Journal of comparative effectiveness research最新文献_第6页

Cost of disease progression among US patients with human epidermal growth factor receptor 2-positive metastatic breast cancer 美国人类表皮生长因子受体 2 阳性转移性乳腺癌患者的疾病进展成本

IF 2.1 4区医学 Q2 Medicine

Journal of comparative effectiveness research

Pub Date : 2024-04-22 DOI: 10.57264/cer-2023-0166

Clara Lam, Brandon J Diessner, Katherine Andrade, Sydnie Stackland, Leah Park, Sandhya Mehta, Feng Lin, Winghan Jackie Kwong

Aim: The objectives were to investigate the differences in per patient per month (PPPM) healthcare resource utilization (HCRU) and costs among commercially insured and Medicare Advantage patients with human epidermal growth factor receptor 2 positive (HER2+) metastatic breast cancer (mBC) who experience disease progression in 12 months compared with those who don't investigate the impact of progression timing on cumulative healthcare costs. Patients & methods: This claims-based study included patients diagnosed with mBC between 1 January 2013 and 30 April 2020 and received HER2-targeted therapy. Patients were categorized as progressed or nonprogressed. For objective one, monthly HCRU and costs were assessed for up to two lines of therapy (LOTs). Data were summarized descriptively and compared using a generalized linear model (GLM). For objective two, patients with at least 6 months of follow-up were assessed and cumulative healthcare costs were estimated in the 3 years following the start of LOT1 or LOT2 using a GLM and Kaplan–Meier weighting. Results: Among the 4113 patients in the study sample, 3406 had at least 12 months of follow-up (or less if due to death). Compared with nonprogressed patients, progressed patients had higher mean PPPM healthcare costs (LOT1: $22,014 vs $18,372, p < 0.001; LOT2: $19,643 vs $16,863, p = 0.001), and HCRU, including number of emergency room visits and inpatient stays (both p < 0.001) in the 12 months following LOT start. Progressed patients had higher 3-year mean cumulative healthcare costs than nonprogressed patients following LOT1 and LOT2 and this difference was greater for patients who progressed earlier. Conclusion: Disease progression was associated with significant increases in HCRU and costs. Delays in progression were associated with lower cumulative healthcare costs. Earlier use of more clinically effective treatments to delay progression may reduce the economic burden among these patients.

目的：该研究旨在调查人表皮生长因子受体 2 阳性（HER2+）转移性乳腺癌（mBC）商业保险和医疗保险优势患者在 12 个月内出现疾病进展与未出现疾病进展的患者相比，每位患者每月医疗资源利用率（PPPM）和费用的差异，并调查疾病进展时间对累计医疗费用的影响。患者与方法：这项基于理赔的研究纳入了 2013 年 1 月 1 日至 2020 年 4 月 30 日期间确诊为 mBC 并接受 HER2 靶向治疗的患者。患者被分为进展期和非进展期。对于目标 1，评估了最多两条治疗线 (LOT) 的每月 HCRU 和费用。对数据进行描述性总结，并使用广义线性模型（GLM）进行比较。目标二：对随访至少 6 个月的患者进行评估，并使用 GLM 和 Kaplan-Meier 加权法估算 LOT1 或 LOT2 开始后 3 年内的累计医疗费用。结果在研究样本的 4113 名患者中，有 3406 名患者接受了至少 12 个月的随访（如果死亡，则随访时间更短）。与非进展期患者相比，进展期患者的平均 PPPM 医疗费用更高（LOT1：22,014 美元 vs 18,372 美元，p < 0.001；LOT2：19,643 美元 vs 16,863 美元，p = 0.001），在 LOT 开始后的 12 个月内，HCRU（包括急诊就诊次数和住院次数）也更高（两者均 p < 0.001）。在 LOT1 和 LOT2 后，进展期患者的 3 年平均累计医疗费用高于非进展期患者，且进展较早的患者的差异更大。结论：疾病进展与 HCRU 和费用的显著增加有关。推迟病情进展与降低累计医疗费用有关。尽早使用临床上更有效的治疗方法来延缓病情恶化可能会减轻这些患者的经济负担。

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引用次数: 0

Access in all areas? a round up of developments in market access and health technology assessment: part 4. 市场准入和卫生技术评估的发展综述：第 4 部分。

