Publications by authors named "Thomas Zimmermann"

65 Publications

Diagnostic and treatment barriers to persistent somatic symptoms in primary care - representative survey with physicians.

BMC Fam Pract 2021 Apr 1;22(1):60. Epub 2021 Apr 1.

Clinic and Outpatients Clinic for Psychosomatic Medicine and Psychotherapy, University Medical Center Hamburg-Eppendorf, Martinistr. 52, 20246, Hamburg, Germany.

Background: Many patients consult their primary care physician with persistent somatic symptoms such as pain or sickness. Quite often these consultations and further diagnostic measures yield no medical explanation for the symptoms - patients and physicians are left in uncertainty. In fact, diagnostic and treatment barriers in primary care hinder timely health-care provision for patients suffering from persistent somatic symptoms (PSS). The significance of individual barriers is still unknown. We compare and quantify these barriers from the perspective of primary care physicians and identify subpopulations of primary care physicians who experience particular barriers as most severe.

Methods: We mailed a questionnaire to primary care physicians (PCP) in Germany and asked them which barriers they consider most important. We invited a random sample of 12,004 primary care physicians in eight federal states in Germany. Physicians provided anonymous mailed or online responses. We also mailed a postcard to announce the survey and a mail reminder. Main measures were Likert rating scales of items relating to barriers in the diagnosis and treatment of PSS in primary care. Information on demography and medical practice were also collected.

Results: We analyzed 1719 data sets from 1829 respondents. PCPs showed strongest agreement with statements regarding (1.) their lack of knowledge about treatment guidelines, (2.) their perceptions that patients with PSS would expect symptom relief, (3.) their concern to overlook physical disease in these patients, and (4.) their usage of psychotropic drugs with these patients. More experienced PCPs were better able to cope with the possibility of overlooking physical disease than those less experienced.

Conclusions: The PCPs in our survey answered that the obligation to rule out severe physical disease and the demand to relieve patients from symptoms belong to the most severe barriers for adequate treatment and diagnosis. Moreover, many physicians admitted to not knowing the appropriate treatment guidelines for these patients. Based on our results, raising awareness of guidelines and improving knowledge about the management of persistent somatic symptoms appear to be promising approaches for overcoming the barriers to diagnosis and treatment of persistent somatic symptoms in primary care.

Trial Registration: German Clinical Trials Register (Deutschen Register Klinischer Studien, DRKS) https://www.drks.de/drks_web/setLocale_EN.do The date the study was registered: October 2 2017 The date the first participant was enrolled: February 9 2018 DRKS-ID: DRKS00012942.
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http://dx.doi.org/10.1186/s12875-021-01397-wDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8017612PMC
April 2021

Catalytic HO Activation by a Diiron Complex for Methanol Oxidation.

Inorg Chem 2020 Nov 21;59(21):15563-15569. Epub 2020 Oct 21.

Fakultät für Chemie, Universität Bielefeld, Universitätsstraße 25, D-33615 Bielefeld, Germany.

In nature, C-H bond oxidation of CH involves a peroxo intermediate that decays to the high-valent active species of either a "closed" {Fe(μ-O)Fe} core or an "open" {Fe(O)(μ-O)Fe(O)} core. To mimic and to obtain more mechanistic insight in this reaction mode, we have investigated the reactivity of the bioinspired diiron complex [(susan){Fe(OH)(μ-O)Fe(OH)}] [susan = 4,7-dimethyl-1,1,10,10-tetrakis(2-pyridylmethyl)-1,4,7,10-tetraazadecane], which catalyzes CHOH oxidation with HO to HCHO and HCOH. The kinetics is faster in the presence of a proton. O-labeling experiments show that the active species, generated by a decay of the initially formed peroxo intermediate [(susan){Fe(μ-O)(μ-O)Fe}], contains one reactive oxygen atom from the μ-oxo and another from the μ-peroxo bridge of its peroxo precursor. Considering an FeFe active species, a "closed" {Fe(μ-O)Fe} core explains the observed labeling results, while a scrambling of the terminal and bridging oxo ligands is required to account for an "open" {Fe(O)(μ-O)Fe(O)} core.
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http://dx.doi.org/10.1021/acs.inorgchem.0c02698DOI Listing
November 2020

Thermodynamic and structural aspects of the aqueous uranium(iv) system - hydrolysis vs. sulfate complexation.

Dalton Trans 2019 Dec 29;48(48):17898-17907. Epub 2019 Nov 29.

Helmholtz-Zentrum Dresden-Rossendorf, Institute of Resource Ecology, Bautzner Landstr. 400, 01328 Dresden, Germany.

The aquatic species of U(iv) in acidic aqueous solution in the presence of sulfate were studied in the micromolar range by a combined approach of optical spectroscopy (UV/vis and mid-IR), quantum-chemical calculations (QCC), and thermodynamic modelling. The number of species occurring in solution within the pH range 0-2 was assessed by decomposition and fitting of photometric spectra using HypSpec and Geochemist's Workbench software. Single component spectra of U, UOH, USO and U(SO) were obtained and extinction coefficients ε were calculated to be 61.7, 19.2, 47.6 and 40.3 L mol cm, respectively. Complex formation constants of two U(iv) sulfate species and the first hydrolysis species UOH in infinitely diluted solution were determined by thermodynamic modelling to be log β = 6.9 ± 0.3, log β = 11.8 ± 0.5 and log β = -(0.36 ± 0.1), respectively. No further U(iv) sulfate and hydrolysis species were observed under the prevailing conditions. Molecular structural information of the sulfate species was derived from vibrational spectra and QCC exhibiting a predominant monodentate coordination of the sulfate ions.
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http://dx.doi.org/10.1039/c9dt02886bDOI Listing
December 2019

Study protocol for the COMET study: a cluster-randomised, prospective, parallel-group, superiority trial to compare the effectiveness of a collaborative and stepped care model versus treatment as usual in patients with mental disorders in primary care.

BMJ Open 2019 11 24;9(11):e032408. Epub 2019 Nov 24.

Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.

Introduction: Mental healthcare is one of the biggest challenges for healthcare systems. Comorbidities between different mental disorders are common, and patients suffer from a high burden of disease. While the effectiveness of collaborative and stepped care models has been shown for single disorders, comorbid mental disorders have rarely been addressed in such care models. The aim of the present study is to evaluate the effectiveness of a collaborative and stepped care model for depressive, anxiety, somatoform and alcohol use disorders within a multiprofessional network compared with treatment as usual.

