Peri- and postoperative morbidity and mortality in older patients with non-small cell lung cancer: a matched-pair study.

BACKGROUND: Reports from case series suggest that operative outcomes are comparable amongst different age groups following surgery with curative intent for non-small cell lung cancer (NSCLC). The purpose of this study was to compare morbidity and mortality after NSCLC surgery in older patients (≥ 75 years) versus younger patients (< 75 years) and identify independent predictive risk factors. METHODS: We identified 2015 patients with postoperative stages IA to IIIA according to AJCC/UICC 7th edition who had undergone NSCLC surgery with curative intent at a single specialized lung cancer center from January 2010 to December 2015. A matched-pair analysis was performed on 227 older patients and corresponding 227 younger patients. Short-term surgical outcomes were postoperative morbidity, length of hospital stay, 30-day and 90-day mortality. Long-term operative outcomes were disease-free and overall survival. RESULTS: 454 patients were included in the matched-pair analysis. 36% of younger patients developed postoperative complications versus 42% in older patients (p = 0.163). Age was not significantly associated with the occurrence of postoperative complications. Median length of hospital stay was 14 days in older patients and 13 days in younger patients (p = 0.185). 90-day mortality was 2.2% in younger patients compared to 4% in older patients (p = 0.424). In patients aged 75 and older impaired performance status (ECOG ≥ 1) was associated with decreased overall survival (HR = 2.15, CI 1.34-3.46), as were preoperative serum C-reactive protein / albumin ratio ≥ 0.3 (HR = 1.95, CI 1.23-3.11) and elevated preoperative serum creatinine levels ≥ 1.1 mg/dl (HR = 1.84, CI 1.15-2.95). In the younger cohort male sex (HR = 2.26, CI 1.17-4.36), postoperative stage III disease (HR 4.61, CI 2.23-9.54) and preoperative anemia (hemoglobin < 12 g/dl) (HR 2.09, CI 1.10-3.96) were associated with decreased overall survival. CONCLUSIONS: Lung resection for NSCLC in older patients is associated with postoperative morbidity and mortality comparable to those of younger patients. In older patients, physical activity, comorbidities and nutritional status are related to survival and should influence the indication for surgery rather than age alone.

Variability of sleep bruxism-findings from consecutive nights of monitoring.

OBJECTIVES: To determine sleep bruxism (SB) behavior during five consecutive nights and to identify correlations between SB episodes per hour (SB index) and sleep-time masseter-muscle activity (sMMA). MATERIAL AND METHODS: Thirty-one participants were included in the study. Of these, 10 were classified as sleep bruxers (group SB-1) and nine as non-sleep bruxers (group non-SB). The bruxism status of these 19 patients was identified by means of questionnaires, an assessment of clinical symptoms, and electromyographic/electrocardiographic data (Bruxoff® device). The remaining 12 participants were also identified as bruxers, but based exclusively on data from the Bruxoff device (group SB-2). Data analysis included descriptive statistics and Spearman's correlation to assess the relationship between the SB index and sMMA. RESULTS: Participants in group SB-1 showed an overall mean SB index of 3.1 ± 1.6 and a mean total sMMA per night of 62.9 ± 38.3. Participants in group SB-2 had an overall mean SB index of 2.7 ± 1.5 and a mean total sMMA of 56.0 ± 29.3. In the non-SB group, participants showed an overall mean SB index of 0.8 ± 0.5 and a mean total sMMA of 56.8 ± 30.3. Spearman's correlation yielded values of - 0.27 to 0.71 for the correlation between sMMA and SB index. CONCLUSIONS: The data revealed variable SB activity and the absence of a reliable correlation between sMMA and the SB index. CLINICAL RELEVANCE: The high variation in SB activity and lack of correlation between sMMA and the SB index should be considered when diagnosing SB. TRIAL REGISTRATION: Clinical Trials [NIH], clinical trial no. NCT03039985.

Validity of patient self-reports and clinical signs in the assessment of sleep bruxism based on home-recorded electromyographic/electrocardiographic data.

