Serving as an Efficient and Effective Steward of Public Resources
Improving Women’s Health and Minority Health, and Eliminating Health Disparities
Women and underserved groups, including racial and ethnic minorities and sexual and gender minorities, have distinct health needs and often experience disparities in health outcomes. Individuals with low socioeconomic status, or who live in rural communities, also often experience such disparities. NCCIH maintains that women, racial and ethnic minorities, rural populations, low-income populations, sexual and gender minorities, and other populations experiencing health disparities should be included in all relevant research, such that there is sufficient representation of each population to conduct relevant analyses. Inclusivity in research generates more broadly applicable information and improves scientific understanding of the health and well-being of specific population groups.
NCCIH is committed to funding research with diverse populations and promoting a diverse scientific workforce. We support training, career development, and research opportunities directed at minority health and health disparities.
Health Disparities Research
NCCIH seeks to expand the research we support involving understudied, underrepresented, and underreported populations. We participate in initiatives targeted toward these populations and are currently supporting research to explore the development, feasibility, optimization, and efficacy of complementary and integrative health interventions within health disparity populations. NIH-designated health disparity populations include racial and ethnic minorities (Blacks/African Americans, Hispanics/Latinos, American Indians/Alaska Natives, Asian Americans, and Native Hawaiians and other Pacific Islanders), sexual and gender minorities, socioeconomically disadvantaged populations, and underserved rural populations. Other vulnerable populations of interest to NCCIH include pregnant and lactating women; homeless youth; children with disabilities; children who have experienced abuse; veterans; military personnel; and military families. In addition, we encourage research in these populations through outreach activities. For example, NCCIH cosponsored the NIH 2019 Traditional Medicine Summit with the NIH Tribal Health Research Office. The goals of this summit were to identify approaches to respectful collaboration between traditional medicine practitioners and health researchers; explore the relationships between traditional medicine and health care services; and connect younger generations of American Indian/Alaska Native people to traditional medicine, integrative health research, and academic research. We plan to continue expanding these efforts.
Specifically, NCCIH will:
- Support community-engaged research on the efficacy and effectiveness of complementary and integrative health approaches for improving minority health and eliminating disparities in mental, emotional, and behavioral health, obesity, and pain.
- Promote research on the use of complementary and integrative health approaches for health promotion and restoration, resilience, disease prevention, and symptom management to address the role of social and structural determinants of health.
- Conduct research to test implementation strategies aimed at improving uptake, scale-up, and sustainability of evidence-based interventions among health disparity populations and in low-resource settings.
- Foster research collaborations between research-intensive institutions and institutions that have a historical mission or a demonstrated commitment to educating students from groups underrepresented in the biomedical research workforce.
- Facilitate research collaborations among health disparities researchers and complementary and integrative health researchers.
- Partner with other NIH Institutes, Centers, and Offices to support interventions that address multiple levels of influence (e.g., individual, community, societal) on health outcomes and target co-occurring conditions among underserved populations.
- Serve as a catalyst in the dissemination of innovative and evidence-based health disparities research and scientific opportunities to our stakeholders.
Women’s Health Research
Signed into law on December 13, 2016, the 21st Century Cures Act (Public Law No. 114-255) reaffirms NIH’s commitment to women’s health. Specifically, the Act endorses the importance of including women in clinical research and considering sex as a biological variable in research using humans and nonhuman vertebrate animals. Further, the Act requires that people of all ages be represented in clinical research, expands sex- and gender-based and race- and ethnicity-based results reporting requirements for phase 3 clinical trials, and incorporates changes to encourage research collaboration among NIH Institutes, Centers, and Offices, with the goal of improving the health of all people (https://www.nih.gov/research-training/medical-research-initiatives/cures).
The 2017 National Health Interview Survey showed that women were more than twice as likely to use yoga compared with men (19.8 percent versus 8.6 percent). Women were also more likely than men to use meditation (16.3 percent versus 11.8 percent) and see a chiropractor (11.1 percent versus 9.4 percent). Women may also use natural products to improve their health during their lifespan, including during pregnancy and lactation.
NCCIH will continue to further research on women’s health and sex as a biological variable by:
- Developing and testing interventions using complementary health approaches for managing symptoms such as perinatal and postpartum depression, stress, anxiety, pain, and sleep disturbance and assessing their impact on maternal health outcomes.
- Supporting research on the use of complementary health approaches to support pregnant and parenting women with opioid use disorder.
- Supporting research on the contributions of sex, gender, and the intersection of sex and gender on the mechanisms of action of complex interventions including various mind and body approaches and natural products.
- Conducting research that investigates the influence of sex and gender on use of complementary health approaches to improve health outcomes among diverse populations, including gender-diverse populations.
