Abstract:
OBJECTIVES:The decision to make protocols of phase III randomized controlled trials (RCTs) publicly accessible by leading journals was a landmark event in clinical trial reporting. Here, we compared primary outcomes defined in protocols with those in publications describing the trials and in trial registration. STUDY DESIGN AND SETTING:We identified phase III RCTs published between January 1, 2012, and June 30, 2015, in The New England Journal of Medicine, The Lancet, The Journal of the American Medical Association, and The BMJ with available protocols. Consistency in primary outcomes between protocols and registries (articles) was evaluated. RESULTS:We identified 299 phase III RCTs with available protocols in this analysis. Out of them, 25 trials (8.4%) had some discrepancy for primary outcomes between publications and protocols. Types of discrepancies included protocol-defined primary outcome reported as nonprimary outcome in publication (11 trials, 3.7%), protocol-defined primary outcome omitted in publication (10 trials, 3.3%), new primary outcome introduced in publication (8 trials, 2.7%), protocol-defined nonprimary outcome reported as primary outcome in publication (4 trials, 1.3%), and different timing of assessment of primary outcome (4 trials, 1.3%). Out of trials with discrepancies in primary outcome, 15 trials (60.0%) had discrepancies that favored statistically significant results. Registration could be seen as a valid surrogate of protocol in 237 of 299 trials (79.3%) with regard to primary outcome. CONCLUSION:Despite unrestricted public access to protocols, selective outcome reporting persists in a small fraction of phase III RCTs. Only studies from four leading journals were included, which may cause selection bias and limit the generalizability of this finding.
journal_name
J Clin Epidemioljournal_title
Journal of clinical epidemiologyauthors
Zhang S,Liang F,Li Wdoi
10.1016/j.jclinepi.2017.07.010subject
Has Abstractpub_date
2017-11-01 00:00:00pages
87-94eissn
0895-4356issn
1878-5921pii
S0895-4356(16)30792-2journal_volume
91pub_type
杂志文章,评审abstract::Although case-crossover analyses have lately emerged as an alternative to case-control analyses in epidemiological studies, it is not yet known in which situations they give reliable conclusions. In this work, the case-crossover and the case-control designs were first compared on the basis of a dataset from a publishe...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/s0895-4356(01)00404-8
更新日期:2001-12-01 00:00:00
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-...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章,评审
doi:10.1016/j.jclinepi.2008.09.011
更新日期:2009-07-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:Podiatry (chiropody) services are one of the most frequently requested services in primary care. The elderly are given priority access to podiatry services in the UK blocking access for other priority groups. To evaluate the clinical and cost-effectiveness of a self-management program as a mea...
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(03)00197-5
更新日期:2003-11-01 00:00:00
abstract::Results from pragmatic trials should reflect the comparative treatment effects encountered in patients in real-life clinical practice to guide treatment decisions. Therefore, pragmatic trials should focus on outcomes that are relevant to patients, clinical practice, and treatment choices. This sixth article in the ser...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2016.12.022
更新日期:2017-10-01 00:00:00
abstract::To effectively evaluate medical literature, practicing physicians and medical researchers must understand the impact of statistical tests on research outcomes. Applying inefficient statistics not only increases the need for resources, but more importantly increases the probability of committing a Type I or Type II err...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/s0895-4356(98)00168-1
更新日期:1999-03-01 00:00:00
abstract:OBJECTIVES:The current format of summary of findings (SoFs) tables for presenting effect estimates and associated quality of evidence improve understanding and assist users finding key information in systematic reviews. Users of SoF tables have demanded alternative formats to express findings from systematic reviews. ...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.jclinepi.2015.12.007
更新日期:2016-06-01 00:00:00
abstract::How well can hospital discharge abstracts be used to estimate patient health status? This paper compares information on comorbidity obtained from hospital discharge abstracts for patients undergoing prostatectomy or cholecystectomy at a Winnipeg teaching hospital with clinical data on preoperative medical conditions p...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/0895-4356(91)90050-j
