[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.

[Pain therapy with metamizole after ambulatory surgery?] / Postoperative Akutschmerztherapie nach ambulanten Operationen mit Metamizol?

One third of operations are performed on an outpatient basis in Germany, but methods of postoperative pain therapy are less studied. We observed 126 patients with ambulatory and planned surgery in the field of orthopedics and trauma surgery. They were treated with the analgesic metamizole intra- and postoperatively and completed the patients' questionnaire QUIPS on the first postoperative day. In all, 79 patients (61.7%) reported current pain ≥4 on the numerical rating scale (NRS); 84 (66.6%) had restrictions in mobility, 48 (38.1%) described sleep disorders, and 26 (20.6%) wished for more or stronger analgesics. However, 91 (72.2%) of our patients were satisfied with the their pain therapy. Chances are that the treatment of nociceptive pain during movement with NSAID or COX-2-inhibitors is more successful. Further investigations should follow.

[Is DRG Coding too Important to be Left to Physicians? - Evaluation of Economic Efficiency by Health Economists in a University Medical Centre]. / Ist die Kodierung im Krankenhaus zu wichtig, um sie Ärzten zu überlassen? ­ Evaluation der betriebswirtschaftlichen Effizienz von Gesundheitsökonomen an einem Zentrum der Maximalversorgung.

Background: We investigated and evaluated the cost effectiveness of coding by health care economists in a centre for orthopaedics and trauma surgery in Germany, by quantifying and comparing the financial efficiency of physicians with basic knowledge of the DRG-system with the results of healthcare economists with in-depth knowledge (M.Sc.). In addition, a hospital survey was performed to establish how DRG-coding is being performed and the identity of the persons involved. Material and Methods: In a prospective and controlled study, 200 in-patients were coded by a healthcare economist (study group). Prior to that, the same cases were coded by physicians with basic training in the DRG-system, who made up the control group. All cases were picked randomly and blinded without informing the physicians coding the controls, in order to avoid any Hawthorne effect. We evaluated and measured the effective weighting within the G-DRG, the DRG returns per patient, the overall DRG return, and the additional time needed. For the survey, questionnaires were sent to 1200 German hospitals. The completed questionnaire was analysed using a statistical program. Results: The return difference per patient between controls and the study group was significantly greater (2472 ± 337 €; p < 0.05); the overall return was raised by 494,500 €. The mean additional time needed was 11.32 ± 0.8 min per case, resulting in an increase in proceeds of 218 ± 38 € per minute. 2.5 % of all cases had to be devaluated by the health economist after the initial coding by the control group. Returned sheets of 60 hospitals were evaluated. The median level of DRG case reports was 1277 (2500-62,300). Coding was performed in 69 % of cases by doctors, 19 % by skilled specialists for DRG coding and in 8 % together. Overall satisfaction with the DRG was described by 61 % of respondents as good or excellent. Conclusion: Our prospective and controlled study quantifies the cost efficiency of health economists in a centre of orthopaedics and trauma surgery in Germany for the first time. We provide some initial evidence that health economists can enhance the CMI, the resulting DRG return per patient as well as the overall DRG return. Data from the survey shows that in many hospitals there is great reluctance to leave the coding to specialists only.

[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.

[Healthcare services research on pain in Germany. A survey]. / Versorgungsforschung zu Schmerz in Deutschland. Eine Bestandsaufnahme.

Within the last ten years healthcare services research has developed into an independent interdisciplinary field of research. A selective search of the literature was conducted in the database Google Scholar and the database on healthcare services research in Germany (http://versorgungsforschung-deutschland.de) for healthcare services research projects on pain in Germany. Healthcare services research projects were conducted by pharmaceutical companies, patient self-help organizations, scientific societies, statutory health insurance companies and university departments on acute and chronic pain. Valid data on the epidemiology, grading and treatment of chronic pain are available. There was an overuse of opioids and invasive procedures in patients with chronic low back pain, fibromyalgia syndrome and somatoform pain disorders. Databases for patients with chronic pain are currently constructed by pain societies. The fragmentation of data from health insurance companies, old age pension insurances, clinical institutions and population surveys and inconsistencies in diagnosing or encoding chronic pain impede the carrying out of significant longitudinal studies. Based on the data available, the needs of care for patients with chronic pain and the necessary care services cannot be derived. Important topics of future healthcare services research on pain are longitudinal studies on the cost efficacy and risks of inpatient and outpatient pain therapy based on routine data of health insurance companies, old age pension insurances and pain registries, longitudinal studies on "patient careers" (i.e. sequences of healthcare) and the identification of potential starting points for control of healthcare.

