International validation of a urinary biomarker panel for identification of active lupus nephritis in children.

Conventional markers of juvenile-onset systemic lupus erythematosus (JSLE) disease activity fail to adequately identify lupus nephritis (LN). While individual novel urine biomarkers are good at detecting LN flares, biomarker panels may improve diagnostic accuracy. The aim of this study was to assess the performance of a biomarker panel to identify active LN in two international JSLE cohorts.Novel urinary biomarkers, namely vascular cell adhesion molecule-1 (VCAM-1), monocyte chemoattractant protein 1 (MCP-1), lipocalin-like prostaglandin D synthase (LPGDS), transferrin (TF), ceruloplasmin, alpha-1-acid glycoprotein (AGP) and neutrophil gelatinase-associated lipocalin (NGAL), were quantified in a cross-sectional study that included participants of the UK JSLE Cohort Study (Cohort 1) and validated within the Einstein Lupus Cohort (Cohort 2). Binary logistic regression modelling and receiver operating characteristic curve analysis [area under the curve (AUC)] were used to identify and assess combinations of biomarkers for diagnostic accuracy.A total of 91 JSLE patients were recruited across both cohorts, of whom 31 (34 %) had active LN and 60 (66 %) had no LN. Urinary AGP, ceruloplasmin, VCAM-1, MCP-1 and LPGDS levels were significantly higher in those patients with active LN than in non-LN patients [all corrected p values (p c) < 0.05] across both cohorts. Urinary TF also differed between patient groups in Cohort 2 (p c = 0.001). Within Cohort 1, the optimal biomarker panel included AGP, ceruloplasmin, LPGDS and TF (AUC 0.920 for active LN identification). These results were validated in Cohort 2, with the same markers resulting in the optimal urine biomarker panel (AUC 0.991).In two international JSLE cohorts, urinary AGP, ceruloplasmin, LPGDS and TF demonstrate an 'excellent' ability for accurately identifying active LN in children

Telemedicine During COVID-19 and Beyond: A Practical Guide and Best Practices Multidisciplinary Approach for the Orthopedic and Neurologic Pain Physical Examination.

BACKGROUND:The COVID pandemic has impacted almost every aspect of human interaction, causing global changes in financial, health care, and social environments for the foreseeable future. More than 1.3 million of the 4 million cases of COVID-19 confirmed globally as of May 2020 have been identified in the United States, testing the capacity and resilience of our hospitals and health care workers. The impacts of the ongoing pandemic, caused by a novel strain of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), have far-reaching implications for the future of our health care system and how we deliver routine care to patients. The adoption of social distancing during this pandemic has demonstrated efficacy in controlling the spread of this virus and has been the only proven means of infection control thus far. Social distancing has prompted hospital closures and the reduction of all non-COVID clinical visits, causing widespread financial despair to many outpatient centers. However, the need to treat patients for non-COVID problems remains important despite this pandemic, as care must continue to be delivered to patients despite their ability or desire to report to outpatient centers for their general care. Our national health care system has realized this need and has incentivized providers to adopt distance-based care in the form of telemedicine and video medicine visits. Many institutions have since incorporated these into their practices without financial penalty because of Medicare\u27s 1135 waiver, which currently reimburses telemedicine at the same rate as evaluation and management codes (E/M Codes). Although the financial burden has been alleviated by this policy, the practitioner remains accountable for providing proper assessment with this new modality of health care delivery. This is a challenge for most physicians, so our team of national experts has created a reference guide for musculoskeletal and neurologic examination selection to retrofit into the telemedicine experience. OBJECTIVES:To describe and illustrate musculoskeletal and neurologic examination techniques that can be used effectively in telemedicine. STUDY DESIGN:Consensus-based multispecialty guidelines. SETTING:Tertiary care center. METHODS:Literature review of the neck, shoulder, elbow, wrist, hand, lumbar, hip, and knee physical examinations were performed. A multidisciplinary team comprised of physical medicine and rehabilitation, orthopedics, rheumatology, neurology, and anesthesia experts evaluated each examination and provided consensus opinion to select the examinations most appropriate for telemedicine evaluation. The team also provided consensus opinion on how to modify some examinations to incorporate into a nonhealth care office setting. RESULTS:Sixty-nine examinations were selected by the consensus team. Household objects were identified that modified standard and validated examinations, which could facilitate the examinations.The consensus review team did not believe that the modified tests altered the validity of the standardized tests. LIMITATIONS:Examinations selected are not validated for telemedicine. Qualitative and quantitative analyses were not performed. CONCLUSIONS:The physical examination is an essential component for sound clinical judgment and patient care planning. The physical examinations described in this manuscript provide a comprehensive framework for the musculoskeletal and neurologic examination, which has been vetted by a committee of national experts for incorporation into the telemedicine evaluation

