Search

Chronic post-surgical pain (CPSP) is a serious problem. Incidence as high as 50% has been reported, depending on type of surgery undergone. Because the etiology of chronic pain is grounded in the bio-psychosocial model, physical, psychological, and social factors are implicated in the development of CPSP. Biomedical factors such as pre-operative pain, severe acute post-operative pain, modes of anesthesia, and surgical approaches have been extensively examined, therefore this systematic review focuses on psychosocial elements. A systematic search was performed using the PubMed, PsychINFO, Embase, and Cochrane Databases. Fifty relevant publications were selected from this search, in which psychosocial predictors for and correlates to CPSP were identified. The level of evidence was assessed for each study, and corresponding score points were awarded for ease of comparison. The grade of association with CPSP for each predictor/correlate was then determined. Depression, psychological vulnerability, stress, and late return to work showed likely correlation with CPSP (grade of association=1). Other factors were determined to have either unlikely (grade of association=3) or inconclusive (grade of association=2) correlations. In addition, results were examined in light of the type of surgery undergone. This review is intended as a first step to develop an instrument for identifying patients at high risk for CPSP, to optimize clinical pain management. [ABSTRACT FROM AUTHOR]

Background: Fractures of the long bones and femur fractures in particular are common in multiple trauma patients, but the optimal management of femur fractures in these patients is not yet resolved. Although there is a trend towards the concept of "Damage Control Orthopedics" (DCO) in the management of multiple trauma patients with long bone fractures as reflected by a significant increase in primary external fixation of femur fractures, current literature is insufficient. Thus, in the era of "evidence-based medicine", there is the need for a more specific, clarifying trial.Methods/design: The trial is designed as a randomized controlled open-label multicenter study. Multiple trauma patients with femur shaft fractures and a calculated probability of death between 20 and 60% will be randomized to either temporary fracture fixation with fixateur externe and defined secondary definitive treatment (DCO) or primary reamed nailing (early total care). The primary objective is to reduce the extent of organ failure as measured by the maximum sepsis-related organ failure assessment (SOFA) score.Discussion: The Damage Control Study is the first to evaluate the risk adapted damage control orthopedic surgery concept of femur shaft fractures in multiple trauma patients in a randomized controlled design. The trial investigates the differences in clinical outcome of two currently accepted different ways of treating multiple trauma patients with femoral shaft fractures. This study will help to answer the question whether the "early total care" or the "damage control" concept is associated with better outcome.Trial Registration: Current Controlled Trials ISRCTN10321620. [ABSTRACT FROM AUTHOR]

Introduction: Evidence on the association of socioeconomic deprivation with occurrence of acute myocardial infarction (AMI) is available from international studies and urban settings in western Germany. This study aimed to assess this association based on small geographical areas in a rural setting in eastern Germany., Methods: This study used routine data of all patients with AMI who were treated in the Hospital Brandenburg in the city of Brandenburg, Germany, between May 2019 and May 2020. Hospitalisation rates of AMI were calculated for postal code regions that were located within the catchment area of the Hospital Brandenburg. Poisson regression was used to compare hospitalisation rates in areas with medium socioeconomic deprivation to areas with high deprivation, controlling for age group, sex and period (before or during COVID-19 pandemic). Publicly available social, infrastructure and healthcare-related features were mapped to characterise the study region., Results: In total, 265 cases of AMI were registered in the study area, which comprised 116,126 inhabitants. The city of Brandenburg was characterised by the highest level of socioeconomic deprivation, while neighbouring areas showed a rural settlement structure and medium levels of deprivation. The number of general practitioners per 10 000 inhabitants did not differ between both areas. The adjusted rate ratio comparing hospitalisations due to AMI in areas with medium socioeconomic deprivation to areas with high socioeconomic deprivation was 0.71 (95%CI 0.56-0.91, p=0.01)., Conclusion: This study adds evidence about the association of socioeconomic deprivation and AMI occurrence from a rural area in eastern Germany. Further research about the relationship of socioeconomic deprivation and cardiovascular health is needed from heterogeneous contexts.

