In This Week’s Issue:
1. PIPC Patient Blog: Abigail Lore, click here to view the blog post.
2. FDA Mulls Establishing Patient Affairs Office to Support Drug Development, see details below.
3. FDA’s Califf to Head New Clinical Research Foundation, see details below.
4. Guidelines for Designing Patient-Centered Research Initiatives, Click here to view the article.
5. CMS: Commenting Open on Pediatric Alternative Payment Model Opportunities, Click here to view the announcement.
6. Epilepsy Foundation: 2017-2018 AAHD Frederick J. Krause Scholarship on Health and Disability, Click here to apply.
7. NYT: Informed Patient? Don’t Bet on It, Click here to view the article.
8. PCORI Blog: How Advisory Panels Contribute to PCORI's Research Agenda, Click here to view the blog post.
9. Upcoming Events and Webinars, see details below.
10. Medical Journal Articles, see details below.
11. AHRQ Effective Program Updates, see details below.
1. PIPC Patient Blog: Abigail Lore, click here to view the blog post.
2. FDA Mulls Establishing Patient Affairs Office to Support Drug Development, see details below.
3. FDA’s Califf to Head New Clinical Research Foundation, see details below.
4. Guidelines for Designing Patient-Centered Research Initiatives, Click here to view the article.
5. CMS: Commenting Open on Pediatric Alternative Payment Model Opportunities, Click here to view the announcement.
6. Epilepsy Foundation: 2017-2018 AAHD Frederick J. Krause Scholarship on Health and Disability, Click here to apply.
7. NYT: Informed Patient? Don’t Bet on It, Click here to view the article.
8. PCORI Blog: How Advisory Panels Contribute to PCORI's Research Agenda, Click here to view the blog post.
9. Upcoming Events and Webinars, see details below.
10. Medical Journal Articles, see details below.
11. AHRQ Effective Program Updates, see details below.
1. PIPC Patient Blog: Abigail Lore
In a new post on the PIPC Blog, college student Abigail Lore discusses the challenges of balancing diabetes management with academics. “I had 14 years of diabetes management under my belt when I was a freshman political science student at American University. I prepared and thought about my transition to college for weeks. I had registered with my school’s Academic Support and Access Center for accommodations, scoped out the dining hall offerings, and had the nerve-wracking talk with my roommate about the Emergency Glucagon Pen. But no level of preparation can prepare you for the ups and downs of having diabetes in college.”
“…Every diabetes patient is different, but for me, the hardest part of being at American were my blood sugar management and remembering to give insulin at mealtimes while balancing being a ‘regular college student.’ But more than that, what seemed next to impossible was figuring out the logistics of managing my diabetes supplies. This meant calculating when I had to reorder supplies, how long it would take to be shipped, and how long it would take to process through my university's package system – not to mention any appeals of prior authorizations I would have to facilitate over and over despite years of demonstrating the medical necessity of the supplies that work for me. It’s like having a double major, one in political science and one in diabetes supplies management.”
“…It is easy to feel defeated when you are surrounded by students performing at the best of their abilities. That’s especially true when you know if could just get access to your trusted insulin pump to spend more time in range, you too could feel that good, get those good grades, and land that prestigious internship. That is why comprehensive coverage for the diabetes equipment and supplies that work for each individual patient is vital, especially to college students.” Click here to view the blog post.
2. FDA Mulls Establishing Patient Affairs Office to Support Drug Development
Last Monday, the FDA announced that it is considering establishing a new office for patient affairs to support the agency’s efforts to engage patients in the drug development process, according to a report by FDANews. The agency is inviting comments for 90 days on the proposal, which responds to calls from stakeholders for more centralized patient engagement. The office is intended to improve patient engagement in the development process across product centers — such as CDER and CBER — with improved transparency and accessibility. It would focus on developing a better understanding of patient experiences with diseases, and on familiarizing patients and advocates with the FDA’s regulatory processes.
3. Califf to Head New Clinical Research Foundation
As BioCentury reports, Former FDA Commissioner Robert Califf will be chair of the newly created People-Centered Research Foundation (PCRF). The group was formed by investigators from the National Patient-Centered Clinical Research Network (PCORnet), which is operated by the Patient-Centered Outcomes Research Institute (PCORI), a publicly funded comparative effectiveness research organization. PCORI said Tuesday it will fund the foundation with up to $25.4 million. PCRF will support PCORnet's sustainability and "provide retrospective observational research using its data network, prospective research that collects new data from patients, and high-impact clinical trials," according to its website.
