Abstract:
BACKGROUND:The randomized, controlled trial (RCT) is the gold standard of scientific evidence for the attribution of clinical effects (benefits and harms) to medical interventions. Many different designs for RCTs have been developed in order to counter legitimate critical objections and to better adapt the trials to the continually changing challenges that face clinical research. METHODS:The diversity and adaptability of randomized trial designs are presented and discussed on the basis of a selective literature review and specific illustrative examples. RESULTS:A wide range of RCT designs enables adaptation to special research tasks and clinical framework conditions. These include (among others) crossover trials, n=1 trials, factorial RCT designs, and cluster-randomized trials. In addition, adaptive designs such as modern platform trials and pragmatic RCTs with simplified clinical questions and less severely restricted patient groups make broad recruitment of patients possible even in routine clinical practice. CONCLUSION:Only the randomized allocation of subjects to the treatment and control groups, which is the defining property of RCTs, can adequately ensure that traits of the subjects which might disturb or bias a comparison of two or more medical interventions, will be evenly distributed across groups, regardless of whether these traits are known or unknown. The methodological variants and further elaborations of the RCT that are discussed here will help protect patients by enabling the assessment of the benefits and harms of medical methods and products on the basis of robust evidence even in the present era of rapid innovation.
journal_name
Dtsch Arztebl Intjournal_title
Deutsches Arzteblatt internationalauthors
Lange S,Sauerland S,Lauterberg J,Windeler Jdoi
10.3238/arztebl.2017.0635subject
Has Abstractpub_date
2017-09-22 00:00:00pages
635-640issue
38issn
1866-0452pii
arztebl.2017.0635journal_volume
114pub_type
杂志文章,评审abstract:BACKGROUND:The regional prevalence of risk factors can vary over time. The Study of Health in Pomerania (SHIP) addresses prevalence trends for common risk factors in a region in northeast Germany. METHODS:A longitudinal study was carried out from 1997 to 2001 (SHIP-0, with 4308 subjects), and a second, independent ran...
journal_title:Deutsches Arzteblatt international
pub_type: 杂志文章
doi:10.3238/arztebl.2015.0185
更新日期:2015-03-13 00:00:00
abstract:BACKGROUND:Pre-hospital hypotension in trauma patients is associated with high mortality. Especially for patients with severe traumatic brain injury (TBI), arterial normotension or even hypertension (AHT) is considered an important mechanism for sustaining adequate cerebral perfusion pressure. The effect of pre-hospita...
journal_title:Deutsches Arzteblatt international
pub_type: 杂志文章
doi:10.3238/arztebl.2012.0849
更新日期:2012-12-01 00:00:00
abstract:BACKGROUND:Many patients in German hospitals complain of inadequate treatment of their postoperative pain. Hospital-related structural and procedural variables may affect pain perception and patient satisfaction. We studied the association of individual variables with outcome quality. METHODS:Data from the years 2011 ...
journal_title:Deutsches Arzteblatt international
pub_type: 杂志文章
doi:10.3238/arztebl.2017.0161
更新日期:2017-03-10 00:00:00
abstract:BACKGROUND:The treatment of pregnant women who have illnesses unrelated to pregnancy can cause uncertainty among physicians. METHODS:We searched the PubMed database and specialty guidelines from Germany and abroad (the guidelines of the German Society for Gynecology and Obstetrics, the American Congress of Obstetri ci...
journal_title:Deutsches Arzteblatt international
pub_type: 杂志文章
doi:10.3238/arztebl.2017.0616
更新日期:2017-09-15 00:00:00
abstract:BACKGROUND:Urinary tract infections (UTI) are among the leading reasons for treatment in adult primary care medicine, accounting for a considerable percentage of antibiotic prescriptions. Because this problem is so common and so significant in routine clinical practice, a high level of diagnostic accuracy is essential....
