Guidelines International Network: toward international standards for clinical practice guidelines.

Guideline development processes vary substantially, and many guidelines do not meet basic quality criteria. Standards for guideline development can help organizations ensure that recommendations are evidence-based and can help users identify high-quality guidelines. Such organizations as the U.S. Institute of Medicine and the United Kingdom's National Institute for Health and Clinical Excellence have developed recommendations to define trustworthy guidelines within their locales. Many groups charged with guideline development find the lengthy list of standards developed by such organizations to be aspirational but infeasible to follow in entirety. Founded in 2002, the Guidelines International Network (G-I-N) is a network of guideline developers that includes 93 organizations and 89 individual members representing 46 countries. The G-I-N board of trustees recognized the importance of guideline development processes that are both rigorous and feasible even for modestly funded groups to implement and initiated an effort toward consensus about minimum standards for high-quality guidelines. In contrast to other existing standards for guideline development at national or local levels, the key components proposed by G-I-N will represent the consensus of an international, multidisciplinary group of active guideline developers. This article presents G-I-N's proposed set of key components for guideline development. These key components address panel composition, decision-making process, conflicts of interest, guideline objective, development methods, evidence review, basis of recommendations, ratings of evidence and recommendations, guideline review, updating processes, and funding. It is hoped that this article promotes discussion and eventual agreement on a set of international standards for guideline development.

[Clinical practice guidelines and knowledge management in healthcare]. / Il ruolo delle linee-guida per il knowledge management in medicina.

Clinical practice guidelines are key tools for the translation of scientific evidence into everyday patient care. Therefore guidelines can act as cornerstones of evidence based knowledge management in healthcare, if they are trustworthy, and its recommendations are not biased by authors' conflict of interests. Good medical guidelines should be disseminated by means of virtual (digital/electronic) health libraries - together with implementation tools in context, such as guideline based algorithms, check lists, patient information, a.s.f. The article presents evidence based medical knowledge management using the German experiences as an example. It discusses future steps establishing evidence based health care by means of combining patient data, evidence from medical science and patient care routine, together with feedback systems for healthcare providers.

Simultaneous development of guidelines and quality indicators -- how do guideline groups act? A worldwide survey.

PURPOSE: The purpose of this paper is to examine the question of how official bodies, health care organisations, and professional associations deal with the absence of a methodological gold standard for the simultaneous development of clinical practice guidelines and quality indicators, what procedures they use and what they feel are major strengths and limitations of their methods. DESIGN/METHODOLOGY/APPROACH: The authors conducted a web-based survey among 90 organisational members of the Guidelines International Network (G-I-N) representing 34 countries from Africa, America, Asia, Europe and Oceania. All organisational G-I-N members were invited to participate in the survey by following a link provided in the invitation e-mail. FINDINGS: The responses of 24 organisations were included in the final analysis. The results indicate a broad variability in the approaches and methods used to develop quality indicators and guidelines simultaneously. The answers of the participants indicated a lack of formal procedures for the simultaneous development. Formal procedures exist in only about half of the participating organisations. In addition, piloting or evaluation of the procedures is almost completely missing. Significantly, respondents mainly reported that the procedure used in their organisation "could certainly be more rigorous". Besides various strengths, participants reported a considerable number of limitations of the development processes they use. ORIGINALITY/VALUE: This survey among G-I-N members -- despite limitations -- gives helpful insights in the state of the simultaneous development of quality indicators and clinical practice guidelines and underlines the need for future activities in methodological standard development and quality improvement of these processes.

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.

[Patient involvement in clinical practice guidelines is poor after 12 years of German guideline standards: A review of guideline methodologies]. / Unzureichende Patientenbeteiligung an der Leitlinienentwicklung in Deutschland ­ eine Analyse der von der AWMF verbreiteten ärztlichen Empfehlungen.

