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Background: The Sarcoma Policy Checklist was created by a multidisciplinary expert group to provide policymakers with priority areas to improve care for sarcoma patients.Main Body: This paper draws on this research, by looking more closely at how France, Germany, Italy, Spain, Sweden and the United Kingdom are addressing each of these priority areas. It aims to highlight key gaps in research, policy and practice, as well as ongoing initiatives that may impact the future care of sarcoma patients in different European countries. A pragmatic review of the published and web-based literature was undertaken. Telephone interviews were conducted in each country with clinical and patient experts to substantiate findings. Research findings were discussed within the expert group and developed into five core policy recommendations. The five identified priority areas were: the development of designated and accredited centres of reference; more professional training; multidisciplinary care; greater incentives for research and innovation; and more rapid access to effective treatments. Most of the countries studied have ongoing initiatives addressing many of these priorities; however, many are in early stages of development, or require additional funding and resources.Conclusion: Gaps in access to quality care are particularly concerning in many of Europe's lower-resourced countries. Equitable access to information, clinical trials, innovative treatments and quality specialist care should be available to all sarcoma patients. Achieving this across Europe will require close collaboration between all stakeholders at both the national and European level. [ABSTRACT FROM AUTHOR]

Background: Intensive care units (ICUs) are often too noisy, exceeding 70–80 dBA, which can have negative effects on staff. The corresponding recommendation of the World Health Organization (average sound pressure level below 35 dBA) is often not achieved. To date there is a lack of intervention studies examining the extent to which unit-based noise management in ICUs contributes to a reduction in noise exposure for the staff. The study therefore aims to provide answers to 1) how unit-based noise management sustainably reduces the subjective noise exposure among staff, and 2) how this intervention affects other noise-related topics. Methods: We performed a monocentric prospective longitudinal study with three measurement points in a German university hospital in three ICUs. We collected data from different healthcare professionals and other professional groups between October 2021 and August 2022 using an online questionnaire. Data were analyzed using descriptive and inference statistics. Results: A total of n = 179 participants took part in the surveys. The majority of participants were nurses or pediatric nurses. Most participants worked more than 75% full-time equivalent. Staff on the three ICUs reported high levels of noise exposure. No significant changes in noise exposure over time were observed. Participants were already aware of the topic and believed that a behavior change could positively influence the noise environment. Conclusions: This study provides an initial insight into how a unit-based noise management could contribute to a reduction in the subjective noise exposure among staff in ICUs. The results of this study highlight the importance of this topic. Future studies should aim to research aspects of adherence and their facilitators or barriers, which promote the sustained implementation of noise-reducing measures by staff. Trial registration: German Clinical Trials Register (DRKS): DRKS00025835; Date of registration: 12.08.2021. [ABSTRACT FROM AUTHOR]

The COVID-19 pandemic led to psychological distress among children and adolescents. Due to multiple psychosocial burdens, the youth in residential care were especially exposed to an increased risk of mental health problems during the pandemic. In a multi-center, single-arm feasibility trial, N = 45 children and adolescents aged 7–14 years were allocated to a 6-week blended care intervention, conducted in six outpatient residential child welfare facilities. The intervention covered a once weekly face-to-face group session for guided creative (art therapy, drama therapy) and movement-oriented (children's yoga, nature therapy) activities. This was accompanied by a resilience-oriented mental-health app. Feasibility and acceptance analyses covered app usage data and qualitative data. Effectiveness was determined by pre-post comparisons in quantitative data on psychological symptoms and resources. Further, subgroups for poorer treatment outcome were explored. The intervention and app were considered to be feasible and were accepted by residential staff and the children. No significant pre-post changes were found across quantitative outcomes. However, being female, being in current psychosocial crisis, a migration background, or a mentally ill parent were correlated with change in score of outcomes from baseline. These preliminary findings pave the way for future research on blended care interventions among at-risk children and adolescents. [ABSTRACT FROM AUTHOR]

Dance therapy and dance theatre are innovative interventions for patients with a chronic disease such as cancer. In this pilot study we investigate both how dance theatre as a supportive intervention may influence the mental health and quality of life of male cancer survivors and how participants experience this type of intervention. We used a pre-post design with two points of measurement based on a mixed-methods approach including quantitative and qualitative data. The sample (N = 16) included male cancer survivors and men indirectly affected by cancer. The results show that the level of distress and depressive symptoms slightly improved during the project. Anxiety symptoms showed a significant reduction. The results of the interviews revealed positive effects of the dance project in terms of coping with late effects, physical strengthening, emotional disclosure and developing personal empowerment and increased self-esteem. The results are preliminary and encourage validation in future studies. [ABSTRACT FROM AUTHOR]

Clinical trials for the treatment of schizophrenia now often include cognitive assessments in addition to clinical ratings of symptoms. Recently, these trials have included cross-national assessments. It is not clear if translated psychological tests produce consistent results across different languages. This paper presents the results of a study of the comparability of the results of cognitive assessments in different English-speaking countries and a number of countries where tests were translated into other languages. Performance on tests of executive functioning, verbal and visuo-spatial learning and memory, language skills, psychomotor speed, and vigilance was compared across the first episode patients with schizophrenia (n=301) assessed in six different languages (English, French, Finnish, German, Hebrew, and Afrikaans), including two different countries where patients were assessed in English and other languages: Canada (French) and South Africa (Afrikaans). The variance in performance across the sites tested in English was as large as the variance between English and non-English speakers when all tests were considered. Performance differences across English and other languages were found only for executive functions, vigilance, and psychomotor speed, with executive functioning differences nonsignificant when education was considered. No differences were found between English and non-English speakers in Canada. These results suggest that the translation of tests of memory and verbal skills can lead to consistent results across translated versions of the tests. Differences between countries were greater than differences between languages, suggesting the need to consider representativeness of patient samples in terms of local educational attainment. In general, these data support the validity of cross-national neuropsychological assessments. [Copyright &y& Elsevier]