Background: The removal of the acute appendix is one of the most frequently performed surgical procedures. Open surgery associated with therapeutic efficacy has been the treatment of choice for acute appendicitis. However, in consequence of the evolution of endoscopic surgery, the operation can also be performed with minimally invasive surgery. Due to smaller incisions, the laparoscopic approach may be associated with reduced postoperative pain, reduced wound infection rate, and shorter time until return to normal activity.This is an update of the review published in 2010., Objectives: To compare the effects of laparoscopic appendectomy (LA) and open appendectomy (OA) with regard to benefits and harms., Search Methods: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), Ovid MEDLINE and Embase (9 February 2018). We identified proposed and ongoing studies from World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP), ClinicalTrials.gov and EU Clinical Trials Register (9 February 2018). We handsearched reference lists of identified studies and the congress proceedings of endoscopic surgical societies., Selection Criteria: We included randomised controlled trials (RCTs) comparing LA versus OA in adults or children., Data Collection and Analysis: Two review authors independently selected studies, assessed the risk of bias, and extracted data. We performed the meta-analyses using Review Manager 5. We calculated the Peto odds ratio (OR) for very rare outcomes, and the mean difference (MD) for continuous outcomes (or standardised mean differences (SMD) if researchers used different scales such as quality of life) with 95% confidence intervals (CI). We used GRADE to rate the quality of the evidence., Main Results: We identified 85 studies involving 9765 participants. Seventy-five trials included 8520 adults and 10 trials included 1245 children. Most studies had risk of bias issues, with attrition bias being the largest source across studies due to incomplete outcome data.In adults, pain intensity on day one was reduced by 0.75 cm on a 10 cm VAS after LA (MD -0.75, 95% CI -1.04 to -0.45; 20 RCTs; 2421 participants; low-quality evidence). Wound infections were less likely after LA (Peto OR 0.42, 95% CI 0.35 to 0.51; 63 RCTs; 7612 participants; moderate-quality evidence), but the incidence of intra-abdominal abscesses was increased following LA (Peto OR 1.65, 95% CI 1.12 to 2.43; 53 RCTs; 6677 participants; moderate-quality evidence).The length of hospital stay was shortened by one day after LA (MD -0.96, 95% CI -1.23 to -0.70; 46 RCTs; 5127 participant; low-quality evidence). The time until return to normal activity occurred five days earlier after LA than after OA (MD -4.97, 95% CI -6.77 to -3.16; 17 RCTs; 1653 participants; low-quality evidence). Two studies showed better quality of life scores following LA, but used different scales, and therefore no pooled estimates were presented. One used the SF-36 questionnaire two weeks after surgery and the other used the Gastro-intestinal Quality of Life Index six weeks and six months after surgery (both low-quality evidence).In children, we found no differences in pain intensity on day one (MD -0.80, 95% CI -1.65 to 0.05; 1 RCT; 61 participants; low-quality evidence), intra-abdominal abscesses after LA (Peto OR 0.54, 95% CI 0.24 to 1.22; 9 RCTs; 1185 participants; low-quality evidence) or time until return to normal activity (MD -0.50, 95% CI -1.30 to 0.30; 1 RCT; 383 participants; moderate-quality evidence). However, wound infections were less likely after LA (Peto OR 0.25, 95% CI 0.15 to 0.42; 10 RCTs; 1245 participants; moderate-quality evidence) and the length of hospital stay was shortened by 0.8 days after LA (MD -0.81, 95% CI -1.01 to -0.62; 6 RCTs; 316 participants; low-quality evidence). Quality of life was not reported in any of the included studies., Authors' Conclusions: Except for a higher rate of intra-abdominal abscesses after LA in adults, LA showed advantages over OA in pain intensity on day one, wound infections, length of hospital stay and time until return to normal activity in adults. In contrast, LA showed advantages over OA in wound infections and length of hospital stay in children. Two studies reported better quality of life scores in adults. No study reported this outcome in children. However, the quality of evidence ranged from very low to moderate and some of the clinical effects of LA were small and of limited clinical relevance. Future studies with low risk of bias should investigate, in particular, the quality of life in children.

Clara Haskil (January 7, 1895-December 7, 1960) was one of the most famous female pianists of the 20th century. In her life and work she set new standards in piano playing. However, her career was beset by poor health and the adversities of two world wars. In her lifetime Haskil had three major disorders: juvenile scoliosis requiring treatment in her adolescence, a tumor of the sellar region requiring surgery at age 47 years, and a traumatic brain injury causing her death at the age of 65. Her medical history illustrates the development of surgical methods and rehabilitation in medicine before and after World War II. At an early age, she spent a year in a nursing home for orthopedic diseases due to scoliosis. In 1942, when she was 47 years old, she displayed the first symptoms of a suprasellar brain tumor: headache and hemianopsia. The famous surgeon Marcel David performed surgery on her without general anesthesia while Haskil mentally played a Mozart piano concerto as a neuronal representation to control her memory and mental abilities. Only 3 months after that operation she played a Mozart piano concerto at a concert that began her career as a great interpreter of Mozart. Her neurologic rehabilitation was remarkable and highlighted new methods in the field. In 1960, she traveled to Brussels for a concert. In the train station she stumbled on the stairs and hit her head on one of the steps. Skull fracture and intracranial hematoma were diagnosed. Doctors tried to operate on her but she lost consciousness and died. Haskil created new styles in piano playing, and her medical history offers indications of new concepts in neurosurgery., (Georg Thieme Verlag KG Stuttgart · New York.)

Introduction: The Appraisal of Guidelines for Research & Evaluation (AGREE) II instrument is the most commonly used guideline appraisal tool. It includes 23 appraisal criteria (items) organized within 6 domains and 2 overall assessments (1. overall guideline quality; 2. recommendation for use). The aim of this systematic review was twofold. Firstly, to investigate how often AGREE II users conduct the 2 overall assessments. Secondly, to investigate the influence of the 6 domain scores on each of the 2 overall assessments., Materials and Methods: A systematic bibliographic search was conducted for publications reporting guideline appraisals with AGREE II. The impact of the 6 domain scores on the overall assessment of guideline quality was examined using a multiple linear regression model. Their impact on the recommendation for use (possible answers: "yes", "yes, with modifications", "no") was examined using a multinomial regression model., Results: 118 relevant publications including 1453 guidelines were identified. 77.1% of the publications reported results for at least one overall assessment, but only 32.2% reported results for both overall assessments. The results of the regression analyses showed a statistically significant influence of all domains on overall guideline quality, with Domain 3 (rigour of development) having the strongest influence. For the recommendation for use, the results showed a significant influence of Domains 3 to 5 ("yes" vs. "no") and Domains 3 and 5 ("yes, with modifications" vs. "no")., Conclusions: The 2 overall assessments of AGREE II are underreported by guideline assessors. Domains 3 and 5 have the strongest influence on the results of the 2 overall assessments, while the other domains have a varying influence. Within a normative approach, our findings could be used as guidance for weighting individual domains in AGREE II to make the overall assessments more objective. Alternatively, a stronger content analysis of the individual domains could clarify their importance in terms of guideline quality. Moreover, AGREE II should require users to transparently present how they conducted the assessments.

Background: The study investigated the incidence of chronic pain as well as causes and mechanisms of pain chronification in orchestra musicians. Aims: Chronic pain is a serious problem in the study group due to very specific playing techniques and body positions while playing, with a high impact on professional and private life. Methods: 8,645 professional musicians from 132 German cultural orchestras were contacted and asked about chronic pain via an online questionnaire. The study group comprised orchestra musicians suffering from pain. The control group consisted of musicians playing the same type of instruments (same working conditions) who reported to be free of pain. Results: The response rate was 8.6% (740 musicians). 66.2% (n=490) out of 740 musicians who completed the questionnaire reported chronic pain. The most frequently reported localizations of pain were the body parts which are mostly involved in instrumental playing such as back (70%), shoulders (67.8%), neck (64.1%), hands and wrists (39.8%). 27.4% of the investigated musicians suffered from pain with a high degree of impairment. Conclusions: These results appear conclusive and indicate a need to continue research into chronic pain in musicians.

