The Reporting Quality of Machine Learning Studies on Pediatric Diabetes Mellitus: Systematic Review.

Background: Diabetes mellitus (DM) is a major health concern among children with the widespread adoption of advanced technologies. However, concerns are growing about the transparency, replicability, biasedness, and overall validity of artificial intelligence studies in medicine.

Objective: We aimed to systematically review the reporting quality of machine learning (ML) studies of pediatric DM using the Minimum Information About Clinical Artificial Intelligence Modelling (MI-CLAIM) checklist, a general reporting guideline for medical artificial intelligence studies.

Methods: We searched the PubMed and Web of Science databases from 2016 to 2020. Studies were included if the use of ML was reported in children with DM aged 2 to 18 years, including studies on complications, screening studies, and in silico samples. In studies following the ML workflow of training, validation, and testing of results, reporting quality was assessed via MI-CLAIM by consensus judgments of independent reviewer pairs. Positive answers to the 17 binary items regarding sufficient reporting were qualitatively summarized and counted as a proxy measure of reporting quality. The synthesis of results included testing the association of reporting quality with publication and data type, participants (human or in silico), research goals, level of code sharing, and the scientific field of publication (medical or engineering), as well as with expert judgments of clinical impact and reproducibility.

Results: After screening 1043 records, 28 studies were included. The sample size of the training cohort ranged from 5 to 561. Six studies featured only in silico patients. The reporting quality was low, with great variation among the 21 studies assessed using MI-CLAIM. The number of items with sufficient reporting ranged from 4 to 12 (mean 7.43, SD 2.62). The items on research questions and data characterization were reported adequately most often, whereas items on patient characteristics and model examination were reported adequately least often. The representativeness of the training and test cohorts to real-world settings and the adequacy of model performance evaluation were the most difficult to judge. Reporting quality improved over time (r=0.50; P=.02); it was higher than average in prognostic biomarker and risk factor studies (P=.04) and lower in noninvasive hypoglycemia detection studies (P=.006), higher in studies published in medical versus engineering journals (P=.004), and higher in studies sharing any code of the ML pipeline versus not sharing (P=.003). The association between expert judgments and MI-CLAIM ratings was not significant.

Conclusions: The reporting quality of ML studies in the pediatric population with DM was generally low. Important details for clinicians, such as patient characteristics; comparison with the state-of-the-art solution; and model examination for valid, unbiased, and robust results, were often the weak points of reporting. To assess their clinical utility, the reporting standards of ML studies must evolve, and algorithms for this challenging population must become more transparent and replicable.