Günter Ollenschläger

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.

Nationale Versorgungsleitlinien von BÄK, AWMF und KBV

ZusammenfassungDas Programm für Nationale Versorgungsleitlinien (NVL-Programm) ist eine im Jahr 2002 von der Bundesärztekammer (BÄK) gestartete Initiative zur Förderung von Qualität und Transparenz in der strukturierten medizinischen Versorgung (Disease Management). Das Programm wird seit 2003 gemeinsam von BÄK, Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften (AWMF) und Kassenärztlicher Bundesvereinigung (KBV) verantwortet und durch das Ärztliche Zentrum für Qualität in der Medizin (ÄZQ) koordiniert. Es zielt auf die Entwicklung und Implementierung von Leitlinien für ausgesuchte Erkrankungen hoher Prävalenz unter Berücksichtigung der Methoden der evidenzbasierten Medizin, an denen verschiedene Disziplinen und Berufsgruppen in mehreren Versorgungsbereichen (primäre Prävention, Früherkennung, Kuration und Rehabilitation) beteiligt sind. Im Jahr 2005 haben die mit den Themenbereichen Asthma, chronisch-obstruktive Lungenerkrankung, koronare Herzkrankheit sowie Typ-2-Diabetes befassten Fachgesellschaften evidenzbasierte NVL konsentiert. Ergänzend dazu entwickelten Experten der Patientenselbsthilfe Patientenleitlinien auf der Grundlage der erstellten Versorgungsleitlinien.Der vorliegende Beitrag beschreibt Hintergrund, Methoden und Instrumente des NVL-Programms und ist erster Teil einer Serie, in der die wichtigsten, klinisch relevanten Empfehlungen zu den Themenbereichen des Programms beschrieben werden.AbstractThe 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.

Nationale VersorgungsLeitlinien – Nutzung im Qualitätsmanagement unter besonderer Berücksichtigung von Klinischen Behandlungspfaden und Regionalen Leitlinien

ZusammenfassungLeitlinien sind eines der wichtigsten Instrumente des Qualitätsmanagements. Dabei ist die Integration von Leitlinien in Qualitätsmanagementprogramme die effektivste Leitlinien-Implementierungsmaßnahme. Seit kurzem ist die Berücksichtigung evidenzbasierter Leitlinien in vertragsärztlichen Versorgungsprogrammen (Disease Management und hausärztliche Versorgung) durch das SGB V gesetzlich vorgeschrieben. Vor diesem Hintergrund wird eine Übersicht über praktikable und wirksame Maßnahmen der Integration Nationaler VersorgungsLeitlinien in Qualitätsmanagementmaßnahmen gegeben. Beschrieben wird der Transfer von Leitlinienempfehlungen in Klinische Behandlungspfade für den stationären Bereich sowie in Regionale Leitlinien durch ambulante Qualitätszirkel. Außerdem wird auf die Bedeutung von Qualitätsindikatoren in diesem Kontext eingegangen.AbstractIn 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. Background, methods, and development process].

ZusammenfassungDas Programm für Nationale Versorgungsleitlinien (NVL-Programm) ist eine im Jahr 2002 von der Bundesärztekammer (BÄK) gestartete Initiative zur Förderung von Qualität und Transparenz in der strukturierten medizinischen Versorgung (Disease Management). Das Programm wird seit 2003 gemeinsam von BÄK, Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften (AWMF) und Kassenärztlicher Bundesvereinigung (KBV) verantwortet und durch das Ärztliche Zentrum für Qualität in der Medizin (ÄZQ) koordiniert. Es zielt auf die Entwicklung und Implementierung von Leitlinien für ausgesuchte Erkrankungen hoher Prävalenz unter Berücksichtigung der Methoden der evidenzbasierten Medizin, an denen verschiedene Disziplinen und Berufsgruppen in mehreren Versorgungsbereichen (primäre Prävention, Früherkennung, Kuration und Rehabilitation) beteiligt sind. Im Jahr 2005 haben die mit den Themenbereichen Asthma, chronisch-obstruktive Lungenerkrankung, koronare Herzkrankheit sowie Typ-2-Diabetes befassten Fachgesellschaften evidenzbasierte NVL konsentiert. Ergänzend dazu entwickelten Experten der Patientenselbsthilfe Patientenleitlinien auf der Grundlage der erstellten Versorgungsleitlinien.Der vorliegende Beitrag beschreibt Hintergrund, Methoden und Instrumente des NVL-Programms und ist erster Teil einer Serie, in der die wichtigsten, klinisch relevanten Empfehlungen zu den Themenbereichen des Programms beschrieben werden.AbstractThe 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.

Problemfelder und Best-Practice-Ansätze in der Arzneimittelversorgung an intersektoralen Schnittstellen – Eine Literaturanalyse☆

Transitions between the outpatient and inpatient sector are a critical phase in medication treatment. This article provides an overview of published problem areas and examples of best practice in the intersectoral medication treatment. Data with regard to related problem areas and examples of best practice was collected in August 2011 by a systematic literature research. The relevant literature was identified using the following databases and search engines: MEDLINE, The Cochrane Library, EMBASE, Google, and Google Scholar. Additionally, a hand search was done on the websites of SpringerLink and Thieme Connect. The initial search yielded a total of 4,409 records which were further selected in two screening steps and analysed according to their relevance. Of the remaining 63 records, 3 exclusively described problem areas, 11 of them examples of best practice, and 49 provided information on both problem areas and examples of best practice with regard to intersectoral medication treatment. Among other things, problem areas include varying legal regulations in inpatient and outpatient medication treatment, drug therapy interruptions after hospital discharge, or deficits in communication and continuity of care. Examples of best practice are projects, programmes, initiatives, recommendations, and points to consider with respect to medication reconciliation, pharmaceutical support, or transitions of care. Problem areas as well as examples of best practice are mainly focused on the transition from inpatient to outpatient care.

