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Real-World Evidence (RWE) in Value of Medical Devices

A special issue of International Journal of Environmental Research and Public Health (ISSN 1660-4601). This special issue belongs to the section "Global Health".

Deadline for manuscript submissions: closed (31 October 2021) | Viewed by 2918

Special Issue Editors


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Guest Editor
Department of Health Policy and Management, School of Public Health and Tropical Medicine, Tulane University, New Orleans, LA, USA
Interests: health technology assessement

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Guest Editor
Chief Data Officer, Blue Cross Blue Shield of Louisiana, Baton Rouge, LA, USA
Interests: health services research

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Guest Editor
Department of Health Policy & Management, Tulane University, School of Public Health & Tropical Medicine, 1440 Canal Street, Suite 1900, New Orleans, LA 70112, USA
Interests: health services research

Special Issue Information

Dear Colleagues,

We are organizing a Special Issue on the real-world evidence in value of medical device in the International Journal of Environmental Research and Public Health. The venue is a peer-reviewed scientific journal that publishes articles and communications in the interdisciplinary area of environmental health sciences and public health. For detailed information on the journal, we refer you to https://0-www-mdpi-com.brum.beds.ac.uk/journal/ijerph.

FDA has recently published several guidance documents/frameworks for use of RWE to support regulatory decision-making for drugs, biologics, and medical devices. While RWE is an increasingly used for drugs and biologics, there may be some unique challenges to generate RWE, specifically for medical devices, that may create barriers to broader utilization of RWE for medical devices. As a result, there is an urgent need to explore the opportunities and challenges of wide use of RWE from the perspectives of all relevant stakeholders. If we are to realize the full promise of RWE, we must address the unmet needs in health care where the utilization of RWE in medical devices can positively impact on quality, access, and cost. 

With this Special Issue, 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 be peer-reviewed by experts in the field, and would be due no later than the end of August 1, 2021. 

Dr. Lizheng Shi
Dr. Somesh Nigam
Dr. Yichen Zhang
Guest Editors

Manuscript Submission Information

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 100 words) can be sent to the Editorial Office for announcement on this website.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. International Journal of Environmental Research and Public Health is an international peer-reviewed open access monthly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 2500 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

Keywords

  • Medical device
  • Cost
  • Access
  • Quality
  • Real-world evidence
  • Adminstrative data
  • Electronic health records
  • Claims

Published Papers (1 paper)

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Research

12 pages, 1289 KiB  
Article
Value of Active Warming Devices for Intraoperative Hypothermia Prevention—A Meta-Analysis and Cost-Benefit Analysis
by He Xu, Zijing Wang, Yijuan Lu, Xin Guan, Yue Ma, Daniel C. Malone, Jack Warren Salmon, Aixia Ma and Wenxi Tang
Int. J. Environ. Res. Public Health 2021, 18(21), 11360; https://0-doi-org.brum.beds.ac.uk/10.3390/ijerph182111360 - 28 Oct 2021
Cited by 5 | Viewed by 2421
Abstract
Purpose: Historically, studies suggested that intraoperative hypothermia (IH) could result in significant resource consumption, but more recent studies have found the opposite. The purpose of this study is to estimate the value of active warming devices for IH prevention based on synthesized evidence. [...] Read more.
Purpose: Historically, studies suggested that intraoperative hypothermia (IH) could result in significant resource consumption, but more recent studies have found the opposite. The purpose of this study is to estimate the value of active warming devices for IH prevention based on synthesized evidence. Methods: A cost-benefit analysis was conducted using the effect of active warming versus passive warming devices for intraoperative hypothermia from a meta-analysis. The item-based aggregated treatment cost approach was adopted to estimate the cost of each adverse event, which was then weighted to calculate the total cost of IH. Results: IH was associated with higher risks of bleeding, surgical site infection, and shivering compared with normothermia. The cost of one case of IH was $363.80, and the use of active warming devices might save $152.80. Extra investment in active warming (e.g., $291.00) might only be cost-beneficial when the minimum willingness-to-pay is $150.00. Conclusions: Synthesized evidence showed that the cost of IH might be overestimated. Furthermore, the value of using active warming devices remains uncertain because the willingness to pay may vary between decision-makers. As not enough awareness of hypothermia prevention in some countries, further research into the clinical use of active warming devices during major surgeries is warranted. Full article
(This article belongs to the Special Issue Real-World Evidence (RWE) in Value of Medical Devices)
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