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  • Continuous(ly) missing outcome data in network meta-analysis: A one-stage pattern-mixture model approach.

    abstract::Appropriate handling of aggregate missing outcome data is necessary to minimise bias in the conclusions of systematic reviews. The two-stage pattern-mixture model has been already proposed to address aggregate missing continuous outcome data. While this approach is more proper compared with the exclusion of missing co...

    journal_title:Statistical methods in medical research

    pub_type: 杂志文章

    doi:10.1177/0962280220983544

    authors: Spineli LM,Kalyvas C,Papadimitropoulou K

    更新日期:2021-01-06 00:00:00

  • Probability intervals of toxicity and efficacy design for dose-finding clinical trials in oncology.

    abstract::Immunotherapy, gene therapy or adoptive cell therapies, such as the chimeric antigen receptor+ T-cell therapies, have demonstrated promising therapeutic effects in oncology patients. We consider statistical designs for dose-finding adoptive cell therapy trials, in which the monotonic dose-response relationship assumed...

    journal_title:Statistical methods in medical research

    pub_type: 杂志文章

    doi:10.1177/0962280220977009

    authors: Lin X,Ji Y

    更新日期:2020-12-16 00:00:00

  • A robust score test of homogeneity for zero-inflated count data.

    abstract::In many applications of zero-inflated models, score tests are often used to evaluate whether the population heterogeneity as implied by these models is consistent with the data. The most frequently cited justification for using score tests is that they only require estimation under the null hypothesis. Because this es...

    journal_title:Statistical methods in medical research

    pub_type: 杂志文章

    doi:10.1177/0962280220937324

    authors: Hsu WW,Todem D,Mawella NR,Kim K,Rosenkranz RR

    更新日期:2020-12-01 00:00:00

  • Unbiasedness and efficiency of non-parametric and UMVUE estimators of the probabilistic index and related statistics.

    abstract::In reliability theory, diagnostic accuracy, and clinical trials, the quantity P ( X > Y ) + ...

    journal_title:Statistical methods in medical research

    pub_type: 杂志文章

    doi:10.1177/0962280220966629

    authors: Verbeeck J,Deltuvaite-Thomas V,Berckmoes B,Burzykowski T,Aerts M,Thas O,Buyse M,Molenberghs G

    更新日期:2020-12-01 00:00:00

  • Reference-based pattern-mixture models for analysis of longitudinal binary data.

    abstract::Pattern-mixture model (PMM)-based controlled imputations have become a popular tool to assess the sensitivity of primary analysis inference to different post-dropout assumptions or to estimate treatment effectiveness. The methodology is well established for continuous responses but less well established for binary res...

    journal_title:Statistical methods in medical research

    pub_type: 杂志文章

    doi:10.1177/0962280220941880

    authors: Lu K

    更新日期:2020-12-01 00:00:00

  • Small sample sizes: A big data problem in high-dimensional data analysis.

    abstract::In many experiments and especially in translational and preclinical research, sample sizes are (very) small. In addition, data designs are often high dimensional, i.e. more dependent than independent replications of the trial are observed. The present paper discusses the applicability of max t-test-type statistics (mu...

    journal_title:Statistical methods in medical research

    pub_type: 杂志文章

    doi:10.1177/0962280220970228

    authors: Konietschke F,Schwab K,Pauly M

    更新日期:2020-11-24 00:00:00

  • A generalization of functional clustering for discrete multivariate longitudinal data.

    abstract::This paper presents a new model-based generalized functional clustering method for discrete longitudinal data, such as multivariate binomial and Poisson distributed data. For this purpose, we propose a multivariate functional principal component analysis (MFPCA)-based clustering procedure for a latent multivariate Gau...

    journal_title:Statistical methods in medical research

    pub_type: 杂志文章

    doi:10.1177/0962280220921912

    authors: Lim Y,Cheung YK,Oh HS

    更新日期:2020-11-01 00:00:00

  • Hybrid test for publication bias in meta-analysis.

