Estimating the COVID-19 prevalence from wastewater.

Wastewater based epidemiology has become a widely used tool for monitoring trends of concentrations of different pathogens, most notably and widespread of SARS-CoV-2. Therefore, in 2022, also in Rhineland-Palatinate, the Ministry of Science and Health has included 16 wastewater treatment sites in a surveillance program providing biweekly samples. However, the mere viral load data is subject to strong fluctuations and has limited value for political deciders on its own. Therefore, the state of Rhineland-Palatinate has commissioned the University Medical Center at Johannes Gutenberg University Mainz to conduct a representative cohort study called SentiSurv, in which an increasing number of up to 12,000 participants have been using sensitive antigen self-tests once or twice a week to test themselves for SARS-CoV-2 and report their status. This puts the state of Rhineland-Palatinate in the fortunate position of having time series of both, the viral load in wastewater and the prevalence of SARS-CoV-2 in the population. Our main contribution is a calibration study based on the data from 2023-01-08 until 2023-10-01 where we identified a scaling factor ( 0.208 ± 0.031 ) and a delay ( 5.07 ± 2.30 days) between the virus load in wastewater, normalized by the pepper mild mottle virus (PMMoV), and the prevalence recorded in the SentiSurv study. The relation is established by fitting an epidemiological model to both time series. We show how that can be used to estimate the prevalence when the cohort data is no longer available and how to use it as a forecasting instrument several weeks ahead of time. We show that the calibration and forecasting quality and the resulting factors depend strongly on how wastewater samples are normalized.

Statistical analysis of three data sources for Covid-19 monitoring in Rhineland-Palatinate, Germany.

In Rhineland-Palatinate, Germany, a system of three data sources has been established to track the Covid-19 pandemic. These sources are the number of Covid-19-related hospitalizations, the Covid-19 genecopies in wastewater, and the prevalence derived from a cohort study. This paper presents an extensive comparison of these parameters. It is investigated whether wastewater data and a cohort study can be valid surrogate parameters for the number of hospitalizations and thus serve as predictors for coming Covid-19 waves. We observe that this is possible in general for the cohort study prevalence, while the wastewater data suffer from a too large variability to make quantitative predictions by a purely data-driven approach. However, the wastewater data and the cohort study prevalence are able to detect hospitalizations waves in a qualitative manner. Furthermore, a detailed comparison of different normalization techniques of wastewater data is provided.

Point estimation, confidence intervals, and P-values for optimal adaptive two-stage designs with normal endpoints.

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 analysis methods which are able to handle this dependency structure have already been developed. In this work, we aim to give a comprehensive summary of these methods and show how they can be applied to the class of designs with planned adaptivity, of which optimal adaptive designs are an important member. The defining feature of these kinds of designs is that the adaptive elements are completely prespecified. This allows for explicit descriptions of the calculations involved, which makes it possible to evaluate different methods in a fast and accurate manner. We will explain how to do so, and present an extensive comparison of the performance characteristics of various estimators between an optimal adaptive design and its group-sequential counterpart.

Sample size calculation for one-armed clinical trials with clustered data and binary outcome.

The formula of Fleiss and Cuzick (1979) to estimate the intraclass correlation coefficient is applied to reduce the task of sample size calculation for clustered data with binary outcome. It is demonstrated that this approach reduces the complexity of sample size calculation to the determination of the null and alternative hypothesis and the formulation of the quantitative influence of the belonging to the same cluster on the therapy success probability.

Comparison of Different Antibiotic Regimes for Preventive Tooth Extractions in Patients with Antiresorptive Intake-A Retrospective Cohort Study.