[QUIPSambulant. An instrument for quality assurance in acute pain therapy after outpatient operations]. / QUIPSambulant. Ein Tool zur Qualitätssicherung in der Akutschmerztherapie nach ambulanten Operationen.

BACKGROUND AND OBJECTIVES: Up until recently no tool for quality assurance (QA) of outpatient pain therapy after outpatient surgery, which currently constitutes one third of all operations, was available with benchmarking capacity. The QUIPS (German abbreviation for quality assurance in postoperative pain therapy) questionnaire, that had primarily been developed and established for inpatient postoperative pain therapy, was to be optimized to not only incorporate the issues with regard to outpatient operations but also a revision for use in the clinical routine. MATERIAL AND METHODS: An interdisciplinary task force reviewed and optimized the QUIPS questionnaire. The optimized questionnaire was then used within the scope of outpatient surgery in their clinics. A total of 121 patients and 12 surgeons received a questionnaire on the first postoperative day containing questions on acceptance and understandability of the QUIPS patient outcome questionnaire. RESULTS: Of the patients 12 (9.9 %) did not understand the original question on special pain therapy procedures stated during the preoperative counseling. For 15 patients (12.4 %) the original questions on chronic or pre-existing pain were misleading and 4 out of the 12 surgeons (33 %) did not conclusively understand these questions. The optimized questionnaire modified the questions in the preoperative counseling in the segment of postoperative pain as follows: question E1 was changed to a yes/no answer. Question E13 was modified to "how content were you with respect to your post-operative pain therapy?" Question E14 was modified to "did you suffer from other pain prior to the operation, hence pain that continued in addition to the postoperative pain?" These changes improved the understandability of the QUIPS patient outcome questionnaire. Surgeons required on average 9.7 min (SD ±3.2 min) to complete the QUIPS documentation sheets and 83 % of the surgeons rated the optimized QUIPS module as usable in the daily routine. The new module QUIPSambulant will soon be available for download on the QUIPS internet website. DISCUSSION: By reducing items on the QUIPS documentation sheets with respect to items relevant for outpatient surgery and redesigning three questions in the patient outcome questionnaire, a new QUIPS module for the QA of postoperative pain in an ambulatory setting is now available for both patients and surgeons. The necessity for quality management (QM) with regard to postoperative pain therapy after outpatient surgery can be considered assured. To what extent the newly adapted QM tool QUIPSambulant will be deemed suitable in a routine hospital setting remains to be seen and requires ongoing investigation.

[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.

[Current status of total hip and knee replacements in Germany - results of a nation-wide survey]. / Aktueller Status der Hüft- und Knieendoprothetik in Deutschland - Ergebnisse einer bundesweiten Umfrage.