BACKGROUND: As early as 1997, the German Guideline for Guidelines laid down patient participation in guideline development as the cornerstone of good, trustworthy medical guidelines. The German Guideline Assessment Tool (DELBI) published in 2005 requires patients or relatives to be involved in the development of medical guidelines. Ideally, this should be effected through membership in the author group. The Association of the Scientific Medical Societies in Germany (AWMF) recommends this approach for the so-called S3 guidelines (systematically developed guidelines) and S2k guidelines (consensus-based guidelines). The present study addresses the question of whether and to what extent German guideline publishers adhere to these principles of patient orientation. METHODS: For this purpose, a descriptive analysis of the guidelines valid at the beginning of November 2017 was carried out. All guidelines (n=520) of the AWMF member societies were assessed. We evaluated S3- and S2k guidelines only, as these are of particular importance for patient involvement due to the requirement of an interdisciplinary guideline group. Data were reported on the involvement of patients (as co-authors of medical guidelines) and on the existence of guidance documents addressing patients and the public (so-called patient information and patient guidelines). RESULTS: Regarding the 105 (165) S3 (S2k) guidelines, we found evidence on patient involvement in guideline development in 99 (134) cases (94 % of S3 / 81 % of S2k guidelines). In 61 (87) guidelines, authors had contributed to the authors group (58 % / 53 %) and 59 (80) guidelines with voting rights (56 % / 48 %). For 50 (15) S3 (S2k) guidelines (48 % / 9 %), the guideline report provided information on the existence or planned development of guidance documents for patients and the public (patient guidelines or patient information). Guidance-related patient information was available on the internet for only 37 (2) S3 (S2k) guidelines (35 % / 2 %). CONCLUSION: A substantial gap remains between patient / public involvement standards for guideline development and practice in Germany, even 12 years after the publication of national guideline standards. This is a missed opportunity since guidelines without adequate participation of those affected by the recommendations have a problem of legitimacy and transparency. Only guidelines where patients were involved in all voting processes during development build and strengthen trust between patients and the medical profession. And only those who present the rationale for medical recommendations in a generally understandable and comprehensible manner let affected individuals make individual decisions.

[Participation of patients in the program for national disease management guidelines--current state and implications]. / Patientenbeteiligung am Programm für Nationale VersorgungsLeitlinien - Stand und Konsequenzen.

Patient involvement has been implemented in the Program for National Disease Management Guidelines since 2005. Currently patient/consumer participation is being incorporated in terms of patients' comments of consultation papers on National Disease Management Guidelines (NDMG) and in the development of NDMG-based patient guidelines (PG). The editorial activities in patient guideline development from the beginnings to its publication are conducted in close cooperation with the patient representatives appointed by the Patient Forum. Between June 2005 and September 2006, three NDMG and three patient guidelines on asthma, chronic obstructive pulmonary disease (COPD) and chronic coronary artery disease (CAD) were produced by including patients in the guideline development process. The information provided in these guidelines is freely accessible at http://www.versorgungsleitlinien.de. The present contribution focuses on the development of patient guidelines. It describes the current state of patient involvement and joint work and indicates the implications that can be derived from patient participation in the NDMG Program. Accompanying the involvement procedures, experiences resulting from previous NDMG and PG development activities are continuously investigated for the possibility of further methodological development of consumer participation by a work group of the Patient Forum in coordination with the patient organizations involved. In particular, the procedures resulting from more intensive patient participation in patient guideline development are to be examined as to their relevance for the expansion of patient involvement in NDMG development.

[The German program for disease management guidelines. Results and perspectives]. / Nationale VersorgungsLeitlinien von BAK, AWMF und KBV. Eine Zwischenbilanz.