    abstract::Publication bias frequently appears in meta-analyses when the included studies' results (e.g., p-values) influence the studies' publication processes. Some unfavorable studies may be suppressed from publication, so the meta-analytic results may be biased toward an artificially favorable direction. Many statistical tes...

    journal_title:Statistical methods in medical research

    pub_type: 杂志文章

    doi:10.1177/0962280220910172

    authors: Lin L

    更新日期:2020-10-01 00:00:00

  • Semiparametric integrative interaction analysis for non-small-cell lung cancer.

    abstract::In genomic analysis, it is significant though challenging to identify markers associated with cancer outcomes or phenotypes. Based on the biological mechanisms of cancers and the characteristics of datasets, we propose a novel integrative interaction approach under a semiparametric model, in which genetic and environm...

    journal_title:Statistical methods in medical research

    pub_type: 杂志文章

    doi:10.1177/0962280220909969

    authors: Li Y,Wang F,Li R,Sun Y

    更新日期:2020-10-01 00:00:00

  • Pattern discovery of health curves using an ordered probit model with Bayesian smoothing and functional principal component analysis.

    abstract::This article is motivated by the need for discovering patterns of patients' health based on their daily settings of care to aid the health policy-makers to improve the effectiveness of distributing funding for health services. The hidden process of one's health status is assumed to be a continuous smooth function, cal...

    journal_title:Statistical methods in medical research

    pub_type: 杂志文章

    doi:10.1177/0962280220951834

    authors: Wang S,Nie Y,Sutherland JM,Wang L

    更新日期:2020-09-25 00:00:00

  • Efficient two-stage sequential arrays of proof of concept studies for pharmaceutical portfolios.

    abstract::Previous work has shown that individual randomized "proof-of-concept" (PoC) studies may be designed to maximize cost-effectiveness, subject to an overall PoC budget constraint. Maximizing cost-effectiveness has also been considered for arrays of simultaneously executed PoC studies. Defining Type III error as the oppor...

    journal_title:Statistical methods in medical research

    pub_type: 杂志文章

    doi:10.1177/0962280220958177

    authors: He L,Du L,Antonijevic Z,Posch M,Korostyshevskiy VR,Beckman RA

    更新日期:2020-09-21 00:00:00

  • A curvilinear bivariate random changepoint model to assess temporal order of markers.

    abstract::In biomedical research, various longitudinal markers measuring different quantities are often collected over time. For example, repeated measures of psychometric scores are very informative about the degradation process toward dementia. These trajectories are generally nonlinear with an acceleration of the decline a f...

    journal_title:Statistical methods in medical research

    pub_type: 杂志文章

    doi:10.1177/0962280219898719

    authors: Segalas C,Helmer C,Jacqmin-Gadda H

    更新日期:2020-09-01 00:00:00

  • Exposure-response modelling approaches for determining optimal dosing rules in children.

    abstract::Within paediatric populations, there may be distinct age groups characterised by different exposure-response relationships. Several regulatory guidance documents have suggested general age groupings. However, it is not clear whether these categorisations will be suitable for all new medicines and in all disease areas....

    journal_title:Statistical methods in medical research

    pub_type: 杂志文章

    doi:10.1177/0962280220903751

    authors: Wadsworth I,Hampson LV,Bornkamp B,Jaki T

    更新日期:2020-09-01 00:00:00

  • Efficient algorithms for covariate analysis with dynamic data using nonlinear mixed-effects model.

    abstract::Nonlinear mixed-effects modeling is one of the most popular tools for analyzing repeated measurement data, particularly for applications in the biomedical fields. Multiple integration and nonlinear optimization are the two major challenges for likelihood-based methods in nonlinear mixed-effects modeling. To solve thes...

