Faculty Bibliography

OBJECTIVE:Although treatment guidelines recommend pulse steroids, induction treatment of lupus nephritis (LN) varies significantly among providers. This paper aims to explore evidence that intravenous pulse provides pharmacological benefits along with improved clinical efficacy without greater toxicity compared with high-dose oral glucocorticoids justifying inclusion for all active LN. METHODS:We conducted a systematic literature review (SLR) using the term 'pulse glucocorticoids in LN' in order to identify studies that summarise the pharmacologic mechanisms of glucocorticoids, reviewed the historical use of glucocorticoids in SLE, and compared pulse therapy with high-dose oral treatment related to their efficacy and toxicities. RESULTS:SLR demonstrated that non-genomic mechanisms of action are more associated with pulse than oral steroids. Some observational studies reported improved renal responses with pulse steroids but in exchange for more adverse metabolic bone disease effects (eg, osteoporosis and avascular necrosis) as well as infections and, importantly, mortality. CONCLUSIONS:Current guidelines promoting pulse therapy for all forms of proliferative LN (and in the case of American College of Rheumatology 2024 treatment guidelines, even isolated class V membranous LN) rely on structured evidence grading processes, including expert consensus and observational data, but are not based on head-to-head randomised controlled trial comparisons. Therefore, there can be an ongoing debate regarding the best approach. The SLR identifies a distinct pharmacological benefit unique to pulse treatment, though without direct evidence necessary for the treatment of LN; includes observational studies with evidence of superior efficacy, but not consistently; and identifies a higher risk of adverse effects. In our opinion, the data advocates for a more selective approach to treatment, foregoing universal treatment with pulse steroids, based on a toxicity versus benefit assessment that patients with mild disease do not require the additional risks.

PURPOSE/OBJECTIVE:To evaluate early clinical outcomes following the establishment of an endovascular neurointerventional service for intracranial aneurysm treatment in Nigeria, emphasizing procedural safety and skill transfer. MATERIALS AND METHODS/METHODS:We retrospectively reviewed the first 22 adult patients who underwent endovascular treatment for intracranial aneurysms. Data collected included demographics, aneurysm characteristics, procedural details, operator type, complications, and short-term neurological outcomes. Skill transfer was defined as a structured mentorship process in which experienced neurointerventional radiologists remotely and/or physically proctored a locally based interventional radiologist, proficient in body endovascular techniques but requiring dedicated neuroendovascular mentorship. RESULTS:Mean patient age was 49.8 years (SD ±12.5), with 81.8% female. The most common aneurysm site was the anterior communicating artery (41.7%), and 75.0% of aneurysms were treated post rupture. Procedural complications occurred in 18.2% of cases, primarily intraoperative rupture/coil perforation (9.1%), vasospasm (4.5%), and thrombus formation (4.5%). One patient developed a new postoperative neurological deficit. Favorable outcomes, defined as modified Rankin Scale (mRS) score of 0 at 30 days, were achieved in 68.2% of patients. Skill transfer was successful, with 45.5% of cases performed independently by the local interventional radiologist and outcomes and postoperative length of stay comparable to proctored cases. Tele-neurocritical care enabled safe postoperative management in the absence of on-site neurocritical care specialists. CONCLUSION/CONCLUSIONS:Establishing a neuroendovascular service in Nigeria yielded favorable early outcomes with a low complications rate. A structured skill-transfer framework, enabled safe progression toward operator independence. Tele-neurocritical care further supported patient management in the absence of an on-site neurocritical care service.

