[Decisions of the German Federal Joint Committee in situations with insufficient data : Decision-making options for new diagnostic and treatment methods]. / Entscheidungen des Gemeinsamen Bundesausschusses bei unzureichender Datenlage : Entscheidungsoptionen bei neuen Untersuchungs- und Behandlungsmethoden.

BACKGROUND: In accordance with legal requirements, the Federal Joint Committee (German: Gemeinsamer Bundesausschuss, G­BA) decides based on the best available evidence which new diagnostic and treatment methods are reimbursed by statutory health insurance. If the benefit is proven with sufficient certainty, statutory health insurance providers pay for the new method, otherwise a trial study must be conducted. OBJECTIVES: To present the G­BA's decision-making options even in the case of insufficient evidence in the field of urology. MATERIALS AND METHODS: A document search was conducted on the homepage of the G­BA for the decisions about method evaluation and quality assurance in the field of urology of the last 10 years. The respective decisions are presented in the light of the decision options available in each case. RESULTS: Using the example of the debate on low-dose rate brachytherapy for localised prostate cancer, the years-long, ultimately futile, effort to increase the evidence base for an innovative method is presented. CONCLUSION: Compared to the development of guidelines, for example, the G­BA can only make dichotomous yes/no decisions and has to accept the often insufficient evidence situation, or (has to) try to increase the evidence base by initiating its own study. The latter is particularly difficult when specific methods are already established in routine care. A particular challenge is posed by new, especially invasive methods in the hospital sector, which has to be evaluated (benefit assessment) and, if necessary, tested by the G­BA with a trial study. To what extent this will succeed in the future is not yet foreseeable.

[Evidence-based therapy of depression: S3 guidelines on unipolar depression]. / Evidenzbasierte Therapie der Depression: Die S3-Leitlinie unipolare Depression.

Unipolar depressive disorders are among the most frequent reasons for utilizing the health care system. Although efficacious treatments are available and further advances have recently been made there is still a need for improving diagnostic and therapeutic procedures. Alignment of treatment on evidence-based treatment guidelines establishes an essential mainstay. The new S3 and National Health Care guidelines on unipolar depression, the compilation of which was coordinated by the German Society of Psychiatry, Psychotherapy and Neurology (DGPPN) and which were approved by 29 scientific and professional associations, is the ambitious effort to present state of the art evidence and clinical consensus for the treatment of depression. For pharmacotherapy of depression differentiated recommendations can be given, also separate from and in addition to psychotherapy.

Grading quality of evidence and strength of recommendations in clinical practice guidelines. Part 1 of 3. An overview of the GRADE approach and grading quality of evidence about interventions.

The GRADE (Grades of Recommendation, Assessment, Development, and Evaluation) approach provides guidance to grading the quality of underlying evidence and the strength of recommendations in health care. The GRADE system's conceptual underpinnings allow for a detailed stepwise process that defines what role the quality of the available evidence plays in the development of health care recommendations. The merit of GRADE is not that it eliminates judgments or disagreements about evidence and recommendations, but rather that it makes them transparent. This first article in a three-part series describes the GRADE framework in relation to grading the quality of evidence about interventions based on examples from the field of allergy and asthma. In the GRADE system, the quality of evidence reflects the extent to which a guideline panel's confidence in an estimate of the effect is adequate to support a particular recommendation. The system classifies quality of evidence as high, moderate, low, or very low according to factors that include the study methodology, consistency and precision of the results, and directness of the evidence.

[Rare diseases in professional health care]. / Seltene Erkrankungen in professionellen Versorgungssystemen.

