable factors which explain 58.6% of the variance: (a) the basic knowledge (α = 0.83), which explains the 45.2% of the variance and (b) the specialist knowledge (α = 0.71), which explains the 13.4% of the variance. The variance and the multiple linear regression data analysis showed significant predictors of correct basic knowledge of toxoplasmosis: the highest age, the highest degree of study, to have previously contracted illness or to know someone who had contracted it, to be working or to be housewives. In conclusion, this study showed limited awareness of toxoplasmosis and suggested the implementation of effective education and learning programs. The results also showed that online data collection, in academic research, might be a valid alternative to more traditional (paper-and-pencil) surveys.

Precis Targeted educational interventions for physicians may be useful in increasing adoption of selective laser trabeculoplasty (SLT) as first line therapy for the treatment of glaucoma. Purpose SLT is a safe and effective first line treatment for glaucoma, however, it is underutilized. To evaluate barriers for the widespread adoption of this procedure, we assessed the beliefs and attitudes of ophthalmologists. We developed an educational intervention directed to physicians to increase the consideration of SLT earlier in the glaucoma treatment paradigm. Subjects and methods In this prospective study, an online survey and educational slide presentation was sent to a group of comprehensive ophthalmologists, ophthalmology residents, and glaucoma specialists. Subjects were asked to respond to questions regarding their beliefs and attitudes towards SLT before and after watching the educational slide presentation. Results A total of 53 subjects were enrolled. Before watching the slide presentation, 85% of subjects stated they offer SLT to newly diagnosed patients, although only 28% preferred it over medications. While 52% of physicians reported between 0% and 10% of their newly diagnosed patients receive laser therapy, 47% said they would use it as a first line therapy for all or most newly diagnosed glaucoma patients. Most subjects (94%) stated the educational slide presentation convinced them that SLT is appropriate as a first line therapy for treatment of open angle glaucoma. Conclusions A better understanding of the barriers for utilizing SLT as a first line therapy provides valuable information to help increase the adoption of this safe and effective procedure. A targeted educational intervention may improve acceptance of SLT as first line therapy for open angle glaucoma.

Referring professionals correctly diagnose urgent or emergent ocular conditions in 65.1% of referrals. Telephone triaging ophthalmology residents make the correct diagnosis in 69.9% of referrals. Both are more accurate when sight or life-threatening diagnoses are referred.

Background: Patients of malignant mesothelioma (MM) and their caregivers face significant physical and psychological challenges. The purpose of the present study is to examine the emotional impact after the diagnosis of MM in a group of patients and familial caregivers in a National Priority Contaminated Site (NPCS). Methods: A sample of 108 patients and 94 caregivers received a sociodemographic/clinical questionnaire, the Beck Depression Inventory II, the Davidson Trauma Scale, the Coping Orientation to the Problems Experienced&mdash, New Italian Version, and the Defense style questionnaire. The risk of depressive and post-traumatic stress disorder (PTSD) symptoms in relation to the strategies of coping and defense mechanisms was estimated in patients and caregivers separately by logistic regression models. Results: For patients, a high risk of depression was associated with high usage of Defense Style Questionnaire (DSQ) Isolation (OR: 53.33, 95% CI: 3.22&ndash, 882.30, p = 0.01) and DSQ Somatization (OR: 16.97, 95% CI: 1.04&ndash, 275.90, p = 0.05). Other significant risks emerged for some coping strategies and some defenses regarding both depression and trauma in patients and caregivers. Conclusions: This research suggests that for both patients and caregivers unconscious adaptive processes have a central role in dealing with overwhelming feelings related to the disease.

Amyotrophic lateral sclerosis (ALS) is a fatal neurodegenerative disease characterized by progressive degeneration of motoneurons. To date, there is no effective treatment available. Exosomes are extracellular vesicles that play important roles in intercellular communication, recapitulating the effect of origin cells. In this study, we tested the potential neuroprotective effect of exosomes isolated from adipose-derived stem cells (ASC-exosomes) on the in vivo model most widely used to study ALS, the human SOD1 gene with a G93A mutation (SOD1(G93A)) mouse. Moreover, we compared the effect of two different routes of exosomes administration, intravenous and intranasal. The effect of exosomes administration on disease progression was monitored by motor tests and analysis of lumbar motoneurons and glial cells, neuromuscular junction, and muscle. Our results demonstrated that repeated administration of ASC-exosomes improved the motor performance, protected lumbar motoneurons, the neuromuscular junction, and muscle, and decreased the glial cells activation in treated SOD1(G93A) mice. Moreover, exosomes have the ability to home to lesioned ALS regions of the animal brain. These data contribute by providing additional knowledge for the promising use of ASC-exosomes as a therapy in human ALS.