4. Guidelines for Designing Patient-Centered Research Initiatives
Patient Engagement HIT has the scoop on PCORI's Patient Engagement Rubric. “...PCORI created the [PCORI Engagement Rubric] to include the following: principles of engagement; definitions of stakeholder types; key considerations for planning, conducting, and disseminating engaged research; potential engagement activities; and examples of promising practices from PCORI-funded projects...‘[The Rubric] provides a practical resource that distills and prioritizes information from promising practices intended to systematically bring stakeholders into the research process in the most impactful way,’ the researchers said.” Click here to view the article.
5. CMS: Commenting Open on Pediatric Alternative Payment Model Opportunities
According to a recent CMS announcement, “input is being sought on approaches to improve the quality and reduce the cost of care for children and youth enrolled in Medicaid and CHIP. In particular, concepts are being explored that encourage pediatric providers to collaborate with health-related social service providers (e.g., early childhood development programs, child welfare services, and home and community based service providers) at the state and local levels and share accountability for health outcomes for children and youth enrolled in Medicaid and CHIP. Specifically, CMS seeks information from the broad community of child and youth-focused stakeholders on concepts critical to addressing the comprehensive health needs of children and youth, such as (1) Opportunities and impediments to extending and enhancing integrated service model concepts like accountable care organizations (ACOs) to the pediatric population (2) Flexibilities and supports states and providers may need in order to offer such models of care to a state’s pediatric population and (3) Approaches for states and providers to coordinate Medicaid and CHIP benefits and waivers with other health-related social services for children and youth.” Click here to view the announcement.
6. Epilepsy Foundation: 2017-2018 AAHD Frederick J. Krause Scholarship on Health and Disability
The American Association on Health and Disability’s Frederick J. Krause Scholarship on Health and Disability is currently accepting applications. The scholarship honors Frederick J. Krause, a lifelong advocate for those with disabilities who passed away in 2014. Beginning with his role as a special education teacher, Mr. Krause’s distinguished career in advocacy included service in the federal government and the cofounding of the American Association on Health and Disability. The scholarship pays tribute to Mr. Krause by awarding scholarships to students with disabilities that are pursuing an education on disability-related topics. Click here to apply.
7. NYT: Informed Patient? Don’t Bet on It
Dr. Mikkael Sekeres and Dr. Timothy Gilligan of the Cleveland Clinic discuss informed consent in a provocative new article in the New York Times. “We want to let you in on a secret… The secret is that informed consent in health care is commonly not-so-well informed. It might be a document we ask you to sign, at the behest of our lawyers, in case we end up in court if a bad outcome happens. Unfortunately, it’s often not really about informing you… Unfortunately the farce of informed consent only worsens in medical research. Before you can enroll in a clinical trial of a cancer drug, we’ll hand you a 25page document that describes the trial’s purpose, its design, the medications you’ll receive, other standard treatments, and the complications you may suffer. Oh, and we’ll tell you that you are responsible for any medical costs not covered by insurance or the trial sponsor. That’s for the lawyers, again. We will then ask you to sign the final page, acknowledging your understanding and your agreement to participate in the trial.”
“A fundamental challenge with this process is that it is often unrealistic to think that you actually could be fully informed of what you’re about to undergo. How can we explain to you the experience of having your chest cracked open, or what it feels like when you go through chemotherapy? Neither of us has undergone heart surgery, or treatment for cancer, and we don’t kid ourselves that any depiction of the experience we provide will be enough… We’ve seen too many patients regret decisions that they made without fully understanding their options, or the possible outcome. We encourage our patients, and our colleagues, to be partners in what are often lifechanging decisions about health care.” Click here to view the article.
8. PCORI Blog: How Advisory Panels Contribute to PCORI's Research Agenda
In a recent post on The PCORI Blog, Bruce Monte Jr., MSCEP of UnitedHealth Group discusses the importance of PCORI’s advisory panels. “This spring, I will complete four years as a member of the PCORI Advisory Panel on Assessment of Prevention, Diagnosis, and Treatment Options... The panel has kept patients at the center of the discussion and considered a vast array of potential research questions, ranging from comparing radiation therapies for breast cancer to weighing treatment options for chronic migraines to comparing medications for pediatric Crohn's disease.” Click here to view the blog post.