Comparing Conventional Medical Management to Spinal Cord Stimulation for the Treatment of Low Back Pain in a Cohort of DISTINCT RCT Patients

Timothy Deer,1,&ast; Robert Heros,2,&ast; Edward Tavel,3 Sayed Wahezi,4 Robert Funk,5 Patrick Buchanan,6 Anne Christopher,7 Jacqueline Weisbein,8 Christopher Gilligan,9 Denis Patterson,10 Ajay Antony,11 Mohab Ibrahim,12 Nathan Miller,13 Keith Scarfo,14 Gayle Johnson,15 Thadchaigeni Panchalingam,15 Udoka Okaro,15 James Yue16 1Pain Management, The Spine and Nerve Center of the Virginias, Charleston, WV, USA; 2Pain Management, Spinal Diagnostics, Tualatin, OR, USA; 3Pain Management, Clinical Trials of South Carolina, Charleston, SC, USA; 4Pain Management, Montefiore Medical Center, Bronx, NY, USA; 5Pain Management, Indiana Spine Group, Indianapolis, IN, USA; 6Pain Management, Spanish Hills Interventional Pain Specialists, Camarillo, CA, USA; 7Pain Management, Saint Louis Pain Consultants, Chesterfield, MO, USA; 8Pain Management, Napa Valley Orthopedic Medical Group, Napa, CA, USA; 9Pain Management, Robert Wood Johnson University Hospital, New Brunswick, NJ, USA; 10Pain Management, Nevada Advanced Pain Specialists, Reno, NV, USA; 11Pain Management, the Orthopedic Institute, Gainesville, FL, USA; 12Pain Management, Coastal Pain & Spinal Diagnostics Medical Group, Carlsbad, CA, USA; 13Pain Management, Banner University Medical Center, Tucson, AZ, USA; 14Pain Management, Rhode Island Hospital, Providence, RI, USA; 15Neuromodulation, Abbott Labs, Austin, TX, USA; 16Orthopaedic spine Surgery, Connecticut Orthopedics, Hamden, CT, USA&ast;These authors contributed equally to this workCorrespondence: Timothy Deer, Pain Management, The Spine and Nerve Center of the Virginias, 400 Court Street, Suite 100, Charleston, WV, 25301, USA, Tel +1 304 347 – 6120, Fax +1 304 347 – 6126, Email [email protected]: Low Back Pain (LBP) is a prevalent condition. Spinal cord stimulation (SCS) has emerged as a more effective, long-term treatment compared to conventional medical management (CMM). The DISTINCT study enrolled and randomized chronic LBP patients with no indication of traditional spine surgery. This analysis focuses comparing study outcomes on patients initially randomized to receive CMM treatment and subsequently crossed over to SCS after 6 months.Purpose: To compare the therapeutic effectiveness and cost-efficiency of passive recharge burst SCS to CMM.Patients and Methods: A total of 269 patients were enrolled with 162 randomly assigned to SCS and 107 to CMM. The DISTINCT study design allowed a crossover to the alternative treatment arm after 6 months. Patients underwent a trial and received a permanent implant if they reported ≥ 50% pain reduction. Outcome analysis included pain (NRS), disability (ODI), catastrophizing (PCS), quality of life (PROMIS-29) and health care utilization.Results: Seventy out of eighty-one patients opted to cross over to trial SCS at 6M with 94% (66/70) undergoing a trial. Among those, 88% (58/66) reported a ≥ 50% or more pain relief and 55 received a permanent implant. At 12M visit, 71.4% reported a ≥ 50% pain improvement sustained at the 18M visit, with 24.5% (12/49) indicating a ≥ 80% improvement. Disability reductions (79% meeting the minimally important difference of a 13-point decrease), decreased catastrophizing, and significant improvements in all PROMIS-29 domains were noted. Furthermore, 42% of the patients reported decreased or discontinued opioid usage. Clinical benefits at the 12M visit were sustained through the 18M visit accompanied by a significant reduction in healthcare utilization and a &dollar;1214 cost savings.Conclusion: SCS demonstrates superior, long-term performance and safety outcomes compared to CMM therapy in LBP patients who received both CMM and SCS therapy. Additionally, SCS patients experienced reduced healthcare resource utilization and lower costs compared to those receiving CMM.Keywords: DISTINCT, low back pain, BurstDR, spinal cord stimulation, healthcare utilization, persistent spinal pain syndrome, neuromodulatio

