IPRCC Meeting - 7/09/2018

National Institutes of Health
Conference Call- Time changed to 4pm ET
Bethesda, MD

Federal Register Notice - Amended June 28, 2018

Welcome and Introduction of Incoming and Extended Members

Walter Koroshetz, MD, Director NINDS and Chair IPRCC

Roll Call and Welcome:

Dr. Koroshetz introduced the new members and gave them the opportunity to introduce themselves. The 2017 slate has been submitted. The final approval has not gone through, therefore all new members are attending as Ad Hoc members.

George Carter
Patient and Advocate for those with Sickle Cell Disease and Executive Director for Statewide Sickle Cell Chapters of Virginia

Katherine Hammitt
Vice President of Medical and Scientific Affairs, Sjögren’s Syndrome foundation and patient

Ms. Hammitt commented that similar to many chronic illnesses, pain is a prevalent part of Sjögren’s Syndrome, which is the second most common autoimmune rheumatic disease. Patients have pain from many sources and the chronicity of the pain can contribute to problems with sleep, fatigue, cognitive disfunction and depression.

Gwenn Herman
Clinical director and Founder of Pain Connection, a program of the US Pain Foundation.

Ms. Herman commented that she has had chronic pain for over 23 years. Seventeen years ago, she started a non-profit called Pain Connection, which offers direct services to people with chronic pain. The services include lives support groups and conference call support groups where guided imagery and meditation is taught. Pain Connection developed a program to train healthcare professionals to work with people with chronic pain and an 8-week program called “Filling the gaps in pain care” for patients and loved ones to educate them about many aspects of pain, including neuroplasticity and psychosocial aspects. It also teaches people techniques such as guided imagery, meditation and nutrition among other complementary treatments for pain care. Pain Connection joined with US Pain Foundation, and now Ms. Herman’s role is directing Pain Connection Programs for the US Pain Foundation. The emphasis for the past year has been training people to be chronic pain support group leaders.  Ms. Herman is excited to be on the committee to share her perspective as both a pain patient and a clinical social worker.

Robert Kerns PhD,
Professor of Psychiatry, Yale Medical School

Dr. Kerns noted that he is a Clinical psychologist by training with a history of clinical work in this area with mostly veterans, but also civilians with a variety of pain conditions. He has a long-standing interest in training and education. Dr. Kerns is a long-standing researcher primarily funded by the VA in the past and now receiving NIH funding from NCCIH.

David Clark, MD, PhD,
Associate Chief of Staff for Research, Palo Alto VA Healthcare Center

Dr. Clark directs a pain service at the Palo Alto VA hospital where they use  a multidisciplinary approach to treating chronic pain. His research is focused on long-term opioid effects and studying processes that delay recovery from injury. He looks forward to participating in the group and hopes that both perspectives will be helpful.

Dr. Koroshetz thanked the extended members, Rami Burstein, Judith Paice, Richard Payne, Christina Spellman and Cindy Steinberg for their extra duty on the IPRCC as we worked to get new members confirmed.

There will be a Face to Face Meeting on November 16, 2018 in Bethesda.

The original IPRCC mandate includes identifying science advances in research in pain and pain care, therefore each year we reach out to the IPRCC and the NIH Pain Consortium to nominate high-profile publications with great potential to advance pain research.  Summaries of these publications are posted on the IPRCC website. The latest batch has been posted at https://iprcc.nih.gov/Pain-Research/Pain-Research-Advances. They reflect the progress and future potential of pain research.

Dr. Koroshetz summarized the manuscript Sociodemographic Disparities in Chronic Pain, Based on 12-Year Longitudinal Data by Dr. Hanna Grol-Prokopczyk.  It was published in the Journal Pain and was based on a National Institute of Aging study that followed 20,000 adults, over 50 years of age, for 12 years. Contrary to previous findings that pain prevalence plateaus after the age of 60, she found that pain prevalence continues to increase in the elderly. Earlier reports did not account for the correlation of chronic pain with death, and therefore prevalence appeared to plateau because individuals with the most severe pain would die earlier than others. Chronic pain is associated with serious co-morbidities that may account for this relationship, and pain may be implicated as a predictor of early death.   Dr. Grol-Prokopczyk also found that when controlling for socioeconomic status, there was no difference between whites and Hispanics in observed pain levels, but African Americans reported lower levels of pain than either group. Finally, the group found that populations that experience the most pain report pain differently than other groups suggesting that pain disparities may be underestimated in women, poor and less educated populations.  This study provides guidance for public health researchers to determine sources of measurement bias to be addressed in future studies. It also suggests that pain is an even more serious burden than previously determined.

