[Rehabilitation for Post-COVID Syndrome covered by the German Pension Insurance in 2021]. / Rehabilitationen bei Post-COVID-Syndrom der Deutschen Rentenversicherung 2021.

AIM OF THE STUDY: The present work is intended to give an overview of rehabilitation of patients with post COVID-19 condition covered by the German Pension Insurance in 2021. METHODS: Cross-sectional analysis of medical rehabilitation completed in 2021, in which COVID-19 sequelae were coded in first or second place in the uniform discharge report according to the International Statistical Classification of Diseases and Related Health Problems was carried out. The codes U08(.9), U09(.9) and U10(.9) as well as the corresponding codes from 2020 were taken into the evaluation as COVID-19-related diseases. Children's rehabilitation and oncological rehabilitation for pensioners and their relatives were excluded. Statistically, relative and absolute frequencies are given for nominal and ordinal variables, and median and quartiles for continuous, skewed distributed variables. RESULTS: 9,666 rehabilitations with one of the codes mentioned in first or second place remained. 54.8% of the patients were women and 43.2% men. The median age was 54 and 55 years (women/men). In all, 64.4% of the rehabilitations were carried out in the pulmonary medicine department. Owing to somatic indications, almost 50% of these patients in rehabilitation remained in the clinic beyond the regular approval period. The most common other diagnoses were diseases of the respiratory system. In 80.7% of those affected, the treating physicians considered the post-COVID-19 condition-associated symptoms as improved through rehabilitation. Furthermore, employment was subject to social security contributions for 88.0% of these patients, and 30.5% were employed in the fields of health, social affairs, teaching, and education. Of those affected, 63.8% were on sick leave when they were admitted, 63.0% when they were discharged. With regard to performance in the last job or on the general job market, over 90.0% received a prognosis for 6 hours and more. CONCLUSION: The importance of post-COVID-19 condition in the context of medical rehabilitation increased significantly over the course of 2021. The disease causes long periods of disability. With regard to performance, the available analyses give a positive picture; only 6.5% of those individuals undergoing rehabilitation were assessed as having a reduced capacity to earn of less than 3 hours on the general labor market.

[Quality-oriented facility selection in the rehabilitation of the German pension insurance]. / Qualitätsorientierte Einrichtungsauswahl in der Rehabilitation der Deutschen Rentenversicherung.

According to Sixth Book of the Social Code (SGB VI), the German Pension Insurance (GPI) has the mandate to maintain or restore the employability of its insured persons. In order to achieve this goal, the GPI offers its insurees rehabilitation benefits. These are, on the one hand, services for prevention and medical rehabilitation (rehab) and, on the other hand, services for return-to-work or stay-at-work, respectively. In order to fulfill this mandate in the best possible way, in 1990 the GPI introduced instruments of external quality assurance (EQS) with scientific support. The system was firmly established in 1997. Since then, all rehab facilities owned and managed by the GPI are obliged to participate in the EQS system.Over the years, a large number of instruments and procedures have been developed that can map various aspects of quality as structure, process, and outcome. Until 2017, results of the EQS had no influence on the cooperation between the GPI and service providers. With the binding decision of the Federal Executive Board of the GPI in 2017, for the first time the GPI linked the allocation of rehab services for specific patients with the results of EQS. On this basis - confirmed by article 3 of the Digital Pension Overview Act - new paths are being taken. As part of the technically supported selection of a suitable facility for insured persons, quality should systematically and transparently acquire special importance and be consistently taken into account when occupying rehab facilities.This article gives an overview of the development of the proved and tested instruments of rehab quality assurance (QA), their current application, and an outlook on the rehab QA of the future.

How can we teach EBM in clinical practice? An analysis of barriers to implementation of on-the-job EBM teaching and learning.