We retrospectively analyzed treatment patterns and healthcare costs among patients diagnosed with diffuse large B-cell lymphoma (DLBCL) during each line of therapy (LOT) using data from the IBM® Ma...

Background The purpose of this study is to present the results of a systematic review of published research that focuses on psychological aspects of malignant mesothelioma patients and asbestos-exposed people. Methods Our research includes primary studies published between 1980 and 2016, using information from the Cochrane Library, the Psychology Behavioral Sciences Collection, PsychINFO, PubMed, PubGet, PubPsych, and Scopus, in compliance with PRISMA guidelines. Results We identified 12 papers that investigated the psychological distress and care needs of mesothelioma patients, and nine papers for asbestos-exposed subjects. Conclusions This paper highlights the paucity of studies on the psychological distress and care needs of mesothelioma patients and asbestos-exposed subjects. It confirms that malignant mesothelioma is associated with the physical, emotional, and social functioning of patients, while also suggesting that the risk of developing asbestos-related diseases among asbestos-exposed subjects is associated with high levels of psychological distress, despair, and mental health difficulties.

As a prevalent cardiovascular disease, heart failure is one of the leading causes of morbidity and premature mortality. Therefore, there is a special interest in the study of efficient markers associated with risk and / or prediction of cardiovascular events. Multiple candidates are proposed, especially those involved in oxidative and inflammatory processes typical of cardiovascular disease, such as superoxide anion, nitric oxide, and peroxynitrite. There is a lack of knowledge on the potential usefulness of these systems as biomarkers. This review aims to contribute to a better understanding of these systems, as well as an improved patient profile. Furthermore, a deep knowledge of these complex systems would also allow proposing new lines of research for the development of new therapeutic tools as a promising start for new approaches to this disease.

Introduction The prevalence of endometriosis and the need for treatment in the USA has led to the need to explore the contemporary cost burden associated with the disease. This retrospective cohort study compared direct and indirect healthcare costs in patients with endometriosis to a control group without endometriosis. Methods Women aged 18–49 years with endometriosis (date of initial diagnosis = index date) were identified in the Truven Health MarketScan® Commercial database between 2010 and 2014 and female control patients without endometriosis were matched by age and index year. The following outcomes were compared: healthcare resource utilization (HRU) during the 12-month pre- and post-index periods (including inpatient admissions, pharmacy claims, emergency room visits, physician office visits, and obstetrics/gynecology visits), annual direct (medical and pharmacy) and indirect (absenteeism, short-term disability, and long-term disability) healthcare costs during the 12-month post-index period (in 2014 US$). Multivariate analyses were conducted to estimate annual total direct and indirect costs, controlling for demographics, pre-index clinical characteristics, and pre-index healthcare costs. Results Overall, 113,506 endometriosis patients and 927,599 controls were included. Endometriosis patients had significantly higher HRU during both the pre- and post-index periods compared to controls (p

