Search

Ein lange beklagtes Struktur- und Prozessdefizit bei der medizinischen Versorgung unserer Bevolkerung ist ihre vergleichsweise geringe Integration und Koordination. Die funf Elemente der Versorgung – Versorgungssektoren, Versorgungsstufen, Heilberufe, arztliche Disziplinen und Einrichtungen – arbeiten zu oft neben- und gegen- statt miteinander. Dies gilt als eine relevante Ursache fur Uber- und Unterversorgung, Fehlversorgung und Ineffizienz. Die Deutsche Gesellschaft fur Innere Medizin (DGIM) und der Berufsverband Deutscher Internisten (BDI) haben gemeinsam „Pfade“ fur die medizinische Versorgung von Patienten mit den Modellkrankheiten Polyangiitis mit Granulomatose (GPA) und primare Hypertonie (pH) entwickelt. Die Empfehlungen mit Fokus auf die ambulante Versorgung fasst dieser Beitrag zusammen.

Die danische Debatte uber Priorisierung und Posteriorisierung in der Medizin hat in den letzten Jahren wieder an Starke zugenommen. Die vorliegende Arbeit stellt die Schwerpunkte der aktuellen Diskussion dar. Untersucht wurde danische Primarliteratur in Form von Artikeln aus Fachzeitschriften, Tageszeitungen und Stellungnahmen von Institutionen. Erstmals seit den 90er Jahren hat sich der danische Ethikrat wieder in einem Projekt von 2011 bis 2013 mit Priorisierung im Gesundheitswesen befasst. Er betont die Wichtigkeit eines legitimen Prozesses und fordert die Einbindung sichtbarer Werte und Kriterien. Ein Schwerpunkt der Priorisierungsdebatte ist der Umgang mit neuen teuren Arzneimitteln. Verschiedene Akteure, u. a. Politiker, Arzteschaft, Gesundheitsokonomen und der Ethikrat, haben in den letzten Jahren die Einrichtung einer nationalen Institution fur Priorisierung im Gesundheitswesen gefordert. Als Vorbilder werden vor allem der norwegische Priorisierungsrat und das britische National Institute for Health and Care Excellence herangezogen. Die danische Regierung erwog zwischenzeitlich, ein Priorisierungsinstitut zu schaffen, setzte die Plane jedoch nicht um. Im Rahmen eines neuen nationalen Projektes werden seit dem Jahr 2012 klinische Leitlinien erstellt. Diese werden von der danischen Arzteschaft als gute Grundlage fur Priorisierung begrust. Wie in den vorangegangenen danischen Priorisierungsdebatten fehlt eine Bundelung und Aufrechterhaltung der Diskussion durch eine koordinierende Institution. Die Debatte scheint schon wieder versandet zu sein. Neu ist, dass die Schaffung einer Priorisierungsinstitution ernsthaft in Erwagung gezogen wurde. Es ist davon auszugehen, dass die Diskussion in naherer Zukunft wieder aufflammen wird, moglicherweise wird die Idee eines Priorisierungsinstituts wieder aufgegriffen. Die Rahmenbedingungen fur Priorisierung in der Gesundheitsversorgung sind in den letzten Jahren verbessert worden.

Many CED-patients struggle with complex problem profiles and may be offered and profit from multidisciplinary multimodal rehabilitation. It is still unclear by whom and with what effects this option is used.We compared the results of an observational cohort study of 199 CED-inpatients of a single rehab clinic with those of 310 gastroenterological outpatients using propensity score matching.Rehabilitands show more complex problem profiles than CED-outpatients. After 6 months of follow up direct and indirect change measures show generally small positive changes - however comparable in quality and size with that of matched outpatients.Complex rehab is mainly used by CED-patients with several bio-psycho-social problems. Our preliminary data do not suggest a marked additional benefit of inpatient rehab compared to specialised outpatient care. Stricter controlled trials are urgently needed.

Chronic and prognostically doubtful diseases like inflammatory bowel diseases (IBD) often lead to reduced work ability. Whether self-management-interventions have positive effects on work related outcomes is so far unclear.Data from a randomized controlled trial of adult members of a German statutory health insurance with medically confirmed IBD were reanalyzed. We focused on 337 gainfully employed study participants. They completed a screening questionnaire enquiring about 22 disease-related bio-psycho-social problems. The intervention group (IG) received individualized (problem-adapted) written recommendations; the control group remained under usual care. 12 months later a follow-up questionnaire was employed, data on sick leave were made available by the health insurance.The IG showed beneficial effects in all primary outcomes (EuroQol visual analog scale score, index for measuring participation restriction and number of self-reported disability days). At baseline one in four of the employed participants reported a negative subjective prognosis of their work capacity (assessed by means of a 3-item Likert scale, SPE scale). No positive intervention effects on work-related outcomes (subjective prognosis of gainful employment, episodes and days of sick leave) could be detected.In IBD patients work and earning capacity is often at risk and should be regularly assessed. Effective interventions to protect or restore gainful employment are needed. Medical-vocational rehabilitation could be a treatment option; its efficacy and benefit (in IBD) are still to be demonstrated.

