Probabilistic bias analysis in pharmacoepidemiology and comparative effectiveness research: a systematic review

Student Author(s)

Jacob N. Hunnicutt

UMMS Affiliation

Department of Quantitative Health Sciences

Publication Date


Document Type



Clinical Epidemiology | Epidemiology | Pharmacy and Pharmaceutical Sciences | Statistics and Probability


PURPOSE: We systematically reviewed pharmacoepidemiologic and comparative effectiveness studies that use probabilistic bias analysis to quantify the effects of systematic error including confounding, misclassification, and selection bias on study results.

METHODS: We found articles published between 2010 and October 2015 through a citation search using Web of Science and Google Scholar and a keyword search using PubMed and Scopus. Eligibility of studies was assessed by one reviewer. Three reviewers independently abstracted data from eligible studies.

RESULTS: Fifteen studies used probabilistic bias analysis and were eligible for data abstraction-nine simulated an unmeasured confounder and six simulated misclassification. The majority of studies simulating an unmeasured confounder did not specify the range of plausible estimates for the bias parameters. Studies simulating misclassification were in general clearer when reporting the plausible distribution of bias parameters. Regardless of the bias simulated, the probability distributions assigned to bias parameters, number of simulated iterations, sensitivity analyses, and diagnostics were not discussed in the majority of studies.

CONCLUSION: Despite the prevalence and concern of bias in pharmacoepidemiologic and comparative effectiveness studies, probabilistic bias analysis to quantitatively model the effect of bias was not widely used. The quality of reporting and use of this technique varied and was often unclear. Further discussion and dissemination of the technique are warranted.


UMCCTS funding, comparative effectiveness, pharmacoepidemiology, probabilistic bias analysis, quantitative bias analysis

DOI of Published Version



Pharmacoepidemiol Drug Saf. 2016 Dec;25(12):1343-1353. doi: 10.1002/pds.4076. Epub 2016 Sep 5. Link to article on publisher's website

Journal/Book/Conference Title

Pharmacoepidemiology and drug safety

Related Resources

Link to article in PubMed

PubMed ID