Methods And Analysis: In a cluster-randomised, prospective, parallel-group superiority trial, n=570 patients will be recruited from primary care practices (n=19 practices per group). The intervention is a newly developed collaborative and stepped care model in which patients will be treated using treatment options of various intensities within an integrated network of outpatient general practitioners, psychiatrists, psychotherapists and inpatient institutions. It will be compared with treatment as usual with regard to effectiveness, cost-effectiveness and feasibility, with the primary outcome being a change in mental health-related quality of life from baseline to 6 months. Patients in both groups will undergo an assessment at baseline, 3, 6 and 12 months after study inclusion.

Ethics And Dissemination: The study has been approved by the ethics committee of the Hamburg Medical Association (No. PV5595) and will be carried out in accordance with the principles of the Declaration of Helsinki. For dissemination, the results will be published in peer-reviewed journals and presented at conferences. Within the superordinate research project Hamburg Network for Health Services Research, the results will be communicated to relevant stakeholders in mental healthcare.

Trial Registration Number: NCT03226743.
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http://dx.doi.org/10.1136/bmjopen-2019-032408DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6887029PMC
November 2019

General practitioners' views on the diagnostic innovations in DSM-5 somatic symptom disorder - A focus group study.

J Psychosom Res 2019 08 1;123:109734. Epub 2019 Jun 1.

Department of Psychosomatic Medicine and Psychotherapy, Center for Internal Medicine, University Medical Center, Hamburg-Eppendorf, Germany. Electronic address:

Background: The innovations concerning the new diagnosis somatic symptom disorder (SSD) in the DSM-5 include the introduction of psychological diagnostic criteria and the elimination of the need to exclude all potential somatic causes of the symptoms. Thus far, it is unknown how general practitioners (GPs) evaluate the innovations conceptually and regarding their applicability in primary care.

Method: We performed six focus groups with GPs. A semi-structured interview-guideline included a presentation of the innovations of SSD and questions about the innovations and their potential (dis-)advantages from the GPs' points of view. The material was analyzed using structuring qualitative content analysis.

Results: A total of 41 GPs participated (mean (sd) age = 51 (8.5) years, female = 17, male = 24). The GPs assessed that the diagnostic innovations could help them to focus on symptom-related concerns and anxiety as core aspects of the patients' complaints. However, the meaning of the term excessive in the psychological diagnostic criteria (i.e., excessive worries, anxiety, time and energy) was ambiguous for the GPs. The GPs appreciated that a mental disorder can be assigned in addition to a severe physical disease. The GPs found it unlikely that diagnostic workup of somatic symptoms would be cut short if the diagnostic criteria of SSD were fulfilled in a given patient.

Conclusion: Altogether, for the GPs, the advantages of the new diagnostic criteria for SSD outweighed the disadvantages. In particular, the newly included psychological criteria were seen as an important advancement in comparison to the previous need of merely excluding a physical disease.
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http://dx.doi.org/10.1016/j.jpsychores.2019.109734DOI Listing
August 2019

[Clinical trial of a stepped and collaborative care model for mental illnesses and comorbidities in the Hamburg Network for Health Services Research].

Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz 2019 Feb;62(2):205-213

Institut und Poliklinik für Medizinische Psychologie, Universitätsklinikum Hamburg-Eppendorf, Martinistr. 52, 20246, Hamburg, Deutschland.

Healthcare for mental disorders is a big challenge for the German healthcare system. In cases of comorbid mental diseases, patients suffer from an especially high burden of disease. So far, innovative care models for collaborative and stepped care have only been investigated with respect to their effectiveness for single mental disorders.The project "Collaborative and Stepped Care in Mental Health by Overcoming Treatment Sector Barriers" (COMET), which is being carried out by the Hamburg Network for Health Services Research (HAM-NET) from 2017 until 2020, examines an innovative, guideline-based healthcare model for the improvement of healthcare for patients with mental illnesses and their potential comorbidities. In this article this new stepped and collaborative care model for patients in primary care that integrates general practitioners, psychiatrists, psychotherapists, and hospitals is presented. For the implementation and facilitation of the model, guideline-based treatment pathways, a tablet-based computer program for screening, diagnostic and guideline-based treatment recommendations, as well as a web-based transferal platform were developed.The results of this project on the effectiveness and efficacy of the model can help determine if the model can be implemented in routine healthcare. This could represent a major step towards more integrated and cross-sectoral healthcare for patients with mental illnesses.
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http://dx.doi.org/10.1007/s00103-018-2865-1DOI Listing
February 2019

Two Unsupported Terminal Hydroxido Ligands in a μ-Oxo-Bridged Ferric Dimer: Protonation and Kinetic Lability Studies.

Inorg Chem 2018 Aug 31;57(16):10457-10468. Epub 2018 Jul 31.

Fakultät für Chemie , Universität Bielefeld , Universitätsstrasse 25 , D-33615 Bielefeld , Germany.

The dinuclear complex [(susan){Fe(OH)(μ-O)Fe(OH)}](ClO) (Fe(OH)(ClO); susan = 4,7-dimethyl-1,1,10,10-tetra(2-pyridylmethyl)-1,4,7,10-tetraazadecane) with two unsupported terminal hydroxido ligands and for comparison the fluorido-substituted complex [(susan){FeF(μ-O)FeF}](ClO) (FeF(ClO)) have been synthesized and characterized in the solid state as well in acetonitrile (CHCN) and water (HO) solutions. The Fe-OH bonds are strongly modulated by intermolecular hydrogen bonds (1.85 and 1.90 Å). UV-vis-near-IR (NIR) and Mössbauer spectroscopies prove that FeF and Fe(OH) retain their structural integrity in a CHCN solution. The OH ligand induces a weaker ligand field than the F ligand because of stronger π donation. This increased electron donation shifts the potential for the irreversible oxidation by 610 mV cathodically from 1.40 V in FeF to 0.79 V versus Fc/Fc in Fe(OH). Protonation/deprotonation studies in CHCN and aqueous solutions of Fe(OH) provide two reversible acid-base equilibria. UV-vis-NIR, Mössbauer, and cryo electrospray ionization mass spectrometry experiments show conservation of the mono(μ-oxo) bridging motif, while the terminal OH ligands are protonated to HO. Titration experiments in aqueous solution at room temperature provide the p K values as p K = 4.9 and p K = 6.8. Kinetic studies by temperature- and pressure-dependent O NMR spectrometry revealed for the first time the water-exchange parameters [ k = (3.9 ± 0.2) × 10 s, Δ H = 39.6 ± 0.2 kJ mol, Δ S = -5.1 ± 1 J mol K, and Δ V = +3.0 ± 0.2 cm mol] and the underlying I mechanism for a {Fe(OH)(μ-O)Fe(OH)} core. The same studies suggest that in solution the monoprotonated {Fe(OH)(μ-O)Fe(OH)} complex has μ-O and μ-OH bridges between the two Fe centers.
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http://dx.doi.org/10.1021/acs.inorgchem.8b01831DOI Listing
August 2018

Reversible Carboxylate Shift in a μ-Oxo Diferric Complex in Solution by Acid-/Base-Addition.