Das Verfahren der Priorisierung zur Bildung von Rangfolgen in der medizinischen Versorgung kann dabei helfen, die dafur bereitgestellten Ressourcen bedarfsgerecht und transparent einzusetzen. Die deutsche Priorisierungsdiskussion ist noch in den Anfangen und hat die Chance, von den Erfahrungen anderer Lander profitieren zu konnen. Das Ziel der vorliegenden Arbeit ist es, die schon vor Jahrzehnten begonnene danische Priorisierungsdebatte zu analysieren und daraus Anregungen fur Deutschland zu gewinnen. Die Methodik umfasst Literatur- und Dokumentenanalysen sowie Experteninterviews. Ihren Anfang nahm die danische Priorisierungsdiskussion in den 1970er Jahren, als eine Regierungskommission sich mit den ubergeordneten Prioritaten des Gesundheitswesens befasste. Mitte der 1980er Jahre entstand eine breitere Debatte mit Beteiligung von Arzten, Politikern, Ethikern und Gesundheitsokonomen, die ihren Hohepunkt Anfang bis Mitte der 1990er Jahre erreichte. Es wurde dabei vor allem auf lokaler Ebene – immer unter Einbeziehung der Burger – diskutiert. Vereinzelt wurden Versuche unternommen, Priorisierung in den Alltag der Gesundheitsversorgung zu integrieren. Sehr aktiv war in diesen Jahren der Ethikrat, der im Jahr 1996 eine ausfuhrliche Stellungnahme zur Priorisierung in der Medizin veroffentlichte. Im neuen Jahrtausend schien Priorisierung zunachst kein Diskussionsthema mehr zu sein, bis der Technologierat und die Danischen Regionen im Jahr 2006 die Debatte wieder anstiesen. Auch aus der Arzteschaft kommt heute wieder der Wunsch nach einer breiten Priorisierungsdebatte, um mehr Gerechtigkeit zwischen verschiedenen Patientengruppen zu erreichen. Aus der langjahrigen danischen Prio­risierungsdebatte ist bisher nur wenig Handfestes hervorgegangen. Die Hauptprobleme der danischen Debatte scheinen zum einen die fehlende Bundelung der vielen lokalen Initiativen auf ubergeordneter Ebene und zum anderen der Mangel an machtvollen Akteuren zu sein, die Diskussionsergebnisse nachhaltig in den Alltag umsetzen. Jedoch wird Priorisierung in der Gesundheitsversorgung von der danischen Bevolkerung heute als wunschenswert angesehen und auch seitens der Politik wird offen daruber gesprochen.

Wahrend das Thema der Prioritatensetzung in der medizinischen Versorgung im Ausland seit Mitte der 1980er-Jahre diskutiert wird, gelingt es in Deutschland nicht, eine solche Diskussion auch nur zu beginnen. Im Gegenteil, sie wird aktiv unterdruckt. Dabei hilft eine bewusste oder fahrlassige Verwechselung von Priorisierung und Rationierung. Auch die gesundheitspolitische Debatte vernachlassigt immer wieder die Frage, wofur die Gesetzliche Krankenversicherung (GKV) ihre im internationalen Vergleich umfangreichen Mittel einsetzen will; sie konzentriert sich auf die Einnahmeseite. Dies schutzt das Postulat der deutschen Gesundheitspolitik, dass jedem GKV-Versicherten alles medizinisch Indizierte jederzeit rasch und uneingeschrankt zur Verfugung stehe. Das Ziel des vorliegenden Beitrages ist es plausibel zu machen, dass Rationierung und Priorisierung zwei ganz unterschiedliche Reflexions- und Handlungsprogramme beinhalten. Dies wird am Beispiel der ersten Empfehlungen der STIKO zur Impfung gegen die pandemische Influenza (H1N1) ausgefuhrt – unter Ruckgriff auf Priorisierungsmodelle in Schweden, England und Oregon/USA. Ausfuhrlicher werden mogliche Gegenstande, Ebenen, Kriterien, ethische Prinzipien und normative Implikationen von Priorisierung dargestellt.

BACKGROUND: The overall aim of the present work was to estimate the potential of early detection of colorectal cancer in persons with familial or hereditary risk. In this paper we present projections on how many persons in the age groups 30 - 49 and 30 - 54 years, respectively, would be classified as being at familial or hereditary risk when a questionnaire distributed by the ”Netzwerk gegen Darmkrebs e. V.” (network against colon cancer) is used for identification. METHODS: Based on the results of a systematic literature search on the validity of questionnaires, the estimated prevalence of familial and hereditary disposition for colorectal cancer as well as actual German tumour incidence data projections were calculated. RESULTS: Given a 10 % prevalence of persons with a familial risk in the German general population and a maximum knowledge of all tumour cases in kindred, a total of 5.7 % of all Germans in the age group 30 - 49 years would be classified as familial risk persons (7.2 % in the age group 30 - 54 years). Taking familial and hereditary risks into account 6.7 % (8.2 %) will have a positive questionnaire result. CONCLUSION: If the questionnaire is used on a population-based level and the participation rate is 35 %, approximately 542 000 persons in the age group 30 - 49 years (816 000 in the age group 30 - 54 years) will be classified as having a familial or hereditary risk for colorectal cancer.

The central question of this study is why workers in the employable age group apply for disability pension although from a medical point of view their vocational ability is maintained. The aim is to identify factors in the system and of the applicant which may serve as subjective prognostic indicators for maintaining employment and for determining influences which may be of prognostic value for a pension application. Concomitantly, it is aimed to obtain guidelines for practical rehabilitation and to generate impulses for further research in this field. Within a qualitative research project 16 problem-focused interviews with patients insured by ,,Deutsche Rentenversicherung Nord" and treated in a cardiac rehabilitation centre in Mecklenburg-Vorpommern were undertaken. Patients with either a positive or a negative subjective prognosis concerning employment were interviewed. In addition, the interviews were followed by a questionnaire one year later. The results show differences and similarities in the motivation of patients applying for disability pension. This can be traced back to psychosocial variables, sociodemographic characteristics, moderating factors and the effects of socialisation. Physical impairment was of secondary importance to the patients' motivation to apply for disability pension. The results of the follow-up questionnaire show that an existing job significantly improves the subjective prognosis for maintaining gainful employment. The application for disability pension offers the affected individual a possibility to ensure a basic existence in the case of illness and unemployment. The identified factors may be influenced by modifying the interventions and improving medical counselling during the rehabilitation period.

BACKGROUND: Medical rehabilitation is a basic component in the German health care system. However, several studies have shown only moderate effects by rehabilitation treatment. The effectiveness of medical rehabilitation depends on different factors, like rehabilitation need, access, preparation for rehabilitation treatment, therapy intensity and rehabilitation aftercare. During the past few years the lack of cooperation and communication between cost carriers and general practitioners has been emphasized. Since general practitioners play a central role in the patients’ decision for rehabilitation treatment, the aim of the present study was to facilitate the identification of rehabilitation need by general practitioners. METHODS: The project group integrated different professions. To facilitate assessment of rehabilitation need in patients attending a medical practice, two different approaches were applied: First, a self-administered patient questionnaire was developed, containing different subjective indicators of rehabilitation need (e. g., subjective health, problems in activities and participation as well as daily or occupational stress). Secondly, the project group worked out a short checklist for general practitioners, containing a number of criteria confirming patients’ potential need for rehabilitation. Both instruments were tested in nine medical practices with 60 patients presumably in need for medical rehabilitation. RESULTS: The short checklist as well as the patient questionnaire proved to be practicable and economical. Nine of 40 general practitioners participated. Based on the checklist a need for rehabilitation was identified in 85% of their patients. In another 10% of the patients the result was questionable, and in three patients the finding was negative. In the self-assessment of the patients, 98% stated a subjective need of rehabilitation (global rating), only one patient indicated no rehabilitation need. The agreement between physician and patient assessments was only weak (kappa: 0.11, p=0.08). Defining deviation by one category as still indicative of agreement of the two ratings, an agreement of 78% is reached. DISCUSSION: Both instruments in principle proved to be useful in medical practice. They allow quick and easy assessment of a potential rehabilitation need in everyday practice. Despite these positive results and the supportive function of the checklist, the participation rate among general practitioners was unexpectedly low, possibly mainly due to the additional bureaucracy, a negative image of the rehabilitation system, and the concurrence with DMPs. CONCLUSION: Poor accessibility of general practitioners regarding questions of medical rehabilitation is well-known from numerous earlier research projects. Satisfying integration of physicians could not be reached, although the approach of needs assessment seems to be promising. Further research should focus on how the urgently required cooperation could be achieved.

