Category: Statistics

J Cardiovasc Surg (Torino). 2021 Aug 2. doi: 10.23736/S0021-9509.21.11945-7. Online ahead of print.

ABSTRACT

BACKGROUND: Aortic and mitral valve replacement are commonly performed by cardiovascular surgeons, but little data quantitatively analyzes the etiology and prevalence of medical malpractice litigations involving these operations. This study aims to analyze incidence, cause, and resolution of medical malpractice lawsuits involving aortic and mitral valve replacements, alone and in combination with coronary artery bypass and/or aortic procedures.

METHODS: The Westlaw legal database was utilized to compile relevant litigations across the United States from 1994-2019. Clinical data, verdict data, demographic data, and litigation attributes were compiled. Fisher-exact tests and Mann-Whitney tests were performed for statistical analyses.

RESULTS: One hundred four malpractice litigations involving aortic valve replacement and 55 litigations involving mitral valve replacement were included in this analysis. The mean age of patients was 55.2 years and proportion of female patients was 32.7% in aortic valve replacements litigations, compared to a mean age of 54.1 years and female patients in 61.8% of mitral valve replacements litigations. Significant relationships exist between an alleged failure to monitor the patient and defendant verdicts (p=0.01), delayed treatment and defendant verdicts (p=0.04), and incidence of infective endocarditis and plaintiff verdicts (p=0.04) in aortic valve replacement litigations. Similarly, significant relationships exist between an alleged failure to diagnose and settlement verdicts (p=0.047), and stroke incidence and defendant verdicts (p=0.03) in mitral valve replacement litigations.

CONCLUSIONS: In addition to excellent surgeon patient/family communication, administering surgical treatment in a timely manner, diagnosing and acting on concomitant medical conditions, and close patient monitoring may diminish medical malpractice litigation involving aortic and mitral valve replacement operations.

PMID:34338496 | DOI:10.23736/S0021-9509.21.11945-7

JBRA Assist Reprod. 2021 Aug 2;0(0):0. doi: 10.5935/1518-0557.20210033. Online ahead of print.

ABSTRACT

OBJECTIVE: To determine the length of exposure to high doses of phthalate that might affect sperm quality in adult male Wistar rats.

METHODS: Forty-two (42) adult male Wistar rats (weighing 150-200 g) were randomly assigned into six groups (n=7): Group A received 0.5 mL of distilled water – placebo – and served as controls; groups B, C, D, E and F received Phthalate (750 mg/kgbw) for 1, 3, 5, 7 and 9 weeks, respectively. The data obtained from the study was expressed as Mean ± SEM with a p-value <0.05 considered significant. The data was analyzed with one-way analysis of variance (ANOVA) followed by Tukey’s post-hoc test using GraphPad Prism, version 8.

RESULTS: The results showed a statistically significant (p<0.05) decrease in testicular weight in the rats exposed to 750 mg/kg of phthalate for 3, 5, 7 and 9 weeks when compared with the controls. Sperm count, motility and viability were also significantly (p<0.05) reduced, while sperm cells with abnormal morphology had increased counts in the groups exposed for 3, 5, 7 and 9 weeks when compared with controls. Serum zinc and magnesium were also significantly reduced (p<0.05) in the subjects treated for 1, 3, 5, 7 and 9 weeks when compared with controls.

CONCLUSIONS: The dosage of phthalate adopted in this study was deleterious to testicular function when rats were exposed to it for as short a period as three weeks.

PMID:34338483 | DOI:10.5935/1518-0557.20210033

Przegl Epidemiol. 2021;75(1):108-118. doi: 10.32394/pe.75.11.

ABSTRACT

INTRODUCTION: Cardiovascular diseases are the main death cause in Poland. Several clinical studies showed association between metabolic syndrome and higher prevalence of diabetes mellitus, cardiac events and mortality. The aim of the study was to estimate cardiovascular complications and death risk in subjects with metabolic syndrome (MS) working in agriculture.

MATERIAL AND METHODS: The study included 332 people working in agriculture in Lodz voivodeship, 231 with MS and 101 healthy ones. Increased risk of cardiovascular complications was determined for pulse pressure (pp) >63 mmHg. Based on the SCORE index, 10-year death risk due to cardiovascular complications was estimated taking into account sex, age, smoking, systolic blood pressure and total cholesterol concentration. A value ≥5% was accepted as high risk of death within 10 years.

