Methodology standards for usual care as a comparator in patient centred, comparative, clinical effectiveness research

Research studies leveraging usual care comparator groups have the potential to produce valuable evidence about current clinical practice and substantially improve clinical care delivery and patient health outcomes. The lack of consensus methods to define usual care comparators in studies can result in a lack of generalisability and translatability of findings to real world clinical contexts. Given the importance of usual care comparators in patient centred, comparative, clinical effectiveness research (CER) studies, the Patient-Centred Outcomes Research Institute (PCORI) has developed research methodology standards to guide the selection and implementation of usual care comparators to improve the generalisability and translation of findings for CER studies using a usual care comparator. This article informs the research community and other funders and international researchers about the new methodology standards developed by PCORI.