Neutral diagnosis: An innovative concept for medical device clinical trials.

Bo Zhang, Shangyuan Ye, Sravya B Shankara, Hui Zhang, Qingfeng Zheng

Open access · goldAbstract read

In one paragraph

Article in Contemporary clinical trials communications, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it

0cells of the map it votes in

0citing papers in PubMed

–field-weighted citation impact, top 88% 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

0 citing papers in PubMed, 0 citations in OpenAlex.

No citing paper in PubMed yet.

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

5 authors at 3 institutions in 2 countries.

Bo ZhangDepartment of Population and Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, MA, 01605, USA.

Shangyuan YeDepartment of Population and Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, MA, 01605, USA.

Sravya B ShankaraDepartment of Population and Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, MA, 01605, USA.

Hui ZhangDivision of Biostatistics, Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, 60611, USA.

Qingfeng ZhengDepartment of Thoracic Surgery, National Cancer Center/ National Clinical Research Center for Cancer/ Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.

University of Massachusetts Chan Medical School · USChinese Academy of Medical Sciences & Peking Union Medical College · CNNorthwestern University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Study design and statistical analysis are crucial in pivotal clinical trials to evaluate the effectiveness and safety of new medical devices under investigation. In recent years, innovative intraoperative

Indexed as

CancerDiagnostic devicesDrug-device combination productNeutral diagnosisSurgical resection

Identifiers

PMID31485547

DOI10.1016/j.conctc.2019.100436

PMCPMC6717093

OpenAlexW2969744581

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.