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Background As individuals with thalidomide embryopathy now reaching their 60's they undergo long-term sequelae of their prenatal damage and experience a wide range of secondary health problems, in particular chronic musculoskeletal pain, movement restrictions, and mental disorders. These health problems are having a negative impact on their life circumstances and their health-related quality of life (HRQOL). Objective The aim of this study was to determine the HRQOL in individuals with thalidomide embryopathy in comparison to individuals of the age-adjusted general population in Germany with and without chronic disease conditions (primary outcome). And, further explore the influence of impairment patterns, pain stage, and mental disorders on physical and mental dimensions of HRQOL (secondary outcome). Methods A cross-sectional survey of 202 individuals with thalidomide embryopathy from North Rhine-Westphalia/Germany was conducted, which gathered information about physical examinations including a standardized determination of the pain stage, a structured psychological interview, and the HRQOL. The final dataset was 186 cases for primary outcome. Results Individuals with thalidomide embryopathy (50.6 years, 55.9% females) show a significantly reduced physical HRQOL comparison to the age-adjusted German population with chronic diseases (physical component score; pcs: 33.4 vs. 45.3, p < .001). In addition, male individuals with thalidomide embryopathy show a significantly reduced mental HRQOL to their male counterparts in this comparison (mental component score; mcs: 45.0 vs. 50.0, p = .005). The subgroup analyses show that individuals with thalidomide embryopathy with quadruple impairment have a significantly lower physical HRQOL than those with hearing loss (pcs: 25.0 vs. 38.5; ci's not overlapping). Second, individuals with thalidomide embryopathy with severe compared to mild stages of pain have significantly poorer levels of physical and mental HRQOL (pcs: 25.8 vs.

Introduction Outpatient parenteral antimicrobial therapy (OPAT) means intravenous administration of antibiotics outside the hospital. The antibiotics are administered at the patient's home. The advantages are the shortening of the inpatient stay, which means that patients can remain in their familiar environment, the reduction of nosocomial infections as well as the reduction of hospital and therapy costs. Nevertheless, OPAT is rarely performed in Germany, despite its international application. Therefore, systematic data on OPAT are not available in Germany. The project objective is to investigate the medical care using OPAT under medical, epidemiological and economic aspects within the framework of the Cologne Network of Infectious Diseases. Methods and analysis Observational study with mixed-methods approach, qualitative analysis to identify physician side factors to assess the attitude of general practitioners in Cologne with regard to possible implementation barriers of an OPAT. Longitudinal analysis of an OPAT patient cohort with respect to clinical and patient-relevant outcomes using descriptive and conclusive statistics. Ethics and dissemination The study has been approved by the Institutional Review Board of the University of Cologne, Germany (19- 1284-1). Written informed consent was obtained from all participants. The results will be submitted for publication in a peer-reviewed journal and presented at one or more scientific conferences.

There is empirical evidence of an association between periodontitis and coronary heart disease (CHD). However, it is uncertain whether periodontal treatment in CHD patients might lead to reduced healthcare costs. This study aims to assess the association between periodontal treatment and healthcare costs in newly diagnosed CHD patients. Data from 21,263 adults who were continuously insured between 2011 and 2016 and who were newly diagnosed with CHD in 2013 were selected from a German claims database. The study population was differentiated by the utilization of periodontal treatment. The average treatment effect (ATE) of periodontal treatment on healthcare costs (total, inpatient, outpatient, drugs) was investigated using weighted Poisson regression models conditional on covariates and is shown as a ratio (of geometric means). Periodontal treatment was documented for 4.7% of the persons in the study population. Newly diagnosed CHD patients showed an ATE of 0.98 for total healthcare cost (95% CI 0.90-1.06), 0.79 for inpatient costs (95% CI 0.61-1.04), and 0.95 for drug costs (95% CI 0.87-1.04). A statistically significant 7% increase in outpatient costs was shown (95% CI 1.01-1.13). Despite a lack of statistical significance in most cases, the study provides evidence of a meaningful decrease in inpatient costs after periodontal treatment. Further studies are needed.

