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Having dealt with Martini's understanding of causality and his procedural elements of evidence in the third part, the concluding article once again takes a historical perspective. It (1) traces the positionings and contexts of Martini's methodology in a sort of historical longitudinal section and (2) discusses the reasons for the rather reluctant response to his research programme in German and international medicine. We then focus (3) on Martini's understanding and concept of clinical research, the specific challenges he faced in post-war German medicine - and what remains of it today. Finally, we summarise the key findings of our article series and reflect on Martini's work in terms of its special nature and significance for clinical medicine in the 20 th century., (Copyright © 2024. Published by Elsevier GmbH.)

In the third part of our quadripartite series on Paul Martini and his concept of clinical proof we shortly present the mostly procedural elements of his test of treatment. We discuss their causal conduciveness: what do they contribute to infer causality from effect? Finally we comment on some of Martini's epistemological assumptions and methodological decisions that underpin his method of proof., (Copyright © 2023. Published by Elsevier GmbH.)

This article aims to examine Paul Martini's early therapeutic research. It traces the development and early practice of his methodology by focussing on four clinical studies which Martini conducted in the years 1928 to 1932. The studies show a methodological transition from uncontrolled drug evaluation to systematic method-based drug testing and the production of increasingly valid results. In addition, we address Martini's inaugural lecture in Bonn (1932) as a source of important conceptual considerations. With its publication in 1932, the "Methodenlehre der therapeutischen Untersuchung" became a firm basis and standard for therapeutic research practice for Martini, which he applied not only to his own, but to all clinical studies., (Copyright © 2023. Published by Elsevier GmbH.)

Hintergrund: Regionale Deprivation ist als ökologischer Parameter eine Komponente der sozialen Determinanten von Gesundheit. Zu ihrer Messung stehen in Deutschland der "German Index of Multiple Deprivation" (GIMD) und der "German Index of Socioeconomic Deprivation" (GISD) zur Verfügung. Chronisch entzündliche Darmerkrankungen (CED) sind keine häufigen, aber ernste körperliche Erkrankungen unklarer Ätiologie, mit vergleichsweise frühem Auftreten im Erwachsenenalter, oft chronisch-behandlungsbedürftigem Verlauf und unsicherer Prognose. Daten einer kontrollierten Versorgungsstudie erlauben es, Assoziationen zwischen regio-naler Deprivation und Merkmalen der Krankheit und ihrer Versorgung zu untersuchen. Wir erwarteten ungünstigere Krankheitsverhältnisse bei höherer Deprivation., Methodik: Vorgestellt werden deskriptive Zusatzauswertungen (n=530) der 2016 bis 2019 durchgeführten MERCED-Studie zu Wirksamkeit und Nutzen einer stationären medizinischen Rehabilitation bei Sozialversicherten mit einer CED. Analysiert wurden Daten aus der Basisbefragung zu selbstberichteten Krankheitsmerkmalen, Krankheitsfolgen und Versorgungsleistungen in ihrem Zusammenhang mit dem Ausmaß regionaler Deprivation der Wohnregion (Kreisebene)., Ergebnisse: Die Zuordnung der Wohnregion der Kranken zu den Quintilen von GIMD und GISD korrelieren unter rho=0,76 miteinander (gewichtetes kappa=0,74). Regionale Deprivation zeigt, gemessen mit dem GIMD, überzufällige Unterschiede allein in den sozialen Teilhabeeinschränkungen (IMET) und der Zahl der "Einschränkungstage". Dabei schildern sich Personen aus dem niedrigsten Deprivationsquintil als am stärksten eingeschränkt. Für die Einschränkungstage findet sich ein irre-guläres Muster. Beim GISD wird eine unsystematische Variation der gesundheitsbezogenen Lebensqualität (EQ-VAS) statistisch auffällig. Auch hier berichten Personen mit der geringsten regionalen Deprivation von einer besonders schlechten Lebensqualität. In einem Extremgruppenvergleich weisen Personen, die in nach GIMD und GISD stark deprivierten Regionen leben, günstigere Werte im Krankheitsverlauf beim IMET und EQ-VAS auf. Auch für Parameter der medizinischen Versorgung lassen sich keine systematischen Zusammenhänge mit den Deprivationsindizes darstellen., Schlussfolgerung: Krankheitsmerkmale, Krankheitsfolgen und die medizinische Versorgung von CED-Kranken zeigen sich weitgehend unabhängig vom Ausmaß der mit zwei Indizes bestimmten regionalen Deprivation. Die wenigen auffälligen Unterschiede weisen in eine überraschende Richtung: Personen aus deprivierten Regionen berichten günstigere Krankheitsverhältnisse., Background: As an ecological parameter, area deprivation is one component of the social determinants of health. For Germany two indices to measure area deprivation are currently available: The German Index of Multiple Deprivation (GIMD) and the German Index of Socioeconomic Deprivation (GISD). Inflammatory bowel diseases (IBD) are not frequent but severe diseases of so far unknown etiology, comparatively early manifestation in adulthood, often chronic course requiring long-lasting medical attention, and uncertain prognosis. Data of a controlled health care trial enable us to study associations between area deprivation and disease and treatment variables. We expected more unfavourable conditions with increasing level of deprivation., Methods: We present secondary descriptive analyses of an RCT on effectiveness and benefit of medical inpatient rehab of 530 socially insured IBD patients. We used data from the initial assessment of numerous self-reported disease characteristics, consequences of disease, and health care items in relation to the extent of area deprivation at patients' county ("Kreis") level., Results: Grouped into quintiles, patients' results from GIMD and GISD are closely correlated (rho=0.76; weighted kappa=0.74). Regional deprivation, as assessed by GIMD, shows noticeable associations only with participation restriction (IMET scale) and number of disability days. However, subjects from least deprived areas report highest restrictions whereas the distribution of disability days exhibits an irregular pattern. GISD data are weakly and unsystematically related to quality of life measurements. Again, patients from least deprived areas show a considerably low quality of life. A comparison of two extreme groups (very low vs. very high deprivation in GIMD and GISD combined) corroborates the finding: Subjects from highly deprived areas report in general more favourable disease characteristics. We found no association between deprivation and any health care item., Conclusion: Disease characteristics, psychosocial consequences, and health care of IBD seem to be mainly independent of the extent of area deprivation. The few statistically noticeable associations are unexpected: Patients from more deprived counties give more favourable reports., Competing Interests: Die Autorinnen/Autoren geben an, dass kein Interessenkonflikt besteht., (Thieme. All rights reserved.)

This is the first contribution to a quadripartite series on Paul Martini, internist and early clinical epidemiologist (1889-1964), and his clinical proof ("klinischer Beweis"). Following a historical introduction and the presentation of our programme, the text deals with Martini as a person and his socio-cultural background between the end of the Great War and the 1960s. It throws light on his original, innovative and risky research programme, and outlines various factors which led Martini to his central life issue: the therapeutic-clinical proof based on controlled investigations., (Copyright © 2022. Published by Elsevier GmbH.)

