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1.  Evaluation of clinical trials by Ethics Committees in Germany – results and a comparison of two surveys performed among members of the German Association of Research-Based Pharmaceutical Companies (vfa) 
GMS German Medical Science  2015;13:Doc02.
Objective: The objective of this project was to evaluate the quality and quantity of initial applications for a clinical trial according to § 7 of the German Good Clinical Practice (GCP) ordinance (German: GCP-Verordnung, GCP-V), the quality of evaluations of those applications by Ethics Committees (ECs)/Investigational Review Boards (IRBs) in Germany as well as the pattern of EC objections in their reasoned opinions (vote). In order to identify a change over time, the results of the present survey were also compared with a survey performed in 2008.
Methods: Based on reasoned opinions issued by the respective EC in charge of the coordinating principle investigator (coordinating EC) in 2011, a written survey among members of the German Association of Research-Based Pharmaceutical Companies (vfa) was conducted in 2012. The answers to the questionnaire were analyzed descriptively. Since the data set collected in 2011 was structurally identical with the data set gained in 2007 both surveys were compared.
Results: Of the 24 companies represented on the vfa Clinical Research/Quality Assurance Subcommittee, 75% (18) took part in the survey. Survey evaluation was based on a total of 251 applications of these 18 companies submitted to 43 ECs. These account for about 21% of 1,214 applications for authorization of commercial and non-commercial phase I–IV clinical trials submitted to the regulatory authorities (BfArM and PEI) in 2011.
In comparison to 2007, a lower amount of applications (n=251 in 2011 vs. n=288 in 2007) was submitted to a slightly higher number of ECs (43 in 2011 vs. 40 in 2007). The amount of objections increased by 21% from 1,299 (2007) to 1,574 (2011) resulting in an average of 4.5 (2007) vs. 6.3 (2011) objections per application. Overall, the analysis of both formal and content related objections revealed almost the same pattern as in the previous survey. In total, the most frequent objections applied to the patient information and consent form followed in descending order by trial protocol content, miscellaneous, other application documents pursuant to § 7 (2) and (3) GCP-V, formal deficiencies pursuant to § 8 (1) GCP-V, and investigator and site qualifications. A trend towards a slightly increased rate of objections concerning patient information and consent form (+4%) and a minimal decrease in objections concerning investigator and site qualifications (–2%) was observed.
As in 2007, about 1 in 6 applications was still incomplete with formal objections. Whilst the proportion of study applications with objections related to the patient information and consent form (+7.2%), the trial protocol content (+11.6%), and documents according to § 7 (2) and (3) GCP-V (+11.8%) increased in 2011 compared to 2007, the amount of study applications with objections related to the investigator and site qualifications decreased by 6.3%.
Conclusions: The majority of findings with respect to quantity, quality and main focus of objections reported in the first survey in 2008 were also found in 2012, indicating a shared understanding of applicable measures and criteria by sponsors and ECs on how to ensure patient rights and well-being, data integrity, and high quality documentation in clinical trials.
doi:10.3205/000206
PMCID: PMC4311050
Ethics Committees; application procedure; formal and content-related objections; clinical trials
2.  Risk of hypoglycaemia in type 2 diabetes patients under different insulin regimens: a primary care database analysis 
GMS German Medical Science  2015;13:Doc01.
Aims: To compare rates and predictors of documented hypoglycaemia in type 2 diabetes patients treated with either basal insulin supported oral therapy (BOT), conventional therapy (CT) or supplementary insulin therapy (SIT) in primary care.
Methods: Data from 10,842 anonymous patients (mean age ± SD: 54 ± 8 yrs) on BOT, 2,407 subjects (56 ± 7 yrs) on CT, and 7,480 patients (52 ± 10 yrs) using SIT from 1,198 primary care practices were retrospectively analyzed (Disease Analyzer, Germany: 01/2005–07/2013). Stepwise logistic regression (≥1 documented hypoglycaemia: ICD code) was used to evaluate risk factors of hypoglycemia.
Results: The unadjusted rates (95% CI) per 100 patient-years of documented hypoglycaemia were 1.01 (0.80–1.20) (BOT), 1.68 (1.10–2.30) (CT), and 1.61 (1.30–1.90) (SIT), respectively. The odds of having ≥1 hypoglycemia was increased for CT (OR; 95% CI: 1.71; 1.13–2.58) and SIT (1.55; 1.15–2.08) (reference: BOT). Previous hypoglycemia (OR: 11.24; 6.71–18.85), duration of insulin treatment (days) (1.06; 1.05–1.07), history of transient ischemic attack (TIA)/stroke (1.91; 1.04–3.50), and former salicylate prescriptions (1.44; 1.06–1.98) also showed an increased odds of having hypoglycemia. Higher age was associated with a slightly lower odds ratio (per year: 0.98; 0.97–0.99).
Conclusions: Insulin naïve type 2 diabetes patients in primary care, initiated with CT and SIT have an increased risk of hypoglycaemia compared to BOT, which is in line with previous randomized controlled trials. As hypoglycaemic events are associated with an increased mortality risk, this real-world finding is of clinical relevance.
doi:10.3205/000205
PMCID: PMC4311049
insulin therapy; type 2 diabetes; hypoglycaemia; risk factors; primary care
3.  Voluntary peer review as innovative tool for quality improvement in the intensive care unit – a retrospective descriptive cohort study in German intensive care units 
GMS German Medical Science  2014;12:Doc17.
