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Randomized Controlled Trial
. 2022 Apr 8;7(1):e000923.
doi: 10.1136/bmjophth-2021-000923. eCollection 2022.

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

Aldina Pivodic  1 , Helena Johansson  2   3 , Lois Eh Smith  4 , Chatarina Löfqvist  1   5 , Kerstin Albertsson-Wikland  6 , Staffan Nilsson  7   8 , Ann Hellström  1
Affiliations
Randomized Controlled Trial

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

Aldina Pivodic et al. BMJ Open Ophthalmol. .

Abstract

Objective: The current grading of retinopathy of prematurity (ROP) does not sufficiently discriminate disease severity for evaluation of trial interventions. The published ROP Activity Scales (original: ROP-ActS and modified: mROP-ActS), describing increasing severity of ROP, versus the categorical variables severe ROP, stage, zone and plus disease were evaluated as discriminators of the effect of an ROP preventive treatment.

Methods and analysis: The Mega Donna Mega trial investigated ROP in infants born <28-week gestational age (GA), randomised to arachidonic acid (AA) and docosahexaenoic acid (DHA) supplementation or no supplementation. Of 207 infants, 86% with finalised ROP screening were included in this substudy. ROP-ActS versus standard variables were evaluated using Fisher's non-parametric permutation test, multivariable logistic and linear regression and marginal fractional response models.

Results: The AA:DHA group (n=84) and the control group (n=93) were well balanced. The maximum ROP-ActS measurement was numerically but not significantly lower in the AA:DHA group (mean: 4.0 (95% CI 2.9 to 5.0)) versus the control group (mean: 5.3 (95% CI 4.1 to 6.4)), p=0.11. In infants with any ROP, the corresponding scale measurements were 6.8 (95% CI 5.4 to 8.2) and 8.7 (95% CI 7.5 to 10.0), p=0.039. Longitudinal profiles of the scale were visually distinguished for the categories of sex and GA for the intervention versus control.

Conclusions: The preventive effect of AA:DHA supplementation versus no supplementation was better discriminated by the trial's primary outcome, severe ROP, than by ROP-ActS. The sensitivity and the linear qualities of ROP-ActS require further validations on large data sets and perhaps modifications.

Trial registration number: NCT03201588.

Keywords: Diagnostic tests/Investigation; Retina; Treatment other; Vision.

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Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
Study flow chart. AA, arachidonic acid; DHA, docosahexaenoic acid; ROP, retinopathy of prematurity; MDM, Mega Donna Mega.
Figure 2
Figure 2
Longitudinal ROP-ActS values by treatment groups on at risk data set, including all data points from the existing ROP examinations without imputation for (A) all infants, (B) boys, (C) girls, (D) GA 22–24 weeks, (E) GA 25–26 weeks and (F) GA 27 weeks. The estimated mean values are not showing expected mean for the whole prematurely born population in this study, but only for infants that require ROP screening at different postnatal time points. Not all infants have regularly reported values over time, since the ROP screening examinations are individually defined for all infants. AA, arachidonic acid; DHA, docosahexaenoic acid; GA, gestational age; ROP, retinopathy of prematurity; ROP-ActS, Retinopathy of Prematurity Activity Scale.
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References

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