BACKGROUND: Reliable and suitable bruxism assessment would be desirable, but available studies presented heterogeneous results. OBJECTIVE: To determine the agreement of patient self-reports and clinical signs of sleep bruxism (SB) with electromyographic/electrocardiographic data. METHODS: Two hundred individuals from a German dental clinic population (120 women and 80 men) participated in the study. Participants completed different SB questionnaires, had a clinical examination to evaluate bruxism signs and used the Bruxoff® device to record electromyographic/electrocardiographic data for five nights. To investigate interrater reliability for clinical diagnosis of bruxism, 126 of the 200 participants were assessed for clinical signs of bruxism by two independent uncalibrated examiners. Statistical evaluation included calculation of sensitivity, specificity and accuracy and of Cohen's kappa. RESULTS: Based on the Bruxoff® data, 106 participants were identified as bruxers and 94 as non-bruxers. The 106 bruxers were further classified into 47 moderate and 59 intense bruxers. The highest accuracy and sensitivity values were recorded for the overall score for clinical bruxism signs (accuracy: 72.0% and sensitivity: 70.8%). The best specificity (96.8%) was seen for the question regarding tooth grinding in the last two weeks reported by others, but concurrent sensitivity was very low (3.8%). Analysis of interrater reliability revealed a substantial agreement (Cohen's kappa of 0.6). CONCLUSION: The study results indicate that self-report questionnaires and clinical signs have moderate sensitivity, specificity and accuracy for diagnosing bruxism comparing with an ambulatory device for current SB (Bruxoff®). Regarding interrater reliability for clinical signs of SB, substantial agreement was found between the two examiners. CLINICAL TRIAL NO: NCT03039985.

Effect of scan-path length on the scanning accuracy of completely dentate and partially edentulous maxillae.

STATEMENT OF PROBLEM: The accuracy of fit of fixed partial dentures is directly dependent on the accuracy of a digital scan. However, the influence of scan-path length on scanning accuracy is unclear. PURPOSE: The purpose of this in vitro study was to evaluate how scan-path length influenced the scanning accuracy of a completely dentate or partially edentulous maxilla captured by 3 intraoral scanners: Omnicam AC (OC), TRIOS 4 (TR), and Primescan (PS). MATERIAL AND METHODS: Each intraoral scanner was used to make 30 scans each of the 2 clinical scenarios (completely dentate and partially edentulous) simulated with a reference model. The partially edentulous model simulated a maxilla with 6 prepared teeth to support a complete arch fixed partial denture. The missing teeth were then added to create a completely dentate model. The prepared teeth were later used to determine distance, angular, and tooth-axis deviations between the reference model (digitized with high precision before the tests) and the intraoral scans. Data were statistically analyzed by using a linear model or, if not applicable, a type II ANOVA (α=.05). RESULTS: Distance deviations increased linearly as the scan-path length increased. In contrast, angular and tooth-axis deviations did not increase linearly. All types of deviation differed depending on the scanning system used. Regarding the 90% quantile values, total distance deviations related to scan-path length amounted to 1.31 µm/mm (OC), 1.00 µm/mm (PS), and 1.45 µm/mm (TR) for the completely dentate maxilla and 1.10 µm/mm (OC), 1.46 µm/mm (PS), and 1.40 µm/mm (TR) for the partially edentulous maxilla. CONCLUSIONS: Distance deviations became larger as the scan-path length increased.

Active vitamin D is cardioprotective in experimental uraemia but not in children with CKD Stages 3-5.

BACKGROUND: Uraemic cardiac remodelling is associated with vitamin D and Klotho deficiency, elevated fibroblast growth factor 23 (FGF23) and activation of the renin-angiotensin system (RAS). The cardioprotective properties of active vitamin D analogues in this setting are unclear. METHODS: In rats with 5/6 nephrectomy (5/6Nx) treated with calcitriol, the cardiac phenotype and local RAS activation were investigated compared with controls. A nested case-control study was performed within the Cardiovascular Comorbidity in Children with Chronic Kidney Disease (4C) study, including children with chronic kidney disease (CKD) Stages 3-5 [estimated glomerular filtration rate (eGFR) 25 mL/min/1.73 m2] treated with and without active vitamin D. Echocardiograms, plasma FGF23 and soluble Klotho (sKlotho) were assessed at baseline and after 9 months. RESULTS: In rats with 5/6Nx, left ventricular (LV) hypertrophy, LV fibrosis and upregulated cardiac RAS were dose-dependently attenuated by calcitriol. Calcitriol further stimulated FGF23 synthesis in bone but not in the heart, and normalized suppressed renal Klotho expression. In the 4C study cohort, treatment over a mean period of 9 months with active vitamin D was associated with increased FGF23 and phosphate and decreased sKlotho and eGFR compared with vitamin D naïve controls, whereas LV mass index did not differ between groups. CONCLUSIONS: Active vitamin D ameliorates cardiac remodelling and normalizes renal Klotho expression in 5/6Nx rats but does not improve the cardiac phenotype in children with CKD Stages 3-5. This discrepancy may be due to further enhancement of circulating FGF23 and faster progression of CKD associated with reduced sKlotho and higher serum phosphate in vitamin D-treated patients.

