Development and Validation of a Model for Predicting Diabetic Nephropathy in Chinese People.

OBJECTIVE: To develop a risk model for predicting later development of diabetic nephropathy (DN) in Chinese people with type 2 diabetes mellitus (T2DM) and evaluate its performance with independent validation. METHODS: We used data collected from the project 'Comprehensive Research on the Prevention and Control of Diabetes', which was a community-based study conducted by the Jiangsu Center for Disease Control and Prevention in 2013. A total of 11,771 eligible participants were included in our study. The endpoint was a clear diagnosis of DN. Data was divided into two components: a training set for model development and a test set for validation. The Cox proportional hazard regression was used for survival analysis in men and women. The model's performance was evaluated by discrimination and calibration. RESULTS: The incidence (cases per 10,000 person-years) of DN was 9.95 (95% CI; 8.66-11.43) in women and 11.28 (95% CI; 9.77-13.03) in men. Factors including diagnosis age, location, body mass index, high-density-lipoprotein cholesterol, creatinine, hypertension, dyslipidemia, retinopathy, diet control, and physical activity were significant in the final model. The model showed high discrimination and good calibration. CONCLUSION: The risk model for predicting DN in people with T2DM can be used in clinical practice for improving the quality of risk management and intervention.

Verification of the correlation between progression-free survival and overall survival considering magnitudes of survival post- progression in the treatment of four types of cancer.

BACKGROUND: With development and application of new and effective anti-cancer drugs, the median survival post-progression (SPP) is often prolonged, and the role of the median SPP on surrogacy performance should be considered. To evaluate the impact of the median SPP on the correlation between progression-free survival (PFS) and overall survival (OS), we performed simulations for treatment of four types of cancer, advanced gastric cancer (AGC), metastatic colorectal cancer (MCC), glioblastoma (GBM), and advanced non-small-cell lung cancer (ANSCLC). MATERIALS AND METHODS: The effects of the median SPP on the statistical properties of OS and the correlation between PFS and OS were assessed. Further, comparisons were made between the surrogacy performance based on real data from meta-analyses and simulation results with similar scenarios. RESULTS: The probability of a significant gain in OS and HR for OS was decreased by an increase of the SPP/ OS ratio or by a decrease of observed treatment benefit for PFS. Similarly, for each of the four types of cancer, the correlation between PFS and OS was reduced as the median SPP increased from 2 to 12 months. Except for ANSCLC, for which the median SPP was equal to the true value, the simulated correlation between PFS and OS was consistent with the values derived from meta-analyses for the other three kinds of cancer. Further, for these three types of cancer, when the median SPP was controlled at a designated level (i.e., < 4 months for AGC, < 12 months for MCC, and <6 months for GBM), the correlation between PFS and OS was strong; and the power of OS reached 34.9% at the minimum. CONCLUSIONS: PFS is an acceptable surrogate endpoint for OS under the condition of controlling SPPs for AGC, MCC, and GBM at their limit levels; a similar conclusion cannot be made for ANSCLC.

[Predictive value of HATCH score on atrial fibrillation recurrence post radiofrequency catheter ablation].

OBJECTIVE: To determine the predictive value of HATCH score on recurrence of atrial fibrillation (AF) after radiofrequency catheter ablation (RFCA). METHODS: The data of 123 consecutive AF patients (74 paroxysmal and 49 persistent AF) who underwent RFCA between April 2009 and December 2010 in our department were retrospectively analyzed. Of theses patients, 65 (52.9%) patients had HATCH score = 0, 41 (33.3%) patients had HATCH score = 1, and 17 (13.8%) patients had HATCH score ≥ 2 (HATCH = 2 in 11 patients, HATCH = 3 in 5 patients, HATCH = 4 in 1 patient). The recurrence was defined as atrial tachyarrhythmia lasting more than 30 seconds after 3 months post RFCA. The patients were divided into recurrence group and no recurrence group. Relationship between HATCH score and recurrence was observed. RESULTS: There were 43 cases in recurrence group and 80 cases in no recurrence group. After 12 months follow-up, HATCH score was significant higher in recurrence group than in non-recurrence group [(0.91 ± 0.94) score vs. (0.53 ± 0.80) score, P < 0.05]. The ratio of patients with HATCH ≥ 2 in recurrence group was higher than in non-recurrence group [23.3% (10/43) vs. 8.8% (7/80), P < 0.01]. The sensitivity and specificity of HATCH ≥ 2 to define the risk of recurrence was 25.0%, 92.4% respectively. Cumulative non-recurrence rate of patients with HATCH score ≥ 2 was lower than patients with HATCH score = 0 and 1 (P < 0.05). CONCLUSION: Higher HATCH score is associated with increased risk of AF recurrence post RFCA.