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1.  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.
PMCID: PMC4071625  PMID: 24971044
2.  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.
PMCID: PMC4036095  PMID: 24872810
mobbing; depression; anxiety; risk factors
3.  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.
PMCID: PMC4012565  PMID: 24808816
depression; anxiety; post-traumatic stress disorder; psychotherapy; psychopharmacology
4.  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.
PMCID: PMC3972438  PMID: 24696674
implementation; questionnaires; primary health care; theory of planned behaviour
5.  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.
PMCID: PMC3972437  PMID: 24696673
DRG; nursing service context factors; nursing monitoring
6.  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.
PMCID: PMC3949419  PMID: 24624049
stroke; putaminal infarction; flexor spasm; movement disorder; basal ganglia infarction
7.  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.
PMCID: PMC3935158  PMID: 24574941
residents; curriculum development; needs assessment; anesthesiology; consensus
8.  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.
PMCID: PMC3935157  PMID: 24574940
child; body weights and measures; quality of life; sick leave; Germany
9.  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.
PMCID: PMC3895867  PMID: 24454275
breast cancer; compliance; persistence; Disease Analyzer
10.  German Medical Science: Editorial 2014 
GMS German Medical Science  2014;12:Doc01.
PMCID: PMC3895865
11.  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.
PMCID: PMC3895866  PMID: 24454274
tuberculosis; pilgrims; poor socioeconomic status; illegal expatriates
12.  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.
PMCID: PMC3884560  PMID: 24403878
autologous fat grafting; lipotransfer; breast reconstruction; mastectomy
13.  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.
PMCID: PMC3836396  PMID: 24265602
cancer; clerical support workers; men's health; occupational health; sedentary life style; technicians
14.  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.
PMCID: PMC3818649  PMID: 24198750
consumer health information; human papillomavirus vaccination; risk knowledge; evidence-based medicine
15.  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.
PMCID: PMC3782719  PMID: 24068980
Actinobacillus equuli; Pasteurella; MALDI-TOF MS; VITEK 2; semi-occlusive dressing; finger amputation
16.  10 years of German Medical Science 
GMS German Medical Science  2013;11:Doc13.
PMCID: PMC3782718  PMID: 24068979
17.  Primary small cell carcinoma of the esophagus: patient data metaanalysis and review of the literature 
GMS German Medical Science  2013;11:Doc12.
We analysed the typical features of primary small cell carcinoma of the esophagus (SCCE) with emphasis on occurrence, behaviour, outcome and treatment options. This metaanalysis was aimed at collecting and analyzing information from international studies about handling this disease. This seems necessary due to the rarity of this disease. Studies were acquired from electronic databases and reference lists. We finally analysed 313 patient cases from the literature with oesophageal SCC. A data extraction was accomplished referring to 13 evaluable features that are described in the “methods”, whereof 7 were analyzed with univariate and multivariate tests. Three hundred thirteen cases were analyzed, 109 patients (35%) had limited stage (LS), whereas 167 (54%) had extensive stage (ES). There is no information about the remaining 35 patients concerning the stage. Univariate and multivariate analysis showed only age (<50 years vs. >50 years, HR 1.024; 95% CI 1.000–1.041, P<0.0001) and disease stage (LS vs. ES, HR 4.884; 95% CI 2.572–9.27, P<0.0001) as significant prognostic factors. There also was a statistically significant difference in survival between those patients who received therapy compared to those who only received best supportive care (11.6 months vs. 0.8 months, HR 0.093, CI 95% 0.053–0.16, P<0.001). In this first multivariate analysis for SCCE we show that SCCE is an aggressive type of tumour with a shorter survival rate compared to its counterpart from the lung. It is demonstrated that only disease stage (limited vs. extensive stage), age (<50 years vs. >50 years) and therapy are independent significant predictors of prognosis.
PMCID: PMC3752626  PMID: 23983673
small cell carcinoma; esophagus; oesophagus; metaanalysis
18.  External tube drainage or omentoplasty in the management of residual hepatic hydatid cyst cavity: a prospective randomized controlled study 
GMS German Medical Science  2013;11:Doc11.
Background: Surgical procedures advocated for management of residual hepatic hydatid cyst cavity have been a subject of controversy. The aim of this study was to compare omentoplasty (OP) and external tube drainage (ETD).
Material and methods: This was a prospective randomized controlled study conducted on radiologically documented cases of hepatic hydatidosis (n=50) in a tertiary care hospital of Kashmir. Patients were divided into two groups; in one group ETD was performed and in another OP was done.
Results: Twenty-eight patients were offered ETD and 22 OP. There was no statistically significant difference in mean operative time. The overall complication rate was higher in ETD (42.86%) as compared to OP (22.73%). In ETD group two patients had bile leak and infection of residual cavity each; whereas no such complication was seen in OP. The mean pain scores were elevated in ETD (p<0.0016).The mean hospital stay was more in ETD as compared to OP (p<0.0031). Also time for resumption of activities of daily life was more in ETD (p<0.0026). The recurrence of disease was seen in three patients in ETD as compared to none in OP.
