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
Pivodic, Aldina, Johansson, Helena, Smith, Lois E. H., Löfqvist, Chatarina, Albertsson-Wikland, Kerstin, Nilsson, Staffan and Hellström, Ann. (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. BMJ Open Ophthalmology. 7(1), p. Article e000923. https://doi.org/10.1136/bmjophth-2021-000923
|Authors||Pivodic, Aldina, Johansson, Helena, Smith, Lois E. H., Löfqvist, Chatarina, Albertsson-Wikland, Kerstin, Nilsson, Staffan and Hellström, Ann|
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.
|Journal||BMJ Open Ophthalmology|
|Journal citation||7 (1), p. Article e000923|
|Publisher||BMJ Publishing Group|
|Digital Object Identifier (DOI)||https://doi.org/10.1136/bmjophth-2021-000923|
|PubMed Central ID||PMC8996016|
|Open access||Published as ‘gold’ (paid) open access|
|Funder||Swedish Medical Research Council|
|Gothenburg Medical Society|
|Government of Sweden|
|De Blindas Vänner|
|Knut and Alice Wallenberg Clinical Scholars|
|National Eye Institute (NEI), National Institutes of Health|
File Access Level
|Online||08 Apr 2022|
|Publication process dates|
|Accepted||28 Mar 2022|
|Deposited||03 Feb 2023|
|License: CC BY-NC 4.0|
|File access level: Open|
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