In This Week’s Issue:
1. Well + Good: This Is What It’s Like to Live with A Rare Autoimmune Disease, click here to read the article.
2. PCORI Video: Improving Communication to Help Manage Chronic Pain, click here to watch the video
3. FDA Public Meeting: Evaluating Inclusion and Exclusion Criteria in Clinical Trials, click here to register.
4. The PCORI Blog: Changing the Landscape of Rare Disease Research, click here to read the article.
5. AJMC: FDA Moves to Era of Active Participant in Drug Development, click here to read the article.
6. Diagnostic Imaging: Patient-Centered Care: How to Involve Patients in Research and Dissemination, click here to read the article.
7. Upcoming Events and Webinars, see details below.
8. Medical Journal Articles, see details below.
9. AHRQ Effective Program Updates, see details below
1. Well + Good: This Is What It’s Like to Live with A Rare Autoimmune Disease, click here to read the article.
2. PCORI Video: Improving Communication to Help Manage Chronic Pain, click here to watch the video
3. FDA Public Meeting: Evaluating Inclusion and Exclusion Criteria in Clinical Trials, click here to register.
4. The PCORI Blog: Changing the Landscape of Rare Disease Research, click here to read the article.
5. AJMC: FDA Moves to Era of Active Participant in Drug Development, click here to read the article.
6. Diagnostic Imaging: Patient-Centered Care: How to Involve Patients in Research and Dissemination, click here to read the article.
7. Upcoming Events and Webinars, see details below.
8. Medical Journal Articles, see details below.
9. AHRQ Effective Program Updates, see details below
1. Well + Good: This Is What It’s Like to Live with A Rare Autoimmune Disease
PIPC member, and founder of the Global Liver Institute, Donna Cryer discusses her experience living with a rare autoimmune disease in Well + Good. “Many of my doctors ask me how I’m able to recover so fast after my surgeries and how I’m doing so well now. I think a lot of it comes down to mindset. I want to do everything I can to create the best environment possible for my treatments to work. It’s like planting a seed in the most fertile soil. I really try to maximize every moment to be a little bit stronger and more resilient every day.” Click here to read the article.
2. PCORI Video: Improving Communication to Help Manage Chronic Pain
In a new PCORI video Christine Goertz discusses how providing patients and clinicians with information about the safety and efficacy of alternative therapies for managing chronic pain may lessen pain and curb opioid dependency. “It can be a very difficult conversation when patients are speaking to their clinicians about how best to manage chronic pain, particularly if the patient has been on opioids.” Click here to watch the video.
3. FDA Public Meeting: Evaluating Inclusion and Exclusion Criteria in Clinical Trials
The FDA is folding a public meeting on April 16 to discuss how to improve eligibility criteria for clinical trials to better represent the broader patient population and increase diversity. “Convened by the Duke-Robert J. Margolis, MD, Center for Health Policy at Duke University and supported by a cooperative agreement with FDA, this public event will bring the stakeholder community together to discuss a variety of topics related to eligibility criteria in clinical trials, their potential impact on patient access to investigational drugs, and how they might facilitate the enrollment of a diverse patient population. Other topics that will be addressed during the public meeting include alternative clinical trial designs that may increase enrollment of more diverse patient populations, as well as opportunities for using data from expanded access trials.” Click here to register.
4. The PCORI Blog: Changing the Landscape of Rare Disease Research
In a post for The PCORI Blog, Vanessa Boulanger writes that PCORI’s support for a research process centering on patients’ voices is proactively changing the research landscape and discourse. “Patient-centered research empowers patient populations to share their personal experiences to inform the design and real-world application of research. By working with and on behalf of patients to fill knowledge gaps and promote equitable and sustained progress in research, NORD aims to improve clinical care, advance new product development, and generate data across all rare diseases.” Click here to read the article.
5. AJMC: FDA Moves to Era of Active Participant in Drug Development
Mary Caffrey reports on patient-centered drug development in a post for The American Journal of Managed Care. “...With the Cures Act, drug development will be simultaneously more evidence driven and patient centered. ‘It makes the FDA an active participant in drug development, and it requires us to focus more on patient-focused drug development using novel innovative trial designs, applying real-world evidence, and create drug development tools to speed this up,’ [FDA's Frank Weichold, MD, PhD] said. Clinical trials as we know them are ‘essentially disconnected from the real word,’ he noted, and that sometimes results in real-world outcomes that don't match what happened in studies—to say nothing of the high research costs.” Click here to read the article.
