Thoracic Epidural Analgesia Is Not Associated With Improved Survival After Pancreatic Surgery: Long-Term Follow-Up of the Randomized Controlled PAKMAN Trial.

BACKGROUND: Perioperative thoracic epidural analgesia (EDA) and patient-controlled intravenous analgesia (PCIA) are common forms of analgesia after pancreatic surgery. Current guidelines recommend EDA over PCIA, and evidence suggests that EDA may improve long-term survival after surgery, especially in cancer patients. The aim of this study was to determine whether perioperative EDA is associated with an improved patient prognosis compared to PCIA in pancreatic surgery. METHODS: The PAKMAN trial was an adaptive, pragmatic, international, multicenter, randomized controlled superiority trial conducted from June 2015 to October 2017. Three to five years after index surgery a long-term follow-up was performed from October 2020 to April 2021. RESULTS: For long-term follow-up of survival, 109 patients with EDA were compared to 111 patients with PCIA after partial pancreatoduodenectomy (PD). Long-term follow-up of quality of life (QoL) and pain assessment was available for 40 patients with EDA and 45 patients with PCIA (questionnaire response rate: 94%). Survival analysis revealed that EDA, when compared to PCIA, was not associated with improved overall survival (OS, HR, 1.176, 95% HR-CI, 0.809-1.710, P = .397, n = 220). Likewise, recurrence-free survival did not differ between groups (HR, 1.116, 95% HR-CI, 0.817-1.664, P = .397, n = 220). OS subgroup analysis including only patients with malignancies showed no significant difference between EDA and PCIA (HR, 1.369, 95% HR-CI, 0.932-2.011, P = .109, n = 179). Similar long-term effects on QoL and pain severity were observed in both groups (EDA: n = 40, PCIA: n = 45). CONCLUSIONS: Results from this long-term follow-up of the PAKMAN randomized controlled trial do not support favoring EDA over PCIA in pancreatic surgery. Until further evidence is available, EDA and PCIA should be considered similar regarding long-term survival.

Peri-implant health after microvascular head and neck reconstruction-A retrospective analysis.

INTRODUCTION: Prosthodontic rehabilitation after reconstruction with microvascular revascularized free flaps following ablative tumor surgery is challenging due to the altered anatomical and functional conditions. The aim of this retrospective study was to determine whether the type of graft and the type of peri-implant tissue have an effect on peri-implant inflammatory parameters and implant survival. MATERIALS AND METHODS: Patients who received a free flap reconstruction with subsequent implant-prosthetic rehabilitation between 2010 and 2022 were retrospectively included. The primary outcome variable was the probing depth (PPD) at a minimum of 1 year after completion of prosthetic restoration. Predictive variables were type of free flap, emergence profile, and history of radiation. RESULTS: Seventy-one patients after free flap reconstruction were included in the analysis. At a minimum of 24 months after implant insertion the primary outcome, PPD showed no clinically relevant differences between the types of free flaps used. The emergence profile through a skin island resulted in an increase in BOP compared to native mucosa in the descriptive analysis (p-value > .05). The analysis showed a 5-year implant survival of 96.2% (95% CI: 0.929-0.996) in cases without irradiation and 87.6% (95% CI: 0.810-0.948) with irradiation of the region evaluated (p-value .034). CONCLUSION: Flap and associated soft tissue type had no significant effect on 5-year implant survival or peri-implant inflammatory parameters. However, the large heterogeneity of the patient population indicates that further prolonged studies are required for a more differentiated assessment of the long-term success.

Intra- and Interobserver Reliability of Shear Wave Elastography in Breast Cancer Diagnosis.

