Putting patients at the heart of health-care research.

www.thelancet.com Vol 385 March 21, 2015 1073 important patient outcomes can be lost. Our systematic review of PRO guidance for trial protocol writers identified a confusing mix of 162 separate recommendations spread across 54 documents. Additionally, although the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) group published guidelines in 2013, this guidance does not provide specific information about PROs. Clearly, consolidated PRO guide lines are needed and could be in the form of a SPIRIT PRO extension. However, a checklist alone is unlikely to be suffi cient to change practice. We need to develop comprehensive guidelines and web-based training resources that are accessible to a range of stakeholders including researchers, funding bodies, journal editors and reviewers, patient advocates involved in trial design, and ethics committees. Additionally, support from journal editors and funding agencies will be essential to help with the appropriate uptake of these proposed SPIRIT PRO guidelines. Development of a SPIRIT PRO extension and the supportive resources is being led by researchers at the University of Birmingham (UK) and University of Sydney (Australia), in collaboration with the International Society for Quality of Life Research, SPIRIT Executive, and international stakeholders. Improvements to PRO research are essential to provide high-quality data and inform patient care.