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.

Considerations for Lumbar Medial Branch Nerve Radiofrequency at Spinal Motion Segments Adjacent to a Fusion Construct.

Instrumented lumbar spinal fusion is common and results in biomechanical changes at adjacent spinal segments that increase facet load bearing. This can cause facet-mediated pain at levels adjacent to the surgical construct. Medial branch nerve radiofrequency ablation (RFA) exists as a treatment for some cases. It is important to acknowledge that the approach and instrumentation used during some specific lumbar fusion approaches will disrupt the medial branch nerve(s). Thus, the proceduralist must consider the fusion approach when determining which medial branch nerves are necessary to anesthetize for diagnosis and then to potentially target with RFA. This article discusses the relevant technical considerations for preparing for RFA to denervate lumbosacral facet joints adjacent to fusion constructs.

A Standardized Emergency Department Order Set Decreases Admission Rates and In-Patient Length of Stay for Adults Patients with Sickle Cell Disease.

INTRODUCTION: Pain associated with sickle cell disease (SCD) causes severe complications and frequent presentation to the emergency department (ED). Patients with SCD frequently report inadequate pain treatment in the ED, resulting in hospital admission. A retrospective analysis was conducted to assess a quality improvement project to standardize ED care for patients presenting with pain associated with SCD. METHODS: A 3-year prospective quality improvement initiative was performed. Our multidisciplinary team of providers implemented an ED order set in 2019 to improve care and provide adequate analgesia management. Our primary outcome was the overall hospital admission rate for patients after the intervention. Secondary outcome measures included ED disposition, rate of return to the ED within 72 hours, ED pain scores at admission and discharge, ED treatment time, in-patient length of stay, non-opioid medication use, and opioid medication use. RESULTS: There was an overall 67% reduction in the hospital admission rate after implementation of the order set (P = 0.005) and a significant decrease in the percentage admission rate month over month (P = 0.047). Time to the first non-opioid analgesic decreased by 71 minutes (P > 0.001), and there was no change in time to the first opioid medication. The rate of return to the ED within 72 hours remained unchanged (7.0% vs 7.1%) (P = 0.93), and the ED elopement rate remained unchanged (1.3% vs 1.85%) (P = 0.93). After the implementation, there were significant increases in the prescribing of orally administered acetaminophen (7%), celecoxib (1.2%), and tizanidine (12.5%) and intravenous ketamine (30.5%) and ketorolac (27%). ED pain scores at discharge were unchanged for both hospital-admitted (7.12 vs 7.08) (P = 0.93) and non-admitted (5.51 vs 6.11) (P = 0.27) patients. The resulting potential cost reduction was determined to be $193,440 during the 12-month observation period, with the mean cost per visit decreasing by $792. CONCLUSIONS: Use of a standardized and multimodal ED order set reduced hospital admission rates and the timeliness of analgesia without negatively impacting patients' pain.

Return to Play Following COVID-19 Infection-A Systematic Review of Current Evidence.

CONTEXT: The COVID-19 pandemic has had catastrophic impact on a global scale, affecting people from all walks of life including elite athletes. OBJECTIVES: The purpose of this study was to evaluate the reported rates of return to play (RTP) in conjunction with the expert-derived guidelines previously recommended to enable safe RTP post COVID-19 infection. EVIDENCE ACQUISITION: Two independent reviewers searched the literature based on Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, utilizing the MEDLINE, Embase, and Scopus databases. Only studies that reported rates of RTP and/or recommended guidelines for safe RTP were included. EVIDENCE SYNTHESIS: Overall, 17 studies (3 level III and 14 level V) were included. A total of 3 studies reported rates of RTP in a total of 1255 athletes and 623 officials; 72 (30 symptomatic) were infected with COVID-19, 100% of whom were able to RTP post COVID-19 infection. Of the 14 studies recommending guidelines for safe RTP, 3 and 9 studies recommended 7 and 14 days of rest in isolation respectively for asymptomatic patients with COVID-19 infection, prior to safe RTP. In contrast, 7 studies recommended 3 to 6 months of rest (following 14 d isolation) in cases of COVID-19-induced myocarditis as a safe timeframe for safe RTP. Of the 11 studies reporting on whether blanket testing prior to RTP was recommended, only 7 studies recommended a negative test result as mandatory prior to RTP for athletes previously infected with COVID-19. CONCLUSIONS: Although excellent rates of RTP have been reported for elite athletes post COVID-19 infection, discrepancies in recommended rest periods, requirement for mandatory negative test results, and the magnitude of screening investigations required continue to exist in the literature, with a need for further standardized international guidelines required in future. LEVEL OF EVIDENCE: Level V; systematic review of all forms of evidence.