Conclusion: Omentoplasty offers a number of advantages over external tube drainage and should remain the preferred option whenever possible.
PMCID: PMC3728644  PMID: 23904825
hydatid cyst; omentoplasty; external tube drainage; laparoscopy; liver
19.  Benefits and risks of benzodiazepines and Z-drugs: comparison of perceptions of GPs and community pharmacists in Germany 
GMS German Medical Science  2013;11:Doc10.
Objective: Newer non-benzodiazepines zolpidem and zopiclone (“Z-drugs”) are often prescribed instead of benzodiazepine hypnotics, although there is no evidence of differences in effectiveness and safety. Aim was to compare perceptions on benefits and harms of benzodiazepines and Z-drugs between general practitioners (GPs) and community pharmacists (CPs).
Methods: A questionnaire was mailed to a random sample of 1,350 GPs and 600 CPs in 2012. They were asked to rate perceptions on a five-point Likert scale used for both benzodiazepines and Z-drugs. Wilcoxon signed rank test was performed for the comparison of perceptions between GPs and CPs. Due to multiple testing, only p-values ≤0.01 were considered statistically significant.
Results: 458 GPs and 202 CPs returned questionnaires (response 33.9% and 33.7%). Mean age of GPs was 53.3 years (40.6% female) and 48.8 years for CPs (59.2% females). Perceptions on benefits of benzodiazepines (and Z-drugs) between GPs and CPs were not different for 3 (and 2) of 5 items. Concerning side effects of benzodiazepines, there were no statistically significant differences for 3 of 5 comparisons. CPs perceived that 4 of 5 studied side effects of Z-drugs occur significantly more often than GPs (p=0.003 or less). For instance, whereas 45.2% of CPs answered that withdrawal effects on stopping happen often or very often/always on Z-drugs, these were only 28.3% of the GPs.
Conclusions: Although it is difficult to draw unambiguous conclusions from these findings, pharmacists might have a somewhat more critical view on Z-drugs, especially concerning side effects.
PMCID: PMC3728643  PMID: 23904824
cross-sectional studies; Germany; hypnotics and sedatives; attitude of health personnel
20.  The German quality indicators in intensive care medicine 2013 – second edition 
GMS German Medical Science  2013;11:Doc09.
Quality indicators are key elements of quality management. The quality indicators for intensive care medicine of the German Interdisciplinary Society of Intensive Care Medicine (DIVI) from the year 2010 were recently evaluated when their validity time expired after two years. Overall one indicator was replaced and further three were in part changed. The former indicator I “elevation of head of bed” was replaced by the indicator “Daily multi-professional ward rounds with the documentation of daily therapy goals” and added to the indicator IV “Weaning and other measures to prevent ventilator associated pneumonias (short: Weaning/VAP Bundle)” (VAP = ventilator-associated pneumonia) which aims at the reduction of VAP incidence. The indicator VIII “Documentation of structured relative-/next-of-kin communication” was refined. The indicator X “Direction of the ICU by a specially trained certified intensivist with no other clinical duties in a department” was also updated according to recent study results. These updated quality indicators are part of the Peer Review in intensive care medicine. The next update of the quality indicators is due in 2016.
PMCID: PMC3728642  PMID: 23904823
quality management; intensive care medicine; quality indicators; peer review
21.  Idiopathic colonic calcification: a case report 
GMS German Medical Science  2013;11:Doc08.
We describe diffuse colonic calcification detected on CT scan of the abdomen in a young female patient who presented to our clinic with vague intermittent abdominal pain of four weeks duration. Her investigative profile was normal and her colonoscopy did not reveal any mucosal changes. Colonic calcification has been known to occur mostly as a result of ischemic phenomenon but the index case had no such features or any other predisposing factor. The patient is currently symptom-free and is following our clinic for the last 8 months. After the review of literature and thorough investigations her colonic calcification remains unexplained.
PMCID: PMC3687241  PMID: 23798912
abdominal CT scan; calcification; phlebosclerosis
22.  Focal neuropathies following percutaneous nephrolithotomy (PCNL) – preliminary study 
GMS German Medical Science  2013;11:Doc07.
Introduction: Postoperative neurological complications in pelvic and renal surgery are a well-known clinical problem and their morbidities are important. We designed this study to determine prevalence and risk factors of such complications after percutaneous nephrolithotomy (PCNL) surgery.
Material and methods: A cross-sectional study was performed during February and July 2011 on 68 PCNL cases. Demographic data and surgery reports were gathered and comprehensive neurological physical examination carried out before and after surgery. Then, data was analyzed using software SPSS 18.
