Verifying the Accuracy of Physician Diagnosis in Infant Cranial Deformation: Japan Medical Company Begins Second Joint Research with Dr. Yoshiaki Sakamoto, Keio University

Japan Medical Company Inc. (Chuo-ku, Tokyo, CEO: Hideaki Ono, hereinafter 'the Company') will conduct a second joint research project regarding the diagnostic accuracy of infant cranial deformation among physicians, in collaboration with a research group led by Dr. Yoshiaki Sakamoto, Assistant Professor at the Department of Plastic and Reconstructive Surgery, Keio University School of Medicine. This research builds upon the published findings of their first joint study, 'Current Status of Diagnosis for Infant Head Shapes,' marking the second collaborative effort between the Keio University School of Medicine's Department of Plastic and Reconstructive Surgery and the Company.

This study aims to evaluate the current state of physicians' diagnostic accuracy and explore evaluation methods that contribute to improving accuracy. The ultimate goal is to properly differentiate between positional cranial deformation (changes in head shape primarily caused by sleeping positions) and pathological cranial deformation requiring surgical treatment (such as craniosynostosis), thereby establishing clinical pathways that connect patients to necessary treatments.

Background of Joint Research: Increasing Importance of Differentiation Demands Practical Clinical Evaluation
In recent years, while helmet therapy for positional cranial deformation has become widespread in Japan, craniosynostosis (a pathological cranial deformation) requires surgical intervention at an appropriate time, making the differentiation between the two clinically critical. Dr. Sakamoto and his team previously conducted a survey on diagnostic accuracy using infant cranial deformation models, reporting a significant gap in diagnostic accuracy between pediatricians and plastic/neurosurgeons involved in treating craniosynostosis. They also highlighted the difficulties of diagnosing based solely on physical models.
Building on these findings, this study designs an evaluation under conditions closer to actual clinical practice to grasp the current state of diagnostic accuracy more precisely and to generate insights applicable in the field, such as the potential utilization of imaging data in diagnosis.

Content of Joint Research: Evaluating Diagnostic Accuracy Combining Skull Models and Imaging Data
In this study, cases of craniosynostosis and positional cranial deformation will be extracted from patients presenting with cranial deformation who underwent CT and simple X-ray examinations. Based on the CT data, physical skull models will be manufactured using a 3D printer and covered with skin-simulating materials. By exhibiting these models along with their corresponding imaging data at relevant medical conferences and requesting attending physicians to perform differentiation via a questionnaire, the study will evaluate diagnostic accuracy and its correlation with background factors.
Evaluation items will include the correct diagnosis rate, as well as analyses factoring in years of medical experience, history of treating the disease, and involvement in treatment.

Significance of the Research: Generating Evidence for Proper Cranial Checkups and Clinical Pathway Establishment
This study aims to clarify the current state of differentiation in infant cranial deformation and to generate insights that contribute to reviewing medical systems leading to appropriate diagnosis, referral, and treatment selection. By organizing diagnostic accuracy and its preconditions, the research is expected to foster shared understanding among medical professionals, promote the appropriate use of image evaluation, and contribute to the establishment of clinical pathways, including referrals to specialists.

Comment on the Joint Research
Dr. Yoshiaki Sakamoto, Assistant Professor, Department of Plastic and Reconstructive Surgery, Keio University School of Medicine:
"Previous research revealed the limits of diagnostic accuracy for infant cranial deformation when relying solely on visual inspection and palpation. This study aims to evaluate the improvement in diagnostic accuracy when simple X-rays are added to visual inspection and palpation. We will quantitatively verify to what extent the correct diagnosis rate improves with the addition of imaging data, thereby clarifying the role of diagnostic imaging in the clinical setting. Furthermore, we aim to improve specialist referrals and..."