Background
Patient-reported outcomes (PROs), which are health outcomes subjectively provided by patients, have been used in various situations over the past decades as tools to understand patients’ health conditions, and accordingly, numerous PRO questionnaires and guidelines have been developed. In this study, existing PRO guidelines for clinical trials and practice were comprehensively collected to support novice PRO users in academia, industry, clinical practice, regulatory and reimbursement decision-making.
Methods
For the scoping review, we searched databases including MEDLINE, Embase, Google Books, WorldCat, and the National Library of Medicine (NLM) Bookshelf from 2009 to 2020. The inclusion criteria were PRO guidelines for clinical trials/practice and application/utilization, which included quality of life (QOL), PRO, health-related QOL, or health state utilities related to psychometric requirements, collection method and analysis, and clinical interpretation. After the systematic search, three members individually reviewed the data collected, and the reviewed articles and books were scrutinized for the same criteria.
Results
The PRO guidelines published in articles and books between 2009 and 2020 were collected. From the database searches, 1,039 articles and 296 books were selected, of which one book and 25 articles were finally selected. A total of 16 guidelines from articles and books on clinical trials covered issues such as design/reporting, questionnaire preparation, and collection methods, including ePRO, analysis, and clinical interpretation. Five of these covered PRO assessment and application in clinical practice. One PRO guideline was published to inform decision-making such as health technology assessment.
Conclusions
This scoping review classified existing PRO guidelines by stage (evaluation or application), setting (clinical trials/practice), and evaluation process. The classification and summary would facilitate beginners’ judgment in the selection and explanation of terms used in the guidelines would enhance understanding of existing PRO guidelines.
