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The wash out behavior of focal liver lesions in contrast-enhanced ultrasound plays a central role in tumor classification. Besides hepatocellular carcinomas, other hypervascular tumor entities like renal cell carcinomas may also show a very late wash out, possibly caused by portal-venous tumor vessels. There is need to observe long enough in the late phase in order to classify them correctly.

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PURPOSE: Non-specific low back pain (NLBP) causes an enormous burden to patients and tremendous costs for health care systems worldwide. Frequently, treatments are not oriented to existing guidelines. In the future, digital elements may be promising tools to support guideline-oriented treatment in a broader range of patients. The cluster-randomized controlled "Rise-uP" trial aims to support a General Practitioner (GP)-centered back pain treatment (Registration No: DRKS00015048) and includes the following digital elements: 1) electronic case report form (eCRF), 2) a treatment algorithm for guideline-based clinical decision making of GPs, 3) teleconsultation between GPs and pain specialists for patients at risk for development of chronic back pain, and 4) a multidisciplinary mobile back pain app for all patients (Kaia App). METHODS: In the Rise-uP trial, 111 GPs throughout Bavaria (southern Germany) were randomized either to the Rise-uP intervention group (IG) or the control group (CG). Rise-uP patients were treated according to the guideline-oriented Rise-uP treatment algorithm. Standard of care was applied to the CG patients with consideration given to the "National guideline for the treatment of non-specific back pain". Pain rating on the numeric rating scale was the primary outcome measure. Psychological measures (anxiety, depression, stress), functional ability, as well as physical and mental wellbeing, served as secondary outcomes. All values were assessed at the beginning of the treatment and at 3-month follow-ups. RESULTS: In total, 1245 patients (IG: 933; CG: 312) with NLBP were included in the study. The Rise-uP group showed a significantly stronger pain reduction compared to the control group after 3 months (IG: M=-33.3% vs CG: M=-14.3%). The Rise-uP group was also superior in secondary outcomes. Furthermore, high-risk patients who received a teleconsultation showed a larger decrease in pain intensity (-43.5%) than CG patients (-14.3%). ANCOVA analysis showed that the impact of teleconsultation was mediated by an increased training activity in the Kaia App. CONCLUSION: Our results show the superiority of the innovative digital treatment algorithm realized in Rise-uP, even though the CG also received relevant active treatment by their GPs. This provides clear evidence that digital treatment may be a promising tool to improve the quality of treatment of non-specific back pain. In 2021, analyses of routine data from statutory health insurances will enable us to investigate the cost-effectiveness of digital treatment.

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Objective: The purpose of this study was to find applicable clusters for the development of different treatment pathways in an inpatient multimodal pain-therapy setting based on the multifaceted nature of CLBP. Methods: Based on data of questionnaires (Hospital Anxiety and Depression Scale (HADS), Marburg Questionnaire on Habitual Health Findings (MFHW), quality of life assessment using the Short-Form 12 (SF 12)), a retrospective two-step cluster analysis involving a sample of chronic low back pain (CLBP) patients (N=320) was calculated. Subsequently, the clusters were precisely described and compared on the basis of further data collected during the patients' standard care: pain characteristics, socio-demographic data and the general state of health, psychological variables, therapy intensity, and Diagnosis Related Groups (DRG) data. Results: We found a three-cluster solution: little psychological interference but marginal physical and mental quality of life (Cluster 1); poor well-being, low physical quality of life, and marginal mental quality of life (Cluster 2); and heavy mental strain and marginal physical quality of life (Cluster 3). Conclusions: Similar to previous studies, our results suggest that patients suffering from CLBP differ with regard to the magnitude of mental burden and the presence of physical impairment. These differences ascertain the need for precise targeting of treatment for CLBP. Inpatient pain centers therefore should offer different multimodal therapy pathways and integrate a meaningful triage, taking into account the multifaceted nature of CLBP based on sophisticated knowledge about forms, differences, and relationships among the biopsychosocial components of CLBP.