PCORI is now accepting applications for the 2017 Advisory Panel member selection cycle. Third-party nominations and applications deadlines are Friday, March 31, by 5:00 p.m. (ET). Before you submit an application, check out the following links for background information:
9. Upcoming Events and Webinars
Webinar: Making the Grade: Utilizing Evidence for Health Technology Initiatives
March 30, 2017
Click here for details.
PCORI: Advisory Panel on Improving Healthcare Systems Spring 2017 Meeting
March 31, 2017
Click here for details.
PCORnet Best Practice Sharing Session: ABOUT GAP Tools
April 4, 2017
Click here for details.
Advisory Panel on Patient Engagement Spring 2017 Meeting
April 7, 2017
Click here for details.
Getting to Know PCORI: From Application to Closeout
April 10 - 11, 2017
Click here for details.
Evaluating Patient Treatment Options: How Do We Know What Works Best?
April 18, 2017
Click here for details.
PCORI Funding Opportunities and Resources for Rare Disease Organizations
April 20, 2017
Click here for details.
Advisory Panel on Communication and Dissemination Research Spring 2017 Meeting
April 21, 2017
Click here for details.
PCORI Board of Governors Meeting
April 25, 2017
Click here for details.
Advisory Panel on Rare Disease Spring 2017 Meeting
April 26, 2017
Click here for details.
Integrating PROs in EHRs: Presentation of a Users' Guide and Discussion of Standardization
May 25-26, 2017
Click here for details.
ICER Orphan Drug Assessment and Pricing Summit
May 31, 2017
Click here for details.
10. Medical Journal Articles
Association Between Choice of Radical Prostatectomy, External Beam Radiotherapy, Brachytherapy, or Active Surveillance and Patient-Reported Quality of Life Among Men With Localized Prostate Cancer, click here to view.
Big Data: Will It Improve Patient-Centered Care?, click here to view.
A Review of HIV-Specific Patient-Reported Outcome Measures, click here to view.
Impact of Measuring Patient-Reported Outcomes in Dermatology Drug Development, click here to view.
Outcomes in Child Health: Exploring the Use of Social Media to Engage Parents in Patient-Centered Outcomes Research, click here to view.
A Patient and Provider Research Agenda on Diabetes and Hypertension Management, click here to view.
Comparative effectiveness of dual-action versus single-action antidepressants for the treatment of depression in people living with HIV/AIDS, click here to view
Patient-Reported Outcomes Following Treatment for Localized Prostate Cancer: Helping Decision Making for Patients and Their Physicians, click here to view
Vital Directions for Health and Health Care: Priorities From a National Academy of Medicine Initiative, click here to view
Translating Comparative Effectiveness Research Into Practice: Effects of Interventions on Lifestyle, Medication Adherence, and Self-Care for Type 2 Diabetes, Hypertension, and Obesity Among Black, Hispanic, and Asian Residents of Chicago and Houston, 2010 to 2013, click here to view.
Maintaining Primacy of the Patient Perspective in the Development of Patient-Centered Patient Reported Outcomes, click here to view.
Value-Based Insurance Design Benefit Offsets Reductions In Medication Adherence Associated With Switch To Deductible Plan, click here to view.
Doxycycline Versus Prednisolone as an Initial Treatment Strategy for Bullous Pemphigoid: A Pragmatic, Non-Inferiority, Randomised Controlled Trial, click here to view.
Detecting Heterogeneous Treatment Effects to Guide Personalized Blood Pressure Treatment: A Modeling Study of Randomized Clinical Trials, click here to view.
A Tale of Two Trials: Reconciling Differences in Results by Exploring Heterogeneous Treatment Effects, click here to view.
11. AHRQ Effective Program Updates
Systematic Review of Intermittent Inhaled Corticosteroids and of Long-acting Muscarinic Antagonists for Asthma, click here to view.
Interventions to Prevent Age-Related Cognitive Decline, Mild Cognitive Impairment, and Clinical Alzheimer's-Type Dementia -- Final Report, click here to view
First- and Second-Generation Antipsychotics in Children and Young Adults: Systematic Review Update -- Final Report, click here to view.
