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Purpose: This study aimed to describe the real-world treatment of German incident COPD patients, compare that treatment with clinical guidelines, and provide insight into disease development after incident diagnosis. In addition, the economic burden of the disease by assessing COPD-related healthcare costs was described., Patients and Methods: Based on a German claims dataset, continuously insured individuals (04/2014-03/2019) aged 40 years or older with at least two incident pulmonologist's diagnoses or one inpatient diagnosis of COPD (ICD-10-GM code J44.-; no respective diagnosis in a 12-month baseline period) were selected. Treatment patterns after incident diagnosis considering inhaled maintenance therapies identified by ATC codes (outpatient prescriptions) were analyzed. Prescription patterns were compared with recommendations of German COPD treatment guidelines. Severe exacerbations were assessed as hospitalizations with main diagnosis ICD-10-GM code J44.1. COPD-associated costs from the perspective of the health insurance fund AOK PLUS were calculated per patient-year (PY)., Results: The sample comprised 17,464 incident COPD patients with a mean age of 71.5 years. 58.9% were male and the mean Charlson-Comorbidity-Index was 5.3. During follow-up (median: 2.0 years), 57.1% of the patients received at least one prescription of an inhaled maintenance therapy, whereas 42.9% did not. Among treated patients, 35.2% started their treatment with LABA/LAMA, 25.3% with LAMA monotherapy, 16.2% with LABA/ICS, and 7.8% with LABA/LAMA/ICS therapy. Within four weeks after initial diagnosis, ICS-containing therapies were prescribed in 14.1% of patients. Of all patients with a prescribed triple therapy, 68.9% had no corresponding exacerbation history documented. On average, 0.16 severe exacerbations and 0.19 COPD-related hospitalizations were observed per PY during available follow-up. Direct COPD-related costs were 3,693 €/PY, with COPD-related hospitalizations being responsible for about 79.2% of these costs., Conclusion: Long-acting bronchodilators are the mainstay of pharmacological treatment of incident COPD patients in Germany, in line with guideline recommendations. Yet, a considerable proportion of incident COPD patients did not receive any inhaled maintenance therapy., Competing Interests: Professor Roland Buhl reports personal fees from AstraZeneca, Berlin-Chemie, Chiesi, Cipla, Sanofi, teva, and grants from Boehringer Ingelheim, GSK, Novartis, and Roche outside the submitted work. Professor Thomas Wilke reports grants from GSK and Cytel during the conduct of the study and grants from Pfizer, Janssen, and Apontis outside the submitted work. Nils Picker and Dr Olaf Schmidt have no conflicts of interest to disclose. Dr Marlene Hechtner and Dr Anke Kondla are employees of Boehringer Ingelheim Pharma GmbH & Co. KG. Professor Claus F Vogelmeier reports personal fees from Aerogen, Insmed, Menarini, and Nuvaira; and grants from AstraZeneca, Boehringer Ingelheim, CSL Behring, Chiesi, GlaxoSmithKline, Grifols, and Novartis outside the submitted work. The authors report no other conflicts of interest in this work., (© 2022 Buhl et al.)

Purpose: The objective of this study was to assess the clinical and cost benefits of treating patients with chronic obstructive pulmonary disease (COPD) according to global and national guidelines compared to real-life clinical practice in the United States and three European countries (Belgium, Germany, Sweden)., Patients and Methods: A cost-consequence model was developed to compare current prescribing patterns with two alternative scenarios, the first aligned with the Global Initiative for Chronic Obstructive Lung Disease (GOLD 2022) recommendations and the second with national guidelines. Costs and clinical outcomes were modeled for these alternative scenarios over a time horizon of one year, based on real-world evidence and health insurance data., Results: Current clinical practice in each of the countries was inconsistent with published recommendations. A redistribution to prescribing patterns according to global and national recommendations led to a substantial decrease in the use of inhaled corticosteroid (ICS) containing therapies of more than 80% and 44%, respectively. There was a reduced incidence of up to 16% of mild-to-moderate pneumonia and up to 29% of severe pneumonia. Exacerbations decreased across all countries apart from Sweden, where a small increase in the rate of exacerbations was due to the redistribution of some patients currently undergoing inhaled triple therapy to non-ICS-containing therapies. Adapting treatment to recommendations could provide potential cost savings of up to 13% in estimated annual direct costs, resulting predominantly from the reduction in cost of healthcare resource use, including hospitalization associated with treating incident pneumonia, particularly severe pneumonia. Cost savings for prevalent adult patients with COPD on long-acting inhaler therapy ranged from €31 to €675 per patient per year., Conclusion: Redistribution of COPD patients from current clinical practice to treatment according to published recommendations would provide clinical benefits and substantial cost savings., Competing Interests: AW, SL, CW: received consulting fees from Boehringer Ingelheim and are affiliated with Maverex. BC, ESHG, MH: employees of Boehringer Ingelheim. SS reports consulting fees and/or honoraria from AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Nuvaira, Pulmotect, Aerogen and Cornerstone, grants from Theravance, Regeneron and Sanofi all outside the submitted work. RB reports personal fees from AstraZeneca, Chiesi, Cipla, Sanofi, and Teva, as well as grants and personal fees from Boehringer Ingelheim, GlaxoSmithKline, Novartis, and Roche, all outside the submitted work. The authors report no other conflicts of interest in this work., (© 2022 Sethi et al.)

