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Access in all areas? A round-up of developments in market access and health technology assessment: part 13. 所有地区都能通行吗?市场准入和卫生技术评估方面的发展综述:第13部分。
IF 2.5 4区 医学 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2026-02-23 DOI: 10.57264/cer-2026-0041
Sreeram V Ramagopalan, Annie Jullien Pannelay

In this update we cover the US-UK Economic Prosperity Deal announced in December 2025, which includes NICE's first major cost-effectiveness threshold increase in over two decades. We also analyze the latest developments in US pharmaceutical pricing policy, including the second cycle of Inflation Reduction Act drug price negotiations and the implementation of the GENEROUS, GUARD and GLOBE Models for Most-Favored-Nation pricing.

在本期更新中,我们将介绍2025年12月宣布的美英经济繁荣协议,其中包括20多年来NICE首次大幅提高成本效益门槛。我们还分析了美国药品定价政策的最新发展,包括通货膨胀削减法案药品价格谈判的第二周期以及最惠国定价的慷慨,GUARD和GLOBE模型的实施。
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引用次数: 0
The effect of infertility support education on treatment outcomes in women with unexplained infertility. 不孕支持教育对不明原因不孕妇女治疗结果的影响。
IF 2.5 4区 医学 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2026-02-18 DOI: 10.57264/cer-2025-0159
Tuğba Tahta, Yeliz Kaya, Vehbi Yavuz Tokgöz, Yunus Aydın

Aim: To study the effect of infertility support education on treatment outcomes in women with unexplained infertility. Materials & methods: This quasi-experimental study with a pretest-posttest comparison group was conducted on women aged 19-45 years who were admitted to EO University Health, Practice and Research Hospital Department of Reproductive Endocrinology and Private D Health Hospital IVF Clinic with the diagnosis of unexplained infertility and decided to undergo in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI) and were included in the treatment plan. A study group and a control group were formed by randomization method with at least 25 infertile women for each group. Data were collected using the Introductory questionnaire, Fertility Readiness Scale for women receiving fertility support, Healthy Lifestyle Behaviors Scale II and post-IVF/ICSI success evaluation form. The pretest scales were administered to the education and control groups at the first interview. Infertility support training was given to the education group in three sessions at 15-day intervals. Post-test data were obtained at the interview on the day of ovum pickup. Embryo transfer was performed in 25 infertile women in both groups, and human chorionic gonadotropic hormone evaluation was performed on day 12. Approximately 4 weeks later the presence of a fetal heartbeat was analyzed by reviewing the medical records, and the post-IVF/ICSI success evaluation form was completed. Results: Fetal heartbeat was detected in 15 women in the training group and only in 10 women in the control group, although the pregnancy rate increased after training and this difference was not statistically significant. Conclusion: Infertility support education has been found to have positive effects on fertility as well as general health.

目的:探讨不孕支持教育对不明原因不孕妇女治疗效果的影响。材料与方法:本准实验研究采用前测后测对照组,选取EO大学卫生实践与研究医院生殖内分泌科和私立D健康医院体外受精(IVF)门诊诊断为不明原因不孕症,决定行体外受精(IVF)/胞浆内单精子注射(ICSI)并纳入治疗方案的19-45岁女性。采用随机分组法,每组至少25名不孕妇女组成研究组和对照组。数据收集采用介绍性问卷、接受生育支持的妇女生育准备量表、健康生活方式行为量表II和体外受精/ICSI后成功评估表。教育组和对照组在第一次面试时使用测试前量表。对教育组进行不育支持培训,每隔15天进行3次培训。在取卵当天的访谈中获得测试后数据。两组各25例不孕妇女进行胚胎移植,第12天进行人绒毛膜促性腺激素评价。大约4周后,通过查看医疗记录分析胎儿心跳的存在,并完成ivf /ICSI后成功评估表。结果:训练组有15例检测到胎儿心跳,对照组仅有10例检测到胎儿心跳,但训练后妊娠率增加,差异无统计学意义。结论:不孕症支持教育对生育和整体健康均有积极作用。
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引用次数: 0
Real-world clinical outcomes of patients with localized prostate cancer treated with radical prostatectomy in SEER-Medicare. SEER-Medicare中根治性前列腺切除术治疗的局限性前列腺癌患者的实际临床结果。
IF 2.5 4区 医学 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2026-02-16 DOI: 10.57264/cer-2025-0004
Lawrence Karsh, Shawn Du, Jinghua He, Neal Shore