Finkelstein1 invited physicians and researchers interested in mesothelioma to investigate on past usage of talcum powders by affected people. In Italy, asbestos contamination in talc for industrial use has been documented,2 and, as he underlines tremolite contamination at low levels of cosmetic and pharmaceutical talc has been reported in USA by Blount3 and Gordon and colleagues.4 In the Italian National Mesothelioma Register (ReNaM), the analysis of intensive exposure to talc has been evaluated with respect to occupational and environmental history. The catalogue of possible asbestos exposure circumstances (a tool for the interviewers) reports the potential presence of industrial talcs in quarries or mines working activities, in leather tanning and in rubber industries. The use of intensive cosmetic talc for personal use is evaluated by means of a structured questionnaire,5 as reported in the ReNaM guidelines (see https://www.inail.it/cs/internet/docs/all-linee-guida-renam.pdf%3Fsection=attivita, p82, p98, in Italian). In our paper regarding gender differences in mesothelioma epidemiology,6 we have presented figures referring to 21 463 MM cases detected by ReNaM with a diagnosis between 1993 and 2012. Among female case list (6087 cases), 4374 cases (71.9%) have been interviewed for defining exposure. During the interview, 30 MM female cases referred an intensive use of talc in the context of occupational or life habits. For five of them, the regional centre has identified an exposure to asbestos due to intensive talc use, classifying such modality of exposure as ‘leisure activities’ (see ReNaM guidelines5). For the remaining 25 cases, an occupational exposure to asbestos in other working (or familiar or environmental) circumstances has been identified and coded. Registry data such as those provided by ReNaM cannot provide estimates of the mesothelioma risk associated with any particular exposure circumstance. We plan to include talc exposure at work and cosmetic talc usage in the analyses of a case–control study on pleural mesothelioma currently under way. A specific survey to compare and discuss how the modalities of exposure to talc have been evaluated in patients with mesothelioma in countries where epidemiological surveillance systems are active could improve knowledge and support prevention policies.

Among children born with laboratory-confirmed Zika virus (ZIKV) infection, visual impairment (VI) can occur despite normal ocular structure. The objective of this report is to describe ocular findings and visual function among children examined during the Department of Health Zika Health Brigade (ZHB) in the United States Virgin Islands in March 2018. This analysis is based on a retrospective chart review of children eligible to participate in the ZHB (i.e., part of the US Zika Pregnancy and Infant Registry) and who were examined by ophthalmologists. Eighty-eight children attended the ZHB. This report includes 81 children [48 (59.3%) males] whose charts were located [average gestational age = 37.6 weeks (range: 27.6–41.3) and average adjusted age at examination = 9.1 months (range: 0.9–21.9)]. Of those examined, 5/81 (6.2%) had microcephaly at birth, 2/81 (2.5%) had a structural eye abnormality, and 19/72 (26.4%) had VI. Among children with normal ocular structure and neurologic examination, 13/51 (25.5%) had VI. Despite a low incidence of abnormal ocular structure and microcephaly, about a quarter of children examined had VI. Our findings emphasize that ophthalmological examinations should be performed in all children with suspicion for antenatal ZIKV infection, even children with normal ocular structure and neurologic examination.

This real-world study assessed the prevalence, risk factors for, and incidence of seizures in patients with metastatic castration-resistant prostate cancer (mCRPC). Patients with mCRPC were selected from MarketScan Commercial and Medicare Supplemental Databases between 1 January 2009 and 31 July 2012. Prevalence of seizure risk factors were described separately and in combination with other risk factors. Seizure incidence was calculated overall and for each risk factor group. The most common risk factors were history of seizure threshold-lowering medication use (35%), history of loss of consciousness (6%), history of transient ischemic attack or cerebrovascular accident (2%), treated brain metastasis (0.9%), history of seizure (0.6%), and dementia (0.5%). Overall, seizure incidence was 1.8 per 100 person-years (PYs) (95% confidence interval [CI] 1.5–2.1), being higher among patients with at least one risk factor (2.8 per 100 PYs; 95% CI 2.2–3.4) than those without risk factors (1.2 per 100 PYs; 95% CI 1.0–1.6). Seizure incidence was highest among a few patients (0.6%) with a history of seizure (82.0 per 100 PYs; 95% CI 45.9–135.2) and within this small subpopulation, higher among those with a history of anticonvulsant use (120.9 per 100 PYs; 95% CI 60.3–216.3) than without anticonvulsant use (43.5 per 100 PYs; 95% CI 11.9–111.3). History of seizure is an important risk factor for seizure occurrence in patients with mCRPC, particularly in those with a history of anticonvulsant use. These findings improve understanding of the risk of seizure occurrence in patients with mCRPC, who are potential users of androgen receptor antagonists, including enzalutamide.

