NIH HEAL Clinical Data Elements (CDE) implementation: NIH HEAL Initiative IMPOWR network IDEA-CC.

OBJECTIVE: The National Institutes of Health (NIH) HEAL Initiative is making data findable, accessible, interoperable, and reusable (FAIR) to maximize the value of the unprecedented federal investment in pain and opioid-use disorder research. This involves standardizing the use of common data elements (CDE) for clinical research. METHODS: This work describes the process of the selection, processing, harmonization, and design constraints of CDE across a pain and opioid use disorder clinical trials network (NIH HEAL IMPOWR). RESULTS: The network alignment allowed for incorporation of newer data standards across the clinical trials. Specific advances included geographic coding (RUCA), deidentified patient identifiers (GUID), shareable clinical survey libraries (REDCap), and concept mapping to standardized concepts (UMLS). CONCLUSIONS: While complex, harmonization across a network of chronic pain and opioid use disorder clinical trials with separate interventions can be optimized through use of CDEs and data standardization processes. This standardization process will support the robust secondary data analyses. Scaling this process could standardize CDE results across interventions or disease state which could help inform insurance companies or government organizations about coverage determinations. The development of the HEAL CDE program supports connecting isolated studies and solutions to each other, but the practical aspects may be challenging for some studies to implement. Leveraging tools and technology to simplify process and create ready to use resources may support wider adoption of consistent data standards.

The Relationship Between Body Mass Index and Pain Intensity Among Veterans with Musculoskeletal Disorders: Findings from the MSD Cohort Study.

OBJECTIVE: To examine the relationship between body mass index (BMI) and pain intensity among veterans with musculoskeletal disorder diagnoses (MSDs; nontraumatic joint disorder; osteoarthritis; low back, back, and neck pain). SETTING: Administrative and electronic health record data from the Veterans Health Administration (VHA). SUBJECTS: A national cohort of US military veterans with MSDs in VHA care during 2001-2012 (N = 1,759,338). METHODS: These cross-sectional data were analyzed using hurdle negative binomial models of pain intensity as a function of BMI, adjusted for comorbidities and demographics. RESULTS: The sample had a mean age of 59.4, 95% were male, 77% were white/Non-Hispanic, 79% were overweight or obese, and 42% reported no pain at index MSD diagnosis. Overall, there was a J-shaped relationship between BMI and pain (nadir = 27 kg/m2), with the severely obese (BMI ≥ 40 kg/m2) being most likely to report any pain (OR vs normal weight = 1.23, 95% confidence interval = 1.21-1.26). The association between BMI and pain varied by MSD, with a stronger relationship in the osteoarthritis group and a less pronounced relationship in the back and low back pain groups. CONCLUSIONS: There was a high prevalence of overweight/obesity among veterans with MSD. High levels of BMI (>27 kg/m2) were associated with increased odds of pain, most markedly among veterans with osteoarthritis.

Using Virtual Human Technology to Examine Weight Bias and the Role of Patient Weight on Student Assessment of Pediatric Pain.

The purpose of the study was to investigate the influence of weight bias and demographic characteristics on the assessment of pediatric chronic pain. Weight status, race, and sex were manipulated in a series of virtual human (VH) digital images of children. Using a web-based platform, 96 undergraduate students with health care-related majors (e.g., Health Science, Nursing, Biology, and Pre-Medicine) read a clinical vignette and provided five ratings targeting the assessment of each VH child's pain. Students also answered a weight bias questionnaire. Group-based analyses were conducted to determine the influence of the VH child's weight and demographic cues, as well as greater weight bias on assessment ratings. Male and VH children with obesity were rated as more likely to avoid non-preferred activities due to pain compared to female and healthy weight children, respectively (both p < .001). The pain of VH children with obesity was rated as more likely to be influenced by psychological/behavioral issues compared to the pain of healthy weight VH children (p = .022). African American VH children were rated as experiencing significantly greater pain than Caucasian VH children (p = .037). As child weight increased, low weight bias participants felt more sympathy, while high weight bias participants felt less sympathy (p = .002). Also, low weight bias participants showed increased motivation to help, while high weight bias participants showed less motivation to help, as VH patient weight increased (p = .008). Child weight and evaluator weight bias may be influential in the assessment of pediatric pain. If supported by future research, results highlight the importance of training in evidence-based practice and education on weight bias for students majoring in health-care fields.

