Deutsches Ärzteblatt International

BACKGROUND: The gold standard for evaluating interventions in medicine and health care is the randomized controlled trial (RCT). In practice, however, RCTs may be difficult to conduct because of high costs, ethical aspects, or practical considerations. This is particularly true of studies on the population level, e.g., for the evaluation of health policy measures. METHODS: We present a type of study design called the interrupted time series (ITS) and its critical interpretation, with several illustrative examples...

BACKGROUND: The treatment options for patients with progressive malignant tumors despite primary radiotherapy are often limited. In selected cases, re-irradiation can be offered. This article concerns the selection criteria and results of re-irradiation for certain types of cancer. METHODS: This review is based on pertinent publications retrieved by a selective search in PubMed, with particular attention to glioblastoma, head and neck tumors, and prostatic carcinoma...

BACKGROUND: Chronic wounds on the leg (below the knee) are called leg ulcers. They have many causes, and thus patients with leg ulcers are treated by many different kinds of medical specialist. Appproximately 80% of sufferers have chronic venous insufficiency (CVI) and/or peripheral arterial occlusive disease (PAOD). Knowledge of the relevant differential diagnoses is important for appropriate treatment, particularly for patients with atypical findings or an intractable course. METHODS: This article is based on publications retrieved by a selective search in PubMed, including current guidelines and expert recommendations...

BACKGROUND: Observational epidemiologic studies often yield different results on the same question. In this article, we explain how this comes about. METHODS: In this review, which is based on publications retrieved by a selective search in PubMed and the Web of Science, we use information from international publications, simulation studies on sampling error, and a quantitative bias analysis on fictitious data to demonstrate why the results of epidemiologic studies are often uncertain, and why it is, therefore, generally necessary to perform more than one study on any particular question...

BACKGROUND: Sudden cardiac death (SCD) is the death of an apparently healthy person within one hour of the onset of symptoms, or within 24 hours of last being seen alive and well-with no evidence of an extra-cardiac cause. In autopsied cases, SCD is defined as the natural unexpected death of unknown or cardiac cause. The reported incidence figures for SCD vary widely. METHODS: This review is based on clinical registry studies, meta-analyses, randomized controlled trials, systematic reviews, and current guidelines that were retrieved by a selective search in PubMed employing the key words "channelopathy," "Brugada syndrome," "long QT syndrome," "catecholaminergic polymorphic ventricular tachycardia," "short QT syndrome," and "early repolarization...

BACKGROUND: Colorectal and pancreatic carcinoma are the most common cancers of the gastrointestinal tract. Their surgical treatment carries a high morbidity: Complications arise in 25% to 30% of cases, often prolonging recovery times and delaying the initiation of adjuvant therapy, leading, in turn, to worse oncological outcomes. The goal of multimodal perioperative management (mPOM) is to lower the postoperative complication rate through a combination of perioperative measures. METHODS: This guideline on the perioperative management of gastrointestinal tumors (POMGAT) meets all requirements for an S3 guideline as specified by the Association of the Scientific Medical Societies in Germany (Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften, AWMF)...

BACKGROUND: The incidence of airborne respiratory infections fell as a result of the protective measures taken during the COVID-19 pandemic and rose again when these were stopped. In 2022, there was a notable rise in invasive group A streptococcal (iGAS) infections in many countries, including Germany. This rise was also reflected in the data of the university otorhinolaryngology department in Ulm, Germany. METHODS: This review is based on publications retrieved by a selective literature search on the rise of iGAS infections in Europe, with particular attention to the timing of disease onset, clinical presentation, pathogenic strains, and potential causes and risk factors...

BACKGROUND: According to current evidence, every 10th to 11th adult with chronic kidney disease (CKD) has a monogenic disease of the kidney. METHODS: This review is based on reported studies in which molecular genetic diagnostic techniques were used to investigate monogenic kidney diseases in adults with CKD. The studies were identified by a selective literature search using predefined criteria. RESULTS: In 12 selected studies, diagnostic variants of 179 different genes were identified in 1467 out of 6607 study participants with CKD (22...

BACKGROUND: The epidemiological characterization of endometriosis, particularly with regard to its incidence, has been inadequate to date both in Germany and other countries. The goal of this study was to determine trends in the incidence of diagnosed endometriosis and changes in age structure at the time of first diagnosis over the period 2014-2022. METHODS: Nationwide claims data from physicians in private practice, obtained according to relevant German law (§ 295 SGB V), were used to identify the population at risk for a first assured diagnosis of endometriosis (ICD-10-GM: N80) during each year of the study period, consisting of women and girls aged 10-52 who were insured by the statutory health insurance system and for whom at least two years of prior observation were possible...