Inorg Chem 2018 May 10;57(9):5400-5405. Epub 2018 Apr 10.

Lehrstuhl für Anorganische Chemie I, Fakultät für Chemie , Universität Bielefeld , Universitätsstrasse 25 , D-33615 Bielefeld , Germany.

A reversible carboxylate shift has been observed in a μ-oxo diferric complex in solution by UV-vis-NIR and FTIR spectroscopy triggered by the addition of a base or an acid. A terminal acetate decoordinates upon the addition of a proton, resulting in a shift of the remaining terminal acetato to a μ-η:η bridge. The addition of a base restores the original structure containing only terminal acetates. The implications for metalloenzymes with carboxylate-bridged nonheme diiron active sites are discussed.
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http://dx.doi.org/10.1021/acs.inorgchem.8b00376DOI Listing
May 2018

[Social problems in primary health care - prevalence, responses, course of action, and the need for support from a general practitioners' point of view].

Z Evid Fortbild Qual Gesundhwes 2018 04 3;131-132:81-89. Epub 2018 Mar 3.

Institut und Poliklinik für Allgemeinmedizin, Universitätsklinikum Hamburg-Eppendorf, Hamburg, Deutschland.

Background: Very often patients utilize primary care services for health conditions related to social problems. These problems, which are not primarily medical, can severely influence the course of an illness and its treatment. Little is known about the extent to which problems like unemployment or loneliness occur in a general practice setting.

Objectives: What are the most frequent health-related social problems perceived by general practitioners (GPs)? How are these problems associated with GP- or practice characteristics? How do general practitioners deal with the social problems they perceive and what kind of support do they need?

Materials And Methods: Cross-sectional, postal questionnaire survey with questions derived from "Chapter Z social problems" of the International Classification of Primary Care - 2 edition. The questionnaire was mailed to available GP addresses in the federal states of Hamburg (n=1,602) and Schleswig-Holstein (n=1,242).

Results: N=489 questionnaires (17.2 %) were analyzed. At least three times a week, GPs were consulted by patients with poverty/financial problems (53.4 %), work/unemployment problems (43.7 %), patients with loneliness (38.7 %) as well as partnership issues (25.5 %). Only rarely did GPs report having perceived assault/harmful event problems (0.8 %). The highest frequency of problems was encountered by practices with a high proportion of a migrant population.

Conclusions: Social problems are a common issue in routine primary care. GPs in Northwestern Germany usually try to find internal solutions for social problems but also indicated further interest in institutionalized support. A possible approach to solving these issues are community-based, locally organized networks.
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http://dx.doi.org/10.1016/j.zefq.2018.01.008DOI Listing
April 2018

Cost-utility of collaborative nurse-led self-management support for primary care patients with anxiety, depressive or somatic symptoms: A cluster-randomized controlled trial (the SMADS trial).

Int J Nurs Stud 2018 Apr 29;80:67-75. Epub 2017 Dec 29.

Department of Health Economics and Health Services Research, Hamburg Center for Health Economics, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.

Background: Anxiety, depressive and somatoform disorders are highly prevalent and cause a huge economic burden. A nurse-led collaborative care intervention has been set up in order to improve self-management of patients with these mental disorders in primary care in Hamburg, Germany. The aim of this study was to determine the cost-utility of this nurse-led intervention from the health care payer perspective.

Methods: This analysis was part of a 12-month cluster-randomized controlled trial aiming to increase perceived self-efficacy of primary care patients with anxiety, depressive or somatic symptoms by collaborative nurse-led self-management support compared with routine care. A cost-effectiveness analysis using quality-adjusted life years was performed. Net-monetary benefit regressions adjusted for baseline differences for different willingness-to-pay thresholds were conducted and cost-effectiveness acceptability curves were constructed.

Results: In total, n = 325 patients (intervention group: n = 134; control group: n = 191) with a mean age of 40 from 20 primary care practices were included in the analysis. The adjusted differences in quality-adjusted life years and mean total costs between intervention group and control group were +0.02 and +€1145, respectively. Neither of the two differences was statistically significant. The probability for cost-effectiveness of the complex nurse-led intervention was 49% for a willingness-to-pay of €50,000 per additional quality-adjusted life year. The probability for cost-effectiveness did not exceed 65%, independent of the willingness-to-pay.

Conclusion: The complex nurse-led intervention promoting self-management for primary care patients with anxiety, depressive or somatic symptoms did not prove to be cost-effective relative to routine care from a health care payer perspective.
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http://dx.doi.org/10.1016/j.ijnurstu.2017.12.010DOI Listing
April 2018

Male and female residents in postgraduate medical education - A gender comparative analysis of differences in career perspectives and their conditions in Germany.

GMS J Med Educ 2017 15;34(5):Doc53. Epub 2017 Nov 15.

Universitätsklinikum Hamburg-Eppendorf, Institut für Allgemeinmedizin, Hamburg, Germany.

