Abstract：
OBJECTIVES:Adjudication committees (ACs) are recommended in randomized controlled trials (RCTs) to standardize the assessment of events. We aimed to assess the reporting and functioning of ACs (synonyms: clinical event committees, endpoint committees) in clinical trials. STUDY DESIGN AND SETTING:We searched five high-impact-factor medical journals for reports of RCTs with clinical event endpoints published between January 1, 2004 and December 31, 2005. RESULTS:ACs were reported in 33.4% of the 314 reports of RCTs. ACs were reported in 29.6% of trials with low risk of misclassification (i.e., "hard" main outcome), in 47.5% of trials with medium risk of misclassification (i.e., subjective main outcome and intervention delivered in a blinded fashion) and in 31% of trials with high risk of misclassification (i.e., subjective main outcome without intervention delivered in a blinded fashion). Selected cases to be adjudicated consisted largely of events identified by site investigators (93.3%). Data provided to the AC were reported for 47.4% of ACs. CONCLUSION:Reporting of ACs is not fitted to the risk of biased misclassification. Important aspects of the functioning of ACs are insufficiently reported or raise methodological issues. We propose some recommendations for planning and reporting ACs in clinical trials.
journal_name
J Clin Epidemioljournal_title
Journal of clinical epidemiologyauthors
Dechartres A,Boutron I,Roy C,Ravaud Pdoi
10.1016/j.jclinepi.2008.09.011subject
Has Abstractpub_date
2009-07-01 00:00:00pages
695-702issue
7eissn
0895-4356issn
1878-5921pii
S0895-4356(08)00274-6journal_volume
62pub_type
杂志文章,评审abstract：:For deaths during the first 13 years of follow-up of the Minnesota Colon Cancer Control Study, an expert committee using numerous medical documents, and a nosologist using only the death certificate independently determined whether colorectal cancer caused the death and, if not, whether the disease was present at deat...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/s0895-4356(99)00016-5
更新日期：1999-05-01 00:00:00
abstract：:Nonresponse and methods of data collection could affect satisfaction measurement. The goal of this study was to estimate the impact of (1) nonresponse and (2) distribution method on evaluation of patient satisfaction in a mail-back study measuring patient opinion of medical and nursing care. The study was conducted in...
journal_title：Journal of clinical epidemiology
pub_type： 临床试验,杂志文章,随机对照试验
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更新日期：2001-11-01 00:00:00
abstract：OBJECTIVE:To assess the effects of abbreviated literature searches on evidence syntheses conclusions. STUDY DESIGN AND SETTING:We randomly selected 60 Cochrane reviews of clinical interventions and repeated literature searches using 14 abbreviated approaches (combinations of MEDLINE, Embase, CENTRAL with and without s...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章,meta分析
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更新日期：2018-10-01 00:00:00
abstract：OBJECTIVES:This study investigated trial consultations to identify whether and to what extent discussions of retention are present. STUDY DESIGN AND SETTING:This embedded mixed-methods study design included a purposive sample of audio-recorded trial consultations obtained from four sites of a large multicenter UK-base...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/j.jclinepi.2020.03.011
更新日期：2020-07-01 00:00:00
abstract：OBJECTIVES:To assess how trial information reported in conference abstracts differs to their subsequent full publication. METHODS:Randomized trials reported at the American Society of Clinical Oncology conference (1992) were identified. CENTRAL and PubMed (December 2002) were searched to identify corresponding full pu...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/j.jclinepi.2005.09.016
更新日期：2006-07-01 00:00:00
abstract：:The aim was to assess relationships between increased aerobic fitness sustained over 4 years, and changes in blood pressure (SBP and DBP) and lipids. Measurements were made of BP, lipids, weight, and fitness in 1000 middle-aged men and women entering a fitness programme, and were repeated 2 and 4 years later. The 342 ...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/0895-4356(93)90052-3
更新日期：1993-02-01 00:00:00
abstract：OBJECTIVE:Lower levels of serum albumin are associated with increased risk of all-cause and cardiovascular mortality as well as with coronary heart disease and stroke incidence. These relationships have been examined with specific focus on the role of cigarette smoking. STUDY DESIGN AND SETTING:A prospective study of ...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/j.jclinepi.2003.07.001
更新日期：2004-02-01 00:00:00
abstract：OBJECTIVES:It is difficult to compare the reliability of triage systems with the kappa statistic. In this article, a method for comparing triage systems was developed and applied to previously conducted triage reliability studies. STUDY DESIGN AND SETTING:From simulations with theoretical distributions, the minimum, n...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章,评审
doi：10.1016/j.jclinepi.2010.01.012
更新日期：2010-11-01 00:00:00
abstract：OBJECTIVES:Case-mix adjustment is difficult for stroke outcome studies using administrative data. However, relevant prescription, laboratory, procedure, and service claims might be surrogates for stroke severity. This study proposes a method for developing a stroke severity index (SSI) by using administrative data. ST...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/j.jclinepi.2015.01.009
更新日期：2015-11-01 00:00:00
abstract：OBJECTIVES:The aim of this study was to reanalyze and reinterpret data obtained in Paracetamol in Acute Low Back Pain (PACE), the first large randomized controlled trial evaluating the efficacy of paracetamol in acute low back pain, to assess the inferential reproducibility of the original conclusions. STUDY DESIGN AN...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章,多中心研究,随机对照试验
doi：10.1016/j.jclinepi.2020.01.010
更新日期：2020-05-01 00:00:00
abstract：:The study assesses the reliability, validity and responsiveness of the UK version of the Seattle Angina Questionnaire (SAQ-UK). The instrument was anglicised and administered by self-completed postal questionnaire to 959 patients recruited from general practices in the North East of England. A total of 655 (68.3%) pat...