The Office of Pain Policy will be sending out a request for nominations of new science advances.

 

Nomination and Vote for IPRCC Chair

Linda Porter, PhD, Director, NINDS Office of Pain Policy

The IPRCC considered and approved the October 23rd, 2017 IPRCC meeting minutes with minor corrections.

The IPRCC nominated and unanimously elected Dr. Koroshetz to remain as chair of the IPRCC for a three-year term.

Helping to End Addiction Long-Term (HEAL) Initiative and Q and A
Walter Koroshetz, MD, Director, NINDS
Nora Volkow, MD, PhD Director NIDA

Dr. Volkow discussed the Improving Treatments for Opioid Misuse and Addiction aspect of the HEAL initiative.

There has been an increase in overdose fatalities driven by opioids that reflects the reliance of opioid medication for the treatment of pain. In addition to being potent analgesics, opioids are among the most rewarding and addictive drugs that we have. Therefore, the over prescription of opioids contributed to diversion and black market sales. In addition, people who are being treated with opioids for chronic pain are at risk of becoming addicted, particularly if they are not properly screened for risk and not properly supervised.

It is evident that the opioid epidemic continues and that limiting the prescribing of opioids will not solve the crisis. It is estimated that there has been a 30% decrease in prescriptions of opioids since 2011, but the number of people dying from opioid overdoses is steadily increasing. Some people who have started on prescription drugs, have moved to heroin. Starting in the early 2000s, there has been a flood of low-cost, high-purity heroin available in the United States. This contributed to the continued increase in opioid deaths, even as prescribing decreased. Finally, around 2013-2014, we began to see a dramatic increase in deaths caused by Fentanyl and other synthetic analogs. In 2011, Fentanyl was a miniscule part of overdoses, but it now surpasses fatalities from prescription opioids or heroin. The fentanyl responsible for overdose deaths is not the same as fentanyl used therapeutically. It is manufactured on the black market and shipped through the mail. It is believed to be made mostly in China and is so potent that very small amounts can result in an overdose. Overdoses with prescription opioids appear to have stabilized while there have been significant increases in those from heroin and fentanyl. The question now is what to do with the changing epidemic of the opioid crisis. 

Dr. Volkow focused on the importance of expanding treatment for people with opioid use disorders. It is estimated that patients who end up in emergency departments as a result of opioid overdoses have a mortality rate of 10% within one year. There are three classes of medications used to treat opioid use disorder; Methadone, a full agonist of the mu opioid receptor; Buprenorphine, a partial agonist of the receptor and Naltrexone, and antagonist of the receptor. Methadone has been used in the United States for the past 50 years, Buprenorphine was approved in 2002 and Naloxone extended was approved in 2010. Treatment with one of these three drugs significantly improves outcomes related to recovery, preventing relapses and decreasing the risk of overdose. Patients treated with one of these medications are three times less likely to die than those not on medication. However, people who could benefit from the medications are not being given access to them or are being given lower doses or for a shorter duration than recommended. This can lead to relapse, and the cascade of care needs to be improved.

The HEAL initiative aims to address this issue with two major strategies.

  1. Implementation Research to expand access to these treatments.
  2. Developing formulations of these medications to help patients to be more compliant. Even in the best medical centers, 50% of the patients on these medications will relapse in 6 months. At that time, they are at very high risk for overdosing.
    • Strategies to improve compliance include extended release formulations to make compliance easier.

Through the HEAL initiative, we will be using $500 million to address opioid use disorders and preventing overdoses and to research pain.  Improving pain management is an important strategy for preventing Opioid Use disorder, and patients with pain have been neglected. Even though the NIH has made significant investments in pain research, there are opportunities to integrate and become more efficient in how we use knowledge to develop new treatments.

Priorities for the HEAL initiative were developed over more than a year of meetings to identify the most important projects to move forward. These meetings included scientific experts from academic centers, clinical centers, private industry and government agencies including FDA, VA, HRSA and CMS.

Priorities in Medication Development

  1. Stronger, longer-acting formulations of antagonists or agonists to counteract overdose from high-potency opioids.
  2. New formulations of existing medications to improve treatment compliance and/or reduce diversion.
  3. Exploring new targets for treatment of addiction.
  4. Interventions against respiratory depression induced by opioids alone or in combination with other substances.
  5. Immunotherapies (vaccines and monoclonal antibodies) to prevent relapse by stimulating the body to generate antibodies that bind to opioids or using highly efficient anti-drug antibodies to neutralize the drug while still in the bloodstream.
  6. Development of stimulation (peripheral or trans-cranial) strategies.

