German S3 Research Articles

Towards User-Oriented Recommendations for Local Therapy of Leg and Foot Ulcers-An Update of a S3-German Guideline.

Background: The German S3- guideline on local therapy of leg ulcers and diabetic foot ulcers is in the process of being updated. Major goals are to improve the guidelines’ applicability and to take steps towards a living guideline according to current methodological standards. The aim of this article is to describe the main measures to achieve these goals. Methods: The context of the guideline in the field of local wound care and the stakeholder requirements are briefly described. Based on a derived framework, the project team adjusted the methods for the guideline. Results: Main adjustments are more specific inclusion criteria, online consensus meetings and the use of an authoring and publication platform to provide information in a multi-layered format. A new set of practice-oriented key questions were defined by the guideline panel to foster the formulation of action-oriented recommendations. Conclusions: The set of new key questions addressing practical problems and patients’ preferences as well as the adjustments made to improve not only the guidelines’ applicability, but also the feasibility of the further dynamic updating processes in the sense of a living guideline, should be steps in the right direction.

Follow-up of renal cell carcinoma based on stage and initial treatment

Renal cell carcinoma is the third most common tumor of the genitourinary system. Small tumors are increasingly treated by nephron-sparing surgery, focal therapy via cryoablation or radiofrequency ablation and also active surveillance. These treatment options are associated with increased follow-up care. What are the current recommendations on follow-up care for different therapeutic approaches in renal cell carcinoma? We analyzed different biological aspects regarding renal cell carcinoma, diagnostic procedures as well as recommendations of current guidelines (e.g. German S3, EAU AUA). Follow-up of renal cell carcinoma is not well standardized due to the limited amount of data. In general, follow-up should be intensified during the first 3years following initial therapy as well as in patients with increased risk for tumor recurrence. For risk calculation different prognostic models based on clinical parameters have been published. Current recommendations on follow-up care in renal cell carcinoma are based on retrospective studies. Future strategies must include markers and be studied in aprospective manner.

Update and Comment on the German S3 "Clinical Guideline for Treating Acute Respiratory Insufficiency with Invasive Ventilation and Extracorporeal Membrane Oxygenation: Evidence-Based Recommendations"

In 2017 the German Clinical Guideline for Treating Acute Respiratory Insufficiency with Invasive Ventilation and Extracorporeal Membrane Oxygenation: Evidence-Based Recommendations were released. This article highlights emerging data and new concepts which were introduced since 2017. Among others it summarizes the current progress made in evidence-based recommendations of mechanical ventilation and extracorporeal membrane oxygenation (ECMO). In detail, the new evidence for treating severe ARDS with ECMO, phenotyping of ARDS, early neuromuscular blockade and the application of non-invasive ventilation and high-flow oxygen therapy are discussed.

Advice Literature on Depression: How Evidence-Based is it?

Advice literature on depression for patients and their relatives is a widespread and low-threshold source of information. In terms of empowerment of the patients it can contribute to the early detection and effective treatment of the disorder. An evaluation of its content quality, particularly its evidence base, is still missing. Considering this, the content of advice literature on depression is reviewed by comparing it systematically with content and recommendations from the German S3-/NV-guideline on unipolar depression. Based on a systematic search within the data base of the book trade, the 30 most widespread German advice books were analysed. For this purpose a rating instrument (RLP-D) with 54 items on diagnostics and treatment was derived from the current S3-/NV-guideline. With the help of the RLP-D one rater analysed both elaboration and accuracy of the 30 books' content. Between 7.4 and 81.5% of the items i. e. of the guideline content, are missing in the analysed advice books (Mdn=25.9%, IQR=22.7%). On average a third of the 54 items is covered extensively as well as without contradictions to the guideline (Mdn=36.1%, IQR=17.1%, Range: 1.9-64.8%). A fifth of the covered items (Mdn=20.4%; IQR=19.0%, Range: 2.9-47.6%) shows clinically relevant contradictions to the guideline content. Information about psychotherapy and pharmacotherapy as treatment options is the content which is covered extensively and correctly most often: The information is given in more than 83% of the books. There is a substantial variability concerning the elaboration and accuracy of the diagnostics and treatment content in advice literature. This also applies to the especially concerning erroneous content in advice literature. The further evaluation of the rating instrument RLP-D is a next important step. An application and reduction to the core contents of the guideline could facilitate the currently rather complex and laborious rating system. Although some basic information is given in almost all of the analysed books, advice literature on depression cannot be recommended per se due to the large differences in quality. Systematic evaluations of quality should be established in order to facilitate a well-grounded choice of literature in order to improve the information for patients.

