Past Opportunities to Provide Input
- Proposed New Methodology Standards for Usual Care as a Comparator (2023)
- Stakeholder Views on Components of 'Patient-Centered Value' in Health and Health Care (2023)
- PCORI's Proposed Research Agenda (2021-2022)
- Proposed National Priorities for Health (2021)
- Proposed Principles for the Consideration of the Full Range of Outcomes Data in PCORI-Funded Research (2020)
- Proposed New PCORI Methodology Standards (2018)
- Data Access and Data Sharing Policy: Public Comment (2017)
- Proposed New PCORI Methodology Standards (2017)
Comment on the Proposed New and Revised PCORI Methodology Standards (2016)
- 1. Standards for Formulating Research Questions
- 10: Standards for Studies of Diagnostic Tests
- 12. Standards on Research Designs Using Clusters
- 13: General Comments on the Proposed Revisions to the PCORI Methodology Standards
- 2: Standards Associated with Patient-Centeredness
- 3: Standards for Data Integrity and Rigorous Analysis
- 4: Standards for Preventing and Handling Missing Data
- 5: Standards for Heterogeneity of Treatment Effects
- 6: Standards for Data Registries
- 7: Standards for Data Networks as Research-Facilitating Structures
- 8. Standards for Causal Inference Methods
- 9. Standards for Adaptive Trial Designs
- Peer-Review Process Comments (2014)
- Draft Methodology Report Public Comment Period (2012)
In June 2022, PCORI's Methodology Committee formally approved a decision to pursue the development of methodology standards for usual care as a comparator in patient-centered comparative clinical effectiveness research.
Between Oct. 2 and Nov. 30, 2023, PCORI invited comments on the proposed new standards, as required under PCORI’s authorizing law. All comments were welcome, but PCORI was specifically interested in feedback on these questions:
- Your overall impressions of the proposed draft standards; in your response, describe how the usual care standards might be applied within a study of interest.
- If you were proposing a study that uses a usual care comparator, how confident are you that you would be able to meet the requirements of the standards? Are you more or less likely to propose a pragmatic study that uses a usual care comparator for a PCORI funding opportunity if the standards are applied?
- Please identify any requirements or best practices that should not be included in the draft standards. Should any of the components currently listed as a best practice be considered a requirement?
The deadline for comments was Nov. 30, 2023, at 5 pm (ET).
Posted: October 2, 2023; Updated: November 30, 2023
What's Happening at PCORI?
The Patient-Centered Outcomes Research Institute sends weekly emails about opportunities to apply for funding, newly funded research studies and engagement projects, results of our funded research, webinars, and other new information posted on our site.