2-year Period Research Articles

Assessing the stability of photon-counting CT: insights from a 2-year longitudinal study.

Among the advancements in computed tomography (CT) technology, photon-counting computed tomography (PCCT) stands out as a significant innovation, providing superior spectral imaging capabilities while simultaneously reducing radiation exposure. Its long-term stability is important for clinical care, especially longitudinal studies, but is currently unknown. This study sets out to comprehensively analyze the long-term stability of a first-generation clinical PCCT scanner. Over a 2-year period, from November 2021 to November 2023, we conducted weekly identical experiments utilizing the same multi-energy CT protocol. Throughout this period, notable software and hardware modifications were meticulously recorded. Various tissue-mimicking inserts were scanned weekly to rigorously assess the stability of Hounsfield Units (HU) and image noise in Virtual Monochromatic Images (VMIs) and iodine density maps. Spectral results consistently demonstrated the quantitative stability of PCCT. VMIs exhibited stable HU values, such as variation in relative error for VMI 70 keV measuring 0.11% and 0.30% for single-source and dual-source modes, respectively. Similarly, noise levels remained stable with slight fluctuations linked to software changes for VMI 40 and 70 keV that corresponded to changes of 8 and 1 HU, respectively. Furthermore, iodine density quantification maintained stability and showed significant improvement with software and hardware changes, especially in dual-source mode with nominal errors decreasing from 1.44 to 0.03 mg/mL. This study provides the first long-term reproducibility assessment of quantitative PCCT imaging, highlighting its potential for the clinical arena. Question Photon-counting CT (PCCT) provides critical spectral imaging for improved diagnostic accuracy, but its long-term quantitative stability over time is still unknown. Findings The clinical PCCT system demonstrated stable Hounsfield Units (HU) and image noise over 2 years, ensuring reliable quantitative imaging and improving diagnostic accuracy. Clinical relevance This study showcased the exceptional value of PCCT in diagnostic radiology, particularly for its application in longitudinal studies.

Best practice peri-extubation bundle reduces neonatal and infant extubation failure after cardiac surgery.

Extubation failure after neonatal cardiac surgery is associated with increased intensive care unit length of stay, morbidity, and mortality. We performed a quality improvement project to create and implement a peri-extubation bundle, including extubation readiness testing, spontaneous breathing trial, and high-risk criteria identification, using best practices at high-performing centers to decrease neonatal and infant extubation failure by 20% from a baseline of 15.7% to 12.6% over a 2-year period. Utilising the transparency of the Pediatric Cardiac Critical Care Consortium database, five centres were identified as high performers, having better-than-expected neonatal extubation success rates with the balancing metric of as-expected or better-than-expected mechanical ventilation duration. Structured interviews were conducted with cardiac intensive care unit physician leadership at the identified centers to determine centre-specific extubation practices. Data from those interviews underwent qualitative content analysis which was used to develop a peri-extubation bundle. The bundle was implemented at a single-centre 17-bed cardiac intensive care unit. Extubation failure, defined as reintubation within 48 hours of extubation for anything other than a procedure, ventilator days and bundle compliance was tracked. There was a 41.4% decrease in extubation failure following bundle implementation (12 failures of 76 extubations pre-implantation; 6 failures of 65 extubations post-implementation). Bundle compliance was 95.4%. There was no difference in ventilator days (p = 0.079) between groups. Implementation of a peri-extubation bundle created from best practices at high-performing centres reduced extubation failure by 41.4% in neonates and infants undergoing congenital heart surgery.

Craniosynostosis: Epidemiology and Pattern at a Tertiary Referral Institute in Oman 2004 to 2023.

To date, there are no published studies From the Sultanate of Oman on the incidence or characteristics of craniosynostosis (CS). This is a population-based epidemiological study of the incidence of CS. The prospective registry of the craniofacial surgery unit in Khoula Hospital was used to retrieve data on all individuals with CS treated between 2004 and 2023. The cohort was divided into four 5-year groups based on year of birth: 2004 to 2008, 2009 to 2013, 2014 to 2018, and 2019 to 2023. We identified 312 individuals with CS. The incidence increased significantly during the study period and was 2.5 per 10 000 live births in the last 5-year period. There was a male preponderance (male/female ratio 1.5:1). Our study findings reveal a notable diversity in the trend of suture involvement, we observed a higher frequency of complex CS within our study population 35.9%. Half of the study population was nonsyndromic, accounting for 51.6%. The nonsyndromic population exhibits a higher proportion of midline suture involvement. The incidence of CS increased during the study period. The majority of cases were identified as nonsyndromic. We found that multiple sutures CS were the most prevalent overall in our population. It is imperative to intensify efforts aimed at raising awareness among the general population regarding these deformities.