journal_title：Journal of clinical epidemiology
pub_type： 临床试验,杂志文章,随机对照试验
doi：10.1016/s0895-4356(01)00352-3
更新日期：2001-09-01 00:00:00
abstract：BACKGROUND:Chronic kidney disease (CKD) is a global health concern that is increasing mainly as the result of increasing incidences of diabetes and hypertension. Furthermore, if left untreated, individuals with CKD may progress to end-stage kidney failure. Identifying individuals with undiagnosed CKD or those who are a...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章,评审
doi：10.1016/j.jclinepi.2012.06.020
更新日期：2013-03-01 00:00:00
abstract：OBJECTIVE:The Kaplan-Meier method may overestimate absolute mortality risk (AMR) in the presence of competing risks. Urgent heart transplantation (UHT) and ventricular assist device implantation (VADi) are important competing events in heart failure. We sought to quantify the extent of bias of the Kaplan-Meier method i...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/j.jclinepi.2018.07.006
更新日期：2018-11-01 00:00:00
abstract：:Community intervention evaluations that measure changes over time may conduct repeated cross-sectional surveys, follow a cohort of residents over time, or (often) use both designs. Each survey design has implications for precision and cost. To explore these issues, we assume that two waves of surveys are conducted, an...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/0895-4356(95)00055-0
更新日期：1995-12-01 00:00:00
abstract：BACKGROUND AND OBJECTIVES:Methods to identify studies for systematic reviews of diagnostic accuracy are less well developed than for reviews of intervention studies. This study assessed (1) the sensitivity and precision of five published search strategies and (2) the reliability and accuracy of reviewers screening the ...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/j.jclinepi.2004.09.011
更新日期：2005-05-01 00:00:00
abstract：OBJECTIVES:The aim of this study was to evaluate how frequently complex interventions are shown to be superior to routine care in general practice-based cluster-randomized controlled studies (c-RCTs) and to explore whether potential differences explain results that come out in favor of a complex intervention. STUDY DE...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章,评审
doi：10.1016/j.jclinepi.2017.10.010
更新日期：2018-02-01 00:00:00
abstract：OBJECTIVES:To recommend methodological standards in the prevention and handling of missing data for primary patient-centered outcomes research (PCOR). STUDY DESIGN AND SETTING:We searched National Library of Medicine Bookshelf and Catalog as well as regulatory agencies' and organizations' Web sites in January 2012 for...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章,评审
doi：10.1016/j.jclinepi.2013.08.013
更新日期：2014-01-01 00:00:00
abstract：OBJECTIVES:To assess differences between three different decision-making approaches in the method of panel diagnosis as reference standard in diagnostic research. STUDY DESIGN AND SETTING:Within a diagnostic study, the prevalence of heart failure (HF) and chronic obstructive pulmonary disease (COPD) was compared using...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/j.jclinepi.2014.09.020
更新日期：2015-04-01 00:00:00
abstract：:Many longitudinal studies attempt to examine changes in outcome measures over time in groups of patients. Applying conventional analytic techniques, such as a single classical linear regression model, to these data will often not result in minimum variance estimates, and may affect the results of tests of significance...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/0895-4356(93)90038-3
更新日期：1993-07-01 00:00:00
abstract：BACKGROUND AND OBJECTIVE:The prospective investigation of repetitive nonfatal suicidal behavior is associated with two methodological problems. Due to the commonly used definitions of nonfatal suicidal behavior, clinical samples usually consist of patients with a considerable between-person variability. Second, repeate...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/j.jclinepi.2005.10.010
更新日期：2006-06-01 00:00:00
abstract：:Clinimetrics is a methodologic discipline that focuses on the quality of clinical measurements, for example, diagnostic characteristics and disease outcomes. Different clinimetric properties, such as reproducibility and responsiveness, are important in both the development and the evaluation of measurement instruments...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/j.jclinepi.2003.08.012
更新日期：2003-12-01 00:00:00
abstract：:Pierre Charles Alexandre Louis (1787-1872) has been the direct or indirect mentor of influential U.S. and English scientists in public health, epidemiology, medicine, and biostatistics during the 19th and 20th century. Louis was primarily a clinician, but his name has been more closely associated with the history of e...
