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Background: There is so far no information on how the third act on amendment of the German guardianship law from 29 July 2009 has affected dying processes of critically ill patients., Methods: This retrospective study analyzed the patterns of dying processes in postoperative critically ill patients treated from 2009 to 2012 (period II after the commencement of the German Living Will Act) and 10 years before (period I, 1999-2002). Independent associations were calculated by logistic regression., Results: In the observation period II (n = 137 dying patients) time until death significantly decreased to 19.3 days (95% CI 14.8-23.8, p = 0.008) vs. 29.2 days (95% CI 23.7-34.6) in period I (n = 163). In period II respect of the patient's will preceded death in 42.3% of the dying patients (period I: 8.6%, p < 0.001). Simultaneously, the frequency of patients with a severe preoperative comorbidity (failure of more than one organ) increased (26.8% of dying patients vs. 5.5% in period I, p = 0.001). The treatment during period II was, in addition to high age and a severe comorbidity, a significant independent predictor for the possibility that respect of the patient's will preceded death (odds ratio 7.42; 95% CI 3.77-14.60)., Conclusion: Independent of various covariables, treatment after the commencement of the German Living Will Act was associated with a broader and earlier respect of the patient's will, thereby shortening the time until death.

Background: The Patient Rights Act has converted court rulings into legal paragraphs. Two new aspects have been introduced: the duty to hand over a copy of the signed written consent form to the patient (in which detailed recommendations are offered) and the obligation of a thorough documentation of findings and treatments within patient files. In addition the legislators, through the Joint Federal Committee (Gemeinsamer Bundesausschuss, GBA) have made the introduction of clinical risk management mandatory. The Infection Protection Act and its regulations have elevated the prerequisites of hygiene within hospitals and private practices with a parallel increase in liability., Results and Discussion: Both laws and regulations offer no reference as to who (and to what extent) is financially responsible for the excessive increase in personnel costs, which are as yet not included in the German diagnosis-related groups (G-DRG) system. Despite all additional measures within the area of risk management, mistakes (avoidable or unavoidable) will nevertheless occur. In order to avoid longstanding legal battles the authors recommend an open and rapid communication with the patient and family. The wall of silence should be a thing of the past.

The organizing institution of a biobank can be of public or private law in nature and the form can be freely selected. Biomaterials must be legally valued as objects whereby inalienable personality rights are still valid even if ownership is transferred. The treating physician does not automatically acquire a comprehensive right of ownership or utilization for the materials taken during the treatment. The biobank acquires tangible property and user rights on the samples by a legal agreement between the donor and the biobank. Reutilization clauses in submission contracts should not be used due to the danger of a formularization development and surprise clauses. During the processing of biomaterials within the biobank substantially new characteristics can appear which have an effect on ownership and commercialization rights. The donor does not have a utilization right in the sense of a patent or copyright. If there are changes in the legal form and the use by third parties, the declaration of consent by the donor remains fully effective. There are special risks for the donor if the biobank transfers these biomaterials. This must be clarified before finalizing the agreement on sample transference and utilization in the sense of an informed decision.

Introduction: Complications after cholecystectomy are continuously documented in a nationwide database in Germany. Recent studies demonstrated a lack of reliability of these data. The aim of the study was to evaluate the impact of a control algorithm on documentation quality and the use of routine diagnosis coding as an additional validation instrument., Methods: Completeness and correctness of the documentation of complications after cholecystectomy was compared over a time interval of 12 months before and after implementation of an algorithm for faster and more accurate documentation. Furthermore, the coding of all diagnoses was screened to identify intraoperative and postoperative complications., Results and Discussion: The sensitivity of the documentation for complications improved from 46 % to 70 % (p = 0.05, specificity 98 % in both time intervals). A prolonged time interval of more than 6 weeks between patient discharge and documentation was associated with inferior data quality (incorrect documentation in 1.5 % versus 15 %, p < 0.05). The rate of case documentation within the 6 weeks after hospital discharge was clearly improved after implementation of the control algorithm. Sensitivity and specificity of screening for complications by evaluating routine diagnoses coding were 70 % and 85 %, respectively. The quality of documentation was improved by implementation of a simple memory algorithm.

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.

