ReviewEuropean respiratory review : an official journal of the European Respiratory Society2016
What type of clinical evidence is needed to assess medical devices?
Review in European respiratory review : an official journal of the European Respiratory Society, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 3 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
24 citing papers in PubMed, 3 syntheses or guidelines pooled it, 42 citations in OpenAlex.
- Regional Citrate Anticoagulation Versus Systemic Heparin in Continuous Kidney Replacement Therapy: Examining the Role of Evidence in Health Technology Assessment.Advances in therapy · 2025Pooled it
- Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review.International journal of health policy and management · 2023Pooled it
- Endovascular versus surgical creation of arteriovenous fistula in hemodialysis patients: Cost-effectiveness and budget impact analyses.The journal of vascular access · 2021Pooled it
- Trial
- Analysis of the challenges in ensuring robust and effective clinical evaluation of AI-based digital medical devices.BMJ digital health & AI · 2026Review
- Article
- Systematic review for the development of a core outcome set for monofocal intraocular lenses for cataract surgery.Frontiers in medicine · 2024Article
- The Challenges for Manufacturers of the Increased Clinical Evaluation in the European Medical Device Regulations: A Quantitative Study.Therapeutic innovation & regulatory science · 2023Article
- Time-Driven Activity-Based Costing for Capturing the Complexity of Healthcare Processes: The Case of Deep Vein Thrombosis and Leg Ulcers.International journal of environmental research and public health · 2023Article
- Impella Versus VA-ECMO for Patients with Cardiogenic Shock: Comprehensive Systematic Literature Review and Meta-Analyses.Journal of cardiovascular development and disease · 2023Review
- Nuclear Medicine and Artificial Intelligence: Best Practices for Evaluation (the RELAINCE Guidelines).Journal of nuclear medicine : official publication, Society of Nuclear Medicine · 2022Article
- Coverage with evidence development for medical devices in Europe: Can practice meet theory?Health economics · 2022Article
- Real-world evidence in health technology assessment of high-risk medical devices: Fit for purpose?Health economics · 2022Article
- Observational study investigating EctoinEuropean archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2022Observational
- Cost-effectiveness analysis of personalised versus standard dosimetry for selective internal radiation therapy with TheraSphere in patients with hepatocellular carcinoma.Frontiers in oncology · 2022Article
- Decision-analytic modeling for early health technology assessment of medical devices - a scoping review.German medical science : GMS e-journal · 2022Article
- The Expanding Role of Real-World Evidence Trials in Health Care Decision Making.Journal of diabetes science and technology · 2020Article
- Quo Vadis HTA for Medical Devices in Central and Eastern Europe? Recommendations to Address Methodological Challenges.Frontiers in public health · 2020Article
- Evaluation of the diagnostic accuracy of smartphone electrocardiogram recorder compared to standard 12 lead electrocardiography in hospital settings.Saudi medical journal · 2019Article
- Propensity Score Methods in Health Technology Assessment: Principles, Extended Applications, and Recent Advances.Frontiers in pharmacology · 2019Review
Corrections and comments
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Authors and funding
3 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The objective of this mini-review is to discuss the role of real-world studies as a source of clinical evidence when experimental studies, such as randomised controlled trials (RCTs), are not available. Waiting for RCT evidence when the technology is diffusing could be anti-economical, inefficient from the policy perspective and methodologically questionable.We explain how real-world studies could provide relevant evidence to decision makers. Matching techniques are discussed as a viable solution for bias reduction.We describe a case study concerning a cost-effectiveness analysis based on real-world data of a technology already in use: Mitraclip combined with medical therapy versus medical therapy alone in patients with moderate-to-severe mitral regurgitation. The CEA has encountered the scepticism of most reviewers, due not to the statistical methodology but to the fact that the study was observational and not experimental. Editors and reviewers converged in considering real-world economic evaluations premature in the absence of a RCT, even if in the meantime the technology had been implanted >30 000 times. We believe there is a need to acknowledge the importance of real-world studies, and engage the scientific community in the promotion and use of clinical evidence produced through observational studies.
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What OpenQuestion holds
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.