BACKGROUND

Diabetic nephropathy is a common complication of diabetes. We investigated the risk factors for diabetic nephropathy in individuals newly diagnosed with type 2 diabetes.

METHODS

Data from the Japanese Diagnosis Procedure Combination in-patient database (April 2008 to December 2018) were analyzed. The endpoint was subsequent diabetic nephropathy diagnosis or as the time when estimated glomerular filtration rate become <60 ml/min/1.73 m². Candidate risk factors included age, Hemoglobin A1c, log-transformed triglyceride, total cholesterol, and high-density lipoprotein cholesterol levels, body mass index, and estimated glomerular filtration rate. Eligible individuals with type 2 diabetes without complications who had pre- and post-diagnosis Hemoglobin A1c and serum creatinine measurements, and a history of hypertension or cardiovascular disease pre-diagnosis. Those with pre-existing kidney diseases, nephropathy onset pre-diagnosis, estimated glomerular filtration rate <60 ml/min/1.73 m² on or before diabetes diagnosis, or age <20 years at diabetes diagnosis were excluded. A multivariate Cox proportional hazards model (p = 0.2 backward selection) was employed.

RESULTS

Of 2,664 eligible individuals (1,775 men, 889 women), 325 men and 175 women developed diabetic nephropathy during follow-up. Cumulative incidence within 5 years was 29.0% in men and 32.5% in women. Age and estimated glomerular filtration rate in both sexes, and total cholesterol in men were significant.

CONCLUSIONS

Age, estimated glomerular filtration rate, and lipid pose potential risks for diabetic nephropathy onset within 5 years of diabetes diagnosis in individuals with hypertension. Collectively, our findings highlight the importance of early monitoring and intervention in this high-risk.

BACKGROUND

This study aimed to compare telephone follow-ups for patients with urologic malignancies in Japan before and during the COVID-19 pandemic.

METHODS

Using the database of the Japan Medical Data Center Co., Ltd., we identified patients with urologic malignancies who underwent at least one telephone follow-up between April 2014 and March 2020.

The self-controlled case series method was used to calculate the incidence rate ratio of telephone follow-up utilization for the pandemic using the pre-pandemic period as a reference.

RESULTS

Of the 289 patients, 31 were women. Their median age was 80 years, and the median observation period was 28 months.

The incidence rate ratio for telephone follow-up utilization during the pandemic was 17.8 compared to that of the pre-pandemic period. In an analysis stratified by type of carcinoma, the incidence rate ratios were higher in all strata than they were before the pandemic. However, among male patients with genital malignancies, particularly prostate cancers, the incidence rate ratio was lower than in other strata.

According to analysis stratified by age, the usage of telephone follow-up for men in their 50s or younger was particularly low. Additionally, the interval between face-to-face visits increased in patients over 60 years-of-age.

CONCLUSIONS

The telephone follow-up among patients with urologic malignancies in Japan increased significantly during the early phase of the COVID-19 pandemic. Our results indicate that telephone follow-up can potentially be a valuable patient-doctor communication tool.

Single-arm trials (SATs) are clinical studies without a parallel control group, serving as a vital alternative to randomized controlled trials (RCTs) in scenarios where traditional trial designs are impractical. These trials are particularly relevant in rare diseases, advanced malignancies, novel treatment modalities, and life-threatening conditions, where ethical concerns, logistical challenges, or small patient populations limit the feasibility of RCTs. SATs enable expedited evaluation of therapeutic interventions, often forming the foundation for regulatory approvals.

This article explores the principles, applications, and methodological considerations of SATs. Their advantages include smaller sample size requirements, faster timelines, and regulatory acceptance by agencies such as the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA). Despite these benefits, SATs face challenges, such as potential biases due to the lack of a control group, limitations in endpoints, and reliance on historical controls that may compromise result validity. Best practices in SAT design are outlined, including refining scientific questions, defining eligibility criteria, selecting clinically meaningful endpoints, and employing robust statistical methods like Simon’s two-stage design and Bayesian approaches.

Propensity score (PS) is the probability of the exposure being assigned, conditional on the observed baseline covariates. Many observational studies have used PS analyses to investigate the effects of exposure on outcomes. This report reviews the five steps of PS analyses: 1) calculating PS; 2) checking the overlap of PS; 3) implementing a matching or weighting method including PS matching, inverse-probability-of-treatment weighting, standardized mortality ratio weighting, matching weighting, and overlap weighting; 4) diagnosing the covariate balance; and 5) comparing the outcomes. Two groups are often compared in PS analyses; however, three-group comparisons can provide clinicians with more benefits in many situations in routine clinical practice. Thus, we describe not only two-group comparisons but also three-group comparisons by introducing a few studies that used generalized PS to compare three groups.