Introduction: Quality improvement and safety in intensive care are rapidly evolving topics. However, there is no gold standard for assessing quality improvement in intensive care medicine yet. In 2007 a pilot project in German intensive care units (ICUs) started using voluntary peer reviews as an innovative tool for quality assessment and improvement. We describe the method of voluntary peer review and assessed its feasibility by evaluating anonymized peer review reports and analysed the thematic clusters highlighted in these reports.
Methods: Retrospective data analysis from 22 anonymous reports of peer reviews. All ICUs – representing over 300 patient beds – had undergone voluntary peer review. Data were retrieved from reports of peers of the review teams and representatives of visited ICUs. Data were analysed with regard to number of topics addressed and results of assessment questionnaires. Reports of strengths, weaknesses, opportunities and threats (SWOT reports) of these ICUs are presented.
Results: External assessment of structure, process and outcome indicators revealed high percentages of adherence to predefined quality goals. In the SWOT reports 11 main thematic clusters were identified representative for common ICUs. 58.1% of mentioned topics covered personnel issues, team and communication issues as well as organisation and treatment standards. The most mentioned weaknesses were observed in the issues documentation/reporting, hygiene and ethics. We identified several unique patterns regarding quality in the ICU of which long-term personnel problems und lack of good reporting methods were most interesting
Conclusion: Voluntary peer review could be established as a feasible and valuable tool for quality improvement. Peer reports addressed common areas of interest in intensive care medicine in more detail compared to other methods like measurement of quality indicators.
doi:10.3205/000202
PMCID: PMC4270273  PMID: 25587245
peer review; critical care; patient safety; quality improvement; quality management
4.  Soy and phytoestrogens: possible side effects 
GMS German Medical Science  2014;12:Doc18.
Phytoestrogens are present in certain edible plants being most abundant in soy; they are structurally and functionally analogous to the estrogens. Phytoestrogens have been applied for compensation of hormone deficiency in the menopause. At the same time, soy products are used in infant food and other foodstuffs. Furthermore, soy is applied as animal fodder, so that residual phytoestrogens and their active metabolites such as equol can remain in meat and influence the hormonal balance of the consumers. There have been only singular reports on modified gender-related behavior or feminization in humans in consequence of soy consumption. In animals, the intake of phytoestrogens was reported to impact fertility, sexual development and behavior. Feminizing effects in humans can be subtle and identifiable only statistically in large populations.
doi:10.3205/000203
PMCID: PMC4270274  PMID: 25587246
phytoestrogens; soy; menopause; nutrition
5.  GMS German Medical Science: Best Paper Award 2013 
GMS German Medical Science  2014;12:Doc19.
doi:10.3205/000204
PMCID: PMC4270275  PMID: 25587247
6.  Arthropathy and proteinuria: nail-patella syndrome revisited 
GMS German Medical Science  2014;12:Doc16.
Nail-patella syndrome (NPS) is a pleiotropic autosomal-dominant disorder due to mutations in the gene LMX1B. It has traditionally been characterized by a tetrad of dermatologic and musculoskeletal abnormalities. However, one of the most serious manifestations of NPS is kidney disease, which may be present in up to 40% of affected individuals. Although diagnosis can be made at birth, it is often missed, presumably due to the rarity of the condition.
A 35-year-old female presented to our clinic with history of small joint pain of 6 months duration. In addition she complained of pedal edema off and on for the last 12 years. Prior to her current presentation she had been managed by a local doctor symptomatically. On evaluation, a nephrotic syndrome was obvious, but no secondary cause could be found. However, her physical examination was characteristic of NPS and keeping in view the autosomal dominant nature of the disorder all her three siblings were screened who too showed classical features of NPS. This rare syndrome as a cause of nephrotic range proteinuria is discussed in this report. The report underlines the importance of a good physical examination in a given clinical setting.
doi:10.3205/000201
PMCID: PMC4235317  PMID: 25408626
nail-patella syndrome; arthropathy; proteinuria; nephropathy
7.  Indirect comparison of lixisenatide versus neutral protamine Hagedorn insulin as add-on to metformin and sulphonylurea in patients with type 2 diabetes mellitus 
GMS German Medical Science  2014;12:Doc14.
Objective: There is currently a lack of evidence from direct comparisons of treatment outcomes with lixisenatide versus neutral protamine Hagedorn (NPH)-insulin in type 2 diabetes mellitus (T2DM) patients with suboptimal glycaemic control with oral antidiabetic drugs (OADs). Hence, the current analysis indirectly compared available evidence on the risk of hypoglycaemia and weight change between lixisenatide and NPH-insulin based on randomized controlled trial (RCT) data with exenatide, insulin glargine and placebo as common references.
