Tuesday, April 23, 2013

Reporting of Patient-Reported Outcomes



Dear New Investigators,

Since you are involved in research regarding Patient Reported Outcomes(PROs) and Health-Related Quality of Life (HRQL), I assume that you are all aware of the relevance of conducting this research. Therefore, I also hope that you are all aware that to forward the field of PROs and HRQL, research needs to be of the highest quality. This necessity not only applies to the design, conduct, and analysis of your study, but also applies to the reporting of your methods and findings. In the end, you want to make sure that your research provides the definitive answer to your specific research question, and you want to make sure that this message is clear and understandable to reviewers and readers alike. 

The ISOQOL Task Force has recently published a PRO extension, containing five additional items on top of the items described in the original CONSORT statement. As result, guideline developers will have a much easier time assessing the quality of the manuscript and thus the quality and relevance of PRO results. In the end, an increase in the quality of PRO reporting will likely result in an increase in the use of PRO data when discussing treatment options with patients.

To help new investigators write an impeccable report of their PRO findings, I have attached several titles of articles that might be of use to you when drafting your manuscript. Many contain tips and checklists that will help you identify which aspects are truly relevant when reporting PRO data. However, not all articles are explicitly related to HRQL outcome reporting, and I am sure that many more articles should be attached to this list as it is hardly exhaustive. 

Therefore, please feel free to update this list. The more information the merrier.

Enjoy!

Best wishes,

Marc Jacobs

 

List of articles
Reporting of Patient-Reported Outcomes in Randomized Trials The CONSORT PRO Extension
Melanie Calvert, PhD, Jane Blazeby, MD, Douglas G. Altman, DSc, Dennis A. Revicki, PhD, David Moher, PhD. Michael D. Brundage, MD

Scientific rigour in psycho-oncology trials: why and how to avoid common statistical errors. Melanie L. Bell, Jake Olivier and Madeleine T. King

Systematic review reveals limitations of studies evaluating health-related quality of life after potentially curative treatment for esophageal cancer. Marc Jacobs • Rhiannon C. Macefield • Jane M. Blazeby • Ida J. Korfage • Mark I. van Berge Henegouwen • Hanneke C. J. M. de Haes • Ellen M. Smets • Mirjam A. G. Sprangers

Analysis and interpretation of health-related quality-of-life data from clinical trials: basic approach of The National Cancer Institute of Canada Clinical Trials Group.
David Osoba, Andrea Bezjak, Michael Brundage, Benny Zee, Dongsheng Tu, Joseph Pater, for the Quality of Life Committee of the NCIC CTG

Cochrane Risk of Bias Tool
http://www.mrc-bsu.cam.ac.uk/cochrane/handbook/chapter_8/table_8_5_a_the_cochrane_collaborations_tool_for_assessing.htm

EQUATOR network for reporting guidelines
http://www.equator-network.org/resource-centre/library-of-health-research-reporting/reporting-guidelines-under-development/