《比较有效性研究杂志》为辩论、新发现和研究方法的展示提供了一个快速出版平台。通过严格的评估和全面的报道，《比较有效性研究杂志》为利益相关者（包括患者、临床医生、医疗保健购买者和卫生政策制定者）​​掌握关键数据和意见，以便就临床实践做出明智和具体的决定。

The Journal of Comparative Effectiveness Research provides a rapid publication platform for the discussion of debates, new findings, and research methodologies. Through rigorous evaluation and comprehensive reporting, the journal assists stakeholders—including patients, clinicians, healthcare purchasers, and health policymakers—in grasping key data and insights to make informed and specific decisions in clinical practice.

《比较有效性研究杂志》为辩论、新发现和研究方法的展示提供了一个快速出版平台。通过严格的评估和全面的报道，该杂志帮助利益相关者（包括患者、临床医生、医疗保健购买者和卫生政策制定者）掌握关键数据和观点，以便在临床实践中做出明智和具体的决策。

Journal of Comparative Effectiveness Research

Aim: This study evaluated the occurrence and associated costs of pacemaker complications in Germany from 2010 to 2013. Patients & methods: Patients with a de novo or replacement implantation of a single or dual chamber pacemaker between 2010 and 2013 were followed for 12 months post-implant using German health insurance claims data. A case-control analysis was performed using propensity score matching to estimate the costs of complications. Results: Out of 12,922 implanted patients, 12.0% had a complication in the year following the implant. Complications related to lead and pocket were found in 10.2% of all implanted patients; infections occurred in 1.7% patients. Healthcare costs up to 36 months post complication were on average €4627 higher than for pacemaker patients without a complication. Conclusion: Pacemaker complications are common and represent a burden for patients and healthcare systems generating substantial costs. Most of the pacemaker complications involved the pacing lead or pacemaker pocket.

Saskia Ludwig

Cathrin Theis

Claudia Wolff

Emmanuelle Nicolle

Andreas Witthohn

Andreas Götte

Complications and associated healthcare costs of transvenous cardiac pacemakers in Germany

德国经静脉心脏起搏器的并发症及相关医疗费用

Aim: Radiofrequency (RF) catheter ablation (CA) is a mainstay treatment for atrial fibrillation (AF). RF catheters with contact force (CF) sensing technology and electroanatomical mapping systems enable real-time assessment of catheter tip-tissue interface CF, facilitating individualized and precise CA. This study examined inpatient hospital readmissions in patients with AF treated with THERMOCOOL™ ST/ THERMOCOOL™ STSF catheter with the CARTO™ 3 System versus TactiCath™ catheter with the EnSite™ System. Materials &amp; methods: Patients undergoing CA for AF between 1 July 2019 to 30 November 2021 were identified from the Premier Healthcare Database and grouped based on use of THERMOCOOL ST/STSF or TactiCath™. Study outcomes were all-cause, cardiovascular (CV)-, and AF-related inpatient readmission at 91–365-day post-CA. Inverse probability of treatment weighting of propensity scores balanced baseline patient, comorbidity and hospital characteristics. A weighted generalized estimating equation (GEE) model examined differences in readmission outcomes. Results: A total of 15,518 patients met inclusion criteria (THERMOCOOL ST/STSF, n = 13,001; TactiCath™, n = 2517). Patient characteristics were generally well-balanced after weighting. Patients treated with THERMOCOOL ST/STSF + CARTO 3 had a 20% lower likelihood of all-cause inpatient readmissions (7.8 vs 9.3%, chi-square p = 0.041; odds ratio [OR]: 0.80, 95% confidence interval [CI]: 0.66–0.96, GEE p = 0.019) and a 21% lower likelihood of CV-related inpatient readmission (5.2 vs 6.2%, chi-square p = 0.133, OR: 0.79, 95% CI: 0.62–0.99, GEE p = 0.043) in 91–365-days post-CA versus those treated with TactiCath™ + Ensite. No significant differences were observed for AF-related readmissions. Conclusion: Patients undergoing CA for AF treated with THERMOCOOL ST/STSF + CARTO 3 had a significantly lower risk of all-cause and CV-related inpatient hospital readmission versus those treated with TactiCath™ + Ensite.

Alexandru I Costea

Rahul Khanna

Maximiliano Iglesias

Yiran Rong

Hospital readmissions following catheter ablation for atrial fibrillation with THERMOCOOL™ STSF/ THERMOCOOL™ ST catheter with CARTO™ 3 system versus TactiCath™ catheter with EnSite™ system

使用CARTO™ 3系统的THERMOCOOL™ STSF/THERMOCOOL™ ST导管与使用EnSite™系统的TactiCath™导管进行房颤消融后的医院再入院情况

Adaptive designs are frequently used in drug randomized controlled trials (RCTs). However, their use in medical device RCTs remains unclear. We aimed to characterize medical device RCTs with adaptive designs.