Implementation of Individualized Pain Care Plans Decreases Length of Stay and Hospital Admission Rates for High Utilizing Adults with Sickle Cell Disease.

OBJECTIVE: Patients with sickle cell disease (SCD) face inconsistent effective analgesic management, leading to high inpatient healthcare utilization and significant financial burden for healthcare institutions. Current evidence does not provide guidance for inpatient management of acute pain in adults with sickle cell disease. We conducted a retrospective analysis of a longitudinal cohort quality improvement project to characterize the role of individualized care plans on improving patient care and reducing financial burden in high healthcare-utilizing patients with SCD-related pain. METHODS: Individualized care plans were developed for patients with hospital admissions resulting from pain associated with sickle cell disease. A 2-year prospective longitudinal cohort quality improvement project was performed and retrospectively analyzed. Primary outcome measure was duration of hospitalization. Secondary outcome measures included: pain intensity; 7, 30, and 90-day readmission rates; cost per day; total admissions; total cost per year; analgesic regimen at index admission; and discharge disposition. RESULTS: Duration of hospitalization, the primary outcome, significantly decreased by 1.23 days with no worsening of pain intensity scores. Seven-day readmission decreased by 34%. Use of intravenous hydromorphone significantly decreased by 25%. The potential cost saving was $1,398,827 as a result of this quality initiative. CONCLUSIONS: Implementation of individualized care plans reduced both admission rate and financial burden of high utilizing patients. Importantly, pain outcomes were not diminished. Results suggest that individualized care plans are a promising strategy for managing acute pain crisis in adult sickle cell patients from both care-focused and utilization outcomes.

Consensus practice guidelines on interventions for cervical spine (facet) joint pain from a multispecialty international working group.

BACKGROUND: The past two decades have witnessed a surge in the use of cervical spine joint procedures including joint injections, nerve blocks and radiofrequency ablation to treat chronic neck pain, yet many aspects of the procedures remain controversial. METHODS: In August 2020, the American Society of Regional Anesthesia and Pain Medicine and the American Academy of Pain Medicine approved and charged the Cervical Joint Working Group to develop neck pain guidelines. Eighteen stakeholder societies were identified, and formal request-for-participation and member nomination letters were sent to those organizations. Participating entities selected panel members and an ad hoc steering committee selected preliminary questions, which were then revised by the full committee. Each question was assigned to a module composed of 4-5 members, who worked with the Subcommittee Lead and the Committee Chairs on preliminary versions, which were sent to the full committee after revisions. We used a modified Delphi method whereby the questions were sent to the committee en bloc and comments were returned in a non-blinded fashion to the Chairs, who incorporated the comments and sent out revised versions until consensus was reached. Before commencing, it was agreed that a recommendation would be noted with >50% agreement among committee members, but a consensus recommendation would require ≥75% agreement. RESULTS: Twenty questions were selected, with 100% consensus achieved in committee on 17 topics. Among participating organizations, 14 of 15 that voted approved or supported the guidelines en bloc, with 14 questions being approved with no dissensions or abstentions. Specific questions addressed included the value of clinical presentation and imaging in selecting patients for procedures, whether conservative treatment should be used before injections, whether imaging is necessary for blocks, diagnostic and prognostic value of medial branch blocks and intra-articular joint injections, the effects of sedation and injectate volume on validity, whether facet blocks have therapeutic value, what the ideal cut-off value is for designating a block as positive, how many blocks should be performed before radiofrequency ablation, the orientation of electrodes, whether larger lesions translate into higher success rates, whether stimulation should be used before radiofrequency ablation, how best to mitigate complication risks, if different standards should be applied to clinical practice and trials, and the indications for repeating radiofrequency ablation. CONCLUSIONS: Cervical medial branch radiofrequency ablation may provide benefit to well-selected individuals, with medial branch blocks being more predictive than intra-articular injections. More stringent selection criteria are likely to improve denervation outcomes, but at the expense of false-negatives (ie, lower overall success rate). Clinical trials should be tailored based on objectives, and selection criteria for some may be more stringent than what is ideal in clinical practice.

The Use of Contrast Agents in Interventional Pain Procedures: A Multispecialty and Multisociety Practice Advisory on Nephrogenic Systemic Fibrosis, Gadolinium Deposition in the Brain, Encephalopathy After Unintentional Intrathecal Gadolinium Injection, and Hypersensitivity Reactions.