EndoPredict improves the prognostic classification derived from common clinical guidelines in ER-positive, HER2-negative early breast cancer

BackgroundIn early estrogen receptor (ER)-positive/HER2-negative breast cancer, the decision to administer chemotherapy is largely based on prognostic criteria. The combined molecular/clinical EndoPredict test (EPclin) has been validated to accurately assess prognosis in this population. In this study, the clinical relevance of EPclin in relation to well-established clinical guidelines is assessed.Patients and methodsWe assigned risk groups to 1702 ER-positive/HER2-negative postmenopausal women from two large phase III trials treated only with endocrine therapy. Prognosis was assigned according to National Comprehensive Cancer Center Network-, German S3-, St Gallen guidelines and the EPclin. Prognostic groups were compared using the Kaplan–Meier survival analysis.ResultsAfter 10 years, absolute risk reductions (ARR) between the high- and low-risk groups ranged from 6.9% to 11.2% if assigned according to guidelines. It was at 18.7% for EPclin. EPclin reassigned 58%–61% of women classified as high-/intermediate-risk (according to clinical guidelines) to low risk. Women reclassified to low risk showed a 5% rate of distant metastasis at 10 years.ConclusionThe EPclin score is able to predict favorable prognosis in a majority of patients that clinical guidelines would assign to intermediate or high risk. EPclin may reduce the indications for chemotherapy in ER-positive postmenopausal women with a limited number of clinical risk factors.

Impact of the EndoPredict-clin score on risk stratification in ER-positive, HER2-negative breast cancer after considering clinical guidelines.

542 Background: Many ER-positive, HER2-negative breast cancer patients are treated by adjuvant chemotherapy according to current clinical guidelines. We retrospectively assessed whether the combined gene expression/ clinicopathological EndoPredict-clin (EPclin) score improved the accuracy of risk classification in addition to considering clinical guidelines. Methods: Three clinical breast cancer guidelines (National Comprehensive Cancer Center Network (NCCN), German S3 and St. Gallen 2011), and the EPclin score - assessed by quantitative RT-PCR in formalin-fixed paraffin-embedded tissue - were used to assign risk groups in 1,702 ER-positive, HER2-negative breast cancer patients from two randomized phase III trials (Austrian Breast and Colorectal Cancer Study Group 6 and 8) treated with endocrine therapy only. Results: Although all analyzed clinical guidelines identified a low-risk group with improved metastasis-free survival, the overwhelming majority of all patients (81-94%) were classified as intermediate / high risk. In contrast to that, the EPclin classified only 37% of all patients as high risk and that stratification resulted in the best separation between low and high risk groups (p < 0.001, HR = 5.11 (3.48-7.51). Consequently, the majority of all patients deemed intermediate / high risk by the clinical guidelines was re-classified as low risk by the EPclin score. Kaplan Meier analyses demonstrated that the re-classified subgroups (47 to 57% of all patients) had an excellent 10-year metastasis-free survival of 95% comparable to the clinical assigned low-risk groups although encompassing a higher proportion of the trial patients. Conclusions: The EPclin score predicted distant recurrence more accurately than all three clinical guidelines and is especially useful to reclassify patients considered as intermediate / high risk by the guidelines. The data suggests that the EPclin score provides clinically useful prognostic information beyond common clinical guidelines and can be used to accurately identify the clinically relevant group of patients who are adequately and sufficiently treated with adjuvant endocrine therapy alone.