Quality versus Risk-of-Bias assessment in clinical research

Luis Furuya-Kanamori,Chang Xu,Syed Shahzad Hasan,Suhail A Doi

doi:10.1016/j.jclinepi.2020.09.044

Luis Furuya-Kanamori, Chang Xu + Show 2 more

Open Access

https://doi.org/10.1016/j.jclinepi.2020.09.044

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Abstract

Assessment of internal validity safeguards implemented by researchers has been used to examine the potential reliability of evidence generated within a study. These safeguards protect against systematic error, and such an assessment has traditionally been called a quality assessment. When the results of a quality assessment are translated through some empirical construct to the potential risk of bias, this has been termed a risk of bias assessment. The latter has gained popularity and is commonly used interchangeably with the term quality assessment. This key concept paper clarifies the differences between these assessments and how they may be used and interpreted when assessing clinical evidence for internal validity.

Highlights

Bias negatively impacts clinical epidemiologic research, and to prevent this requires the placement of methodological safeguards within research studies
Before a body of research can get its results embedded into evidence-based practice, there should be a quality assessment for the presence of such safeguards against bias in the various included studies on the topic to ensure the credibility of research results, and this is formally undertaken using a quality assessment
This assessment has been called the risk of bias assessment

Summary

Introduction

Bias negatively impacts clinical epidemiologic research, and to prevent this requires the placement of methodological safeguards within research studies. This can be taken a step further, and these assessments ( the quality assessment) can be used for bias adjustment of metaanalysis results [4] These assessments require tools that include a list of safeguard items likely to influence internal validity (quality assessment) or estimated intervention effects (risk of bias assessment) that can be looked for in the published research. By and large, these safeguard items are the same, and the only reason why they may be labeled by either term is the intent of the particular assessment. GRADE incorporates a risk of bias assessment within this generic quality construct

Application

Key points