[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.

[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.

[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.

[Effectiveness of quality assurance programmes for inpatient care in Germany: a literature review]. / 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.

When Choosing Wisely meets clinical practice guidelines.

The American Board of Internal Medicine (ABIM) Foundation launched the Choosing Wisely campaign in 2012 and until today convinced more than 50 US specialist societies to develop lists of interventions that may not improve people's health but are potentially harmful. We suggest combining these new efforts with the already existing efforts in clinical practice guideline development. Existing clinical practice guidelines facilitate a more participatory and evidence-based approach to the development of top 5 lists. In return, adding top 5 lists (for overuse and underuse) to existing clinical practice guidelines nicely addresses a neglected dimension to clinical practice guideline development, namely explicit information on which Do or Don't do recommendations are frequently disregarded in practice.

[Problem areas and examples of best practice in intersectoral medication treatment--a literature review]. / 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.

[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.

[Evidence-based medicine teaching activities in the German-speaking area: a survey]. / Evidenzbasierte Medizin in Aus-, Weiter- und Fortbildung im deutschsprachigen Raum: Ein Survey.

INTRODUCTION: In the last 15 years Evidence-based Medicine (EbM) has gained much publicity in the German-speaking countries, but it is currently difficult to conclude how much the contents of EbM with its five steps according to Sackett have spread. Data from the year 2006 show that less than half of all medical faculties in Germany have introduced EbM into undergraduate teaching and that there is a shortage in EbM teaching activities for graduates in the German-speaking countries as well. The goal of this survey is to display the undergraduate and graduate Evidence-based Practice teaching activities in the German-speaking countries. METHODS: In a two-step survey, we first sent out a total of 551 letters to medical faculties, colleges, boards of physicians, the German Hospital Association, the associations of statutory health insurance physicians in Germany, the Medical Service of the German health insurances and asked the 30 participants of the 2011 EbM Academy as key informants in writing to give details about potential providers of EbM teaching activities. Via email we also consulted the members of the German-speaking colleges of general practitioners and family medicine and the German Network for EBM, course participants and contact persons of familiar teaching activities. In a second step a pre-tested detailed questionnaire with 36 items in the five categories framework and structure, participant characterisation, contents and didactics, evaluation and publication, and planning and publicity was sent to potential providers. RESULTS: Altogether 185 teaching activities were identified, 80 % of which were located in Germany, 13 % in Austria and 7 % in Switzerland. In 82.6 % of the cases it was either a seminar, a course or a workshop with a median of 20 participants and an average duration of 17.9hours. The teaching activities mainly addressed students (63.2 %), physicians (37.8 %), caregivers and members of other health care professions with little or no prior knowledge of EbM. The first three steps of EbM (formulating clinical questions, search for and appraisal of the literature) were taught in more than 75 % of the teaching activities, whereas steps four and five (integration of results, evaluation) were only taught in 53.9 % and 33.3 % of the cases, respectively. DISCUSSION AND CONCLUSION: Compared to 2006, a remarkable increase in EbM teaching activities was observed in the German-speaking areas. These activities address different target audiences; the main content focus is on the first steps of EbM.

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.

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.

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.