Priority: Expanding the NIDA clinical trials network

A network of 13 nodes that partner with healthcare systems across the United States has helped slowly change the culture around the treatment of addiction.

  • Currently, less than 10% of addiction treatments are given in a healthcare setting. Through the clinical trials network, researchers have developed models of care that take advantage of the current healthcare system (ex. Infectious disease clinics, emergency departments and primary care providers).
  • Infrastructure Development (supplements):Incorporation of new sites and investigators into existing Nodes to add expertise in critical clinical and scientific areas; expansion of Coordinating and Data Centers
  • Active Studies (supplements):Expansion of current studies to address “next step” research questions on OUD
  • New Studies (supplements):Improve access to care and quality of care for OUD

Priority: Justice Community Opioid Innovation Network

Taking advantage of the justice settings to provide medication assisted treatment (MAT).

Many individuals in jails and prisons have an opioid use disorder.  Studies have shown that these individuals are at risk of dying from an overdose, but these overdoses can be prevented if individuals are treated for OUD in prison. However, very few prison or jail systems have implemented medication assisted treatment (MAT) programs. This requires a culture change.

HEAL initiative funds will allow us to:

  • Identify the status of OUD in the criminal justice system.
  • Determine how to change the culture of treatment within the justice system.
  • Provide access to antagonist treatments.
  • Determine how to link individuals in the prison/jail system with a healthcare provider upon release.

Priority: The HEALing Communities Study

The HEALing Communities Study will take advantage of community-based interventions to prevent OUD and sustain treatment for those addicted to opioids. Some examples of this involvement are the dispensing of MAT by pharmacies, police departments and faith-based organizations referring individuals for treatment.

The goal of the HEALing Communities Study is to test the implementation of an integrated, evidence-based intervention demonstration project to prevent and treat Opioid Use Disorder and prevent overdose death in two to three high-impact areas of the country. This multisite implementation research study will be carried out in close partnership with SAMHSA. It will assess the effectiveness for preventing OUD and overdose include expanding MAT, engaging individuals who are not seeking treatment, sustaining treatment, expanding the use of naloxone and expanding the use of community programs.

Points of discussion:

The group discussed recent commercials from the Office of National Drug Control Policy the Ad Council that show people hurting themselves to get more opioids.   Dr. Volkow clarified that physical dependence can happen within 5 days, but this is relatively easy to treat. Addiction is much more difficult to treat but takes longer to develop. The committee expressed concern that the advertisements are fueling misperceptions.

Dr. Koroshetz described research that the HEAL initiative plans to initiate on pain.

One part of the HEAL initiative is to improve pain management with more effective, safer strategies and balance pain management with addiction. The crisis led congress to invest $500 M per year for 2018 and 2019. This includes research to improve pain management as well as to better treat addiction. 

We have developed plans with industry and academia to move forward.

  • Perform research that will lead to a better understanding of the neurobiology of pain.
  • Accelerate discovery and pre-clinical and clinical development of non-addictive pain treatments.
  • Perform research that will inform the practice of pain management.
  • Comparative effectiveness research in pain to inform targeting the best treatment for different types of pain.

A HEAL initiative strategy has been conceived that includes numerous programs that move us from discovery science (ex. Discovery of new targets for developing non-addictive pain medication) through pre-clinical development then into clinical trials. Much of the work that has been done was within the public-private partnership with industry and therefore skewed towards therapy development. Dr. Collins and the Institute directors are working to solidify plans for best practices research.

Some of the HEAL funds were used to supplement several ongoing projects. Some of these projects are:

  • Mechanisms of psychosocial treatment for chronic low back pain
  • Cannabinoid-based therapy and approaches to quantify pain in sickle cell disease
  • Pharmacologically-based strategies for buprenorphine treatment during pregnancy
  • Clinical and translational research center in West Virginia (IDeA)
  • Native American Research Centers for Health, American Indian Wellness through Research Engagement
  • Prospective study of racial and ethnic disparities in chronic pain and pain burden

Dr. Koroshetz described upcoming planned projects that will use HEAL funds.

Discover and validate novel targets for pain

Our current understanding of pain pathways is incomplete, but it includes targets in both the peripheral and central nervous system that could be modulated for pain relief.  Some pathways in the spinal cord change with the development of chronic pain syndromes that may be useful targets for pharmaceuticals or direct stimulation. The studies will be basic research with the focus of accelerating the discovery pathway towards therapy development.

