Statistical issues related to dietary intake as the response variable in intervention trials.

Abstract:

:The focus of this paper is dietary intervention trials. We explore the statistical issues involved when the response variable, intake of a food or nutrient, is based on self-report data that are subject to inherent measurement error. There has been little work on handling error in this context. A particular feature of self-reported dietary intake data is that the error may be differential by intervention group. Measurement error methods require information on the nature of the errors in the self-report data. We assume that there is a calibration sub-study in which unbiased biomarker data are available. We outline methods for handling measurement error in this setting and use theory and simulations to investigate how self-report and biomarker data may be combined to estimate the intervention effect. Methods are illustrated using data from the Trial of Nonpharmacologic Intervention in the Elderly, in which the intervention was a sodium-lowering diet and the response was sodium intake. Simulations are used to investigate the methods under differential error, differing reliability of self-reports relative to biomarkers and different proportions of individuals in the calibration sub-study. When the reliability of self-report measurements is comparable with that of the biomarker, it is advantageous to use the self-report data in addition to the biomarker to estimate the intervention effect. If, however, the reliability of the self-report data is low compared with that in the biomarker, then, there is little to be gained by using the self-report data. Our findings have important implications for the design of dietary intervention trials. © 2016 The Authors. Statistics in Medicine published by John Wiley & Sons Ltd.

journal_name

Stat Med

journal_title

Statistics in medicine

authors

Keogh RH,Carroll RJ,Tooze JA,Kirkpatrick SI,Freedman LS

doi

10.1002/sim.7011

subject

Has Abstract

pub_date

2016-11-10 00:00:00

pages

4493-4508

issue

25

eissn

0277-6715

issn

1097-0258

journal_volume

35

pub_type

杂志文章
  • Stochastic approximation EM for large-scale exploratory IRT factor analysis.

    abstract::A stochastic approximation EM algorithm (SAEM) is described for exploratory factor analysis of dichotomous or ordinal variables. The factor structure is obtained from sufficient statistics that are updated during iterations with the Robbins-Monro procedure. Two large-scale simulations are reported that compare accurac...

    journal_title:Statistics in medicine

    pub_type: 杂志文章

    doi:10.1002/sim.8217

    authors: Camilli G,Geis E

    更新日期:2019-09-20 00:00:00

  • A method for meta-analysis of molecular association studies.

    abstract::Although population-based molecular association studies are becoming increasingly popular, methodology for the meta-analysis of these studies has been neglected, particularly with regard to two issues: testing Hardy-Weinberg equilibrium (HWE), and pooling results in a manner that reflects a biological model of gene ef...

    journal_title:Statistics in medicine

    pub_type: 杂志文章

    doi:10.1002/sim.2010

    authors: Thakkinstian A,McElduff P,D'Este C,Duffy D,Attia J

    更新日期:2005-05-15 00:00:00

  • Modelling the geographical distribution of co-infection risk from single-disease surveys.

    abstract:BACKGROUND:The need to deliver interventions targeting multiple diseases in a cost-effective manner calls for integrated disease control efforts. Consequently, maps are required that show where the risk of co-infection is particularly high. Co-infection risk is preferably estimated via Bayesian geostatistical multinomi...

    journal_title:Statistics in medicine

    pub_type: 杂志文章

    doi:10.1002/sim.4243

    authors: Schur N,Gosoniu L,Raso G,Utzinger J,Vounatsou P

    更新日期:2011-06-30 00:00:00

  • Exact test size and power of a Gaussian error linear model for an internal pilot study.

    abstract::Wittes and Brittain recommended using an 'internal pilot study' to adjust sample size. The approach involves five steps in testing a general linear hypothesis for a general linear univariate model, with Gaussian errors. First, specify the design, hypothesis, desired test size, power, a smallest 'clinically meaningful'...

    journal_title:Statistics in medicine

    pub_type: 杂志文章

    doi:10.1002/(sici)1097-0258(19990530)18:10<1199::aid-s

    authors: Coffey CS,Muller KE

    更新日期:1999-05-30 00:00:00

  • Individualizing drug dosage with longitudinal data.

    abstract::We propose a two-step procedure to personalize drug dosage over time under the framework of a log-linear mixed-effect model. We model patients' heterogeneity using subject-specific random effects, which are treated as the realizations of an unspecified stochastic process. We extend the conditional quadratic inference ...

    journal_title:Statistics in medicine

    pub_type: 杂志文章

    doi:10.1002/sim.7016

    authors: Zhu X,Qu A

    更新日期:2016-10-30 00:00:00

  • A Bayesian multivariate joint frailty model for disease recurrences and survival.

