Abstract:
OBJECTIVES:The STAndards for Reporting studies of Diagnostic accuracy (STARD) for investigators and editors and the Quality Assessment of Diagnostic Accuracy Studies (QUADAS) for reviewers and readers offer guidelines for the quality and reporting of test accuracy studies. These guidelines address and propose some solutions to two major threats to validity: spectrum bias and test review bias. STUDY DESIGN AND SETTING:Using a clinical example, we demonstrate that these solutions fail and propose an alternative solution that concomitantly addresses both sources of bias. We also derive formulas that prove the generality of our arguments. RESULTS:A logical extension of our ideas is to extend STARD item 23 by adding a requirement for multivariable statistical adjustment using information collected in QUADAS items 1, 2, and 12 and STARD items 3-5, 11, 15, and 18. CONCLUSION:We recommend reporting not only variation of diagnostic accuracy across subgroups (STARD item 23) but also the effects of the multivariable adjustments on test performance. We also suggest that the QUADAS be supplemented by an item addressing the appropriateness of statistical methods, in particular whether multivariable adjustments have been included in the analysis.
journal_name
J Clin Epidemioljournal_title
Journal of clinical epidemiologyauthors
Bachmann LM,ter Riet G,Weber WE,Kessels AGdoi
10.1016/j.jclinepi.2008.02.007subject
Has Abstractpub_date
2009-04-01 00:00:00pages
357-361.e2issue
4eissn
0895-4356issn
1878-5921pii
S0895-4356(08)00056-5journal_volume
62pub_type
杂志文章abstract:OBJECTIVE:Both randomized and observational studies commonly examine composite end points, but the literature on model development and criticism in this setting is limited. STUDY DESIGN AND SETTING:We examined approaches for evaluating heterogeneity in the effects of risk factors for different components of the end po...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2003.02.001
更新日期:2004-02-01 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::Studies predicting mortality after myocardial infarction (MI) usually rely on in-hospital data, and combine patients admitted for the first MI with recurrent MI patients. Since treatment decisions are often made or modified at the first outpatient clinic visit, this study was designed to evaluate the importance of pos...
journal_title:Journal of clinical epidemiology
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
doi:10.1016/s0895-4356(96)00221-1
更新日期:1996-11-01 00:00:00
abstract::More than one odds ratio estimate will often arise from a single epidemiologic study. Examples of designs where this may occur include those where there is more than one case or control group, and investigations of several risk factors as part of the same study. Various methods for presenting multiple interval estimat...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/0895-4356(89)90132-7
更新日期:1989-01-01 00:00:00
abstract:OBJECTIVES:The aim of this study was to evaluate how often the European Medicines Agency (EMA) has authorized drugs based on nonrandomized studies and whether there is an association between treatment effects and EMA preference for further testing in randomized clinical trials (RCTs). STUDY DESIGN AND SETTING:We revie...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章,评审
doi:10.1016/j.jclinepi.2018.01.011
更新日期:2018-06-01 00:00:00
abstract::For randomized trials that do not require prompt onset of therapy, a pre-admission preparation, called the qualification period, can deal with certain customary difficulties in design, analysis, and ethics. For the patients' baseline state, the qualification period can be used to "wash out" effects of previous treatme...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/0895-4356(91)90208-q
更新日期:1991-01-01 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::In a community based, prospective study to determine risk factors for falls, 465 women and 296 men 70 years and over were followed for 1 year and 507 falls were documented. A greater proportion of women (32.7%) than men (23.0%) experienced at least one fall in which there was no or minimal external contribution. Using...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/0895-4356(90)90110-b
更新日期:1990-01-01 00:00:00
abstract:OBJECTIVES:The aim of the study was to identify the range of issues labeled as "non-financial conflicts of interest" in biomedicine, articulate the associated concerns, and analyze the implications of defining these issues as conflicts of interest. STUDY DESIGN AND SETTING:This was a qualitative study, triangulating d...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2019.12.014
更新日期:2020-04-01 00:00:00
abstract:OBJECTIVES:N-of-1 trials can be aggregated to estimate population treatment effects using hierarchical Bayesian models. It is very important to report core items in hierarchical Bayesian analysis. In this study, we assessed reporting of items in hierarchical Bayesian analysis for aggregating N-of-1 trials to estimate p...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章,评审
doi:10.1016/j.jclinepi.2016.02.023
更新日期:2016-08-01 00:00:00
