Copyright 2005 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.2005
The Early Treatment for Retinopathy of Prematurity article1 is a valuable report reflecting a massive amount of work by its authors and investigators. However, we have concerns regarding some aspects of this report.
The very large number of centers and investigators creates the potential for inconsistency and bias when interpreting the ophthalmoscopic findings, especially since there were no photographic documentation and centralized review typical of large multicenter trials. The only photograph mentioned in the report is a standardized image defining plus disease. (Incidentally, it would have been helpful to have this photograph included in the article since the presence or absence of plus disease is a critical variable when interpreting the study findings.) Masked confirmatory examinations were used to ensure eligibility for randomization. It is likely that in some cases the 2 examiners would agree that an infant was eligible for the trial but would not necessarily agree on the specific findings. How many discrepancies were there, and how were these resolved?
Vander JF, McNamara JA, Tasman W, Brown GC. Revised Indications for Early Treatment of Retinopathy of Prematurity. Arch Ophthalmol. 2005;123(3):406-407. doi:10.1001/archopht.123.3.406-b