Methods: A systematic search of PubMed, Embase, the Cochrane database and clinical registries identified English- and German-language articles published from January 1980 to October 2012 reporting data from RCTs. Only publications of trials that reported outcomes from 24 to 30 weeks comparing glucagon-like peptide-1 receptor agonists or basal insulin versus another antidiabetic agent or placebo were included. Hypoglycaemia, patients at glycated haemoglobin (HbA1c) target and discontinuations due to adverse events (AEs) were treated as binary variables, with risk ratios and odds ratios (ORs) calculated. HbA1c and body weight were treated as continuous variables with difference in mean change from baseline (MD) calculated. Meta-analyses were performed with random effects models and indirect comparisons were performed according to Bucher’s method.
Results: Seven RCTs (n=3,301 patients) comparing the efficacy and safety of lixisenatide, exenatide, insulin glargine and NPH-insulin with different antidiabetic treatments in adult patients with T2DM were included in the final analysis. In the adjusted indirect comparison, there was a significant difference in symptomatic hypoglycaemia (OR = 0.38; 95% CI = [0.17, 0.85]) and in confirmed hypoglycaemia (OR = 0.46; 95% CI = [0.22, 0.96]) favouring lixisenatide over NPH-insulin and comparable changes in HbA1c from baseline (MD = 0.07%; 95% CI = [–0.26%, 0.41%]). In contrast to NPH-insulin, there was a significant reduction in body weight with lixisenatide (MD = –3.62 kg; 95% CI = [–5.86 kg, –1.38 kg]) at study completion. The number of discontinuations due to AEs numerically favoured NPH-insulin over lixisenatide (OR = 2.64; 95% CI = [0.25, 27.96]), with a broad confidence interval.
Conclusions: Lixisenatide treatment was associated with a lower risk of hypoglycaemia and a greater weight loss compared with NPH-insulin. Glycaemic control with lixisenatide treatment was comparable with NPH-insulin. These data suggest that lixisenatide is a beneficial treatment option for T2DM patients with inadequate glycaemic control on OADs, and is associated with reduced risk of hypoglycaemia and weight gain.
doi:10.3205/000199
PMCID: PMC4202665  PMID: 25332702
lixisenatide; basal insulin; hypoglycaemia; weight change; type 2 diabetes; adjusted indirect comparison
8.  Which adverse effects influence the dropout rate in selective serotonin reuptake inhibitor (SSRI) treatment? Results for 50,824 patients 
GMS German Medical Science  2014;12:Doc15.
Background: Nowadays, selective serotonin reuptake inhibitors (SSRIs) are the most frequently prescribed antidepressants due to their superior clinical efficacy, effectiveness, tolerability, and safety as compared to tricyclic antidepressants or monoamino oxidase inhibitors. However, despite these advantages SSRIs are still associated with a number of adverse drug reactions, especially in the early stages of treatment, which may lead to premature discontinuation of therapy in some cases. The aim of the present study was to assess the most common adverse drug reactions of SSRIs as well as their impact on dropout rate in a large study population.
Patients and methods: Data for 50,824 patients treated for major depressive disorder with SSRIs for the first time was accessed via the Disease Analyzer database (IMS Health, Germany), providing information on SSRI adverse drug reactions and their influence on premature treatment discontinuation calculated by regression analysis. The presence of certain co-morbidities was also registered.
Results: The mean age was 54.5 ± 19 years, two-thirds of the study population being female. The adverse effects mentioned most frequently were: “discomfort” of the digestive system (10%), sleep disorders (8.6%), and heart rhythm disorders (4%); however, these were of tolerable severity as they did not significantly influence the dropout rate. Contrary to that, somnolence and younger age (≤50 years) in particular increased the chance of premature treatment discontinuation, while patients suffering from cardiovascular risk factors or osteoporosis tended to adhere to the therapy.
Conclusions: Overall, there is high tolerability for early SSRI treatment, whereas the occurrence of somnolence leads to discontinuation.
doi:10.3205/000200
PMCID: PMC4202666  PMID: 25332703
antidepressants; selective serotonin reuptake inhibitors; adverse drug reactions; dropout
9.  The simultaneous incidence of acute pancreatitis and autoimmune hemolytic anemia: a rare duo in a patient with SLE 
GMS German Medical Science  2014;12:Doc12.
A young female presented with acute abdominal pain of two days duration consistent with acute pancreatitis. During her stay in the hospital she had a sudden drop in hemoglobin to 6 g/dl without any overt blood loss. On evaluation, it was evident that she had acute pancreatitis, in addition to displaying features of autoimmune hemolytic anemia. She had been a known case of systemic lupus erythematosus (SLE) and had discontinued her treatment. She was managed with methylprednisolone pulse therapy. Her clinical condition improved, and she has been regularly attending our clinic for the last 2 years. According to a literature search in Medline, it would appear that this is the first report of a case in which SLE with autoimmune hemolytic anemia has been associated with acute pancreatitis in a single case.
doi:10.3205/000197
PMCID: PMC4178942  PMID: 25276114
systemic lupus erythematosus (SLE); acute pancreatitis; autoimmune hemolytic anemia; massive hemolysis
10.  Varus deformity of the left lower extremity causing degenerative lesion of the posterior horn of the left medial meniscus in a patient with Paget’s disease of bone 
GMS German Medical Science  2014;12:Doc13.