Aim: This study examined the clinical outcomes of patients in the US with low/intermediate-risk localized prostate cancer (LIR-LPC) and high-risk localized prostate cancer (HR-LPC) who received radical prostatectomy (RP) as initial treatment. Materials & methods: This is a retrospective analysis of the SEER-Medicare database. Patients newly diagnosed with LPC at age of ≥65 years during 2012-2019 who underwent RP as initial definitive treatment and had continuous Medicare Fee-For-Service for ≥12 months prior to RP were included. Eligible patients were stratified into LIR-LPC and HR-LPC cohorts. Overall survival, metastatic free survival and time to advanced prostate cancer treatment (TTAT) were described and compared using the Kaplan-Meier method and Cox proportional-hazards model. Results: The LIR-LPC cohort (n = 4120) and the HR-LPC cohort (n = 5359) had comparable socio-demographic characteristics, with a mean age of approximately 70 years. Survival analysis showed that HR-LPC was associated with significantly shorter overall survival, metastatic free survival and TTAT than LIR-LPC (log rank p < 0.001). After adjusting for comprehensive socio-demographic and baseline clinical characteristics, patients with HR-LPC had an approximately 70% increased risk for all-cause death (hazard ratio [HR]: 1.72; confidence interval [CI]:1.39-2.12), 2.5-fold increased risk for metastasis or death (HR: 2.57; CI: 2.14-3.09), and ninefold increased risk for initiating advanced treatments (HR: 9.06; CI: 6.22-13.18) compared with patients with LIR-LPC. Conclusion: In patients with LPC who received RP as initial definitive treatment, high risk is strongly associated with suboptimal clinical outcomes. Novel therapeutic approaches are needed to enhance the management and improve the outcomes for this patient population.

目的:本研究探讨了在美国接受根治性前列腺切除术(RP)作为初始治疗的低/中危局限性前列腺癌(LIR-LPC)和高危局限性前列腺癌(HR-LPC)患者的临床结果。材料与方法:这是对SEER-Medicare数据库的回顾性分析。纳入2012-2019年期间新诊断为LPC的年龄≥65岁的患者,这些患者接受RP作为初始最终治疗,并且在RP之前连续接受医疗保险服务收费≥12个月。符合条件的患者被分为低级别lpc组和高级别lpc组。使用Kaplan-Meier方法和Cox比例风险模型描述和比较总生存期、无转移生存期和晚期前列腺癌治疗时间(TTAT)。结果:LIR-LPC队列(n = 4120)和HR-LPC队列(n = 5359)具有可比的社会人口学特征,平均年龄约为70岁。生存分析显示,与LIR-LPC相比,HR-LPC的总生存期、无转移生存期和TTAT显著缩短(log rank p)。结论:在接受RP作为初始最终治疗的LPC患者中,高风险与次优临床结果密切相关。需要新的治疗方法来加强管理和改善这一患者群体的结果。
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引用次数: 0
Cost of hepatic decompensation and liver transplantation events in primary biliary cholangitis: a retrospective observational study. 原发性胆道胆管炎患者肝功能失代偿和肝移植事件的代价:一项回顾性观察研究。
IF 2.5 4区 医学 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2026-02-16 DOI: 10.57264/cer-2025-0110
Robert G Gish, Joanna P MacEwan, Yutong Liu, Dannielle Lebovitch, Radhika Nair, Leona Bessonova, Jing Li, Zobair M Younossi

