ArticleBMJ surgery, interventions, & health technologies2022
Advancing the Real-World Evidence for Medical Devices through Coordinated Registry Networks.
Article in BMJ surgery, interventions, & health technologies, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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
20 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Methodologies for generating and evaluating clinical and performance evidence for high-risk and innovative medical devices andFrontiers in medical technology · 2026Pooled it
- Evidence integration and bridging methodologies for high-risk and innovative medical devices andFrontiers in medicine · 2026Pooled it
- Leveraging Clinical Registries and Electronic Health Systems to Advance Value-Based Medicine Across Specialties.The Permanente journal · 2026Review
- Accelerating novel therapies for sickle cell disease with RWE: ASH RC Data Hub as a strategically coordinated registry network.Blood advances · 2026Article
- Monitoring performance and improving outcomes: characteristics and outputs of Australian clinical registries.Health information management : journal of the Health Information Management Association of Australia · 2026Article
- 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
- Navigating the Real World: A Scoping Review of Structured Frameworks to Effectively Identify, Evaluate, and Select Real-World Data Sources for Fit-for-Purpose Studies.Clinical pharmacology and therapeutics · 2025Article
- Prognostic risk profiling in COPD using Global Initiative for Chronic Obstructive Lung Disease 2023 ABE and comorbidity assessment: evidence from a register-based COPD cohort.Journal of global health · 2025Article
- Adverse local tissue reactions in arthroplasty: opportunities and challenges for a common terminology across scientific, clinical and regulatory fields.EFORT open reviews · 2025Article
- Long-term outcomes of initial thoracic endovascular repair versus medical therapy in acute uncomplicated type B aortic dissection: real-world evidence from a nationwide claims database in Japan - a retrospective cohort study.BMJ surgery, interventions, & health technologies · 2025Article
- Development of a minimum checklist to assess the quality of evidence produced using registry data for the evaluation of medical device safety and performance.BMJ surgery, interventions, & health technologies · 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
- A review on the evolving environment of medical device real-world evidence regulation on market access in the USA.Cost effectiveness and resource allocation : C/E · 2024Review
- Determining the value of the abdominal core health quality collaborative to support regulatory decisions.Hernia : the journal of hernias and abdominal wall surgery · 2024Article
- The IDEAL framework for surgical robotics: development, comparative evaluation and long-term monitoring.Nature medicine · 2024Review
- Developing the foundation for assessment of Devices used for Acute Ischemic Stroke Interventions (DAISI) using a Coordinated Registry Network.BMJ surgery, interventions, & health technologies · 2022Review
- Maturity framework and select approaches for developing Coordinated Registry Networks (CRNs): Medical Device Epidemiology Network (MDEpiNet) supplement.BMJ surgery, interventions, & health technologies · 2022Article
- Development of a core minimum data set to advance real-world evidence generation for uterine fibroids treatment technologies.BMJ surgery, interventions, & health technologies · 2022Article
- Building Blocks for the Long-acting and Permanent Contraceptives Coordinated Registry Network.BMJ surgery, interventions, & health technologies · 2022Article
- Development of a coordinated registry network for pelvic organ prolapse technologies.BMJ surgery, interventions, & health technologies · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
31 authors.
Funding
Abstract
Objectives: Generating and using real-world evidence (RWE) is a pragmatic solution for evaluating health technologies. RWE is recognized by regulators, health technology assessors, clinicians, and manufacturers as a valid source of information to support their decision-making. Well-designed registries can provide RWE and become more powerful when linked with electronic health records and administrative databases in coordinated registry networks (CRNs). Our objective was to create a framework of maturity of CRNs and registries, so guiding their development and the prioritization of funding. Design setting and participants: We invited 52 stakeholders from diverse backgrounds including patient advocacy groups, academic, clinical, industry and regulatory experts to participate on a Delphi survey. Of those invited, 42 participated in the survey to provide feedback on the maturity framework for CRNs and registries. An expert panel reviewed the responses to refine the framework until the target consensus of 80% was reached. Two rounds of the Delphi were distributed via Qualtrics online platform from July to August 2020 and from October to November 2020. Main outcome measures: Consensus on the maturity framework for CRNs and registries consisted of seven domains (unique device identification, efficient data collection, data quality, product life cycle approach, governance and sustainability, quality improvement, and patient-reported outcomes), each presented with five levels of maturity. Results: Of 52 invited experts, 41 (79.9%) responded to round 1; all 41 responded to round 2; and consensus was reached for most domains. The expert panel resolved the disagreements and final consensus estimates ranged from 80.5% to 92.7% for seven domains. Conclusions: We have developed a robust framework to assess the maturity of any CRN (or registry) to provide reliable RWE. This framework will promote harmonization of approaches to RWE generation across different disciplines and health systems. The domains and their levels may evolve over time as new solutions become available.
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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.