OBJECTIVES: Shear wave elastography (SWE) is increasingly used in breast cancer diagnostics. However, large, prospective, multicenter data evaluating the reliability of SWE is missing. We evaluated the intra- and interobserver reliability of SWE in patients with breast lesions categorized as BIRADS 3 or 4. METHODS: We used data of 1288 women at 12 institutions in 7 countries with breast lesions categorized as BIRADS 3 to 4 who underwent conventional B-mode ultrasound and SWE. 1243 (96.5%) women had three repetitive conventional B-mode ultrasounds as well as SWE measurements performed by a board-certified senior physician. 375 of 1288 (29.1%) women received an additional ultrasound examination with B-mode and SWE by a second physician. Intraclass correlation coefficients (ICC) were calculated to examine intra- and interobserver reliability. RESULTS: ICC for intraobserver reliability showed an excellent correlation with ICC >0.9, while interobserver reliability was moderate with ICC of 0.7. There were no clinically significant differences in intraobserver reliability when SWE was performed in lesions categorized as BI-RADS 3 or 4 as well as in histopathologically benign or malignant lesions. CONCLUSION: Reliability of additional SWE was evaluated on a study cohort consisting of 1288 breast lesions categorized as BI-RADS 3 and 4. SWE shows an excellent intraobserver reliability and a moderate interobserver reliability in the evaluation of solid breast masses.

Potential of Lesion-to-Fat Elasticity Ratio Measured by Shear Wave Elastography to Reduce Benign Biopsies in BI-RADS 4 Breast Lesions.

OBJECTIVES: We evaluated whether lesion-to-fat ratio measured by shear wave elastography in patients with Breast Imaging Reporting and Data System (BI-RADS) 3 or 4 lesions has the potential to further refine the assessment of B-mode ultrasound alone in breast cancer diagnostics. METHODS: This was a secondary analysis of an international diagnostic multicenter trial (NCT02638935). Data from 1288 women with breast lesions categorized as BI-RADS 3 and 4a-c by conventional B-mode ultrasound were analyzed, whereby the focus was placed on differentiating lesions categorized as BI-RADS 3 and BI-RADS 4a. All women underwent shear wave elastography and histopathologic evaluation functioning as reference standard. Reduction of benign biopsies as well as the number of missed malignancies after reclassification using lesion-to-fat ratio measured by shear wave elastography were evaluated. RESULTS: Breast cancer was diagnosed in 368 (28.6%) of 1288 lesions. The assessment with conventional B-mode ultrasound resulted in 53.8% (495 of 1288) pathologically benign lesions categorized as BI-RADS 4 and therefore false positives as well as in 1.39% (6 of 431) undetected malignancies categorized as BI-RADS 3. Additional lesion-to-fat ratio in BI-RADS 4a lesions with a cutoff value of 1.85 resulted in 30.11% biopsies of benign lesions which correspond to a reduction of 44.04% of false positives. CONCLUSIONS: Adding lesion-to-fat ratio measured by shear wave elastography to conventional B-mode ultrasound in BI-RADS 4a breast lesions could help reduce the number of benign biopsies by 44.04%. At the same time, however, 1.98% of malignancies were missed, which would still be in line with American College of Radiology BI-RADS 3 definition of <2% of undetected malignancies.

The Potential of Shear Wave Elastography to Reduce Unnecessary Biopsies in Breast Cancer Diagnosis: An International, Diagnostic, Multicenter Trial.

PURPOSE: In this prospective, multicenter trial we evaluated whether additional shear wave elastography (SWE) for patients with BI-RADS 3 or 4 lesions on breast ultrasound could further refine the assessment with B-mode breast ultrasound for breast cancer diagnosis. MATERIALS AND METHODS: We analyzed prospective, multicenter, international data from 1288 women with breast lesions rated by conventional 2 D B-mode ultrasound as BI-RADS 3 to 4c and undergoing 2D-SWE. After reclassification with SWE the proportion of undetected malignancies should be < 2 %. All patients underwent histopathologic evaluation (reference standard). RESULTS: Histopathologic evaluation showed malignancy in 368 of 1288 lesions (28.6 %). The assessment with B-mode breast ultrasound resulted in 1.39 % (6 of 431) undetected malignancies (malignant lesions in BI-RADS 3) and 53.80 % (495 of 920) unnecessary biopsies (biopsies in benign lesions). Re-classifying BI-RADS 4a patients with a SWE cutoff of 2.55 m/s resulted in 1.98 % (11 of 556) undetected malignancies and a reduction of 24.24 % (375 vs. 495) of unnecessary biopsies. CONCLUSION: A SWE value below 2.55 m/s for BI-RADS 4a lesions could be used to downstage these lesions to follow-up, and therefore reduce the number of unnecessary biopsies by 24.24 %. However, this would come at the expense of some additionally missed cancers compared to B-mode breast ultrasound (rate of undetected malignancies 1.98 %, 11 of 556, versus 1.39 %, 6 of 431) which would, however, still be in line with the ACR BI-RADS 3 definition (< 2 % of undetected malignancies).