Developing a typology of patient-generated behavioral goals for cognitive behavioral therapy for chronic pain (CBT-CP): classification and predicting outcomes.

Patient-generated treatment goals describe what patients value, yet the content of these goals, and the relationship among goal types, goal accomplishment, and treatment outcomes has received little examination. We used inductive sorting to categorize patient-generated goals made by 147 adults receiving cognitive-behavioral therapy for chronic pain. The resulting goal categories were: Physical Activity (29.0%), Functional Status (24.6%), Wellness (16.3%), Recreational Activities (11.3%), House/Yard Work (9.7%), Socializing (7.1%), and Work/School (2.0%). Next, we examined associations between number of goals by category, goal accomplishment, and clinically meaningful improvements in pain-related interference, pain intensity and depressive symptoms. Improvement in all outcome domains was related to goal accomplishment. Additionally, depressive symptoms were related to number of Physical Activity, House/Yard Work, Recreational Activities, and Wellness goals, whereas improved pain-intensity was significantly related to House/Yard Work. Classifying patient-generated goals facilitates investigation of the relationships among goal type, goal accomplishment and treatment outcomes.

The influence of health care professional characteristics on pain management decisions.

OBJECTIVE: Evidence suggests that patient characteristics such as sex, race, and age influence the pain management decisions of health care providers. Although this signifies that patient demographics may be important determinants of health care decisions, pain-related care also may be impacted by the personal characteristics of the health care practitioner. However, the extent to which health care provider characteristics affect pain management decisions is unclear, underscoring the need for further research in this area. METHODS: A total of 154 health care providers (77 physicians, 77 dentists) viewed video vignettes of virtual human (VH) patients varying in sex, race, and age. Practitioners provided computerized ratings of VH patients' pain intensity and unpleasantness, and also reported their willingness to prescribe non-opioid and opioid analgesics for each patient. Practitioner sex, race, age, and duration of professional experience were included as predictors to determine their impact on pain management decisions. RESULTS: When assessing and treating pain, practitioner sex, race, age, and duration of experience were all significantly associated with pain management decisions. Further, the role of these characteristics differed across VH patient sex, race, and age. CONCLUSIONS: These findings suggest that pain assessment and treatment decisions may be impacted by the health care providers' demographic characteristics, effects which may contribute to pain management disparities. Future research is warranted to determine whether findings replicate in other health care disciplines and medical conditions, and identify other practitioner characteristics (e.g., culture) that may affect pain management decisions.

Challenges and opportunities for research clinicians interested in pain: results of a survey.

The National Institutes of Health and its independent advisors recognize the need to develop a strong pain research workforce and provide opportunities, particularly for clinicians, to pursue research careers. A survey was conducted to better understand the challenges facing the clinical pain research community. Respondents reported that time and funding to pursue research were the most critical factors either enabling or holding them back from a research career. Respondents who received some kind of formal research training or mentorship were more likely than those who did not to have federal research funding and to be at more advanced stages of their careers. The findings point to a need for all stakeholders in the pain research community to help formalize research training and provide funding or protected time to support the ambitions of aspiring researchers.

Comparing the clinical and cost-effectiveness of remote (telehealth and online) cognitive behavioral therapy-based treatments for high-impact chronic pain relative to usual care: study protocol for the RESOLVE multisite randomized control trial.