    abstract::Motivated by a study for soft tissue sarcoma, this article considers the analysis of diseases recurrence and survival. A multivariate frailty hazard model is established for joint modeling of three correlated time-to-event outcomes: local disease recurrence, distant disease recurrence (metastasis), and death. The goal...

    journal_title:Statistics in medicine

    pub_type: 杂志文章

    doi:10.1002/sim.7030

    authors: Wen S,Huang X,Frankowski RF,Cormier JN,Pisters P

    更新日期:2016-11-20 00:00:00

  • Joint analysis of multi-level repeated measures data and survival: an application to the end stage renal disease (ESRD) data.

    abstract::Shared random effects models have been increasingly common in the joint analyses of repeated measures (e.g. CD4 counts, hemoglobin levels) and a correlated failure time such as death. In this paper we study several shared random effects models in the multi-level repeated measures data setting with dependent failure ti...

    journal_title:Statistics in medicine

    pub_type: 杂志文章

    doi:10.1002/sim.3392

    authors: Liu L,Ma JZ,O'Quigley J

    更新日期:2008-11-29 00:00:00

  • Confidence intervals for the standardized effect arising in the comparison of two normal populations.

    abstract::Confidence intervals for a standardized effect are derived after stabilizing the variance of the Welch t-statistic. Simulation studies demonstrate the viability of the resulting intervals for a wide range of parameter values and sample sizes as small as five. The methodology is extended to the combination of results f...

    journal_title:Statistics in medicine

    pub_type: 杂志文章

    doi:10.1002/sim.2751

    authors: Kulinskaya E,Staudte RG

    更新日期:2007-06-30 00:00:00

  • Analysis of the ratio of marginal probabilities in a matched-pair setting.

    abstract::Statistical methods for testing and interval estimation of the ratio of marginal probabilities in the matched-pair setting are considered in this paper. We are especially interested in the situation where the null value is not one, as in one-sided equivalence trials. We propose a Fieller-type statistic based on constr...

    journal_title:Statistics in medicine

    pub_type: 杂志文章

    doi:10.1002/sim.1017

    authors: Nam JM,Blackwelder WC

    更新日期:2002-03-15 00:00:00

  • Segmented regression with errors in predictors: semi-parametric and parametric methods.

    abstract::We consider the estimation of parameters in a particular segmented generalized linear model with additive measurement error in predictors, with a focus on linear and logistic regression. In epidemiologic studies segmented regression models often occur as threshold models, where it is assumed that the exposure has no i...

    journal_title:Statistics in medicine

    pub_type: 杂志文章

    doi:10.1002/(sici)1097-0258(19970130)16:2<169::aid-sim

    authors: Küchenhoff H,Carroll RJ

    更新日期:1997-01-15 00:00:00

  • Multinomial goodness-of-fit tests for logistic regression models.

    abstract::We examine the properties of several tests for goodness-of-fit for multinomial logistic regression. One test is based on a strategy of sorting the observations according to the complement of the estimated probability for the reference outcome category and then grouping the subjects into g equal-sized groups. A g x c c...

    journal_title:Statistics in medicine

    pub_type: 杂志文章

    doi:10.1002/sim.3202

    authors: Fagerland MW,Hosmer DW,Bofin AM

    更新日期:2008-09-20 00:00:00

  • Modelling risk when binary outcomes are subject to error.

    abstract::We present methods for binomial regression when the outcome is determined using the results of a single diagnostic test with imperfect sensitivity and specificity. We present our model, illustrate it with the analysis of real data, and provide an example of WinBUGS program code for performing such an analysis. Conditi...

    journal_title:Statistics in medicine

    pub_type: 杂志文章

    doi:10.1002/sim.1656

    authors: McInturff P,Johnson WO,Cowling D,Gardner IA

    更新日期:2004-04-15 00:00:00

  • Methodological pitfalls in the analysis of contraceptive failure.

    abstract::Although the literature on contraceptive failure is vast and is expanding rapidly, our understanding of the relative efficacy of methods is quite limited because of defects in the research design and in the analytical tools used by investigators. Errors in the literature range from simple arithmetical mistakes to outr...

    journal_title:Statistics in medicine

    pub_type: 杂志文章,评审

    doi:10.1002/sim.4780100206

    authors: Trussell J

    更新日期:1991-02-01 00:00:00

  • Global goodness-of-fit tests for group testing regression models.

    abstract::In a variety of biomedical applications, particularly those involving screening for infectious diseases, testing individuals (e.g. blood/urine samples, etc.) in pools has become a standard method of data collection. This experimental design, known as group testing (or pooled testing), can provide a large reduction in ...