We report on a 42-year-old woman who presented with persistent pain in her left knee with no history of trauma. Sagittal T1-weighted MRI of the left knee showed discontinuity between the anterior and posterior horns of the left medial meniscus, causing effectively the development of degenerative lesion of the posterior horn. The latter was correlated to varus deformity of the left lower extremity associated with subsequent narrowing of the medial knee joint. The unusual craniofacial contour of the patient, the skeletal survey and the elevated serum alkaline phosphatase were compatible with the diagnosis of Paget’s disease of the bone. To alleviate the adverse effect of the mal-alignment of the left femur onto the left knee, corrective osteotomy of the left femoral diaphysis by means of fixators was performed. To the best of our knowledge this is the first clinical report describing the management and the pathological correlation of a unilateral varus deformity of the femoral shaft and degenerative lesions of the left knee in a patient with Paget’s disease of the bone.
doi:10.3205/000198
PMCID: PMC4178943  PMID: 25276115
Paget's disease of bone; varus deformity; degenerative lesion of medial meniscus; radiology
11.  Evaluation of medical research performance – position paper of the Association of the Scientific Medical Societies in Germany (AWMF) 
GMS German Medical Science  2014;12:Doc11.
Objective: The evaluation of medical research performance is a key prerequisite for the systematic advancement of medical faculties, research foci, academic departments, and individual scientists’ careers. However, it is often based on vaguely defined aims and questionable methods and can thereby lead to unwanted regulatory effects. The current paper aims at defining the position of German academic medicine toward the aims, methods, and consequences of its evaluation.
Methods: During the Berlin Forum of the Association of the Scientific Medical Societies in Germany (AWMF) held on 18 October 2013, international experts presented data on methods for evaluating medical research performance. Subsequent discussions among representatives of relevant scientific organizations and within three ad-hoc writing groups led to a first draft of this article. Further discussions within the AWMF Committee for Evaluation of Performance in Research and Teaching and the AWMF Executive Board resulted in the final consented version presented here.
Results: The AWMF recommends modifications to the current system of evaluating medical research performance. Evaluations should follow clearly defined and communicated aims and consist of both summative and formative components. Informed peer reviews are valuable but feasible in longer time intervals only. They can be complemented by objective indicators. However, the Journal Impact Factor is not an appropriate measure for evaluating individual publications or their authors. The scientific “impact” rather requires multidimensional evaluation. Indicators of potential relevance in this context may include, e.g., normalized citation rates of scientific publications, other forms of reception by the scientific community and the public, and activities in scientific organizations, research synthesis and science communication. In addition, differentiated recommendations are made for evaluating the acquisition of third-party funds and the promotion of junior scientists.
Conclusions: With the explicit recommendations presented in the current position paper, the AWMF suggests enhancements to the practice of evaluating medical research performance by faculties, ministries and research funding organizations.
doi:10.3205/000196
PMCID: PMC4071625  PMID: 24971044
12.  Risk of psychiatric and neurological diseases in patients with workplace mobbing experience in Germany: a retrospective database analysis 
GMS German Medical Science  2014;12:Doc10.
Introduction: The number of mobbing experiences recorded has increased during recent years and it has now been established as global phenomenon among the working population. The goal of our study was to analyze the incidence of certain neurologic and psychiatric diseases as a consequence of mobbing as compared with a control group and to examine the possible influence of previous diseases that occurred within one year before the first mobbing documentation on the incidence of mobbing.
Material & methods: We used a large database (IMS® Disease Analyzer, Germany) to collect data from general practitioners in Germany from 01/2003 until 12/2012. Based on age, gender, and health insurance, patients with experience of mobbing were matched with a control group of patients who had not reported workplace mobbing and who were being treated by the same physicians. At first, diseases that occurred within one year before the bullying experience took place (“index date”) were noted and compared to a control group of similar composition in terms of gender, age, and health insurance. Subsequently, the prevalence of depression, anxiety, somatoform disorders, and sleep disorders following experiences of mobbing were determined. After adjustment to take into account the odds of bullying, the ratios of these diseases were assessed using a logistic regression model.
Results: The study population consisted of n=2,625 patients and n=2,625 controls, of which 33% were men. The number of cases of bullying documented rose continuously from 2003 to 2011 and remained high in 2012. Those who would later become victims of mobbing demonstrated a considerably higher prevalence of diseases in general – these diseases were not confined to the neurologic-psychiatric spectrum. Following experiences of bullying, depression, anxiety, somatoform disorders, and sleep disorders were significantly more prevalent than in the control group (for all, p<0.05). Similarly, odds ratios (OR) representing the risk of suffering from diseases were higher in affected patients, with the highest value (4.28) for depression and the lowest value for sleep disorders (OR=2.4).
Conclusion: Those who will later become the victims of bullying are more prone to suffer from diseases in general, even before this experience of mobbing has occurred, which underlines the importance of supporting (chronically) ill patients to protect them against bullying. Sequelae of mobbing include, in particular, diseases from the neurologic-psychiatric spectrum.
doi:10.3205/000195
PMCID: PMC4036095  PMID: 24872810
mobbing; depression; anxiety; risk factors
13.  Position paper on the importance of psychosocial factors in cardiology: Update 2013 
GMS German Medical Science  2014;12:Doc09.
Background: The rapid progress of psychosomatic research in cardiology and also the increasing impact of psychosocial issues in the clinical daily routine have prompted the Clinical Commission of the German Heart Society (DGK) to agree to an update of the first state of the art paper on this issue which was originally released in 2008.