Chronische Ruckenschmerzen sind selten das alleinige gesundheitliche Problem. Bevolkerungsbezogene Aussagen zum Zusammenhang zwischen behandlungsbedurftigen Komorbiditaten und unterschiedlich weit amplifizierten Ruckenschmerzen fehlen. Im Rahmen einer Langsschnittstudie des Deutschen Forschungsverbundes Ruckenschmerz (DFRS) wurden 4811 Bewohner in 4 westdeutschen Stadten im Alter von 18–75 Jahren postalisch nach Ruckenschmerzen sowie 14 Komorbiditaten befragt, 3765 Personen beteiligten sich an der Befragung. In Abhangigkeit vom Amplifikationsstadium der Ruckenschmerzen steigen Anzahl und Wahrscheinlichkeit fur das Vorliegen von Komorbiditaten deutlich an. Ein Drittel der Personen mit weit amplifizierten Ruckenschmerzen (Stadium 2 oder 3) befinden sich aktuell wegen mindestens 3 Erkrankungen in Behandlung, unter Personen ohne Ruckenschmerzamplifikation (Stadium 0) sind es nicht mehr als 5%. Behandlungskonzepte fur Personen mit chronifizierten Ruckenschmerzen mussen uber das Schmerzgeschehen hinaus bestehende Komorbiditaten einbeziehen.

Medical Rehabilitation in Germany needs change. Weaknesses of the present care system are pointed out, and the potential for change is explored. The latter implies a more active search for rehabilitation need and the implementation of problem-focussed, flexible programmes. Above all, better evidence for the effectiveness of the German rehabilitation system is crucial.

In the framework of an early-diagnosis out-patients clinic 100 patients (mean age 51 years), 82 of them female, were identified as highly suspicious of having chronic rheumatoid arthritis of recent onset (2-12 months). Five or more ARA criteria were present in 77 patients. IgM rheumatic factor was present in serum of 51 patients (latex-fixation test). A Waaler-Rose test of greater than or equal to 32 IU/ml was present in 21. After adjusting for alpha errors, there was a significantly higher prevalence of HLA-DR4 among those seropositive in the latex fixation test (64 vs 29%). A further 19 constitutional, anamnestic, clinical, biochemical and psychosocial criteria failed to reveal any different distribution between seropositive and seronegative cases. Using the specific definition of seropositivity in the Waaler-Rose test eliminated HLA-DR4 differences. The latter did not serve as a distinguishing criterion. There was only a marginal difference between DR4-positive and negative patients. These results fail to lend support to recent views of a special position of seronegative chronic rheumatoid arthritis.

Summary Patients with established coronary artery disease (CAD) were recruited in 11 hospitals and randomized to an intervention (telemedicine system; n = 752) or a control group (usual medical care; n = 748). On the day before discharge, patients in the intervention group were equipped with a 12-lead event recorder and trained to use the device. Whenever they had symptoms, they could contact the call centre, transmit an ECG (without redialling) and consult a physician. During a 12-month study, 171 patients (23%) in the intervention group contacted the call centre, a total of 269 times. The main reasons for calling were chest pain and radiating pain. Pathological changes were seen in 24% of the transmitted ECGs. Only 23% of the calls were made in the first hour after onset of symptoms and a further 12% in the subsequent hour, suggesting that patients should be encouraged to use ECG transmission at an earlier stage. At follow-up, 157 patients (21%) had had at least one recurrent cardiac event (myocardial infarction, cardiac hospital stay, re-vascularization). The proportion was significantly higher in telemedicine users (35%) than in non-users (17%), P < 0.001. Regardless of utilization, the majority of the intervention patients considered that the telemedicine system was helpful (users = 93%, non-users = 89%; P = 0.095).

SUMMARYThe objective of this case-control study was to identify the main risk factors for community-acquired pneumonia (CAP) in a German adult population. A self-administered questionnaire was given to CAP cases provided by the German competence network CAPNETZ and population-based, randomly selected controls (sex- and age-matched). Multivariate analysis showed that in addition to known risk factors such as previous CAP [odds ratio (OR) 1·6, 95% confidence interval (CI) 1·3–2·1], more than one respiratory infection during the previous year (OR 3·6, 95% CI 2·9–4·5), chronic pulmonary diseases (OR 2·3, 95% CI 1·7–3·0), number of comorbidities (OR 1·6, 95% CI 1·4–1·9), and number of children in the household (2 children: OR 2·2, 95% CI 1·5–3·4; ⩾3 children: OR 3·2, 95% CI 1·5–7·0) were independent risk factors for CAP. This was pronounced in particular in people aged ⩽65 years. The most likely explanation for this finding is higher exposure to infectious agents.

Rehabilitation in Germany is an important sector of the medical system. Rehabilitation need of insurees who claim rehabilitation benefits is assessed by the financially responsible agency (mostly pension funds). Legal regulations allow little time for this decision so insurers aim at making decisions from the records only. Information on the specific case often is however insufficient. Self-administered questionnaires have been employed in the past to remedy that problem. In this article typical problems are illustrated which arise when administering additional questionnaires to assist the assessment, and solutions for these problems are shown. Important questions concern the instruments that should be used, technical problems of computer-aided assessment and processing of the data, and possible legal objections. Also, general problems and limitations of the approach are discussed.

