ArticleBMJ surgery, interventions, & health technologies2020
Use of data from the Vascular Quality Initiative registry to support regulatory decisions yielded a high return on investment.
Article in BMJ surgery, interventions, & health technologies, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
13 citing papers in PubMed, 16 citations in OpenAlex.
- Making vascular outcomes visible: an implementation framework for an Irish national vascular registry.Irish journal of medical science · 2026Review
- Building Real-World Evidence Infrastructure to Improve Health and Healthcare in the United States: Part II-How Coordinated Registry Networks Operate Like Systemic Coordinated Inter-Organizational Networks.International journal of translational medical research and public health · 2025Article
- Building Real-World Evidence Infrastructure to Improve Health and Healthcare in the United States: Part I-Coordinated Registry Networks and Systemic Coordinated Inter-Organizational Networks.International journal of translational medical research and public health · 2025Article
- Building Real-World Evidence Infrastructure to Improve Health and Healthcare in the United States: Part III-Questions for Translational Science and Action Theory.International journal of translational medical research and public health · 2025Article
- A Comprehensive Framework for Evaluating the Value Created by Real-World Evidence for Diverse Stakeholders: The Case for Coordinated Registry Networks.Therapeutic innovation & regulatory science · 2024Article
- Real-world data to support post-market safety and performance of embolization coils: evidence generation from a medical device manufacturer and data institute partnership.BMC medical informatics and decision making · 2024Article
- Determining the value of the abdominal core health quality collaborative to support regulatory decisions.Hernia : the journal of hernias and abdominal wall surgery · 2024Article
- Use of linked registry claims data for long term surveillance of devices after endovascular abdominal aortic aneurysm repair: observational surveillance study.BMJ (Clinical research ed.) · 2022Observational
- Maturity framework and select approaches for developing Coordinated Registry Networks (CRNs): Medical Device Epidemiology Network (MDEpiNet) supplement.BMJ surgery, interventions, & health technologies · 2022Article
- [The quality assurance and device register of the German Institute for Vascular Medicine Health Research (DGG) in the COVID-19 era, big data and artificial intelligence].Gefasschirurgie : Zeitschrift fur vaskulare und endovaskulare Chirurgie : Organ der Deutschen und der Osterreichischen Gesellschaft fur Gefasschirurgie unter Mitarbeit der Schweizerischen Gesellschaft fur Gefasschirurgie · 2022Article
- Advancing the Real-World Evidence for Medical Devices through Coordinated Registry Networks.BMJ surgery, interventions, & health technologies · 2022Article
- Endovascular versus open repair in patients with abdominal aortic aneurysm: a claims-based data analysis in Japan.BMJ surgery, interventions, & health technologies · 2022Article
- Postmarket surveillance of high-risk medical devices needs transparent, comprehensive and independent registries.BMJ surgery, interventions, & health technologies · 2020Article
Corrections and comments
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Authors and funding
16 authors at 12 institutions in 2 countries.
Funding
Abstract
backgroundReal-world data (RWD) from the Society for Vascular Surgery Vascular Quality Initiative (VQI) registry has been used to support US Food and Drug Administration (FDA) regulatory decisions regarding vascular devices. The variables of cost and time needed for these registry-based studies have not been previously compared to traditional, independent, industry studies that would otherwise have been conducted to support regulatory decisions.
objectivesTo determine the potential value (cost and time saving and return on investment) created by device evaluation studies using the VQI registry infrastructure.
methodsWe compared studies that used data from the VQI registry with estimated costs of independent industry studies (counterfactual studies) using an established model using design specifications determined by FDA reviewers.
resultsWe analyzed the initial six studies evaluating vascular devices for regulatory decisions using data from the VQI registry that generated evidence for four device manufacturers. Return on investment for these studies was estimated to be 143% and cost saving as 59% based on an actual per patient (with 5-year follow-up) cost of US$11K using VQI data versus US$26K from the counterfactual when averaged across all studies. Significant enrollment time savings (45%-71%) were also realized compared with industry-based estimates.
conclusionsThe use of RWD from the VQI registry in this study and the transcatheter valve treatment coordinated registry network in a prior study indicates that substantial value was added to device evaluation projects by the reuse of registry data, with additional potential savings if linked claims data can be used instead of costly long-term in-person follow-up.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.