Correction to: Patient-Specific Mandibular Reconstruction Plates Increase Accuracy and Long-Term Stability in Immediate Alloplastic Reconstruction of Segmental Mandibular Defects.

[This corrects the article DOI: 10.1007/s12663-019-01323-9.].

Patient-Specific Mandibular Reconstruction Plates Increase Accuracy and Long-Term Stability in Immediate Alloplastic Reconstruction of Segmental Mandibular Defects.

OBJECTIVES: The aim of the current study was to evaluate potential differences in the accuracy of mandibular reconstruction and long-term stability, with respect to different reconstructive procedures. METHODS: In total, 42 patients who had undergone primary segmental mandibular resection with immediate alloplastic reconstruction, with either manually pre-bent or patient-specific mandibular reconstruction plates (PSMRP), were included in this study. Mandibular dimensions, in terms of six clinically relevant distances (capitulum [most lateral points], capitulum [most medial points], incisura [most caudal points], mandibular foramina, coronoid process [most cranial points], dorsal tip of the mandible closest to the gonion point) determined from tomographic images, were compared prior to, and after surgery. RESULTS: Dimensional alterations were significantly more often found when conventionally bent titanium reconstruction plates were used. These occurred in the area of the coronoid process (p = 0.014). Plate fractures were significantly (p = 0.022) more often found within the manually pre-bent group than within the PSMRP group (17%/0%). CONCLUSION: The results suggest that the use of PSMRP may prevent rotation of the proximal mandibular segment, thus avoiding functional impairment. In addition, the use of PSMRP may potentially enhance the long-term stability of alloplastic reconstructions.

[Studies on localized low-risk prostate cancer : Do we know enough?] / Studien zum lokal begrenzten Niedrigrisikoprostatakarzinom : Wissen wir genug?

BACKGROUND: Treatment of localized low-risk prostate cancer (PCa) is undergoing a paradigm shift: Invasive treatments such as surgery and radiation therapy are being replaced by defensive strategies such as active surveillance (AS) and watchful waiting (WW). OBJECTIVE: The aim of this work is to evaluate the significance of current studies regarding defensive strategies (AS and WW). METHODS: The best-known AS studies are critically evaluated for their significance in terms of input criteria, follow-up criteria, and statistical significance. RESULTS: The difficulties faced by randomized studies in answering the question of the best treatment for low-risk cancer in two or even more study groups with known low tumor-specific mortality are clearly shown. Some studies fail because of the objective, others-like PIVOT-are underpowered. ProtecT, a renowned randomized, controlled trial (RCT), lists systematic and statistical shortcomings in detail. CONCLUSION: The time and effort required for RCTs to answer the question of which therapy is best for locally limited low-risk cancer is very large because the low specific mortality rate requires a large number of participants and a long study duration. In any case, RCTs create hand-picked cohorts for statistical evaluation that have little to do with care in daily clinical practice. The necessary randomization is also offset by the decision-making of the informed patient. If further studies of low-risk PCa are needed, they will need real-world conditions that an RCT can not provide. To obtain clinically relevant results, we need to rethink things: When planning the study, biometricians and clinicians must understand that the statistical methods used in RCTs are of limited use and they must select a method (e.g. propensity scores) appropriate for health care research.

Physician cooperation in outpatient cancer care. An amplified secondary analysis of qualitative interview data.

The importance of outpatient cancer care services is increasing due to the growing number of patients having or having had cancer. However, little is known about cooperation among physicians in outpatient settings. To understand what inter- and multidisciplinary care means in community settings, we conducted an amplified secondary analysis that combined qualitative interview data with 42 general practitioners (GPs), 21 oncologists and 21 urologists that mainly worked in medical practices in Germany. We compared their perspectives on cooperation relationships in cancer care. Our results indicate that all participants regarded cooperation as a prerequisite for good cancer care. Oncologists and urologists mainly reported cooperating for tumour-specific treatment tasks, while GPs' reasoning for cooperation was more patient-centred. While oncologists and urologists reported experiencing reciprocal communication with other physicians, GPs had to gather the information they needed. GPs seldom reported engaging in formal cooperation structures, while for specialists, participation in formal spaces of cooperation, such as tumour boards, facilitated a more frequent and informal discussion of patients, for instance on the phone. Further research should focus on ways to foster GPs' integration in cancer care and evaluate if this can be reached by incorporating GPs in formal cooperation structures such as tumour boards.

[Monitoring of NOAC]. / Monitoring von NOAK.

