Stakeholders have a unique opportunity to help the Patient-Centered Outcomes Research Institute (PCORI) modify its Methodology Standards. PCORI is currently accepting comments in response to its Proposed New and Revised Methodology Standards, which reflect changes to 25 of the current 47 standards and add five new standards. The intent of the revisions is primarily to clarify wording and streamline overlapping content. Some of the most impactful proposed changes include:
- Investigators must justify their approach to engagement: This new standard associated with patient-centeredness is supported by revisions that better specify how patients and stakeholders are to be involved in both the processes for conducting research and the dissemination of findings.
- Re–ordering of the “Standards for Data Integrity and Rigorous Analyses”: Changes in this section also include new guidance on documenting covariates, registering studies with appropriate registries, and guidance on masking.
- Standards for Data Registries: These revisions add more detailed guidance on stakeholder engagement, linking to data from electronic health records (EHRs) and claims files, and reporting documentation of registry materials.
- Standards for Causal Inference Methods: The new rules ask researchers to specify their causal model. A causal model represents the key variables in a research question and the known or hypothesized relationships among them. Causal models are informed by populations, interventions, comparators, outcomes, timing and settings.
- Five new standards in a new category, “Standards of Research Designs Using Clusters.” These standards address the use of cluster randomization as a research design, which is generally less precise than random sampling but sometimes necessary due to cost or difficulty in construction a complete list of population elements. Clusters are often used when an intervention: is delivered at the cluster level, changes the physical or social environment, involves group processes, or cannot be delivered without a serious risk of contamination.
Comments must be submitted to PCORI by March 28, 2016. Stay tuned for an update on the final Methodology Standards!
You can also click here to read about current PCORI funding opportunities.