INTRODUCTION: Evidence-based medicine (EBM) improves the quality of health care. Courses on how to teach EBM in practice are available, but knowledge does not automatically imply its application in teaching. We aimed to identify and compare barriers and facilitators for teaching EBM in clinical practice in various European countries. METHODS: A questionnaire was constructed listing potential barriers and facilitators for EBM teaching in clinical practice. Answers were reported on a 7-point Likert scale ranging from not at all being a barrier to being an insurmountable barrier. RESULTS: The questionnaire was completed by 120 clinical EBM teachers from 11 countries. Lack of time was the strongest barrier for teaching EBM in practice (median 5). Moderate barriers were the lack of requirements for EBM skills and a pyramid hierarchy in health care management structure (median 4). In Germany, Hungary and Poland, reading and understanding articles in English was a higher barrier than in the other countries. CONCLUSION: Incorporation of teaching EBM in practice faces several barriers to implementation. Teaching EBM in clinical settings is most successful where EBM principles are culturally embedded and form part and parcel of everyday clinical decisions and medical practice.

Evidence needs, training demands, and opportunities for knowledge translation in social security and insurance medicine: A European survey.

OBJECTIVE: To perform a European survey of the evidence needs and training demands of insurance medicine professionals related to professional tasks and evidence-based practice. DESIGN: International survey. SUBJECTS: Professionals working in insurance medicine. METHODS: Experts designed an online questionnaire including 26 questions related to 4 themes: evidence needs; training demands; evidence-seeking behaviour; and attitudes towards evidence-based medicine. Descriptive statistics were presented by country/conference and the total sample. RESULTS: A total of 782 participants responded. Three-quarter of participants experienced evidence needs at least once a week, related to mental disorders (79%), musculoskeletal disorders (67%) and occupational health (65%). Guidelines (76%) and systematic reviews (60%) were the preferred types of evidence and were requested for assessment of work capacity (64%) and prognosis of return-to-work (51%). Evidence-based medicine was thought to facilitate decision-making in insurance medicine (95%). Fifty-two percent of participants felt comfortable finding, reading, interpreting, and applying evidence. Countries expressed similar needs for reviews on typical topics. CONCLUSION: This study reveals evidence gaps in key areas of insurance medicine, supporting the need for further research, guidelines and training in evidence-based insurance medicine. Importantly, insurance medicine professionals should recognize that evidence-based practice is crucial in producing high-quality assessments.

Cardiac Rehabilitation in German Speaking Countries of Europe-Evidence-Based Guidelines from Germany, Austria and Switzerland LLKardReha-DACH-Part 1.

BACKGROUND: Although cardiovascular rehabilitation (CR) is well accepted in general, CR-attendance and delivery still considerably vary between the European countries. Moreover, clinical and prognostic effects of CR are not well established for a variety of cardiovascular diseases. METHODS: The guidelines address all aspects of CR including indications, contents and delivery. By processing the guidelines, every step was externally supervised and moderated by independent members of the "Association of the Scientific Medical Societies in Germany" (AWMF). Four meta-analyses were performed to evaluate the prognostic effect of CR after acute coronary syndrome (ACS), after coronary bypass grafting (CABG), in patients with severe chronic systolic heart failure (HFrEF), and to define the effect of psychological interventions during CR. All other indications for CR-delivery were based on a predefined semi-structured literature search and recommendations were established by a formal consenting process including all medical societies involved in guideline generation. RESULTS: Multidisciplinary CR is associated with a significant reduction in all-cause mortality in patients after ACS and after CABG, whereas HFrEF-patients (left ventricular ejection fraction <40%) especially benefit in terms of exercise capacity and health-related quality of life. Patients with other cardiovascular diseases also benefit from CR-participation, but the scientific evidence is less clear. There is increasing evidence that the beneficial effect of CR strongly depends on "treatment intensity" including medical supervision, treatment of cardiovascular risk factors, information and education, and a minimum of individually adapted exercise volume. Additional psychologic interventions should be performed on the basis of individual needs. CONCLUSIONS: These guidelines reinforce the substantial benefit of CR in specific clinical indications, but also describe remaining deficits in CR-delivery in clinical practice as well as in CR-science with respect to methodology and presentation.