Reliability and reproducibility of sciatic nerve magnetization transfer imaging and T2 relaxometry.

OBJECTIVES: To assess the interreader and test-retest reliability of magnetization transfer imaging (MTI) and T2 relaxometry in sciatic nerve MR neurography (MRN). MATERIALS AND METHODS: In this prospective study, 21 healthy volunteers were examined three times on separate days by a standardized MRN protocol at 3 Tesla, consisting of an MTI sequence, a multi-echo T2 relaxometry sequence, and a high-resolution T2-weighted sequence. Magnetization transfer ratio (MTR), T2 relaxation time, and proton spin density (PSD) of the sciatic nerve were assessed by two independent observers, and both interreader and test-retest reliability for all readout parameters were reported by intraclass correlation coefficients (ICCs) and standard error of measurement (SEM). RESULTS: For the sciatic nerve, overall mean ± standard deviation MTR was 26.75 ± 3.5%, T2 was 64.54 ± 8.2 ms, and PSD was 340.93 ± 78.8. ICCs ranged between 0.81 (MTR) and 0.94 (PSD) for interreader reliability and between 0.75 (MTR) and 0.94 (PSD) for test-retest reliability. SEM for interreader reliability was 1.7% for MTR, 2.67 ms for T2, and 21.3 for PSD. SEM for test-retest reliability was 1.7% for MTR, 2.66 ms for T2, and 20.1 for PSD. CONCLUSIONS: MTI and T2 relaxometry of the sciatic nerve are reliable and reproducible. The values of measurement imprecision reported here may serve as a guide for correct interpretation of quantitative MRN biomarkers in future studies. KEY POINTS: • Magnetization transfer imaging (MTI) and T2 relaxometry of the sciatic nerve are reliable and reproducible. • The imprecision that is unavoidably associated with different scans or different readers can be estimated by the here presented SEM values for the biomarkers T2, PSD, and MTR. • These values may serve as a guide for correct interpretation of quantitative MRN biomarkers in future studies and possible clinical applications.

Evaluation of new motorized articulating laparoscopic instruments by laparoscopic novices using a standardized laparoscopic skills curriculum.

BACKGROUND: Motorized articulating laparoscopic instruments (ALI) offer more degrees of freedom than conventional laparoscopic instruments (CLI). However, a difficult learning curve and complex instrument handling are still a problem of ALI. We compared the performance of new prototypes of motorized ALI with CLI in a series of standardized laparoscopic tasks performed by laparoscopic novices. Further, usability of the new ALI was assessed. METHODS: A randomized cross-over study with 50 laparoscopic novices who either started with CLI and then changed to ALI (CA) or vice versa (AC) was conducted. All participants performed the European training in basic laparoscopic urological skills (E-BLUS) with each instrument in given order. Time and errors were measured for each exercise. Instrument usability was assessed. RESULTS: Overall, using CLI was significantly faster (CLI 4:27 min vs. ALI 4:50 min; p-value 0.005) and associated with fewer exercise failures in needle guidance (CLI 0 vs. ALI 12; p-value 0.0005) than ALI. Median amount of errors was similar for both instruments. Instrument sequence did not matter, as CA and AC showed comparable completion times. Regarding the learning effect, participants were significantly faster in the second attempt of exercises than in the first. In the needle guidance task, participants using CLI last demonstrated a significant speed improvement, whereas ALI were significantly slower in the second run. Regarding usability, CLI were preferred over ALI due to lighter weight and easier handling. Nevertheless, participants valued ALI's additional degrees of freedom. CONCLUSION: Using new motorized ALI in the E-BLUS examination by laparoscopic novices led to a worse performance compared to CLI. An explanation could be that participants felt overwhelmed by ALI and that ALI have an own distinct learning curve. As participants valued ALI's additional degrees of freedom, however, a future application of ALI could be for training purposes, ideally in combination with CLI.

Differences in the serum metabolome and lipidome identify potential biomarkers for seronegative rheumatoid arthritis versus psoriatic arthritis.