BACKGROUND: Cognitive behavioral therapy for chronic pain (CBT-CP) is an effective but underused treatment for high-impact chronic pain. Increased access to CBT-CP services for pain is of critical public health importance, particularly for rural and medically underserved populations who have limited access due to these services being concentrated in urban and high income areas. Making CBT-CP widely available and more affordable could reduce barriers to CBT-CP use. METHODS: As part of the National Institutes of Health Helping to End Addiction Long-term® (NIH HEAL) initiative, we designed and implemented a comparative effectiveness, 3-arm randomized control trial comparing remotely delivered telephonic/video and online CBT-CP-based services to usual care for patients with high-impact chronic pain. The RESOLVE trial is being conducted in 4 large integrated healthcare systems located in Minnesota, Georgia, Oregon, and Washington state and includes demographically diverse populations residing in urban and rural areas. The trial compares (1) an 8-session, one-on-one, professionally delivered telephonic/video CBT-CP program; and (2) a previously developed and tested 8-session online CBT-CP-based program (painTRAINER) to (3) usual care augmented by a written guide for chronic pain management. Participants are followed for 1 year post-allocation and are assessed at baseline, and 3, 6, and 12 months post-allocation. The primary outcome is minimal clinically important difference (MCID; ≥ 30% reduction) in pain severity (composite of pain intensity and pain-related interference) assessed by a modified 11-item version of the Brief Pain Inventory-Short Form at 3 months. Secondary outcomes include pain severity, pain intensity, and pain-related interference scores, quality of life measures, and patient global impression of change at 3, 6, and 12 months. Cost-effectiveness is assessed by incremental cost per additional patient with MCID in primary outcome and by cost per quality-adjusted life year achieved. Outcome assessment is blinded to group assignment. DISCUSSION: This large-scale trial provides a unique opportunity to rigorously evaluate and compare the clinical and cost-effectiveness of 2 relatively low-cost and scalable modalities for providing CBT-CP-based treatments to persons with high-impact chronic pain, including those residing in rural and other medically underserved areas with limited access to these services. TRIAL REGISTRATION: ClinicalTrials.gov NCT04523714. This trial was registered on 24 August 2020.

Developing consensus on core outcome sets of domains for acute, the transition from acute to chronic, recurrent/episodic, and chronic pain: results of the INTEGRATE-pain Delphi process.

Background: Pain is the leading cause of disability worldwide among adults and effective treatment options remain elusive. Data harmonization efforts, such as through core outcome sets (COS), could improve care by highlighting cross-cutting pain mechanisms and treatments. Existing pain-related COS often focus on specific conditions, which can hamper data harmonization across various pain states. Methods: Our objective was to develop four overarching COS of domains/subdomains (i.e., what to measure) that transcend pain conditions within different pain categories. We hosted a meeting to assess the need for these four COS in pain research and clinical practice. Potential COS domains/subdomains were identified via a systematic literature review (SLR), meeting attendees, and Delphi participants. We conducted an online, three step Delphi process to reach a consensus on domains to be included in the four final COS. Survey respondents were identified from the SLR and pain-related social networks, including multidisciplinary health care professionals, researchers, and people with lived experience (PWLE) of pain. Advisory boards consisting of COS experts and PWLE provided advice throughout the process. Findings: Domains in final COS were generally related to aspects of pain, quality of life, and physical function/activity limitations, with some differences among pain categories. This effort was the first to generate four separate, overarching COS to encourage international data harmonization within and across different pain categories. Interpretation: The adoption of the COS in research and clinical practice will facilitate comparisons and data integration around the world and across pain studies to optimize resources, expedite therapeutic discovery, and improve pain care. Funding: Innovative Medicines Initiative 2 Join Undertaking; European Union Horizon 2020 research innovation program, European Federation of Pharmaceutical Industries and Associations (EFPIA) provided funding for IMI-PainCare. RDT acknowledges grants from Esteve and TEVA.

Predicting chronic postsurgical pain: current evidence and a novel program to develop predictive biomarker signatures.

