The NIH Pain Common Data Elements: A Great Start but a Long Way to the Finish Line.

BACKGROUND: The NIH Pain Common Data Elements (CDEs) provide a standardized framework for pain research, but their implementation and interpretation present challenges. OBJECTIVES: To review the NIH CDE Program's selected pain domains, provide best practices for implementing required questions, and offer a checklist for appropriate CDE use in clinical trials and secondary data analysis. METHODS: This work analyzed the ten core pain research domains selected by the NIH CDE Program and discuss their limitations and considerations for use. RESULTS: The manuscript provides an overview of the ten core pain research domains, including pain intensity, interference, physical function, sleep, catastrophizing, depression, anxiety, global impression of change, substance use screening, and quality of life. It offers sample scenarios for implementing required questions and presents a checklist to guide researchers in using pain CDEs effectively for clinical trials and secondary data analysis. DISCUSSION: Key challenges identified include contextual variability, lack of validation across all pain conditions and populations, and potential misuse or misinterpretation of measures. This work proposes solutions such as supplementary measures, context-specific guidance, comprehensive training programs, and ongoing refinement of the CDE framework. CONCLUSION: While NIH Pain CDEs are valuable tools for standardizing pain assessment in research, addressing challenges in their implementation and interpretation is crucial for improving the consistency, validity, and interpretability of pain research data, ultimately advancing the field and enhancing patient care.

Academic anaesthesiology: a global perspective on training, support, and future development of early career researchers.

As anaesthesiologists face increasing clinical demands and a limited and competitive funding environment for academic work, the sustainability of academic anaesthesiologists has never been more tenuous. Yet, the speciality needs academic anaesthesiologists in many roles, extending beyond routine clinical duties. Anaesthesiologist educators, researchers, and administrators are required not only to train future generations but also to lead innovation and expansion of anaesthesiology and related specialities, all to improve patient care. This group of early career researchers with geographically distinct training and practice backgrounds aim to highlight the diversity in clinical and academic training and career development pathways for anaesthesiologists globally. Although multiple routes to success exist, one common thread is the need for consistent support of strong mentors and sponsors. Moreover, to address inequitable opportunities, we emphasise the need for diversity and inclusivity through global collaboration and exchange that aims to improve access to research training and participation. We are optimistic that by focusing on these fundamental principles, we can help build a more resilient and sustainable future for academic anaesthesiologists around the world.

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.

Striatal networks for tinnitus treatment targeting.

Neuromodulation treatment effect size for bothersome tinnitus may be larger and more predictable by adopting a target selection approach guided by personalized striatal networks or functional connectivity maps. Several corticostriatal mechanisms are likely to play a role in tinnitus, including the dorsal/ventral striatum and the putamen. We examined whether significant tinnitus treatment response by deep brain stimulation (DBS) of the caudate nucleus may be related to striatal network increased functional connectivity with tinnitus networks that involve the auditory cortex or ventral cerebellum. The first study was a cross-sectional 2-by-2 factorial design (tinnitus, no tinnitus; hearing loss, normal hearing, n = 68) to define cohort level abnormal functional connectivity maps using high-field 7.0 T resting-state fMRI. The second study was a pilot case-control series (n = 2) to examine whether tinnitus modulation response to caudate tail subdivision stimulation would be contingent on individual level striatal connectivity map relationships with tinnitus networks. Resting-state fMRI identified five caudate subdivisions with abnormal cohort level functional connectivity maps. Of those, two connectivity maps exhibited increased connectivity with tinnitus networks-dorsal caudate head with Heschl's gyrus and caudate tail with the ventral cerebellum. DBS of the caudate tail in the case-series responder resulted in dramatic reductions in tinnitus severity and loudness, in contrast to the nonresponder who showed no tinnitus modulation. The individual level connectivity map of the responder was in alignment with the cohort expectation connectivity map, where the caudate tail exhibited increased connectivity with tinnitus networks, whereas the nonresponder individual level connectivity map did not.

Designing Actionable Solutions and Curriculum for Pain Disparities Education.

The Liaison Committee on Medical Education (LCME) require medical schools to teach their students how to recognize and work toward eliminating health disparities. However, time constraints and a dearth of guidance for educators in teaching pain disparities curricula pose significant challenges. Herein we describe successes and lessons learned after designing, implementing, and evaluating an innovative pain disparities curriculum that was embedded in a longitudinal health equity curriculum for third year medical school students at an academic institution. Although the curriculum was developed for medical school students, the concepts may be broadly applicable to other training settings such as residency and fellowship programs.

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.

Assessing the fear of COVID-19 scale among health care workers in Israel: a psychometric validation study.

We explored the psychometric properties of the Hebrew version of the Fear of COVID-19 (FCV-19S) scale among health care workers in a large medical center in Israel. Participants (N = 705) completed the FCV-19S scale, as well as resilience, subjective well-being, and meaning in life using validated scales. Results showed a two-factor structural model accounting for 79.33% of the total variance. Both factors were negatively associated with resilience and satisfaction with life. Results suggest the FCV-19S has good psychometric properties among health care workers and may be used to assess the effects of the pandemic in this population.