Adapting the German version of the dental environment stress questionnaire.

AIMS: To develop a German version of the Dental Environment Stress (DES) questionnaire, and to evaluate its reliability and validity. METHODS: The original English DES questionnaire was translated into German using a forward-backward translation process. To evaluate construct stability, a subgroup of dental students (n = 43) completed the DES twice (interval: 1 week). To evaluate how the DES responds to anticipated changes in stress, all dental students' (n = 64) DES scores and saliva cortisol levels administered from a clinical study were compared between holiday and term time. Furthermore, the Depression, Anxiety and Stress Scale (DASS) and a stress self-assessment were used to determine the validity of the DES. Reliability analyses were calculated using Kendall's tau correlations. To estimate reliability strength, correlation coefficients and intraclass correlations (ICCs) were used. RESULTS: Regarding construct stability, 24 of 25 DES items had at least moderate correlations, and most items showed strong correlations. Correlations for the seven subdomains were good (range: 0.778-1.000). The same was true for the total DES score (ICC: 0.944). Correlations for response to term-time stress were weaker and more varied. Validity analyses revealed fair correlations between the DES and students' self-assessment (Pearson's r = .592) and DASS score (Pearson's r = .392), suggesting satisfactory validity. Stress levels were quite similar between baseline and follow-up. CONCLUSION: The German DES is a reliable tool for evaluating stress in dental students. Because it can be used to identify individual stressors in various categories, it might enable the detection of specific stress situations in educational situations and facilitate solutions (adjustment of curricula, tailored consulting services).

Remote assessment of dental records by using intraoral scan-based digital three-dimensional models in an elderly patient population - an exploratory study.

AIM: To assess the agreement rates of dental records derived from intraoral scan-based digital three-dimensional models (3DM) and 3DM + panoramic radiographs (3DM+PAN-X) compared to clinical findings. MATERIALS AND METHODS: Based on the 3DM/3DM+PAN-X of 50 patients undergoing supportive periodontal therapy (SPT), ten remote raters (inexperienced in using IOS or 3DM) assessed for each site of the dental scheme (32 sites) whether a tooth was missing (M), filled (F), restoration- and caries-free (H), replaced by an implant (I) or decayed (D). Remote records were compared to the clinical reference record of each patient at tooth-level. The clinical records were assessed by an experienced dentist who supplemented the clinical findings with information from available radiographs and the patient records to define the clinical reference record. RESULTS: The agreement-rates for 3DM/3DM+PAN-X at tooth-level are: M: 93%/94%, F: 84%/88%, H: 92%/92%, I: 65%/96%, D: 29%/29%. The overall agreement-rate is 88% for the 3DM-based dental records (14093 of 16000 entries true) and 91% for 3DM+PAN-X (14499 of 16000 entries true). Using 3DM for dental record assessment, posterior teeth had higher odds of correct findings compared to anterior teeth (upper jaw OR=2.34, lower jaw OR=1.27). CONCLUSIONS: The remote detection of healthy, missing and filled teeth and implants by raters inexperienced in using IOS or 3DM shows a high agreement-rate with the clinical findings. The additional evaluation of PAN-X increased the agreement-rate significantly for implants. Thus, the remote assessment of dental records using 3DM+PAN-X has a high accuracy when applied in SPT-patients with low caries activity.

A Comprehensive Comparison of Additional Benefit Assessment Methods Applied by Institute for Quality and Efficiency in Health Care and European Society for Medical Oncology for Time-to-Event Endpoints After Significant Phase III Trials-A Simulation Study.