ABSTRACT: Chronic pain affects more than 50 million Americans. Treatments remain inadequate, in large part, because the pathophysiological mechanisms underlying the development of chronic pain remain poorly understood. Pain biomarkers could potentially identify and measure biological pathways and phenotypical expressions that are altered by pain, provide insight into biological treatment targets, and help identify at-risk patients who might benefit from early intervention. Biomarkers are used to diagnose, track, and treat other diseases, but no validated clinical biomarkers exist yet for chronic pain. To address this problem, the National Institutes of Health Common Fund launched the Acute to Chronic Pain Signatures (A2CPS) program to evaluate candidate biomarkers, develop them into biosignatures, and discover novel biomarkers for chronification of pain after surgery. This article discusses candidate biomarkers identified by A2CPS for evaluation, including genomic, proteomic, metabolomic, lipidomic, neuroimaging, psychophysical, psychological, and behavioral measures. Acute to Chronic Pain Signatures will provide the most comprehensive investigation of biomarkers for the transition to chronic postsurgical pain undertaken to date. Data and analytic resources generatedby A2CPS will be shared with the scientific community in hopes that other investigators will extract valuable insights beyond A2CPS's initial findings. This article will review the identified biomarkers and rationale for including them, the current state of the science on biomarkers of the transition from acute to chronic pain, gaps in the literature, and how A2CPS will address these gaps.

Predictors and Outcomes of Early vs. Later English Language Proficiency Among English Language Learners.

The development of English language learners (ELLs) was explored from kindergarten through eighth grade within a nationally representative sample of first-time kindergartners (N = 19,890). Growth curve analyses indicated that, compared to native English speakers, ELLs were rated by teachers more favorably on approaches to learning, self control, and externalizing behaviors in kindergarten and generally continued to grow in a positive direction on these social/behavioral outcomes at a steeper rate compared to their native English-speaking peers, holding other factors constant. Differences in reading and math achievement between ELLs and native English speakers varied based on the grade at which English proficiency is attained. Specifically, ELLs who were proficient in English by kindergarten entry kept pace with native English speakers in both reading and math initially and over time; ELLs who were proficient by first grade had modest gaps in reading and math achievement compared to native English speakers that closed narrowly or persisted over time; and ELLs who were not proficient by first grade had the largest initial gaps in reading and math achievement compared to native speakers but the gap narrowed over time in reading and grew over time in math. Among those whose home language is not English, acquiring English proficiency by kindergarten entry was associated with better cognitive and behavioral outcomes through eighth grade compared to taking longer to achieve proficiency. Multinomial regression analyses indicated that child, family, and school characteristics predict achieving English proficiency by kindergarten entry compared to achieving proficiency later. Results are discussed in terms of policies and practices that can support ELL children's growth and development.

NIH's Helping to End Addiction Long-termSM Initiative (NIH HEAL Initiative) Clinical Pain Management Common Data Element Program.

The Helping to End Addiction Long-term Initiative (NIH HEAL Initiative) is an aggressive trans-NIH effort to speed solutions to stem the national opioid public health crisis, including through improved pain management. Toward this end, the NIH HEAL Initiative launched a common data element (CDE) program to ensure that NIH-funded clinical pain research studies would collect data in a standardized way. NIH HEAL Initiative staff launched a process to determine which pain-related core domains should be assessed by every clinical pain study and what questionnaires are required to ensure that the data is collected uniformly. The process involved multiple literature reviews, and consultation with experts inside and outside of NIH and the investigators conducting studies funded by the initiative. Ultimately, 9 core pain domains, and questionnaires to measure them, were chosen for studies examining acute pain and chronic pain in adults and pediatric populations. These were augmented with dozens of study-specific supplemental questionnaires to enable uniform data collection methods of outcomes outside of the core domains. The selection of core domains will ensure that valuable clinical pain data generated by the initiative is standardized, useable for secondary data analysis, and useful for guiding future research, clinical practice decisions, and policymaking. PERSPECTIVE: The NIH HEAL Initiative launched a common data element program to ensure that NIH-funded clinical pain research studies would collect data in a standardized way. Nine core pain domains and questionnaires to measure them were chosen for studies examining acute pain and chronic pain in adults and pediatric populations.

Multi-Site Observational Study to Assess Biomarkers for Susceptibility or Resilience to Chronic Pain: The Acute to Chronic Pain Signatures (A2CPS) Study Protocol.

