Category: Statistics

Acta Neurol Belg. 2024 Aug 5. doi: 10.1007/s13760-024-02612-y. Online ahead of print.

ABSTRACT

BACKGROUND AND OBJECTIVE: Intracerebral hemorrhage (ICH) is a serious medical condition with high mortality. However, factors leading to long-term mortality after ICH are largely unclear. The aim of this community-based study is to assess predictors of long-term mortality after spontaneous ICH.

METHODS: We identified all patients admitted with spontaneous ICH to hospitals with a certified stroke unit in Brno, the second largest city in the Czech Republic (CR), in 2011, the year of the Czech Population and Housing Census. We reviewed their medical records for risk factors, radiographic parameters, and measures of post-stroke neurological deficit [National Institutes of Health Stroke Scale (NIHSS)]. Using the dates of death from the Czech National Mortality Register, we calculated mortality at 30 days, six months, one year, and three years after the ICH. Multivariate analysis with forward stepwise logistic regression was performed to determine independent predictors of mortality (p < 0.05).

RESULTS: In 2011, 1086 patients with stroke were admitted to the four stroke-certified hospitals in Brno, CR. Of these, 134 had spontaneous ICH, with complete data available in 93 of them entering the final analysis. The mortality at 30 days, 6 months, 1 year, and 3 years post-ICH was 34%, 47%, 51%, and 63%, respectively. The mortality was highest in the first few days post-event, with 50% of patients dying in 255 days and average survival being 884 ± 90 days. Both NIHSS and modified ICH (MICH) score showed to be strong and reliable predictors of short- as well as long-term mortality; the risk of death post-ICH increased with older age and size of ICH. Other risk factors contributing to higher, primarily shorter-term mortality included history of cardiac failure, myocardial infarction, or atrial fibrillation.

CONCLUSIONS: In our community-based study, we found that severity of neurological deficit at admission (NIHSS), combined with age and size of ICH, well predicted short- as well as long-term mortality after spontaneous ICH. A history of cardiac failure, myocardial infarction, or atrial fibrillation at presentation were also predictors of mortality, underscoring the need for optimal cardiac management in patients with ICH.

PMID:39102105 | DOI:10.1007/s13760-024-02612-y

3D Print Med. 2024 Aug 5;10(1):26. doi: 10.1186/s41205-024-00230-1.

ABSTRACT

BACKGROUND: . Mitral transcatheter edge-to-edge repair (m-TEER) is a minimally invasive procedure for treating mitral regurgitation (MR). m-TEER is a highly technical procedure, and a steep learning curve needs to be overcome for operators to ensure optimal patient outcomes and minimise procedural complications. Training via online simulation and observation of procedures is not sufficient to establish operator confidence; thus, advanced hands-on training modalities need to be explored and developed.

METHODS: . In this study, a novel anatomical simulator for m-TEER training was evaluated in comparison to a standard model. The proposed simulator resembled the anatomical features of the right and left atrium, left ventricle and mitral valve apparatus. Participants in the questionnaire (n = 18) were recruited across 4 centres in London with (n = 8) and without (n = 10) prior experience in m-TEER. Participants were asked to simulate procedures on both an idealised, routinely used simulator and the newly proposed anatomical model. The questionnaire was designed to assess (i) participants’ confidence before and after training and (ii) the realism of the model in the context of the m-TEER procedure. The results of the questionnaires were collected, and statistical analysis (t-test) was performed.

RESULTS: . Both models were equally beneficial in increasing operator confidence before and after the simulation of the intervention (P = 0.43). However, increased confidence after training with the anatomical model was recorded (P = 0.02). Participants with prior experience with m-TEER therapy were significantly more confident about the procedure after training with the anatomical model than participants who had no prior experience (P = 0.002). On average, all participants thought that the anatomical model was effective as a training simulator (P = 0.013) and should be integrated into routine training (P = 0.015)). Participants with experience thought that the anatomical model was more effective at reproducing the m-TEER procedure than the idealised model (P = 0.03).

CONCLUSIONS: . This study showed how a more realistic simulator can be used to improve the effectiveness of m-TEER procedural training. Such pilot results suggest planning future and large investigations to evaluate improvements in clinical practice.