OBJECTIVES: The differential diagnosis of seronegative rheumatoid arthritis (negRA) and psoriasis arthritis (PsA) is often difficult due to the similarity of symptoms and the unavailability of reliable clinical markers. Since chronic inflammation induces major changes in the serum metabolome and lipidome, we tested whether differences in serum metabolites and lipids could aid in improving the differential diagnosis of these diseases. METHODS: Sera from negRA and PsA patients with established diagnosis were collected to build a biomarker-discovery cohort and a blinded validation cohort. Samples were analysed by proton nuclear magnetic resonance. Metabolite concentrations were calculated from the spectra and used to select the variables to build a multivariate diagnostic model. RESULTS: Univariate analysis demonstrated differences in serological concentrations of amino acids: alanine, threonine, leucine, phenylalanine and valine; organic compounds: acetate, creatine, lactate and choline; and lipid ratios L3/L1, L5/L1 and L6/L1, but yielded area under the curve (AUC) values lower than 70%, indicating poor specificity and sensitivity. A multivariate diagnostic model that included age, gender, the concentrations of alanine, succinate and creatine phosphate and the lipid ratios L2/L1, L5/L1 and L6/L1 improved the sensitivity and specificity of the diagnosis with an AUC of 84.5%. Using this biomarker model, 71% of patients from a blinded validation cohort were correctly classified. CONCLUSIONS: PsA and negRA have distinct serum metabolomic and lipidomic signatures that can be used as biomarkers to discriminate between them. After validation in larger multiethnic cohorts this diagnostic model may become a valuable tool for a definite diagnosis of negRA or PsA patients.

A Comparison of Additional Benefit Assessment Methods for Time-to-Event Endpoints Using Hazard Ratio Point Estimates or Confidence Interval Limits by Means of a Simulation Study.

BACKGROUND: For time-to-event endpoints, three additional benefit assessment methods have been developed aiming at an unbiased knowledge about the magnitude of clinical benefit of newly approved treatments. The American Society of Clinical Oncology (ASCO) defines a continuous score using the hazard ratio point estimate (HR-PE). The European Society for Medical Oncology (ESMO) and the German Institute for Quality and Efficiency in Health Care (IQWiG) developed methods with an ordinal outcome using lower and upper limits of the 95% HR confidence interval (HR-CI), respectively. We describe all three frameworks for additional benefit assessment aiming at a fair comparison across different stakeholders. Furthermore, we determine which ASCO score is consistent with which ESMO/IQWiG category. METHODS: In a comprehensive simulation study with different failure time distributions and treatment effects, we compare all methods using Spearman's correlation and descriptive measures. For determination of ASCO values consistent with categories of ESMO/IQWiG, maximizing weighted Cohen's Kappa approach was used. RESULTS: Our research depicts a high positive relationship between ASCO/IQWiG and a low positive relationship between ASCO/ESMO. An ASCO score smaller than 17, 17 to 20, 20 to 24, and greater than 24 corresponds to ESMO categories. Using ASCO values of 21 and 38 as cutoffs represents IQWiG categories. LIMITATIONS: We investigated the statistical aspects of the methods and hence implemented slightly reduced versions of all methods. CONCLUSIONS: IQWiG and ASCO are more conservative than ESMO, which often awards the maximal category independent of the true effect and is at risk of overcompensating with various failure time distributions. ASCO has similar characteristics as IQWiG. Delayed treatment effects and underpowered/overpowered studies influence all methods in some degree. Nevertheless, ESMO is the most liberal one. HIGHLIGHTS: For the additional benefit assessment, the American Society of Clinical Oncology (ASCO) uses the hazard ratio point estimate (HR-PE) for their continuous score. In contrast, the European Society for Medical Oncology (ESMO) and the German Institute for Quality and Efficiency in Health Care (IQWiG) use the lower and upper 95% HR confidence interval (HR-CI) to specific thresholds, respectively. ESMO generously assigns maximal scores, while IQWiG is more conservative.This research provides the first comparison between IQWiG and ASCO and describes all three frameworks for additional benefit assessment aiming for a fair comparison across different stakeholders. Furthermore, thresholds for ASCO consistent with ESMO and IQWiG categories are determined, enabling a comparison of the methods in practice in a fair manner.IQWiG and ASCO are the more conservative methods, while ESMO awards high percentages of maximal categories, especially with various failure time distributions. ASCO has similar characteristics as IQWiG. Delayed treatment effects and under/-overpowered studies influence all methods. Nevertheless, ESMO is the most liberal one. An ASCO score smaller than 17, 17 to 20, 20 to 24, and greater than 24 correspond to the categories of ESMO. Using ASCO values of 21 and 38 as cutoffs represents categories of IQWiG.

Intrafraction organ movement in adaptive MR-guided radiotherapy of abdominal lesions - dosimetric impact and how to detect its extent in advance.