Several projects of the North German Association for Rehabilitation Research had focused on needs assessment in the field of medical rehabilitation to be provided by statutory pension funds. Their results prompted a more differentiated understanding of the concepts of rehabilitation-neediness, -ability and -prognosis and lead to the development of the "Lubecker algorithm". It is based on (a) assessing the present health disorder and its consequences in terms of activity limitations and participation restrictions, (b) defining rehabilitation goals, and (c) selecting a rehabilitative intervention. The three components form the corners of a triangle. Its connecting sides can be described in terms of norms and expectations (disorder-goals), theoretical considerations (disorder-intervention), and empirical evidence from systematic research (intervention-goals). Needs assessment can thus be--partly--objectified, and "need" can be safely distinguished from related concepts such as "burden of illness", "wish", "demand", "supply", and "provision".

Aim: The aim of this study was to investigate the prevalence of pain and characteristics of pain (frequency, duration, intensity) among children and adolescents and to compare them across different age and gender groups. Methods: 735 children and adolescents aged 10–18 y from schools in the Luebeck region of Germany were surveyed using a modified German version of the self-completion pain questionnaire of Perquin and co-workers. Results: 715 out of 735 questionnaires (97.3%) were returned completed. Pain during the preceding 3 mo was reported by 85.3% (n= 610) of the respondent children and adolescents. The prevalence of pain increased with age. The most common complaints were headache (65.6%), abdominal pain (47.7%), limb pain (46.4%) and back pain (38.6%). A pain duration of longer than 3 mo was reported by 45.5% (35.4% for longer than 6mo). Pain once a week or more frequently was reported by 33.7% of children and adolescents. Conclusion: Almost half of the surveyed children and adolescents had suffered complaints for longer than 3 mo. The experience of pain in general and especially pain with a duration of longer than 3 mo is very common in children and adolescents, and requires further attention. Further studies are necessary to investigate the natural course, functional implications and prognosis due to pain complaints in children and adolescents.

In the last years, the Danish debate about priority setting in medicine has gained new strength. This paper shows the main focuses of the current discussion based on a research of Danish primary literature. For the first time since the 1990s the Danish Council of Ethics has been involved with priority setting in medicine in a project running from 2011 to 2013. The Council emphasises the importance of legitimate processes and calls for visible values and criteria. A focus of the debate is how to deal with new expensive drugs. Politicians, physicians, health economists and the Council of Ethics have called for a national institution for priority setting in medicine. They have mainly looked to the Norwegian National Council for Priority Setting in Health Care and the British National Institute for Health and Care Excellence for inspiration. The Danish Government considered establishing a national institute for priority setting, but the plans were not put into practice. In the year 2012 a new national project was launched to create clinical guidelines. Danish doctors welcome the guidelines as a good basis for priority setting. Just like in earlier Danish priority setting debates, a coordinating institution is lacking to bundle the discussion and keep it going. The debate seems to have come to an end once again. The fact that it was seriously considered to establish an institute for priority setting is a new development. It can be expected that the discussion will be resumed in the near future, possibly the idea of an institute for priority setting will be readopted. The general conditions for priority setting in health care have improved.

As many breast cancer cases are detected outside mammographic screening, a multidisciplinary quality management (QuaMaDi) project involving gynaecologists, double reading by radiologists. and centralised assessment, documentation, evaluation and feedback was implemented into routine breast cancer diagnosis in part of Schleswig-Holstein (Germany) with a population of 365 000 women. A cohort of 59 514 patients eligible for diagnostic mammography was examined from May 2001 to December 2005 and quality indicators, breast cancer incidence and tumour stage distribution were analysed. A total of 102 744 diagnostic processes were initiated, for 23.8% of which (24 470) a third expert reading at the reference centre was performed. Further assessment was recommended for 6.3% (6442) of all patients. In total, 1056 breast cancer cases were diagnosed (10.3 per 1000 examinations). Patients of the QuaMaDi project had a higher proportion of ‘in situ' and T1 tumours (62.6% vs Schleswig-Holstein: 48.6%), showing that the implementation of high standards in routine diagnostic mammography can improve the quality of breast cancer diagnosis and care.

The "Quality Community Medical Rehabilitation" (QGmR) is a voluntary association of several rehabilitation clinics in Schleswig-Holstein. The QGmR is closely oriented along the quality assurance programme of the national pension insurance scheme. As local initiative its emphasis lies in patient outcomes. The patients of the QGmR were interviewed twice (pre-post: before and four months after rehabilitation), and all patients were included consecutively during a defined period of time. After a pilot phase the main study of the QGmR was accomplished between 2002 and 2004. Twenty Schleswig-Holstein rehabilitation clinics with six diagnostic groups and a total of 3094 patients participated (2026 at both points of measurement). The majority of the patients interviewed were orthopaedic patients, and the smallest number were patients with heart disease and neurologic conditions. Most patients showed clearly health-related impairments before rehabilitation compared with population-referred data, four months after rehabilitation patients showed significant improvements in all health-related parameters. In addition to health improvement the patients showed a high satisfaction with all areas of the rehabilitation treatment and processes they were asked to judge (administration, therapy, care) independent of diagnostic group or rehabilitation clinic. But, also independent of diagnostic group and clinic, there were clear deficits in the field of post-rehabilitative treatment. Some of the results varied according to diagnostic group and clinic. The results of a comparison between the clinics showed some differences to the effect that some clinics were better than others, but these differences were not very large although statistically significant in a few cases. Nevertheless the "best" can be determined, which could motivate the clinics to participate in regular quality assurance working groups.

Objective: The prevalence of type 2 diabetes mellitus is increasing rapidly in industrialized countries, and adrenal glucocorticoids may intensify this disease. We sought to assess the relationship between diabetes-associated metabolic disturbances and cortisol concentrations in patients with type 2 diabetes. Design: We investigated 190 type 2 diabetic patients who volunteered from a population study of 12 430 people in Luebeck and its suburbs. The target population comprised men and women born between 1939 and 1958 who initially received a postal questionnaire about their health status. We identified 346 subjects with confirmed diabetes mellitus and 216 patients participated in the study. Patients with type 1 diabetes were excluded. Methods: Five salivary cortisol samples were collected before and after lunch, in the evening and then the next morning before and after standing. Clinical variables associated with diabetes were measured and correlated with cortisol concentrations. Results: None of the cohort had salivary cortisol concentrations that exceeded the normally accepted range. Based on cortisol samples collected just prior to a standard lunch, the cohort was divided into tertiles. Cortisol was positively related to: fasting blood, urinary and postprandial glucose; glycosylated hemoglobin; and systolic and diastolic blood pressures (all P < 0.05). Cortisol concentrations also correlated with the relative abdominal mass (P < 0.05) when patients with marked glucosuria were excluded. Conclusions: The degree of severity of several clinical measures of type 2 diabetes correlates with cortisol concentrations. Moreover, the results provide evidence for a positive relationship between metabolic disturbances and cortisol concentrations that are within the accepted normal range.