IF 2.1 4区医学 Q2 Medicine

Journal of comparative effectiveness research

Pub Date : 2024-04-22 DOI: 10.57264/cer-2024-0060

Alice Beattie, Catrin Treharne, S. Ramagopalan

In this latest update, we look at recent developments in market access including the pricing agreement of Libmeldy® by the Beneluxa Initiative, the financial impact of managed entry agreements in Italy and the restructuring of Agenzia Italiana del Farmaco (AIFA). We also highlight the collaboration between FINOSE and the New Expensive Drug (NED) section of the Nordic Pharmaceutical Forum.

在本期最新消息中，我们将介绍市场准入方面的最新进展，包括比荷卢倡议（Beneluxa Initiative）对 Libmeldy® 的定价协议、意大利管理性准入协议的财务影响以及意大利农业机构（AIFA）的重组。我们还重点介绍了 FINOSE 与北欧制药论坛新贵药物 (NED) 分部之间的合作。

引用次数: 0

Letter in reply: network meta-analysis for indirect comparison of lanadelumab and for the treatment of hereditary angioedema 回信：间接比较 Lanadelumab 和治疗遗传性血管性水肿的网络荟萃分析

IF 2.1 4区医学 Q2 Medicine

Journal of comparative effectiveness research

Pub Date : 2024-04-12 DOI: 10.57264/cer-2024-0041

Maureen Watt, Mia Malmenas, Katrin Haeussler

引用次数: 0

Polymer-based drug-eluting stent treatment extends the time to reintervention for patients with symptomatic femoropopliteal artery disease: clinical evidence and potential economic value. 聚合物药物洗脱支架治疗可延长症状性股浅动脉疾病患者再介入治疗的时间：临床证据和潜在经济价值。

IF 2.1 4区医学 Q2 Medicine

Journal of comparative effectiveness research

Pub Date : 2024-04-12 DOI: 10.57264/cer-2024-0025

William A. Gray, Y. Soga, M. Fujihara, Osamu Iida, A. Babaev, D. Kawasaki, Thomas Zeller, David O’Connor, Michael R. Jaff, Anna M Chavez, Stefan Müller-Hülsbeck

Aim: Use long-term follow-up data from the IMPERIAL study to determine whether drug-eluting polymer-based nitinol stent treatment can delay the time to repeat intervention for femoropopliteal artery disease and how such a delay may result in cost savings in a value-based episode of care. Patients & methods: The IMPERIAL randomized controlled trial was an international study of a paclitaxel-eluting polymer-coated stent (Eluvia, Boston Scientific, MA, USA) versus a polymer-free paclitaxel-coated stent (Zilver PTX, Cook Corporation, IN, USA) for treating lesions of the femoropopliteal arterial segment. Study patients (n = 465) had symptomatic lower limb ischemia. Safety and efficacy assessments were performed through 5 years. Mean time to first reintervention was calculated in post-hoc analysis for patients who underwent a clinically driven target lesion revascularization (CD-TLR) through 3 or 5 years following the index procedure. To simulate potential cost savings associated with differential CD-TLR burden over time, a cost-avoidance analysis using input parameters from IMPERIAL and US 100% Medicare standard analytical files was developed. Results: Among patients with a first CD-TLR through 3 years of follow-up, mean time to reintervention was 5.5 months longer (difference 166 days, 95% CI: 51, 282 days; p = 0.0058) for patients treated with Eluvia (n = 56) than for those treated with Zilver PTX (n = 30). Through the 5-year study follow-up period, CD-TLR rates were 29.3% (68/232) for Eluvia and 34.2% (39/114) for Zilver PTX (p = 0.3540) and mean time to first reintervention exceeded 2 years for patients treated with Eluvia at 737 days versus 645 days for the Zilver PTX group (difference 92 days, 95% CI: -85, 269 days; p = 0.3099). Simulated savings considering reinterventions occurring over 1 and 5 years following initial use of Eluvia over Zilver PTX were US $1,395,635 and US $1,531,795, respectively, when IMPERIAL CD-TLR rates were extrapolated to 1000 patients. Conclusion: IMPERIAL data suggest initial treatment with Eluvia extends the time patients spend without undergoing reintervention. This extension may be associated with cost savings in relevant time frames.

