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Individual participant data meta-analysis of intervention studies with time-to-event outcomes: A review of the methodology and an applied example.

ABSTRACT: Many randomized trials evaluate an intervention effect on time-to-event outcomes. Individual participant data (IPD) from such trials can be obtained and combined in a so-called IPD meta-analysis (IPD-MA), to summarize the overall intervention effect. We performed a narrative literature review to provide an overview of methods for conducting an IPD-MA of randomized intervention studies with a time-to-event outcome. We focused on identifying good methodological practice for modeling frailty of trial participants across trials, modeling heterogeneity of intervention effects, choosing appropriate association measures, dealing with (trial differences in) censoring and follow-up times, and addressing time-varying intervention effects and effect modification (interactions).We discuss how to achieve this using parametric and semi-parametric methods, and describe how to implement these in a one-stage or two-stage IPD-MA framework. We recommend exploring heterogeneity of the effect(s) through interaction and non-linear effects. Random effects should be applied to account for residual heterogeneity of the intervention effect. We provide further recommendations, many of which specific to IPD-MA of time-to-event data from randomized trials examining an intervention effect.We illustrate several key methods in a real IPD-MA, where IPD of 1225 participants from 5 randomized clinical trials were combined to compare the effects of Carbamazepine and Valproate on the incidence of epileptic seizures.

SUBMITTER: de Jong VMT

PROVIDER: S-EPMC7079159 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature

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Individual participant data meta-analysis of intervention studies with time-to-event outcomes: A review of the methodology and an applied example.

de Jong Valentijn M T VMT Moons Karel G M KGM Riley Richard D RD Tudur Smith Catrin C Marson Anthony G AG Eijkemans Marinus J C MJC Debray Thomas P A TPA

Research synthesis methods 20200206 2

Many randomized trials evaluate an intervention effect on time-to-event outcomes. Individual participant data (IPD) from such trials can be obtained and combined in a so-called IPD meta-analysis (IPD-MA), to summarize the overall intervention effect. We performed a narrative literature review to provide an overview of methods for conducting an IPD-MA of randomized intervention studies with a time-to-event outcome. We focused on identifying good methodological practice for modeling frailty of tri ...[more]

PMID: 31759339

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Project description:BACKGROUND:Data repositories have the potential to play an important role in the effective and safe sharing of individual-participant data (IPD) from clinical studies. We analysed the current landscape of data repositories to create a detailed description of available repositories and assess their suitability for hosting data from clinical studies, from the perspective of the clinical researcher. METHODS:We assessed repositories that enable storage, sharing, discoverability, re-use of the IPD and associated documents from clinical studies using a pre-defined set of 34 items and publicly available information from April to June 2018. For this purpose, we developed an indicator set to capture the maturity of the repositories' procedures and their suitability for the hosting of IPD. The indicators cover guidelines for data upload and data de-identification, data quality controls, contracts for upload and storage, flexibility of access, application of identifiers, availability of metadata, and long-term preservation. RESULTS:We analysed 25 repositories, from an initial set of 55 identified as possibly relevant. Half of the included repositories were generic, i.e. not limited to a specific disease or clinical area and 13 were launched in the last 8 years. The sample was extremely heterogeneous and included repositories developed by research funders, infrastructures, universities, and editors. All but three repositories do not apply a fee for uploading, storage or access to data. None of the repositories completely demonstrated all the items included in the indicator set, but three repositories (Dryad, Drum, EASY) met - fully or partially - all items. Flexibility of data-access modalities appears to be limited, being lacking in half of the repositories. CONCLUSIONS:Our evaluation, though often hampered by the lack of sufficient information, can help researchers to find a suitable repository for their datasets. Some repositories are more mature because of their support for clinical dataset preparation, contractual agreements, metadata and identifiers, different modalities of access, and long-term preservation of data. Further work is now required to achieve a more robust and accurate system for evaluation, which in turn may encourage the sharing of clinical study data. TRIAL REGISTRATION:Study protocol available at https://zenodo.org/record/1438261#.W64kW9Egrcs .

Project description:AimsTo investigate cross-sectional and longitudinal associations between personality and smoking, and test whether socio-demographic factors modify these associations.DesignCross-sectional and longitudinal individual-participant meta-analysis.SettingNine cohort studies from Australia, Germany, the United Kingdom and the United States.ParticipantsA total of 79 757 men and women (mean age = 50.8 years).MeasurementsPersonality traits of the five-factor model (extraversion, neuroticism, agreeableness, conscientiousness and openness to experience) were used as exposures. Outcomes were current smoking status (current smoker, ex-smoker and never smoker), smoking initiation, smoking relapse and smoking cessation. Associations between personality and smoking were modelled using logistic and multinomial logistic regression, and study-specific findings were combined using random-effect meta-analysis.FindingsCurrent smoking was associated with higher extraversion [odds ratio per 1 standard deviation increase in the score: 1.16; 95% confidence interval (CI) = 1.08-1.24], higher neuroticism (1.19; 95% CI = 1.13-1.26) and lower conscientiousness (95% CI = 0.88; 0.83-0.94). Among non-smokers, smoking initiation during the follow-up period was predicted prospectively by higher extraversion (1.22; 95% CI = 1.04-1.43) and lower conscientiousness (0.80; 95% CI = 0.68-0.93), whereas higher neuroticism (1.16; 95% CI = 1.04-1.30) predicted smoking relapse among ex-smokers. Among smokers, smoking cessation was negatively associated with neuroticism (0.91; 95% CI = 0.87-0.96). Socio-demographic variables did not appear to modify the associations between personality and smoking.ConclusionsAdult smokers have higher extraversion, higher neuroticism and lower conscientiousness personality scores than non-smokers. Initiation into smoking is associated positively with higher extraversion and lower conscientiousness, while relapse to smoking among ex-smokers is associated with higher neuroticism.

Dataset Information

Individual participant data meta-analysis of intervention studies with time-to-event outcomes: A review of the methodology and an applied example.

Publications

Individual participant data meta-analysis of intervention studies with time-to-event outcomes: A review of the methodology and an applied example.

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