The treatment of patients with rare diseases is a challenge for all those involved, since it frequently requires decisions on the basis of uncertainty. Uncertainty is of particular importance for the risk/benefit assessment of therapeutic interventions which "normally" imposes extensive requirements on the quality of evidence through explicit specifications. These requirements concern the assessment of potential benefit within the framework of statutory health insurance as well as the proof of efficacy and safety within the framework of pharmaceutical law. As a consequence drugs prescribed to patients with rare diseases are often applied outside approved indications, with immediate effects regarding reimbursement and drug safety. Another concern is that patients with rare diseases may be deprived of potential therapies as the requirements for clinical evidence are not fulfilled because of the rareness of the disease. The Federal Social Court takes this into consideration, but at the same time imposes strict requirements for the proof of efficacy. In contrast, the procedure of the Federal Joint Committee appears more adequate for the special requirements of rare diseases. Using some decisions of the Federal Social Court and of the Federal Court of Justice as examples, it is discussed how the uncertainty associated with the treatment of patients with rare diseases is dealt with and how this might be improved are discussed.

[Development of national guidelines for depression]. / Entwicklung der S3- und Nationalen Versorgungs-Leitlinie Depression.

Depressive disorders rank among the most frequent causes of consultation and diseases in health care. Although they are treatable, there is further need to optimize diagnostics and therapy, despite sizable progress in recent years. The implementation of evidence- and consensus-based guidelines is an appropriate measure to improve care for depressive patients. An evidence-based guideline for depression is currently being developed for Germany. In order to ensure its acceptance and a wide dissemination, this guideline will be adopted in consensus by all relevant health care providers in this field. According to this, it is a future challenge to anchor guideline-based diagnostics and treatment in routine care.

[The National Programme for Disease Management Guidelines. Goals, contents, patient involvement]. / Das Programm für Nationale VersorgungsLeitlinien von BAK, AWMF und KBV : Ziele, Inhalte, Patientenbeteiligung.

The Programme for National Disease Management Guidelines (German DM-CPG Programme) aims at the implementation of best practice recommendations for prevention, acute care, rehabilitation and chronic care. The programme, focussing on high priority healthcare topics, has been sponsored since 2003 by the German Medical Association (BAEK), the Association of the Scientific Medical Societies (AWMF), and by the National Association of Statutory Health Insurance Physicians (KBV). 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 programme is to establish consensus of the medical professions on evidence-based key recommendations covering all sectors of health care provision and facilitating the coordination of care for the individual patient through time and across disciplines. Within this framework experts from national patient self-help groups have been developing patient guidance based upon the recommendations for healthcare providers. The article describes goals, topics and selected contents of the DM-CPG programme - using asthma as an example.

An e-learning platform for guideline implementation--evidence- and case-based knowledge translation via the Internet.

OBJECTIVES: Effective knowledge translation in medicine is an essential element of a modern health care system. Evidence-based clinical practice guidelines (CPGs) are considered relevant instruments for the transfer of knowledge into clinical practice. To improve this transfer we have created Internet-based continuing medical education (CME) modules and online case-based learning objects. METHODS: Building upon existing CPGs, an e-learning platform including a multi-step review process was developed to generate CME modules. These CME modules were presented through a modified content management system (CMS) that fulfils specific requirements of CME. An online questionnaire using a four-point Likert scale was designed to receive mandatory feedback from participating physicians. In the second step of development, case-based learning objects were added to the CMS. RESULTS: Existing clinical practice guidelines allowed a rapid development of CME modules specific to individual clinical indications. The modified CMS proved to be technically stable but also resource-intensive. 3105 physicians registered and used the platform between June 2003 and April 2005. 95% of the physicians expressed positive feedback in an evaluation questionnaire; only 35% of physicians actually used the corresponding CPGs in practice. Suggestions from the CME users led to the development of interactive medical case-based learning objects related to the main topics of the CPGs. CONCLUSIONS: To support the implementation of CPGs, an Internet platform for CME including case-based learning objects and examination tests was developed. An interactive online CME platform can support active learning and may establish an additional stimulus for knowledge translation into daily medical practice.

[Evidence based guidelines and clinical pathways: complementation or contradiction?]. / Evidenzbasierte Leitlinien und Behandlungspfade: Ergänzung oder Widerspruch?

