Comparative effectiveness research: guidelines for good practices are just the beginning

Abstract

The International Society for Pharmacoeconomics and Outcomes Research formed a task force to gather state-of-the-art recommendations on good research practices for comparative effectiveness research using retrospective databases. The report of the task force was published in three sections in the journal Value in Health in December 2009, and addressed issues of design, analysis, framing the research question, and reporting and interpreting the findings from nonrandomized studies of treatment effects. This article will briefly examine the structure, process and outcomes of that task force, comment on the potential impact of the report in the context of comparative effectiveness research, and offer a few observations on the future of this field.

Keywords::

• comparative effectiveness research
• good research practices
• ISPOR
• recommendations
• retrospective database studies
• task force

Acknowledgements

The authors wish to acknowledge Sebastian Schneeweiss for his gracious assistance in the initial formation of the task force.

Financial & competing interests disclosure

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

No writing assistance was utilized in the production of this manuscript.

Notes

Note: some recommendations have been edited for brevity and clarity from the original report.

DAG: Directed acyclic graph; RCT: Randomized controlled trial; ROC: Receiver operating characteristic.