This article focuses on the gender-specific career differences of residents in their postgraduate medical education in Germany. In particular the structural obstacles female physicians have to overcome during residency are investigated. Moreover, the study examines the position preferences of male and female physicians in the hospital and in how far occupational self-efficacy corresponds to the interest in a hospital leading position. The KarMed-Study's database consists of annual postal surveys throughout the entire residency of medical students, who were in their "Practical Year" in 2008/2009. Descriptive statistics and regression models were used in the analysis. Male and female physicians differ in terms of their preferred work place (hospital, ambulatory care, others), hospital position and working hours. Female physicians prefer part-time work and rarely assume leading positions compared to male physicians. In addition, female physicians, especially those with children, need more time to complete their postgraduate training. Female physicians with children are burdened and disadvantaged more often than their female colleagues without children as well as male physicians in general (e.g. belated start and completion of residency, lower rate of doctorate titles, higher quota of part-time contracts, short-term employment contracts, and higher rates of residency interruption or termination). Besides gender and doctorate title, the occupational self-efficacy expectation has an influence on the preference of leading positions in hospitals. Respondents with a low occupational self-efficacy score are less likely to strive for leading positions with more responsibilities than those with a high score. The results demonstrate clear gender disparities in postgraduate training. Female physicians, especially those with children, are disadvantaged in various areas when compared with their male colleagues. In particular, the low rate of doctorate titles and the low score of self-efficacy expectation are associated negatively with the willingness to aim at leading positions in hospitals. Special measures and programmes should be developed for female physicians to counteract these differences.
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http://dx.doi.org/10.3205/zma001130DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5704604PMC
November 2018

Diagnostic barriers for somatic symptom disorders in primary care: study protocol for a mixed methods study in Germany.

BMJ Open 2017 08 11;7(8):e014157. Epub 2017 Aug 11.

Psychosomatic Medicine and Psychotherapy, University Medical Center Hamburg-Eppendorf and Schön Clinic Hamburg Eilbek, Hamburg, Germany.

Introduction: Somatoform or somatic symptom disorders ((S)SD) are common and have a negative impact on the patients' health-related quality of life, healthcare use and costs. In primary care, which is central to the management of (S)SD, diagnosis and treatment tend to be delayed. There is a significant lack of evidence regarding the barriers in the diagnostic process of (S)SD in primary care and how interventions should be tailored to address them. The aim of this study is to analyse the diagnostic process in primary care that results in the diagnosis or non-diagnosis of a (S)SD.

Methods And Analysis: This mixed methods study will investigate the topic with qualitative methods, subsequently proceeding to a quantitative phase where the initial results will be validated and/or generalised. First, focus groups will explore meanings and patterns, inconsistencies and conflicts in general practitioners' (GPs) thoughts and behaviours when diagnosing (S)SD. Second, the results of these focus groups will be used to develop interview guidelines for subsequent face-to-face interviews. Patients and their treating GPs will be interviewed separately on how they experience the history of illness, the diagnostic process and treatment. Third, based on the results of the first two study parts, a questionnaire will be derived and a nationwide survey among German GPs will be conducted, quantifying the barriers and difficulties identified before.

Ethics And Dissemination: Ethics approval was obtained from the Ethics Committee of the Hamburg Medical Association, Germany (approval number PV4763). The results of this study will be disseminated through conference presentation and publications in peer-reviewed journals.

Trial Registration Number: The study is registered in the German Clinical Trial Register (DRKS), DRKS-ID DRKS00009736.
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http://dx.doi.org/10.1136/bmjopen-2016-014157DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5724128PMC
August 2017

Master Maker: Understanding Gaming Skill Through Practice and Habit From Gameplay Behavior.

Top Cogn Sci 2017 04 15;9(2):437-466. Epub 2017 Feb 15.

Microsoft Research.

The study of expertise is difficult to do in a laboratory environment due to the challenge of finding people at different skill levels and the lack of time for participants to acquire mastery. In this paper, we report on two studies that analyze naturalistic gameplay data using cohort analysis to better understand how skill relates to practice and habit. Two cohorts are analyzed, each from two different games (Halo Reach and StarCraft 2). Our work follows skill progression through 7 months of Halo matches for a holistic perspective, but also explores low-level in-game habits when controlling game units in StarCraft 2. Players who played moderately frequently without long breaks were able to gain skill the most efficiently. What set the highest performers apart was their ability to gain skill more rapidly and without dips compared to other players. At the beginning of matches, top players habitually warmed up by selecting and re-selecting groups of units repeatedly in a meaningless cycle. They exhibited unique routines during their play that aided them when under pressure.
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http://dx.doi.org/10.1111/tops.12251DOI Listing
April 2017

A Mixed-Valence Fluorido-Bridged FeFe Complex.

Inorg Chem 2017 Feb 27;56(4):1779-1782. Epub 2017 Jan 27.

Lehrstuhl für Anorganische Chemie I, Fakultät für Chemie, Universität Bielefeld ,D-33615 Bielefeld, Germany.

The reaction of the new dinucleating ligand susan with Fe(BF)·6HO results in formation of the homovalent FeFe complex [(susan){Fe(μ-F)Fe}] and the mixed-valence FeFe complex [(susan){FeF(μ-F)FeF}] depending on the absence or presence of dioxygen, respectively. Complex [(susan){FeF(μ-F)FeF}] is the first molecular mixed-valence complex with a fluorido bridge. The short Fe-μ-F bond of 1.87 Å causes a large reorganization energy, resulting in a localized class II system with an intervalence charge-transfer band of high energy at 10000 cm.
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http://dx.doi.org/10.1021/acs.inorgchem.6b03093DOI Listing
February 2017

Collaborative nurse-led self-management support for primary care patients with anxiety, depressive or somatic symptoms: Cluster-randomised controlled trial (findings of the SMADS study).

Int J Nurs Stud 2016 Nov 21;63:101-111. Epub 2016 Aug 21.

Department of General Practice / Primary Care, Center for Psychosocial Medicine, University Medical Center Hamburg-Eppendorf, Martinistr. 52, 20246 Hamburg, Germany. Electronic address:

Background: Collaborative, nurse-led care is a well-established model of ambulatory care in many healthcare systems. Nurses play a key role in managing patients' conditions as well as in enhancing symptom- and self-management skills.

Objective: The SMADS trial evaluated the effectiveness of a primary care-based, nurse-led, complex intervention to promote self-management in patients with anxiety, depressive or somatic symptoms. Change in self-efficacy 12 months post baseline was used as the primary outcome.

Design: The SMADS trial set up a two-arm, cluster randomised controlled trial in the city of Hamburg, a large metropolitan area in the North West of Germany.

Setting: We randomly allocated participating primary care practices to either the intervention group (IG), implementing a nurse-led collaborative care model, or to the control group (CG), where patients with the above psychosomatic symptoms received routine treatment.

Participants: Patients from 18 to 65 years of age, regularly consulting a participating primary care practice, scoring≥5 on the anxiety, depressive or somatic symptom scales of the Patient Health Questionnaire (PHQ-D), German version.