    journal_title:Statistical methods in medical research

    pub_type: 杂志文章

    doi:10.1177/0962280220949898

    authors: Yuan M,Zhu Z,Yang Y,Zhao M,Sasser K,Hamadeh H,Pinheiro J,Xu XS

    更新日期:2020-08-24 00:00:00

  • Long-term frailty modeling using a non-proportional hazards model: Application with a melanoma dataset.

    abstract::The semiparametric Cox regression model is often fitted in the modeling of survival data. One of its main advantages is the ease of interpretation, as long as the hazards rates for two individuals do not vary over time. In practice the proportionality assumption of the hazards may not be true in some situations. In ad...

    journal_title:Statistical methods in medical research

    pub_type: 杂志文章

    doi:10.1177/0962280219883905

    authors: Calsavara VF,Milani EA,Bertolli E,Tomazella V

    更新日期:2020-08-01 00:00:00

  • Adaptive designs in multi-reader multi-case clinical trials of imaging devices.

    abstract::Evaluation of medical imaging devices often involves clinical studies where multiple readers (MR) read images of multiple cases (MC) for a clinical task, which are often called MRMC studies. In addition to sizing patient cases as is required in most clinical trials, MRMC studies also require sizing readers, since both...

    journal_title:Statistical methods in medical research

    pub_type: 杂志文章

    doi:10.1177/0962280219869370

    authors: Huang Z,Samuelson F,Tcheuko L,Chen W

    更新日期:2020-06-01 00:00:00

  • A monotone data augmentation algorithm for longitudinal data analysis via multivariate skew-t, skew-normal or t distributions.

    abstract::The mixed effects model for repeated measures has been widely used for the analysis of longitudinal clinical data collected at a number of fixed time points. We propose a robust extension of the mixed effects model for repeated measures for skewed and heavy-tailed data on basis of the multivariate skew-t distribution,...

    journal_title:Statistical methods in medical research

    pub_type: 杂志文章

    doi:10.1177/0962280219865579

    authors: Tang Y

    更新日期:2020-06-01 00:00:00

  • Joint nested frailty models for clustered recurrent and terminal events: An application to colonoscopy screening visits and colorectal cancer risks in Lynch Syndrome families.

    abstract::Joint models for recurrent and terminal events have not been yet developed for clustered data. The goals of our study are to develop a statistical framework for modelling clustered recurrent and terminal events and to perform dynamic predictions of the terminal event in family studies. We propose a joint nested frailt...

    journal_title:Statistical methods in medical research

    pub_type: 杂志文章

    doi:10.1177/0962280219863076

    authors: Choi YH,Jacqmin-Gadda H,Król A,Parfrey P,Briollais L,Rondeau V

    更新日期:2020-05-01 00:00:00

  • Inferring the direction of a causal link and estimating its effect via a Bayesian Mendelian randomization approach.

    abstract::The use of genetic variants as instrumental variables - an approach known as Mendelian randomization - is a popular epidemiological method for estimating the causal effect of an exposure (phenotype, biomarker, risk factor) on a disease or health-related outcome from observational data. Instrumental variables must sati...

    journal_title:Statistical methods in medical research

    pub_type: 杂志文章

    doi:10.1177/0962280219851817

    authors: Bucur IG,Claassen T,Heskes T

    更新日期:2020-04-01 00:00:00

  • Maximum likelihood estimation based on Newton-Raphson iteration for the bivariate random effects model in test accuracy meta-analysis.

    abstract::A bivariate generalised linear mixed model is often used for meta-analysis of test accuracy studies. The model is complex and requires five parameters to be estimated. As there is no closed form for the likelihood function for the model, maximum likelihood estimates for the parameters have to be obtained numerically. ...

    journal_title:Statistical methods in medical research

    pub_type: 杂志文章

    doi:10.1177/0962280219853602

    authors: Willis BH,Baragilly M,Coomar D

    更新日期:2020-04-01 00:00:00

  • Correcting for non-participation bias in health surveys using record-linkage, synthetic observations and pattern mixture modelling.