RESULTS: Increased risk of cardiovascular complications (pulse pressure >63 mmHg) was found in 31.60% subjects with MS and 6.93% healthy ones.

CONCLUSIONS: High risk of cardiovascular complications and death occurs statistically more frequently in subjects with MS than in the rest of the population.

PMID:34338476 | DOI:10.32394/pe.75.11

Minerva Surg. 2021 Aug 2. doi: 10.23736/S2724-5691.21.08934-6. Online ahead of print.

ABSTRACT

BACKGROUND: The purpose of this study was to compare the short-term outcomes of laparoscopic right hemicolectomy between intracorporeal (IA) and extracorporeal (EA) anastomosis techniques.

METHODS: A retrospective chart review of 77 consecutive patients who underwent laparoscopic right hemicolectomy from January 2016 to June 2018 was performed. The intracorporeal group included 36 patients and the extracorporeal group 41 patients.

RESULTS: Patient demographics and disease-related characteristics were similar. Mean operative time was 152±38.3 minutes in IA vs. 148±34.8 minutes in EA (p = 0.664). IA was not associated with less overall postoperative complications and decreased rate of surgical site infections. There was no statistically significant difference in the incidence of postoperative leak, length of stay, mortality in both groups. There was no perioperative difference in median number of lymph node harvested. There was statistically significant difference in the length of larger incision [50 (50-70) mm in IA vs 80 (70-100) mm in EA; p<0.001], length of the specimen (323 ±52.7 mm in IA vs 295±64.7 mm in EA; p<0.05), free tumor margin (113.6±47.4 in IA vs 75.6±37.4 mm in EA; p<0.001). There was a statistically significant difference in IA in the less postoperative use of analgesics (p<0.032), and return of bowel function (p<0.021).

CONCLUSIONS: IA seems feasible and safe; it does not significantly affect the length of surgery, and it guarantees maintenance of radical oncological standards. Furthermore, IA significantly improves cosmesis and patient comfort postoperatively, reducing the rates of emesis, which leads to higher rates of early regular diet tolerance. Therefore, laparoscopic right hemicolectomy with intracorporeal anastomosis is associated with improved short-term outcomes.

PMID:34338461 | DOI:10.23736/S2724-5691.21.08934-6

Minerva Surg. 2021 Aug 2. doi: 10.23736/S2724-5691.21.08997-8. Online ahead of print.

ABSTRACT

BACKGROUND: The aim was to evaluate the relevance of pneumoperitoneum on the success rate of non-operative management (NOM) of patients with complicated acute diverticulitis (AD), and the risk factors associated with failure.

METHODS: Observational retrospective cohort study of patients attended at the emergency department for AD from January 2015-August 2019. Patient demographics, blood tests, radiological data and initial treatment strategies were registered. NOM, based on intravenous antibiotics (ATB) and bowel rest, was defined as unsuccessful when emergency surgery (ES) and/or infection-related death took place. Patients initially treated with ES were excluded. Analysis was done with the IBM SPSS statistics 23.0.0.2 software.

RESULTS: According to modified Hinchey and WSES criteria, 99 (12%) of 826 AD episodes were complicated, with pneumoperitoneum on the CT scan in 89 (90.5%). NOM was undertaken in 93 (94%) cases, with a 91.5% success rate. Multivariate analysis revealed ASA class III-IV, and the presence of fluid collections >3cm in diameter, but not distant free air, to be associated with NOM failure. However, the success rate of NOM was significantly higher in patients with pericolic pneumoperitoneum (98.5%) than in those with distant free air (80%) (p=0.02). Risk factors of NOM failure were an advanced age, high CRP and WBC values, and the presence of free fluid in >2 abdominal quadrants.

CONCLUSIONS: NOM in hemodynamically stable patients with complicated AD is a safe and feasible approach, even in the context of distant free air. Nevertheless, patients with isolated pericolic air did better in our series.

PMID:34338467 | DOI:10.23736/S2724-5691.21.08997-8

Przegl Epidemiol. 2021;75(1):86-95. doi: 10.32394/pe.75.09.

ABSTRACT

INTRODUCTION: Healthcare-associated infections (HCAIs) are a global health problem, and the problem of HCAIs in Ukraine remains poorly understood because of problems with the registration system.