Methods: A mixed model regression approach was used to analyse the outcome data. Analyses were based on the intention-to-treat population: All enrolled patients were analysed at their follow-up. Additionally, we reported results as effect sizes. The robustness of the results was investigated by performing an observed cases analysis.

Results: 325 participants (IG N=134, CG N=191) from ten practices in each study arm consented to take part and completed a baseline assessment. The mean group difference (ITT-LOCF, IG vs. CG) in self-efficacy at the post baseline follow-up (median 406days) was 1.65 points (95% CI 0.50-2.8) in favour of IG (p=0.004). This amounts to a small Cohen's d effect size of 0.33. An observed cases analysis (168 participants, IG=56, CG=105) resulted in a mean difference of 3.13 (95% CI 1.07-5.18, p=0.003) between the groups, amounting to a moderate effect size of d=0.51.

Conclusion: A complex, nurse-led intervention, implemented as a collaborative care model, increased perceived self-efficacy in patients with symptoms of anxiety, depression or somatisation compare to control patients. For the first time in the German healthcare system, the SMADS trial validated the belief that a nurse can successfully complement the work of a general practitioner - particularly in supporting self-management of patients with psychosomatic symptoms and their psychosocial needs.
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http://dx.doi.org/10.1016/j.ijnurstu.2016.08.007DOI Listing
November 2016

Design and synthesis of a dinucleating ligand system with varying terminal donor functions that provides no bridging donor and its application to the synthesis of a series of Fe(III)-μ-O-Fe(III) complexes.

Dalton Trans 2016 Feb;45(8):3340-61

Lehrstuhl für Anorganische Chemie I, Fakultät für Chemie, Universität Bielefeld, Universitätsstr. 25, D-33615 Bielefeld, Germany.

Based on a rational ligand design for stabilizing high-valent {Fe(μ-O)2Fe} cores, a new family of dinucleating bis(tetradentate) ligands with varying terminal donor functions has been developed: redox-inert biomimetic carboxylates in H4julia, pyridines in susan, and phenolates in H4hilde(Me2). Based on a retrosynthetic analysis, the ligands were synthesized and used for the preparation of their diferric complexes [(julia){Fe(OH2)(μ-O)Fe(OH2)}]·6H2O, [(julia){Fe(OH2)(μ-O)Fe(OH2)}]·7H2O, [(julia){Fe(DMSO)(μ-O)Fe(DMSO)}]·3DMSO, [(hilde(Me2)){Fe(μ-O)Fe}]·CH2Cl2, [(hilde(Me2)){FeCl}2]·2CH2Cl2, [(susan){FeCl(μ-O)FeCl}]Cl2·2H2O, [(susan){FeCl(μ-O)FeCl0.75(OCH3)0.25}](ClO4)2·0.5MeOH, and [(susan){FeCl(μ-O)FeCl}](ClO4)2·0.5EtOH, which were characterized by single-crystal X-ray diffraction, FTIR, UV-Vis-NIR, Mössbauer, magnetic, and electrochemical measurements. The strongly electron-donating phenolates afford five-coordination, while the carboxylates and pyridines lead to six-coordination. The analysis of the ligand conformations demonstrates a strong flexibility of the ligand backbone in the complexes. The different hydrogen-bonding in the secondary coordination sphere of [(julia){Fe(OH2)(μ-O)Fe(OH2)}] influences the C-O, C[double bond, length as m-dash]O, and Fe-O bond lengths and is reflected in the FTIR spectra. The physical properties of the central {Fe(μ-O)Fe} core (d-d, μ-oxo → Fe(III) CT, νas(Fe-O-Fe), J) are governed by the differences in terminal ligands - Fe(III) bonds: strongly covalent π-donation with phenolates, less covalent π-donation with carboxylates, and π-acceptation with pyridines. Thus, [(susan){FeCl(μ-O)FeCl}](2+) is oxidized at 1.48 V vs. Fc(+)/Fc, which is shifted to 1.14 V vs. Fc(+)/Fc by methanolate substitution, while [(julia){Fe(OH2)(μ-O)Fe(OH2)}] is oxidized ≤1 V vs. Fc(+)/Fc. [(hilde(Me2)){Fe(μ-O)Fe}] is oxidized at 0.36 V vs. Fc(+)/Fc to a phenoxyl radical. The catalytic oxidation of cyclohexane with TONs up to 39.5 and 27.0 for [(susan){FeCl(μ-O)FeCl}](2+) and [(hilde(Me2)){Fe(μ-O)Fe}], respectively, indicates the potential to form oxidizing intermediates.
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http://dx.doi.org/10.1039/c5dt03711eDOI Listing
February 2016

Effectiveness, tolerability and acceptance of a low-dosed estradiol/dienogest formulation (Lafamme 1 mg/2 mg) for the treatment of menopausal complaints: a non-interventional observational study over 6 cycles of 28 days.

Gynecol Endocrinol 2015 Jul 28;31(7):560-4. Epub 2015 Jul 28.

a Jenapharm GmbH & Co. KG, Medical Affairs , Jena , Germany and.

Background: Concern and controversy characterize nowadays the use of hormone therapy for management of patients with menopausal complaints. This observational non-interventional study examined the use of a marketed oral formulation containing 1 mg estradiol valerate and 2 mg dienogest for treatment of menopausal symptoms in 1292 women visiting 243 gynecological practices in Germany.

Methods: Score changes in the Menopausal Rating Scale (MRS) after three and six 28-day cycles were primary endpoints. Subjective reports on skin- and hair-related complaints and satisfaction with treatment effects were assessed. The incidence of adverse drug reactions (ADRs), adverse events (AEs) and vaginal bleeding was evaluated.

Results: MRS total score decreased substantially and stronger than the clinically relevant change of 5 points (p < 0.0001) as compared with baseline. Subjective skin- and hair-related complaints declined. No unexpected ADRs were reported. AEs (including ADRs) were registered in 8.8% of the participants; most frequent AEs/ADRs were postmenopausal hemorrhage (2.9%) and drug ineffective (1.4%). Nearly 76% of the subjects remained amenorrheic. Approximately 90% of the patients rated the medication's effectiveness/tolerability as good/very good; 84% intended to continue the treatment.

Conclusion: This low-dose estradiol/dienogest formulation proved efficient and well-tolerated option for the alleviation of menopausal symptoms associated with estrogen deficiency.
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http://dx.doi.org/10.3109/09513590.2015.1024220DOI Listing
July 2015

[Promoting Self-Management in Primary Care - the Association of Motivation for Change, Self-Efficacy and Psychological Distress Prior to the Onset of Intervention].

