Evidence map›Paper›PMID 35113918›Full record

ArticlePloS one2022

A protocol for the VISION study: An indiVidual patient data meta-analysis of randomised trials comparing MRI-targeted biopsy to standard transrectal ultraSound guided bIopsy in the detection of prOstate cancer.

Veeru Kasivisvanathan, Vinson Wai-Shun Chan, Keiran D Clement, Brooke Levis, Masoom Haider, Ridhi Agarwal, Mark Emberton, Gregory R Pond, Yemisi Takwoingi, Laurence Klotz and 2 more

Abstract readClinical Trial Protocol
In one paragraph

Article in PloS one, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
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

2 citing papers in PubMed.

  1. Article
  2. The Role of [Cancers · 2022
    Review
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

12 authors.

Veeru KasivisvanathanDivision of Surgery and Interventional Sciences, University College London, United Kingdom.
Vinson Wai-Shun ChanDivision of Surgery and Interventional Sciences, University College London, United Kingdom.ORCID 0000-0002-6108-9315
Keiran D ClementDepartment of Urology, NHS Greater Glasgow & Clyde, Glasgow, United Kingdom.
Brooke LevisCentre for Prognosis Research, School of Medicine, Keele University, Staffordshire, United Kingdom.
Masoom HaiderToronto General Hospital, Department of Radiology, University of Toronto, Toronto, Ontario, Canada.
Ridhi AgarwalTest Evaluation Research Group, Institute of Applied Health Research, University of Birmingham, and NIHR Birmingham Biomedical Research Centre, University Hospitals Birmingham NHS Foundation Trust and University of Birmingham, Birmingham, United Kingdom.
Mark EmbertonDivision of Surgery and Interventional Sciences, University College London, United Kingdom.
Gregory R PondDepartment of Biostatistics, McMaster University, Hamilton, Ontario, Canada.
Yemisi TakwoingiTest Evaluation Research Group, Institute of Applied Health Research, University of Birmingham, and NIHR Birmingham Biomedical Research Centre, University Hospitals Birmingham NHS Foundation Trust and University of Birmingham, Birmingham, United Kingdom.
Laurence KlotzDivision of Urology, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada.
Caroline M MooreDivision of Surgery and Interventional Sciences, University College London, United Kingdom.
VISION study collaborators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTransrectal ultrasound (TRUS) guided biopsy for prostate cancer is prone to random and systemic error and has been shown to have a negative predictive value of 70%. PRECISION and PRECISE are among the first randomised studies to evaluate the new MRI-targeted biopsy (MRI-TB) pathway with a non-paired design to detect clinically significant prostate cancer and avoid unnecessary treatment. The trials' results individually demonstrated non-inferiority of MRI-TB compared to TRUS biopsy. An individual patient data (IPD) meta-analysis was planned from the outset of the two trials in parallel and this IPD meta-analysis aims to further elucidate the utility of MRI-TB as the optimal diagnostic pathway for prostate cancer. METHODS AND MATERIALS: This study is registered on PROSPERO (CRD42021249263). A search of Medline, Embase, Cochrane Central Register of Registered Trials (CENTRAL), Web of Science, and ClinicalTrials.gov was performed up until 4th February 2021. Only randomised controlled trials (PRECISE, PRECISION and other eligible trials) comparing the MRI-targeted biopsy pathway and traditional TRUS biopsy pathway will be included. The primary outcome of the review is the proportion of men diagnosed with clinically significant prostate cancer in each arm (Gleason ≥ 3+4 = 7). IPD and study-level data and characteristics will be sought from eligible studies. Analyses will be done primarily using an intention-to-treat approach, and a one-step IPD meta-analysis will be performed using generalised linear mixed models. A non-inferiority margin of 5 percentage points will be used. Heterogeneity will be quantified using the variance parameters from the mixed model. If there is sufficient data, we will investigate heterogeneity by exploring the effect of the different conducts of MRIs, learning curves of MRI reporting and MRI targeted biopsies.

trial registrationThis systematic review is registered on PROSPERO (CRD42021249263).

Indexed as

BiopsyHumansImage-Guided BiopsyMagnetic Resonance ImagingMalePredictive Value of TestsProstateProstatic NeoplasmsRandomized Controlled Trials as TopicRiskUltrasonography

Identifiers

PMID35113918
PMCPMC8812968

What OpenQuestion holds

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Registered trials

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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.