6. Diagnostic Imaging: Patient-Centered Care: How to Involve Patients in Research and Dissemination
Mia DeFino discusses the importance of the patient voice in the research and dissemination process for DiagnosticImaging.com. “Patient-centered care involves thinking about the outcomes that are important to the patient, such as the health status achieved, the process of recovery, and the maintenance of health after therapy, says Ruth C. Carlos, MD, MS, from the University of Michigan and ECOG-ACRIN Cancer Research Group. But in order to understand what outcomes are important to patients, one must ask them directly, which is where patient engagement comes in. Patient engagement involves initiating and maintaining partnerships between researchers and stakeholders (patients/patient advocates); understanding, using, and optimizing the patient perspective across all phases of research; sharing and using what is learned from patient partnerships; and training patients how the research process works. Carlos proposes these actions for patient engagement off of the Patient-Centered Outcomes Research Institute (PCORI) principles of trust, honesty, co-learning, transparency, reciprocal relationships, and respect.” Click here to read the article.
7. Upcoming Events and Webinars
IBI Webinar on "Toward Better Value: Employer Perspectives on Managing Prescription Drug Benefits"
March 5, 2018
Click here for details.
Examining the Impact of Real-World Evidence on Medical Product Development: A Workshop Series | Workshop 2: Practical Approaches
March 6-7, 2018
Click here for details.
PCORnet Best Practice Sharing Session – Lessons Learned in ADAPTABLE: Recruitment, Retention, and Endpoint Ascertainment
March 7, 2018
Click here for details.
Preventing and Treating America's Number One Killer: The Need for Evidence-Based Strategies in Cardiovascular Disease
March 14, 2018
Click here for details.
Webinar: Getting Real About Real World Evidence: Practical Next Steps for Drug and Device Manufacturers
March 15, 2018
Click here for details.
PCORI Board of Governors Meeting
March 20, 2018
Click here for details.
Advisory Panel on Rare Disease Spring 2018 Meeting
March 21, 2018
Click here for details.
Webinar: Health Care Coverage Challenges: New Treatments With High Upfront Costs, Long-term Benefits and Delayed Savings
March 29, 2018
Click here for details.
DIA 2018 Global Annual Meeting
June 24-28, 2018
Click here for details.
8. Medical Journal Articles
PCORnet's Collaborative Research Groups, click here to view.
Increasing Uptake of Comparative Effectiveness and Patient-Centered Outcomes Research Among Stakeholders: Insights from Conference Discussion, click here to view.
Comparative Effectiveness and Patient-Centered Outcomes Research: Enhancing Uptake and Use by Patients, Clinicians and Payers, click here to view.
Comparative Effectiveness Research Requires Competitive Effectiveness, click here to view.
What Parents of Children With Complex Medical Conditions Want Their Child’s Physicians to Understand, click here to view.
PCORnet's Collaborative Research Groups, click here to view.
Guidelines for Patient-Reported Outcomes in Clinical Trial Protocols, click here to view.
Ensuring the Patient Voice in Quality: An Educational Program for Patient Groups and Advocates, click here to view.
Patient-Reported Outcomes: Design with the End in Mind, click here to view.
Beliefs, Critical Thinking and Evidence-Based Medicine, click here to view.
Changes in patient-centered attitude and confidence in communicating with patients: a longitudinal study of resident physicians, click here to view.
January Issue: Journal of Comparative Effectiveness Research, click here to view.
Toward Patient-Centered Outcomes for Cognitive Evaluations: The Perspective of Those Affected by Parkinson's Disease, click here to view.
Viewpoint: Funding Innovation in a Learning Health Care System, click here to view.
Including the Patient Voice in Patient-Centered Outcomes Research in Integrative Oncology, click here to view.
Patient and Provider Perspectives on Shared Decision Making: A Systematic Review of the Peer-Reviewed Literature, click here to view.
Gene Therapy: Evidence, Value and Affordability in the US Health Care System, click here to view.
9. AHRQ Effective Program Updates
Prioritization and Selection of Harms for Inclusion in Systematic Reviews, click here to view.
