In This Week’s Issue:
1. PCORI Board Adopts Strategic Plan, Approves 2014 Budget and Advisory Panel Charters, Accepts Revised Methodology Report, click here to view the press release
2. PCORI Issues Report on Methodological Best Practices in Patient-Centered Outcomes Research, click here to view the press release, and here to view the Methodology Report.
3. Modern Healthcare: PCORI Approves over $1B for Comparative Effectiveness Research in 2014-15, click here to view the article.
4. Concerns About Pharma-Sponsored Research Removed From PCORI Methodology Report, click here to view the article (subscription only).
5. PCORI Blog: Responding to Rural Health's Unique Challenges, click here to view the blog.
6. NEJM: Perspective: Adding Value to Relative-Value Units, click here to view (subscription only).
1. PCORI Board Adopts Strategic Plan, Approves 2014 Budget and Advisory Panel Charters, Accepts Revised Methodology Report, click here to view the press release
2. PCORI Issues Report on Methodological Best Practices in Patient-Centered Outcomes Research, click here to view the press release, and here to view the Methodology Report.
3. Modern Healthcare: PCORI Approves over $1B for Comparative Effectiveness Research in 2014-15, click here to view the article.
4. Concerns About Pharma-Sponsored Research Removed From PCORI Methodology Report, click here to view the article (subscription only).
5. PCORI Blog: Responding to Rural Health's Unique Challenges, click here to view the blog.
6. NEJM: Perspective: Adding Value to Relative-Value Units, click here to view (subscription only).
1. PCORI Board Adopts Strategic Plan, Approves 2014 Budget and Advisory Panel Charters, Accepts Revised Methodology Report
According to a press release following last week’s Patient-Centered Outcomes Research Institute (PCORI) Board of Governors meeting, the PCORI Board “approved PCORI’s strategic plan and a Fiscal Year 2014 budget along with a resolution for PCORI to commit up to $1.03 billion in research funding over the next two fiscal years. In addition, the Board at its latest meeting […] approved the charters for two new advisory panels, one on rare disease and the other on clinical trials. And it accepted the revised version of the PCORI Methodology Report, which provides a roadmap for conducting scientifically rigorous comparative clinical effectiveness research centered on questions and results that matter most to patients and other end-users of research results. The Board approved a proposed Fiscal Year 2014 budget that includes $182 million in expenditures and up to $528 million in research funding commitments. PCORI can commit far more in research support because funds for multi-year studies will be paid out incrementally over several years.”
“With the Board’s approval of charters for a new Advisory Panel on Rare Disease and Advisory Panel on Clinical Trials, both required by PCORI’s authorizing legislation, PCORI will begin to plan the open application process to seek potential members for each. Each of the new panels will be made up of individuals with the appropriate expertise as outlined by the Patient Protection and Affordable Care Act, PCORI’s authorizing legislation. People with rare diseases, their caregivers, and representatives of rare disease advocacy groups, will make up at least a third of the Advisory Panel on Rare Disease members. Moreover, the panel members will help PCORI identify experts to serve on condition-specific ad hoc advisory panels to provide additional expert input on specific potential research studies.” Click here to view the press release.
During the public comment period, PIPC Executive Director Sara van Geertruyden presented recommendations outlined in the Partnership’s recent White Paper, Road Map for Prioritizing Research. The White Paper calls upon PCORI to implement changes in the culture of research, through an open and transparent process, in order to meet its mandate to conduct patient-centered comparative clinical effectiveness research. As Ms. van Geertruyden explained to the Board, PIPC has developed a priority-setting “road map” that:
· Calls on PCORI to establish a targeted research agenda based on a broad and structured solicitation of topics from patients and providers;
· Directs PCORI staff to evaluate and distill the suggested research topics to ensure research topics meet PCORI’s mandate of patient-centeredness and the statutory criteria for research;
· Develops a rationale and topic brief for research topics to provide both the PCORI board and the public with a clear and transparent understanding of PCORI’s research agenda;
· Utilizes the relevant clinical expertise (both within and beyond PCORI’s advisory panels) to help rank the topic list;
· Ensures the opportunity for public comment on the draft priority list and research agenda;
· Provides for input and approval by Board of Governors; and
· Promotes transparency of the priority-setting process in its entirety.