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 conditions under antiresorptive therapy. Three antibiotic regimens were distinguished: (Group 1) intravenous for 7 days, (Group 2) oral for 14 days, and (Group 3) oral for 7 days of application. The primary endpoint was the occurrence of medication-related osteonecrosis of the jaw at 12 weeks after surgery. A total of 760 patients and 1143 extraction regions were evaluated (Group 1 n = 719; Group 2 n = 126; Group 3 n = 298). The primary endpoint showed no significant difference in the development of medication-related osteonecrosis of the jaw between the groups studied (Group 1 n = 50/669 (7%); Group 2 n = 9/117 (7%); Group 3 n = 17/281 (6%); p = 0.746). Overall, the success rate was 93% after intervention when preventive measures were followed. With the same success rate, a reduced, oral administration of antibiotics seems to be sufficient regarding the possible spectrum of side effects, the development of resistance and the health economic point of view.

Amitriptyline's anticholinergic adverse drug reactions-A systematic multiple-indication review and meta-analysis.

BACKGROUND: Half the US population uses drugs with anticholinergic properties. Their potential harms may outweigh their benefits. Amitriptyline is among the most frequently prescribed anticholinergic medicinal products, is used for multiple indications, and rated as strongly anticholinergic. Our objective was to explore and quantify (anticholinergic) adverse drug reactions (ADRs) in patients taking amitriptyline vs. placebo in randomized controlled trials (RCTs) involving adults and healthy individuals. METHODS: We searched electronic databases from their inception until 09/2022, and clinical trial registries from their inception until 09/2022. We also performed manual reference searches. Two independent reviewers selected RCTs with ≥100 participants of ≥18 years, that compared amitriptyline (taken orally) versus placebo for all indications. No language restrictions were applied. One reviewer extracted study data, ADRs, and assessed study quality, which two others verified. The primary outcome was frequency of anticholinergic ADRs as a binary outcome (absolute number of patients with/without anticholinergic ADRs) in amitriptyline vs. placebo groups. RESULTS: Twenty-three RCTs (mean dosage 5mg to 300mg amitriptyline/day) and 4217 patients (mean age 40.3 years) were included. The most frequently reported anticholinergic ADRs were dry mouth, drowsiness, somnolence, sedation, fatigue, constitutional, and unspecific anticholinergic ADRs. Random-effects meta-analyses showed anticholinergic ADRs had a higher odd's ratio for amitriptyline versus placebo (OR = 7.41; [95% CI, 4.54 to 12.12]). Non-anticholinergic ADRs were as frequent for amitriptyline as placebo. Meta-regression analysis showed anticholinergic ADRs were not dose-dependent. DISCUSSION: The large OR in our analysis shows that ADRs indicative of anticholinergic activities can be attributed to amitriptyline. The low average age of participants in our study may limit the generalizability of the frequency of anticholinergic ADRs in older patients. A lack of dose-dependency may reflect limited reporting of the daily dosage when the ADRs occurred. The exclusion of small studies (<100 participants) decreased heterogeneity between studies, but may also have reduced our ability to detect rare events. Future studies should focus on older people, as they are more susceptible to anticholinergic ADRs. REGISTRATION: PROSPERO: CRD42020111970.

Hospital Admission and Discharge: Lessons Learned from a Large Programme in Southwest Germany.

Introduction: In the context of a GP-based care programme, we implemented an admission, discharge and follow-up programme. Description: The VESPEERA programme consists of three sets of components: pre-admission interventions, in-hospital interventions and post-discharge interventions. It was aimed at all patients with a hospital stay participating in the GP-based care programme and was implemented in 7 hospitals and 72 general practices in southwest Germany using a range of strategies. Its' effectiveness was evaluated using readmissions within 90 days after discharge as primary outcome. Questionnaires with staff were used to explore the implementation process. Discussion: A statistically significant effect was not found, but the effect size was similar to other interventions. Intervention fidelity was low and contextual factors affecting the implementation, amongst others, were available resources, external requirements such as legal regulations and networking between care providers. Lessons learned were derived that can aid to inform future political or scientific initiatives. Conclusion: Structured information transfer at hospital admission and discharge makes sense but the added value in the context of a GP-based programme seems modest. Primary care teams should be involved in pre- and post-hospital care.