Development of the interdisciplinary evidence-based s3 guideline for the diagnosis and treatment of prostate cancer: methodological challenges and solutions.

Evidence-based guidelines are important sources of knowledge in everyday clinical practice. In 2005, the German Society for Urology decided to develop a highquality evidence-based guideline for the early detection, diagnosis and treatment of the different clinical manifestations of prostate cancer. The guideline project started in 2005 and involved 75 experts from 10 different medical societies or medical organizations including a patient organization. The guideline was issued in September 2009 and consists of 8 chapters, 170 recommendations, and 42 statements. Due to the broad spectrum of clinical questions covered by the guideline and the high number of participating organizations and authors, the organizers faced several methodological and organizational challenges. This article describes the methods used in the development of the guideline and highlights critical points and challenges in the development process. Strategies to overcome these problems are suggested which might be beneficial in the development of new evidence-based guidelines in the future.

How are "teaching the teachers" courses in evidence based medicine evaluated? A systematic review.

BACKGROUND: Teaching of evidence-based medicine (EBM) has become widespread in medical education. Teaching the teachers (TTT) courses address the increased teaching demand and the need to improve effectiveness of EBM teaching. We conducted a systematic review of assessment tools for EBM TTT courses. To summarise and appraise existing assessment methods for teaching the teachers courses in EBM by a systematic review. METHODS: We searched PubMed, BioMed, EmBase, Cochrane and Eric databases without language restrictions and included articles that assessed its participants. Study selection and data extraction were conducted independently by two reviewers. RESULTS: Of 1230 potentially relevant studies, five papers met the selection criteria. There were no specific assessment tools for evaluating effectiveness of EBM TTT courses. Some of the material available might be useful in initiating the development of such an assessment tool. CONCLUSION: There is a need for the development of educationally sound assessment tools for teaching the teachers courses in EBM, without which it would be impossible to ascertain if such courses have the desired effect.

Early detection of breast cancer: benefits and risks of supplemental breast ultrasound in asymptomatic women with mammographically dense breast tissue. A systematic review.

BACKGROUND: Mammographic screening alone will miss a certain fraction of malignancies, as evidenced by retrospective reviews of mammograms following a subsequent screening. Mammographic breast density is a marker for increased breast cancer risk and is associated with a higher risk of interval breast cancer, i.e. cancer detected between screening tests. The purpose of this review is to estimate risks and benefits of supplemental breast ultrasound in women with negative mammographic screening with dense breast tissue. METHODS: A systematic search and review of studies involving mammography and breast ultrasound for screening of breast cancer was conducted. The search was performed for the period 1/2000-8/2008 within the data source of PubMed, DARE, and Cochrane databases. Inclusion and exclusion criteria were determined prospectively, and the Oxford evidence classification system for diagnostic studies was used for evidence level. The parameters biopsy rate, positive predictive value (PPV) for biopsy, cancer yield for breast ultrasound alone, and carcinoma detection rate by breast density were extracted or constructed. RESULTS: The systematic search identified no randomized controlled trials or systematic reviews, six cohort studies of intermediate level of evidence (3b) were found. Only two of the studies included adequate follow-up of subjects with negative or benign findings. Supplemental breast ultrasound after negative mammographic screening permitted diagnosis of primarily invasive carcinomas in 0.32% of women in breast density type categories 2-4 of the American College of Radiology (ACR); mean tumor size for those identified was 9.9 mm, 90% with negative lymph node status. Most detected cancers occurred in mammographically dense breast ACR types 3 and 4. Biopsy rates were in the range 2.3%-4.7%, with PPV of 8.4-13.7% for those biopsied due to positive ultrasound, or about one third of the PPV of biopsies due to mammography. LIMITATIONS: The study populations included wide age ranges, and the application to women age 50-69 years as proposed for mammographic screening could result in less striking benefit. Further validation studies should employ a uniform assessment system such as BI-RADS and report not only PPV, but also negative predictive value, sensitivity and specificity. CONCLUSION: Supplemental breast ultrasound in the population of women with mammographically dense breast tissue (ACR 3 and 4) permits detection of small, otherwise occult, breast cancers. Potential adverse impacts for women in this intermediate risk group are associated with an increased biopsy rate.