Epidemiology of talus fractures in Finland: a nationwide register study from 1997 to 2020

BackgroundThe aim of this study was to estimate the nationwide incidence of talus fractures (per 100 000 person-years) and to determine the incidence of operative treatment in the Finnish population.MethodsBased on Finnish Care Register for Health Care data, all patients 18 years and older admitted to hospital with talar fractures between 1997 and 2020 were included.ResultsDuring the 24-year study period, 5247 patients with primary or secondary diagnoses of talar fracture were identified. The mean incidence during the whole study period was 50.4 per 100 000 person-years. There was a clear increase starting from the year 2009 (61.4 per 100 000 person-years), that continued and the incidence in 2018 raised up to 106.8 person-years. The total incidence of operations performed on talar fractures remained almost the same during the study period (9.1 per 100 000 person-years from 1997 to 2020).ConclusionsWhile the incidence of performed operations had remained stable, the incidence of talar fractures in Finland has increased during the last decades. The increase was more prominent in men. The observed change is possibly due to the progress and availability of computer tomography.Level of EvidenceIII

A quality improvement program to reduce surgical site infections after cardiac surgery: A 10-year cohort study.

To assess trends in surgical site infection (SSI) incidence in cardiosurgery following a quality improvement initiative in infection prevention and control (IP&C). This is a historical cohort study encompassing a 10-year surveillance period (2014-2023) in a cardiosurgical department in a multi-organ transplant center. The study encompassed three periods: a baseline period (Phase_1: January 2014-December 2018); an implementation phase covering quality improvement initiatives targeting various aspects of IP&C including organizational factors, pre-operative, intra-operative, post-operative measures, and post-hospitalization care (Phase_2: January 2019-June 2021); a post-implementation phase (Phase_3: July 2021-September 2023). A general linear mixed model was used to assess differences in SSI rates between distinct phases, adjusted for length of hospitalization, American Society of Anaesthesiologists (ASA) physical status classification, and Diagnostic-Related Groups (DRG) weight. The latter two were used as random effects. Results are reported as odds ratios [OR] with 95% confidence interval [CI]. All cardiac surgery patients were included (n=5851). A total of 208 patients developed SSI (3.5%). SSI incidence for phase_1, phase_2 and phase_3 were 4.5%, 4.1%, and 1.2%, respectively. The mixed model regression analysis indicated that, compared with the reference period (Phase1), SSI risk did not drop during the implementation phase (OR 0.81, 95% CI 0.59-1.13, P<0.001 vs. reference period). A decrease in SSI risk was observed during the post-implementation phase (OR 0.19, 95% CI 0.11-0.32) CONCLUSIONS: A quality improvement initiative encompassing measurements at all levels potentially impacting SSI risk was implemented over a 2.5years period. While no risk reduction was observed during the implementation phase, a significant reduction in SSI risk took place in the post-implementation phase. This study suggests that considerable time may be required to achieve a substantial SSI risk reduction. We assume this may be attributed to the time required to achieve appropriate adherence with IP&C protocols.

Postcertification Wages Among Certified Peer Specialists Working in Peer Support and Other Occupations.

