The single-monitor trial: an embedded CADe system increased adenoma detection during colonoscopy: a prospective randomized study

Liu, Peixi; Wang, Pu; Brown, Jeremy R. Glissen; Berzin, Tyler M.; Zhou, Guanyu; Liu, Weihui; Xiao, Xincai; Chen, Ziyang; Zhang, Zhihong; Zhou, Chao; Lei, Lei; Xiong, Fei; Li, Liangping; Liu, Xiaogang

doi:10.1177/1756284820979165

Cited by 60 publications

(89 citation statements)

References 35 publications

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“…Variations in practices have led to inconsistent reports on the frequency of FPs. The CADe-assisted detection of colon polyps has reported an average of 0.071 to 0.201 FPs per colonoscopy [ 4 , 5 , 6 , 7 , 8 , 14 ]. However, studies using FPs as the primary outcome reported an average of 26.3 to 27.3 FPs per colonoscopy, despite having extracted videos from the same RCT [ 5 ] or having used a similar CADe model to that of a previous RCT [ 7 ].…”

Section: Definition Of False Positivesmentioning

confidence: 99%

“…Although the frequency of FPs was reported as per-colonoscopy, RCTs evaluating CADe systems did not employ the algorithm during insertion [ 4 , 6 , 7 , 8 , 14 ], and the post hoc analysis of videos for FPs invariably involved only the withdrawal phase [ 12 ]. It is conceivable that more FPs would be observed during insertion, where the bowel lumen is supposed to be kept minimally distended and the bowel contents have not yet been removed through cleaning.…”

Section: Definition Of False Positivesmentioning

confidence: 99%

“…Some studies added those FPs that were detected by the CADe, considered to be a polyp, and removed by the endoscopist—but that were later determined to be normal tissue through pathological examination [ 14 ].…”

Section: Definition Of False Positivesmentioning

confidence: 99%

“…Out of these 6 studies, 5 were conducted in China, where the reported ADR was usually lower than those in the Western countries. All 6 studies consistently showed that the CADe increased the ADR [ 4 , 5 , 6 , 7 , 8 , 14 ], and most of the studies did not report missing any polyps [ 4 , 6 , 7 , 8 ]. All 6 studies saw an increase in the number of diminutive (<5 mm) adenomas, and some also saw an increase in the number of small (<10 mm) adenomas [ 4 , 5 , 6 ].…”

Section: Studies That Report False Positivesmentioning

confidence: 99%

“…All 6 studies saw an increase in the number of diminutive (<5 mm) adenomas, and some also saw an increase in the number of small (<10 mm) adenomas [ 4 , 5 , 6 ]. The withdrawal time, excluding biopsy, was comparable between the CADe and the control groups [ 4 , 5 , 7 , 8 , 14 ]. A false positive was defined in some reports as an area that was traced continuously but deemed not to be a polyp by the endoscopist [ 4 , 7 , 8 ] or was not defined in others [ 5 , 6 , 14 ].…”

Section: Studies That Report False Positivesmentioning

confidence: 99%

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Computer-Aided Detection False Positives in Colonoscopy

et al. 2021

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Randomized control trials and meta-analyses comparing colonoscopies with and without computer-aided detection (CADe) assistance showed significant increases in adenoma detection rates (ADRs) with CADe. A major limitation of CADe is its false positives (FPs), ranked 3rd in importance among 59 research questions in a modified Delphi consensus review. The definition of FPs varies. One commonly used definition defines an FP as an activation of the CADe system, irrespective of the number of frames or duration of time, not due to any polypoid or nonpolypoid lesions. Although only 0.07 to 0.2 FPs were observed per colonoscopy, video analysis studies using FPs as the primary outcome showed much higher numbers of 26 to 27 per colonoscopy. Most FPs were of short duration (91% < 0.5 s). A higher number of FPs was also associated with suboptimal bowel preparation. The appearance of FPs can lead to user fatigue. The polypectomy of FPs results in increased procedure time and added use of resources. Re-training the CADe algorithms is one way to reduce FPs but is not practical in the clinical setting during colonoscopy. Water exchange (WE) is an emerging method that the colonoscopist can use to provide salvage cleaning during insertion. We discuss the potential of WE for reducing FPs as well as the augmentation of ADRs through CADe.

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Section: Definition Of False Positivesmentioning

confidence: 99%

Section: Definition Of False Positivesmentioning

confidence: 99%

Section: Definition Of False Positivesmentioning

confidence: 99%

Section: Studies That Report False Positivesmentioning

confidence: 99%

Section: Studies That Report False Positivesmentioning

confidence: 99%

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Computer-Aided Detection False Positives in Colonoscopy

et al. 2021

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Randomized Clinical Trials of Machine Learning Interventions in Health Care

et al. 2022

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ImportanceDespite the potential of machine learning to improve multiple aspects of patient care, barriers to clinical adoption remain. Randomized clinical trials (RCTs) are often a prerequisite to large-scale clinical adoption of an intervention, and important questions remain regarding how machine learning interventions are being incorporated into clinical trials in health care.ObjectiveTo systematically examine the design, reporting standards, risk of bias, and inclusivity of RCTs for medical machine learning interventions.Evidence ReviewIn this systematic review, the Cochrane Library, Google Scholar, Ovid Embase, Ovid MEDLINE, PubMed, Scopus, and Web of Science Core Collection online databases were searched and citation chasing was done to find relevant articles published from the inception of each database to October 15, 2021. Search terms for machine learning, clinical decision-making, and RCTs were used. Exclusion criteria included implementation of a non-RCT design, absence of original data, and evaluation of nonclinical interventions. Data were extracted from published articles. Trial characteristics, including primary intervention, demographics, adherence to the CONSORT-AI reporting guideline, and Cochrane risk of bias were analyzed.FindingsLiterature search yielded 19 737 articles, of which 41 RCTs involved a median of 294 participants (range, 17-2488 participants). A total of 16 RCTS (39%) were published in 2021, 21 (51%) were conducted at single sites, and 15 (37%) involved endoscopy. No trials adhered to all CONSORT-AI standards. Common reasons for nonadherence were not assessing poor-quality or unavailable input data (38 trials [93%]), not analyzing performance errors (38 [93%]), and not including a statement regarding code or algorithm availability (37 [90%]). Overall risk of bias was high in 7 trials (17%). Of 11 trials (27%) that reported race and ethnicity data, the median proportion of participants from underrepresented minority groups was 21% (range, 0%-51%).Conclusions and RelevanceThis systematic review found that despite the large number of medical machine learning–based algorithms in development, few RCTs for these technologies have been conducted. Among published RCTs, there was high variability in adherence to reporting standards and risk of bias and a lack of participants from underrepresented minority groups. These findings merit attention and should be considered in future RCT design and reporting.

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Artificial Intelligence in Gastroenterology

Walradt¹,

Berzin²

2023

AI in Clinical Medicine

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The single-monitor trial: an embedded CADe system increased adenoma detection during colonoscopy: a prospective randomized study

Cited by 60 publications

References 35 publications

Computer-Aided Detection False Positives in Colonoscopy

Computer-Aided Detection False Positives in Colonoscopy

Randomized Clinical Trials of Machine Learning Interventions in Health Care

Artificial Intelligence in Gastroenterology

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