Objective: This study aims to identify pathways patients and their relatives take to outpatient psychosocial cancer counselling centres. We had a special interest in how access for men can be eased., Methods: Cancer patients and relatives were purposively sampled in two regions in Germany. Participants were either outpatient cancer counselling centres (OCCCs) users or non-users and participated in qualitative face-to-face interviews. We used different guidelines for users and non-users. The interviews were analysed using content analysis., Results: One hundred and three people participated in the study. Important pathways to outpatient psychosocial cancer counselling centres for both men and women were: information about the service and its content, easy access (obtaining appointments quickly and without bureaucracy, close to home), and recommendations from another person, in particular from their treating physician. Pathways especially important for men are positive and repeated recommendations from their treating physician and other people they trust, organisation by others on the men's behalf, the Internet, the possibility to talk to a male counsellor, making it a routine in the hospital to refer distressed patients to the counselling services, and the emphasis on information sharing. Women reported more often than men that they discovered and accessed OCCCs via information material., Conclusions: Men in particular need recommendations from others, especially from their treating physician, in order to make use of psychosocial cancer counselling. In addition, stressing the provision of information instead of exploring and expressing emotions can ease access for men to cancer counselling., (© 2022 The Authors. Psycho-Oncology published by John Wiley & Sons Ltd.)

Purpose: To investigate the work situation of lung cancer survivors and to identify the factors associated with their returning to work., Methods: Descriptive analysis and logistic regression were used to evaluate study population characteristics and independent factors of subsequently returning to work. To analyze time to return to work, Cox regression was used., Results: The study sample included 232 lung cancer survivors of working age from 717 enrolled participants in the multi-center cross-sectional LARIS (Quality of Life and Psychosocial Rehabilitation in Lung Cancer Survivors) study. About 67% of the survivors were not employed during the survey. More than 51% of the survivors who were employed before their illness did not return to their work. The survivors who had returned to their careers were younger, associated with higher household income, lower fatigue score, and stable relationship and vocational training. Patients who received social service counseling showed a higher chance of regaining their career., Conclusions: Lung cancer survivors were found to be associated with a high risk of unemployment and very low professional reintegration after interruption due to illness. More comprehensive studies are needed to support lung cancer survivors and targeting of patients in need of special attention in rehabilitation that would benefit from the findings in the present study.

Background: Glaucomatous eyes often show strong intraocular pressure (IOP) fluctuations and individual measurements at different time points are necessary for personalized therapy. To survey IOP variations 48-hours diurnal and nocturnal IOP measurements were performed on two consecutive days. Aims of this study were to investigate the short-term repeatability of 48-hours measurements within one patient's IOP profile and long-term repeatability between two separate IOP profiles of the same patient., Methods: A retrospective cohort study was performed evaluating data of 90 glaucoma patients in a German university medical center between 2006 and 2013. All patients underwent two separate diurnal IOP profiles of 48 h. IOP was measured at 8 am, 2 pm, 6 pm, 9 pm using Goldmann applanation tonometry and at 12 midnight using Perkins tonometry in supine position on two consecutive days. Intraclass correlation coefficients (ICC) were calculated to evaluate agreement for the same time points (each time point agreement) and for consecutive measurements within the IOP profiles (between time point agreement). ICC ≤ 0.4 was defined as poor agreement, 0.4-0.75 as moderate and ≥ 0.75 as excellent. Differences between time points were investigated by Bland Altman plots., Results: Each time point measurements of profile 1 showed moderate to excellent agreement (ICCs 0.62-0.93). There was a moderate to excellent agreement for measurements between time points of profile 1 (ICCs day one 0.57-0.86, day two 0.71-0.90). Profile 2 was performed at a median interval of 12.0 months (quartiles 11.0 to 21.0). Each time point agreements within profile 2 showed ICCs from 0.23 to 0.81. It showed moderate to excellent agreement for changes between time points (ICCs 0.53-0.94). Day two demonstrated ICCs from 0.74 to 0.88. Long term IOP repeatability (over both pressure profiles) showed moderate to good agreement (ICCs 0.39-0.67)., Conclusions: Short and long-term agreement of IOP measurements evaluated by diurnal IOP profiles is moderate to good. Due to mostly moderate agreements, which we believe represent IOP fluctuations, we conclude that it is necessary to perform 48-hours IOP profiles to gain a better overview of the individual IOP fluctuations.

Background and Purpose: Preserving health related quality of life (HRQOL) plays an important role in considering stereotactic body fractionated radiotherapy (SBRT). The prospective monocenter phase II STRIPE trial investigated long-term HRQOL after SBRT, efficacy and toxicity., Materials and Methods: Patients with ≤2 pulmonary lesions ≤5 cm were treated with 4DPET/CT-based SBRT (3 × 12.5 Gy or risk-adapted 5 × 7 Gy, to 60% isodose). Follow up (FU) was performed 2 and 7 weeks after SBRT, then 3-monthly for 2 years with assessment of response (primary endpoint: 2-year cumulative incidence of local progression (LP); secondary endpoints: local progression free survival (LPFS), overall survival (OS) and toxicity (CTCAE)). Impact of predefined patient and treatment related factors on HRQOL (EORTC QLQ-C30 and EORTC QLQ-LC13) was evaluated., Results: Between 02/2011 and 11/2014, 100 patients were given SBRT for 56 NSCLC and 44 pulmonary metastases (M1). Long-term FU overall revealed stable Quality of Life (QoL)/Global health status (GHS), functions-scores and symptoms. For QoL/GHS, patients with low (