Although certification can raise the status of peer support work, certified peer specialists (CPSs) may continue to face financial hardship that affects their employment choices. This study aimed to explore how wages and financial well-being changed for CPSs over a 3-year postcertification period. This study examined wages, job characteristics, and financial well-being for a cohort of 448 employed CPSs working in peer support (PS) or other, nonpeer (NP) jobs during the study period. Self-report survey data were collected on current jobs, hours worked, and job tenure. Financial well-being was assessed by using the Consumer Financial Protection Bureau's Financial Well-Being Scale. Differences in job characteristics over time were described by using chi-square and t tests, and mixed-effects logistic regression models were used to model job attributes and financial well-being. Hourly wages for both PS and NP jobs increased significantly between 2020 and 2022, with smaller increases for PS than for NP positions. Individuals with PS jobs were significantly more likely to have longer job tenures than those with NP jobs. Higher hourly wages were associated with a greater likelihood of longer job tenure. Financial well-being did not improve significantly over time. The larger wage increases and shorter tenures characteristic of NP jobs, relative to PS positions, suggest that workers may have switched from PS jobs to other jobs to improve their financial and career mobility opportunities. CPSs are part of a trend in the general U.S. adult population of declining financial well-being, despite increased wages.

Longitudinal associations of lipid profiles with sleep disorders in patients with Parkinson's disease.

To examine the associations of apolipoprotein E (APOE) carrier status and lipid profiles with sleep disorders, including excessive daytime sleepiness (EDS) and probable rapid eye movement sleep behavior disorder (pRBD), among patients with early Parkinson's disease (PD) over 5-year follow-up periods. The Parkinson's Progression Markers Initiative is a multicenter cohort study based on an ongoing and open-ended registry. Data from baseline and 5-year follow-up visits from participants of de novo PD were analyzed. Longitudinal associations of APOE carrier status and lipid profiles with sleep disorders were estimated via linear mixed-effects models. A total of 657 participants with complete APOE genotypes were enrolled at baseline. Among them, 153 (25.3%) had available lipid profiles at baseline. In the linear mixed-effects models, baseline APOE ε2/ε3/ε4 carrier status did not exhibit significant associations with EDS and pRBD (all p > 0.05) in all models. However, reduced high-density lipoprotein (HDL) and elevated triglycerides (TG) were associated with developing EDS (β = -0.04, 95% CI: -0.07, -0.00) and pRBD (β = 0.01, 95% CI: 0.00, 0.02) in PD patients, respectively. In the APOE ε4+ subgroup, decreased HDL and increased TG displayed substantial associations with developing EDS and sleep disorders (all p < 0.05) in all models, respectively, whereas no significant differences were noted in the APOE ε4- subgroup (all p > 0.05). Our study did not demonstrate a clear association between APOE ε2/ε3/ε4 and sleep disorders in PD patients. However, the presence of APOE ε4 was associated with changes in lipid profiles, notably affecting TG and HDL levels.

Intrathecal catheter after accidental dural puncture in obstetric patients: Safety and effectiveness reducing post-dural puncture headache.

Post-dural puncture headache (PDPH) after an accidental dural puncture (ADP) is a common complication in obstetric analgesia. It has been proposed that inserting an intrathecal catheter (ITC) after an ADP may reduce PDPH incidence and the need for therapeutic epidural blood patch (EBP). Our primary objective was to assess if the insertion of an ITC after an ADP reduces the incidence of PDPH in obstetric patients. Secondary objectives included evaluating EBP requirements and ITC-related complications. We conducted a retrospective study of all obstetric patients with a documented ADP during their labour analgesia between January 2018 to December 2022. Data from the patients in whom an ITC was inserted and those with a repeated epidural were compared. Over our 5-year study period, 35 cases of ADP were documented. Of these, 16 patients (45.7%) received an ITC for 24 hours, while 19 (54.3%) underwent epidural re-siting. No significant difference was observed in PDPH incidence between ITC and re-sited epidural groups (62.5% vs 68.4%; RR 0.84; P = 0.713), nor in EBP requirement (18.8% vs 31.6%; RR 0.84; P = 0.387). Follow-up duration did not differ significantly between groups and no ITC-related complications were reported within 1 month. Our findings align with previously reported literature, indicating a trend favoring ITC utilization. In addition to the potential benefit of reducing CPPD incidence, their use is safe and provides quality analgesia with rapid onset. IIBSP-CEF-2022-146.

Risk of mortality in Fusobacterium species bloodstream infection from a large Australian cohort.

