Clinical Epidemiology最新文献

Background: Capmatinib was approved by the US Food and Drug Administration (FDA) in 2020 for the treatment of non-small cell lung cancer with MET exon 14 mutation (METex14). Real-world studies on the safety of Capmatinib are still lacking. The aim of this study was to explore the significant adverse drug reactions (ADRs) associated with Capmatinib through the FDA Adverse Event Reporting System (FAERS) database.

Methods: We employed the reported odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and the Empirical Bayes Geometric Mean (EBGM) as primary algorithms for the disproportionality analysis. Adverse events (AEs) were classified as adverse drug reactions (ADRs) solely upon fulfillment of criteria across all four algorithms.

Results: In our study, there were 1767 cases explicitly attributed to Capmatinib. A total of 38 ADRs in preferred terms (PTs) level in 14 system-organ categories (SOCs) were identified after filtering. Notably, unexpected SOC "Ear and labyrinth disorders" and PTs "hypoacusis" and "deafness" were identified, without being specified in the drug label.

Conclusion: Our study identified unexpected ADRs associated with Capmatinib, with a focus on ototoxicity-related events, underscoring the need for enhanced clinical monitoring and further investigation into the underlying mechanisms.

Background: Previous studies have suggested a potential association between plasma aldosterone concentration (PAC) and calcium regulation. However, it remains unclear whether elevated PAC levels increase the risk of urinary stones. Therefore, this study aimed to investigate the relationship between PAC levels and urinary stones, including their subtypes, in patients with hypertension.

Methods: This large-scale study included a total of 35161 hypertensive patients. Multivariable logistic regression was used to analyze the association between PAC levels and urinary stones, as well as their subtypes. Additionally, a dose-response relationship was explored using restricted cubic spline (RCS) analysis, and a two-stage comparative analysis was conducted based on the RCS turning point. The importance of PAC was further confirmed through variable importance analysis. Finally, extensive subgroup analyses and sensitivity analyses were performed to assess the robustness of the findings.

Results: Multivariable logistic regression revealed a significant association between elevated PAC levels and the occurrence of urinary stones and their subtypes. Specifically, for every 5 ng/dL increase in PAC, the risk of urinary stones increased by 26% (odds ratios [OR] 1.26, 95% confidence interval [CI], 1.22-1.30, P<0.001). Furthermore, RCS threshold analysis demonstrated a marked increase in urinary stone risk when PAC levels exceeded 14.2 ng/dL (OR 1.50, 95% CI, 1.38-1.63, P<0.001). These findings were consistent across subtypes, including kidney stones and ureteral stones. Subgroup analyses showed that the results were unaffected by stratification factors, and sensitivity analyses further confirmed the stability of the findings.

Conclusion: This study demonstrated that elevated PAC levels are significantly associated with the occurrence of urinary stones and their subtypes in hypertensive patients. These findings suggest that controlling PAC levels in hypertensive patients may help reduce the risk of urinary stone formation.

Introduction: Venous thromboembolism (VTE) is a common disease with a serious prognosis. Nonetheless, many aspects of this multicausal disease are poorly understood. The aim of establishing The Danish Venous Thromboembolism Cohort was to study VTE risk and prognosis within a life-course context.

Methods: The Danish Venous Thromboembolism Cohort was based on respondents to the questionnaire-based Danish National Health Survey (DNHS) conducted in 2010, 2013, and 2017 and was linked to Danish national health and administrative registries.

Results: A total of 474,022 unique respondents to the DNHS were included in this cohort, 8,460 of whom were diagnosed with VTE before the survey response date. The survey's response rate varied between 54% and 60%. The median age at the survey response date was 54 years (interquartile range: 40-66 years), and 46.1% of respondents were men. The cohort contains detailed information on lifestyle factors (smoking habits, alcohol consumption, physical activity level, and dietary habits), health status indicators (healthcare-seeking behavior, body mass index, self-rated health, and mental distress), and self-reported morbidities. In addition, the survey data were linked to records in Danish medical and administrative registries to obtain information on clinical data and outcomes, including hospitalizations, medication use, laboratory test results, labor market participation, vital status, and causes of death.

Discussion: The Danish Venous Thromboembolism Cohort is a valuable data resource for use in future studies on VTE research, with a focus on risk factors, complications, interactions, and prognosis.

