Multicenter Investigation Research Articles

Anemia, iron metabolism, and anemia medication habits in patients undergoing maintenance hemodialysis and peritoneal dialysis are different: a multicenter investigation.

This study aimed to investigate anemia, iron metabolism status, and treatment in patients undergoing maintenance hemodialysis (HD) and peritoneal dialysis (PD). Patients aged ≥ 18years undergoing HD and PD were surveyed using a case report form to collect information. Data were collected from 1071 patients undergoing HD and 630 undergoing PD at eight centers. Anemia was observed in 96.2% of the patients (96.7% for HD vs. 95.2% for PD, P = 0.121). Of these, 38.3% had hemoglobin (Hb) levels between 110 and 130g/L (41.2% for HD vs. 33.3% for PD, P < 0.001), 22.8% had absolute iron deficiency (ID) (31.2% for HD vs. 8.4% for PD, P < 0.001), and 5.8% had functional ID (4.7% for HD vs. 7.6% for PD, P = 0.012). Among patients with Hb < 110g/L, 13.0% received no treatment with erythropoiesis-stimulating agents (ESAs, all recombinant human erythropoietin) or hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHI, all roxadustat) (12.6% for HD vs. 13.6% for PD, P = 0.667), while 64.6% had no iron treatment (69.4% for HD vs. 57.4% for PD, P < 0.001). Logistic regression was used to explore the relationship between dialysis mode and hemoglobin target achievement, suggesting that the attainment of hemoglobin targets may be associated with the use of ESAs or HIF-PHI. Anemia, iron metabolism, and medication habits have distinct characteristics in patients undergoing HD and PD. Iron deficiency is prevalent, and achieving hemoglobin targets is suboptimal, possibly influenced by the administration of ESAs or HIF-PHI. Therefore, timely adjustments of medication habits are necessary to prevent anemia exacerbation.

Predictive model of the surgical difficulty of robot-assisted total mesorectal excision for rectal cancer: a multicenter, retrospective study

Rectal cancer robotic surgery is becoming more and more common, but evidence for predicting surgical difficulty is scarce. Our goal was to look at the elements that influence the complexity of robot-assisted total mesorectal excision (R-TME) in the medical care of middle and low rectal cancer as well as to establish and validate a predictive model on the basis of these factors. Within this multicenter retrospective investigation, 166 consecutive patients receiving R-TME between January 2021 and December 2022 with middle and low rectal cancer were included and categorized according to the median operation time. A nomogram was created to forecast the procedure’s complexity after variables that could affect its difficulty were found using logistic regression analysis. Using R software, a total of 166 patients were randomly split into two groups: a test group (48 patients) and a training group (118 patients) at a ratio of 7 to 3. The median operation time of all patients was 207.5 min; patients whose operation time was ≥ 207.5 min were allocated to the difficult surgery group (83 patients), and patients whose operation time was < 207.5 min were allocated to the nondifficult surgery group. Multivariate analysis revealed that body mass index (BMI), the gap between the tumor and the anal verge and the posterior rectal mesenteric thickness were independent predictors of surgical duration. A clinical predictive model was created and assessed employing the above independent predictors. The results of the receiver operating characteristic (ROC) analysis revealed the adequate discriminative ability of the predictive model. Our study revealed that it is feasible to predict surgical difficulty by obtaining clinical and magnetic resonance parameters for imaging (the gap between the anal verge and the tumour, and posterior mesorectal thickness), and these predictions could be useful in making clinical decisions.

Cost effective clinical methods to evaluate the efficacy of gait training devices: A systematic review of randomized controlled trials

Abstract Aim: This systematic review was aimed at identifying cost-effective outcome assessment metrics to perform clinical trials for assessing the efficacy of novel, low-cost gait training devices. Materials and methods: The search was conducted by the investigators through electronic databases, namely SCOPUS (91), Web of Science (93), PubMed (141) and Cochrane Library (164), from origination to 31st March 2024. The study design was a PRISMA style systematic review of randomized controlled trials (RCTs) of robotic gait training devices (RGTDs) that treated stroke patients. Results: Based on our inclusion and exclusion criteria, 17 randomized controlled trials were studied to identify suitable outcome assessment measures. This involved 705 patients at different stages of stroke, who were treated with different intervention durations, devices, randomization and blinding methods. It was observed from the extensive clinical trials with the RGTDs that it was tested with a variety of assessment methods. Cost-effective outcome assessment measures that require commonly available materials are chosen and discussed in this review. It is identified that the most extensively used measures possess concurrent validity, sufficient inter-rater, intra-rater and test-retest reliability. Conclusion: Clinical trials with a sophisticated setup cannot be afforded by clinics in low-income countries. It is vital to identify assessment methods that require commonly available materials that do not incur huge material costs. The methods discussed in this review can be administered without special training. This can facilitate quantifying and comparing the efficacy of these devices through clinical trials and multi-centric investigations.