The Program for National Disease Management Guidelines (German DM-CPG Program) is a joint initiative of the German Medical Association (umbrella organization of the German Chambers of Physicians), the Association of the Scientific Medical Societies (AWMF), and of the National Association of Statutory Health Insurance Physicians (NASHIP). The program aims at developing, implementing and continuously updating best-practice recommendations for countrywide and regional disease management programs in Germany. Since 2003 twelve national guidelines (topics: asthma, chronic obstructive pulmonary disease, HI (Chronic heart failure), CVD (Chronic coronary heart disease) back pain, depression, several aspects of diabetes) have been produced by use of a standardized procedure in accordance with internationally consented methodologies. For countrywide dissemination and implementation the program uses a wide range of specialist journals, continuous medical education and quality management programs. So far, 36 out of 150 national scientific medical associations, four allied health profession organizations, and twelve national consumer organizations have been participating in the DM-CPG Program. Studies to evaluate the program's effects on health-care providers' behavior and patients' outcomes are under way.

[The German Program for Disease Management Guidelines: COPD Guideline 2006. Short review]. / Die Nationale VersorgungsLeitlinie COPD: Ein zusammenfassender Bericht.

In Germany, the first national consensus on evidence-based recommendations for COPD prevention and disease management was reached in spring 2006. After a development period of 9 months, the National Disease Management Guideline COPD was finalized by nominal group process under the authorship of the scientific societies for pneumology (DGP and Atemwegsliga), general internal medicine (DGIM), family medicine (DEGAM), and the Drug Commission of the German Medical Association (AKDAE). The recommendations' main sources are the NICE COPD Guideline 2004, the GOLD Recommendations as well as existing German guidelines and reviews of recent scientific evidence. The article gives an overview on authors, sources, and key recommendations of the German National Disease Management Guideline COPD 2006 (www.copd.versorgungsleitlinien.de).

[The German program for disease management guidelines--implementation with pathways and quality management]. / Nationale VersorgungsLeitlinien--Nutzung im Qualitätsmanagement unter besonderer Berücksichtigung von Klinischen Behandlungspfaden und Regionalen Leitlinien.

In Germany, physicians enrolled in disease management programs are legally obliged to follow evidence-based clinical practice guidelines. That is why a Program for National Disease Management Guidelines (German DM-CPG Program) was established in 2002 aiming at implementation of best-practice evidence-based recommendations for nationwide as well as regional disease management programs. Against this background the article reviews programs, methods and tools for implementing DM-CPGs via clinical pathways as well as regional guidelines for outpatient care. Special reference is given to the institutionalized program of adapting DM-CPGs for regional use by primary-care physicians in the State of Hesse.

[The German program for disease management guidelines: type 2 diabetes--diabetic retinopathy/maculopathy guideline 2006. Short review]. / Die Nationale VersorgungsLeitlinie Typ-2-Diabetes--Netzhautkomplikationen. Ein zusammenfassender Bericht.

In Germany, the first national consensus between six medical scientific associations on evidence-based recommendations for prevention and therapy of retinopathy/maculopathy in type 2 diabetes was reached in fall 2006. The recommendations' main sources are the NICE Retinopathy Guideline 2002, and existing German guidelines and reviews of recent scientific evidence. The article gives an overview on authors, sources, and key recommendations of the German National Disease Management Guideline Type 2 Diabetes-Retinopathy/Maculopathy 2006 (www.diabetes.versorgungsleitlinien.de).

[The German Program for Disease Management Guidelines Type 2 Diabetes - Diabetic Foot Guideline 2006. Short review]. / Die Nationale VersorgungsLeitlinie Typ-2-Diabetes - Fusskomplikationen. Ein zusammenfassender Bericht.

In Germany, the first national consensus between 14 medical scientific associations on evidence-based recommendations for prevention and therapy of foot problems in type 2 diabetes was reached in fall 2006. The recommendations' main sources are the NICE Guideline 2003 on foot problems in type 2 diabetes, as well as existing German guidelines and reviews of recent scientific evidence. The article gives an overview on authors, sources, and key recommendations of the German National Disease Management Guideline Type 2 Diabetes - Diabetic Foot 2006 (www.diabetes.versorgungsleitlinien.de).