Attention Deficit Hyperactivity Disorder: Diagnosis and Treatment in Children and Adolescents, click here to view.
A Framework for Conceptualizing Evidence Needs of Health Systems, click here to view.
Nonsurgical Treatments for Urinary Incontinence in Adult Women: A Systematic Review Update, click here to view.
Drug Therapy for Early Rheumatoid Arthritis: A Systematic Review Update, click here to view.
Effects of Dietary Sodium and Potassium Intake on Chronic Disease Outcomes and Related Risk Factors, click here to view.
Management of Insomnia Disorder - Consumer and Clinician Summaries, click here to view
Harms of First-Line Depression Treatment in Older Adults, click here to view.
Management of Renal Masses and Localized Renal Cell Carcinoma: Current State of the Evidence - Clinician Summary, click here to view.
PIPC member, and founder of the Global Liver Institute, Donna Cryer discusses her experience living with a rare autoimmune disease in Well + Good. “Many of my doctors ask me how I’m able to recover so fast after my surgeries and how I’m doing so well now. I think a lot of it comes down to mindset. I want to do everything I can to create the best environment possible for my treatments to work. It’s like planting a seed in the most fertile soil. I really try to maximize every moment to be a little bit stronger and more resilient every day.” Click here to read the article.
2. PCORI Video: Improving Communication to Help Manage Chronic Pain
In a new PCORI video Christine Goertz discusses how providing patients and clinicians with information about the safety and efficacy of alternative therapies for managing chronic pain may lessen pain and curb opioid dependency. “It can be a very difficult conversation when patients are speaking to their clinicians about how best to manage chronic pain, particularly if the patient has been on opioids.” Click here to watch the video.
3. FDA Public Meeting: Evaluating Inclusion and Exclusion Criteria in Clinical Trials
The FDA is folding a public meeting on April 16 to discuss how to improve eligibility criteria for clinical trials to better represent the broader patient population and increase diversity. “Convened by the Duke-Robert J. Margolis, MD, Center for Health Policy at Duke University and supported by a cooperative agreement with FDA, this public event will bring the stakeholder community together to discuss a variety of topics related to eligibility criteria in clinical trials, their potential impact on patient access to investigational drugs, and how they might facilitate the enrollment of a diverse patient population. Other topics that will be addressed during the public meeting include alternative clinical trial designs that may increase enrollment of more diverse patient populations, as well as opportunities for using data from expanded access trials.” Click here to register.
4. The PCORI Blog: Changing the Landscape of Rare Disease Research
In a post for The PCORI Blog, Vanessa Boulanger writes that PCORI’s support for a research process centering on patients’ voices is proactively changing the research landscape and discourse. “Patient-centered research empowers patient populations to share their personal experiences to inform the design and real-world application of research. By working with and on behalf of patients to fill knowledge gaps and promote equitable and sustained progress in research, NORD aims to improve clinical care, advance new product development, and generate data across all rare diseases.” Click here to read the article.
5. AJMC: FDA Moves to Era of Active Participant in Drug Development
Mary Caffrey reports on patient-centered drug development in a post for The American Journal of Managed Care. “...With the Cures Act, drug development will be simultaneously more evidence driven and patient centered. ‘It makes the FDA an active participant in drug development, and it requires us to focus more on patient-focused drug development using novel innovative trial designs, applying real-world evidence, and create drug development tools to speed this up,’ [FDA's Frank Weichold, MD, PhD] said. Clinical trials as we know them are ‘essentially disconnected from the real word,’ he noted, and that sometimes results in real-world outcomes that don't match what happened in studies—to say nothing of the high research costs.” Click here to read the article.
6. Diagnostic Imaging: Patient-Centered Care: How to Involve Patients in Research and Dissemination
Mia DeFino discusses the importance of the patient voice in the research and dissemination process for DiagnosticImaging.com. “Patient-centered care involves thinking about the outcomes that are important to the patient, such as the health status achieved, the process of recovery, and the maintenance of health after therapy, says Ruth C. Carlos, MD, MS, from the University of Michigan and ECOG-ACRIN Cancer Research Group. But in order to understand what outcomes are important to patients, one must ask them directly, which is where patient engagement comes in. Patient engagement involves initiating and maintaining partnerships between researchers and stakeholders (patients/patient advocates); understanding, using, and optimizing the patient perspective across all phases of research; sharing and using what is learned from patient partnerships; and training patients how the research process works. Carlos proposes these actions for patient engagement off of the Patient-Centered Outcomes Research Institute (PCORI) principles of trust, honesty, co-learning, transparency, reciprocal relationships, and respect.” Click here to read the article.