This Practice Advisory presents a comprehensive and evidence-based set of position statements and recommendations for the use of contrast media in interventional pain procedures. The advisory was established by an international panel of experts under the auspices of 11 multinational and multispecialty organizations based on a comprehensive review of the literature up to December 31, 2019. The advisory discusses the risks of using gadolinium-based contrast agents. These include nephrogenic systemic fibrosis, gadolinium brain deposition/retention, and encephalopathy and death after an unintentional intrathecal gadolinium injection. The advisory provides recommendations on the selection of a specific gadolinium-based contrast agent in patients with renal insufficiency, those who had multiple gadolinium-enhanced magnetic resonance imaging examinations, and in cases of paraspinal injections. Additionally, recommendations are made for patients who have a history of mild, moderate, or severe hypersensitivity reactions to contrast medium.

Primary Care Clinicians' Beliefs and Strategies for Managing Chronic Pain in an Era of a National Opioid Epidemic.

BACKGROUND: Little is known about how primary care clinicians (PCCs) approach chronic pain management in the current climate of rapidly changing guidelines and the growing body of research about risks and benefits of opioid therapy. OBJECTIVE: To better understand PCCs' approaches to managing patients with chronic pain and explore implications for technological and administrative interventions. DESIGN: We conducted adapted critical decision method interviews with 20 PCCs. Each PCC participated in 1-5 interviews. PARTICIPANTS: PCCs interviewed had a mean of 14 years of experience. They were sampled from 13 different clinics in rural, suburban, and urban health settings across the state of Indiana. APPROACH: Interviews included discussion of participants' general approach to managing chronic pain, as well as in-depth discussion of specific patients with chronic pain. Interviews were audio recorded. Transcripts were analyzed thematically. KEY RESULTS: PCCs reflected on strategies they use to encourage and motivate patients. We identified four associated strategic themes: (1) developing trust, (2) eliciting information from the patient, (3) diverting attention from pain to function, and (4) articulating realistic goals for the patient. In discussion of chronic pain management, PCCs often explained their beliefs about opioid therapy. Three themes emerged: (1) Opioid use tends to reduce function, (2) Opioids are often not effective for long-term pain treatment, and (3) Response to pain and opioids is highly variable. CONCLUSIONS: PCC beliefs about opioid therapy generally align with the clinical evidence, but may have some important gaps. These findings suggest the potential value of interventions that include improved access to research findings; organizational changes to support PCCs in spending time with patients to develop rapport and trust, elicit information about pain, and manage patient expectations; and the need for innovative clinical cognitive support.

AAAPT Diagnostic Criteria for Acute Low Back Pain with and Without Lower Extremity Pain.

OBJECTIVE: Low back pain is one of the most common reasons for which people visit their doctor. Between 12% and 15% of the US population seek care for spine pain each year, with associated costs exceeding $200 billion. Up to 80% of adults will experience acute low back pain at some point in their lives. This staggering prevalence supports the need for increased research to support tailored clinical care of low back pain. This work proposes a multidimensional conceptual taxonomy. METHODS: A multidisciplinary task force of the ACTTION-APS-AAPM Pain Taxonomy (AAAPT) with clinical and research expertise performed a focused review and analysis, applying the AAAPT five-dimensional framework to acute low back pain. RESULTS: Application of the AAAPT framework yielded the following: 1) Core Criteria: location, timing, and severity of acute low back pain were defined; 2) Common Features: character and expected trajectories were established in relevant subgroups, and common pain assessment tools were identified; 3) Modulating Factors: biological, psychological, and social factors that modulate interindividual variability were delineated; 4) Impact/Functional Consequences: domains of impact were outlined and defined; 5) Neurobiological Mechanisms: putative mechanisms were specified including nerve injury, inflammation, peripheral and central sensitization, and affective and social processing of acute low back pain. CONCLUSIONS: The goal of applying the AAAPT taxonomy to acute low back pain is to improve its assessment through a defined evidence and consensus-driven structure. The criteria proposed will enable more rigorous meta-analyses and promote more generalizable studies of interindividual variation in acute low back pain and its potential underlying mechanisms.

American Society for Enhanced Recovery and Perioperative Quality Initiative-4 Joint Consensus Statement on Persistent Postoperative Opioid Use: Definition, Incidence, Risk Factors, and Health Care System Initiatives.