Introduction: Diverticulosis is a relevant disease in Germany with a prevalence of over 60 % in patients aged ≥70 years. The S2k guidelines for the treatment of diverticulosis were recently published. Systematic epidemiological data on treatment modalities do not exist., Methods: Analysis of in-hospital treatment modalities for diverticulosis based on data from the Federal Office of Statistics., Results: Approximately 130,000 inpatient cases of diverticulosis are treated in Germany per year. Approximately 25 % undergo surgery and of these slightly under 50 % (12,000 procedures) are carried out by laparoscopy. The complication rates are 18 % in a best case scenario and up to 85 % in a worst case scenario. A stage-adjusted classification of treatment modalities based on data from the Federal Office of Statistics is currently practically impossible., Conclusion: To enable stage-adjusted epidemiological analysis of diverticulosis, a standardized and transparent documentation system enabling systematic analysis is necessary, which does not currently exist (e. g. ICD 10 coding); moreover, information on conservative and interventional treatment options are not included in the operations and procedures key (OPS) coding system.

Using the best quality of clinical research evidence is essential for choosing the right treatment for patients. How to identify the best research evidence is, however, difficult. In this narrative review we summarise these threats and describe how to minimise them. Pertinent literature was considered through literature searches combined with personal files. Treatments should generally not be chosen based only on evidence from observational studies or single randomised clinical trials. Systematic reviews with meta-analysis of all identifiable randomised clinical trials with Grading of Recommendations Assessment, Development and Evaluation (GRADE) assessment represent the highest level of evidence. Even though systematic reviews are trust worthier than other types of evidence, all levels of the evidence hierarchy are under threats from systematic errors (bias); design errors (abuse of surrogate outcomes, composite outcomes, etc.); and random errors (play of chance). Clinical research infrastructures may help in providing larger and better conducted trials. Trial Sequential Analysis may help in deciding when there is sufficient evidence in meta-analyses. If threats to the validity of clinical research are carefully considered and minimised, research results will be more valid and this will benefit patients and heath care systems., (Copyright © 2016 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.)

In addition to clinical trials, registries and cohort studies are the fundamental basis of patient-orientated research. The importance of registries is increasing because more questions involving patient care under routine conditions (real world data) need to be answered. This article supplies answers to the questions: what can be achieved with registries and what are the limitations? Starting with a consensus definition of a registry from the German Network of Health Services Research (DNVF), the question of existing registries was examined and it was concluded that there was a lack of transparency. Consequently, a registry of registries similar to clinical trials registries is urgently needed as well as an evaluation of the quality of existing registries. Criteria are deduced that allow an assessment of the quality of a registry and which comprehensive possibilities registries can provide are discussed in eight different areas of interest to clinicians. The limitations of registries compared to randomized clinical trials and cohort studies are emphasized and discussed in this article. In the future, the use of registry-based randomized clinical trials (RRCT) will allow data related to efficacy as well as to effectiveness to be collated.

Background: Severe trauma continues to represent a global public health issue and mortality and morbidity in trauma patients remains substantial. A number of initiatives have aimed to provide guidance on the management of trauma patients. This document focuses on the management of major bleeding and coagulopathy following trauma and encourages adaptation of the guiding principles to each local situation and implementation within each institution., Methods: The pan-European, multidisciplinary Task Force for Advanced Bleeding Care in Trauma was founded in 2004 and included representatives of six relevant European professional societies. The group used a structured, evidence-based consensus approach to address scientific queries that served as the basis for each recommendation and supporting rationale. Expert opinion and current clinical practice were also considered, particularly in areas in which randomised clinical trials have not or cannot be performed. Existing recommendations were reconsidered and revised based on new scientific evidence and observed shifts in clinical practice; new recommendations were formulated to reflect current clinical concerns and areas in which new research data have been generated. This guideline represents the fourth edition of a document first published in 2007 and updated in 2010 and 2013., Results: The guideline now recommends that patients be transferred directly to an appropriate trauma treatment centre and encourages use of a restricted volume replacement strategy during initial resuscitation. Best-practice use of blood products during further resuscitation continues to evolve and should be guided by a goal-directed strategy. The identification and management of patients pre-treated with anticoagulant agents continues to pose a real challenge, despite accumulating experience and awareness. The present guideline should be viewed as an educational aid to improve and standardise the care of the bleeding trauma patients across Europe and beyond. This document may also serve as a basis for local implementation. Furthermore, local quality and safety management systems need to be established to specifically assess key measures of bleeding control and outcome., Conclusions: A multidisciplinary approach and adherence to evidence-based guidance are key to improving patient outcomes. The implementation of locally adapted treatment algorithms should strive to achieve measureable improvements in patient outcome.

Ludwig van Beethoven is nowadays considered to be one of the greatest composers in the history of music and his myth-like reputation is enhanced by his deafness; however, deafness was not the only condition which affected his genius. Due to the many lamentations contained in his letters about continuously recurring health problems, various attempts at an interpretation of Beethoven's personality have been undertaken. These included psychoanalytical considerations with respect to his father-mother relationship and also diagnostic attempts with reference to the symptoms of a possible borderline personality syndrome. The aim of this article is to comprehensively analyze the diseases of the patient Beethoven from the perspective of specialized medical disciplines based on new research results, to summarize various discipline-specific considerations and to make a contemporary assessment from the viewpoint of current scientific results.