We are working with the National Center for the Advancement of Translational Sciences (NCATS) to develop human cell and tissue models with induced Pluripotent Stem Cells (iPSCs) for the study of pain pathways. Neurons are engineered from human skin biopsies allowing us to work with neurons from human patients. These neurons can also be combined with other engineered cell types to develop human tissue chips and “organoids” with potential structure and function. These techniques allow for examination of pain pathways in human tissue and screening of large libraries of drugs and chemicals to find methods of interfering with those pathways.

NINDS is working to develop a more effective animal screening platform. The goal is to develop or refine animal models for pain conditions and validate those models. The models will then be made available to academia or industry to facilitate early testing of small molecules or devices. If successful, these molecules and devices could move into clinical trials.  

Industry partners have expressed interest in biomarkers for pain to inform phase 2, early stage clinical trials. When something is successful in animal models, it is moved into a well-phenotyped cohort of human pain patients. However, it is difficult to know if a drug is working as expected, or to know the proper dose or duration of treatment. An outcome measure such as a biomarker would be useful to speed the therapy development process. These would be used in phase 2 trials before moving to much more expensive phase 3 trials. Programs have been announced where we will call for grants to discover new biomarkers and validate them in multi-site studies to determine which will be most useful for the therapy development process. 

Many companies shelved pain therapy development programs, and there currently are assets that are unused or currently used for non-pain conditions with potential benefits in pain management. The effort will involve data sharing among academia and industry and asset repurposing.  Assets with therapeutic potential as determined by the discovery, animal models and validation process will move into the clinical trials network.

Dr. Clinton Wright from the NINDS division of clinical research described the development of a clinical trial network to test potential therapies.

The goal is to set up an infrastructure that will efficiently move potential assets through the clinical trials process. It would be set up as a hub and spoke design which allows trials to be started, patients to be enrolled and trials to be completed more quickly than starting a new trial individually for each asset.  Hubs will specialize and provide patients with well-defined pain conditions that have high unmet needs.  When an asset is brought into the network, a clinical trial will be run in the hub that is most appropriate for the asset. The network will be open to assets from both academia and industry. In addition, the network allows biomarkers to be included into clinical trial studies for validation. Once the clinical trials network is established, it presents the opportunity for innovative trial design with the potential for adaptive design and potentially testing combinations of assets.

Dr. Koroshetz clarified that the work on acceleration of non-addictive therapy development will be carried out as a partnership with industry. The work will be funded solely from NIH funds with in-kind resources and special expertise from private partners.

A separate initiative based on research for best practices in different pain conditions hopefully will be ready to discuss at the next IPRCC meeting.

Points of discussion:

The committee discussed the number of assets currently available and the process for using them.

  • Part of the public private partnership was a call for assets that are available in companies. The foundation for NIH has received approximately 70 compounds so far. They have not yet been characterized. This was from a first round of polling that did not include biotech or device companies. There will likely be a plethora of assets to test, but a small fraction will be run through the clinical trials network.
  • The NIH would prefer if the industry kept the IND or IDE, but in certain cases the NIH may take it over if necessary.
  • The process for categorizing which assets are ready for primetime was discussed. The process is still being finalized, but a general idea is as follows. The hope is that industry partners will be able to set up a group to advise on how to systematically characterize the assets so that each asset has a dossier of its characteristics when it comes to the NIH. The special review group will characterize, review and prioritize the assets. The top assets will be sent to the clinical coordinating center to develop a protocol. This protocol will be reviewed by the committee and executed by the clinical coordinating center. This process is designed to move quickly and have a continuous stream of assets moving through the system. Some of the hubs will be able to do multiple trials at once.

The committee discussed that the timeframe for this project is very quick. Notices are out and the funds will need to be spent by the end of fiscal year 2019.

The committee discussed how conditions were selected as “unmet needs”. There have not been specific conditions chosen, but a strategy has been suggested. The strategy is to focus on pain conditions with high unmet need rather than focusing on a drug for all pain conditions that will be taken by a large population.  These would include pain conditions in which we have a well-defined population where the therapies are widely considered inadequate, and where the asset or biomarker would match up nicely with the predicted biological process. The potential drawback of focusing on a small, specific population is that treatments may not generalize well, and the risk/benefits may not generalize, but it’s certainly a reasonable place to start.

