[Inflammatory Bowel Diseases: Regional Deprivation, Disease Characteristics and Relevant Health Care]. / Regionale Deprivation und Merkmale der Krankheit und ihrer Versorgung bei chronisch-entzündlichen Darmerkrankungen.

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.

[Assessment of Psychosocial Problems in Inflammatory Bowel Diseases - Who Uses the Online Version at www.CED-aktiv-werden.de?] / Psychosoziales Problemfeld-Assessment bei chronisch entzündlichen Darmerkrankungen ­ wer nutzt die online-Version unter www.CED-aktiv-werden.de?

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.

[Medical Rehabilitation for Inflammatory Bowel Disease: Access, Process, and Results - Further Analyses of a Randomised Controlled Trial]. / Medizinische Rehabilitation bei chronisch entzündlichen Darmerkrankungen: Zugang, Prozess und Ergebnisse.

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.

Prognostic ability of the German version of the STarT Back tool: analysis of 12-month follow-up data from a randomized controlled trial.

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.

[Medical Methods: What Makes them Necessary? Part I: Medical Methods, medical Necessity and its Main Criteria]. / Medizinische Behandlungsmethoden: Was macht sie medizinisch notwendig? Teil I: Medizinische Methoden, medizinische Notwendigkeit und ihre Hauptkriterien.

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.

[Medical Methods: What Makes them Medically Necessary? Part II: Further Criteria, Overuse, Moving Thresholds, and Grey Zones]. / Medizinische Behandlungsmethoden: Was macht sie medizinisch notwendig? Teil II: Weitere Kriterien, Übermaßverbot, wandernde Grenzen und Grauzonen.

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.

[Evaluation of a Proactive Health Programme for Insured Persons with Persistent Back Pain: One-year Follow-up of a Randomised Controlled Trial]. / Evaluation eines proaktiv angebotenen Gesundheitsprogramms für Versicherte mit anhaltenden Rückenschmerzen ­ Ein-Jahres-Follow-up einer randomisierten, kontrollierten Studie.

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.

Validation of the "German Inflammatory Bowel Disease Activity Index (GIBDI)": An Instrument for Patient-Based Disease Activity Assessment in Crohn's Disease and Ulcerative Colitis.

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 (GIBDICD) and UC (GIBDIUC) 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, GIBDIUC) and 0.57 (HBI, GIBDICD), 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.

[Laudation at the presentation of the Salomon Neumann Medal 2017 to Prof. Dr. med. med. Bernt-Peter Robra, MPH]. / Laudatio zur Salomon Neumann-Medaille 2017 an Herrn Prof. Dr. med. Bernt-Peter Robra, MPH.

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.

[Clinical research in service of clinical medicine: Contexts, practice, methodology and theory of Paul Martini's "clinical proof" - part 4: Adoption, resonance, and a résumé]. / Klinische Forschung im Dienst der Heilkunde: Kontexte, Praxis, Methodik und Theorie des "klinischen Beweises" von Paul Martini ­ Beitrag 4: Rezeption, Resonanz und Resümee.

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 20th century.

Agreement between pre-post measures of change and transition ratings as well as then-tests.

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.

[Clinical research in service of clinical medicine: Contexts, practice, methodology and theory of Paul Martinís "clinical proof" - part 3: Causally relevant elements of Martini's clinical proof and epistemological remarks]. / Klinische Forschung im Dienst der Heilkunde: Kontexte, Praxis, Methodik und Theorie des "klinischen Beweises" von Paul Martini. Beitrag 3: Kausalanalytisch relevante Elemente des klinischen Beweises und epistemologische Kommentare.

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.

[Clinical research in service of clinical medicine: Contexts, practice, methodology and theory of Paul Martini's "clinical proof" - part 2: Martini's early therapeutic research]. / Klinische Forschung im Dienst der Heilkunde: Kontexte, Praxis, Methodik und Theorie des "klinischen Beweises" von Paul Martini ­ Beitrag 2: Martinis frühe Forschungspraxis.

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.