This study explored the association between celiac disease (CeD) and Dupuytren's contracture (DC) using data from the Swedish ESPRESSO cohort. We analyzed 49,699 CeD patients and 245,267 matched controls, identifying 1420 incident DC cases. CeD patients had a 1.21-fold increased risk of DC compared to controls, with a more pronounced risk in women and older individuals. Further research is needed to understand the underlying mechanisms of this relationship.

Background: With global aging, cancer burden rises. Kidney cancer is significantly influenced by high body mass index (BMI), especially in the elderly. This study analyzes the burden of kidney cancer attributable to high BMI in those aged ≥60, clarifying causes and future trends.

Methods: Using Global Burden of Disease (GBD) 2021 study, we assessed kidney cancer burden due to high BMI in population aged ≥60 from 1990 to 2021, comparing deaths, disability-adjusted life years (DALYs), age-standardized rate (ASR) of DALYs (ASDR), and mortality (ASMR). Stratified by Socio-Demographic Index (SDI), region, sex, and age, we evaluated spatiotemporal trends and inequalities. Finally, the Bayesian Age-Period-Cohort (BAPC) model predicted burden changes through 2040.

Results: From 1990 to 2021, DALYs and deaths from high BMI-induced kidney cancer in those aged ≥60 increased by 165.82% and 186.39%, driven by population growth. In 2021, ASDR was 45.55/100,000 and ASMR 2.39/100,000. Regional differences were significant. DALYs and deaths expanded, especially in those aged ≥95. Males had higher burden than females. SDI correlated positively with ASDR and ASMR (r>0, P<0.05). Health inequalities continue to rise. By 2040, burden is projected to rise, especially in low-middle and low SDI regions, more in males.

Conclusion: This study shows a significant increase in kidney cancer burden due to high BMI in those aged ≥60 over 32 years, driven by population growth. Disparities across regions, genders, and age groups highlight the need for targeted prevention and early intervention, especially for high-risk groups (males, elderly, low-middle SDI regions), to reduce burden and optimize healthcare resource allocation.

Background: Observational studies aimed at evaluating the effectiveness of screening mammography are prone to self-selection due to differences in personal characteristics between women attending and those not attending screening. A method based on a quantity Dr has been promoted to correct for this bias, Dr being the risk of breast cancer death in a group of women not attending screening compared to the risk of breast cancer death in a population without screening.

Objective: To estimate the amount of self-selection in observational studies aimed at evaluating screening mammography effectiveness and to estimate Dr quantities needed to correct for this bias.

Methods: A first step quantified self-selection and Dr quantities specific to Swedish randomized trials using the most recent publications. A second step estimated self-selection specific to cohort studies on screening mammography effectiveness using the relative risk of 0.54 for all-cause death from these studies and the relative risk of all-cause death of 0.98 reported in Swedish trials. Using self-selection estimated from cohort studies, the Dr quantity needed to correct observational studies on screening mammography effectiveness was estimated. In a last step, corrections for self-selection in observational studies on screening mammography were retrieved.

Results: The self-selection bias was 2.10 in Swedish trials. Self-selection in cohort studies was computed as (0.98/0.54) = 1.78. The Dr quantity required to correct results of observational studies was 1.53. In 19 case-control and cohort studies on screening mammography effectiveness, the median Dr quantity used for correction purposes was 1.16 (IQR: 1.11-1.28).

Conclusion: Compared to women attending screening, the risk of breast cancer death was approximately two times greater in women not attending screening. This increased risk was independent of screening effects. Most observational studies have overestimated the effectiveness of screening mammography because they used Dr quantities that were too small to correct for self-selection.

Introduction: Ensuring the validity and completeness of clinical data is crucial when utilizing nationwide registers such as the Danish National Patient Registry (DNPR) for epidemiological research. The literature on this topic is, however, strongly lacking for Ear-nose-and-throat (ENT) surgery. The aim of this study was to assess the validity and completeness of the septoplasty surgical procedure code in DNPR.

Methods: This population-based validation and completeness study included all cases of septoplasty surgical procedure codes registered in the DNPR in 2021 and 2022 at the ENT department at Odense University Hospital (OUH) in Denmark. The unique personal registration number was used to identify cases from the DNPR in OUH data registrations. All surgical notes were evaluated manually to determine whether septoplasty had been performed. The primary outcomes were validity (PPV) and completeness assessed as the sensitivity, presented with 95% confidence intervals (CI).