    abstract::Surveys are key means of obtaining policy-relevant information not available from routine sources. Bias arising from non-participation is typically handled by applying weights derived from limited socio-demographic characteristics. This approach neither captures nor adjusts for differences in health and related behavi...

    journal_title:Statistical methods in medical research

    pub_type: 杂志文章

    doi:10.1177/0962280219854482

    authors: Gray L,Gorman E,White IR,Katikireddi SV,McCartney G,Rutherford L,Leyland AH

    更新日期:2020-04-01 00:00:00

  • Estimating the dependence of mixed sensitive response types in randomized response technique.

    abstract::Sensitive questions are often involved in healthcare or medical survey research. Much empirical evidence has shown that the randomized response technique is useful for the collection of truthful responses. However, few studies have discussed methods to estimate the dependence of sensitive responses of multiple types. ...

    journal_title:Statistical methods in medical research

    pub_type: 杂志文章

    doi:10.1177/0962280219847492

    authors: Chu AM,So MK,Chan TW,Tiwari A

    更新日期:2020-03-01 00:00:00

  • Estimation of data adaptive minimal clinically important difference with a nonconvex optimization procedure.

    abstract::Understanding the limitation of solely relying on statistical significance, researchers have proposed methods to draw biomedical conclusions based on clinical significance. The minimal clinically important significance is one of the most fundamental concepts to study clinical significance. Based on an anchor question ...

    journal_title:Statistical methods in medical research

    pub_type: 杂志文章

    doi:10.1177/0962280219850191

    authors: Zhou Z,Zhao J,Bisson LJ

    更新日期:2020-03-01 00:00:00

  • Nonparametric estimation of risk tracking indices for longitudinal studies.

    abstract::Tracking a subject's risk factors or health status over time is an important objective in long-term epidemiological studies with repeated measurements. An important issue of time-trend tracking is to define appropriate statistical indices to quantitatively measure the tracking abilities of the targeted risk factors or...

    journal_title:Statistical methods in medical research

    pub_type: 杂志文章

    doi:10.1177/0962280219839427

    authors: Wu CO,Tian X,Tian L,Reis JP,Zhao L,Allen NB,Bae S,Liu K

    更新日期:2020-02-01 00:00:00

  • Efficient estimation of a linear transformation model for current status data via penalized splines.

    abstract::We propose a flexible and computationally efficient penalized estimation method for a semi-parametric linear transformation model with current status data. To facilitate model fitting, the unknown monotone function is approximated by monotone B-splines, and a computationally efficient hybrid algorithm involving the Fi...

    journal_title:Statistical methods in medical research

    pub_type: 杂志文章

    doi:10.1177/0962280218820406

    authors: Lu M,Liu Y,Li CS

    更新日期:2020-01-01 00:00:00

  • Prediction intervals with random forests.

    abstract::The classical and most commonly used approach to building prediction intervals is the parametric approach. However, its main drawback is that its validity and performance highly depend on the assumed functional link between the covariates and the response. This research investigates new methods that improve the perfor...

    journal_title:Statistical methods in medical research

    pub_type: 杂志文章

    doi:10.1177/0962280219829885

    authors: Roy MH,Larocque D

    更新日期:2020-01-01 00:00:00

  • Accurate quantification of uncertainty in epidemic parameter estimates and predictions using stochastic compartmental models.

    abstract::Stochastic transmission dynamic models are needed to quantify the uncertainty in estimates and predictions during outbreaks of infectious diseases. We previously developed a calibration method for stochastic epidemic compartmental models, called Multiple Shooting for Stochastic Systems (MSS), and demonstrated its comp...

    journal_title:Statistical methods in medical research

    pub_type: 杂志文章

    doi:10.1177/0962280218805780

    authors: Zimmer C,Leuba SI,Cohen T,Yaesoubi R

    更新日期:2019-12-01 00:00:00

  • A quick and accurate method for the estimation of covariate effects based on empirical Bayes estimates in mixed-effects modeling: Correction of bias due to shrinkage.