Aim of the Study: Taking into consideration and addressing patients' psychosocial problems is one of the characteristics of good clinical practice; this applies to IBD-patients as well. Since 2014, such patients have been offered an online questionnaire-based problem assessment linked to care recommendations. The primary aim of our data analysis was to carry out a comparative description of socio-demographic and disease-related characteristics of users of the free service., Methodology: For a retrospective data analysis, the online sample (OG) comprising 2156 CD and UC patients was compared with 852 individuals who participated in 2 IBD health services research studies (CG). Besides descriptive statistics, regression and covariance analyses were carried out., Results: The OG differed from CG in a highly significant and partly clinically relevant way. One in 3 of the OG was younger than 30 years of age (CG: 19%); 45% had completed high school (CG: 36%). In the OG, fewer were in disease remission (OG 34%; CG 59%). Even controlling for these differences, the OG reported more often greater burden in 12 of 17 psychosocial problem areas and expressed a greater need for information on 5 of 9 disease-related topic areas., Conclusion: The internet-based assessment of psychosocial problems is used primarily by younger, better educated, and physically as well as psychosocially more burdened IBD patients with comparatively high information needs. The assessment may help them to actively participate in their care. Our data sheds further light on the peculiarities of internet-based study groups., Competing Interests: Die Autorinnen/Autoren geben an, dass kein Interessenkonflikt besteht., (Thieme. All rights reserved.)

Background: MERCED is a pragmatic randomised health care trial on the effectiveness and benefit of medical rehab in socially insured employees with chronic inflammatory bowel disease. After on average 8 months post rehab the intervention group showed, compared to continued routine care, a moderate but clinically relevant additional benefit in indicators of social participation, clinical and psychological status. However, no differences were observed for employment status, days off work, and subjective vocational prognosis., Methods: We used questionnaire-based reports and ratings of the 211 members of the intervention group on access to medical rehab, its processes and subjective global success as well as a range of health effects calculating pre-post differences., Results: Contact with three employment/work related services (focused on vocational counselling, legal advice, aftercare) were reported by 33, 48, and 23% resp. of all rehab patients. Patients with pronounced vocational problems had equally frequent contacts as those without. Compared to 12 other services the three received inferior ratings on a scale from 1 (very good) to 5 (very bad): mean 2,5 - 2,3 - 3,0 resp., Conclusion: Medical rehab's relative neglect of vocational elements may partially explain its ineffectiveness in improving participation in work and employment. From MERCED's procedures and results we inferred recommendations to intensify access to medical rehab and its vocational orientation and evaluate its effects., Competing Interests: Die Autorinnen/Autoren geben an, dass kein Interessenkonflikt besteht., (Thieme. All rights reserved.)

Background: The poor evidence base is a major problem for the German rehabilitation sector. This trial focused on testing the efficacy and benefit of inpatient medical rehabilitation compared to routine care in a single common entity, namely, chronic inflammatory bowel disease (IBD)., Methods: This pragmatic, multicenter, randomized controlled trial with a parallel group design included gainfully employed patients with IBD who were covered by one of four statutory health insurance providers. Patients in the intervention group were actively advised regarding options for rehabilitation and given support in applying for it; patients in the control group continued with the care they had been receiving before participation in the trial. The primary endpoint was social participation, and there were various secondary endpoints, including disease activity and sick days taken off from work. All parameters were assessed by questionnaire at the beginning of the trial and twelve months later. This was trial no. DRKS00009912 in the German clinical trials registry., Results: In a complete case analysis, the intervention group (211 patients, of whom 112 underwent rehabilitation) did better than the control group (220 patients, of whom 15 underwent rehabilitation) in multiple respects. The reported limitation in social participation was reduced by 7.3 points in the intervention group and 2.9 points in the control group (p = 0.018; d = 0.23). Significant improvements were also seen in disease activity, vitality, health-related quality of life, and self-management, with effect sizes between 0.3 and 0.4. No benefit was seen in outcomes related to working capacity. Sensitivity analyses lent further support to the findings., Conclusion: Rehabilitation research can be conducted with individually randomized, controlled trials. The findings of this trial indicate the absolute effectiveness of ied rehabilitation for IBD patients, as well as its additional benefit compared to routine care.

Objectives: "Medical necessity" (MedN) is a fuzzy term. Our project aims at concretising the concept between medical ethics, social law, and social medicine to support health care regulation, primarily within Germany's statutory health insurance system. In a previous publication we identified MedN as a tripartite predicate: A specific clinical condition requires a specific medical intervention to reach a specific medical goal. Our two-part text searches for and discusses criteria to classify medical methods as generally medically necessary (medn), provided a non-trivial clinical condition and a relevant, legitimate, and reachable goal actually exist. In this paper we present the first part of our results., Methods: Based on an extensive ethical, sociolegal and sociomedical body of literature, and starting with an non-controversial case vignette (thrombolysis in acute stroke), we generally followed a critical reconstructive approach. First we defined the term "medical method". In several interdisciplinary rounds, we then collected and discussed criteria from three sources: methods to develop clinical practice guidelines as compendia of indication rules, the National Model of Prioritisation in Swedish Health Care, and the HTA Core Model of the European Network for Health Technology Assessment as an instrument of political counselling., Results: We identified general clinical efficacy and benefit as the 2 main "medical" criteria of MedN. As a third - epistemic - criterion, the corresponding bodies of evidence are always to be considered. Since clinical and prioritising guidelines grade their recommendations, the question arises whether MedN should be conceptualised as a dichotomous or finer graded predicate. In accord with German social law we advocate for the binary form. Further discussions focused on multifactorial MedN-configurations, the range of the term, and the variability of evidence requirements., Conclusions: No matter how the content of MedN is conceptualised, it seems impossible to include its criteria in an algorithm. So deliberative effort is indispensable at any stage of developing a programme to classify medical methods as medically necessary., Competing Interests: Die Autoren geben an, dass kein Interessenkonflikt besteht., (© Georg Thieme Verlag KG Stuttgart · New York.)

Objectives: "Medical necessity" (MedN) is a fuzzy term. Our project aims at concretising the concept between medical ethics, social law, and social medicine to support health care regulation, primarily within Germany's statutory health insurance system. In Part I, we identified efficacy, (net)benefit, and the corresponding bodies of evidence as obligatory criteria of MedN. This is the second part suggesting and discussing further criteria., Methods: See Part I RESULTS: (Part II): As further MedN-criteria we critically assessed a method's effectiveness and acceptance in routine care, its potential beneficiaries, theoretical fundament, cost, and being without alternative as well as patients' self-responsibility, cooperation, and preferences. Since MedN has both lower and upper bounds, we had to consider certain cases of mis- and overuse, due for instance to "indication creep" or "disease mongering"., Conclusions: The additional criteria neither establish MedN (when met singly or together) nor exclude it (when not met). If MedN is rejected in view of the 3 obligatory criteria then further information does not overturn the verdict. If a method is already assessed as being medn then further criteria do not make it "more or less necessary". Though we advocated for a binary MedN-concept (Part I) we are nonetheless convinced that not all medical methods deemed medn are equally medically relevant. Respective differences within the range of MedN could be assessed by techniques to prioritise medical conditions, methods, and aims., Competing Interests: Die Autoren geben an, dass kein Interessenkonflikt besteht., (© Georg Thieme Verlag KG Stuttgart · New York.)

