[Health services research : Definition, objective, method and perspectives]. / Versorgungsforschung : Definition, Gegenstand, Methodik und Perspektiven.

This overview article highlights the central role of health services research (HSR) for the further development of the healthcare system. As a young scientific discipline in Germany, HSR covers five important elements with different weighting in different definitions, which are elaborated in some detail in this article: patient orientation, results and outcome orientation at the patient and population levels, implementation perspectives and context relation, complex interventions and improvement, multidisciplinarity and multiprofessionalism. One of the fundamental pillars of HRS is related to the insufficient implementation of scientifically proven treatment methods and improvement strategies into routine patient care. Healthcare research is therefore the so-called second translation of clinical trials in the routine daily care (from bedside to practice) after the first translation from bench to bedside. The scientific methods used in HSR clearly extend beyond the spectrum of (clinical) epidemiology. The methodological standards are developed as consensus memoranda of members of the German network of HSR, which serve as orientation points for qualitatively good HSR. Finally, various perspectives for the long-term safeguarding and improvement of the quality of HSR in Germany are proposed.

[Evaluation of the infrastructure for clinical surgical studies in Germany : A nationwide survey of the surgical study network CHIR-Net]. / Evaluation zur Infrastruktur für klinisch chirurgische Studien in Deutschland : Eine bundesweite Umfrage des chirurgischen Studiennetzwerks (CHIR-Net).

BACKGROUND: In order to improve the quality and quantity of clinical trials in Germany a surgical study network called CHIR-Net funded by the Federal Ministry of Education and Research (BMBF) was established. The focus was on building an infrastructure for the performance of surgical multicenter, randomized controlled clinical trials with the inclusion of university and non-university hospitals. The education of clinicians with an interest in clinical research and the transfer of research ideas (as investigator initiated trials, IIT) were clear goals for this grant. The aim of this article is to evaluate the incentive measures by comparison of clinics with and without participation in CHIR-Net structures. MATERIAL AND METHODS: A nationwide online survey included a total of 475 heads of surgical departments of whom 268 worked in hospitals with participation in CHIR-Net structures and 207 at hospitals without. They were asked to answer 20 questions in the following categories: education and activities in clinical trials, number of publications and participation in grant applications at the BMBF and/or German Research Foundation (DFG). The evaluation of the survey was performed according to a priori defined criteria. RESULTS: The response rate was 23.4% and 68 CHIR-Net hospitals and 43 non-CHIR-Net hospitals participated in the survey. The comparison of the results between the hospitals showed that the network significantly contributed to improvement of the study culture, especially in the areas of education in clinical research, infrastructure for clinical trials, study activity, grant applications and publication rates. CONCLUSION: The hospitals that participate in CHIR-Net structures were superior to hospitals that do not participate in CHIR-Net structures regarding study activity, infrastructure for clinical trials, study-specific education of clinicians, grant applications and publication rates. The goal of the grant was achieved and the funding led to manifold, long-term cooperation and a clear improvement of the study culture in surgery.

[Sigmoid colon diverticulitis : Treatment modalities 2011-2013]. / Sigmadivertikulitis : Behandlungsmodalitäten 2011 bis 2013.

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.

[What can and cannot be achieved by registries : Perspective of the registry working group of the German Network of Health Services Research]. / Was Register leisten können und was nicht : Sicht der AG Register des Deutschen Netzwerks Versorgungsforschung e. V. (DNVF).

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.

[A registry of registries and cohorts: recommendations for metadata and policies]. / Ein Register für Register und Kohorten: Empfehlungen zu Metadaten und Verfahrensregeln.