Identification of health trajectories of patients with persistent spinal pain syndrome type 2 using latent class trajectory methods.

Persistent spinal pain syndrome Type 2 (PSPS-T2) is a long-lasting condition that consists of persistent pain following spinal surgery. Although this condition has long-term effects, it is currently studied at a given time point or over a limited period of time, which does not reflect the true impact of pain patients. To bridge this gap, we used latent class trajectory models to extract clusters with different trajectories of patients with PSPS-T2. Data from the PREDIBACK study, an observational, multicentric, and longitudinal investigation carried out prospectively, were used. This study focuses on patients with PSPS-T2, tracking their outcomes at 3-month intervals over a one-year period. Health status was evaluated using a novel multidimensional clinical response index (MCRI). The trajectories of patients' health status were extracted using mixture of mixed effect models. Two hundred (200) PSPS-T2 patients were included. Two clusters were identified, including 'persistent low health' trajectories (63.1%) and 'improving health' trajectories (36.9%). Regarding the factors associated with these trajectories, our results showed that lower age, lower body mass index, lower pain intensity, lower functional disability, lower anxiety and less extended pain surface were associated with improving health status. Clustering methods provide an opportunity to identify two distinct clusters of pain-related health trajectories of PSPS-T2 patients. Persistence of the symptoms was not observed in one third of the PSPS-T2 study patients, who belong to the improving pain-related health cluster, while the other two thirds did not achieve improved health over a 1-year follow-up. Our study findings suggest that the use of trajectory-based methods could improve patient evaluation and pain management as it allows for obtaining a global view of patients during their care pathway compared to conventional methods, which only focus on specific visits. Our study also advocates for multidimensional assessment and management of pain by targeting not only pain intensity but also the psychological distress, functional capacity and pain surface at an early stage of pain onset after spine surgery.

“Comprehensive Analysis of Factors Influencing Recurrence and Survival in Glioblastoma: Implications for Treatment Strategies”: A Single Center Study

Glioblastoma is a highly aggressive malignancy affecting the brain and central nervous system. It is the most common malignant primary brain tumor, yet its prognosis remains poor. Median survival typically ranges from around 13 months with standard treatment to up to 19.9 months in some recent clinical trials. Despite advances in treatment, the aggressive nature of glioblastoma continues to present significant challenges for improving patient outcomes. This study aimed to analyze various biological, radiological, and molecular factors associated with glioblastoma recurrence and to estimate survival outcomes. A total of 104 glioblastoma patients diagnosed between January 2017 and September 2022 were included. Patient demographics, treatment received, and molecular characteristics were obtained from the Electronic Patient Record (EPR). Tumor molecular characteristics were analyzed using the OnkoSight Advanced CNS NGS panel. Statistical analyses were performed to develop a prognostic model for glioblastoma recurrence and estimate survival rates. Among the patients, 65.4% had no recurrence, with a mean age of 63 years. No gender or BMI differences were observed, but ages &lt;60 years were associated with recurrence. Radiological findings showed no significant differences in tumor size, necrosis, site, or focality. In multivariate analysis, the female gender, obesity, old age (&gt;60 years), or bifocal tumors were associated with decreased glioblastoma recurrence. However, factors like tumor site, size, necrosis, MGMT promoter methylation, and EGFR alteration showed no significant association with recurrence. Median survival was 12 months, with older age significantly associated with shorter survival. Tumor sizes &gt;4 cm showed shorter survival trends but not statistically significantly. Patients who lived longer experienced more tumor recurrence incidents. Standard or non-standard treatments were associated with longer median survival compared to no treatment. Our findings provide insights into factors influencing glioblastoma recurrence and survival. Age, gender, and tumor characteristics play pivotal roles in recurrence. Understanding these factors could aid in optimizing treatment strategies and improving patient outcomes. However, further multicentric investigations are needed to validate these findings. This study emphasizes the importance of considering biological and radiological factors in clinical decision-making for glioblastoma cases.

Predictors of acute kidney injury in chronic kidney disease patients treated for cardiovascular disease in the cardiac intensive care unit (MORCOR-TURK subgroup analysis).