journal_title:Deutsches Arzteblatt international
pub_type: 杂志文章,评审
doi:10.3238/arztebl.2010.0361
更新日期:2010-05-01 00:00:00
abstract:BACKGROUND:An estimated 1.4 to 2.6 million people in German suffer from drug dependence. Most of them are long-term users of benzodiazepines (BZD), Z drugs (ZD), or opioid analgesics (OA). METHODS:This analysis is based on prescription data from patients of the national statutory health insurance system in the German ...
journal_title:Deutsches Arzteblatt international
pub_type: 杂志文章
doi:10.3238/arztebl.2019.0607
更新日期:2019-09-13 00:00:00
abstract:BACKGROUND:Dear Doctor Letters (also known as Direct Healthcare Professional Communications) inform physicians about significant newly discovered drug risks and about measures to take to reduce these risks. How far these warnings actually influence prescribing behavior is unclear. METHOD:The Geriatrics in Bavaria-Data...
journal_title:Deutsches Arzteblatt international
pub_type: 杂志文章
doi:10.3238/arztebl.2014.0255
更新日期:2014-04-11 00:00:00
abstract:BACKGROUND:Lung transplantation is the final treatment option in the end stage of certain lung diseases, once all possible conservative treatments have been exhausted. Depending on the indication for which lung transplantation is performed, it can improve the patient's quality of life (e.g., in emphysema) and/ or prolo...
journal_title:Deutsches Arzteblatt international
pub_type: 杂志文章,meta分析,评审
doi:10.3238/arztebl.2014.0107
更新日期:2014-02-14 00:00:00
abstract:BACKGROUND:Abdominal and thoracic aortic aneurysms are diagnosed in 40 and 10 to 15 out of 100 000 persons per year, respectively. Fenestrated (fEVAR) and branched (bEVAR) stent grafts have been developed for abdominal juxtarenal and thoracoabdominal aneurysms. We discuss the patency and complication rates of fEVAR and...
journal_title:Deutsches Arzteblatt international
pub_type: 杂志文章,meta分析,评审
doi:10.3238/arztebl.2015.0816
更新日期:2015-11-27 00:00:00
abstract:BACKGROUND:4-10% of the general population and 20% of primary care patients have what are called "non-specific, functional, and somatoform bodily complaints." These often take a chronic course, markedly impair the sufferers' quality of life, and give rise to high costs. They can be made worse by inappropriate behavior ...
journal_title:Deutsches Arzteblatt international
pub_type: 杂志文章
doi:10.3238/arztebl.2012.0803
更新日期:2012-11-01 00:00:00
abstract:BACKGROUND:Delirium is a common complication in elderly hospitalized patients. It prolongs the length of hospital stay, raises costs, increases the workload of the nursing staff, and may necessitate transfer of the patient to a nursing home. The risk of postoperative delirium is particularly high in elderly patients wi...
journal_title:Deutsches Arzteblatt international
pub_type: 杂志文章
doi:10.3238/arztebl.2015.0289
更新日期:2015-04-24 00:00:00
abstract:BACKGROUND:In endocrine orbitopathy (EO), disfiguring proptosis and diplopia impair patients' quality of life both at home and at work. METHODS:From late 2006 to the beginning of 2008, 250 outpatients in an interdisciplinary thyroid and eye clinic filled out a questionnaire about their quality of life, occupational di...
journal_title:Deutsches Arzteblatt international
pub_type: 杂志文章
doi:10.3238/arztebl.2009.0283
更新日期:2009-04-01 00:00:00
abstract:BACKGROUND:The epidermal growth factor receptor (EGFR) is an important target in the treatment of metastatic colorectal carcinoma (mCRC). The combination of anti-EGFR antibodies with chemotherapy has led to a higher response rate of certain kinds of tumor as well as a significant prolongation of the progression-free in...
