Maximilian Pilz

• Dr.
• Researcher at Fraunhofer Institute for Industrial Mathematics

Background Title-abstract screening in the preparation of a systematic review is a time-consuming task. Modern techniques of natural language processing and machine learning might allow partly automatization of title-abstract screening. In particular, clear guidance on how to proceed with these techniques in practice is of high relevance. Methods...

Due to the dependency structure in the sampling process, adaptive trial designs create challenges in point and interval estimation and in the calculation of P ‐values. Optimal adaptive designs, which are designs where the parameters governing the adaptivity are chosen to maximize some performance criterion, suffer from the same problem. Various ana...

In the present study, the impacts on success rates between three different antibiotic regimes in patients receiving preventive tooth extraction during/after antiresorptive treatment were compared. For the retrospective analysis, we enrolled patients who had undergone tooth extraction from 2009 to 2019 according to the specified preventive condition...

Surgical therapy of osteoradionecrosis of the jaw (ORN) is challenging and requires treatment of the affected hard and soft tissue. To understand how tissue injury after irradiation influences surgical outcomes, the objective of this study was to find out whether (a) bone-related, (b) soft tissue-related, and (c) treatment-related parameters influe...

If design parameters are chosen appropriately, group sequential trial designs are known to be able to reduce the expected sample size under the alternative hypothesis compared to single‐stage designs. The same holds true for the so‐called ‘gold‐standard’ design for non‐inferiority trials, a design involving an experimental group, an active control...

When applying group-sequential designs in clinical trials with normally distributed outcomes, approximate critical values are often applied. Here, normally distributed test statistics are assumed which, however, are in fact t-distributed. For small sample sizes, the approximation may lead to a serious inflation of the type I error rate. Recently, a...

Adaptive planning of clinical trials allows modifying the entire trial design at any time point mid‐course. In this paper, we consider the case when a trial‐external update of the planning assumptions during the ongoing trial makes an unforeseen design adaptation necessary. We take up the idea to construct adaptive designs with defined features by...

Adaptive designs are an increasingly popular method for the adaptation of design aspects in clinical trials, such as the sample size. Scoring different adaptive designs helps to make an appropriate choice among the numerous existing adaptive design methods. Several scores have been proposed to evaluate adaptive designs. Moreover, it is possible to...

Background: The optimal timing of surgical therapy for traumatic spinal cord injury (TSCI) remains unclear. The purpose of this study is to evaluate the impact of "ultra-early" (<4 h) versus "early" (4-24 h) time from injury to surgery in terms of the likelihood of neurologic recovery. Methods: The effect of surgery on neurological recovery was...

Background This retrospective observational study was undertaken to assess the ENT emergency workload during the COVID-19 pandemic caused by the severe acute respiratory coronavirus‑2 (SARS-CoV-2).Materials and methodsAll 3230 patients who were treated as an emergency from 23.01.2020 to 06.08.2020 in the Department of Otolaryngology at the SLK-Klin...

Background: To find out whether preventive tooth extractions in patients on antiresorptive therapy have a direct impact on the patients' overall quality of life (QoL); Methods: QoL using the five-level version of the EuroQol Group's EQ-5D instrument (EQ-5D-5L) was longitudinally assessed in N = 114 prospectively enrolled patients with indication o...

Background It is a constant debate among surgeons whether the use of prolonged postoperative antibiotics may reduce surgical site infection rates. As specific treatment guidelines are still lacking, many surgeons continue to use broad-spectrum antibiotics, causing not only increased costs but also contributing to the potential for antibiotic resist...

Objective To assess the relative contribution of intravenous antibiotic prophylaxis, mechanical bowel preparation, oral antibiotic prophylaxis, and combinations thereof towards the reduction of surgical site infection (SSI) incidence in elective colorectal resections. Methods and analysis A systematic search of randomised controlled trials compari...