Osteoradionecrosis of the Jaw-Comparison between Bone and Soft Tissue Injury and Their Influence on Surgical Outcomes-A Retrospective Cohort Study.

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 influence the surgical success of patients with ORN. A total of 175 patients (324 lesions) were included in this retrospective, single-center study. All patients were diagnosed with ORN and underwent surgical therapy. The primary outcome was complete soft tissue recovery (mucosa/skin) and the absence of symptoms 3 months after surgery. At the time of follow-up, 58% of patients (189 of 324 lesions) had intact intraoral or extraoral soft tissue. The extent of bone destruction had no effect on treatment success, whereas soft tissue injury due to fibrosis (OR: 0.344; CI 0.142-0.834; p = 0.01818) and xerostomia (OR: 0.163; CI 0.064-0.419; p = 0.00016) increased the probability of treatment failure. Soft tissue reconstruction with a microvascular graft improved therapeutic success compared to local wound closure (OR: 2.998; CI 1.371-6.555; p = 0.006). Thus, for the treatment of ORN, it is extremely important to pay attention not only to the extent of bone destruction but especially to soft tissue defects. Because the extent of soft tissue injury is a predictor for therapeutic success, it should influence the choice of surgical treatment.

Diagnostic accuracy comparing OPT and CBCT in the detection of non-vital bone changes before tooth extractions in patients with antiresorptive intake.

OBJECTIVES: To compare the diagnostic accuracy in detecting early non-vital bone changes between orthopantomography (OPT) and cone-beam computed tomography (CBCT) in correlation with histopathological findings before tooth extractions in patients with antiresorptive (AR) intake. SUBJECTS: Patients with an indication tooth extraction who had received OPT and CBCT preoperatively while or after undergoing AR treatment were prospectively enrolled over a 24-month period in the progesterone in spontaneous miscarriage (PRISM) trial. Imaging studies were randomly analyzed by three examiners for early non-vital bone changes using specific predefined characteristics and a 5-level scale (1 definite absence of criteria to 5 definite presence of criteria). Sensitivity and specificity values were calculated in correlation with the histopathologically evaluated bone samples at the time point of tooth extraction. RESULTS: One hundred thirty patients with 237 treated extraction sites met the inclusion criteria. For all images evaluated by all examiners, CBCT (430/492; 87.4%; receiver operating characteristic [ROC]: area under the curve [AUC] = 0.88; p < 0.001) was more likely to detect histopathologically confirmed non-vital bone than the OPT (132/492; 26.8%; ROC: AUC = 0.562; p = 0.115). CONCLUSIONS: In the detection of non-vital bone changes, CBCT is superior to OPT in both sensitivity and specificity. Specific imaging characteristics allow for the prediction of early non-vital bone changes already at the time before tooth extractions.

Two-stage designs with small sample sizes.

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 method for computing the exact critical boundaries assuring type I error rate control was proposed and the critical boundaries for Pocock- and O'Brien-Fleming-like group-sequential designs were provided. For designs with one interim analysis, we present six alternative designs, which also control the type I error rate and in addition allow flexible design modifications. We compare the characteristics of these 6 two-stage designs. It is shown that considerable sample size savings can be achieved by including futility stopping and by optimizing the designs. Therefore, for clinical trials with small sample sizes as, for example, in the area of rare diseases, optimal two-stage designs with futility stopping may be a valuable alternative to classical group-sequential designs.

Optimization of the two-stage group sequential three-arm gold-standard design for non-inferiority trials.

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 group, and a placebo group. However, choosing design parameters that maximize the advantages of a two-stage approach for the three-arm gold-standard design for non-inferiority trials is not a straightforward task. In particular, optimal choices of futility boundaries for this design have not been thoroughly discussed in existing literature. We present a variation of the hierarchical testing procedure, which allows for the incorporation of binding futility boundaries at interim analyses. We show that this procedure maintains strong control of the family-wise type I error rate. Within this framework, we consider the futility and efficacy boundaries as well as the sample size allocation ratios as optimization parameters. This allows the investigation of the efficiency gain from including the option to stop for futility in addition to the ability to stop for efficacy. To analyze the extended designs, optimality criteria that include the design's performance under the alternative as well as the null hypothesis are introduced. On top of this, we discuss methods to limit the allocation of placebo patients in the trial while maintaining relatively good operating characteristics. The results of our numerical optimization procedure are discussed and a comparison of different approaches to designing a three-arm gold-standard non-inferiority trial is provided.