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BACKGROUND: Even though modern concepts of disease management of unspecific low back pain (LBP) postulate active participation of patients, this strategy is difficult to adapt unless multidisciplinary pain therapy is applied. Recently, mobile health solutions have proven to be effective aides to foster self-management of many diseases. OBJECTIVE: The objective of this paper was to report on the retrospective short-term results of a digital multidisciplinary pain app for the treatment of LBP. METHODS: Kaia is a mobile app that digitalizes multidisciplinary pain treatment and is in the market as a medical product class I. For the current study, the data of anonymized Kaia users was retrospectively analyzed. User data were evaluated for 12 weeks regarding duration of use and effect on in-app user reported pain levels, using the numerical rating scale (NRS), depending on whether LBP was classified as acute, subacute, or chronic back pain according to current guidelines. RESULTS: Data of 180 users were available. The mean age of the users was 33.9 years (SD 10.9). Pain levels decreased from baseline NRS 4.8 to 3.75 for all users at the end of the observation period. Users who completed 4, 8, or 12 weeks showed an even more pronounced decrease in pain level NRS (baseline 4.9 [SD 1.7] versus 3.6 [SD 1.5] at 4 weeks; baseline 4.7 [SD 1.8] versus 3.2 [SD [2.0] at 8 weeks; baseline 4.6 [SD 2.2] versus 2.6 [SD 2.0] at 12 weeks). In addition, subgroup analysis of acute, subacute, or chronic classification revealed no significant main effect of group (P>.30) on the reduction of pain. Conclusions: This retrospective study showed that in a pre-selected population of app users, an app digitalizing multidisciplinary rehabilitation for the self-management of LBP reduced user-reported pain levels significantly. The observed effect size was clinically relevant. Ongoing prospective randomized controlled trials (RCTs) will adjust for potential bias and selection effects. CONCLUSIONS: This retrospective study showed that in a pre-selected population of app users, an app digitalizing multidisciplinary rehabilitation for the self-management of LBP reduced user-reported pain levels significantly. The observed effect size was clinically relevant. Ongoing prospective RCTs will adjust for potential bias and selection effects.

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BACKGROUND: Little is known about ICU physicians' self-confidence and knowledge related to palliative care. Our objective was to investigate self-confidence and knowledge of German ICU physicians related to palliative care, and to assess the impact of work experience, gender, specialty and additional certifications in pain or palliative medicine. METHODS: In a multicentre prospective observational study ICU physicians of ten hospitals were asked to rate their self-confidence and to complete a multiple choice questionnaire for the assessment of knowledge. Beyond descriptive statistics and non-parametric tests for group comparisons, linear regression analysis was used to assess the impact of independent variable on self-confidence and knowledge. Spearman's rank test was calculated. RESULTS: 55% of answers in the knowledge test were correct and more than half of the participants rated themselves as "rather confident" or "confident". Linear regression analysis revealed that an additional certificate in either pain or palliative medicine significantly increased both knowledge and self-confidence, but only 15 out of 137 participants had at least one of those certificates. Relation between self-confidence and the results of the knowledge test was weak (r = 0.270 in female) and very weak (r = -0.007 in male). CONCLUSIONS: Although the questionnaire needs improvement according to the item analysis, it appears that, with respect to palliative care, ICU Physicians' self-confidence is not related to their knowledge. An additional certificate in either pain or palliative medicine was positively correlated to both self-confidence and knowledge. However, only a minority of the participants were qualified through such a certificate.

