Good Research Practices for Measuring Drug Costs in Cost-Effectiveness Analyses: Medicare, Medicaid and Other US Government Payers Perspectives: The ISPOR Drug Cost Task Force Report—Part IV

Objectives Public programs finance a large share of the US pharmaceutical expenditures. To date, there are not guidelines for estimating the cost of drugs financed by US public programs. The objective of this study was to provide standards for estimating the cost of drugs financed by US public programs for utilization in pharmacoeconomic evaluations. Methods This report was prepared by the ISPOR Task Force on Good Research Practices—Use of Drug Costs for Cost-Effectiveness Analysis Medicare, Medicaid, and other US Government Payers Subgroup. The Subgroup was convened to assess the methodological and practical issues confronted by researchers when estimating the cost of drugs financed by US public programs, and to propose standards for more transparent, accurate and consistent costing methods. Results The Subgroup proposed these recommendations: 1) researchers must consider regulation requirements that affect the drug cost paid by public programs; 2) drug cost must represent the actual acquisition cost, incorporating any rebates or discounts; 3) transparency with respect to cost inputs must be ensured; 4) inclusion of the public program\u27s perspective is recommended; 5) high cost drugs require special attention, particularly when drugs represent a significant proportion of health-care expenditures for a specific disease; and 6) because of variations across public programs, sensitivity analyses for actual acquisition cost, real-world adherence, and generics availability are warranted. Specific recommendations also were proposed for the Medicare and Medicaid programs. Conclusions As pharmacoeconomic evaluations for coverage decisions made by US public programs grows, the need for precise and consistent estimation of drug costs is warranted. Application of the proposed recommendations will allow researchers to include accurate and unbiased cost estimates in pharmacoeconomic evaluations

Validation of Biomechanical Computed Tomography for Fracture Risk Classification in Metastatic Hormone-sensitive Prostate Cancer.

BACKGROUND: Guidelines recommend dual-energy x-ray absorptiometry (DXA) screening to assess fracture risk and benefit from antiresorptive therapy in men with metastatic hormone-sensitive prostate cancer (mHSPC) on androgen deprivation therapy (ADT). However, <30% of eligible patients undergo DXA screening. Biomechanical computed tomography (BCT) is a radiomic technique that measures bone mineral density (BMD) and bone strength from computed tomography (CT) scans. OBJECTIVE: To evaluate the (1) correlations between BCT- and DXA-assessed BMD, and (2) associations between BCT-assessed metrics and subsequent fracture. DESIGN, SETTING, AND PARTICIPANTS: A multicenter retrospective cohort study was conducted among patients with mHSPC between 2013 and 2020 who received CT abdomen/pelvis or positron emission tomography/CT within 48 wk before ADT initiation and during follow-up (48-96 wk after ADT initiation). OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: We used univariate logistic regression to assess the associations between BCT measurements and the primary outcomes of subsequent pathologic and nonpathologic fractures. RESULTS AND LIMITATIONS: Among 91 eligible patients, the median ([interquartile range) age was 67 yr (62-75), 44 (48.4%) were White, and 41 (45.1%) were Black. During the median follow-up of 82 wk, 17 men (18.6%) developed a pathologic and 15 (16.5%) a nonpathologic fracture. BCT- and DXA-assessed femoral-neck BMD T scores were strongly correlated (R2 = 0.93). On baseline CT, lower BCT-assessed BMD (odds ratio [OR] 1.80, 95% confidence interval or CI [1.10, 3.25], p = 0.03) was associated with an increased risk of a pathologic fracture. Lower femoral strength (OR 1.63, 95% CI [0.99, 2.71], p = 0.06) was marginally associated with an increased risk of a pathologic fracture. Neither BMD (OR 1.52, 95% CI [0.95, 2.63], p = 0.11) nor strength (OR 1.14, 95% CI [0.75, 1.80], p = 0.57) was associated with a nonpathologic fracture. BCT identified nine (9.9%) men eligible for antiresorptive therapy, of whom four (44%) were not treated. Limitations include low fracture numbers resulting in lower power to detect fracture associations. CONCLUSIONS: Among men diagnosed with mHSPC, BCT assessments were strongly correlated with DXA, predicted subsequent pathologic fracture, and identified additional men indicated for antiresorptive therapy. PATIENT SUMMARY: We assess whether biomechanical computer tomography (BCT) from routine computer tomography (CT) scans can identify fracture risk among patients recently diagnosed with metastatic prostate cancer. We find that BCT and dual-energy x-ray absorptiometry-derived bone mineral density are strongly correlated and that BCT accurately identifies the risk for future fracture. BCT may enable broader fracture risk assessment and facilitate timely interventions to reduce fracture risk in metastatic prostate cancer patients