INTRODUCTION: Magnetic resonance guided radiotherapy (MRgRT) allows daily adaptation of treatment plans to compensate for positional changes of target volumes and organs at risk (OARs). However, current adaptation times are relatively long and organ movement occurring during the adaptation process might offset the benefit gained by adaptation. The aim of this study was to evaluate the dosimetric impact of these intrafractional changes. Additionally, a method to predict the extent of organ movement before the first treatment was evaluated in order to have the possibility to compensate for them, for example by adding additional margins to OARs. MATERIALS & METHODS: Twenty patients receiving adaptive MRgRT for treatment of abdominal lesions were retrospectively analyzed. Magnetic resonance (MR) images acquired at the start of adaptation and immediately before irradiation were used to calculate adapted and pre-irradiation dose in OARs directly next to the planning target volume. The extent of organ movement was determined on MR images acquired during simulation sessions and adaptive treatments, and their agreement was evaluated. Correlation between the magnitude of organ movement during simulation and the duration of simulation session was analyzed in order to assess whether organ movement might be relevant even if the adaptation process could be accelerated in the future. RESULTS: A significant increase in dose constraint violations was observed from adapted (6.9%) to pre-irradiation (30.2%) dose distributions. Overall, OAR dose increased significantly by 4.3% due to intrafractional organ movement. Median changes in organ position of 7.5 mm (range 1.5-10.5 mm) were detected within a median time of 17.1 min (range 1.6-28.7 min). Good agreement was found between the range of organ movement during simulation and adaptation (66.8%), especially if simulation sessions were longer and multiple MR images were acquired. No correlation was determined between duration of simulation sessions and magnitude of organ movement. CONCLUSION: Intrafractional organ movement can impact dose distributions and lead to violations of OAR tolerance doses, which impairs the benefit of daily on-table plan adaptation. By application of simulation images, the extent of intrafractional organ movement can be predicted, which possibly allows to compensate for them.

Robotic versus open partial pancreatoduodenectomy (EUROPA): a randomised controlled stage 2b trial.

Background: Open partial pancreatoduodenectomy (OPD) represents the current gold standard of surgical treatment of a wide range of diseases of the pancreatic head but is associated with morbidity in around 40% of cases. Robotic partial pancreatoduodenectomy (RPD) is being used increasingly, yet, no randomised controlled trials (RCTs) of RPD versus OPD have been published, leaving a low level of evidence to support this practice. Methods: This investigator-initiated, exploratory RCT with two parallel study arms was conducted at a high-volume pancreatic centre in line with IDEAL recommendations (stage 2b). Patients scheduled for elective partial pancreatoduodenectomy (PD) for any indication were randomised (1:1) to RPD or OPD with a centralised web-based tool. The primary endpoint was postoperative cumulative morbidity within 90 days, assessed via the Comprehensive Complication Index (CCI). Biometricians were blinded to the intervention, but patients and surgeons were not. The trial was registered prospectively (DRKS00020407). Findings: Between June 3, 2020 and February 14, 2022, 81 patients were randomly assigned to RPD (n = 41) or OPD (n = 40), of whom 62 patients (RPD: n = 29, OPD: n = 33) were analysed in the modified intention to treat analysis. Four patients in the OPD group were randomised, but did not undergo surgery in our department and one patient was excluded in the RPD group due to other reason. Nine patients in the RPD group and 3 patients in the OPD were excluded from the primary analysis because they did not undergo PD, but rather underwent other types of surgery. The CCI after 90 days was comparable between groups (RPD: 34.02 ± 23.48 versus OPD: 36.45 ± 27.65, difference in means [95% CI]: -2.42 [-15.55; 10.71], p = 0.713). The RPD group had a higher incidence of grade B/C pancreas-specific complications compared to the OPD group (17 (58.6%) versus 11 (33.3%); difference in rates [95% CI]: 25.3% [1.2%; 49.4%], p = 0.046). The only complication that occurred significantly more often in the RPD than in the OPD group was clinically relevant delayed gastric emptying. Procedure-related and overall hospital costs were significantly higher and duration of surgery was longer in the RPD group. Blood loss did not differ significantly between groups. The intraoperative conversion rate of RPD was 23%. Overall 90-day mortality was 4.8% without significant differences between RPD and OPD. Interpretation: In the setting of a very high-volume centre, both RPD and OPD can be considered safe techniques. Further confirmatory multicentre RCTs are warranted to uncover potential advantages of RPD in terms of perioperative and long-term outcomes. Funding: Federal Ministry of Education and Research (BMBF: 01KG2010).

Cerebellar Mutism Syndrome After Posterior Fossa Tumor Surgery in Children-A Retrospective Single-Center Study.

