Comment on the Proposed New and Revised PCORI Methodology Standards (2016)

PCORI released its initial set of Methodology Standards in December 2012. Required under PCORI’s authorizing law and developed under the guidance of PCORI’s Methodology Committee, the 47 standards provide guidance on clinical research practices in 11 topic areas. In 2015, the Methodology Committee began reviewing the standards with an eye toward updating them and adding any new standards as needed. As a result, the Committee proposes the following changes to the current standards: Revise 25 existing standards; combine 12 existing standards into groups of two or three to form six revised standards; delete one existing standard; leave nine existing standards unchanged; add three new standards to the existing 11 methodological categories; and add five new standards in a new category (Standards for Designs Using Clusters).

We invited the public to comment on these proposed changes, as required under PCORI’s authorizing law. The deadline for submitting comments was April 11, 2016 at 5 p.m. ET

Related: New and Improved Methodology Standards: Let Us Know What You Think

View Submitted Comments

Click on the categories below to view the submitted comments for them.

Cross-Cutting Standards for PCOR

1. Standards for Formulating Research Questions
Revisions consist of minor changes in wording to help define certain terms and to streamline and clarify the standards. The content of the standards remains essentially the same.

2. Standards Associated with Patient-Centeredness
Revisions specify more clearly how patients and stakeholders are involved in both the processes for conducting the research and the dissemination of the research findings. They also instruct investigators to justify their approach to engagement.

3. Standards for Data Integrity and Rigorous Analyses
Revisions change the order of the standards in this category and clarify the wording. Other revisions provide guidance on documenting covariates and include guidance on registering studies with the appropriate registries. A new standard, IR-6, was added to include guidance on masking.

4. Standards for Preventing and Handling Missing Data
Revisions clarify the standards and identify other forms of missingness other than patient drop out. Two standards were combined, MD-2 and MD-3, due to overlap of concepts.

5. Standards for Heterogeneity of Treatment Effects
Existing standards were combined to streamline overlapping content in this category. Additional revisions clarify the language.

Standards for Specific Study Designs and Methods

6. Standards for Data Registries
Revisions consolidate and clarify the language. Revisions also add further guidance on stakeholder engagement, linking to data from electronic health records and claims files, and reporting and documentation of registry materials.

7. Standards for Data Networks as Research-Facilitating Structures
Revisions provide more complete language on data integration and ownership of data.  

8. Standards for Causal Inference Methods
Revisions clarify and streamline language of the standards. The revisions also are inclusive of non-time and time-varying exposures, specify that propensity scores are used to control for measured confounders, and specify that instrumental variables are used to address unmeasured confounding. There is also a new standard, CI-1, requiring researchers to specify their causal model. 

9. Standards for Adaptive Trial Designs
Revisions streamline and clarify the language of the standards. Additionally the revisions keep the reference to the 2010 CONSORT statement up to date.

10. Standards for Studies of Diagnostic Tests
Revisions streamline and clarify the language, sometimes by combining existing standards. The content of the standards remains essentially the same.   

11. Standards for Systematic Reviews
There are no revisions to this category of standards. 

12. Standards on Research Designs Using Clusters
There are five completely new standards in this new category. 

Cross-Standard Comments

General Comments on the Proposed New and Revised PCORI Methodology Standards

Posted: January 25, 2016; Updated: November 22, 2016