Sex-dependent effect of socioeconomic status on cardiovascular event risk in a population-based cohort of patients with type 2 diabetes.

BACKGROUND: Socioeconomic status (SES) factors often result in profound health inequalities among populations, and their impact may differ between sexes. The aim of this study was to estimate and compare the effect of socioeconomic status indicators on incident cardiovascular disease (CVD)-related events among males and females with type 2 diabetes (T2D). METHODS: A population-based cohort from a southern European region including 24,650 patients with T2D was followed for five years. The sex-specific associations between SES indicators and the first occurring CVD event were modeled using multivariate Fine-Gray competing risk models. Coronary Heart Disease (CHD) and stroke were considered secondary outcomes. RESULTS: Patients without a formal education had a significantly higher risk of CVD than those with a high school or university education, with adjusted hazard ratios (HRs) equal to 1.24 (95%CI: 1.09-1.41) for males and 1.50 (95%CI: 1.09-2.06) for females. Patients with <18 000€ income had also higher CVD risk than those with ≥18 000€, with HRs equal to 1.44 (95%CI: 1.29-1.59) for males and 1.42 (95%CI: 1.26-1.60) for females. Being immigrant showed a HR equal to 0.81 (95%CI: 0.66-0.99) for males and 1.13 (95%CI: 0.68-1.87) for females. Similar results were observed for stroke, but differed for CHD when income is used, which had higher effect in females. CONCLUSION: Socioeconomic inequalities in CVD outcomes are present among T2D patients, and their magnitude for educational attainment is sex-dependent, being higher in females, suggesting the need to consider them when designing tailored primary prevention and management strategies.

Prostatic Artery Embolization Versus Transurethral Resection of the Prostate: A Post Hoc Cost Analysis of a Randomized Controlled Clinical Trial.

PURPOSE: To perform a post hoc analysis of patient-incurred costs in a randomized controlled clinical trial comparing prostatic artery embolization (PAE) and transurethral resection of the prostate (TURP). MATERIALS AND METHODS: Patients older than 60 years with indication of TURP were randomized to PAE or TURP procedure. After intervention and hospital discharge, patients were follow-up during 12 months The associated patient costs were categorized according to the study period: pre-intervention, intervention, hospitalization, and follow-up. Several items for both groups were analyzed within each study period. RESULTS: The mean total costs per patient were lower for PAE (€ 3,192.87) than for TURP (€ 3,974.57), with this difference of € 781.70 being significant (p = 0.026). For most evaluated items, the mean costs were significantly higher for TURP. No significant differences were observed in the mean costs of PAE (€ 1,468.00) and TURP (€ 1,684.25) procedures (p = 0.061). However, the histopathology analysis, recovery room stay, and intraoperative laboratory analysis increased the interventional costs for TURP (€ 1,999.70) compared with PAE (€ 1,468.00) (p < 0.001). No cost differences were observed between PAE (€ 725.26) and TURP (€ 556.22) during the 12 months of follow-up (p = 0.605). None of patients required a repeat intervention during the study period. CONCLUSIONS: Considering the short-term follow-up, PAE was associated with significantly lower costs compared with TURP. Future investigations in the context of routine clinical practice should be aimed at comparing the long-term effectiveness of both procedures and determining their cost-effectiveness. LEVEL OF EVIDENCE: Level 1 (a-c).

Cancer Clinical Trials: Treatment Costs Associated With a Spanish National Health System Institution.

BACKGROUND: Clinical trials should be part of routine health care. There is a common perception that enrolling patients into clinical trials results in additional costs. We conducted a retrospective cost analysis to compare medical costs attributable to participation in cancer treatment trials versus standard of care in a single Spanish institution. METHODS: Patients recruited into cancer clinical trials between 2014 and 2016 were selected. Each research protocol was reviewed to identify trial-associated medical procedures and costs, as well as the equivalent care had the patient not been entered in the trial. Treatment cost difference was the difference between the cost of the clinical trial and that of the standard of care. RESULTS: A total of 68 adult patients were treated in 20 different clinical trials. The overall cost treatment of the patients included in the trials was 79% lower in comparison to the standard of care. However, the load of medical procedures was 32% higher. The average treatment cost per patient and protocol ranged from an excess of €8193 to a saving of €59,770. CONCLUSIONS: There is a wide range of difference in treatment costs for cancer clinical trial participants versus standard of care. Commercial trial protocols were associated with larger savings compared with the noncommercial ones, even though these may involve excess treatment costs. Overall, clinical trials provide not only the best context for progress of clinical research and health care but also creates opportunities for reducing cancer care costs.

Socioeconomic inequalities in cardiometabolic control in patients with type 2 diabetes.

BACKGROUND: The aim of this study was to determine if the achievement of control targets in patients with type 2 diabetes was associated with personal socioeconomic factors and if these associations were sex-dependent. METHODS: This cross-sectional, population-based study was conducted in Spain. Glycated haemoglobin (HbA1c) level and other clinical parameters were obtained from electronic primary care records (n = 32,638 cases). Socioeconomic status was determined using education level and yearly income. Among patients, having their HbA1c level checked during the previous year was considered as an indirect measure of the process of care, whereas tobacco use and clinical parameters such as HbA1c, low-density lipoprotein cholesterol (LDL-c) and blood pressure (BP) were considered intermediate control outcomes. General linear mixed effect models were used to assess associations. RESULTS: The achievement of metabolic and cardiovascular control targets in patients with type 2 diabetes was associated with educational level and income, and socioeconomic gradients differed by sex. The probability of having had an HbA1c test performed in the previous year was higher in patients with lower education levels. Patients in the lowest income and education level categories were less likely to have reached the recommended HbA1c level. Males in the lowest education level categories were less likely to be non-smokers or to have achieved the blood pressure targets. In contrast, patients within the low income categories had a higher probability of reaching the recommended LDL-c level. CONCLUSIONS: Our results suggest the presence of socioeconomic inequalities in the achievement of cardiovascular and metabolic control that differed in direction and magnitude depending on the measured outcome and sex of the patient. These findings may help health professionals focus on high-risk individuals to decrease health inequalities.

On the use of randomization tests following adaptive designs.

Randomization tests (sometimes referred to as "re-randomization" tests) are used in clinical trials, either as an assumption-free confirmation of parametric analyses, or as an independent analysis based on the principle of randomization-based inference. In the context of adaptive randomization, either restricted or response-adaptive procedures, it is unclear how accurate such Monte Carlo approximations are, or how many Monte Carlo sequences to generate. In this paper, we describe several randomization procedures for which there is a known exact or asymptotic distribution of the randomization test. For a special class of procedures, called [Formula: see text], and binary responses, the exact test statistic has a simple closed form. For the limited subset of existing procedures with known exact and asymptotic distributions, we can use these as a benchmark for the accuracy of Monte Carlo randomization techniques. We conclude that Monte Carlo tests are very accurate, and require minimal computation time. For simple tests with binary response in the class of [Formula: see text] procedures, the exact distribution provides the best test, but Monte Carlo approximations can be used when the exact distribution is difficult to compute.