journal_title：Journal of clinical epidemiology
pub_type： 传,历史文章,杂志文章
doi：10.1016/s0895-4356(96)00294-6
更新日期：1996-12-01 00:00:00
abstract：:Antiretroviral therapy (ART) use was examined in a cohort of homosexual men infected with HIV-1 for long periods. Multivariate logistic regression models, stratified by clinical indication (below and above 500 CD4 cells/microl or prior AIDS), were used to determine predictors of ART naivete. Of the 673 men seen at vis...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/s0895-4356(00)00274-2
更新日期：2001-02-01 00:00:00
abstract：:Moderate consumers of alcohol have lower mortality than either nondrinkers or heavy drinkers. This systematic review aimed to quantify the level of alcohol consumption (termed the nadir) at which the lowest mortality occurs. Twenty cohort studies reported analyses of all-cause mortality for at least three categories o...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章,meta分析
doi：10.1016/s0895-4356(99)00076-1
更新日期：1999-10-01 00:00:00
abstract：OBJECTIVES:To evaluate whether noninferiority trials are designed to adequately preserve the historical treatment effect of their active comparators. STUDY DESIGN AND SETTING:We reviewed 162 noninferiority trials published in high-impact medical journals. We assessed whether trials were designed to ensure that interve...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章,评审
doi：10.1016/j.jclinepi.2019.03.003
更新日期：2019-06-01 00:00:00
abstract：OBJECTIVE:To develop a questionnaire with which to measure quality of life (QoL) in patients with knee and hip osteoarthritis (OA). STUDY DESIGN AND SETTING:Thirty-two caregivers and 96 OA patients were interviewed individually (using cognitive and face-to-face techniques) and in focus groups. A group of experts worki...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章,多中心研究
doi：10.1016/j.jclinepi.2004.04.011
更新日期：2005-01-01 00:00:00
abstract：OBJECTIVE:Treatments may be more effective in some patients than others, and individual participant data (IPD) meta-analysis of randomized trials provides perhaps the best method of investigating treatment-covariate interactions. Various methods are used; we provide a comprehensive critique and develop guidance on meth...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章,评审
doi：10.1016/j.jclinepi.2010.11.016
更新日期：2011-09-01 00:00:00
abstract：:To investigate reproductive maternal risk factors of intrapartum fetal asphyxia, we analyzed 556 women with singleton pregnancies complicated by intrapartum fetal asphyxia who gave birth at Kuopio University Hospital from January 1990 to December 1998. The general obstetric population (N=21746) was selected as the ref...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/s0895-4356(00)00329-2
更新日期：2001-04-01 00:00:00
abstract：OBJECTIVE:To assess the extent to which meta-analysis publications of drugs and biologics focus on specific named agents or even only a single agent, and identify characteristics associated with such focus. STUDY DESIGN AND SETTING:We evaluated 499 articles with meta-analyses published in 2010 and estimated how many d...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章,评审
doi：10.1016/j.jclinepi.2012.10.014
更新日期：2013-04-01 00:00:00
abstract：OBJECTIVE:Exposure to ultraviolet radiation has consistently been linked to an increased risk of melanoma. Epidemiologic studies are susceptible to measurement error, which can distort the magnitude of observed effects. Although the reliability of self-report of many sun exposure factors has been previously described i...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/j.jclinepi.2004.09.004
更新日期：2005-04-01 00:00:00
