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 comparing pathogen isolates between infected vaccinated subjects and infected unvaccinated subjects. A survey of efficacy trial reports reveals a lack of systematic, quantitative investigation in this question. Analysis tools for testing if vaccine protection against disease is superior against some pathogen strains, and for estimating the magnitude of this differential vaccine protection, are described. The broad applicability of the methods is illustrated through analysis of isolates taken from persons infected while participating in vaccine trails for cholera, HIV-1, hepatitis B, rotavirus, and pneumococcus. These analyses reveal intriguing trends for Genentech's monovalent rgp120 HIV-1 vaccine, for two whole-killed-cell oral cholera vaccines, and for other vaccines.
journal_name
J Clin Epidemioljournal_title
Journal of clinical epidemiologyauthors
Gilbert P,Self S,Rao M,Naficy A,Clemens Jdoi
10.1016/s0895-4356(00)00258-4subject
Has Abstractpub_date
2001-01-01 00:00:00pages
68-85issue
1eissn
0895-4356issn
1878-5921pii
S0895-4356(00)00258-4journal_volume
54pub_type
杂志文章,评审abstract：:Occasionally, the efficacy of screening for cancer recurrence has been evaluated by means of case-control studies. However, these studies generally have not been designed and analyzed in a manner that will yield an unbiased result. The commentary shows that by adhering to the principles developed for the analysis of s...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/j.jclinepi.2010.07.013
更新日期：2011-01-01 00:00:00
abstract：OBJECTIVES:To study the statistical power of randomized clinical trials and examine developments over time. STUDY DESIGN AND SETTING:We analyzed the statistical power in 136,212 clinical trials between 1975 and 2014 extracted from meta-analyses from the Cochrane database of systematic reviews. We determined study powe...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/j.jclinepi.2018.06.014
更新日期：2018-10-01 00:00:00
abstract：:This study reports the use of psychotropic drugs and pregnancy outcome in a prospective survey carried out in northern Finland in 1985-1986, consisting of 7933 pregnant women and their 8030 births. Of the mothers, 120 (1.5%) used psychotropic drugs during pregnancy and of them 26 (0.3% of the total) used these drugs b...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/s0895-4356(96)00203-x
更新日期：1996-11-01 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：:A prospective study on the effects of occupational and individual factors on neck trouble was carried out among 1832 men representing static work with whole-body vibration (machine operators), dynamic physical work (construction carpenters) and sedentary work (office workers). Neck trouble and occupational and individ...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/0895-4356(94)90085-x
更新日期：1994-12-01 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：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：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：: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：:Pragmatic trials aim to inform clinical decision making by measuring the effect of a treatment in clinical practice. The purpose of the PRECIS-2 tool is to support in designing a truly pragmatic trial. We comment on a study by Forbes et al., who assessed the applicability of the PRECIS-2 tool. The tool will prove part...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/j.jclinepi.2017.06.006
更新日期：2017-10-01 00:00:00
abstract：:Information concerning people's relative preferences for health care outcomes is usually obtained using questionnaires which ask subjects to imagine health states of various kinds. When using illness- or treatment-specific states, elaborate descriptions of patients' quality of life may adequately convey to the rater a...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/0895-4356(92)90083-y
更新日期：1992-03-01 00:00:00
abstract：OBJECTIVES:To explore how the concept of randomization is described by clinicians and understood by patients in randomized controlled trials (RCTs) and how it contributes to patient understanding and recruitment. STUDY DESIGN AND SETTING:Qualitative analysis of 73 audio recordings of recruitment consultations from fiv...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章,多中心研究
doi：10.1016/j.jclinepi.2018.02.018
更新日期：2018-07-01 00:00:00
abstract：BACKGROUND AND OBJECTIVE:Novel cancer therapies are often approved with evidence from a single pivotal trial alone. There are concerns about the credibility of this evidence. Higher validity may be indicated by five methodological and statistical characteristics of pivotal trial evidence that were described by the U.S....