Background: The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13) assesses quality of life (QOL) in patients with lung cancer and was the first EORTC module developed for use in international clinical trials. Since its publication in 1994, major treatment advances with possible effects on QOL have occurred. These changes called for an update of the module and its international psychometric validation. We aimed to investigate the scale structure and psychometric properties of the updated lung cancer module, QLQ-LC29, in patients with lung cancer., Methods: This international, observational field study was done in 19 hospitals across 12 countries. Patients aged older than 18 years with a confirmed diagnosis of lung cancer and no other previous primary tumour, and who were mentally fit with sufficient language skills to understand and complete the questionnaire were included. Patients were asked during a hospital visit to fill in the paper versions of the core questionnaire EORTC QLQ-C30 plus QLQ-LC29, and investigators selected half of these patients to complete the questionnaire again 2-4 weeks later. Our primary aim was to assess the scale structure and psychometric properties of EORTC QLQ-LC29. We analysed scale structure using confirmatory factor analysis; reliability using Cronbach's α value (internal consistency) and intra-class coefficient (test-retest reliability); sensitivity using independent t tests stratified by Karnofsky performance status; and responsiveness to change over time by ANOVA. This study is registered with ClinicalTrials.gov, NCT02745691., Findings: Between April 12, 2016, and Sept 26, 2018, 523 patients with a confirmed diagnosis of either non-small-cell lung cancer (n=442) or small-cell lung cancer (n=81) were recruited. Confirmatory factor analysis provided a solution composed of five multi-item scales (coughing, shortness of breath, fear of progression, hair problems, and surgery-related symptoms) plus 15 single symptom or side-effect items: χ 2 =370·233, root mean square error of approximation=0·075, and comparative-fit index=0·901. Cronbach's α for internal consistencies of all multi-item scales were above the threshold of 0·70. Intra-class coefficients for test-retest reliabilities ranged between 0·82 and 0·97. Three (shortness of breath, fear of progression, and hair problems) of the five multi-item scales showed responsiveness to change over time (p values <0·05), as did nine of 15 single symptom items. Four (coughing, shortness of breath, fear of progression, and surgery-related symptoms) of the five multi-item scales and ten of the 15 single symptom items were sensitive to known group differences (ie, lower vs higher Karnofsky performance status)., Interpretation: Results determined the psychometric properties of the updated lung cancer module, which is ready for use in international clinical studies., Funding: EORTC Quality of Life Group., (Copyright © 2020 Elsevier Ltd. All rights reserved.)

Objective: To evaluate the perception of esthetic orthodontic appliances by means of eye-tracking measurements and survey investigation., Materials and Methods: En face and close-up images with different orthodontic appliances (aligner appliance [a], aligner appliance and attachments [b], lingual appliance [c], ceramic brackets [d], no appliance [e; control]) were shown to 140 participants. Eye movement and gaze direction was recorded by eye-tracking system. For different anatomical areas and areas of the appliances, time to first fixation and total fixation time were recorded. The questions included in a visual analog scale regarding individual sentiency were answered by the participants., Results: For all groups, the anatomical landmarks were inspected in the following order: (1) eyes, (2) mouth, (3) nose, (4) hair, and (5) ears. Only in group d, first fixation was on the mouth region (1.10 ± 1.05 seconds). All appliances except the lingual appliance (1.87 ± 1.31 seconds) resulted in a longer fixation on the mouth area (a, 2.97 ± 1.32 seconds; b, 3.35 ± 1.38 seconds; d, 3.29 ± 1.36 seconds). For close-up pictures, the fastest (0.58 seconds) and longest (3.14 seconds) fixation was found for group d, followed by group b (1.02 seconds/2.3 seconds), group a (2.57 seconds/0.83 seconds), and group c (3.28 seconds/0.05 seconds). Visual analog scale scoring of questions on visibility were consistent with eye-tracking measurements. With increasing visibility, the feeling of esthetic impairment was considered higher., Conclusions: Lingual orthodontic appliances do not change how the face is perceived. Other esthetic orthodontic appliances may change the pattern of facial inspection and are different in subjective perception.

Purpose: Little is known about the use of psychosocial services in lung cancer survivors and patients who have survived the diagnosis for at least one year. We investigated the frequency of use, stratified by radiation therapy received, its associated factors, and the reasons for non-use of those services., Methods: We performed a multicenter (n = 6 hospitals) cross-sectional study using data from medical records, patient reported questionnaires, and computer-assisted telephone interviews. Odds ratios (OR) for factors potentially associated with the use of any type of psychosocial services were calculated using multivariable logistic regression., Results: We included 604 lung cancer patients/survivors. Of them, 60% (69% of those who had received radiotherapy) had used some kind of psychological and/or social service in the past (47% psychological, 42% social); 39% had used inpatient care, 24% outpatient care (cancer counselling center, general counselling center, psychological counselling by family doctor, psychotherapy, patient support group, pastoral work). Of those who visited a rehabilitation clinic, 66% received psychosocial care there. Factors associated with using psychosocial services in general were female gender (OR 1.96, 95% CI 1.32-2.93), poor emotional functioning (per unit decrease: OR 0.99, 95% CI 0.98-0.996), and younger age (per year decrease: OR 0.95, 95% CI 0.93-0.97)., Conclusions/implications: The high proportion of psychosocial care users among lung cancer survivors in Germany indicates that patients are interested in using it and that an unmet need exists. The creation of a broad spectrum of easily accessible services with high quality is important to enable and facilitate use.

Background: Percutaneous therapy with various sclerosants is an established treatment of venous malformations in general. We investigated the safety and effectiveness of polidocanol in the craniofacial region., Purpose: To present and evaluate our subjective and objective mid- and long-term results of patients with craniofacial venous malformations (CFVM) after percutaneous sclerotherapy using polidocanol., Material and Methods: Twenty patients with CFVM treated by percutaneous sclerotherapy were followed up and asked to fill in a questionnaire comparing levels of the following CFVM-related symptoms before and after treatment: pain; functional impairment; cosmetic deformities; and impairment in daily life. Additionally, both size reduction as well as procedural-related complication rates were analyzed., Results: Evaluation of the questionnaire revealed an improvement or complete relief of CFVM-related symptoms with significant reduced impairment in daily life after percutaneous sclerotherapy. Eighteen (90%) patients noticed a post-sclerotherapy improvement of at least one of their corresponding symptoms and expressed satisfaction with regard to their treatment. For 13 patients, a > 50% size reduction of the CFVM could be observed, while seven exhibited a < 50% size reduction. One minor complication was encountered in 56 treatment sessions (1.8%)., Conclusion: Percutaneous sclerotherapy using polidocanol is a well-tolerated treatment for CFVM with a low complication rate. Size reduction and positive results with improvement of different clinical symptoms can be achieved.