Methods: The circle of experts was increased, general aspects were implemented and the state of the art was updated. Particular emphasis was dedicated to coronary heart diseases (CHD), heart rhythm diseases and heart failure because to date the evidence-based clinical knowledge is most advanced in these particular areas. Differences between men and women and over the life span were considered in the recommendations as were influences of cognitive capability and the interactive and synergistic impact of classical somatic risk factors on the affective comorbidity in heart disease patients.
Results: A IA recommendation (recommendation grade I and evidence grade A) was given for the need to consider psychosocial risk factors in the estimation of coronary risks as etiological and prognostic risk factors. Furthermore, for the recommendation to routinely integrate psychosocial patient management into the care of heart surgery patients because in these patients, comorbid affective disorders (e.g. depression, anxiety and post-traumatic stress disorder) are highly prevalent and often have a malignant prognosis. A IB recommendation was given for the treatment of psychosocial risk factors aiming to prevent the onset of CHD, particularly if the psychosocial risk factor is harmful in itself (e.g. depression) or constrains the treatment of the somatic risk factors. Patients with acute and chronic CHD should be offered anti-depressive medication if these patients suffer from medium to severe states of depression and in this case medication with selective reuptake inhibitors should be given. In the long-term course of treatment with implanted cardioverter defibrillators (ICDs) a subjective health technology assessment is warranted. In particular, the likelihood of affective comorbidities and the onset of psychological crises should be carefully considered.
Conclusions: The present state of the art paper presents an update of current empirical evidence in psychocardiology. The paper provides evidence-based recommendations for the integration of psychosocial factors into cardiological practice and highlights areas of high priority. The evidence for estimating the efficiency for psychotherapeutic and psychopharmacological interventions has increased substantially since the first release of the policy document but is, however, still weak. There remains an urgent need to establish curricula for physician competence in psychodiagnosis, communication and referral to ensure that current psychocardiac knowledge is translated into the daily routine.
doi:10.3205/000194
PMCID: PMC4012565  PMID: 24808816
depression; anxiety; post-traumatic stress disorder; psychotherapy; psychopharmacology
14.  Development and validation of a generic questionnaire for the implementation of complex medical interventions 
GMS German Medical Science  2014;12:Doc08.
Introduction: The implementation of complex medical interventions in daily practice is often fraught with difficulties. According to the iterative phase model proposed by the British Medical Research Council (MRC), the development, implementation and evaluation of complex interventions should be theory-driven. A conceptual model that seems to be a promising framework is the Theory of planned behaviour (TPB). In our study we aimed to develop and validate a generic and multifaceted questionnaire based on the TPB to detect physicians’ willingness to implement complex medical interventions and the factors influencing this willingness.
Methods: The questionnaire was developed according to the literature and was informed by previous qualitative research of our department. It was validated on the example of an electronic library of decision aids, arriba-lib. The sample consisted of 181 General Practitioners (GPs) who received a training regarding arriba-lib and subsequently filled in the questionnaire, assessing the TPB variables attitude, subjective norm, perceived behaviour control and intention. Follow-up assessments were conducted after two (assessing retest reliability) and eight weeks (assessing target behaviour). We performed a confirmatory factor analysis investigating the factorial structure of our questionnaire according to the TPB. Beside the calculation of the questionnaire’s psychometric properties we conducted a structural equation model and an ordinal regression to predict actual behaviour regarding the installation and application of arriba-lib.
Results: The postulated three factorial model (attitude, subjective norm, perceived behaviour control) of our questionnaire based on the TPB was rejected. A two factorial model with a combined factor subjective norm/perceived behaviour control was accepted. The explained variance in the ordinal regression was low (Nagelkerke’s R2=.12). Neither attitude nor intention were able to predict the use or non-use of arriba-lib (attitude: p=.68, intention: p=.44). For the combined factor subjective norm/perceived behaviour control a significant, but small effect (p=.03) was shown.
Conclusions: The TPB is not an adequate theoretical framework to guide the development of a generic questionnaire in the context of the implementation of complex interventions. To enable the successful implementation of complex medical interventions evaluators have to go through the whole development and evaluation process according to the MRC-model, without short cuts. Further, it has to be discussed if a generic instrument can be valid and useful. Regarding the TPB a publication bias regarding the theory’s applicability might have to be considered.
doi:10.3205/000193
PMCID: PMC3972438  PMID: 24696674
implementation; questionnaires; primary health care; theory of planned behaviour
15.  Monitoring the impact of the DRG payment system on nursing service context factors in Swiss acute care hospitals: Study protocol 
GMS German Medical Science  2014;12:Doc07.
Aims: With this study protocol, a research program is introduced. Its overall aim is to prepare the instruments and to conduct the first monitoring of nursing service context factors at three university and two cantonal hospitals in Switzerland prior to the introduction of the reimbursement system based on Diagnosis Related Groups (DRG) and to further develop a theoretical model as well as a methodology for future monitoring following the introduction of DRGs.