    abstract::Nonlinear mixed-effects modeling is a popular approach to describe the temporal trajectory of repeated measurements of clinical endpoints collected over time in clinical trials, to distinguish the within-subject and the between-subject variabilities, and to investigate clinically important risk factors (covariates) th...

    journal_title:Statistical methods in medical research

    pub_type: 杂志文章

    doi:10.1177/0962280218812595

    authors: Yuan M,Xu XS,Yang Y,Xu J,Huang X,Tao F,Zhao L,Zhang L,Pinheiro J

    更新日期:2019-12-01 00:00:00

  • A proof-of-concept-to-confirmatory multiple adaptation design in the development of an anti-viral treatment.

    abstract::In the clinical development of some new infectious disease drugs, early clinical pharmacology trials may predict with high confidence that the efficacious doses are well below the range of the safety margin. In this case, a dose-ranging study may be unnecessary after a proof-of-concept (PoC) study testing the highest ...

    journal_title:Statistical methods in medical research

    pub_type: 杂志文章

    doi:10.1177/0962280218807950

    authors: Fan XF,Gallo P,Su G,Menton R,Segal F

    更新日期:2019-12-01 00:00:00

  • Modelling of zero-inflation improves inference of metagenomic gene count data.

    abstract::Metagenomics enables the study of gene abundances in complex mixtures of microorganisms and has become a standard methodology for the analysis of the human microbiome. However, gene abundance data is inherently noisy and contains high levels of biological and technical variability as well as an excess of zeros due to ...

    journal_title:Statistical methods in medical research

    pub_type: 杂志文章

    doi:10.1177/0962280218811354

    authors: Jonsson V,Österlund T,Nerman O,Kristiansson E

    更新日期:2019-12-01 00:00:00

  • Copas-like selection model to correct publication bias in systematic review of diagnostic test studies.

    abstract::The accuracy of a diagnostic test, which is often quantified by a pair of measures such as sensitivity and specificity, is critical for medical decision making. Separate studies of an investigational diagnostic test can be combined through meta-analysis; however, such an analysis can be threatened by publication bias....

    journal_title:Statistical methods in medical research

    pub_type: 杂志文章

    doi:10.1177/0962280218791602

    authors: Piao J,Liu Y,Chen Y,Ning J

    更新日期:2019-10-01 00:00:00

  • Underestimation of treatment effects in sequentially monitored clinical trials that did not stop early for benefit.

    abstract::In recent years, there has been a prominent discussion in the literature about the potential for overestimation of the treatment effect when a clinical trial stops at an interim analysis due to the experimental treatment showing a benefit over the control. However, there has been much less attention paid to the conver...

    journal_title:Statistical methods in medical research

    pub_type: 杂志文章

    doi:10.1177/0962280218795320

    authors: Marschner IC,Schou IM

    更新日期:2019-10-01 00:00:00

  • Adaptive non-inferiority margins under observable non-constancy.

    abstract::A central assumption in the design and conduct of non-inferiority trials is that the active-control therapy will have the same degree of effectiveness in the planned non-inferiority trial as in the prior placebo-controlled trials used to define the non-inferiority margin. This is referred to as the 'constancy' assumpt...

    journal_title:Statistical methods in medical research

    pub_type: 杂志文章

    doi:10.1177/0962280218801134

    authors: Hanscom B,Hughes JP,Williamson BD,Donnell D

    更新日期:2019-10-01 00:00:00

  • Joint modelling for organ transplantation outcomes for patients with diabetes and the end-stage renal disease.

    abstract::This article is motivated by jointly modelling longitudinal and time-to-event clinical data of patients with diabetes and end-stage renal disease. All patients are on the waiting list for the pancreas transplant after kidney transplant, and some of them have a pancreas transplant before kidney transplant failure or de...