OBJECTIVE: To analyze the official data of the number of registered HCAIs in Ukraine for the period 2009-2019, compare them with the available data in scientific publications.

MATERIAL AND METHODS: Statistical analysis of information from the “Laboratory Centers of the Ministry of Health of Ukraine” kindly provided by the State Institution “Public Health Center of the Ministry of Health of Ukraine”.

RESULTS: In 2019, 2,611 cases of HCAIs were registered, the lowest annual number of registered HCAIs in the last twelve years. The maximum number of HCAIs in 2011 was 7,448. An average of 5,089±756 cases of HCAIs has been registered annually. By age structure, the average for 2009-2019 was 78.0±5.8 % for adults and 22.0 % for children (0-17 y.o.). In 2019 13.8% of registered potential HCAIs agents were identified as MDR, and 80.0-87.0% belongs to the group of 12-17, the most common pathogens.

CONCLUSIONS: The estimated minimum number of HCAIs in Ukraine was expected to be about 1 million per year. Official statistics on registered cases of HCAIs in Ukraine do not reflect reality, so the registration system and investigation of HCAIs in Ukraine needs to be reformed.

PMID:34338474 | DOI:10.32394/pe.75.09

Minerva Surg. 2021 Aug 2. doi: 10.23736/S2724-5691.21.08895-X. Online ahead of print.

ABSTRACT

BACKGROUND: Minimally invasive anatomic sublobar resection is increasingly being considered as an alternative to lobectomy in selected cases. However, this remains a technically challenging procedure and only 5 studies evaluating learning curves have been published to date. The aim of this study was to evaluate a single surgeon’s learning curve for completely thoracoscopic anatomic sublobar resection.

METHODS: A retrospective review was conducted of all thoracoscopic anatomic sublobar resections by one surgeon proficient in VATS lobectomy between January 2015 and January 2020. The primary outcome was operative time. Secondary outcomes were perioperative complications, duration of chest tube drainage and length of stay.

RESULTS: There were 67 thoracoscopic anatomic sublobar resections performed in 66 patients. A Time-series plot and Cumulative Sum analysis of operative times showed a drop off after case 32, suggesting achievement of competency. After case 32, mean operative times were decreased (128,59+/- 32,42min. vs 153,63+/-40,16 min, p=0,013) and there was a trend toward decreased blood loss (124,26+/- 76,0 vs 175,0ml+/-141,99, p=0,073). 13,6% of patients had postoperative complications other than air leak and 88,9% of these were Clavien-Dindo class 1-2; postoperative complications were evenly distributed before and after case 32. Cumlulative Sum curves for the duration of chest tube drainage and length of stay did not show any significant change during the study period.

CONCLUSIONS: This study suggests that for a surgeon proficient in VATS lobectomy, competency in completely thoracoscopic anatomic sublobar resection can be achieved after 32 cases and can be accomplished in a way that does not compromise perioperative outcomes.

PMID:34338457 | DOI:10.23736/S2724-5691.21.08895-X

Minerva Surg. 2021 Aug 2. doi: 10.23736/S2724-5691.21.08902-4. Online ahead of print.

ABSTRACT

BACKGROUND: The prognostic role of the extension of lymphadenectomy in Non-small-cell lung cancer is still a debated and intriguing issue. The aim of this study is to validate a prognostic score including the number of resected lymph-nodes previously reported using a large multicentre dataset.

METHODS: From 01/2002 to 12/2012, data on 4858 NSCLC patients undergoing curative-intent surgery in six Institutions were retrospectively reviewed. To test the discriminative ability of the model, composed of a panel of high-risk,pathologic stage, nodal status, age, number of Resected Nodes and intermediate risk factors (gender, grading, histology), was determined. The Kaplan-Meier method was used to estimate Overall(OS), Cancer-Specific(CSS) and Disease-free Survival(DFS) curves, and the log rank test was adopted to evaluate the differences between groups.

RESULTS: Pathological stages were: I in 46,5%, II in 24,1%, III in 27,8% and IV in 1,6% of cases. Overall, 5-years OS, CSS and DFS were 54,6%, 76,7% and 44,8%, respectively. Stratifying the sample of 3948 patients with complete data into Low-risk (LR, #107), Intermediate-risk (IR, #1268) and High-Risk (HR, #2573) groups, the optimal prognostic discrimination power of this score was confirmed (C-statistics: 0.71, 95%CI 69-73). Specifically in LR, IR and HR, 5-years OS was 83,5%, 66,4% and 46,2% (p<0.0001), 5y-CSS was 95,8%, 89% and 69% (p<0.0001), and 5y-DFS was 74,7%, 59.1% and 35,5% (p<0.0001), respectively CONCLUSIONS: Our study confirms the optimal prognostic discrimination power of the previous prognostic model including the number of harvested nodes.