Background: To facilitate access to evidence-based care for back pain, a German private medical insurance offered a health program proactively to their members. Feasibility and long-term efficacy of this approach were evaluated., Methods: Using Zelen's design, adult members of the health insurance with chronic back pain according to billing data were randomized to the intervention (IG) or the control group (CG). Participants allocated to the IG were invited to participate in the comprehensive health program comprising medical exercise therapy and life style coaching, and those allocated to the CG to a longitudinal back pain survey. Primary outcomes were back pain severity (Korff's Chronic Pain Grade Questionnaire) as well as health-related quality of life (SF-12) assessed by identical online questionnaires at baseline and 2-year follow-up in both study arms. In addition to analyses of covariance, a subgroup analysis explored the heterogeneity of treatment effects among different risks of back pain chronification (STarT Back Tool)., Results: Out of 3462 persons selected, randomized and thereafter contacted, 552 agreed to participate. At the 24-month follow-up, data on 189 of 258 (73.3%) of the IG were available, in the CG on 255 of 294 (86.7%). Significant, small beneficial effects were seen in primary outcomes: Compared to the CG, the IG reported less disability (1.6 vs 2.0; p = 0.025; d = 0.24) and scored better at the SF-12 physical health scale (43.3 vs 41.0; p < 0.007; d = 0.26). No effect was seen in back pain intensity and in the SF-12 mental health scale. Persons with medium or high risk of back pain chronification at baseline responded better to the health program in all primary outcomes than the subgroup with low risk at baseline., Conclusions: After 2 years, the proactive health program resulted in small positive long-term improvements. Using risk screening prior to inclusion in the health program might increase the percentage of participants deriving benefits from it., Trial Registration: The trial was registered at the German Clinical Trials Register under DRKS00015463 retrospectively (dated 4 Sept 2018).

Background: To facilitate access to evidence-based care for persisting back pain, a private medical insurance developed a health programme and offered it proactively to their members. The aim of this study was to evaluate the feasibility and efficacy of this procedure., Methods: The design of the study was a Zelen randomized controlled trial. Adult insured persons with persistent back pain were randomized to the control (CG) or intervention group (IG) prior to giving consent. The IG was invited to participate in the health programme, the CG in a survey. Primary outcomes were back pain intensity and disability (according to von Korff) and health-related quality of life (SF-12). At baseline, 12- and 24-month follow-up, outcomes were documented by identical online questionnaires., Results: 552 of 3462 randomized insured persons agreed to participate in the study; 132 of 258 (51.2%) from the IG and 243 of 294 (82.7%) from the CG completed the questionnaires at the 12-month follow-up. Small beneficial effects were seen for 3 of 4 primary outcomes. Compared to the CG, the IG reported less severe pain intensity (38.6 vs 44.5; p=0.001; d=0.36) and less disability (1.6 vs 2.2; p=0.002; d=0.41). The IG scored better at the SF-12 physical health scale (43.6 vs 39.0; p<0.001; d=0.54); no beneficial effect was seen in the SF-12 mental health scale., Conclusions: The pro-active health programme seems to be feasible and effective as determined by patient-reported outcomes. Final evaluation awaits cost analysis and the results of the 24-month follow-up., Competing Interests: 3 der 6 Autoren sind bei der PKV beschäftigt, deren Gesundheitsprogramm evaluiert wurde. Darüber hinaus bestehen keine Interessenskonflikte., (© Georg Thieme Verlag KG Stuttgart · New York.)

Background: Stratified care is an up-to-date treatment approach suggested for patients with back pain in several guidelines. A comprehensively studied stratification instrument is the STarT Back Tool (SBT). It was developed to stratify patients with back pain into three subgroups, according to their risk of persistent disabling symptoms. The primary aim was to analyse the disability differences in patients with back pain 12 months after inclusion according to the subgroups determined at baseline using the German version of the SBT (STarT-G). Moreover, the potential to improve prognosis for disability by adding further predictor variables, an analysis for differences in pain intensity according to the STarT-Classification, and discriminative ability were investigated., Methods: Data from the control group of a randomized controlled trial were analysed. Trial participants were members of a private medical insurance with a minimum age of 18 and indicated as having persistent back pain. Measurements were made for the risk of back pain chronification using the STarT-G, disability (as primary outcome) and back pain intensity with the Chronic Pain Grade Scale (CPGS), health-related quality of life with the SF-12, psychological distress with the Patient Health Questionnaire-4 (PHQ-4) and physical activity. Analysis of variance (ANOVA), multiple linear regression, and area under the curve (AUC) analysis were conducted., Results: The mean age of the 294 participants was 53.5 (SD 8.7) years, and 38% were female. The ANOVA for disability and pain showed significant differences (p < 0.01) among the risk groups at 12 months. Post hoc Tukey tests revealed significant differences among all three risk groups for every comparison for both outcomes. AUC for STarT-G's ability to discriminate reference standard 'cases' for chronic pain status at 12 months was 0.79. A prognostic model including the STarT-Classification, the variables global health, and disability at baseline explained 45% of the variance in disability at 12 months., Conclusions: Disability differences in patients with back pain after a period of 12 months are in accordance with the subgroups determined using the STarT-G at baseline. Results should be confirmed in a study developed with the primary aim to investigate those differences.

Introduction:  Assessment of disease activity in Crohn's disease (CD) and ulcerative colitis (UC) is usually based on the physician's evaluation of clinical symptoms, endoscopic findings, and biomarker analysis. The German Inflammatory Bowel Disease Activity Index for CD (GIBDI CD ) and UC (GIBDI UC ) uses data from patient-reported questionnaires. It is unclear to what extent the GIBDI agrees with the physicians' documented activity indices., Methods:  Data from 2 studies were reanalyzed. In both, gastroenterologists had documented disease activity in UC with the partial Mayo Score (pMS) and in CD with the Harvey Bradshaw Index (HBI). Patient-completed GIBDI questionnaires had also been assessed. The analysis sample consisted of 151 UC and 150 CD patients. Kappa coefficients were determined as agreement measurements., Results:  Rank correlations were 0.56 (pMS, GIBDI UC ) and 0.57 (HBI, GIBDI CD ), with p < 0.001. The absolute agreement for 2 categories of disease activity (remission yes/no) was 74.2 % (UC) and 76.6 % (CD), and for 4 categories (none/mild/moderate/severe) 60.3 % (UC) and 61.9 % (CD). The kappa values ranged between 0.47 for UC (2 categories) and 0.58 for CD (4 categories)., Discussion:  There is satisfactory agreement of GIBDI with the physician-documented disease activity indices. GIBDI can be used in health care research without access to assessments of medical practitioners. In clinical practice, the index offers a supplementary source of information., Competing Interests: Disclosure The authors report no conflicts of interest in this work., (© Georg Thieme Verlag KG Stuttgart · New York.)