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ISSUE: In 2012 the German medical licensure regulations (Approbationsordnung) made teaching and assessing the conduction of medical consultations a mandatory part of medical education. A catalogue of learning objectives (LO) based on existing references was developed to assist medical schools in meeting this requirement. METHODS: A body of relevant material was compiled using literature research and surveying experts. Then, in a multiphase Delphi process, this was evaluated and condensed by an interdisciplinary working group in dialogue with external (clinical) experts. Competence levels and examples of clinical application were assigned to enhance implementation. The catalogue was revised by the medical faculties, professional associations and the BVMD. RESULTS: This learning catalogue comprised 116 learning objectives for the specific skills necessary to conducting medical consultations as well as exemplary application contexts. The catalogue proved to be practical in terms of developing curricula and networking at medical schools. DISCUSSION: This catalogue of learning objectives can serve as the basis for developing a sample communication curriculum for use by medical faculties.

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BACKGROUND: In 2009, palliative medicine became an integrated and compulsory part of undergraduate training in Germany by legislation. After a transitional period, all medical faculties were required to provide adequate teaching with an according examination and certification procedure. In parallel, we conducted bi-annual surveys on all medical faculties in Germany to examine for potential discrepancies between the implementation process and their intended consequences on teaching time and content. METHODS: Four consecutive bi-annual surveys (2006, 2008, 2010, 2012) of all 36 medical faculties in Germany were performed, using purposively for this study developed questionnaires. Likert scales and closed questions were analyzed descriptively. RESULTS: Medical Faculty response rate increased from 50 % in 2006 to 88.9 % in 2012. Teaching coordinators in palliative medicine primarily had an anesthesiology or internal medicine background. There was a noted increase over time of the involvement of specialized palliative care units (PCUs) as providing the setting for education. The number of faculties that were able to offer a complete 16 weeks of training in palliative medicine during the "final year" rose steadily. In addition, increased patient-centered teaching formats have been implemented over time. The faculties which offered innovative teaching formats with actors as patients (standardized patient interaction) increased, as did the total number of mandatory examinations. The number of faculties that provided compulsory teaching in a condensed manner within a single academic year increased sharply from 3 of 31 responding faculties in 2010 to 19 of 32 responding faculties in 2012. CONCLUSIONS: Until now, teaching conditions and structures in palliative medicine in Germany have proven to be extraordinarily heterogeneous. Although professorships ("Chairs") in palliative medicine proved to be particularly beneficial and supportive in curricular and structural development, only a minority of faculties provide leading academic positions in palliative medicine.

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Decades after the publication of the World Health Organization's analgesic ladder, cancer pain is still a major cause of suffering for patients with cancer and affects millions of people worldwide. Owing to the increasing incidence of cancer, cancer-related pain is a major public health problem worldwide. Unfortunately, current research revealed that available options for the successful treatment of cancer pain is still massively underutilized by physicians, and many patients suffer from insufficiently controlled pain despite available treatment options. This review aims to present a concise update about new data or treatment recommendations from the field of cancer pain management. Therefore, information from guidelines, systematic reviews, and original articles that were published in the year 2012 are presented. Specifically, the publication covers information on tapentadol, fixed oxycodone/naloxone combinations, rapid onset fentanyl, nabiximols, ketamine, denusomab, and specialized psychosocial interventions including early palliative care.

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BACKGROUND: By law in 2013, palliative medicine will be integrated into the undergraduate curriculum as part of a mandatory training program and examinations at German medical schools. For this reason a national curriculum in palliative medicine has to be developed. AIM: The aim of this study was to analyze international undergraduate curricula in palliative medicine, and thus support further curriculum development in Germany. DESIGN: Available international curricula were sought through general search engines (Google, Medline/Pubmed) in German and/or the English language. We used the palliative care education assessment tool (PEAT) for analysis of available curricula. The PEAT comprises 7 domains, and 83 objectives. RESULTS: We identified 17 international undergraduate curricula on palliative medicine. There was a wide variation in curricular design. Mapping the curricula, the results showed that five of the seven PEAT domains were represented in the curricula retrieved. Sixteen objectives were included in more than 75% and 46 objectives in up to 50% of the curricula, respectively. Eighteen objectives were included in less than 25% of the curricula. Three PEAT objectives were absent in all curricula examined. CONCLUSION: There is an overlap between objectives presented in the PEAT and in the curricula, suggesting that there are "core objectives" such as "respect for differing values," "bereavement process," and "use of opioids" which might be mandatory for undergraduate palliative medical education.