OBJECTIVE: Cerebellar mutism syndrome (CMS) is a well-known complication after posterior fossa tumor surgery in pediatric patients. We evaluated the incidence of CMS in our institute and analyzed its association with multiple risk factors, such as tumor entity, surgical approach, and hydrocephalus. METHODS: All pediatric patients who had undergone intra-axial tumor resection in the posterior fossa between January 2010 and March 2021 were included in the retrospective analysis. Various data points, including demographic, tumor-associated, clinical, radiological, surgery-associated, complications, and follow-up data, were collected and statistically evaluated for an association with CMS. RESULTS: A total of 63 surgeries in 60 patients were included. The median patient age was 8 years. Pilocytic astrocytoma was the most common tumor type (50%), followed by medulloblastoma (28%) and ependymomas (10%). Complete, subtotal, and partial resection was achieved in 67%, 23%, and 10%, respectively. A telovelar approach had been used the most often (43%) compared with a transvermian approach (8%). Of the 60 children, 10 (17%) had developed CMS and showed marked improvement but with residual deficits. The significant risk factors were a transvermian approach (P = 0.03), vermian splitting when added to another approach (P = 0.002), an initial presentation with acute hydrocephalus (P = 0.02), and hydrocephalus present after tumor surgery (P = 0.004). CONCLUSIONS: Our CMS rate is comparable to those described in the literature. Despite the limitations of the retrospective study design, we found that CMS was not only associated with a transvermian approach but was also associated with a telovelar approach, although to a lesser extent. Acute hydrocephalus at the initial presentation necessitating urgent management was significantly associated with a greater incidence of CMS.

Free-Flap Reconstruction in Early-Stage Squamous Cell Carcinoma of the Oral Cavity-A Prospective Monocentric Trial to Evaluate Oncological Outcome and Quality of Life.

Surgery is generally accepted as standard treatment in oral cancer, but the reconstructive procedures remain a matter of debate. The aim of this study was to evaluate oncological outcome and quality of life following surgical resection and free-flap reconstruction in patients with early oral squamous cell carcinoma. The presented trial was performed as a prospective, single-center observation study. Inclusion criteria were primary surgery in early-stage oral squamous cell carcinoma with free-flap reconstruction. Endpoints were overall and progression-free survival and quality of life up to 24 months after surgery. Twenty-six patients were included. Overall survival was 100% and progression-free survival was 92.3% in a maximum follow-up time of 21 months. Global quality of life showed no significant alteration after surgery. Patients reported a significant reduction in pain (p = 0.048) and a decreasing impairment of speech one year after surgery (p = 0.021). Free-flap reconstruction is a safe procedure that results in excellent oncological outcome and quality of life. Functional outcome is of high relevance in early-stage tumors of the head and neck and may mostly be affected by reconstructive procedures. Therefore, a prospective evaluation to explore success and the effects of surgical therapy is highly warranted.

Regional Variation in Hemoglobin Distribution Among Individuals With CKD: the ISN International Network of CKD Cohorts.

Introduction: Despite recognized geographic and sex-based differences in hemoglobin in the general population, these factors are typically ignored in patients with chronic kidney disease (CKD) in whom a single therapeutic range for hemoglobin is recommended. We sought to compare the distribution of hemoglobin across international nondialysis CKD populations and evaluate predictors of hemoglobin. Methods: In this cross-sectional study, hemoglobin distribution was evaluated in each cohort overall and stratified by sex and estimated glomerular filtration rate (eGFR). Relationships between candidate predictors and hemoglobin were assessed from linear regression models in each cohort. Estimates were subsequently pooled in a random effects model. Results: A total of 58,613 participants from 21 adult cohorts (median eGFR range of 17-49 ml/min) and 3 pediatric cohorts (median eGFR range of 26-45 ml/min) were included with broad geographic representation. Hemoglobin values varied substantially among the cohorts, overall and within eGFR categories, with particularly low mean hemoglobin observed in women from Asian and African cohorts. Across the eGFR range, women had a lower hemoglobin compared to men, even at an eGFR of 15 ml/min (mean difference 5.3 g/l, 95% confidence interval [CI] 3.7-6.9). Lower eGFR, female sex, older age, lower body mass index, and diabetic kidney disease were all independent predictors of a lower hemoglobin value; however, this only explained a minority of variance (R2 7%-44% across cohorts). Conclusion: There are substantial regional differences in hemoglobin distribution among individuals with CKD, and the majority of variance is unexplained by demographics, eGFR, or comorbidities. These findings call for a renewed interest in improving our understanding of hemoglobin determinants in specific CKD populations.

Five-year clinical performance of monolithic and partially veneered zirconia single crowns-a prospective observational study.