Objective: In this randomized controlled trial, we evaluated the effectiveness of a telephone-delivered intervention based on the Health Action Process Approach (HAPA) after discharge from inpatient rehabilitation to address behavior change, emotional status, and glycemic control in patients with Type 2 diabetes., Design: In a German rehabilitation center, 249 patients with Type 2 diabetes were separated into randomized groups, either a 12-month telephone follow-up support group or the usual care group. The counselor identified personal target areas and intervention modules and developed with the patient an individualized action plan for the telephone support. To enhance motivational processes, they used motivational interviewing techniques. Counselors called patients monthly to support the implementation of the personal plans into the patients' daily routines and to screen for emotional problems. Assessments measured exercise, diet, medication adherence, psychological variables, body mass index, HbA1c, and cardiovascular risk., Results: Twelve months after inpatient rehabilitation, the telephone group's rate of physical activity rose by 26% compared with the usual care group's 10%. Patients in the intervention group exhibited greater improvements in terms of their illness burden, psychological well-being, and depression. HbA1c fell in the telephone group but increased in the usual care group (-0.68% vs. 0.12%). The intervention group's cardiovascular risk fell, whereas the usual care group's rose (-0.57 vs. 0.23)., Conclusion: A theory-based telephone-delivered follow-up intervention utilizing motivational interviewing techniques and focusing on personalized action planning demonstrated improvements in patients' level of activity and health status 12-months postrehabilitation discharge and may be a beneficial supplement to rehabilitation programs. (PsycINFO Database Record, ((c) 2018 APA, all rights reserved).)

Since about 2005 VbHC has become a prominent movement on the border between population medicine and health economics. The "value" it is aiming at is defined as health care "outcomes per dollar spent". The text focuses on the work of two prominent proponents: M.E. Porter and J.A.M. Gray. It considers background and central elements of VbHC and discusses similarities and differences between the two authors. Especially the differences raise questions that will hopefully play a role in the German discussion that is still in its infancy. Three complex topics seem to be particularly relevant: the relationship between VbHC and evidence-based health care, the question of who is to benefit from VbHC (total, diseased, patient population?), and the role of moral values especially the value of solidarity with the severely ill and socially deprived., (Copyright © 2018. Published by Elsevier GmbH.)

The Choosing Wisely Initiative (CWI) started in 2012 follows a proposal by Howard Brody (2010). Using CWI, the US ABIM Foundation continued its work to strengthen medical professionalism. The text describes CWI's development, aims, mission, and dissemination. It discusses some of its limits and problems. An appendix tabulates similarities and differences between CWI and a (2016) subsequent initiative from the German Society of Internal Medicine (DGIM: Klug Entscheiden Empfehlungen/decide wisely recommendations)., (Copyright © 2017. Published by Elsevier GmbH.)

The German Society for Social Medicine and Prevention (DGSMP) confers the Salomon Neumann Medal for outstanding merit in the field of Preventive and Social Medicine. The Salomon Neumann Medal 2017 was awarded to Bernt-Peter Robra, Institute for Social Medicine and Health Economics (ISMG) of the Otto von Guericke University Magdeburg. It honours an outstanding representative of social medicine, in whose person and Institute the essential problem areas of social medicine as well as the competencies of the 3 scientific bodies that gathered in Lübeck - epidemiology, medical sociology and social medicine - and the sociopolitical engagement of Salomon Neumann come together., Competing Interests: Interessenkonflikt: Der Autor gibt an, dass kein Interessenkonflikt besteht., (© Georg Thieme Verlag KG Stuttgart · New York.)

Background/aims: Patients with inflammatory bowel disease (IBD) need comprehensive, interdisciplinary and cross-sectoral health care. In Germany, evidence-based care pathways have been developed to improve the quality of care of IBD patients. We aimed to evaluate the effects of the implementation of some of these recommendations on patient-related outcomes., Methods: In a region of North Germany, outpatients with IBD were recruited by gastroenterologists (intervention group). Three activities based on the recommendations of the IBD pathways were implemented, namely, 1) patient participation in a questionnaire-based assessment of 22 somatic and psychosocial problems combined with individualized care recommendations (patient activation procedure); 2) patient invitation to participate in a 2-day patient education program and 3) invitation to their gastroenterologists to participate in periodic interdisciplinary case conferences. For the control group, IBD patients receiving standard care at gastroenterology practices outside the specified region were recruited by their doctors. At baseline, 6- and 12-month follow-up, study patients were invited to complete questionnaires. Generic health-related quality of life, social participation and self-management skills were the main outcomes., Results: At baseline, 349 patients were included in the study (intervention group: 189; control group: 160); 142 patients from the former and 140 from the latter group returned completed questionnaires at the 12-month follow-up. Over time, improvement in health-related quality of life and social participation was similar in both groups. Participants of the intervention group demonstrated improved self-management skills and more often followed steroid-free medication regimens., Conclusion: In a real-world clinical context, patient activation procedure combined with patient education and case conferences was less effective than expected. The observed beneficial effects, however, encourage the evaluation of more intensive and addressee-centered activities., Competing Interests: Disclosure The authors report no conflicts of interest in this work.

Background: 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., Methods: 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., Results: 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., Conclusion: 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., (© Georg Thieme Verlag KG Stuttgart · New York.)

Background: 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., Methods: 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., Results: 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., Conclusions: 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., (© Georg Thieme Verlag KG Stuttgart · New York.)

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., (© Georg Thieme Verlag KG Stuttgart · New York.)

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., (© Georg Thieme Verlag KG Stuttgart · New York.)

Background and Study Aims: 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., Methods: 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., Results: 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., Discussion: 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., (© Georg Thieme Verlag KG Stuttgart · New York.)