Mantle cell lymphoma (MCL) is a non-Hodgkin's lymphoma with an often aggressive course, incurable by chemotherapy. Consolidation with high-dose therapy and autologous stem cell transplantation (autoSCT) has a low transplant-related mortality but does not lead to a survival plateau. Allogeneic stem cell transplantation (alloSCT) is associated with a higher early mortality, but can cure MCL. To investigate alloSCT for therapy of MCL, we conducted two prospective trials for de novo MCL (OSHO#74) and for relapsed or refractory MCL (OSHO#60). Fifteen and 24 patients were recruited, respectively. Induction was mainly R-DHAP alternating with R-CHOP. Conditioning was either Busulfan/Cyclophosphamide or Treosulfan/Fludarabin. Either HLA-identical siblings or matched-unrelated donors with not more than one mismatch were allowed. ATG was mandatory in mismatched or unrelated transplantation. Progression-free survival (PFS) was 62% and overall survival (OS) was 68% after 16.5-year follow-up. Significant differences in PFS and OS between both trials were not observed. Patients below 56 years and patients after myeloablative conditioning had a better outcome compared to patients of the corresponding groups. Nine patients have died between day +8 and 5.9 years after SCT. Data from 7 long-term surviving patients showed an excellent Quality-of-life (QoL) after alloSCT. AlloSCT for MCL delivers excellent long-term survival data. The early mortality is higher than after autoSCT; however, the survival curves after alloSCT indicate the curative potential of this therapy. AlloSCT is a standard of care for all feasible patients with refractory or relapsed MCL and should offer to selected patients with de novo MCL and a poor risk profile. For defining the position of alloSCT in the therapeutic algorithm of MCL therapy, a randomized comparison of autoSCT and alloSCT is mandatory. [ABSTRACT FROM AUTHOR]

Background: Cancer-related fatigue represents one major cause of reduced quality of life in cancer patients and can seriously affect the physical, emotional, and cognitive functioning impeding coping with the disease. Options for effective treatment of cancer-related fatigue are limited, consisting only of non-pharmacologic interventions like physical activity, psychosocial, and mind-body interventions. Recent evidence suggests that vitamin D3 supplementation might alleviate cancer-related fatigue. However, confirmation in a randomized controlled trial is needed.Methods: In this multicenter, randomized, double-blind, placebo-controlled trial, 456 colorectal cancer (CRC) patients aged 18 years and older are being recruited in three German rehabilitation clinics. Study inclusion requires hospitalization of at least 3 weeks at such a clinic, a diagnosis of non-metastatic CRC (stage I-III), surgical removal of the tumor within the past 9 months, and season-adapted vitamin D insufficiency or deficiency. Eligible patients are randomly assigned to a personalized regimen of vitamin D3 or placebo for 12 weeks. In the intervention group, a loading dose of 20,000 or 40,000 IU vitamin D3 will be administered daily during the first 11 days, followed by a maintenance dose of 2000 IU daily. Patients will complete questionnaires for secondary outcomes (fatigue subdomains, quality of life and subdomains, depression, functional well-being, and infection frequency). Blood and urine samples will be collected for analyses of safety parameters (hypervitaminosis D, hypercalcemia, hypercalciuria, and renal impairment) and efficacy biomarkers (25-hydroxyvitamin D, HbA1c, white blood cell count, leukocyte subtype counts, serum C-reactive protein, uric acid, creatinine, triglycerides, total, low- and high-density lipoprotein cholesterol).Discussion: This trial tests whether a personalized vitamin D3 dosing regimen reduces or prevents fatigue among non-metastatic CRC patients by treating the underlying vitamin D deficiency/insufficiency. If efficacy can be confirmed, personalized vitamin D3 supplementation could be used as a tertiary prevention measure in addition to non-pharmacological treatments of cancer-related fatigue in CRC patients. We expect to detect an effect of vitamin D3 supplementation on secondary outcomes like quality of life, depression, functional well-being, infections, inflammatory biomarkers, diabetes mellitus, and dyslipidemia.Trial Registration: European Clinical Trials Database: EudraCT-No: 2019-000502-30, January 21, 2019; German Clinical Trials Register (DRKS): DRKS00019907 , April 30, 2019. [ABSTRACT FROM AUTHOR]

Purpose: This study aims to provide insights into the impact of organizational family-centered care characteristics at German neonatal intensive care units (NICUs) on the satisfaction of parents of very low birthweight (VLBW) infants.Materials and methods: Using multilevel modeling, this study analyzed whether organizational characteristics of NICUs fostering parent-infant interaction (by way of the existence of a recreation room, possibility of rooming in, existence of unrestricted visiting hours for parents, existence of parental classes, and the connection to parent associations as well as the existence of standards on developmentally supportive care) increase the satisfaction of parents after the infants' high-intensive care phase within the NICU.Results: Nine hundred and twenty-three VLBW infants from 66 NICUs in Germany born between May and October 2013 were enrolled in this multicenter study. We retrieved 1493 questionnaires completed by 1277 parents. The existence of unrestricted visiting hours (adjusted odds ratio (AOR): 1.967; 95% CI [1.118, 3.459]) and standardized procedures for developmentally supportive care (AOR: 1.775; 95% CI [1.166, 2.704]) were positively associated with parental satisfaction.Conclusions: Fostering the parent-infant interaction through the provision of developmentally supportive care and unrestricted visiting hours for parents whose infants are hospitalized within an NICU significantly contributes to the satisfaction of parents. [ABSTRACT FROM AUTHOR]