目的：利用 IMPERIAL 研究的长期随访数据，确定基于药物洗脱聚合物的镍钛诺支架治疗能否延迟股骨腘动脉疾病重复介入治疗的时间，以及这种延迟如何在基于价值的护理中节省成本。患者与方法：IMPERIAL随机对照试验是一项国际性研究，研究对象是紫杉醇洗脱聚合物涂层支架（Eluvia，波士顿科学公司，美国马萨诸塞州）与不含聚合物的紫杉醇涂层支架（Zilver PTX，库克公司，美国印第安纳州），用于治疗股腘动脉段的病变。研究对象（n = 465）均为有症状的下肢缺血患者。安全性和疗效评估持续了5年。在事后分析中计算了接受临床驱动靶病变血运重建（CD-TLR）的患者在指数手术后 3 年或 5 年内首次再介入的平均时间。为了模拟随时间推移 CD-TLR 负担不同而可能节省的成本，我们使用 IMPERIAL 和美国 100% 医疗保险标准分析文件中的输入参数进行了成本规避分析。结果：在随访 3 年的首次 CD-TLR 患者中，接受 Eluvia 治疗的患者（n = 56）比接受 Zilver PTX 治疗的患者（n = 30）再次干预的平均时间长 5.5 个月（差异为 166 天，95% CI：51，282 天；p = 0.0058）。在为期 5 年的研究随访期间，Eluvia 的 CD-TLR 率为 29.3%（68/232），Zilver PTX 为 34.2%（39/114）（p = 0.3540），Eluvia 治疗患者首次再干预的平均时间超过 2 年，为 737 天，而 Zilver PTX 组为 645 天（差异为 92 天，95% CI：-85，269 天；p = 0.3099）。如果将 IMPERIAL CD-TLR 率推算到 1000 名患者，考虑到首次使用 Eluvia 超过 Zilver PTX 后 1 年和 5 年内发生的再干预，模拟节省的费用分别为 1,395,635 美元和 1,531,795 美元。结论IMPERIAL 数据表明，使用 Eluvia 进行初始治疗可延长患者无需接受再介入治疗的时间。在相关时间段内，这种延长可能与成本节约有关。

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引用次数: 0

Comparing the outcomes and costs of cardiac monitoring with implantable loop recorders and mobile cardiac outpatient telemetry following stroke using real-world evidence. 利用真实世界的证据，比较中风后使用植入式循环记录器和移动式心脏门诊遥测技术进行心脏监测的结果和成本。

IF 2.1 4区医学 Q2 Medicine

Journal of comparative effectiveness research

Pub Date : 2024-04-11 DOI: 10.57264/cer-2024-0008

V. Norlock, Reynaldo Vazquez, A. Dunn, Christian Siegfried, Manish K. Wadhwa, Goran Medic

Aim: Patients with ischemic stroke (IS) commonly undergo monitoring to identify atrial fibrillation with mobile cardiac outpatient telemetry (MCOT) or implantable loop recorders (ILRs). The authors compared readmission, healthcare cost and survival in patients monitored post-stroke with either MCOT or ILR. Materials & methods: The authors used claims data from Optum's de-identified Clinformatics® Data Mart Database to identify patients with IS hospitalized from January 2017 to December 2020 who were prescribed ambulatory cardiac monitoring via MCOT or ILR. They compared the costs associated with the initial inpatient visit as well as the rate and causes of readmission, survival and healthcare costs over the following 18 months. Datasets were balanced using patient baseline and hospitalization characteristics. Multivariable generalized linear gamma regression was used for cost comparisons. Cox proportional hazard regression was used for survival and readmission analysis. Sub-cohorts were analyzed based on the severity of the index IS. Results: In 2244 patients, readmissions were significantly lower in the MCOT monitored group (30.2%) compared with the ILR group (35.4%) (hazard ratio [HR] 1.23; 95% CI: 1.04-1.46). Average cost over 18 months starting with the index IS was $27,429 (USD) lower in the MCOT group (95% CI: $22,353-$32,633). Survival difference bordered on statistical significance and trended to lower mortality in MCOT (8.9%) versus ILR (11.3%) (HR 1.30; 95% CI: 1:00-1.69), led by significance in patients with complications or comorbidities with the index event (MCOT 7.5%, ILR 11.5%; HR 1.62; 95% CI: 1.11-2.36). Conclusion: The use of MCOT versus ILR as the primary monitor following IS was associated with significant decreases in readmission, lower costs for the initial IS and total care over the next 18 months, significantly lower mortality for patients with complications and comorbidities at the index stroke, and a trend toward improved survival across all patients.

