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Health Economics and Outcomes Research in Medical Device

Cost Effectiveness and Resource Allocation is delighted to publish a thematic series on ‘Health economics and outcomes research in medical devices’.

Outcomes research for medical devices has always lagged behind drugs, with good reason. Regulatory and reimbursement initiatives for medical devices will spur higher demand for high quality data, which will translate to better quality outcomes research in medical devices. For example, the FDA has recently published several guidance documents/frameworks pertaining to the use of Real-World Evidence (RWE) to support regulatory decision-making for drugs, biologics, and medical devices. While RWE is increasingly used for drugs and biologics, there may be some unique challenges to generate RWE, specifically for medical devices. This in turn, creates potential barriers towards the broader utilization of RWE for medical devices. Additionally, the diversity of methodological issues associated with the conduct of outcomes research under the umbrella of medical devices, with products ranging from diagnostics to implantable devices, makes it difficult to develop a unifying set of standards for the industry., As a result, there is an urgent need to explore the opportunities and challenges of a wide range of health outcomes research in medical devices from the perspectives of all relevant stakeholders. If we are to realize the full promise of outcomes research in medical devices, we must address the unmet needs in health care where the utilization of medical devices can positively impact on quality, access, and cost.  

With this thematic series, we invite you to submit high-quality original research articles or reviews that provide solid new findings extending the current state of knowledge. Preference will be given to contributions using longitudinal data such as electronic health records, claims, and patient-reported outcomes. All manuscripts will undergo the journal’s normal peer review process and be subject to an article-processing charge. Manuscripts should be formatted according to our submission guidelines and submitted via the online submission system. In the submission system please make sure that the correct collection title is chosen from the drop down list on the 'details' tab. Please also indicate clearly in the covering letter that the manuscript is to be considered for this collection. This series is currently open to new submissions. This series is now closed to new submissions.  

Edited by Lizheng Shi and Mihajlo Jakovljevic

In the last five years, Lizheng Shi received research funding from the Patient-Centered Outcomes Research, Centers for Disease Control and Prevention, National Institute of Health,  China Medical Board, Louisiana Department of Health, and Industry (Argenx, Astra Zeneca, BioMarin,  Chiasma, Eli Lilly, Genentech, Intuitive Surgical, Johnson and Johnson, Sanofi, and Takeda). Lizheng Shi is one of the co-owners of the BRAVO4HEALTH, LLC, which owns a pending patient of BRAVO diabetes risk equations and simulation model. 

Mihajlo (Michael) Jakovljevic received research funding from the Japanese Society for Promotion of Science  (JSPS), or Gakushin ; Swedish FORTE government funding agency under the Swedish Ministry of Health and Social Affairs ; European Commission and diverse national science funding agencies across Europe without Conflict of Interests issues related to this thematic series.

  1. Although economic evaluations (EEs) have been increasingly applied to medical devices, little discussion has been conducted on how the different health realities of specific populations may impact the applicat...

    Authors: Edgar Mascarenhas, Luís Silva Miguel, Mónica D Oliveira and Ricardo M Fernandes
    Citation: Cost Effectiveness and Resource Allocation 2024 22:33
  2. The medical pricing system strongly influences physicians’ job satisfaction and patient health outcomes. This study aimed to investigate the current relative value unit (RVU)-based pricing and utility of patie...

    Authors: Yoon Hyo Choi, Tae Hun Kwon, Chin Youb Chung, Naun Jeong and Kyoung Min Lee
    Citation: Cost Effectiveness and Resource Allocation 2024 22:27
  3. The prominent efficacy in terms of increasing progression-free survival (PFS) of Daratumumab, Lenalidomide and dexamethasone (DRd) triplet therapy versus Carfilzomib, Lenalidomide and dexamethasone (KRd) was p...