Background: The objective of the IMPROVE study was patients' preference for either endocrine-based therapy or combined chemo- and anti-angiogenic therapy in advanced HR-positive/HER2-negative breast cancer.Methods: In this randomized, cross-over phase IV study, 77 patients were recruited in 26 sites in Germany. Patients were randomized 1:1 to receive either capecitabine plus bevacizumab (Cap+Bev) as first-line therapy followed by cross-over to everolimus plus exemestane (Eve+Exe) as second-line therapy (Arm A) or the reverse sequence (Arm B). The primary endpoint was patients' preference for either regimen, assessed by the Patient Preference Questionnaire 12 weeks after cross-over. Key secondary endpoints included progression-free survival (PFS), overall survival (OS), safety, and quality of life (QoL).Results: 61.5% of patients preferred Cap+Bev (p = 0.1653), whereas 15.4% preferred Eve+Exe and 23.1% were indecisive. Physicians showed a similar tendency towards Cap+Bev (58.1%) as the preferred regimen versus Eve+Exe (32.3%). Median first-line PFS was longer for Cap+Bev than for Eve+Exe (11.1 months versus 3.5 months). Median second-line PFS was similar between Cap+Bev and Eve+Exe (3.6 months versus 3.7 months). Median OS was comparable between Arm A (28.8 months) and Arm B (24.7 months). 73.0% and 52.6% (first-/second-line, Cap+Bev) and 54.1% and 52.9% (first-/second-line, Eve+Exe) of patients experienced grade 3/4 TEAEs. No treatment-related deaths occurred. QoL and treatment satisfaction were not significantly different between arms or treatment lines.Conclusions: Patients tended to favor Cap+Bev over Eve+Exe, which was in line with physicians' preference. Cap+Bev showed superior first-line PFS, while QoL was similar in both arms. No new safety signals were reported.Trial Registration: EudraCT No: 2013-005329-22. Registered on 19 August 20. [ABSTRACT FROM AUTHOR]

Importance: Fecal immunochemical tests for hemoglobin are widely used for colorectal cancer (CRC) screening. Observational studies suggested that sensitivity of fecal immunochemical tests for detecting advanced neoplasms could be increased by acetylsalicylic acid (aspirin), especially among men.Objective: To evaluate the potential to increase sensitivity of fecal immunochemical tests by administering a single 300-mg oral aspirin dose 2 days before stool sampling.Design, Setting, and Participants: A randomized, placebo-controlled, double-blind trial was conducted in 14 gastroenterology practices and 4 hospitals in Germany, and included 2422 men and women aged 40 to 80 years scheduled for colonoscopy, with no recent use of aspirin or other drugs with antithrombotic effects (enrollment from June 2013 to November 2016, and final follow-up January 27, 2017).Interventions: Administration of a single tablet containing 300 mg of aspirin (n = 1208) or placebo (n = 1214) 2 days before fecal sampling for fecal immunochemical test.Main Outcome and Measures: The primary outcome was sensitivity of a quantitative fecal immunochemical test at 2 predefined cutoffs (10.2 and 17-μg Hb/g stool) for detecting advanced neoplasms (colorectal cancer or advanced adenoma).Results: Among 2422 randomized patients (mean [SD] age, 59.6 [7.9] years; 1219, 50%, men), 2134 were included in the analysis (78% for primary screening colonoscopy, 22% for diagnostic colonoscopy). Advanced neoplasms were identified in 224 participants (10.5%), including 8 participants (0.4%) with CRC and 216 participants (10.1%) with advanced adenoma. Sensitivity was 40.2% in the aspirin group and 30.4% in the placebo group (difference 9.8%, 95% CI, -3.1% to 22.2%, P = .14) at cutoff 10.2-μg Hb/g stool and 28.6% in the aspirin and 22.5% in the placebo group (difference 6.0%, 95% CI, -5.7% to 17.5%, P = .32) at cutoff 17-μg Hb/g stool.Conclusions and Relevance: Among adults aged 40 to 80 years not using aspirin or other antithrombotic medications, administration of a single dose of oral aspirin prior to fecal immunochemical testing, compared with placebo, did not significantly increase test sensitivity for detecting advanced colorectal neoplasms at 2 predefined cutoffs of a quantitative fecal immunochemical test.Trial registration: Deutsches Register Klinischer Studien Identifier: DRKS00003252; EudraCT Identifier: 2011-005603-32/DE. [ABSTRACT FROM AUTHOR]

Background: Total hip or knee replacement is one of the most frequently performed surgical procedures. Physical rehabilitation following total hip or knee replacement is an essential part of the therapy to improve functional outcomes and quality of life. After discharge from inpatient rehabilitation, a subsequent postoperative exercise therapy is needed to maintain functional mobility. Telerehabilitation may be a potential innovative treatment approach. We aim to investigate the superiority of an interactive telerehabilitation intervention for patients after total hip or knee replacement, in comparison to usual care, regarding physical performance, functional mobility, quality of life and pain.Methods/design: This is an open, randomized controlled, multicenter superiority study with two prospective arms. One hundred and ten eligible and consenting participants with total knee or hip replacement will be recruited at admission to subsequent inpatient rehabilitation. After comprehensive, 3-week, inpatient rehabilitation, the intervention group performs a 3-month, interactive, home-based exercise training with a telerehabilitation system. For this purpose, the physiotherapist creates an individual training plan out of 38 different strength and balance exercises which were implemented in the system. Data about the quality and frequency of training are transmitted to the physiotherapist for further adjustment. Communication between patient and physiotherapist is possible with the system. The control group receives voluntary, usual aftercare programs. Baseline assessments are investigated after discharge from rehabilitation; final assessments 3 months later. The primary outcome is the difference in improvement between intervention and control group in 6-minute walk distance after 3 months. Secondary outcomes include differences in the Timed Up and Go Test, the Five-Times-Sit-to-Stand Test, the Stair Ascend Test, the Short-Form 36, the Western Ontario and McMaster Universities Osteoarthritis Index, the International Physical Activity Questionnaire, and postural control as well as gait and kinematic parameters of the lower limbs. Baseline-adjusted analysis of covariance models will be used to test for group differences in the primary and secondary endpoints.Discussion: We expect the intervention group to benefit from the interactive, home-based exercise training in many respects represented by the study endpoints. If successful, this approach could be used to enhance the access to aftercare programs, especially in structurally weak areas.Trial Registration: German Clinical Trials Register (DRKS), ID: DRKS00010009 . Registered on 11 May 2016. [ABSTRACT FROM AUTHOR]