Gui Su

Dan Shen

Dongyuan Deng

Qianqian Bai

Hui Xie

Characterization of medical device randomized controlled trials with adaptive designs

医疗器械随机对照试验适应性设计的特征分析

Aim: To understand the impact of the niraparib individualized starting dose (ISD), compared with fixed starting dose (FSD), on the cost of hematologic adverse event (AE) management from a US payer perspective. Methods: The frequencies of grade ≥3 hematologic AEs that occurred in &gt;1% of patients treated with niraparib were obtained from the primary analysis results of the phase III PRIMA/ENGOT-OV26/GOG-3012 trial. US unit costs for each grade ≥3 AE in the base case were obtained from the 2017 Agency for Healthcare Research and Quality Healthcare Cost and Utilization Project database; unit costs were adjusted to 2020 US dollars. AE management costs per patient were calculated by multiplying AE unit cost by the frequency of each AE by niraparib starting dose. Because AEs were assumed to occur independently of one another, costs were added to derive the total cost. Results: For niraparib, the estimated AE management cost per patient was lower for the ISD than the FSD for all hematologic AEs (FSD vs ISD: thrombocytopenia, $4701.87 vs $1921.89; anemia, $2784.00 vs $1760.59; platelet count decreased, $2103.47 vs $922.51; neutropenia, $2112.50 vs $1369.56; neutrophil count decreased, $1285.87 vs $770.38). The total mean calculated AE management cost per patient was $12,987.71 with the FSD and $6744.93 with the ISD. Conclusion: For niraparib, the cost of managing hematologic AEs in the US was reduced by almost half with the ISD compared with the FSD. The cost reduction and improvements in safety associated with the niraparib ISD support its use in clinical practice.

Whitney S Graybill

Ignace Vergote

Bhavana Pothuri

Maarit Anttila

David M O'Malley

Domenica Lorusso

Ashley F Haggerty

Michel Fabbro

John K Chan

Florian Heitz

Lyndsay J Willmott

Ilan Bruchim

Ying Zhuo

Purificación Estévez-García

Bradley J Monk

Hannelore Denys

Anja Knudsen

Anna V Tinker

Luis Manso Sánchez

Diane Provencher

Maria Pilar Barretina-Ginesta

John Hartman

Donna V Booth

Antonio González-Martín

Use of individualized starting dose and niraparib hematologic adverse event management costs in ovarian cancer

卵巢癌中个性化起始剂量及尼拉帕利血液学不良事件管理成本的应用

In this update, we discuss a position statement from the National Institute of Health and Care Excellence (NICE) on the use of artificial intelligence for evidence generation and publications reviewing the use of real-world data as external control arms. Finally, we discuss a number of recent studies investigating the real-world effectiveness of glucagon-like peptide-1 receptor agonists and whether these studies are informative for reimbursement decision making.

Paul Arora

Sreeram V Ramagopalan

R WE ready for reimbursement? A round up of developments in real-world evidence relating to health technology assessment: part 17

现实世界证据在卫生技术评估中的应用进展综述：第17部分

Aim: Percutaneous transluminal angioplasty (PTA) for peripheral artery disease (PAD) commonly leads to dissections which are associated with higher target lesion revascularization (TLR) rates. Clinical and economic consequences of dissection management in the femoropopliteal artery following PTA, and specifically the potential economic benefit of focal dissection repair using the novel Tack Endovascular System, remain unknown. Methods: A decision-analytic model was used to estimate 24-month clinical events, costs and quality-adjusted life year (QALY) gain for a Tack-supported versus status-quo PTA strategy. Patient and lesion characteristics and TLR rates were derived from the PTA cohort of the TOBA II clinical trial, an observational cohort, and literature. Cost–effectiveness was determined from a US payer and provider perspective separately for the non-severe (grade A or B), severe (grade C and higher) and the entire dissection cohort. Results: TLR rates were lower for the Tack-supported strategy compared with PTA (7.7 vs 27.4% in the non-severe, 13.9 vs 25.8% in the severe and 12.0 vs 26.3% in the entire dissection cohort). Cost and QALY differences were +$297/ + 0.0110 in the non-severe dissection cohort and -$1602/ + 0.0067 in the severe dissection cohort, resulting in an incremental cost–effectiveness ratio (ICER) of $25,622 in the non-severe cohort and dominance in the severe cohort and the entire cohort. Conclusion: Compared with a ‘status-quo’ approach, proactive focal stenting may lead to fewer reinterventions and improved quality of life. There appears to be a graded economic benefit of focal dissection treatment, being cost-effective in non-severe dissections and even cost saving in severe dissections.