    Authors: Zahra Goudarzi, Rahil Sadat Shahtaheri, Zhila Najafpour, Haleh Hamedifar and Hamidreza Ebrahimi
    Citation: Cost Effectiveness and Resource Allocation 2024 22:17
  4. Prostate cancer is the second most common cancer in males worldwide and the third most common among Iran’s male population. However, there is a lack of evidence regarding its direct and indirect costs in low a...

    Authors: Farbod Alinezhad, Farhad Khalili, Hossein Zare, Chunling Lu, Zahra Mahmoudi and Mahmood Yousefi
    Citation: Cost Effectiveness and Resource Allocation 2023 21:84
  5. The increasing global prevalence of atrial fibrillation (AF) has led to a growing demand for stroke prevention strategies, resulting in higher healthcare costs. High-quality economic evaluations of stroke prev...

    Authors: Sumudu A. Hewage, Rini Noviyani, David Brain, Pakhi Sharma, William Parsonage, Steven M. McPhail, Adrian Barnett and Sanjeewa Kularatna
    Citation: Cost Effectiveness and Resource Allocation 2023 21:76
  6. The use of peripherally inserted central catheters and midline catheters is growing due to their potential benefits. These devices can increase patient safety and satisfaction while reducing the use of resourc...

    Authors: Laura Ricou Ríos, Candela Esposito Català, Arnau Pons Calsapeu, Cristina Adroher Mas, Isabel Andrés Martínez, Isaac Nuño Ruiz, Mònica Castellà Creus, Laia Castellà Fàbregas, Maria José García Quesada, Oriol Estrada Cuxart, Jordi Ara del Rey and Francesc López Seguí
    Citation: Cost Effectiveness and Resource Allocation 2023 21:67
  7. In an effort to minimize positive margins and subsequent re-excision after breast conserving surgery (BCS), many providers and facilities have implemented either a Full Cavity Shave (FCS) approach or adding th...

    Authors: Richard Gilmore, Jennifer Chen, Robert Dembinski, Yannis Reissis, David Milek, Lisa Cadena and Mehran Habibi
    Citation: Cost Effectiveness and Resource Allocation 2023 21:66
  8. To date, there have been no published studies evaluating the cost-effectiveness of robot-assisted gait training (RAGT) in adolescent and adult patients with cerebral palsy (CP). The study´s aim was to analyse ...

    Authors: Stanislava Klobucká, Robert Klobucký, Katarína Valovičová, Pavol Šiarnik and Branislav Kollár
    Citation: Cost Effectiveness and Resource Allocation 2023 21:60
  9. In Morocco, hospitals do not have cost accounting systems that allow them to produce reliable budget forecasts to know and justify the costs of their operations. Moroccan hospitals are thus among the public or...

    Authors: A. Benabdallah and T. Jellouli
    Citation: Cost Effectiveness and Resource Allocation 2023 21:53
  10. The morbidity and mortality of adult diseases caused by S. pneumoniae increase with age and presence of underlying chronic diseases. Currently, two vaccine technologies against S. pneumoniae are used: the 23-vale...

    Authors: Mikkelsen Malene B, Husby Oyvind, Molden Tor, Mwaura David N, Olsen Jens, Kristensen Nanna V and Vietri Jeffrey
    Citation: Cost Effectiveness and Resource Allocation 2023 21:52
  11. Stereotactic body radiotherapy (SBRT) is a novel radio-therapeutic technique that has recently emerged as standard-of-care treatment for medically inoperable, early-stage non-small cell lung cancer (NSCLC). In...

    Authors: Hui Sun, Huishan Wang, Yan Wei, Haiyin Wang, Chunlin Jin and Yingyao Chen
    Citation: Cost Effectiveness and Resource Allocation 2023 21:46
  12. Ceftazidime avibactam (CA) is an effective treatment against carbapenem-resistant Enterobacteriaceae (CRE), but its cost-effectiveness is unclear. This study was performed to evaluate the cost-effectiveness of...