Persistent postoperative opioid use is thought to contribute to the ongoing opioid epidemic in the United States. However, efforts to study and address the issue have been stymied by the lack of a standard definition, which has also hampered efforts to measure the incidence of and risk factors for persistent postoperative opioid use. The objective of this systematic review is to (1) determine a clinically relevant definition of persistent postoperative opioid use, and (2) characterize its incidence and risk factors for several common surgeries. Our approach leveraged a group of international experts from the Perioperative Quality Initiative-4, a consensus-building conference that included representation from anesthesiology, surgery, and nursing. A search of the medical literature yielded 46 articles addressing persistent postoperative opioid use in adults after arthroplasty, abdominopelvic surgery, spine surgery, thoracic surgery, mastectomy, and thoracic surgery. In opioid-naïve patients, the overall incidence ranged from 2% to 6% based on moderate-level evidence. However, patients who use opioids preoperatively had an incidence of >30%. Preoperative opioid use, depression, factors associated with the diagnosis of substance use disorder, preoperative pain, and tobacco use were reported risk factors. In addition, while anxiety, sex, and psychotropic prescription are associated with persistent postoperative opioid use, these reports are based on lower level evidence. While few articles addressed the health policy or prescriber characteristics that influence persistent postoperative opioid use, efforts to modify prescriber behaviors and health system characteristics are likely to have success in reducing persistent postoperative opioid use.

Preferential Disruption of Auditory Word Representations in Primary Progressive Aphasia With the Neuropathology of FTLD-TDP Type A.

Four patients with primary progressive aphasia displayed a greater deficit in understanding words they heard than words they read, and a further deficiency in naming objects orally rather than in writing. All four had frontotemporal lobar degeneration-transactive response DNA binding protein Type A neuropathology, three determined postmortem and one surmised on the basis of granulin gene (GRN) mutation. These features of language impairment are not characteristic of any currently recognized primary progressive aphasia variant. They can be operationalized as manifestations of dysfunction centered on a putative auditory word-form area located in the superior temporal gyrus of the left hemisphere. The small size of our sample makes the conclusions related to underlying pathology and auditory word-form area dysfunction tentative. Nonetheless, a deeper assessment of such patients may clarify the nature of pathways that link modality-specific word-form information to the associations that mediate their recognition as concepts. From a practical point of view, the identification of these features in patients with primary progressive aphasia should help in the design of therapeutic interventions where written communication modalities are promoted to circumvent some of the oral communication deficits.

Re-assessing the Validity of the Opioid Risk Tool in a Tertiary Academic Pain Management Center Population.

OBJECTIVE: To analyze the validity of the Opioid Risk Tool (ORT) in a large. diverse population. DESIGN: A cross-sectional descriptive study. SETTING: Academic tertiary pain management center. SUBJECTS: A total of 225 consecutive new patients, aged 18 years or older. METHODS: Data collection included demographics, ORT scores, aberrant behaviors, pain intensity scores, opioid type and dose, smoking status, employment, and marital status. RESULTS: In this population, we were not able to replicate the findings of the initial ORT study. Self-report was no better than chance in predicting those who would have an opioid aberrant behavior. The ORT risk variables did not predict aberrant behaviors in either gender group. There was significant disparity in the scores between self-reported ORT and the ORT supplemented with medical record data (enhanced ORT). Using the enhanced ORT, high-risk patients were 2.5 times more likely to have an aberrant behavior than the low-risk group. The only risk variable associated with aberrant behavior was personal history of prescription drug misuse. CONCLUSIONS: The self-report ORT was not a valid test for the prediction of future aberrant behaviors in this academic pain management population. The original risk categories (low, medium, high) were not supported in the either the self-reported version or the enhanced version; however, the enhanced data were able to differentiate between high- and low-risk patients. Unfortunately, without technological automation, the enhanced ORT suffers from practical limitations. The self-report ORT may not be a valid tool in current pain populations; however, modification into a binary (high/low) score system needs further study.

Functional Connectivity is Reduced in Early-stage Primary Progressive Aphasia When Atrophy is not Prominent.

Primary progressive aphasia (PPA) is a clinical syndrome of language decline caused by neurodegenerative pathology. Although language impairments in PPA are typically localized via the morphometric assessment of atrophy, functional changes may accompany or even precede detectable structural alterations, in which case resting state functional connectivity (RSFC) could provide an alternative approach. The goal of this study was to determine whether language network RSFC is reduced in early-stage PPA when atrophy is not prominent. We identified 10 individuals with early-stage agrammatic variant of PPA with no prominent cortical thinning compared with nonaphasic controls. RSFC between 2 nodes of the language network and 2 nodes of the default mode network were compared between agrammatic variant of PPA and healthy control participants. Language network connectivity was comparable with controls among patients with milder agrammatism, but was significantly reduced in patients with more pronounced agrammatism. No group differences were observed in default mode network connectivity, demonstrating specificity of findings. In early stages of PPA when cortical atrophy is not prominent, RSFC provides an alternative method for probing the neuroanatomic substrates of language impairment. RSFC may be of particular utility in studies on early interventions for neurodegenerative disease, either to identify anatomic targets for intervention or as an outcome measure of therapeutic efficacy.

