Validation of DIGIROP- Birth and DIGIROP- Screen for the discovery of retinopathy of prematurity requiring treatment in preterm births in Saudi Arabia

Huda K. Ahmedhussain; Lina H. Raffa; Amal M. Alosaimif; Sarah K. Alessa; Suzan Y. Alharbi; Hashem Almarzouki; Mansour A. AlQurashi

doi:10.15537/smj.2025.46.4.20240773

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Figure 1
- Receiver operating characteristic (ROC) curves for type 1 retinopathy of prematurity (ROP) risk estimates obtained by DIGIROP-Birth and DIGIROP-Screen at postnatal age 6-14 weeks. PNA: postnatal age
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Figure 2
- Receiver operating characteristic (ROC) curves for type 1 retinopathy of prematurity (ROP) risk estimates obtained by DIGIROP-Birth and DIGIROP-Screen at PNA 6 weeks in comparison to other existing algorithms.

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Table 1

- Baseline characteristics of the study cohort by ROP status (N=363).

Variables	Types of ROP			P-values
Variables	No ROP	Treatable ROP	Any stage ROP	P-values
Total	238 (65.6)	32 (8.8)	93 (25.6)	-
Age (years), mean±SD	4.18±1.6^{^*}	3.56±1.7^{^*}	4.77±1.8^{^†}	<0.001^{^*,^‡}
GA (weeks), mean±SD	28.37±1.4^{^*}	26.16±1.7†	27.47±1.6‡	<0.001^{^*,^§}
BW (grams), mean±SD	1145.12±248.6^{^*}	786.56±167.3^{^†}	968.23±252.1^{^‡}	<0.001^{^*,^§}
Probability (n=368), mean±SD	1.63±3.7^{^*}	11.79±11.1^{^†}	4.92±7.9^{^‡}	<0.001^{^*,^§}
Gender
Male (n=175)	116 (66.3)	14 (8.0)	45 (25.7)	0.868
Female (n=188)	122 (64.9)	18 (9.6)	48 (25.5)	0.868
GA
24 (n=14)	2 (14.3)	6 (42.9)	6 (42.9)	<0.001^{^†}
25 (n=20)	9 (45.0)	8 (40.0)	3 (15.0)
26 (n=38)	13 (34.2)	6 (15.8)	19 (50.0)
27 (n=52)	31 (59.6)	4 (7.7)	17 (32.7)
28 (n=78)	56 (71.8)	3 (3.8)	19 (24.4)
29 (n=99)	75 (75.8)	5 (5.1)	19 (19.2)
30 (n=62)	52 (83.9)	0 (0.0)	10 (16.1)
Worst ROP stage either eye
1 (n=73)	0 (0.0)	0 (0.0)	73 (100)	<0.001^{^†}
2 (n=36)	0 (0.0)	17 (47.2)	19 (52.8)
3 (n=15)	0 (0.0)	14 (93.3)	1 (6.7)
4 (n=1)	0 (0.0)	1 (100)	0 (0.0)
N/A (n=238)	238 (100)	0 (0.0)	0 (0.0)

Values are presented as numbers and percentages (%).

ROP: retinopathy of prematurity, GA: gestational age, BW: body weight, N/A: not available, SD: standard deviation

↵* Significant using One-Way ANOVA test at <0.05 level.
↵† Significant using Fisher’s Exact test at <0.05 level.
↵‡ Post-Hoc test = LSD.
↵§ Post-Hoc test = Games-Howell.

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Table 2

- Sensitivity, specificity, positive predictive value, negative predictive value, model accuracy, and area under the receiver operating characteristic curve with 95% confidence interval for DIGIROP-Birth and DIGIROP-Screen for type 1 retinopathy of prematurity risk prediction (N=363).