Wirksamkeit von Qualitätsprogrammen in der stationären Versorgung in Deutschland – eine Literaturanalyse☆

BACKGROUND Over the past decades, a large number of measures for quality management and quality assurance (QM/QA) of healthcare were established in the German healthcare system. Considering the resources required, it has been repeatedly demanded that such quality programmes be checked for their effectiveness. In this context, the present paper describes the results of a systematic literature review to evaluate German QM/QA programmes in the inpatient sector. METHODS A systematic literature search was conducted in the electronic databases Medline, Cochrane Library and topic-related institution websites. In addition, hand searches were conducted, and the search engine Google Scholar was used. For Germany, no time limit was placed on the literature search. Evaluation studies were only selected if they included a comparison group without or at the beginning of a QM/QA programme and measured the effects on outcomes, process or structure of inpatient care. The methodological quality of the eligible studies was assessed and summarised. RESULTS Out of 3,065 hits, 18 publications were included in the literature review. In Germany, no causal relationships between QM/QA programmes and a relevant benefit for improved quality of care for patients in the hospital sector could be detected in any study. Results were inconsistent or insufficiently reliable without demonstrating a clear positive or negative impact of the analysed programmes on the quality of care. Overall, the quality of the included studies was low. CONCLUSION No acceptable scientific studies for the German healthcare system could be detected that provided proof for a patient-related effectiveness or ineffectiveness of the established quality programmes. Due to the insufficient evidence and despite the challenges faced when conducting convincing evaluation studies in the field of QM/QA, established methods of the evaluation research should be applied and extended.

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.

Auf einheitlicher Basis entscheiden

ZusammenfassungIn Qualitätsdebatten zur sektorenübergreifenden Versorgung wird der Patientenaufklärung und -beratung eine große Bedeutung beigemessen. Als ein entscheidendes Medium hierfür werden leitlinienbasierte Patienteninformationen angesehen. Sie sollen Patienten als Entscheidungsgrundlage dienen und darüber hinaus die Implementierung der Leitlinien selbst unterstützen. Der Beitrag stellt heraus, dass PatientenLeitlinien zu Nationalen VersorgungsLeitlinien als einheitliche Informationsbasis für Arzt und Patient im Rahmen der Aufklärung und Beratung mit dem Ziel einer gemeinsamen Entscheidungsfindung dienen können. Er geht darauf ein, welche Inhalte PatientenLeitlinien haben sollten, um diesen Anforderungen gerecht zu werden, und welche Maßnahmen zur Überprüfung ihrer Qualität erforderlich sind. Der vorliegende Beitrag setzt die Serie über das Programm für Nationale VersorgungsLeitlinien fort.AbstractIn 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.

Die Nationale VersorgungsLeitlinie KHK 2006

ZusammenfassungIm Rahmen des Programms für Nationale VersorgungsLeitlinien (NVL-Programm) von BÄK, AWMF und KBV ist im Sommer 2006 die NVL Chronische KHK fertiggestellt worden. Die beteiligten Organisationen (AkdÄ, DEGAM, DGIM, DGK, DGPR, DGTHG) konsentierten nach einem 4 Jahre dauernden Entwicklungs- und Abstimmungsprozess evidenzbasierte Empfehlungen zu Prävention, Diagnostik, Therapie und Rehabilitation bei chronischer KHK.Die NVL nimmt u.a. zu folgenden Fragen Stellung: nichtinvasive und invasive Diagnostik, Prognose und Risikostratifizierung, Symptomkontrolle und Sekundärprophylaxe, Indikationen zur Revaskularisation (Vergleich PCI vs. CABG), Koordination von hausärztlicher und spezialisierter, ambulanter, akutstationärer und rehabilitativer Betreuung.Der Beitrag gibt eine kurze Übersicht über beteiligte Autoren, Quellen und inhaltliche Schwerpunkte der NVL Chronische KHKAbstractIn 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--implementation with pathways and quality management].

ZusammenfassungLeitlinien sind eines der wichtigsten Instrumente des Qualitätsmanagements. Dabei ist die Integration von Leitlinien in Qualitätsmanagementprogramme die effektivste Leitlinien-Implementierungsmaßnahme. Seit kurzem ist die Berücksichtigung evidenzbasierter Leitlinien in vertragsärztlichen Versorgungsprogrammen (Disease Management und hausärztliche Versorgung) durch das SGB V gesetzlich vorgeschrieben. Vor diesem Hintergrund wird eine Übersicht über praktikable und wirksame Maßnahmen der Integration Nationaler VersorgungsLeitlinien in Qualitätsmanagementmaßnahmen gegeben. Beschrieben wird der Transfer von Leitlinienempfehlungen in Klinische Behandlungspfade für den stationären Bereich sowie in Regionale Leitlinien durch ambulante Qualitätszirkel. Außerdem wird auf die Bedeutung von Qualitätsindikatoren in diesem Kontext eingegangen.AbstractIn 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.