Jan B Pietzsch

Benjamin P Geisler

Abigail M Garner

Anne M Ryschon

William A Gray

Masahiko Fujihara

Peter A Schneider

Clinical and economic implications of focal dissection treatment following percutaneous transluminal angioplasty of the superficial femoral artery: an exploratory analysis based on the TOBA II Study

浅表股动脉经皮腔内血管成形术后局部解剖治疗的临床和经济意义：基于TOBA II研究的探索性分析

Aim: Vaginitis and other vaginal discharge syndromes lead to high healthcare utilization. Molecular tests like syndromic multiplex real-time (RT) polymerase chain reaction (PCR)-based tests are highly sensitive and specific at diagnosing the infectious causes of vaginitis. This study compared the healthcare resource utilization (HCRU) and direct all-cause healthcare costs among patients with vaginitis in the US receiving next-day syndromic multiplex RT-PCR tests with those receiving other PCR tests or no diagnostic test of interest. Patients &amp; methods: This retrospective study utilized claims data from IQVIA PharMetrics ® Plus database to identify adult patients with a diagnosis for vaginitis (first claim = index) from January 2021 to April 2023, with 6 months of continuous enrollment prior to (baseline) and after index (follow-up). Pairwise comparisons were conducted between RT-PCR and 1:1 propensity matched Other PCR and No Test subcohorts for all-cause HCRU and costs during follow-up. Results: Each of the RT-PCR, Other PCR and No Test subcohorts included 1946 matched patients. Mean(SD) follow-up total cost was significantly lower for the RT-PCR than the No Test subcohort ($5607 [$15,122] vs $6680 [$20,751], p = 0.0023). Mean(SD) overall outpatient and other medical service costs were lower for RT-PCR versus Other PCR (outpatient: $2964 [$9666] vs $3174 [$7113], p = 0.0110; other medical: $1961 [$9244] vs $2099 [$6475], p = 0.0002) and No Test subcohorts (outpatient: $2964 [$9666] vs $4067 [$12,341], p &lt; 0.0001; other medical: $1961 [$9244] vs $2973 [$11,685]; p &lt; 0.0001). A lower proportion had any outpatient service HCRU in RT-PCR versus Other PCR subcohort (92.6% vs 94.2%, p = 0.0349). A lower proportion had any other medical service claim in RT-PCR versus Other PCR (78.3% vs 83.2%, p &lt; 0.0001) and No Test subcohorts (78.3% vs 83.0%, p = 0.0001). Physician office, emergency room (ER), prescription use and costs were similar between the subcohorts. Conclusion: The use of syndromic multiplex RT-PCR diagnostics with next day test results in patients with vaginitis was associated with lower outpatient costs and total healthcare costs than those in the no test cohort over 6 months. These findings indicate that use of syndromic multiplex RT-PCR diagnostics may contribute to improved patient management compared with clinical diagnosis alone.

Azia Evans

Riddhi Doshi

Jason Yeaw

Katharine Coyle

Steven Goldberg

Elizabeth Wang

Maren S Fragala

Jairus Reddy

Healthcare utilization and costs following molecular diagnostic testing among patients with vaginitis

阴道炎患者分子诊断检测后的医疗利用与成本

Abbreviation	J. Comp. Eff. Res.
Journal Impact	1.85
Quartiles(Global)	HEALTH CARE SCIENCES & SERVICES(Q3)

ISSN	2042-6305, 2042-6313
h-index	34

Publication Information	Publisher: Becaris Publishing Ltd，Publishing cycle: ，Journal Type: journal，Open Access Journals: No
Basic data	Year of publication: 2012，Proportion of original research papers: 82.57%，Self Citation Rate:10.50%， Gold OA Rate: 46.89%

Journal of Comparative Effectiveness Research

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Complications and associated healthcare costs of transvenous cardiac pacemakers in Germany

Hospital readmissions following catheter ablation for atrial fibrillation with THERMOCOOL™ STSF/ THERMOCOOL™ ST catheter with CARTO™ 3 system versus TactiCath™ catheter with EnSite™ system

Characterization of medical device randomized controlled trials with adaptive designs

Use of individualized starting dose and niraparib hematologic adverse event management costs in ovarian cancer

R WE ready for reimbursement? A round up of developments in real-world evidence relating to health technology assessment: part 17

Hospital readmissions following catheter ablation for atrial fibrillation with THERMOCOOL™ STSF/ THERMOCOOL™ ST catheter with CARTO™ 3 system versus TactiCath™ catheter with EnSite™ system

Characterization of medical device randomized controlled trials with adaptive designs

Use of individualized starting dose and niraparib hematologic adverse event management costs in ovarian cancer

Clinical and economic implications of focal dissection treatment following percutaneous transluminal angioplasty of the superficial femoral artery: an exploratory analysis based on the TOBA II Study

Healthcare utilization and costs following molecular diagnostic testing among patients with vaginitis