Chronic pain has become a global health problem contributing to years lived with disability and reduced quality of life. Advances in the clinical management of chronic pain have been limited due to incomplete understanding of the multiple risk factors and molecular mechanisms that contribute to the development of chronic pain. The Acute to Chronic Pain Signatures (A2CPS) Program aims to characterize the predictive nature of biomarkers (brain imaging, high-throughput molecular screening techniques, or "omics," quantitative sensory testing, patient-reported outcome assessments and functional assessments) to identify individuals who will develop chronic pain following surgical intervention. The A2CPS is a multisite observational study investigating biomarkers and collective biosignatures (a combination of several individual biomarkers) that predict susceptibility or resilience to the development of chronic pain following knee arthroplasty and thoracic surgery. This manuscript provides an overview of data collection methods and procedures designed to standardize data collection across multiple clinical sites and institutions. Pain-related biomarkers are evaluated before surgery and up to 3 months after surgery for use as predictors of patient reported outcomes 6 months after surgery. The dataset from this prospective observational study will be available for researchers internal and external to the A2CPS Consortium to advance understanding of the transition from acute to chronic postsurgical pain.

Guest editorial: Psychologists aim to HEAL the opioid and pain crises.

The opioid and pain crises affect every domain of family and community life with two million Americans living with opioid addiction, and 46,802 people dying from opioid overdoses in 2018 alone (National Center for Health Statistics, 2019). In addition, over 50 million Americans experience chronic pain, and half of those people suffer from chronic pain daily. Opioids are widely used to treat acute and chronic pain, and the lack of widespread access to nonpharmacological strategies to manage pain has contributed to the misuse of opioids. In fiscal year 2018, Congress added $500 million to the NIH's base appropriation to generate scientific solutions to the opioid and pain crises in America. The result was the Helping to End Addiction Long-Term Initiative, or NIH HEAL Initiative, a bold transagency effort. The authors of this editorial-psychologists in leadership roles in three NIH institutes- highlight several investments of the NIH HEAL Initiative, note the role of psychologists involved in HEAL, and describe the unprecedented steps the NIH is taking to harmonize data and rapidly and widely disseminate HEAL findings. (PsycInfo Database Record (c) 2020 APA, all rights reserved).

Treatment of a Large Cohort of Veterans Experiencing Musculoskeletal Disorders with Spinal Cord Stimulation in the Veterans Health Administration: Veteran Characteristics and Outcomes.

OBJECTIVE: Spinal cord stimulator (SCS) implantation is used to treat chronic pain, including painful musculoskeletal disorders (MSDs). This study examined the characteristics and outcomes of veterans receiving SCSs in Veterans Health Administration (VHA) facilities. METHODS: The sample was drawn from the MSD Cohort and limited to three MSDs with the highest number of implants (N=815,475). There were 1490 veterans with these conditions who received SCS implants from 2000 to 2012, of which 95% (n=1414) had pain intensity numeric rating scale (NRS) data both pre- and post-implant. RESULTS: Veterans who were 35-44 years old, White, and married reported higher pain NRS ratings, had comorbid inclusion diagnoses, had no medical comorbidities, had a BMI 25-29.9, or had a depressive disorder diagnosis were more likely to receive an SCS. Veterans 55+ years old or with an alcohol or substance use disorder were less likely to receive an SCS. Over 90% of those receiving an SCS were prescribed opioids in the year prior to implant. Veterans who had a presurgical pain score ≥4 had a clinically meaningful decrease in their pain score in the year following their 90-day recovery period (Day 91-456) greater than expected by chance alone. Similarly, there was a significant decrease in the percent of veterans receiving opioid therapy (92.4% vs 86.6%, p<0.0001) and a significant overall decrease in opioid dose [morphine equivalent dose per day (MEDD) =26.48 vs MEDD=22.59, p<0.0003]. CONCLUSION: Results offer evidence of benefit for some veterans with the examined conditions. Given known risks of opioid therapy, the reduction is an important potential benefit of SCS implants.

Core competencies for the emerging specialty of pain psychology.

