Abstract:
:Over the past decades, the randomized controlled trial has entered an era of continuous improvement and has gradually become accepted as the most effective way of determining the relative efficacy and toxicity of new therapies because it controls for placebo and time effects. However, even sensitive and properly designed and executed trials do not always confirm hypotheses to be tested, and conclusions are not always confirmed by subsequent trials. Although the former may be due to wrong hypotheses, the latter is likely to be due to the presence of certain imperfections within the design and execution of the trial itself. In this opinion paper, while focusing on such imperfections, the author searched for methods for further improvement of controlled trials, particularly clinical trials. The examples used in this paper are obtained from literature search as well as recent studies performed by the Netherlands Working Group on Cardiovascular Research (WCN). Methods for improvement could include: 1. making every effort to avoid asymmetries in the treatment groups; 2. emphasis on statistical power rather than just null-hypothesis testing; 3. adjusting for asymmetries not only of patient characteristics but also of outcome variables; 4. accounting routinely for type III errors; 5. routinely weighing benefits of a new drug against risks.
journal_name
Clin Chem Lab Medjournal_title
Clinical chemistry and laboratory medicineauthors
Cleophas TJdoi
10.1515/CCLM.1999.152keywords:
subject
Has Abstractpub_date
1999-11-01 00:00:00pages
1035-41issue
11-12eissn
1434-6621issn
1437-4331journal_volume
37pub_type
杂志文章abstract:BACKGROUND:Squamous cell carcinoma antigen-immunoglobulin M (SCCA-IgM) is a useful biomarker for the risk of development of hepatocellular carcinoma (HCC) in patients with cirrhosis due to its progressive increase associated to HCC evolution. In patients with cirrhosis, other assays have been affected by interfering re...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/CCLM.2010.044
更新日期:2010-02-01 00:00:00
abstract::The mutant of CYP2D6*3 allele with A2637 deletion in exon 5 and the mutant of CYP2D6*4 allele G1934-->A, splice site defect are among the most common polymorphic alleles of CYP2D6 gene, resulting in a decreased or no activity of CYP isoenzyme. In this study, a reliable polymerase chain reaction-restriction fragment le...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/CCLM.1998.116
更新日期:1998-08-01 00:00:00
abstract:BACKGROUND:Quantification of serum free light chains (FLC) is important in the diagnosis of plasma cell diseases where an abnormal kappa:lambda ratio infers a population of monoclonal plasma cells. The Freelite™ and N Latex assays have been validated in populations without kidney disease but there is a paucity of data ...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/cclm-2015-0799
更新日期:2016-06-01 00:00:00
abstract:BACKGROUND:The aim of the current study was to investigate levels of adenosine deaminase in plasma of patients with hydatidiform mole. METHODS:Plasma adenosine deaminase levels were determined in 17 women with normal pregnant course, in 17 women with hydatidiform mole, and in 17 non-pregnant healthy volunteers. RESUL...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/CCLM.2007.010
更新日期:2007-01-01 00:00:00
abstract::Increased expression of sialyl Lewis X or A antigens on metastatic cancer cells leads to their selectin-mediated extravasation. Profound fucosylation of the serum microenvironment may be a factor that interrupts adhesion and influences the formation of metastases. In this study we quantitatively analyzed fucosylation ...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/CCLM.2005.066
更新日期:2005-01-01 00:00:00
abstract::Background While quantitation methods for small-molecule and tryptic peptide bottom-up mass spectrometry (MS) have been well defined, quantitation methods for top-down or middle-up MS approaches have not been as well defined. Therapeutic monoclonal antibodies (t-mAbs) are a group of proteins that can be used to both d...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/cclm-2019-0862
更新日期:2020-06-25 00:00:00
abstract::Lipid peroxidation biomarkers and antioxidant status were measured in 76 cystic fibrosis (CF) patients and compared to 40 control subjects. Univariate and multivariate statistics were performed in this study. Results showed that indicators of lipid peroxidation were higher in CF patients than in controls; thiobarbitur...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/CCLM.1999.082
更新日期:1999-05-01 00:00:00
abstract::Recent progress in the understanding of the pathophysiology of hemostasis has established that blood coagulation disorders causing bleeding or thrombosis often indicate a multi-casual nature in which the interaction between genetic and acquired factors plays a major mechanistic role. The interaction of two or more fac...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章,评审