Acute kidney injury (AKI) is a common complication in chronic kidney disease (CKD) patients in the cardiac intensive care unit (cardiac ICU). In this study, we aimed to identify predictors of AKI in CKD patients treated in the cardiac ICU for cardiovascular diseases. The MORCOR-TURK trial was conducted as a multicenter, prospective, cross-sectional, and noninterventional investigation. A total of 3157 patients treated in the cardiac ICU were enrolled from 50 centers over the course of one month. In this subgroup analysis, 615 patients with CKD treated in the cardiac ICU for cardiovascular disease were included in the study. The primary outcome of this study was the development of AKI. During hospitalization, patients who developed AKI were identified. AKI developed in 288 patients (46%). After multivariable analysis, decompensated heart failure (OR: 3.72, p = 0.005), primary percutaneous coronary intervention (OR: 3.75, p = 0.004), non-primary percutaneous coronary intervention(OR: 2.85, p = 0.033), troponin levels (OR: 1.04, p = 0.031), and need for mechanical ventilation (OR: 3.11, p < 0.001) were identified as independent predictors of AKI development in CKD patients. Our efforts to identify AKI predictors in cardiac ICU patients with CKD have yielded directly applicable results in clinical practice. AKI can be prevented by developing personalized strategies to follow up and treat cardiac ICU patients with CKD who have decompensated heart failure, are undergoing percutaneous coronary intervention (primary and non-primary), have high troponin levels, and need mechanical ventilation.

Development and validation of a risk prediction model for postpartum urinary incontinence in primiparas with singleton pregnancies: a multicenter clinical investigation.

Postpartum urinary incontinence (UI) is a serious condition that significantly affects the quality of life. Several studies have demonstrated that it is associated with pelvic floor dysfunction. This study aimed to develop and validate a UI risk prediction model to identify primiparas with singleton pregnancies at high risk. A multistage stratified random sampling process was used. UI was measured using the International Standard Consultation on Incontinence Questionnaire Form (a modified Bristol questionnaire, ICIQ-FLUTS). Records of 1,340 primiparas with singleton pregnancies were reviewed, and data were collected from January 2014 to December 2014 in multiple centers. A univariate logistic regression analysis was performed, followed by a multivariable logistic regression analysis of the data. Using bootstrap resampling, we constructed a nomogram to assess postpartum UI risk. A total of 1,340 patients were enrolled, including 345 with postpartum UI and 995 with non-postpartum UI. The occurrence of postpartum UI was significantly related to the mode of delivery, family history of UI, coffee or tea consumption, antenatal UI, and frequent cough. The nomogram exhibited good discriminatory ability with a C-index of 0.718 (95% confidence interval: 0.684-0.752) and a bootstrap-corrected C-index of 0.716. Additionally, the calibration curve demonstrated that the predicted outcomes aligned well with the actual observations. Ultimately, the decision curve analysis indicated that the nomogram exhibited favorable clinical applicability. The decision curve analysis suggests that the nomogram could provide clinical value. The clinician will then feel more confident about making clinical recommendations regarding postpartum UI screening for primiparous women with singleton pregnancies.

Application of the NSE score (Neurology-Stability-Epidural compression assessment) to establish the need for surgery in spinal metastases of elderly patients: a multicenter investigation.

This retropective multicentric study aims to investigate the clinical applicability of the NSE score in the elderly, to verify the role of this tool as an easy help for decision making also for this class of patients. All elderly patients (> 65 years) suffering from spinal metastases undergoing surgical or non-surgical treatment at the authors' Institutions between 2015 and 2022 were recruited. An agreement group (AG) and non-agreement group (NAG) were identified accordingly to the agreement between the NSE score indication and the performed treatment. Neurological status and axial pain were evaluated for both groups at follow-up (3 and 6 months). The same analysis was conducted specifically grouping patients older than 75 years. A strong association with improvement or preservation of clinical status (p < 0.001) at follow-up was obtained in AG. The association was not statistically significant in NAG at the 3-month follow-up (p 1.00 and 0.07 respectively) and at 6 months (p 0.293 and 0.09 respectively). The group of patients over 75 years old showed similar results in terms of statistical association between the agreement group and better outcomes. Far from the need or the aim to build dogmatic algorithms, the goal of preserving a proper performance status plays a key role in a modern oncological management: functional outcomes of the multicentric study group showed that the NSE score represents a reliable tool to establish the need for surgery also for elderly patients.