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.

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.

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.

Trends in Management of Ménière Disease: A TriNetX Network Database Analysis.

This study investigated management practices for Meniere's disease (MD) and their temporal trends from 2008 to 2022 within the TriNetX network database. Study cohort included adult patients (≥18 years) with the diagnosis of MD from TriNetX's multi-institutional medical records (n = 77,493). MD diagnosis and management were queried based on the international classification of diseases, tenth revision, current procedural terminology, and RXNorm codes. Temporal trends were analyzed using joinpoint regression. There was significant increase in rates of relevant medications prescribed within 12 months of MD diagnosis from 2008 to 2022 (annual percent change [APC]: 1.2 [95% confidence interval, CI: 0.4-1.9]). There were no significant changes in rate of intratympanic injection within 12 months of MD diagnosis (1.7 [95% CI: -1.1 to 4.5]). Rate of endolymphatic sac surgery and labyrinthectomy any time after MD diagnosis gradually decreased from 2008 to 2022 at APC of -8.1 (95% CI: -11.8 to -4.2) and -11.0 (95% CI: -14.0 to -7.7), respectively. Use of relevant medications has significantly increased during the early management of MD and the overall use of surgical treatments has decreased.

Connecting Chronic Pain and Opioid Use Disorder Clinical Trials Through Data Harmonization: Wake Forest IMPOWR Dissemination, Education, and Coordination Center (IDEA-CC).

The National Institutes of Health (NIH) has developed the NIH HEAL Integrative Management of chronic Pain and OUD for Whole Recovery (IMPOWR) network to address the interconnected nature of chronic pain (CP) and opioid use disorder (OUD), which are influenced by mental health. The network aims to develop integrated treatment pathways across multiple sites in the United States. The IMPOWR Dissemination, Education, and Coordination Center (IDEA-CC) is proposed to support the NIH HEAL IMPOWR network by developing a CP- and OUD-focused infrastructure that includes measures of stigma, trauma, and quality of life. This includes deploying a data framework to link clinical sites, developing an educational infrastructure to address stigma and health disparities, and disseminating research findings. The IDEA-CC will standardize data collection processes, develop web-based data commons, and facilitate data sharing opportunities. The IDEA-CC will support the development and validation of composite CP and OUD measures and will develop educational materials to address stigma and health disparities. Overall, the IDEA-CC will create a research community and data commons that connect NIH HEAL IMPOWR centers to translate findings and develop a key CP-OUD research data, and education infrastructure.

Cerumen impaction: Prevalence and associated factors in the United States population.

Objective: To examine the prevalence of cerumen impaction in a nationally representative sample of the US population and the association of cerumen impaction with sociodemographic factors, hearing loss, and tinnitus. Methods: The cohort included 14,230 individuals aged ≥12 years who completed otoscopy and audiometry in NHANES (2005-2016). Cerumen impaction (partial/complete) was determined by otoscopy. Hearing level was defined by speech-frequency pure-tone average (PTA). Multivariable regression analysis was performed to identify factors associated with cerumen impaction. Results: The prevalence of any cerumen impaction was 18.6% [95% CI: 17.3%-19.9%] among individuals ≥12 years and 32.4% [29.9%-35.1%] among those ≥70 years. The prevalence of bilateral partial and complete cerumen impaction was 6.3% [5.6%-7.1%] and 1.2% [1.0%-1.9%], respectively. Any cerumen impaction was associated with male sex (OR 1.77 [1.5-2.1]), identifying as Black race (vs. Caucasian, OR: 1.78 [1.5-2.9]), lower level of education (OR: 0.84 [0.71-0.98]), and older age (OR: 1.02 [1.01-1.03]). After adjusting for sociodemographic and clinical factors, complete impaction was associated with increased PTA (right ear: ß = 4.1 dB [2.4-5.8 dB], left ear: ß = 1.9 dB [0.46-3.4 dB]), but not with tinnitus. Conclusions: Cerumen impaction is highly prevalent in the US population, especially among older adults, and has disproportionate sociodemographic impacts. Complete impaction is associated with a small, statistically significant elevation in PTA, but there is no association with tinnitus. These findings emphasize the need to implement and disseminate best practices for ear hygiene and cerumen management broadly and equitably. Level of Evidence: 2B.

Magnetic Resonancy Imaging Safety in Active Osseointegrated (Osia®) and Cochlear Implants: New Technology Creating Confusion.

OBJECTIVE: There is increased confusion regarding MRI-compatible CIs and BAHAs. This report describes two cases when patients underwent MRIs with non-MRI compatible devices. RESULTS: One patient with bilateral Cochlear Osias experienced dislocation of both internal magnets after 1.5 Tesla MRI. Both magnets were outside the silastic sheath, with the left magnet flipped. A second patient with a legacy CI experienced similar internal magnet dislocation and inversion after 3 Tesla MRI. CONCLUSIONS: This study describes internal magnet dislocation/inversion with the Cochlear Osia and a legacy CI after MRI. Our findings suggest the need for improved patient education and simplified radiology guidelines. Laryngoscope, 134:393-396, 2024.