Free trade and environment regulations: A study on North American Free Trade Agreement

A challenge identified at Earth Summit is to ensure that trade and environment are mutually supportive. The environmental provisions of NAFTA have implications for future trade and environmental efforts. This dissertation aims to address hypothesis and policy questions regarding trade and environment using NAFTA. The Hecksher-Ohlin model of international trade acts as a framework and yields useful insights about effects of pollution controls on international trade. Theoretical and quantitative general equilibrium models are used to analyze questions regarding trade and environment. NAFTA is a major step for Mexico, Canada and U.S. Though polluting industry products in Mexico have increased between 1968 to 1988, compared to Canada and U.S., the relative change is small. U.S. will view Canada and Mexico as suppliers of natural gas, oil and electricity. Mexico should deregulate its energy market to benefit from NAFTA. Through 1970-90, Mexico has specialized in exports of primary product, whereas U.S. and Canada exports manufacturing products. Productivity in manufacturing is increasing for all NAFTA countries, in Mexico this is so since 1986 due to liberalization of economy. In U.S., increased labor productivity in manufacturing is associated with decreased air pollution. Relation between increased income and pollution level is different for U.S. and Canada. U.S. economy consumes indirect energy that is embodied in non-energy products. NAFTA will increase certain pollution due to increased production and consumption. Canada faces the largest impact, in terms of metric tons/GDP, followed by Mexico. While uniform environmental taxes have little impact on pollution reduction, they affect consumption and trade pattern. To reduce CO\sb2 and SO\sb2 level by 10%, both U.S. and Canada have to reduce consumption by 5-6%. Given the reduction in pollution it has achieved, CAA hasn\u27t significantly affected the trade pattern during 80\u27s. CAA should incorporate comparative advantage situation to increase its efficiency. Free trade increases consumption and production, thus increasing income levels and productivity, leading to reduction in overall levels of pollution. Hence, free trade is environmentally more friendlier

Patient-Centered Outcomes Research and Patient-Centered Care for Older Adults

Patient-centered care that reflects consumer-driven health care decision of an individual as opposed to collective or social choice–based health decision has many implications for clinical decision and resource allocation. With possession of required information and faced with appropriate assessment of preferences, older adults make better choices for their own health. However, one must acknowledge that patient-centered approach for older adults should effectively integrate tenets of value-based care to improve overall quality of care and societal well-being. In this perspective, I present the importance and challenges of patient-centered care and patient-centered outcomes research among older adults

Association between age, substance use, and outcomes in Medicare enrollees with prostate cancer

