Abstract：
:Hepatitis C virus (HCV) is a leading cause of chronic liver disease. The natural history of HCV infection is heterogeneous, and a person infected with HCV can clear the virus or progress to a chronic infection. The chronic infection can remain asymptomatic for decades before the development of liver cirrhosis and/or carcinoma. Currently, there are no assays that can differentiate a transient infection (an acute infection that would clear) from a chronic infection, and serial HCV RNA testing is used to operationally define chronic hepatitis C (e.g. detectable HCV over 6 months). Therefore, HCV vaccine trial planning can benefit from the assessment of the endpoint candidates that are aimed at the chronic infection. Operationally defined endpoints based on the virological tests at study visits have been previously studied in the context of human papillomavirus (HPV) vaccine trials. However, HCV natural history is different from HPV, requiring separate considerations. In this work, several definitions of chronic infection that are based on the periodically observed HCV RNA statuses are evaluated, using a multi-state, time-homogeneous Markov model for transient and chronic infections under various infection settings. Our results show some inflation in the type I error in the log-rank test on the vaccine efficacy against chronic infections in the presence of vaccine efficacy related to transient infections. A type I error up to almost four times the planned rate of 5% is observed in one setting. Overall, simple operational endpoints yield higher power than more complex endpoints, but the simplest endpoint is most affected by the type I error inflation and misclassification error due to the assay imperfection.
journal_name
Contemp Clin Trialsjournal_title
Contemporary clinical trialsauthors
Kang M,Nicolay Udoi
10.1016/j.cct.2008.03.006subject
Has Abstractpub_date
2008-09-01 00:00:00pages
671-8issue
5eissn
1551-7144issn
1559-2030pii
S1551-7144(08)00034-7journal_volume
29pub_type
杂志文章abstract：AIMS:To outline the study design, outcome measures, protocol and baseline characteristics of enrolled participants of Texas (TX) Sprouts, a one-year school-based gardening, nutrition, and cooking cluster randomized trial. METHODS:Eight schools were randomly assigned to the TX Sprouts intervention and eight schools to ...
journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2019.105834
更新日期：2019-10-01 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: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: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：:The Medication Adherence and BP Control Trial (ABC Trial) is a randomized, controlled, multi-site, medication adherence and blood pressure (BP) control trial in an economically disadvantaged and multi-cultural population of hypertensive patients followed in primary care practices. To date, no other such trial has been...
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：:If randomized controlled trials (RCTs) are to fulfill their potential to allow health care providers to make informed inferences about the validity of the trials upon which they base their clinical practice, then the reporting of key methodological factors must improve. The revised Consolidated Standards for Reporting...
journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2005.02.008
更新日期：2005-08-01 00:00:00
abstract：:Assessing the probability that a Phase III clinical trial will demonstrate clinically relevant efficacy based on Phase II data is an important topic in clinical drug development. An accurate estimate of how likely a Phase III trial will succeed based on available data will inform the decision on whether to move an exp...
journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2010.08.008
更新日期：2010-11-01 00:00:00
abstract：BACKGROUND:The addition of specialty palliative care to standard oncology care improves outcomes for patients with advanced cancer and their caregivers, but many lack access to specialty care services. Primary palliative care-meaning basic palliative care services provided by clinicians who are not palliative care spec...
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：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: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：:Although therapeutic treatments exist for substance use disorder (SUD), about half of individuals who enter treatment leave early and relapse to substance use. Early dropout from residential treatment places individuals at risk of relapse, and women in SUD residential treatment represent a vulnerable population. Evide...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2017.09.004
更新日期：2017-11-01 00:00:00
abstract：:The ability to recruit qualified subjects who are willing to adhere to the study protocol in clinical trials is an essential component of translational research. Such tasks can be particularly challenging for chemoprevention studies when the targeted study population is healthy, at risk individuals who do not have sig...