Type 1 ROP	Sensitivity	Specificity	Disease prevalence	Positive predictive value	Negative predictive value	Accuracy	Area under the curve
DIGIROP-Birth	93.8 (79.2-99.2)	48.9 (43.4-54.5)	8.8 (6.1-12.2)	15.1 (13.4-16.9)	98.8 (95.5-99.7)	52.9 (47.6-58.1)	0.70 (0.58-0.82)
DIGIROP-Screen PNA6w	93.8 (79.2-99.2)	45.0 (39.5-50.5)	8.9 (6.1-12.3)	14.2 (12.7-15.9)	98.7 (95.1-99.7)	49.3 (44.0-54.6)	0.68 (0.56-0.81)
DIGIROP-Screen PNA7w	96.8 (83.3-99.9)	45.0 (39.5-50.5)	8.6 (5.9-12.0)	14.2 (12.9-15.7)	99.3 (95.5-99.9)	49.4 (44.2-54.7)	0.68 (0.56-0.81)
DIGIROP-Screen PNA8w	89.7 (72.7-97.8)	57.5 (51.9-62.9)	8.1 (5.5-11.4)	15.7 (13.5-18.1)	98.4 (95.6-99.5)	60.1 (54.8-65.2)	0.75 (0.64-0.86)
DIGIROP-Screen PNA9w	80.8 (60.7-93.5)	66.0 (60.6-71.1)	7.3 (4.8-10.6)	15.8 (12.9-19.3)	97.8 (95.2-99.0)	67.0 (61.9-71.9)	0.75 (0.62-0.88)
DIGIROP-Screen PNA10w	80.0 (59.3-93.2)	72.6 (67.5-77.4)	7.1 (4.6-10.3)	18.2 (14.6-22.4)	98.0 (95.6-99.1)	73.2 (68.2-77.7)	0.82 (0.72-0.92)
DIGIROP-Screen PNA11w	85.7 (63.7-97.0)	74.5 (69.4-79.1)	6.0 (3.8-9.0)	17.7 (14.3-21.7)	98.8 (96.6-99.6)	75.1 (70.3-79.6)	0.83 (0.73-0.93)
DIGIROP-Screen PNA12w	94.1 (71.3-99.9)	75.1 (70.0-79.7)	4.9 (2.9-7.8)	16.3 (13.5-19.6)	99.6 (97.4-99.9)	76.0 (71.2-80.4)	0.83 (0.74-0.93)
DIGIROP-Screen PNA13w	73.3 (44.9-92.2)	83.6 (79.1-87.4)	4.4 (2.5-7.1)	16.9 (12.1-23.1)	98.6 (96.7-99.4)	83.1 (78.8-86.9)	0.75 (0.59-0.91)
DIGIROP-Screen PNA14w	75.0 (42.8-94.5)	83.5 (79.1-87.4)	3.5 (1.8-6.1)	14.3 (10.0-20.0)	98.9 (97.2-99.6)	83.2 (78.8-87.1)	0.79 (0.65-0.94)

Values are presented as numbers with 95% confidence intervals. ROP: retinopathy of prematurity, PNA: Postnatal age in weeks

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Table 3

- Comparison of DIGIROP-Screen with other existing retinopathy of prematurity prediction models.

Type 1 ROP	Total	Sensitivity	Specificity	Disease prevalence	PPV	NPV	Accuracy	AUC
DIGIROP-Birth	272	94.7 (74.0-99.9)	43.5 (37.3-49.8)	7.0 (4.3-10.7)	11.2 (9.8-12.8)	99.1 (94.2-99.9)	47.1 (41.0-53.2)	0.68 (0.54-0.82)
DIGIROP-Screen PNA6w	272	94.7 (74.0-99.9)	40.7 (34.6-47.0)	7.0 (4.3-10.7)	10.7 (9.4-12.2)	99.0 (93.8-99.9)	44.5 (38.5-50.6)	0.65 (0.51-0.79)
ROPSCORE alarm	272	100 (82.4-100)	28.5 (23.0-34.5)	7.0 (4.3-10.7)	9.5 (8.9-10.2)	100 (95.0-100)	33.5 (27.9-39.4)	0.63 (0.49-0.77)
CO-ROP	272	94.7 (74.0-99.9)	5.1 (2.8-8.6)	7.0 (4.3-10.7)	7.0 (6.3-7.7)	92.9 (64.2-99.0)	11.4 (7.9-15.8)	0.51 (0.34-0.69)
HgCO-ROP	272	89.5 (66.9-98.7)	19.4 (14.7-24.8)	7.0 (4.3-10.7)	7.7 (6.6-9.0)	96.1 (86.6-98.9)	24.3 (19.3-29.8)	0.56 (0.39-0.72)
WINROP Alarm	272	100 (82.4-100)	20.2 (15.4-25.6)	7.0 (4.3-10.7)	8.6 (8.1-9.1)	100 (93.0-100)	25.7 (20.7-31.4)	0.61 (0.46-0.75)
G-ROP 1	146	100 (76.8-100)	15.2 (9.5-22.4)	9.6 (5.3-15.6)	11.1 (10.4-11.8)	100 (83.2-100)	23.3 (16.7-31.0)	0.58 (0.42-0.73)
G-ROP 2	146	100 (76.8-100)	9.1 (4.8-15.3)	9.6 (5.3-15.6)	10.5 (10.0-11.0)	100 (73.5-100)	17.8 (12.0-25.0)	0.55 (0.38-0.71)

Values are presented as numbers with 95% confidence intervals. PNA : postnatal age in weeks, ROP: retinopathy of prematurity, CO-ROP: Colorado retinopathy of prematurity, HgCO-ROP: high grade Colorado-retinopathy of prematurity model, WINROP: weight insulin-like growth factor 1 neonatal retinopathy of prematurity, G-ROP: postnatal growth and retinopathy of prematurity, PPV: positive predictive value, NPV: negative predictive value, AUC: area under the curve