Prognostic Impact of Low Muscle Mass and Inflammatory Markers in Stage III Nonsmall Cell Lung Cancer Turkish Oncology Group and Turkish Society of Radiation Oncology Thoracic Cancer Study Group (08-005).

The aim of this retrospective multicenter study was to evaluate the prognostic significance of low muscle mass, and inflammatory markers in patients with stage III nonsmall cell lung cancer (NSCLC) who received definitive chemoradiotherapy (CRT). Furthermore, the study aimed to determine the threshold value of disease-specific low muscle mass. A total of 461 patients with stage III NSCLC were evaluated. Low muscle mass, prognostic nutritional index (PNI), and biochemical inflammatory markers were assessed. The Kaplan-Meier method and Cox regression analysis were used to analyze overall survival (OS) and progression-free survival (PFS). This study found a disease-specific low muscle mass threshold of LSMI <38.7cm²/m² for women and <45.1cm²/m² for men, with 25.2% of patients having disease-specific low muscle mass. Multivariate cox regression analysis revealed that low PNI was found to be an independent unfavorable prognostic factor for both PFS (HR=0.67; 95% CI: 0.48-0.92, P= 0.015) and OS (HR=0.67; 95% CI: 0.50-0.91, P=0.008). Other factors including ECOG PS 3 (HR=7.76; 95% CI: 1.73-34.76, P=0.007), induction CT (HR=0.66; 95% CI: 0.49-0.88, P= 0.004), and disease-specific low muscle mass (HR=1.40; 95% CI: 1.02-1.92, P= 0.038) also had independent effects on prognosis. The present study provides evidence that the presence of low muscle mass and low PNI significantly impacts the prognosis of patients with stage III NSCLC who undergo definitive CRT. Furthermore, our study is notable for being the first multicenter investigation to identify a disease-specific low muscle mass threshold.

Do novel inflammation biomarkers arising from routine complete blood count play a role in patients with systemic lupus erythematosus?

Laboratory-based biomarkers accurately presenting systemic lupus erythematosus (SLE) disease activity may have a practical value in clinical routine. As shown in many other conditions, complete blood count (CBC)-derived biomarkers may also play a role in SLE. We aimed to study for the first time the pan-immune-inflammation value (PIV, monocytes x platelets x neutrophils/lymphocytes) and the more established systemic immune-inflammation index (SII, neutrophils x platelets /lymphocytes) in SLE patients and correlate it with serological and clinical findings including disease outcomes. In this retrospective multicentric investigation, we reviewed the clinical records of 148 SLE who had an available CBC at baseline. The latter served for the determination of the neutrophil-to-lymphocyte ratio (NLR), SII, and the PIV. Control groups were studied as well. Univariable as well as multivariable statistics were employed. The values for baseline systemic immune-inflammation biomarkers (SIIB) studied were significantly (p < 0.0001) higher than those observed in healthy controls but comparable to those obtained from patients with other inflammatory conditions. Multivariable analysis revealed that ANA titer > 1:640 remained the only significant (p < 0.0001) baseline predictor of SLE flare (odds ratio: 7.6, 95% CI 3.1 to 18.8). Improvement of SLE following treatment was associated with the absence of lymphopenia as well as ANA > 1:640 (p = 0.041). The SLEDAI-2K significantly correlated with NLR, SII, CRP, lymphocytes, and monocytes only on univariable testing. Compared to healthy controls the CBC-based SIIB investigated are significantly increased in SLE patients. However, SIIB do not appear to be useful in managing SLE clinically. Nevertheless, we confirm that higher ANA titers can predict flares of SLE.

Serum Autotaxin Levels Predict Liver-Related Events in Patients With Primary Biliary Cholangitis: A Long-Term Multicenter Observational Study.

A straightforward, reliable, and noninvasive method for predicting the development of liver-related events (LRE) in primary biliary cholangitis (PBC) has not been attained thus far. This study investigated whether serum autotaxin (ATX) could predict LRE in patients with PBC. This retrospective multicenter investigation included 190 biopsy-proven untreated patients with PBC. All subjects were followed for at least 1 year, during which time the prevalence of LRE, including newly developing hepatocellular carcinoma, esophagogastric varices, ascites, and hepatic encephalopathy, was investigated in relation with ATX levels at the time of liver biopsy. During the median follow-up period of 9.7 years, LRE were observed in 22 patients (11.6%). The area under the receiver operating characteristic curve and cutoff value of serum ATX for predicting LRE were 0.80 and 1.086 mg/L, respectively. Patients with serum ATX ≥1.086 had a significantly higher cumulative incidence of LRE compared with patients with ATX < 1.086 (33.3% vs 3.6%, P < 0.00001). Notably, the predictive capability of ATX for LRE in patients with PBC surpassed that of FIB-4, ALBI, APRI, and Mac-2-binding protein glycan isomer. A multivariate Cox proportional hazards model revealed ATX as an independent associated factor for LRE (hazard ratio 6.24, 95% confidence interval 1.87-20.80, P = 0.003) along with Nakanuma stage (hazard ratio 2.75, 95% confidence interval 1.52-4.99, P < 0.001). These results were closely replicated in a serologically diagnosed PBC validation cohort (n = 32). Serum ATX levels may serve as a predictive marker for LRE in patients with PBC.