Background: Inflammatory bowel diseases impose on patients a broad spectrum of somatic and psychosocial burden. We hypothesized that patients' self-responsibility in planning and initiating adequate usually multimodal health care can be supported by self-assessment and proactive information, thus improving health-related quality of life and social participation., Methods: We conducted a randomized controlled trial among a random sample of adult members of a German statutory health insurance with Crohn's disease or ulcerative colitis with at least 1 inflammatory bowel diseases-related hospital stay or sick leave in 2009 or 2010. Five hundred fourteen patients completed a postal screening questionnaire inquiring about 22 problems. The intervention group (IG) received an automated data analysis with individualized written advice on appropriate health services, and the control group received usual care. Main outcomes were health-related quality of life and social participation. Secondary outcomes included health care utilization, number of screened problems, and self-management skills., Results: After 12 months, small beneficial effects were seen for all primary outcomes in the IG: EuroQol visual analog scale score (difference between IG and control group: 4.4; 95% confidence interval, 7.7-1.0; P = 0.011), index for measuring participation restriction (IMET) score (difference between IG and control group: 0.4; 95% confidence interval, 0.07-0.62; P = 0.013). The number of disability days improved only in the IG. The IG reported significantly fewer outpatient visits, fewer disease-related problems, and improved self-management skills (health education impact questionnaire scores) with no increase in disease activity, hospital stays, or consultations with allied health professionals., Conclusions: Our activation and information procedure is effective and beneficial. Further studies might show its usefulness in comprehensive management of patients with inflammatory bowel diseases.

Aims: In Germany, in contrast to many foreign countries, scientists and medical professionals have been discussing prioritisation in medicine almost without consulting German citizens. We address the question of what questionnaire surveys can contribute to the understanding of citizens' attitudes towards prioritisation - with a focus on some difficulties and challenges of the method., Method: We conducted a postal survey with a random sample of 3 000 residents of the City of Lübeck (age ≥18). Respondents were asked to appraise different substantial and procedural criteria for prioritisation in medicine. In addition to descriptive statistical analyses, logistical regression models were performed to identify potential explanatory variables for the appraisal of prioritisation criteria., Results: The response rate was 45.6% (N=1 363). Some prioritisation criteria are accepted by the majority: severity of disease, effectiveness of an intervention and a firm evidence base. Other criteria were appraised controversially: personal life-style, responsibility for family members and general prioritisation of children. A patient's responsibility in society and age as well as an intervention's cost-benefit ratio were generally rejected. The results of logistic regression analyses showed some significant but minor effects of demographic and health-related variables. The citizens in our study want decision-making procedures in health care to be transparent and equally applied to all patients. According to the survey respondents decisions about the catalogue of services of Germany's statutory health insurance should mainly be made by doctors. The statutory health insurance as well as patients and scientists also should take part in the decision-making procedure., Discussion: Comparing our results to those of a national interview survey reveals some relevant differences: The respondents' assessment of some substantial criteria seems to vary according to the contextualisation and wording of the items. We found less difference - but still some inconsistent results - in the participants' appraisal of potential decision-makers in health care. To our surprise, the logistic regression models including standard demographic and health-related variables account for only a small proportion of the variance of all dependent variables., Conclusion: Our discussion emphasises some difficulties and challenges of questionnaire surveys on prioritisation criteria - reflecting on the state of the German debate on prioritisation. There has been hardly any public discussion on this issue prior to our survey in autumn 2009. It is thus unlikely that people have been able to state well-informed preferences. Instead they seem to have followed some kind of "social reflexes" depending on the context and wording of each item. Subsequent studies on preferences and priorities should (i) more closely assess the understanding of each item in advance and (ii) adapt the aims of their study and its methodology to the actual stage of the public discourse on the topic in question., (© Georg Thieme Verlag KG Stuttgart · New York.)

Background: Medical rehabilitation seems suitable for implementing multimodal interventions for the treatment of type 2 diabetes. Rehabilitation in Germany on principle requires that insurees file an application. Proactive screening for rehabilitation need has only been explored in pilot projects so far. It seems a promising attempt to assess rehab need by questionnaire especially in patients with type 2 diabetes. We do not know though how patients who have been screened positive for rehab need differ from other patients with type 2 diabetes as to their health and risk profiles. This could provide an indication of the validity of the proactive approach., Methods: Members of an Allgemeine Ortskrankenkasse (AOK) Disease Management Program (DMP) for type 2 diabetes were screened for rehab need by questionnaire. 13 diabetes-specific problem areas were assessed. Problems were assigned to 10 specific treatments (problem-treatment-pairs). Rehab need was presumed if patients needed 3 or more treatments. Patients were then compared to regular rehab patients as well as patients with type 2 diabetes from primary care medical offices., Results: From 5500 DMP-patients 829 returned the questionnaire (return rate: 15.5%). From these 94% met the criteria for rehab need; of these 55% needed 6 or more treatments (complex problems). Patients who screened positive for rehab suffered from more health problems and had worse risk profiles as compared to patients from medical offices, and disease burden was comparable or worse as compared to regular rehab patients., Conclusions: This indicates that proactive screening for rehab need in patients with type 2 diabetes leads to reasonable (valid) results. The very low return rate suggests that the sample may be considerably biased, though. Possibly, mainly patients with greater impairment to health responded to the screening., (© Georg Thieme Verlag KG Stuttgart · New York.)

The American Board of Internal Medicine (ABIM) Foundation launched the Choosing Wisely campaign in 2012 and until today convinced more than 50 US specialist societies to develop lists of interventions that may not improve people's health but are potentially harmful. We suggest combining these new efforts with the already existing efforts in clinical practice guideline development. Existing clinical practice guidelines facilitate a more participatory and evidence-based approach to the development of top 5 lists. In return, adding top 5 lists (for overuse and underuse) to existing clinical practice guidelines nicely addresses a neglected dimension to clinical practice guideline development, namely explicit information on which Do or Don't do recommendations are frequently disregarded in practice., (Copyright © 2014. Published by Elsevier GmbH.)

Objectives: The Social Code Book Nine (SGB IX), which was implemented in 2001, contains the "Wunsch- und Wahlrecht" for medical rehabilitation services in para. 9. This describes a right to participate and choose in the process of rehabilitation. The aim of the study was to collect representative data about the implementation of the para. 9 SGB IX during application for medical rehabilitation services from the applicants' point of view., Methods: A total of 2 000 applicants for rehabilitation services (all somatic and psychosomatic indications) of a federal pension fund and a compulsory health insurance fund were invited to take part in a postal survey about the "Wunsch- und Wahlrecht"., Results: The response rate was 66%. Most respondents reported that their application for rehabilitation services was approved immediately. People who supported respondents during application and gave information about the "Wunsch- und Wahlrecht" differed according to the kind of rehabilitation services the respondent applied for. Half of the respondents reported to have known about their "Wunsch- und Wahlrecht". The percentage was considerably higher for patients applying for post-hospital rehabilitation. Approximately 2/3 of the respondents had wishes concerning the choice of rehabilitation clinic. Half of those respondents reported their wishes to the insurer. Most wishes concerned the choice of a specific clinic, a place/region or the clinic's distance from the applicant's home. Wishes reported to the insurer were often considered (89%). Most important selection criteria for rehabilitation clinics were aspects of accommodation, clinic facilities and location, followed by aspects of treatment and the respectful treatment of rehabilitation patients. Concerning the mode of information about rehabilitation clinics, applicants preferred brochures (vs. internet), comparative and impartial information about the clinic and subjective accounts of individual rehabilitation patients., Conclusions: This study is an evaluation of how the "Wunsch- und Wahlrecht" has been translated to reality of rehabilitation services provided by a federal pension fund and a compulsory health insurance fund. The findings show that many respondents know about their "Wunsch- und Wahlrecht" and make use of it to a certain degree. At the moment wishes still relate mainly to the place or region of rehabilitation. This shows the necessity of informing applicants about their "Wunsch- und Wahlrecht" on a regular basis. At the same time they must be enlightened about potentially important criteria for choosing a rehabilitation clinic., (© Georg Thieme Verlag KG Stuttgart · New York.)

