In This Week’s Issue:
1. Chairman's Corner: Five Years Closer to a Patient-Centered Health System, click here to view the full blog.
2. PIPC Patients Blog: Ronni Marks, click here to view the full post.
3. PIPC: Statement on Hepatitis C Research at PCORI, click here to view the statement.
4. PIPC Attends Webinar on PCORI Dissemination and Implementation Plan, click here to view the webinar slides.
5. Star-Tribune: ‘Big Data' is Changing American Medical Care, click here to view the full article.
6. PCORI, NIH Partnership to Fund Research Asking How to Reduce Hypertension Disparities, click here to view the full blog post.
7. New York Times: Don't Homogenize Health Care, click here to view the full article.
8. PCORI: In New Process, PCORI Will Invite Resubmission of Selected Applications, click here to view the full post.
9. Medical Journal Articles, see details below.
10. AHRQ Effective Program Updates, see details below.
1. Chairman's Corner: Five Years Closer to a Patient-Centered Health System, click here to view the full blog.
2. PIPC Patients Blog: Ronni Marks, click here to view the full post.
3. PIPC: Statement on Hepatitis C Research at PCORI, click here to view the statement.
4. PIPC Attends Webinar on PCORI Dissemination and Implementation Plan, click here to view the webinar slides.
5. Star-Tribune: ‘Big Data' is Changing American Medical Care, click here to view the full article.
6. PCORI, NIH Partnership to Fund Research Asking How to Reduce Hypertension Disparities, click here to view the full blog post.
7. New York Times: Don't Homogenize Health Care, click here to view the full article.
8. PCORI: In New Process, PCORI Will Invite Resubmission of Selected Applications, click here to view the full post.
9. Medical Journal Articles, see details below.
10. AHRQ Effective Program Updates, see details below.
1. Chairman's Corner: Five Years Closer to a Patient-Centered Health System
Recently, PIPC Chairman Tony Coelho wrote a blog post highlighting the coalition’s work, “Our recent forum was not just about research – it was about how we effectively build a patient-centered health system. Value-based payment models are playing a growing role in how we apply comparative effectiveness research. The financial incentives included in these new payment models will reshape patient access to care and decision-making between patients and physicians. Therefore, we invited Senate Finance Committee staff to talk to us about their work related to alternative payment models and how they align with principles of patient-centeredness that empower patients in their care. We also had an expert panel to discuss with us the infrastructure of a patient-centered health system, from research to the development of measures of quality, and the data networks needed to support research and quality measurement. Throughout the discussion, I emphasized that principles of patient-centeredness must be incorporated into evolving value-based payment models.” Click here to view the full blog.
2. PIPC Patients Blog: Ronni Marks
Introducing, PIPC’s new patient blogger! “My name is Ronni Marks, and I was first diagnosed with Hepatitis C (HCV) in 1997. Before people began to talk about things like 'comparative effectiveness' or 'patient-centeredness,' patients like me were just focused on where to go for help. Treatment options back then were painful, protracted, and unpredictable. And while my friends and family tried to support me as best they could, they didn’t understand the enormity of what HCV was or what I was experiencing. At that time, the Internet was new, and there were no HCV support groups."
“Now, almost twenty years later, we can finally see a light at the end of the tunnel. Since I was diagnosed, I’ve dedicated my life to creating communities for HCV patients to reach out to others facing the same challenges that they’re struggling with. And scientists have finally discovered a cure that promises manageable treatment time and limited side effects. But even though I know we’ve come a long way in improving the lives of some individuals with HCV, many patients still can’t access the drugs, and others are left with staggering medical bills.” Click here to view the full post.