[Clinical research in service of clinical medicine: Contexts, practice, methodolody, and theory of Paul Marini's "clinical proof" - part 1]. / Klinische Forschung im Dienst der Heilkunde: Kontexte, Praxis, Methodik und Theorie des "klinischen Beweises" von Paul Martini ­ Beitrag 1.

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.

In-patient cardiac rehabilitation versus medical care - a prospective multicentre controlled 12 months follow-up in patients with coronary heart disease.

BACKGROUND: The aim of this study was to evaluate a 3-week inpatient cardiac rehabilitation (Rehab) started early after the index event in patients with coronary heart disease and evidence-based secondary preventive medication. METHOD: All patients had acute coronary angiography, 679 were discharged from hospital receiving usual care (Hosp), 795 completed a comprehensive Rehab. Follow-up was 12 months. RESULTS: Rehab patients were older (64 vs. 62 years; p < 0.001), had more multivessel disease (51 vs. 37%; p < 0.001), heart failure (64 vs. 40%, p < 0.001), ST-segment elevation myocardial infarction (59 vs. 52%, p = 0.014), and renal insufficiency (10 vs. 7%, p = 0.036). Gender, peripheral artery disease, diabetes, hypertension, and socioeconomic status were similar in groups. Rehab patients had more beta-blockers (88 vs. 75%, p < 0.001) and angiotensin-converting enzyme inhibitors (81 vs. 70%, p < 0.001), a lower low-density lipoprotein cholesterol (102 vs. 122 mg/dl, p < 0.001), and a higher proportion of non-smokers (44 vs. 39%, p = 0.024). Primary combined endpoint of mortality, myocardial infarction (MI), revascularization, and hospitalization occurred in 32.6% of Rehab patients and in 38.7% of Hosp patients [p = 0.014; absolute risk reduction 0.0615, relative risk reduction 16%, number needed to treat (NNT) 17]. Myocardial infarction (MI) (1.8 vs. 3.8%, p = 0.015; NNT 49) and hospitalization (31.8 vs. 38.0%, p = 0.013; NNT 17) were reduced. In multivariate analysis, primary endpoint was reduced significantly (OR 0.729; 95% CI 0.585-0.909; p = 0.005) giving a relative risk reduction of 27% in favour of Rehab. CONCLUSION: Although Rehab patients were sicker at entry, their outcome was substantially improved within 12 months. With very low NNT, Rehab is highly effective and should be advised to all suitable patients with coronary heart disease.

Medium-term effects of cardiac rehabilitation in Germany: systematic review and meta-analysis of results from national and international trials.

BACKGROUND: Contrary to international practice, cardiac rehabilitation (CR) in Germany is predominantly offered as comprehensive inpatient treatment lasting for 3 weeks. Evidence for this kind of health care is poor, comprising observational cohort studies only. METHODS: We conducted a systematic search for relevant German studies (1990-2004). International studies were selected from recent meta-analyses. Medium-term (12 month) results for blood lipids, blood pressure, functional capacity and psychological wellbeing, as well as cardiac morbidity and mortality are reported. RESULTS: For most outcomes, effect sizes in national studies are poorer than those from international interventions or, in the case of blood pressure and depression, even poorer than international controls. CONCLUSIONS: Altogether, our analysis does not suggest that comprehensive inpatient rehabilitation treatment is superior to international practice of long-term outpatient rehabilitation.

Individual health services and the denial of health services in German medical practices: prevalence, regional differences and socio-demographic determinants.

BACKGROUND: Internationally, in many healthcare systems financial pressure has led to the implementation of co-payments, private medical (extra) services and rationing. In Germany, members of statutory health insurances (SHIs) increasingly report the denial of medical services and the offer/demand of privately financed supplementary health services individual health services, (IHSs) in medical practices. The public discussion on both denial and IHSs is chequered, mainly critical, partly polemic. The present study aims to operationalize IHSs and denial and investigates their occurrence, socio-demographic determinants within two regional populations. METHODS: Two postal surveys were conducted in 4898 German inhabitants of Lübeck (Northern Germany) and Freiburg (Southern Germany), aged 20-79 years. The survey focused on experiences with IHSs and denial of health services in medical practices among members of SHIs. RESULTS: In all members of SHIs that had consulted a physician during the past 12 months (n =1899), the one-year-prevalence of IHSs and denial of medical services were 41.7 and 20.5%. About 40% were offered a denied medical service as an IHS later. CONCLUSION: The study presents population-based, quantitative data on IHSs and denial of medical services in German practices. The results partly confirm former findings on the occurrence of IHSs. Contrary to other studies, socio-demographics seemed to play a minor role in the offer/demand of IHSs.