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Transfusion-dependent patients with low- or intermediate-1-risk myelodysplastic syndrome, <5% bone marrow (BM) blasts and isolated 5q-deletion received lenalidomide within the German MDS study group phase-II clinical trial LE-MON-5 (EudraCT:2008-001866-10) of the University of Duesseldorf, Germany. Cytogenetic monitoring was performed by chromosome banding analyses (CBA) of BM cells and fluorescence in situ hybridization (FISH) analyses of peripheral blood (PB) mononuclear CD34+ cells using extended probe panels. Out of 144 patients screened for study enrollment, 24% failed to meet inclusion criteria due to cytogenetic findings. Eighty-seven patients were followed with a median observation time of 30 months. Cytogenetic response detected by FISH and CBA in 74 and 66% of patients, respectively, was predictive for hematologic response as well as of high prognostic relevance. After 2 years, AML rate was 8% for all patients. Karyotype evolution was detected in 21 (FISH)-34% (CBA) of patients associated with significantly shorter AML-free survival. Disease progression was first detectable on the cytogenetic level on average 5-6 months before recurrence of transfusion dependence. Our data show for the first time in a prospective setting that a cytogenetic monitoring from the PB helps to early identify treatment failure and progressive disease in lenalidomide-treated patients to improve clinical management.Trial Registration: EudraCT:2008-001866-10. [ABSTRACT FROM AUTHOR]

Background: While randomized controlled trials (RCTs) are based on strict inclusion/exclusion criteria, non-interventional studies (NISs) might provide additional information to guide management in patients more representative to the real-world setting. The aim of this study was to compare baseline characteristics of patients receiving intravitreal treatment in the NIS OCEAN with those from published RCTs.Methods: The ongoing OCEAN study enrolled patients treated with ranibizumab for neovascular age-related macular degeneration (nAMD), diabetic macular oedema (DME) or branch/central retinal vein occlusion (B/CRVO). Baseline patient characteristics were compared by indication within the OCEAN cohort. Furthermore, the characteristics were set in reference to those of published RCTs in the same indications. Confidence intervals (CIs) were calculated and assessed for statistically significant differences as indicated by non-overlapping CIs.Results: Patient characteristics in the NIS OCEAN were evaluated for 3,614 patients with nAMD, 1,211 with DME, 204 with BRVO and 121 with CRVO. Between these groups, significant differences in mean age, gender distributions, and mean baseline VA were seen, reflecting known differences between the indications. Compared to the patient characteristics of published RCTs (trials selected by literature search: nAMD: 13 RCTs, DME: 9, RVO: 5), the OCEAN patients' mean age was significantly higher in every indication. The gender distributions across the trials were comparable, with only few differences between OCEAN and the RCTs. Regarding the mean baseline VA, notable differences were found in nAMD and in DME, with VA significantly higher in some RCTs and lower in others.Conclusions: The described differences underline the complementarity of NISs and RCTs. OCEAN covers a broader spectrum and more variability of patients than do RCTs. As baseline values may have impact on the treatment response (ceiling effect), there is an ongoing need for research in all patient subgroups. Country-specific assessments of patient populations can better reflect the real-world situation. NISs can deliver insights that RCTs may not, as NISs can include non-typical patients, patients with comorbidities, a broader age spectrum and patients of various disease stages.Trial Registration: The NIS OCEAN was registered on www.clinicaltrials.gov (identifier: NCT02194803 ). [ABSTRACT FROM AUTHOR]

Objective: To evaluate the safety and effectiveness of round window (RW), oval window (OW), CliP and Bell couplers for use with an active middle ear implant.Methods: This is a multicenter, long-term, prospective trial with consecutive enrollment, involving 6 university hospitals in Germany. Bone conduction, air conduction, implant-aided warble-tone thresholds and Freiburger monosyllable word recognition scores were compared with unaided preimplantation results in 28 moderate-to-profound hearing-impaired patients after 12 months of follow-up. All patients had previously undergone failed reconstruction surgeries (up to 5 or more). In a subset of patients, additional speech tests at 12 months postoperatively were used to compare the aided with the unaided condition after implantation with the processor switched off. An established quality-of-life questionnaire for hearing aids was used to determine patient satisfaction.Results: Postoperative bone conduction remained stable. Mean functional gain for all couplers was 37 dB HL (RW = 42 dB, OW = 35 dB, Bell = 38 dB, CliP = 27 dB). The mean postoperative Freiburger monosyllable score was 71% at 65 dB SPL. The postimplantation mean SRT50 (speech reception in quiet for 50% understanding of words in sentences) improved on average by 23 dB over unaided testing and signal-to-noise ratios also improved in all patients. The International Outcome Inventory for Hearing Aids (IOI-HA)quality-of-life questionnaire was scored very positively by all patients.Conclusion: A significant improvement was seen with all couplers, and patients were satisfied with the device at 12 months postoperatively. These results demonstrate that an active implant is an advantage in achieving good hearing benefit in patients with prior failed reconstruction surgery. [ABSTRACT FROM AUTHOR]