Spinal Cord Stimulation Explantation and Chronic Pain: A Systematic Review and Technology Recommendations

Sayed E Wahezi,1 Ugur Yener,1 Tahereh Naeimi,1 Joshua B Lewis,1 Sandeep Yerra,1 Philip Sgobba,2 Hatice Begum Ciftci,3 Amaresh Vydyanathan,2 Elisa Chiu,1 Denis Cherkalin,4 Jay Y Darji,5 Ryan Masterson,6 Danielle Lee,7 Atthakorn Jarusriwanna,8 Suwannika Palee,9 Nicole R Ortiz,10 Moorice Caparo,1 Eli Dayon,11 Camille Fontaine,2 Marom Bikson,12 Michael E Schatman,13 Scott G Pritzlaff,14 Timothy R Deer,15 Corey W Hunter16 1Department of Physical Medicine &amp; Rehabilitation, Montefiore Medical Center, Bronx, NY, USA; 2Department of Anesthesiology, Montefiore Medical Center, Bronx, NY, USA; 3Physical Medicine and Rehabilitation, ROMMER International Physical Therapy and Rehabilitation Medical Center, Bursa, Turkey; 4Pain Management, New York Spine Specialist, New York, NY, USA; 5Pain Management, Regenerative Spine and Pain Institute, Plainsboro Township, NJ, USA; 6Pain Management, Old Mill District Clinic, Summit Health, Bend, OR, USA; 7Department of Neurology, Hackensack University Medical Center, Hackensack, NJ, USA; 8Department of Orthopaedics, Faculty of Medicine, Naresuan University, Phitsanulok, Thailand; 9Department of Rehabilitation Medicine, Faculty of Medicine, Naresuan University, Phitsanulok, Thailand; 10Pain Management, Sage Pain &amp; Wellness Institute, San Diego, CA, USA; 11Department of Physical Medicine &amp; Rehabilitation, Burke Rehabilitation Hospital, White Plains, NY, USA; 12Department of Biomedical Engineering, the City College of New York, New York, NY, USA; 13Department of Anesthesiology, Perioperative Care and Pain Medicine, Department of Population Health &ndash; Division of Medical Ethics, NYU Grossman School of Medicine, New York, NY, USA; 14Department of Anesthesiology and Pain Medicine, University&nbsp;of California, Davis, CA, USA; 15The Spine and Nerve Center of the Virginias, West Virginia University Hospitals, Charleston, WV, USA; 16Ainsworth Institute of Pain Management, Department of Rehabilitation &amp; Human Performance, Icahn School of Medicine at Mount Sinai, New York, NY, USACorrespondence: Sayed E Wahezi, Department of Physical Medicine and Rehabilitation, Montefiore Medical Center, 1250 Waters Place, Tower #2&nbsp; 8th Floor, Bronx, NY, 10461, USA, Tel +1 718-920-7246, Fax +1 929-263-3950, Email [email protected]: Chronic pain affects 20.5% of the US population, costing $296 billion annually in lost productivity. Spinal cord stimulation (SCS) has become a key treatment for refractory neuropathic and nociceptive pain, with increasing usage due to technological advancements. However, the durability of SCS therapy, including explantation rates, remains a concern. Understanding explantation causes is essential for improving patient selection and device effectiveness. This study aims to analyze SCS explantation rates and reasons, as well as evaluate the financial burden of these procedures on the healthcare system.Methods: Three primary screening methods were used: manual search with keywords, MeSH term query, and reference list screening. The search covered PubMed, Cochrane, and Web of Science databases from inception to November 2024, yielding 719 articles. After applying eligibility criteria, 72 articles were identified, and 25 were selected for analysis. Data extraction was done by independent reviewers, with a second reviewer ensuring accuracy. Discrepancies were resolved by the corresponding editor.Results: We reviewed data from 13,026 patients who underwent permanent SCS implantation between 1984 and 2024, across 25 studies. A total of 1882 patients (9.82$35,000 to $70,000) and revision costs ($15,000 to $25,000) raise concerns among payors. The hardware-driven model limits waveform flexibility, highlighting the need for innovation.Keywords: chronic pain, spinal cord stimulation, explantation, implant removal, cost-effectivenes