Introduction: The objective was to assess quality of life (QoL) in lung cancer survivors, compare it to the general population, and identify factors associated with global QoL, physical functioning, emotional functioning, fatigue, pain, and dyspnea., Methods: Data from NSCLC patients who had survived 1 year or longer after diagnosis were collected cross-sectionally in a multicenter study. QoL was assessed with the European Organisation for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 and the lung cancer module QLQ-LC13 across different clinical subgroups and compared to age- and sex-standardized general population reference values. Multivariable linear regression analyses were performed to test the associations of patient-, tumor-, and treatment-related factors with the six primary QoL scales., Results: Six hundred fifty-seven NSCLC patients participated in the study with a median time since diagnosis of 3.7 years (range, 1.0-21.2 years). Compared to the age- and sex-standardized general population, clinically meaningful differences in the QoL detriment were found on almost all domains: lung cancer survivors had clinically relevant poorer global QoL (10 points, p < 0.001). Whereas in 12 months or longer treatment-free patients this detriment was small (8.3), it was higher in patients currently in treatment (16.0). Regarding functioning and symptom scales, respective detriments were largest for dyspnea (41 points), role function (33 points), fatigue (27 points), social function (27 points), physical function (24 points), and insomnia (21 points) observed across all subgroups. The main factor associated with poorer QoL in all primary QoL scales was mental distress (β |19-31|, all p < 0.001). Detriments in QoL across multiple primary QoL scales were also observed with current treatment (β |8-12|, p < 0.01), respiratory comorbidity (β |4-5|, p < 0.01), and living on a disability pension (β |10-11|, p < 0.01). The main factor associated with better QoL in almost all primary QoL scales was higher physical activity (β |10-20|, p < 0.001). Better QoL was also observed in patients with high income (β |10-14|, p < 0.01)., Conclusions: Lung cancer survivors experience both functional restrictions and symptoms that persist long term after active treatment ends. This substantiates the importance of providing long-term supportive care., (Copyright © 2018 International Association for the Study of Lung Cancer. Published by Elsevier Inc. All rights reserved.)

Introduction: Quality of life (QoL) of comorbid patients with pulmonary malignancies is a key issue in considering fractionated stereotactic body radiotherapy (SBRT) indication. This study investigates the early impact of SBRT on QoL., Methods: One hundred patients with pulmonary lesions were treated with SBRT from February 2011 to December 2014 within the prospective, monocenter, phase II STRIPE trial. The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core module (EORTC QLQ-C30) and the QLQ-LC13 lung cancer-specific questionnaire were used to evaluate QoL before, 2 and 7 weeks after SBRT, then every 3 months for 2 years. We report on the analysis of early changes from baseline to 7-week follow-up exam. Impact of patient- and treatment-related factors on the change in QoL was analyzed., Results: QoL was assessed in 97 patients; compliance was 92% and 85% at baseline and 7 weeks after SBRT, respectively. No clinically relevant changes greater than or equal to 10 in the QoL/global health status (GHS), function scores and inquired symptoms were observed. Patients with baseline QoL below the median showed clinically relevant improvement in QoL/GHS (Δ16.7 ± 25.3, p = 0.003), emotional function (Δ14.4 ± 25.4, p = 0.013), and fatigue (Δ -10.1 ± 26.5, p = 0.089) in contrast to patients with high initial scores. No changes were observed in the dichotomized subgroups of initial Karnofsky index, Charlson Comorbidity Index, age, diagnosis, and tumor localization., Conclusions: In short-term follow-up, QoL is well maintained after pulmonary SBRT. Especially patients with low initial QoL/GHS scores show benefit from SBRT with respect to QoL., (Copyright © 2018 International Association for the Study of Lung Cancer. Published by Elsevier Inc. All rights reserved.)

Objectives: Most studies identifying inflammatory markers for early detection of colorectal cancer (CRC) were conducted using clinically manifest cases. We aimed to identify circulating inflammatory biomarkers for early detection of CRC and validate them in both a clinical setting and a true screening setting., Study Design and Setting: A total of 92 inflammatory proteins were quantified in baseline plasma samples from individuals clinically diagnosed with CRC and neoplasm-free controls matched on age and sex (training set). A multimarker panel was selected and evaluated in samples from another clinical setting (validation set C) and a screening setting (validation set S)., Results: In the training set (N = 330), a five-biomarker signature was selected that provided an area under curve (AUC) of 0.85 and 60.9% sensitivity to detect CRC at 90% specificity. When this algorithm was applied to validation set C (N = 318), the AUC (0.80) and sensitivity (49.5%) at 90% specificity for CRC diagnosis were only slightly lower than those in the training set. By contrast, the diagnostic performance of the algorithm in validation set S (N = 126) from a true screening setting was much poorer, with an AUC of 0.59 and a sensitivity of 28.6% at 90% specificity., Conclusions: An inflammation-related protein panel with apparently good diagnostic properties for CRC detection was identified and confirmed in an independent clinical validation set. However, the biomarker combination performed substantially worse in a validation sample from a true screening setting. Our results underline the importance of validation in screening settings subsequently to novel signature discovery for cancer early detection., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Guidelines recommend early colonoscopy for individuals with a positive family history of colorectal cancer (CRC), but little is known about the utilization of colonoscopy and the frequency of colorectal neoplasms among younger affected individuals in Germany. The aim of this study was to determine the utilization of colonoscopy and the frequency of colorectal neoplasms in this risk group. We conducted a cross-sectional study in a general practice setting. Patients aged 40-54 years with at least one first-degree relative with CRC were identified, counseled on their increased risk, and referred to colonoscopy if they decided to undergo this procedure. We assessed the reported utilization of colonoscopy before study participation with a questionnaire and obtained results of colonoscopies performed during the study period from colonoscopy reports. Out of 484 patients with a positive family history of CRC, 191 (39.5%) fulfilled the inclusion criteria and participated in the study: 54% reported that at least one colonoscopy had been performed before study participation. Out of 191 participants, 86 (45%) underwent a colonoscopy during study period. No CRC was found, but 16.3% had any adenoma, and 7.0% had advanced adenomas. Overall, 155 (82%) study participants underwent a colonoscopy either before or during the study period. The utilization of colonoscopies among participants was remarkably high even before study participation. This rate increased up to 82% after counseling by general practitioners. A relevant number of participants had (advanced) adenomas. It appears worthwhile to involve general practitioners in identifying and counseling younger individuals with familial risk for CRC.