Additional materials made available at last week’s meeting are included below:
Board Meeting Materials and Presentations:
•Meeting Agenda
•Draft September Board Minutes
•Strategic Plan (approved without changes)
•Proposed Charter of the Clinical Trials Advisory Panel
•Proposed Charter of the Rare Disease Advisory Panel
•Methodology Report
PCORI Staff Presentations:
•Executive Director's Report, Joe Selby, Executive Director
•Consideration of Strategic Plan Document for Approval, Joe Selby, Executive Director
•Consideration of Research Funding Plan for Approval, Joe Selby, Executive Director
•Decision Support and Primary Comparative Effectiveness Research, Joe Selby, Executive Director
•Consideration of Proposed 2014 Budget for Approval, Regina Yan, Chief Operating Officer
•Consideration of Clinical Trials Advisory Panel Charter and Rare Disease Advisory Panel Charter for Approval, Bryan Luce, Chief Science Officer
•Consideration of Modifications to the Decision Matrix for Approval, Regina Yan, Chief Operating Officer
•Submission of Revised Methodology Report to Board for Acceptance: Robin Newhouse, Chair, Methodology Committee and David Hickam, CER Program Director
2. PCORI Issues Report on Methodological Best Practices in Patient-Centered Outcomes Research
As outlined in a recent press release, “PCORI issued its revised PCORI Methodology Report, which offers minimal requirements for following best practices in the conduct of scientifically valid patient-centered outcomes research (PCOR). During its latest public meeting in Atlanta, PCORI’s Board of Governors accepted the report presented by PCORI’s Methodology Committee, which was revised to address extensive feedback received from the healthcare community during a public comment period that followed the July 2012 release of a draft. The report provides context for PCORI’s Methodology Standards, which set forth baseline requirements for clinical comparative effectiveness research centered on questions and results that matter most to patients, clinicians, and other end-users of research findings. The report includes stories and examples that illustrate different ways that good methodology makes a difference to patients and their care.” Click here to view the press release, and here to view the Methodology Report.
3. Modern Healthcare: PCORI Approves over $1B for Comparative Effectiveness Research in 2014-15
Reporting on last week’s PCORI Board of Governors Meeting, Maureen McKinney of Modern Healthcare writes, “That figure, which covers 2014 and 2015, marks a significant per-year jump from the $400 million PCORI officials have estimated they will award by the end of 2013, an amount that includes $114 million in research grants announced in September. Dr. Joe Selby, PCORI's executive director, proposed allocating those funds at higher levels over the next three years and then gradually tapering off in later years, an approach he said would fund more comparative effectiveness research in the near future and produce faster results.” Click here to view the article.
4. Concerns About Pharma-Sponsored Research Removed From PCORI Methodology Report
Gregory Twachtman of The Pink Sheet reports, “One section of the draft report drew criticism, in particular from the pharmaceutical industry, by raising concerns about whether industry was perceived to be capable of producing trustworthy research...In responding to comments on trust, the revised committee report acknowledges that a number of commenters raised issues related to trust and conflict of interest, ‘among them a lack of patient trust for payers, physicians, and industry, and the perception by some stakeholders that they will be excluded from PCORI's work. Some reviewers felt that the draft report cited examples of limitations and past failings of CER and PCOR that targeted particular actors.’” Click here to view the article (subscription only).
5. PCORI Blog: Responding to Rural Health's Unique Challenges
Dr. Bryan Luce, PCORI’s Chief Science Officer, and Dr. Romana Hasnain-Wynia, Director of PCORI’s Addressing Disparities program comment on The PCORI Blog, “For the approximately 60 million Americans-nearly one in five-who live in rural areas, limited access to healthcare professionals is a critical barrier to achieving favorable health outcomes...PCORI is investing in research that will build a body of evidence on effective strategies for health care in rural areas. The first step is to identify relevant high-priority research questions. Earlier this year, we hosted a workshop in Wichita, Kansas to solicit input from rural communities regarding research topics we should support. We've also explored related issues at workshops in Memphis and Albuquerque.” Click here to view the blog.