Teaching trainers to incorporate evidence-based medicine (EBM) teaching in clinical practice: the EU-EBM project.

BACKGROUND: Evidence based medicine (EBM) is considered an integral part of medical training, but integration of teaching various EBM steps in everyday clinical practice is uncommon. Currently EBM is predominantly taught through theoretical courses, workshops and e-learning. However, clinical teachers lack confidence in teaching EBM in workplace and are often unsure of the existing opportunities for teaching EBM in the clinical setting. There is a need for continuing professional development (CPD) courses that train clinical trainers to teach EBM through on-the-job training by demonstration of applied EBM real time in clinical practice. We developed such a course to encourage clinically relevant teaching of EBM in post-graduate education in various clinical environments. METHODS: We devised an e-learning course targeting trainers with EBM knowledge to impart educational methods needed to teach application of EBM teaching in commonly used clinical settings. The curriculum development group comprised experienced EBM teachers, clinical epidemiologists, clinicians and educationalists from institutions in seven European countries. The e-learning sessions were designed to allow participants (teachers) to undertake the course in the workplace during short breaks within clinical activities. An independent European steering committee provided input into the process. RESULTS: The curriculum defined specific learning objectives for teaching EBM by exploiting educational opportunities in six different clinical settings. The e-modules incorporated video clips that demonstrate practical and effective methods of EBM teaching in everyday clinical practice. The course encouraged focussed teaching activities embedded within a trainer's personal learning plan and documentation in a CPD portfolio for reflection. CONCLUSION: This curriculum will help senior clinicians to identify and make the best use of available opportunities in everyday practice in clinical situations to teach various steps of EBM and demonstrate their applicability to clinical practice. Once fully implemented, the ultimate outcome of this pilot project will be a European qualification in teaching EBM, which will be used by doctors, hospitals, professional bodies responsible for postgraduate qualifications and continuing medical education.

The effectiveness of a clinically integrated e-learning course in evidence-based medicine: a cluster randomised controlled trial.

BACKGROUND: To evaluate the educational effects of a clinically integrated e-learning course for teaching basic evidence-based medicine (EBM) among postgraduates compared to a traditional lecture-based course of equivalent content. METHODS: We conducted a cluster randomised controlled trial in the Netherlands and the UK involving postgraduate trainees in six obstetrics and gynaecology departments. Outcomes (knowledge gain and change in attitude towards EBM) were compared between the clinically integrated e-learning course (intervention) and the traditional lecture based course (control). We measured change from pre- to post-intervention scores using a validated questionnaire assessing knowledge (primary outcome) and attitudes (secondary outcome). RESULTS: There were six clusters involving teaching of 61 postgraduate trainees (28 in the intervention and 33 in the control group). The intervention group achieved slightly higher scores for knowledge gain compared to the control, but these results were not statistically significant (difference in knowledge gain: 3.5 points, 95% CI -2.7 to 9.8, p = 0.27). The attitudinal changes were similar for both groups. CONCLUSION: A clinically integrated e-learning course was at least as effective as a traditional lecture based course and was well accepted. Being less costly than traditional teaching and allowing for more independent learning through materials that can be easily updated, there is a place for incorporating e-learning into postgraduate EBM curricula that offer on-the-job training for just-in-time learning. TRIAL REGISTRATION NUMBER: ACTRN12609000022268.