2016 ACR-EULAR adult dermatomyositis and polymyositis and juvenile dermatomyositis response criteria-methodological aspects

Objective. The objective was to describe the methodology used to develop new response criteria for adult DM/PM and JDM. Methods. Patient profiles from prospective natural history data and clinical trials were rated by myositis specialists to develop consensus gold-standard ratings of minimal, moderate and major improvement. Experts completed a survey regarding clinically meaningful improvement in the core set measures (CSM) and a conjoint-analysis survey (using 1000Minds software) to derive relative weights of CSM and candidate definitions. Six types of candidate definitions for response criteria were derived using survey results, logistic regression, conjoint analysis, application of conjoint-analysis weights to CSM and published definitions. Sensitivity, specificity and area under the curve were defined for candidate criteria using consensus patient profile data, and selected definitions were validated using clinical trial data. Results. Myositis specialists defined the degree of clinically meaningful improvement in CSM for minimal, moderate and major improvement. The conjoint-analysis survey established the relative weights of CSM, with muscle strength and Physician Global Activity as most important. Many candidate definitions showed excellent sensitivity, specificity and area under the curve in the consensus profiles. Trial validation showed that a number of candidate criteria differentiated between treatment groups. Top candidate criteria definitions were presented at the consensus conference. Conclusion. Consensus methodology, with definitions tested on patient profiles and validated using clinical trials, led to 18 definitions for adult PM/DM and 14 for JDM as excellent candidates for consideration in the final consensus on new response criteria for myositis

Device Evaluation, Treatment, and Explantation Recommendations (DETER): Review and Best Practices for Managing Neuromodulation Device Infections