Optimal unplanned design modification in adaptive two-stage trials.

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 solving an optimization problem and apply it to the situation of unplanned design reassessment. By using the conditional error principle, we present an approach on how to optimally modify the trial design at an unplanned interim analysis while at the same time strictly protecting the type I error rate. This linking of optimal design planning and the conditional error principle allows sound reactions to unforeseen events that make a design reassessment necessary.

Optimization of adaptive designs with respect to a performance score.

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 determine optimal two-stage adaptive designs with respect to a customized objective score by solving a constrained optimization problem. In this paper, we use the conditional performance score by Herrmann et al. (2020) as the optimization criterion to derive optimal adaptive two-stage designs. We investigate variations of the original performance score, for example, by assigning different weights to the score components and by incorporating prior assumptions on the effect size. We further investigate a setting where the optimization framework is extended by a global power constraint, and additional optimization of the critical value function next to the stage-two sample size is performed. Those evaluations with respect to the sample size curves and the resulting design's performance can contribute to facilitate the score's usage in practice.

Eccentric Overload during Resistance Exercise: A Stimulus for Enhanced Satellite Cell Activation.

PURPOSE: This study aimed to assess if one bout of concentric/eccentric exercise with damaging eccentric overload (CON/ECC+) provides a sufficient stimulus to induce SC activation, proliferation, and differentiation. METHODS: Biopsies from the vastus lateralis muscle of recreationally active men were obtained in the rested condition and again from the contralateral leg 7 d after exhaustive concentric/eccentric (CON/ECC) (n = 15) or CON/ECC+ (n = 15) leg extension exercise and in a nonexercising control group (CG) (n = 10). Total SC number (Pax7+), activated (Pax7+/MyoD+), and differentiating (myogenin+) SCs, fiber type distribution, and myofibers expressing neonatal myosin heavy chain (MHCneo) were determined immunohistochemically. Creatine kinase and myoglobin were measured in venous blood. Isokinetic strength tests were repeatedly conducted. RESULTS: Significant increases in creatine kinase and myoglobin (P = 0.001) indicated myofiber damage, whereas maximal strength was not impaired. Only after CON/ECC+, SC content (P = 0.019) and SC related to type II fibers (P = 0.011) were significantly increased. A significant increase in the proportion of activated SCs occurred after CON/ECC+ only (P = 0.003), the increase being significantly (P < 0.05) different from the changes after CON/ECC and in CG. The number of differentiating SC and MHCneo remained unchanged. CONCLUSIONS: Eccentric overload during leg extension exercise induced significant SC activation, increases in SC content and in SC number related to type II myofibers. However, there were no signs of increased SC differentiation or formation of new myofibers.

[Analysis of ENT emergency patients during the COVID-19 pandemic in Germany]. / Analyse von HNO-Notfallpatienten während der COVID-19-Pandemie in Deutschland.