Aim: To assess the potential danger of belated diagnosis or underdiagnosis of cutaneous infraorbital pathologies that are partially or fully covered by face masks worn due to the COVID-19 pandemic.Methods: We evaluated data of 257 patients with infraorbital pathologies presenting at a large tertiary German university center between 04/2020 and 06/2021. This mono-centric, retrospective analysis included descriptive statistics and non-parametric tests.Results: Out of 257 cutaneous infraorbital pathologies, 32 (12.5%) were partially and 20 (7.8%) fully covered by the required face mask. Significantly more patients with lesions that were partially or fully covered came from a single household (p=0.003, Fisher's exact test) with 125 (48.6%) patients reportedly living alone. In patients with multiple periocular pathologies (n = 51, 19.8%), the risk of at least one periocular lesion being covered by the face mask was significantly elevated (p=0.009, Fisher's exact test). As expected, malignant tumors were significantly larger than benign pathologies (largest diameter, malignant median 9.0mm, range 1.3-34.0mm, mean 10.5mm, and benign median 3.0mm, range 1.0-7.0mm, mean 4.3mm, respectively;p<0.001, Mann-Whitney-Utest) and patients presenting with malignant lesions were significantly older (median age 78.4, range 33-93, mean 73.7 years versus median age 57.9, range 18-90, mean 59.8 years, respectively; p<0.001, Mann-Whitney-U test). Additionally, in subgroup analysis, patients with malignant lesions coming from single households were significantly older (p=0.041, Mann-Whitney-U test).Conclusion: For adequate and timely treatment of infraorbital lesions, patients should be examined without their face mask. This is of utmost importance for the elderly (being at greater risk for malignant pathologies) and patients coming from single households. The presence of multiple pathologies must always be excluded. Trial Registration Number: Not applicable.

Annemarie Klingenstein,1 Christina Samel,2 Christoph Hintschich1 1Department of Ophthalmology, Ludwig-Maximilians-University, Klinikum der Universität München, Campus Innenstadt, Munich, D-80336, Germany; 2Institute of Medical Statistics and Computational Biology, Faculty of Medicine, University of Cologne, Cologne, D-50924, GermanyCorrespondence: Annemarie Klingenstein, Tel +49 89 44005 3811, Fax +49 89 44005 5160, Email Annemarie.Klingenstein@med.uni-muenchen.deAim: To assess the potential danger of belated diagnosis or underdiagnosis of cutaneous infraorbital pathologies that are partially or fully covered by face masks worn due to the COVID-19 pandemic.Methods: We evaluated data of 257 patients with infraorbital pathologies presenting at a large tertiary German university center between 04/2020 and 06/2021. This mono-centric, retrospective analysis included descriptive statistics and non-parametric tests.Results: Out of 257 cutaneous infraorbital pathologies, 32 (12.5%) were partially and 20 (7.8%) fully covered by the required face mask. Significantly more patients with lesions that were partially or fully covered came from a single household (p=0.003, Fisher’s exact test) with 125 (48.6%) patients reportedly living alone. In patients with multiple periocular pathologies (n = 51, 19.8%), the risk of at least one periocular lesion being covered by the face mask was significantly elevated (p=0.009, Fisher’s exact test). As expected, malignant tumors were significantly larger than benign pathologies (largest diameter, malignant median 9.0mm, range 1.3– 34.0mm, mean 10.5mm, and benign median 3.0mm, range 1.0– 7.0mm, mean 4.3mm, respectively; p< 0.001, Mann–Whitney-U test) and patients presenting with malignant lesions were significantly older (median age 78.4, range 33– 93, mean 73.7 years versus median age 57.9, range 18– 90, mean 59.8 years, respectively; p< 0.001, Mann–Whitney-U test). Additionally, in subgroup analysis, patients with mal