Even methodological sound guidelines will only achieve their goals when the recommendations are transferred into practice. Guideline introduction and dissemination must therefore be accompanied by active implementation measures. For inpatient care clinical pathways can serve as tools, especially taking advantage of their sequential character. Complementary evidence based guidelines can serve as an optimal source of systematically appraised evidence in developing clinical pathways. Considering them is of major help to assure that the content of clinical pathways is in accordance with evidence. The article highlights methodological requirements in guideline and pathway development and gives prospects on how both tools can be used together.

[Online continuing medical education based on national disease management guidelines. The e-learning platform leitlinien-wissen.de]. / Online-Fortbildung auf der Basis nationaler Versorgungsleitlinien : Die Fortbildungsplattform leitlinien-wissen.de.

Effective translation of relevant knowledge into clinical practice is essential for modern health care systems. National Disease Management Guidelines (NDMG) are considered relevant instruments to support this transfer. To implement NDMG Internet-based continuing medical education (CME), modules and online case-based learning objects were designed and published. To ensure high quality the contents are based on NDMG and subjected to multi-step review processes. Presentation on the web was realized through a modified content management system. To obtain a CME certificate, completing an online questionnaire using a four-point Likert scale was mandatory. Between June 2003 and April 2005, 3,105 physicians were registered and used the platform: 95% of the physicians expressed positive feedback in the evaluation questionnaire, and 35% actually used the corresponding NDMG in practice. This prompted the development of interactive medical case-based learning objects as a second learning pathway. An Internet platform for CME including case-based learning objects can be a helpful tool to assure the provision of scientific knowledge for patient care.

[Clinical guidelines. What do doctors and patients get from them]. / Leitlinien. Was haben Arzte und Patienten davon.

Now more than ever physicians need effective management of the constantly increasing flood of medical information. The authors discuss possibilities for developing clinical guidelines as a core element of this information management and the requirements of these possibilities. The development of clinical guidelines is a process also suitable for involving patient and consumer expertise in health care. Models of involving patients are described and how these processes can build an important base for shared decision making of physicians and patients.

[Value of inpatient care in rheumatoid arthritis-an evidence based report]. / Nutzen der stationären Therapie in der Versorgung von Patienten mit Rheumatoider Arthritis. Ein Evidenzbericht.

Our aim was to analyze the existing body of evidence about inpatient care of patients suffering from rheumatoid arthritis (RA). The report was induced by the executive board of the German Society of Rheumatology which assigned the "Oliver-Sangha committee" to dissect and point out the tasks of inpatient care during the next few years. A systemic search of the literature was performed covering the years 1966 to 2001. A total of 16 studies were selected and thoroughly appraised in a systematic way. Four randomized controlled trials addressing the question could be identified. All of them included only patients in a clinical condition allowing outpatient care as well. Two studies indicate some advantage of inpatient care in comparison to outpatient treatment. Two studies, both equivalence studies from design, reveal that RA patients do not generally experience additional benefit from hospitalization. Consideration of two additional cohort studies demonstrates the increased need of inpatient care in RA patients. None of the studies was derived from the German health care system. Emergency cases were not the subject of any of these trials. General statements about the value of inpatient care of RA patients can not be drawn from the analyzed studies. The committee makes suggestions for future investigations that may help to answer this important question considering the special circumstances of the German health care system.

[Evidence-based guidelines--what is the present situation?]. / Evidenzbasierte Leitlinien--Wo stehen wir heute?

Guidelines have proven to be an important tool for improving quality of health care. Evidence-based guidelines are particularly well accepted and have a high degree of credibility based on the transparent process of their development and the explicit use of clinical patient-oriented research, on which the recommendations are based. The goal of the guidelines "Management of early rheumatoid arthritis", currently developed by an interdisciplinary working group, is to minimize out existing deficiencies in the provision of health care.