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. Among studies reporting methods to evaluate blinding effectiveness, many have compared groups with respect to the proportions correctly identifying their intervention at the end of the trial. Instead, we reasoned that participants' beliefs, and not their correctness, are more directly associated with potential bias, especially in relation to self-reported health outcomes. During the Water Evaluation Trial performed in northern California in 1999, we investigated blinding effectiveness by sequential interrogation of participants about their "blinded" intervention assignment (active or placebo). Irrespective of group, participants showed a strong tendency to believe they had been assigned to the active intervention; this translated into a statistically significant intergroup difference in the correctness of participants' beliefs, even at the start of the trial before unblinding had a chance to occur. In addition, many participants (31%) changed their belief during the trial, suggesting that assessment of belief at a single time does not capture unblinding. Sequential measures based on either two or all eight questionnaires identified significant group-related differences in belief patterns that were not identified by the single, cross-sectional measure. In view of the relative insensitivity of cross-sectional measures, the minimal additional information in more than two assessments of beliefs and the risk of modifying participants' beliefs by repeated questioning, we conclude that the optimal means of assessing unblinding is an intergroup comparison of the change in beliefs (and not their correctness) between the start and end of a randomized controlled trial.
journal_name
Contemp Clin Trialsjournal_title
Contemporary clinical trialsauthors
Rees JR,Wade TJ,Levy DA,Colford JM Jr,Hilton JFdoi
10.1016/j.cct.2004.11.020keywords:
subject
Has Abstractpub_date
2005-02-01 00:00:00pages
25-37issue
1eissn
1551-7144issn
1559-2030pii
S1551-7144(05)00015-7journal_volume
26pub_type
杂志文章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：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：:Large, "practical" or streamlined trials (LSTs) are used to study the effectiveness and/or safety of medicines in real world settings with minimal study imposed interventions. While LSTs have benefits over traditional randomized clinical trials and observational studies, there are inherent challenges to their conduct....
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.2012.12.001
更新日期：2013-03-01 00:00:00
abstract：:Cluster randomised controlled trials for health promotion, education, public health or organisational change interventions are becoming increasingly common to inform evidence-based policy. However, there is little published methodological evidence on recruitment strategies for primary care population clusters. In this...
journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2006.08.004
更新日期：2007-05-01 00:00:00
abstract：INTRODUCTION:In rural America cigarette smoking is prevalent, few cessation services are available, and healthcare providers lack the time and resources to help smokers quit. This paper describes the design and participant characteristics of Connect2Quit (C2Q), a randomized control trial (RCT) that tests the effectiven...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2014.04.008
更新日期：2014-07-01 00:00:00
abstract：:Physical therapy (PT) is a key component of treatment for knee osteoarthritis (OA) and can decrease pain and improve function. Given the expected rise in prevalence of knee OA and the associated demand for treatment, there is a need for models of care that cost-effectively extend PT services for patients with this con...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2012.12.007
更新日期：2013-03-01 00:00:00
abstract：:Interactive voice response (IVR) technology is a robust method of data collection that has been underutilized in behavioral medicine and clinical pharmacotherapy research. While it is clear that there is an increasing interest in this technology, published research in the medical field has not described its implementa...
journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2007.02.007
更新日期：2007-09-01 00:00:00
abstract：:In order to better characterize the safety profile of investigational new drugs (INDs) during clinical development, more interest and attention have been paid to ongoing safety monitoring and evaluation. The 2015 US FDA IND safety reporting draft guidance compels sponsors to periodically evaluate unblinded safety data...
journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2019.06.022
更新日期：2019-08-01 00:00:00
abstract：:Major depressive disorder (MDD) is the most common mental illness and the leading cause of disability worldwide. Electroconvulsive therapy (ECT) is the most effective treatment for MDD and the gold-standard therapy for treatment-resistant depression (TRD), yet it remains underutilized due to factors such as limited av...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2018.12.009
更新日期：2019-02-01 00:00:00
abstract：UNLABELLED:Fatigue is a common and distressing symptom that can last for months or years in up to one-third of cancer survivors. Despite its prevalence, the nature and mechanisms of cancer-related fatigue are poorly understood and the available treatments may not provide sufficient relief. Fatigue has been identified a...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2016.07.004
更新日期：2016-07-01 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：BACKGROUND:Extant obesity efforts have had a limited impact among low-income underserved children, in part because existing programs are limited in terms of their short duration and low dosage, limited accessibility and sustainability; and failure to address barriers faced by diverse low-income families. METHODS:This ...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2018.12.010
更新日期：2019-02-01 00:00:00
abstract：OBJECTIVE:Our goal is to test the efficacy of a family-based, multi-component intervention focused on infants of African-American (AA) mothers and families, a minority population at elevated risk for pediatric obesity, versus a child safety attention-control group to promote healthy weight gain patterns during the firs...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2017.06.002
更新日期：2017-09-01 00:00:00
abstract：BACKGROUND:Mindfulness-based relapse prevention (MBRP) is a method that combines cognitive behavioral relapse prevention with mindfulness practice. Research suggests that MBRP can effectively reduce withdrawal/craving in people with substance use disorder (SUD). An important part of MBRP is to practice mindfulness medi...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2018.04.006
更新日期：2018-07-01 00:00:00
abstract：BACKGROUND:Obesity, a disorder associated with a myriad of comorbidities, is increasing at an alarming rate around the world. Given that pharmacotherapy has limited available options and that bariatric surgery is reserved for those who are morbidly obese or who have significant comorbidities, the most common approach t...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2005.08.002
更新日期：2006-02-01 00:00:00
abstract：BACKGROUND:Thousands of people die annually from prescription opioid overdoses; however there are few strategies to ensure patients receive medication risk information at the time of prescribing. OBJECTIVES:To compare the effectiveness of the Emergency Department (ED) Electronic Medication Complete Communication (EMC2...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2017.05.003
更新日期：2017-08-01 00:00:00
abstract：:The HIV pandemic is a pressing threat to global public health; HIV vaccine development is critical. Clinical evaluation of HIV vaccine candidates differs from the standard therapeutics trial framework primarily due to the fact that healthy individuals are studied. We present an early stage evaluation program developed...
journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2005.11.008
更新日期：2006-04-01 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：:Dosing is potentially the most important decision that must be made when building or refining behavioral interventions. In this paper, we propose standardized terminology and reporting of dosing information, which would inform intervention development, refinement for dissemination, and systematic reviews of dose-respo...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,评审
doi：10.1016/j.cct.2012.07.011
更新日期：2012-11-01 00:00:00
abstract：BACKGROUND:Although individuals with psychiatric disorders are disproportionately affected by cigarette smoking, few outpatient mental health treatment facilities offer smoking cessation services. In this paper, we describe the development of a smartphone-assisted mindfulness smoking cessation intervention with conting...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2017.12.014
更新日期：2018-03-01 00:00:00
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：:The Rare Diseases Clinical Research Network (RDCRN) Contact Registry has grown in size and scope since it was first reported in this journal in 2007. In this paper, we reflect on our seven years' experience developing and expanding the RDCRN Contact Registry to include many more rare diseases. We present the functiona...
journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2012.02.012
更新日期：2012-07-01 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：:Ethically sound clinical research requires that prospective study participants provide voluntary informed consent before any study procedures begin. The original intent was to provide the participant with clear, accurate information about study specifics (e.g., risks/benefits) to aid in the decision to participate. Br...
journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2016.06.005
更新日期：2016-07-01 00:00:00
abstract：INTRODUCTION:Many low-income parent/caregivers do not understand the importance of cavity-free primary (baby) teeth and the chronic nature of dental caries (tooth decay). As a consequence, dental preventive and treatment utilization is low even when children are screened in schools and referred for care. This study aim...
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.2015.10.006
更新日期：2015-11-01 00:00:00
abstract：BACKGROUND:Cancer survivors suffer from long-term adverse effects that reduce health-related quality of life (QOL) and physical functioning, creating an urgent need to develop effective, durable, and disseminable interventions. Harvest for Health, a home-based vegetable gardening intervention, holds promise for these d...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2016.08.014
更新日期：2016-09-01 00:00:00
abstract：PURPOSE:African-American women (AAW) are more likely to be metabolically unhealthy than White women (WW). Metabolic syndrome (MetS) is associated with increased breast cancer risk and mortality from breast cancer is greater in AAW compared to WW. Data show MetS affects health-related quality of life (HRQoL). Exercise s...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2018.02.005
更新日期：2018-04-01 00:00:00
abstract：INTRODUCTION:Cardiac rehabilitation (CR) programs reduce overall and cardiovascular mortality in patients with a history of acute coronary events or revascularization procedures, but only 30% of patients enroll in CR and attrition rates reach up to 60%. Tai chi, a mind-body practice based on light/moderate aerobic exer...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2015.06.020
更新日期：2015-07-01 00:00:00
abstract：BACKGROUND:We evaluated the association of demographic and clinical characteristics with participation in an epidemiologic study of diabetes mellitus among youth. METHODS:SEARCH for Diabetes in Youth is a multicenter study of physician-diagnosed diabetes in youth under the age of 20 comprising a surveillance and a coh...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,多中心研究
doi：10.1016/j.cct.2008.05.008
更新日期：2008-11-01 00:00:00
abstract：BACKGROUND:Training non-specialist health workers (NSHWs) at scale is a major barrier to increasing the coverage of depression care in India. This trial will test the effectiveness of two forms of digital training compared to conventional face-to-face training in changing the competence of NSHWs to deliver a brief evid...
journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2021.106267
更新日期：2021-01-06 00:00:00