BACKGROUND: Monitoring non-vitamin K antagonist oral anticoagulants (NOAC) is usually not necessary; however, in some patients it may prove beneficial. OBJECTIVES: Patient subgroups who may profit from monitoring were identified, and methods of monitoring (including assessment of which coagulation parameters are affected by NOAC) are described. MATERIALS AND METHODS: We searched the PubMed database for each of the search terms, "NOAC", "DOAC", "rivaroxaban", "dabigatran", and "apixaban", in combination with one of the terms, "monitoring", "measurement", "measuring", or "assessment". The results were compiled and reviewed. RESULTS: Monitoring is most advantageous in emergency cases with severe bleeding where drug activity needs to be assessed. It can also help in deciding for or against lysis therapy after acute stroke in patients taking NOAC. Furthermore, it can also identify compliance problems and help in planning periprocedural management. There are quantitative measurement methods which measure plasma concentrations exactly and qualitative methods which only allow for a rough estimate or a general confirmation of drug activity. Recommended quantitative measurement methods are diluted thrombin time for dabigatran, and anti-factor Xa activity (calibrated) for rivaroxaban and apixaban. CONCLUSIONS: Several patient subgroups may profit from monitoring of NOAC plasma concentration. One should, however, take several issues into consideration before measurements, such as the objective of each individual measurement, possible consequences (e. g., dose adjustment), and which measurement method to pick.

[TNM-Classification of localized prostate cancer : The clinical T-category does not correspond to the required demands]. / TNM-Klassifikation des lokalisierten Prostatakarzinoms : Die cT-Kategorie entspricht nicht ihren klinischen Erfordernissen.

BACKGROUND: The TNM staging system for localized prostate cancer (PCa) divides tumors based on clinical parameters into a clinical (c)T category and, after radical prostatectomy (RP), a pathological (p)T category. OBJECTIVES: This study examines the extent to which the cT and the pT category correspond to each other and whether the two categories differ in their prediction for organ-confined disease. PATIENTS AND METHODS: Data of 687 RP patients were collected in a prospective, noninterventional, multicenter health service research study for the treatment of localized PCa (HAROW). Group comparisons were performed by analysis of variance and student t­test as well as the chi-squared test or the Fisher exact test. RESULTS: Clinical cT1 category (62.9%) and pathological pT2c category (56.6%) were diagnosed most frequently. The correspondence of cT and pT category was 15% for cT2a , 10.5% for cT2b, and 55% for cT2c. An extraprostatic extension (≥pT3) was observed for the categories cT1 and cT2 in 23.5% and 36.4% (p < 0.001), differences in the subcategories cT2a-c were not significant: cT2a = 28.8%, cT2b = 42.1%, and cT2c = 38.8% (p = 0.194). Tumors with a pathologically extraprostatic extension were not recognized clinically in >50%. CONCLUSIONS: For localized PCa there is low agreement between clinical and pathologic T category, thus, often leading to understaging. An adaptation of the T classification of the TNM system with division into "not palpable" and "palpable" appears sufficient for a prognostic prediction.

[Treatment costs of localized prostate cancer in Germany : Economic results from the HAROW observational study]. / Behandlungskosten des lokal begrenzten Prostatakarzinoms in Deutschland : Ökonomische Ergebnisse der HAROW-Beobachtungsstudie.

BACKGROUND: Prostate cancer (PCa) is the most common cancer in men. For medical treatment of PCa, a number of therapies are available. The economic consequences associated with these individual treatment options in routine care in Germany are unclear so far. METHODS: The present analysis was based on the Germany-wide HAROW observational study, which was conducted from 2008-2013. During this study, all participating physicians and involved patients reported and documented individual health care resource consumption. These data were evaluated in monetary terms stratified by treatment regime (hormone therapy, HT; active surveillance, AS; radiotherapy, RT; radical prostatectomy, RP; watchful waiting, WW). RESULTS: Overall, the data of 2672 patients were available for analysis. Based on the observational study design, the included patient groups were heterogeneous in their baseline characteristics. The annual total costs from the societal perspective were the largest for patient undergoing RP (9254 €; 95 % CI 8353-10,154), mainly driven by the costs for the initial hospital stay for surgery. HT, AS, RT, and WW seem to be comparable in terms of direct costs, ranging from 805 € (95 % CI 154-1455) for WW up to 1115 € (95 % CI 826-1405) for RT. The highest indirect costs were observed for patients receiving RT (3928 €; 95 % CI 0-10,675), which can be justified by the frequent incapacity to work in this patient group. CONCLUSION: The treatment of prostate cancer can lead to significant economic follow-up costs which vary greatly depending on the type of treatment. The analysis indicates a need for the implementation of a long-term health economic study in the future, which will be more suitable to show treatment-specific differences in the temporal occurrence of costs.

Morbidity and mortality after surgery for lower urinary tract symptoms: a study of 95 577 cases from a nationwide German health insurance database.

