OBJECTIVES: Electronically captured patient-reported outcomes (ePRO) have become essential in clinical research and are a welcome platform to promote the patients’ perspective on how they feel function and survive. Regulatory agencies and working groups have published guidance; yet between the various stakeholders involved in the process, issues and ambiguities are readily encountered in practice. The aim of this research was to summarize current guidance and make comparisons to issues identified in practice.

METHODS: A pragmatic literature search was conducted in PubMed from January 2007 to April 2017 to identify key articles reporting methodology or recommendations for ePRO development or migration. In addition, the authors identified additional publically available documents based on their experience and by searching websites of key working groups and organizations in the ePRO field. Issues encountered in practice were identified from various stakeholders including a panel of PRO experts (including the study authors) working in the field and from a survey sent to corresponding authors/publishers of questionnaires (n=28).

RESULTS: From the PubMed search, a total of 25 articles or conference abstracts, with a primary focus on ePRO methods, good practices and recommendations, were selected. In addition, the authors identified over 16 regulatory documents or presentations/guidance from key working groups or organizations in the ePRO field. Content mainly addressed migration from paper to ePRO systems: general implementation considerations and migration study methodology to document adequacy. The identification of issues encountered in practice is on-going (April-June 2017). Results from the panel discussion and the questionnaires’ author/publisher survey are currently analyzed. A comparison of these results with the content of the documents retrieved during the literature search will be undertaken to identify gaps and unanswered questions.

CONCLUSIONS: Publically available guidance provides a useful starting point for the general process of ePRO development/migration with probable room for improvement from a practical perspective.