Abstract：
:Missing data is common in clinical trials. Depending on the volume and nature of missing data, it may reduce statistical power for detecting treatment difference, introduce potential bias and invalidate conclusions. Non-responder imputation (NRI), where patients with missing information to determine endpoint status are considered as treatment failures, is widely used to handle missing data for dichotomous efficacy endpoints in inflammatory bowel disease (IBD) trials. However, it does not consider the mechanisms leading to missing data and can potentially underestimate the treatment effect. We proposed a hybrid imputation approach combining NRI and multiple imputation (MI) as an alternative to NRI to assess the impact of dropouts for different missing data mechanisms (categorized as "missing not at random [MNAR]" and "missing at random [MAR]"). Two phase 3 vedolizumab clinical trials under different study designs in patients with moderate-to-severe ulcerative colitis (UC), VISIBLE 1 and VARSITY, are presented to illustrate how the proposed hybrid approach can be implemented as a pre-specified sensitivity analysis in practice. The proposed hybrid imputation provided consistent efficacy results with those using NRI, and can serve as a useful pre-specified sensitivity analysis to assess the impact of dropouts under different missing data mechanisms and evaluate the robustness of efficacy conclusions.
journal_name
Contemp Clin Trialsjournal_title
Contemporary clinical trialsauthors
Chen J,Hunter S,Kisfalvi K,Lirio RAdoi
10.1016/j.cct.2020.106226subject
Has Abstractpub_date
2020-11-22 00:00:00pages
106226eissn
1551-7144issn
1559-2030pii
S1551-7144(20)30304-9journal_volume
100pub_type
杂志文章abstract：OBJECTIVE:To explore a better administration way through comparison of the pharmacodynamics of cisatracurium administered by continuous infusion or intermittent bolus injection. METHODS:Thirty patients (ASAI-II) who had no neuromuscular disease and underwent selective surgery under general anesthesia were randomly div...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2012.01.002
更新日期：2012-05-01 00:00:00
abstract：:The combined use of cigarettes and alcohol is associated with an increased risk of morbidity and mortality. Yet, efficacious interventions that address both behaviors concurrently are lacking. Smoking cessation and alcohol modification not only garner health benefits, but there is also value in addressing alcohol use ...
journal_title：Contemporary clinical trials
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doi：10.1016/j.cct.2020.106218
更新日期：2020-11-14 00:00:00
abstract：:The Flexibility, Toning, and Balance (FlexToBa) Trial is a two-armed randomized controlled trial which will contrast the effects of a DVD-delivered, home-based, physical activity intervention and a Healthy Aging attention control condition on physical activity, functional performance, functional limitations, and quali...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,多中心研究,随机对照试验
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abstract：BACKGROUND:Patients with high blood pressure (BP) visit a physician an average of 4 times or more per year in the U.S., yet BP is controlled in fewer than half. Practical, robust and sustainable models are needed to improve BP in patients with uncontrolled hypertension. OBJECTIVES:The Home Blood Pressure Telemonitorin...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2012.03.014
更新日期：2012-07-01 00:00:00
abstract：OBJECTIVE:Maternal adiposity confers an increased risk of GDM in pregnancy. A low glycemic index (GI) dietary intervention has been found to improve glucose homeostasis and reduce gestational weight gain. Mobile Health (mHealth) Technology-assisted interventions are becoming commonplace as an aid to treating many chron...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2015.11.018
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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:Primary and secondary progressive multiple sclerosis (MS), collectively called progressive multiple sclerosis (PMS), is characterized by gradual progression of disability. The current anti-inflammatory treatments for MS have little or no efficacy in PMS in the absence of obvious active inflammation. Optimal ...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2016.08.009
更新日期：2016-09-01 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：: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
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journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2018.10.013
更新日期：2019-01-01 00:00:00
abstract：BACKGROUND:Despite efforts by the U.S. Department of Defense to train behavioral health (BH) providers in evidence-based psychotherapies (EBPs) for posttraumatic stress disorder (PTSD), numerous barriers limit EBP implementation. A context-tailored implementation approach called TACTICS (Targeted Assessment and Context...
journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2020.106008
更新日期：2020-06-01 00:00:00
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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: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
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journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2009.05.004
更新日期：2009-09-01 00:00:00
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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.2017.02.009
更新日期：2017-05-01 00:00:00
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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.2007.01.003
更新日期：2007-07-01 00:00:00
abstract：BACKGROUND:Extended-release naltrexone (XR-NTX, Vivitrol; Alkermes Inc.) is an injectable monthly sustained-release mu opioid receptor antagonist. XR-NTX is a potentially effective intervention for opioid use disorders and as relapse prevention among criminal justice system (CJS) populations. METHODS:This 5-site open-...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2015.01.005
更新日期：2015-03-01 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
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journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2011.01.015
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journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2019.06.001
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journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2017.01.005
更新日期：2017-03-01 00:00:00
abstract：:Clinical trial is considered a breakthrough method in medicine and essential to the development of new drugs. Clinical trials that comply with international and national regulations require an appropriate infrastructure and team qualification. The goal of this study was to evaluate clinical trial groups in Brazil: pro...
journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2010.06.002
更新日期：2010-09-01 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：: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 o...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,评审
doi：10.1016/j.cct.2015.07.019
更新日期：2015-11-01 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：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：: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：BACKGROUND:Although people who inject drugs (PWID) having the highest incidence and prevalence of hepatitis C virus (HCV) in the US, HCV treatment is rarely provided to PWID due to assumptions about poor adherence and reinfection risk. As direct-acting antiviral agents (DAAs) have achieved sustained virologic response ...
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.2019.105859
更新日期：2019-12-01 00:00:00
abstract：BACKGROUND:Despite significant advancements in psychopharmacology, treating major depressive disorder (MDD) is still a challenge considering the efficacy, tolerability, safety, and economical costs of most antidepressant drugs. One approach that has been increasingly investigated is modulation of cortical activity with...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2010.09.007
更新日期：2011-01-01 00:00:00
abstract：:College student alcohol use and associated negative consequences are clear public health problems with consequences including damage to self, others, and institutions. This paper describes the protocol of a research study designed to answer a number of important questions in the development of an adaptive preventive i...
journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2020.106089
更新日期：2020-09-01 00:00:00
