1.Assessment of the Important Potential Risks of SGLT–2 Inhibitors: a cohort study using a claims database
Takuya MAEKAWA ; Takaaki KITADE ; Azusa HARA ; Hisashi URUSHIHARA
Japanese Journal of Pharmacoepidemiology 2025;():31.e1-
Objective:We aimed to evaluate the important potential risks listed in the risk management plans of SGLT–2 inhibitors (SGLT–2i) using a real world database.Design: A cohort study of patients prescribed either SGLT–2i (exposure group) or DPP–4 inhibitors (DPP–4i, control group), using a large–scale health insurance database including claims and specific health checkup.Methods:The study population included the patients with type 2 diabetes between April 2014 and August 2021, and received either SGLT–2i or DPP–4i monotherapy, based on the claims in the database provided by DeSC Healthcare, Inc.The comparability between treatment groups was ensured by propensity score matching (PSM) and inverse probability treatment weighting (IPTW). The outcome events included liver disorder, malignant tumors, fractures, cardiovascular disease, acute pancreatitis, acute kidney injury, and lower limb amputation. Hazard ratios (HRs) were estimated using the Cox proportional hazards model, in addition to five types of bias analyses.Results:In the PSM population, the HRs (95% confidential interval [CI]) of the SGLT–2i group versus the DPP–4i group were 0.63 (0.28–1.44) for acute kidney injury, 0.75 (0.58–0.95) for fractures, 0.85 (0.67–1.07) for liver disorders, 0.87 (0.71–1.05) for cardiovascular diseases, 1.15 (0.88–1.51) for malignant tumors, 1.51 (0.71–3.19) for acute pancreatitis, and with no observation of lower limb amputation.In the IPTW population, the HRs (95% CI) of the SGLT–2i group versus the DPP–4i group were 0.72 (0.47–1.10) for acute kidney injury, 0.76 (0.67–0.86) for fractures, 0.91 (0.80–1.02) for liver disorders, 0.86 (0.78–0.94) for cardiovascular diseases, 1.04 (0.92–1.18) for malignant tumors, 1.81 (1.24–2.64) for acute pancreatitis, and 2.89 (0.69–12.1) for lower limb amputation. The ad hoc analysis of malignant tumors by type revealed several organ–specific statistically significant increases or decreases in HRs among the IPTW subjects; however, no significant overall HR for malignant tumors was observed. Some of the bias analysis revealed that there were significant decreases in HRs for acute kidney injury and liver disorders and a significant increase in HR for lower limb amputation.Conclusion:In comparison to DPP–4i, the use of SGLT–2i was not associated with overall risk of malignant tumors. Further confirmatory studies with fit–for–purpose design are warranted to verify the potential, increased or decreased organ–specific risks of malignant tumors by type and the results suggesting decreased risks of bone fracture and cardiovascular diseases, and an increased risk of acute pancreatitis.
2.A novel brief questionnaire using a face rating scale to assess dental anxiety and fear
Takuya MINO ; Aya KIMURA-ONO ; Hikaru ARAKAWA ; Kana TOKUMOTO ; Yoko KUROSAKI ; Yoshizo MATSUKA ; Kenji MAEKAWA ; Takuo KUBOKI
The Journal of Advanced Prosthodontics 2024;16(4):244-254
PURPOSE:
This study aimed to evaluate the reliability and validity of a four-item questionnaire using a face rating scale to measure dental trait anxiety (DTA), dental trait fear (DTF), dental state anxiety (DSA), and dental state fear (DSF).
MATERIALS AND METHODS:
Participants were consecutively selected from patients undergoing scaling (S-group; n = 47) and implant placement (I-group; n = 25). The S-group completed the questionnaire both before initial and second scaling, whereas the I-group responded on the pre-surgery day (Pre-day), the day of implant placement (Imp-day), and the day of suture removal (Post-day).
RESULTS:
The reliability in the S-group was evaluated using the test-retest method, showing a weighted kappa value of DTA, 0.61; DTF, 0.46; DSA, 0.67; DSF, 0.52. Criterion-related validity, assessed using the State-Trait Anxiety Inventory’s trait anxiety and state anxiety, revealed positive correlations between trait anxiety and DTA/DTF (DTA, ρ = 0.30; DTF, ρ = 0.27, ρ: correlation coefficient) and between state anxiety and all four items (DTA, ρ = 0.41; DTF, ρ = 0.32; DSA, ρ = 0.25; DSF, ρ = 0.25). Known-group validity was assessed using the initial data and Imp-day data from the S-group and I-group, respectively, revealing significantly higher DSA and DSF scores in the I-group than in the S-group. Responsiveness was gauged using I-group data, showing significantly lower DSA and DSF scores on post-day compared to other days.
CONCLUSION
The newly developed questionnaire has acceptable reliability and validity for clinical use, suggesting its usefulness for research on dental anxiety and fear and for providing patient-specific dental care.
3.Rating criteria to evaluate student performance in digital wax-up training using multi-purpose software
Takuya MINO ; Yoko KUROSAKI ; Kana TOKUMOTO ; Takaharu HIGUCHI ; Shinichi NAKANODA ; Ken NUMOTO ; Ikue TOSA ; Aya KIMURA-ONO ; Kenji MAEKAWA ; Tae Hyung KIM ; Takuo KUBOKI
The Journal of Advanced Prosthodontics 2022;14(4):203-211
PURPOSE:
. The aim of this study was to introduce rating criteria to evaluate student performance in a newly developed, digital wax-up preclinical program for computer-aided design (CAD) of full-coverage crowns and preliminarily investigate the reliability and internal consistency of the rating system.
MATERIALS AND METHODS:
. This study, conducted in 2017, enrolled 47 fifth-year dental students of Okayama University Dental School. Digital wax-up training included a fundamental practice using computer graphics (CG), multipurpose CAD software programs, and an advanced practice to execute a digital waxup of the right mandibular second molar (#47). Each student’s digital wax-up work (stereolithography data) was evaluated by two instructors using seven qualitative criteria. The total qualitative score (0-90) of the criteria was calculated.The total volumetric discrepancy between each student’s digital wax-up work and a reference prepared by an instructor was automatically measured by the CAD software. The inter-rater reliability of each criterion was analyzed using a weighted kappa index. The relationship between the total volume discrepancy and the total qualitative score was analyzed using Spearman’s correlation.
RESULTS:
. The weighted kappa values for the seven qualitative criteria ranged from 0.62 - 0.93. The total qualitative score and the total volumetric discrepancy were negatively correlated (ρ = -0.27, P = .09, respectively); however, this was not statistically significant.
CONCLUSION
. The established qualitative criteria to evaluate students’ work showed sufficiently high inter-rater reliability; however, the digitally measured volumetric discrepancy could not sufficiently predict the total qualitative score.


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