3. PIPC: Statement on Hepatitis C Research at PCORI
In response to the PCORI Board’s vote for $50 million toward hepatitis C research, PIPC Chairman Tony Coelho and other patient advocates applauded PCORI for convening diverse stakeholders and for using a process that, with continued patient engagement, will prioritize the research questions that matter most to patients. PIPC Chairman Tony Coelho stated, “PCORI’s process of engaging a panel of experts on hepatitis C is more aligned with what Congress intended them to do as they prioritize specific research topics and create a research agenda that reflects the potential for new evidence to improve patient health, well-being, and the quality of care...I look forward to PCORI learning from and improving upon this process of engagement for other specific high-priority areas of research.” Ms. Donna Cryer, President and CEO of the Global Liver Institute, stated, “...The urgency with which PCORI has stepped in to support the development of an ethical, collaborative process to build the body of high-quality information to guide researchers, patients, and their care teams to make the most of this opportunity further demonstrates the value PCORI provides to the healthcare system.” Ms. Angela Ostrom, a member of PIPC's Steering Committee on behalf of the Epilepsy Foundation, stated, “...We are hopeful PCORI will do more to identify specific priorities for research in its public comment process in 2015 with similar subsequent stakeholder engagement within those priority areas to identify the most useful questions for research.
In a blog post by Executive Director, Dr. Joe Selby prior to the Board meeting, he stated, “PCORI recently convened a large stakeholder workshop to discuss whether new comparative clinical effectiveness research (CER) studies we might fund could answer key questions about how to best diagnose and treat hepatitis C (HCV) infection. It was a particularly timely event given recent regulatory approvals of groundbreaking new treatments for this serious condition. I summarized the workshop event in an earlier blog post and now want to update you on our next steps. […] Based on the discussions at the workshop, our Scientific Oversight Committee will recommend to the PCORI Board of Governors at its December 8 meeting that the Board approve development of a targeted PCORI Funding Announcement (PFA) addressing key questions in detection and treatment of HCV infection. If approved, the PFA would commit up to $50 million in research funding and seek proposals to address CER questions in each of four specific areas identified by workshop attendees. […]” The Board did vote to approved the funding and to continue developing the questions in preparation for a funding announcement. Click here to view the full blog.
Author Jaimy Lee reported in Modern Healthcare, “The funding awards are expected to be released in February. Areas of focus will likely include comparing patients who start treatment right after a diagnosis to those who undergo active surveillance until disease begins to manifest, whether there are more side effects or adverse events than what was reported in the clinical trials, and how best to treat patients who are high risk of transmitting the disease, such as men who have sex with men and active injection-drug users.” Click here to view the full article (subscription required).
Also regarding Hepatitis C research, Kerry Young of CQ HealthBeat commented, “The board of governors for the Patient Centered Outcomes Research Institute on Monday approved by voice vote a proposal designed to encourage projects that could include head-to-head studies of new medicines. This could fund as many as four studies examining different approaches to hepatitis C infection, PCORI staff said.” Click here to view the full article (subscription required).
Similarly, the Pink Sheet Daily said, “Head-to-head trials will compare new drugs such as Gilead Sciences Inc.'s Harvoni (sofosbuvir/ledipasvir) to other drugs PCORI refers to as ‘emerging’ therapies, such as AbbVie Inc.'s triple combination drug, expected to be approved by the end of December...PCORI would expect that researchers would not bear the cost of paying for the hepatitis C drugs studied, but rather that the cost would be covered by the provider organization, David Hickam, PCORI's science program director, explained[...]” Click here to view the full article (subscription required).
4. PIPC Attends Webinar on PCORI Dissemination and Implementation Action Plan
PIPC’s Executive Director and several PIPC Members attended the webinar hosted by Mathematica last week on the development of PCORI’s Dissemination and Implementation Action Plan. The webinar provided an opportunity for participants to review the D&I strategies under consideration at PCORI, offer their perspectives and experience-based feedback, and provide input into the development of the final framework and toolkit. PIPC was pleased that the draft had taken into consideration recommendations provided to PCORI in the past, particularly the inclusion of a Dissemination Advisory Panel. PIPC intends to further urge PCORI to identify its priority topic areas (both the areas in which funding has been defacto determined to a priority as a result of the broad funding announcement process, and the more targeted areas of research that PCORI has selected for funding in the future), so that it has expert patients and stakeholders engaged from topic development and solicitation all the way through dissemination and implementation of research. An overarching theme of the webinar discussion was the need for simplification of the draft toolkit proposed by Mathematica that is specific to various audiences, but ultimately responds to the information being sought by patients. Comments to Mathematica are due tomorrow, December, 16. Click here for additional information and to comment.