6. NEJM: Perspective: Adding Value to Relative-Value Units
Dr. Eric C. Stecker and Dr. Steven A. Schroeder comment in The New England Journal of Medicine, “After a more comprehensive set of comparative-effectiveness data is developed, relative-value units (RVUs) could be assigned to clinical activities in an evidence-based manner, proportionately to their influence on patient outcomes and clinical efficiency. Activities for which comparative-effectiveness data are lacking (e.g., clinic counseling for low-risk patients with headaches, fatigue, or palpitations; workup of nonspecific symptoms such as dyspnea; or multistage workup and treatment of complex disorders) could have RVU values assigned by expert consensus in a prescribed and transparent process.” Click here to view (subscription only).
According to a press release following last week’s Patient-Centered Outcomes Research Institute (PCORI) Board of Governors meeting, the PCORI Board “approved PCORI’s strategic plan and a Fiscal Year 2014 budget along with a resolution for PCORI to commit up to $1.03 billion in research funding over the next two fiscal years. In addition, the Board at its latest meeting […] approved the charters for two new advisory panels, one on rare disease and the other on clinical trials. And it accepted the revised version of the PCORI Methodology Report, which provides a roadmap for conducting scientifically rigorous comparative clinical effectiveness research centered on questions and results that matter most to patients and other end-users of research results. The Board approved a proposed Fiscal Year 2014 budget that includes $182 million in expenditures and up to $528 million in research funding commitments. PCORI can commit far more in research support because funds for multi-year studies will be paid out incrementally over several years.”
“With the Board’s approval of charters for a new Advisory Panel on Rare Disease and Advisory Panel on Clinical Trials, both required by PCORI’s authorizing legislation, PCORI will begin to plan the open application process to seek potential members for each. Each of the new panels will be made up of individuals with the appropriate expertise as outlined by the Patient Protection and Affordable Care Act, PCORI’s authorizing legislation. People with rare diseases, their caregivers, and representatives of rare disease advocacy groups, will make up at least a third of the Advisory Panel on Rare Disease members. Moreover, the panel members will help PCORI identify experts to serve on condition-specific ad hoc advisory panels to provide additional expert input on specific potential research studies.” Click here to view the press release.
During the public comment period, PIPC Executive Director Sara van Geertruyden presented recommendations outlined in the Partnership’s recent White Paper, Road Map for Prioritizing Research. The White Paper calls upon PCORI to implement changes in the culture of research, through an open and transparent process, in order to meet its mandate to conduct patient-centered comparative clinical effectiveness research. As Ms. van Geertruyden explained to the Board, PIPC has developed a priority-setting “road map” that:
· Calls on PCORI to establish a targeted research agenda based on a broad and structured solicitation of topics from patients and providers;
· Directs PCORI staff to evaluate and distill the suggested research topics to ensure research topics meet PCORI’s mandate of patient-centeredness and the statutory criteria for research;
· Develops a rationale and topic brief for research topics to provide both the PCORI board and the public with a clear and transparent understanding of PCORI’s research agenda;
· Utilizes the relevant clinical expertise (both within and beyond PCORI’s advisory panels) to help rank the topic list;
· Ensures the opportunity for public comment on the draft priority list and research agenda;
· Provides for input and approval by Board of Governors; and
· Promotes transparency of the priority-setting process in its entirety.