Scott G Pritzlaff,1 Johnathan Heck Goree,2 Ryan Keith Dare,3 Ryan S D’Souza,4 David W Lee,5 Andrew Adams Dudas,6 Hemant Kalia,7 Vwaire Orhurhu,8 Naileshni Singh,1 Jonathan Michael Hagedorn,4 Arman Mousavi,9 Whitney James,10 Michael Spencer Leong,11 Kathleen W Meacham,12 Amitabh Gulati,13 Samir J Sheth,14 Israel Pena,15 Jarna R Shah,2 Melissa Zhu Murphy,16 Sara E Nashi,17 Morad Nasseri,9 Andrew M Khoury,18 Michael J Dorsi,19 Steven Michael Falowski,20 Erika A Petersen,21 Nestor D Tomycz,22 Sayed Wahezi,23 Krishnan V Chakravarthy,24 Jason E Pope,25 Michael E Schatman,26,27 Kasra Amirdelfan,28 Dawood Sayed,29 Timothy Ray Deer30,31 1Anesthesiology and Pain Medicine, University of California, Davis, Sacramento, CA, USA; 2Anesthesiology, University of Arkansas for Medical Sciences, Little Rock, AR, USA; 3Internal Medicine/Division of Infectious Diseases, University of Arkansas for Medical Sciences, Little Rock, AR, USA; 4Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN, USA; 5Fullerton Orthopedics, University of California, Fullerton, CA, USA; 6Mays and Schnapp Neurospine and Pain, Memphis, TN, USA; 7Center for Research & Innovation in Spine & Pain (CRISP), Rochester, NY, USA; 8Anesthesiology, University of Pittsburgh Medical Center, Williamsport, PA, USA; 9Neurology and Interventional Pain Medicine, Boomerang Healthcare, Walnut Creek, CA, USA; 10Neurosurgery, James-Marco Health, Prescott, AZ, USA; 11Anesthesiology, Perioperative and Pain Medicine, Stanford University, Stanford, CA, USA; 12Veteran’s Affairs Healthcare System, Saint Louis, MO, USA; 13Anesthesiology and Critical Care, Memorial Sloan Kettering Cancer Center, New York, NY, USA; 14Neurosciences, Sutter Health, Roseville, CA, USA; 15Pain Management, Lakeside Physicians, Granbury, TX, USA; 16North Texas Orthopedics and Spine Center, Dallas Fort Worth, TX, USA; 17Interventional Pain & Spine, TriHealth, Cincinnati, OH, USA; 18Advanced Spine and Pain Specialists, The Woodlands, TX, USA; 19Neurosurgery, University of California Los Angeles, Los Angeles, CA, USA; 20Neurosurgery, Neurosurgical Associates of Lancaster, Lancaster, PA, USA; 21Neurosurgery, University of Arkansas for Medical Sciences, Little Rock, AR, USA; 22Neurological Surgery, Allegheny Health Network, Pittsburgh, PA, USA; 23Rehabilitation Medicine, Montefiore Medical Center, New York, NY, USA; 24Anesthesiology and Pain Medicine, Solaris Research Institute, San Diego, CA, USA; 25Evolve Restorative Center, Santa Rosa, CA, USA; 26Department of Anesthesiology, Perioperative Care and Pain Medicine, NYU Grossman School of Medicine, New York, NY, USA; 27Department of Population Health - Division of Medical Issues, NYU Grossman School of Medicine, New York, NY, USA; 28Clinical Research, Boomerang Healthcare, Inc., Walnut Creek, CA, USA; 29Anesthesiology, The University of Kansas Health System, Kansas City, KS, USA; 30Anaesthesiology and Pain Medicine, West Virginia University School of Medicine, Charleston, WV, USA; 31Pain Services, WVU Medicine – Thomas Hospitals, Charleston, WV, USACorrespondence: Scott G Pritzlaff, University of California, Davis, 4860 Y Street, Suite 3020, Sacramento, CA, 95817, USA, Email [email protected]: Infections related to neuromodulation devices such as spinal cord stimulators (SCS) and intrathecal pumps (ITPs) present complex challenges due to potential complications such as localized infections, deep infections, sepsis, and neurological injury. Prompt diagnosis requires patients and providers to be educated on wound management and sepsis symptoms for immediate medical attention. Antibiotic therapy and duration vary based on infection severity, with deep infections often requiring device removal despite recent improvements in salvage rates with aggressive initial intervention. Deep infections necessitate timely diagnosis through imaging modalities such as magnetic resonance imaging (MRI) or computed tomography (CT), followed by device removal and culture-guided antibiotic therapy, often in collaboration with infectious disease specialists and spine surgeons. ITP infections pose similar challenges along with the risk of meningitis and may require careful management of medication withdrawal symptoms during emergent pump removal. Lab monitoring may aid treatment assessment, although negative cultures can occur due to post-antibiotic exposure. Postoperative recommendations stress standardized guidelines, patient education, and vigilant surveillance, with close follow-up crucial for early infection detection and intervention. Managing device-related infections demands a multi-specialty approach to minimize complications and optimize outcomes. This paper outlines best practices for diagnosing, managing, and treating neuromodulation device infections, focusing on guiding clinical decision-making from the onset of infection through treatment and potential reimplantation.Keywords: spinal cord stimulation, intrathecal pumps, procedure complications, infection control, surgical site infectio