Background: DRG was introduced to all acute care hospitals in Switzerland in 2012. In other countries, DRG introduction led to rationing and subsequently to a reduction in nursing care. As result, nursing-sensitive patient outcomes were seriously jeopardised. Switzerland has the opportunity to learn from the consequences experienced by other countries when they introduced DRGs. Their experiences highlight that DRGs influence nursing service context factors such as complexity of nursing care or leadership, which in turn influence nursing-sensitive patient outcomes. For this reason, the monitoring of nursing service context factors needs to be an integral part of the introduction of DRGs. However, most acute care hospitals in Switzerland do not monitor nursing service context data. Nursing managers and hospital executive boards will be in need of this data in the future, in order to distribute resources effectively.
Methods/Design: A mixed methods design in the form of a sequential explanatory strategy was chosen. During the preparation phase, starting in spring 2011, instruments were selected and prepared, and the access to patient and nursing data in the hospitals was organized. Following this, online collection of quantitative data was conducted in fall 2011. In summer 2012, qualitative data was gathered using focus group interviews, which helped to describe the processes in more detail. During 2013 and 2014, an integration process is being conducted involving complementing, comparing and contrasting quantitative and qualitative findings.
Conclusion: The research program will produce baseline data on nursing service context factors in Swiss acute care hospitals prior to DRG introduction as well as a theoretical model and a methodology to support nursing managers and hospital executive boards in distributing resources effectively.
The study was approved by the ethics committees of Basel, Bern, Solothurn and Zürich.
doi:10.3205/000192
PMCID: PMC3972437  PMID: 24696673
DRG; nursing service context factors; nursing monitoring
16.  Can a stroke present with flexor spasms? A highly rare experience 
GMS German Medical Science  2014;12:Doc06.
Involuntary movement disorders are not a common presentation of basal ganglia ischemia which may be induced by cerebral hemodynamic insufficiency. In secondary causes of movements disorders cerebrovascular diseases represent up to 22% and involuntary movements develop after 1–4% of strokes. We describe a case of a middle-aged woman who presented with intermittent involuntary tonic spasms or seizure-like episodes followed by weakness due to contralateral putaminal infarction. Initially thought to have Todd’s paralysis she was not thrombolysed, but later she developed dense hemiplegia. Flexor spasms are generally thought to occur in lesions of the spinal cord but they can also occur in cerebral lesion, may be because of disinhibition of the spinal cord. Certain other theories also have been narrated, but this field still needs to be worked upon.
doi:10.3205/000191
PMCID: PMC3949419  PMID: 24624049
stroke; putaminal infarction; flexor spasm; movement disorder; basal ganglia infarction
17.  Anesthesiology residents’ perspective about good teaching – a qualitative needs assessment 
GMS German Medical Science  2014;12:Doc05.
Background: Germany, like many other countries, will soon have a shortage of qualified doctors. One reason for the dissatisfaction amongst medical residents are the relatively unstructured residency training programs despite increasing importance of outcome-based education. The aim of our study was to identify characteristics and requirements for good teaching during anesthesiology residency training from the resident’s point of view.
Methods: A consensus workshop with residents from all medical universities in Germany was held. Participants were allocated to one of the three topics, chosen based on a 2009 nationwide evaluation of residency. The three topics were (A) characteristics of helpful/good teachers, (B) characteristics of helpful/good conditions and (C) characteristics of helpful/good curricular structure. Each group followed a nominal group technique consensus process to define and rank characteristics for a good residency.
Results: 31 (79.5%) resident representatives were present. The consented results put emphasis on the importance of structured curricula including transparent goals and objectives, in training formative assessments and quality assurance measures for the program. Residents further long for trained trainers with formal teaching qualifications and protected teaching time.
Conclusions: Good residency training requires careful consideration of all stakeholders’ needs. Results reflect and extend previous findings and are at least to some degree easily implemented. These findings are an important step to establish a broader consensus within the discipline.
doi:10.3205/000190
PMCID: PMC3935158  PMID: 24574941
residents; curriculum development; needs assessment; anesthesiology; consensus
18.  Illness and determinants of health-related quality of life in a cross-sectional sample of schoolchildren in different weight categories 
GMS German Medical Science  2014;12:Doc04.
Aim: To study associations between health-related quality of life (HRQoL), frequency of illness, and weight in primary school children in southern Germany.
Methods: Data from baseline measurements of the outcome evaluation of a teacher based health promotion programme (“Join the Healthy Boat”) were analysed. Parents provided information about their children’s HRQoL (KINDLR, EQ5D-Y Visual Analogue Scale). The number of visits to a physician, children’s days of absence because of sickness, and parental days of absence from work due to their children’s illness during the last year of school/kindergarten were queried. Children’s weight status was determined by body mass index (BMI), central obesity by waist to height ratio (WHtR ≥0.5).
Results: From 1,888 children (7.1±0.6 years), 7.8% were underweight, 82% had normal weight, 5.7% were overweight and 4.4% obese. 8.4% of all children were centrally obese. Bivariate analysis showed no significant differences for parental absence and visits to a physician in weight groups classified by BMI, but obese children had more sick days than non-obese. Centrally obese children differed significantly from the rest in the number of sick days and visits to a physician, but not in the frequency of parental absence. In regression analyses, central obesity correlated significantly with EQ5D-Y VAS, KINDLR total score and the subscales of “psyche”, “family” and “friends”. BMI weight groups showed no significant associations.