Background: The transcatheter aortic valve implantation (TAVI), a minimally invasive surgical procedure to treat patients with severe symptomatic aortic stenosis, showed a rapid diffusion in Germany compared to the international level. The aim of this study is to identify and analyze factors affecting the implementation and diffusion of the procedure in hospitals using a qualitative application of the diffusion of innovations theory., Methods: We conducted problem-centered interviews with cardiologists and cardiac surgeons working in German hospitals. The multi-level model "diffusion of innovations in health services organizations" developed by Greenhalgh et al. was used to guide the research. Data was analyzed using content and a thematic analysis., Results: Among the ten participants who were interviewed, we found both barriers and facilitators related to the innovation itself, system readiness and antecedents, communication and influence, and the outer context. Key issues were the collaboration between cardiologists and cardiac surgeons, reimbursement policies, requirements needed to conduct the procedure, and medical advantages of the method., Conclusions: The findings show that there are multiple factors influencing the diffusion of TAVI that go beyond the reimbursement and cost issues. The diffusion of innovations model proved to be helpful in understanding the different aspects of the uptake of the procedure. A central theme that affected the implementation of TAVI was the collaboration and competition between involved medical departments: cardiology and cardiac surgery. Against this background, it seems especially important to moderate and coordinate the cooperation of the different medical disciplines.

Chronic wounds represent a major socio-economic problem in developed countries today. Wound healing is a complex biological process. It requires a well-orchestrated interaction of mediators, resident cells and infiltrating cells. In this context, mesenchymal stem cells and keratinocytes play a crucial role in tissue regeneration. In chronic wounds these processes are disturbed and cell viability is reduced. Hydroxyectoine (HyEc) is a membrane protecting osmolyte with protein and macromolecule stabilising properties. Adipose-derived stem cells (ASC) and keratinocytes were cultured with chronic wound fluid (CWF) and treated with HyEc. Proliferation was investigated using MTT test and migration was examined with transwell-migration assay and scratch assay. Gene expression changes of basic fibroblast growth factor (b-FGF), vascular endothelial growth factor (VEGF), matrix metalloproteinases-2 (MMP-2) and MMP-9 were analysed by quantitative real-time polymerase chain reaction (qRT-PCR). CWF significantly inhibited proliferation and migration of keratinocytes. Addition of HyEc did not affect these results. Proliferation capacity of ASC was not influenced by CWF whereas migration was significantly enhanced. HyEc significantly reduced ASC migration. Expression of b-FGF, VEGF, MMP-2 and MMP-9 in ASC, and b-FGF, VEGF and MMP-9 in keratinocytes was strongly induced by chronic wound fluid. HyEc enhanced CWF induced gene expression of VEGF in ASC and MMP-9 in keratinocytes. CWF negatively impaired keratinocyte function, which was not influenced by HyEc. ASC migration was stimulated by CWF, whereas HyEc significantly inhibited migration of ASC. CWF induced gene expression of VEGF in ASC and MMP-9 in keratinocytes was enhanced by HyEc, which might partly be explained by an RNA stabilising effect of HyEc., (© 2013 The Authors. International Wound Journal © 2013 Medicalhelplines.com Inc and John Wiley & Sons Ltd.)

Background: Several systematic reviews (SRs) of randomised controlled trials (RCTs) comparing laparoscopic versus open appendectomy have been published, but there has been no overview of SRs of these two interventions. This overview (review of review) aims to summarise the results of such SRs in order to provide the most up to date evidence, and to highlight discordant results., Methods: Medline, Embase, Cinahl, the Cochrane Database of Systematic Reviews and the Database of Abstracts of Reviews of Effects were searched for SRs published up to August 2014. Study selection and quality assessment using the AMSTAR tool were carried out independently by two reviewers. We used standardised forms to extract data that were analysed descriptively., Results: Nine SRs met the inclusion criteria. All were of moderate to high quality. The number of randomized controlled trials (RCTs) they included ranged from eight to 67. The duration of surgery pooled by eight reviews was 7.6 to 18.3 minutes shorter using the open approach. Pain scores on the first postoperative day were lower after laparoscopic appendectomy in two out of three reviews. The risk of abdominal abscesses was higher for laparoscopic surgery in half of six meta-analyses. The occurrence of wound infections pooled by all reviews was lower after laparoscopic appendectomy. One review showed no difference in mortality. The laparoscopic approach shortened hospital stay from 0.16 to 1.13 days in seven out of eight meta-analyses, though the strength of the evidence was affected by strong heterogeneity., Conclusion: Laparoscopic and open appendectomy are both safe and effective procedures for the treatment of acute appendicitis. This overview shows discordant results with respect to the magnitude of the effect but not to the direction of the effect. The evidence from this overview may prove useful for the development of clinical guidelines and protocols.

Wound healing requires a proper functioning of keratinocytes that migrate, proliferate and lead to a competent wound closure. Impaired wound healing might be due to a disturbed keratinocyte function caused by the wound environment. Basically, chronic wound fluid (CWF) differs from acute wound fluid (AWF). The aim of this study was to analyse the effects of AWF and CWF on keratinocyte function. We therefore investigated keratinocyte migration and proliferation under the influence of AWF and CWF using MTT [3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide] test and scratch assay. We further measured the gene expression by qRT-PCR regarding growth factors and matrixmetalloproteinases (MMPs) involved in regeneration processes. AWF had a positive impact on keratinocyte proliferation over time, whereas CWF had an anti-proliferative effect. Keratinocyte migration was significantly impaired by CWF in contrast to an undisturbed wound closure under the influence of AWF. MMP-9 expression was strongly upregulated by CWF compared with AWF. Keratinocyte function was significantly impaired by CWF. An excessive induction of MMP-9 by CWF might lead to a permanent degradation of extracellular matrix and thereby prevent wounds from healing., (© 2013 The Authors. International Wound Journal © 2013 Medicalhelplines.com Inc and John Wiley & Sons Ltd.)