Background: The aim of this cross-sectional study was to establish an online inflammatory bowel disease (IBD) registry for a first picture of the situation of IBD outpatients' treatment in Germany., Methods: Between March 2006 and July 2007 IBD outpatients from 24 gastroenterological specialist practices and two hospitals in Germany were enrolled in an Internet-based registry to evaluate the outpatients' clinical status, psychological impairments, provided health care, as well as medical treatment and medication costs., Results: 1032 IBD patients (ulcerative colitis/UC: 519; Crohn's disease/CD: 511; indeterminate colitis: 2) were enrolled in the study (age: 43 ± 14 years/M ± SD). Disease duration of all patients averaged 10 ± 8.5 years. In 519 UC-patients (49% male; 33% pancolitis), 66% were in remission as were 55% of CD patients (37 % male; 41 % active smokers). Associated with higher rates of disease activity (CDAI ≥ 150; CAI>4) were corticosteroids (CD, UC), topical medication (UC), relevant reported depressive symptoms (15%; 6-31%) and impairments in sexuality (21%; 9-42%). Relevant medication groups prescribed were oral aminosalicylates (UC: 70%; CD: 47%); immunosuppressive therapy - mostly azathioprine/6 MP (CD: 47%; UC: 26%), and Infliximab (CD: 8%; UC: 3%). Strongly associated with their clinical disease activity in UC as well as CD patients, 15% (6-31%) reported relevant depressive symptoms and 21% (9-42%) relevant impairments in sexuality., Conclusions: The registry constitutes a large complemental database for the patient population in Germany. About one third of the IBD patients were not in clinical remission (CDAI ≥150/CAI >4) (CD: 45%; UC: 27%), although high rates of immunosuppressive drugs (CD: 47%; UC 26%) were administered. This study shows a large burden of active disease associated with an unexpectedly high (co)morbidity and high psychosocial impairments, indicating a reduced health state in IBD patients., (Copyright © 2012 European Crohn's and Colitis Organisation. Published by Elsevier B.V. All rights reserved.)

Obese patients were coached after inpatient medical rehabilitation with a 6 units comprehensive multimodal Liveonline aftercare program. In the randomized controlled study design, significant improvements in all outcome criteria were found both in treatment and control group. The improvements in the treatment group, however, were only partially superior to the control group, especially in the area of food habits. A statistically significant superiority of the treatment group concerning the primary targets waist circumference and body mass index could not be determined. The Liveonline aftercare was evaluated positively by the participants. Future research is discussed., (© Georg Thieme Verlag KG Stuttgart · New York.)

Diverse methods are available for evaluation of (medical) interventions. In each case one has to decide on a specific method. Our aim was to analyze typical problems involved in the measurement of change. Different methods are delineated, and their specific pros and cons are set out. Subsequently, empirically derived recommendations are outlined on which method should be employed for which problem and under which circumstances. A characteristic of rehab treatment is that as a rule a multitude of problems are addressed, and accordingly, treatment goals are heterogenic. Straightforward recommendations for one or the other method cannot be given., (© Georg Thieme Verlag KG Stuttgart · New York.)

Background: Different approaches have been developed for measuring change. Direct measurement of change (transition ratings) requires asking a patient directly about his judgment about the change he has experienced (reported change). With indirect measures of change, the patients' status is assessed at different time points and differences between them are calculated (measured change). When using the quasi-indirect approach ('then-test'), patients are asked after an intervention to rate their statuses both before the intervention as well as at the time of the enquiry. Associations previous studies have found between the different approaches might be biased because transition ratings are generally assessed using a single, general item, while indirect measures of change are generally based on multi-item scales. We aimed to quantify the agreement between indirect and direct as well as indirect and quasi-indirect measures of change while using multi-item scales exclusively. We explored possible reasons for non-agreement (present-state bias, recall bias)., Methods: We re-analysed a data set originally collected to investigate the prognostic validity of different approaches of change measurements. Patients from a 3-week inpatient rehabilitation programme for either cardiac or musculoskeletal disorders filled in health-status questionnaires (which included scales for sleep function, physical function, and somatisation) both at admission and at discharge. The patients were then randomised to receive either an additional transition-rating or then-test questionnaire at discharge., Results: Out of 426 patients, 395 (92.7%) completed all questionnaires. Correlation coefficients between indirect and quasi-indirect measures of change ranged from r = .60 to r = .71, compared to r = .37 to r = .48 between indirect and direct measures of change. Correlation coefficients between pre-test and retrospective pre-test (then-test) results ranged from r = .69 to r = .82, indicating a low level of recall bias. Pre-test variation accounted for a substantial amount of variance in transition ratings in addition to the post-test scores, indicating a low level of present-state bias., Conclusions: Indirect and quasi-indirect measurements of change yielded comparable results indicating that recall bias does not necessarily affect quasi-indirect measurement of change. Quasi-indirect measurement might serve as a substitute for pre-post measurement under conditions still to be specified. Transition ratings reflect different aspects of change than indirect and quasi-indirect methods do, but are not necessarily biased by patients' present states.

Background: Health care for inflammatory bowel diseases (IBD), to be comprehensive, takes a broad range of patients' somatic and psychosocial problems into account. Patients should be actively involved in health-care planning and organisation., Methods: 431 adult patients with Crohn's disease (50 %) or ulcerative colitis participated in a postal questionnaire survey; 6 months apart it twice assessed the patients' individual problem profiles. The results of the assessment were back-reported to each patient combined with targeted (though standardised) recommendations for future care. This publication is the first of a series. It presents the basic study design, describes the prevalence of 16 psychosocial problem domains and analyses their association with socio-demographic and disease variables., Results: Participants had a mean age of 46 years; 61 % were female; 57 % in remission (GIBDI ≤ 3). The most prevalent problems reported addressed sexual impairments (27 %), high stress (26 %) and depression (21 %). 27 % of the respondents did not report any psychosocial problem. One in five (21 %) described highly complex problem profiles (≥ 5 "active" problems) combined with a mean of 28 disability days within the past 3 months. Complex psychosocial profiles were associated with active disease, Crohn's disease and low educational level., Conclusions: IBD patients show a highly variable spectrum of psychosocial problems. Their number is closely associated with disease activity and a social status variable (school education). The gradient could complicate efforts to increase patient participation in care and to enhance self-management., (© Georg Thieme Verlag KG Stuttgart · New York.)