Ethical and moral topics have always been an integral part of surgery. The rapid progress of highly advanced medicine has induced public discussions about medico-ethical problems as well as respective legislation. Interdisciplinary ethical committees, appointed by political as well as professional associations, have published guidelines concerning current ethical topics. However, what about the doctor's attitude and the influence of the ever changing "Zeitgeist"? With the surplus of unproven health information on the web, modern information technologies have changed the doctor-patient relationship. Active leadership of the doctor is still required. For the benefit of the patient the physician should confront increasing economic pressures and the requirements of higher performance levels with competence. Indications have to be based on the results of valid quality controls. Special moral standards should be applied for working within the surgical community and for the pursuit of a career in academic surgery. By strengthening mutual respect and the community spirit surgery will remain attractive for aspiring young doctors.

Informed consent of donors of biomaterials represents an essential pillar of legal conformity of business organizations even for biobanks. For the assessment of self-determination of donors and freedom of research for users of biobanks there is a general consensus on the necessity for a social and individual agreement for the participation of donors in research projects. However, demands are often made for which the legal implementation is at least contentious and can be considered as excessive and biased. In part 2 of this review series the current legal foundation of data protection and informed consent is summarized on the basis of normative and ethical principles. With respect to appropriation of data and biosamples it can be deduced that by conformation to corresponding framework conditions the informed consent of donors in particular can be constructed independent of the project.

Research biomaterial banks (biobanks) are institutions which collect and prepare samples of human bodily substances (e.g. cells, tissues, body fluids and isolates from them), store personal, health and problem-related data of donors, collate samples and data and make them available in a suitable form for research purposes. The valid legal norms for the utilization and running of biobanks are complex and sometimes necessitate an assessment by the legal guardian.

More than 20 years ago living donor liver transplantation was introduced into clinical practice. Specifics of this method were developed initially for children and later on for adults particularly in regions where a liver transplantation program using deceased donors was not readily available. The most sensitive aspect of living donation, namely the danger to a healthy relative in order to perform the transplantation is immanent in the system and, thus, it is definitively a secondary option as compared to deceased organ donation. Following worldwide initial euphoria the numbers have markedly decreased in the western world since the start of the new millennium. In Asian countries in particular, much work has been done to optimize the procedure so that the donor safety and the outcome quality for the recipient have been impressively demonstrated in large patient populations. There is still a severe donor organ shortage and the option to allocate an optimal (partial) organ on an individual basis by living donation has given new impact to the discussion about a further rise in the profile of living donations here as well. The new version of the German transplantation legislation implemented in summer 2012 requires a number of conditions with respect to insurance for living donors. The current state and perspectives are presented here.

The presentation of tumor patients to tumor boards has widely developed into a medical standard. The necessary compliance to the medical standard can lead to obligatory presentation if the complexity of a case dictates that this cannot be comprehensively covered by a single treating physician. The organization of a tumor board must be so that the structure and specialist competence guarantees an adequate consultative function of the represented specialties. Tumor board members are not automatically promoted to become part of the treating team just by participation and therefore do not have a guarantor position but do have the obligation of care of a consulting physician. Tumor board decisions have a recommendation character, are not binding in the legal sense and do not relieve the treating physician from the obligation to critically scrutinize the recommendations before implementation. On the other hand the treating physician must be able to justify not following the recommendations on the basis of the medical obligation to care. The tumor board must fulfil the same requirements for documentation as any other consultative activity.

For several years academic disciplines have discussed the potential conflict between scarcity of funding and fair health care. This review article shows the necessity of involving economic scientists in this discussion as well as their contribution to rationalisation, prioritisation and rationing of health care services. Thereby, it becomes clear that rationing and justice are not a contradiction per se. The interdisciplinary discussion in Germany needs less disciplinary egotism and more willingness to seek solutions and compromises. In this context the procedures followed in other countries can serve as examples.

The committee draft for the new patient rights act was approved by the Federal Cabinet on 23 May 2012. Both the demands of the patient representative of the Federal government and some of the demands from the cornerstone paper of the State commission were taken into consideration.The draft of the new act contains comprehensive amendments to the Civil Code with the subtitle"Treatment contract in accordance with §630" and encompasses §§630a-h. The valid legal situation is therefore to all intents and purposes now codified.