Background and Objective: As systematic reviews may run out of date, it might be necessary to update them. Out-of-date reviews may jeopardize the comparability when used in the context of overviews (review of reviews)., Methods: Seven electronic databases were searched for overviews up to November 2012. We first aimed to analyze whether the authors of overviews additionally searched for primary studies or alternatively explained why they did not. Second, we sought to analyze the actual publication lag (publication date of the overview - publication date of the review) in overviews and to develop recommendations for authors of overviews., Results: We included 147 overviews. The mean publication lag in overviews was more than 5 years. A median of 36% of the reviews were published more than 6 years ago. Only one in four reviews considered up-to-dateness. The methods for updating reviews were heterogeneous. We found no overview that systematically investigated whether an update was necessary., Conclusion: The issue of up-to-dateness when conducting overviews seems to be neglected by most authors of overviews. Authors should assess the quality of evidence, based on their included reviews first., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Background: Assessment of the quality of medical care plays an increasingly important role in the German healthcare system. Requirements for quality indicators include validity, reliability, responsiveness, interpretability and feasibility. Because of the high impact of guidelines, quality indicators that are recommended in such guidelines are of special relevance., Methods: We conducted a systematic review of all German S3 guidelines (actual as of November 30(th), 2013) to investigate the proportion of guidelines recommending quality indicators, which categories to classify quality indicators were used, and whether quality indicators in German S3 guidelines were developed following evidence-based methods., Results: In 34 from 87 S3 guidelines (39%) a total of 394 quality indicators were defined. The vast majority of the recommended quality indicators focused on process quality. Outcome indicators were only recommended in 9 S3 guidelines (10%). None of the guidelines analysed reported the properties of the recommended quality indicators., Conclusion: Despite the increasing relevance of quality assessment for all stakeholders in the German healthcare system only approximately 40% of the S3 guidelines define indicators to measure the quality of care. Recommendations to assess outcome indicators are only provided in 10% of S3 guidelines. The process of the development and recommendation of quality indicators is heterogeneous and frequently not transparently reported. The current practice for the recommendation and validation of quality indicators in German S3 guidelines does not meet the requirements of evidence-based healthcare., (© Georg Thieme Verlag KG Stuttgart · New York.)

Purpose of this essay is to provide a historical overview how music has dealt with the emotion and sensation of pain, as well as an overview over the more recent medical research into the relationship of music and pain. Since the beginnings of western music humans have put their emotions into musical sounds. During the baroque era, composers developed musical styles that expressed human emotions and our experiences of nature. In some compositions, like in operas, we find musical representations of pain. During Romanticism artists began to intrude into the soul of their audience. New expressive harmonies and styles touch the soul and the consciousness of the listener. With the inception of atonality dissonant sounds where experienced as a physical pain.The physiology of deep brain structures (like thalamus, hypothalamus or limbic system) and the physiology of the acoustic pathway process consonant and dissonant sound and musical perceptions in ways, that are similar to the perception of pain. In the thalamus and in the limbic system music and pain meet.The relationships of music and pain is a wide open research field with such interesting questions as the role of dopamine in the perception of consonant or dissonant music, or the processing of pain during music listening. Musicology has not yet embarked on a general investigation of how musical compositions express pain and how that has developed or changed over the centuries. Music therapy, neuro-musicology and the performing arts medicine are scientific fields that offer a lot of ideas for medical and musical research projects., (© Georg Thieme Verlag KG Stuttgart · New York.)

Background: In August 2010, the Federal Joint Committee (G-BA) decided that negative pressure wound therapy (NPWT) would not be reimbursable in German ambulatory care. This decision was based on reports from the Institute for Quality and Efficiency in Health Care (IQWiG), which concluded that there is no convincing evidence in favor of NPWT. The aim of this diabetic foot study (DiaFu study) is to evaluate whether the clinical, safety and economic results of NPWT are superior to the results of standard wound treatment., Methods/design: The DiaFu study is designed as a national, multicenter, randomized controlled clinical superiority trial with a special focus on outpatient care in Germany. Competent patients in inpatient and outpatient care suffering from a chronic diabetic foot wound for a minimum of four weeks may be included in the study. The trial evaluates the treatment outcome of the application of a technical medical device which is based on the principle of NPWT (intervention group) in comparison to standard moist wound therapy (control group). All treatment systems used in the intervention group bear the symbol of free trade capacity in the European Union (CE mark) and will be operated within normal conditions of clinical routine and according to manufacturer's instructions. Primary endpoints are the time to complete wound healing and the rate of wound healing achieved in each group within the maximum study treatment time of 16 weeks. Primary endpoints will be confirmed by blinded assessment of wound photographs., Discussion: The DiaFu study will provide solid evidence regarding the efficacy and effectiveness of NPWT until 31 December 2014, the date when G-BA plans to decide on future reimbursement of NPWT in both ambulatory and in-hospital care. The study is designed to comply with all quality requirements of G-BA and IQWiG and will contribute to evidence-based wound care in Germany. The study has been initiated by the statutory health insurance companies in Germany and is co-funded by two manufacturers of NPWT systems., Trial Registration: Clinical Trials.gov registration number: NCT01480362 (date of registration: 23 November 2011).German Clinical Trials Register number: DRKS00003347 (date of registration: 22 November 2011).

Objective: This study investigated the incidence and determinants of chronic postsurgical pain (CPSP) in a general surgical patient population., Design: This is a prospective cross-sectional study at a university-affiliated clinic/level 1 trauma center. Patients were followed at least 1 year postoperatively. By surgical discipline, procedures were 50% orthopedic/trauma, 33% general (abdominal/visceral), and 17% vascular., Setting: All patients admitted during one year (N = 3020) were eligible. Exclusion criteria were cognitive impairment, communication/language barrier, nonoperative treatment, and refusal to participate. A CPSP questionnaire was completed. Step-by-step analysis followed with a 2(nd) questionnaire to detect CPSP with numeric rating scale (NRS) pain intensity ≥3. Finally, individual follow-up examinations were performed., Results: 911 patients responded (30.2%). 522 complained of pain intensity ≥3 on NRS (scale 0-10). The second step identified 214 patients with chronic pain (NRS ≥3, mean 29 months postoperatively). On final examination, 83 CPSP patients (14.8%) were identified. By surgical discipline, 28% were general, 15% vascular, and 57% trauma/orthopedic surgery. Most oftenly cited pain sites were joint (49.4%), incisional/scar (37.7%), and nerve pain (33.7%). By procedure, patients underwent pelvic surgery, colon surgery, laparoscopies, inguinal herniorrhaphies, arthroscopies, and hardware extractions. All patients in the "laborer" and "unemployed" categories reported chronic pain., Conclusion: Bias due to study design and/or heterogeneity of patients is possible, but there was a high CPSP rate after 2 years both generally and particularly in orthopedic/trauma (57%) patients. Both "major" and "minor" surgical procedures led to CPSP., (Wiley Periodicals, Inc.)