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/j.jclinepi.2019.05.033
更新日期：2019-10-01 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：: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：:Cross-sectional data from the Epidemiology of Diabetes Complications Study were used to examine the relationships between waist to hip circumference ratio (WHR) and the presence of diabetes complications in IDDM adults ages 18-45 years (N = 586). Significantly higher WHRs were observed among both genders with prolifer...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/0895-4356(94)90291-7
更新日期：1994-05-01 00:00:00
abstract：:The different measurement properties necessary for instruments whose goal is to detect differences between subjects at a single point in time (discriminative instruments) and those whose goal is to detect longitudinal change within subjects (evaluative instruments) is becoming increasingly recognized. Up to now, requi...
journal_title：Journal of clinical epidemiology
pub_type： 评论,杂志文章
doi：10.1016/0895-4356(92)90194-r
更新日期：1992-12-01 00:00:00
abstract：OBJECTIVES:To determine which factors predict favorable results and positive conclusions in systematic reviews (SRs) and to assess the level of agreement between SR results and conclusions. STUDY DESIGN AND SETTING:A sample of 296 English SRs indexed in MEDLINE (November, 2004) was obtained. Two investigators independ...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/j.jclinepi.2008.08.008
更新日期：2009-04-01 00:00:00
abstract：:Sun sensitivity is a major risk factor for melanoma, basal cell carcinoma, and squamous cell carcinoma of the skin. Several variables have been used in epidemiologic studies to measure sun sensitivity. The present study assesses their validity and combines them to form a prediction rule for an objective measure of sun...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/0895-4356(92)90104-u
更新日期：1992-05-01 00:00:00
abstract：OBJECTIVE:Risk difference (RD) is often estimated from relative association measures generated by meta-analysis and a particular group's baseline risk. We describe a problematic situation in using this approach. STUDY DESIGN AND SETTING:We encountered a meta-analysis in which a confidence interval (CI) of relative ris...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/j.jclinepi.2008.11.005
更新日期：2009-08-01 00:00:00
abstract：OBJECTIVE:To examine the impact of changes in comorbidity--as measured by the Charlson comorbidity index--on self-rated health in a large sample of community-dwelling elderly over a 1-year period, and to examine the differential effects of changes in specific Charlson diagnostic categories. STUDY DESIGN AND SETTING:Lo...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/j.jclinepi.2008.05.009
更新日期：2009-02-01 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：:Trialists argue about the usefulness of stratified randomization. For investigators designing trials and readers who use them, the argument has created uncertainty regarding the importance of stratification. In this paper, we review stratified randomization to summarize its purpose, indications, accomplishments, and a...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章,评审
doi：10.1016/s0895-4356(98)00138-3
更新日期：1999-01-01 00:00:00
abstract：OBJECTIVES:To provide GRADE guidance on how to prepare Summary of Findings tables and Evidence Profiles for time-to-event outcomes with a focus on the calculation of the corresponding absolute effect estimates. STUDY DESIGN AND SETTING:This guidance was justified by a research project identifying frequent errors and l...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/j.jclinepi.2019.10.015
更新日期：2020-02-01 00:00:00
abstract：:Validation of the London School of Hygiene (Rose) Questionnaire with objective measures of myocardial ischemia is incomplete. Therefore, we compared the Rose Questionnaire with exercise thallium-201 myocardial scintigraphy in 147 male and 97 female patients with chest pain referred for clinical exercise testing. Of th...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/0895-4356(92)90048-r
更新日期：1992-07-01 00:00:00
abstract：BACKGROUND AND OBJECTIVE:In many observational studies, the association between drugs and disease is analyzed with information from a baseline interview. We investigated the magnitude and direction of exposure misclassification by comparing interview data at baseline with prospectively gathered pharmacy data. METHODS:...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/j.jclinepi.2003.12.017
更新日期：2004-09-01 00:00:00
abstract：OBJECTIVES:To investigate the application of the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach and the quality of evidence ratings in systematic reviews of complex interventions. STUDY DESIGN AND SETTING:This study examined all 40 systematic reviews published in three Cochrane Rev...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章,评审
doi：10.1016/j.jclinepi.2016.03.014
更新日期：2016-10-01 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
abstract：:The aim of this paper was to evaluate the combined effect of alcohol, smoking habits and frequency of consumption of selected dietary items, which are the major sources of retinoids and beta-carotene in the Italian diet, on the risk of esophageal cancer (EC). The adequacy of the multiplicative structure for describing...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/0895-4356(92)90035-l
更新日期：1992-04-01 00:00:00
abstract：OBJECTIVE:We review the uses of electronic health care data algorithms, measures of their accuracy, and reasons for prioritizing one measure of accuracy over another. STUDY DESIGN AND SETTING:We use real studies to illustrate the variety of uses of automated health care data in epidemiologic and health services resear...
journal_title：Journal of clinical epidemiology
pub_type： 杂志文章
doi：10.1016/j.jclinepi.2011.09.002
更新日期：2012-03-01 00:00:00