Background: Patient-reported outcomes are of high importance in clinical neuro-oncology. However, assessment is still suboptimal. We aimed at exploring factors associated with the probability for a) drop out of study and b) death during follow-up., Methods: Patients were assessed twice during follow-up visits scheduled within 3 to 5 months of each other by using 3 validated patient-reported outcome measures (t1: first assessment, t2: second assessment). As "death" was seen as a competing risk for drop out, univariate competing risk Cox regression models were applied to explore factors associated with dropping out (age, gender, WHO grade, living situation, recurrent surgery, Karnofsky Performance Status, time since diagnosis, and patient-reported outcomes assessed by Distress Thermometer, EORTC-QLQ-C30, EORTC-QLQ-BN20, and SCNS-SF-34G)., Results: Two hundred forty-six patients were eligible, 173 (70%) participated. Patients declining participation were diagnosed with glioblastomas more often than with other gliomas (56% vs 39%). At t2, 32 (18%) patients dropped out, n = 14 death-related, n = 18 for other reasons. Motor dysfunction (EORTC-QLQ-BN20) was associated with higher risk for non-death-related drop out (HR: 1.02; 95% CI, 1.00-1.03; P = .03). Death-related drop out was associated with age (HR: 1.09; 95% CI, 1.03-1.14; P = .002), Karnofsky Performance Status (HR: 0.92; 95% CI, 0.88-0.96; P < .001), lower physical functioning (EORTC-QLQ-C30; HR: 0.98; 95% CI, 0.96-1.00; P = .04) and lower motor functioning (EORTC-QLQ-BN20; HR: 1.020; 95% CI, 1.00-1.04; P = .02)., Conclusion: Patients with motor dysfunction and poorer clinical condition seem to be more likely to drop out of studies applying patient-reported outcome measures. This should be taken into account when planning studies assessing glioma patients and for interpretation of results of patient-reported outcome assessments in clinical routine.

Introduction: Short-stem THA has become increasingly popular over the last decade. However, implantation technique differs from conventional THA and thus possibly involves a distinct learning curve. The purpose of this study was to evaluate the value of intraoperative radiography and the influence of the surgeon's experience on intraoperative adjustments in short-stem THA., Methods: A total of 287 consecutive short-stem THAs, operated by a total of 24 senior consultants, consultants and residents in training, were prospectively included. Intraoperative radiography was performed after trial reduction. Preoperative planning and intraoperative outcome with regard to positioning, sizing of components as well as resulting offset and leg length were compared. Frequency, reason and type of intraoperative adjustments were documented in relation to the surgeon's experience. Operation time was assessed., Results: One hundred and fifty-six (54.4%) procedures were carried out by one of three senior consultants, and a total of nine consultants and 12 residents in training performed 105 (36.6%) and 26 (9.0%) operations, respectively. In 121 cases (42.2%), intraoperative adjustments were made following intraoperative radiography. Intraoperative adjustments of one or more components were made by senior consultants in 51 cases (32.7%), by consultants in 53 cases (50.5%) and by residents in 17 cases (65.4%), respectively. The most common cause was undersizing of the stem. Operation time varied markedly between groups of surgeons., Discussion: Short-stem THA involves a learning curve. Intraoperative radiography is decisive for prevention of malpositioning and undersizing of components, as well as loss of offset and leg length discrepancies. Hence, it should be considered mandatory, especially for less experienced surgeons.

Background and Purpose: To evaluate the quality of life (QoL) of patients with inoperable non-small cell lung cancer treated with conventionally fractionated radiotherapy (CF) vs. continuous hyperfractionated accelerated radiotherapy weekend-less (CHARTWEL)., Material and Methods: The largest monocentric subgroup of the phase III CHARTWEL trial was analyzed up to three years after randomization. QoL was assessed with the European Organization for Research and Treatment of Cancer QoL Core Questionnaire (QLQ-C30) and lung cancer module (QLQ-LC13) and compared using linear mixed models. QoL interrelations with recurrence, metastasis, and death were explored by multi-state modeling., Results: 160 patients (98%) provided at least one QoL assessment. Average treatment differences of CF vs. CHARTWEL over three years were -5.4 points (95%CI [-13.6,2.8], p = 0.19) in global QoL, 11.9 ([2.8,21.0], p = 0.01) in fatigue, 13.4 ([3.5,23.3], p = 0.009) in pain, 10.5 ([1.3,19.6], p = 0.03) in dyspnea, and 5.2 ([-2.7,13.0], p = 0.19) in dysphagia. At 12 months, the probabilities of being disease-free with good, good or moderate, any global QoL, or alive were 5.1%, 20.3%, 34.2%, 54.4% under CF and 10.4%, 21.0%, 37.5%, 65.3% under CHARTWEL., Conclusions: Over three years, QoL was similar or more favorable under CHARTWEL compared to CF. Modeling QoL together with disease states provided additional insight into treatment comparisons., (Copyright © 2017 Elsevier B.V. All rights reserved.)