Background: This study compares the effectiveness of psychotherapeutic consultation in the workplace (PSIW) with psychotherapeutic outpatient care (PSOC) in Germany.Methods: Work ability (WAI), quality of life (SF-12), clinical symptoms (PHQ) and work-related stress (MBI, IS) were assessed in 367 patients seeking mental health care via two routes (PSIW n = 174; PSOC n = 193) before consultation and 12 weeks later. Changes in outcome variables were assessed using covariance analysis with repeated measures (ANCOVA) with sociodemographic variables (propensity score method), therapy dose, setting and symptom severity as covariates.Results: The PSIW and PSOC groups included 122 and 66 men respectively. There were 102 first-time users of mental healthcare in the PSIW group and 83 in the PSOC group. There were group differences in outcome variables at baseline (p < 0.05); PSIW patients were less impaired overall. There were no group difference in sociodemographic variables, number of sessions within the offer or symptom severity. There was no main effect of group on outcome variables and no group*time interaction. Work-related stress indicators did not change during the intervention, but work ability improved in both groups (F = 10.149, p = 0.002; baseline M = 27.2, SD = 8.85); follow-up M = 28.6, SD = 9.02), as did perceived mental health (SF-12 MCS), depression (PHQ-9) and anxiety (PHQ-7). Effect sizes were between η(2) = 0.028 and η(2) = 0.040.Conclusions: Psychotherapeutic consultation is similarly effective in improving patients' functional and clinical status whether delivered in the workplace or in an outpatient clinic. Offering mental health services in the workplace makes it easier to reach patients at an earlier stage in their illness and thus enables provision of early and effective mental health care.Trial Registration: DRKS00003184 , retrospectively registered 13 January 2012. [ABSTRACT FROM AUTHOR]

Background: In German emergency medical services (EMS), the analgesia is restricted to physicians. In this prospective, interventional, multicentre trial, complications with and quality of telemedically delegated analgesia were evaluated.Methods: If prehospital analgesia was necessary, five telemedically equipped paramedic ambulances from four different districts could consult a telemedicine centre. Analgesics were delegated based on a predefined algorithm. Telemedically assisted cases were compared with local historical regular EMS missions using matched pairs. The primary outcome was the frequency of therapeutic complications (respiratory/circulatory insufficiency, allergic reactions). Secondary outcomes were quality of analgesia (11-point numerical rating scale, NRS) and the frequency of nausea/vomiting.Results: Analgesia was necessary in 106 telemedically assisted missions. In 23 cases, the telemedical procedure was used until an EMS physician arrived. Of the remaining 83 cases, 80 could be matched to comparable controls. Complications did not occur in either the study group or the control group (0 vs. 0; p = N/A). Complete NRS documentation was noted in 65/80 (study group) and 32/80 (control group) cases (p < 0.0001). Adequate initial pain reduction (quality indicator: reduction of NRS ≥ 2 points or NRS < 5 at end of mission) occurred in 61/65 versus 31/32 cases (p = 1.0); NRS reduction during mission was 3.78 ± 2.0 versus 4.38 ± 2.2 points (p = 0.0159). Nausea and vomiting occurred with equal frequency in both groups.Conclusions: Telemedical delegation of analgesics to paramedics was safe and led to a pain reduction superior to the published minimum standard in both groups. The documentation quality was better in the telemedicine group. WHAT DOES THIS STUDY ADD?: Little is known about the safety and quality of prehospital analgesia carried out by emergency medical services (EMS). Beside potential quality problems, in some countries meaningful pain reduction is limited by legal regulations that allow only physicians to administer analgesics. This first multicentre prospective trial for telemedically delegated analgesia demonstrates that remote analgesia is possible and safe and retains equivalent analgesic quality compared with that administered by onsite EMS physicians. [ABSTRACT FROM AUTHOR]

Background: Sedation prior to esophagogastroduodenoscopy is widespread and increases patient comfort. However, it demands additional trained personnel, accounts for up to 40 % of total endoscopy costs and impedes rapid hospital discharge. Most patients lose at least one day of work. 98 % of all serious adverse events occurring during esophagogastroduodenoscopy are ascribed to sedation. Acupuncture is reported to be effective as a supportive intervention for gastrointestinal endoscopy, similar to conventional premedication. We investigated whether acupuncture during elective diagnostic esophagogastroduodenoscopy could increase the comfort of patients refusing systemic sedation.Methods: We performed a single-center, double-blinded, placebo-controlled superiority trial to compare the success rates of elective diagnostic esophagogastroduodenoscopies using real and placebo acupuncture. All patients aged 18 years or older scheduled for elective, diagnostic esophagogastroduodenoscopy who refused systemic sedation were eligible; 354 patients were randomized. The primary endpoint measure was the rate of successful esophagogastroduodenoscopies. The intervention was real or placebo acupuncture before and during esophagogastroduodenoscopy. Successful esophagogastroduodenoscopy was based on a composite score of patient satisfaction with the procedure on a Likert scale as well as quality of examination, as assessed by the examiner.Results: From February 2010 to July 2012, 678 patients were screened; 354 were included in the study. Baseline characteristics of the two groups showed a similar distribution in all but one parameter: more current smokers were allocated to the placebo group. The intention-to-treat analysis included 177 randomized patients in each group. Endoscopy could successfully be performed in 130 patients (73.5 %) in the real acupuncture group and 129 patients (72.9 %) in the placebo group. Willingness to repeat the procedure under the same conditions was 86.9 % in the real acupuncture group and 87.6 % in the placebo acupuncture group.Conclusions: Esophagogastroduodenoscopy without sedation is safe and can successfully be performed in two-thirds of patients. Patients planned for elective esophagogastroduodenoscopy without sedation do not benefit from acupuncture of the Sinarteria respondens (Rs) 24 Chengjiang middle line, Pericard (Pc) 6 Neiguan bilateral, or Dickdarm (IC) 4 Hegu bilateral, according to traditional Chinese medicine meridian theory.Trial Registration: DRKS00000164 . Registered on 10 December 2009. [ABSTRACT FROM AUTHOR]

