Evidence map›Paper›PMID 36806135›Full record

ArticleBMJ open2023

Early discontinuation and results reporting of robot-assisted surgery studies registered on ClinicalTrials.gov: a research on research study.

Youlin Long, Tengyue Hu, Zixin Yang, Liqin Liu, Yifei Lin, Jin Huang, Liang Du

Open access · goldAbstract read
In one paragraph

Article in BMJ open, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.8field-weighted citation impact, top 26% 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

1 citing paper in PubMed, 3 citations in OpenAlex.

  1. Article
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

7 authors at 1 institution in 1 country.

Youlin LongChinese Evidence-Based Medicine Center, West China Hospital, Sichuan University, Chengdu, PR China.ORCID 0000-0002-5421-2645
Tengyue HuWest China School of Medicine, Sichuan University, Chengdu, PR China.
Zixin YangWest China School of Medicine, Sichuan University, Chengdu, PR China.
Liqin LiuWest China School of Medicine, Sichuan University, Chengdu, PR China.
Yifei LinWest China Hospital, Sichuan University, Chengdu, PR China.
Jin HuangMedical Device Regulatory Research and Evaluation Center, West China Hospital, Sichuan University, Chengdu, PR China duliang@scu.edu.cn michael_huangjin@163.com.
Liang DuMedical Device Regulatory Research and Evaluation Center, West China Hospital, Sichuan University, Chengdu, PR China duliang@scu.edu.cn michael_huangjin@163.com.ORCID 0000-0003-1855-9139
Sichuan University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesIn this study, we aimed to investigate the characteristics of robot-assisted surgery studies registered on ClinicalTrials.gov and identify factors associated with early trial discontinuation and timely results reporting.

designWe searched ClinicalTrials.gov to identify interventional studies on robot-assisted surgery on 24 May 2021. All structured information of the potential studies was downloaded and reviewed. A descriptive analysis was performed. Logistic and Cox regression analyses were respectively performed to determine the significance of the association of study characteristics with results reporting and early discontinuation.

resultsA total of 529 interventional studies on robot-assisted surgery were included, with 45 studies reporting results and 54 studies being stopped early. Of the 289 due studies, only 45 (16%) had submitted their results, and only 6 (2%) had submitted their results within the 1-year deadline. Funding source was associated with results reporting: academic funded were 63% less likely than industry to report results (OR=0.37, 95% CI: 0.16 to 0.83, p=0.02). Studies related to device feasibility were associated with greater risk of early discontinuation compared to treatment-related studies (HR=2.30, 95% CI: 1.08 to 4.89, p=0.03). Surprisingly, National Institutes of Health-funded studies were at greater hazard of discontinuation compared to industry-funded studies (HR=3.30, 95% CI: 1.09 to 10.00, p=0.04).

conclusionsThere was poor compliance with results reporting requirements for robot-assisted surgical studies. It is important that investigators remain informed about the regulatory requirements, and should be helped to develop a sense of responsibility for reporting results. Also, they need to ensure the careful design of the study protocol and adequate resources to reduce the risk of early discontinuation.

Indexed as

Robotic Surgical ProceduresHumansIndustryNational Institutes of Health (U.S.)Research PersonnelUnited Statesgastroenterologygenitourinary medicinegynaecologysurgery

Identifiers

PMID36806135
PMCPMC9944654
OpenAlexW4321370634

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.