Aim: Complications of primary biliary cholangitis (PBC) are proposed to confer substantial economic burden to patients and healthcare systems. This retrospective observational study evaluated the cost of PBC-related hepatic decompensation and liver transplantation using a large administrative claims database. Materials & methods: Patients aged ≥18 years at the time of first claim with a diagnosis of PBC were identified using Optum's de-identified Clinformatics® Data Mart Database. Two cohorts were established based on the type of event (hepatic decompensation or liver transplantation) that patients experienced on or after the date of their first claim with the PBC diagnosis. Costs for the hepatic decompensation hospitalization and 30-day post-discharge period were examined at the event level. Hospitalizations occurring within the 30-day post-discharge period after a hepatic decompensation event were considered readmissions, and costs from the initial event were combined with those from the ensuing readmissions. In the liver transplantation cohort, costs for the pretransplant evaluation, hospitalization for transplantation, and post-transplant care and complications were assessed per patient. Results: A total of 2118 and 163 patients met study inclusion criteria in the hepatic decompensation and liver transplantation cohorts, respectively. The overall mean cost per hepatic decompensation event (n = 3581) was $63,612.09. The mean cost per event with readmission within 30 days (n = 991, 27.7%) was $116,424.25; for events without readmission, the mean cost was $43,404.81. The mean total cost of liver transplantation per patient was $328,336.60. The mean cost per patient was highest for the hospitalization for transplantation ($226,908.70). Conclusion: This comprehensive cost analysis demonstrates the high-cost burden of PBC disease progression. Appropriate patient management may help to mitigate the economic burden of PBC-related hepatic decompensation and liver transplantation.

目的:原发性胆管炎(PBC)的并发症给患者和医疗保健系统带来了巨大的经济负担。本回顾性观察性研究使用大型行政索赔数据库评估了与肝代偿相关的肝移植和肝移植的成本。材料与方法:首次申请时年龄≥18岁且诊断为PBC的患者使用Optum的去识别Clinformatics®数据集市数据库进行识别。根据患者在首次诊断为PBC时或之后经历的事件类型(肝失代偿或肝移植)建立了两个队列。在事件水平上检查肝功能失代偿住院和出院后30天的费用。肝失代偿事件后出院后30天内发生的住院被视为再入院,初始事件的费用与随后再入院的费用合并。在肝移植队列中,对每位患者的移植前评估、移植住院、移植后护理和并发症的费用进行评估。结果:在肝失代偿组和肝移植组中,分别有2118例和163例患者符合研究纳入标准。每次肝失代偿事件的总平均成本(n = 3581)为63,612.09美元。30天内再入院的平均每次事件费用(n = 991, 27.7%)为116,424.25美元;对于没有再入院的事件,平均费用为43,404.81美元。每位患者肝移植的平均总费用为328,336.60美元。每位患者因移植住院的平均费用最高(226,908.70美元)。结论:这项综合成本分析显示了PBC疾病进展的高成本负担。适当的患者管理可能有助于减轻与pbc相关的肝代偿和肝移植的经济负担。
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引用次数: 0
Treatment burden and healthcare resource utilization in patients with chronic rhinosinusitis with nasal polyps who did or did not undergo functional endoscopic sinus surgery: a US real-world retrospective cohort study. 接受或未接受功能性内窥镜鼻窦手术的慢性鼻窦炎鼻息肉患者的治疗负担和医疗资源利用:一项美国现实世界回顾性队列研究
IF 2.5 4区 医学 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2026-02-11 DOI: 10.57264/cer-2025-0065
Danielle L Isaman, Mark Corbett, Stella E Lee, Anju T Peters, Peter H Hwang, Sietze Reitsma, Natalia Petruski-Ivleva, Scott Nash, Juby A Jacob-Nara