BACKGROUND: Little real-world data is available on the comparison of different methods in surgery for lower urinary tract symptoms due to benign prostatic obstruction in terms of complications. The objective was to evaluate the proportions of TURP, open prostatectomy (OP) and laser-based surgical approaches over time and to analyse the effect of approach on complication rates. METHODS: Using data of the German local healthcare funds (Allgemeine Ortskrankenkassen (AOK)), we identified 95 577 cases with a primary diagnosis of hyperplasia of prostate who received TURP, laser vaporisation (LVP), laser enucleation (LEP) of the prostate or OP between 2008 and 2013. Univariable logistic regression was used to analyse proportions of surgical approach over time, and the effect of surgical method on outcomes was analysed by means of multivariable logistic regression. RESULTS: The proportion of TURP decreased from 83.4% in 2008 to 78.7% in 2013 (P<0.001). Relative to TURP and adjusting for age, co-morbidities, AOK hospital volume, year of surgery and antithrombotic medication, OP had increased mortality (odds ratio (OR) 1.47, P<0.05), transfusions (OR 5.20, P<0.001) and adverse events (OR 2.17, P<0.001), and lower re-interventions for bleeding (OR 0.75, P<0.001) and long-term re-interventions (OR 0.55, P<0.001). LVP carried a lower risk of transfusions (OR 0.57, P<0.001) and re-interventions for bleeding (OR 0.76, P<0.001), but a higher risk of long-term re-interventions (OR 1.43, P<0.001). LEP had increased re-interventions for bleeding (OR 1.35, P<0.01). Complications were also dependent on age and co-morbidity. Limitations include the lack of clinical information and functional results. CONCLUSIONS: OP has the greatest risks of complication despite a low re-intervention rate. LVP demonstrated favourable results for transfusion and bleeding, but increased long-term re-interventions compared with TURP, while LEP showed increased re-interventions for bleeding. Findings support a careful indication and choice of method for surgery for LUTS, taking age and co-morbidities into account.

[Demographic change: Changes in society and medicine and developmental trends in geriatrics]. / Demografischer Wandel : Veränderungen in Gesellschaft und Medizin und Entwicklungstendenzen in der Geriatrie.

BACKGROUND: Increasing life expectancy means growing numbers of elderly survive the critical age for cardiac and vascular diseases only to later experience cancer and dementia. OBJECTIVES: Of the types of cancer affecting men, prostate cancer continues to be diagnosed early by prostate-specific antigen (PSA) screening. The clinical relevance and quality of life of those affected must be critically judged. Depending on life expectancy, active surveillance (AS) and watchful waiting (WW) will be increasingly used in geriatric patients. Risk stratification as guided by CGA facilitates the therapeutic decisions of urologists and spares metastatic castration-resistant prostate cancer patients from unnecessary and adverse overtreatment. By 2030, approximately 1.8 million people will have dementia. CONCLUSIONS: Thus, in the future, the health care system will have to treat an aging population, which will require the creation of increasing numbers of geriatric hospital departments and cooperative models between geriatrics and other specialties. The future training of medical students and continuing medical education must also be further developed to include aspects on aging. Only in this manner will it be possible to effectively confront the challenges associated with demographic change in the specialty of geriatrics.

[Sexuality in the elderly: The role of the physicians in maintaining sexual health of older men]. / Sexualität im Alter : Die Rolle des Arztes bei der Erhaltung sexueller Gesundheit älterer Männer.

BACKGROUND: Sexuality in the elderly is still a social taboo. A commitment by medical practices to address the topic of sexuality in later life is essential, given that the sexual health is part of the quality of life. OBJECTIVES: Identification of barriers and discourse of effects in the physician's behavior when dealing with the sexuality of older people. MATERIALS AND METHODS: Review and discussion of interdisciplinary literature and social discourse. Compilation of expert opinions. RESULTS: Although the introduction of phosphodiesterase 5 inhibitors led to a removal of taboos concerning erectile dysfunction, the sexuality of older men became narrowed to physiological aspects. The elderly still complain that consultations concerning their sexuality receives too little attention in medical practice. Problems are boundaries of shame and disregard of the sexuality of elderly. CONCLUSIONS: Sexuality in old age will have to become more prominent in medical practices, due to demographic changes and changing self-images of the elderly. The social role of physicians enables straightforward discussions about sexuality. Taking a sexual history and choosing an active approach proved to be practicable to discuss sexual problems with older people.

[Patterns of care of patients with localized prostate cancer in Germany: a health care study with focus on active surveillance]. / Die Versorgung von Patienten mit lokal begrenztem Prostatakarzinom in Deutschland : Active-Surveillance-Ergebnisse einer nicht-interventionellen Versorgungsstudie.