Clinical Analysis of Inhaled Nitric Oxide Therapy in Preterm Infants at Different Gestational Ages: A National Retrospective Multicenter Study.

This study aimed to investigate clinical features of inhaled nitric oxide (iNO) in preterm infants with a gestational age (GA) < 34 weeks in China. The clinical data of 434 preterm infants with GA < 34 weeks, treated with iNO in the neonatology departments of eight Class A tertiary hospitals in China over a 10-year period from January 2013 to December 2022, were included in this retrospective multicenter investigation. The infants were divided into three groups based on GA: 24 to 27 weeks (extremely preterm infants), 28 to 31 weeks (very preterm infants), and 32 to 33 weeks (moderate preterm infants). The use of iNO, perinatal data, incidence and mortality of indication for iNO treatment, therapeutic effects of iNO, incidence of short-term complications for iNO treatment, and mortality were compared among these three groups. Over the past 10 years, the proportion of iNO use was highest in extremely preterm infants each year. The lower the GA, the higher the iNO use rate: 4.20% for GA 24 to 27 weeks, 1.54% for GA 28 to 31 weeks, and 0.85% for GA 32 to 33 weeks. There was no significant difference in the therapeutic effect of iNO among the three groups. The incidence of neonatal pulmonary hemorrhage, neonatal shock, late-onset diseases, retinopathy of prematurity requiring intervention, intracranial hemorrhage (grade 3 or 4), periventricular leukomalacia, neonatal necrotizing enterocolitis (≥stage II), and moderate to severe bronchopulmonary dysplasia was highest in extremely preterm infants and increased with decreasing GA. Mortality was negatively correlated with GA and birth weight. The highest rate of iNO treatment in 24 to 27 weeks' preterm infants was due to hypoxic respiratory failure (HRF), whereas the highest rate of iNO treatment in 32 to 33 weeks' preterm infants was due to documented persistent pulmonary hypertension of the newborn (PPHN). The rates of iNO treatment due to HRF and documented PPHN were 54.3 and 60.6%, respectively, in extremely preterm infants, significantly higher than in very preterm and moderate preterm infants (all p < 0.05). Within the same GA group, the proportion of preterm infants treated with iNO for HRF was lower than that for documented PPHN (all p < 0.05), but there was no statistically significant difference in mortality between HRF and documented PPHN treated with iNO (all p > 0.05). Among preterm infants with GA < 34 weeks, the rate of iNO usage was highest in extremely preterm infants. However, iNO failed to improve the clinical outcome of extremely preterm infants with refractory hypoxemia, and there was no significant difference in the therapeutic effect of iNO among preterm infants with different GAs.

Risk factors for nonunion in femoral neck fracture patients with internal fixation: A multicenter (TRON group) retrospective study

IntroductionFemoral neck fractures (FNFs) are common in elderly individuals. When minimally displaced, they are typically treated with internal fixation. Nonunion is a complication of internal fixation of FNF, that sometimes necessitates reoperation. Radiographic parameters, including the Pauwels angle and posterior tilt angle, are risk factors for nonunion. However, these parameters are assessed solely in a two-dimensional context. We developed a novel radiographic parameter named the “Kindex.” This multicenter investigation aimed to identify risk factors for nonunion following FNF fixation and evaluate the validity of this index. MethodsThis retrospective multicenter study collected data from 939 FNF patients who underwent internal fixation between 2016 and 2020 at 11 facilities (TRON group). The following exclusion criteria were applied: age <65, insufficient data, and Garden Stage III or IV fracture. Patient data, including age, sex, BMI, ASA classification, alcohol and smoking history, and comorbidities, were recorded. Radiographic measurements of the Pauwels angle and posterior tilt angle at the time of injury were used to calculate the Kindex. Correlations between the Pauwels angle, posterior tilt angle, Kindex, and nonunion were evaluated. A multivariate logistic regression analysis was performed to investigate independent risk factors for nonunion. A receiver operating characteristic (ROC) analysis was performed to determine the cutoff value of the Kindex, and the area under the curve (AUC) was calculated. ResultsThe study included 594 patients (males, n = 151; females, n = 443; average age, 80.9 years). Nonunion was observed in 13 cases (2.2 %). While the Pauwels angle and posterior tilt angle did not show significant correlations, the Kindex exhibited strong correlations with both parameters. In the multivariate analysis, the Kindex and renal impairment were independent risk factors for nonunion (Kindex: OR 1.06, p = 0.015; renal impairment: OR 1.48, p = 0.021). In the ROC analysis, a Kindex of 50 was identified as the optimal cutoff value (AUC 0.72). ConclusionThe nonunion rate after internal fixation of FNF was 2.2 %. Renal impairment and the Kindex were identified as independent risk factors. The Kindex at the time of injury may serve as a novel radiographic parameter to consider when evaluating the need for internal fixation in FNF cases.