目的：缺血性中风（IS）患者通常会接受移动式心脏门诊遥测（MCOT）或植入式环路记录仪（ILR）的监测，以识别心房颤动。作者比较了使用 MCOT 或 ILR 监测卒中后患者的再入院率、医疗成本和存活率。材料与方法：作者使用 Optum 去标识化 Clinformatics® Data Mart 数据库中的理赔数据，确定了 2017 年 1 月至 2020 年 12 月期间住院的 IS 患者，这些患者均接受了通过 MCOT 或 ILR 进行的非卧床心脏监护。他们比较了首次住院就诊的相关费用，以及随后 18 个月的再入院率和原因、存活率和医疗费用。数据集根据患者基线和住院特征进行了平衡。多变量广义线性伽马回归用于成本比较。生存和再入院分析采用 Cox 比例危险回归。根据指数 IS 的严重程度对子队列进行分析。结果显示在 2244 名患者中，MCOT 监测组的再入院率（30.2%）明显低于 ILR 组（35.4%）（危险比 [HR] 1.23；95% CI：1.04-1.46）。从指数 IS 开始的 18 个月内，MCOT 组的平均费用比 ILR 组低 27,429 美元（95% CI：22,353-32,633 美元）。MCOT组（8.9%）与ILR组（11.3%）的存活率差异接近统计学意义，并呈死亡率降低趋势（HR 1.30；95% CI：1:00-1.69），这主要体现在有并发症或合并症的患者中（MCOT组7.5%，ILR组11.5%；HR 1.62；95% CI：1.11-2.36）。结论使用 MCOT 与 ILR 作为 IS 后的主要监测手段可显著降低再入院率，降低初始 IS 成本和未来 18 个月的总护理成本，显著降低卒中指数并发症和合并症患者的死亡率，并有改善所有患者生存率的趋势。

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引用次数: 0

Augmenting external control arms using Bayesian borrowing: a case study in first-line non-small cell lung cancer 利用贝叶斯借法增强外部对照臂：一线非小细胞肺癌案例研究

IF 2.1 4区医学 Q2 Medicine

Journal of comparative effectiveness research

Pub Date : 2024-04-04 DOI: 10.57264/cer-2023-0175

Alessandria Struebing, C. McKibbon, H. Ruan, Emma K. Mackay, N. Dennis, Russanthy Velummailum, P. He, Yoko Tanaka, Y. Xiong, Aaron Springford, M. Rosenlund

Aim: This study aimed to improve comparative effectiveness estimates and discuss challenges encountered through the application of Bayesian borrowing (BB) methods to augment an external control arm (ECA) constructed from real-world data (RWD) using historical clinical trial data in first-line non-small-cell lung cancer (NSCLC). Materials & methods: An ECA for a randomized controlled trial (RCT) in first-line NSCLC was constructed using ConcertAI Patient360™ to assess chemotherapy with or without cetuximab, in the bevacizumab-inappropriate subpopulation. Cardinality matching was used to match patient characteristics between the treatment arm (cetuximab + chemotherapy) and ECA. Overall survival (OS) was assessed as the primary outcome using Cox proportional hazards (PH). BB was conducted using a static power prior under a Weibull PH parameterization with borrowing weights from 0.0 to 1.0 and augmentation of the ECA from a historical control trial. Results: The constructed ECA yielded a higher overall survival (OS) hazard ratio (HR) (HR = 1.53; 95% CI: 1.21–1.93) than observed in the matched population of the RCT (HR = 0.91; 95% CI: 0.73–1.13). The OS HR decreased through the incorporation of BB (HR = 1.30; 95% CI: 1.08–1.54, borrowing weight = 1.0). BB was applied to augment the RCT control arm via a historical control which improved the precision of the observed HR estimate (1.03; 95% CI: 0.86–1.22, borrowing weight = 1.0), in comparison to the matched population of the RCT alone. Conclusion: In this study, the RWD ECA was unable to successfully replicate the OS estimates from the matched population of the selected RCT. The inability to replicate could be due to unmeasured confounding and variations in time-periods, follow-up and subsequent therapy. Despite these findings, we demonstrate how BB can improve precision of comparative effectiveness estimates, potentially aid as a bias assessment tool and mitigate challenges of traditional methods when appropriate external data sources are available.