Device Evaluation, Treatment, and Explantation Recommendations (DETER): Review and Best Practices for Managing Neuromodulation Device Infections

Infections related to neuromodulation devices such as spinal cord stimulators (SCS) and intrathecal pumps (ITPs) present complex challenges due to potential complications such as localized infections, deep infections, sepsis, and neurological injury. Prompt diagnosis requires patients and providers to be educated on wound management and sepsis symptoms for immediate medical attention. Antibiotic therapy and duration vary based on infection severity, with deep infections often requiring device removal despite recent improvements in salvage rates with aggressive initial intervention. Deep infections necessitate timely diagnosis through imaging modalities such as magnetic resonance imaging (MRI) or computed tomography (CT), followed by device removal and culture-guided antibiotic therapy, often in collaboration with infectious disease specialists and spine surgeons. ITP infections pose similar challenges along with the risk of meningitis and may require careful management of medication withdrawal symptoms during emergent pump removal. Lab monitoring may aid treatment assessment, although negative cultures can occur due to post-antibiotic exposure. Postoperative recommendations stress standardized guidelines, patient education, and vigilant surveillance, with close follow-up crucial for early infection detection and intervention. Managing device-related infections demands a multi-specialty approach to minimize complications and optimize outcomes. This paper outlines best practices for diagnosing, managing, and treating neuromodulation device infections, focusing on guiding clinical decision-making from the onset of infection through treatment and potential reimplantation

Comparing Presenting Clinical Features in 48 Children With Microscopic Polyangiitis to 183 Children Who Have Granulomatosis With Polyangiitis (Wegener&apos;s) : an ARChiVe Cohort Study

OBJECTIVE: To uniquely classify children with microscopic polyangiitis (MPA), to describe their demographic characteristics, presenting clinical features, and initial treatments in comparison to patients with granulomatosis with polyangiitis (Wegener's) (GPA). METHODS: The European Medicines Agency (EMA) classification algorithm was applied by computation to categorical data from patients recruited to the ARChiVe (A Registry for Childhood Vasculitis: e-entry) cohort, with the data censored to November 2015. The EMA algorithm was used to uniquely distinguish children with MPA from children with GPA, whose diagnoses had been classified according to both adult- and pediatric-specific criteria. Descriptive statistics were used for comparisons. RESULTS: In total, 231 of 440 patients (64% female) fulfilled the classification criteria for either MPA (n\u2009=\u200948) or GPA (n\u2009=\u2009183). The median time to diagnosis was 1.6 months in the MPA group and 2.1 months in the GPA group (ranging to 39 and 73 months, respectively). Patients with MPA were significantly younger than those with GPA (median age 11 years versus 14 years). Constitutional features were equally common between the groups. In patients with MPA compared to those with GPA, pulmonary manifestations were less frequent (44% versus 74%) and less severe (primarily, hemorrhage, requirement for supplemental oxygen, and pulmonary failure). Renal pathologic features were frequently found in both groups (75% of patients with MPA versus 83% of patients with GPA) but tended toward greater severity in those with MPA (primarily, nephrotic-range proteinuria, requirement for dialysis, and end-stage renal disease). Airway/eye involvement was absent among patients with MPA, because these GPA-defining features preclude a diagnosis of MPA within the EMA algorithm. Similar proportions of patients with MPA and those with GPA received combination therapy with corticosteroids plus cyclophosphamide (69% and 78%, respectively) or both drugs in combination with plasmapheresis (19% and 22%, respectively). Other treatments administered, ranging in decreasing frequency from 13% to 3%, were rituximab, methotrexate, azathioprine, and mycophenolate mofetil. CONCLUSION: Younger age at disease onset and, perhaps, both gastrointestinal manifestations and more severe kidney disease seem to characterize the clinical profile in children with MPA compared to those with GPA. Delay in diagnosis suggests that recognition of these systemic vasculitides is suboptimal. Compared with adults, initial treatment regimens in children were comparable, but the complete reversal of female-to-male disease prevalence ratios is a provocative finding