Abstract:
BACKGROUND:Clinical studies provide formalised experience for evidence-based medicine (EBM). Many people consider a controlled randomised trial (CRT, identical to a randomised controlled trial RCT) to be the non-plus-ultra design. However, CRTs also have limitations. The problem is not randomisation itself but informed consent for randomisation and masking of therapies according to today's legal and ethical standards. We do not want to de-rate CRTs, but we would like to contribute to the discussion on clinical research methodology. SITUATION:Informed consent to a CRT and masking of therapies plainly select patients. The excellent internal validity of CRTs can be counterbalanced by poor external validity, because internal and external validity act as antagonists. In a CRT, patients may feel like guinea pigs, this can decrease compliance, cause protocol violations, reduce self-healing properties, suppress unspecific therapeutic effects and possibly even modify specific efficacy. DISCUSSION:A control group (comparative study) is most important for the degree of evidence achieved by a trial. Study control by detailed protocol and good clinical practice (controlled study) is second in importance and randomisation and masking is third (thus the sequence CRT instead of RCT). Controlled non-randomised trials are just as ambitious and detailed as CRTs. RECOMMENDATION:We recommend clinicians and biometricians to take high quality controlled non-randomised trials into consideration more often. They combine good internal and external validity, better suit daily medical practice, show better patient compliance and fewer protocol violations, deliver estimators unbiased by alienated patients, and perhaps provide a clearer explanation of the achieved success.
journal_name
Contemp Clin Trialsjournal_title
Contemporary clinical trialsauthors
Gaus W,Muche Rdoi
10.1016/j.cct.2013.02.011subject
Has Abstractpub_date
2013-05-01 00:00:00pages
127-32issue
1eissn
1551-7144issn
1559-2030pii
S1551-7144(13)00029-3journal_volume
35pub_type
杂志文章abstract:OBJECTIVE:To describe the methodology of a 2-arm randomized controlled trial that compared the effects of a narrative and didactic version of the Witness CARES (Community Awareness, Reach, & Empowerment for Screening) intervention on colorectal cancer screening behavior among African Americans, as well as the cognitive...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1016/j.cct.2017.11.019
更新日期:2018-02-01 00:00:00
abstract::Despite strong anti-smoking efforts, at least 12% of American women cannot quit smoking when pregnant resulting in >450,000 smoke-exposed infants born yearly. Smoking during pregnancy is the largest preventable cause of childhood respiratory illness including wheezing and asthma. Recent studies have shown a protective...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2017.05.008
更新日期:2017-07-01 00:00:00
abstract::Modified Zelen's approach is a randomization technique useful in multi-center trials where balance in treatment assignments within a center is desired. It has great balancing properties in a study with equal allocation to several treatment arms. This technique can also be used in studies with unequal allocation, where...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,评审
doi:10.1016/j.cct.2011.08.006
更新日期:2011-11-01 00:00:00
abstract:BACKGROUND:Early pregnancy through the first year of life represents an important period for family health promotion and obesity prevention. Overall, preventive interventions in pregnancy and infancy have insufficiently engaged fathers. We describe the rationale and design of First Heroes, an intervention to improve pe...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2020.106253
更新日期:2020-12-17 00:00:00
abstract::Smokers are at high risk for oral disease. As a result, they represent an important target group for population-level, public oral health promotion efforts. While dental health professionals often address smoking with their patients, no systematic efforts have been made to offer smokers an intervention to improve thei...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2017.04.003
更新日期:2017-06-01 00:00:00
abstract::Double-blinding is an important and widely implemented feature of clinical trials although its success is rarely assessed. In a randomized, placebo-controlled trial of tea tree oil, an aromatic essential oil, for the treatment of recurrent herpes labialis (RHL), or cold sores, deception was used to prevent volunteers ...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2007.04.006
