Table 1 Results of study endpoints

From: A novel cloud-based artificial intelligence for real-time detection of colorectal neoplasia – a randomized controlled trial (EAGLE)

Outcome

Metric

Study arm

N patients

Total resections

Summarya

Differenceb (95% CI)

p value

Safety endpoint

PPA

SoC

424

517

276 (53.4%)

0

CADe

417

700

377 (53.9%)

0.5% (−5.0%, ∞)c

Adenoma detection metrics

APC (overall)

SoC

424

262

0.62 ± 1.19

1

0.01

CADe

417

343

0.82 ± 1.40

1.33 (1.06, 1.67)

APC (distal)

SoC

424

121

0.29 ± 0.61

1

0.07

CADe

417

158

0.38 ± 0.84

1.32 (0.98, 1.79)

APC (proximal)

SoC

424

141

0.33 ± 0.85

1

0.05

CADe

417

185

0.44 ± 0.86

1.33 (1.00, 1.77)

ADR

SoC

424

152 (35.9%)

0

0.03

CADe

417

180 (43.2%)

7.3% (0.7%, 13.9%)

Neoplastic polyp detection metrics

NPPC

SoC

424

280

0.66 ± 1.20

1

0.002

CADe

417

381

0.91 ± 1.48

1.39 (1.12, 1.73)

NSP-PC

SoC

424

18

0.04 ± 0.21

1

0.03

CADe

417

38

0.09 ± 0.46

2.15 (1.07, 4.32)

Polyps (all) detection metrics

PDR

SoC

424

225 (53.1%)

0

0.04

CADe

417

251 (60.2%)

6.8 (0.3, 13.3)

PPC (overall)

SoC

424

451

1.06 ± 1.53

1

0.001

CADe

417

589

1.41 ± 1.85

1.35 (1.13, 1.61)

PPC (distal)

SoC

424

238

0.56 ± 0.94

1

0.008

CADe

417

315

0.76 ± 1.25

1.35 (1.08, 1.69)

PPC (proximal)

SoC

424

213

0.50 ± 0.97

1

0.02

CADe

417

274

0.66 ± 1.07

1.31 (1.04, 1.65)

SSL detection metric

SSL-PC

SoC

424

11

0.03 ± 0.16

1

0.006

CADe

417

34

0.08 ± 0.45

3.30 (1.41, 7.571

  1. APC adenomas per colonoscopy, ADR adenoma detection rate, NPPC neoplastic polyps per colonoscopy, PDR polyp detection rate, PPA positive percent agreement, PPC polyps per colonoscopy, NSP-PC serrated neoplastic polyps per colonoscopy, SSL-PC sessile serrated lesions per colonoscopy.
  2. aSummary statistics are mean ± standard deviation, median [inter-quartile range], or number (percentage).
  3. bGroup differences are ratio of values in CADe relative to SoC (continuous outcomes), or difference in percentages for adenoma detection rate.
  4. cPercentage difference performed analyzed using one-sided 97.5% CI.