目的：本研究旨在通过应用贝叶斯借用（BB）方法，利用一线非小细胞肺癌（NSCLC）的历史临床试验数据，增强由真实世界数据（RWD）构建的外部对照臂（ECA），从而提高比较效果估计值，并讨论所遇到的挑战。材料与方法：使用 ConcertAI Patient360™ 构建了一线非小细胞肺癌随机对照试验 (RCT) 的 ECA，以评估在贝伐珠单抗不合适的亚群中使用西妥昔单抗或不使用西妥昔单抗的化疗情况。采用卡方匹配法匹配治疗组（西妥昔单抗+化疗）和ECA的患者特征。总生存期（OS）作为主要结果，采用 Cox 比例危险度法（PH）进行评估。使用Weibull PH参数化下的静态功率先验进行BB，借用权重从0.0到1.0，并从历史对照试验中增加ECA。结果构建的 ECA 得出的总生存期（OS）危险比（HR）（HR = 1.53；95% CI：1.21-1.93）高于在 RCT 匹配人群中观察到的结果（HR = 0.91；95% CI：0.73-1.13）。加入 BB 后，OS HR 有所下降（HR = 1.30；95% CI：1.08-1.54，借用权重 = 1.0）。通过历史对照将 BB 应用于增强 RCT 对照组，与单独的 RCT 匹配人群相比，提高了观察到的 HR 估计值的精确度（1.03；95% CI：0.86-1.22，借用权重 = 1.0）。结论在本研究中，RWD ECA 无法成功复制所选 RCT 匹配人群的 OS 估计值。无法复制的原因可能是未测量的混杂因素以及时间段、随访和后续治疗的差异。尽管有这些发现，我们还是展示了 BB 如何提高比较效应估算的精确度，如何作为偏倚评估工具提供潜在帮助，以及如何在有适当外部数据源的情况下减轻传统方法的挑战。

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引用次数: 1

The impact of willingness-to-pay threshold on price reduction recommendations for oncology drugs: a review of assessments conducted by the Canadian Agency for Drugs and Technologies in Health 支付意愿阈值对肿瘤药物降价建议的影响：加拿大药品和卫生技术局进行的评估回顾

IF 2.1 4区医学 Q2 Medicine

Journal of comparative effectiveness research

Pub Date : 2024-04-03 DOI: 10.57264/cer-2023-0178

C. Balijepalli, L. Gullapalli, Juhi Joshy, Nigel S. B. Rawson

Since late 2020, the Canadian Agency of Drugs and Technologies in Health (CADTH) has been using a threshold of $50,000 (CAD) per quality-adjusted life-year (QALY) for both oncology and non-oncology drugs. When used for oncology products, this threshold is hypothesized to have a higher impact on the time to access these drugs in Canada. We studied the impact of price reductions on time to engagement and negotiation with the pan-Canadian Pharmaceutical Alliance for oncology drugs reviewed by CADTH between January 2020 and December 2022. Overall, 103 assessments reported data on price reductions recommended by CADTH to meet the cost–effectiveness threshold for reimbursement. Of these assessments, 57% (59/103) recommendations included a price reduction of greater than 70% off the list price. Eight percent (8/103) were not cost-effective even at a 100% price reduction. Of the 47 assessments that had a clear benefit, in 21 (45%) CADTH recommended a price reduction of at least 70%. The median time to price negotiation (not including time to engagement) for assessments that received at least 70% vs >70% price reduction was 2.6 vs 4.8 months. This study showed that there is a divergence between drug sponsor's incremental cost–effectiveness ratio (ICER) and CADTH revised ICER leading to a price reduction to meet the $50,000/QALY threshold. For the submissions with clear clinical benefit the median length of engagement (2.5 vs 3.3 months) and median length of negotiation (3.1 vs 3.6 months) were slightly shorter compared with the submissions where uncertainties were noted in the clinical benefit according to CADTH. This study shows that using a $50,000 per QALY threshold for oncology products potentially impacts timely access to life saving medications.