The committee discussed the affordability of any new treatments that are developed as a result of the HEAL initiative. A problem with the rare disease approach to discovery is that it has resulted in some very effective, but expensive drugs.  The NIH’s mission is to understand the biology and support the science of therapy discovery. It is up to the marketplace, Medicare and Medicaid to assure that access is fair and uniform. Dr. Hertz commented that because the FDA is not allowed to require comparative effectiveness studies or efficacy studies when sponsors are developing new treatments, it is difficult for payers to make decisions about payment for new treatments. The FDA has had conversations with CMS and other payers about how to convey information that is useful for making decisions about coverage.

The committee discussed the FDA meeting on chronic pain patient focused drug development. There were concerns expressed at the meeting and in public comments about over-reliance on the CDC guidelines for opioid prescribing.

It was noted that there is a complicated dynamic with pain management and it is important that the best pain management possible be made available while mitigating risks of addiction. Congress has recognized that both sides of the issue are important and have made investments on both the pain and addiction sides.

 

Common Fund Program on Acute to Chronic Pain Signatures

Linda Porter, PhD, Director, NINDS Office of Pain Policy

John Satterlee, PhD, Coordinator for Trans-NIH Programs and Activities, Developmental Neuroscience Branch, NIDA

Dr. Porter introduced Dr. Satterlee.  Drs. Porter, Satterlee and Patricia Labosky from the NIH Office of Strategic Planning are working to develop and implement the common fund project on pain.

Dr. Porter described the Common Fund. It is a central pot of money that is managed by the Office of the Director and used to fund large transformative projects that are beyond the scope of a single institute. Although the Common Fund money is separate from the congressional appropriation, the Acute to Chronic Pain Signatures Common Fund project (A2CP) is part of the HEAL initiative and falls under the “Understanding the Neurobiology of Pain” objective. A trans-NIH working group has designed the project and is working to get announcements out so that projects can hopefully be funded in 2019.

In 2010 there were 51 million inpatient surgeries. Many people go on to a chronic pain state after an injury or procedure should have healed. Procedures such as Thoracotomy (52%), Breast Surgery (47%), Amputation (81%) and injuries such as fracture (41%) have relatively high rates of a transition to chronic pain. Disease states can also lead to chronic pain states such as post herpetic neuralgia from shingles (20%) and painful neuropathy from diabetes (50%) can lead to chronic pain states. Clearly, we need to understand why some people move to a chronic pain state and why some are resilient.

Dr. Satterlee described that the A2CP project is interested in patients with an acute pain event and whether they develop chronic pain or whether they might be resilient. The goal is to identify objective biosignatures that would predict that transition. If we have this type of biomarker, it could provide potentially personalized acute pain care, to treat patients and prevent them from transitioning to chronic pain. Hopefully this would reduce the use of opioids and some of the biomarkers may be useful as therapeutic targets.

Dr. Satterlee presented an overview of the project. A patient with nn acute pain event, such as surgery will be assessed at time zero, just before surgery, then again at three and six months after the event. All of the data would then be used to look for biosignatures for the transition to or resilience from chronic pain. 

From the literature, potential biomarkers fall into 5 categories:

  1. Basic patient assessments,
    • What can be gathered from electronic health records
  2. Patient reported outcomes
    • What kinds of instruments could be used to assess depression, for example
  3. Brain imaging
    • Ex, FMRI, other assays could be used
  4. Quantitative sensory testing
    • How sensitive or not are individuals to types of pain
  5. Bio-specimen analysis
    • Blood or other fluids

The goal is that several different markers could be combined to develop a biosignature that would identify people susceptible to or resilient from the transition from acute to chronic pain.

The program components will include:

  • Two multisite clinical centers, one focused on surgical and one on musculoskeletal pain - doing all assessments
  • The clinical coordinating center (CCC) will establish protocols, standardize procedures and coordinate across sites
  • The Data Integration and Resource center (DIRC) will coordinate data standards and make them available to the scientific community for mining. They will also lead the data analysis.
  • Biospecimens will be sent to the omics data generation center and the resulting data will be sent to the DIRC.

All data will be archived and made publicly available.

Discussion points:

  • There was a discussion that “care received” will include all information relevant to the procedure. This will include the administration of local anesthesia, the nature of the incision, the types of analgesics, medications and physical therapy administered. The hope is that the procedures will be the same and that the cohort will be homogeneous.

 

Pain Management Best Practices Task Force

Dr. Vanila Singh, Chief Medical Officer, Office of the Assistant Secretary, HHS

Dr. Singh is trained in molecular and cellular biology. She is board certified in pain medicine and regional anesthesia, serves on a number of editorial boards and is currently the chief medical officer in the Office of the Assistant Secretary for Health. She is the chair of the Pain Management Best Practices task force that is now working on a set of recommendations related to gaps and needs in practice guidelines for pain care.