OBJECTIVES: After a successful Marketing Authorization Application for clinical trials with time-to-event endpoints, the degree of the added benefit from new treatments remains unknown and needs to be assessed. Unfortunately, until now no clear definition for added benefit determination of a treatment exists. Nevertheless, European authorities / societies have developed 2 "additional benefit assessment" methods, which have up to now not been compared: the European Society for Medical Oncology (ESMO) developed a dual rule considering relative and absolute benefit. The German Institute for Quality and Efficiency in Health Care (IQWiG) developed a method using upper 95% hazard ratio confidence interval. METHODS: We evaluate and compare both methods in an extensive simulation study including different censoring rates, failure time distributions, and treatment effects for sample size calculation. The methods' performance is assessed via Receiver Operating Characteristic curves, Spearman correlation, and percentage of achieved maximal scores. RESULTS: The results show that IQWiG's method has in many situations a lower maximal scoring proportion than ESMO's rule, that is, up to 28.5% versus 94.7%. Various failure time distributions lead to strongly changed maximal scoring percentages for ESMO. High positive correlation between the methods is present for moderate treatment effects. CONCLUSIONS: IQWiG's method is usually more conservative than ESMO's. ESMO's rule tends to be more susceptible for various failure time distributions. Using the lower confidence interval limit seems to be a better solution resulting in a higher true-positive rate without increasing the false-positive rate. Thus, IQWiG's method might need to be adapted accordingly to achieve a better overall classification.

A New Practical Decision Rule to Better Differentiate BI-RADS 3 or 4 Breast Masses on Breast Ultrasound.

OBJECTIVES: The BI-RADS classification provides a standardized way to describe ultrasound findings in breast cancer diagnostics. However, there is little information regarding which BI-RADS descriptors are most strongly associated with malignancy, to better distinguish BI-RADS 3 (follow-up imaging) and 4 (diagnostic biopsy) breast masses. METHODS: Patients were recruited as part of an international, multicenter trial (NCT02638935). The trial enrolled 1294 women (6 excluded) categorized as BI-RADS 3 or 4 upon routine B-mode ultrasound examination. Ultrasound images were evaluated by three expert physicians according to BI-RADS. All patients underwent histopathological confirmation (reference standard). We performed univariate and multivariate analyses (chi-square test, logistic regression, and Krippendorff's alpha). RESULTS: Histopathologic evaluation showed malignancy in 368 of 1288 masses (28.6%). Upon performing multivariate analysis, the following descriptors were significantly associated with malignancy (P < .05): age ≥50 years (OR 8.99), non-circumscribed indistinct (OR 4.05) and microlobulated margin (OR 2.95), nonparallel orientation (OR 2.69), and calcification (OR 2.64). A clinical decision rule informed by these results demonstrated a 97% sensitivity and missed fewer cancers compared to three physician experts (range of sensitivity 79-95%) and a previous decision rule (sensitivity 59%). Specificity was 44% versus 22-83%, respectively. The inter-reader reliability of the BI-RADS descriptors and of the final BI-RADS score was fair-moderate. CONCLUSIONS: A patient should undergo a diagnostic biopsy (BI-RADS 4) instead of follow-up imaging (BI-RADS 3) if the patient is 50 years or older or exhibits at least one of the following features: calcification, nonparallel orientation of mass, non-circumscribed margin, or posterior shadowing.

The effect of transcrestal sinus-floor elevation without graft on the long-term prognosis of maxillary implants.

AIM: To evaluate the effects of (a) transcrestal sinus-floor elevation (TSFE) and (b) residual bone height on long-term implant survival. MATERIALS AND METHODS: Chi-squared and t tests were used for descriptive comparison of the groups. Kaplan-Meier survival curves and corresponding log-rank tests were used to investigate implant survival over time. Multivariable Cox regressions were performed for the total population and experimental group. RESULTS: A total of 634 patients received 648 implants with TSFE, while 674 implants without TSFE served as controls. Thirty implant failures occurred in the experimental group and 28 in the control group. Ten-year Kaplan-Meier survival curves for the 157 implants (24.3%) still under observation showed a probability of survival of 93.7% for the implants with TSFE and 92.9% for the 72 implants without TSFE (p = .678). The probability of 10-year survival of all implants in the experimental group decreased to 77.4% for implants placed in residual bone heights of 1-3 mm, compared with 95.7% for implant sites with bone heights of 4-6 mm and 97.6% for bone heights of >6 mm. CONCLUSIONS: Transcrestal sinus-floor elevation has no negative effect on the long-term implant survival. Membrane perforation or negligible bone height, however, reduces the probability of 10-year survival.