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OBJECTIVE: Simulations of doctor-patient interactions have become a popular method for the training of medical skills, primarily communication skills. A new questionnaire for the measurement of students' satisfaction with medical courses using this technique is presented, the Student Evaluation Scale for Medical Courses with Simulations of the Doctor-Patient Interaction (SES-Sim). METHOD: A set of items focusing on the course quality and the core elements of simulations was created and presented to 220 medical students who had been trained with this method. RESULTS: Based on factor-analyses 18 items were selected for the final version of the scale, which represent five dimensions: learning success, actors, premises, tutors and students. The five dimensions are all significantly correlated with a 1-item-measure of the general satisfaction with the course. CONCLUSION: The SES-Sim enables tutors to assess in an economic way whether the course has met the students' needs and what can be done better.

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BACKGROUND: In the last week of life, the daily opioid dose in children is highly variable, making the use of patient-controlled analgesia (PCA) a useful therapy option. Scientific data on the use of PCA in paediatric palliative care are rare. MATERIALS AND METHODS: Retrospective chart review over a 7-year period (Jan 1998-Jan 2005) of PCA treated children dying of cancer was used. RESULTS: Eight children were on PCA for a median duration of 9 days (range, 1 to 50). The daily median intravenous morphine equivalent dose referenced to body weight increased significantly when PCA was initiated and during the last week of life. In the last week of life, the median daily number of delivered and undelivered bolus requests ranged from 7.5-21 and 0-4.5, respectively. To meet children's individual needs, 39 PCA parametre changes on 22 opportunities were performed. Median daily mean pain scores remained low (range, 0-3; numerical rating scale 0-10) throughout the period. CONCLUSION: PCA proved an ideal, dependable and feasible mode of analgesic administration for the individual titration of dose to effect.

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INTRODUCTION: Studies on opioid use in terminally ill cancer patients have shown a prefinal dose increase in the majority of patients. Mostly oral opioids were used. Due to the pharmacokinetic properties of opioids, it is rather difficult to get a reliable estimate of the true opioid need from those results. MATERIALS AND METHODS: Retrospectively, we analyzed opioid use during the last week of life of 30 consecutive outpatients with cancer on intravenous (i.v.) morphine patient-controlled analgesia (PCA). A dose increase (decrease) was defined as an increase (decrease) of the patient's individual daily dose by at least 30% with respect to their prior daily dose. We also analyzed circadian variations in morphine use. RESULTS: Thirty patients fulfilled the primary study inclusion criteria. Fulfilling the exclusion criteria, seven patients had to be excluded from analysis (n = 3, on PCA for less than 7 days; n = 4, PCA was finished before death). Twenty-three patients with a total of 161 treatment days were analyzed. The patients' median age was 57 years (range, 4 to 72). The median duration of intravenous morphine PCA was 19 days (range, 8 to 58). The median daily intravenous morphine dose during the last week of life was 96 to 115 mg, without significant change over time/from day to day (Friedman test). On 144/161 days (89.2%), morphine dose remained stable. On 9 treatment days (5.6%), the dose increased, and on 8 days (5.0%), it decreased. In three patients, only dose increases, and in four patients, only dose decreases were observed. In four patients, both dose increases and decreases were observed. Twelve patients showed no change in daily morphine dose. Opioid use lacked a diurnal pattern. CONCLUSION: During their end-of-life phase, cancer patients on i.v. morphine PCA showed a stable daily opioid need.