Parkinson's disease is increasingly viewed as a complex disorder including a range of typical non-motor symptoms in addition to the cardinal motor signs. This cohort was set up in 2010 to investigate the specificity of non-motor symptoms for Parkinson's disease. For this, we included several control groups with decreasing contrast from Parkinson's disease patients. Group definitions ranged from healthy control subjects to those with suspected early motor signs of parkinsonism. Using a mailed questionnaire, we screened 5838 inhabitants of Lübeck, Germany, out of a target population of 10 000 citizens, enquiring about motor impairment, pain, quality of life, comorbidities, somatization and demographics. Based on this information, participants were assigned to screening groups, and selected participants were invited for in-person examination (n = 623). The examination included cognitive examinations, transcranial ultrasound, a brief psychiatric interview and a standardized motor examination that was used to assign examination groups. In addition, all participants answered questionnaires addressing depression, anxiety, sleep and quality of life. The first-year follow-up examination was performed either in person using the same protocol or via mailed questionnaires. This study is ongoing and publications are in preparation, but you may contact the first author (meike.kasten@neuro.uni-luebeck.de) with suggestions for collaboration or data requests.

Background and Objective: German statutory health insurance-registered physicians increasingly offer individual health services (IHS). Within a mixed methods study, focus groups were conducted to describe deficits and recommendations from patients' point of view about how physicians should handle IHS., Patients and Methods: Seven semi-structured focus groups (alltogether 50 participants) were conducted, stratified for region, gender and school education and homogenised for age and health status. The discussions were recorded, transcribed and content-analysed (thematic coding)., Results: Across all focus groups patients wished in-depth advise, neutral information, transparent dissociation of IHS from services of statutory health insurances (SHI), appropriate time for consideration and information, consultations for a second opinion and transparent billing of all medical services. There was no consensus about who should initiate IHS and who should develop and disseminate information on IHS. Members of SHI wish for information on SHI services and transparent information developed by neutral parties., Discussion: The handling of IHS needs to be regulated urgently. Based on the integration of quantitative and qualitative data we infer patient-centred conclusions and recommendations for SHI-accredited physicians.

Objective: The question of which methods should be used to assess the effects of medical rehabilitation has a long and controversial history. With regard to this background the project "Outcome measurement in medical rehabilitation" aimed at developing a better understanding of the process of change and its assessment. We also looked into possible causes for discrepancies between the results of direct and indirect measures of change. Aims of our study were: (1) to picture trajectories of change in a simple and descriptive way, (2) to compare the resulting solutions, (3) to highlight relations with direct measurement of change and/or global estimation of effects, (4) to compare the predictive value of different measurements of change., Methods: We used available data from rehabilitation research which covered direct and indirect measurement of change as well as global measurement of effects and which therefore enabled us to compare different methods of outcome measurements. The well documented record includes data from n=466 patients with chronic back pain. Different trajectories (3 and 5 groups) were defined using their pre/post data., Results: Depending on limits chosen for positive or negative courses and chosen outcome 20% to almost 40% of the patients showed improvements over the follow-up period. About the same percentages changed for the worse. However, two-thirds of the patients improved at least in one outcome. Compared with those, who did not experience improvements in any outcome, this group indicated better global rehabilitation effects. The different types of trajectories (3 and 5 groups) substantially contribute to the explained variance of catamnestic status at 12 months beyond other predictors as well as beyond initial status. The same applies to the prediction of disability days., Conclusion: The description of trajectories of change yields useful results. In contrast to complex statistical methods we were able to identify groups of patients that can easily be described., (© Georg Thieme Verlag KG Stuttgart · New York.)

Background: Evidence-based and consented pathways for patients with inflammatory bowel diseases (IBD, Crohn's disease, ulcerative colitis) call for tailored education programmes to foster shared decision-making and patient self-management. Their preferences should be taken into account., Methods: In 2005 a cross-sectional postal questionnaire survey was conducted in different regions of Germany. Adult patients with ulcerative colitis (UC) or Crohn's disease (CD) were recruited from specialised gastroenterological practices, university outpatient clinics and the member registry of the relevant patient organisation DCCV. They returned a questionnaire including (inter)nationally established scales (e. g., HADS) as well as questions on their information needs, preferred information sources and their role in decision-making., Results: Data of 1056 responders could be analysed (65 % female; CD: 58 %; DCCV member: 71 %). The mean age of the patients was 42 (SD 12,8) years. Almost all patients wanted more information on "treatment alternatives" (83 %), "causes of disease" (80 %) and "what can I (still) do by myself" (79 %). 27 % of the patients asked for more information on 15 or more of overall 19 topics. The high information need was significantly associated with HADS potential depressive disorder (score > 8) and HADS probable anxiety disorder (score > 10). Most IBD patients (70 %) obviously regard their physicians as the most desirable source of information, 67 % prefer an active involvement in clinical decision-making., Conclusions: The data demonstrate high information needs of IBD patients and may serve in the planning of future educational programmes., (© Georg Thieme Verlag KG Stuttgart · New York.)

This paper introduces the concept of priority setting in health care. Priority setting is understood as a notional approach to find out what to regard as more important or less important in health care. It primarily means to bring aspects into a ranking order. Priority setting is first and foremost theoretical work aimed at preparing decisions. It does not replace these decisions. Priority setting is not restricted to circumstances of scarce resources. It can be used, for example, for working more efficiently, for quality assurance, and also for rationing. Values or value decisions form the basis of priority setting. There should be a societal consensus regarding these values and the way priority setting is conducted. Priority settings can be done to very different objects, including objects from a macro-level, e. g. general goals of health care, from a meso-level, e. g. condition-treatment pairs, as well as from a micro-level, e. g. waiting lists. Swedish national prioritization guidelines serve as an example of how priority setting can be conducted. Here, condition-treatment pairs are developed on the basis of present health care occurrences. Then, priorities from 1 (highest priority) to 10 (lowest priority) are assigned on the basis of a priority setting model. The process includes all relevant stakeholders. Priorities are set on the basis of the severity of the problem, knowledge of the effect of an intervention and its cost-effectiveness, as well as the level of evidence of the knowledge contributing to the decision. In rehabilitation, priority setting is still an unfamiliar topic which only few scientific papers have taken up to date. Different aspects of priority setting that may be deemed important for rehabilitation are introduced., (© Georg Thieme Verlag KG Stuttgart · New York.)