Neurosurgical Management of Lateral Meningocele Syndrome: A Clinical Update for the Pediatric Neurosurgeon.

BACKGROUND: Lateral meningocele syndrome (LMS) is an exceedingly rare connective tissue disease with phenotypic anomalies similar to those seen in Marfan syndrome, Ehler-Danlos syndrome, and Loeys-Dietz syndrome. However, this syndrome is invariably associated with the presence of multiple lateral thoracolumbar spinal meningoceles: a distinct point of phenotypic divergence from other connective tissue disorders. The etiopathogenesis of this syndrome has recently been linked to truncating mutations within exon 33 of NOTCH3. Despite numerous reports, neurosurgical management of multiple spinal meningoceles remains poorly defined in the literature. We conducted a literature review to provide insight into the nosology, clinical significance, and neurosurgical management strategies of this distinct connective tissue disorder. SUMMARY: Our literature search revealed 11 articles (16 cases) of LMS, which included 9 males and 7 females, belonging to 14 different families. Half of these cases underwent genetic screening: all of which were discovered to exhibit a truncating mutation within exon 33 of NOTCH3. All patients exhibited multiple lateral thoracolumbar spinal meningoceles with craniofacial dysmorphisms. Other clinical characteristics included pathologic changes in spine morphology, Chiari I malformation, syringomyelia, hydrocephalus, and tethered cord. Operative management of multiple spinal meningoceles in LMS is complicated by the presence of such coexisting structural neurologic pathologies, which may alter cerebrospinal fluid flow dynamics and, ultimately, impact operative intervention. Key Messages: LMS is an exceedingly rare connective tissue disorder with severe spinal dural involvement. Neurosurgical management of multiple spinal meningoceles is complex, which is further complicated by the presence of coexisting neuropathology, such as pathologic transformation of spine morphology and Chiari I malformation. Patients with a connective tissue disorder phenotype found to have multiple spinal meningoceles on imaging studies may benefit from evaluation by a medical geneticist and a pediatric neurosurgeon.

Long-term apical bone gain after implant placement combined with internal sinus-floor elevation without graft.

BACKGROUND: To assess changes in apical bone height/bone gain over up to 8 years after implant placement combined with simultaneous internal sinus-floor elevation (ISFE) without use of graft. METHODS: 217 implants were placed in combination with graft-free ISFE and successfully healed in the posterior maxilla of 138 patients. Radiographs after surgery across an evaluation time of up to 8 years were analyzed. Changes in apical and marginal bone height related to the implants were measured. Differences in bone height over the study period were evaluated by use of Wilcoxon tests. To identify possible influencing factors on apical bone gain and marginal bone loss, backward linear regression variable selections and linear mixed regression models were performed. RESULTS: At the apical aspects of the implants, significant mean vertical bone gain of 2.4 mm (mesial) and 2.6 mm (distal) was observed after 6 months (p < 0.05). Radiographic analysis yielded additional bone gain of up to approximately 3.5 mm over the study period. Small initial bone height was crossed with more pronounced apical bone gain (p < 0.05). CONCLUSIONS: If implants are placed combined with graft-free ISFE, significant vertical bone gain, especially in the first year post-op, can be expected. Smaller initial bone height is associated with a higher likelihood for greater bone gain.

The dental esthetic screening index: A new tool for assessment of dento-facial esthetics in restorative dentistry.