Neil A Accortt,1 James B Chung,2 Machaon Bonafede,3 Brendan L Limone,3 David M Mannino4 1Amgen, Inc., Center for Observational Research, Thousand Oaks, CA, 2Amgen, Inc., US Medical Organization, Thousand Oaks, CA, 3Truven Health Analytics, an IBM Company, Outcomes Research, Cambridge, MA, 4University of Kentucky College of Public Health, Lexington, KY, USA Background: Limited information exists on the impact of tumor necrosis factor inhibition on COPD exacerbations. This retrospective study characterized this impact among COPD patients with underlying autoimmune conditions, exposed to tumor necrosis factor inhibitors (TNFi) and/or non-biologic disease-modifying antirheumatic drugs (DMARDs).Patients and methods: Adult COPD patients with ≥1 diagnosis for rheumatoid arthritis (RA), psoriasis (PsO), psoriatic arthritis (PsA), or ankylosing spondylitis (AS) before or within 6 months following the index COPD diagnosis were identified from the Truven Health MarketScan® databases. Patients were required to have a second claim for RA, PsO, PsA, AS, or DMARD use (biologic or non-biologic) prior to or up to 6 months following the index date. Incidence of COPD-related hospitalizations and emergency room (ER) visits was evaluated in relation to treatment with TNFi and/or DMARDs and other potential risk factors.Results: The study cohort included 40,687 patients (untreated, 37.7%; non-biologic DMARD, 35.4%; TNFi + non-biologic DMARD, 18%; TNFi, 8.8%). The proportion of patients with a COPD-related hospitalization and the incidence of COPD-related hospitalization (per 100 person-years) were lowest in the TNFi cohort (8.6%; 3.54, 95% confidence interval [CI]: 3.16–3.95) and the TNFi + non-biologic DMARD cohort (8.4%; 2.85, 95% CI: 2.63–3.08). In multivariate models, treatment with TNFi + non-biologic DMARD reduced the risk of COPD-related hospitalization or ER visits by 32% relative to non-biologic DMARDs (hazard ratio: 0.68; 95% CI: 0.61–0.75).Conclusion: In real-world settings, TNFi monotherapy confers similar risk for COPD-related hospitalization or ER visits as a non-biologic DMARD. Decreased risk was found among those treated with both TNFi and a non-biologic DMARD. Keywords: COPD, TNF inhibitor, exacerbation, incidence, biologic DMARD

Heart failure (HF) is a growing medical problem and it is of interest to study new biomarkers for better characterisation. In this sense, nitric oxide, reactive oxygen species (ROS), NADPH, and superoxide dismutase (SOD) were evaluated, along with their possible predictive value in patients with HF. An analysis was also performed on the potential differences between patients with and without secondary pulmonary hypertension (SPH), considered to have a worse prognosis. A significant decrease of nitric oxide and SOD was noted in HF, whereas ROS and NADPH were increased. These results agree with the pathophysiological changes characteristic of HF. It was also demonstrated that in patients with HF and SPH that nitric oxide and SOD were decreased when compared to HF without SPH, whereas ROS and NADPH were increased. Therefore, our results suggest that nitric oxide, ROS, NADPH, and SOD, could be considered as possible markers in HF, and could also characterise patients with SPH.

Objectives After treatment failure with a tumor necrosis factor inhibitor (TNFi), patients with rheumatoid arthritis (RA) can switch to another TNFi (TNFi cyclers) or to a targeted disease-modifying antirheumatic drug (DMARD) with a non-TNFi mechanism of action (non-TNFi switchers). This study compared treatment patterns and treatment effectiveness between TNFi cyclers and non-TNFi switchers in patients with RA. Methods The analysis included a cohort of patients from the Truven Health Analytics MarketScan Commercial database with RA who switched from a TNFi (adalimumab, certolizumab pegol, etanercept, golimumab, or infliximab) either to another TNFi or to a non-TNFi targeted DMARD (abatacept, tocilizumab, or tofacitinib) between January 1, 2010 and September 30, 2014. A claims-based algorithm was used to estimate treatment effectiveness based on six criteria (adherence, no dose increase, no new conventional therapy, no switch to another targeted DMARD, no new/increased oral glucocorticoid, and intra-articular injections on