Results: The ultimate sample included 30 (46.2%) male and 35 (53.8%) female patients with a mean age of 47.9 ± 11.47 years. In intercostal and lumbosacral plexus area, sensory neurological complications occurred in 8 patients (12.31%), 4 men and 4 women. The most common involved dermatomes and nerves were T12 (8 cases). There was a significant correlation between prolonged duration of surgery and prevalence of sensory complications (p<0.010). The highest hemoglobin value drop after surgery occurred in patients with neurological complications (p<0.001). There were no correlations between age, tracts used, diabetes mellitus, BMI, hypertension, positioning of patients and side of surgery with incidence of sensory neurological complications. No motor neurological complications occurred.
Conclusion: Prolonged duration of PCNL and increased value of hemoglobin drop may lead to increased risk of neuropathy. Larger prospective studies with retroperitoneal imagings and patients’ follow up is suggested for better understanding of this complication.
PMCID: PMC3687240  PMID: 23798911
percutaneous nephrollithotomy; neuropathy; complication
23.  Spinal and extraspinal deformities in a patient with dysspondyloenchondromatosis 
GMS German Medical Science  2013;11:Doc06.
Anisospondyly (irregularly shaped vertebral bodies) and enchondroma-like lesions in the metaphyseal and diaphyseal portions of the long tubular bones are the characteristic features in patients with dysspondyloenchondromatosis (DSC). Thoraco-lumbar scoliosis and windswept deformity of the lower limbs were the major abnormalities encountered in this patient. To the best of our knowledge this is the first case report delineating the spine pathology via reformatted CT scan and the correction of a windswept deformity by means of temporary hemiepiphysiodesis in a patient with (DSC).
PMCID: PMC3614015  PMID: 23555318
dysspondyloenchondromatosis; anisospondyly; windswept deformity; hemiepiphysiodesis
24.  Is tamoxifen associated with an increased risk for thromboembolic complications in patients undergoing microvascular breast reconstruction? 
GMS German Medical Science  2013;11:Doc05.
Introduction: Tamoxifen is associated with a twofold increased risk of thromboembolic events. Third generation aromatase inhibitors (AIs), such as letrozole, anastrozole, and exemestane have therefore replaced tamoxifen in the adjuvant therapy of hormone receptor-positive breast cancer. A retrospective review was performed in patients who underwent delayed microvascular breast reconstruction and received tamoxifen at the time of surgery in order to assess the risk of both minor and major flap complications including thromboembolic events.
Patients and methods: Twenty-nine patients who underwent delayed microsurgical breast reconstruction with autologous tissue between 2006 and 2012 were included in the study. The overall complication rates were compared between patients who did versus those who did not receive tamoxifen at the time of microsurgical breast reconstruction.
Results: Breast reconstruction was performed with a DIEP flap in 25 patients and with a TRAM flap in 4 patients. Overall, the complication rate was 37.9% (n=11) consisting of 5 major (including one total flap loss) and 6 minor complications. In patients receiving tamoxifen (n=5), we observed one minor complication and one major complication with a total flap loss due to thrombus formation at the anastomosis site. In one patient pulmonary embolism occurred without association to tamoxifen. The number of thromboembolic events was equivalent in both groups (p=0.642). No increase of major (p=0.858) or minor (p=0.967) complications in the tamoxifen group could be observed. Taking the overall complication rate into account there was no statistically difference between the two groups (p=0.917).
Conclusion: In our study we could not observe an increased risk for thromobembolic events in patients receiving tamoxifen while undergoing autologous microvascular breast reconstruction.
PMCID: PMC3575563  PMID: 23423877
Tamoxifen; breast cancer; adjuvant therapy; microvascular breast reconstruction
25.  The future of monitoring in clinical research – a holistic approach: Linking risk-based monitoring with quality management principles 
GMS German Medical Science  2013;11:Doc04.
Since several years risk-based monitoring is the new “magic bullet” for improvement in clinical research. Lots of authors in clinical research ranging from industry and academia to authorities are keen on demonstrating better monitoring-efficiency by reducing monitoring visits, monitoring time on site, monitoring costs and so on, always arguing with the use of risk-based monitoring principles. Mostly forgotten is the fact, that the use of risk-based monitoring is only adequate if all mandatory prerequisites at site and for the monitor and the sponsor are fulfilled.
Based on the relevant chapter in ICH GCP (International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use – Good Clinical Practice) this publication takes a holistic approach by identifying and describing the requirements for future monitoring and the use of risk-based monitoring. As the authors are operational managers as well as QA (Quality Assurance) experts, both aspects are represented to come up with efficient and qualitative ways of future monitoring according to ICH GCP.
PMCID: PMC3563312  PMID: 23382708
monitoring; risk-based monitoring; quality management

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