Enhanced RBD-Specific Antibody Responses and SARS-CoV-2-Relevant T-Cell Activity in Healthcare Workers Following Booster Vaccination.

COVID-19 continues to impact healthcare workers (HCWs), making it crucial to investigate vaccine response rates. This study examined HCWs' humoral and cellular immunological responses to COVID-19 booster dosages. We enrolled thirty-four vaccinated HCWs. Twelve received a booster. Post-immunization, the participants' anti-COVID-19 IgG antibodies and IFN-γ secretion were assessed. The median second immunization response time was 406.5 days. Eighteen of twenty-two (81.8%) experienced breakthrough infections after the second vaccination, whereas ten out of twelve individuals who received booster doses had breakthrough infections (83.3%). Six of thirty-four HCWs (17.6%) had no breakthrough infections. Booster-injection recipients had a median antibody titer of 19,592 AU/mL, compared to 7513.55 AU/mL. HCWs with breakthrough infections exhibited a median antibody titer of 13,271.9 AU/mL, compared to 7770.65 AU/mL for those without infections. Breakthrough-infection and booster-injection groups had a slightly higher median T-cell response to antigens 1, 2, and 3. SARS-CoV-2 antibody titer and T-cell responsiveness were positively associated. HCWs sustain cellular and humoral immunity for over 10 months. Irrespective of the type of vaccine, booster injections enhance these immune responses. The results of our research are consistent with previous studies, and a multicenter investigation could validate the findings.

Elderly trochanteric fracture outcomes: Unveiling the risks of excessive postoperative sliding - A retrospective multicenter (TRON group) investigation

BackgroundIntramedullary nailing (IMN) for femoral trochanteric fractures (FTF) is the primary surgical intervention. Excessive lag screw sliding (ES) of the femoral neck screw sometimes occurs. This multicenter investigation sought to 1) determine the prevalence of ES, 2) evaluate the relationship between ES and postoperative complications, and 3) identify the factors of ES in elderly patients with FTF undergoing IMN. MethodsFrom 2016 to 2020, 1448 patients with FTF were treated using a short IMN across 11 institutions (TRON group). Upon applying exclusion criteria, 519 patients (127 men, 392 women; mean age, 84.4 years) were included. The postoperative sliding distance was measured immediately after surgery and at final follow-up. A sliding distance of ≥8 mm categorized patients as having ES. We identify the factors contributing to ES using the logistic regression analysis, with a p < 0.05 as statistical significance. ResultsES was observed in 116 patients (22.4 %). Patients with ES had a higher incidence of postoperative cut-out and peri-implant fracture. Logistic regression analysis showed that achieving optimal reduction in both AP and lateral views (odds ratio (OR) 0.48, p = 0.0012) and the use of a double screw system or twin screws with integrated locking mechanism significantly reduced the risk of ES (OR 0.27, 0.17; p = 0.0027, <0.001). ConclusionsThe incidence rate of ES was 22.4 %. ES was associated with a higher risk of postoperative complications. The surgeons should aim for optimal reduction and use a double screw or twin screws with an integrated interlocking mechanism as the implant of choice.

Regorafenib monotherapy as the later-line treatment for elderly patients with metastatic colorectal cancer: a multicenter real-world study.

