Reply: ⁶⁸Ga NODAGA-Exendin-4 PET Scanning for Focal Congenital Hyperinsulinism: Need for Replication

Abstract

REPLY: Science needs differences in opinions to ensure that facts are presented in a truly reproducible way. That is why we welcome the comments by Banerjee et al. ( 1), and we have to admit that we actually agree with most of them.Needless to say, the results of our study must be tested for replicability-as every set of novel data must be tested. Having said that, we would like to highlight that we have never claimed that this study was a registration trial. In fact, we clearly state that these are the first results of clinical imaging of congenital hyperinsulinism with 68 Ga NODAGA-exendin-4, and we did raise this issue in the discussion and conclusion sections (2).Pertaining to the comments on retrospectively including 11 patients outside the prospective study, we do agree that there is a possibility of extending the bias. However, as the nature of the study was proof of concept and considering the expertise of the Charit e Berlin Centre in treating congenital hyperinsulinism patients from all around the world, we decided to include all available patient data.

Bridging the gaps: recent advances in diagnosis, care, and outcomes in congenital hyperinsulinism

“…When interpreted by a blinded nuclear medicine expert, sensitivity of the two modalities was more similar (93%, 95% CI: 66–100% vs. 86%, 95% CI: 57–98%). Notably, this study was subject to several forms of bias [21 ▪ ,22]. Observer bias was likely introduced due to the inclusion of retrospective data.…”