Foster Discovery and Innovation by Setting Priorities and Enhancing Stewardship
NCCIH strives to invest in research that will drive new discoveries to lead to improved public health and health care. The Center’s research priorities reflect public health needs, scientific promise, amenability of topics to rigorous scientific inquiry, potential to impact health care practices, and relationship to use and practice.
The relative burden of a disease or condition on human health and well-being is an important consideration for priority setting. According to the Institute for Health Metrics and Evaluation, the top five leading causes of years lived in less than ideal health include low-back and neck pain, other musculoskeletal disorders, depressive disorders, and anxiety disorders. Complementary and integrative health approaches have shown promise in treating and managing these conditions, but additional research is needed to identify and optimize beneficial interventions.
The U.S. population at large is in an alarmingly poor overall state of health and is seeing a decline in life expectancy2, with many people suffering from co-occurring chronic diseases such as obesity, diabetes, cardiovascular disease, and degenerative joint disease. Many of these chronic diseases are not only linked to the epidemics of chronic pain, depression, opioid addiction, and suicide but also share common roots, such as poor diet, sedentary lifestyle, and chronic stress. Racial and ethnic minorities are often diagnosed with many of these chronic diseases at a higher rate than non-Hispanic Whites3. In the COVID-19 pandemic, we saw in real time an example of why this is important: although severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causes a respiratory infection, chronic conditions in other body systems (e.g., diabetes, hypertension) are important factors in its severity and mortality. And while there have been many advances in science and medicine, they tend to remain siloed within one disease or organ system. A focus on whole person research will bring these scientific disciplines together to treat the whole person and to improve and restore health.
NCCIH has also made pain management a major emphasis in its research efforts. Pain is a major public health problem and is the most common reason why Americans use complementary and integrative health practices. Data from the 2012 National Health Interview Survey estimated that 126.1 million adults reported some pain in the previous 3 months, with 25.3 million adults (11.2 percent) suffering from daily (chronic) pain and 23.4 million (10.3 percent) reporting a lot of pain. Conventional care often fails to manage chronic pain effectively, and other approaches to relieve or reduce pain and increase functional ability are needed. Research studies have shown that some complementary health modalities may reduce pain associated with some chronic conditions: examples include massage, spinal manipulation, and yoga for chronic back pain, and tai chi for fibromyalgia pain.
2Murphy SL, Xu J, Kochanek KD, et al. Mortality in the United States, 2017. NCHS Data Brief. 2018;(328):1-8.
3Woolf SH, Schoomaker H. Life expectancy and mortality rates in the United States, 1959-2017. JAMA. 2019;322(20):1996-2016.
Scientific Plausibility and Rigor
NCCIH strives to invest in research that will drive new discoveries and focuses on areas that will have the greatest impact by prioritizing research topics that show scientific opportunity and promise and are amenable to rigorous scientific inquiry. No matter how interesting an approach may be, if the evidence favoring it is too limited to support the scope and direction of a proposed study, or if reliable, rigorous methods of measurement do not exist, that topic is not suitable for a full-scale investigation.
As a responsible steward of its publicly provided resources, NCCIH is highly selective in the choice of topics for major clinical trials. Decisions about which large-scale trials to support must be based on the strength, reliability, and reproducibility of signals from clinical experience and preliminary, smaller pilot studies, as well as on evidence of scientific plausibility obtained from mechanistic studies. Adequate methods and tools to measure clinical outcomes accurately and effectively are equally important to sound research design. Objective, validated measurement tools are essential, and so are processes and procedures to ensure quality control, whether the intervention is physical, psychological, nutritional, or a combination. For example, NCCIH has developed a strict natural product integrity policy to ensure that natural products used in research supported by the Center are fully identified, characterized, and standardized.
Priority Setting Framework
NCCIH is committed to funding research in areas that will have an impact on health and health care. When considering funding a potential research project, the Center assesses whether it is reasonably likely that the results of the research could lead to changes in the health practices of individuals or health care providers or in the decisions of health policymakers. The Center also considers whether the research addresses an important public health concern or need for scientific information regarding the mechanism of action, safety, efficacy, or effectiveness of complementary and integrative health approaches.
- Scientific Promise
- Does a reasonable body of evidence support the potential of the proposed research to lead to improved (1) options or strategies to treat health conditions or symptoms or (2) approaches to promote disease prevention, health promotion, resilience, or health restoration?
- Is evidence sufficient to support the scope and directions of the proposed research? If not, what research is needed to establish such evidence?
- Amenability to Rigorous Scientific Inquiry
- Are the key research goals achievable, and are the key research questions amenable to rigorous scientific investigation, given needed and available methods for measurement, translational tools, and technologies?
- Are potential approaches feasible and scientifically plausible? Do they lend themselves to rigorous quality control? If not, does the proposed research focus appropriately on developing needed methods, tools, and technologies?
- Potential to Change Health Practices
- Is it reasonably likely that the results of the research or program could lead to changes in the health practices of individuals or health care providers or in the decisions of health policymakers?