Registries and cohort studies play a central role in patient-oriented medical research, in particular in health services research. In order to increase the transparency about ongoing registries and cohort studies in Germany, and to promote communication and cooperation between the drivers in the field a so-called register portal should be established. Metadata are characteristics that are used to describe registries and cohort studies in the register portal. A limited set of characteristics, the core set, should correctly describe the projects on the one hand while reducing workload for data capture and data administration on the other hand. The core set consists of 26 data elements that had been defined in a Delphi-consensus process involving experts from the working group registries of the German Network for Health Services Research (DNVF) and the working group IT infrastructure and quality management of the Technology, Methods, and Infrastructure for Networked Medical Research (TMF). Transparent policies are required to guarantee traceability and reliability of the portal's services. Six so-called top-level-tasks and 37 use cases were defined in an interim report so far. The metadata have been agreed upon by most of the member associations of the DNVF. Metadata and rules of procedures are the starting point for the practical implementation of the register portal in the next future.

[Recommendations for quality indicators in German S3 guidelines: a critical appraisal]. / Empfehlungen zur Messung der Versorgungsqualität in aktuellen S3-Leitlinien: Eine kritische Bestandsaufnahme.

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.

[The phenomenon of pain in the history of music ­ observations of neurobiological mechanisms of pain and its expressions in western music]. / Der Schmerz in der Musikgeschichte. Betrachtungen über die neurobiologischen Mechanismen des Schmerzes und seine Darstellungen in der abendländischen Musik.

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.

Felix Mendelssohn-Bartholdy and Fanny Hensel: two cases of intracerebral hemorrage and great composers of the nineteenth century.

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.

[Assessment of the benefit of medical devices in surgical practice. Problems and possible solutions]. / Nutzenbewertung von Medizinprodukten in der chirurgischen Praxis. Probleme und Lösungsmöglichkeiten.

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.

[Minimum thresholds under scrutiny]. / Mindestmengen auf dem Prüfstand.

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.

[Surgical patients with chronic pain or chronic postsurgical pain: a prospective analysis of psychological and social factors]. / Chirurgische Patienten mit chronischem Schmerz oder chronisch-postoperativem Schmerz : Eine prospektive Analyse psychologischer und sozialer Faktoren.

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.

[Patient safety in health service research]. / Patientensicherheit in der Versorgungsforschung.

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.

[Pain therapy options in trauma and emergency surgery]. / Schmerztherapeutische Möglichkeiten in der Unfallchirurgie.

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.

[Why nurses fly and surgeons rotate. The surgical study network CHIR-Net]. / Warum Schwestern fliegen und Ärzte rotieren. Das chirurgische Studiennetzwerk CHIR-Net.

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.

[Preparedness of hospital physicians for a mass casualty incident. A German survey amongst 7,700 physicians]. / Wie gut sind Ärzte auf einen Massenanfall von Verletzten vorbereitet?. Ergebnisse einer bundesweiten Umfrage bei 7700 Klinikärzten.

INTRODUCTION: The bomb attacks in Madrid (2004) and London (2005) have increased awareness that terrorist attacks are also a real threat in Germany. Hospitals and health care providers should be prepared. METHODS: We distributed an anonymous online questionnaire to physicians working in trauma centers of different categories. The results were analyzed using descriptive statistical methods. RESULTS: The questionnaire was returned by 1,204 of 7,700 physicians. This reflects a response rate of 15.6%. Of the participants, 53.3% answered that their hospital had a disaster control plan and that they knew the content; 33.9% reported that their hospital had participated in a disaster training scenario. CONCLUSION: As only 53.3% of physicians in hospitals know their disaster control plan and only 33.9% of hospitals have participated in a disaster training scenario we conclude that more action is needed to increase awareness of the problem. Furthermore standardized training programs are needed to disseminate knowledge and skills in order to enable health care providers to face the occurrence of terroristic attacks in Germany.

Impact of fluid therapy on apoptosis and organ injury during haemorrhagic shock in an oxygen-debt-controlled pig model.

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.

[Contact allergies in musicians]. / Zur besonderen Problematik von Kontaktallergien bei Instrumentalisten.