Aim: To compare oral corticosteroid (OCS) burden and healthcare resource utilization (HCRU) in patients with chronic rhinosinusitis with nasal polyps undergoing functional endoscopic sinus surgery (FESS; intervention) versus not undergoing FESS. Materials & methods: Retrospective cohort study using US claims data (Optum's de-identified Clinformatics® Data Mart Database; 2011-2021). Groups were propensity score (PS) matched to adjust for confounding. OCS burden (cumulative dose in mg prednisone equivalents) and HCRU were assessed during baseline (365 days pre-index), intervention (days 0-44), and follow-up (days 45-365); costs during intervention and follow-up. Results: Before PS-matching, both groups had substantial comorbidity burden (>50% allergic rhinitis; >25% asthma) and over half of patients had used OCS (65% [FESS] vs 52% [non-FESS]; p < 0.01). After PS-matching (n = 8909 per group), OCS cumulative dose during follow-up was 18% lower among FESS versus non-FESS patients (mean difference: -40 mg per patient [95% CI: -57, -23; p < 0.01]). Similar proportions of patients filled OCS prescriptions during follow-up (35% [FESS], 36% [non-FESS]) and in these patients, OCS burden remained high (mean [SD] cumulative dose 521 [786] vs 612 [906] mg, respectively). Mean total healthcare costs per patient during the intervention period were $28,832 (FESS) and $2537 (non-FESS), but similar during follow-up ($15,659 and $15,926, respectively). HCRU was similar in follow-up, except more FESS patients visited an otolaryngologist (57% vs 32%, p < 0.01). Conclusion: In US clinical practice, OCS burden in patients with chronic rhinosinusitis with nasal polyps was significantly lower but remained substantial following FESS, and HCRU and costs during follow-up were similar to matched patients without FESS.

目的:比较慢性鼻窦炎合并鼻息肉患者接受功能性内窥镜鼻窦手术(FESS;干预)与未接受FESS的口服皮质类固醇(OCS)负担和医疗资源利用率(HCRU)。材料和方法:回顾性队列研究,使用美国索赔数据(Optum的去识别Clinformatics®数据集市数据库;2011-2021)。各组进行倾向评分(PS)匹配以校正混杂。在基线(指数前365天)、干预(0-44天)和随访(45-365天)期间评估OCS负担(以毫克强的松当量计的累积剂量)和HCRU;干预和随访期间的费用。结果:在ps配型前,两组患者的合并症负担均较重(bbb50 %过敏性鼻炎;>25%哮喘),超过一半的患者使用过OCS (65% [FESS] vs 52%[非FESS]); p结论:在美国临床实践中,慢性鼻窦炎合并鼻息肉患者的OCS负担显著降低,但在FESS后仍很重,随访期间的HCRU和费用与未配型FESS患者相似。
{"title":"Treatment burden and healthcare resource utilization in patients with chronic rhinosinusitis with nasal polyps who did or did not undergo functional endoscopic sinus surgery: a US real-world retrospective cohort study.","authors":"Danielle L Isaman, Mark Corbett, Stella E Lee, Anju T Peters, Peter H Hwang, Sietze Reitsma, Natalia Petruski-Ivleva, Scott Nash, Juby A Jacob-Nara","doi":"10.57264/cer-2025-0065","DOIUrl":"https://doi.org/10.57264/cer-2025-0065","url":null,"abstract":"<p><p><b>Aim:</b> To compare oral corticosteroid (OCS) burden and healthcare resource utilization (HCRU) in patients with chronic rhinosinusitis with nasal polyps undergoing functional endoscopic sinus surgery (FESS; intervention) versus not undergoing FESS. <b>Materials & methods:</b> Retrospective cohort study using US claims data (Optum's de-identified Clinformatics<sup>®</sup> Data Mart Database; 2011-2021). Groups were propensity score (PS) matched to adjust for confounding. OCS burden (cumulative dose in mg prednisone equivalents) and HCRU were assessed during baseline (365 days pre-index), intervention (days 0-44), and follow-up (days 45-365); costs during intervention and follow-up. <b>Results:</b> Before PS-matching, both groups had substantial comorbidity burden (>50% allergic rhinitis; >25% asthma) and over half of patients had used OCS (65% [FESS] vs 52% [non-FESS]; p < 0.01). After PS-matching (n = 8909 per group), OCS cumulative dose during follow-up was 18% lower among FESS versus non-FESS patients (mean difference: -40 mg per patient [95% CI: -57, -23; p < 0.01]). Similar proportions of patients filled OCS prescriptions during follow-up (35% [FESS], 36% [non-FESS]) and in these patients, OCS burden remained high (mean [SD] cumulative dose 521 [786] vs 612 [906] mg, respectively). Mean total healthcare costs per patient during the intervention period were $28,832 (FESS) and $2537 (non-FESS), but similar during follow-up ($15,659 and $15,926, respectively). HCRU was similar in follow-up, except more FESS patients visited an otolaryngologist (57% vs 32%, p < 0.01). <b>Conclusion:</b> In US clinical practice, OCS burden in patients with chronic rhinosinusitis with nasal polyps was significantly lower but remained substantial following FESS, and HCRU and costs during follow-up were similar to matched patients without FESS.</p>","PeriodicalId":15539,"journal":{"name":"Journal of comparative effectiveness research","volume":" ","pages":"e250065"},"PeriodicalIF":2.5,"publicationDate":"2026-02-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146157266","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
R WE ready for reimbursement? A round-up of developments in real-world evidence relating to health technology assessment: part 24. 我们准备好报销了吗?与卫生技术评估有关的真实世界证据发展综述:第24部分。
IF 2.5 4区 医学 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2026-02-09 DOI: 10.57264/cer-2026-0019
Paul Arora, Sreeram V Ramagopalan