PMID:39102099 | DOI:10.1186/s41205-024-00230-1

Australas J Dermatol. 2024 Aug 5. doi: 10.1111/ajd.14358. Online ahead of print.

ABSTRACT

Children and adolescents suffering from moderate-to-severe atopic dermatitis (AD) face a significant disease burden that greatly impacts their quality of life. Treatment options for AD are currently limited. To assess the safety and efficacy of biologic drugs, dupilumab, lebrikizumab, or tralokinumab, in improving outcomes in patients with moderate to severe inadequately controlled AD. We searched PubMed, Embase and Cochrane databases for randomized controlled trials (RCTs) comparing dupilumab, lebrikizumab or tralokinumab to placebo in patients with AD. We computed odds ratios (ORs) for binary endpoints, with 95% confidence intervals (CIs), random effects model was used and a p-value <0.05 was considered as statistically significant. We analysed data into Review Manager 5.4. A total of five RCTs and 973 patients were included, of whom 592 were prescribed a biologic drug. Compared with placebo, patients receiving a biologic drug had a greater improvement, achieved an Investigator Global Assessment (IGA) score of 0 or 1 (OR 5.05; 95% CI 3.08-8.29), Eczema Area and Severity Index (EASI) 75 (OR 6.87; 95% CI 4.71-10.02), EASI 50 (OR 8.89; 95% CI 6.18-12.78) and EASI 90 (8.30; 95% CI 4.81-14.31). The proportion of patients with 3 points or more (OR 6.56; 95% CI 4.34-9.90) or 4 points or more (OR 8.09; 95% CI 5.19-12.59) improvement from baseline in peak pruritus NRS was significantly higher with biologic drugs than placebo. There were no significant differences between groups regarding adverse events (OR 0.79; 95% CI 0.58-1.07), and conjunctivitis (OR 2.08; 95% CI 1.00-4.33). In this meta-analysis, dupilumab, lebrikizumab, and tralokinumab have shown significant improvements in signs, symptoms and quality of life in children or adolescents with moderate to severe AD. Larger studies may be needed to continue evaluating the safety and efficacy of these biologic drugs in this patient population.

PMID:39101303 | DOI:10.1111/ajd.14358

Knee Surg Sports Traumatol Arthrosc. 2024 Aug 5. doi: 10.1002/ksa.12399. Online ahead of print.

ABSTRACT

PURPOSE: This study aimed to compare in vivo kinematics during weight-bearing daily activities and determine the relationship with clinical outcomes in patients undergoing total knee arthroplasty (TKA) with a medial-pivot (MP, Evolution™) versus a posterior-stabilized (PS, Persona®) design under constant conditions of intraoperative soft tissue balance.

METHODS: Forty patients undergoing MP or PS-TKA under similar conditions of soft tissue balance were enrolled in this prospective randomized controlled trial. Outcome measures included clinical knee society scores (KSS) and knee injury and osteoarthritis outcome scores (KOOS). A kinematic assessment was conducted while the participants performed lunge and step-up activities under fluoroscopic guidance.

RESULTS: Eighteen patients in each arm completed 1-year follow-up and were included in the analysis. All patients experienced pain relief and satisfactory knee function postoperatively. In kinematics, in the MP arm, the medial femoral condyle remained consistent, whereas the lateral femoral condyle gradually shifted posteriorly with increasing knee flexion. Conversely, in the PS arm, paradoxical anterior movement of the medial femoral condyle accompanied the lateral pivot motion. During lunge and step-up activities, a medial-pivot motion was observed in 83% and 72% of knees in the MP arm, respectively, compared with 22% and 11% in the PS arm. Despite these differences in kinematics, there were no statistically significant differences in the KSS and KOOS between the two groups.

CONCLUSION: Under weight-bearing conditions during flexion, knees that underwent Evolution™ MP-TKA did not show superior clinical results compared to Persona® PS-TKA, despite exhibiting in vivo kinematics closely resembling the normal in vivo pattern.

LEVEL OF EVIDENCE: Therapeutic studies-Level I.