Aim: To present the long-term angiographic and subjective results of patients with head and neck arteriovenous malformations (HNAVMs) after endovascular treatment., Methods: We retrospectively analyzed the medical files of 14 patients with HNAVM who were treated between 2000 and 2014. The treatment of choice was a transarterial superselective microcatheter-based approach followed by embolization using liquid embolic agents. The patients were asked to answer a quality of life questionnaire about the following symptoms before and after treatment: pain, functional impairment, cosmetic deformity, impairment in daily life, and bleeding., Results: Complete or >90% closure of the AVM was achieved in 6 of 14 patients (43%). >50% shunt reduction was achieved in 10 patients (71%). Three complications were encountered in a total of 86 interventional procedures. Six patients presented with bleeding which was cured in all cases (100%). Four of the 14 patients (29%) specified pain which was resolved in two of them. Another six patients (43%) presented with functional impairment; four were cured and two noted an improvement. All 14 patients presented with cosmetic concerns; four were cured and eight experienced a clearly visible improvement. Nine of 13 patients (69%) presented with impairment in daily life which was resolved in five patients and four reported an improvement., Conclusions: Endovascular embolization is a well-tolerated therapy for HNAVM with a low complication rate. Good angiographic results, positive subjective results, and improvement in different aspects of quality of life can be achieved., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.)

Objective of this study aimed at assessing glioma patients' supportive care needs in a neurosurgical outpatient setting and identifying factors that are associated with needs for support. In three neuro-oncological outpatient departments, glioma patients were assessed for their psychosocial needs using the Supportive Care Needs Survey short-form (SCNS-SF34-G). Associations between clinical, sociodemographic, treatment related factors as well as distress (measured with the distress thermometer) and supportive care needs were explored using multivariable general linear models. One-hundred and seventy three of 244 eligible glioma patients participated, most of them with primary diagnoses of a high-grade glioma (81%). Highest need for support was observed in 'psychological needs' (median 17.5, range 5-45) followed by 'physical and daily living needs' (median 12.5, range 0-25) and 'health system and information needs' (median 11.3, range 0-36). Needs in the psychological area were associated with distress (R 2  = 0.36) but not with age, sex, Karnofsky performance status (KPS), extend of resection, currently undergoing chemotherapy and whether guidance during assessment was offered. Regarding 'health system and information needs', we observed associations with distress, age, currently undergoing chemotherapy and guidance (R 2  = 0.31). In the domain 'physical and daily living needs' we found associations with KPS, residual tumor, as well as with distress (R 2  = 0.37). Glioma patients in neuro-oncological departments report unmet supportive care needs, especially in the psychological domain. Distress is the factor most consistently associated with unmet needs requiring support and could serve as indicator for clinical neuro-oncologists to initiate support.

Introduction: Heterotopic ossification (HO) is known to be a common complication after total hip arthroplasty (THA). The minimal invasive (MIS) modified anterolateral approach has become popular in combination with a short stem. We analysed the incidence of HO following short-stem THA using this approach in combination with a postoperative administration of nonsteroidal anti-inflammatory drugs (NSAIDs)., Materials and Methods: 216 short stems were implanted in 162 patients. NSAIDs were administered for 2 weeks after surgery in 154 patients (95.1%). Standardised pre- and postoperative radiographic imaging was done at 2-year follow-up. HO was analysed according to the Brooker classification. Influence of age, gender, body mass index (BMI), and blood transfusion were analysed. Harris Hip Score (HHS) and visual analogue scale (VAS) of satisfaction were assessed. Operation time and blood-transfusion rate was documented. Short-term gastrointestinal side effects were recorded., Results: The overall incidence of HO was 7.8% (16 cases). HO Brooker type 3 and 4 occurred in only 1 case (0.5%). No correlation with age, gender or BMI was revealed. HHS improved largely from 45.8 (SD 15.9) before surgery to 98.1 (SD 4.7) after a minimum of 2 years. At that point VAS satisfaction was 9.7 (SD 0.9). Mean operative time was 45.8 minutes (SD 18.7). 12 patients (7.4%) received at least 1 blood-transfusion. Gastrointestinal side effects occurred in 13 of 154 patients (8.4%)., Conclusions: The combination of short-stem THA, the MIS modified anterolateral approach and a postoperative application of NSAIDs resulted in the effective prevention of HO and excellent clinical results.

Background: Evidence on the frequency of a positive family history of colorectal cancer (CRC) among individuals aged <55 years is lacking. General practice setting might be well suited for the identification of individuals in this above-average risk group., Objective: To determine the frequency of a reported positive family history of CRC among patients aged 40 to 54 years in a general practice setting., Methods: We conducted a cross-sectional study in 21 general practices in Germany. Patients aged 40 to 54 years were identified by means of the practice software and interviewed by health care assistants using a standardized four-item questionnaire. Outcome was occurrence of a positive family history of CRC, defined as at least one first-degree relative (FDR: parents, siblings, or children) with CRC. Further measurements were FDRs with CRC / colorectal polyps (adenomas) diagnosed before the age of 50 and occurrence of three or more relatives with colorectal, stomach, cervical, ovarian, urethel or renal pelvic cancer., Results: Out of 6723 participants, 7.2% (95% confidence interval [CI] 6.6% to 7.8%) reported at least one FDR with CRC and 1.2% (95% CI 0.9% to 1.5%) reported FDRs with CRC diagnosed before the age of 50. A further 2.6% (95% CI 2.3% to 3.0%) reported colorectal polyps in FDRs diagnosed before the age of 50 and 2.1% (95% CI 1.8% to 2.5%) reported three or more relatives with entities mentioned above., Conclusion: One in 14 patients reported at least one FDR with CRC. General practice should be considered when defining requirements of risk-adapted CRC screening., (© The Author 2016. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