Fusobacterium species are anaerobic Gram-negative bacilli which are uncommon causes of bloodstream infection (BSI). This genus commonly colonises the gastrointestinal tract and can result in significant morbidity. All blood cultures with growth of Fusobacterium species among residents of Queensland, Australia (population ≈ 5million) were retrospectively identified over a 20-year period. Clinical, microbiological and outcome information was obtained from state-wide databases. 377 incident Fusobacterium species BSI among 375 individuals for an age and sex-standardised incidence of 4.4 per million residents per year. Median age was 47 years (IQR, 24.9-65.8) and 156 (42%) incident episodes were in females. There was a bimodal frequency distribution with respect to age with peaks occurring around 20 and 65 years, respectively. The most identified source of infection was the abdominal (17%), followed by head and neck (12%). 8% of patients had a septic thrombus present, and 4% had an abscess associated with their BSI. Most isolates were F. nucleatum (142, 38%) and F. necrophorum (140, 37%). 9% of isolates were resistant to penicillin. Older age (aHR 1.02, 95% CI 1.01-1.05), healthcare-associated hospital onset (aHR 3.16, 95% CI 1.35-7.40), and Charlson Comorbidity index (aHR 1.20, 95% CI 1.06-1.35) were all associated with 30-day all cause case-fatality. Oropharyngeal source appeared to be a protective factor (P = 0.02). Fusobacterium species BSI results in significant morbidity and can cause death in vulnerable patient groups such as the elderly and those with malignancy. An identifiable oropharyngeal source identifies a favourable host.

Serotype distribution and clinical characteristics of Group B Streptococcus Bacteremia in nonpregnant adults: a 15-Year Multicenter Study in Korea

BackgroundGroup B Streptococcus (GBS) bacteremia in nonpregnant adults is of increasing concern, particularly among the elderly in underlying conditions. This study analyzed the serotype distribution, antimicrobial resistance patterns, and clinical characteristics of GBS bacteremia in nonpregnant adults over a 15-year period in two tertiary hospitals in Korea.MethodsFrom 2007 to 2021, patients aged ≥ 19 years with GBS bacteremia were identified via retrospective electronic medical record review. GBS isolates were collected through a hospital-wide surveillance system and confirmed via MALDI-TOF-MS. Multilocus sequence typing (MLST) was conducted for serotype VIII and undetermined serotype isolates. Clinical and laboratory data were analyzed to assess trends and mortality risk factors.ResultsA total of 264 episodes of GBS bacteremia were identified, with 147 isolates successfully re-cultured and 125 isolates and patients included in the clinical characteristic analysis. Serotype VIII emerged as the most common serotype (42.1% in 2019–2021) with a significant increase in prevalence over time (P = 0.02). MLST of serotype VIII revealed ST2 as the dominant sequence type (87.8%). Antimicrobial resistance rates for erythromycin, clindamycin, and levofloxacin were 27.2%, 30.4%, and 23.2%, respectively, with notable variability among serotypes. The 30-day mortality rate was 12.8%. Male sex (aOR: 2.18; 95% CI: 1.15–4.13, P = 0.02) and SOFA score (aOR per unit increase: 1.25; 95% CI: 1.12–1.38, P < 0.001) were significantly associated with mortality.ConclusionsThis study highlights the emergence of serotype VIII as a predominant cause of GBS bacteremia and its association with ST2 in South Korea. Male sex and higher SOFA scores were independent risk factors for mortality. The findings emphasize the need for ongoing surveillance and consideration of serotype-specific strategies in clinical management and vaccine development.

Changes in the Volume and Diameter of Benign Thyroid Nodules: A 10-Year Follow-Up Study.