- Relationship to Use and Practice
- Does the proposed project address an important public health concern or scientific information need regarding the fundamental mechanism, efficacy, safety, or public use of complementary health approaches?
To fulfill its mission and leverage its research investments, NCCIH collaborates with other NIH Institutes, Centers, and Offices; other Federal agencies; professional societies; patient advocacy groups; and organizations with an interest in furthering our understanding of complementary approaches and their integration into health care with the goal of improving health. Through these collaborations, NCCIH enhances its research portfolio, expands its multidisciplinary expertise, and incorporates a broader understanding of the health needs and perspectives of the community.
Story: NCCIH Partnership With SAMHSA To Combat Opioid Use Disorder
More than 4 million people in the United States report using opioids for nonmedical purposes in the past month, and almost 2 million report symptoms consistent with an opioid use disorder (OUD). Fewer than half of those with an OUD receive treatment and even fewer receive treatment of adequate duration. The number of drug overdose deaths involving opioids has quadrupled between 1999 and 2015, to more than 33,000 annually.
Chronic pain is an important comorbidity in patients with OUD. Twenty to 30 percent of U.S. adults report chronic pain. Treatment of acute and chronic pain conditions with opioids is contributing to the OUD epidemic. Patients at increased risk of developing OUD are those with pain that is inadequately controlled, those exposed to opioids during acute pain episodes, and/or those with chronic pain and a history of substance abuse. Among patients with OUD treatment and chronic pain, barriers to actively engaging in treatment include fear of inadequately treated pain and depression. Many behavioral interventions have shown value for management of chronic pain. Recent American College of Physicians guidelines for management of chronic low-back pain include recommendations to consider interventions including mindfulness-based stress reduction, multidisciplinary rehabilitation, tai chi, yoga, progressive relaxation, operant therapy, and cognitive behavioral therapy. However, there are relatively few studies evaluating their effectiveness for the comorbidity of OUD and chronic pain. In addition, despite the proven effectiveness of medication-assisted treatment (MAT) for OUD, approximately 50 percent of people who begin methadone maintenance therapy, for example, discontinue within 12 months, and 50 percent of people retained have an opioid relapse within 6 months. Research also suggests that pain, which is highly prevalent, may be an important contributor to MAT dropout, opioid relapse, and opioid overdose.
NCCIH has partnered with the Substance Abuse and Mental Health Services Administration (SAMHSA) to study the impact of behavioral interventions for primary or secondary prevention of OUD, or as a complement to MAT of OUD. Researchers are examining whether select behavioral interventions such as mindfulness meditation, cognitive behavioral therapy, or multidisciplinary rehabilitation improve adherence to and retention in MAT or reduce resumption of drug use in individuals with OUD. NCCIH has awarded six research grants, totaling $9.4 million over 3 years. In addition to support from NCCIH, funding for these awards will come from NIH’s HEAL Initiative. The NCCIH-administered grants will support research around the treatment supported by the $1 billion SAMHSA State Targeted Response (STR) to the Opioid Crisis Grants initiative, also known as Opioid STR grants.
As part of the 21st Century Cures Act, Opioid STR grants have been distributed to all 50 U.S. states, U.S. territories, and free-associated states to expand access to evidence-based prevention, treatment, and recovery support services; reduce unmet treatment needs; and help prevent opioid overdose death. The six research awards supported by NCCIH will examine the impact of behavioral and complementary health interventions within the context of states’ plans for use of Opioid STR grant funds. As such, each of the funded research projects includes relevant state agency staff to ensure adequate input on study design from the SAMHSA-funded projects. The overarching idea of this collaboration is that researchers, health professionals, and community members all have a role in implementing evidence-based prevention and treatment strategies for OUD. In addition, this collaboration provides an opportunity to study, in a clinical setting, whether complementary approaches in combination with certain psychosocial interventions and medications can further improve treatment outcomes and/or help manage co-occurring pain.
The NCCIH Office of Administrative Management leads the Center in identifying and proactively managing risks, improving strategic decision making, increasing efficiency and effectiveness, and promoting accountability and integrity. The Center created a Risk Management Council in 2020 to ensure that we are considering risks from across the Center and developing appropriate ways to mitigate them.
Assessing Programs, Processes, Outcomes, and Impact
NCCIH uses a variety of approaches, including monitoring, performance measurement, analysis, and evaluation, to assess the progress and effectiveness of its programs, policies, and operations, and to generate information for decision making. NCCIH will follow NIH guidance in the implementation of the Foundations for Evidence-Based Policymaking Act to further develop its data-driven, results-oriented culture.
The NCCIH Office of Policy, Planning, and Evaluation often conducts portfolio analyses and evaluation of NCCIH’s programs. The Center works in conjunction with partners across NIH, including the Office of Portfolio Analysis; Office of Evaluation, Performance, and Reporting; and other NIH components.