Dr. Singh updated the committee on the activities of the task force.

CARA legislation of 2016 asked for a best-practices, interagency task force. The inaugural meeting was held on May 30, 31 2018 with a broad stakeholder group. The group included prescribers, members of the mental health community, addiction treatment community, researchers in pain, addiction and mental health. It also included state medical boards, hospital groups, veteran services organization representatives and patient advocates. The group has nine federal members representing HHS (NIH, CDC, FDA, SAMHSA, OASH), DoD, VA, ONDCP).

The purpose of the Task Force is to identify gaps and inconsistencies that exist in current best practices clinical guidelines. The Task Force is due to sunset a year after commencement when a report will be provided to Congress. The report will address the scope of pain and the neurologic processes that underlie chronic pain. It will also address acute pain, and the transition from acute to chronic pain as well as a focus on persistent pain.

The May 30 meeting included presentations from a broad sampling of people in the medical and pain community. A very important part of the meeting was a presentation of public comments in person or by phone. The public comments were varied and set the tone for the importance of the issues addressed by this task force.

HHS Secretary Azar and Assistant Secretary Giroir and the Surgeon General spoke at the meeting to highlight the importance of the task force and to assert that pain is real. Dr. Volkow gave a presentation to set the stage for the scientific landscape.

The task force also had an environmental scan of clinical guidelines at the federal, state and local levels, as well as professional societies. It provided a basis for what the taskforce members are looking at, but additional reviews and guidelines will be included as the taskforce members meet to work on the report.

The meeting also included overviews from HHS, CMS, FDA, VA and state health authorities as well as medical professional societies.  There was also a pain management provider panel and presentations from pain management professionals.

The sub-committees are currently meeting and there will be a preliminary set of guidelines at the second public meeting in September. There will then be a required 90 day public comment period and some federal clearance.

 

Healthy People 2030 and “Prevalence of chronic pain and high impact chronic pain among adults--United States, 2016”

Chad Helmick, MD, Medical Epidemiologist, Arthritis program, CDC

Dr. Helmick spoke about Healthy people 2030 update and a paper that’s coming out in September on the impact of High Impact Chronic Pain.

In 2012, the IPRCC was asked to develop the National Pain Strategy. At the same time, the Assistant Secretary for Health, Dr. Koh asked that we include chronic pain objectives in Healthy People 2020. He thought that it was important to have as part of the national objectives. 

Healthy People 2020 (HP2020) Health Objectives for the Nation

  • Attain high-quality, longer lives free of preventable disease, disability, injury and premature death.
  • Achieve health equity, eliminate disparities, and improve health of all groups.
  • Create social and physical environments that promote good health for all.
  • Promote quality of life, healthy development, and healthy behaviors across all life stages.

Four HP2020 Developmental Objectives for Pain were included:

  • Decrease the prevalence of adults having high impact chronic pain.
  • Increase self-management of high impact chronic pain.
  • Reduce impact of high impact chronic pain on family/ significant others.
  • Increase public awareness/knowledge of high impact chronic pain.

With funding from NINDS, questions defining high impact chronic pain into the 2016 and 2017 National Health Interview Survey (NHIS) were included. This means that the first objective will become a real objective for Healthy People 2020 rather than just a developmental objective. We were not able to make progress on the other three in this short period of time. The good news is that in Healthy People 2030, we are keeping the first three objectives. We are able to do this because the National Center for Health Statistics has decided to add a rotating pain module to the NHIS. That pain module has questions on self-management as well as impact on family and significant others, so we are proposing to keep these objectives for Healthy People 2030. This is a decision in progress. We have decided to drop the fourth objective. We felt that it is not possible to measure progress on increasing public awareness/knowledge because there is no current effort to change the way that people think about high impact chronic pain. We will keep it to the side and have it in reserve for the future.

Prevalence of chronic pain and high impact chronic pain among adults – U.S., 2016

We used 2016 NHIS data. The National Center for Health Statistics decided to analyze those data quickly, so we took advantage of that.

In the survey, High Impact Chronic Pain was defined with two questions.

  1. In the past six months, how often did you have pain?

Never    Some days    Most Days    Every Day

  1. Over the past six months, how often did pain limit your life or work activities?

Never    Some days    Most Days    Every Day

If you answered most days or every day for both questions, then you met the definition for high impact chronic pain.