自 2020 年底以来，加拿大药品和卫生技术局（CADTH）一直对肿瘤和非肿瘤药物采用每质量调整生命年（QALY）50,000 加元的阈值。据推测，如果将这一阈值用于肿瘤产品，则会对在加拿大获得这些药物的时间产生较大影响。我们研究了降价对 2020 年 1 月至 2022 年 12 月期间由 CADTH 审查的肿瘤药物的参与时间和与泛加拿大制药联盟谈判时间的影响。总体而言，103 项评估报告了加拿大卫生部建议的降价数据，以达到报销的成本效益阈值。在这些评估中，57%（59/103）的建议降价幅度超过清单价格的 70%。8%（8/103）的评估即使降价 100%，也不符合成本效益。在 47 项有明确效益的评估中，21 项（45%）"计算机辅助设计与制造 "建议降价至少 70%。降价至少 70% 与降价超过 70% 的评估中，价格谈判的中位时间（不包括参与时间）分别为 2.6 个月与 4.8 个月。这项研究表明，药物申办者的增量成本效益比（ICER）与 CADTH 修订后的 ICER 之间存在差异，导致降价幅度达不到 50,000 美元/QALY 临界值。与 CADTH 认为临床效益不确定的申请相比，临床效益明确的申请的参与时间中位数（2.5 个月对 3.3 个月）和谈判时间中位数（3.1 个月对 3.6 个月）略短。这项研究表明，对肿瘤产品使用每 QALY 50,000 美元的阈值可能会影响及时获得挽救生命的药物。

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引用次数: 0

Comparing the performance of two-stage residual inclusion methods when using physician's prescribing preference as an instrumental variable: unmeasured confounding and noncollapsibility 使用医生处方偏好作为工具变量时两阶段残差包含法的性能比较：未测量混杂因素和非可比性

IF 2.1 4区医学 Q2 Medicine

Journal of comparative effectiveness research

Pub Date : 2024-04-03 DOI: 10.57264/cer-2023-0085

Lisong Zhang, J. Lewsey

Aim: The first objective is to compare the performance of two-stage residual inclusion (2SRI), two-stage least square (2SLS) with the multivariable generalized linear model (GLM) in terms of the reducing unmeasured confounding bias. The second objective is to demonstrate the ability of 2SRI and 2SPS in alleviating unmeasured confounding when noncollapsibility exists. Materials & methods: This study comprises a simulation study and an empirical example from a real-world UK population health dataset (Clinical Practice Research Datalink). The instrumental variable (IV) used is based on physicians' prescribing preferences (defined by prescribing history). Results: The percent bias of 2SRI in terms of treatment effect estimates to be lower than GLM and 2SPS and was less than 15% in most scenarios. Further, 2SRI was found to be robust to mild noncollapsibility with the percent bias less than 50%. As the level of unmeasured confounding increased, the ability to alleviate the noncollapsibility decreased. Strong IVs tended to be more robust to noncollapsibility than weak IVs. Conclusion: 2SRI tends to be less biased than GLM and 2SPS in terms of estimating treatment effect. It can be robust to noncollapsibility in the case of the mild unmeasured confounding effect.

目的：第一个目的是比较两阶段残差包含（2SRI）、两阶段最小平方（2SLS）与多变量广义线性模型（GLM）在减少未测量混杂偏差方面的性能。第二个目的是证明 2SRI 和 2SPS 在非可比性存在时减轻未测量混杂的能力。材料与方法：本研究包括一项模拟研究和一个来自真实世界的英国人口健康数据集（临床实践研究数据链）的经验范例。使用的工具变量（IV）基于医生的处方偏好（由处方历史定义）。研究结果就治疗效果估计值而言，2SRI 的偏差百分比低于 GLM 和 2SPS，在大多数情况下小于 15%。此外，还发现 2SRI 对轻度非可比性具有稳健性，偏差百分比低于 50%。随着未测量混杂水平的增加，缓解非可比性的能力也在下降。与弱IV相比，强IV对非胶合性的稳健性更高。结论：就估计治疗效果而言，2SRI 比 GLM 和 2SPS 的偏差更小。在存在轻度未测量混杂效应的情况下，2SRI 对非可比性具有稳健性。

