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

Extensions of the CONSORT Statement

The main CONSORT Statement is based on the "standard" two-group parallel design. However, there are several variations to the standard trial methodology, including different design aspects (e.g., cluster), interventions (e.g., herbals) and data (e.g., harms).

To help improve the reporting of these trials the main CONSORT Statement has been extended and modified by members of the CONSORT group for application in these various areas. The resulting CONSORT extensions are presented in this section. This list is, by no means, exhaustive; and work is constantly in progress.

Please note that modifications to the CONSORT checklist or flow diagram that are not developed with the involvement of the CONSORT Group do not have permission to name their work "CONSORT".

Some work, however, has been done to modify the CONSORT Statement without the involvement of the Group. These unofficial extensions of the CONSORT Statement can be found here.


Finding the Appropriate Extension

The table below lists the current official extensions of the CONSORT statement.  You can click on each extension to learn more about it or to explore that extension in the checklist viewer application.


Cluster Trials Herbal Medicinal Interventions CONSORT-Outcomes 2022 Checklist (for combined completion of CONSORT 2010) CONSORT-PRO
Non-Inferiority and Equivalence Trials Non-Pharmacologic Treatment Interventions CONSORT-Outcomes 2022 Extension items only (for separate completion of CONSORT 2010 and CONSORT-Outcomes 2022 items) Harms
Pragmatic Trials Acupuncture Interventions  


N-of-1 Trials Chinese Herbal Medicine Formulas   Equity
Pilot and Feasibility Trials  Social and Psychological Interventions   Randomised Crossover Trial Reporting
Within Person Trials      
Multi-Arm Parallel-Group Randomized Trials      
Adaptive Designs