Conclusions: Central obesity but not BMI derived overweight and obesity is associated with HRQoL and visits to a physician in primary school children. Future studies should include WHtR. Preventive measures for children should focus on a reduction of or slowed increase in waist circumference.
doi:10.3205/000189
PMCID: PMC3935157  PMID: 24574940
child; body weights and measures; quality of life; sick leave; Germany
19.  Physicians’ influence on breast cancer patient compliance 
GMS German Medical Science  2014;12:Doc03.
In recent years there have been major advances in the treatment of breast cancer. However, taking the prescribed medication for a sufficient period of time is crucial to the success of any therapy. Thus far, no database-based studies have been published in German-speaking countries empirically examining the influence of the physician on the compliance of patients. The aim of this study is to investigate, quantify, and critically discuss the effect treating physicians have on the compliance of their breast cancer patients.
Patients with a confirmed breast cancer diagnosis who started therapy (tamoxifen or aromatase inhibitors) between January 2001 and December 2011 were selected from the representative IMS Disease Analyzer database and analyzed with regard to their compliance. Practices were grouped into two categories concerning the compliance of all treated patients. A regression model showed that a breast cancer patient who is treated in a practice with a trend toward poor compliance has a nearly 60% higher risk for treatment discontinuation than would be the case in a practice with good compliance. It shows how important it is to motivate physicians to strive toward good compliance rates.
doi:10.3205/000188
PMCID: PMC3895867  PMID: 24454275
breast cancer; compliance; persistence; Disease Analyzer
20.  German Medical Science: Editorial 2014 
GMS German Medical Science  2014;12:Doc01.
doi:10.3205/000186
PMCID: PMC3895865
21.  Population dynamics and tuberculosis: a cross sectional study of an overlooked disease in Saudi Arabia 
GMS German Medical Science  2014;12:Doc02.
Background: International travel, migration and human population movements facilitate the spread of tuberculosis (TB).
Objective: To study the impact of poorly screened expatriates working in Saudi Arabia on the local incidence of TBs.
Patients and methods: This cross sectional study was carried out in the Chest Disease Hospital, Taif. All confirmed cases of TB from June 2009 to May 2010 admitted to the hospital were enrolled. Inclusion criteria were diagnosed cases of TB (pulmonary & extra-pulmonary) in patients between the ages of 14 to 65 years. Patients with HIV and coexistent malignancies were excluded. The age, gender and ethnic group of each patient was recorded, and patients were divided into two groups. Of the two groups, Group A consisted of Taif residents and group B of patients referred from other cities in the country.
Results: Of the 686 cases studied, 370 (54%) were Saudi nationals (Group A = 80 & Group B = 290) and 316 (46%) cases were from other countries. Males outnumbered females and most of the patients were aged 20 to 29 years. The number of cases from the areas close to the pilgrimage sites, i.e. Makah (233) and Jeddah (275), outnumbered those in Taif (110).
Conclusions: Our study identifies an increased prevalence of TB cases in areas close to the pilgrimage (Group B). The higher proportion of non-Saudi TB patients in group B is most likely explained by the higher number of poorly screened illegal expatriates in the region.
doi:10.3205/000187
PMCID: PMC3895866  PMID: 24454274
tuberculosis; pilgrims; poor socioeconomic status; illegal expatriates
22.  Breast reconstruction de novo by water-jet assisted autologous fat grafting – a retrospective study 
GMS German Medical Science  2013;11:Doc17.
Background: Autologous fat grafting has become a frequent, simple, reproducible and low-risk technique for revisional or partial breast reconstruction. The presented European multicenter study describes an optimized treatment and follow-up protocol for the de novo breast reconstruction after total mastectomy by lipotransfer alone.
Methods: A retrospective European multicenter trial included 135 procedures on 28 (35 breasts) postmastectomy patients (mean 52.4 years). All women were treated with the water-jet assisted fat grafting method (BEAULI™) combined with additional procedures (NAC reconstruction, contralateral mastoplasty) and evaluated with at least 6 months follow-up (mean 2.6 years). Sonography or mammography, clinical examination, patient questionnaire (10-point Likert scale) and digital photographs were carried out.
Results: On average the patients received 4 to 6 procedures each with a single volume of 159 ml (±61 ml) over 21 months (range 9 months to 2.5 years). In total 1,020 ml (±515 ml) fat were grafted till a complete breast reconstruction was achieved. Irradiated patients needed a significantly higher volume than non-irradiated (p<0.041). Main treatment complications were liponecrosis (2.59%), infection (0.74%) and granuloma (0.74%). Patient satisfaction was overall high to very high (96%) and confirmed the good aesthetic results (68%) and the natural softness, contour and shape of the reconstructed breast.
Conclusions: A complete breast reconstruction with large volume fat grafting is alternatively possible to standard techniques in selected cases. It takes at least 4 to 6 lipotransfers in the course of 2 years. Patients with prior radiotherapy may require even up to 8 sessions over nearly 3 years of treatment.
doi:10.3205/000185
PMCID: PMC3884560  PMID: 24403878
autologous fat grafting; lipotransfer; breast reconstruction; mastectomy
23.  Occupational risk factors for testicular cancer: a registry-based case-control study in Rhineland Palatinate – Germany 
GMS German Medical Science  2013;11:Doc16.