7. Upcoming Events and Webinars
IBI Webinar on "Toward Better Value: Employer Perspectives on Managing Prescription Drug Benefits"
March 5, 2018
Click here for details.
Examining the Impact of Real-World Evidence on Medical Product Development: A Workshop Series | Workshop 2: Practical Approaches
March 6-7, 2018
Click here for details.
PCORnet Best Practice Sharing Session – Lessons Learned in ADAPTABLE: Recruitment, Retention, and Endpoint Ascertainment
March 7, 2018
Click here for details.
Preventing and Treating America's Number One Killer: The Need for Evidence-Based Strategies in Cardiovascular Disease
March 14, 2018
Click here for details.
Webinar: Getting Real About Real World Evidence: Practical Next Steps for Drug and Device Manufacturers
March 15, 2018
Click here for details.
PCORI Board of Governors Meeting
March 20, 2018
Click here for details.
Advisory Panel on Rare Disease Spring 2018 Meeting
March 21, 2018
Click here for details.
Webinar: Health Care Coverage Challenges: New Treatments With High Upfront Costs, Long-term Benefits and Delayed Savings
March 29, 2018
Click here for details.
DIA 2018 Global Annual Meeting
June 24-28, 2018
Click here for details.
8. Medical Journal Articles
PCORnet's Collaborative Research Groups, click here to view.
Increasing Uptake of Comparative Effectiveness and Patient-Centered Outcomes Research Among Stakeholders: Insights from Conference Discussion, click here to view.
Comparative Effectiveness and Patient-Centered Outcomes Research: Enhancing Uptake and Use by Patients, Clinicians and Payers, click here to view.
Comparative Effectiveness Research Requires Competitive Effectiveness, click here to view.
What Parents of Children With Complex Medical Conditions Want Their Child’s Physicians to Understand, click here to view.
PCORnet's Collaborative Research Groups, click here to view.
Guidelines for Patient-Reported Outcomes in Clinical Trial Protocols, click here to view.
Ensuring the Patient Voice in Quality: An Educational Program for Patient Groups and Advocates, click here to view.
Patient-Reported Outcomes: Design with the End in Mind, click here to view.
Beliefs, Critical Thinking and Evidence-Based Medicine, click here to view.
Changes in patient-centered attitude and confidence in communicating with patients: a longitudinal study of resident physicians, click here to view.
January Issue: Journal of Comparative Effectiveness Research, click here to view.
Toward Patient-Centered Outcomes for Cognitive Evaluations: The Perspective of Those Affected by Parkinson's Disease, click here to view.
Viewpoint: Funding Innovation in a Learning Health Care System, click here to view.
Including the Patient Voice in Patient-Centered Outcomes Research in Integrative Oncology, click here to view.
Patient and Provider Perspectives on Shared Decision Making: A Systematic Review of the Peer-Reviewed Literature, click here to view.
Gene Therapy: Evidence, Value and Affordability in the US Health Care System, click here to view.
9. AHRQ Effective Program Updates
Prioritization and Selection of Harms for Inclusion in Systematic Reviews, click here to view.
Attention Deficit Hyperactivity Disorder: Diagnosis and Treatment in Children and Adolescents, click here to view.
A Framework for Conceptualizing Evidence Needs of Health Systems, click here to view.
Nonsurgical Treatments for Urinary Incontinence in Adult Women: A Systematic Review Update, click here to view.
Drug Therapy for Early Rheumatoid Arthritis: A Systematic Review Update, click here to view.
Effects of Dietary Sodium and Potassium Intake on Chronic Disease Outcomes and Related Risk Factors, click here to view.
Management of Insomnia Disorder - Consumer and Clinician Summaries, click here to view
Harms of First-Line Depression Treatment in Older Adults, click here to view.
Management of Renal Masses and Localized Renal Cell Carcinoma: Current State of the Evidence - Clinician Summary, click here to view.
