Guideline registries and libraries: a mixed-methods approach identified issues to be addressed with content.

OBJECTIVE: To establish what GIN guideline community members see as the desirable features of a guidelines library and registry of guidelines in development STUDY DESIGN AND SETTING: An explorative mixed-methods study was undertaken, including scoping activity and semi-structured interviews with guideline developers and endorsers from nine member organizations of the Guidelines International Network. RESULTS: A small number of desirable features of a guideline library were identified: comprehensiveness; single source of information to avoid searching multiple sites; inclusion of related materials; being up to date; searchability and ease of use. No existing library of guidelines was considered to have all of these features. A number of issues arose out of the desire to have a comprehensive library of guidelines, including inclusion of 'high quality guidelines' and limiting the scope to include only national guidelines. For registries of guidelines in development, the data set should be limited to avoid placing undue burden on those entering information. CONCLUSION: Our findings identify ongoing issues for the guideline community, including the tension between comprehensiveness and ease of use, which can result in limited uptake, reporting of guideline quality and the need for clarity on the purpose of any library or registry.

[Short version of the 2nd edition of the German-Austrian S3 guidelines "Cardiogenic shock complicating myocardial infarction-Diagnosis, monitoring and treatment"]. / Kurzversion der 2. Auflage der deutsch-österreichischen S3-Leitlinie "Infarkt-bedingter Kardiogener Schock ­ Diagnose, Monitoring und Therapie".

BACKGROUND: The present guidelines ( http://leitlinien.net ) focus exclusively on cardiogenic shock due to myocardial infarction (infarction-related cardiogenic shock, ICS). The cardiological/cardiac surgical and the intensive care medicine strategies dealt with in these guidelines are essential to the successful treatment and survival of patients with ICS; however, both European and American guidelines on myocardial infarction and heart failure and also position papers on cardiogenic shock focused mainly on cardiological aspects. METHODS: Evidence on the diagnosis, monitoring and treatment of ICS was collected and recommendations compiled in a nominal group process by delegates of the German Cardiac Society (DGK), the German Society for Medical Intensive Care Medicine and Emergency Medicine (DGIIN), the German Society for Thoracic and Cardiovascular Surgery (DGTHG), the German Society for Anaesthesiology and Intensive Care Medicine (DGAI), the Austrian Society for Internal and General Intensive Care Medicine (ÖGIAIM), the Austrian Cardiology Society (ÖKG), the German Society for Prevention and Rehabilitation of Cardiovascular Diseases (DGPR) and the German Interdisciplinary Association for Intensive Care and Emergency Medicine (DIVI), under the auspices of the Working Group of the Association of Medical Scientific Societies in Germany (AWMF). If only poor evidence on ICS was available, general study results on intensive care patients were inspected and presented in order to enable analogue conclusions. RESULTS: A total of 95 recommendations, including 2 statements were compiled and based on these 7 algorithms with defined instructions on the course of treatment.

Surgical therapy of adrenal tumors: guidelines from the German Association of Endocrine Surgeons (CAEK).

BACKGROUND AND AIMS: Previous guidelines addressing surgery of adrenal tumors required actualization in adaption of developments in the area. The present guideline aims to provide practical and qualified recommendations on an evidence-based level reviewing the prevalent literature for the surgical therapy of adrenal tumors referring to patients of all age groups in operative medicine who require adrenal surgery. It primarily addresses general and visceral surgeons but offers information for all medical doctors related to conservative, ambulatory or inpatient care, rehabilitation, and general practice as well as pediatrics. It extends to interested patients to improve the knowledge and participation in the decision-making process regarding indications and methods of management of adrenal tumors. Furthermore, it provides effective medical options for the surgical treatment of adrenal lesions and balances positive and negative effects. Specific clinical questions addressed refer to indication, diagnostic procedures, effective therapeutic alternatives to surgery, type and extent of surgery, and postoperative management and follow-up regime. METHODS: A PubMed research using specific key words identified literature to be considered and was evaluated for evidence previous to a formal Delphi decision process that finalized consented recommendations in a multidisciplinary setting. RESULTS: Overall, 12 general and 52 specific recommendations regarding surgery for adrenal tumors were generated and complementary comments provided. CONCLUSION: Effective and balanced medical options for the surgical treatment of adrenal tumors are provided on evidence-base. Specific clinical questions regarding indication, diagnostic procedures, alternatives to and type as well as extent of surgery for adrenal tumors including postoperative management are addressed.