Colorectal cancer is one of the tumors with the highest morbidity and mortality rates in China and the world. Regorafenib is a targeted drug for standard third-line treatment of metastatic colorectal cancer (mCRC). Regorafenib monotherapy has shown certain efficacy in the elderly population, but more robust evidence is needed. The aim of this study was to evaluate the dosing characteristics, prognosis, and safety of regorafenib monotherapy in elderly Chinese patients with mCRC. This retrospective study comprised elderly patients (aged ≥60 years) with mCRC who received regorafenib monotherapy as a third-line or above treatment in 10 hospitals from August 2017 to June 2020. We analyzed the association between different dosing regimens and prognosis. The primary endpoint was overall survival (OS), and other endpoints included progression-free survival (PFS) and adverse events (AEs). In total, 203 patients were included in the analysis. The median PFS was 3.88 months [95% confidence interval (CI): 3.48-5.65], and the median OS was 10.1 months (95% CI: 8.94-12.1). There was no significant difference in the survival curves between the different dosage groups. The multivariate Cox analysis showed a significant benefit in OS in the high final daily dose group (120-160 mg/day) [hazard ratio (HR): 0.45, 95% CI: 0.25-0.84, P=0.01], which was further confirmed by the propensity score matching (PSM) and inverse probability of treatment weighting (IPTW) analysis. No significant association was found between the initial daily dose and prognosis. Nor was any significant association found between PFS and drug dosage. Subsequently, an age subgroup analysis was conducted using 70 years as the cut-off value. In those aged <70 years, the application of higher final doses (120-160 mg/day) was significantly associated with the prolongation of OS compared to a final dose of 80 mg/day [HR (95% CI): 0.38 (0.16-0.91), P=0.03], and the prolongation of OS was predominantly observed in the 120 mg/day dose group [HR (95% CI): 0.24 (0.09-0.67), P=0.006]. Besides, we observed a statistically insignificant increase in the incidence of AEs in the higher dose group compared to the lower dose group. Regorafenib monotherapy was shown to be efficacious in the elderly population, but further evidence is needed for guidance. Based on our multicenter real-world investigation, the final daily dose was significantly associated with OS. For those aged <70 years, maintaining the final dose at 120 mg/day may have prognostic advantages. The suggested medication protocol requires validation through comprehensive clinical trials.

Cytomegalovirus prophylaxis in pediatric liver transplantation: A comparison of strategies across the Society of Pediatric Liver Transplantation consortium

Although cytomegalovirus (CMV) is a common complication after pediatric liver transplantation (PLT), the optimal method for CMV prevention is uncertain and lacks multicentered investigation. We compared the effectiveness of short (<120 days) vs long (>180 days) CMV primary antiviral prophylaxis to prevent CMV disease in PLT, through a prospective cohort study of primary PLT (aged <18 years) recipients enrolled in the Society of Pediatric Liver Transplantation registry from 2015 to 2019 with either donor or recipient CMV seropositivity. Participants were grouped into short or long prophylaxis based on their center’s practice and intended duration. In total, 199 PLT recipients were enrolled including 112 (56.3%) short and 87 (43.7%) long prophylaxis. End-organ disease was rare and similar between groups (2.7% and 1.1%; P = .45). CMV DNAemia and syndrome were more common in the short compared with those in long prophylaxis (26.8% vs 13.8%; P = .03; 18.8% vs 6.9%; P = .02). Neutropenia occurred more commonly with long prophylaxis (55.2% vs 16.1%; P < .001). Graft and patient survival were similar. Consideration of a short prophylaxis must weigh increased risk of CMV syndrome/DNAemia against medication burden and neutropenia of longer prophylaxis.

Advancing microvascular invasion diagnosis: a multi-center investigation of novel MRI-based models for precise detection and classification in early-stage small hepatocellular carcinoma (≤ 3cm).