PURPOSE: The purpose of this study was to prospectively evaluate the medium-term clinical performance and esthetics of monolithic and partially (i.e., facially) veneered zirconia single crowns (MZ-SC and PZ-SC, respectively). METHODS: Between September 2011 and June 2013, 68 participants received 90 MZ-SC and 72 PZ-SC. Clinical study documentation was performed at crown cementation (baseline), at 6-month follow-up, and then yearly thereafter using standardized report forms. Three participants with four MZ-SC dropped out during clinical follow-up. Thus, 65 participants (n = 31, 47.7% men) fitted with 158 restorations (86 MZ-SC, 72 PZ-SC) were evaluated. The mean observation period of the restorations was 5.8 ±2.5 years; 6.3 ±2.2 for MZ-SC and 5.2 ±2.6 for PZ-SC. RESULTS: The 5-year rate of complication-free survival (success) was 87.0% for MZ-SC and 95.8% for PZ-SC (log-rank test, p = 0.026). The 5-year failure-free survival rate was 93.1% for MZ-SC and 96.2% for PZ-SC (log-rank test, p = 0.111), and the 5-year ceramic fracture-free survival rate was 100% for MZ-SC and 98.6% for PZ-SC (log-rank test, p = 0.274). Crowns of both designs were awarded excellent scores for esthetics by participants and dentists. CONCLUSION: Monolithic and partially veneered zirconia crowns can be used clinically with high medium-term survival and success and uncompromised esthetic results.

In-vitro accuracy of complete arch scans of the fully dentate and the partially edentulous maxilla.

PURPOSE: This in-vitro study aimed to compare the accuracy of complete arch scans (CAS) of a fully dentate (FD) and a partially edentulous (PE) maxillary model. Three intraoral scanning systems were used: Omnicam AC (OC), TRIOS 4 (TR), and Primescan (PS). METHODS: Each intraoral scanner was used to take 30 scans each of two clinical scenarios (FD and PE) simulated by a reference model. The PE model simulated a maxilla with six prepared teeth to accommodate a jaw-spanning fixed partial denture (FPD). The missing teeth were then added to create an FD model. Five ceramic precision balls (ball centers P1-P5) mounted on metal pins were welded to the metal base on the buccal side of the dental arch. These were later used to determine dimensional (given by each 2 ball centers) and angular changes (given by each 3 or 4 ball centers) between the reference model (digitized with high precision before the tests) and the intraoral scans. Data were statistically analyzed using a type II ANOVA. RESULTS: The maximum mean absolute distance deviations were as follows. OC: 147 µm (FD) and 139 µm (PE). TR: 133 µm (FD) and 136 µm (PE). PS: 87 µm (FD) and 80 µm (PE). The scanning system used had a significant effect on distance deviations (p < 0.027) and CAS scanning time (p < 0.001). Dental status had no clear effect on distance deviations but did significantly affect angular changes (p < 0.001) and scanning time (p < 0.001). CONCLUSION: The manufacture of jaw-spanning FPDs based on a CAS cannot yet be recommended.

Ceramic Crowns and Sleep Bruxism: First Results from a Randomized Trial.

Background: This randomized clinical trial was conducted to assess whether sleep bruxism (SB) is associated with an increased rate of technical complications (ceramic defects) in lithium disilicate (LiDi) or zirconia (Z) molar single crowns (SCs). Methods: Adult patients were classified as affected or unaffected by SB based on structured questionnaires, clinical signs, and overnight portable electromyography (BruxOff) and block randomized into four groups according to SB status and crown material (LiDi or Z): LiDi-SB (n = 29), LiDi-no SB (n = 24), Z-SB (n = 23), and Z-no SB (n = 27). Differences in technical complications (main outcome) and survival and success rates (secondary outcomes) one year after crown cementation were assessed using Fisher's exact test with significance level α = 0.05. Results: No technical complications occurred. Restoration survival rates were 100% in the LiDi-SB and LiDi-no SB groups, 95.7% in the Z-SB group, and 96.3% in the Z-no SB group (p > 0.999). Success rates were 96.6% in the LiDi-SB group, 95.8% in the LiDi-no SB group (p > 0.999), 91.3% in the Z-SB group, and 96.3% in the Z-no SB group (p ≥ 0.588). Conclusions: With a limited observation time and sample size, no effect of SB on technical complication, survival, and success rates of molar LiDi and Z SCs was detected.

The 2018 classification of periodontal diseases: Its predictive value for tooth loss.

