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 versus Aspirin in Patients at risk of Ischemic Events) trial by the British National Institute for Health and Clinical Excellence (NICE) and the German Institute for Quality and Efficiency in Health Care (IQWiG), we illustrate that there was no consensus for the interpretation of possible heterogeneity in treatment comparisons across subgroups. RESULTS:The NICE concluded that CAPRIE demonstrated clinical benefit for the overall intention-to-treat (ITT) population with sufficient robustness to possible sources of heterogeneity. The IQWiG interpreted the alleged heterogeneity as implying that the clinical benefit only applied to the subgroup of patients with a statistically significant result irrespective of the results of the ITT analysis. CONCLUSION:International standards for the performance and interpretation of subgroup analyses as well as for the assessment of heterogeneity between strata are needed.
journal_name
J Clin Epidemioljournal_title
Journal of clinical epidemiologyauthors
Hasford J,Bramlage P,Koch G,Lehmacher W,Einhäupl K,Rothwell PMdoi
10.1016/j.jclinepi.2009.10.009subject
Has Abstractpub_date
2010-12-01 00:00:00pages
1298-304issue
12eissn
0895-4356issn
1878-5921pii
S0895-4356(09)00365-5journal_volume
63pub_type
杂志文章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：:The evaluation of diagnostic tests attempts to obtain one or more statistical parameters which can indicate the intrinsic diagnostic utility of a test. Sensitivity, specificity and predictive value are not appropriate for this use. The likelihood ratio has been proposed as a useful measure when using a test to diagnos...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/0895-4356(88)90051-0
更新日期：1988-01-01 00:00:00
abstract：OBJECTIVES:The uncertainty around number needed to treat (NNT) is often represented through a confidence interval (CI). However, it is not clear how the CI can help inform treatment decisions. We developed decision-theoretic measures of uncertainty for the NNT. STUDY DESIGN AND SETTING:We build our argument on the bas...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/j.jclinepi.2012.01.022
更新日期：2012-08-01 00:00:00
abstract：:We investigated the value of the ankle-brachial systolic pressure index (ABPI) as a test for the diagnosis of peripheral arterial occlusive disease (PAOD) in general practice. ABPI measurements on 231 legs of 117 subjects performed in three general practice centers (GPC) were compared with the diagnostic conclusions o...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章,多中心研究
doi：10.1016/s0895-4356(96)00275-2
更新日期：1996-12-01 00:00:00
abstract：OBJECTIVE:Graphical methods for generating explanatory hypotheses from limited categorical data are described and illustrated. STUDY DESIGN AND SETTING:Univariate, bivariate, multivariate, and multiplicative graphical methods were applied to clinical data regarding very ill older persons. The data to which these metho...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/j.jclinepi.2011.06.007
更新日期：2012-02-01 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
abstract：:To investigate the possible association between changes in coffee consumption and serum cholesterol levels, information was obtained from 2109 healthy nonsmokers aged 25-65 years at two clinic visits to a preventive medical center between 1987 and 1991 (mean interval between visits: 16.7 months). After adjusting for a...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/0895-4356(95)00023-w
更新日期：1995-10-01 00:00:00
abstract：:The purpose of this study was to relate the 1-year risk of death and development of acute myocardial infarction among diabetics with acute chest pain to whether they had a history of hypertension or not. All patients with a history of diabetes mellitus who, during 21 months, were admitted to the Emergency Room in Sahl...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/0895-4356(94)90174-0
更新日期：1994-07-01 00:00:00
abstract：:With advances made in the treatment of people with HIV/AIDS, there is an increasing number of persons who are reaching old age. This is a heterogeneous group. Yet, all of these diverse patients share in common the challenge of aging successfully despite their condition. There is little room in most gerontological conc...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章,评审
doi：10.1016/s0895-4356(01)00447-4
更新日期：2001-12-01 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：:The purpose of this study was to describe patterns of health care use by inner-city patients with asthma and to identify patients at risk for hospitalization. We performed a retrospective cohort study of 1788 patients with asthma aged 5 to 34 years from a large hospital-based multi-specialty practice in inner-city Ind...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/s0895-4356(96)00333-2
更新日期：1997-02-01 00:00:00
abstract：:To assess the accuracy of Bayesian probability analysis for the prediction of coronary artery disease, post-test probabilities were generated by the application of three Bayesian algorithms to the clinical and noninvasive test results of 199 patients undergoing angiography in a veterans' hospital. All assumed conditio...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/0895-4356(88)90065-0
更新日期：1988-01-01 00:00:00
abstract：:Differences in the rate of metacarpal bone loss were evaluated in a 9 year population based follow-up study among 799 women initially aged 45-64 years, using initial and follow-up radiographs of the hands. Metacarpal bone loss started around the age of 50 years and was present in more than 95% of the women. The averag...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/0895-4356(90)90162-i
更新日期：1990-01-01 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:For people with dementia, the concept of quality of life (Qol) reflects the disease's impact on the whole person. Thus, Qol is an increasingly used outcome measure in dementia research. This systematic review was performed to identify available dementia-specific Qol measurements and to assess the quality of l...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章,评审