BACKGROUND: To date, evidence on active surveillance (AS) is restricted to protocol-based studies and the current practice pattern outside medical centers is unknown. OBJECTIVES: The goal of this work was to capture the current treatment pattern of AS for localized prostate cancer (PCa) in patients managed by office-based urologists in Germany. MATERIALS AND METHODS: Our cohort consisted of 361 patients included in the AS arm of the HAROW (Hormonal Treatment, Active Surveillance, Radiation Therapy, OP, Watchful Waiting) study, an observational health service study in Germany. Descriptive characteristics and active-treatment-free survival (ATFS), surgical outcomes, and triggers for active treatment were assessed. RESULTS: Currently, only 15% of all patients with localized PCa were treated with AS. At baseline, 83% and 58% of all AS patients met the Chism and PRIAS low-risk criteria, respectively. After a median follow-up of 24 months, no systemic progression was observed, 5 patients died of non-disease-specific causes and active treatment was delivered in 20.5% of all patients. Triggers for active therapy were progression at biopsy (42%), rise in prostate-specific antigen level (27%), medical advice (16%) and patient's preference (10%), respectively. CONCLUSION: Our short-term results indicate that - in the hands of office-based urologists - active surveillance might represent a feasible treatment option for patients with localized PCa. The majority of patients were free of active treatment 2 years after AS initiation. Generally accepted inclusion and progression criteria are lacking and should be developed in order to facilitate and standardize AS in patients with low-risk PCa.

[The HAROW study: an example of outcomes research: a prospective, non-interventional study comparing treatment options in localized prostate cancer]. / Die HAROW-Studie: ein Beispiel für Versorgungsforschung : Prospektive, nicht-interventionelle Studie zur Behandlung des Niedrig-Risiko-Prostatakarzinoms.

BACKGROUND: The HAROW study was initiated to investigate the provision of ongoing medical care for patients with localized prostate cancer in a prospective, noninterventional setting and to investigate treatment options (Hormonal treatment, Active surveillance, Radiotherapy, Operation, Watchful waiting) under real-life conditions. MATERIALS AND METHODS: A total of 3169 patients were enrolled by 259 participating physicians in private practice in Germany. The median follow-up was 28.4 months. At 6-month intervals, the treating physicians reported data on clinical parameters, clinical course of disease, and quality of patient-physician interaction. RESULTS: The highest proportion of patients with low risk tumor was found in the defensive treatment groups (AS and WW). As expected, the AS group showed the highest progression rate. In all, 112 AS patients (23.9%) changed therapeutic strategy, 21 of them upon medical advice in the absence of any signs of progression. Metastases were seen most frequently in the WW group (1.5%). No metastases occurred in AS patients. Medical support in managing the disease reached high scores in all groups, the highest in AS. CONCLUSION: The data enable a differentiated comparative analysis of patient and tumor characteristics of each treatment group. Indication of AS was predominantly consistent with the guideline. The high rate of AS termination based on the physician's recommendation rather than on clinical progression is remarkable, and may be interpreted as a kind of insecurity in dealing with AS. Results regarding communication indicate that patients appreciated being involved in treatment decisions.

[Elderly prostate cancer patients: patient information and shared decision making]. / Der ältere Prostatakrebspatient : Information und Einbezug in die Therapieentscheidung.

INTRODUCTION: Some data exist on information and decision-making preferences of elderly prostate cancer patients but little is known about whether communication needs are being met in urological practice. Therefore, it was the aim of this study to examine the information and shared decision-making experiences of prostate cancer patients over 75 years old. MATERIALS AND METHODS: The HAROW (hormonal therapy, active surveillance, radiation, operation and watchful waiting) study is a prospective, observational study designed to collect clinical data and patient reported outcome of different treatment options for patients newly diagnosed with localized prostate cancer under real conditions. At 6-month intervals general clinical data, PROs (e.g. quality of life, quality of physician-patient interaction) and individual costs are documented. Data from 2,482 patients at 4 time points from T0 (initial diagnosis) to T3 (24 months follow-up) were analyzed. RESULTS: T-tests and χ(2)-tests revealed no significant differences in terms of shared decision-making and information to different treatment options between patients aged over 75 years old and the rest of the sample. Regarding information on self-help groups, rehabilitation options and a second medical opinion, there were significant differences between prostate cancer patient age groups: patients aged over 75 years old received less information on these aspects at all points in time. CONCLUSION: Patients at all ages feel activated by urologists and are informed about different treatment options. However, there is room for improvement in terms of informing especially elderly prostate cancer patients about rehabilitation, second medical opinions and self-help groups. Special information tools and decision aids for prostate cancer patients aged over 75 years old should be developed and implemented to meet the specific information needs.