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Validation of the Postnatal Growth and Retinopathy of Prematurity Screening Criteria
Gil Binenbaum1,2, Lauren A Tomlinson1, Alejandra G de Alba Campomanes3
1Division of Ophthalmology, The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.
Insights
The G-ROP screening criteria demonstrated 100% sensitivity for detecting type 1 retinopathy of prematurity (ROP) in a large validation cohort. These criteria effectively reduce the number of infants requiring ROP examinations, improving screening efficiency.
Area of Science:
- Ophthalmology
- Neonatal care
- Public health
Background:
- Retinopathy of prematurity (ROP) is a significant cause of vision impairment in premature infants.
- Current screening guidelines for ROP may lead to over-examination of infants.
- The Postnatal Growth and Retinopathy of Prematurity Study (G-ROP-1) developed novel screening criteria.
Purpose of the Study:
- To prospectively validate the generalizability of the G-ROP screening criteria in a new cohort of at-risk infants.
- To assess the sensitivity and specificity of the G-ROP criteria for identifying type 1 ROP.
- To evaluate the potential reduction in the number of infants undergoing ROP examinations.
Main Methods:
- A prospective validation cohort study (G-ROP-2) was conducted across 41 hospitals in the US and Canada.
- 3981 premature infants at risk for ROP were included, with known ROP outcomes.
- The G-ROP screening criteria were applied to this cohort.
Main Results:
- The G-ROP criteria achieved 100% sensitivity (219/219 cases) for type 1 ROP in the G-ROP-2 cohort.
- This resulted in a 35.6% reduction in infants requiring examinations.
- In a combined cohort (G-ROP-1 and G-ROP-2), the G-ROP criteria showed 100% sensitivity and reduced examinations by 32.5% compared to current guidelines.
Conclusions:
- The G-ROP screening criteria are generalizable and effective for ROP screening.
- Clinical implementation could significantly reduce the number of infants undergoing unnecessary examinations.
- The G-ROP criteria offer higher sensitivity and specificity for type 1 ROP than existing guidelines.
Importance:
The first Postnatal Growth and Retinopathy of Prematurity Study (G-ROP-1) developed new screening criteria with 100% sensitivity for type 1 retinopathy of prematurity (ROP) and 30% reduction of infants requiring examinations in a retrospective development cohort of 7483 infants from 29 North American hospitals in 2006-2012. Infants meeting 1 or more of the following criteria undergo examinations: gestational age less than 28 weeks or birth weight less than 1051 g; weight gain less than 120 g during age 10 to 19 days, weight gain less than 180 g during age 20 to 29 days, or weight gain less than 170 g during age 30 to 39 days; or hydrocephalus.
Objective:
To evaluate the generalizability of the G-ROP screening criteria in a new cohort of at-risk infants.
Design, Setting, And Participants:
This prospective validation cohort study (G-ROP-2) was conducted at 41 hospitals in the United States and Canada (25 G-ROP-1 hospitals and 16 new hospitals) from September 8, 2015, to June 13, 2017, among 3981 premature infants at risk for ROP and with known ROP outcomes.
Main Outcomes And Measures:
Sensitivity for Early Treatment for Retinopathy of Prematurity Study type 1 ROP and potential reduction in infants receiving examinations.
Results:
Among the 3981 infants in the study (1878 girls and 2103 boys; median gestational age, 28 weeks [range, 22-35 weeks]; median birth weight, 1072 g [range, 350-4080 g]; 1966 white; 942 black; 321 Latino; 120 Asian; 22 Native Hawaian or Pacific Islander; and 25 American Indian or Alaskan Native), the G-ROP criteria correctly predicted 219 of 219 cases of type 1 ROP (sensitivity, 100%; 95% CI, 98.3%-100%), while reducing the number of infants undergoing examinations by 35.6% (n = 1418). In a combined G-ROP-1 and G-ROP-2 cohort of 11 463 infants, the G-ROP criteria predicted 677 of 677 cases of type 1 ROP (sensitivity, 100%; 95% CI, 99.4%-100%), reducing the number of infants receiving examinations by 32.5% (n = 3730), while current criteria (birth weight <1501 g or gestational age ≤30 weeks 0 days) predicted 674 of 677 type 1 cases (sensitivity, 99.6%; 95% CI, 98.7%-99.8%).
Conclusions And Relevance:
This study found that the G-ROP screening criteria were generalizable on validation and, if used clinically in the United States and Canada, could reduce the number of infants receiving examinations. The large G-ROP cohorts provide evidence-based screening criteria that have higher sensitivity and higher specificity (fewer infants receiving examinations) for type 1 ROP than currently recommended guidelines.