The Convention on Human Rights and Biomedicine, its Additional Protocol, the European Parliament's Good Clinical Practice (GCP)-Directive as well as the German Medicines Law and GCP-Decree all require certain forms of "benefit" for participants of clinical trials and other forms of clinical-evaluative research. However, they do not provide any attempt to define e. g. "direct benefit" or group benefit -- contrary to our text. It additionally discusses qualitative and quantitative aspects and the inherently probabilistic nature of any benefit from clinical research. Clinically most relevant study types and designs (such as placebo-controlled trials; diagnostic studies of phases 1 - 3) do not offer any potential individual benefit at least for parts of the samples, they are at best beneficial for the group of similarly affected patients. At present those trials if including incapacitated adults not able to give informed consent are forbidden by German law, a situation different from that of trials involving minors.

Background The ninth book of the German social code, SGB IX, has intensified questions on the effectiveness and usefulness of medical rehabilitation, a multimodal multidisciplinary team care model, especially but not exclusively for chronic back pain. In 2002 back pain was the reported leading cause for 29 % of all medical and other rehabilitative services provided by German statutory pension funds. A previous systematic review of all available German studies (January 1980 to June 2001) analysed the effectiveness of inpatient rehabilitation for chronic back pain. The present report provides an update and critical appraisal of the review. Method Again we conducted a systematic search for relevant German studies from between July 2001 and December 2003 using electronic data bases, hand-searching of congress abstracts and postal questionnaires. The quality of relevant studies was assessed according to the recommendations of the Cochrane Back Review Group. For each study effect sizes for up to six central outcome parameters were calculated using pre-post comparisons from short and medium term follow-ups, they were correlated with prognostically relevant characteristics of the studies and samples. The combined weighted intra-group effect sizes were compared with results from international studies. Results 16 studies, both controlled and uncontrolled, were included. Again we could not identify any study confirming the effectiveness of medical rehabilitation in chronic back pain compared to no treatment or usual care. The methodological quality of the new studies did not seem to exceed that of the earlier ones. Depending on the outcome variable, small effects (e. g. on functional ability) to relevant effects (e. g. vitality) can be observed at or immediately after the end of rehabilitation. Now the effects after three to 12 months seem to be smaller than previously observed. Discussion and conclusions The small size of medium term effects indicates a basic problem of inpatient rehabilitation for chronic back pain in Germany. This becomes even greater when the results of international controlled studies are used as reference. Possible reasons for the disappointing situation (weak methodology, inappropriate selection of patients, weak intervention) are to be discussed. At present, we have no convincing evidence for a general effectiveness of Germany's system of inpatient rehabilitation for chronic back pain.

Chronic back pain is one of the most common and costly disorders. An overview shows that chronicity has various definitions, of which purely temporal ones predominate. Back pain is said to be "chronic" if it lasts for a variable number of weeks or months. Our attempt to refine such definitions is based on three previous works: Loeser's multidimensional pain model, the oncological TNM model and the International Classification of Functioning, Disability and Health of WHO (ICF). We suggest an unidirectional process of pain in the back to a complex pain syndrome including other types of pain, various bodily complaints and cognitive as well as emotional impairments, and propose an empirically testable research model.

BACKGROUND Chronic back pain has a high personal impact, is frequent and of outstanding economical relevance. Analysis of the international literature indicates strong or moderate evidence for the effectiveness of multimodal multidisciplinary team care of chronic back pain. Our review aims at a complete review and critical appraisal of German studies of inpatient medical rehabilitation. METHODS We conducted a systematic search for relevant German studies (1/1980 - 6/2001) using electronic data bases, manual search of congress abstracts and postal questionnaires of 712 German rehabilitation clinics. Relevant studies were categorized according to the recommendation of the Cochrane Back Review Group. For all studies, aims, participants, type of intervention, evaluation time, main outcomes and results were extracted and tabulated. The effect size for 6 central outcome parameters (pain intensity, functional status, catastrophizing, depression, vitality, days on sickness leave) were calculated using pre-post comparisons and were integrated into short and long term weighted means of intra-group effect sizes. RESULTS 30 studies, both controlled and uncontrolled, report a multitude of positive changes with inpatient rehabilitation treatment. Improvements included both somatic and psychological parameters. However, methodological quality was often poor; only three studies fulfilled the criteria for high quality. Comparison of meta analyses of German and international studies indicates partly good agreement (e. g. changes in pain intensity), partly discrepancies (e. g. functional ability in daily activities). Taken together, inpatient rehabilitation treatment for chronic low back pain in Germany appears to be of low to moderate efficacy. DISCUSSION AND CONCLUSIONS In the era of evidence based medicine, inpatient rehabilitation has to show its usefulness, necessity and efficiency as any other type of health care. For the German system of inpatient rehabilitation of chronic back pain available evidence is not conclusive, due to a lack of randomised controlled studies. The prevailing design of observational cohort studies has severe limitations in proving a causal relationship between outcomes and intervention. The international literature however provides more valid evidence in favour of the multimodal multidisciplinary intervention in chronic back pain. Under the assumption of a "class effect" of medical rehabilitation the German data seem to corroborate the conclusions drawn from international studies.