[Shared decision-making based on equal information. Patient guidelines as a tool for patient counseling]. / Auf einheitlicher Basis entscheiden: die Rolle von NVL-basierten PatientenLeitlinien.

In discussions on the quality of cross-sectorial health-care services high importance is attributed to patient education and patient counseling, with guideline-based patient information being considered a crucial tool. Guideline-based patient information is supposed to serve patients as a decision-making basis and, in addition, to also support the implementation of the guidelines themselves. The article highlights how patient guidelines for National Disease Management Guidelines in Germany--within the scope of patient education and patient counseling--may provide a uniform information platform for physicians and patients aiming to promote shared decision-making. The authors will also address the issue which contents should be included in patient guidelines in order to meet these requirements and which measures are required to review their quality. The present paper continues the series of articles on the Program for German National Disease Management Guidelines.

[The German program for disease management guidelines: evaluation by use of quality indicators]. / Nationale VersorgungsLeitlinien--Evaluation durch Qualitätsindikatoren.

The Program for National Disease Management Guidelines (German DM-CPG Program) in Germany aims at the implementation of best-practice recommendations for prevention, acute care, rehabilitation and chronic care in the setting of disease management programs and integrated health-care systems. Like other guidelines, DM-CPG need to be assessed regarding their influence on structures, processes and outcomes of care. However, quality assessment in integrated health-care systems is challenging. On the one hand, a multitude of potential domains for measurement, actors and perspectives need to be considered. On the other hand, measures need to be identified that assess the function of the diagnostic and therapeutic chain in terms of cooperation and coordination of care. The article reviews methods and use of quality indicators in the context of the German DM-CPG Program.

[The German Disease Management Guideline Asthma: methods and development process]. / Nationale VersorgungsLeitlinie Asthma: Methodik und Entwicklungsprozess.

The German National Program for Disease Management Guidelines, which is being operated under the auspices of the German Medical Association (GMA), the Association of the Scientific Medical Societies (AWMF) and the National Association of Statutory Health Insurance Physicians (NASHIP), provides a conceptual basis for the disease management of prioritized healthcare aspects. The main objective of the program is to establish consensus of the medical professions on 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 scope of this program, the Scientific Medical Societies concerned with the prevention, diagnosis, treatment and rehabilitation of asthma in children, adolescents and adults have reached consensus on the core contents for a National Disease Management Guideline for Asthma. This consensus was reached by applying formal techniques and on the basis of the adaptation of recommendations from existing guidelines with high quality standards in methodology and reporting, and information from evidence reports.

[National Disease Management Guideline for Asthma: recommendations and evidence for "asthma prevention" issues]. / Nationale VersorgungsLeitlinie Asthma: Empfehlungen und Evidenz zum Thema "Asthma-Prävention".

The National Disease Management Program (NDM Program) represents the basic content of structured, cross-sectoral healthcare. In particular, the NDM Program is directed towards coordinating different disciplines and areas of healthcare. The recommendations are developed through interdisciplinary consensus of the scientific medical societies on the basis of the best available evidence. Within this scope the scientific medical societies concerned with the prevention, diagnosis, therapy and rehabilitation of asthma consented upon a National Disease Management Guideline for Asthma in 2005. Among other things, the following cornerstones of asthma prevention were agreed upon: Breastfeeding and non-smoking were suggested as primary prevention measures for (expectant) parents. With respect to secondary prevention, recommendations have been made for allergen avoidance, active/passive smoking and immunotherapy. Regarding tertiary prevention, position statements on vaccination and specific immunotherapy are developed. The present paper presents both the original texts of the recommendations and the evidence underlying them.

[The German Program for Disease Management Guidelines: CHD Guideline 2006. Short review]. / Die Nationale VersorgungsLeitlinie KHK 2006: Ein zusammenfassender Bericht.