Introduction Migraine management is characterized by the poor use of preventive therapy and the overuse of acute medications. An analysis of current treatment patterns in migraineurs is needed to improve care in this patient population. The aim of this study was to describe treatment patterns and healthcare utilization of newly diagnosed migraine patients. Methods This was a retrospective observation study of newly diagnosed migraine patients (no indication of migraine in the past year) identified in the IBM MarketScan Commercial Claims and Encounters database from 1 January 2010 to 30 June 2014. The final study population comprised persons aged 18–64 years at index (new diagnosis of migraine) with 12 months of continuous enrollment in an insurance plan with medical and pharmacy benefits pre-index and post-index. Treatment patterns and healthcare resource utilization were assessed during the post-index period (at least 12-months). Results Of the 1,588,666 migraine patients identified in the database as potentially eligible to participate in the study, 284,719 (17.9%) met the final inclusion criteria. Patients generally used acute and preventive therapies to manage migraine attacks, with most patients using preventive therapy (59.1%). However, 67.9% of those using preventive therapy discontinued the current therapy, with a median time to discontinuation of 5 months. Most of the patients who discontinued preventative therapy also used an acute treatment to manage migraine attacks after discontinuation (77.6%), generally in the year following discontinuation (68.4%). Patients on acute therapies were found to use triptans excessively (1.6%) and other non-migraine-specific acute medications for treatment (7.1%). Acute patients were also at risk of opioid dependence (12.0%) and commonly received opioids or barbiturates as first-line therapy (34.1%). Conclusion Newly diagnosed migraine patients are not being properly treated, as indicated by their excessive use of acute therapies and short time on preventive treatment before discontinuation of that treatment. Further study of the reasons why patients discontinue preventive therapy (adverse events, no response, etc.) and continue to excessively use acute treatments once their treatment regimen has been established is needed.

Aim: This study compared real-world complication rates, hospitalization duration and costs, among patients undergoing arterial repair using the Perclose ProGlide (ProGlide) versus surgical cutdown (Cutdown). Materials & methods: Retrospective study of matched patients who underwent transcatheter aortic valve replacement/repair, endovascular abdominal aortic aneurysm repair, thoracic endovascular aortic repair or balloon aortic valvuloplasty with arterial repair by either ProGlide or Cutdown between 1 January 2013 and 24 April 2017. Results: Infections and blood transfusions were lower in the ProGlide cohort. Patients in the ProGlide cohort had a 42.5% shorter index hospitalization, which corresponded to US$14,687 lower costs. Conclusion: The use of ProGlide for arterial repair was associated with significantly lower transfusion rates, shorter index hospitalization and lower hospitalization costs compared with surgical cutdown.

BACKGROUND AND OBJECTIVE: To analyze the anatomic success rate of pars plana vitrectomy (PPV), retinectomy, and silicone oil (SO) tamponade without scleral buckle (SB) for repair of recurrent rhegmatogenous retinal detachment (RRD) associated with proliferative vitreoretinopathy (PVR). PATIENTS AND METHODS: Retrospective, consecutive, single-surgeon case series of 28 eyes of 28 patients with PVR-associated RRD repaired with PPV, retinectomy, and SO tamponade without SB. RESULTS: The single-procedure anatomic success rate was 85.2% at 3 months and 82.1% at 12 months. Final reattachment rate was 100.0%. There were no preoperative factors that predicted single procedure anatomic success. Mean logarithm of the minimal angle of resolution visual acuity (VA) was improved at 3 months (1.61 to 1.51, P = .732) and at 12 months (1.61 to 1.41; P = .271). VA outcome was related to preoperative macula and lens status. CONCLUSION: The single-procedure anatomic success rate of PPV, retinectomy, and SO tamponade without SB for PVR-related recurrent RRD is comparable to prior reports of similar surgery incorporating SB. [ Ophthalmic Surg Lasers Imaging Retina. 2019;50:e278–e287.]