Fragestellung. Uber die Pravalenz von Schmerzen im Kindes- und Jugendalter gibt es in Deutschland gegenwartig nur wenige Informationen. Zielsetzung der vorliegenden explorativen epidemiologischen Studie war es, die Pravalenz von Schmerzen bei Kindern und Jugendlichen zu erheben. Methodik. Modifizierte Eltern-, Kinder- und Jugendlichenversionen des strukturierten Schmerzfragebogens nach Perquin et al. [1] wurden 1077 Eltern, Kindern und Jugendlichen im Alter von 3–20 Jahren zur Beantwortung vorgelegt. In der Altersgruppe der 3- bis 7-Jahrigen beantworteten die Eltern den Fragebogen (Fremdeinschatzung).Kinder und Jugendliche im Schulalter beantworteten den Fragebogen selbst in der Schule (Selbsteinschatzung).Der Fragebogen ist selbsterklarend und in weniger als 10 min ohne Hilfe beantwortbar.Die Studie wurde in 2 Kindergarten, einer Grund- und Hauptschule und einem Gymnasium des Grosraums Lubeck durchgefuhrt. 1030 der 1077 Fragebogen wurden beantwortet (Rucklauf 95,6%). 991 der 1030 Fragebogen (96,2%) konnten in die Auswertung einbezogen werden. Ergebnisse. 794 von 991 Kindern und Jugendlichen (80,1%) hatten nach eigenen Angaben bzw.Angaben der Eltern in den letzten 3 Monaten Schmerzen. Die Pravalenz fur Schmerzen in mehr als einer Korperregion betrug 66,3%. 57% der Kinder hatten in den letzten 3Monaten nach eigenen Angaben bzw. Angaben der Eltern Kopfschmerzen, 43,2% Bauchschmerzen, 41,6% Schmerzen in Armen oder Beinen, 32,9% Ruckenschmerzen und 30% Halsschmerzen.16,2% der Kinder und Jugendlichen gaben mehr als einen Hauptschmerz an. 30,7% der Kinder und Jugendlichen hatten nach eigenen Angaben bzw.Angaben der Eltern ihre Hauptschmerzen langer als 6 Monate. Schlussfolgerungen. Die Ergebnisse dieser explorativen Studie zeigen, dass Schmerzerfahrungen bei Kindern und Jugendlichen allgemein haufig sind und bei fast 1/3 der befragten Kinder und Jugendlichen langer als 6 Monate bestehen.Weiterfuhrende Studien sind notwendig, um Merkmale der Chronifizierung von Schmerzen im Kindes- und Jugendalter zu untersuchen.

The psychometric properties of a 3-item scale for the assessment of subjective vocational disability were tested in 4279 blue-collar workers. Internal consistency of the scale was estimated by Guttman scaling. To evaluate construct validity the scale was compared to other measures of vocational ability, functional capacity, comorbidity, psychic status, and indicators of occupational handicap. The results are highly satisfactory, and the scale can be recommended for further use in rehabilitation research. Ongoing research is discussed.

Objective. To examine the nosological concept of fibromyalgia in the general population. Methods. A postal survey of rheumatic pain and non-specific bodily complaints was sent to all 3174 German female residents of Bad Sackingen, Germany, aged 35 to 74 yr. A stratified random sample of 653 subjects was further examined in a clinical survey. Results. On the population level the point prevalence of chronic widespread pain was 13.5%. In the clinical survey, tender point count was associated not only with the extent of rheumatic pain, but also independently with the extent of bodily complaints. Subjects with no history of rheumatic pain but with non-specific bodily complaints had as many positive tender points as subjects without bodily complaints but with a history of rheumatic pain. Subjects could be identified who met the tender point criterion of the ACR without a history of widespread pain. Multivariate analyses demonstrated that some symptoms carry a risk for positive tender points (low physical mobility, pain, bodily complaints) and some for chronic widespread pain (poor health status, catastrophizing, emotional reactions, low energy level, sleep disturbances) that are independent of each other and of age. Conclusions. The results do not only question the relevance and specificity of a history of widespread pain in diagnosing fibromyalgia, but also the concept of fibromyalgia as a distinct rheumatological disorder. The results support the concept of fibromyalgia as part of a wider spectrum of dysfunctional syndromes.

Objective Multidisciplinary team care is an opportunity to improve the long-term metabolic situation of patients with diabetes mellitus, hence can help reduce the individual and financial burden of diabetes-related complications. The aim of this study is to evaluate the extent to which patients undergoing rehabilitation carried by the German Federal Insurance Institute for Salaried Employees (BfA) were treated in accordance with recent evidence-based clinical practice guidelines on diabetes mellitus. Methods We extracted specific treatment recommendations relevant to inpatient rehabilitation from national and international evidence-based guidelines and allocated them to general subjects of diabetes care (e. g. [disease specific] education, physical activity, psychosocial interventions). In the "Classification of Therapeutic Procedures (KTL)", an instrument used to classify therapeutic procedures in rehabilitation, we then identified those procedures that represented the recommendations of the guidelines. The coded procedures were allocated to the general aspects of diabetes care, too. In total, 9 "therapeutic modules" were designed, each containing guideline-recommendations and coded procedures. Using the KTL codes documented as a routine in discharge reports, we were able to describe, analyse and evaluate the procedures performed during rehabilitation. The data set we used contained KTL codes and medical information from 9,456 patients whose rehabilitation was carried by the BfA diagnosed with either diabetes mellitus type 1 or 2, who received an inpatient rehabilitation procedure during the years 2000 and 2001. Results The number of patients who received at least one procedure out of the particular therapeutic module is as follows (numbers in brackets represent the total number of KTL codes in that therapeutic module): Therapeutic module "Education (3)" - 98.66 %, "Exercise Training (63)" - 92.42 %, "Nutrition Training (14)" - 96.44 %, "Stress (18)" - 35.33 %, "Motivation (15)" - 82.87 %, "Coping Skills (15)" - 27.42 %, "Social Work (26)" - 11.44 %, "Alcohol and Nicotine (24)" - 3.69 %, "Diabetic Complications (81)" - 75.42 %. On average patients received procedures out of 5.2 different therapeutic modules. The results were consistent over subgroups (type 1/type 2 diabetes, men/women) but varied considerably between clinics. The care provided in clinics with higher numbers of diabetic patients is more in line with guideline specifications. Discussion A substantial number of patients received procedures out of the therapeutic modules "Education", "Exercise Training", "Nutrition Training" and "Motivation". In other therapeutic modules (e. g. "Alcohol and Nicotine") deficits were noted. These deficits as well as the substantial variation between clinics demonstrate the need to develop clinical practice guidelines for rehabilitation of patients with diabetes. In principle, the results of this study have to be interpreted carefully because we did not examine to which extent the documented processes are in accordance with the realities. Conclusions Inpatient rehabilitation of diabetic patients carried by the BfA can be characterised as multidisciplinary and in accordance with the recommendations of recent evidence-based guidelines. Certain problematic aspects should be put into focus. A guideline taking into account all rehabilitative aspects, including the preparation for and the care after the rehabilitation process, can be instrumental in reducing deficits in rehabilitative care as well as differences between clinics. To gain wide acceptance, guideline development should be coordinated by a scientific institute and involve members of all groups concerned (e. g. the rehabilitative team, GPs, patients). Within certain limits the "KTL" instrument permits evaluation of process quality in rehabilitation of patients with diabetes mellitus.