Effectiveness and cost of atypical versus typical antipsychotic treatment for schizophrenia in routine care.

BACKGROUND: In two recent randomised clinical trials, a meta-analysis and in an effectiveness study analysing routine data from the U.S. Veterans Administration the superiority of the newer atypical drugs over typical antipsychotic drugs, concerning both their efficacy and their side-effect profile, has been questioned. AIMS OF THE STUDY: To analyse the effectiveness and cost of atypical versus typical antipsychotic treatment for schizophrenia in routine care. METHODS: Cohort study using routine care data from a statutory sickness fund with 5.4 million insured in Germany. To be included, patients had to be discharged with a diagnosis of schizophrenia in 2003 and fulfil membership criteria. Main outcome measures were rehospitalisation rates, mean hospital bed days, mean length of stay, cost of inpatient and pharmaceutical care to the sickness fund during follow-up and medication used to treat side-effects. RESULTS: 3121 patients were included into the study. There were no statistically significant differences in the effectiveness of atypical and typical antipsychotics on rehospitalisation during follow-up (rehospitalisation rate ratio 1.07, 95% confidence interval 0.86 to 1.33). However, there were consistent observations of atypical antipsychotics being more effective for severe cases of schizophrenia (14.6% of study population; >61 prior bed days per year in 2000-2002) in the follow-up period, whereas for the other severity strata typical antipsychotics seemed more effective in reducing various rehospitalisation outcomes. Patients treated with atypical antipsychotics received significantly less prescriptions for anticholinergics or tiaprid (relative risk 0.26, 95% confidence interval 0.18 to 0.38). DISCUSSION: The effectiveness of atypical antipsychotics for schizophrenia on rehospitalisation measures appeared similar to that of typical antipsychotics. With the exception of severe cases, the higher costs for atypical antipsychotics were not offset by savings from reduced inpatient care. Major limitations include the lack of statistical power for subgroup analyses, the lack of clinical severity scale data and of life-course medical history data which both increase the risk of residual confounding by disease severity. CONCLUSIONS: This study provides evidence that the effectiveness of atypical and typical antipsychotics measured in terms of hospital readmissions appears to be similar in routine care. IMPLICATIONS FOR HEALTH CARE PROVISION AND USE: From a clinical perspective, this study provides evidence that the effectiveness of atypical and typical antipsychotics measured in terms of hospital readmissions appears to be similar in routine care. IMPLICATIONS FOR HEALTH POLICIES: Routine data studies can yield valuable information for policy decision-makers on the costs and the effectiveness of pharmaceuticals in routine care, complementing efficacy data from randomised clinical trials currently used for licensing and reimbursement decisions. IMPLICATIONS FOR FURTHER RESEARCH: The non-significant differences in the effectiveness of atypical compared to typical antipsychotics according to severity of disease should be investigated in a prospective observational study or in a randomised clinical trial.

Harmonising evidence-based medicine teaching: a study of the outcomes of e-learning in five European countries.

BACKGROUND: We developed and evaluated the outcomes of an e-learning course for evidence based medicine (EBM) training in postgraduate medical education in different languages and settings across five European countries. METHODS: We measured changes in knowledge and attitudes with well-developed assessment tools before and after administration of the course. The course consisted of five e-learning modules covering acquisition (formulating a question and search of the literature), appraisal, application and implementation of findings from systematic reviews of therapeutic interventions, each with interactive audio-visual learning materials of 15 to 20 minutes duration. The modules were prepared in English, Spanish, German and Hungarian. The course was delivered to 101 students from different specialties in Germany (psychiatrists), Hungary (mixture of specialties), Spain (general medical practitioners), Switzerland (obstetricians-gynaecologists) and the UK (obstetricians-gynaecologists). We analysed changes in scores across modules and countries. RESULTS: On average across all countries, knowledge scores significantly improved from pre- to post-course for all five modules (p < 0.001). The improvements in scores were on average 1.87 points (14% of total score) for module 1, 1.81 points (26% of total score) for module 2, 1.9 points (11% of total score) for module 3, 1.9 points (12% of total score) for module 4 and 1.14 points (14% of total score) for module 5. In the country specific analysis, knowledge gain was not significant for module 4 in Spain, Switzerland and the UK, for module 3 in Spain and Switzerland and for module 2 in Spain. Compared to pre-course assessment, after completing the course participants felt more confident that they can assess research evidence and that the healthcare system in their country should have its own programme of research about clinical effectiveness. CONCLUSION: E-learning in EBM can be harmonised for effective teaching and learning in different languages, educational settings and clinical specialties, paving the way for development of an international e-EBM course.