doi:10.1515/CCLM.2009.331
更新日期:2009-01-01 00:00:00
abstract::The present paper describes an evaluation of the interferences found with an immunochemical drug test performed during a workplace control. During the period 1993-2003 more than 200,000 urine samples from workers were examined by the Italian Air Force. Samples were screened for drugs of abuse (opiates, cocaine, cannab...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/CCLM.2006.142
更新日期:2006-01-01 00:00:00
abstract:BACKGROUND:International recommendations highlight the superior value of cardiac troponins (cTns) for early diagnosis of myocardial infarction along with analytical requirements of improved precision and detectability. In this multicenter study, we investigated the analytical performance of a new high sensitive cardiac...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章,多中心研究
doi:10.1515/cclm-2014-0107
更新日期:2014-11-01 00:00:00
abstract:BACKGROUND:The improvement of the consistency of gamma-glutamyltransferase (GGT) activity results among different assays after calibration with a common material was estimated. We evaluated if this harmonization could lead to reference limits common to different routine methods. METHODS:Seven laboratories measured GGT...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/CCLM.2007.290
更新日期:2007-01-01 00:00:00
abstract:BACKGROUND:Detection of systemic sclerosis-associated autoantibodies (SSc-Ab) is mostly restricted to anti-centromere and anti-topoisomerase-I. However, anti-RNA-polymerase-III and anti-PM/Scl are also important diagnostic markers for the disease supporting their incorporation in the laboratory repertoire. The aim of t...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/cclm-2013-0211
更新日期:2013-11-01 00:00:00
abstract::Introduction Element-tagged immunoassay coupled with inductively coupled plasma-mass spectrometry (ICP-MS) detection has the potential to revolutionize immunoassay analysis in clinical detection; however, a systematic evaluation with the standard guidelines of the assay is needed to ensure its performance meets the re...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/cclm-2019-0566
更新日期:2020-06-25 00:00:00
abstract::Background Brevican, neurocan, tenascin-C and tenascin-R are extracellular matrix proteins present in brain that show increased expression in experimental animal models of brain injury. However, little is known about the dynamics of these proteins in human body fluids, such as cerebrospinal fluid (CSF) and serum, afte...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/cclm-2019-0034
更新日期:2019-09-25 00:00:00
abstract:BACKGROUND:An E670G polymorphism of the exon 12 of the proprotein convertase subtilisin/kexin type 9 (PCSK9) gene was recently found to be associated with increased plasma low-density lipoprotein cholesterol (LDL-C) levels and severity of coronary atherosclerosis. This case-control study tested for a possible link betw...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/CCLM.2009.032
更新日期:2009-01-01 00:00:00
abstract::An outbreak of the so-called Coronavirus disease 2019 (COVID-19), caused by the severe acute respiratory syndrome Coronavirus 2 (SARS-CoV-2), has been spreading rapidly nationwide in China since December 2019. Wuhan, Hubei Province, is the hardest-hit region, with a rise in confirmed cases and its hospitals overwhelme...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/cclm-2020-0332
更新日期:2020-06-25 00:00:00
abstract::A software has been developed on quality control, department economics, information supervise and personal administration. In this article, we discuss the part of quality control, from which we benefit most, on developing ideas, running principle, and application. This network will enable the implementation of total q...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/CCLM.2001.195
更新日期:2001-12-01 00:00:00
abstract::Iron status in man is influenced by environmental and genetic factors. The molecular variation of haptoglobin is one of the genetic factors influencing iron status in Caucasians. Differences in iron metabolism between blacks and whites have been reported. We wanted to investigate the effect of haptoglobin polymorphism...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/CCLM.2002.140
更新日期:2002-08-01 00:00:00
abstract::In the relatively short time frame since the introduction of next generation sequencing, it has become a method of choice for complex genomic research studies. As a paradigm shifting technology, we are now witnessing its translation into clinical diagnostic laboratories for patient care. Multi-gene panels for a variet...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章,评审