Update of the evidence based, interdisciplinary guideline for anti-inflammatory treatment of uveitis associated with juvenile idiopathic arthritis.

BACKGROUND: Uveitis in juvenile idiopathic arthritis (JIAU) is frequently associated with the development of complications and visual loss. Topical corticosteroids are the first line therapy, and disease modifying anti-rheumatic drugs (DMARDs) are commonly used. However, treatment has not been standardized. METHODS: Interdisciplinary guideline were developed with representatives from the German Ophthalmological Society, Society for Paediatric Rheumatology, Professional Association of Ophthalmologists, German Society for Rheumatology, parents' group, moderated by the Association of the Scientific Medical Societies in Germany. A systematic literature analysis in MEDLINE was performed, evidence and recommendations were graded, an algorithm for anti-inflammatory treatment and final statements were discussed in a consensus meeting (Nominal Group Technique), a preliminary draft was fine-tuned and discussed thereafter by all participants (Delphi procedure). RESULTS: Consensus was reached on recommendations, including a standardized treatment strategy according to uveitis severity in the individual patient. Thus, methotrexate shall be introduced for uveitis not responding to low-dose (≤ 2 applications/day) topical corticosteroids, and a TNFalpha antibody (preferably adalimumab) used, if uveitis inactivity is not achieved. In very severe active uveitis with uveitis-related deterioration of vision, systemic corticosteroids should be considered for bridging until DMARDs take effect. If TNFalpha antibodies fail to take effect or lose effect, another biological should be selected (tocilizumab, abatacept or rituximab). De-escalation of DMARDs should be preceded by a period of  ≥ 2 years of uveitis inactivity. CONCLUSIONS: An interdisciplinary, evidence-based treatment guideline for JIAU is presented.

[Impact of conflicts of interest on guideline recommendations : Empirical study within the second update of the German interdisciplinary S3 guidelines on fibromyalgia syndrome]. / Der Einfluss von Interessenkonflikten auf Leitlinienempfehlungen : Eine empirische Studie zur zweiten Aktualisierung der interdisziplinären S3­Leitlinie zum Fibromyalgiesyndrom.

BACKGROUND: The impact of conflicts of interest (COI) in general and of academic COI in particular on guideline recommendations in pain medicine has not yet been studied. Whether the inclusion of patients and of representatives of all relevant healthcare professions into a guidelines group is protective against a systematic bias of decisions of a guidelines group is currently unknown. METHODS: All members of the guidelines group declared their COI before the consensus conferences by a standard form according to the rules and standards of the Association of the German Medical and Scientific Societies. The acceptance or rejection and the strength of consensus of recommendations of the second update of the interdisciplinary guidelines on fibromyalgia syndrome was analyzed twice by first including and then excluding the votes of the guideline group members with COI related to a recommendation from the results of anonymous voting via an internet platform. RESULTS: A total of 42 persons from different healthcare professions and patients participated in the online voting on recommendations. Of the participants 29% had no COI according to the predefined criteria, 53% met the criteria of academic and 33% the criteria of financial COI. In the case of exclusion of participants with a COI related to a specific recommendation, 2 out of 23 recommendations (homeopathy, tramadol) were not accepted. In all votes, there were more participants without COI than with COI. CONCLUSION: Academic COI were more frequent than financial COI in the second update of the German interdisciplinary guidelines group on fibromyalgia syndrome. The impact of COI on guideline recommendations was low. The inclusion of patients and of all relevant healthcare professionals into a guidelines group is a protective factor against the influence of COI on guideline recommendations.

[Methodology of the S3 guidelines on alcohol and tobacco-related disorders]. / Methodik der S3-Leitlinien für alkohol- und tabakbezogene Störungen.