Psychiatr Prax 2015 Jul 2;42 Suppl 1:S44-8. Epub 2015 Jul 2.

Institut für Allgemeinmedizin, Zentrum für Psychosoziale Medizin, Universitätsklinikum Hamburg-Eppendorf.

Anxiety, depressive and somatoform disorders are highly prevalent in primary care. Managing these disorders is time-consuming and requires strong commitment on behalf of the general practitioners (GPs). Furthermore, the resources for the management of these patients are limited by the increasing workload in primary care practices, especially in the German health care system. In order to address the SMADS-study within psychenet - the Hamburg Network for Mental Health (NCT01726387) implements and evaluates a complex, low-threshold, nurse-led intervention using a goal-oriented set of case management and counseling techniques to promote self-management in these patients. This paper investigates the association of the patients' motivation for change and their perceived self-efficacy, the primary outcome - to get to know whether the intervention will target the appropriate population.
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http://dx.doi.org/10.1055/s-0034-1387686DOI Listing
July 2015

Loads and loads and loads: the influence of prospective load, retrospective load, and ongoing task load in prospective memory.

Front Hum Neurosci 2015 2;9:322. Epub 2015 Jun 2.

Institute of Psychology and Center for Cognition, Learning and Memory, University of Bern Bern, Switzerland.

In prospective memory tasks different kinds of load can occur. Adding a prospective memory task can impose a load on ongoing task performance. Adding ongoing task load (OTL) can affect prospective memory performance. The existence of multiple target events increases prospective load (PL) and adding complexity to the to-be-remembered action increases retrospective load (RL). In two experiments, we systematically examined the effects of these different types of load on prospective memory performance. Results showed an effect of PL on costs in the ongoing task for categorical targets (Experiment 2), but not for specific targets (Experiment 1). RL and OTL both affected remembering the retrospective component of the prospective memory task. We suggest that PL can enhance costs in the ongoing task due to additional monitoring requirements. RL and OTL seem to impact the division of resources between the ongoing task and retrieval of the retrospective component, which may affect disengagement from the ongoing task. In general, the results demonstrate that the different types of load affect prospective memory differentially.
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http://dx.doi.org/10.3389/fnhum.2015.00322DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4451344PMC
June 2015

Diverse Genotypes of Yersinia pestis Caused Plague in Madagascar in 2007.

PLoS Negl Trop Dis 2015 Jun 12;9(6):e0003844. Epub 2015 Jun 12.

Bundeswehr Institute of Microbiology & German Center for Infectious Diseases, Munich, Germany.

Background: Yersinia pestis is the causative agent of human plague and is endemic in various African, Asian and American countries. In Madagascar, the disease represents a significant public health problem with hundreds of human cases a year. Unfortunately, poor infrastructure makes outbreak investigations challenging.

Methodology/principal Findings: DNA was extracted directly from 93 clinical samples from patients with a clinical diagnosis of plague in Madagascar in 2007. The extracted DNAs were then genotyped using three molecular genotyping methods, including, single nucleotide polymorphism (SNP) typing, multi-locus variable-number tandem repeat analysis (MLVA), and Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) analysis. These methods provided increasing resolution, respectively. The results of these analyses revealed that, in 2007, ten molecular groups, two newly described here and eight previously identified, were responsible for causing human plague in geographically distinct areas of Madagascar.

Conclusions/significance: Plague in Madagascar is caused by numerous distinct types of Y. pestis. Genotyping method choice should be based upon the discriminatory power needed, expense, and available data for any desired comparisons. We conclude that genotyping should be a standard tool used in epidemiological investigations of plague outbreaks.
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http://dx.doi.org/10.1371/journal.pntd.0003844DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4466568PMC
June 2015

First data from the German Lipoprotein Apheresis Registry (GLAR).

Atheroscler Suppl 2015 May;18:41-4

Scientific Institute for Nephrology (WiNe), Düsseldorf, Germany.

Objective: In recent years the Federal Joint Committee (G-BA), a paramount decision-making body of the German health care system challenged the approval of diagnostic and therapeutic procedures for regular reimbursement, including lipoprotein apheresis therapy. Years before an interdisciplinary German apheresis working group, established by members of both German Societies of Nephrology (Verband Deutsche Nierenzentren (VDN), Deutsche Gesellschaft für Nephrologie (DGfN)), initiated a revision of the indication of lipoprotein apheresis therapy according to current guidelines and recommendations for the treatment of lipid disorders. This working group was convinced, that data derived from a registry would support lipoprotein apheresis as a therapy for severe hyperlipidemic patients suffering from progressive cardiovascular diseases.

Methods And Results: In 2009 the working group established the indication for lipoprotein apheresis with respect to current cardiovascular guidelines and scientific knowledge for the registry, which are in line with the reimbursement guidelines. In 2011 financing by sponsors was secured and an internet-based registry was created. A pilot project with 5 apheresis centers finished in 2012 - since then the registry is available to all German apheresis centers.

Conclusions: There has been consensus between the medical societies and health care carriers regarding the need for a German Lipoprotein Apheresis Registry (GLAR). The launch of this registry complies with requirements of the Federal Joint Committee (G-BA). Complementing the Pro(a)LiFe-Study, first data from GLAR support the safety of the different apheresis treatment procedures. In addition these first data suggest, with respect to the results of Pro(a)LiFe-Study, effectiveness in preventing cardiovascular progression as well. Here, further data are needed to statistically substantiate these early findings.
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http://dx.doi.org/10.1016/j.atherosclerosissup.2015.02.006DOI Listing
May 2015

Impact of the German Lipoprotein Apheresis Registry (DLAR) on therapeutic options to reduce increased Lp(a) levels.

Clin Res Cardiol Suppl 2015 Apr;10:14-20

Centre of Nephrology Göttingen GbR, An der Lutter 24, 37075, Göttingen, Germany,

Background: The German Lipoprotein Apheresis Registry (DLAR) has been initiated by members of the Nephrology Foundation (WiNe), the German association of kidney centres (DN), the German society of nephrology (DGfN) and additional medical associations taking part in the apheresis working group. Its goal is the introduction of a substantial database, suitable to provide statistical evidence for the assessment of extracorporeal procedures. Data have been added to the DLAR since October 2011. In this article, preliminary results are first reported.