Satellite cells (SC) are of importance for muscular adaptation to various forms of exercise. A single bout of high-force eccentric exercise has been shown to induce SC activation and, for electrically stimulated exercise, SC differentiation. Purpose: This study aimed to assess if one bout of concentric/eccentric exercise with damaging eccentric o...

Objectives: To compare the diagnostic accuracy in detecting early non-vital bone changes between OPT and CBCT in correlation with histopathological findings before tooth extractions in patients with antiresorptive intake. Subjects: Patients with an indication tooth extraction who had received OPT and CBCT preoperatively while or after undergoing...

Background We set out to investigate how the ongoing coronavirus pandemic affected the size of tumors and the duration of treatment delay in patients with surgically treated oral squamous cell carcinoma. Methods Patients with surgically treated oral cavity squamous cell carcinoma were assessed retrospectively and divided into two groups depending...

Purpose To investigate the safety, clinical efficacy, virus pharmacokinetics, shedding, and immune response after administration of an oncolytic parvovirus (H-1PV, ParvOryx) to patients with metastatic pancreatic ductal adenocarcinoma (PDAC) refractory to first-line therapy. Patients and Methods This is a noncontrolled, single-arm, open-label, dos...

Even though adaptive two-stage designs with unblinded interim analyses are becoming increasingly popular in clinical trial designs, there is a lack of statistical software to make their application more straightforward. The package adoptr fills this gap for the common case of two-stage one- or two-arm trials with (approximately) normally distribute...

Background: Oral leukoplakia is a potentially malignant lesion with a clinical impression similar to different benign and malignant lesions. Ex vivo fluorescence confocal microscopy is a developing approach for a rapid “chairside” detection of oral lesions with a cellular-level resolution. A possible application of interest is a quick differentiati...

Monocytes and lymphocytes elicit crucial activities for the regenerative processes after various types of injury. The survival of neurons exposed to mechanical and oxidative stress after traumatic spinal cord injury (TSCI) depends on a multitude of factors. The current study sought to evaluate a correlation between remission after TSCI and dynamics...

Background: It is a constant debate among surgeons whether the use of prolonged postoperative antibiotics may reduce surgical site infection rates. As specific treatment guidelines are still lacking, many surgeons continue to use broad-spectrum antibiotics, causing not only increased costs but also contributing to the potential for antibiotic resis...

Sample size calculations in clinical trials need to be based on profound parameter assumptions. Wrong parameter choices may lead to too small or too high sample sizes and can have severe ethical and economical consequences. Adaptive group sequential study designs are one solution to deal with planning uncertainties. Here, the sample size can be upd...

Background Occult infections (OI) lack typical inflammatory signs, making them challenging to diagnose. Uncertainty remains regarding OI’s influence on the outcome of autologous bone grafting (ABG), and evidence-based recommendations regarding an appropriate course of action are missing. Thus, we sought to determine the incidence of an OI in patien...

Background Currently, patient selection in TAVI is based upon a multidisciplinary heart team assessment of patient comorbidities and surgical risk stratification. In an era of increasing need for precision medicine and quickly expanding TAVI indications, machine learning has shown promise in making accurate predictions of clinical outcomes. This st...

Adaptive designs are playing an increasingly important role in the planning of clinical trials. While there exists various research on the optimal determination of a two‐stage design, non‐optimal versions still are frequently applied in clinical research. In this article, we strive to motivate the application of optimal adaptive designs and give gu...

The aim of this study was to investigate the impact of a prolonged treatment delay on survival in patients with primary oral squamous cell carcinoma. The investigators hypothesized that treatment delay affects survival, supposing a poor outcome in patients with prolonged treatment initiation. In addition, a critical treatment delay should be define...

SARS-CoV-2 infections cause the current coronavirus disease (COVID-19) pandemic and challenge the immune system with ongoing inflammation. Several redox-relevant micronutrients are known to contribute to an adequate immune response, including the essential trace elements zinc (Zn) and selenium (Se). In this study, we tested the hypothesis that COVI...