更新日期:2008-01-01 00:00:00
abstract::The use of blinding strengthens the credibility of randomized controlled trials (RCTs) by minimizing bias. However, there is confusion surrounding the definition of blinding as well as the terms single, double, and triple blind. It has been suggested that these terms should be discontinued due to their broad misinterp...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2010.11.004
更新日期:2011-03-01 00:00:00
abstract::Chronic insomnia disorder is a prevalent condition and a significant proportion of these individuals also have obstructive sleep apnea (OSA). These two sleep disorders have distinct pathophysiology and are managed with different treatment approaches. High comorbidity rates have been a catalyst for emerging studies exa...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2015.12.017
更新日期:2016-03-01 00:00:00
abstract:INTRODUCTION:Focal ablation therapy is playing an increasing role in oncology and may reduce the toxicity of current surgical treatments while achieving adequate oncological benefit. Irreversible electroporation (IRE) has been proposed to be tissue-selective with potential advantages compared with current thermal-ablat...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2015.05.002
更新日期:2015-07-01 00:00:00
abstract:OBJECTIVE:Characteristics that may influence participation in DNA banks are not well defined. The purpose of this study was to examine characteristics associated with participation in a DNA bank among veterans diagnosed with Amyotrophic Lateral Sclerosis (ALS). METHODS:Veterans who screened eligible for the National R...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2007.01.009
更新日期:2007-09-01 00:00:00
abstract:BACKGROUND:Low-wage workers suffer disproportionately high rates of chronic disease and are important targets for workplace health and safety interventions. Child care centers offer an ideal opportunity to reach some of the lowest paid workers, but these settings have been ignored in workplace intervention studies. ME...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2018.02.018
更新日期:2018-05-01 00:00:00
abstract::Pediatric primary care is an important setting in which to address obesity prevention, yet relatively few interventions have been evaluated and even fewer have been shown to be effective. The development and evaluation of cost-effective approaches to obesity prevention that leverage opportunities of direct access to f...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2013.06.017
更新日期:2013-09-01 00:00:00
abstract::Depression affects 20-30% of people living with HIV/AIDS (PLWHA) in the U.S. and predicts greater sexual risk behaviors, lower antiretroviral (ARV) medication adherence, and worse clinical outcomes. Yet little experimental evidence addresses the critical clinical question of whether depression treatment improves ARV a...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2012.04.002
更新日期:2012-07-01 00:00:00
abstract::This study was set up to test an ecological intervention using a pragmatic cluster randomised controlled design (RCT) aimed at increasing physical activity (PA) within the community in a deprived inner-city area in the UK. The research will provide a detailed mapping (using Graphical Information Systems GIS) of the en...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2008.03.005
更新日期:2008-09-01 00:00:00
abstract::Cancer related cognitive impairments (CRCI) are frequently reported by patients prior to, during and after medical treatment. Although this cognitive decline severely affects patients' quality of life, little is known about effective treatments. Exercise programs represent a promising supportive strategy in this field...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2016.05.007
更新日期:2016-07-01 00:00:00
abstract::This paper proposes a method for balancing prognostic variables between treatment and control groups in design of clinical trials. It assumes that some of prognostic variables are continuous and others are categorical and that they are independently distributed. The proposed method uses the Kullback-Leibler divergence...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2006.05.002
更新日期:2006-10-01 00:00:00
abstract::Double-blinded trials are often considered the gold standard for research, but significant bias may result from unblinding of participants and investigators. Although the CONSORT guidelines discuss the importance of reporting "evidence that blinding was successful", it is unclear what constitutes appropriate evidence....