ObjectiveTo determine whether there is a measurable change in hyperopia in children with accommodative esotropia over time.Methods and analysisA retrospective cohort of children with fully or partially accommodative esotropia diagnosed by age 7 years, followed to age 10 or older, and with at least two cycloplegic refractions, one before age 7 years and one after age 10 years. The annual change was calculated from linear mixed-effect models, overall and during two age periods with subgroup analysis by baseline refractive error (Results405 subjects were studied. Mean age at first and last visit was 3.2 and 12.1 years, respectively, with mean 7.6 cycloplegic refractions. The annual change (95% CI) in refractive error was −0.071 (−0.087 to –0.055) D/yr. Between ages 3 and 7, hyperopia among children with baseline hyperopia ConclusionHyperopia in children with accommodative esotropia is stable or increases up to age 7 years, depending on baseline hyperopia, but decreases gradually between ages 7 and 15 years regardless of baseline refractive error.

Background: Knee osteoarthritis (OA) is a painful, disabling condition with increasing prevalence. Objectives: To compare characteristics and treatment patterns of patients newly diagnosed with knee OA by rheumatologists (RH) to those diagnosed by general practitioners (GP) and those diagnosed by orthopedic surgeons (OS). Methods: U.S. administrative claims data from 2011-2018 (IBM Watson Health MarketScan® Research Database) was used to perform an observational cohort study. Inclusion criteria included ≥18 years and ≥1 claim with ICD9 lower-leg OA diagnosis prior to October 2015, followed by a confirmatory ICD10 knee OA diagnosis or ≥1 claim with an ICD10 knee OA diagnosis. Index date was the earliest claim/diagnosis date preceded by ≥2 years of prior continuous enrollment without these diagnoses. Demographic characteristics and diagnosing physician specialty were assessed on index date, whereas comorbid conditions and treatment patterns were observed during the variable post-index follow-up period. A two-sample t-test or a two-sample proportion test, where appropriate, was used to perform comparisons in GP vs RH and OS vs RH (P Results: 488,510 knee OA patients met inclusion criteria of which 76% (371,219) had physician type of interest noted on initial diagnosis claim. RH-diagnosed knee OA accounted for 3.2% (15,517), while GP and OS for 20.2% (98,911) and 47.6% (232,567), respectively. The average age of patients diagnosed by RH and OS was less than those GP-diagnosed (RH, 58.9; GP, 63.4; OS, 58.9; RH vs GP, P 30-day supply (RH, 27.3%; GP, 23.5%; OS, 19.8%; RH vs GP, P Conclusion: This descriptive claims analysis suggested that rheumatologists saw a considerable number of knee OA patients, with different characteristics to other providers, particularly females and those with co-occurring RA. Rheumatologist-diagnosed patients received the least number of TKRs, which may represent a higher CCI patient population not suitable for surgery. However, rheumatologists prescribed pharmaceutical therapies more than general practitioners. Further research into treatment patterns and characteristics of knee OA patients treated by rheumatologists is warranted. Disclosure of Interests: Angela Bedenbaugh Shareholder of: shares, Employee of: employee, Machaon Bonafede: None declared, Joanne Wu: None declared, Elizabeth Marchlewicz: None declared, Vinson Lee Consultant for: Samumed, LLC, Jeyanesh Tambiah Shareholder of: Samumed, LLC, Employee of: Samumed , LLCÂ