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引用次数: 0

Early-stage hepatocellular carcinoma screening in patients with chronic hepatitis B in China: a cost-effectiveness analysis. 中国慢性乙型肝炎患者早期肝细胞癌筛查：成本效益分析。

IF 2.1 4区医学 Q2 Medicine

Journal of comparative effectiveness research

Pub Date : 2024-04-01 Epub Date: 2024-02-28 DOI: 10.57264/cer-2023-0146

Yuemin Nan, Osvaldo Ulises Garay, Xianzhong Lu, Yue Zhang, Li Xie, Zhongyi Niu, Wen Chen

Aim: To evaluate the cost-effectiveness of seven screening strategies for chronic hepatitis B (CHB) patients in China. Methods: A discrete event simulation model combining a decision tree and Markov structure was developed to simulate a CHB cohort aged ≥40 years on a lifetime horizon and evaluate the costs and health outcomes (quality-adjusted life years [QALYs] gained) of ultrasonography (US), alpha-fetoprotein (AFP), protein induced by vitamin K absence-II (PIVKA-II), AFP+US, AFP+PIVKA-II, GAAD (a diagnostic algorithm based on gender and age combined with results of AFP and PIVKA-II) and GAAD+US. Epidemiologic, clinical performance, utility and cost data were obtained from the literature, expert interviews and real-world data. Uncertainties on key parameters were explored through deterministic and probabilistic sensitivity analyses (DSA and PSA). Results: Compared with other strategies, GAAD+US detected the most HCC patients at early stage, and GAAD was the screening strategy with the lowest average cost per HCC case diagnosed. Using 3× China's 2022 GDP per capita ($38,233.34) as the threshold, the three strategies of US, GAAD and GAAD+US formed a cost-effectiveness frontier. Screening with US, GAAD, or GAAD+US was associated with costs of $6110.46, $7622.05 and $8636.32, and QALYs of 13.18, 13.48 and 13.52, respectively. The ICER of GAAD over US was $4993.39/QALY and the ICER of GAAD+US over GAAD was $26,691.45/QALY, which was less than 3× GDP per capita. Both DSA and PSA proved the stability of the results. Conclusion: GAAD+US was the most cost-effective strategy for early HCC diagnosis among CHB patients which could be considered as the liver cancer screening scheme for the high-risk population in China.

目的：评估中国慢性乙型肝炎（CHB）患者七种筛查策略的成本效益。方法：建立一个结合决策树和马尔可夫结构的离散事件模拟模型，模拟年龄在建立一个结合决策树和马尔可夫结构的离散事件模拟模型，模拟一个年龄≥40岁的慢性乙型肝炎队列，评估超声波检查（US）的成本和健康结果（获得的质量调整生命年[QALYs]）、甲胎蛋白（AFP）、维生素 K 缺乏诱导的蛋白质-II（PIVKA-II）、AFP+US、AFP+PIVKA-II、GAAD（一种基于性别和年龄并结合 AFP 和 PIVKA-II 结果的诊断算法）和 GAAD+US。流行病学、临床表现、效用和成本数据均来自文献、专家访谈和实际数据。通过确定性和概率敏感性分析（DSA 和 PSA）探讨了关键参数的不确定性。结果：与其他筛查策略相比，GAAD+US 在早期发现的 HCC 患者最多，GAAD 是平均每例 HCC 诊断成本最低的筛查策略。以中国 2022 年人均 GDP 的 3 倍（38,233.34 美元）为临界值，US、GAAD 和 GAAD+US 三种策略形成了一个成本效益前沿。采用US、GAAD或GAAD+US进行筛查的成本分别为6110.46美元、7622.05美元和8636.32美元，QALY分别为13.18、13.48和13.52。GAAD相对于US的ICER为4993.39美元/QALY，GAAD+US相对于GAAD的ICER为26691.45美元/QALY，低于人均GDP的3倍。DSA 和 PSA 均证明了结果的稳定性。结论GAAD+US是CHB患者早期诊断HCC最具成本效益的策略，可作为中国高危人群的肝癌筛查方案。