journal_title:Deutsches Arzteblatt international
pub_type: 杂志文章,评审
doi:10.3238/arztebl.2009.0202
更新日期:2009-03-01 00:00:00
abstract:BACKGROUND:Cluster-randomized trials (CRT) are needed to compare interventions that are allocated to entire groups of subjects, rather than to individuals. Publications about CRT have become steadily more common over the past decade. Readers of such publications should be able to categorize and interpret the findings o...
journal_title:Deutsches Arzteblatt international
pub_type: 杂志文章,评审
doi:10.3238/arztebl.2018.0163
更新日期:2018-03-09 00:00:00
abstract:BACKGROUND:The treatment options for bcr-abl positive chronic myelogenous leukemia (CML) include chemotherapy, immune therapy, allogeneic stem cell transplantation, and molecular therapy. The tyrosine kinase inhibitor imatinib was approved for the treatment of CML in 2002. Data from clinical trials allow a comparison o...
journal_title:Deutsches Arzteblatt international
pub_type: 杂志文章,meta分析,评审
doi:10.3238/arztebl.2010.0114
更新日期:2010-02-01 00:00:00
abstract:BACKGROUND:Nail disorders can arise at any age. About half of all nail disorders are of infectious origin, 15% are due to inflammatory or metabolic conditions, and 5% are due to malignancies and pigment disturbances. The differential diagnosis of nail disorders is often an area of uncertainty. METHODS:This review is b...
journal_title:Deutsches Arzteblatt international
pub_type: 杂志文章,评审
doi:10.3238/arztebl.2016.0509
更新日期:2016-07-25 00:00:00
abstract:INTRODUCTION:Military missions abroad carry a high risk of psychological traumatization. In this study, we examined the reasons for increased utilization of the treatments offered to soldiers by the German armed forces' psychiatric services. METHOD:We analyzed trends in initial contacts with psychiatrists and psychoth...
journal_title:Deutsches Arzteblatt international
pub_type: 杂志文章
doi:10.3238/arztebl.2012.0569
更新日期:2012-09-01 00:00:00
abstract:BACKGROUND:Patients with ovarian cancer usually present to a family physician with nonspecific symptoms, most often abdominal pain. The outcome depends above all on the stage of the disease when it is diagnosed and on the quality of treatment. METHODS:This article is based on a review of selected publications from 200...
journal_title:Deutsches Arzteblatt international
pub_type: 杂志文章,评审
doi:10.3238/arztebl.2011.0635
更新日期:2011-09-01 00:00:00
abstract:BACKGROUND:25% of all women report involuntary loss of urine, and 7% may require treatment. METHODS:This review is based on a selection of pertinent literature, including guidelines and Cochrane reviews. RESULTS:The assessment of pelvic floor dysfunction in women begins with a basic evaluation that is followed by spe...
journal_title:Deutsches Arzteblatt international
pub_type: 杂志文章,评审
doi:10.3238/arztebl.2015.0564
更新日期:2015-08-17 00:00:00
abstract:BACKGROUND:A meta-analysis of studies from multiple countries has shown that the incidence of incisional hernia varies from 4% to 10% depending on the type of operation. No epidemiological surveys have been conducted so far. The worst possible complication of an incisional hernia if it is not treated surgically is inca...
journal_title:Deutsches Arzteblatt international
pub_type: 杂志文章,meta分析
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abstract:BACKGROUND:The treatment of Hodgkin's disease (HD; also called Hodgkin's lymphoma) in children and adolescents with radiotherapy and chemotherapy leads to high survival rates but has a number of late effects. The most serious one is the development of a secondary malignant tumor, usually in the field that was irradiate...
journal_title:Deutsches Arzteblatt international
pub_type: 杂志文章
doi:10.3238/arztebl.2014.0003
更新日期:2014-01-06 00:00:00
abstract:BACKGROUND:Prostatic cancer (PCa) is the most common cancer in men in Germany. The goal of this review is to define the indication for hormonal treatment in patients over age 70. METHODS:A selective search of the literature up to 2008 for the terms "prostate cancer", "androgen suppression and deprivation", "hormone th...