更新日期:1991-01-01 00:00:00
abstract::Toxic Oil Syndrome (TOS) is a previously unreported condition which affected more than 20,000 people in Spain in 1981 and whose natural history is unknown. In 1993-94, a stratified random sample of 1400 survivors was drawn to measure their health status through clinical examination and their self-perception of well-be...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/s0895-4356(98)00062-6
更新日期:1998-10-01 00:00:00
abstract:OBJECTIVES:The objective of the study was to describe and compare current practices in developing guidelines about the use of healthcare-related tests and diagnostic strategies (HCTDS). STUDY DESIGN AND SETTING:We sampled 37 public health and clinical practice guidelines about HCTDS from various sources without langua...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章,评审
doi:10.1016/j.jclinepi.2017.09.004
更新日期:2017-12-01 00:00:00
abstract:OBJECTIVE:To assess the consistency of an index of the scientific quality of research overviews. DESIGN:Agreement was measured among nine judges, each of whom assessed the scientific quality of 36 published review articles. ITEM SELECTION: An iterative process was used to select ten criteria relative to five key tasks...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章,meta分析
doi:10.1016/0895-4356(91)90205-n
更新日期:1991-01-01 00:00:00
abstract:OBJECTIVE:Adding risk factors to a prediction model often increases the area under the receiver operating characteristic curve (AUC) only slightly, particularly when the AUC of the model was already high. We investigated whether a risk factor that minimally improves the AUC may nevertheless improve the predictive abili...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2016.07.002
更新日期:2016-11-01 00:00:00
abstract:OBJECTIVE:Hypertension is a risk factor for aortic dissection. Besides hypertension, associated factors for incidence of aortic dissection are not clear. The aim of this study was to examine whether other factors exist by an epidemiologic case-control approach. STUDY DESIGN AND SETTING:240 consecutive cases suffering ...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2003.09.010
更新日期:2004-04-01 00:00:00
abstract::Efficient use of cholesterol measurements to screen for coronary heart disease in the elderly is not well defined. The purpose of this report is to examine such screening based on national guidelines in a sample of older men. Since relations between cholesterol and coronary heart disease are better established in thos...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/s0895-4356(99)00130-4
更新日期:1999-12-01 00:00:00
abstract:OBJECTIVES:Intervention Modeling Experiments (IMEs) are a way of developing and testing behavior change interventions before a trial. We aimed to test this methodology in a Web-based IME that replicated the trial component of an earlier, paper-based IME. STUDY DESIGN AND SETTING:Three-arm, Web-based randomized evaluat...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.jclinepi.2016.07.008
更新日期:2016-12-01 00:00:00
abstract::Previous work has suggested that recall bias in case-control studies may be more serious when the overall study quality is lower. This paper summarizes a systematic literature search to examine the question. All relevant studies published between 1966 and 1990 were included if they met the following criteria: (1) they...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/0895-4356(94)00132-a
更新日期:1995-02-01 00:00:00
abstract::Evaluating the incremental cost-effectiveness of a technology is critical to understanding the impact of its adoption. The purpose of this study was to evaluate, using a particular example, how the specific alternatives selected for a cost-effectiveness analysis may influence the results of the analysis. In this examp...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/s0895-4356(99)00021-9
更新日期:1999-06-01 00:00:00
abstract:OBJECTIVES:Meta-analyses inform clinical practice by summarizing treatment effect estimates based on results from several trials. However, the statistical significance of a meta-analysis (i.e., whether the pooled treatment effect is statistically significant or not) may rely on the outcome of only a few patients from s...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2019.03.012
更新日期:2019-07-01 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:OBJECTIVE:To investigate the behavior of predictive performance measures that are commonly used in external validation of prognostic models for outcome at intensive care units (ICUs). STUDY DESIGN AND SETTING:Four prognostic models (Simplified Acute Physiology Score II, the Acute Physiology and Chronic Health Evaluati...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2006.08.011
