[Educational material as part of risk minimisation]. / Schulungsmaterial zur Minimierung von Arzneimittelrisiken.

Educational material, for example in the form of information booklets, checklists, patient alert cards, therapeutic passports, emergency ID cards, or videos, is an important aid for the safe use of a medicinal product or drug and supplements the summary of product characteristics and package information. It is ordered, tested and approved by the competent national authorities, the Federal Institute for Drugs and Medical Devices (BfArM) and the Paul Ehrlich Institute (PEI), and made available by the respective marketing authorization holder and published on the websites of BfArM and PEI. Educational material is part of the marketing authorization of a medicinal product. Since 1 December 2016, officially approved educational material can be recognized by the blue-hand logo in Germany. There is currently specific educational material for 202 active substances with further recommendations on how to avoid or reduce risks for patients. Although educational material is one of the most common additional risk minimisation measures, little is known about its effectiveness, including related process and outcome indicators. Key elements as well as an overview of educational material are described.

[General practitioners' guideline for palliative care. A survey of guideline acceptance in quality circles of primary medical care]. / Hausärztliche Leitlinie "Palliativversorgung" : Ergebnisse einer Akzeptanzbefragung in Qualitätszirkeln der Hausarztzentrierten Versorgung.

PURPOSE: The implementation of the general practitioners' (GPs) guideline for palliative care released in 2007 with consent of the developing group was accompanied by an anonymous and voluntary survey designed to assess acceptance and feasibility of the recommendations. 60 quality circles of the GP-based care program in Hesse which are run by the PMV research group were used for guideline implementation. MATERIAL AND METHODS: The quality of the palliative care quality circle meeting itself was checked with a standardized questionnaire (feedback, n = 473 of 515 participating GPs). After several weeks, the follow-up questioning on acceptance of the corresponding guideline was performed (n = 391 of 440 attendees) using twelve items to evaluate the guideline recommendations. The closed questions were appraised employing a Likert scale and the open questions after classifying the free text in categories. RESULTS: 96% of the respondents considered palliative medicine to be important in daily routine. The majority agreed with form and content of this CME meeting (feedback, response rate 91%). The complexity, handling, and practical relevance of the guideline were evaluated positively (response rate 88%). 82% of GPs reported that they would recommend the guideline to colleagues. Specific, practical guideline recommendations on (non)pharmacological strategies in treating dyspnea, on reducing xerostomia and on comedication in the case of opioid treatment were confirmed by 80-94% of the participants, and 75-92% rated these recommendations as practical. CONCLUSION: The relevance of palliative care in daily routine was shown by the responses evaluating the quality circle session. The grade of acceptance of the guideline is comparable to the other GPs' guidelines with focus on pharmacotherapy. 10-13% of the respondents were not able to judge the relevance nor the practicability of selected recommendations. Future implementation should therefore consider attitude and experience with palliative care. To date, the questionnaires have not been designed to evaluate individual adherence to palliative care guideline.

['To read' does not imply 'to act upon': indicators of the acceptance of general practice guidelines. Results of a survey among quality circles of general practitioner centred care (Hausarztzentrierte Versorgung; HZV)]. / Gelesen ist noch nicht getan: Hinweise zur Akzeptanz von hausärztlichen Leitlinien. Eine Befragung in Zirkeln der Hausarztzentrierten Versorgung (HZV).

CONTEXT: Successful guideline implementation requires that the authors get feedback from target groups on the general acceptance of a guideline and the barriers to its implementation. The Guideline Group of General Practitioners (GPs) in Hesse continually surveyed participants of quality circles on pharmacotherapy who discussed these GP specific guidelines together with an analysis of their prescription behaviour. MATERIAL AND METHODS: Written survey of six general practice guidelines conducted among the members of quality circles in Hesse during 2006 and 2007. The response rate ranged from 69% (n=268; guideline on 'GP Communication Skills') and 80% (n=374; Guideline on 'Chronic Heart Failure'). The questionnaire focused on both general acceptance and the relevance and practicability of individual recommendations. RESULTS: With pharmacotherapeutic guidelines, between 75% (guideline for dyslipidaemia) and 86% (guideline for stable angina) would be recommended by the respondent GPs to colleagues. High practice relevance was attributed to the communication skills guideline by 70% of the GPs, but only about 50% would recommend it. Three quarters of the GP rated 18 out of 22 selected recommendations as being relevant to therapeutic quality assurance, and 11 of these recommendations as being practicable. Non-medical procedures requiring communication resources and time input as well as motivated patients were more often assessed as being more difficult to implement. DISCUSSION AND CONCLUSION: A written survey is a suitable tool for gaining insight into the acceptance of diagnostic and therapeutic strategies and for investigating reasons for the refusal of or the barriers to implementation. Recommendations that are poorly accepted and less likely to be implemented as well as possible barriers should be discussed within the guideline group and during circle sessions in order to modify the recommendation and/or develop aids to assist with its transfer into everyday practice.

[The German program for disease management guidelines. Background, methods, and development process]. / Nationale Versorgungsleitlinien von BAK, AWMF und KBV : Hintergrund, Methodik und Instrumente.

The Program for National Disease Management Guidelines (German DM-CPG Program) was established in 2002 by the German Medical Association (umbrella organization of the German Chambers of Physicians) and joined by the Association of the Scientific Medical Societies (AWMF; umbrella organization of more than 150 professional societies) and by the National Association of Statutory Health Insurance Physicians (NASHIP) in 2003. The program provides a conceptual basis for disease management, focusing on high-priority health-care topics and aiming at the implementation of best practice recommendations for prevention, acute care, rehabilitation and chronic care. It is organized 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 Program 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 interfaces. Within the last year, DM-CPGs have been published for asthma, chronic obstructive pulmonary disease, 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 health-care providers. The article describes background, methods, and tools of the DM-CPG Program, and is the first of a publication series dealing with innovative recommendations and aspects of the program.

[Clinical practice guidelines in Germany, 1994 to 2004. From guideline methodology towards guideline implementation]. / Medizinische Leitlinien in Deutschland, 1994 bis 2004. Von der Leitlinienmethodik zur Leitlinienimplementierung.

The role of clinical practice guidelines (CPG) as a tool for continuous medical education (CME), and quality management in health care is now widely accepted in Germany. Since the 90ies, the physicians' professional associations as well as health care authorities and parliament have been introducing several incentives and regulations in order to promote the use of evidence based CPG. In the past German CPG agencies have been focussing their work on developing and optimising methodological CPG standards. Future CPG activities should address much more other key factors for the success of CPGs, such as medical relevance, practicability, effective dissemination, and implementation. The article describes the process of guideline adaptation by regional physician audit groups as a tool for CPG implementation.