Purpose: To prospectively compare the clinical performance of posterior inlay-retained and wing-retained monolithic zirconia fixed partial dentures (FPDs). Materials and methods: After simple randomization, 30 participants received either one inlay-retained (n = 15; mean age: 56.38 ±12.70 years; 10 men [66.7%]) or one wing-retained (n = 15; mean...

Objective To assess the relationship between bimaxillary orthognathic surgery in class II and III patients, the three-dimensional extent of the posterior airway space (PAS) using cone-beam computed tomography (CBCT). Methods A retrospective evaluation of a cohort of Class II and III patients, who had undergone orthognathic surgery (Le Fort I osteo...

The experience of pain involves the activation of multiple brain areas. Pain-specific activity patterns within and between these local networks remain, however, largely unknown. We measured neuronal network oscillations in different relevant regions of the mouse brain during acute pain, induced by subcutaneous injection of capsaicin into the left h...

Background: The optimal level of positive end-expiratory pressure is still under debate. There are scare data examining the association of PEEP with transpulmonary pressure (TPP), end-expiratory lung volume (EELV) and intraabdominal pressure in ventilated patients with and without ARDS. Methods: We analyzed lung mechanics in 3 patient groups: gr...

SARS-CoV-2 infections underlie the current coronavirus disease (COVID-19) pandemic and are causative for a high death toll particularly among elderly subjects and those with comorbidities. Selenium (Se) is an essential trace element of high importance for human health and particularly for a well-balanced immune response. The mortality risk from a s...

SARS-CoV-2 infections underlie the current Coronavirus disease (COVID-19) pandemic and are causative for a high death toll particularly among elderly subjects and those with comorbidities. Selenium (Se) is an essential trace element of high importance for human health and particularly for a well-balanced immune response. Mortality risk from severe...

Objectives To compare success rates between the sub‐periosteal prepared (SPP) muco‐periosteal flap and the epi‐periosteal (EPP) prepared mucosa flap and the feasibility of alveoplasty after surgical tooth extractions in patients undergoing/after antiresorptive treatment. Subjects Patients with an indication for preventive tooth extraction undergoi...

Adaptive two-stage designs for clinical trials are well understood from a statistical perspective. However, there is still few research on how the stage-two sample size looks like when it is regarded as a function of the first-stage test statistic. In this paper, a formal proof on the concavity of the sample size function is provided if the design’...

Objectives: The goal was to develop a scoring system to predict the 30-day mortality rate for patients undergoing surgery for acute type A aortic dissection on the basis of the German Registry for Acute Type A Aortic Dissection (GERAADA) data set and to provide a Web-based application for standard use. Methods: A total of 2537 patients enrolled...

Real‐time microscopic imaging of freshly excised tissue enables a rapid bedside‐pathology. A possible application of interest is the detection of oral squamous cell carcinomas (OSCCs). The aim of this study was to analyze the sensitivity and specificity of ex vivo fluorescence confocal microscopy (FCM) for OSCCs and to compare confocal images visua...

In standard clinical trial designs, the required sample size is fixed in the planning stage based on initial parameter assumptions. It is intuitive that the correct choice of the sample size is of major importance for an ethical justification of the trial. The required parameter assumptions should be based on previously published results from the l...

Abstract Background Unwanted anticholinergic effects are both underestimated and frequently overlooked. Failure to identify adverse drug reactions (ADRs) can lead to prescribing cascades and the unnecessary use of over-the-counter products. The objective of this systematic review and meta-analysis is to explore and quantify the frequency and severi...

Recalculating the sample size in adaptive two‐stage designs is a well‐established method to gain flexibility in a clinical trial. Jennison and Turnbull (2015) proposed an “optimal” adaptive two‐stage design based on the inverse normal combination test, which minimizes a mixed criterion of expected sample size under the alternative and conditional p...

Elastic Net regularization is a powerful tool to do prediction as well as variable selection. De Mol et al. (2009) developed a theoretical framework to analyse the Elastic Net and proved important properties as the consistency of the Elastic Net estimator under certain model assumptions. In this paper, these assumptions are relaxed and extended to...