Strategies for Improving the Lives of Women Aged 40 and Above Living With HIV/AIDS -- Disposition of Comments, click here to view.
Physiologic Predictors of the Need for Trauma Center Care: A Systematic Review -- Research Protocol, click here to view.
Treatments for Adults with Schizophrenia: A Systematic Review, click here to view.
Anxiety in Children, click here to view.
Patient Safety in Ambulatory Settings -- Disposition of Comments Report, click here to view.
Data Linkage Strategies To Advance Youth Suicide Prevention -- Disposition of Comments Report, click here to view.
Effects of Dietary Sodium and Potassium Intake on Chronic Disease Outcomes and Related Risk Factors -- Research Protocol, click here to view.
Obesity Prevention and Control -- Research Protocol, click here to view.
Telehealth for Acute and Chronic Care Consultations -- Research Protocol, click here to view.
In a new post on the PIPC Blog, college student Abigail Lore discusses the challenges of balancing diabetes management with academics. “I had 14 years of diabetes management under my belt when I was a freshman political science student at American University. I prepared and thought about my transition to college for weeks. I had registered with my school’s Academic Support and Access Center for accommodations, scoped out the dining hall offerings, and had the nerve-wracking talk with my roommate about the Emergency Glucagon Pen. But no level of preparation can prepare you for the ups and downs of having diabetes in college.”
“…Every diabetes patient is different, but for me, the hardest part of being at American were my blood sugar management and remembering to give insulin at mealtimes while balancing being a ‘regular college student.’ But more than that, what seemed next to impossible was figuring out the logistics of managing my diabetes supplies. This meant calculating when I had to reorder supplies, how long it would take to be shipped, and how long it would take to process through my university's package system – not to mention any appeals of prior authorizations I would have to facilitate over and over despite years of demonstrating the medical necessity of the supplies that work for me. It’s like having a double major, one in political science and one in diabetes supplies management.”
“…It is easy to feel defeated when you are surrounded by students performing at the best of their abilities. That’s especially true when you know if could just get access to your trusted insulin pump to spend more time in range, you too could feel that good, get those good grades, and land that prestigious internship. That is why comprehensive coverage for the diabetes equipment and supplies that work for each individual patient is vital, especially to college students.” Click here to view the blog post.
2. FDA Mulls Establishing Patient Affairs Office to Support Drug Development
Last Monday, the FDA announced that it is considering establishing a new office for patient affairs to support the agency’s efforts to engage patients in the drug development process, according to a report by FDANews. The agency is inviting comments for 90 days on the proposal, which responds to calls from stakeholders for more centralized patient engagement. The office is intended to improve patient engagement in the development process across product centers — such as CDER and CBER — with improved transparency and accessibility. It would focus on developing a better understanding of patient experiences with diseases, and on familiarizing patients and advocates with the FDA’s regulatory processes.
3. Califf to Head New Clinical Research Foundation
As BioCentury reports, Former FDA Commissioner Robert Califf will be chair of the newly created People-Centered Research Foundation (PCRF). The group was formed by investigators from the National Patient-Centered Clinical Research Network (PCORnet), which is operated by the Patient-Centered Outcomes Research Institute (PCORI), a publicly funded comparative effectiveness research organization. PCORI said Tuesday it will fund the foundation with up to $25.4 million. PCRF will support PCORnet's sustainability and "provide retrospective observational research using its data network, prospective research that collects new data from patients, and high-impact clinical trials," according to its website.
4. Guidelines for Designing Patient-Centered Research Initiatives
Patient Engagement HIT has the scoop on PCORI's Patient Engagement Rubric. “...PCORI created the [PCORI Engagement Rubric] to include the following: principles of engagement; definitions of stakeholder types; key considerations for planning, conducting, and disseminating engaged research; potential engagement activities; and examples of promising practices from PCORI-funded projects...‘[The Rubric] provides a practical resource that distills and prioritizes information from promising practices intended to systematically bring stakeholders into the research process in the most impactful way,’ the researchers said.” Click here to view the article.