Methods And Results: Data are stored on a secured Internet platform. The recorded information comprises mean values and rates of change in lipid levels (cholesterol, triglyceride, low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol, lipoprotein(a) (Lp(a)) before and after apheresis therapy, blood/plasma volume, frequency and type of adverse effects, medication, vascular events, diagnoses and comorbidity. It is collected by participating apheresis centres from all over Germany. Up until October 2014, a total of 7946 lipoprotein apheresis (LA) treatments of 991 patients (787 with documented LDL-C and 688 with documented Lp(a) levels) via 96 medical accounts were documented and analysed. The current share of Lp(a) patients is 50.6 % (Lp(a) ≥ 60 mg/dl; n = 348/688). For both LDL-C and Lp(a), lowering rates exceeding 60 % have been observed. Likely in conjunction with these reduction rates, the preliminary analysis shows a 90 % decline in major adverse coronary events (MACE) as well as a decrease in major adverse non-coronary events (MANCE) by 69 %. As before, good tolerability and low rates of adverse effects (< 3 %) of LA therapy were found.

Conclusions: The available numbers suggest in parts very good response by the participating centres to the DLAR. Unfortunately, there are also centres that have not documented any patients so far or LA treatments at all. The benchmark values for reduction rates in lipoprotein concentration required by the directives of the German Federal Joint Committee (G-BA) have all been met. The decrease in MACE and MANCE rates currently observed is very promising. However, the comparably short runtime of the registry does not allow for high confidence in the current results. Certainly, reliable data will be extractable in the coming years. Given the high interest expressed by European neighbours, the extension of the registry to the European level should be a future goal for the DLAR as well.
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http://dx.doi.org/10.1007/s11789-015-0073-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4361719PMC
April 2015

Determination of aromatic amines in human urine using comprehensive multi-dimensional gas chromatography mass spectrometry (GCxGC-qMS).

Anal Bioanal Chem 2015 Jan 21;407(1):241-52. Epub 2014 Aug 21.

Instrumental Analytical Chemistry, University of Duisburg-Essen, Universitätstrasse 5, 45141, Essen, Germany.

Aromatic amines are an important class of harmful components of cigarette smoke. Nevertheless, only few of them have been reported to occur in urine, which raises questions on the fate of these compounds in the human body. Here we report on the results of a new analytical method, in situ derivatization solid phase microextraction (SPME) multi-dimensional gas chromatography mass spectrometry (GCxGC-qMS), that allows for a comprehensive fingerprint analysis of the substance class in complex matrices. Due to the high polarity of amino compounds, the complex urine matrix and prevalence of conjugated anilines, pretreatment steps such as acidic hydrolysis, liquid-liquid extraction (LLE), and derivatization of amines to their corresponding aromatic iodine compounds are necessary. Prior to detection, the derivatives were enriched by headspace SPME with the extraction efficiency of the SPME fiber ranging between 65 % and 85 %. The measurements were carried out in full scan mode with conservatively estimated limits of detection (LOD) in the range of several ng/L and relative standard deviation (RSD) less than 20 %. More than 150 aromatic amines have been identified in the urine of a smoking person, including alkylated and halogenated amines as well as substituted naphthylamines. Also in the urine of a non-smoker, a number of aromatic amines have been identified, which suggests that the detection of biomarkers in urine samples using a more comprehensive analysis as detailed in this report may be essential to complement the approach of the use of classic biomarkers.
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http://dx.doi.org/10.1007/s00216-014-8080-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4281360PMC
January 2015

Effectiveness, tolerability and acceptance of an oral estradiol/levonorgestrel formulation for the treatment of menopausal complaints: a non-interventional observational study over six cycles of 28 days.

Gynecol Endocrinol 2014 Oct 6;30(10):712-6. Epub 2014 Jun 6.

Medical Affairs, Jenapharm GmbH & Co. KG , Jena , Germany.

Background: Use of hormone therapy for menopausal complaints is a subject of controversy and increased uncertainty and concerns. This non-interventional study aimed to investigate a marketed oral formulation containing 1 mg estradiol and 0.04 mg levonorgestrel for continuous treatment of menopausal symptoms for approximately 6 months in women visiting gynecological practices in Germany.

Methods: Changes in the menopause rating scale (MRS) total and sub-domain scores after three and six 28-d cycles served as primary endpoint. Skin- and hair-related complaints, quality of sexual life and subjective satisfaction with the treatment were assessed. Adverse drug reactions (ADRs), adverse events (AEs) and vaginal bleeding were evaluated.

Results: MRS scores improved significantly above 5 points of clinical relevance as compared to baseline (n = 736, p < 0.0001). Skin- and hair-related symptoms abated; quality of sexual life improved. AEs were registered in 9.9% of the participants. No unexpected ADRs were reported. Bleeding episodes consistently decreased; >75% of the subjects were amenorrheic throughout the study. Medication's effectiveness and tolerability was rated very good/good by >80% of the participants, who also continued treatment.

Conclusion: This estradiol/low-dose levonorgestrel formulation safely alleviates menopausal symptoms in peri- and postmenopausal women with add-on benefits regarding dermatological and sexual life complaints.
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http://dx.doi.org/10.3109/09513590.2014.925867DOI Listing
October 2014

Effectiveness of a primary care based complex intervention to promote self-management in patients presenting psychiatric symptoms: study protocol of a cluster-randomized controlled trial.

BMC Psychiatry 2014 Jan 3;14. Epub 2014 Jan 3.

Department of Primary Medical Care, Center for Psychosocial Medicine, University Medical Center Hamburg-Eppendorf, Martinistr, 52, Hamburg 20246, Germany.

Background: Anxiety, Depression and Somatoform (ADSom) disorders are highly prevalent in primary care. Managing these disorders is time-consuming and requires strong commitment on behalf of the General Practitioners (GPs). Furthermore, the management of these patients is restricted by the high patient turnover rates in primary care practices, especially in the German health care system.In order to address this problem, we implement a complex, low-threshold intervention by an Advanced Practice Nurse (APN) using a mixture of case management and counseling techniques to promote self-management in these patients. Here we present the protocol of the "Self-Management Support for Anxiety, Depression and Somatoform Disorders in Primary Care" (SMADS)-Study.

