Bias Due to Within-Subject Exposure Dependency With or Without Bias Due to Lack of Pairwise Exchangeability When Exposure Is Chronic in Case-Crossover and Case–Time-Control Studies: A Simulation Study.

The case-crossover study design has been proposed as a suitable design for use when a brief exposure causes a transient change in risk of an acute-onset disease. In pharmacoepidemiology, the condition of "brief exposure" is rarely satisfied because medication use is often chronic or successive, whic...

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Publicado en:American Journal of Epidemiology Vol. 192; no. 10; pp. 1701 - 1712
Autores principales: Kubota, Kiyoshi, Kelly, Thu-Lan
Formato: equations & formulas research tables/charts Journal Article
Publicado: Oxford University Press / USA Oct2023
Acceso en línea:Ver este registro en EBSCOhost
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      dt: Oct2023
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      pub: Oxford University Press / USA
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        10.1093/aje/kwad104
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        atl: Bias Due to Within-Subject Exposure Dependency With or Without Bias Due to Lack of Pairwise Exchangeability When Exposure Is Chronic in Case-Crossover and Case–Time-Control Studies: A Simulation Study.
      aug:
        au:
          Kubota, Kiyoshi
          Kelly, Thu-Lan
      sug:
        subj:
          Research Subjects
          Bias (Research)
          Crossover Design
          Case Control Studies
          Simulations
          Acute Disease Drug Therapy
          Drugs, Prescription Administration and Dosage
          Treatment Duration
          Drug Efficacy
          Human
          Prospective Studies
          Logistic Regression
          Odds Ratio
          Mantel-Haenszel Test
          Drug Substitution
          Funding Source
          Confidence Intervals
          Epidemiological Research
      ab: The case-crossover study design has been proposed as a suitable design for use when a brief exposure causes a transient change in risk of an acute-onset disease. In pharmacoepidemiology, the condition of "brief exposure" is rarely satisfied because medication use is often chronic or successive, which may result in bias due to within-subject exposure dependency. Here we describe a simulation of a case-crossover study conducted within a cohort, where patients successively used a drug for 60 or more days and the rate ratio for the outcome occurrence was 4.0. Standard conditional logistic regression for the analysis produced overestimated odds ratios ranging up to 7.8. This bias due to within-subject exposure dependency from chronic use can be removed by the Mantel-Haenszel method or by our recently proposed weighting method. We also show that when some patients are censored after switching to another drug, a lack of pairwise exchangeability causes bias which is similar to bias due to an exposure time trend. This bias can be removed by using the case–time-control study design. We show that bias due to within-subject exposure dependency and lack of pairwise exchangeability occur independently and can occur separately or simultaneously, and we demonstrate how to detect and remove them.
      pubtype: Academic Journal
      doctype:
        equations & formulas
        research
        tables/charts
        Journal Article
      ougenre: Article
    language: English
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