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Comparison of statistical methods for the analysis of recurrent adverse events in the presence of non-proportional hazards and unobserved heterogeneity: a simulation study

Abstract:

Background: In preventive drug trials such as intermittent preventive treatment for malaria prevention during pregnancy (IPTp), where there is repeated treatment administration, recurrence of adverse events (AEs) is expected. Challenges in modelling the risk of the AEs include accounting for time-to-AE and within-patient-correlation, beyond the conventional methods. The correlation comes from two sources; (a) individual patient unobserved heterogeneity (i.e. frailty) ...

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Publication status:
Published
Peer review status:
Peer reviewed

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Publisher copy:
10.1186/s12874-021-01475-8

Authors


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Institution:
University of Oxford
Division:
MSD
Department:
NDM
Sub department:
Tropical Medicine
Role:
Author
ORCID:
0000-0002-5036-6583
Publisher:
BioMed Central
Journal:
BMC Medical Research Methodology More from this journal
Volume:
22
Article number:
24
Publication date:
2022-01-20
Acceptance date:
2021-11-19
DOI:
EISSN:
1471-2288
Pmid:
35057743
Language:
English
Keywords:
Pubs id:
1237034
Local pid:
pubs:1237034
Deposit date:
2022-12-07

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