The Effectiveness of Actively Induced Medical Rehabilitation in Chronic Inflammatory Bowel Disease.

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.

Advance and unmet need of health care for patients with rheumatoid arthritis in the German population--results from the German Rheumatoid Arthritis Population Survey (GRAPS).

OBJECTIVES: To assess the quality of health care for RA patients in the general population of Germany. METHODS: A three-stage population survey was conducted to identify individuals with RA using a health care access panel (18-79 years; n = 70,112). A 20-item postal screening questionnaire of musculoskeletal symptoms and diagnoses was followed by a detailed questionnaire for those who indicated the possibility of having RA. Respondents who fulfilled the modified ACR decision tree, who reported an RA diagnosis, care by a rheumatologist or the use of DMARDs were asked to participate in a clinical examination by rheumatologists who diagnosed the participants and rated the adequacy of treatment. RESULTS: RA could not be ruled out in 1177 cases, of which 643 agreed to participate in the clinical examination, which was finally attended by 317 participants. Attendees did not differ with regard to any health or treatment measure from those who did not attend. Forty-one RA patients were detected. Of them, 93% had seen a rheumatologist at least once and 63% within the last 12 months. A total of 73% had received DMARD therapy at some time and 59% were currently receiving it. An unmet need for DMARDs was discovered in 29% of the RA attendees. It pertained almost exclusively to the seronegative cases of which 29% had a need to start and 17% to increase a DMARD therapy according to the opinion of the examining rheumatologist. CONCLUSION: Health care for RA patients has improved significantly since the last German RA survey in 1989. However, DMARD prescription still does not meet clinical recommendations, specifically in RF-negative patients. Since seronegative RA is a treatable disease, this group should not be overlooked.

General and health-related life satisfaction of patients with community-acquired pneumonia.

When assessing the quality of care, patients' characteristics such as general and health-related life satisfaction, are of major significance. Our study examined the general and health-related life satisfaction of patients with community-acquired pneumonia (CAP). To quantify the general and health-related life satisfaction, we used the validated instrument Questions on Life Satisfaction(Modules) by Henrich and Herschbach. CAP cases included in the German competence network on CAP (CAPNETZ) were asked to answer questions on their personal satisfaction with aspects of their life and health and on the individual importance of each addressed aspect. Data were compared with a normal population sample. In addition, several subgroup analyses were conducted. One thousand eight hundred ninety-nine (50.5%) CAP patients returned the questionnaire within a median time of 3 days. The mean age of the study sample was 55.1 +/- 17.1 years, 47.0% were female. The CAP patients reported not only a lower satisfaction with health (52.1 +/- 42.6 vs. 74.4 +/- 41.5, p < 0.001), but also a lower general life satisfaction (55.0 +/- 35.2 vs. 60.5 +/- 37.3, p < 0.001) than the normative German sample. Subgroup analyses revealed a significantly impaired general life satisfaction in patients with comorbidities (52.2 +/- 34.7) compared with patients without any underlying disease (58.1 +/- 35.4, p = 0.001). A non-significant lower general life satisfaction (53.3 +/- 35.1 vs. 57.0 5 +/- 35.2, p = 0.052) as well as a lower health-related life satisfaction (49.25 +/- 42.0 vs. 55.3 +/- 43.0, p = 0.602) could be observed in men compared with those in women. Patients aged 65 years and older and patients with a severe CAP reported a lower health-related life satisfaction, but a higher general life satisfaction than younger patients or patients with mild CAP. The lower general life satisfaction observed in patients with CAP was found to reflect comorbidity rather than the effects of the pneumonia itself.