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Introduction
Publications
Publications (82)
Bayesian predictive probabilities of success (PPoS) use interim trial data to calculate the probability of trial success. These quantities can be used to optimize trial size or to stop for futility. In this paper, we describe a simulation-based approach to compute the PPoS for clinical trials with competing event data, for which no specific methodo...
Background
Monitoring metabolites of tamoxifen, such as endoxifen, has been suggested as a strategy to ascertain therapeutic effect of tamoxifen therapy, but clinical guidelines are missing. Herein, we aim to investigate the outcome of endoxifen concentrations of low-dose tamoxifen, using change in mammographic breast density as a proxy for therapy...
ProBio is the first outcome-adaptive platform trial in prostate cancer utilizing a Bayesian framework to evaluate efficacy within predefined biomarker signatures across systemic treatments. Prospective circulating tumor DNA and germline DNA analysis was performed in patients with metastatic castration-resistant prostate cancer before randomization...
Previous studies have reported inconsistent results about exogenous melatonin's sleep‐promoting effects. A possible explanation relies on the heterogeneity in administration schedule and dose, which might be accountable for differences in treatment efficacy. In this paper, we undertook a systematic review and meta‐analysis of double‐blind, randomiz...
Copy number analysis is an important aspect of cancer genomics that enables identification of activated oncogenes, inactivated tumor suppressor genes and genome-wide signatures such as homologous recombination deficiency and the tandem duplication phenotype. Despite continuous development of copy number algorithms, the current sensitivity to detect...
Importance
Noninvasive brain stimulation (NIBS) interventions have been shown to be efficacious in several mental disorders, but the optimal dose stimulation parameters for each disorder are unknown.
Objective
To define NIBS dose stimulation parameters associated with the greatest efficacy in symptom improvement across mental disorders.
Data Sour...
Objective: Evidence on the optimal “dose” of cognitive behavioral therapy (CBT) for treating major depressive disorder is sparse. This analysis aimed to evaluate the dose–response curve in CBT using a nonlinear approach, whereby “dose” was defined as number of treatment sessions. The dose–response curve of CBT was compared to other psychotherapies...
Background
Despite evidence associating inflammatory biomarkers with worse outcomes in hospitalized adults with COVID-19, trials of immunomodulatory therapies have met with mixed results, likely due in part to biological heterogeneity of participants. Latent class analysis (LCA) of clinical and protein biomarker data has identified two subtypes of...
Objective
To evaluate the performance of risk calculators (RCs) predicting lymph node invasion (LNI) and extraprostatic extension (EPE) in men undergoing transperineal magnetic resonance imaging/transrectal ultrasound (TRUS)‐fusion template saturation biopsy (TTSB) and conventional systematic TRUS‐guided biopsy (SB).
Patients and Methods
The RCs w...
Background:
Artificial intelligence (AI) as an independent reader of screening mammograms has shown promise, but there are few prospective studies. Our aim was to conduct a prospective clinical trial to examine how AI affects cancer detection and false positive findings in a real-world setting.
Methods:
ScreenTrustCAD was a prospective, populati...
Background
Adherence to adjuvant tamoxifen therapy is suboptimal, and acceptance of tamoxifen for primary prevention is poor. Published results indicate effect of low-dose tamoxifen therapy. Using questionnaire data from a randomised controlled trial, we describe side effects of standard and low-dose tamoxifen in healthy women.
Methods
In the KARI...
Objective To estimate the dose–response associations between non-occupational physical activity and several chronic disease and mortality outcomes in the general adult population.
Design Systematic review and cohort-level dose-response meta-analysis.
Data sources PubMed, Scopus, Web of Science and reference lists of published studies.
Eligibilit...
Objective: To investigate the association of metabolic side effects with antipsychotic dose, we conducted a dose-response meta-analysis of randomized controlled trials (RCTs) in which antipsychotics were administered to people with schizophrenia. The primary outcome was mean change in weight. The secondary outcomes were the mean changes in metaboli...