Background: The use of comprehensive instruments for guideline appraisal is time-consuming and requires highly qualified personnel. Since practicing physicians are generally busy, the rapid-assessment Mini-Checklist (MiChe) tool was developed to help them evaluate the quality and utility of guidelines quickly. The aim of this study was to validate the MiChe in comparison to the AGREE II instrument and to determine its reliability as a tool for guideline appraisal.Methods: Ten guidelines that are relevant to general practice and had been evaluated by 2 independent reviewers using AGREE II were assessed by 12 GPs using the MiChe. The strength of the correlation between average MiChe ratings and AGREE II total scores was estimated using Pearson's correlation coefficient. Inter-rater reliability for MiChe overall quality ratings and endorsements was determined using intra-class correlations (ICC) and Kendall's W for ordinal recommendations. To determine the GPs' satisfaction with the MiChe, mean scores for the ratings on five questions were computed using a six-point Likert scale.Results: The study showed a high level of agreement between MiChe and AGREE II in the quality rating of guidelines (Pearson's r = 0.872; P < 0.001). Inter-rater-reliability for overall MiChe ratings (ICC = 0.755; P < 0.001) and endorsements (Kendall's W = 0.73; P < 0.001) were high. The mean time required for guideline assessment was less than 15 min und user satisfaction was generally high.Conclusions: The MiChe performed well in comparison to AGREE II and is suitable for the rapid evaluation of guideline quality and utility in practice.Trial Registration: German Clinical Trials Register: DRKS00007480. [ABSTRACT FROM AUTHOR]

Background: Acute kidney injury remains a common complication in critically ill patients and despite multiple trials and observational studies, the optimal timing for initiation of renal replacement therapy is still unclear. The early versus late initiation of renal replacement therapy in critically ill patients with acute kidney injury (ELAIN) study is a randomized, single-center, prospective, two-arm, parallel group trial to reduce mortality in patients with severe acute kidney injury. We describe the study design and discuss aspects of the need for a trial in this patient cohort.Methods/design: Our plan is to randomize critically ill patients with acute kidney injury to 'early' or 'late' initiation of renal replacement therapy according to stage 2 and 3 of the KDIGO classification using a specific trial protocol. We plan to guide data collection and analysis using pre-existing definitions and testing. The primary endpoint is overall survival in a 90-day follow-up period. Secondary endpoints include 28-day, 60-day, 90-day and 1-year all-cause mortality, recovery of renal function, ICU and hospital length-of-stay. The primary analysis will be an intention-to-treat analysis; secondary analyses include treated analyses. We will also specify rules for handling data and determining outcome.Discussion: Several challenges for study design and execution can be seen in our trial, and it should generate results that will inform and influence the practice of renal replacement therapy in critically ill patients with acute kidney injury.Trial Registration: German Clinical Trials Register: DRKS00004367 ( www.germanctr.de ); 28 May 2013. [ABSTRACT FROM AUTHOR]

Purpose: To describe the implementation process of a computer-adaptive test (CAT) for measuring health-related quality of life (HRQoL) of children and adolescents in two pediatric clinics in Germany. The study focuses on the feasibility and user experience with the Kids-CAT, particularly the patients' experience with the tool and the pediatricians' experience with the Kids-CAT Report.Methods: The Kids-CAT was completed by 312 children and adolescents with asthma, diabetes or rheumatoid arthritis. The test was applied during four clinical visits over a 1-year period. A feedback report with the test results was made available to the pediatricians. To assess both feasibility and acceptability, a multimethod research design was used. To assess the patients' experience with the tool, the children and adolescents completed a questionnaire. To assess the clinicians' experience, two focus groups were conducted with eight pediatricians.Results: The children and adolescents indicated that the Kids-CAT was easy to complete. All pediatricians reported that the Kids-CAT was straightforward and easy to understand and integrate into clinical practice; they also expressed that routine implementation of the tool would be desirable and that the report was a valuable source of information, facilitating the assessment of self-reported HRQoL of their patients.Conclusions: The Kids-CAT was considered an efficient and valuable tool for assessing HRQoL in children and adolescents. The Kids-CAT Report promises to be a useful adjunct to standard clinical care with the potential to improve patient-physician communication, enabling pediatricians to evaluate and monitor their young patients' self-reported HRQoL. [ABSTRACT FROM AUTHOR]

Background: The current study was conducted to examine the activity of a docetaxel/oxaliplatin (DocOx) combination as second line treatment for advanced pancreatic ductal adenocarcinoma (Trial registration: NCT00690300. Registered June 2, 2008) METHODS: DocOx is a prospective, multi-center, single arm, phase II trial using docetaxel (75 mg/m(2), 60 min, d 1) and oxaliplatin (80 mg/m(2), 120 min, d 2) in 21-day cycles. The treatment period was scheduled for up to 8 cycles. Primary endpoint was tumor response according to RECIST 1.0. Secondary endpoints were progression free survival, overall survival, safety/toxicity, quality of life and clinical benefit.Results: Data represent the intention to treat analysis of 44 patients with chemorefractory pancreatic cancer enrolled between 2008 and 2012 at five institutions in Germany. The primary endpoint of tumor response was achieved in 15.9% of the patients (7 partial remissions, no complete remission), with a disease control rate of 48% after the first two treatment cycles. Median progression free survival (PFS) was 1.82 months (CI 95% 1.5-3.96 months) and median overall survival (OS) was 10.1 months (CI 95% 5.1-14.1 months).Conclusions: This single-arm trial demonstrates that the combination of docetaxel and oxaliplatin yields promising results for the treatment of advanced pancreatic ductal adenocarcinoma patients. Selected patients had particular benefit from this treatment as indicated by long PFS and OS times. Even after 8 cycles of treatment with DocOx a partial response was observed in 2 patients and stable disease was observed in another 6 patients. The data obtained with the DocOx protocol compare well with other second line protocols such as OFF (oxaliplatin, 5-FU, leucovorin). The DocOx regimen could be an interesting option for patients who received gemcitabine as first line treatment for metastatic pancreatic cancer. [ABSTRACT FROM AUTHOR]