A clinically integrated curriculum in evidence-based medicine for just-in-time learning through on-the-job training: the EU-EBM project.

BACKGROUND: Over the last years key stake holders in the healthcare sector have increasingly recognised evidence based medicine (EBM) as a means to improving the quality of healthcare. However, there is considerable uncertainty about the best way to disseminate basic knowledge of EBM. As a result, huge variation in EBM educational provision, setting, duration, intensity, content, and teaching methodology exists across Europe and worldwide. Most courses for health care professionals are delivered outside the work context ('stand alone') and lack adaptation to the specific needs for EBM at the learners' workplace. Courses with modern 'adaptive' EBM teaching that employ principles of effective continuing education might fill that gap. We aimed to develop a course for post-graduate education which is clinically integrated and allows maximum flexibility for teachers and learners. METHODS: A group of experienced EBM teachers, clinical epidemiologists, clinicians and educationalists from institutions from eight European countries participated. We used an established methodology of curriculum development to design a clinically integrated EBM course with substantial components of e-learning. An independent European steering committee provided input into the process. RESULTS: We defined explicit learning objectives about knowledge, skills, attitudes and behaviour for the five steps of EBM. A handbook guides facilitator and learner through five modules with clinical and e-learning components. Focussed activities and targeted assignments round off the learning process, after which each module is formally assessed. CONCLUSION: The course is learner-centred, problem-based, integrated with activities in the workplace and flexible. When successfully implemented, the course is designed to provide just-in-time learning through on-the-job-training, with the potential for teaching and learning to directly impact on practice.

[Method report 2007 of the Programme for National Disease Management Guidelines--background and content]. / Der Methodenreport 2007 des Nationalen Programms für VersorgungsLeitlinien - Hintergrund und Inhalt.

The Programme for National Disease Management Guidelines (German DM-CPG Programme) was established in 2002 by the German Medical Association (umbrella organisation of the German Chambers of Physicians) and joined by the Association of the Scientific Medical Societies (AWMF)--umbrella organisation of more than 150 professional societies--and by the National Association of Statutory Health Insurance Physicians (NASHIP) in 2003. The programme provides a conceptual basis for disease management, focussing on high priority healthcare topics and aiming at the implementation of best practice recommendations for prevention, acute care, rehabilitation and chronic care. It is organised by the German Agency for Quality in Medicine, a founding member of the Guidelines International Network G-I-N. The main objective of the German DM-CPG Programme is to establish consensus among the medical professions on evidence-based key recommendations covering all sectors of healthcare provision and facilitating the coordination of care for the individual patient through time and across interfaces. Within the last year DM-CPGs have been published for asthma, COPD, type 2 diabetes and coronary heart disease. In addition, experts from national patient self-help groups have been developing patient guidance based upon the recommendations for healthcare providers. The article describes background, methods and tools of the DM-CPG programme using the DM-CPG Method Report 2007.

[Evidence-based Medicine online for young doctors - a randomised controlled trial]. / Evidenzbasierte Medizin online zum ärztlichen Berufsstart- eine randomisiert-kontrollierte Studie.