NCHS staff and IPRCC experts used those questions as well as questions about sociodemographic and health outcomes (e.g. Psych, limitations, work, health status, visits, walking, bed days, sleep) to explore behavior of different pain definitions.

A two-pronged approach for publication was used:

  • Morbidity and Mortality Weekly Report (MMWR) is a CDC publication that is usually very fast and visible to the media. The idea is to get the basic information out to the public.
  • Article in an academic journal with more detail.

The MMWR article is scheduled for September 14, 2018. It has been led by Jim Dahlhammer from the National Center for Health Statistics. We are working on a communications plan to get out this information and communicate some of our other interests to change how people think about pain in the United States.

Points of discussion:

  • It was noted that it is appropriate that the High Impact Chronic Pain paper will be released during Pain Awareness Month and the International Association for the Study of Pain, World Congress on Pain, and that this may be useful to draw media attention.

 

AHRQ Systematic Review and Clinical Decision Support Initiatives on Pain

Ric Ricciardi, PhD, CRNP, Health Scientist, AHRQ

Dr. Ricciardi noted that in June of 2018 the Agency for Healthcare Research and Quality (AHRQ) published a comparative effectiveness review that was conducted by the Pacific Northwest Evidence Based Practice Center out of Portland, OR titled “Non-invasive, Non-pharmacological treatment for chronic pain: a systematic review,” that is available on the AHRQ website.  It looked at 6 key areas.

  1. Chronic low back pain
  2. Chronic neck pain
  3. Knee osteoarthritis
  4. Hip osteoarthritis
  5. Fibromyalgia
  6. Chronic tension headache

The review supports many of the discussions we had on multimodal pain management looking at non-invasive, non-pharmacological treatments that are part of multimodal therapy for patients that have chronic pain. There were a lot of small effects and evidence to demonstrate that many modalities such as exercise, cognitive based therapy, tai chi, chi gong or acupuncture were effective in minimizing or reducing pain in many of these chronic pain conditions.

Dr. Ricciardi also noted that AHRQ has a website that is looking to move evidence to practice through clinical decision support. AHRQ has a way of accelerating evidence through two venues: The Patient Centered Clinical Decisions Support Learning Network and CDS connect. They have contracted with the Mitre corporation to develop an online web presence that will function as a repository for clinical decision artifacts. Taking evidence, moving it through an algorithm and moving it into CDS artifacts through programmer language. It allows electronic health records vendors and other systems to take the artifacts and deploy them in such a way that it can facilitate clinical decision support at the practice level. Currently, the program is working on chronic pain to facilitate decision support through a sophisticated dashboard that you can pull up and it will show the patient, contextual factors around the patient, drugs that they’re on and side-effects associated with the drugs that they’re on, etc. It is also linked to opioid prescribing. It’s an update on moving the National Pain Strategy into practice.

Points of discussion:

  • The committee discussed the nature of “artifacts.”It was clarified that artifacts are generated when the computer programming language uses clinical and evidence-based guidelines to build algorithms which are then pushed into “programming artifacts.” These artifacts are put into a publicly accessible repository and can be used by clinical informaticists to tailor clinical decision support to an electronic health record, or into an app.
  • The group discussed that the recommendations from the AHRQ report will be very important. There is a lot of interest at the NIH for testing non-pharmacological treatments for painful conditions. It was discussed that NCCIH has been very interested in discussions of the best practices research component of the HEAL initiative, but specific discussions will need to wait for a later call.
  • Dr. Porter will send the materials that Dr. Ricciardi presented along with his contact information.

Update on Federal Pain Research Database and Portfolio Analysis

Cheryse Sankar, PhD, Senior Policy Analyst OPPP and Leah Pogorzala, PhD, Policy Analyst, OPPP

Dr. Sankar gave a brief overview of updates that have been made to the Interagency Pain Research Portfolio Database.

When the IPRCC was established it was clear that it would be helpful to conduct a portfolio analysis where we could gather the pain related research across the agencies that make up the IPRCC. This could be used to understand critical gaps in basic and clinical research and look for opportunities for expanding collaborative research. To this end the IPRCC members and the NIH Pain Consortium worked together to generate a portfolio analysis and develop a pain taxonomy that allows us to better characterize and classify pain related research grants. The taxonomy is broken down into three tiers.

Tier 1:  Basic, translation or clinical research

Tier 2: Overarching research themes and scientific categories

Tier 3: Grouped pain conditions

The value added of the pain database compared to NIH reporter, for example, is that grants are classified in a pain-relevant way.  The public database can be used to view current research and NIH staff use it internally for programmatic needs. The overview of research themes, secondary categories and pain conditions used to characterize grants in the database is available at paindatabase.nih.gov.