Introduction: Recently, information availability has become more elaborate and widespread, and treatment decisions are based on a multitude of factors. Gathering relevant data, also referred to as Big Data, is therefore critical for reaching the best patient care, and enhancing interdisciplinary and clinical research. Combining patient data from all involved systems is essential to prepare unstructured data for analyses. This demands special coordination in data management. Our study aims to characterize current developments in German-speaking hospital departments and practices. We successfully conducted the survey with the members of the Deutsche Gesellschaft für Radioonkologie (DEGRO).Methods: A questionnaire was developed consisting of 17 questions related to data management, documentation and clinical trial analyses, reflecting the clinical topics such as basic patient information, imaging, follow-up information as well as connection of documentation tools with radiooncological treatment planning machines.Results: A total of 44 institutions completed the online survey (University hospitals n = 17, hospitals n = 13, practices/institutes n = 14). University hospitals, community hospitals and private practices are equally equipped concerning IT infrastructure for clinical use. However, private practices have a low interest in research work. All respondents stated the biggest obstacles about introducing a documentation system into their unit lie in funding and support of the central IT departments. Only 27 % (12/44) of responsible persons are specialists for documentation and data management.Conclusion: Our study gives an understanding of the challenges and solutions we need to be looking at for medical data storage. In the future, inter-departmental cross-links will enable the radiation oncology community to generate large-scale analyses. [ABSTRACT FROM AUTHOR]

We investigated the differential effectiveness of a parent management training program for children with externalizing problem behavior. The parent management training was tested using a within-subject control group design. 270 families with children aged 3-10 years were included and assessments were made at 3 months before treatment, immediately before treatment, immediately after treatment, and at 12 months follow-up. We analyzed data using growth mixture modeling. For attention problems, we obtained a two-subgroup solution. One subgroup started with high initial values indicating more severe impairment, and the other subgroup had low initial values. The more impaired group showed stronger treatment effects. For disruptive behavior problems, our analyses revealed a three-subgroup solution. Two subgroups exhibited high initial levels of disruptive behavior problems and the third subgroup had low initial levels. One of the more impaired groups exhibited a strong decrease in problem behavior during treatment, while the other two groups only showed moderate decreases. For attention problems and disruptive behavior problems, some of the most impaired children gained the most from parent training. [ABSTRACT FROM AUTHOR]

Background: Bevacizumab plus interferon-alpha2a (IFN) prolongs progression-free survival to >10 months, which is comparable with sunitinib as first-line treatment of metastatic renal cell carcinoma (RCC). The two regimens have different tolerability profiles; therefore, costs for managing adverse events may be an important factor in selecting therapy.Methods: Costs of managing adverse events affecting patients with metastatic RCC eligible for treatment with bevacizumab plus IFN or sunitinib were evaluated using a linear decision analytical model. Management costs were calculated from the published incidence of adverse events and health-care costs for treating adverse events in the United Kingdom, Germany, France and Italy.Results: Adverse event management costs were higher for sunitinib than for bevacizumab plus IFN. The average cost per patient for the management of grade 3-4 adverse events was markedly lower with bevacizumab plus IFN compared with sunitinib in the United Kingdom (euro1475 vs euro804), Germany (euro1785 vs euro1367), France (euro2590 vs euro1618) and Italy (euro891 vs euro402). The main cost drivers were lymphopaenia, neutropaenia, thrombocytopaenia, leucopaenia and fatigue/asthaenia for sunitinib; and proteinuria, fatigue/asthaenia, bleeding, anaemia and gastrointestinal perforation for bevacizumab plus IFN.Conclusion: The costs of managing adverse events are lower for bevacizumab plus IFN than for sunitinib. The potential for cost savings should be considered when selecting treatments for RCC. [ABSTRACT FROM AUTHOR]

Unlabelled: Meningococcal disease may present as sepsis, meningitis or a combination of both. Impaired fibrinolysis and massive elevation of the plasminogen activator inhibitor-1 (PAI-1) is a characteristic feature of meningococcal sepsis. Previously, an association between mortality and the functional 4G/5G promoter polymorphism of the PAI-1gene in a cohort of UK and Dutch children with meningococcal sepsis was reported. We carried out a prospective, multicentre study to investigate the association of the 4G/5G PAI-1 polymorphism, diagnosis, and outcome in meningococcal disease in a Central European and UK population. Blood samples and clinical information of 347 previously healthy children with meningococcal infection were collected from 95 paediatric hospitals in Germany, Switzerland, Italy, the United Kingdom, and Austria from 2000 until 2002. Mortality was significantly associated with the 4G/4G genotype (12 of 90 (13%) vs. 15 of 240 (6%), P = 0.037), resulting in an odds ratio of 2.31. The diagnosis of sepsis (independent of symptoms of meningitis) was significantly more frequent in carriers of the 4G/4G genotype (P = 0.01), resulting in an odds ratio of 2.21 to develop sepsis. Meningitis was not associated with the PAI-1 4G/5G polymorphism, and allele frequencies were similar in patient and control groups.Conclusion: Our data show a correlation between the 4G/4G genotype in the plasminogen activator inhibitor-1 gene and poor outcome in children with meningococcal infection. In addition, 4G homozygous patients were prone to develop sepsis. We found no influence of the plasminogen activator inhibitor-1 polymorphism on the susceptibility to invasive meningococcal infection. [ABSTRACT FROM AUTHOR]