5. Star-Tribune: ‘Big Data' is Changing American Medical Care
Early last week in the Minneapolis Star-Tribune, “Mayo's Optum Labs is one of several projects nationally that analyze massive banks of patient records and medical data to see what works best in health care...PCORI funds studies that compare the efficacy of various treatment options, known as ‘comparative effectiveness research.’ It is funded by the federal government, plus fees assessed on Medicare and on private insurance plans.” Click here to view the full article.
6. PCORI, NIH Partnership to Fund Research Asking How to Reduce Hypertension Disparities
PCORI’s Science Program Director, Dr. Romana Hasnain-Wynia, wrote last week for the agency’s blog, “Hypertension, a leading cause of cardiovascular disease and premature death, affects nearly one in three adults in the United States.[...] I am pleased to report the latest step in this collaboration—a funding opportunity just announced by NIH for trials of up to five years. PCORI is providing $25 million through the Hypertension Disparities Reduction Program Partnership, a collaboration between PCORI and two NIH institutes—the National Heart, Lung and Blood Institute and the National Institute of Neurological Diseases and Stroke. Applications will be due in January.” Click here to view the full blog post.
7. New York Times: Don't Homogenize Health Care
Last week, the New York Times commented, “Not surprisingly, guidelines and checklists are unpopular among most American physicians. Instead of being allowed to deliver ‘patient-centered’ care, many physicians feel they are being co-opted by regulations. Some feel pressured to prescribe ‘mandated’ treatment, even to frail older adults who may not benefit. Guidelines are supposed to assist and advise. But all too often, recommended care in certain situations becomes mandated care in all situations.” Click here to view the full article.
8. PCORI: In New Process, PCORI Will Invite Resubmission of Selected Applications
Dr. Tsahai Tafari, Associate Director of Science for PCORI, blogged last week, “For our upcoming Spring 2015 cycle [...] PCORI staff will invite selected applicants who were not funded during the previous cycle to resubmit revised applications...We'll choose high-quality applications that were responsive to our national research priorities, but for which the merit reviewers and PCORI staff raised concerns that seem remediable. Staff will recommend revisions to the selected applicants and discuss options with them. Those invited to resubmit will not be asked to provide the Letter of Intent (LOI) required of other applicants.” Click here to view the full post.
9. Medical Journal Articles
High-Dimensional Propensity Score Algorithm in Comparative Effectiveness Research with Time-Varying Interventions: Click here to view. Radiologists' Perspectives About Evidence-Based Medicine and Their Clinical Practice: A Semistructured Interview Study: Click here to view.
Assessment Vs. Appraisal of Ethical Aspects of Health Technology Assessment: Can the Distinction Be Upheld? : Clickhere to view. Integrating the Use of Patient-Reported Outcomes for Both Clinical Practice and Performance Measurement: Views of Experts from 3 Countries: Click here to view.
New Issue: Journal of Comparative Effectiveness Research: Click here to view: Click here to view.
10. AHRQ Effective Program Updates
Imaging for Pretreatment Staging of Small Cell Lung Cancer: Click here to view Research protocol. Diagnosis and Treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Click here to view final report. Radiotherapy Treatments for Head and Neck Cancer Update: Click here to view final report.
Recently, PIPC Chairman Tony Coelho wrote a blog post highlighting the coalition’s work, “Our recent forum was not just about research – it was about how we effectively build a patient-centered health system. Value-based payment models are playing a growing role in how we apply comparative effectiveness research. The financial incentives included in these new payment models will reshape patient access to care and decision-making between patients and physicians. Therefore, we invited Senate Finance Committee staff to talk to us about their work related to alternative payment models and how they align with principles of patient-centeredness that empower patients in their care. We also had an expert panel to discuss with us the infrastructure of a patient-centered health system, from research to the development of measures of quality, and the data networks needed to support research and quality measurement. Throughout the discussion, I emphasized that principles of patient-centeredness must be incorporated into evolving value-based payment models.” Click here to view the full blog.
2. PIPC Patients Blog: Ronni Marks
Introducing, PIPC’s new patient blogger! “My name is Ronni Marks, and I was first diagnosed with Hepatitis C (HCV) in 1997. Before people began to talk about things like 'comparative effectiveness' or 'patient-centeredness,' patients like me were just focused on where to go for help. Treatment options back then were painful, protracted, and unpredictable. And while my friends and family tried to support me as best they could, they didn’t understand the enormity of what HCV was or what I was experiencing. At that time, the Internet was new, and there were no HCV support groups."