journal_title:Deutsches Arzteblatt international
pub_type: 杂志文章,meta分析,评审
doi:10.3238/arztebl.2009.0242
更新日期:2009-04-01 00:00:00
abstract:BACKGROUND:Eliminating measles in Europe by 2015 is a WHO health goal. In Germany, physicians are legally required to report measles cases, yet it seems likely that reporting is less than universal. The goal of this study is to compare the number of measles cases that are reflected by data from the statutory health ins...
journal_title:Deutsches Arzteblatt international
pub_type: 杂志文章
doi:10.3238/arztebl.2011.0191
更新日期:2011-03-01 00:00:00
abstract:INTRODUCTION:Data on the prevalence and regional distribution of the metabolic syndrome in Germany are lacking, in particular for primary care. METHODS:In October 2005 anthropometric measurements were taken from 35 869 consecutive patients aged 18 to 99 years, in 1511 primary care practices. Waist circumference, blood...
journal_title:Deutsches Arzteblatt international
pub_type: 杂志文章
doi:10.3238/artzebl.2008.0207
更新日期:2008-03-01 00:00:00
abstract:BACKGROUND:Monoclonal antibodies (mAb) and fusion proteins (FP) are increasingly being used in children and adolescents. In this review, we analyze the evidence for their safety and efficacy in the treatment of the most common chronic inflammatory diseases. METHODS:We systematically searched PubMed, AWMF.org, and othe...
journal_title:Deutsches Arzteblatt international
pub_type: 杂志文章
doi:10.3238/arztebl.2019.0703
更新日期:2019-10-18 00:00:00
abstract:BACKGROUND:A number of studies have revealed higher postoperative mortality after operations that were performed toward the end of the week. It is not yet known whether a day-of-the-week effect exists after visceral surgical procedures for cancer in Germany. METHODS:Data on resections of carcinomas of the colon, rectu...
journal_title:Deutsches Arzteblatt international
pub_type: 杂志文章
doi:10.3238/arztebl.2020.0521
更新日期:2020-08-03 00:00:00
abstract:BACKGROUND:Patients with acquired brain injury who have been discharged from inpatient neurological rehabilitation often continue to suffer from limited independence, participation, and quality of life. Participation-focused outpatient treatment (in German: teilhabeorientierte ambulan. METHODS:In a randomized, control...
journal_title:Deutsches Arzteblatt international
pub_type: 杂志文章,随机对照试验
doi:10.3238/arztebl.2016.0634
更新日期:2016-09-23 00:00:00
abstract:BACKGROUND:The German Federal Law on Radiation Control contains no special provisions for X-ray studies in children and adolescents, even though exposure to ionizing radiation must be kept especially low in young persons, because their tissues are highly radiosensitive. Children, who have many years left to live, are m...
journal_title:Deutsches Arzteblatt international
pub_type: 杂志文章
doi:10.3238/arztebl.2011.0407
更新日期:2011-06-01 00:00:00
abstract:BACKGROUND:Breast cancer is the most common cancer in women. The German S3 guideline of 2012 has now been updated to take account of advances in the early detection, diagnostic evaluation, treatment, and follow-up care of this disease. METHODS:The updating process was based on the adaptation of identified source guide...
journal_title:Deutsches Arzteblatt international
pub_type: 杂志文章
doi:10.3238/arztebl.2018.0316
更新日期:2018-05-04 00:00:00
abstract:INTRODUCTION:This study analyzes the prevalence and associated factors for smoking and passive smoking among young people. METHODS:The data are derived from a subsample of the German Health Interview and Examination Survey for Children and Adolescents (KiGGS), carried out by the Robert Koch Institute between May 2003 ...
journal_title:Deutsches Arzteblatt international
pub_type: 杂志文章
doi:10.3238/arztebl.2008.0265
更新日期:2008-04-01 00:00:00