    Authors: Zahra Goudarzi, Fattaneh Danayi, Khosro Keshavarz and Ahmad Gholami
    Citation: Cost Effectiveness and Resource Allocation 2023 21:45
  13. In Colombia, the best strategy to establish indication for adjuvant chemotherapy in early breast cancer (EBC) remains unknown. This study aimed to identify the cost-utility of Oncotype DX™ (ODX) or Mammaprint™...

    Authors: Leonardo Rojas, María X. Rojas-Reyes, Diego Rosselli, Juan Guillermo Ariza, Alejandro Ruiz-Patiño and Andrés F. Cardona
    Citation: Cost Effectiveness and Resource Allocation 2023 21:42
  14. To estimate and compare the cost-effectiveness of COVID-19 critical care intervention approaches: noninvasive (oxygen without intubation) and invasive (intubation) management in Ethiopia.

    Authors: Senait Alemayehu Beshah, Arega Zeru, Wogayehu Tadele, Atkure Defar, Theodros Getachew and Lelisa Fekadu Assebe
    Citation: Cost Effectiveness and Resource Allocation 2023 21:40
  15. Chronic obstructive pulmonary disease (COPD) is a progressive debilitating condition with frequent exacerbations that have a high burden for patients and society. Digital tools may help to reduce the economic ...

    Authors: Timothy J. Inocencio, Kimberly L. Sterling, Sibel Sayiner, Michael E. Minshall, Leanne Kaye and Umur Hatipoğlu
    Citation: Cost Effectiveness and Resource Allocation 2023 21:36
  16. By evaluating equity and effectiveness, this study provides evidence-based knowledge for scientific decision-making and the optimization of magnetic resonance imaging (MRI) configuration and utilization at the...

    Authors: Xiaoling Huang, Yan Wei, Hui Sun, Jiaqi Huang, Yingyao Chen and Jingliang Cheng
    Citation: Cost Effectiveness and Resource Allocation 2023 21:32
  17. Understanding related risk factors of health-related quality of life (HRQoL) could avoid treatment failure and provide an insight of personalized treatment approach among people living with HIV/AIDS (PLWH). Th...

    Authors: Ming Guan and Hongyi Guan
    Citation: Cost Effectiveness and Resource Allocation 2023 21:25
  18. Hepatocellular carcinoma (HCC) is one of the leading causes of cancer-related death worldwide, especially in China. According to the 2021 Chinese Society of Clinical Oncology guidelines, sorafenib, lenvatinib,...

    Authors: Hongyu Gong, Siew Chin Ong, Fan Li, Zhiying Weng, Keying Zhao and Zhengyou Jiang
    Citation: Cost Effectiveness and Resource Allocation 2023 21:20
  19. Cost-effectiveness analysis plays a key role in evaluating health systems and services. Coronary artery disease is one of the primary health concerns worldwide. This study sought to compare the cost-effectiven...

    Authors: NourolHoda Fakhrzad, Mohsen Barouni, Reza Goudarzi, Javad Kojuri, Yunes Jahani and Mohammad Tasavon Gholamhoseini
    Citation: Cost Effectiveness and Resource Allocation 2023 21:16
  20. Renal cell carcinoma (RCC) is the most common type of kidney cancer. VEGF inhibitors and mTORs are the most common therapeutic options among the different classes of available treatments. In this study, the ef...

    Authors: Zahra Goudarzi, Mehrdad Mostafavi, Mahmood Salesi, Mojtaba Jafari, Iman Mirian, Amir Hashemi Meshkini, Khosro Keshavarz and Younes Ghasemi
    Citation: Cost Effectiveness and Resource Allocation 2023 21:10
  21. This article aims to summarize the development and challenges of real-world data (RWD) and real-world evidence (RWE) in China and introduce a unique opportunity for medical devices to gain accelerated regulato...

    Authors: Jiahe Li, Lichang Liu, Haijun Cao, Mei Yang and Xin Sun
    Citation: Cost Effectiveness and Resource Allocation 2023 21:7
  22. Image-guided system (IGS) has been gradually applied in the field of rhinology, making functional endoscopic sinus surgery (FESS) a truly minimally invasive and precise surgery. This study was based on real-wo...