PMID:39101251 | DOI:10.1002/ksa.12399

Foot Ankle Spec. 2024 Aug 5:19386400241266361. doi: 10.1177/19386400241266361. Online ahead of print.

ABSTRACT

The purpose of this study was to examine the changes in annual incidence and patient population undergoing lateral ankle ligament repair (LALR) for the surgical treatment of chronic ankle instability. The IBM Watson Health MarketScan Database was queried for patients who underwent LALR from January 2009 to December 2019 based on CPT code 27698. Volume and incidence per 100 000 population were determined for annual sums, gender, age, and geographical regions based on population estimates from the United States Census Bureau. Future annual volumes were statistically projected with linear regression modeling to the year 2032. Overall, 160 457 LALR procedures were identified in the database from 2009 to 2019. Annual incidence increased 76.6% from 3.46 to 6.11 cases per 100 000 population, while estimates of annual volumes are projected to increase 61.5% from 19 829 to 32 033 procedures to the year 2032. Interestingly, the greatest increase in incidence was observed among patients above 70 years old, which might suggest older patients are staying active longer and desiring elective procedures to maintain their activity levels. As the incidence of LALR increases in older patients, more research will be needed to understand the unique surgical considerations and risk factors impacting patient-reported outcomes.Level of Evidence: Level IV.

PMID:39101246 | DOI:10.1177/19386400241266361

Br J Psychiatry. 2024 Aug 5:1-10. doi: 10.1192/bjp.2024.101. Online ahead of print.

ABSTRACT

BACKGROUND: A clinical tool to estimate the risk of treatment-resistant schizophrenia (TRS) in people with first-episode psychosis (FEP) would inform early detection of TRS and overcome the delay of up to 5 years in starting TRS medication.

AIMS: To develop and evaluate a model that could predict the risk of TRS in routine clinical practice.

METHOD: We used data from two UK-based FEP cohorts (GAP and AESOP-10) to develop and internally validate a prognostic model that supports identification of patients at high-risk of TRS soon after FEP diagnosis. Using sociodemographic and clinical predictors, a model for predicting risk of TRS was developed based on penalised logistic regression, with missing data handled using multiple imputation. Internal validation was undertaken via bootstrapping, obtaining optimism-adjusted estimates of the model’s performance. Interviews and focus groups with clinicians were conducted to establish clinically relevant risk thresholds and understand the acceptability and perceived utility of the model.

RESULTS: We included seven factors in the prediction model that are predominantly assessed in clinical practice in patients with FEP. The model predicted treatment resistance among the 1081 patients with reasonable accuracy; the model’s C-statistic was 0.727 (95% CI 0.723-0.732) prior to shrinkage and 0.687 after adjustment for optimism. Calibration was good (expected/observed ratio: 0.999; calibration-in-the-large: 0.000584) after adjustment for optimism.

CONCLUSIONS: We developed and internally validated a prediction model with reasonably good predictive metrics. Clinicians, patients and carers were involved in the development process. External validation of the tool is needed followed by co-design methodology to support implementation in early intervention services.

PMID:39101211 | DOI:10.1192/bjp.2024.101

Circulation. 2024 Aug 5. doi: 10.1161/CIRCULATIONAHA.124.068788. Online ahead of print.

ABSTRACT

BACKGROUND: Systemic arterial compliance and venous capacitance are typically impaired in patients with heart failure with preserved ejection fraction (HFpEF), contributing to hemodynamic congestion with stress. Sodium-glucose cotransporter-2 inhibitors reduce hemodynamic congestion and improve clinical outcomes in patients with HFpEF, but the mechanisms remain unclear. This study tested the hypothesis that Dapagliflozin would improve systemic arterial compliance and venous capacitance during exercise in patients with HFpEF.

METHODS: In this secondary analysis from the Cardiac and Metabolic Effects of Dapagliflozin in Heart Failure With Preserved Ejection Fraction Trial, 37 patients with HFpEF (mean age 68 ± 9 years, women 65%) underwent invasive hemodynamic exercise testing with simultaneous echocardiography at baseline and following treatment for 24 weeks with Dapagliflozin or placebo. Radial artery pressure (BP) was measured continuously using a fluid-filled catheter with transformation to aortic pressure, central hemodynamics were measured using high-fidelity micromanometers, and stressed blood volume was estimated from hemodynamic indices fit to a comprehensive cardiovascular model.