The Institute of Medicine (IOM) has reported that approximately 100 million Americans experience chronic pain. The IOM report on pain and the subsequent National Pain Strategy (NPS) issued by the U.S. Department of Health and Human Services have both noted the educational gaps regarding pain management and highlighted the pivotal role that psychology plays in the field of pain management. Fishman and colleagues (2013) emphasized the need for all providers involved in the study and practice of pain management to acquire a common fund of knowledge and proposed a comprehensive set of core competencies that would apply across multiple professions and specialty areas (e.g., anesthesiology, nursing, and psychology). These core competencies are meant to be tailored to allow each pain-related subspecialty to incorporate the factors and competencies unique to their discipline. To date, the terms pain psychology and pain psychologist are routinely used in public discourse to refer to psychologists practicing integrated, multimodal, and multidisciplinary pain care, but the field of psychology has not yet defined this emerging specialty. It is important for the discipline itself to define these terms and for psychologists to specify the competencies that would be expected of a clinician working as a pain psychologist. The current article represents an initial effort to define the core competencies necessary to fulfill the role of a pain psychologist working in the field of pain management. (PsycINFO Database Record (c) 2019 APA, all rights reserved).

Racial and Ethnic Differences in Total Knee Arthroplasty in the Veterans Affairs Health Care System, 2001-2013.

OBJECTIVE: To examine black-white and Hispanic-white differences in total knee arthroplasty from 2001 to 2013 in a large cohort of patients diagnosed with osteoarthritis (OA) in the Veterans Affairs (VA) health care system. METHODS: Data were from the VA Musculoskeletal Disorders cohort, which includes data from electronic health records of more than 5.4 million veterans with musculoskeletal disorders diagnoses. We included white (non-Hispanic), black (non-Hispanic), and Hispanic (any race) veterans, age ≥50 years, with an OA diagnosis from 2001-2011 (n = 539,841). Veterans were followed from their first OA diagnosis until September 30, 2013. As a proxy for increased clinical severity, analyses were also conducted for a subsample restricted to those who saw an orthopedic or rheumatology specialist (n = 148,844). We used Cox proportional hazards regression to examine racial and ethnic differences in total knee arthroplasty by year of OA diagnosis, adjusting for age, sex, body mass index, physical and mental diagnoses, and pain intensity scores. RESULTS: We identified 12,087 total knee arthroplasty procedures in a sample of 473,170 white, 50,172 black, and 16,499 Hispanic veterans. In adjusted models examining black-white and Hispanic-white differences by year of OA diagnosis, total knee arthroplasty rates were lower for black than for white veterans diagnosed in all but 2 years. There were no Hispanic-white differences regardless of when diagnosis occurred. These patterns held in the specialty clinic subsample. CONCLUSION: Black-white differences in total knee arthroplasty appear to be persistent in the VA, even after controlling for potential clinical confounders.

Assessment of the Influence of Demographic and Professional Characteristics on Health Care Providers' Pain Management Decisions Using Virtual Humans.

Disparities in health care associated with patients' gender, race, and age are well documented. Previous studies using virtual human (VH) technology have demonstrated that provider characteristics may play an important role in pain management decisions. However, these studies have largely emphasized group differences. The aims of this study were to examine dentists' and physicians' use of VH characteristics when making clinical judgments (i.e., cue use) and to identify provider characteristics associated with the magnitude of the impact of these cues (ß-weights). Providers (N=152; 76 physicians, 76 dentists) viewed video vignettes of VH patients varying in gender (male/female), race (white/black), and age (younger/older). Participants rated VH patients' pain intensity and unpleasantness and then rated their own likelihood of administering non-opioid and opioid analgesics. Compared to physicians, dentists had significantly lower ß-weights associated with VH age cues for all ratings (p<0.001; d>0.69). These effects varied by provider race and gender. For pain intensity, professional differences were present only among non-white providers. White providers had greater ß-weights than non-white providers for pain unpleasantness but only among men. Provider differences regarding the use of VH age cues in non-opioid analgesic administration were present among all providers except non-white males. These findings highlight the interaction of patient and provider factors in driving clinical decision making. Although profession was related to use of VH age cues in pain-related clinical judgments, this relationship was modified by providers' personal characteristics. Additional research is needed to understand what aspects of professional training or practice may account for differences between physicians and dentists and what forms of continuing education may help to mitigate the disparities.