Incorporating patients’ input in the development and validation of patient-reported outcome measures in oncology: a comprehensive scoping review

Background: Patient-reported outcome measures (PROMs) play a crucial role in evaluating oncological interventions. Although PROMs are developed to assess the patient’s health status, it remains unknown if patients’ perspectives are considered when developing and validating PROMs. This review aims to describe the nature of patient involvement in PROM development and validation in oncology research. Methods: A scoping review was conducted to identify relevant articles on patient involvement in PROM development and validation in cancer research published between 1993 and 2023 using PubMed/Medline, Embase, Scopus, and Cochrane databases, with the aim of exploring the extent and nature of patient involvement in developing and validating PROMs specifically in cancer research. Results: Out of 1354 initially identified articles, 34 met the inclusion criteria, and included various cancer types. The majority of studies (76%) engaged patients in item development through methods such as focus groups and interviews. Patient involvement across all phases of development and validation was documented in 35% of the studies. The value of patient involvement was illustrated by the improved relevance of the PROM content, leading to the inclusion of issues that were meaningful to patients. Conclusion: This scoping review demonstrates that even though the nature and extent of involvement varied throughout the stages of PROM development, the value of patients’ voices was not in question. A potential next step could be to introduce standardized terminology and develop guidelines to enhance a consistent and effective integration of patients’ input into the development of PROMs in the oncology setting.