BACKGROUND: This retrospective observational study was undertaken to assess the ENT emergency workload during the COVID-19 pandemic caused by the severe acute respiratory coronavirus­2 (SARS-CoV-2). MATERIALS AND METHODS: All 3230 patients who were treated as an emergency from 23.01.2020 to 06.08.2020 in the Department of Otolaryngology at the SLK-Kliniken Heilbronn were included in this study. Demographic data, diagnostics, diagnosis, and treatment (in-/outpatient) were retrospectively retrieved. Not only did the physicians on call triage the emergency department (ED) ENT patients, but the patients also self-assessed their urgency of treatment. RESULTS: The number of patients consulting our ED decreased significantly during the pandemic, by 42.2%. However, the top diagnoses remained almost constant, with epistaxis being the most frequent diagnosis before, during, and after COVID-19. Facial trauma remained the second most frequent consultation reason. The hospitalization rate decreased from 21.9% before COVID-19 to 16.2% during the pandemic. Surgical therapy was necessary in 17.6% of patients before COVID-19 and this increased to 23.5% during COVID-19. The self-referral rate increased from 61 to 66% during the pandemic. More men than women consulted the ED during COVID-19. Regarding the triage assessment by the physician on call and the patient's self-assessment, a significant discrepancy was noted before, during, and after COVID-19. CONCLUSION: The reasons for reduction in ENT ED visits are multifactorial. The clinical consequences of decreased hospitalizations remain uncertain. However, health authorities need to advocate the safety of the hospital environment to limit potential damage.

Pursuing More Aggressive Timelines in the Surgical Treatment of Traumatic Spinal Cord Injury (TSCI): A Retrospective Cohort Study with Subgroup Analysis.

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 investigated by comparing the assessed initial and final values of the American Spinal Injury Association (ASIA) Impairment Scale (AIS). A post hoc analysis was performed to gain insight into different subgroup regeneration behaviors concerning neurological injury levels. RESULTS: Datasets from 69 cases with traumatic spinal cord injury were analyzed. Overall, 19/46 (41.3%) patients of the "ultra-early" cohort saw neurological recovery compared to 5/23 (21.7%) patients from the "early" cohort (p = 0.112). The subgroup analysis revealed differences based on the neurological level of injury (NLI) of a patient. An optimal cutpoint for patients with a cervical lesion was estimated at 234 min. Regarding the prediction of neurological improvement, sensitivity was 90.9% with a specificity of 68.4%, resulting in an AUC (area under the curve) of 84.2%. In thoracically and lumbar injured cases, the estimate was lower, ranging from 284 (thoracic) to 245 min (lumbar) with an AUC of 51.6% and 54.3%. CONCLUSIONS: Treatment within 24 h after TSCI is associated with neurological recovery. Our hypothesis that intervention within 4 h is related to an improvement in the neurological outcome was not confirmed in our collective. In a clinical context, this suggests that after TSCI there is a time frame to get the right patient to the right hospital according to advanced trauma life support (ATLS) guidelines.

Influence of Preventive Tooth Extractions on Quality of Life in Patients with Antiresorptive Intake-A Prospective Longitudinal Study.

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 of preventive tooth extraction over a period of 12 months. Patients were stratified as high-risk (malignant disease with bone metastasis or multiple myeloma, with monthly high-dose antiresorptive therapy delivered intravenously [bisphosphonate] or subcutaneously [denosumab]) and low-risk/osteoporosis patients (weekly low-dose antiresorptive therapy administered orally [bisphosphonate] or half-yearly subcutaneously [denosumab]). The measurement time points were 4 weeks preoperatively (T0), 2 months (T1) and 1 year postoperatively (T2), respectively. RESULTS: EQ-5D-5L index scores fell in a range from -0.21 to 1.00 in the low-risk group to 0.15 to 1.00 in the high-risk group. The t-test comparing the baseline index scores of both groups showed EQ-5D-5L index score in the low-risk group (0.708 ± 0.292) to be significantly smaller (p = 0.037) than in the high-risk group (0.807 ± 0.19). ANCOVA showed no significant differences in EQ-5D-5L index scores between the groups at T1 and T2. CONCLUSIONS: Preventive tooth extractions in patients undergoing antiresorptive treatment have no negative effect on QoL. Therefore, if indicated, preventive tooth extraction should not be omitted. Patient-oriented outcome measures are important to obtain a good risk-benefit balance for patient-specific treatment.

APOS-antibiotic prophylaxis for preventing infectious complications in orthognathic surgery: study protocol for a phase III, multicentre, randomised, controlled, double blinded, clinical trial with two parallel study arms.