In this update, we review a new bias appraisal tool, explore lessons from a trial emulation study, and describe the development of real-world evidence guidance in the Philippines.

在本期更新中,我们回顾了一种新的偏见评估工具,探讨了一项试验模拟研究的经验教训,并描述了菲律宾现实世界证据指南的发展。
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引用次数: 0
Acthar Gel versus standard of care for adults with proteinuria in nephrotic syndrome due to focal segmental glomerulosclerosis: cost-per-response analysis from the US healthcare perspective. Acthar凝胶与标准护理对局灶节段性肾小球硬化所致肾病综合征的蛋白尿成人:从美国医疗保健角度的每反应成本分析
IF 2.5 4区 医学 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2026-02-01 Epub Date: 2026-01-28 DOI: 10.57264/cer-2025-0155
Jas Bindra, Ishveen Chopra, Kyle Hayes, John Niewoehner, Mary Panaccio, George J Wan

Aim: Proteinuria poses a significant challenge in focal segmental glomerulosclerosis (FSGS), particularly when resistant to standard treatments. Acthar® Gel, a Food and Drug Administration (FDA)-approved treatment, may be a potential option for proteinuria in nephrotic syndrome (NS) due to FSGS, particularly given the limited alternative therapies. This study assessed the cost-per-response of Acthar Gel versus standard of care (SoC) for the treatment of refractory proteinuria in NS due to FSGS among adults from a US healthcare payer perspective over a 1- to 3-year horizon. Materials & methods: A probabilistic, cohort-based state-transition model tracked adults with nephrotic-range proteinuria due to FSGS through clinically relevant health states in 6-month cycles. All patients entered in relapse and received either Acthar Gel or SoC. At each cycle, individuals could transition to response or remain uncontrolled, progress to renal failure, or continue in relapse; death was permitted from any state. Responders were allowed to either sustain response or experience relapse in subsequent cycles. Model inputs for clinical event rates, healthcare utilization and medical costs were sourced from the published literature, and drug costs were valued using wholesale acquisition cost. Cost-per-response was defined as total healthcare costs (drug and nondrug medical costs) per patient divided by the response rate. Results: Acthar Gel showed a lower cost-per-response ($469,735) versus cyclophosphamide ($2,140,400) and rituximab ($1,272,477) over 1 year. This advantage for Acthar Gel was sustained for 2 and 3 years. Acthar Gel was potentially a dominant treatment option at 2 and 3 years, with a lower overall cost of care and higher response rates than SoC. Conclusion: From a US healthcare payer perspective, Acthar Gel appears to be a cost-effective, value-based treatment option for adults with proteinuria in NS due to FSGS over 1 to 3 years. These findings may aid providers and payers in making informed treatment decisions when conventional therapies are ineffective for these patients.