Background: The incidence of asymptomatic thyroid nodules has risen enormously, with > 90% being benign. Despite limited long-term data, significant nodule growth (SNG) is common. Guidelines recommend cytology reevaluation if SNG occurs. Our study aimed to identify the rate and factors associated with SNG, compare diameter and volume-based assessments, and examine the association between SNG and malignancy risk over the long term (10 years). Methods: The retrospective cohort study, conducted at Ankara University, School of Medicine, Department of Endocrinology and Metabolism, included 732 nodules from 376 euthyroid patients, all monitored over a 10-year period by the same experienced sonographer, with evaluations at baseline, 5th and 10th years. The nodules were cytologically benign and/or sonographically in the low-to-intermediate risk category. Size changes at the 5th and 10th years were considered significant if there was a 20% or 2 mm increment in two diameters according to diameter-based criterion (DBC) or 50% increment in volume-based criterion (VBC) designed by the ellipsoid formula. Generalized linear mixed-effects models were used to account for the clustered data structure and analyze factors affecting nodule growth. Nodule growth was the dependent variable, while sex, age at diagnosis, initial TSH level, total nodule count, nodule volume, echogenicity, and localization were independent variables. Results: At the 5th and 10th years, SNG frequencies were higher when calculated using VBC [27.7% (n = 203) and 44% (n = 321), respectively] compared with DBC [19.1% (n = 140) and 35% (n = 256), respectively], with the differences being statistically significant (McNemar test, p < 0.01). Factors associated with SNG included being younger than 45 years of age (VBC OR = 1.704, CI = 1.227-2.366, p = 0.002; DBC OR = 1.913, CI = 1.379-2.656, p < 0.001), having higher number of nodules (VBC: OR = 1.171, CI = 1.061-1.291, p = 0.002; DBC: OR = 1.147, CI = 1.040-1.265, p = 0.006), and having smaller nodule volume (VBC: OR = 0.870, CI = 0.806-0.940, p < 0.001; DBC: OR = 0.912, CI = 0.850-0.978, p = 0.010). Thyroid cancer was diagnosed in four original nodules (0.5%), whereas the malignancy rate in biopsies performed was 1.4% (n = 4). Conclusions: In long-term follow-ups of sonographically and/or cytologically benign thyroid nodules, SNG is not rare. Growth is more likely in younger patients, those with higher number of nodules and smaller nodules. In the follow-up of nodule size, VBCs yield augmented results compared with DBCs. However, malignancy is quite rare in growing nodules. Therefore, adopting flexible long-term follow-up protocols appears to be practical for benign nodular thyroid disease.

Risk factors for complications from challenging lower third molar extractions in tertiary hospital patients.

Third molar extraction is a common procedure with occasional complications. This study aimed to determine the incidence and types of complications in challenging lower third molar extractions and to identify complication risk factors in tertiary hospital patients. A retrospective cohort study was conducted on 354 patients who underwent unilateral lower third molar extraction during a 2-year period in 2018-2019 at Helsinki University Hospital. The outcome was the presence of a complication, and patient-related and operation-related variables served as determinants. Statistical analyses included Mann-Whitney U and Chi-squared tests, and binary logistic regression. Complications occurred in 16.7% of patients. The most common complication was local infection (7.6%), followed by nerve injury (5.6%). The complication risk was 3.7-fold (95% confidence interval (CI) 1.97-6.77, p < 0.001) higher in extractions defined as demanding than in routine operative extraction. If the third molar was acutely infected, the complication risk increased 2.0-fold (95% CI 1.08-3.75, p = 0.027). Due to the high rate of complications in challenging extractions, scheduling a follow-up visit is important, and risk factors must be considered properly, especially in demanding extractions and in acutely infected third molars.

Genetic diversity and Wolbachia infection in the Japanese encephalitis virus vector Culex tritaeniorhynchus in the Republic of Korea

BackgroundCulex tritaeniorhynchus, a major vector of Japanese encephalitis virus (JEV), is found across a broad geographical range, including Africa, Asia, Australia and Europe. Understanding the population structure and genetic diversity of pathogen vectors is increasingly seen as important for effective disease control. In China and Japan, two countries in close proximity to the Republic of Korea (ROK), Cx. tritaeniorhynchus has been categorized into two clades based on the DNA barcoding region of mitochondrial cytochrome c oxidase subunit I (COI), suggesting the presence of cryptic species. No comprehensive analysis of the genetic diversity in Cx. tritaeniorhynchus has been conducted in the ROK. To address this gap, we investigated the population structure of Cx. tritaeniorhynchus in the ROK.MethodsIn Daegu, mosquito collections were conducted over a 2-year period from 2022 to 2023. For all other regions, Cx. tritaeniorhynchus specimens collected in 2023 were used. The COI barcoding region was analyzed to determine the genetic structure of the populations, supplemented with data from the 28S ribosomal DNA region. Each population was also examined for the eventual presence of Wolbachia infection. Finally, a back trajectory analysis was conducted to assess the possibility of international introduction of Cx. tritaeniorhynchus into the ROK.ResultsThe analysis of the COI region revealed the presence of two distinct clades within Cx. tritaeniorhynchus; these clades were the same as Cx. tritaeniorhynchus continental type (Ct-C) and C. tritaeniorhynchus Japanese type (Ct-J) previously reported. In contrast, the nuclear 28S region showed no significant genetic differentiation between these clades. Wolbachia infection was confirmed in some populations, but there was no evidence of an association with Wolbachia in Ct-C and Ct-J. It was also confirmed that the ROK is currently dominated by the Ct-J clade, with a possible introduction of Ct-C via air currents.ConclusionsDetermining the presence of cryptic species is important for preventing vector-borne diseases. The results of this study confirm the existence of two clades of Cx. tritaeniorhynchus in the ROK, with Ct-J being the dominant clade. Our findings enhance current understanding of the genetic diversity within Cx. tritaeniorhynchus and provide valuable insights for the prevention of JEV outbreaks and the effective management of Cx. tritaeniorhynchus populations in East Asia.Graphical