George Gershwin, the famous American composer, died in 1937 of a temporal lobe glioma. An emergency surgery was performed by R. Nafziger and W. E. Dandy. The case of George Gershwin indicates the beginning of a new era in music history as well as in the history of neurosurgery.

Background: Today, there is a trend toward damage-control orthopedics (DCO) in the management of multiple trauma patients with long bone fractures. However, there is no widely accepted concept. A risk-adapted approach seems to result in low acute morbidity and mortality. Multiple trauma patients with bilateral femoral shaft fractures (FSFs) are considered to be more severely injured. The objective of this study was to validate the risk-adapted approach in the management of multiple trauma patients with bilateral FSF., Methods: Data analysis is based on the trauma registry of the German Trauma Society (1993-2008, n = 42,248). Multiple trauma patients with bilateral FSF were analyzed in subgroups according to the type of primary operative strategy. Outcome parameters were mortality and major complications as (multiple) organ failure and sepsis., Results: A total of 379 patients with bilateral FSF were divided into four groups as follows: (1) no operation (8.4%), (2) bilateral temporary external fixation (DCO) (50.9%), bilateral primary definitive osteosynthesis (early total care [ETC]) (25.1%), and primary definitive osteosynthesis of one FSF and DCO contralaterally (mixed) (15.6%). Compared with the ETC group, the DCO group was more severely injured. The incidence of (multiple) organ failure and mortality rates were higher in the DCO group but without significance. Adjusted for injury severity, there was no significant difference of mortality rates between DCO and ETC. Injury severity and mortality rates were significantly increased in the no-operation group. The mixed group was similar to the ETC group regarding injury severity and outcome., Conclusion: In Germany, both DCO and ETC are practiced in multiple trauma patients with bilateral FSF so far. The unstable or potentially unstable patient is reasonably treated with DCO. The clearly stable patient is reasonably treated with nailing. When in doubt, the patient is probably not totally stable, and the safest precaution may be to use DCO as a risk-adapted approach., Level of Evidence: Therapeutic study, level IV. Epidemiologic study, level III.

The composer Felix Mendelssohn-Bartholdy and his sister, Fanny Hensel, both died in 1847 of intracerebral hemorrhage. Also their father and grandfather had died of cerebral strokes. Their cases show the dramatic progress of an arteriovenous malformation in the nineteenth century, but also the development of new romantic styles in the history of western music. Since the late nineteenth and the early twentieth century, neurology and neurosurgery had developed as highly specialized medical subjects. Today, neurosurgery is a highly developed medical subject, and the neurosurgeon uses high-tech equipment for neurosurgical procedures and intensive care. But before the 1960s, when modern neurosurgery began with the invention of the surgical microscope and other techniques, neurosurgical and neurological treatments were only helpless attempts with an experimental character to help a patient with a fatal disease. In the middle of the nineteenth century, symptoms of strokes or brain tumors were know, but medical knowledge and equipment were lacking. The cases of the Mendelssohn family are an interesting review of early neurology and the cultural life of the nineteenth century.

The market approval of medical devices in Germany does not yet require a benefit assessment. Thus, there is a lack of high quality studies that clearly prove the benefit of medical innovations. In the past, the Federal Joint Committee in Germany (G-BA) did not have the opportunity to adequately address this issue of lacking evidence. A law for the improvement of the care structure in the statutory health insurance offers the possibility for the G-BA to obtain evidence for the benefit of medical practice. With an integrated regulation for testing of medical devices the manufacturers have the option to apply for an assessment of new and established treatment methods and to provide scientific evidence for the benefit of medical devices as a requirement for inclusion in the catalogue of services of the statutory health insurance. However, this expanded scope of action is also a challenge for clinicians. The already existing problem of integrating multicenter clinical trials in the surgical routine will remain. The Surgical Study Network Germany (CHIR-Net) offers an ideal way to cope with the increased requirements on studies in the field of medical devices through established partnerships with methodological institutions and practitioners in clinical settings.

Objectives: The objective of this study was to determine if the authors mention overlapping reviews in overviews (reviews of reviews). In addition, we aimed to calculate the actual overlap in published overviews using newly introduced, validated measures., Study Design and Settings: We systematically searched for overviews from 2009 to 2011. Reviews included in the overviews were obtained. Tables (review×primary publication) were generated for each overview. The first occurrence of a primary publication is defined as the index publication. We calculated the "corrected covered area" (CCA) as a measure of overlap by dividing the frequency of repeated occurrences of the index publication in other reviews by the product of index publications and reviews, reduced by the number of index publications. Subgroup analyses were performed to investigate further differences in the overviews., Results: Only 32 of 60 overviews mentioned overlaps. The median CCA was 4.0. Validation of the CCA and other overlap measures was in accordance with our predefined hypotheses. The degree of overlap tended to be higher in health technology assessment reports than in journal publications and was higher with increasing numbers of publications., Conclusions: Overlaps must be reported in well-conducted overviews, and this can comprehensively be accomplished using the CCA method., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Minimum volume thresholds for specific medical treatments have been implemented in Germany since 2004. In the last 9 years the catalogue of procedures, which is determined by the Federal Joint Committee, has changed continuously and currently consists of 8 procedures. In this article the basis of decision making for the enrolment in the catalogue of procedures and the determination of minimum volume thresholds are examined. An overview of systematic reviews was published in 2012 outlining the correlation between the volume components and medical outcome. The body of evidence identified is compared to the current regulatory conditions of the Federal Joint Committee.

