Abstract：
:Determining the quality of a randomized clinical trial (RCT) is necessary for decision-makers to determine the believability and applicability of the trial findings. Issues that are likely to affect the utility of RCT evidence include issues of bias, random error and applicability. In this article we focus primarily on issues of bias and examine the evidence for whether reporting methodological items, including allocation concealment, sequence generation, and blinding of participants can be relied upon as evidence of bias. We present the findings of a systematic review of meta-epidemiological studies and a simulation study demonstrating that commonly examined sources of bias likely play little role in treatment exaggeration. We discuss other issues that may additionally influence trial outcomes including sample size, publication bias, and expertise of trialists. We conclude by discussing strategies to moderate the effect of known biases in assessing overall estimates of treatment effects.
journal_name
Contemp Clin Trialsjournal_title
Contemporary clinical trialsauthors
Mills EJ,Ayers D,Chou R,Thorlund Kdoi
10.1016/j.cct.2015.07.019subject
Has Abstractpub_date
2015-11-01 00:00:00pages
2-7issue
Pt Aeissn
1551-7144issn
1559-2030pii
S1551-7144(15)30056-2journal_volume
45pub_type
杂志文章,评审abstract：BACKGROUND:Suboptimal diet and inactive lifestyle are among the most prevalent preventable causes of premature death. Interventions that target multiple behaviors are potentially efficient; however the optimal way to initiate and maintain multiple health behavior changes is unknown. OBJECTIVE:The Make Better Choices 2...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2015.01.009
更新日期：2015-03-01 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：:Obesity prevalence is higher in rural compared to urban residents. Rural health clinics offer a potential venue for delivery of weight management. However, traditional programs require travel to attend on-site meetings which is impractical or inconvenient for rural residents. Clinic staff in most rural settings are un...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2018.02.006
更新日期：2018-04-01 00:00:00
abstract：:Research indicates that exercise is an efficacious intervention for depression among adults; however, little is known regarding its efficacy for preventing postpartum depression. The Healthy Mom study was a randomized controlled trial examining the efficacy of an exercise intervention for the prevention of postpartum ...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2012.07.015
更新日期：2012-11-01 00:00:00
abstract：BACKGROUND:The comprehension of informed consent is an integral part of clinical trials. Though India is rapidly becoming a hub of clinical trials very few studies have dealt with the issue of comprehension of informed consent by the patients participating in these trials. METHODS:Patients who were invited to particip...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,多中心研究
doi：10.1016/j.cct.2009.03.005
更新日期：2009-09-01 00:00:00
abstract：:Managing chronic pain effectively is often challenging for health care providers and patients. Telehealth technologies can bridge geographic distance and improve patients' quality of care in communities where access to pain specialists has previously been unavailable. This paper describes the development and evaluatio...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2014.05.005
更新日期：2014-07-01 00:00:00
abstract：:Traditionally, children presenting with appendicitis are referred for urgent appendectomy. Recent improvements in the quality and availability of diagnostic imaging allow for better pre-operative characterization of appendicitis, including severity of inflammation; size of the appendix; and presence of extra-luminal i...
journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2019.06.013
更新日期：2019-08-01 00:00:00
abstract：BACKGROUND:Evidence suggests that periodontitis is associated with prevalent and incident type 2 diabetes mellitus (T2DM), raising the question of whether periodontitis treatment may improve glycemic control in patients with T2DM. Meta-analyses of mostly small clinical trials suggest that periodontitis treatment result...
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.2013.09.010
更新日期：2013-11-01 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:In the past 20-30 years, the prevalence of atopic diseases, particularly among children in the Western world, has increased. It has been suggested that Western lifestyle may have reduced the overall exposure to microbial stimulation early in life. The role of the gut flora in this connection has been studied...
journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2006.02.009
更新日期：2006-08-01 00:00:00
abstract：BACKGROUND:The FEVER (Frail Elderly Vibration Exercise Response) study aims to address a paucity of research focusing on the use of Whole Body Vibration (WBV) by frail elderly who, with the highest levels of dependence and fall-related hospitalisation/mortality, potentially stand to benefit most from such accessible ex...
journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2015.08.008
更新日期：2015-09-01 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：PURPOSE:The aims of the study protocol are to investigate different adapted physical training programs in patients with advanced lung cancer undergoing palliative chemo- or radiotherapy and to evaluate their effects on physical performance, quality of life, symptom burden, and efficacy of oncologic treatment. METHODS:...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2013.11.013
更新日期：2014-01-01 00:00:00
abstract：:Behavioral weight loss programs help people achieve clinically meaningful weight losses (8-10% of starting body weight). Despite data showing that only half of participants achieve this goal, a "one size fits all" approach is normative. This weight loss intervention science gap calls for adaptive interventions that pr...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2016.01.011
更新日期：2016-03-01 00:00:00
abstract：BACKGROUND:Medicaid recipients with serious mental illness die 25-30 years earlier than people in the general population due to health conditions that are modifiable through lifestyle changes. Cardiovascular diseases from excess weight, smoking, and sedentary lifestyle contribute substantially to this life expectancy d...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2019.04.005
更新日期：2019-06-01 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：PURPOSE:This article describes the protocol for a Hybrid Type I cost-effectiveness and implementation study of interpersonal psychotherapy (IPT) for men and women prisoners with major depressive disorder (MDD). The goal is to promote uptake of evidence-based treatments in criminal justice settings by conducting a rando...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2016.01.013
更新日期：2016-03-01 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：:Recruiting sufficient patients within an acceptable time horizon is an issue for most clinical trials and is especially challenging in the field of rare diseases. It is therefore an attractive option to include historical data from previous (pilot) trials in the current study thus reducing the recruitment burden. In c...
journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2017.07.013
更新日期：2017-12-01 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：: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：:Upstream interventions - e.g. housing programs and community health worker interventions- address socioeconomic and behavioral factors that influence health outcomes across diseases. Studying these types of interventions in clinical trials raises a methodological challenge: how should researchers measure the effect of...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2016.12.009
更新日期：2017-02-01 00:00:00
abstract：:Although the Diabetes Prevention Program (DPP) developed a lifestyle weight loss intervention that has been demonstrated to prevent type 2 diabetes in high-risk individuals, it has yet to be widely adopted at the community level. The Healthy Living Partnership to Prevent Diabetes study (HELP PD) was designed to transl...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2009.09.002
更新日期：2010-01-01 00:00:00
abstract：:A response-adaptive randomization (RAR) design refers to the method in which the probability of treatment assignment changes according to how well the treatments are performing in the trial. Holding the promise of treating more patients with the better treatments, RARs have been successfully implemented in clinical tr...
journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2014.11.006
更新日期：2015-01-01 00:00:00
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：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...
journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2013.02.011
更新日期：2013-05-01 00:00:00
abstract：:Establishing a holistic approach for the enrollment of subjects into clinical trials that includes strategies for the recruitment of non-traditional and minority populations has been an elusive task. The existence of such a design, that is understood and embraced by investigators and the target communities, would stre...
journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2007.11.003
更新日期：2008-07-01 00:00:00
abstract：:Numerous studies have attempted to identify successful dietary strategies for weight loss, and many have focused on Low-Fat vs. Low-Carbohydrate comparisons. Despite relatively small between-group differences in weight loss found in most previous studies, researchers have consistently observed relatively large between...
journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2016.12.021
更新日期：2017-02-01 00:00:00
abstract：BACKGROUND:The 9-valent human papillomavirus (HPV) (9vHPV) vaccine targets the four HPV types (6/11/16/18) covered by the licensed quadrivalent HPV (qHPV) vaccine and five additional types (31/33/45/52/58). A large outcome trial of 9vHPV vaccine was conducted. METHODS:An active control (qHPV vaccine) was used because ...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,多中心研究
doi：10.1016/j.cct.2015.02.009
更新日期：2015-05-01 00:00:00
abstract：UNLABELLED:Despite short-term efficacy, many weight loss studies demonstrate poor long-term results and have difficulty recruiting men. Cost-effective treatments that help men achieve long-term weight loss are required. Using a two-phase, assessor-blinded, parallel-group randomised controlled trial design this study wi...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2013.11.004
更新日期：2014-01-01 00:00:00