BACKGROUND: From 2010 until 2015 two interdisciplinary evidence-based guidelines were developed to summarize the current knowledge regarding screening, diagnostics and treatment of alcohol and tobacco-related disorders. METHODS: Both guidelines were prepared under the auspices of the German Society for Psychiatry, Psychotherapy and Psychosomatics (Deutsche Gesellschaft für Psychiatrie, Psychotherapie, Psychosomatik und Nervenheilkunde, DGPPN) and the German Society for Addiction Research and Therapy (Deutsche Gesellschaft für Suchtforschung und -therapie, DG-Sucht). To meet the methodological criteria for the highest quality guidelines (S3 criteria) as defined by the Association of the Scientific Medical Societies in Germany (Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften, AWMF) the following criteria were realized: (1) a systematic search, selection and appraisal of the international literature, (2) a structured process to reach consensus and (3) inclusion of all relevant representatives of future guideline users. RESULTS: More than 60 clinical experts and researchers analyzed the scientific literature. In total 41 international and national guidelines (23 for alcohol and 18 for tobacco) were used. Moreover, 83 systematic Cochrane reviews (alcohol 28, tobacco 55) and 5863 articles (alcohol 2213, tobacco 3650) were analyzed. A total of 7 expert groups formulated 174 recommendations for the screening, diagnosis and treatment of alcohol-related disorders. Six expert groups created 81 recommendations for the screening, diagnosis and treatment of tobacco-related disorders. Approximately 50 scientific associations, professional organizations, patient and family initiatives, as well as representatives of the healthcare system formed a consensus group. In seven 1 and 2-day conferences, all clinical recommendations were discussed and approved by this group. Both guidelines will be revised on a regular basis to guarantee that the clinical recommendations are kept up to date. CONCLUSIONS: Both systematically developed, evidence-based treatment guidelines are comprehensive instruments to provide orientation and assist the decision-making process for physicians, psychologists and other therapists as well as patients and their families in the diagnosis and treatment of alcohol and tobacco use related disorders.

S3-Guideline non-traumatic adult femoral head necrosis.

INTRODUCTION: The treatment of adult non-traumatic avascular necrosis of the femoral head (AVN; N-ANFH) within an estimated incidence of 5000-7000 cases per annum in Germany remains a challenge. Risk factors include steroids, alcohol abuse, chemotherapy and immunosuppressive medication, but a genetic predisposition has been suggested. Early diagnosis of this often bilateral disease process is essential for successful conservative or joint preserving surgical management. In this review, we present the update German consensus S3 guideline "diagnosis and management for N-ANFH" as a concise summary. MATERIALS AND METHODS: This systematic review is based on the published literature from January 1, 1970 to April 31, 2013 (German and English language). Inclusion criteria were systematic reviews, meta-analyses and relevant peer review publications. We identified a total of 3715 related publications, of which 422 were suitable according to the SIGN criteria, but only 159 fulfilled our inclusion criteria. RESULTS AND CONCLUSIONS: Clinical suspicion of N-ANFH mandates radiographic evaluation. If radiographs are normal MRI scans are recommended, which should be evaluated according to the ARCO-classification. Differential diagnoses include transient osteoporosis, bone bruise, insufficiency fracture and destructive arthropathy. Untreated, subchondral fractures commonly occur within 2 years, during which the risk for contralateral involvement is high-thereafter unlikely. Conservative management with Ilomedin and Alendronat can be tried, but other pharmacological or physical treatments are inappropriate. No specific joint preserving procedure can be recommended, but core decompression should be considered in early stages if necrosis is <30 %. In ARCO stages IIIc or IV total hip arthroplasty (THA) should be contemplated, which offers similar outcome compared to osteoarthritis. Young age is the main risk factor for higher revision rates after THA for N-ANFH.

[Erratum to: Methodology of the development of the updated LONTS guidelines for long-term administration of opioids in noncancer pain]. / Erratum zu: Methodenreport der aktualisierten Leitlinie "Langzeitanwendung von Opioiden bei nicht-tumorbedingten Schmerzen - LONTS".

In the sentence "For dichotomous variables, the threshold for 'appreciable benefit' or 'appreciable harm' was set at a relative risk reduction (RRR) or relative risk increase (RRI) ≥ 10 % [5]" the relative risk increase (RRI) is not ≥10 %, but ≥ 25 %.

[Implementation of clinical practice guidelines: how can we close the evidence-practice gap?]. / Leitlinienimplementierung : Wie schließen wir die Lücke zwischen Evidenz und Anwender?