The Impact of Comorbid Sleep-Disordered Breathing on Hospitalization Risk Related to Diabetes and Atherosclerotic Disease: A Retrospective Cohort Analysis.

Objective: To determine the relationship between comorbid sleep-disordered breathing (SDB) and hospitalization rates related to diabetes mellitus (DM) and atherosclerotic disease (AD). Methods: This study used a retrospective cohort design from a large medical claims database with 5 years of data between 2018 and 2022. The presences of SDB, DM, and AD were identified using International Classification of Diseases (ICD-10) and relevant Current Procedural Terminology (CPT) codes. Hospitalizations related to DM and AD were identified primarily using Place of Service (POS) code 21. Propensity-score matching was first used on data from the entire 5-year period to select matched controls (unadjusted n = 883,910, adjusted n = 888,619) compared to those diagnosed with SDB (n = 519,818) on hospitalization rates during the concurrent 5-year period. A second analysis used propensity-score matching on data from year 1 only to select matched controls (unadjusted n = 248,848, adjusted n = 260,298) compared to those diagnosed with SDB in year 1 (n = 193,671) on hospitalization outcomes in the subsequent 4-year period. Results: Odds ratios (ORs) revealed a significant association between SDB diagnosis and hospitalizations related to DM (OR 1.23-1.71), AD (OR: 1.08-1.34), and either condition (OR 1.17-1.49) in both analyses. Post hoc analysis revealed sex differences in the relationship between SDB and future hospitalizations, with females showing a pattern of significantly elevated risk across all future hospitalization outcomes (OR: 1.25-1.44), whereas males were found to have a significant relationship between SDB diagnosis and future DM hospitalization only (OR 1.10). Conclusions: These findings provide real-world evidence that comorbid SDB increases the risk for hospitalizations related to chronic cardiometabolic conditions. Sex is a potential moderator of this relationship and should be further explored.

Analyzing the temporal trends of kidney transplantation surgeries and their impact on warm and cold ischemia time in a Canadian setting.

The effect of weekend admission and surgery on patient morbidity and mortality has been studied in many settings and has been shown to lead to worse outcomes. Several studies have sought to determine whether there is a weekend effect in kidney transplantation specifically, but a clear effect on outcomes and graft survival has not been established. We analyzed data from all deceased-donor organ procurements and cadaveric kidney transplants occurring during the 5-year period between Apr. 1, 2013, and Dec. 31, 2017, included in the database of the Trillium Gift of Life Network, Ontario's organ and tissue donation agency. A total of 1116 deceased donor nephrectomies (DNs) and 1858 recipient procedures were performed in Ontario during the study period. The overall rate of after-hours DNs on weekdays was significantly greater than during working hours (23.1/30 d v. 15.4/30 d, p < 0.001). Donations after neurological determination of death were more frequent during weekday working hours (22.8/30 d) than after hours on weekdays (17.3/30 d, p < 0.001) or weekends (16.3/30 d, p < 0.001), whereas donations after cardiac death were significantly more frequent after hours on weekdays than during working hours (10.3/30 d v. 7.7/30 d, p = 0.021). On weekdays, mean warm ischemia time (WIT) was significantly longer after hours than during working hours (40.75 ± 12.26 min v. 38.52 ± 11.92 min, p = 0.017). Similarly, mean WIT was longer after hours than during working hours on weekends (40.23 ± 12.48 min v. 38.59 ± 11.91 min, p = 0.015). Kidney transplantations occurred more frequently after hours and were associated with increased WIT. Further study is needed across multiple Canadian centres to better understand the temporal patterns of kidney transplantation and implications for patients, providers, and health care systems.

