Clinical Epidemiology最新文献

Background: Real-world evidence about adherence to proprotein convertase subtilisin/kexin type-9 inhibition (PCSK9i) is needed in Chinese population.

Objective: We aimed to evaluate the adherence patterns using anti-PCSK9 monoclonal antibody in Chinese clinical practice and explored the association between adherence to PCSK9i and low-density lipoprotein cholesterol (LDL-C) reduction ratio and variability.

Methods: A total of 5373 patients initiating PCSK9i in the First Affiliated Hospital of Sun Yat-sen University were included as sub-analysis of the RED-CARPET registry. Adherence to PCSK9i was measured by proportion of days covered (PDC), calculated for treatment covered days divided by 365 days during a one-year period. Reduction ratio (percentage points, range 0-100) was calculated as the ratio of reduction degree (difference between baseline value and the lowest value) to the baseline value. LDL-C variability was measured as standard deviation of three LDL-C measurement 2 weeks after medication initiation. We used linear regression to measure the association between PCSK9i PDC and the reduction ratio and variability of LDL-C. PDC (range 0-1) was scaled by 10 in the model.

Results: At 12 months, the mean PDC was 0.09 ± 0.10. PCSK9i PDC was positively associated with LDL-C reduction ratio after adjustment for traditional risk factors (Adjusted β 4.05, 95% CI [2.61, 5.50]), p<0.001), which means for every 0.1-unit increase in PDC, the LDL-C reduction ratio increases by 4.05 percentage points. PCSK9i PDC was negatively associated with LDL-C standard deviation after fully adjustment (Adjusted β -0.042, 95% CI [-0.066, -0.018]), p=0.001). For every 0.1-unit increase in PDC, the LDL-C standard deviation decreased by 0.042 units, indicating improved lipid stability with higher adherence.

Conclusion: The adherence to PCSK9i presented as a skewed distribution, most people only received one injection, which did not reach the ideal adherence goal. Unsatisfactory adherence to PCSK9i reduce the lipid-lowering effect of PCSK9i.

Background/objectives: Faecal Immunochemical Testing (FIT) is recommended for patients presenting to primary care with symptoms suggestive of colorectal cancer. This study quantified variations in use across England.

Methods: Retrospective cohort of English patients (≥18 years) with a FIT result reported in routinely collected primary care records, 2019-2023. Rates of FIT testing by age, sex, year and region were adjusted using Poisson regression. Multivariate logistic regression compared the effect of factors on the proportion of results exceeding the recommended referral threshold (10µgHb/g).

Results: Between 01/01/2019 and 05/06/2023 there were 531,735 FIT results among 495,121 patients. Rates of testing increased from 0.69 per thousand person-years in 2019 (95% CI 0.68-0.71) to 27.70 in 2023 (95% CI 27.56-27.85). There were large variations in testing between regions, with rates >3-fold higher in the Northeast than the West Midlands: 17.05 (95% CI 16.87-17.23) versus 4.72 (95% CI 4.67-4.76) per thousand person-years. About 20.4% of FIT results were ≥10µgHb/g. Despite increased testing, this did not change over time. The proportion of FIT ≥10µgHb/g was lower in regions with higher rates of testing, from 16.7% (Southwest) to 25.3% (Southeast; rates of testing 14.62 and 8.00 per thousand person-years respectively). This difference in proportion of FIT ≥10µgHb/g persisted after adjusting for year, sex and age (OR 0.57, 95% CI 0.55-0.58).

Conclusion: Rapid increases in FIT testing in primary care show large, persistent variations between English regions, which correlate with the proportion of results meeting the criteria for onward referral. Differences in the population tested and FIT's implementation between regions are likely to explain these variations.

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.