Patient-Reported Outcome Measures for Swallowing: A Proposed Checklist.

Purpose: Patient-reported outcome measures (PROMs) are an important tool both in clinical practice and research involving patients with swallowing disorders. There are several challenges to be overcome and methodological details to be adequately reported to ensure rigor and transparency in studies utilizing PROMs in dysphagia research. For this reason, the Framework for RigOr aNd Transparency In REseaRch on Swallowing (FRONTIERS), a critical appraisal tool developed to ensure rigor and transparency in dysphagia research, has devoted a domain to PROMs. The aim of this current article, as part of a larger forum of articles, is to present the PROM section of FRONTIERS and describe its development.

Method: A literature review was carried out on PROMs in the field of dysphagia by three members of the FRONTIERS collaborative to identify items that were necessary for the rigorous application and transparent reporting of PROMs utilized in research of swallowing disorders in human subjects. Framework items were then subjected to an iterative process of feedback and consensus among the three members of the working group as well as all members of the FRONTIERS collaborative. Items were flagged for review and revised as needed until consensus was achieved on the final list. The final item list was compared to existing critical appraisal tools for PROMs.

Results: The final checklist for the PROMs domain included 20 "Yes/No" questions that can be broadly divided into three categories: (a) development and validation, (b) patient population, and (c) PROM administration method. Each item is presented with a rationale for its inclusion.

Conclusions: The use of the FRONTIERS Framework will serve researchers and those appraising quality of research involving PROMs. More broadly, the FRONTIERS Framework will facilitate improved rigor and transparency across dysphagia research. Special considerations and future goals are discussed.