目的:蛋白尿是局灶节段性肾小球硬化(FSGS)的重要挑战,特别是当对标准治疗有耐药性时。Acthar凝胶是美国食品和药物管理局(FDA)批准的治疗药物,可能是治疗FSGS引起的肾病综合征(NS)蛋白尿的潜在选择,特别是考虑到有限的替代疗法。本研究评估了Acthar凝胶与标准护理(SoC)治疗成人FSGS引起的难治性蛋白尿的每效成本,从美国医疗保健支付者的角度来看,时间跨度为1- 3年。材料与方法:一个基于队列的概率状态转换模型追踪了6个月周期内由FSGS引起的肾范围蛋白尿成人的临床相关健康状态。所有患者均进入复发期,接受Acthar凝胶或SoC治疗。在每个周期,个体可以过渡到反应或保持不受控制,进展到肾功能衰竭,或继续复发;任何州都允许死亡。应答者被允许维持应答或在随后的周期中经历复发。临床事件率、医疗保健利用和医疗费用的模型输入来自已发表的文献,药品成本使用批发获取成本来评估。每次响应成本定义为每位患者的总医疗保健成本(药物和非药物医疗成本)除以响应率。结果:与环磷酰胺(2140400美元)和利妥昔单抗(1272477美元)相比,Acthar凝胶在1年内显示出更低的单效成本(469735美元)。Acthar凝胶的这种优势持续了2到3年。Acthar凝胶可能是2年和3年的主要治疗选择,与SoC相比,其总体护理成本更低,反应率更高。结论:从美国医疗保健支付者的角度来看,Acthar凝胶似乎是一种具有成本效益的、基于价值的治疗选择,适用于1至3年以上因FSGS导致的成人NS蛋白尿。当传统疗法对这些患者无效时,这些发现可能有助于提供者和支付者做出明智的治疗决定。
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引用次数: 0
The importance and challenge of comparing stroke care, utilization and outcomes in Medicare Advantage and Fee-for-Service Medicare: a narrative review and vision for the future. 比较医疗保险优势和按服务收费的医疗保险中风治疗、利用和结果的重要性和挑战:叙述回顾和对未来的展望。
IF 2.5 4区 医学 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2026-02-01 Epub Date: 2026-01-12 DOI: 10.57264/cer-2025-0157
Emily J Bian, Priyanka Menon, Kathleen A McManus, Timothy J Layton, Bradford B Worrall, Jonathan R Crowe

Stroke prevalence is highest in adults ≥65 years, the majority of whom are Medicare beneficiaries. Fee-for-Service Medicare (FFS) incentivizes utilization by paying for each service. Medicare Advantage (MA) uses capitated payments to reduce overutilization. It is not clear if stroke patients with FFS or MA receive different stroke preventive care and whether those differences are associated with differences in post-acute care utilization, cost and clinical outcomes. We performed an empirical narrative review of published peer-reviewed studies in the PubMed, EMBASE and Web of Science databases comparing stroke preventive care between FFS and MA using the American Heart Association's Life's Essential 8 and American Heart Association/American Stroke Association national guidelines. We added atrial fibrillation (AF), post-acute care utilization and outcomes, including mortality. 7/1356 studies met inclusion criteria. Studies were heterogenous in their design and settings. There was limited availability of clinical data. Within those limitations, published studies suggest that MA appears to allow for guideline-directed stroke preventive care for hyperlipidemia, smoking cessation and AF in specific study populations. Post-acute care utilization was generally lower in MA. Functional outcomes improvements were similar but occurred in fewer days in MA, though the absence of acute stroke treatment data is notable. Mortality data were mixed. Given the importance of stroke in Medicare and the growth in MA enrollment, comparing the effectiveness of MA and FFS warrants further study among appropriately matched MA and FFS beneficiaries with stroke.