In the welding of more sensitive metals such as stainless steel, titanium and some specific nickel alloys, the presence and application of a protective gas is essential. Without the use of a nonreactive shielding gas, defects occur in or adjacent to the weld joint, which vary from light discoloration of the weld bead to the direct onset and propagation of cracks. The supply of shielding gas is usually via the welding tool. Unfortunately, when it comes to welding pipes, the problem arises when the root bead comes into contact with the oxygen present within the pipe. Since the shielding gas supplied from the welding tool has no possibility of penetrating into the pipe and protecting the melt from the oxygen, the result consequence will be defects in the weld bead. To prevent this from happening, the pipes are sealed before welding and the oxygen in the pipe is purged and replaced with protective gas. Due to the fact that pipe welding operations concern a vast spectrum of pipe dimensions, complications arise for the welding operator as the solutions available have a low degree of adaptability. Thus, the purpose of this project is to investigate the possibility of designing and developing a new method of supplying root gas protection that can be adapted to several pipe diameters. Field studies at welding companies resulted in the clarification of which diameter spans the root gas protection solution should comply with, the pipe diameter span to cater for was identified as 25-100 mm in diameter. Requests were also made regarding the robustness of the product, with expressed desire for the product to withstand the strenuous working environment often encountered during welding operations. Solution proposals were produced which later developed into six separate concepts. From these six concepts, one was selected as the foremost solution and further developed for construction. The concept was sketched out and reproduced using CAD and a model was made using 3D printers. The model showed a need for modifications as it was not of a sufficiently adaptable nature. A modified model was thus developed and manufactured using a 3D printer, this modified model showed better results of adaptation to different pipe diameters. Furthermore, a flow analysis of the gas as it enters via the root gas plug and into the pipe was conducted, to verify total distribution of the gas within the pipe. The material with which to construct the concept with will be silicone infused with additives to make it more heat resistant and more resistant to wear. However, the exact mixture of silicone and additives in question was not available for this project but is something that is intended for future work. The concept meets the specified requirements of being applicable to multiple pipe diameters, more specifically so meeting the wishes of those active within the industry, covering a pipe span of 25- 100 mm.Vid svetsning av mer känsliga metaller såsom rostfritt stål, titan och vissa specifika nickellegeringar är närvaron och tillämpningen av en skyddsgas väsentligt. Utan nyttjandet av en icke reaktiv skyddsgas uppkommer defekter i eller intill svetsfogen, vilka varierar från lätta missfärgningar av svetssträngen till den direkta uppkomsten och propageringen av sprickor. Tillförseln av skyddsgas sker vanligtvis via svetsverktyget. När det kommer till svetsning av rör uppstår dessvärre problemet att rotsträngen kommer i kontakt med syret som finns på insidan av röret. Eftersom att den skyddsgas som tillförs från svetsverktyget inte har någon möjlighet att tränga sig in i röret och skydda smältan från syret kommer det resultera i en svetssträng med defekter. För att förhindra detta från att ske tätas rören innan svetsning och syret i röret ersätts med skyddsgas. Eftersom att de rör som skall sammanfogas förekommer i flera dimensioner uppstår komplikationer för svetsoperatören ty de lösningar som finns tillgängliga har låg anpassningsgrad. Därmed är syftet med detta projekt att undersöka möjligheten att designa och utveckla ett nytt rotgasskydd som kan anpassas till flera diametrar. Fältstudier hos svetsföretag resulterade i ett tydligt spann för vilka diametrar som bör tillgodoses med sagda rotgasskydd, detta spann av rördiametrar var 25-100 mm. Det uppgavs även önskemål om säkerställning av att produkterna är robusta nog att klara den påfrestande arbetsmiljö som ofta förekommer vid svetsning. Lösningsförslag lades fram vilket senare utvecklades till sex separata koncept. Från dessa sex koncept utsågs en som den främsta lösningen och togs vidare till konstruktion. Konceptet skissades upp i CAD och en modell gjordes i 3D-skrivare. Modellen visade upp behov på modifieringar då den inte var av tillräckligt anpassningsbar karaktär. En modifierad modell togs därmed fram och tillverkades i en 3D-skrivare, denna modifierade modell visade bättre prov på anpassning till olika  rördiametrar. Vidare gjordes en flödesanalys av gasen då den färdas in via rotgaspluggen, vilket visade att gasen fyller röret som önskat. Materialet som konceptet kommer tillverkas i är silikon med tillförda additiv för att göra det mer värmebeständigt och mer resistent mot slitage. Den exakta blandningen av silikon och additiv i fråga var dock inte tillgängliga till detta projekt utan är något som får gå till vidare arbete. Konceptet uppfyller kraven på anpassning till flera rördiametrar och möter mer specifikt även önskemålet från branschaktiva med dess spann på 25-100 mm

Survival Outcomes with Photodynamic Therapy, Chemotherapy and Radiation in Patients with Stage III or Stage IV Non-Small Cell Lung Cancer

Data regarding the association between photodynamic therapy (PDT) and mortality in lung cancer patients are limited. We analyzed the association between PDT and mortality in patients with stage III or IV non-small cell lung cancer (NSCLC) using data from the National Cancer Database (NCDB) between 2004 and 2016. From the NCDB, we identified patients receiving laser ablation/cryosurgery or local tumor destruction/excision (which includes PDT). From Medicare and Medicaid claims between 2000 and 2013, we identified NSCLC patients receiving PDT and those receiving bronchoscopy, then used these to confirm the PDT treatment. From NCDB, we extracted NSCLC patients who received radiation with chemotherapy, radiation alone or chemotherapy alone. We used survival analysis to determine the association between PDT and mortality. Between 2004 and 2016, 457,556 NSCLC patients with stage III or stage IV were identified, of which 147 received PDT with radiation and chemotherapy, 227,629 received radiation with chemotherapy, 106,667 had radiation therapy alone and 122,193 received chemotherapy alone. Compared to the radiation alone group, the PDT group and radiation with chemotherapy group had lower hazard of mortality (50% and 53% lower, respectively). Among the NSCLC patients with stage III or stage IV disease, the addition of PDT to radiation therapy offers survival benefit over radiation therapy alone