    journal_title:Statistics in medicine

    pub_type: 杂志文章

    doi:10.1002/sim.3678

    authors: Chen P,Tebbs JM,Bilder CR

    更新日期:2009-10-15 00:00:00

  • Parameters of mortality in human populations with widely varying life spans.

    abstract::A three-component, competing-risk mortality model, developed for animal survival data, fits human life table data for all ages over a range of mean life spans from 16 to 74 years. The competing risks are a novel exponentially-decreasing hazard, dominant during immaturity; a constant hazard, dominant during adulthood; ...

    journal_title:Statistics in medicine

    pub_type: 杂志文章

    doi:10.1002/sim.4780020309

    authors: Siler W

    更新日期:1983-07-01 00:00:00

  • Bayesian modelling of imperfect ascertainment methods in cancer studies.

    abstract::Tumour registry linkage, chart review and patient self-report are all commonly used ascertainment methods in cancer epidemiology. These methods are used for estimating the incidence or prevalence of different cancer types in a population, and for investigating the effects of possible risk factors for cancer. Tumour re...

    journal_title:Statistics in medicine

    pub_type: 杂志文章

    doi:10.1002/sim.2116

    authors: Bernatsky S,Joseph L,Bélisle P,Boivin JF,Rajan R,Moore A,Clarke A

    更新日期:2005-08-15 00:00:00

  • Group sequential designs for cure rate models with early stopping in favour of the null hypothesis.

    abstract::Ewell and Ibrahim derived the large sample distribution of the logrank statistic under general local alternatives. Their asymptotic results enable us to extend several group sequential designs which allow for early stopping in favour of the null hypothesis to the setting in which the cure rate model is appropriate. In...

    journal_title:Statistics in medicine

    pub_type: 杂志文章

    doi:10.1002/1097-0258(20001130)19:22<3023::aid-sim638>

    authors: Patricia Bernardo MV,Ibrahim JG

    更新日期:2000-11-30 00:00:00

  • Correction of sampling bias in a cross-sectional study of post-surgical complications.

    abstract::Cross-sectional designs are often used to monitor the proportion of infections and other post-surgical complications acquired in hospitals. However, conventional methods for estimating incidence proportions when applied to cross-sectional data may provide estimators that are highly biased, as cross-sectional designs t...

    journal_title:Statistics in medicine

    pub_type: 杂志文章

    doi:10.1002/sim.5608

    authors: Fluss R,Mandel M,Freedman LS,Weiss IS,Zohar AE,Haklai Z,Gordon ES,Simchen E

    更新日期:2013-06-30 00:00:00

  • Spatial clustering of the failure to geocode and its implications for the detection of disease clustering.

    abstract::Geocoding a study population as completely as possible is an important data assimilation component of many spatial epidemiologic studies. Unfortunately, complete geocoding is rare in practice. The failure of a substantial proportion of study subjects' addresses to geocode has consequences for spatial analyses, some of...

    journal_title:Statistics in medicine

    pub_type: 杂志文章

    doi:10.1002/sim.3288

    authors: Zimmerman DL,Fang X,Mazumdar S

    更新日期:2008-09-20 00:00:00

  • Assessment of postpartum time-dependent disease risk in case-control studies: an application for examining age-specific effect estimates.

    abstract::Among subjects who have experienced a biological event, such as menarche, menopause or a delivery, one cannot distinguish the effects of time since the event from age at the event due to the linear dependency among these time variables and age at study ('current age'). This is a well-known problem that also exists in ...

    journal_title:Statistics in medicine

    pub_type: 杂志文章

    doi:10.1002/(SICI)1097-0258(19960730)15:14<1545::AID-S

    authors: Hsieh CC,Lan SJ

    更新日期:1996-07-30 00:00:00

  • Current development in clinical trials: issues old and new.

    abstract::Clinical trials, especially the randomized clinical trial, have been and will remain the gold standard for the evaluation of new interventions, including pharmaceuticals, biologics, medical devices, procedures, or behavioral modifications. Despite more than five decades of experience, there are still challenges in the...

    journal_title:Statistics in medicine

    pub_type: 杂志文章

    doi:10.1002/sim.5405

    authors: DeMets DL

    更新日期:2012-11-10 00:00:00

  • Mean square error of estimates of HIV prevalence and short-term AIDS projections derived by backcalculation.

    abstract::We simulated multinomial AIDS incidence counts from 27 'representative' AIDS epidemics that spanned a period corresponding to previous applications of backcalculation (1 January 1977 to 1 July 1987) and assessed mean square error for several back-calculated estimators of HIV prevalence and short-term AIDS projections....

