Research Methodology

Developing and improving the science and methods of patient-centered outcomes research is a central part of PCORI’s work.  PCORI’s Methodology Committee works to define methodological standards for this research and develop and regularly update a translation table to guide health care stakeholders towards the best methods for patient-centered outcomes research. Better methods will produce trusted information and lead to better health care decisions, and ultimately to better health.

The 17-member Methodology Committee is appointed by Comptroller General of the United States. For more information about the committee, please visit the following links:

Methodology Report

The Methodology Committee, in accordance with PCORI’s authorizing legislation, submitted to the Board of Governors on May 10, 2012, the first draft PCORI Methodology Report. Following a 54-day public comment period, the report’s draft Methodology Standards were revised and approved by the PCORI Board on November 19, 2012. A full narrative report, providing context for the standards, will be revised and published next spring. For more information, see:

Note: Applicants responding to the PCORI Funding Announcements (PFAs) are required to adhere to the contents of the PCORI draft Methodology Report in developing their research plan.

Supporting the Committee’s Work

The Methodology Committee periodically conducts workshops and funds contract research to support its work to produce and update PCORI’s Methodology Report.

The following reports were produced to inform the first draft of the Methodology Report.

All statements in these reports, including their findings and conclusions, are solely those of the authors and do not necessarily represent the views of PCORI, its Board of Governors or Methodology Committee.  PCORI has not peer-reviewed or edited this content. The report is being made available free of charge for the information of the scientific community and general public as part of PCORI’s ongoing research programs. Questions or comments about this report may be sent to PCORI at info@pcori.org or by mail to 1828 L St., NW, Washington, DC 20036.

Methodology Workshops

 

Workshops to Support the Development of PCORI’s First Methodology Report:

Workshop on Methods for Setting Research Priorities – March 6-7, 2012 (Summary Report)

Workshop on Methods for Setting Research Priorities – March 6-7, 2012 (Workshop Presentation Slides)

Workshop on Incorporating the Patient Perspective into PCOR – March 6-7, 2012 (Summary Report)

Workshop on Incorporating the Patient Perspective into PCOR – March 6-7, 2012 (Workshop Presentation Slides)

Contractor Reports

Reports to Support the Development of PCORI’s First Methodology Report:

Review of Guidance Documents for Selected Methods in Patient Centered Outcomes Research

Enhancing the Patients Voice Standards in the Design and Selection of Patient-Reported Outcomes Measures for Use in Patient-Centered Outcomes Research

Minimal Standards in the Prevention and Handling of Missing Data in Observational and Experimental Patient Centered Outcomes Research

Standards for the Design, Conduct, and Evaluation of Adaptive Randomized Clinical Trials

Standards for Causal Inference Methods in Analyses of Data from Observational and Experimental Studies in Patient-Centered Outcomes Research

Standards in Addressing Heterogeneity of Treatment Effectiveness in Observational and Experimental Patient Centered Outcomes Research

Standards in the Design, Conduct and Evaluation of Diagnostic Testing for Use in Patient Centered Outcomes Research

Standards in the Conduct of Registry Studies for Patient-Centered Outcomes Research

Standards in the Use of Collaborative or Distributed Data Networks in Patient Centered Outcomes Research

The Design and Selection of Patient-Reported Outcomes Measures for Use in Patient-Centered Outcomes Research

Review and Synthesis of Evidence for Eliciting the Patient’s Perspective in Patient-Centered Outcomes Research

Integrating Patients’ Voices in Study Design Elements with a Focus on Hard-to-Reach Populations 

Expert Stakeholder Interviews to Identify Evidence for Eliciting the Patient’s Perspective in Patient-Centered Outcomes Research

Eliciting Patient Perspective in Patient-Centered Outcomes Research – A Meta Narrative Systematic Review

Eliciting Patient Perspective in Patient-Centered Outcomes Research – Expert Interviews Part 1

Eliciting Patient Perspective in Patient-Centered Outcomes Research – Expert Interviews Part 2

Eliciting Patient Perspective in Patient-Centered Outcomes Research – Expert Interviews Part 3

Eliciting Patient Perspective in Patient-Centered Outcomes Research – Expert Interviews Part 4

Methods for Setting Priorities in Research

Methods for Involving Patients in Topic Generation for Patient-Centered Comparative Effectiveness Research – An International Perspective

Value of Information and Research Prioritization

Value-of-Information Analysis for Patient-Centered Outcomes Research Prioritization

Peer Review – A Research Priority

Prioritizing Future Research through Examination of Research Gaps in Systematic Reviews