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GPI 15715 is the first water-soluble propofol prodrug that has been studied in humans. Present propofol lipid formulations have well known undesirable properties, for example, pain on injection and increased triglyceride concentrations. We investigated whether GPI 15715 is suitable to achieve and maintain moderate sedation for 2 h. Six male and six female volunteers received a target-controlled infusion of GPI 15715, with an initial propofol target concentration of 1.8 microg/mL and the possibility to adjust the propofol target once after 1 h. Propofol concentrations, the bispectral index, and modified Observer's Assessment of Alertness/Sedation Scale (MOAA/S) scores were monitored. The median MOAA/S score was 4 during the first hour and was 3 during the second hour of infusion. The propofol target had to be changed to 2.4 microg/mL in seven volunteers and to 3.0 microg/mL in two volunteers. A propofol concentration of 1.9 microg/mL had the highest probability to result in an MOAA/S score of 3, which corresponds with moderate sedation. We observed no serious side effects. We conclude that GPI 15715 produces excellent sedation.

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BACKGROUND: GPI 15715 is a new water-soluble prodrug that is hydrolyzed to release propofol. The objectives of this crossover study in volunteers were to investigate the pharmacokinetics and pharmacodynamics of GPI 15715 in comparison with propofol emulsion. METHODS: In two separate sessions, nine healthy male volunteers (19-35 yr, 70-86 kg) received GPI 15715 and propofol emulsion as a target controlled infusion over 60 min. In the first 20 min, the propofol target concentration increased linearly to 5 microg/ml. Subsequently, the targets were reduced to 3 microg/ml and 1.5 microg/ml for 20 min each. The plasma concentrations of GPI 15715 and propofol were measured from arterial and venous blood samples up to 24 h and pharmacokinetics were analyzed. The pharmacodynamic effect was measured by the median frequency of the power spectrum of the electroencephalogram, and a sigmoid model with effect compartment was fitted to the data. RESULTS: Compared with propofol emulsion, propofol from GPI 15715 showed a different disposition function and especially larger volumes of distribution. The propofol effect site concentration for half maximum effect was 2.0 +/- 0.5 microg/ml for GPI 15715 and 3.0 +/- 0.7 microg/ml for propofol emulsion (P < 0.05). Propofol from GPI 15715 did not show a hysteresis between plasma concentration and effect. CONCLUSIONS: Compared with propofol emulsion, propofol from GPI 15715 showed different pharmacokinetics and pharmacodynamics, particularly a higher potency with respect to concentration. These differences may indicate an influence of the formulation.

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BACKGROUND: GPI 15715 (AQUAVAN injection) is a new water-soluble prodrug which is hydrolyzed to release propofol. The objectives of this first study in humans were to investigate the safety, tolerability, pharmacokinetics, and clinical pharmacodynamics of GPI 15715. METHODS: Three groups of three healthy male volunteers (aged 19-35 y, 67-102 kg) received 290, 580, and 1,160 mg GPI 15715 as a constant rate infusion over 10 min. The plasma concentrations of GPI 15715 and propofol were measured from arterial and venous blood samples up to 24 h. Pharmacokinetics were analyzed with compartment models. Pharmacodynamics were assessed by clinical signs. RESULTS: GPI 15715 was well tolerated without pain on injection. Two subjects reported a transient unpleasant sensation of burning or tingling at start of infusion. Loss of consciousness was achieved in none with 290 mg and in one subject with 580 mg. After 1,160 mg, all subjects experienced loss of consciousness at propofol concentrations of 2.1 +/- 0.6 microg/ml. A two-compartment model for GPI 15715 (central volume of distribution, 0.07 l/kg; clearance, 7 ml. kg-1 min-1; terminal half-life, 46 min) and a three-compartment model for propofol (half-lives: 2.2, 20, 477 min) best described the data. The maximum decrease of blood pressure was 25%; the heart rate increased by approximately 35%. There were no significant laboratory abnormalities. CONCLUSIONS: Compared with propofol lipid emulsion, the potency seemed to be higher with respect to plasma concentration but was apparently less with respect to dose. Pharmacokinetic simulations showed a longer time to peak propofol concentration after a bolus dose and a longer context-sensitive half-time.

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