OBJECTIVES: There is a lack of comprehensive indexes, which can measure conditions or changes in dento-facial esthetics before and after treatment. Therefore, the 12-item Dental Esthetic Screening Index (DESI) was developed and validated. MATERIALS AND METHODS: Reliability was tested by five dental professionals, who evaluated 30 standardized patient photographs baseline and after 14 days. Clinical validation was done on 52 patients before and after restorative treatment. For subjective assessment, patients completed a validated questionnaire before and after treatment. Statistical analysis included inter and intrarater reliability, Wilcoxon test and linear regression analysis. RESULTS: The single item analysis identified two weak extraoral items (κ = 0.15; κ = -0.05), that were removed from the DESI. After this modification, both inter- (κ = 0.83-0.86) and intrarater reliability (ICC1-5 = 0.75-0.86) were in excellent to good agreement. In the clinical validation, the DESI was significantly lower after restorative treatment (P < .0001). The patients' perception questionnaires showed significant improvement after restorative therapy (P < .0001). A correlation of the DESI and the results of patients' perception questionnaires could be assumed (P < .0001; R2 = 0.32). CONCLUSIONS: The DESI was found to be a reliable and valid instrument for the quantitative assessment of dento-facial esthetics. It correlated well with the subjective assessment of the patients. CLINICAL SIGNIFICANCE: This comprehensive index would allow for objective quantification of clinical situations, for reliable baseline and outcome assessment in esthetic dentistry. As patients' esthetic feelings and sensations are subjective, this objective index is also proven to be congruent to patients' individual subjective assessment of dento-facial esthetics.

ACTA2 Cerebral Arteriopathy: Not Just a Puff of Smoke.

BACKGROUND: Missense mutations in the gene that codes for smooth muscle actin, ACTA2, cause diffuse smooth muscle dysfunction and a distinct cerebral arteriopathy collectively known as multisystemic smooth muscle dysfunction syndrome (MSMDS). Until recently, ACTA2 cerebral arteriopathy was considered to be a variant of moyamoya disease. However, recent basic science and clinical data have demonstrated that the cerebral arteriopathy caused by mutant ACTA2 exhibits genetic loci, histopathology, neurological sequelae, and radiographic findings unique from moyamoya disease. We conducted a literature review to provide insight into the history, clinical significance, and neurosurgical management of this recently described novel cerebral arteriopathy. SUMMARY: We performed a literature search using PubMed with the key words "ACTA2 mutation," "ACTA2 cerebral arteriopathy," and "multisystemic smooth muscle dysfunction syndrome." Case reports with confirmed ACTA2 mutations and cerebral arteriopathy were included in our review. Our literature search revealed 15 articles (58 cases) of confirmed ACTA2 cerebral arteriopathy. Distinctive features of this arteriopathy included an aberrant internal carotid circulation with dilatation of the proximal segments, occlusive disease at the distal segments, and dolichoectasia. As such, mutant ACTA2 predisposed patients to ischemic strokes as children. Direct and indirect cerebral revascularization procedures are the mainstay treatment options with varying degrees of success. Key Messages: ACTA2 cerebral arteriopathy is a recently described novel cerebrovascular disease seen in patients with MSMDS. Patients currently diagnosed with moyamoya disease who also have dysfunction of smooth muscle organs may benefit from reevaluation by a medical geneticist and ACTA2 genotyping.

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.

Iliac crest vertical block grafts -placing outside or inside the bone contour: A cohort study.

OBJECTIVE AND AIM: Challenging defect configurations and dimensions arise from severe, localized vertical alveolar ridge defects caused by trauma or prior surgery. This study aims to analyze three-dimensional bone gain, assess marginal bone stability in such defect configurations, and evaluate the impact of grafting outside the bone contour on the overall outcome, with a focus on iliac crest block grafts as a valid treatment option. MATERIALS AND METHODS: The prospective cohort study evaluated patients who required vertical block grafting due to localized bone defects in the maxilla or mandible and who had received iliac grafts. Three-dimensional bone gain was analyzed using cone beam computed tomography (CBCT) after 3 months of bone healing for each treated site and implant position. A comparison between bone grafts inside and outside the bone contour was conducted. Marginal bone stability was measured using intraoral radiographs during routine annual follow-up visits. RESULTS: Seventy patients with 89 treated sites were evaluated. After 3 months of graft healing, the mean vertical bone gain was 11.03 ± 3.54 mm, the mean horizontal bone gain was 7.18 ± 2.00 mm, and the mean graft length was 28.19 ± 11.01 mm. A total of 217 implants were placed in the augmented regions. On implant level, a mean vertical bone gain of 10.44 ± 3.44 mm and a mean horizontal bone gain of 6.54 ± 1.86 mm were measured. Over a 43-month observation period, mesial and distal marginal bone loss averaged 0.44 ± 0.92 mm and 0.49 ± 1.05 mm, respectively. Eight implants were diagnosed with periimplantitis, resulting in the loss of four implants, while no early implant losses were reported. CONCLUSION: Within the limitations of this study, vertical bone grafts with iliac crest block grafts were found to be a dependable treatment option for dental implant placement, and placing block grafts outside the bone contour did not lead to inferior outcomes.