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2004.11.020
更新日期:2005-02-01 00:00:00
abstract::Competency-Based Approaches to Community Health (COACH) is a randomized controlled trial of a family-centered, community-based, and individually-tailored behavioral intervention for childhood obesity among Latino pre-school children. COACH focuses on improving personal agency for health behavior change by tailoring co...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2018.08.006
更新日期:2018-10-01 00:00:00
abstract::Clinical trial research is the cornerstone for successful advancement of medicine that provides hope for millions of people in the future. Full transparency in clinical trials may allow independent investigators to evaluate study designs, perform additional analysis of data, and potentially eliminate duplicate studies...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2014.01.001
更新日期:2014-03-01 00:00:00
abstract::The 2-in-1 adaptive design [Chen et al. 2018] allows seamless expansion of an ongoing Phase 2 trial into a Phase 3 trial to expedite a drug development program. An intermediate endpoint can be used for the adaptive decision. Under a mild assumption that is expected to generally hold in practice, both the Phase 2 trial...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2020.106053
更新日期:2020-08-01 00:00:00
abstract:PURPOSE:To describe the strategies-based on the social triad concept of a partnership of researchers, school personnel and community-employed to recruit low-income, minority parent/caregivers of kindergarten children into a school-based tooth decay prevention trial in the United States. METHODS:The study site was an u...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1016/j.cct.2011.09.012
更新日期:2012-01-01 00:00:00
abstract::The purpose of this paper is to evaluate the efficacy and safety of recombinant human hepatocyte growth factor (rh-HGF) for liver failure (LF) using meta-analysis of data from the literature involving available randomized controlled trials of rh-HGF plus comprehensive therapy (CT) compared with that of CT alone (Thera...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,meta分析
doi:10.1016/j.cct.2008.04.006
更新日期:2008-09-01 00:00:00
abstract::The convention in clinical trials is to regard outcomes as independently distributed, possibly conditional on covariates, but in some situations they may be correlated. For example, in infectious diseases, correlation may be induced if participants have contact with a common infectious source, or share hygienic tips t...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2014.08.001
更新日期:2014-09-01 00:00:00
abstract:BACKGROUND:Atorvastatin and metformin are known energy restricting mimetic agents that act synergistically to produce molecular and metabolic changes in advanced prostate cancer (PCa). This trial seeks to determine whether these drugs favourably alter selected parameters in men with clinically-localized, aggressive PCa...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2016.06.014
更新日期:2016-09-01 00:00:00
abstract::An instrumental variable (IV) estimator has been widely used to estimate causal effects among compliers in randomized trials with noncompliance. The estimator of complier average treatment effect can be expressed as a ratio of two unbiased estimators but the ratio estimator is not unbiased. The bias of IV estimator ca...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2012.03.013
更新日期:2012-07-01 00:00:00
abstract:BACKGROUND:With increased internet accessibility worldwide, it is now possible to assemble individuals with rare diseases through web-based patient registries. However, the validity of participant-reported medical diagnoses is unknown. The objective of this study was to evaluate the accuracy of participant-reported Neu...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2014.12.006
更新日期:2015-01-01 00:00:00
abstract::Lumbar spinal stenosis is a common degenerative disorder of the spine in elderly patients that can be effectively treated with decompression surgery in some patients. Radiological findings in the diagnostic work-up of the patients do not always correlate well with clinical symptoms, and guidance about when to proceed ...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2011.01.015
更新日期:2011-05-01 00:00:00
abstract::Slow or insufficient enrollment in clinical research and a high demand for research participants raises questions about the need for and use of incentives to participate, including payment. Much of the available literature on payment to research participants focuses on ethical concerns, and rarely addresses guidelines...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2012.05.001
更新日期:2012-09-01 00:00:00
abstract:BACKGROUND:Lifelong antiretroviral therapy (ART) (Option B+) is recommended for all HIV-infected pregnant/postpartum women, but high adherence is required to maximize HIV prevention potential and maintain maternal health. Mobile health (mHealth) interventions may provide treatment adherence support for women during, an...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2017.03.007
更新日期:2017-06-01 00:00:00
abstract::This pilot study examined knowledge, understanding and perceived acceptability of key methodological concepts in clinical trials among injecting drug users (IDUs) in Sydney, Australia. Participants were clinical trial-experienced (n = 17) and trial-naïve (n = 99) IDUs recruited from community needle and syringe progra...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2009.04.002
更新日期:2009-09-01 00:00:00