PMID:34338459 | DOI:10.23736/S2724-5691.21.08902-4

Dermatol Ther. 2021 Aug 2:e15074. doi: 10.1111/dth.15074. Online ahead of print.

ABSTRACT

vascular malformations (VM) are congenital, benign, relatively frequent lesions. Scant data have been published about the epidemiology, clinical presentation and treatment of VM from a dermatologist’s perspective. The substantial differences between subtypes, broad range of specialists consulted and confusing nomenclature used over previous years may hamper a correct diagnosis. The main objective of this study is to describe VM epidemiology. As a secondary endpoint we evaluate clinical characteristics, clinical-radiological correlation and treatment approaches. we carried out an observational, descriptive, retrospective study. Cases presented to the multidisciplinary committee of our hospital from 2009 to 2019 were retrieved. Electronic medical records, monthly committee reports and the iconographic archive were reviewed and statistically analyzed. Overall, venous malformations are the most frequent VM, followed by capillary malformations, arteriovenous malformations and lymphatic malformations. Considering only patients under 16, capillary malformations are the most frequent ones. Capillary and lymphatic malformations are larger than venous or arteriovenous. While capillary malformations are usually asymptomatic, symptomatic cases are threefold more frequent in the other subtypes. Decisions on active or conservative management depend on VM size but not location or patient age. Capillary malformations are mainly treated with laser therapy; venous with sclerotherapy or surgery; arteriovenous with surgery and lymphatic with surgery or sirolimus. Dermatologists play an important role in VM diagnosis and management. Our 10-year multidisciplinary experience should contribute to the literature and represent a practical resource for clinicians and researchers. This article is protected by copyright. All rights reserved.

PMID:34338412 | DOI:10.1111/dth.15074

Int J Clin Pract. 2021 Aug 2:e14696. doi: 10.1111/ijcp.14696. Online ahead of print.

ABSTRACT

BACKGROUND: Effects of abdominal obesity on outcomes of atrial fibrillation (AF) ablation remains ill-defined. Here, we evaluated the impact of abdominal obesity on the long-term efficacy and safety of catheter AF ablation among Korean patients.

METHODS: We utilized the Korean National Health Insurance Service database to identify patients who underwent AF ablation. Abdominal obesity was defined as waist circumference ≥90cm (males) and ≥85cm (females). The primary endpoint was AF recurrence and secondary endpoints were ischemic stroke, intracranial hemorrhage and death. Additionally, safety endpoints of peri-procedural complications were studied.

RESULTS: Among 5,397 patients (median age 58 [IQR 51 – 65] years; 23.6% females), abdominal obesity was present in 1,759 (32.6%). The rate of AF recurrence was not statistically different between the groups at 1-year (10.3 vs 8.7 events/100-PYs, p=0.078), though abdominal obesity was associated with significantly higher rates of AF recurrence at 3-year (7.6 vs 6.3 events/100-PYs, p=0.008) and 6-year (6.3 vs 5.2 events/100-PYs, p=0.004) follow-ups. Kaplan-Meier survival analysis found significantly higher rates of AF recurrence in patients with obesity based on body mass index (BMI) and waist circumference (log-rank for trend p=0.006). Using multivariable regression analysis, obesity by both BMI and waist circumference was an independent predictor for AF recurrence (HR 1.21 [95% CI,1.05 – 1.40]), after accounting for other risk factors. There was a trend for increased rates of ischemic stroke at 3-year and 6-year follow-ups in patients with abdominal obesity. Furthermore, this group of patients had a greater rate of intracranial hemorrhage. All-cause death was comparable between both groups. Total peri-procedural complications were not associated with abdominal obesity.

CONCLUSION: Abdominal obesity as indicated by waist circumference was associated with a greater burden of concomitant diseases and an independent risk factor for long-term redo AF intervention following catheter ablation but had no effects on total peri-procedural complications.

PMID:34338415 | DOI:10.1111/ijcp.14696