The association between health-related quality of life (HRQoL), psychosocial distress, and supportive care is in the focus of patient-centered neuro-oncology. We investigated the relationship between the aforementioned in glioma-patients to evaluate the association of these instruments and determine cut-off values for suitable HRQoL scales indicating a potential need for intervention. In an observational multi-center study, outpatients completed the Distress Thermometer (DT), EORTC Quality of Life Questionnaire (EORTC-QLQ-C30/BN20, HRQoL), and Supportive-Care-Needs-Survey-SF34-G (SCNS). Based on nine EORTC-function and selected -symptom scales items of the questionnaires were matched. Convergent validity of related single items and scores across the instruments was estimated. EORTC cut-off values were calculated. Data of 167 patients were analyzed. The strongest correlation of EORTC-QLQ-C30 and DT was found for cognitive function (cogf), global health status (GHS), emotional (emof), role function (rolef), future uncertainty (FU), fatigue, and between EORTC-QLQ-C30 and SCNS for FU, emof, rolef (r = |0.4-0.7|; p < 0.01). EORTC cut-off values of <54.2 (GHS/QoL) and <62.5 (emof) predicted a DT ≥ 6 (AUC 0.79, 0.85, p < 0.01). EORTC cut-off values of <70.8 (emof) and <52.8 (FU) predicted the need for supportive care (AUC 0.78, 0.85; p < 0.01). Worse EORTC-C30 scores correlate with higher DT and SCNS scores. With this exploratory assessment, cut-off values for EORTC-C30 subscores to predict distress and pathological SCNS-scores could be determined, which could influence patients' referral to further treatment. However, further prospective clinical trials are needed to confirm the clinical relevance of these cut-off values.

Introduction: Balloon angioplasty and/or selective intra-arterial vasodilator therapies are treatment options in patients with vasospasm after subarachnoid hemorrhage (SAH). We analyzed the effect of balloon angioplasty and/or selective intra-arterial vasodilator therapy in our patients., Methods: Twenty-six patients (vasodilation group, VDT) were treated with intra-arterial nimodipine. The balloon angioplasty with nimodiopine-group (BAP-N group) comprised 21 patients. The primary endpoint of this study was successful angiographic vessel dilation in vasospastic vessels after balloon angioplasty, together with nimodipine (BAP-N group), compared to intra-arterial vasodilator therapy (VDT group) with nimodipine alone., Results: A significant effect of angioplasty plus nimodipine was found in the central arteries (composite endpoint) with an OR of 2.4 (95% CI: 1.4-4.2], p = 0.002), indicating a chance of improvement of the BAP-N group of more than twice compared to nimodipine infusions alone. Significant advantages for BAP-N-therapy were also encountered in the internal carotid artery (OR 5.4, p < 0.001) and basilar artery (OR 29.7, p = 0.003). A joint analysis of all arteries combined failed to show significant benefit of BAP-N therapy (OR 1.5, p = 0.079), which was also true for cerebral peripheral arteries (OR 0.77, p = 0.367). There was no difference in clinical outcome between both groups., Conclusions: In SAH patients with vasospasm, a combination therapy of balloon angioplasty and intra-arterial nimodipine resulted in a more than doubled vasodilative effect in the central cerebral arteries compared to the sole infusion of nimodipine. Regarding the ICA and BA arteries, this beneficial effect was even more pronounced. Although there was a tendency of better effects of the BAP-N group, regarding the overall effect in all territories combined, this failed to reach statistical evidence. In cerebral peripheral arteries, no differences were observed, and there was no difference in clinical outcome, too.

Background: Although the risk of developing colorectal cancer (CRC) is 2-4 times higher in case of a positive family history, risk-adapted screening programs for family members related to CRC- patients do not exist in the German health care system. CRC screening recommendations for persons under 55 years of age that have a family predisposition have been published in several guidelines. The primary aim of this study is to determine the frequency of positive family history of CRC (1st degree relatives with CRC) among 40-54 year old persons in a general practitioner (GP) setting in Germany. Secondary aims are to detect the frequency of occurrence of colorectal neoplasms (CRC and advanced adenomas) in 1st degree relatives of CRC patients and to identify the variables (e.g. demographic, genetic, epigenetic and proteomic characteristics) that are associated with it. This study also explores whether evidence-based information contributes to informed decisions and how screening participation correlates with anxiety and (anticipated) regret., Methods/design: Prior to the beginning of the study, the GP team (GP and one health care assistant) in around 50 practices will be trained, and about 8,750 persons that are registered with them will be asked to complete the "Network against colorectal cancer" questionnaire. The 10% who are expected to have a positive family history will then be invited to give their informed consent to participate in the study. All individuals with positive family history will be provided with evidence-based information and prevention strategies. We plan to examine each participant's family history of CRC in detail and to collect information on further variables (e.g. demographics) associated with increased risk. Additional stool and blood samples will be collected from study-participants who decide to undergo a colonoscopy (n ~ 350) and then analyzed at the German Cancer Research Center (DKFZ) Heidelberg to see whether further relevant variables are associated with an increased risk of CRC. One screening list and four questionnaires will be used to collect the data, and a detailed statistical analysis plan will be provided before the database is closed (expected to be June 30, 2015)., Discussion: It is anticipated that when persons with a family history of colorectal cancer have been provided with professional advice by the practice team, there will be an increase in the availability of valid information on the frequency of affected individuals and an increase in the number of persons making informed decisions. We also expect to identify further variables that are associated with colorectal cancer. This study therefore has translational relevance from lab to practice., Trial Registration: German Clinical Trials Register DRKS00006277.