Due to the increasing proportion of women in health care, as well as changes in working conditions (implementation of safety devices, minimally invasive/endoscopic procedures) the question arises whether the applicable laws and regulations for the protection of working mothers are outdated and should be updated.Individual risk analysis, as well as the inclusion of the pregnant health care worker in the decision-making process with regard to continuation or modification of the work practice serves as a protection of the expectant mother and unborn child and allows a continuation of the occupational activities.

Up to approximately 15-20 years ago it could be safely assumed that the promotion to senior consultant surgeon was a lifetime position. Nowadays it is different. Contracts for senior consultants are normally for an unlimited period but as with other employees there is the possibility to legally terminate the employment conditions and approximately 50% make use of this. The reasons very rarely concern an inability of the physician and are mostly concerned with the surrounding working conditions. Poor contractual structures, incompatibility in the spectrum of responsibilities, financial restrictions by the finance department and poor communication with the finance department and colleagues are the main problem areas. In this article the potential points of conflict are demonstrated.

Background: Progressive health care implies progress also in physician/patient interaction, especially with regard to moribund patients and their relatives. Advance health care directives emerged from the desire to influence medical treatment even in borderline situations. In spite of the present political and public discussions in Germany, advance directives are rarely of much importance in everyday surgical practice. By means of questionnaires, this study aimed at the frequency of advance directives among the patients of a surgical hospital and at related influencing factors., Methods: Between August 2007 and January 2008, 450 patients at our hospital were interviewed, prior to scheduled surgery, on the topic of advance health care directives by means of anonymous questionnaires. In addition to questions about the existence of or the intention to draw up advance directives, the study focussed particularly on the relationship between patient and attending physician. Patient-specific and sociodemographic data were collected as well., Results: Of the patients interviewed, 16.7% stated they had drawn up advance directives, while 21.3% did not know about the possibility of drawing up such a document. A mere 9.7% of the patients interviewed saw no need for such directives, whereas the majority (65.3%) considered it an option. Among the factors influencing the drawing up of advance directives, age and prior experience with severe disease figured significantly. Of the patients interviewed, 64.8% wished for more information on the topic of advance health care directives and health care proxies. The wish was expressed by 80.1% of patients that the attending surgeon mention the topic prior to surgery., Conclusions: Although the proportion of patients that draw up advance health care directives continues to be less than one fifth, surgical patients have a great need for information regarding the topic. Surgical hospital personnel should also set themselves to this task.

Applying the principle "practice makes perfect" to interventional medicine would mean that surgeons and departments with high treatment volumes for special procedures should have better results than low-volume institutions. In the last three decades several studies were published dealing with the association of therapy volume and treatment quality, e.g. in oncologic and vascular surgery as well as interventional cardiology. Concerning colorectal cancer it has been shown that an individual surgeon's case load is important but by far not the only therapy-associated prognostic factor. For example interdisciplinarity and multimodality including adequate pathological classification are no less important. For continual improvement of clinical outcome, quality management and control will grow in importance. Thus, it is necessary to develop structures and to specify standards for colorectal surgery. Based on the data available it is not yet possible to define minimum volumes for colorectal surgery.

Due to an increasing interest in patient safety and quality health care, many studies attempt to show a relationship between procedural volume at the institutional and individual level and patient outcome. Despite the correlation between number of surgeons and institutional volume in major operative procedures such as coronary artery bypass graft, pancreatic resection, and esophagectomy, these parameters are likely to be proxy for individual factors such as experience and structural aspects. In general the relationship between case numbers and results is more convincing in cancer surgery than for cardiovascular procedures, and risk adjustment may play an important role for interpreting results of the various studies. Exact thresholds cannot be determined and thus remain speculative. It appears difficult to implement practical changes based on the observations, because the etiology and causality of the relationship between volume and outcome are still not understood. The simple focus on volume does not apply to measurements of quality but can be a starting point for further studies to identify more specific factors associated with surgical quality.

The dependence of operation lethality on hospital volume has been scientifically determined for thoracic surgery. Conclusions on the quality of the results are possible based on the structure and quality of the procedure. Minimum quantities for specialized centers in thoracic surgery have been established as 300 resectional operations on thoracic organs without mediastinoscopy, operations with the heart-lung machine, and thoracic drainage. Minimum quantities are necessary to uphold sufficient complication management by appropriate practice and experience and to keep operation lethality down. They are also needed for financing staff (at least two full-time active specialists in thoracic surgery). The concentration of thoracic surgical services at main hospitals (minimum 300 operations per year) and organ centers (minimum 500 resectional operations on thoracic organs per year) is reasonable for the 45,500 operations expected in Germany.