The Office of Pain Policy has spent the past year updating the database to make sure that it is accurate. It now has 2012 through 2016 data. FY2015-2016 are publicly available as of today. Visit the site to learn more about the ontology. Updated reports are in progress.

Dr. Pogorzala gave a brief overview of the portfolio analysis report in progress. The current report uses 2011 data and is currently being updated with 2016 data. A cursory analysis shows that there are some potentially interesting changes between 2011 and 2016 that will be explored in greater detail in the report.

Dr. Pogorzala requested that members assist with the Highlighted Pain Research Analyses. For the 2011 report, the IPRCC members volunteered to write brief one-page reports for an area of interest. Members were paired with NIH program staff and the OPP provided a detailed analysis of the topic chosen. The member was then asked to write a report detailing an overview of the portfolio, gaps, commonalities with other pain conditions and shared interests and opportunities to collaborate.

At the November meeting we will be providing an update to the FPRS which aligns very well with our portfolio analysis. Both can be viewed at IPRCC.nih.gov and paindatabase.nih.gov.

Adjourn: No public comments were submitted.

The meeting was adjourned

 

We certify that, to the best of our knowledge, the foregoing minutes are accurate and complete.

Linda Porter, PhD
Designated Federal Official
Interagency Pain Research Coordinating Committee
Director, Office of Pain Policy, National Institute of Neurological Disorders and Stroke
 
Walter Koroshetz, PhD
Chair Interagency Pain Research Coordinating Committee
Director, National Institute of Neurological Disorders and Stroke
 
These minutes have been formally approved by the committee.

IPRCC Meeting

July 9, 2018, 4:00-6:00pm ET

Note time change: Now 4pm ET
See amended Federal Register Notice

Conference call by Webex

 

AGENDA

4:00 pm Walter Koroshetz, Director NINDS, Chair IPRCC
  • Roll Call and Welcome
4:05 pm Walter Koroshetz
  • Introduction of Incoming Members and Extended Members
4:15 pm Linda Porter, Designated Federal Official, IPRCC
  • Nomination and Vote for IPRCC Chair
4:25 pm Walter Koroshetz and Nora Volkow, Director, NIDA
  • Helping to End Addiction Long-Term (HEAL) Initiative and Q and A
5:05 pm Linda Porter and John Satterlee, Developmental Neuroscience Branch Coordinator for Trans-NIH Programs and Activities
  • Common Fund Program on Acute to Chronic Pain Signatures
5:20 pm Vanila Singh, Chief Medical Officer, Office of the Assistant Secretary, HHS
  • Pain Management Best Practices Task Force
5:35 pm Chad Helmick, Medical Epidemiologist, CDC
  • Healthy People 2030 and “Prevalence of chronic pain and high impact chronic pain among adults--United States, 2016”
5:45 pm Ric Ricciardi, Health Scientist, AHRQ
  • AHRQ Systematic Review and Clinical Decision Support Initiatives on Pain
5:50 pm Cheryse Sankar, Senior Policy Analyst OPPP and Leah Pogorzala, Policy Analyst, OPPP
  • Update on Federal Pain Research Database and Portfolio Analysis

The July 9, 2018 meeting of the Interagency Pain Research Coordinating Committee (IPRCC) was convened at 4:00 p.m. as a conference call by Webex.  In accordance with Public Law 92-463, the meeting was open to the public. Walter Koroshetz, MD, Director National Institute of Neurological Disorders and Stroke (NINDS), presided as chair.

In attendance were the following members of the IPRCC:

Federal Members: Walter Koroshetz, MD; Chester Buckenmaier, MD; Charles G. Helmick, III, MD; Sharon Hertz, MD; Richard Ricciardi, PhD, CRNP; Martha J. Somerman, DDS, PhD;

Scientific Members: Roger Fillingim, PhD; Daniel Carr, MD; Judith Paice, PHD, RN; Richard Payne, MD

Public Members: Christina Spellman, PhD; Cindy Steinberg; Catherine Underwood, MBA; Michael Pasternak, PhD

Ex-Officio Members: Nora Volkow, MD, PhD; David Shurtleff, Ph.D.,

Designated Federal Official: Linda L. Porter, PhD

Ad hoc IPRCC Members: George Carter; Katherine Hammitt; Gwenn Herman; Robert Kerns, PhD; David Clark, MD, PhD

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