ReviewNeurosurgery practice2023
Second-Generation Wide-Field Visualization Devices for 5-ALA-Induced Fluorescence and Concepts for Validation in Neurosurgery-A Systematic Review.
Review in Neurosurgery practice, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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
1 citing paper in PubMed.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
objectivesFluorescence-guided resection (FGR) of malignant gliomas with five-aminolevulinic acid (5-ALA) is an established method using surgical microscopes equipped with filter systems for observing fluorescence. Over the past decade, new technologies have been introduced for the same purpose, with available publications evaluating their clinical efficacy based on varying criteria. This study aims to review technologies and concepts of validation in the context of 5-ALA-mediated FGR.
methodsA systematic review following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement was performed to identify devices capable of detecting 5-ALA-induced fluorescence. Articles found eligible for this review were analyzed, focusing on the methods of validation used for novel devices. A qualitative analysis is presented.
resultsUsing predefined eligibility criteria, 22 studies were analyzed. Publications on the following visualization devices were reviewed: FL400 (Leica Microsystems), Aeos (Aesculap), BLUE400 and BLUE400 AR Filter System (Carl Zeiss Meditec AG), Endoscope with D-Light C (Karl Storz), Fiberscope N-4L (Machida), ORBEYE 4K 3D Digital Video Microscope (Olympus), and several customized surgical loupe systems. In many cases, validation seemed unstandardized, with inherent biases and limited reproducibility.
conclusionThis review illustrates the significance of device validation within the framework of FGR. It emphasizes the criticality of validating devices in accordance with established standard, i.e. the BLUE400 filter system, which was employed in the approval studies of 5-ALA. Furthermore, standardized concepts of validation are required to assess whether new devices are, in fact, a reliable or superior alternative in the field of FGR. Published guidelines should be considered when performing future studies.
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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.