Background: Assessment of the quality of included studies is an essential component of any systematic review. A formal quality assessment is facilitated by using a structured tool. There are currently no guidelines available for researchers wanting to develop a new quality assessment tool.
Methods: This paper provides a framework for developing quality assessment tools based on our experiences of developing a variety of quality assessment tools for studies of differing designs over the last 14 years. We have also drawn on experience from the work of the EQUATOR Network in producing guidance for developing reporting guidelines.
Results: We do not recommend a single 'best' approach. Instead, we provide a general framework with suggestions as to how the different stages can be approached. Our proposed framework is based around three key stages: initial steps, tool development and dissemination.
Conclusions: We recommend that anyone who would like to develop a new quality assessment tool follow the stages outlined in this paper. We hope that our proposed framework will increase the number of tools developed using robust methods.
Keywords: Quality; Risk of bias; Systematic reviews.