Good methods are essential for producing high-quality patient-centered clinical comparative effectiveness research (CER), and improving these methods is a key imperative outlined in PCORI’s Strategic Plan. Indeed, the PCORI Methodology Committee is charged in our authorizing legislation with working to “develop and improve the science and methods” of CER.
Last year, we posted a set of 47 methodology standards, along with a report providing context. However, the committee’s work is far from finished.
Although the existing standards provide a good baseline for research, they don’t cover all the issues that investigators encounter. So we are looking to other organizations and the broader community of patient-centered outcomes research stakeholders for ideas for additional standards. To this end, we are pleased to announce the launch of a new effort to engage the public in improving scientific methods for patient-centered CER.
Public input shaped our initial set of standards. We released the version drafted by the Methodology Committee for public comment in 2012. More than 120 individuals and organizations provided feedback, which strongly influenced the revision of the standards and the PCORI Methodology Report. The standards and report, posted in 2013, received a robust, favorable response from a wide variety of stakeholders.
How We Develop New Standards
The Methodology Committee is taking three approaches to developing additional standards and endorsing standards of other organizations.
The first strategy is to focus on gaps in our current set of standards that are becoming apparent as we begin to examine the early results of PCORI-supported research. Committee members are focusing on two new areas: Research Designs with Clusters and Complex Interventions. As the Committee and others at PCORI continue to examine our portfolio, we will identify additional areas for standards.
In a second strategy, the Committee is examining standards and guidelines offered by other organizations. We will consider opportunities to endorse these. In preparing our current standards on systematic reviews, we developed criteria to review standards from the Institute of Medicine. We will use similar criteria to evaluate other standards and guidelines.
Finally, we are asking the full range of healthcare stakeholders to suggest topics for new standards.
How to Make Suggestions
We recently created a web page where you can suggest either a set of current standards that PCORI might endorse or a topic area for new standards. You have the opportunity to describe the suggested area and tell us why it is important. You may also submit supporting documents and reference a website.
All the submissions will be considered by the Methodology Committee as it selects areas in which to develop and endorse standards. On the PCORI website, we will share information about the committee’s progress. Development of draft standards requires collaboration between the Methodology Committee members and PCORI staff and often includes a literature review (see Reports to Support the Development of PCORI’s First Methodology Report), interviews with experts, and/or a workgroup to convene key stakeholders in the topic area.
Throughout these stages of information gathering, the committee will consider how a proposed topic area meets criteria for patient-centeredness, scientific rigor, transparency, and empirical evidence. All proposed new standards will be posted for public comment and revised based on the feedback received.
We invite individuals and organizations to submit topics for consideration and look forward to the guidance we receive.
Hickam is Director of PCORI’s Clinical Effectiveness Research program
Rader is a Program Associate in the Office of PCORI’s Executive Director