doi：10.1016/j.jclinepi.2015.08.002
更新日期：2016-02-01 00:00:00
abstract：OBJECTIVE:To systematically review methodological articles which focus on nonpublication of studies and to describe methods of detecting and/or quantifying and/or adjusting for dissemination in meta-analyses. To evaluate whether the methods have been applied to an empirical data set for which one can be reasonably conf...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章,评审
doi：10.1016/j.jclinepi.2016.04.015
更新日期：2016-12-01 00:00:00
abstract：OBJECTIVES:The massive growth in the publication of meta-analyses may cause redundancy and wasted efforts. We performed a metaepidemiologic study to evaluate the extent of potential redundancy in published meta-analyses in genetic epidemiology. STUDY DESIGN AND SETTING:Using a sample of 38 index meta-analyses of genet...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章,评审
doi：10.1016/j.jclinepi.2020.05.035
更新日期：2020-11-01 00:00:00
abstract：OBJECTIVES:To propose a multidimensional item response theory (MIRT) scoring system for the Short Form 12 (SF-12) with good psychometric properties in terms of fit and reliability. STUDY DESIGN AND SETTINGS:Two models, indicating physical (PCS) and mental component summary (MCS) dimensions, were fitted to SF-12 data f...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/j.jclinepi.2013.02.007
更新日期：2013-07-01 00:00:00
abstract：BACKGROUND AND OBJECTIVE:Hui and Walter developed a latent class approach to assess the accuracy of a diagnostic procedure when no reference test is available. Our objective was to compare sensitivity and specificity estimates obtained with this reference-free approach and standard approaches, and to examine how and wh...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/j.jclinepi.2004.10.021
更新日期：2005-07-01 00:00:00
abstract：INTRODUCTION:Weight loss interventions often present small mean weight changes over time, despite the fact that a substantial proportion of the participants lost more weight. This effect is often leveled out by the substantial proportion of participants who gained weight during the trial. The aim of this study is to id...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章,随机对照试验
doi：10.1016/j.jclinepi.2014.03.007
更新日期：2014-08-01 00:00:00
abstract：:We review methods for the analysis of categorical clinical and epidemiological data, in which the observations are subject to misclassification. Under certain conditions, it is possible to estimate error parameters such as sensitivity, specificity, relative risk, or predictive value, even though no definitive classifi...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章,评审
doi：10.1016/0895-4356(88)90110-2
更新日期：1988-01-01 00:00:00
abstract：:We investigated the relationship between antihypertensive drug treatment of hypertensives and their mean serum lipid concentrations in population based studies in Germany. Data from three surveys (Luebeck Blood Pressure Study (LBS) of 1984, MONICA Augsburg Survey I of 1984/85, MONICA Augsburg Survey II of 1989/90), ob...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/0895-4356(92)90204-z
更新日期：1992-12-01 00:00:00
abstract：OBJECTIVE:Secondary databases are used in descriptive studies of patient subgroups; evaluation of associations between individual characteristics and diagnosis, prognosis, and/or service utilization rates; and studies of the quality of health care delivered. This article identifies sources of bias for health state char...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/j.jclinepi.2006.08.012
更新日期：2007-07-01 00:00:00
abstract：:This paper focuses on the appropriateness of outcome measures to evaluate trauma care. The preventable death rate (PDR), based on the study of deceased patients only, has been the traditional measure of the impact of trauma care on improving the survival of patients with severe trauma. Another measure frequently used ...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/0895-4356(90)90125-9
更新日期：1990-01-01 00:00:00
abstract：OBJECTIVES:To determine the effectiveness of interventions designed to prevent or reduce publication and related biases. STUDY DESIGN AND SETTING:We searched multiple databases and performed manual searches using terms related to publication bias and known interventions against publication bias. We dually reviewed cit...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章,评审
doi：10.1016/j.jclinepi.2015.01.008
更新日期：2015-07-01 00:00:00
abstract：:The aim of this cross-sectional study was to estimate the prevalence of iron deficiency and overload in the adult population in Iceland, a developed Scandinavian country. The study population consisted of 4240 individuals aged 25-74 years randomly selected from the national roster. Basic hematological, S-iron, S-total...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/0895-4356(91)90090-v
更新日期：1991-01-01 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：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：OBJECTIVE:Traditionally, measures have been developed using classical test theory (CTT). This study examines the psychometrics of the PedsQL 4.0 Generic Core Scales (parent report) using a modern psychometric approach (i.e., Rasch analysis) to determine if further insight regarding the behavior of the measure can be ga...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章,多中心研究
doi：10.1016/j.jclinepi.2012.04.014
更新日期：2012-10-01 00:00:00
abstract：OBJECTIVES:To illustrate how multiple hypotheses testing can produce associations with no clinical plausibility. STUDY DESIGN AND SETTING:We conducted a study of all 10,674,945 residents of Ontario aged between 18 and 100 years in 2000. Residents were randomly assigned to equally sized derivation and validation cohort...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/j.jclinepi.2006.01.012
更新日期：2006-09-01 00:00:00
