Part 2 (a) Development of methods to present the ‘take home/trial exegesis’ message of PRO with clinical data in trials

Methods to report the ‘take home’ messages of clinical and PROs in trials were developed through an in-depth analysis of items 2a and P2b (rationale/hypotheses for PRO measurement), and P20/21 and 22 (limitations and implications for clinical practice, and interpretation of PROs in relation to clinical outcomes) to identify good practice and produce methods to inform a PRO take home message from trials. All papers were read and re-read independently by at least two (AM, RM and JMB) researchers to become immersed in the data and relevant text was independently coded, copied verbatim into an electronic database and analysed for consistency between researchers. Discrepancies in coding were discussed within the study team (AM, RM and JMB). Methods for reporting trial ‘take home’ message were developed and applied iteratively to relevant text. Deviant examples were sought to challenge theories. Primary quotations are provided in accordance to methods of qualitative rigor. It was also noted whether primary papers indicated the future publication of a supplemental PRO paper (defined as “signposting”).