Endometriosis is a painful chronic inflammatory disease caused by endometrial tissue implanting and growing outside the uterus, resulting in pelvic pain symptoms and subfertility. Treatment imposes a substantial economic burden on the patient and health care system.To evaluate direct health care utilization and costs among women newly diagnosed with endometriosis compared with age-matched controls in a U.S. Medicaid population.This retrospective cohort study used deidentified health care claims from the 2007-2015 MarketScan Multi-State Medicaid Database. Women (aged 18-49 years) newly diagnosed with endometriosis (ICD-9-CM 617.xx) during January 2008 through September 2014 were identified (date of first diagnosis = index date). Age-matched women without endometriosis (controls) were selected from the database and assigned index dates matching the distribution for endometriosis patients. Direct health care resource utilization (HCRU) and costs (medical and pharmacy) over the 12-month post-index period (2015 U.S. dollars) were computed by service category (hospitalization, emergency room visits, outpatient services, and prescriptions) and compared between study cohorts using the chi-square test for proportions and t-test for continuous variables.The final sample included 15,615 endometriosis patients and 86,829 matched controls. HCRU during the 12-month post-index follow-up period was significantly higher for endometriosis cases compared with controls in all measured categories. Hospital admissions occurred among 33.1% of cases and 7.2% of controls, and 65.8% of endometriosis patients were admitted for endometriosis-related surgery. Emergency room visits occurred in 71.5% of cases, and 42.2% of controls. Mean (SD) office visits were 10.4 (8.5) for endometriosis patients and 5.1 (6.9) for controls. Endometriosis patients had significantly more prescription claims than controls, 45.9 (42.0) versus 25.1 (39.1). Mean total direct health care costs were $13,670 ($29,843) for cases versus $5,779 ($23,614) for controls. All differences between cases and controls were significant atHealth care costs and resource utilization in all measured categories were higher among endometriosis cases than controls. The economic burden of endometriosis among patients with Medicaid insurance is substantial, underscoring the unmet medical need for earlier diagnosis and cost-effective treatments.This study was funded by AbbVie and conducted by Truven Health Analytics, an IBM Company. AbbVie participated in developing the study design, data analysis and interpretation, manuscript writing and revisions, and approval for publication. Soliman and Vora are employees of AbbVie and may own AbbVie stock/stock options. Surrey has served in a consulting role on research to AbbVie and is on the speaker bureau for Ferring Laboratories. Bonafede and Nelson are employees of Truven Health Analytics, an IBM Company, which received compensation from AbbVie for the overall conduct of the study and preparation of the manuscript. Agarwal has served in a consulting role on research to AbbVie. Preliminary results of this study were previously presented in a podium session at the 2017 American Society for Reproductive Medicine Scientific Congress and Expo; October 28-November 1, 2017; San Antonio, TX.

Purpose This study examined clinical and economic outcomes among patients with advanced hepatocellular carcinoma (HCC) treated with systemic agents by line of therapy. Methods Adults with ≥ 2 medical claims for primary diagnosed HCC (from January 1, 2008, through September 30, 2015) and ≥ 1 claim for systemic HCC-related therapy were identified in the IBM MarketScan® Research Databases. Continuous enrollment was required 6 months before and 1 month after diagnosis. Patients were categorized into first- (1L) and second-line (2L) treatment cohorts; those receiving sorafenib as 1L were evaluated. Treatment patterns, healthcare resource utilization, costs, and survival during 1L and 2L therapy were measured. Survival was assessed for patients linked to the Social Security Administration Master Death File. Results 1459 patients, 758 with death data, met the 1L cohort criteria; 163 patients, 87 with death data, later received 2L therapy. 77.1% had 1L sorafenib, alone or in combination. Median 1L treatment duration was 3.0 months; median survival time from start of 1L to death or censor was 6.8 months. There was no predominant 2L agent. Median 2L treatment duration was 3.0 months; median survival time from start of 2L was 9.3 months. Median total healthcare costs per patient per month were $13,297 for 1L (all), $13,471 for 1L (sorafenib), and $11,786 for 2L. Conclusions Findings confirm high 1-year mortality for advanced HCC, suggesting a high cost burden. While no 2L therapy was available during this analysis, recently approved 2L agents have the potential to improve survival after sorafenib failure or intolerance.

Objectives To describe long-term treatment patterns in migraine patients initiating prophylactic therapy and to evaluate acute medication use and adverse events associated with opioids. Methods This study used the 2005–2014 IBM MarketScan® databases to evaluate migraine patients initiating prophylactic medication. Outcome measures included persistence with prophylactic migraine medications over 2–5 years. Acute medication use and gastrointestinal-related adverse events and opioid abuse following opioid use were evaluated. Cox proportional hazards models were used to evaluate predictors of non-persistence and predictors of gastrointestinal-related AEs and opioid abuse associated with long-term opioid use. Results In total, 147,832 patients were analyzed. Non-persistence was observed in 90% of patients; 39% switched, 30% restarted, and 31% discontinued treatment. Over the follow-up, 59.9% of patients received triptans, 66.6% non-steroidal anti-inflammatory drugs, 77.4% opioids, and 2.6% ergotamines. Among opioid users, 16.6% experienced nausea/vomiting, 12.2% had constipation, and 10.4% had diarrhea. Opioid abuse was reported in Conclusions Non-persistence to prophylactic treatment was frequent among migraine patients. Opioid use was common in migraine patients and the risk of gastrointestinal-related adverse events and opioid abuse increased with long-term use of opioids. These results suggest a need for more effective prophylactic migraine treatments.