RESULTS: There was no statistically significant effect of Dapagliflozin on resting BP, but Dapagliflozin reduced systolic BP during peak exercise (estimated treatment difference [ETD], -18.8 mm Hg [95% CI, -33.9 to -3.7] P=0.016). Reduction in BP was related to improved exertional total arterial compliance (ETD, 0.06 mL/mm Hg/m² [95% CI, 0.003-0.11] P=0.039) and aortic root characteristic impedance (ETD, -2.6 mm Hg/mL*sec [95% CI: -5.1 to -0.03] P=0.048), with no significant effect on systemic vascular resistance. Dapagliflozin reduced estimated stressed blood volume at rest and during peak exercise (ETD, -292 mm Hg [95% CI, -530 to -53] P=0.018), and improved venous capacitance evidenced by a decline in ratio of estimated stressed blood volume to total blood volume (ETD, -7.3% [95% CI, -13.3 to -1.3] P=0.020). Each of these effects of Dapagliflozin at peak exercise were also observed during matched 20W exercise intensity. Improvements in total arterial compliance and estimated stressed blood volume were correlated with decreases in body weight, and reduction in systolic BP with treatment was correlated with the change in estimated stressed blood volume during exercise (r=0.40, P=0.019). Decreases in BP were correlated with reduction in pulmonary capillary wedge pressure during exercise (r=0.56, P<0.001).

CONCLUSIONS: In patients with HFpEF, treatment with Dapagliflozin improved systemic arterial compliance and venous capacitance during exercise, while reducing aortic characteristic impedance, suggesting a reduction in arterial wall stiffness. These vascular effects may partially explain the clinical benefits with sodium-glucose cotransporter-2 inhibitors in HFpEF.

REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04730947.

PMID:39101201 | DOI:10.1161/CIRCULATIONAHA.124.068788

Diabetol Int. 2024 May 23;15(3):315-326. doi: 10.1007/s13340-024-00725-6. eCollection 2024 Jul.

ABSTRACT

In the large-scale, prospective, observational JDCP study, a total of 5944 people with type 2 diabetes (mean age at baseline, 61.4 years old; women, 39.9%; and duration of diabetes, 10.8 years) were followed up for incidence of malignancy. During a mean 5.38 ± 2.92 years of follow-up, malignancies occurred in 322 individuals, accounting for a crude incidence of 10.35/1000 person-years. The 3 most frequently reported malignancies included colorectal cancers (20.4%), breast cancer (16.5%) and lung cancers (13.6%) in women, and gastric cancers (18.3%), colorectal cancers (15.7%) and lung/prostate cancers (12.7%) in men. During follow-up, men had a significantly higher relative risk for malignancy than women. In contrast, women had a significantly shorter time to the first diagnosis of malignancy following a diagnosis of diabetes than men (13.79 ± 7.90 and 17.11 ± 8.50 years, respectively), although there was no marked difference in the age at the diagnosis of malignancy (67.39 ± 7.27 and 68.44 ± 6.62 years, respectively). Cox proportional hazard models revealed that increasing age, a history of drinking and a history of acute myocardial infarction were significantly associated with an increased risk of malignancy. This report may be of interest in that it provides valuable insight into which malignancies Japanese people with type 2 diabetes are likely to be at risk of developing over time.

PMID:39101169 | PMC:PMC11291822 | DOI:10.1007/s13340-024-00725-6

Front Pharmacol. 2024 Jul 19;15:1427318. doi: 10.3389/fphar.2024.1427318. eCollection 2024.

ABSTRACT

BACKGROUND: Statins, which are medications that lower lipid levels, are extensively used to decrease cardiovascular disease risk. Recently, the use of statins in cancer prevention has attracted considerable interest. However, it is still unclear whether the use of statins has a causal effect on bladder cancer.