“Now, almost twenty years later, we can finally see a light at the end of the tunnel. Since I was diagnosed, I’ve dedicated my life to creating communities for HCV patients to reach out to others facing the same challenges that they’re struggling with. And scientists have finally discovered a cure that promises manageable treatment time and limited side effects. But even though I know we’ve come a long way in improving the lives of some individuals with HCV, many patients still can’t access the drugs, and others are left with staggering medical bills.” Click here to view the full post.
3. PIPC: Statement on Hepatitis C Research at PCORI
In response to the PCORI Board’s vote for $50 million toward hepatitis C research, PIPC Chairman Tony Coelho and other patient advocates applauded PCORI for convening diverse stakeholders and for using a process that, with continued patient engagement, will prioritize the research questions that matter most to patients. PIPC Chairman Tony Coelho stated, “PCORI’s process of engaging a panel of experts on hepatitis C is more aligned with what Congress intended them to do as they prioritize specific research topics and create a research agenda that reflects the potential for new evidence to improve patient health, well-being, and the quality of care...I look forward to PCORI learning from and improving upon this process of engagement for other specific high-priority areas of research.” Ms. Donna Cryer, President and CEO of the Global Liver Institute, stated, “...The urgency with which PCORI has stepped in to support the development of an ethical, collaborative process to build the body of high-quality information to guide researchers, patients, and their care teams to make the most of this opportunity further demonstrates the value PCORI provides to the healthcare system.” Ms. Angela Ostrom, a member of PIPC's Steering Committee on behalf of the Epilepsy Foundation, stated, “...We are hopeful PCORI will do more to identify specific priorities for research in its public comment process in 2015 with similar subsequent stakeholder engagement within those priority areas to identify the most useful questions for research.
In a blog post by Executive Director, Dr. Joe Selby prior to the Board meeting, he stated, “PCORI recently convened a large stakeholder workshop to discuss whether new comparative clinical effectiveness research (CER) studies we might fund could answer key questions about how to best diagnose and treat hepatitis C (HCV) infection. It was a particularly timely event given recent regulatory approvals of groundbreaking new treatments for this serious condition. I summarized the workshop event in an earlier blog post and now want to update you on our next steps. […] Based on the discussions at the workshop, our Scientific Oversight Committee will recommend to the PCORI Board of Governors at its December 8 meeting that the Board approve development of a targeted PCORI Funding Announcement (PFA) addressing key questions in detection and treatment of HCV infection. If approved, the PFA would commit up to $50 million in research funding and seek proposals to address CER questions in each of four specific areas identified by workshop attendees. […]” The Board did vote to approved the funding and to continue developing the questions in preparation for a funding announcement. Click here to view the full blog.
Author Jaimy Lee reported in Modern Healthcare, “The funding awards are expected to be released in February. Areas of focus will likely include comparing patients who start treatment right after a diagnosis to those who undergo active surveillance until disease begins to manifest, whether there are more side effects or adverse events than what was reported in the clinical trials, and how best to treat patients who are high risk of transmitting the disease, such as men who have sex with men and active injection-drug users.” Click here to view the full article (subscription required).
Also regarding Hepatitis C research, Kerry Young of CQ HealthBeat commented, “The board of governors for the Patient Centered Outcomes Research Institute on Monday approved by voice vote a proposal designed to encourage projects that could include head-to-head studies of new medicines. This could fund as many as four studies examining different approaches to hepatitis C infection, PCORI staff said.” Click here to view the full article (subscription required).
Similarly, the Pink Sheet Daily said, “Head-to-head trials will compare new drugs such as Gilead Sciences Inc.'s Harvoni (sofosbuvir/ledipasvir) to other drugs PCORI refers to as ‘emerging’ therapies, such as AbbVie Inc.'s triple combination drug, expected to be approved by the end of December...PCORI would expect that researchers would not bear the cost of paying for the hepatitis C drugs studied, but rather that the cost would be covered by the provider organization, David Hickam, PCORI's science program director, explained[...]” Click here to view the full article (subscription required).