A Remote Patient Monitoring System with Feedback Mechanisms using a Smartwatch: Concept, Implementation and Evaluation based on the activeDCM Randomized Controlled Trial.

BACKGROUND: Technological advances allow recording and sharing of health-related data in a patient-centric way using smartphones and wearables. Secure sharing of such patient-generated data with physicians would enable a dense management of individual health trajectories, monitoring of risk factors and asynchronous feedback. However, most Remote Patient Monitoring (RPM) systems currently available are not fully integrated into hospital IT systems or lack the patient-centric design. OBJECTIVE: The objective was to conceptualize and implement a user-friendly, reusable, interoperable and secure RPM system incorporating asynchronous feedback mechanisms, using a broadly available consumer wearable (Apple Watch). Additionally, the study sought to evaluate factors influencing patient acceptance of such systems. METHODS: The RPM system requirements were established through focus group sessions. Subsequently, a system concept was designed and implemented using an iterative approach, ensuring technical feasibility from the beginning. To assess clinical feasibility, the system was employed as part of the activeDCM prospective, randomized, interventional study focusing on Dilated Cardiomyopathy (DCM). Each patient used the system for at least 12 months. The System Usability Scale (SUS) was employed to measure usability from a subjective patient perspective. Additionally, an evaluation was conducted on the objective wearable interaction frequency as well as the completeness of transmitted data, classified into Sensor-based Health Data (SHD) and Patient Reported Outcome Measures (PROM). Descriptive statistics using boxplots, along bootstrapped multiple linear regression with a 95% confidence interval (CI) were utilized for evaluation, analyzing the influence of age, sex, device experience and intervention group membership. RESULTS: The RPM system consists of four interoperable components: patient-devices, data-server, data-viewer and notification-service. The evaluation of the system was conducted with 95 consecutive DCM patients (female: 28 of 95 (29%), age: 50±12 years) completing the activeDCM study protocol. The wearable/ smartphone application of the system achieved a mean SUS score of 78±17, which was most influenced by device experience. 83 of 95 patients (87%) could integrate the wearable application (very) well into their daily routine and 67 of 95 (70%) saw a benefit of the RPM system for management of their health condition. Patients interacted on average with the wearable on 61%±26% of days enrolled in the study, corresponding to 239±99 of 396±39 days. SHD was available on average for 78%±23% of days and PROM data 64%±27% of weeks enrolled in the study, corresponding to 307±87 of 396±39 days and 35±15 of 56±5 weeks, respectively. Wearable interaction frequency, SHD and PROM completeness were most influenced by intervention group membership. CONCLUSIONS: Our results mark a first step towards integrating RPM systems, based on a consumer wearable device for primary patient input, into standardized clinical workflows. They can serve as a blueprint for creating a user-friendly, reusable, interoperable and secure RPM system, that can be integrated into patients' daily routines. CLINICALTRIAL: ClinicalTrials.gov-Identifier: NCT04359238.

Ceramic anterior veneer restorations in periodontally compromised patients: A retrospective study.

BACKGROUND: Successful periodontal therapy can lead to poor esthetic results, especially in the anterior region, for which there are treatment options such as direct composite or indirect veneer restorations. Until now, there are no data describing the long-term results of veneer restorations in periodontally treated patients. The aim of this retrospective study was to evaluate the outcome of anterior porcelain veneer restorations in periodontally compromised and noncompromised patients. METHODS: Periodontally healthy and periodontally compromised patients, who had received anterior veneer restorations at least 5 years ago, were invited to a follow-up examination. Groups were divided according to their periodontal diagnosis (periodontally healthy, stage I/II, stage III/IV). Tooth loss, veneer loss, biologic parameters, and complication rates were examined. Also, veneers were evaluated according to modified United States Public Health Service criteria. RESULTS: A total of 68 patients with 312 veneers were examined with a mean follow-up time of 8 years. Veneered teeth in patients with periodontitis stage III/IV showed no difference regarding tooth-specific, overall, and functional veneer survival when compared to periodontally healthy patients (Kaplan-Meier analyses). In Cox regression analysis, follow-up time had an impact on complications and veneer loss, whereas periodontal diagnosis showed no significant influence on the survival of restorations. Comparative tests showed that patients with severe periodontitis at baseline have slightly lower veneer survival rates after 8 years and slightly higher complication rates after 13 years. CONCLUSION: Long-term results and complication rates of veneer restorations in periodontally compromised patients are comparable to periodontally healthy patients over a mean follow-up of 8 years.