Emerging viral infections represent a public health risk pointed out by the spreading of pathogens with potential zoonotic risk. Moreover, the risk of zoonosis has probably been underestimated in occupational settings. A literature review between 2007 and 2018 was performed to identify evidences concerning the epidemiological associations between some emerging viruses and occupational diseases. Observational studies and case-reports were selected and analyzed. West Nile Virus (WNV) disease, Crimean-Congo Hemorrhagic Fever (CCHF) disease and Hepatitis E virus (HEV) infection were included in the review for their potential zoonotic transmission. The most important risk factor for acquiring WNV infection and CCHF infection is the exposure to infected mosquitoes and ticks, respectively; therefore, outdoor workers are at risk of infection. HEV is responsible for epidemics and endemics of acute hepatitis in humans, that can become infected through waterborne, foodborne and zoonotic transmission routes. A total of 10, 34 and 45 eligible studies for WNV, CCHF virus (CCFHV) and HEV, respectively, were analyzed by year, country, study design, risk group and outcomes. The occupational risk groups mainly included farm and agricultural workers, veterinarians, slaughterers, animal handlers, healthcare workers and soldiers. These findings support the need to develop effective interventions to prevent transmission of emerging viruses., This systematic review summarizes epidemiological studies published from 2007 until October 2018 on West Nile Virus infection, Crimean-Congo Haemorrhagic fever and Hepatitis E in occupational settings

BACKGROUND Growing evidence indicates that the exposure to high heat levels in the workplace results in health problems in workers. A meta-analysis was carried out to summarize the epidemiological evidence of the effects of heat exposure on the risk of occupational injuries. METHODS A search strategy was conducted to retrieve studies on the effects of climate change on occupational injury risk. Among the 406 identified, 5 time-series and 3 case-crossover studies were selected for meta-analysis. RESULTS Pooled risk estimates for time-series and case-crossover studies combined, and then separated, were 1.005 (95%CI: 1.001-1009), 1.002 (95%CI: 0.998-1.005), and 1.014 (95%CI: 1.012-1.017), respectively. Subgroup analyses found increased risks (not statistically significant) for male gender, age

Purpose: Human osteosarcoma is a genetically heterogeneous bone malignancy with poor prognosis despite the employment of aggressive chemotherapy regimens. Because druggable driver mutations have not been established, dissecting the interactions between osteosarcoma cells and supporting stroma may provide insights into novel therapeutic targets. Experimental Design: By using a bioluminescent orthotopic xenograft mouse model of osteosarcoma, we evaluated the effect of tumor extracellular vesicle (EV)–educated mesenchymal stem cells (TEMSC) on osteosarcoma progression. Characterization and functional studies were designed to assess the mechanisms underlying MSC education. Independent series of tissue specimens were analyzed to corroborate the preclinical findings, and the composition of patient serum EVs was analyzed after isolation with size-exclusion chromatography. Results: We show that EVs secreted by highly malignant osteosarcoma cells selectively incorporate a membrane-associated form of TGFβ, which induces proinflammatory IL6 production by MSCs. TEMSCs promote tumor growth, accompanied with intratumor STAT3 activation and lung metastasis formation, which was not observed with control MSCs. Importantly, intravenous administration of the anti-IL6 receptor antibody tocilizumab abrogated the tumor-promoting effects of TEMSCs. RNA-seq analysis of human osteosarcoma tissues revealed a distinct TGFβ-induced prometastatic gene signature. Tissue microarray immunostaining indicated active STAT3 signaling in human osteosarcoma, consistent with the observations in TEMSC-treated mice. Finally, we isolated pure populations of EVs from serum and demonstrated that circulating levels of EV-associated TGFβ are increased in osteosarcoma patients. Conclusions: Collectively, our findings suggest that TEMSCs promote osteosarcoma progression and provide the basis for testing IL6- and TGFβ-blocking agents as new therapeutic options for osteosarcoma patients. Clin Cancer Res; 23(14); 3721–33. ©2017 AACR.