Methods/design: The study is designed as a cluster-randomized controlled trial, comparing an intervention and a control group of 10 primary care practices in each case. We will compare the effectiveness of the intervention applied by an APN with usual GP-care. A total of 340 participants will be enrolled in the study, 170 in either arm. We use the Patient Health Questionnaire-German version (PHQ-D) as a screening tool for psychiatric symptoms, including patients with a score above 5 on any of the three symptom scales. The primary outcome is self-efficacy, measured by the General Self-Efficacy Scale (GSE), here used as a proxy for self-management. As secondary outcomes we include the PHQ-D symptom load and questionnaires regarding coping with illness and health related quality of life. Outcome assessments will be applied 8 weeks and 12 months after the baseline assessment.

Discussion: The SMADS-study evaluates a complex, low threshold intervention for ambulatory patients presenting ADSom-symptoms, empowering them to better manage their condition, as well as improving their motivation to engage in self-help and health-seeking behaviour. The benefit of the intervention will be substantiated, when patients can enhance their expected self-efficacy, reduce their symptom load and engage in more self-help activities to deal with their everyday lives. After successfully evaluating this psychosocial intervention, a new health care model for the management of symptoms of anxiety, depression and somatoform disorders for ambulatory patients could emerge, supplementing the work of the GP.

Trial Registration: Clinicaltrials.gov Identifier: NCT01726387.
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http://dx.doi.org/10.1186/1471-244X-14-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3898061PMC
January 2014

Patient preferences for outcomes of depression treatment in Germany: a choice-based conjoint analysis study.

J Affect Disord 2013 Jun 3;148(2-3):210-9. Epub 2013 Jan 3.

Health Outcomes, Lilly Deutschland GmbH, Bad Homburg, Germany.

Background: In general, treatment efficacy in depressed patients is evaluated mainly based on the core symptoms of depression. However, patients might consider different outcomes. This study used choice-based conjoint analysis (CBC) to evaluate patient preferences for depression treatment outcomes.

Methods: Adult subjects from Germany, currently or previously on antidepressant treatment, were presented with 18 pairs of hypothetical treatment outcome scenarios, differing in eight attributes (2-3 factor levels each): depressed mood, loss of interest and enjoyment, loss of energy/fatigue, sleep disturbance, feelings of guilt, depression-related pain, treatment duration, side effects after 2 weeks. Attributes and factor levels were defined by literature review, expert consultations, and in-depth subject interviews. Data were analyzed using multinomial logit modeling; individual part-worth utilities were estimated using hierarchical Bayes routines.

Results: Two hundred twenty-seven subjects (89.4% currently treated with antidepressants, 30.0% with depression-related pain) completed the survey. They valued the relative importance of outcomes as follows: loss of energy/fatigue 18.5%, side effects after 2 weeks 14.2%, loss of interest and enjoyment 13.5%, depression-related pain 12.0%, sleep disturbance 12.0%, feelings of guilt 11.5%, treatment duration 9.9%, depressed mood 8.5%.

Limitations: Participants were not required to meet ICD-10 or DSM-IV criteria for depression and had heterogeneous disease severity.

Conclusions: CBC analysis was able to reveal patient preferences for outcomes of depression treatment. Subjects valued the ability to cope with activities of everyday living highest. They considered being free of depression-related pain and side effects more important than being free of depressed mood. These findings should be considered when making treatment decisions.
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http://dx.doi.org/10.1016/j.jad.2012.11.062DOI Listing
June 2013

Recommendations on bioanalytical method stability implications of co-administered and co-formulated drugs by Global CRO Council for Bioanalysis (GCC).

Bioanalysis 2012 Sep;4(17):2117-26

Advion Bioanalytical Laboratories, Quintiles, NY, USA.

An open letter written by the Global CRO Council for Bioanalysis (GCC) describing the GCC survey results on stability data from co-administered and co-formulated drugs was sent to multiple regulatory authorities on 14 December 2011. This letter and further discussions at different GCC meetings led to subsequent recommendations on this topic of widespread interest within the bioanalytical community over the past 2 years.
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http://dx.doi.org/10.4155/bio.12.192DOI Listing
September 2012

Depression treatment with duloxetine and reduction of inability to work.

Depress Res Treat 2012 2;2012:264854. Epub 2012 Aug 2.

Medical Department, Lilly Deutschland GmbH, 61352 Bad Homburg, Germany.

Data on inability to work from an observational study in patients treated with duloxetine for major depressive disorder in clinical practice in Germany were collected. Ability to work was compared between baseline and up to 6 months after initiation of duloxetine. All patients with a working status at baseline other than retired or retired early were included. 2,825 patients were analyzed, 54.8% were able to work at baseline increasing to 83.8% at 6 months. Of those patients unable to work at baseline, 72.7% were able to work after 6 months. A relevant reduction of inability to work was also found for patient subgroups with moderate to severe pain at baseline and those with and without MDD pretreatment. As inability to work is one of the main cost drivers for depressive patients in Germany, the reduction of inability to work could potentially result in considerable cost savings for health insurance companies and society.
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http://dx.doi.org/10.1155/2012/264854DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3419398PMC
August 2012

Rapid resolution liquid chromatography for monitoring the quality of stockpiled atropine preparations for injection.

Drug Test Anal 2012 Mar-Apr;4(3-4):222-8

Central Institute of the Bundeswehr Medical Service Munich, Ingolstaedter Landstrasse 102, Garching Hochbrück, Germany.

We describe a rapid resolution liquid chromatography (RRLC) method for analyzing atropine sulfate, its degradation products (tropic acid, apoatropine, atropic acid) and other components (e.g. phenol, methylparaben) in injectable medicines that are used by the German armed forces in emergency situations. Chromatography is performed using an acetonitrile/phosphate buffer gradient (pH = 1.0) and an RP 18 column (50 x 4.6 mm, 1.8 µm) with the detection wavelength set at 220 nm. The concentration of the active ingredient (atropine sulfate) in the tested products ranges from about 1 mg•ml(-1) to 10 mg•ml(-1) . The concentrations of the detected degradation products range from 0.2% to 4.7% (tropic acid) in relation to the active pharmaceutical ingredient (API). Using shorter separation columns and smaller particle sizes of the stationary phase improved analysis time from 40 to 10 min and reduced the consumption of solvents by approximately 75%. Owing to the pressure conditions (< 200 bar), UHPLC (ultra high performance liquid chromatography) systems are not needed. Comparison of the atropine and tropic acid results obtained with the previously used HPLC (high performance liquid chromatography) method of the MAH (marketing authorization holder) show that there is no indication of a significant difference between the two methods.
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http://dx.doi.org/10.1002/dta.402DOI Listing
July 2012