Alternatives to Opioids in the Pharmacologic Management of Chronic Pain Syndromes: A Narrative Review of Randomized, Controlled, and Blinded Clinical Trials.

Chronic pain exerts a tremendous burden on individuals and societies. If one views chronic pain as a single disease entity, then it is the most common and costly medical condition. At present, medical professionals who treat patients in chronic pain are recommended to provide comprehensive and multidisciplinary treatments, which may include pharmacotherapy. Many providers use nonopioid medications to treat chronic pain; however, for some patients, opioid analgesics are the exclusive treatment of chronic pain. However, there is currently an epidemic of opioid use in the United States, and recent guidelines from the Centers for Disease Control (CDC) have recommended that the use of opioids for nonmalignant chronic pain be used only in certain circumstances. The goal of this review was to report the current body of evidence-based medicine gained from prospective, randomized-controlled, blinded studies on the use of nonopioid analgesics for the most common noncancer chronic pain conditions. A total of 9566 studies were obtained during literature searches, and 271 of these met inclusion for this review. Overall, while many nonopioid analgesics have been found to be effective in reducing pain for many chronic pain conditions, it is evident that the number of high-quality studies is lacking, and the effect sizes noted in many studies are not considered to be clinically significant despite statistical significance. More research is needed to determine effective and mechanism-based treatments for the chronic pain syndromes discussed in this review. Utilization of rigorous and homogeneous research methodology would likely allow for better consistency and reproducibility, which is of utmost importance in guiding evidence-based care.

The ACTTION-APS-AAPM Pain Taxonomy (AAAPT) Multidimensional Approach to Classifying Acute Pain Conditions.

Objective: With the increasing societal awareness of the prevalence and impact of acute pain, there is a need to develop an acute pain classification system that both reflects contemporary mechanistic insights and helps guide future research and treatment. Existing classifications of acute pain conditions are limiting, with a predominant focus on the sensory experience (e.g., pain intensity) and pharmacologic consumption. Consequently, there is a need to more broadly characterize and classify the multidimensional experience of acute pain. Setting: Consensus report following expert panel involving the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION), American Pain Society (APS), and American Academy of Pain Medicine (AAPM). Methods: As a complement to a taxonomy recently developed for chronic pain, the ACTTION public-private partnership with the US Food and Drug Administration, the APS, and the AAPM convened a consensus meeting of experts to develop an acute pain taxonomy using prevailing evidence. Key issues pertaining to the distinct nature of acute pain are presented followed by the agreed-upon taxonomy. The ACTTION-APS-AAPM Acute Pain Taxonomy will include the following dimensions: 1) core criteria, 2) common features, 3) modulating factors, 4) impact/functional consequences, and 5) putative pathophysiologic pain mechanisms. Future efforts will consist of working groups utilizing this taxonomy to develop diagnostic criteria for a comprehensive set of acute pain conditions. Perspective: The ACTTION-APS-AAPM Acute Pain Taxonomy (AAAPT) is a multidimensional acute pain classification system designed to classify acute pain along the following dimensions: 1) core criteria, 2) common features, 3) modulating factors, 4) impact/functional consequences, and 5) putative pathophysiologic pain mechanisms. Conclusions: Significant numbers of patients still suffer from significant acute pain, despite the advent of modern multimodal analgesic strategies. Mismanaged acute pain has a broad societal impact as significant numbers of patients may progress to suffer from chronic pain. An acute pain taxonomy provides a much-needed standardization of clinical diagnostic criteria, which benefits clinical care, research, education, and public policy. For the purposes of the present taxonomy, acute pain is considered to last up to seven days, with prolongation to 30 days being common. The current understanding of acute pain mechanisms poorly differentiates between acute and chronic pain and is often insufficient to distinguish among many types of acute pain conditions. Given the usefulness of the AAPT multidimensional framework, the AAAPT undertook a similar approach to organizing various acute pain conditions.

Eye movements as probes of lexico-semantic processing in a patient with primary progressive aphasia.

Eye movement trajectories during a verbally cued object search task were used as probes of lexico-semantic associations in an anomic patient with primary progressive aphasia. Visual search was normal on trials where the target object could be named but became lengthy and inefficient on trials where the object failed to be named. The abnormality was most profound if the noun denoting the object could not be recognized. Even trials where the name of the target object was recognized but not retrieved triggered abnormal eye movements, demonstrating that retrieval failures can have underlying associative components despite intact comprehension of the corresponding noun.