Public Comment Period Begins for PCORI's Draft Methodology Report
The Patient-Centered Outcomes Research Institute (PCORI) today announced that it will begin accepting public comments on its draft methodology report. This document, which outlines a set of 60 best research practices, is intended to set the groundwork for the standards and types of research methods that can be used to develop comparative effectiveness research (CER). The report is divided into nine chapters with references and appendices:
The Patient-Centered Outcomes Research Institute (PCORI) today announced that it will begin accepting public comments on its draft methodology report. This document, which outlines a set of 60 best research practices, is intended to set the groundwork for the standards and types of research methods that can be used to develop comparative effectiveness research (CER). The report is divided into nine chapters with references and appendices:
- Chapter 2 of this report focuses on how the PCORI methodology committee approached this core task of developing methodological standards;
- Chapter 3 provides an overview of the standards and actions the committee recommends to make them effective;
- Chapter 4 describes the rationale for standards for patient-centeredness;
- Chapter 5 examines the rationale for prioritizing topics for research;
- Chapter 6 outlines the rationale for choosing a study design;
- Chapters 7-8 explains the rationale for designing, conducting, and reporting research; and
- Chapter 9 describes priority areas for the methodology committee over the next 2-3 years.
Comments will be accepted online through September 14, 2012. According to PCORI, the "feedback will be analyzed and potentially incorporated into a revised version of the report that the PCORI Board of Governors will review and consider for adoption at its November public meeting in Boston."
The National Pharmaceutical Council (NPC) has been working with other research organizations to improve the quality of evidence that is generated by researchers and used by decision makers. Collaborative projects include the GRACE Principles, which are rigorous, generally agreed upon methods and standards intended to reduce bias in observational studies. GRACE collaborators also are developing a checklist that can serve as a validated tool for the assessment of observational CER quality and usefulness for decision making. In addition, NPC is working with the Academy of Managed Care Pharmacy and the International Society for Pharmacoeconomics and Outcomes Research on a toolkit that payers can use to determine the validity and applicability of an observational study to answer the research question at hand.
NPC intends to review the draft methodology report and submit comments.