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
abstract：BACKGROUND:Many studies on the health effects of the glycemic index (GI) are confounded by differences in the intakes of other macronutrients and fibre. Little data exist about the within- and between-subject variability of the GI. OBJECTIVE:Our objectives were therefore (i) to calculate the GI of eight commonly used ...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2009.08.001
更新日期：2010-01-01 00:00:00
abstract：:Thirty percent of all military personnel smoke cigarettes. Because of the negative health consequences and their impact on physical fitness, overall health, and military readiness, the Department of Defense has identified the reduction of tobacco use as a priority of US military forces. This study aims to evaluate the...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2012.04.009
更新日期：2012-09-01 00:00:00
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 ar...
journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2020.106226
更新日期：2020-11-22 00:00:00
abstract：:Dyslipidemia and insulin resistance occur in a large proportion of HIV-infected patients treated with highly active antiretroviral therapy (HAART); anthropomorphic changes, such as lipoatrophy and central obesity, occur in a subset of patients. This cluster of clinical features, which is termed HIV lipodystrophy, plac...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2006.07.002
更新日期：2006-12-01 00:00:00
abstract：:It is of vital importance to the success of a randomized clinical trial to maintain the balance of baseline characteristics (covariates) that could potentially confound the outcomes of the trial. Various randomization methods have been proposed to increase the likelihood of having balanced covariates at the end of a t...
journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2011.03.004
更新日期：2011-07-01 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:Many of the health behaviors known to contribute to cardiometabolic risk and disease (CMRD), including physical activity, diet, sleep, and screen time, begin during childhood. Given the population-wide burden of CMRD, novel ways of assessing risk and providing feedback to support behavior change are needed. ...
journal_title：Contemporary clinical trials
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.cct.2016.07.012
更新日期：2016-07-01 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：:Parents of young children with type 1 diabetes (T1D) experience unique, developmental challenges in managing their child's T1D, resulting in psychosocial distress. Only a small portion of young children reach glucose goals and adherence to diabetes devices that help improve T1D management have historically been low in...
journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2019.05.008
更新日期：2019-07-01 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：INTRODUCTION:Robotic assistance during laparoscopic surgery for pelvic organ prolapse rapidly disseminated across the United States without level I data to support its benefit over traditional open and laparoscopic approaches [1]. This manuscript describes design and methodology of the Abdominal Colpopexy: Comparison o...
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.2012.05.007
更新日期：2012-09-01 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：:Benign prostatic hyperplasia (BPH) is a highly prevalent condition in aging men, which can be progressive and lead to acute urinary retention (AUR) and the need for surgery. It is commonly treated with alpha-blockers and 5alpha-reductase inhibitors (5ARIs), both of which improve the symptoms of BPH. Long-term treatmen...
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.2007.07.008
更新日期：2007-11-01 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：: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：:As a convention, a p-value is often computed in hypothesis testing and compared with the nominal level of 0.05 to determine whether to reject the null hypothesis. Although the smaller the p-value, the more significant the statistical test, it is difficult to perceive the p-value in a probability scale and quantify it ...
journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2015.07.001
更新日期：2015-09-01 00:00:00
abstract：:The fraction of patients who respond to treatment and the duration of response in the subset of responding patients are commonly evaluated in oncology trials of cytotoxic compounds. While formal, comparative analysis of the fraction of patients responding to treatment is straightforward in a randomised trial, analyses...
journal_title：Contemporary clinical trials
pub_type： 杂志文章
doi：10.1016/j.cct.2007.10.008
更新日期：2008-07-01 00:00:00
abstract：OBJECTIVE:To retrospectively analyze the effects of long-acting gonadotropin-releasing hormone agonist (GnRH-a) combined with transvaginal ultrasound-guided cyst aspiration on the pregnancy outcomes of in vitro fertilization-embryo transfer (IVF-ET) in the infertile patients with ovarian endometriosis. METHODS:The 134...
journal_title：Contemporary clinical trials
pub_type： 临床试验,杂志文章
doi：10.1016/j.cct.2012.07.009
更新日期：2012-11-01 00:00:00