    journal_title:Statistics in medicine

    pub_type: 杂志文章

    doi:10.1002/sim.4780100802

    authors: Rosenberg PS,Gail MH,Pee D

    更新日期:1991-08-01 00:00:00

  • Estimating transmission probabilities for chlamydial infection.

    abstract::Estimates of transmission probabilities for sexually transmitted diseases historically come from studies of uninfected individuals exposed to those with a high disease prevalence (for example, prostitutes). However, changes in sexual behaviour, much of which relates to concerns about AIDS, has made identification of p...

    journal_title:Statistics in medicine

    pub_type: 杂志文章

    doi:10.1002/sim.4780110502

    authors: Katz BP

    更新日期:1992-03-01 00:00:00

  • Nonparametric meta-analysis for diagnostic accuracy studies.

    abstract::Summarizing the information of many studies using a meta-analysis becomes more and more important, also in the field of diagnostic studies. The special challenge in meta-analysis of diagnostic accuracy studies is that in general sensitivity and specificity are co-primary endpoints. Across the studies both endpoints ar...

    journal_title:Statistics in medicine

    pub_type: 杂志文章

    doi:10.1002/sim.6583

    authors: Zapf A,Hoyer A,Kramer K,Kuss O

    更新日期:2015-12-20 00:00:00

  • An easy-to-implement approach for analyzing case-control and case-only studies assuming gene-environment independence and Hardy-Weinberg equilibrium.

    abstract::The case-control study is a simple and an useful method to characterize the effect of a gene, the effect of an exposure, as well as the interaction between the two. The control-free case-only study is yet an even simpler design, if interest is centered on gene-environment interaction only. It requires the sometimes pl...

    journal_title:Statistics in medicine

    pub_type: 杂志文章

    doi:10.1002/sim.4028

    authors: Lee WC,Wang LY,Cheng KF

    更新日期:2010-10-30 00:00:00

  • Comparison of predictive values of two diagnostic tests from the same sample of subjects using weighted least squares.

    abstract::Screening and diagnostic tests are important in disease prevention or control. The predictive values of positive and negative (PPV and NPV) test results are two of four operational characteristics of a screening test. We review an existing method based on the generalized estimating equation (GEE) methodology for compa...

    journal_title:Statistics in medicine

    pub_type: 杂志文章

    doi:10.1002/sim.2332

    authors: Wang W,Davis CS,Soong SJ

    更新日期:2006-07-15 00:00:00

  • Models for the propensity score that contemplate the positivity assumption and their application to missing data and causality.

    abstract::Generalized linear models are often assumed to fit propensity scores, which are used to compute inverse probability weighted (IPW) estimators. To derive the asymptotic properties of IPW estimators, the propensity score is supposed to be bounded away from zero. This condition is known in the literature as strict positi...

    journal_title:Statistics in medicine

    pub_type: 杂志文章

    doi:10.1002/sim.7827

    authors: Molina J,Sued M,Valdora M

    更新日期:2018-10-30 00:00:00

  • Concordance correlation coefficient applied to discrete data.

    abstract::In any field in which decisions are subject to measurements, interchangeability between the methods used to obtain these measurements is essential. To consider methods as interchangeable, a certain degree of agreement is needed between the measurements they provide. The concordance correlation coefficient is an index ...

    journal_title:Statistics in medicine

    pub_type: 杂志文章

    doi:10.1002/sim.2397

    authors: Carrasco JL,Jover L

    更新日期:2005-12-30 00:00:00

  • A numerical strategy to evaluate performance of predictive scores via a copula-based approach.

    abstract::Assessing and comparing the performance of correlated predictive scores are of current interest in precision medicine. Given the limitations of available theoretical approaches for assessing and comparing the predictive accuracy, numerical methods are highly desired which, however, have not been systematically develop...

    journal_title:Statistics in medicine

    pub_type: 杂志文章

    doi:10.1002/sim.8566

    authors: Zhang Y,Shao Y

    更新日期:2020-09-10 00:00:00

  • Assessing surrogacy from the joint modelling of multivariate longitudinal data and survival: application to clinical trial data on chronic lymphocytic leukaemia.

    abstract::In clinical research, we are often interested in assessing how a biomarker changes with time, and whether it could be used as a surrogate marker when evaluating the efficacy of a new drug. However, when the longitudinal marker is correlated with survival, linear mixed models for longitudinal data may be inappropriate....

    journal_title:Statistics in medicine

    pub_type: 杂志文章

    doi:10.1002/sim.3142

    authors: Deslandes E,Chevret S

    更新日期:2007-12-30 00:00:00