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Objectives: This study aims to independently and externally validate the Risk Prediction Model for Diabetic Kidney Disease (RPM-DKD) in patients with type 2 diabetes mellitus (T2DM)., Design: This is a retrospective cohort study., Setting: Outpatient clinics at Lee's United Clinics, Taiwan, China., Participants: A total of 2504 patients (average age 55.44 years, SD, 7.49 years) and 4455 patients (average age 57.88 years, SD, 8.80 years) were included for analysis in the DKD prediction and progression prediction cohorts, respectively., Exposure: The predicted risk for DKD and DKD progression for each patient were all calculated using the RPM-DKD., Primary and Secondary Outcome Measures: The primary outcome measure was overall incidence of DKD. Secondary outcomes included DKD progression. The discrimination, calibration and precision of the RPM-DKD score were assessed., Results: The DKD prediction cohort and progression prediction cohort consisted of patients with 2504 and 4455 T2DM, respectively. The RPM-DKD examined in this study showed moderately discriminative ability with area under the curve ranged from 0.636 to 0.681 for the occurrence of DKD and 0.620 to 0.654 for the progression of DKD. The Hosmer-Lemeshow χ 2 test indicted the RPM-DKD was not well calibrated for predicting the occurrence of DKD and overestimated the progression of DKD. The precision for predicting the occurrence and progression of DKD were 43.2% and 42.2%, respectively., Conclusions: On external validation, the RPM-DKD cannot accurately predict the risk of DKD occurrence and progression in patients with T2DM., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Informed consent is essential for the ethical conduct of clinical research and is a culturally sensitive issue. But, a measurable Chinese version of the scale to evaluate the informed consent process has not yet been explored in the existing literature., Research Objectives: This study aimed to develop and psychometrically test the Chinese version of the Informed Consent Process Scale., Research Design: Back-translation was conducted to develop the Chinese version of the questionnaire. A cross-sectional survey was administered, after which an exploratory factor analysis was conducted., Participants: We recruited a total of 375 participants who had experience in signing an informed consent form within the previous 3 years in Taiwan., Ethical Considerations: This study was approved by two Institutional Review Boards and the autonomy of the participants was respected., Findings: The Chinese version of the Informed Consent Process Scale is composed of three factors with 23 items showing evidence of acceptable reliability and validity. Three major factors were extracted and labeled: Factor 1 - 'Understanding of the research', Factor 2 - 'Trust and confidence' and Factor 3 - 'Doubt and uncertainty'. The three factors accounted for is 52.954 of the total variance with Cronbach's α of .917., Discussion and Conclusion: The finding corroborates previous studies showing that participants had too little understanding on the informed consent forms they signed and implied the need to clarify the critical points in clinical research. The psychometric results indicated good internal consistency and validity for this newly constructed instrument, and it was found worthy of conducting further testing and application.