[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.

[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.

[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.

[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.

[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.

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.

[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.

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.

[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.

Telephone-delivered lifestyle support with action planning and motivational interviewing techniques to improve rehabilitation outcomes.

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

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.

[Value-based health care (VbHC): Whence and wither]. / Value based health care (VbHC): woher und wohin?

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.

[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.

[The Choosing Wisely Initiative (CWI): Background, aims and problems of a professional campaign against oversupply]. / Die Choosing Wisely Initiative: Hintergründe, Ziele und Probleme einer professionellen Initiative zur Vermeidung von Überversorgung.

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).

Quality of care in inflammatory bowel disease: results of a prospective controlled cohort study in Germany (NETIBD).

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.

When Choosing Wisely meets clinical practice guidelines.

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.