INTRODUCTION: Evidence-based Medicine (EbM) was originally developed as a teaching tool for young doctors, but in Germany the last surveys among residents in 2009 and 2011 demonstrated that, across all topics, the largest deficits were seen in the field of EbM. One reason may be a deficit in customised offers for continuing medical education in EbM. In a randomised controlled trial with a wait-control design we investigated a possible gain in knowledge and the acceptance of an online course in EbM for first-year residents. METHODS: All first-year residents at the Hospital of the Goethe University in Frankfurt received the offer to voluntarily take part in an online EbM course. The tutored course consisted of five modules according to the five steps of EbM, each module being complemented by practical tasks. The participants were randomised via telephone to the course right away or after a three-month waiting period. The primary endpoint (i.e., knowledge) was tested via two sets of 13 multiple choice questions before and after the course and after 6 and 12 months. The participants were asked to subjectively evaluate the course by using an A-F grading system and to semiquantitatively assess its level of difficulty; they were also asked to evaluate the usefulness of its content in their clinical setting. RESULTS: 114 out of the 120 randomised participants took part. After 3 months the immediate intervention group (n=58) achieved a median of 10 (95 % confidence interval 10 to 11) correct answers following the course, whereas the waiting intervention group only received a median of 4 (95% confidence interval 4 to 5) correct answers after the three month waiting period (p ≤ 0.0001). The median gain in knowledge for both groups throughout the course was 5 correct answers (p ≤ 0.0001), and this proved to remain constant within a twelve month period. Six months after the course, this course was rated as clinically useful by 96.4 % of the participants, and 38.1% stated that they would volunteer again in further teaching activities. The course received a median grade of B. DISCUSSION AND CONCLUSIONS: A German online EbM course for first-year residents leads to a remarkable and sustainable gain in knowledge, is well marked, and its contents were regarded as clinically relevant. This tutored practical course is applicable to various settings and could provide an important contribution to EbM residency programs.

Conflicts of interest among authors of medical guidelines: an analysis of guidelines produced by German specialist societies.

BACKGROUND: Conflicts of interest can bias the recommendations of clinical guidelines. In 2010, the Association of Scientific Medical Societies in Germany (Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften, AWMF) revised its rules about how conflicts of interest in guidelines should be managed. METHODS: All S2 and S3 guidelines in the AWMF database that were created in the years 2009-2011 were independently examined by two reviewers each (TL, MG, SC, BW, LF, SS). Information on conflicts of interest was extracted and descriptively analyzed. The effects of the new AWMF rules were studied with a before-and-after comparison. RESULTS: 60 (20%) of the 297 guidelines studied contained explicit declarations of conflict of interest by their authors. 680 authors (49%) stated that they had financial relationships that constituted a conflict of interest; 86% declared conflicts arising from membership in specialty societies or professional associations. From 2009 to 2011, there was a substantial rise in the frequency of conflict-of-interest declarations in guidelines (8% of 256 guidelines that were created before the AWMF revised its rules in 2010 and 95% of 41 guidelines created afterward). The percentage of persons declaring financial conflicts of interest rose after the new rules were introduced, while the mode of documentation of conflict-of-interest evaluation and of any measures that might have been taken as a result remained unchanged. CONCLUSION: From 2011 onward, all conflict-of-interest declarations by guideline authors have been published in the AWMF database. There is no current standard for the evaluation and management of conflicts of interest in guideline-creating groups, and this situation urgently needs to be remedied.

[Quality indicators for National Disease Management Guidelines using the example of the National Disease Management Guideline for "Chronic Heart Failure"]. / Qualitätsindikatoren zu Nationalen VersorgungsLeitlinien (NVL) am Beispiel der NVL Herzinsuffizienz.