Objective: To estimate the 3-year incremental cost effectiveness and cost utility of introducing leflunomide into sequential therapy, consisting of the most frequently used disease-modifying antirheumatic drugs (DMARDs), for patients with rheumatoid arthritis in specialised, i.e. rheumatological, care in Germany.Design and Setting: The analysis was conducted from the societal perspective in Germany using an existing 3-year simulation model, which was adapted to the German healthcare system after secondary analysis of relevant publications and data. DMARD sequences including leflunomide were compared with those excluding leflunomide. Costs comprised direct costs incurred by treatment and indirect costs incurred by loss of productivity (sick leave and premature retirement) of rheumatoid arthritis patients. Effectiveness parameters were given by response years gained (RYGs) according to the American College of Rheumatology (ACR) criteria for 20%, 50% and 70% improvement (ACR20/50/70RYGs) and by QALYs gained (QALYGs). Costs, effects and QALYs were discounted by 5% per annum. In the base-case analysis, average values of costs, response years and QALYs were applied. Costs were in 1998-2001 values (euro 1 approximately equal to $US 0.91, average of the period from the year 2000 through 2001).Main Outcome Measures and Results: After 3 years, adding leflunomide was less costly and more effective than the strategy excluding leflunomide when total (direct and indirect) costs were considered. There were savings of euro 271,777 and 8.1, 4.3, 5.1 and 4.9 ACR20RYGs, ACR50RYGs, ACR70RYGs and QALYGs per 100 patients, respectively, obtained through adding leflunomide. Focusing on direct costs, adding leflunomide was more costly and more effective compared with excluding leflunomide, with an incremental cost effectiveness of euro 5004 per ACR20RYG, euro 9535 per ACR50RYG, euro 7996 per ACR70RYG, and an incremental cost utility of euro8301 per QALYG, after 3 years. The robustness of the results was shown in comprehensive sensitivity analyses. In the analysis of extremes, different combinations of the limits of cost, effectiveness and utility parameters were investigated. Adding leflunomide to sequential DMARD therapy remained dominant in 79% of the possible cases, i.e. was less costly and more effective than the strategy excluding leflunomide. Focusing on direct costs, adding leflunomide became dominant in 29% and remained more costly and more effective in 50% of possible cases.Conclusions: Our analysis suggests, with its underlying data and assumptions, that having leflunomide as an additional option in a DMARD treatment sequence extends the time patients benefit from DMARD therapy at reasonable additional direct costs. Adding leflunomide may even be cost saving when total (direct and indirect) costs are considered. As data on DMARD effectiveness were extracted from the results of clinical trials, real-world data from observational studies would be needed to corroborate the findings of the present analysis. [ABSTRACT FROM AUTHOR]

Objectives: Determination of the ovulation inhibition efficacy of a new, transparent, transdermal, combined hormonal contraceptive patch (area 10 cm2) containing 0.9 mg ethinylestradiol and 1.9 mg gestodene in an open-label study of healthy, female volunteers (aged 18-35 years).Methods: A total of 199 volunteers from two centers were requested to use the contraceptive patch (one patch/week for 3 weeks, followed by 1 week of no treatment), throughout two menstrual cycles. Ovarian activity was monitored by transvaginal ultrasonography and serum hormone determinations, and classified according to the Hoogland score.Results: Ovulation inhibition was achieved in all participants (Hoogland score < 6). Secondary efficacy measures, including suppression of serum concentrations of estradiol and progesterone, and of the mid-cycle luteinizing hormone surge, confirmed ovulation inhibition. Ovulation returned in 85.7% of participants during the first cycle after cessation of treatment. There were no abnormal changes in safety parameters. A large majority of users rated the contraceptive patch as 'very convenient'.Conclusions: This study showed that the new, combined ethinylestradiol/gestodene contraceptive patch was highly effective in reversibly inhibiting ovulation, well tolerated and regarded as 'very convenient' by the majority of users. This new, transparent, transdermal matrix patch is an attractive alternative form of contraception. [ABSTRACT FROM AUTHOR]

The suicide-related mortality among patients with affective disorders is approximately 30 times higher, and overall mortality 2 to 3 times higher, than suicide-related mortality in the general population. Lithium has demonstrated possibly specific antisuicidal effects apart from its prophylactic efficacy: it significantly reduces the high excess mortality of patients with affective disorders. To date, suicide-prevention effects have not been shown for antidepressant or anticonvulsant long-term treatment. Clozapine appears to reduce the suicide rate in schizophrenia patients. Against this background, guidelines and algorithms for selecting an appropriate prophylactic strategy for affective disorders should consider the presence of suicidality in patient history. Appropriate lithium prophylaxis prevents approximately 250 suicides yearly in Germany, although lithium salts are infrequently prescribed within the National Health Scheme (specifically, to 0.06% of the population). Rational treatment strategies most likely would demand that prescription rates be about 10 times higher. [ABSTRACT FROM AUTHOR]

Background: Advanced peri-implant intrabony defects require comprehensive surgical treatment regimens different from periodontal therapy strategies. The purpose of this longitudinal trial was to evaluate the peri-implant outcomes following guided bone regeneration with 3 treatment protocols. Methods: In 25 patients, 41 peri-implant defects with supporting bone loss >50% of the implant length were treated with flap surgery plus autogenous bone grafts alone (FG) (controls, n = 12) plus non-resorbable (FGM) (test 1, n = 20) or bioabsorbable barriers (FGRM) (test 2, n = 9) and supportive antimicrobial therapy. Following submerged healing, the membranes were removed (FGM), and the peri-implant probing depths (PD), probing bone levels (BL), mobility scores (PT), and intrabony defect height (DH) were radiographically evaluated at baseline, 6 months, and 1 and 3 years post-therapy. Results: Non-surgical/anti-infective therapy resulted in a limited improvement of PD scores after 6 months. At the 3-year visit, surgical treatment revealed significant changes from baseline for the controls and both of the test groups for PD: 5.1 +/- 2.7 mm (FG), 5.4 +/- 3.0 mm (FGM), and 2.6 +/- 1.6 mm (FGRM), and for BL: 3.2 +/- 2.4 mm (FG), 3.4 +/- 2.4 mm (FGM), and 2.3 +/- 1.6 mm (FGRM), Mann-Whitney test, P < or = 0.05. The changes for DH and PT were significant only for FG- and FGM-treated subjects. The overall improvement for FGRM-treated patients during the 3-year observation was less marked. However, the differences between the 3 surgical treatment protocols did not affect the treatment outcomes after 3 years. Conclusions: Autogenous bone grafting is an appropriate treatment regimen to augment open crater-formed peri-implant defects. Although certain clinical situations require an additional fixation of barrier membranes, their routine application should be approached with caution. [ABSTRACT FROM AUTHOR]