Trial-level surrogates are useful tools for improving the speed and cost effectiveness of trials but surrogates that have not been properly evaluated can cause misleading results. The evaluation procedure is often contextual and depends on the type of trial setting. There have been many proposed methods for trial-level surrogate evaluation, but non...
Trial level surrogates are useful tools for improving the speed and cost effectiveness of trials, but surrogates that have not been properly evaluated can cause misleading results. The evaluation procedure is often contextual and depends on the type of trial setting. There have been many proposed methods for trial level surrogate evaluation, but no...
Introduction
The COVID-19 pandemic brought an urgent need to discover novel effective therapeutics for patients hospitalised with severe COVID-19. The Investigation of Serial studies to Predict Your Therapeutic Response with Imaging And moLecular Analysis (ISPY COVID-19 trial) was designed and implemented in early 2020 to evaluate investigational a...
Introduction
The COVID-19 pandemic brought an urgent need to discover novel effective therapeutics for patients hospitalized with severe COVID-19. The ISPY COVID trial was designed and implemented in early 2020 to evaluate investigational agents rapidly and simultaneously on a phase 2 adaptive platform. This manuscript outlines the design, rational...
Importance:
Mortality rates resulting from bladder cancer have remained unchanged for more than 30 years. The surgical community has put hope in robot-assisted radical cystectomy (RARC) with intracorporeal urinary diversion (ICUD) in an effort to improve surgical outcomes and bladder cancer survival without strong supporting evidence.
Objective:...
Objective
To estimate dose-response associations between non-occupational physical activity and multiple chronic disease outcomes in the general adult population.
Eligibility criteria
Prospective cohort studies with (a) general population samples >10,000 adults, (b) ≥3 exposure categories, and (c) risk measures and confidence intervals for all-cau...
ProBio is an outcome-adaptive, multiarm, multiple-assignment randomised, biomarker-driven platform trial in men with metastatic castration-resistant prostate cancer. Here we describe the amended clinical protocol, focusing on expansion of the trial to include patients with de novo metastatic hormone-sensitive prostate cancer.
Determining the optimal antipsychotic target dose in acute phase treatment is of high clinical relevance. The effect of antipsychotics on negative symptoms should be taken into account because patients will often continue on the treatment received in the acute phase. Therefore, we conducted a formal dose-response meta-analysis of negative symptoms...
Several studies evaluated prostate cancer (PCa) outcomes in Black men on active surveillance (AS); most studies contained few Black men and results were conflicting. We performed a systematic review and meta-analyze of race and outcomes on AS.
A systematic search was performed for articles of men with Grade Group 1 or 2 (GG1 or GG2) PCa on AS. All...
Background:
Negative symptoms are a core aspect of psychopathology in schizophrenia. Currently available pharmacological agents have proven minimally efficacious for remediating negative symptoms. A promising treatment avenue is the intranasal administration of the neuropeptide oxytocin. However, there have been inconsistencies in effects of oxyto...
Background
Negative symptoms are a core aspect of psychopathology in schizophrenia. Currently available pharmacological agents have proven minimally efficacious for remediating negative symptoms. A promising treatment avenue is the intranasal administration of the neuropeptide oxytocin. However, there have been inconsistencies in effects of oxytoci...
PurposeTo describe the predictive value of information on previous benign biopsy for the outcome of MRI-targeted biopsies.Methods
An exploratory analysis was conducted using data from a prospective, multicenter, paired diagnostic study of 532 men undergoing diagnostics for prostate cancer during 2016–2017. All men underwent 1.5 T MRI; systematic pr...
Metastatic castration-resistant prostate cancer (mCRPC) is a heterogeneous disease, characterized by common and rare driver gene alterations that provide a selective growth advantage for progressing tumour cells. We hypothesized that the number of distinct gene driver alteration-affected pathways or gene classes was associated with poor prognosis i...
PURPOSE
Tamoxifen prevents breast cancer in high-risk women and reduces mortality in the adjuvant setting. Mammographic density change is a proxy for tamoxifen therapy response. We tested whether lower doses of tamoxifen were noninferior to reduce mammographic density and associated with fewer symptoms.
PATIENTS AND METHODS
Women, 40-74 years of a...