    Authors: Zaixing Wang, Chunling Liu, Baoying Tan, Guoqing Sun, Poucheok Pang, Kangchen lv, Hui Xie, Xiong Ou, Xianhai Zeng and Jianwei Xuan
    Citation: Cost Effectiveness and Resource Allocation 2023 21:1
  23. Has the medical arms race (MAR) increased healthcare expenditures? Existing literature has yet to draw a consistent conclusion. Hence, this study aims to reexamine the relationship between the MAR and medical ...

    Authors: Paicheng Liu, Xue Gong, Qianhui Yao and Qiong Liu
    Citation: Cost Effectiveness and Resource Allocation 2022 20:73
  24. Surgical lung resection involves a critical task of stapled ligation and transection of major vascular structures and tissue, which may lead to bleeding and complications. A newer powered stapling system with ...

    Authors: Chongzhi Gan, Fuchun Zeng, Wei Cong, Tiange Tang and Gang Feng
    Citation: Cost Effectiveness and Resource Allocation 2022 20:72
  25. An inefficient health system wastes scarce resources even if it makes considerable gains in accountability and equity. Such a system is expected to perform better. Therefore, it is vital to examine the current...

    Authors: Siamak Aghlmand, Sadegh Feizollahzadeh, Behrouz Fathi, Hasan Yusefzadeh and Mina Alinejhad
    Citation: Cost Effectiveness and Resource Allocation 2022 20:65
  26. Health Technology Assessment (HTA) has been widely recognized as informing healthcare decision-making, and interest in HTA of medical devices has been steadily increasing. How does the assessment of medical de...

    Authors: Jian Ming, Yunzhen He, Yi Yang, Min Hu, Xinran Zhao, Jun Liu, Yang Xie, Yan Wei and Yingyao Chen
    Citation: Cost Effectiveness and Resource Allocation 2022 20:54
  27. The objective of this paper is to assess the economic profile of Enzyme Replacement Therapy (ERT) to symptomatic patients with Pompe, Fabry, Gaucher disease and Lysosomal acid lipase (LAL) deficiency.

    Authors: Eleni Ioanna Katsigianni and Panagiotis Petrou
    Citation: Cost Effectiveness and Resource Allocation 2022 20:51

    The Correction to this article has been published in Cost Effectiveness and Resource Allocation 2022 20:64

  28. In Germany, CRT devices with defibrillator capability (CRT-D) have become the predominant treatment strategy for patients with heart failure and cardiac dyssynchrony. However, according to current guidelines, ...

    Authors: Moritz Hadwiger, Laura Schumann, Nora Eisemann, Nikolaos Dagres, Gerhard Hindricks, Janina Haug, Michael Wolf, Ursula Marschall, Alexander Katalinic and Fabian-Simon Frielitz
    Citation: Cost Effectiveness and Resource Allocation 2022 20:48
  29. This study aimed to examine the economic and clinical benefits of a new powered circular stapler for left-sided colorectal construction in China.

    Authors: Junwei Bai, Yingnan Zhao, Hong Liang, Junmeng Li and Chao Zhang
    Citation: Cost Effectiveness and Resource Allocation 2022 20:45
  30. Chronic kidney disease (CKD) is a health problem due to its increasing prevalence and imposes a significant economic burden on the health system. This study aimed to analyze the cost–benefit of kidney transpla...

    Authors: Farzaneh Abdi, Cyrus Alinia, Ali Taghizadeh Afshari and Hasan Yusefzadeh
    Citation: Cost Effectiveness and Resource Allocation 2022 20:37
  31. The misconception of the purpose of strabismus treatment has, on the one hand, affected the motivation of strabismus patients to seek care and, on the other hand, has resulted in strabismus not being covered b...

    Authors: Lei Yang, Yiduo Min, Zhiyan Jia, Yupeng Wang, Rihui Zhang and Bitong Sun
    Citation: Cost Effectiveness and Resource Allocation 2022 20:27