abstract::The duration of protection offered by Pap screening for cervical cancer was examined using data on 101 cases of invasive cervical cancer and 396 controls from a Maryland case-control study. Receipt of a Pap test up to 4 years ago afforded significant protection, compared to women screened 11 or more years ago, or neve...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/0895-4356(89)90166-2
更新日期:1989-01-01 00:00:00
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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::Measuring the effectiveness of cognitive rehabilitation programs poses both conceptual and practical challenges. We compared several standardized outcome measures with goal attainment scaling (GAS) to assess their sensitivity to changes in health status in patients undergoing cognitive rehabilitation. GAS is a measure...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/s0895-4356(97)00014-0
更新日期:1997-05-01 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
abstract:OBJECTIVES:In this article, we describe how to include considerations about resource utilization when making recommendations according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. STUDY DESIGN AND SETTINGS:We focus on challenges with rating the confidence in effect estima...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章,评审
doi:10.1016/j.jclinepi.2012.04.012
更新日期:2013-02-01 00:00:00
abstract::Our objective was to describe distortion in outcome studies due to "frailty bias" or differential susceptibility to adverse health outcomes due to frailties but attributed to other factors. We linked an administrative database to survey data (n = 5934) containing functional, condition, and outcome measures. The diseas...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/s0895-4356(99)00056-6
更新日期:1999-08-01 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: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
doi:10.1016/j.jclinepi.2018.05.022
更新日期:2018-10-01 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::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:BACKGROUND AND OBJECTIVE:Psychometrically sound questionnaires for the assessment of vision-related quality of life (QOL) are scarce. Therefore, the objective was to further validate two vision-related QOL questionnaires in a Dutch population of visually impaired elderly. METHODS:A total of 329 visually impaired older...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2005.04.007
更新日期:2005-12-01 00:00:00
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journal_title:Journal of clinical epidemiology
pub_type: 杂志文章,评审
doi:10.1016/j.jclinepi.2010.12.012
更新日期:2011-10-01 00:00:00
abstract::The Indonesian Food and Drug Agency began to evaluate drug applications in the early 1970s through an Advisory Committee. This was in response to the perestroika-like policy applied to our drug industry; nowadays there are more than 300 drug companies formulating some 13,5600 drug products. During 1977-1988, 603 drugs...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/0895-4356(91)90111-l
更新日期:1991-01-01 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::Early identification of pregnant women infected with the human immunodeficiency virus (HIV) is becoming increasingly important in light of recent findings that interventions during and shortly after pregnancy can reduce the rates of vertical transmission. The ability of patients to accurately self-report previous HIV ...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/s0895-4356(96)00301-0
更新日期:1997-01-01 00:00:00
abstract:OBJECTIVE:Asymptomatic peripheral arterial occlusive disease (PAOD) is a common atherosclerotic disorder among the elderly population. Scarce data are available on the risk of nonfatal and fatal cardiovascular diseases in these subjects. We investigated cardiovascular morbidity and mortality of asymptomatic PAOD subjec...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章,多中心研究
doi:10.1016/j.jclinepi.2003.09.003
更新日期:2004-03-01 00:00:00
abstract::Plasma fibrinogen was measured in a sample of 8824 men and women aged 40-59 years participating in the Scottish Heart Health Study, and related to cardiovascular risk factors. Women had higher fibrinogen levels than men. In both sexes, multivariate analysis showed that fibrinogen was positively associated with age, sm...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/0895-4356(90)90075-z
更新日期:1990-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:A large number of trials remain difficult to locate or unpublished for systematic reviews. The objective of this article was to determine the usefulness of making e-mail contact with authors of clinical trials and literature reviews found in MEDLINE to identify unpublished or difficult to locat...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章
doi:10.1016/j.jclinepi.2005.11.022
更新日期:2006-07-01 00:00:00
abstract:OBJECTIVES:Complex longitudinal sampling and the observational structure of patient registers in health services research are associated with methodological challenges regarding data management and statistical evaluation. We exemplify common pitfalls and want to stimulate discussions on the design, development, and dep...
journal_title:Journal of clinical epidemiology
pub_type: 杂志文章,多中心研究
doi:10.1016/j.jclinepi.2016.11.001
更新日期:2017-02-01 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