Type 2 diabetes (DM II) is the world's most widespread metabolic disease. Numerous investigations have demonstrated that intensive, multimodal interventions can reduce the occurrence of DM-associated comobidities and mortality. Medical rehabilitation could offer such an alternative, albeit one with an obvious time limit. There is currently no active program in Germany designed to screen for pa-tients' need for rehab. Here, we investigated -whether screening for rehab need in DMII pa-tients accompanied by written advice to file an application for rehab treatment would generate a relevant number of rehab measures, whether -inpatient rehab results in improved mid-term prognoses, and which patients demonstrate a particular benefit from such a program.We screened 5 500 employed individuals aged 18-54 years for their need for rehab via an extensive questionnaire based on the "Lübeck Algorithm". The patients were registered in the DMP (disease management program) Diabetes mellitus Type 2 in the AOK Rheinland/-Hamburg health insurance division, and payed into DRV (German statutory pension insurance -scheme) Rheinland retirement insurance. Pa-tients needing rehab who presented no exclusion criteria (i. e., for a rehab intervention far from their place of residence) were randomized to a control or intervention group at a ratio of 3:1. Patients in the intervention group received a letter from the AOK advising them to fill out an application for rehab. A very short, simple application form was included in the mailing. 12 months after randomization we conducted a query to determine the effects of rehab. Our primary endpoint was a cardiovascular risk score specifically devised for diabetics. Multi-level models were applied to measure changes in cardiovascular risk.850 patients (rate of return=16%) returned completed screening forms to us. After having excluded those with faulty diagnoses and/or those who had refused to participate, 829 patients remained. 94% of them presented a need for rehab according to specific criteria (39% with a simple and 55% with complex problem profiles). 266 patients stated in the questionnaire that a rehab program was impossible for them for personal reasons. Of those patients who remained, we randomized 299 to the intervention cohort and 102 to the control group. Almost 70% of the intervention group completed an application for rehab, and our follow-up revealed that most of them participated in a rehab intervention. Return rate after one year was 82%. Analysis on the intention-to-treat (ITT) principle revealed no significant effect on cardiovascular risk (p=0.68); however, per-protocol analysis demonstrated a significant effect in the intervention cohort (p=0.025). Males, and patients with an uncomplicated problem profile profited from the intervention.We discovered that a proactive procedure leads to the identification of a highly relevant group of insured individuals, and that it is suited to generating a large number of medically -justified rehab applications. ITT analysis on the effi-cacy of inpatient rehabilitation for type 2 diabetes mellitus in terms of the cardiovascular 5-year risk, however, failed to display a significant statistical effect in this study population (insurees of generally lower socioeconomic status having no intention to apply for rehab treatment). Rehab treatment for type 2 diabetes does not seem to be universally effective. This of course does not apply to rehab in general, as patients usually participate in rehab of their own volition. More research is needed on this issue.

Gaucher's disease is, when left untreated, a progressive and in some subsets even life-threatening lysosomal storage disease. It is caused by a genetically linked deficit of acid beta-glucocerebrosidase. The enzyme can be replaced by Cerezyme(®)/imiglucerase produced by Genzyme Corp. The therapy has the potential to induce remis-sion and normalise the patient's life. In June 2009 Genzyme had to announce a viral contamination of its bioreactors which led to a sudden stop of the entire production of imiglucerase. Subsequently only 50-20% of the former supply could be provided worldwide. The situation was not normalised until the beginning of the year 2011. Due to this unexpected shortage the relevant actors had to clarify quickly and unprepared which patient groups to prioritise and whom to supply with what quantities of imiglucerase. The shortly enforced prioritisation and rationing provide an opportunity to describe and analyse the spontaneously choosen prioritisation criteria and reveal value preferences shared by clinicians, patients, patient representatives, and company representatives. To reconstruct the chain of events and reactions and the revealed criteria and value preferences partly standardised interviews with representatives of the relevant stakeholder groups were conducted. Very clearly, the actors spontaneously chose to follow a medical need and a social solidarity principle.

Die “Pravalenz” chronischer Schmerzen in der Allgemeinbevolkerung reicht je nach Untersuchung und Definition von 10% bis uber 40%. Chronische Schmerzen sind mit hohen direkten und indirekten Kosten fur das Gesundheitswesen auf der einen Seite und einer erheblichen personlichen Beeintrachtigungen der Lebensqualitat des Einzelnen auf der anderen Seite verbunden. Die vorliegende Arbeit gibt eine Ubersicht uber Haufigkeit und Verteilung chronischer Schmerzen in der Allgemeinbevolkerung und bei Inanspruchnahmepopulationen. Die Grenzen epidemiologischer Untersuchungen liegen in der Schwierigkeit eine subjektive innere Erfahrung moglichst valide zu erfassen, zudem ist das Stellen von Diagnosen im eigentlichen Sinn nicht moglich. Die Untersuchung von Inanspruchnahmepatienten bietet demgegenuber die Moglichkeit einer weiteren diagnostischen Differenzierung und besseren Erfassung der qualitativen Aspekte des Schmerzerlebens, doch auch die Aussagekraft dieser Studien ist, auch aufgrund qualitativer Probleme, begrenzt. Trotz der methodischen Begrenzungen der untersuchten Studien wird die weite Verbreitung und Bedeutung chronischer Schmerzen, insbesondere durch die Berucksichtigung von Studien in der Allgemeinbevolkerung und an Inanspruchnahmepopulationen, deutlich.