更新日期:2007-05-01 00:00:00
abstract:OBJECTIVE:To evaluate the mechanisms of action in two successful geriatric clinical trials that tested multicomponent physical conditioning programs and to determine whether the pathways for overall benefit were through improvement in physical ability and/or self-confidence. STUDY DESIGN AND SETTING:PREHAB and DRIVER ...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.jclinepi.2006.04.009
更新日期:2007-01-01 00:00:00
abstract::Dupuytren's disease or palmar fibromatosis is a common disabling hand disorder, mainly confined to Caucasians of northwestern European origin. The prevalence of Dupuytren's disease and possible risk factors related to the disease were evaluated in a random sample of 1297 males and 868 females, aged 46 to 74 years. Blo...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/s0895-4356(99)00145-6
更新日期:2000-03-01 00:00:00
abstract::Health screening is defined as the use of a test or a series of tests to detect unrecognized health risks or preclinical disease in apparently healthy populations to permit prevention and timely intervention. A health screening strategy consists of the sequence of a screening test, confirmatory test(s), and finally, t...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2010.09.009
更新日期:2011-03-01 00:00:00
abstract::In middle-aged people, social class is one of the strongest predictors of mortality. However, to date, research prospectively evaluating the relationship between social class and mortality in the older persons has produced conflicting results. This may be due to the lack of clinical covariates in many analyses. The ob...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/s0895-4356(02)00464-x
更新日期:2002-10-01 00:00:00
abstract:OBJECTIVE:Statistical interaction between a single, instantaneous exposure and attained age (age during follow-up; attained age = age at exposure + time since exposure) is used in risk analyses to assess potential effect modification by unmeasured factors correlated with age. However, the impact of such interaction on ...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2015.10.004
更新日期:2016-03-01 00:00:00
abstract:OBJECTIVES:The methodology for the critical assessment of medical interventions is well established. Regulatory agencies and institutions adhere, in principle, to the same standards. This consistency, however, is not always the case in practice. STUDY DESIGN AND SETTING:Using the evaluation of the CAPRIE (Clopidogrel ...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2009.10.009
更新日期:2010-12-01 00:00:00
abstract:OBJECTIVES:The aim of article was to assess the risk for random errors in outcomes graded as high certainty of evidence (CoE). STUDY DESIGN AND SETTING:We randomly selected 100 Cochrane reviews with dichotomous outcomes rated as high CoE using Grading of Recommendations Assessment, Development, and Evaluation. To dete...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2018.10.009
更新日期:2019-02-01 00:00:00
abstract:OBJECTIVE:Regression discontinuity (RD) is a quasi-experimental design that may provide valid estimates of treatment effects in case of continuous outcomes. We aimed to evaluate validity and precision in the RD design for dichotomous outcomes. STUDY DESIGN AND SETTING:We performed validation studies in three large ran...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2018.02.015
更新日期:2018-06-01 00:00:00
abstract::A key component in the evaluation of efficacy of a vaccine to protect against disease caused by an antigenically diverse infectious pathogen in a preventative vaccine trial is assessing how vaccine-induced protection depends on genotypic and phenotypic variations of the exposing pathogen. This assessment is made by co...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章,评审
doi:10.1016/s0895-4356(00)00258-4
更新日期:2001-01-01 00:00:00
abstract::The uses of hypothesis in scientific medicine and in clinical medicine are broadly similar; but they differ in subtle but important logical details. The key distinction is that scientific medicine deals with broad ("public") hypotheses about entire populations; and the predominant problem of inference is statistics in...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/0895-4356(89)90028-0
更新日期:1989-01-01 00:00:00
abstract::This study compared the utility of different health indicators in frail older people, as a component of a larger study of medical evaluations of 183 adult day care participants in five Maryland centers. Indices examined included: number of disease categories, number of active categories, number of severe categories, n...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/s0895-4356(01)00389-4
更新日期:2001-11-01 00:00:00