In Germany, the first national consensus on evidence-based recommendations for disease management in patients with chronic coronary heart disease was reached in summer 2006. After a development period of 4 years, the National Disease Management Guideline Chronic Coronary Heart Disease was finalized by nominal group process under the authorship of the scientific associations for cardiac rehabilitation (DGPR), cardiac surgery (DGTHG), cardiology (DGK), general internal medicine (DGIM), family medicine (DEGAM), and the Drug Commission of the German Medical Association (AKDAE). The recommendations' main sources are the ACC/AHA guidelines 2002 updates as well as existing German guidelines and reviews of recent scientific evidence. The article gives an overview on authors, sources, and key recommendations of the German National Disease Management Guideline Chronic Coronary Heart Disease 2006 (www.khk.versorgungsleitlinie.de).

[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.

[Conflict of interest in continuing medical education - Studies on certified CME courses]. / Interessenkonflikte in der ärztlichen Fortbildung - Untersuchungen an zertifizierten Online-Fortbildungsangeboten.

OBJECTIVES: Although the problem of conflict of interest in medical education is discussed intensively, few valid data have been published on how to deal with the form, content, funding, sponsorship, and the influence of economic interests in continuing medical education (CME). Against this background, we carried out an analysis of data which had been documented for the purpose of certification by a German Medical Association. A central aim of the study was to obtain evidence of possible influences of economic interests on continuing medical education. Furthermore, strategies for quality assurance of CME contents and their implementation were to be examined. METHODS: We analyzed all registration data for courses certified in the category D ("structured interactive CME via print media, online media and audiovisual media") by the Bavarian Chamber of Physicians in 2012. To measure the effects of conflict of interest, relationships between topics of training and variables relating to the alleged self-interest of the organizer/sponsor (for example, drug sales in a group of physicians) were statistically verified. These data were taken from the Bavarian Medical Statistics 2012 and the GKV-Arzneimittelschnellinformation. RESULTS: In 2012, a total of 734 CME course offerings have been submitted for 51 medical specialties by 30 course suppliers in the Bavarian Medical Association. To ensure the neutrality of interests of the CME courses the course suppliers signed a cooperation treaty ensuring their compliance with defined behavior towards the Bavarian Medical Association concerning sponsorship. The correlation between course topics and drug data suggests that course suppliers tend to submit topics that are economically attractive to them. There was a significant correlation between the number of CME courses in a specific field and the sales from drug prescriptions issued by physicians in the respective field. CONCLUSIONS: The results show that neutrality of interests regarding continuing medical education is difficult to achieve under the current framework for the organization, certification, and especially the funding of CME events in Germany. The cooperation agreement between the Bavarian Medical Association and training applicants is taken as an example of how legal certainty can be ensured. Based on the findings described below, suggestions and strategies to strengthen assessment expertise of course participants have been developed and elaborated.

[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.

[Short information leaflets for patients - a service offered to physicians: Early implementation experiences]. / Kurzinformationen für Patienten (KiP) als Service-Angebot für Ärztinnen und Ärzte - erste Erfahrungen mit der Implementierung.

Since 2010, the German Agency for Quality in Medicine has developed so-called short information leaflets for patients that are specifically designed for use in doctor-patient encounters. Physicians, patient representatives and communication specialists were involved in the development of this format. Their implementation aims at enhancing awareness and dissemination of these leaflets amongst the members of the self-governing bodies and other multipliers (like medical specialty societies, patient organisations, other bodies and institutions of the healthcare system). This paper describes the first implementation experiences on the basis of internally collected data on the involvement of multipliers, availability and assessment of their relevance. A first analysis shows that the short information leaflets are broadly available amongst the self-governing bodies and that they are considered to be of high relevance. Due to the direct involvement of the members of specialty societies and patient organisations and other experts, short information leaflets are also gaining acceptance outside the self-governing system. This is emphasised by the rising number of requests to reprint or cite or use the leaflets. Consistency with evidence-based treatment recommendations promotes acceptance of these leaflets among physicians.