Challenges with Forecasting Budget Impact: A Case Study of Six ICER Reports

Background

Payers frequently rely on budget impact model (BIM) results to help determine drug coverage policy and its effect on their bottom line. It is unclear whether BIMs typically overestimate or underestimate real-world budget impact.

尿液10项肾损伤标志物检测试剂的性能评价

摘要:目的对尿液 10项肾损伤标志物检测试剂进行性能评价,并评估其临床适用性。方法对北京利德曼公司尿液a1 微球蛋白(u-a|MG)、总蛋白(u-TP)、免疫球蛋白G(u-IgG) 、微量清蛋白(u-Alb)、中性粒细胞明胶酶相关脂质运载蛋白(u-NGAL)、半胱氨酸蛋白酶抑制剂C(u-CysC).视黄醇结合蛋白(u-RBP)、β2微球蛋白(u-β2MG)、N-乙酰-β-D-氨基葡萄糖苷酶(u-NAG).、转铁蛋白(u-Trf)检测试剂盒进行性能评价。正确度和精密度验证参考美国临床和实验室标准协会(CLSI)EP15-A3,验证物质采用ERM-DA470k、ERM-DA471、B2M-NIBSC等参考物质及纯度物质;线性验证参考CLSI EP06;抗干扰能力参考CISI EP07;不同检测系统间比对参考CISI EP09。结果正确度方面,10 项标志物检测试剂测定标准物质在低值、中值、高值的偏倚分别为-2.69% ~4.67%、-3.60% ~3.33% .-2.38% ~3.02%;不精密度方面,重复性以不精密度表示,在低值和高值处分别为1.90%~5.43%、0.63% ~2.42%,室内不精密度为2.27%~5.63%、1.09%~3.41%,均满足临床要求;10项尿液标志物线性范围在0.06~4.40 mg/L至21.83~2 146.77 mg/L之间。抗干扰方面,u-1 MG、u-Alb、u-β2MG、u-Trf 、u-CysC、u-NAG分别在血红蛋白终浓度≤8 g/L、≤8 g/L、≤4 g/L、≤4 g/L、≤2g/L、≤1 g/L时,未受到明显干扰(百分偏差≤+ 10%) ,而u-TP、u-IgG、 u-RBP、u-NGAL在血红蛋白终浓度≥0.125 g/L时即受干扰。不同检测系统间偏差超出临床允许范围。结论尿液 10项肾损伤标志物的正确度、精密度、线性范围和抗血红蛋白干扰能力满足临床需要,不同检测系统间标志物测量结果可比性欠佳。     

Developing Organ Offer and Acceptance Measures: When 'Good' Organs Are Turned Down

Turndowns of offers of deceased donor kidneys for transplantation can contribute to inefficiencies in the organ distribution system and inequality in access to donated organs. Match run data were obtained for 4967 'good' kidneys placed and transplanted in 2005 after fewer than 50 offers. These kidneys were not recovered from donation after cardiac death or expanded criteria donors, or from donors with a history of substance abuse. On average, these good kidneys were not accepted until after seven offers to candidates and after offers to 2.4 programs. Models for the likelihood of acceptance found several donor and candidate characteristics to be significantly related to acceptance rates (p < 0.05). After accounting for these variables, there remained 2- to 3-fold differences among transplant programs in acceptance rates. These models could be used to identify kidney transplant centers with exceptional acceptance practices. Several strategies might be employed to increase acceptance rates for good organs.     

显露血管内皮下层纤维连接素的方法

本文报道了一种显露内皮下层纤维连接素的理想方法。大白鼠主动脉壁分别用1.0％NP-40作用5min,30.0mmol/L KCl作用10min后,内皮细胞全部脱离,内皮下层大部分纤维连接素被保留。本法适用于建立细胞与血管壁相互作用的体外实验模型。     

Guidelines for Trials of Behavioral Treatments for Recurrent Headache, First Edition: American Headache Society Behavioral Clinical Trials Workgroup

Guidelines for design of clinical trials evaluating behavioral headache treatments were developed to facilitate production of quality research evaluating behavioral therapies for management of primary headache disorders. These guidelines were produced by a Workgroup of headache researchers under auspices of the American Headache Society. The guidelines are complementary to and modeled after guidelines for pharmacological trials published by the International Headache Society, but they address methodologic considerations unique to behavioral and other nonpharmacological treatments. Explicit guidelines for evaluating behavioral headache therapies are needed as the optimal methodology for behavioral (and other nonpharmacologic) trials necessarily differs from the preferred methodology for drug trials. In addition, trials comparing and integrating drug and behavioral therapies present methodological challenges not addressed by guidelines for pharmacologic research. These guidelines address patient selection, trial design for behavioral treatments and for comparisons across multiple treatment modalities (eg, behavioral vs pharmacologic), evaluation of results, and research ethics. Although developed specifically for behavioral therapies, the guidelines may apply to the design of clinical trials evaluating many forms of nonpharmacologic therapies for headache.