Additional materials made available at last week’s meeting are included below:
Board Meeting Materials and Presentations:
•Meeting Agenda
•Draft September Board Minutes
•Strategic Plan (approved without changes)
•Proposed Charter of the Clinical Trials Advisory Panel
•Proposed Charter of the Rare Disease Advisory Panel
•Methodology Report
PCORI Staff Presentations:
•Executive Director's Report, Joe Selby, Executive Director
•Consideration of Strategic Plan Document for Approval, Joe Selby, Executive Director
•Consideration of Research Funding Plan for Approval, Joe Selby, Executive Director
•Decision Support and Primary Comparative Effectiveness Research, Joe Selby, Executive Director
•Consideration of Proposed 2014 Budget for Approval, Regina Yan, Chief Operating Officer
•Consideration of Clinical Trials Advisory Panel Charter and Rare Disease Advisory Panel Charter for Approval, Bryan Luce, Chief Science Officer
•Consideration of Modifications to the Decision Matrix for Approval, Regina Yan, Chief Operating Officer
•Submission of Revised Methodology Report to Board for Acceptance: Robin Newhouse, Chair, Methodology Committee and David Hickam, CER Program Director
2. PCORI Issues Report on Methodological Best Practices in Patient-Centered Outcomes Research
As outlined in a recent press release, “PCORI issued its revised PCORI Methodology Report, which offers minimal requirements for following best practices in the conduct of scientifically valid patient-centered outcomes research (PCOR). During its latest public meeting in Atlanta, PCORI’s Board of Governors accepted the report presented by PCORI’s Methodology Committee, which was revised to address extensive feedback received from the healthcare community during a public comment period that followed the July 2012 release of a draft. The report provides context for PCORI’s Methodology Standards, which set forth baseline requirements for clinical comparative effectiveness research centered on questions and results that matter most to patients, clinicians, and other end-users of research findings. The report includes stories and examples that illustrate different ways that good methodology makes a difference to patients and their care.” Click here to view the press release, and here to view the Methodology Report.
3. Modern Healthcare: PCORI Approves over $1B for Comparative Effectiveness Research in 2014-15
Reporting on last week’s PCORI Board of Governors Meeting, Maureen McKinney of Modern Healthcare writes, “That figure, which covers 2014 and 2015, marks a significant per-year jump from the $400 million PCORI officials have estimated they will award by the end of 2013, an amount that includes $114 million in research grants announced in September. Dr. Joe Selby, PCORI's executive director, proposed allocating those funds at higher levels over the next three years and then gradually tapering off in later years, an approach he said would fund more comparative effectiveness research in the near future and produce faster results.” Click here to view the article.
4. Concerns About Pharma-Sponsored Research Removed From PCORI Methodology Report
Gregory Twachtman of The Pink Sheet reports, “One section of the draft report drew criticism, in particular from the pharmaceutical industry, by raising concerns about whether industry was perceived to be capable of producing trustworthy research...In responding to comments on trust, the revised committee report acknowledges that a number of commenters raised issues related to trust and conflict of interest, ‘among them a lack of patient trust for payers, physicians, and industry, and the perception by some stakeholders that they will be excluded from PCORI's work. Some reviewers felt that the draft report cited examples of limitations and past failings of CER and PCOR that targeted particular actors.’” Click here to view the article (subscription only).
5. PCORI Blog: Responding to Rural Health's Unique Challenges
Dr. Bryan Luce, PCORI’s Chief Science Officer, and Dr. Romana Hasnain-Wynia, Director of PCORI’s Addressing Disparities program comment on The PCORI Blog, “For the approximately 60 million Americans-nearly one in five-who live in rural areas, limited access to healthcare professionals is a critical barrier to achieving favorable health outcomes...PCORI is investing in research that will build a body of evidence on effective strategies for health care in rural areas. The first step is to identify relevant high-priority research questions. Earlier this year, we hosted a workshop in Wichita, Kansas to solicit input from rural communities regarding research topics we should support. We've also explored related issues at workshops in Memphis and Albuquerque.” Click here to view the blog.
6. NEJM: Perspective: Adding Value to Relative-Value Units
Dr. Eric C. Stecker and Dr. Steven A. Schroeder comment in The New England Journal of Medicine, “After a more comprehensive set of comparative-effectiveness data is developed, relative-value units (RVUs) could be assigned to clinical activities in an evidence-based manner, proportionately to their influence on patient outcomes and clinical efficiency. Activities for which comparative-effectiveness data are lacking (e.g., clinic counseling for low-risk patients with headaches, fatigue, or palpitations; workup of nonspecific symptoms such as dyspnea; or multistage workup and treatment of complex disorders) could have RVU values assigned by expert consensus in a prescribed and transparent process.” Click here to view (subscription only).