Evidence map›Paper›PMID 37672093›Full record

ReviewActa neurochirurgica2023

Methodological and ethical challenges in the use of focused ultrasound for blood-brain barrier disruption in neuro-oncology.

Santhosh G Thavarajasingam, John L Kilgallon, Daniele S C Ramsay, Leila Motedayen Aval, Ishaan Ashwini Tewarie, Andreas Kramer, Dannis Van Vuurden, Marike L D Broekman

Open access · hybridAbstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in Acta neurochirurgica, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.5field-weighted citation impact, top 38% of its field
1 · What the graph read from 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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 5 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 5 institutions in 4 countries.

Santhosh G ThavarajasingamComputational Neurosciences Outcomes Center, Department of Neurosurgery, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA. sgt16@ic.ac.uk.ORCID 0000-0002-9274-0350
John L KilgallonComputational Neurosciences Outcomes Center, Department of Neurosurgery, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
Daniele S C RamsayFaculty of Medicine, Imperial College London, London, UK.
Leila Motedayen AvalFaculty of Medicine, Imperial College London, London, UK.
Ishaan Ashwini TewarieComputational Neurosciences Outcomes Center, Department of Neurosurgery, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
Andreas KramerDepartment of Neurosurgery, University Medical Centre Mainz, Mainz, Germany.
Dannis Van VuurdenPrincess Maxima Center for Pediatric Oncology, Utrecht, Netherlands.
Marike L D BroekmanDepartment of Neurosurgery, Haaglanden Medical Center, The Hague, Netherlands.
Brigham and Women's Hospital · USImperial College London · GBJohannes Gutenberg University Mainz · DELeiden University Medical Center · NLPrincess Máxima Center · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFocused ultrasound (FUS) shows promise for enhancing drug delivery to the brain by temporarily opening the blood-brain barrier (BBB), and it is increasingly used in the clinical setting to treat brain tumours. It remains however unclear whether FUS is being introduced in an ethically and methodologically sound manner. The IDEAL-D framework for the introduction of surgical innovations and the SYRCLE and ROBINS-I tools for assessing the risk of bias in animal studies and non-randomized trials, respectively, provide a comprehensive evaluation for this. OBJECTIVES AND

methodsA comprehensive literature review on FUS in neuro-oncology was conducted. Subsequently, the included studies were evaluated using the IDEAL-D framework, SYRCLE, and ROBINS-I tools.

resultsIn total, 19 published studies and 12 registered trials were identified. FUS demonstrated successful BBB disruption, increased drug delivery, and improved survival rates. However, the SYRCLE analysis revealed a high risk of bias in animal studies, while the ROBINS-I analysis found that most human studies had a high risk of bias due to a lack of blinding and heterogeneous samples. Of the 15 pre-clinical stage 0 studies, only six had formal ethical approval, and only five followed animal care policies. Both stage 1 studies and stage 1/2a studies failed to provide information on patient data confidentiality. Overall, no animal or human study reached the IDEAL-D stage endpoint.

conclusionFUS holds promise for enhancing drug delivery to the brain, but its development and implementation must adhere to rigorous safety standards using the established ethical and methodological frameworks. The complementary use of IDEAL-D, SYRCLE, and ROBINS-I tools indicates a high risk of bias and ethical limitations in both animal and human studies, highlighting the need for further improvements in study design for a safe implementation of FUS in neuro-oncology.

Indexed as

Blood-Brain BarrierBrain NeoplasmsAnimalsBrainDrug Delivery SystemsHumansBrain tumorFocused ultrasoundGlioblastomaGliomaIDEALNeuro-oncologyROBINS-ISYRCLE

Identifiers

PMID37672093
PMCPMC10739192
OpenAlexW4386466714

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.