Results: A total of 479 cases were identified from the DNPR. Upon evaluation of the surgical notes and after withdrawal of duplicates, 470 cases were confirmed to have undergone septoplasty, resulting in a PPV of 99% (95% CI (97.6-99.7)). From the OUH data registrations, 485 registrations of septoplasty were identified. Evaluation of the surgical notes left 475 cases of confirmed septoplasty, corresponding to five missing cases in the DNPR, resulting in a sensitivity of 99% (95% CI (97.6-99.7)).

Conclusion: This study showed high validity and completeness for registrations of the septoplasty surgical procedure code in the DNPR. We therefore conclude that the DNPR is a reliable tool for epidemiological research concerning septoplasty.

Background: Statins, though widely used, may accelerate diabetes progression, necessitating interventions to counteract this effect.

Purpose: To compare the effect of sodium-glucose co-transporter 2 inhibitors (SGLT2is) and sulfonylureas or meglitinides on diabetes progression in individuals receiving statins.

Patients and methods: This retrospective cohort study utilized data from the National Health Insurance Research Database of Taiwan. We included patients with diabetes receiving statins and newly initiated SGLT2is or sulfonylureas/meglitinides between July 1, 2016 and December 31, 2020. Diabetes progression was defined as insulin initiation, increase in antidiabetic medication class, or occurrence of new acute hyperglycemic complications. Propensity score matching was used to adjust baseline characteristics. Cox proportional hazards regression was used to calculate the hazard ratios for diabetes progression between users of SGLT2is and those of sulfonylureas or meglitinides. The statistical significance level was set at 0.05 for all analyses.

Results: SGLT2i users had a significantly lower risk of diabetes progression compared to sulfonylurea/meglitinide users (HR: 0.53, 95% CI: 0.50-0.57, p-value < 0.001). Similar results were found in insulin initiation (HR: 0.48, 95% CI: 0.38-0.61, p-value < 0.001) and increase in antidiabetic medication class (HR: 0.53, 95% CI: 0.50-0.57, p-value < 0.17). However, the risk of new acute glycemic complications did not significantly differ between groups (HR: 2.47, 95% CI: 0.67-9.08, p-value = 0.17).

Conclusion: SGLT2is may be an effective second-line therapy for statin-treated patients by slowing diabetes progression and potentially mitigating statin-induced metabolic disturbances. Further research, including randomized controlled trials or observational studies with comprehensive laboratory data, is needed to confirm these findings and evaluate their broader applicability.

Purpose: Statin use has been consistently associated with improved clinical outcomes (especially recurrence) in breast cancer in multiple observational studies backed by compelling preclinical evidence. The strength of this evidence warrants a clinical trial to test the efficacy of statin exposure on breast cancer recurrence.

Patients and methods: The double-blind, phase III, randomized, placebo-controlled MASTER (MAmmary cancer STatins in ER positive breast cancer) trial includes women diagnosed with early-stage, estrogen receptor-positive (ER+) breast cancer who are candidates for systemic (neo)adjuvant therapy. Enrolled patients are given standard (neo)adjuvant therapy and additionally randomized to either atorvastatin (80 mg/day) or placebo for two years. The trial's primary outcome is invasive disease-free survival (IDFS), with a target accrual of 3360 patients in total to achieve 80% power (two-sided alpha=0.05) to detect a 25% reduction in the risk of an IDFS event comparing the statin and placebo arms. At 3-, 6-, 12-, and 24-month follow-up time points, patients will have blood drawn for biomarker studies, answer patient-reported outcome (PRO) questionnaires, and control for adverse events. Subsequently, patients will receive annual PRO-criteria for Adverse Events (CTCAE) questionnaires until the completion of their 10 years of follow-up. Secondary endpoints include additional clinical endpoints; pathological response (neo-adjuvant treated patients), recurrence-free survival, distant-recurrence-free interval, overall survival and cardiac death-free interval, co-morbidity, and health-related quality-of-life measured by PRO-CTCAE questionnaires during and beyond study medication. Translational endpoints are evaluated in collected blood- and tumor samples.

Discussion: If a protective effect of statins on breast cancer recurrence is supported by evidence from the MASTER trial, then the indications for a safe, well-tolerated, and inexpensive treatment can be expanded towards improved clinical outcomes for breast cancer patients.