BACKGROUND: Predictive models and assessment tools for disease susceptibility and progression are necessary to enhance personalized medicine. The aim of this study is to assess the predictive accuracy of using the 2018 classification to predict likelihood of tooth loss. METHODS: A total of 134 patients were screened 10 years after periodontal therapy. Data were extracted from 82 patients' records and periodontal diagnoses were assigned according to the 1999 and 2018 classifications at baseline, whereas patient- and tooth-related parameters were documented at baseline and at reexamination. Statistical analysis included descriptive statistics, hurdle regression with a zero and count model as well as logistic regression. RESULTS: Significantly more teeth were lost during SPT in patients with Stage IV or Grade C (P < 0.05). Patients' adherence seems to have an impact on the predictability of the 2018 classification (P < 0.001). In comparison, neither classification system alone (1999 vs 2018) showed a high predictive value for tooth loss (area under the curve [AUC] = 59.2% vs 58.2%). CONCLUSION: Class III and IV/Grade C of the 2018 classification of periodontal diseases show similar predictive accuracy for tooth loss as severe cases in the former classification. Patients adherence seems to influence the prognostic value of the classification.

Dorsal Root Ganglia Volume-Normative Values, Correlation with Demographic Determinants and Reliability of Three Different Methods of Volumetry.

Background: Dorsal root ganglia (DRG) volume assessment by MR-Neurography (MRN) has evolved to an important imaging marker in the diagnostic workup of various peripheral neuropathies and pain syndromes. The aim of this study was (1) to assess normal values of DRG volume and correlations with demographic determinants and (2) to quantify the inter-reader and inter-method reliability of three different methods of DRG volumetry. Methods: Sixty healthy subjects (mean age: 59.1, range 23-79) were examined using a 3D T2-weighted MRN of the lumbosacral plexus at 3 Tesla. Normal values of DRG L3 to S2 were obtained after exact volumetry based on manual 3D segmentation and correlations with demographic variables were assessed. For the assessment of inter-reader and inter-method reliability, DRG volumes in a subset of 25 participants were measured by two independent readers, each applying (1) exact volumetry based on 3D segmentation, (2) axis-corrected, and (3) non-axis-corrected volume estimation. Intraclass correlation coefficients were reported and the Bland-Altman analysis was conducted. Results: Mean DRG volumes ranged from 124.8 mm3 for L3 to 323.3 mm3 for S1 and did not differ between right and left DRG. DRG volume (mean of L3 to S1) correlated with body height (r = 0.42; p = 0.0008) and weight (r = 0.34; p = 0.0087). DRG of men were larger than of women (p = 0.0002); however, no difference remained after correction for body height. Inter-reader reliability was high for all three methods but best for exact volumetry (ICC = 0.99). While axis-corrected estimation was not associated with a relevant bias, non-axis-corrected estimation systematically overestimated DRG volume by on average of 15.55 mm3 (reader 1) or 18.00 mm3 (reader 2) when compared with exact volumetry. Conclusion: The here presented normal values of lumbosacral DRG volume and the correlations with height and weight may be considered in future disease specific studies and possible clinical applications. Exact volumetry was most reliable and should be considered the gold standard. However, the reliability of axis-corrected and non-axis-corrected volume estimation was also high and might still be sufficient, depending on the degree of the required measurement accuracy.

Quantitative MR-Neurography at 3.0T: Inter-Scanner Reproducibility.

BACKGROUND: Quantitative MR-neurography (MRN) is increasingly applied, however, the impact of the MR-scanner on the derived parameters is unknown. Here, we used different 3.0T MR scanners and applied comparable MR-sequences in order to quantify the inter-scanner reproducibility of various MRN parameters of the sciatic nerve. METHODS: Ten healthy volunteers were prospectively examined at three different 3.0T MR scanners and underwent MRN of their sciatic nerve using comparable imaging protocols including diffusion tensor imaging (DTI) and T2 relaxometry. Subsequently, inter-scanner agreement was assessed for seven different parameters by calculating the intraclass correlation coefficients (ICCs) and the standard error of measurement (SEM). RESULTS: Assessment of inter-scanner reliability revealed good to excellent agreement for T2 (ICC: 0.846) and the quantitative DTI parameters, such as fractional anisotropy (FA) (ICC: 0.876), whereas moderate agreement was observed for proton spin density (PD) (ICC: 0.51). Analysis of variance identified significant inter-scanner differences for several parameters, such as FA (p < 0.001; p = 0.02), T2 (p < 0.01) and PD (p = 0.02; p < 0.01; p = 0.02). Calculated SEM values were mostly within the range of one standard deviation of the absolute mean values, for example 0.033 for FA, 4.12 ms for T2 and 27.8 for PD. CONCLUSION: This study quantifies the measurement imprecision for peripheral nerve DTI and T2 relaxometry, which is associated with the use of different MR scanners. The here presented values may serve as an orientation of the possible scanner-associated fluctuations of MRN biomarkers, which can occur under similar conditions.