Objectives
To evaluate the postoperative complication and mortality rate following laparoscopic radical cystectomy (RARC) with intracorporeal urinary diversion (ICUD) in octogenarians.
Patients and Methods
We conducted a retrospective analysis comparing postoperative complication and mortality rates depending on age in a consecutive series of 1890...
Objectives
To evaluate the postoperative complication and mortality rate following laparoscopic radical cystectomy (RARC) with intracorporeal urinary diversion (ICUD) in octogenarians.
Patients and Methods
We conducted a retrospective analysis comparing postoperative complication and mortality rates depending on age in a consecutive series of 1890...
Background
Multiple therapies exist for patients with metastatic castration-resistant prostate cancer (mCRPC). However, their improvement on progression-free survival (PFS) remains modest, potentially explained by tumor molecular heterogeneity. Several prognostic molecular biomarkers have been identified for mCRPC that may have predictive potential...
Background: Multiple therapies exist for patients with metastatic castration-resistant prostate cancer (mCRPC). However, their improvement on progression free survival (PFS) remains modest, potentially explained by tumour molecular heterogeneity. Several prognostic molecular biomarkers have been identified for mCRPC that may have predictive potenti...
Background: Multiple therapies exist for patients with metastatic castration-resistant prostate cancer (mCRPC). However, their improvement on progression free survival (PFS) remains modest, potentially explained by tumour molecular heterogeneity. Several prognostic molecular biomarkers have been identified for mCRPC that may have predictive potenti...
Objective:
The dose-response relationships of antipsychotic drugs for schizophrenia are not well defined, but such information would be important for decision making by clinicians. The authors sought to fill this gap by conducting dose-response meta-analyses.
Methods:
A search of multiple electronic databases (through November 2018) was conducte...
Objectives
To coherently examine the responsiveness of the Swedish National Tobacco Quitline (SNTQ) to different types of anti-smoking policies over an extended period of calendar time.
Design
Quasi-experimental design with an intervention time-series analysis based on 19 years series of data collected between January 1999 and August 2017 (224 mon...
Background
Metastatic castration-resistant prostate cancer (mCRPC) is a heterogeneous disease with rare driver gene alteration combinations in most men, requiring large sample sizes for stratified evaluations. We therefore hypothesized that the number of driver genes or pathways would affect prognosis in patients initiating androgen receptor signal...
Background
Despite multiple retrospective studies have demonstrated the clinical validity of molecularly-guided therapy selection in metastatic castrate-resistant prostate cancer (mCRPC), none have validated the actual clinical utility in the context of a randomised controlled trial. We hypothesise that treatment decisions based on plasma-derived c...
Objectives
To systematically review and analyse studies of high amounts of physical activity and mortality risk in the general population.
Eligibility criteria
Inclusion criteria related to follow-up (minimum 2 years), outcome (mortality from all causes, cancer, cardiovascular disease (CVD) or coronary heart disease), exposure (eg, a category of >...
BACKGROUND:
A causal link between outdoor air pollution and childhood leukemia has been proposed, but some older studies suffer from methodological drawbacks. To the best of our knowledge, no systematic reviews have summarized the most recently published evidence and no analyses have examined the dose-response relation.
OBJECTIVE:
We investigated...
Objectives:
To evaluate the association between nutritional status, defined on the basis of a multidimensional evaluation, and body mass index (BMI) with the risk of falls and recurrent falls in community-dwelling older people.
Design:
Systematic literature review and meta-analysis.
Setting and participants:
Community-dwelling older adults.
M...
Aim:
Cigarette smoking is an established risk factor for pancreatic cancer but an updated quantification of the association is lacking. Our aim is to provide the most accurate and updated estimate of the dose-response relationships between cigarette smoking and pancreatic cancer risk.
Methods:
Using an innovative approach for the identification...
The standard two-stage approach for estimating non-linear dose–response curves based on aggregated data typically excludes those studies with less than three exposure groups. We develop the one-stage method as a linear mixed model and present the main aspects of the methodology, including model specification, estimation, testing, prediction, goodne...