Objective The aim of the study was to show the frequency, localisation, intensity, quality and degree of chronic pain in people with thalidomide-induced congenital defects (thalidomide embryopathy) and to investigate the association with biopsychosocial factors more closely. Methods A group of 202 people from North Rhine-Westphalia with thalidomide embryopathy were studied for the first time both physically for the pattern of the original damage and also psychiatrically in a structured diagnostic interview (SCID & SCID II). The results were combined with a standardized pain interview ( MPSS) and questionnaires on further pain-related (SF-36, painDETECT) and sociodemographic variables and analysed. In the analysis 167 completed datasets were included. Results The prevalence of pain in the sample population was 94 %. The majority (107, 54.0 %) already showed an advanced stage of chronicity in the MPSS: 63 subjects with Stage II (37.7 %) and 44 with Stage III (26.3 %). In 74 subjects (44.3 %) the PainDetect score showed a possible or neuropathic pain component. The factors that most reliably influenced the chronicity of pain proved to be hip pain (p < 0.001) and also mental health disorders (p = 0.001), above major depression (p < 0.001) and also somatic symptom disorders and substance-related disorders (p = 0.001 in each case). Social variables proved nonsignificant here (p = 0.094 for living alone, p = 0.122 for unemployment, p = 0.167 for lack of college education), as did the care situation (p = 0.191 for care dependency) and the underlying pattern of organ damage (p = 0.229 for damage to hearing, p = 0.764 for dysmelia). Conclusions People with thalidomide defects frequently suffer from a separate pain disorder which can be seen as secondary thalidomide-induced damage and which requires specialized and personalized multimodal pain management.

Musculoskeletal disorders (MSDs) are among the most common cause for reduced work capacity and sick leave. Workplace health promotion programs are often neither tailored to the workplace nor the individual needs of the employees. To counteract lacking intersectional care, this four-year randomized controlled trial (RCT) aimed to investigate the effects of modular coordinating case management (treatment group) compared to supported self-management (control group) on MSD specific sick leave days (routine data), workability (WAI), self-efficacy (self-efficacy scale), and pain (German pain questionnaire, GPQ). The study network comprised 22 companies, 15 company health insurance funds, and 12 pension funds in Germany. Overall, 852 participants (Module A/early intervention: n = 651, Module B/rehabilitation: n = 190, Module C/reintegration: n = 10) participated. Both groups achieved fewer sick leave days, higher workability, and less pain (p < 0.0001) at follow-up compared to baseline. At follow-up, the coordinating case management group showed fewer disability days (GPQ), lower disability scores (GPQ), and lower pain intensities (GPQ) than the supported self-management group (p < 0.05), but no superiority regarding MSD specific sick leave days, workability, nor self-efficacy. Module A showed more comprehensive differences. The accompanying process evaluation shows barriers and facilitators for the implementation of the program, especially in a RCT setting.

Introduction International standards of care require the complete integration of psycho-oncological care into biomedical cancer treatment. The structured integrated, cross-sectoral psycho-oncological programme 'isPO' is aiming to ensure a provision of care in inpatient and outpatient settings according to a stepped-care approach. Up to now, psycho-oncological care is missing regulated and standardised processes to demonstrate the effectiveness. This study protocol describes the process and outcome evaluation that is conducted, along with the isPO study. The programme evaluation is aiming to proof effectiveness, explain potential discrepancies between expected and observed outcomes. Additionally, provide insight into the implementation process, as well as contextual factors that might promote or inhibit the dissemination and implementation of the stepped care programme will be gained. In addition to these measures, a cost-consequence analysis will provide further evidence aimed at integrating psycho-oncological care into primary healthcare. Methods and analysis The evaluation concept is based on a tripartite strategy consisting of a prospective, formative and summative evaluation. To capture all determinants, a concurrent mixed-method design is applied comprising qualitative (interviews and focus groups) and quantitative (standardised questionnaires) surveys of patients and healthcare providers. In addition, analysis of the psycho-oncological care data (isPO care data) and statutory health insurance claims data will be conducted. Primary and secondary data will complement one another (data linkage) to obtain a more comprehensive picture of the effectiveness and implementation of the complex intervention within the isPO study. Ethics and dissemination The study has been approved by the ethics committee of the Medical Faculty of the University of Cologne. For all collected data, the relevant national and European data protection regulations will be considered. All pers