Full block or split block?-Comparison of two different autogenous block grafting techniques for alveolar ridge reconstruction.

OBJECTIVE: To evaluate radiographic bone gain after alveolar ridge augmentation with two different designs of autogenous block graft harvested from the mandible. MATERIALS AND METHODS: Alveolar ridge defects were evaluated by preoperative cone beam computed tomography (CBCT) and grafted in a staged approach using intraoral block grafts. The ridge augmentation was either performed using the full-block technique (group 1) or the split-block technique (cortical plate with autogenous bone chips) (group 2). After 4 months of bone healing, a further CBCT scan was performed before implant placement. Horizontal and vertical bone gain were measured. RESULTS: In this retrospective study, 91 patients were grafted with block grafts (36 patients with full-block grafts; 55 patients with split-block grafts) resulting in 171 block grafts in total. The mean horizontal bone gain was 3.37 ± 0.71 mm in group 1 and 5.79 ± 2.20 mm in group 2. A linear mixed-effect model also showed a statistically significant group difference (p < 0.001, estimate: 3.455, 95% CI: [2.082-4.829]). The mean vertical bone gain was 2.85 ± 0.73 mm in group 1 and 7.60 ± 1.87 mm in group 2. A linear mixed-effect model also showed a statistically significant group difference (p: 0.029, estimate: 3.126, 95% CI: [0.718-5.557]). Mean marginal bone level was 0.33 ± 0.37 mm (group 1) and 0.17 ± 0.29 mm (group 2). CONCLUSION: The split-block technique resulted in a greater bone gain than the full-block technique. This effect was observed in both the vertical and the horizontal dimensions.

Early outcomes of patients with Marfan syndrome and acute aortic type A dissection.

BACKGROUND: Acute aortic Stanford type A dissection remains a frequent and life-limiting event for patients with Marfan syndrome. Outcome results in this high-risk group are limited. METHODS: The German Registry for Acute Aortic Dissection Type A collected the data of 56 centers between July 2006 and June 2015. Of 3385 patients undergoing operations for acute aortic Stanford type A dissection, 117 (3.5%) were diagnosed with Marfan syndrome. We performed a propensity score match comparing patients with Marfan syndrome with patients without Marfan syndrome in a 1:2 fashion. RESULTS: Patients with Marfan syndrome were significantly younger (42.9 vs 62.2 years; P < .001), predominantly male (76.9% vs 62.9%; P = .002), and less catecholamine dependent (9.4% vs 20.3%; P = .002) compared with the unmatched cohort. They presented with aortic regurgitation (41.6% vs 23.0%; P < .001) and involvement of the supra-aortic vessels (50.4% vs 39.5%; P = .017) more often. Propensity matching revealed 82 patients with Marfan syndrome (21 female) with no significant differences in baseline characteristics compared with patients without Marfan syndrome (n = 159, 36 female; P = .607). Although root preservation was more frequent in patients with Marfan syndrome, procedure types did not differ significantly (18.3% vs 10.7%; P = .256). Aortic arch surgery was performed more frequently in matched patients (87.5% vs 97.8%; P = .014). Thirty-day mortality did not differ between patients with and without Marfan syndrome (19.5% vs 20.1%; P = .910). Multivariate regression showed no influence of Marfan syndrome on 30-day mortality (odds ratio, 0.928; 95% confidence interval, 0.346-2.332; P = .876). CONCLUSIONS: Marfan syndrome does not adversely affect 30-day outcomes after surgical repair for acute aortic Stanford type A dissection compared with a matched cohort. Long-term outcome analysis is needed to account for the influence of further downstream interventions.