    journal_title:Statistical methods in medical research

    pub_type: 杂志文章

    doi:10.1177/0962280218786980

    authors: Dong JJ,Wang S,Wang L,Gill J,Cao J

    更新日期:2019-09-01 00:00:00

  • Semiparametric analysis of correlated and interval-censored event-history data.

    abstract::We propose a semiparametric multi-state frailty model to analyze clustered event-history data subject to interval censoring. The proposed model is motivated by an attempt to study the life course of dental caries at the tooth level, taking into account the multiplicity of caries states and the intra-oral clustering of...

    journal_title:Statistical methods in medical research

    pub_type: 杂志文章

    doi:10.1177/0962280218788383

    authors: Pak D,Li C,Todem D

    更新日期:2019-09-01 00:00:00

  • Flexible and structured survival model for a simultaneous estimation of non-linear and non-proportional effects and complex interactions between continuous variables: Performance of this multidimensional penalized spline approach in net survival trend ana

    abstract::Cancer survival trend analyses are essential to describe accurately the way medical practices impact patients' survival according to the year of diagnosis. To this end, survival models should be able to account simultaneously for non-linear and non-proportional effects and for complex interactions between continuous v...

    journal_title:Statistical methods in medical research

    pub_type: 杂志文章

    doi:10.1177/0962280218779408

    authors: Remontet L,Uhry Z,Bossard N,Iwaz J,Belot A,Danieli C,Charvat H,Roche L,CENSUR Working Survival Group.

    更新日期:2019-08-01 00:00:00

  • Sample size for binary logistic prediction models: Beyond events per variable criteria.

    abstract::Binary logistic regression is one of the most frequently applied statistical approaches for developing clinical prediction models. Developers of such models often rely on an Events Per Variable criterion (EPV), notably EPV ≥10, to determine the minimal sample size required and the maximum number of candidate predictor...

    journal_title:Statistical methods in medical research

    pub_type: 杂志文章

    doi:10.1177/0962280218784726

    authors: van Smeden M,Moons KG,de Groot JA,Collins GS,Altman DG,Eijkemans MJ,Reitsma JB

    更新日期:2019-08-01 00:00:00

  • Semi-supervised identification of cancer subgroups using survival outcomes and overlapping grouping information.

    abstract::Identification of cancer patient subgroups using high throughput genomic data is of critical importance to clinicians and scientists because it can offer opportunities for more personalized treatment and overlapping treatments of cancers. In spite of tremendous efforts, this problem still remains challenging because o...

    journal_title:Statistical methods in medical research

    pub_type: 杂志文章

    doi:10.1177/0962280217752980

    authors: Wei W,Sun Z,da Silveira WA,Yu Z,Lawson A,Hardiman G,Kelemen LE,Chung D

    更新日期:2019-07-01 00:00:00

  • On adaptive propensity score truncation in causal inference.

    abstract::The positivity assumption, or the experimental treatment assignment (ETA) assumption, is important for identifiability in causal inference. Even if the positivity assumption holds, practical violations of this assumption may jeopardize the finite sample performance of the causal estimator. One of the consequences of p...

    journal_title:Statistical methods in medical research

    pub_type: 杂志文章

    doi:10.1177/0962280218774817

    authors: Ju C,Schwab J,van der Laan MJ

    更新日期:2019-06-01 00:00:00

  • Testing hypotheses under adaptive randomization with continuous covariates in clinical trials.

    abstract::Covariate-adaptive designs are widely used to balance covariates and maintain randomization in clinical trials. Adaptive designs for discrete covariates and their asymptotic properties have been well studied in the literature. However, important continuous covariates are often involved in clinical studies. Simply disc...

    journal_title:Statistical methods in medical research

    pub_type: 杂志文章

    doi:10.1177/0962280218770231

    authors: Li X,Zhou J,Hu F

    更新日期:2019-06-01 00:00:00

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