4. PIPC Attends Webinar on PCORI Dissemination and Implementation Action Plan
PIPC’s Executive Director and several PIPC Members attended the webinar hosted by Mathematica last week on the development of PCORI’s Dissemination and Implementation Action Plan. The webinar provided an opportunity for participants to review the D&I strategies under consideration at PCORI, offer their perspectives and experience-based feedback, and provide input into the development of the final framework and toolkit. PIPC was pleased that the draft had taken into consideration recommendations provided to PCORI in the past, particularly the inclusion of a Dissemination Advisory Panel. PIPC intends to further urge PCORI to identify its priority topic areas (both the areas in which funding has been defacto determined to a priority as a result of the broad funding announcement process, and the more targeted areas of research that PCORI has selected for funding in the future), so that it has expert patients and stakeholders engaged from topic development and solicitation all the way through dissemination and implementation of research. An overarching theme of the webinar discussion was the need for simplification of the draft toolkit proposed by Mathematica that is specific to various audiences, but ultimately responds to the information being sought by patients. Comments to Mathematica are due tomorrow, December, 16. Click here for additional information and to comment.
5. Star-Tribune: ‘Big Data' is Changing American Medical Care
Early last week in the Minneapolis Star-Tribune, “Mayo's Optum Labs is one of several projects nationally that analyze massive banks of patient records and medical data to see what works best in health care...PCORI funds studies that compare the efficacy of various treatment options, known as ‘comparative effectiveness research.’ It is funded by the federal government, plus fees assessed on Medicare and on private insurance plans.” Click here to view the full article.
6. PCORI, NIH Partnership to Fund Research Asking How to Reduce Hypertension Disparities
PCORI’s Science Program Director, Dr. Romana Hasnain-Wynia, wrote last week for the agency’s blog, “Hypertension, a leading cause of cardiovascular disease and premature death, affects nearly one in three adults in the United States.[...] I am pleased to report the latest step in this collaboration—a funding opportunity just announced by NIH for trials of up to five years. PCORI is providing $25 million through the Hypertension Disparities Reduction Program Partnership, a collaboration between PCORI and two NIH institutes—the National Heart, Lung and Blood Institute and the National Institute of Neurological Diseases and Stroke. Applications will be due in January.” Click here to view the full blog post.
7. New York Times: Don't Homogenize Health Care
Last week, the New York Times commented, “Not surprisingly, guidelines and checklists are unpopular among most American physicians. Instead of being allowed to deliver ‘patient-centered’ care, many physicians feel they are being co-opted by regulations. Some feel pressured to prescribe ‘mandated’ treatment, even to frail older adults who may not benefit. Guidelines are supposed to assist and advise. But all too often, recommended care in certain situations becomes mandated care in all situations.” Click here to view the full article.
8. PCORI: In New Process, PCORI Will Invite Resubmission of Selected Applications
Dr. Tsahai Tafari, Associate Director of Science for PCORI, blogged last week, “For our upcoming Spring 2015 cycle [...] PCORI staff will invite selected applicants who were not funded during the previous cycle to resubmit revised applications...We'll choose high-quality applications that were responsive to our national research priorities, but for which the merit reviewers and PCORI staff raised concerns that seem remediable. Staff will recommend revisions to the selected applicants and discuss options with them. Those invited to resubmit will not be asked to provide the Letter of Intent (LOI) required of other applicants.” Click here to view the full post.
9. Medical Journal Articles
High-Dimensional Propensity Score Algorithm in Comparative Effectiveness Research with Time-Varying Interventions: Click here to view. Radiologists' Perspectives About Evidence-Based Medicine and Their Clinical Practice: A Semistructured Interview Study: Click here to view.
Assessment Vs. Appraisal of Ethical Aspects of Health Technology Assessment: Can the Distinction Be Upheld? : Clickhere to view. Integrating the Use of Patient-Reported Outcomes for Both Clinical Practice and Performance Measurement: Views of Experts from 3 Countries: Click here to view.
New Issue: Journal of Comparative Effectiveness Research: Click here to view: Click here to view.
10. AHRQ Effective Program Updates
Imaging for Pretreatment Staging of Small Cell Lung Cancer: Click here to view Research protocol. Diagnosis and Treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Click here to view final report. Radiotherapy Treatments for Head and Neck Cancer Update: Click here to view final report.