5. CMS: Commenting Open on Pediatric Alternative Payment Model Opportunities
According to a recent CMS announcement, “input is being sought on approaches to improve the quality and reduce the cost of care for children and youth enrolled in Medicaid and CHIP. In particular, concepts are being explored that encourage pediatric providers to collaborate with health-related social service providers (e.g., early childhood development programs, child welfare services, and home and community based service providers) at the state and local levels and share accountability for health outcomes for children and youth enrolled in Medicaid and CHIP. Specifically, CMS seeks information from the broad community of child and youth-focused stakeholders on concepts critical to addressing the comprehensive health needs of children and youth, such as (1) Opportunities and impediments to extending and enhancing integrated service model concepts like accountable care organizations (ACOs) to the pediatric population (2) Flexibilities and supports states and providers may need in order to offer such models of care to a state’s pediatric population and (3) Approaches for states and providers to coordinate Medicaid and CHIP benefits and waivers with other health-related social services for children and youth.” Click here to view the announcement.
6. Epilepsy Foundation: 2017-2018 AAHD Frederick J. Krause Scholarship on Health and Disability
The American Association on Health and Disability’s Frederick J. Krause Scholarship on Health and Disability is currently accepting applications. The scholarship honors Frederick J. Krause, a lifelong advocate for those with disabilities who passed away in 2014. Beginning with his role as a special education teacher, Mr. Krause’s distinguished career in advocacy included service in the federal government and the cofounding of the American Association on Health and Disability. The scholarship pays tribute to Mr. Krause by awarding scholarships to students with disabilities that are pursuing an education on disability-related topics. Click here to apply.
7. NYT: Informed Patient? Don’t Bet on It
Dr. Mikkael Sekeres and Dr. Timothy Gilligan of the Cleveland Clinic discuss informed consent in a provocative new article in the New York Times. “We want to let you in on a secret… The secret is that informed consent in health care is commonly not-so-well informed. It might be a document we ask you to sign, at the behest of our lawyers, in case we end up in court if a bad outcome happens. Unfortunately, it’s often not really about informing you… Unfortunately the farce of informed consent only worsens in medical research. Before you can enroll in a clinical trial of a cancer drug, we’ll hand you a 25page document that describes the trial’s purpose, its design, the medications you’ll receive, other standard treatments, and the complications you may suffer. Oh, and we’ll tell you that you are responsible for any medical costs not covered by insurance or the trial sponsor. That’s for the lawyers, again. We will then ask you to sign the final page, acknowledging your understanding and your agreement to participate in the trial.”
“A fundamental challenge with this process is that it is often unrealistic to think that you actually could be fully informed of what you’re about to undergo. How can we explain to you the experience of having your chest cracked open, or what it feels like when you go through chemotherapy? Neither of us has undergone heart surgery, or treatment for cancer, and we don’t kid ourselves that any depiction of the experience we provide will be enough… We’ve seen too many patients regret decisions that they made without fully understanding their options, or the possible outcome. We encourage our patients, and our colleagues, to be partners in what are often lifechanging decisions about health care.” Click here to view the article.
8. PCORI Blog: How Advisory Panels Contribute to PCORI's Research Agenda
In a recent post on The PCORI Blog, Bruce Monte Jr., MSCEP of UnitedHealth Group discusses the importance of PCORI’s advisory panels. “This spring, I will complete four years as a member of the PCORI Advisory Panel on Assessment of Prevention, Diagnosis, and Treatment Options... The panel has kept patients at the center of the discussion and considered a vast array of potential research questions, ranging from comparing radiation therapies for breast cancer to weighing treatment options for chronic migraines to comparing medications for pediatric Crohn's disease.” Click here to view the blog post.
PCORI is now accepting applications for the 2017 Advisory Panel member selection cycle. Third-party nominations and applications deadlines are Friday, March 31, by 5:00 p.m. (ET). Before you submit an application, check out the following links for background information:
- Find out more about the current openings on each advisory panel;
- Learn about the requirements and expectations for submitting an application;
- Learn how to submit a third-party nomination; and
- Find out how to apply.
9. Upcoming Events and Webinars
Webinar: Making the Grade: Utilizing Evidence for Health Technology Initiatives
March 30, 2017
Click here for details.
PCORI: Advisory Panel on Improving Healthcare Systems Spring 2017 Meeting
March 31, 2017
Click here for details.
PCORnet Best Practice Sharing Session: ABOUT GAP Tools
April 4, 2017
Click here for details.
Advisory Panel on Patient Engagement Spring 2017 Meeting
April 7, 2017
Click here for details.