BACKGROUND: Chronic rhinosinusitis (CRS) is a heterogeneous condition characterized by local chronic inflammation of the mucous membranes of the nose and paranasal sinuses. It affects approximately 5% of the population. METHODS: This review is based on relevant publications retrieved by a selective search of the literature, with particular attention to current national and international guidelines. RESULTS: CRS is defined by, and diagnosed on the basis of, a combination of symptoms and objective findings of nasal endoscopy and imaging studies...

BACKGROUND: For children and adolescents with chronic inflammatory bowel disease (IBD), treatment that is not in adequate conformity with the guidelines can adversely affect both the course of disease and the patients' development. The targeted use of digital patient registries may improve real-life adherence to the recommendations of evidence-based guidelines. METHODS: In a cluster-randomized, controlled trial (DRKS00015505), treatment providers for the intervention group (IG) documented the treatment of children and adolescents with IBD in the CEDATA-GPGE patient registry; they received automated feedback on the data they entered and on potential deviations of the documented treatment from recommendations contained in the guidelines (care deficits)...

BACKGROUND: Readers of clinical trial reports should be able to critically evaluate the design, results, and conclusions of the trial. There are internationally accepted guidelines that define methodological standards for trial planning, statistical methods, and the display and interpretation of the results. Publications may nonetheless contain erroneous findings and interpretations. METHODS: Statistical errors can arise in the planning of the trial, the analysis and display of the results, as well as in the interpretation of p-values and treatment effects in experimental and observational clinical trials...

BACKGROUND: Hereditary hemorrhagic telangiectasia (HHT, Rendu-Osler-Weber disease, or Osler's disease for short) is a systemic disease that can severely impair the quality of life and that requires interdisciplinary treatment. Among rare diseases, it is relatively common, with a prevalence of approximately 1/5000. METHODS: This review is based on publications retrieved by a selective literature search, including the two international guidelines on clinically relevant aspects of HHT...

BACKGROUND: Magnetic resonance imaging (MRI) yields important information on the development and current status of many different diseases. Whole-body MRI was accordingly made a part of the multicenter, population-based NAKO Health Study. The present analysis concerns the feasibility of the baseline MRI examination and various aspects of quality assurance over the period 2014-2019. METHODS: 32 252 participants in the NAKO Health Study, aged 20 to 74, who had no contraindication to MRI were invited to undergo scanning in one of five MRI study centers across Germany...

BACKGROUND: Carpal fractures (incidence: 30-60 per 100 000 persons per year) are one of the more commonly overlooked fracture types. They can have serious consequences, as the use of the hand is indispensable in everyday life. In the following article, we present the elements of the diagnosis and treatment of fractures of the carpal bones. METHODS: This review is based on meta-analyses and randomized controlled trials (RCTs) published from 2013 to 2023 that were retrieved by a structured literature search, supplemented by guideline recommendations and expert consensus statements...

BACKGROUND: Approximately 15 000 people receive a diagnosis of renal cell carcinoma (RCC) in Germany each year; in 20-30% of cases, metastatic RCC (mRCC) is already present at the time of diagnosis. This disease in the metastatic stage is still mainly treated palliatively, yet the multimodal therapeutic landscape has changed markedly over the past 15 years, with the approval of many new treatments for patients with mRCC. METHODS: This review is based on prospective studies retrieved by a selective search in PubMed and the ASCO and ESMO databases and on the German and European oncological and urological guidelines for RCC...

BACKGROUND: Rigid age limits in the current allocation system for post-mortem donor kidneys in Germany may have problematic effects. The new German national transplantion registry enables data analysis with respect to this question. METHODS: Using anonymized data from the German national transplantion registry, we extracted and evaluated information on the recipients and postmortem donors of kidneys that were allocated in Germany through Eurotransplant over the period 2006-2020...

BACKGROUND: We studied whether an individualized digital decision aid can improve decision-making quality for or against knee arthroplasty. METHODS: An app-based decision aid (EKIT tool) was developed and studied in a stepped-wedge, cluster-randomized trial. Consecutive patients with knee osteoarthritis who were candidates for knee replacement were included in 10 centers in Germany. All subjects were asked via app on a tablet about their symptoms, prior treatments, and preferences and goals for treatment...

BACKGROUND: It is estimated that 6% of persons over age 75 have clinically relevant tricuspid regurgitation (TR). This condition carries a high mortality and is of particular interest because of the recent development of new interventional treatments. METHODS: This review is based on publications that were retrieved by a selective search in the PubMed database for randomized controlled trials (RCTs), observational studies, registry studies, expert recommendations, and current international guidelines...

BACKGROUND: Partial or total avoidance of weight-bearing by a lower limb is regularly needed after trauma and surgery. There are approximately 200 such cases per 100 000 persons per year. Underarm crutches have mainly been used in Germany until now to keep these patients mobile. For those who lack the strength or coordination needed to use crutches, a wheelchair may become necessary, or they might find themselves forced to continue weight-bearing on the affected limb, with possible impending adverse consequences and complications...