Background: In Germany public opinion is increasingly in favour of being included in decisions on priority and ra-tionalisation of health care, as practised in other countries for years. One question is, which influence medical know-how and patients' experience have on the assessment of health services (importance or reimbursement of expenses). In addition to a representative survey it would be appropriate to include certain groups like physicians, medical students, nursing staff, patients and inhabitants of old people's homes in a relevant survey. Design: We conducted a survey of six groups, differing in medical know-how, personal affliction and age, by a highly standardized questionnaire. The group of physicians received the questionnaire by mail with one reminder. The questionnaire was handed out to the other groups (directly). Setting: 150 practices of internal specialists and general practitioners in and around Lubeck, a preclinical and a clinical semester of the Medical University of Lubeck, an old people's home in Lubeck-Travemunde and a cardiological clinic for rehabilitation in Bad Segeberg. Subjects: 150 practising physicians (internal specialists, general practitioners), 100 medical students of a preclinical semester and another 100 of the fifth clinical semester, 100 patients in cardiological consulting hours in a cardiological clinic, 100 members of the nursing staff of the same clinic and 110 residents in an old people's home. The survey period was between December 1997 and February 1998. Instrument: The questionnaire was identical to a parallel public survey. On the one hand defined health services were assessed in respect of importance and reimbursement of expenses. On the other hand, more general questions were asked regarding possible ways of financing or economization in public health. Results: A response rate of 82% was achieved in the group of inhabitants of the old people's home. Doctors and students showed a response rate between 60% and 70%, while the response rate of patients and nursing staff was about 50%. A clear agreement between groups could be found in the evaluation of health services in the case of severe illnesses of children, which achieved the highest rating. The evaluation of health services of controversial effectivity like homoeopathic drugs or acupuncture varied most. There was a tendency in the patients' group to rate the importance of the listed health services higher than in the other groups, especially doctors and clinical students. All groups showed readiness to assign more financial consequences to patients with illnesses caused by the patient's behaviour, e.g. dangerous forms of sports or smoking. Conclusion: Laity as well as experts showed a distinct interest in the complex subject. Medical know-how goes along with a more critical evaluation of the importance of numerous indications. Patients distinguished less between different health services. The questionnaire showed that those directly concerned wish to be included in the discussion and feel that decisions concerning priority-setting in public health should not be left to politicians and health insurance companies alone.

Background: Statutory health insurance bodies in Germany are experiencing increasing deficits, which raises the demand for rationalising health benefits. This, however, requires the establishment of priorities unless absolutely necessary benefits have to be cut. In other words, we must examine the preferences, expectations and experiences of the insured population. Within the framework of this study, we tried to find out the preferences and assessment of health services by the German population in the Lubeck region. Design: Mail survey (questionnaire and two reminders) to register the preferences and attitudes to guaranteed medical services in the light of threatening deficits. The random sample was drawn by the residents' registration office in Lubeck, the criteria being an age of between 25 and 64 years, German nationality and principle domicile in Lubeck. Instrument: Postal questionnaire with 7 pages including 9 question complexes on the importance of preventive, curative and rehabilitative health services with 88 items and personal data. Results: We succeeded in contacting 992 persons and achieved a response rate of 64.1 %. 67 % of the participants (n=634) conveyed about their opinion on economic decisions in health care. 12% refused any involvement. In respect of importance and the cost of medical interventions, preventive, curative and rehabilitative interventions for children have highest priority. In the curative and rehabilitative sphere the emphasis lies on the severity of the illness. Interventions with controversial effectiveness were rated less important by the respondents and hence these should not be financed by the health insurance companies in every case, in the opinion of the persons who had been questioned. Conclusions: The evaluation shows that most participants could cope quite well with this questionnaire and were ready to be involved in decisions concerning health care. Like the participants of Ann Bowling's survey about the investigation of preferences in the UK, our respondents give medical interventions for children (independent from the medical sector) a higher priority. Mit vorang. Satz weicht die engl. Zusammenfassung von der dt. Zusammenfassung ab Apart from this it is obvious that interventions with controversial effectivity should not be covered by the health insurance companies to the same extent as those with established effectivity, which is, in a way, in contrast to valid German legal regulations.

The guideline "Joint Swelling" is addressed to primary care physicians--general practitioners, internists or orthopedists without special experience in rheumatology. It provides a framework for interviewing patients, as well as for physical, laboratory and imaging examinations and for selection of treatment appropriate to the level of primary care. Situations which call for urgent evaluation and criteria for referral to rheumatologists are described. The appendix contains comments on signs and symptoms to differentiate arthralgia from joint swelling and on the diagnostic value of a history of joint swelling without confirmation by the physician. Further recommendations for the evaluation of patient history and physical and technical examinations are given in a tabular form. The significance of laboratory and imaging procedures is discussed.

Die Leitlinie „Gelenkschwellung” richtet sich an den Hausarzt – Allgemeinarzt oder hausarztlicher Internist – sowie an den nicht spezialisierten Orthopaden. Sie beschreibt die Anamnese, die problemorientierte klinische Untersuchung, die labormedizinische und bildgebende Diagnostik sowie therapeutische Masnahmen, die auf der primararztlichen Ebene einzuleiten sind. Situationen, die sofortiger Abklarung bedurfen und Uberweisungsindikationen zum Spezialarzt werden genannt. Der Anhang enthalt Erlauterungen zur Differenzierung der Symptome von Gelenkschmerz und Gelenkschwellung, zur Wertigkeit der anamnestischen Angabe einer fruheren Gelenkschwellung ohne Nachweis durch den Arzt und zu Gelenkschwellungen aus mechanischer Ursache. In tabellarischer Form werden nahere Hinweise zur Anamnese und Untersuchung gegeben und die Bedeutung der labormedizischen und bildgebenden Diagnostik diskutiert.

Der Begriff der „Evidenz-basierten Medizin” fuhrt in Deutschland immer noch zu Verwirrungen. Wir verstehen unter Evidenz das, was ohne weitere methodische Vermittlung auf der Hand liegt, selbst-„evident” ist. Im angelsachsischen Sprachraum wird unter „evidence” das verstanden, was den Wahrheitsgehalt einer Aussage als starkeres oder schwacheres Beweismittel stutzt. Fur das klinische Handeln sind beide Typen von Evidenz unverzichtbar. Neben den vielfaltigen internen Evidenzen (unseres Verstandnisses) brauchen wir heute dringender als fruher die sog. „external evidence” aus systematischer klinischer Forschung, um unsere Indikationsregeln zu begrunden. Dabei spielen v.a. Gesichtspunkte der Zweckrationalitat eine Rolle. Der Aufsatz diskutiert auch einige der damit verbundenen ethischen Spannungen.