ReviewBMJ surgery, interventions, & health technologies2021
IDEAL as a guide to designing clinical device studies consistent with the new European Medical Device Regulation.
Review in BMJ surgery, interventions, & health technologies, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 1 of them a synthesis 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
11 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Methodologies for generating and evaluating clinical and performance evidence for high-risk and innovative medical devices andFrontiers in medical technology · 2026Pooled it
- How to optimise the use of innovative invasive devices: considerations for feasibility studies.Pilot and feasibility studies · 2026Article
- Recommended methodologies for clinical investigations of high-risk medical devices-Conclusions from the European Union CORE-MD Project.The Lancet regional health. Europe · 2025Review
- Mind the (research) gap: a retrospective observational study on the utilization of new medical technologies and related research activities in German hospitals.Health research policy and systems · 2025Observational
- Bayesian dynamic borrowing in group-sequential design for medical device studies.BMC medical research methodology · 2025Article
- CORE-MD clinical risk score for regulatory evaluation of artificial intelligence-based medical device software.NPJ digital medicine · 2025Review
- 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
- Reporting Guidelines for the Early-Phase Clinical Evaluation of Applications Using Extended Reality: RATE-XR Qualitative Study Guideline.Journal of medical Internet research · 2024Article
- Suitability of the Current Health Technology Assessment of Innovative Artificial Intelligence-Based Medical Devices: Scoping Literature Review.Journal of medical Internet research · 2024Article
- Assessment of Advanced Diagnostic Bronchoscopy Outcomes for Peripheral Lung Lesions: A Delphi Consensus Definition of Diagnostic Yield and Recommendations for Patient-centered Study Designs. An Official American Thoracic Society/American College of Chest Physicians Research Statement.American journal of respiratory and critical care medicine · 2024Article
- The magnetic field strength and the force distance dependency of the magnetically controlled growing rods used for early onset scoliosis.Scientific reports · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
PubMed holds no abstract for this paper.
Indexed as
Identifiers
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.