Validation of the Retinopathy of Prematurity Activity Scale (ROP‐ActS) using retrospective clinical data

Abstract

The International Neonatal Consortium recently published a proposed retinopathy of prematurity (ROP) activity scale intended for use in clinical trials after validation. The aim of this study was to validate the ROP activity scale (ROP-ActS) in a ROP screened cohort with protocol based collected data by evaluating the ability of the ROP-Act scores to predict ROP treatment. In addition, we aimed to evaluate the scale's sensitivity characteristic of disease severity by studying association with gestational age (GA) in comparison with conventionally used ROP stage and zone. Methods: A cohort of 535 preterm infants with 3324 ROP examinations with an end-point of ROP treatment or end of screening in Gothenburg, Sweden, was included. Median GA was 28.1 weeks, 47.5% were girls, and 74 (13.8%) infants were treated for ROP. The validation was performed by estimating probabilities for ROP treatment, and by applying logistic and linear regression. Results: The original ROP-ActS was overall well-ordered with respect to ability to predict ROP treatment but could be improved by reordering score 3 (zone II stage 1) and 5 (zone III stage 3) based on our clinical cohort data. The modified ROP-ActS was superior to ROP stage and zone in the prediction analysis of ROP treatment. Modified ROP-ActS was more strongly related to GA than currently used ROP stage, but not zone. Conclusion: In the studied cohort, the modified ROP-ActS could better predict ROP treatment compared to ROP stage and zone. Retinopathy of Prematurity Activity Scale (ROP-ActS) had a superior sensitivity characteristic studied through association to GA than conventionally used ROP stage.

Evaluation of the Retinopathy of Prematurity Activity Scale (ROP-ActS) in a randomised controlled trial aiming for prevention of severe ROP: a substudy of the Mega Donna Mega trial

“…It was proposed to switch scores 3 (zone II stage 1) and 5 (zone III stage 3). 12 In the current study, the percentage of infants with score 3 that finally led to ROP treatment was 24%, and for score 5 was 22%, compared with 33% and 14% in the retrospective study. The decision for switching the scores 3 and 5 would not be as substantiated in this study as in the previous one.…”

“…In the retrospective validation study of ROP-ActS, including 535 infants and 3324 ROP screening examinations, we concluded that the original ROP-ActS was relatively well ordered against the short-term outcome, treated ROP. It was proposed to switch scores 3 (zone II stage 1) and 5 (zone III stage 3) 12. In the current study, the percentage of infants with score 3 that finally led to ROP treatment was 24%, and for score 5 was 22%, compared with 33% and 14% in the retrospective study.…”

“…In order to visually compare the linearity characteristic of ROP-ActS and mROP-ActS in the current cohort, as was previously evaluated on a retrospective cohort, the two scale variables were studied against ROP treatment. 12 Percentage of infants with ROP treatment among those having reported a certain score was presented in a bar chart.…”

“…To date, ROP-ActS has been evaluated in one ROP screened cohort where a small modification of the scale was proposed (mROP-ActS). 12 In the Mega Donna Mega (MDM) trial, designed by our group to study preventive effects of arachidonic acid (AA) and docosahexaenoic acid (DHA) supplementation on severe ROP (stage 3 and type 1), we demonstrated that the incidence of severe ROP was 50% lower in the AA:DHA group compared with the control group. 13 In the current study, we evaluated the mean levels of the maximum ROP-ActS scores in the two randomised groups from the MDM cohort.…”

Retinopathy of prematurity – update on screening, treatment, recent studies and long-term outcomes

“…Beyond ROP treatment and prevention, we will see a new ROP nomenclature, ICROP 3, being published in 2021 taking into account the new forms of the disease we see after anti-VEGF therapy (namely regression and reactivation). We have in recent months also seen important progress in diagnosing and grading ROP with the help of artificial intelligence [25,26] and we have seen ROP severity scores being developed to better compare ROP disease severity during the course of an individual disease [27,28].…”