During the last years, the problem of allergic diseases has increased. Allergies are errant immune responses to a normally harmless substance. In musicians the allergic contact dermatitis to exotic woods is a special problem. Exotic rosewood contains new flavonoids, which trigger an allergic reaction after permanent contact with the instrument. High quality woodwind instruments such as baroque flute or clarinets are made in ebony or palisander because of its great sound. Today instruments for non-professional players are also made in these exotic materials and non-professionals may have the risk to develop contact dermatitis, too. Brass-player has the risk of an allergic reaction to the different metals contained in the metal sheets of modern flutes and brass instruments. Specially nickel and brass alloys are used to product flute tubes or brass instruments. Special problem arises in children: patients who are allergic to plants or foods have a high risk to develop contact dermatitis. Parents don't know the materials of low-priced instruments for beginners. Often unknown cheap woods from exotic areas are used. Low-priced brass instruments contain high amount of brass and other cheap metals. Physicians should advice musician-patients or parents about the risks of the different materials and look for the reason of eczema on mouth, face, or hands.

Prevention and treatment of bile duct injuries during laparoscopic cholecystectomy: the clinical practice guidelines of the European Association for Endoscopic Surgery (EAES).

BACKGROUND: Laparoscopic cholecystectomy is one of the most common surgical procedures in Europe (and the world) and has become the standard procedure for the management of symptomatic cholelithiasis or acute cholecystitis in patients without specific contraindications. Bile duct injuries (BDI) are rare but serious complications that can occur during a laparoscopic cholecystectomy. Prevention and management of BDI has given rise to a host of publications but very few recommendations, especially in Europe. METHODS: A systematic research of the literature was performed. An international expert panel was invited to appraise the current literature and to develop evidence-based recommendations. Statements and recommendations were drafted after a consensus development conference in May 2011, followed by presentation and discussion at the annual congress of the EAES held in Torino in June 2011. Finally, full guidelines were consented and adopted by the expert panel via e-mail and web conference. RESULTS: A total of 1,765 publications were identified through the systematic literature search and additional submission by panellists; 671 publications were selected as potentially relevant. Only 46 publications fulfilled minimal methodological criteria to support Clinical Practice Guidelines recommendations. Because the level of evidence was low for most of the studies, most statements or recommendations had to be based on consensus of opinion among the panel members. A total of 15 statements and recommendations were developed covering the following topics: classification of injuries, epidemiology, prevention, diagnosis, and management of BDI. CONCLUSIONS: Because BDI is a rare event, it is difficult to generate evidence for prevention, diagnosis, or the management of BDI from clinical studies. Nevertheless, the panel has formulated recommendations. Due to the currently limited evidence, a European registry should be considered to collect and analyze more valid data on BDI upon which recommendations can be based.

[Quality management in acute pain therapy: results from a survey of certified hospitals]. / Qualitätsmanagement in der Akutschmerztherapie : Ergebnisse einer Befragung TÜV-zertifizierter Kliniken.

AIM: Systems for and methods of quality management are increasingly being implemented in public health services. The aim of our study was to analyze the current state of the integrated quality management concept "quality management acute pain therapy" of the TÜV Rheinland® (TÜV) after a 5-year project period. MATERIAL AND METHODS: General characteristics of the participating hospitals, number of departments certified by the TÜV and implementation of structures and processes according to the TÜV guidelines were evaluated by a mail questionnaire. Furthermore, positive and negative aspects concerning the effects of certification were evaluated by the hospitals' representatives of certification. RESULTS: A total of 36 questionnaires were returned. Since 2006 the number of certified hospitals (2011: n = 48) and surgical departments (2011: n = 202) has increased continuously. The number of certified medical departments is low (2011: n = 39); however, in the last 3 years, it has increased by about 200-300% annually. Standard operative procedures for pain therapy and measurement of pain intensity at regular intervals were implemented in all certified clinics (100%). Although 41% take part in the benchmarking project QUIPS (Quality Improvement in Postoperative Pain Therapy), 24% do not systematically check the quality of the outcome of pain management. Acceptance of the new pain therapy concepts among nursing staff was rated positively (ratio positive:negative 16:1); however, acceptance among physicians was rated negatively (1:15). CONCLUSION: Certification by the TÜV leads to sustainable implementation of quality management principles. Future efforts should focus on better integration of physicians in acute pain therapy and the development of an integrated tool to measure patients' outcome.