doi:10.1515/cclm-2011-0841
更新日期:2011-12-23 00:00:00
abstract::Human protein 1/Clara cell Mr 10,000 protein consists of two identical subunits of seventy amino acid residues each. In the present study, eight clones of monoclonal antibodies against native protein 1 were prepared and their respective epitopes were immunochemically and immunohistochemically characterized using nativ...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/CCLM.1999.098
更新日期:1999-06-01 00:00:00
abstract::This review presents an overview of current research on the use of capillary electrophoretic techniques for the analysis of drugs in biological matrices. The discussion focuses on the applicability of the methods for the identification of unknown toxic compounds, which is defined as systematic toxicological analysis (...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章,评审
doi:10.1515/CCLM.2003.117
更新日期:2003-06-01 00:00:00
abstract:BACKGROUND:The objective of the study was to find the incidence of hemolysis in samples transported through a pneumatic tube system (PTS) at different speeds. METHODS:This prospective observational study was done in three phases: "short distance and high speed (115 m at 3 m/s)", "long distance and high speed (225 m at...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/CCLM.2011.779
更新日期:2011-11-10 00:00:00
abstract::Both technological advances and economic drivers have led to major changes in clinical laboratories across the world, with vastly improved testing productivity. However, the production process capability advances have far outpaced the clinical pathologists' success in assuring optimal test utilization and interpretati...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章,评审
doi:10.1515/CCLM.2010.194
更新日期:2010-07-01 00:00:00
abstract:PURPOSE:The aim of our study was to measure the inter-assay variation and accuracy of serum creatinine assays and to assess the effect of standardized calibration procedures on this variability. METHODS:We analyzed 30 human sera and three reference materials, using 17 creatinine assays (12 colorimetric, 4 enzymatic an...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/CCLM.2005.213
更新日期:2005-01-01 00:00:00
abstract:BACKGROUND:EML4-ALK fusion oncogene has emerged as a novel molecular target in non-small cell lung cancer (NSCLC). Although break-apart fluorescent in situ hybridization (FISH) is the standard method for diagnosis, it is expensive, not readily available and sometimes difficult to interpret. In addition, ALK immunohisto...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/cclm-2013-0044
更新日期:2013-09-01 00:00:00
abstract:BACKGROUND:Interleukins, interferons and oxidative DNA products are important biomarkers assessing the inflammations and tissue damages caused by toxic materials in the body. We tried to evaluate distributions, reference values and age related changes of blood levels of inflammatory cytokines, C-reactive protein (CRP),...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/cclm-2012-0330
更新日期:2013-02-01 00:00:00
abstract:BACKGROUND:Haptoglobin (Hp) is an abundant serum protein which binds extracorpuscular hemoglobin (Hb). Two alleles exist in humans for the Hp gene, denoted 1 and 2. Diabetic individuals with the Hp 2-2 genotype are at increased risk of developing vascular complications including heart attack, stroke, and kidney disease...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/cclm-2013-0018
更新日期:2013-08-01 00:00:00
abstract::Since PSA is supposed to play an active role in the progression of prostate cancer, we applied a quantitative RT-PCR to measure the absolute levels of prostate-specific antigen (PSA) mRNA expression in benign and malignant prostatic tissue. Consecutive fine needle prostate biopsy material from 59 patients (43 with pro...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/CCLM.2003.040
更新日期:2003-03-01 00:00:00
abstract:BACKGROUND:Electrospray ionization mass spectrometry (ESI-MS) can be used for the measurement of glycated adult hemoglobin. Here, we describe the evaluation of ESI-MS for measurement of glycated (GHbF) and acetylated (AcHbF) fetal hemoglobin and the identification by mass of different chains of fetal hemoglobin. METHO...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/CCLM.2008.257
更新日期:2008-01-01 00:00:00
abstract:BACKGROUND:Automated systems for antinuclear antibody analysis are being introduced. The aim was to evaluate whether automated quantitative reading of fluorescence intensity is clinically relevant and allows for value-added reporting of test results. METHODS:Consecutive samples (n=260) were used to correlate fluoresce...
journal_title:Clinical chemistry and laboratory medicine
pub_type: 杂志文章
doi:10.1515/cclm-2013-0610
更新日期:2014-04-01 00:00:00