Objectives: To conduct a systematic review of the methods used to determine when and how to update clinical practice guidelines (CPGs) and develop a procedure for updating CPGs., Study Design and Setting: We searched MEDLINE, Embase, and the Cochrane Methodology Register for methodological publications on updating CPGs. Guideline development manuals were obtained from the Web sites of guideline-developing organizations. Using the information obtained from these records, a procedure for updating CPGs was developed., Results: A total of 5,116 journal articles were screened, and seven articles met the criteria for inclusion. Forty-seven manuals were included; of these, eight included details about the methods used to update the guidelines. Most of the included publications focused on assessing whether the CPGs needed updating and not on how to update them. The developed procedure includes a systematic monitoring system and a scheduled process for updating the CPGs, which includes guidance on how to determine the type and scope of an update., Conclusion: Partial updating often makes more sense than updating the whole CPG because topics and recommendations differ in terms of the need for updating. Guideline developers should implement a systematic updating procedure that includes an ongoing monitoring system that is appropriate for the nature of the guideline topics and the capabilities of the developers., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Introduction: Clinical practice guidelines can improve healthcare processes and patient outcomes, but are often of low quality. Guideline appraisal tools aim to help potential guideline users in assessing guideline quality. We conducted a systematic review of publications describing guideline appraisal tools in order to identify and compare existing tools., Methods: Among others we searched MEDLINE, EMBASE and the Cochrane Database of Systematic Reviews from 1995 to May 2011 for relevant primary and secondary publications. We also handsearched the reference lists of relevant publications. On the basis of the available literature we firstly generated 34 items to be used in the comparison of appraisal tools and grouped them into thirteen quality dimensions. We then extracted formal characteristics as well as questions and statements of the appraisal tools and assigned them to the items., Results: We identified 40 different appraisal tools. They covered between three and thirteen of the thirteen possible quality dimensions and between three and 29 of the possible 34 items. The main focus of the appraisal tools were the quality dimensions "evaluation of evidence" (mentioned in 35 tools; 88%), "presentation of guideline content" (34 tools; 85%), "transferability" (33 tools; 83%), "independence" (32 tools; 80%), "scope" (30 tools; 75%), and "information retrieval" (29 tools; 73%). The quality dimensions "consideration of different perspectives" and "dissemination, implementation and evaluation of the guideline" were covered by only twenty (50%) and eighteen tools (45%) respectively., Conclusions: Most guideline appraisal tools assess whether the literature search and the evaluation, synthesis and presentation of the evidence in guidelines follow the principles of evidence-based medicine. Although conflicts of interest and norms and values of guideline developers, as well as patient involvement, affect the trustworthiness of guidelines, they are currently insufficiently considered. Greater focus should be placed on these issues in the further development of guideline appraisal tools.

Introduction: The interference of biological, social, and psychological factors of the patient, collectively known as the biopsychosocial perspective, plays an important role in the chronification of postsurgical pain. The aim of this pilot study was to detect whether patients suffering from chronic pain without a relationship to a recent operation (CP) differ from chronic pain patients whose pain exists since a recent operation and is related with it (CPSP) in these factors., Materials and Methods: A step-by-step analysis of patients with chronic pain was conducted via a questionnaire of 36 questions in which mental state, pain, fear, and depression [Hospital Anxiety and Depression Scale - Deutsche Version (HADS-D), Chronic Pain Grade Questionnaire (CPGQ, von Korff), SF-12, McGill Pain Questionnaire (sensoric/affective)] were surveyed., Statistical Analysis: Fisher's exact test for counts, U test for continuous variables; group comparisons with: χ(2) test; p < 0.05 was considered significant., Results: On average 29 months postoperatively (24-35 ± 3.5 months), 113 chronic pain patients were analyzed. A group comparison between the CPSP group (n = 73 with chronic postsurgical pain) and the group CP (n = 29 with chronic pain) was conducted. Both groups showed highly significant reductions of SF-12 data compared to a German normal collective (p < 0.001), but normal results regarding depression in the HADS-D and a moderately limiting, highly pain-related limitation in the CPGQ (von Korff III). No differences in the sensoric and affective parameters of the McGill Pain Questionnaire were found. Compared with the CPSP group, the CP group demonstrated higher pain intensities (p = 0.022)., Conclusion: Regarding these results critically, there were no group differences concerning psychological and social patient factors in chronic pain patients with or without postsurgical pain.

Background: A decision of the Federal Joint Committee Germany in 2008 stated that negative pressure wound therapy is not accepted as a standard therapy for full reimbursement by the health insurance companies in Germany. This decision is based on the final report of the Institute for Quality and Efficiency in Health Care in 2006, which demonstrated through systematic reviews and meta-analysis of previous study projects, that an insufficient state of evidence regarding the use of negative pressure wound therapy for the treatment of acute and chronic wounds exists. Further studies were therefore indicated., Methods/design: The study is designed as a multinational, multicenter, prospective randomized controlled, adaptive design, clinical superiority trial, with blinded photographic analysis of the primary endpoint. Efficacy and effectiveness of negative pressure wound therapy for wounds in both medical sectors (in- and outpatient care) will be evaluated. The trial compares the treatment outcome of the application of a technical medical device which is based on the principle of negative pressure wound therapy (intervention group) and standard conventional wound therapy (control group) in the treatment of subcutaneous abdominal wounds after surgery. The aim of the SAWHI-VAC® study is to compare the clinical, safety and economic results of both treatment arms., Discussion: The study project is designed and conducted with the aim of providing solid evidence regarding the efficacy of negative pressure wound therapy. Study results will be provided until the end of 2014 to contribute to the final decision of the Federal Joint Committee Germany regarding the general admission of negative pressure wound therapy as a standard of performance within both medical sectors., Trial Registration: Clinical Trials.gov NCT01528033German Clinical Trials Register DRKS00000648.

Patient safety is an essential quality criterion for good medical care. A main aim of patient safety interventions is the prevention and/or reduction of adverse events. Various approaches are available for this. The multidisciplinarity in health services research as well as the wide range of methods and topics leads to the fact that health services research is predestined to deal with many of the resulting research questions and with respect to the complexity.