中风患病率在≥65岁的成年人中最高,其中大多数是医疗保险受益人。按服务收费的医疗保险(FFS)通过为每项服务付费来激励使用。医疗保险优势(MA)使用资本化支付来减少过度使用。目前尚不清楚FFS或MA脑卒中患者是否接受不同的脑卒中预防护理,以及这些差异是否与急性后护理利用、成本和临床结果的差异有关。我们对PubMed、EMBASE和Web of Science数据库中发表的同行评议研究进行了实证叙述性回顾,使用美国心脏协会的生命基本8和美国心脏协会/美国中风协会国家指南,比较FFS和MA之间的卒中预防护理。我们增加了心房颤动(AF)、急性后护理利用和结果,包括死亡率。7/1356项研究符合纳入标准。研究在设计和设置上是异质的。临床资料的可用性有限。在这些限制范围内,已发表的研究表明,MA似乎允许在特定研究人群中针对高脂血症、戒烟和房颤进行指导性卒中预防护理。急性期后护理使用率普遍较低。功能结果的改善与MA相似,但在更短的时间内发生,尽管缺乏急性卒中治疗数据值得注意。死亡率数据是混合的。鉴于卒中在医疗保险中的重要性和MA入组人数的增长,比较MA和FFS的有效性值得在适当匹配的卒中MA和FFS受益人中进一步研究。
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引用次数: 0
Sieving for gold: external comparator studies to prioritize drugs for late-stage clinical trial. 筛选黄金:外部比较研究优先考虑晚期临床试验的药物。
IF 2.5 4区 医学 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2026-02-01 Epub Date: 2026-02-03 DOI: 10.57264/cer-2024-0201
Samuel Vennin, Will Sopwith, Emiliano Calvo, Chiara Cantoni, Paula Cárdenes Del Valle, Benedikt Maissenhaelter, Gerd Rippin, Bettina Ryll, Bruno Osterwalder

External comparator (EC) studies can improve identification of compounds with the most promising performance in pre-pivotal single-arm trials (SAT). As SAT output lacks comparative insights, EC studies allow efficient contextualization of compound performance in early phases of drug development. Improving insights from pre-pivotal SATs allows more informed prioritization of compounds and investment choices and enables faster and more substantiated development of the most promising molecules to the benefit of patients. The extensive digitization of healthcare information routinely generated during patient treatment journeys makes EC studies using real-world data an attractive alternative to other approaches (such as systematic literature review and repurposed trial data). Using oncology as an illustration, this paper presents how real-world data EC studies can address some of the fundamental challenges the pharmaceutical sector faces in developing novel therapies, and especially those pertaining to emerging biopharma companies.

外部比较器(EC)研究可以提高在关键前单臂试验(SAT)中最有希望的化合物的鉴定。由于SAT输出缺乏可比性见解,EC研究允许在药物开发的早期阶段对化合物性能进行有效的背景化。从关键前SATs中获得的洞察力可以使化合物和投资选择的优先级更明智,并使最有希望的分子的开发更快,更有根据,从而使患者受益。在患者治疗过程中常规产生的医疗保健信息的广泛数字化使得使用真实世界数据的EC研究成为其他方法(如系统文献综述和重新利用的试验数据)的有吸引力的替代方法。本文以肿瘤学为例,介绍了现实世界数据EC研究如何解决制药行业在开发新疗法时面临的一些基本挑战,特别是那些与新兴生物制药公司有关的挑战。
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引用次数: 0
Difference in hospital readmission among patients with atrial fibrillation undergoing ablation using nonintegrated pulsed field catheter with CARTO™ 3 versus EnSite™ electroanatomical mapping system. 使用CARTO™3非集成脉冲场导管与EnSite™电解剖定位系统消融房颤患者再入院的差异
IF 2.5 4区 医学 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2026-02-01 Epub Date: 2026-01-08 DOI: 10.57264/cer-2025-0151
Alexandru I Costea, Rahul Khanna, Maximiliano Iglesias, Yiran Rong

