Patient-Reported Outcomes (CONSORT PRO)

The 2013 CONSORT-PRO extension provides guidance for authors of trials describing patient-reported outcomes. Specifically, it extends five items of the CONSORT 2010 checklist to facilitate optimal reporting of RCTs in which PRO's are primary or secondary end points.

Available Downloads

The main CONSORT flow diagram should be used.

Document Word Format PDF Format
Statement/Elaboration n/a Download
Checklist n/a Download


Calvert M, Blazeby J, Altman DG, et al. Reporting of Patient-Reported Outcomes in Randomized Trials: The CONSORT PRO Extension. JAMA 2013; 309(8): 814-822. PMID: 23443445

Brundage M, Blazeby J, Revicki D, Bass B, de Vet H, Duffy H, Efficace F, King M, Lam C, Moher D, Scott J, Sloan J, Snyder C , Yount S, Calvert M Patient-reported outcomes in randomized clinical trials: development of ISOQOL reporting standards Qual Life Res DOI 10.1007/s11136-012-0252-1 Published online 18 Sept 2012. PMID: 22987144

Calvert M, Blazeby J, Revicki D, Moher D, Brundage M. Reporting quality of life in clinical trials: a CONSORT extension? Lancet. 2011;378(9804):1684-5. PMID: 22078674