Patient-reported outcomes (PRO) data is becoming increasingly important in randomized controlled trials. Without complete and transparent reporting, though, readers may have difficulty understanding the methodology used and interpreting trial results. The result is an unfortunate waste of research efforts and an undermining of PRO data value.
Lori McLeod, PhD
Head, Psychometrics & Executive Director,
Patient-Centered Outcomes Assessment
RTI Health Solutions
In 2010, the CONSORT Statement was created to improve trials reporting. It has been widely accepted, but does not specifically include PRO reporting criteria. The CONSORT-PRO Extension, which provided needed PRO reporting standards, was released in 2013.
The International Society for Quality of Life Research (ISOQOL) Best Practices for PRO Reporting Taskforce has conducted research to determine the level of the extension’s adoption and implementation.
As part of the ISOQOL task force, Lori McLeod, PhD, of RTI Health Solutions, was involved in the analysis of PRO reporting of randomized controlled trials since the release of the extension. Dr. McLeod commented, “The CONSORT Statement is endorsed by many of the prominent medical journals. The quality of articles summarizing clinical trial results has benefited because of journals requiring CONSORT checklists as part of submissions. We look forward to the uptake of the PRO extension and the benefits of greater clarity for PRO reporting in the future, as well.”
The task force study Preliminary evidence on the uptake, use and benefits of the CONSORT-PRO extension, recently published in Quality of Life Research, suggests that endorsement and promotion of the CONSORT-PRO guidelines by journals does result in greater adherence. Moreover, PRO reporting guidance is key, and stronger journal support for the guidelines would continue to improve PRO reporting.
Further work is needed to promote appropriate use of CONSORT-PRO guidelines.
Visit our publications to view RTI Health Solutions patient-reported outcomes research.