This study aimed to develop two preoperative magnetic resonance imaging (MRI) based models for detecting and classifying microvascular invasion (MVI) in early-stage small hepatocellular carcinoma (sHCC) patients. MVI is graded as M0 (no invasion), M1 (invasion of five or fewer vessels located within 1cm of the tumor's peritumoral region), and M2 (invasion of more than five vessels or those located more than 1cm from the tumor's surface). This study enrolled 395 early-stage sHCC (≤ 3cm) patients from three centers who underwent preoperative gadopentetate-enhanced MRI. From the first two centers, 310 patients were randomly divided into training (n = 217) and validation (n = 93) cohorts in a 7:3 ratio to develop the first model for predicting MVI presence. Among these, 153 patients with identified MVI were further divided into training (n = 112) and validation (n = 41) cohorts, using the same ratio, to construct the second model for MVI classification. An independent test cohort of 85 patients from the third center to validate both models. Univariate and multivariate logistic regression analyses identified independent predictors of MVI and its classification in the training cohorts. Based on these predictors, two nomograms were developed and assessed for their discriminative ability, calibration, and clinical usefulness. Besides, considering the two models are supposed applied in a serial fashion in the real clinical setting, we evaluate the performance of the two models together on the test cohorts by applying them simultaneously. Kaplan-Meier survival curve analysis was employed to assess the correlation between predicted MVI status and early recurrence, similar to the association observed with actual MVI status and early recurrence. The MVI detection nomogram, with platelet count (PLT), activated partial thromboplastin time (APTT), rim arterial phase hyperenhancement (Rim APHE) and arterial peritumoral enhancement, achieved area under the curve (AUC) of 0.827, 0.761 and 0.798 in the training, validation, and test cohorts, respectively. The MVI classification nomogram, integrating Total protein (TP), Shape, Arterial peritumoral enhancement and enhancement pattern, achieved AUC of 0.824, 0.772, and 0.807 across the three cohorts. When the two models were applied on the test cohorts in a serial fashion, they both demonstrated good performance, which means the two models had good clinical applicability. Calibration and decision curve analysis (DCA) results affirmed the model's reliability and clinical utility. Notably, early recurrence was more prevalent in the MVI grade 2 (M2) group compared to the MVI-absent and M1 groups, regardless of the actual or predicted MVI status. The nomograms exhibited excellent predictive performance for detecting and classifying MVI in patients with early-stage sHCC, particularly identifying high-risk M2 patients preoperatively.

Quantifying attention in children with intellectual and developmental disabilities through multicenter electrooculogram signal analysis.

In a multicenter case-control investigation, we assessed the efficacy of the Electrooculogram Signal Analysis (EOG-SA) method, which integrates attention-related visual evocation, electrooculography, and nonlinear analysis, for distinguishing between intellectual and developmental disabilities (IDD) and typical development (TD) in children. Analyzing 127 participants (63 IDD, 64 TD), we applied nonlinear dynamics for feature extraction. Results indicated EOG-SA's capability to distinguish IDD, with higher template thresholds and Correlation Dimension values correlating with clinical severity. The template threshold proved a robust indicator, with higher values denoting severe IDD. Discriminative metrics showed areas under the curve of 0.91 (template threshold) and 0.85/0.91 (D2), with sensitivities and specificities of 77.6%/95.9% and 93.5%/71.0%, respectively. EOG-SA emerges as a promising tool, offering interpretable neural biomarkers for early and nuanced diagnosis of IDD.

Summary: Appropriate Use Criteria for the Use of Nuclear Medicine in Fever of Unknown Origin.

The diagnostic work-up of patients with fever of unknown origin (FUO) begins with a thorough history and physical examination, complete blood count with differential, chest x-ray, urinalysis and culture, electrolyte panel, liver enzymes, erythrocyte sedimentation rate, and C-reactive protein level. Additional imaging procedures, including nuclear medicine tests, are generally used as second-line procedures, with 18F-FDG PET and PET/CT assuming increasingly important roles in the diagnostic work-up. The Society of Nuclear Medicine and Molecular Imaging, the Infectious Diseases Society of America, and the American College of Nuclear Medicine convened an autonomous expert work group to comprehensively review the published literature for nuclear imaging in adults and children with FUO and establish appropriate use criteria (AUC). This process was performed in accordance with the Protecting Access to Medicare Act of 2014, which requires that all referring physicians consult AUC by using a clinical decision support mechanism before ordering advanced diagnostic imaging services. The complete findings and discussions of the work group were published on January 8, 2023, and are available at https://www.snmmi.org/ClinicalPractice/content.aspx?ItemNumber=15666 The AUC in the final document are intended to assist referring health care providers in appropriate use of nuclear medicine imaging procedures in patients with FUO. The work group noted limitations in the current literature on nuclear medicine imaging for FUO, with the need for well-designed prospective multicenter investigations. Consensus findings from published data and expert opinions were used to create recommendations in common clinical scenarios for adults and children. Included in the complete document is a discussion of inflammation of unknown origin (IUO), a recently described entity. In view of the fact that the criteria for FUO and IUO are similar (except for fever > 38.3°C [100.9°F]) and that the most common etiologies of these 2 entities are similar, it is the expert opinion of the work group that the recommendations for nuclear medicine imaging of FUO are also applicable to IUO. These recommendations are included in the full guidance document. This summary reviews rationale, methodology, and main findings and refers the reader to the complete AUC document.