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 resistance. Hence, there is an urgent need for an appropriately designed prospective clinical trial, to investigate whether a prophylactic use of antibiotics after surgery actually decreases surgical site infections to a clinically relevant degree. METHODS: This study presents a multicentre, randomised, controlled, double-blinded, clinical trial with two parallel study arms to demonstrate that no postoperative antibiotic prophylaxis (AP) is not inferior to antibiotic prophylaxis with respect to surgical site infections in patients having undergone orthognathic surgery. The primary efficacy endpoint is defined as the occurrence of postoperative surgical site infections within 30 days of surgery. Secondary endpoints are further efficacy and subject-oriented parameters within 90 days after surgery. The entire trial is planned for 54 months, with an enrolment of 1420 patients over 39 months by 14 national participating centres. DISCUSSION: As a highly standardised procedure on an exceeding, healthy and young homogenous study population and identical processes all over the world, elective orthognathic surgery as clean-contaminated procedure provides comparable intervention groups with balanced baseline characteristics, comparable surgical duration, even when performed within multiple centres. Therefore, evaluating antibiotic prophylaxis after orthognathic surgery will be of high scientific value representable for other surgical procedures. TRIAL REGISTRATION: DRKS-German Clinical Trials Register- DRKS00022838 ; EudraCT No. 2020-001397-30. Registered on 29 March 2021.

Interventions to reduce the incidence of surgical site infection in colorectal resections: systematic review with multicomponent network meta-analysis (INTRISSI): study protocol.

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 comparing interventions to reduce SSI incidence will be conducted with predefined search terms in the following databases: MEDLINE, LILACS, Cochrane Central Register of Controlled Trials (CENTRAL) and the Cochrane Database of Systematic Reviews (CDSR). Additionally, several online databases will be searched for ongoing trials, and conference proceedings and reference lists of retrieved articles will be hand searched. The title-abstract screening will be partly performed by means of a semiautomated supervised machine learning approach, which will be trained on a subset of the identified titles and abstracts identified through traditional screening methods.The primary analysis will be a multicomponent network meta-analysis, as we expect to identify studies that investigate combinations of interventions (eg, mechanical bowel preparation combined with oral antibiotics) as well as studies that focus on individual components (mechanical bowel preparation or oral antibiotics). By means of a multicomponent network meta-analysis, we aim at estimating the effects of the separate components along the effects of the observed combinations. To account for between-trial heterogeneity, a random-effect approach will be combined with inverse variance weighting for estimation of the treatment effects. Associated 95% CIs will be calculated as well as the ranking for each component in the network using P scores. Results will be visualised by network graphics and forest plots of the overall pairwise effect estimates. Comparison-adjusted funnel plots will be used to assess publication bias. ETHICS AND DISSEMINATION: Ethical approval by the Ethical Committee of the Medical Faculty of the Martin-Luther-University Halle-Wittenberg (ID of approval: 2021-148). Results shall be disseminated directly to decision-makers (eg, surgeons, gastroenterologists, wound care specialists) by means of publication in peer-reviewed journals, presentation at conferences and through the media (eg, radio, TV, etc). PROSPERO REGISTRATION NUMBER: CRD42021267322.

Treatment delay and tumor size in patients with oral cancer during the first year of the COVID-19 pandemic.

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 on when they had first presented at our clinic. Patients presenting from 2010 to 2019, that is, before COVID-19 onset (n = 566) were compared to patients presenting in 2020 (n = 58). RESULTS: A total of 624 patients were included. Treatment delay was significantly longer in 2020 (median = 45 days) versus 2010-2019 (median = 35 days) (p = 0.004). We observed a higher pathological T classification in 2020 (p = 0.046), whereas pathological N classification was unchanged between groups (p = 0.843). CONCLUSIONS: While extraordinary efforts continue to be made in the context of the pandemic, it is imperative that this does not lead to significant disadvantages for many people with oral cancer.