Influence of Autonomic Neuropathy, Systemic Inflammation and other Clinical Parameters on Mortality in Dialysis Patients

Abstract Background Autonomic neuropathy (AN) is prevalent in diabetes and chronic kidney disease. The Composite Autonomic Symptom Score 31 (COMPASS 31) is a self-assessment test developed to determine not only cardiac AN but also AN of other organs, including the vasomotor, pupillomotor, secretomotor, and gastrointestinal systems. As yet there are no data on the effects of combined AN-scores of a variety of affected organ systems on mortality in dialysis patients. Methods In 119 patients undergoing hemodialysis therapy, symptoms of AN were documented using COMPASS 31. After 5 years, survival rates were calculated depending on AN-scores and other parameters. After this 5-year-period, AN-scores were assessed for a second time and correlated with those obtained 5 years earlier. Results Survival rates for patients with lower AN-scores were better than for those with higher AN-scores. Patients with lower CRP showed better survival compared to those with higher values. Dialysis patients with diabetes had a lower survival rate compared to non-diabetic patients. In women, survival rates were better than in men. AN-scores remained unchanged over the 5-year period. Conclusion AN is frequently observed in dialysis patients and can be identified through COMPASS 31 questionnaire. Patients with higher AN-scores exhibit poorer survival rates compared to those with lower scores. This observation is applicable not only for cardiac AN but also to AN-scores reflecting changes in other organ systems. Therefore, AN-scores can be used effectively to detect various AN symptoms in dialysis patients and identify their increased risk of mortality.

Strength of clinical evidence supporting the United States Food and Drug Administration Accelerated Approvals from 2015 to 2022

BackgroundThe Food and Drug Administration (FDA)’s Accelerated Approval (AA) pathway has increasingly used to authorize market approval of new drugs amid controversy. The present study aims to inform the most recent data on the strength of clinical evidence supporting such approvals.MethodsEvidentiary characteristics of pre-approval pivotal clinical studies and regulator-required post-approval confirmatory studies supporting AAs between 2015 and 2022 were extracted from publicly available FDA documents. Descriptive analyses were conducted for each of the characteristic including study design, study phase, primary endpoint, number of participants, and magnitude of effect. Trends of these characteristics over time were documented and accounted for class of drugs, application type, novelty, orphan status, and oncology/non-oncology indications.ResultsDuring 2015–2022, 156 drug-indication pairs received AA. To support these AAs, 77% of pre-approval pivotal trials employed single-arm designs, and 22% were phase I trials, with a median of 92 participants (IQR, 45–125); 61% of post-approval confirmatory studies were required by FDA to use randomized controlled design, 25% to use clinical endpoints, and 33% specified the number of participants requirement. During the 8-year observation period, the pairs approved via AA pathway almost tripled from 20 (2015–2016) to 59 (2019–2020) and fell to 36 (2021–2022); the corresponding proportion to all new drug approvals showed the same trend. Single-arm pre-approval pivotal studies increased from 55% (2015–2016) to 91% (2019–2020) and fell to 69% (2021–2022), while the median number of participants decreased from 106 (2015–2016) to 59 (2019–2020) and rose to 106 (2021–2022). Randomized controlled post-approval confirmatory studies decreased from 75% (2015–2016) to 42% (2019–2020) and rebounded to 75% (2021–2022), while those using surrogate endpoints increased from 50% (2015–2016) to 72% (2021–2022). Analyses adjusting for drug class, application type, novelty, orphan status, and oncology/non-oncology showed similar results.ConclusionsThe number of drug-indication pairs receiving AA increased sharply during 2015–2016 to 2019–2020 but fell in 2021–2022. Meanwhile, the strength of clinical evidence supporting FDA’s AAs appeared to decline from 2015 to 2020 but seems to have improved in 2021–2022. Measures should be taken to further improve the strength of evidence in Accelerated Approvals.