METHODS: The two-sample Mendelian Randomization (MR) was performed to infer the causal relationship between statin therapy (atorvastatin, simvastatin, and rosuvastatin) and bladder cancer. Single-nucleotide polymorphisms (SNP)-based genome-wide association studies (GWAS) of statins (atorvastatin, simvastatin, and rosuvastatin) were gathered from the UK Biobank, involving 462,933 participants. We acquired summary-level genetic data on bladder cancer from a European cohort of 175,121 individuals. The inverse variance weighted (IVW) method was the main analytical technique used, supplemented by MR-Egger, weighted median, weighted mode, and simple mode to estimate causal effects. Additionally, sensitivity analyses were conducted to verify the robustness and reliability of our findings.

RESULTS: Based on the IVW analysis, we identified a significant causal association between rosuvastatin use and a decreased risk of bladder cancer, with genetic analysis inferring the substantial reduction in odds (OR = 3.52E-19, 95% CI: 5.48E-32-2.26E-06, p = 0.005). In contrast, the IVW results did not reveal a statistically significant relationship between the genetically estimated use of atorvastatin (OR = 7.42E-03, 95% CI: 6.80E-06-8.084, p = 0.169) or simvastatin (OR = 0.135, 95% CI: 0.008-2.330, p = 0.168) and bladder cancer risk.

CONCLUSION: We investigated the causal link between statin therapy (atorvastatin, simvastatin, and rosuvastatin) and bladder cancer using a two-sample Mendelian Randomization analysis among the European population. Our findings indicated that genetically predicted use of rosuvastatin was associated with a decreased risk of bladder cancer, whereas no significant genetically predicted causal effects were observed for atorvastatin and simvastatin use.

PMID:39101139 | PMC:PMC11294080 | DOI:10.3389/fphar.2024.1427318

Front Pharmacol. 2024 Jul 19;15:1378140. doi: 10.3389/fphar.2024.1378140. eCollection 2024.

ABSTRACT

BACKGROUND: Within-day glycemic variability (GV), characterized by frequent and significant fluctuations in blood glucose levels, is a growing concern in hospitalized patients with type 2 diabetes mellitus (T2DM). It is associated with an increased risk of hypoglycemia and potentially higher long-term mortality rates. Robust clinical evidence is needed to determine whether traditional Chinese medicine (TCM) decoctions can be a beneficial addition to the management of within-day GV in this patient population.

METHODS: This retrospective cohort study utilized data from adult inpatients diagnosed with T2DM admitted to the Traditional Chinese Medicine Hospital of Kaifeng. The primary outcome investigated was the association between the use of TCM decoctions and improved stability of within-day GV. Blood glucose variability was assessed using the standard deviation of blood glucose values (SDBG). For each patient, the total number of hospitalization days with SDBG below 2 mmol/L was calculated to represent within-day GV stability. Hospitalization duration served as the secondary outcome, compared between patients receiving TCM decoctions and those who did not. The primary analysis employed a multivariable logistic regression model, with propensity score matching to account for potential confounding variables.

RESULTS: A total of 1,360 patients were included in the final analysis. The use of TCM decoctions was significantly associated with enhanced stability of within-day GV (OR = 1.77, 95% CI: 1.34-2.33, P < 0.01). This association was most prominent in patients with a diagnosis of deficiency syndrome (predominantly qi-yin deficiency, accounting for 74.8% of cases) and a disease duration of less than 5 years (OR = 2.28, 95% CI: 1.21-4.29, P = 0.03). However, TCM decoctions did not exert a statistically significant effect on hospitalization duration among patients with T2DM (OR = 0.96, 95% CI: 0.91-1.01, P = 0.22).

CONCLUSION: This study suggests that TCM decoctions may be effective in improving within-day GV stability in hospitalized patients with T2DM. This effect appears to be most pronounced in patients diagnosed with deficiency syndrome, particularly those with qi-yin deficiency and a shorter disease course. Further investigation is warranted to confirm these findings and elucidate the underlying mechanisms.

PMID:39101135 | PMC:PMC11294233 | DOI:10.3389/fphar.2024.1378140