In a two-stage dose-response meta-analysis a common functional relationship is applied to each study and an overall curve is obtained by combining study-specific dose-response coefficients. Possible limitations are: 1) a common dose-response model may have a poor fit in some of the studies; 2) combining dose-response coefficients discard informatio...
Background
It is important to better understand the optimum doses and equivalent doses of antipsychotic drugs. Several methods to understand these relationships have been published, but all these methods have weaknesses. In this paper we present a dose-response meta-analysis which theoretically is the most appropriate method for this purpose.
Meth...
Background/objectives:
Several epidemiological studies have analyzed the associations between red and processed meat and bladder cancer risk but the shape and strength of the associations are still unclear. Therefore, we conducted a dose-response meta-analysis to quantify the potential association between red and processed meat and bladder cancer...
Table S1. Additional Description of Studies Included in the Meta‐Analysis
Figure S1. Preferred Reporting Items for Systematic Reviews and Meta‐Analyses flow chart.
Background:
Several studies have shown an inverse relationship between ideal cardiovascular health (CVH) and mortality. However, there are no studies that pool these data to show the shape of the relationship and quantify the mortality benefit from ideal CVH.
Methods and results:
We conducted a systematic internet literature search of multiple d...
Aims/hypothesis:
Inverse associations between physical activity (PA) and type 2 diabetes mellitus are well known. However, the shape of the dose-response relationship is still uncertain. This review synthesises results from longitudinal studies in general populations and uses non-linear models of the association between PA and incident type 2 diab...
AIMS/HYPOTHESIS: Inverse associations between physical activity (PA) and type 2 diabetes mellitus are well known. However, the shape of the dose-response relationship is still uncertain. This review synthesises results from longitudinal studies in general populations and uses non-linear models of the association between PA and incident type 2 diabe...
Background
The possibility that lifestyle factors such as diet, specifically potassium intake, may modify the risk of stroke has been suggested by several observational cohort studies, including some recent reports. We performed a systematic review and meta‐analysis of existing studies and assessed the dose–response relation between potassium intak...
Table S1. Number of Participants, Number of Events, Years of Follow‐Up and Adjustment Factors of Included Studies (SBP, Systolic Blood Pressure; BP, Blood Pressure; BMI, Body Mass Index; LDL, Low‐Density Lipoprotein; HDL, High‐Density Lipoprotein)
Table S2. Newcastle–Ottawa Quality Assessment Scale for Included Studies (A), With Details of Score A...
Background
Meta-analytical methods are frequently used to combine dose-response findings expressed in terms of relative risks. However, no methodology has been established when results are summarized in terms of differences in means of quantitative outcomes.
Methods
We proposed a two-stage approach. A flexible dose-response model is estimated with...
An increasing number of quantitative reviews of epidemiological data includes a doseresponse analysis. Aims of this paper are to describe the main aspects of the methodology and to illustrate the novel R package dosresmeta developed for multivariate dose-response meta-analysis of summarized data. Specific topics covered are reconstructing covarianc...
Assessing the magnitude of heterogeneity in a meta-analysis is important for determining the appropriateness of combining results. The most popular measure of heterogeneity, I(2) , was derived under an assumption of homogeneity of the within-study variances, which is almost never true, and the alternative estimator, R^I, uses the harmonic mean to e...
Background: Studies have shown that individuals with higher levels of Ideal Cardiovascular Health (ICVH) metrics have favorable health outcomes. However, none of these studies quantify the reduction in the risk of death per unit increase in ICVH. In this study, we estimated the reduction in CVD and all-cause mortality attributable to per unit impro...
Goodness of fit evaluation should be a natural step in assessing and reporting dose-response meta-analyses from aggregated data of binary outcomes. However, little attention has been given to this topic in the epidemiological literature, and goodness of fit is rarely, if ever, assessed in practice. We briefly review the two-stage and one-stage meth...
Results from epidemiological studies of milk consumption and mortality are inconsistent. We conducted a systematic review and meta-analysis of prospective studies assessing the association of non-fermented and fermented milk consumption with mortality from all causes, cardiovascular disease, and cancer. PubMed was searched until August 2015. A two-...