Eight year results of patients with varicose vein underwent endovenous occlusion using n-butyl cyanoacrylate.

To present the 8-year results of 180 patients on whom we performed endovenous occlusion using N-butyl cyanoacrylate in 2014. We have previously published the 30-month results for 168 patients available for follow-up. Thirteen more patients were lost to follow-up in the 8-year research period. The remaining 155 patients underwent clinical examinations and their Venous Clinical Severity Score (VCSS) values were recorded. Doppler ultrasonography was performed, and whether the saphenous vein was occluded, or whether partial or complete recanalization were present was evaluated. The mean age of the 155 patients we were able to follow-up was 47.4 ± 11.8 years. Sixty-eight of the patients were men, and 87 were women. Mean VCSS scores were 10.2 before the procedure, 2.7 at 30 months, and 2.6 ± 0.7 at 8years. Complete recanalization was observed in seven patients over the 8years, and partial recanalization in six. Occlusion rates were 94.1% at 30 months and 91.7% at 8years. The long-term results of the use of N-butyl cyanoacrylate in the treatment of patients with varices are highly satisfying in terms of a high ablation rate.

Computer-assisted total bilateral knee arthroplasty for a patient with severe hyperextension in residual poliomyelitis: a case report

Background. Total knee arthroplasty in patients in the residual stage of poliomyelitis is a technically difficult job. The reasons for this are anatomical features and therefore difficulties in an implant choice and conflicting results. In the present case report, we describe a unique method of a computer-navigated installation of a rotating-hinge implant in a non-standard position for a patient with residual poliomyelitis. The aim of the study is to demonstrate a method of a computer-navigated installation of rotating-hinge knee implants in a patient with severe hyperextension and valgus deformity in the residual stage of poliomyelitis. Case description. The clinical case presents a 55-year-old man with lower peripheral paraparesis as a consequence of poliomyelitis and bilateral valgus knee arthritis with severe hyperextension. The patient moved on crutches at a distance no more than 300 meters. Two-stage total knee arthroplasty was performed using a navigation system and second-generation rotating-hinge implants. At the 4-year follow-up period, we note a good clinical result, and the patient is satisfied with the total knee arthroplasty outcomes. Conclusion. The clinical case demonstrates good results of performing total knee arthroplasty in a patient with bilateral severe hyperextension and knee valgus deformity in residual poliomyelitis. Having analyzed available topic-related literature, we developed an original method of a computer-navigated installation of a second-generation rotating-hinge implant. The method can be an effective treatment solution for patients with knee arthritis deformity in the residual stage of poliomyelitis.

Minimum number of readings necessary for determining long-term visit-to-visit blood pressure variability to predict cardiovascular outcomes in people with diabetes.

People with diabetes often have increased blood pressure (BP) variability because of autonomic dysfunction and arterial stiffness, making it a critical factor in predicting clinical outcomes. We investigated the reproducibility of long-term visit-to-visit BP variability (VVV) and the minimum number of BP readings to reliably determine VVV in people with diabetes. This multicenter retrospective study used data from electronic health records of the Korea University Medical Center database. Altogether, 10 475 people with diabetes who had more than nine BP readings during a maximum period of 2 years were identified. This study focused on the coefficient of variation of these readings and their correlation with major adverse cardiovascular events (MACE) over a 3-year follow-up period. The mean age of the participants was 65.2 years. Of these, 53.2% were men, and 87.4% had hypertension. The mean coefficient of variation of multiple SBP readings that best predicted the 3-year MACE were 8.4, 9.5, 9.0, 9.0, and 9.7 for three, five, seven, nine, and all readings, respectively. Patients with high VVV (coefficient of variation of five SBP readings >9) exhibited a higher incidence of 3-year MACE (10.1%) than those with low VVV (5.4%, P < 0.001). In the multivariable analysis, high VVV of both SBP and DBP were independently associated with 3-year MACE. Long-term VVV in the BP is a reproducible and reliable predictor of cardiovascular outcomes in people with diabetes. A minimum of five BP measurements are recommended for effective intraindividual VVV estimation and cardiovascular risk assessment.