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引用次数: 0

Use of interrupted time-series analyses in evaluating health economic outcomes following implementation of multilayer water-tight wound closure in a primary total joint arthroplasty population. 使用间断时间序列分析评估在初级全关节成形术人群中实施多层防水伤口闭合后的卫生经济效益。

IF 2.1 4区医学 Q2 Medicine

Journal of comparative effectiveness research

Pub Date : 2024-04-01 Epub Date: 2024-02-28 DOI: 10.57264/cer-2023-0110

Ziyu Tan, Joerg Tomaszewski, Brian Po-Han Chen, Najmuddin J Gunja, Katherine Etter

Aim: Total joint arthroplasty (TJA) with multi-layer, watertight closure (MLWC) using knotless barbed suture and 2-octyl cyanoacrylate plus polymer mesh tape was compared with conventional closure (CC) using Vicryl™ sutures and staples. Patients & methods: Electronic medical records of patients undergoing TJA (1574: total knee arthroplasty; 580: total hip arthroplasty; 13: unknown) from a single surgeon at a US hospital (CC 2011 to 2013; MLWC 2015 to 2020) were reviewed. Outcomes were length of stay (LOS), discharge to skilled nursing facility (SNF), 90-day surgical site infection (SSI) and 90-day readmission. Logistic regression controlled for baseline characteristics. Adjusted interrupted time series (ITS) analyses accounted for decreasing trends in LOS and SNF discharge over time. Results: Among 2167 TJA cases (mean [standard deviation] age 66.0 [9.7] years, 53.3% female), 906 received CC and 1261 received MLWC. Bivariate analysis showed no statistically significant differences in 90-day SSI rates; however, MLWC patients had 60% lower 90-day readmission rates (1.5 vs 3.8%, p < 0.05), 44% lower LOS (1.4 vs 2.5 days, p < 0.05) and 40% lower discharge rates to a skilled care facility (8.5 vs 14.1%, p < 0.05). Multivariable analyses showed CC patients were 2.45-times more likely to be readmitted within 90 days, 1.88-times more likely to be discharged to SNF and had 1.67-times longer LOS compared with MLWC. ITS analyses showed a sharp decline in LOS (0.9 days) and discharge to SNF (5.6% incidence) after implementation of MLWC, followed by no further changes for the remainder of the study period. Conclusion: MLWC was associated with ≥40% reduction in 90-day readmission, LOS and SNF discharge compared with TJA CC. LOS and discharge rate to SNF declined sharply after the implementation of MLWC.

目的：使用无结倒刺缝合线和 2-辛基氰基丙烯酸酯加聚合物网带进行多层防水闭合（MLWC）的全关节关节置换术（TJA）与使用 Vicryl™ 缝合线和订书钉的传统闭合（CC）进行了比较。患者和方法：回顾了美国一家医院的一名外科医生为接受 TJA 手术的患者（1574 例：全膝关节置换术；580 例：全髋关节置换术；13 例：未知）提供的电子病历（CC 2011 年至 2013 年；MLWC 2015 年至 2020 年）。结果包括住院时间（LOS）、出院至专业护理机构（SNF）、90天手术部位感染（SSI）和90天再入院。逻辑回归控制了基线特征。调整后的间断时间序列 (ITS) 分析考虑了住院时间和出院到专业护理机构的时间的下降趋势。结果：在 2167 例 TJA 患者（平均 [标准差] 年龄 66.0 [9.7] 岁，53.3% 为女性）中，906 例接受了 CC，1261 例接受了 MLWC。双变量分析表明，90 天 SSI 发生率无统计学差异；但 MLWC 患者的 90 天再入院率降低了 60%（1.5 vs 3.8%，P 结论：MLWC 与 SSI 发生率的相关性≥50%：与 TJA CC 相比，MLWC 可使 90 天再入院率、LOS 和 SNF 出院率降低≥40%。在实施 MLWC 后，LOS 和出院到 SNF 的比率急剧下降。

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