The German debate on prioritisation in medicine is getting well under way. This development has raised the question of which substantial and procedural criteria should be used to guide fair and legitimate prioritisation. It seems to be obvious that in a pluralist, democratic society citizens should be involved in such a discussion. But which is the adequate method, and what is the potential of citizen participation? In this paper we compare the results of a regional citizens' conference on prioritisation in medicine with various European reports on principles and criteria for prioritisation, and thereby aim to identify the conference members'contributions to the German debate on prioritisation criteria. The results of this exemplary deliberative event can provide hints towards the general potential of discursive participation. (As supplied by publisher)., (Copyright © 2012. Published by Elsevier GmbH.)

In December 2010, the Institutes for Social Medicine and Cancer Epidemiology of the University of Lübeck hosted the first Workshop for Early Career Investigators in the area of Health Services Research. This workshop was funded by the Deutsche Forschungsgemeinschaft (DFG, German Research Foundation) with the aim to promote young scientists and researchers that wish to pursue research in the field of Health Services Research in an early phase of their career. The following report addresses the background, concept and progress of the initiative. All applicants had to submit a detailed project proposal and underwent a rigorous selection process. The projects presented at the workshop covered a wide range of topics, such as, for example, access to health care, common elements of mental illnesses and psychosomatic disorders, quality assurance in medical practices (i.e., evaluation of disease management programmes) and targets in rehabilitation. A major subject was migration as a challenge to Health Services Research. The 20 best applicants out of 121 were invited to attend the programme. During five days the participants had the opportunity to present their projects and discuss current issues as well as fundamental themes in study design. At the same time, national and international leading experts gave a series of lectures on current topics of Health Services Research. In numerous discussion groups and topical workshops participants and speakers explored and sought solutions to specific research issues. Following the programme participants are expected to finalise their research proposals and apply for funding to the DFG. To foster networking among early-career researchers, an alumni meeting is scheduled after 12 months. The DFG Workshop for Early Career Investigators was the first of its kind in the field of Health Services Research in Germany. However, evidence of its sustainability will have to be obtained from the future development of the German Health Services Research., (Copyright © 2011. Published by Elsevier GmbH.)

Germany's Central Ethics Committee of the Federal Chamber of Physicians (FCP) and other relevant national actors called for a public discourse on priority setting in health care. Politicians, members of a Federal Joint Committee and health insurance representatives, however, refused to promote or participate in the establishment of a public discussion. A change to that attitude only became apparent after former FCP President Hoppe's opening speech at the annual FCP assembly in Mainz in 2009. The present paper applies the Sociology of Knowledge Approach to Discourse, implemented through Qualitative Content Analysis and elements of Grounded Theory, to examine the development of the national public discourse in leading German print media. It creates a matrix that represents the discourse development between May 2009 and May 2010 and reflects central actors, their "communicative phenomena" and their interactions. Additionally, the matrix has been extended to cover the period until December 2011. Hoppe's arguments for priority setting in health care are faced with a wide opposition assuming opposing prerequisites and thus demanding alternative remedies. The lack of interaction between the different parties prevents any development of the speakers' positions. Incorrect accounts, reductions and left-outs in the media representation add to this effect. Consequently, the public discussion on priority setting is far from being an evolving rational discourse. Instead, it constitutes an exchange of preformed opposing positions., (Copyright © 2012. Published by Elsevier GmbH.)

Background: An ageing population, a growing prevalence of chronic diseases and limited financial resources for health care underpin the importance of prevention of disabling health disorders and care dependency in the elderly. A wide variety of measures is generally available for the prevention of falls and fall-related injuries. The spectrum ranges from diagnostic procedures for identifying individuals at risk of falling to complex interventions for the removal or reduction of identified risk factors. However, the clinical and economic effectiveness of the majority of recommended strategies for fall prevention is unclear. Against this background, the literature analyses in this HTA report aim to support decision-making for effective and efficient fall prevention., Research Questions: The pivotal research question addresses the effectiveness of single interventions and complex programmes for the prevention of falls and fall-related injuries. The target population are the elderly (> 60 years), living in their own housing or in long term care facilities. Further research questions refer to the cost-effectiveness of fall prevention measures, and their ethical, social and legal implications., Methods: Systematic literature searches were performed in 31 databases covering the publication period from January 2003 to January 2010. While the effectiveness of interventions is solely assessed on the basis of randomised controlled trials (RCT), the assessment of the effectiveness of diagnostic procedures also considers prospective accuracy studies. In order to clarify social, ethical and legal aspects all studies deemed relevant with regard to content were taken into consideration, irrespective of their study design. Study selection and critical appraisal were conducted by two independent assessors. Due to clinical heterogeneity of the studies no meta-analyses were performed., Results: Out of 12,000 references retrieved by literature searches, 184 meet the inclusion criteria. However, to a variable degree the validity of their results must be rated as compromised due to different biasing factors. In summary, it appears that the performance of tests or the application of parameters to identify individuals at risk of falling yields little or no clinically relevant information. Positive effects of exercise interventions may be expected in relatively young and healthy seniors, while studies indicate opposite effects in the fragile elderly. For this specific vulnerable population the modification of the housing environment shows protective effects. A low number of studies, low quality of studies or inconsistent results lead to the conclusion that the effectiveness of the following interventions has to be rated unclear yet: correction of vision disorders, modification of psychotropic medication, vitamin D supplementation, nutritional supplements, psychological interventions, education of nursing personnel, multiple and multifactorial programs as well as the application of hip protectors. For the context of the German health care system the economic evaluations of fall prevention retrieved by the literature searches yield very few useful results. Cost-effectiveness calculations of fall prevention are mostly based on weak effectiveness data as well as on epidemiological and cost data from foreign health care systems. Ethical analysis demonstrates ambivalent views of the target population concerning fall risk and the necessity of fall prevention. The willingness to take up preventive measures depends on a variety of personal factors, the quality of information, guidance and decision-making, the prevention program itself and social support. THE ANALYSIS OF PAPERS REGARDING LEGAL ISSUES SHOWS THREE MAIN CHALLENGES: the uncertainty of which standard of care has to be expected with regard to fall prevention, the necessity to consider the specific conditions of every single case when measures for fall prevention are applied, and the difficulty to balance the rights to autonomous decision making and physical integrity., Discussion and Conclusions: The assessment of clinical effectiveness of interventions for fall prevention is complicated by inherent methodological problems (esp. absence of blinding) and meaningful clinical heterogeneity of available studies. Therefore meta-analyses are not appropriate, and single study results are difficult to interpret. Both problems also impair the informative value of economic analyses. With this background it has to be stated that current recommendations regarding fall prevention in the elderly are not fully supported by scientific evidence. In particular, for the generation of new recommendations the dependency of probable effects on specific characteristics of the target populations or care settings should be taken into consideration. This also applies to the variable factors influencing the willingness of the target population to take up and pursue preventive measures. In the planning of future studies equal weight should be placed on methodological rigour (freedom from biases) and transferability of results into routine care. Economic analyses require input of German data, either in form of a "piggy back study" or in form of a modelling study that reflects the structures of the German health care system and is based on German epidemiological and cost data.