The introduction of minimum provider volumes for certain medical procedures has been the subject of scientific investigation and political controversy for quite a while. The core of the discussion focuses on the hypothesis that minimum provider volumes could significantly improve operative results and cost efficiency. In Germany the Fifth Volume of Social Law (Sozialgesetzbuch V) set the legal stage for the implementation of minimum provider volumes. This article is a brief review on the experience with minimum provider volumes in cardiac surgery. The main focus is on coronary artery bypass surgery, as this happens to be the most frequently investigated procedure.

The implementation of minimum provider volumes in orthopaedic surgery appears to be logically evident. A general volume outcome relationship could be found for total knee and hip replacement on a high level of evidence, but no definite threshold value could be identified. For other orthopaedic procedures the evaluated data hint at a volume outcome relationship but do not prove one. Preliminary model calculations on the effects of a regulation based on volume outcome considerations concerning medical care in Germany show that, though for total hip and knee replacement quite a large number of hospitals would be excluded from medical care, the number of patients to be reallocated would be small. Since 1 January 2007 a minimum provider volume of 50 total knee replacements per year per hospital has been mandatory in Germany. The further application of a minimum requirement regulation based on volume outcome considerations in the German health care system must be performed very carefully, because significant effects are to be expected.

Background: Consequences of the volume outcome relationship are controversial. Objectification based on data analysis is strongly needed. The aim of this publication was to analyse the effects of volume outcome reallocations based on German inpatient data., Method: The analysis based on inpatient data of the Krankenhauszweckverband Koeln, Bonn und Region (Hospital Association of the Cologne and Bonn Region) of 2002 and 2005. Relevant data sets were identified according to the effects of current German regulations on volume outcome on the special fields liver transplant, kidney transplant, complex pancreatic surgery, and complex oesophageal surgery., Results: The effects of current German regulations on volume outcome results differed greatly between the four surgical specialities. There were fewer effects on kidney transplant, but due to an already very high level of centralisation 34% (oesophagus) and 8% (pancreas) of the hospitals stopped related surgery. This affected 8.9% (oesophagus) and 2.2% (pancreas) of related cases., Conclusion: Concentration and the formation of specialised medical centres are results of the implementation of volume outcome relationships. The quality of medical treatment does not automatically improve from this development. It is necessary to analyse any correlation between quality and frequency of treatment or other criteria such as know-how, structure and process management, and multidisciplinarity.

Background: New demands and possibilities of collaboration between hospitals and private practices in Germany have appeared, now that the way has been opened legally. A poll was conducted to analyse the current status of collaboration between outpatient gastroenterologists and hospital surgical departments and to identify possible future collaborations., Materials and Methods: One thousand twenty-six private practices specialising in endoscopy were found by contacting the Association of Statutory Health Insurance Physicians and additional internet research. Of these, 50% were randomly selected (513 private practices) and contacted by mail with anonymous questionnaires about cooperation with their clinical partners. Two hundred three (39.6%) practices responded, of which 200 could be analysed., Results: Of all practices reached, 75% considered the cooperation with clinics very valuable or even exceptional. Still, almost half (46%) suggested necessary improvements in these collaborations. Around a third of all contacted colleagues were already involved in projects following integrated care models. In about 80% of all participants, the main interest in integrated models was specified to be common therapy planning., Conclusion: The data analysis of this study shows a substantial interest of private-practice gastroenterologists in close collaboration with hospitals. It is now up to the hospitals to open contracts with their medical outpatient partners.

The epidemic-like increase of obesity in all western countries is associated with a growing incidence of morbid obesity. Here, efficient and lasting weight loss is mostly obtained by surgical interventions today performed in a reliable and safe manner. In that way comorbidities associated with obesity can be reduced or abolished. Treating the sequelae of bariatric surgery, with frequent massive weight loss and generalized skin excess, is challenging for the plastic surgeon. The goal is to restore a normal body contour as a prerequisite for complete psychosocial integration of the patients, who are often stigmatized by their outward appearance not only before but also after the weight loss. The present work provides an overview of current concepts and trends in post-bariatric plastic surgery.