Aim: Pulsed field ablation (PFA) is a minimally thermal alternative to traditional thermal catheter ablation for atrial fibrillation (AF), with comparable efficacy and minimal risk of collateral tissue injury. Three-dimensional (3D) electroanatomical mapping systems have been adopted with nonintegrated PFA catheters to improve precision and procedural efficiency. This study compared arrhythmia-related hospital readmissions and procedure-related complications among patients with AF treated with PFA, using either the CARTO™ 3 or EnSite™ electroanatomical mapping system. Materials & methods: Patients who underwent PFA for AF using nonintegrated pulsed field catheters with either CARTO 3 or EnSite were identified from the 2023-2024 Premier Healthcare Database (PHD). The primary outcome was 30-day inpatient readmission and emergency room (ER) visit for AF/atrial flutter (AFL)/atrial tachycardia following the index PFA procedure. Secondary outcomes included 30-day cardiovascular-related readmissions and procedure-related complications. Cohorts were balanced using inverse probability of treatment weighting. Descriptive analyses and a weighted Generalized Estimating Equation (GEE) model were used to assess differences in outcomes between groups. Results: A total of 2894 patients were treated using CARTO 3 and 2015 using EnSite. After weighting, patient and hospital characteristics were well balanced across cohorts. The CARTO 3 group was significantly less likely to experience AF/AFL/atrial tachycardia-related readmissions (0.3% vs 0.9%, chi-square p = 0.023; odds ratio [OR], 0.39; 95% CI, 0.17-0.90, GEE p = 0.028) and a composite outcome of AF/AFL/atrial tachycardia-related inpatient readmission or ER visits (0.5% vs 1.1%, chi-square p = 0.020; OR: 0.44, 95% CI: 0.21-0.89, GEE p = 0.023) within 30 days of PFA procedure than the EnSite group. No differences were observed in cardiovascular-related readmission or complications. Conclusion: In this retrospective, real-world study, patients with AF who underwent PFA using CARTO 3 had lower 30-day AF/AFL/atrial tachycardia-related readmissions rates than those treated with EnSite suggesting that choice of mapping system may influence early AF outcomes and could translate into reduced downstream hospitalizations and resource use.

目的:脉冲场消融(PFA)是传统热导管消融治疗心房颤动(AF)的最小热替代方法,具有相当的疗效和最小的侧支组织损伤风险。三维电解剖定位系统已被应用于非集成PFA导管,以提高精度和操作效率。本研究使用CARTO™3或EnSite™电解剖定位系统,比较了接受PFA治疗的房颤患者心律失常相关的再入院率和手术相关的并发症。材料和方法:从2023-2024年Premier Healthcare Database (PHD)中确定使用CARTO 3或EnSite非整合脉冲场导管进行房颤PFA的患者。主要终点是在指数PFA手术后因房颤/心房扑动(AFL)/房性心动过速再次住院30天和急诊室(ER)就诊。次要结局包括30天心血管相关再入院和手术相关并发症。使用治疗加权逆概率来平衡队列。描述性分析和加权广义估计方程(GEE)模型用于评估组间结果的差异。结果:CARTO 3治疗2894例,EnSite治疗2015例。加权后,患者和医院的特征在队列中得到了很好的平衡。与EnSite组相比,CARTO 3组在PFA术后30天内AF/AFL/房性心动过速相关再入院(0.3% vs 0.9%,卡方p = 0.023;优势比[OR], 0.39; 95% CI, 0.17-0.90, GEE p = 0.028)和AF/AFL/房性心动过速相关住院再入院或急诊就诊的综合结局(0.5% vs 1.1%,卡方p = 0.020; OR: 0.44, 95% CI: 0.21-0.89, GEE p = 0.023)的可能性显著降低。在心血管相关的再入院或并发症方面没有观察到差异。结论:在这项现实世界的回顾性研究中,使用CARTO - 3进行PFA治疗的房颤患者比使用EnSite治疗的房颤患者有更低的30天房颤/AFL/房性心动过速相关再入院率,这表明选择绘图系统可能会影响房颤的早期结局,并可能转化为减少后续住院和资源使用。
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Journal of comparative effectiveness research
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