Objectives: Testicular cancer affects mainly men below the age of 50. An association with occupation and social status has been suggested but risk factors are not well understood. A registry-based case-control study focusing on occupation was performed in Germany.
Methods: All 348 testicular cancer cases with available gainful occupational information registered between 2000 and 2005; as well as 564 suitable controls (from a pool of other cancers) were drawn from the Cancer Registry of Rhineland-Palatinate. Unconditional logistic regression was used to compute odds ratios (OR) and associated 95% confidence intervals (CI).
Results: Slightly elevated OR were observed for technicians and related professionals (OR 1.62, 95% CI 1.00–2.63) and for clerical support workers (OR 1.71, 95% CI 1.14–2.56). This increase was highest in the age group 20–50 for technicians (OR 2.02, 95% CI 1.23–3.33) and clerks (OR 2.00, 95% CI 1.30–3.09), respectively. An association with testicular cancer was observed for no other occupation.
Conclusion: An increased risk of testicular cancer was observed for technicians and related professionals and clerical support workers. This could be related to socioeconomic status or sedentary life style, two factors that were identified in previous studies. While the feasibility of a purely registry-based study was shown, missing occupational data and the choice of cancer controls represent challenges to the validity of this approach.
doi:10.3205/000184
PMCID: PMC3836396  PMID: 24265602
cancer; clerical support workers; men's health; occupational health; sedentary life style; technicians
24.  Impact of numerical information on risk knowledge regarding human papillomavirus (HPV) vaccination among schoolgirls: a randomised controlled trial 
GMS German Medical Science  2013;11:Doc15.
Introduction: In Germany the implementation of human papillomavirus (HPV) vaccination for women aged 12–17 years was accompanied by various campaigns. Evidence-based information including numerical data was not provided. However, standard information leads to overestimation of cancer risk and effects of HPV vaccination. Confidence in children’s ability to deal with numerical data is low, especially in disadvantaged pupils.
The aim of the present study was to compare the effects of a standard leaflet with an information leaflet supplemented with numerical data on ‘risk knowledge’ regarding HPV vaccination among schoolgirls.
Methods: Randomised-controlled short-term trial. All 108 schoolgirls of seven school classes were asked to participate and 105 agreed. Participants were vocational schoolgirls who were preparing for grade 10 graduation and who were members of the target group for HPV vaccination. The control group was asked to read a standard leaflet on HPV vaccination of the German Women’s Health Network. The intervention group received the same leaflet, but it was supplemented with numerical information on cancer risk and assumed effects of the HPV vaccination on cancer prevention.
As baseline characteristics we surveyed: age, vaccination status, attitude towards HPV vaccination and aspects regarding migration background. The primary end point was ‘risk knowledge’. Questionnaire surveys were performed under experimental conditions. Individual randomisation, participants, and intention-to-treat data analyses were blinded. The study was approved by the Ministry of Education and Culture of Schleswig-Holstein and the ethics committee of the Hamburg Chamber of Physicians.
Results: We analysed ‘risk knowledge’ for all 105 randomised participants. Baseline characteristics of the two groups were comparable. Numerical risk information recipients were more likely to give correct answers compared to standard information recipients: Mean value of risk knowledge score (0–5 points): 4.6±1.0 vs. 2.6±1.2 (mean difference 2.0 (95% CI 1.6–2.4)); (P<0.001). Post hoc distractor analysis of single items was performed. Incorrect answers of control participants indicated that cervical cancer risk was highly overestimated whereas total cancer risk was mostly underestimated, and possible impact of HPV vaccination on cancer prevention was overestimated.
Conclusion: Supplementing health information on HPV vaccination with numerical data improves ‘risk knowledge’ among schoolgirls.
doi:10.3205/000183
PMCID: PMC3818649  PMID: 24198750
consumer health information; human papillomavirus vaccination; risk knowledge; evidence-based medicine
25.  Actinobacillus equuli ssp. haemolyticus in a semi-occlusively treated horse bite wound in a 2-year-old girl 
GMS German Medical Science  2013;11:Doc14.
We report on the isolation of Actinobacillus equuli ssp. haemolyticus from wound smears of a 2-year-old girl who was admitted to the hospital due to partial amputation of the distal phalanx of her right middle finger caused by a horse bite. A. equuli typically causes diseases in horses and only very few reports describing human infections (mostly associated with wounds) are available in the literature. Interestingly, although the bacteria could be found in consecutive samples taken at different points in time, there were no signs of advancing infection or inflammation. Moreover, the fingertip regenerated after 74 days under semi-occlusive dressings with very pleasant results. For strain identification two automated systems were employed producing discrepant results: VITEK 2 described the pathogens as Pasteurella pneumotropica while MALDI-TOF MS analysis revealed A. equuli. Sequence analysis of 16S rDNA gene finally confirmed A. equuli ssp. haemolyticus as the isolated strain. The antimicrobial susceptibility testing was performed according to the CLSI criteria for Pasteurella spp. Additionally we conducted a test according to the EUCAST criteria.
doi:10.3205/000182
PMCID: PMC3782719  PMID: 24068980
Actinobacillus equuli; Pasteurella; MALDI-TOF MS; VITEK 2; semi-occlusive dressing; finger amputation

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