BACKGROUND: Total hip and knee replacements are very frequently performed operative procedures in German hospitals. Despite the high number of cases, only few data on treatment procedures of the clinical routine and their impact on postoperative length of stay and clinical outcome are available. The aim of our survey was to gain detailed insights of the treatment procedures in patients scheduled for elective hip or knee replacement in order to extract recommendations for improving patient care. METHODS: In a nation-wide survey, we asked leading physicians of 694 trauma surgery and orthopaedic surgery departments and their corresponding colleagues in the departments of anaesthesia for treatment procedures including the process of patient admission, surgical techniques, postoperative analgesia, discharge management and follow-up. We used a multiple linear regression for analysing variables impacting on the postoperative length of stay. RESULTS: Altogether, 303 replies representing 31.8 % of the contacted hospitals could be evaluated. For hip arthroplasty, the anterolateral approach was most commonly chosen. For knee arthroplasty, the parapatellar approach was most frequently used. Tourniquet and wound drainage (mostly removed on the second postoperative day) were widely used with more than 90 %. The avoidance of wound drainage was associated with a lower postoperative length of stay for patients following total hip or knee replacement. Only 70 % of the German departments followed up their patients after discharge checking especially the range of motion of the artificial joint replacement. CONCLUSION: The treatment procedures for elective hip and knee replacement are very heterogeneous in German hospitals. The quality of the clinical outcome cannot be related to a single procedure; in fact the choice and complementary interaction of interventions are essential for improving patient care. These results provide first important evidence to which extent organisational structures and treatment procedures affect patient care and length of stay. Therefore, the analyses show relevant indications for an optimised standard in patient care.

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.

[Transfer managment of postoperative acute pain therapy to outpatient aftercare]. / Das Überleitungsmanagement der postoperativen Akutschmerztherapie in die ambulante Weiterbehandlung.

The significance of postoperative pain management for patients in the hospital is well known and has been a focus of research for several years. The ambulatory care after hospital discharge, however, is not well investigated. A prospective observational study was therefore conducted to study the transfer management from in-hospital patients to ambulatory care. A patient questionnaire was developed and patients were asked to fill it out at different time points after the operation: during the time in the hospital, then at 2 weeks and 6 months after hospital discharge. In addition, the responsible family doctor was approached and interviewed. The main focus of the questionnaire was the measurement of post-surgical pain (numeric rating scale NRS), patient satisfaction (Cologne patient questionnaire), and quality of life (SF 12). Of a total of 128 patients 72.9% described moderate to severe pain after the orthopaedic operations in the hospital. 90.8% of the patients had pain directly after discharge from the hospital; in 67.4% of the cases pain was ≥3 and in 23.4% of the cases pain was ≥6. Six months after discharge pain was significant in 29.4% of the patients, 60.8% of the patients were satisfied with the transfer to the home setting. 16% were not satisfied at all and 23.2% were neutral. Important factors for dissatisfaction with the transfer management were, according to stepwise logistic regeression analysis, sex (female patients), young age, a poor bodily constitution at the hospital and thereafter, and the pain management in the hospital and after discharge. The study shows the significance of the acute pain therapy not only during the hospital stay but also after discharge. There are very few data on pain therapy after discharge from the hospital. Based on the significance of the chronification of acute pain it is of the utmost importance to close this gap.

[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.

Distinguishing between pain intensity and pain resolution: using acute post-surgical pain trajectories to predict chronic post-surgical pain.

BACKGROUND: High intensity of acute post-surgical pain is one of the strongest predictors for chronic post-surgical pain (CPSP). We investigated the predictive power of acute post-surgical pain trajectories and the interplay of pain trajectories and diverse psychosocial risk factors in the development of CPSP. METHODS: Data from 199 patients were examined using latent growth curve analysis by means of structural equation modelling. This analytical approach was used to explicitly test the mediating role of acute pain trajectories within the association between preoperative psychosocial vulnerability factors and CPSP. RESULTS: Both initial pain intensity and pain resolution during the first five post-operative days independently contributed to the prediction of CPSP 6 months after surgery. In terms of vulnerability, anxiety and depression had clear but opposing effects on post-operative pain trajectories. Whereas depressive patients exhibited impaired pain resolution, patients with high anxiety showed better rates of pain resolution after surgery. Both effects on acute pain resolution extended to chronic pain 6 months after surgery. CONCLUSIONS: In this study, we demonstrated that going beyond conventional one-time measurements of acute pain by modelling pain trajectories may substantially enhance research on pain chronification in two ways: First, pain trajectories bear great potential to improve the prediction of CPSP. Second, they represent a meaningful link between psychosocial vulnerability and CPSP because they can be used to uncover mechanisms by which psychosocial vulnerability unfolds. The reported findings suggest that the incidence of CPSP may be reduced by optimizing post-operative pain monitoring.