Aim: To assess a profile of uveal melanoma patients at risk of requiring active psychooncological intervention by employing the National Comprehensive Cancer Network (NCCN) distress thermometer. Methods: Multivariate correlation and multiple linear regression analysis of data collected retrospectively from 106 consecutive patients suffering from uveal melanoma. Results: Distress levels correlated with practical (p = 0.01), emotional (p = 0.003) and physical problems (p = 0.001) as well as the total number of issues reported (p < 0.001; ANOVA, respectively). Emotional issues added up to 39% of influence on distress levels. Nervousness, worry and sadness as the most important emotional issues tested correlated significantly with anatomic stage, tumor T-category, metastatic status and time after primary diagnosis and were present more frequently in patients with higher distress levels (p < 0.001, p = 0.002, p = 0.004, respectively, Fisher's exact test). Pre-existing psycho-oncological support was more frequent in metastatic patients and patients with higher anatomic stage tumors (p = 0.008 and p = 0.003; Fisher's exact test). Conclusion: The distress thermometer proved to be useful for rapid assessment of patients requiring active intervention. A higher number of distress items recorded correlated with elevated distress levels. Emotional issues were responsible for the majority of problems. A typical patient profile at risk of developing distress requiring close attention of caregivers includes high anatomic stage, high T-category, presence of metastases and early follow-up. Correct diagnosis and interpretation of distress-levels should help improve the quality of life of uveal melanoma survivors. Trial Registration: Not applicable.

Objectives To assess cancer detection rates of different target-dependent transperineal magnetic resonance (MR)/ultrasonography (US) fusion-guided biopsy templates with reduced number of systematic cores. Patients and Methods Single-centre outcome of transperineal MR/US fusion-guided biopsies of 487 men with a single target MR imaging (MRI) lesion, prospectively collected between 2012 and 2016. All men underwent transperineal targeted biopsy (TB) with two cores, followed by 18-24 systematic sector biopsies (SB) using the Ginsburg protocol. Gleason score >= 7 prostate cancer detection rates for two-core TB, four-core extended TB (eTB), 10- to 20-core saturation TB (sTB) including cores from sectors adjacent to the target, and 14 core ipsilateral TB (iTB) were compared to combined TB+SB. Results Cancer was detected in 345 men and Gleason score 7-10 cancer in 211 men. TB alone detected 67%, eTB 76%, sTB 91% and iTB 91% of these Gleason score 7-10 cancers. In the subgroup of 33 men (7% of cohort) with an anterior >0.5 mL highly suspicious MRI lesion and a prostate volume <= 45 mL, four-core eTB detected 31 of 32 cancers (97%) and all 26 Gleason score 7-10 cancers. Conclusion sTB detected Gleason score 7-10 cancer in 25% more of the men than a two-core TB approach, and in almost as many men (91%) as the 20-26-core combined TB+SB, while needing only 10-20 cores. A four-core extended TB may suffice for large, highly suspicious anterior lesions in small or slightly enlarged prostates.

Annemarie Klingenstein,1 Christina Samel,2 Aylin Garip-Kuebler,1 Siegfried G Priglinger,1 Paul I Foerster1 1Department of Ophthalmology, Ludwig-Maximilians-University, Munich, Germany; 2Institute of Medical Statistics and Computational Biology, Faculty of Medicine, University of Cologne, Cologne, GermanyCorrespondence: Annemarie KlingensteinDepartment of Ophthalmology, Ludwig-Maximilians-University, Klinikum der Universität München, Campus Innenstadt, Mathildenstraße 8, Munich D-80336, GermanyTel +49 89 44005 3811Fax +49 89 44005 5160Email Annemarie.Klingenstein@med.uni-muenchen.deAim: To assess a profile of uveal melanoma patients at risk of requiring active psycho-oncological intervention by employing the National Comprehensive Cancer Network (NCCN) distress thermometer.Methods: Multivariate correlation and multiple linear regression analysis of data collected retrospectively from 106 consecutive patients suffering from uveal melanoma.Results: Distress levels correlated with practical (p = 0.01), emotional (p = 0.003) and physical problems (p = 0.001) as well as the total number of issues reported (p < 0.001; ANOVA, respectively). Emotional issues added up to 39% of influence on distress levels. Nervousness, worry and sadness as the most important emotional issues tested correlated significantly with anatomic stage, tumor T-category, metastatic status and time after primary diagnosis and were present more frequently in patients with higher distress levels (p < 0.001, p = 0.002, p = 0.004, respectively, Fisher’s exact test). Pre-existing psycho-oncological support was more frequent in metastatic patients and patients with higher anatomic stage tumors (p = 0.008 and p = 0.003; Fisher’s exact test).Conclusion: The distress thermometer proved to be useful for rapid assessment of patients requiring active intervention. A higher number of distress items recorded correlated with elevated distress levels. Emoti