Guidelines are intended as instruments of knowledge transfer to support decision-making by physicians, other health professionals and patients in clinical practice and thereby contribute to quality improvements in healthcare. To date they are an indispensable tool for healthcare. Their benefit for patients can only be seen in application, i.e. the implementation of guideline recommendations. For successful implementation, implementability and practicability play a crucial role and these characteristics can be influenced and should be promoted by the guideline development group. In addition, a force field analysis to identify barriers against and facilitators for the implementation of specific guideline recommendations from the perspective of physicians and patients is recommended to guide the development of an individual implementation strategy and the selection of appropriate interventions. However, implementation cannot be achieved by the guideline development group alone and a universal implementation strategy does not exist. Therefore, a process using theory, analysis, experience and shared responsibility of stakeholders in healthcare is recommended, with the aim to achieve sustainable behavioral change and improve the quality of care by guideline-oriented behavior.

[Methodology of the development of the updated LONTS guidelines for long-term administration of opioids in noncancer pain]. / Methodenreport der aktualisierten Leitlinie "Langzeitanwendung von Opioiden bei nicht-tumorbedingten Schmerzen - LONTS".

BACKGROUND: The update of the German S3 guidelines on long-term opioid therapy of chronic noncancer pain (CNCP), the"LONTS" (AWMF registration number 145/003) was scheduled for May 2014. METHODS: The guidelines were developed by 25 scientific societies and two patient self-help organizations under the coordination of the German Pain Society and the Association of the Scientific Medical Societies in Germany (AWMF). RESULTS: A systematic literature search was performed in the CENTRAL, MEDLINE and Scopus databases from October 2008 to October 2013. Meta-analyses of randomized controlled trials (RCT) of opioids in CNPC of study duration ≥ 4 weeks were conducted. Levels of evidence were assigned according to the Oxford Centre for Evidence-Based Medicine version 2009 classification system. The formulation and strength of recommendations was established in a multistep formalized consensus procedure, in accordance with AWFM rules and standards. The guidelines were reviewed by three scientific societies not involved in their development and were approved by the executive boards of the societies that were engaged in development of the guidelines. CONCLUSION: The guidelines will be published in several forms: complete and short scientific versions, as well as clinical practice and patient versions.

Guidelines in the Register of the Association of Scientific Medical Societies in Germany - A Quality Improvement Campaign.

The Association of Scientific Medical Societies in Germany (AWMF) is the umbrella organization of medical scientific societies in Germany. The development of guidelines goes back to an initiative of the medical scientific societies and is coordinated by the AWMF. Rules for the inclusion of guidelines in the AWMF Guideline Register have been defined including how guidelines are classified. S1 guidelines are based only on recommendations by experts, whereas S2 guidelines require a structured consensus process or a systematic literature review. S3 guidelines include both elements. In addition to compulsory disclosure of any potential conflict of interest, transparent handling of potential conflicts of interest is an important confidence-building measure. For years, the trend has been to develop higher order (S2/S3) guidelines, and the German Society for Gynecology and Obstetrics (DGGG) has been no exception to the trend. In addition to its responsibility for specific S2 and S3 guidelines, the DGGG is also involved in numerous other interdisciplinary guidelines. When developing a guideline, it is essential to define the guideline's scope, identify aspects which require improvement and agree on the goals. Target groups affected by the guidelines should be involved if they are interested. Different formats (long and short versions, practical instructions, conventional or electronic decision aids, patient versions) are useful to disseminate the guideline. The guideline can be adapted to local circumstances to encourage implementation of its recommendations. Implementation can be measured using quality indicators. Feedback from practitioners is important as this highlights areas which require improvement. The medical scientific societies in Germany can look back on almost two decades of work spent on developing guidelines, most of it done by unpaid voluntary contributors, making this a very successful quality initiative.

[Methodological fundamentals of the development of the guideline]. / Methodenreport zur Erstellung der Leitlinie.