Getting to Know PCORI: From Application to Closeout
April 10 - 11, 2017
Click here for details.
Evaluating Patient Treatment Options: How Do We Know What Works Best?
April 18, 2017
Click here for details.
PCORI Funding Opportunities and Resources for Rare Disease Organizations
April 20, 2017
Click here for details.
Advisory Panel on Communication and Dissemination Research Spring 2017 Meeting
April 21, 2017
Click here for details.
PCORI Board of Governors Meeting
April 25, 2017
Click here for details.
Advisory Panel on Rare Disease Spring 2017 Meeting
April 26, 2017
Click here for details.
Integrating PROs in EHRs: Presentation of a Users' Guide and Discussion of Standardization
May 25-26, 2017
Click here for details.
ICER Orphan Drug Assessment and Pricing Summit
May 31, 2017
Click here for details.
10. Medical Journal Articles
Association Between Choice of Radical Prostatectomy, External Beam Radiotherapy, Brachytherapy, or Active Surveillance and Patient-Reported Quality of Life Among Men With Localized Prostate Cancer, click here to view.
Big Data: Will It Improve Patient-Centered Care?, click here to view.
A Review of HIV-Specific Patient-Reported Outcome Measures, click here to view.
Impact of Measuring Patient-Reported Outcomes in Dermatology Drug Development, click here to view.
Outcomes in Child Health: Exploring the Use of Social Media to Engage Parents in Patient-Centered Outcomes Research, click here to view.
A Patient and Provider Research Agenda on Diabetes and Hypertension Management, click here to view.
Comparative effectiveness of dual-action versus single-action antidepressants for the treatment of depression in people living with HIV/AIDS, click here to view
Patient-Reported Outcomes Following Treatment for Localized Prostate Cancer: Helping Decision Making for Patients and Their Physicians, click here to view
Vital Directions for Health and Health Care: Priorities From a National Academy of Medicine Initiative, click here to view
Translating Comparative Effectiveness Research Into Practice: Effects of Interventions on Lifestyle, Medication Adherence, and Self-Care for Type 2 Diabetes, Hypertension, and Obesity Among Black, Hispanic, and Asian Residents of Chicago and Houston, 2010 to 2013, click here to view.
Maintaining Primacy of the Patient Perspective in the Development of Patient-Centered Patient Reported Outcomes, click here to view.
Value-Based Insurance Design Benefit Offsets Reductions In Medication Adherence Associated With Switch To Deductible Plan, click here to view.
Doxycycline Versus Prednisolone as an Initial Treatment Strategy for Bullous Pemphigoid: A Pragmatic, Non-Inferiority, Randomised Controlled Trial, click here to view.
Detecting Heterogeneous Treatment Effects to Guide Personalized Blood Pressure Treatment: A Modeling Study of Randomized Clinical Trials, click here to view.
A Tale of Two Trials: Reconciling Differences in Results by Exploring Heterogeneous Treatment Effects, click here to view.
11. AHRQ Effective Program Updates
Systematic Review of Intermittent Inhaled Corticosteroids and of Long-acting Muscarinic Antagonists for Asthma, click here to view.
Interventions to Prevent Age-Related Cognitive Decline, Mild Cognitive Impairment, and Clinical Alzheimer's-Type Dementia -- Final Report, click here to view
First- and Second-Generation Antipsychotics in Children and Young Adults: Systematic Review Update -- Final Report, click here to view.
Strategies for Improving the Lives of Women Aged 40 and Above Living With HIV/AIDS -- Disposition of Comments, click here to view.
Physiologic Predictors of the Need for Trauma Center Care: A Systematic Review -- Research Protocol, click here to view.
Treatments for Adults with Schizophrenia: A Systematic Review, click here to view.
Anxiety in Children, click here to view.
Patient Safety in Ambulatory Settings -- Disposition of Comments Report, click here to view.
Data Linkage Strategies To Advance Youth Suicide Prevention -- Disposition of Comments Report, click here to view.
Effects of Dietary Sodium and Potassium Intake on Chronic Disease Outcomes and Related Risk Factors -- Research Protocol, click here to view.
Obesity Prevention and Control -- Research Protocol, click here to view.
Telehealth for Acute and Chronic Care Consultations -- Research Protocol, click here to view.
