Evidence map›Paper›PMID 28673277›Full record

Trial reportBMC urology2017

Impact of a protein-based assay that predicts prostate cancer aggressiveness on urologists' recommendations for active treatment or active surveillance: a randomized clinical utility trial.

John W Peabody, Lisa M DeMaria, Diana Tamondong-Lachica, Jhiedon Florentino, M Czarina Acelajado, Othman Ouenes, Jerome P Richie, Trever Burgon

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC urology, 2017. 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
1.0field-weighted citation impact, top 22% 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, 10 citations in OpenAlex.

  1. Article
  2. Review
  3. Review
  4. Article
  5. 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

8 authors at 1 institution in 2 countries.

John W PeabodyQURE Healthcare, 450 Pacific Ave, Suite 200, San Francisco, CA, USA. jpeabody@qurehealthcare.com.ORCID http://orcid.org/0000-0002-0210-9232
Lisa M DeMariaQURE Healthcare, 450 Pacific Ave, Suite 200, San Francisco, CA, USA.
Diana Tamondong-LachicaQURE Healthcare, 450 Pacific Ave, Suite 200, San Francisco, CA, USA.
Jhiedon FlorentinoQURE Healthcare, 450 Pacific Ave, Suite 200, San Francisco, CA, USA.
M Czarina AcelajadoQURE Healthcare, 450 Pacific Ave, Suite 200, San Francisco, CA, USA.
Othman OuenesQURE Healthcare, 450 Pacific Ave, Suite 200, San Francisco, CA, USA.
Jerome P RichieMetamark Genetics, 245 First Street, 10th Floor, Cambridge, MA, USA.
Trever BurgonQURE Healthcare, 450 Pacific Ave, Suite 200, San Francisco, CA, USA.
Qarshi University · PK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOf the more than 1.1 million men diagnosed worldwide annually with prostate cancer, the majority have indolent tumors. Distinguishing between aggressive and indolent cancer is an important clinical challenge. The current approaches for assessing tumor aggressiveness are recognized as insufficient. A validated protein-based assay has been shown to predict tumor aggressiveness from prostate biopsy. The main objective of this study was to measure the clinical utility of this new assay in the management of early-stage prostate cancer.

methodsOne hundred twenty nine board-certified urologists were asked to participate in a randomized, two-arm experiment. We collected data over 2 rounds using simulated clinical cases administered via an online platform. The cases were all newly diagnosed Gleason 3 + 3 or 3 + 4 prostate camcer patients. Urologists in the intervention arm received a 15-min webinar on this protein-based assay and given assay test results for their simulated patients in round 2. Each case had a preferred recommendation of either active surveillance or active treatment. The measured outcome was rate of preferred recommendation, defined as urologists who recommended the proper treatment course. Analyses were done using difference-in-difference estimations.

resultsUsing multinomial logistical regression, urologists who were given the assay results were significantly more likely to choose the preferred recommendation (active surveillance or active treatment) compared to controls (p = 0.004). These urologists were also significantly more likely to involve their patients in the treatment decision compared to controls (p = 0.001).

conclusionsBy providing additional information to inform the physician's treatment plan, a protein-based assay shows demonstrable clinical utility confirmed through a rigorous randomized controlled study design and regression analyses to test for effects.

Indexed as

Watchful WaitingAgedFluorescent Antibody TechniqueHumansMaleMiddle AgedNeoplasm ProteinsPractice Guidelines as TopicPredictive Value of TestsProstatic NeoplasmsProteomicsRisk AssessmentUrologyNeoplasm ProteinsActive surveillanceActive treatmentEvidence-based treatmentGleason scoreProtein-based assayProteomic biomarkerSimulated patients

Identifiers

PMID28673277
PMCPMC5496184
OpenAlexW2726291882

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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.