BACKGROUND: The scheduled update to the German S3 guidelines on fibromyalgia syndrome (FMS) by the Association of the Scientific Medical Societies ("Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften", AWMF; registration number 041/004) was planned starting in March 2011. MATERIALS AND METHODS: The development of the guidelines was coordinated by the German Interdisciplinary Association for Pain Therapy ("Deutsche Interdisziplinären Vereinigung für Schmerztherapie", DIVS), 9 scientific medical societies and 2 patient self-help organizations. Eight working groups with a total of 50 members were evenly balanced in terms of gender, medical field, potential conflicts of interest and hierarchical position in the medical and scientific fields. Literature searches were performed using the Medline, PsycInfo, Scopus and Cochrane Library databases (until December 2010). The grading of the strength of the evidence followed the scheme of the Oxford Centre for Evidence-Based Medicine. The formulation and grading of recommendations was accomplished using a multi-step, formal consensus process. Efficacy, risks, patient preferences and applicability of therapies available were summarized into a balance sheet. The guidelines were reviewed by the boards of the participating scientific medical societies. CONCLUSION: The guidelines were published in several forms: complete and short scientific versions, clinical practice and patient versions. The English full-text version of this article is available at SpringerLink (under "Supplemental").

[S3 guidelines on diagnostics and therapy of bipolar disorders: development process and essential recommendations]. / S3-Leitlinie zur Diagnostik und Therapie bipolarer Störungen: Entwicklungsprozess und wesentliche Empfehlungen.

Bipolar disorders are severe psychiatric disorders with extensive individual and health economic consequences. Starting in 2007 the first German evidence and consensus based guideline for diagnostics and treatment of bipolar disorders was developed which holds the potential of increasing confidence of therapists, patients and relatives in the decision-making process and improving healthcare service experiences of patients and relatives. Apart from recommendations for diagnostics and treatment the guidelines provide those for trialogue action, knowledge transfer and self-help and for strategies for healthcare provision of this complex disorder. In the present article the methodology and essential recommendations are outlined and complemented in specific topics by corresponding articles in this special issue. Due to restrictions of the length of this presentation there is the need to refer to the comprehensive version of the guidelines at several points also regarding a detailed discussion of the limitations.

[The German National Disease Management Guideline "Chronic Heart Failure"]. / Nationale VersorgungsLeitlinie Chronische Herzinsuffizienz.

Chronic heart failure (CHF) is an illness mostly affecting elderly people. In Germany CHF is one of the most common causes of death and at the same time one of the most common diagnosis in inpatient care. Due to the expected increase in life expectancy in the next few years experts predict a further step-up of the incidence. Against this background development of a national guideline on chronic heart failure was prioritised and accordingly the National Disease Management Guideline (NDMG) Chronic Heart Failure was developed by a multi- and interdisciplinary group. The guideline group comprised experts from all relevant scientific medical societies as well as a patient expert. The National Disease Management Guideline (NDMG) on Chronic Heart Failure aims at supporting patients and health care providers with respect to decisions on a specific health care problem by giving recommendations for actions. Recommendations are informed by the best available scientific evidence on this topic.Patients with CHF often suffer from multiple conditions. Due to this fact and the old age patients do have very complex and demanding health care needs. Thus accounting for co-morbidities is paramount in planning and providing health care for theses patients and communication between doctor and patient but also between all health care providers is crucial.Basic treatment strategies in chronic heart failure comprise management of risk factors and prognostic factors as well as appropriate consideration of co-morbidities accompanied by measures empowering patients in establishing a healthy life style and a self-dependant management of their illness.Psycho-social aspects have a very strong influence on patients' acceptance of the disease and their self-management. In addition they have a strong influence on therapy management of the treating physician thus they have to be addressed adequately during the consultation.The National Disease Management Guideline (NDMG) Chronic Heart Failure (CHF) is an interdisciplinary guideline putting particular emphasis on giving recommendations for health care management at the interfaces of the health care system. The NDMG CHF provides a collection of evidence-based and consensus-based recommendations for diagnostics and therapy of patients with CHF. This CPG is meant to improve health care for all affected patients regardless of stage of disease or health care setting. Quality improvement though can only happen when the NDMG CHF is adopted into daily routine. To support implementation a patient version of the guideline was developed. The article compiles the most relevant recommendations and algorithms of the National Disease Management Guideline (NDMG) Chronic Heart Failure (CHF).