Sufficient acute pain therapy has been scientifically proven to be one of the therapeutic pillars for rapid patient convalescence, a low rate of pain chronification, and a high grade of patient satisfaction. This includes not only systemic pharmacological pain therapy, but also nonpharmaceutical measures, e.g., physical, psychological, locoregional, and adequate patient information. This requires a specific infrastructure, exact clinical control mechanisms, and fundamental knowledge about pain avoidance. The surgeon can responsibly contribute to this. The goal of the following article is to demonstrate and deepen this knowledge and to describe the newest scientific developments.

Background and Objectives: Inhalation injury, especially in combination with cutaneous burns, is the major cause of morbidity and mortality in patients admitted to burn care centers. Either with or without the presence of a cutaneous burn, inhalation injury contributes to high risk for developing severe pulmonary complications. Steroids may reduce a prolonged and destructive inflammatory response to toxic or allergic substances. The objective of this study was to evaluate the effect of early single-shot intravenous steroids on pulmonary complications and mortality in burned or scalded patients with or without inhalation injury., Methods: Retrospective analysis of a prospective single center database of patients registered between 1989 and 2011 who were admitted to the intensive care unit of our burn care center after burn or scald injury. Uni-variate statistical analysis was performed comparing two groups (steroid treated vs. non steroid treated patients) with regard to clinical outcome. Main parameters were sepsis, mortality and pulmonary complications such as pneumonia, ALI and ARDS. Multi-variate analysis was used by logistic regression with mortality and pulmonary complications as the dependent variables to identify independent risk factors after burn or scald injuries., Results: A total of 1637 patients with complete data were included in the present analysis. 199 (12.2%) received single-shot intravenous steroids during the prehospital phase of care. In 133 (66.8%) of these patients, inhalation injury was diagnosed via bronchoscopy. Steroid treated patients had sustained a significantly higher severity of burn than non-steroid treated patients (Abbreviated Burn Severity Index 7.1±3 vs. 6.0±2.9; p<0.001). In a multivariate analysis using a logistic regression model early intravenous steroid treatment had no significant effect on pulmonary complications and mortality., Conclusions: In our single center cohort of burned and scalded patients single-shot intravenous steroids during the pre-hospital phase of care was not associated with pulmonary complications or mortality., (Copyright © 2012 Elsevier Ltd and ISBI. All rights reserved.)

Introduction: Apoptosis, or programmed cell death, seems to play a role in the physiology of shock. The influence of fluid resuscitation on the occurrence of apoptosis during haemorrhage is still unclear. Using an experimental randomised study, the goal of this investigation was to find a relation between different frequently used resuscitation fluids and evidence of apoptosis., Materials and Methods: Sixty female pigs with a mean body weight of 20 kg were randomised into six groups, each receiving a different resuscitation fluid therapy: malated Ringer, lactated Ringer, hypertonic saline, hypertonic saline solution/Dextran 60, carbonate/gelatine and a sham group (no shock, no resuscitation). A haemorrhagic shock with a predefined oxygen debt with high mortality expected was induced for a period of 60 min. Then, the resuscitation fluid therapy within each group was initiated. At the beginning, after 1 h of shock and 1 and 2 h after resuscitation, biopsies from the liver were taken, as one of the most important metabolism organs of shock. Three hours after the beginning of the resuscitation period, the animals were allowed to recover under observation for 3 days. At the end of this period, a state of narcosis was induced and another liver biopsy was taken. Finally, the animals were sacrificed and samples were taken from the liver, kidney, heart and hippocampus. The TUNEL method was used for identifying apoptosis. Impairment of liver function was indicated by the measurement of transaminase levels., Results: There was no observed difference in the rate of apoptosis in all groups and a low number of apoptotic cells were found in all the organs sampled. The sham group also showed a low count of apoptosis. The hypoxia-sensitive neurons within the hippocampus did not show any signs of apoptosis. The high oxygen debt during haemorrhage led to a high mortality. The non-treated animals died very quickly, as an indicator for severe shock. Animals treated with hypertonic saline showed a significant increase in aspartate transaminase (AST) plasma levels on the first day after shock., Conclusion: The different resuscitation fluids used in the treatment of haemorrhagic shock in this experimental model showed no evidence of a different apoptosis rate in the end organs.

Background: The German National Surgical Trial Network (CHIR-Net) which has been funded since 2006 by the Federal Ministry of Education and Research (BMBF, funding code 01GH1001A-01GH1001F, 01GH0702) is made up of eight regional surgical centers. The aim of the CHIR-Net is the design, implementation and publication of prospective, randomized, multicenter trials to support evidence-based medicine in surgery. Two main pillars of the CHIR-Net are the surgeon on rotation program and the flying study nurse program. With these two programs the surgical hospitals are supported in their trial working by educating competent investigators and the infrastructural support of flexible and mobile study nurses., Methods: The surgeon on rotation program and the concept of the flying study nurse are presented descriptively. Furthermore, this paper provides reports of experiences of a surgeon on rotation and a flying study nurse of the CHIR-Net. Additionally, the results of an on-line evaluation of the regional surgical hospitals (belonging to the regional surgical center of the universities Witten/Herdecke and Cologne) regarding the needs and requirements of the regional surgical hospitals are presented., Results: The surgeon on rotation program of the CHIR-Net offers investigators the possibility to acquire the basics of designing, developing and implementation of high quality clinical trials. In addition, their own study projects could be intensively driven forward. The flying study nurse program enables in particular non-university surgical hospitals to be supported competitively in performing their own study projects and participating in muliticenter clinical trials. The success of these two programs has been confirmed by the conducted evaluations and the presented field reports., Conclusion: The CHIR-Net is able to develop a high quality study culture in Germany with its surgeon on rotation and flying study nurse program. In addition to the funding period by the BMBF, the continuance of the CHIR-Net should be a primary aim of further measures.