Objectives: Class III therapy using a face mask is a common approach for treatment of a deficient maxilla and reverse overbite. Usually, maxillary protraction is combined with transverse palatal expansion using intraoral appliances. The purpose of this study was to systematically review the effectiveness of face mask therapy in combination with concepts of palatal expansion and compression., Material and Methods: A systematic review and meta-analysis were performed to identify studies that address class III treatment using a face mask. The search was carried out using common electronic databases as well as hand search. Both screening and study eligibility analysis were performed with consideration of PRISMA and Cochrane Guidelines for systematic reviews. Several terms describing class III face mask treatment were searched. Particular attention was paid to new strategies of enhancing maxillary protraction., Results: The initial search identified 2048 studies. After a thorough selection process, a total of 22 articles met the inclusion criteria. After assessment of the individual quality scoring of each article, eight studies were provided for meta-analysis of the cephalometric parameters. The statistical analysis of treatment changes advocates a positive influence on sagittal maxillary development, which is not primarily influenced by transverse expansion. Dental side effects are more distinct when no expansion was carried out. For the concept of alternating activation/deactivation of the expansion appliance (alt-RAMEC), two articles of high methodological scoring were identified. They indicate an enhancement of face mask treatment., Conclusions: The findings are consistent with results of previous literature studies regarding the efficiency of class III face mask treatment. A further need for more randomized controlled studies was identified especially with regard to the new concept of alternating maxillary expansion and compression, which showed a positive influence on the maxillary protraction based on two studies., Clinical Relevance: Class III therapy using extraoral face mask anchorage is effective for maxillary protraction. The recently discussed new protocols potentially improve this treatment.

Aims: Epidemiological studies suggest the existence of a relationship between aircraft noise exposure and increased risk for myocardial infarction and stroke. Patients with established coronary artery disease and endothelial dysfunction are known to have more future cardiovascular events. We therefore tested the effects of nocturnal aircraft noise on endothelial function in patients with or at high risk for coronary artery disease., Methods: 60 Patients (50p 1-3 vessels disease; 10p with a high Framingham Score of 23%) were exposed in random and blinded order to aircraft noise and no noise conditions. Noise was simulated in the patients' bedroom and consisted of 60 events during one night. Polygraphy was recorded during study nights, endothelial function (flow-mediated dilation of the brachial artery), questionnaires and blood sampling were performed on the morning after each study night., Results: The mean sound pressure levels L eq(3) measured were 46.9 ± 2.0 dB(A) in the Noise 60 nights and 39.2 ± 3.1 dB(A) in the control nights. Subjective sleep quality was markedly reduced by noise from 5.8 ± 2.0 to 3.7 ± 2.2 (p < 0.001). FMD was significantly reduced (from 9.6 ± 4.3 to 7.9 ± 3.7%; p < 0.001) and systolic blood pressure was increased (from 129.5 ± 16.5 to 133.6 ± 17.9 mmHg; p = 0.030) by noise. The adverse vascular effects of noise were independent from sleep quality and self-reported noise sensitivity., Conclusions: Nighttime aircraft noise markedly impairs endothelial function in patients with or at risk for cardiovascular disease. These vascular effects appear to be independent from annoyance and attitude towards noise and may explain in part the cardiovascular side effects of nighttime aircraft noise.

Background: Little is known about the relationship between specific subtypes of treatment-associated motor complications and different domains of health-related Quality of Life (QoL) in patients with Parkinson's disease (PD). Larger studies that investigate these aspects within a cross-cultural setting are scarce., Objective: To assess QoL and its association with on-off fluctuations, peak-dose dyskinesias, biphasic dyskinesias, and off-dystonias in PD patients from five European countries., Methods: Data from 817 PD patients were collected cross-sectionally in France, Germany, Italy, Spain, and the UK. QoL was measured with the generic EuroQoL 5-Dimension questionnaire (EQ-5D) and the disease-specific Parkinson's Disease Questionnaire-39 (PDQ-39). Multivariable linear regression analyses were performed to test the associations of motor complication subtypes with QoL., Results: Thirty-three percent of the patients (varying from 23% in Italy to 58% in France) suffered from motor complications, either a single subtype or a combination of different subtypes. On-off fluctuations were associated with a 7.1 percentage point decrease in the EQ-5D (p < 0.001) and a 3.6 percentage point deterioration in the PDQ-39 (p = 0.01). Dyskinesias were not seen to affect global QoL scores, but had detrimental effects on the PDQ-39 dimensions activities of daily living, cognitions, stigma, and bodily discomfort. Patients from Spain, Italy, and France had lower global QoL scores in the multivariable analyses than patients from Germany and the UK., Conclusion: Motor complications, primarily on-off fluctuations, may impact QoL in PD patients. This substantiates the importance of clinical strategies targeting the prevention, delay of onset, and management of motor complications in PD patients., (Copyright © 2014 Elsevier Ltd. All rights reserved.)

Introduction: This study determined the amount and severity of EARR (external apical root resorption) after orthodontic treatment with self-ligating (SL) and conventional (Non-SL) brackets. Differences regarding rate of extraction cases, appointments and treatment time were evaluated., Material and Methods: 213 patients with a mean age of 12.4 ± 2.2 years were evaluated retrospectively. The treatments were performed with SL brackets (n = 139, Smartclip, 3 M Unitek, USA) or Non-SL brackets (n = 74, Victory Series, 3 M Unitek, USA). Measurements of the crown and root length of the incisors were taken using panoramic radiographs. Three-factor analysis of variance (ANOVA) was performed for an appliance effect., Results: There was no difference between patients treated with Non-SL or SL brackets regarding the amount (in percentage) of EARR (Non-SL: 4.5 ± 6.6 vs. SL: 3.0 ± 5.6). Occurrence of severe EARR (sEARR) did also not differ between the two groups (Non-SL 0.5 vs. SL: 0.3). The percentage of patients with need of tooth extraction for treatment (Non SL: 8.1 vs. SL: 6.9) and the number of appointments (Non-SL: 12.4 ± 3.4 vs. SL: 13.9 ± 3.3) did not show any differences. The treatment time was shorter with Non-SL brackets (Non-SL: 18.1 ± 5.3 vs. SL: 20.7 ± 4.9 months)., Conclusions: This is the largest study showing that there is no difference in the amount of EARR, number of appointments and extraction rate between conventional and self-ligating brackets. For the first time we could demonstrate that occurrence of sEARR does not differ between the two types of brackets.