Together with an expert committee a structured approach to determining quality indicators for National Disease Management Guidelines has been developed. The key steps of this approach include: introducing guideline authors to the methodology at an early stage of the process of guideline development, pre-selecting recommendations of the guideline which are potentially measurable by means of quality indicators, assessing the potentially measurable quality indicators in written form using five criteria (including their importance for the health care system and clarity of definitions) and approving them in a formal consensus process. For lack of a database these quality indicators must be regarded as preliminary. For the National Disease Management Guideline "Chronic Heart Failure" nine rate-based indicators have been chosen. The indicators correspond to important strong recommendations (grade of recommendation: A) from the fields of diagnosis (two), general therapeutic strategy (two), specific treatment (three), clinical monitoring (one) and co-ordination of care (one). In a second step, the quality indicators have to be validated within a pilot project. The determination and assessment of the potential quality indicators have revealed room for improvement of guideline development. In particular, there is a need for more health care data and for specification of recommendations.

[Using routine data for quality of care assessments: a critical review, taking quality indicators for the "National Disease Management Guideline for Chronic Heart Failure" as an example]. / Nutzung von Routinedaten zur Einschätzung der Versorgungsqualität: Eine kritische Beurteilung am Beispiel von Qualitätsindikatoren für die "Nationale Versorgungsleitlinie Chronische Herzinsuffizienz"

In December 2009, the first version of the German Disease Management Guideline (DM-CPG) for chronic heart failure was completed, including a set of proposed quality indicators for heart failure. This article explores whether proposed indicators can be derived from data collected routinely in general practices. For this purpose, previous experiences and data from the research project CONTENT (CONTinuous morbidity registration Epidemiologic NeTwork) conducted under guidance of the Department of General Medicine and Health Services Research at the University of Heidelberg, Germany, were applied. The availability of numerators and denominators needed for calculating the four quality indicators for diagnosis and pharmacotherapy proposed in the DM-CPG was checked within so-called "routine data" from the existing dataset of the CONTENT project. Within the given context, routine data are defined as data that are periodically transmitted from health care providers to cost units within the health care system. A thorough assessment has revealed that within the given context only one indicator could be deduced from routine data collection. This was the indicator measuring the proportion of patients receiving beta receptor antagonists, compared to all patients with heart failure NYHA class II to IV. Indeed, this single indicator will only be computable if the NYHA grade of heart failure severity and the presence or absence of contraindications to beta receptor antagonist therapy are routinely collected and the data merged into a central database. Against the background of these results it is obvious that a fully developed, transsectoral concept for data collection and data transfer needs to be implemented.

[Gender: new methodological approaches in guideline development]. / Gender: Neue methodische Herausforderungen bei der Leitlinienentwicklung.

Gender and diversity have a strong impact on health and illness as evidenced by sex and gender differences in the onset and progression of diseases as well as in diagnosis, therapy, and therapeutic outcome. The number of sex/gender-specific studies in medicine has increased steadily in recent years, indicating sex (biological) and gender (social) differences in numerous diseases. Despite this evidence, however, sex/gender differences are rarely considered in medical practice or in health systems, suggesting a delay in transferring such research into evidence-based medical treatment. Similarly, quality improvement guidelines in medical care do not systematically integrate the sex/gender perspective. Against this backdrop, this paper seeks to enumerate the necessary components of a guideline development and evaluation process that systematically integrates sex/gender differences in addition to providing a sex/gender-based methodological approach. The latter is illustrated by a pilot study in which four international guidelines on depression were selected. The sex/gender appropriateness of these guidelines was analysed using two methods: first, sex/gender-relevant words were counted; and second, relevant sex/gender differences were summarised based on a systematic literature review and then compared with the information given in the guidelines. The findings of the pilot study revealed that although strong evidence exists on sex/gender differences in depression, such research was rarely implemented in the guidelines. Given the scope and potential of guidelines to improve the quality of health care, it is essential that they consider the crucial role of sex/gender differences. To date, sex/gender differences have been insufficiently addressed in guideline development and evaluation when they should be an integral component of the process.