Although temperamental negative affectivity has been identified as a developmental mechanism mediating the link between perinatal risk and internalizing problems in early childhood, its role in predicting broader behavioral and emotional problems across childhood remains understudied. We examined the longitudinal relations among perinatal complications (i.e., prenatal maternal depression and cardiometabolic complications, preterm birth, and low birth weight), children's negative affectivity (M

CONTEXT/BACKGROUND:Although the safety and effectiveness of recombinant human growth hormone therapy (rhGH) has been reported for several years, the level of consensus on the outcomes that should be reported is unclear. OBJECTIVE:This work aims to understand the frequency and trends in reported outcomes of safety and effectiveness for rhGH therapy for growth hormone deficiency (GHD) in childhood. METHODS:A systematic review was performed in 7 English- and Chinese-language databases. Eligibility criteria included all studies published between 2003 and 2022, with participants who started rhGH before age 16 years for GHD. RESULTS:The 219 eligible studies that were identified included 171 cohort studies, 39 controlled trials, and 9 case-control studies. The median age of the participants at start of rhGH was 9.5 years (10th-90th: 7.1-11.9). The most commonly reported outcomes included change in height SDS in 117 (53%), height velocity in 105 (48%), insulin-like growth factor-1 (IGF-1) in 66 (30%), height in 63 (29%), bone age in 58 (26%), IGF-1 SDS in 45 (21%), injection site adverse events in 44 (20%), glucose concentration in 42 (19%), insulin-like growth factor-binding protein 3 in 34 (16%), and thyroid function in 30 (14%). Of the 342 different outcomes, 178 (52%) were considered as outcomes that were mainly focused on safety, 94 (28%) on efficacy, and 70 (20%) on both. Over the two decades, height SDS and height velocity remained the most frequently reported outcomes. Of the 342 outcomes, 9 (3%) were on quality of life and these were reported in 29 of 219 (13%) studies. CONCLUSION/CONCLUSIONS:The results of this systematic review allow the development of a core outcome set that is recommended for routine use in all children receiving rhGH for childhood GHD.

OBJECTIVE:This study aimed to understand the factors limiting access to medications for the preventive treatment of migraine and to improve access to evidence-based preventive care. BACKGROUND:For decades, the effective use of medication for the preventive treatment of migraine was limited by slow onset, slow and complex dose titration schedules, modest benefits, drug interactions, frequent side effects, and very low long-term adherence. The calcitonin gene-related peptide (CGRP) targeted preventive medications mitigate some of these limitations and demonstrated substantial therapeutic benefits in a significant proportion of adults with migraine. The American Headache Society considers these medications among the first-line options for migraine prevention, although access to them remains limited. The American Migraine Foundation hosted a single-day, multidisciplinary expert panel discussion to identify barriers to optimal preventive care and developed recommendations to address them. METHODS:Participants identified and prioritized barriers and used a modified nominal group technique to achieve consensus on them. A series of moderated discussions in plenary and breakout sessions was used to create possible solutions. Modified nominal group technique was also employed to achieve consensus on the priorities among these barriers and to achieve whole-group consensus on the recommendations. Ethical issues that inform access were discussed. RESULTS:Participants included eight neurologists and board-certified headache specialists, six representatives of reimbursement decision-makers, six employees of life sciences companies, four patient advocates with lived experience with migraine, and a medical ethicist. Among those who have consulted healthcare professionals and received a diagnosis of migraine, we identified four main barriers to accessing preventive treatment: restrictive prior authorization requirements, the perceived lack of real-world evidence and treatment guidelines, the need for clinician education, and the need for patient education. Consensus recommendations for eliminating barriers centered on using new evidence to evaluate policies that restrict the selection of first-line therapies, initiating/improving collaboration among stakeholders, sharing of data and best practices, and increased training. Participants agreed to explore novel definitions of the value of preventive treatment and to establish the Migraine Prevention Network to facilitate ongoing cooperation and collective action. However, due to financial limitations, staffing changes, and time constraints, post-meeting discussions led to a shift from establishing a broad Migraine Prevention Network to forming smaller task forces focused on the top-priority barriers (real-world evidence and The Patient Playbook) identified through collaborative voting among American Headache Society, American Migraine Foundation, and industry stakeholders. CONCLUSIONS:Adults with migraine face multiple barriers in accessing novel migraine-specific, CGRP-targeted preventive treatment. Stakeholders in the delivery of care, including clinicians, reimbursement decision-makers, life sciences companies, and patient and clinician advocates, may be able to overcome many of these barriers and improve access by working with and on behalf of patients.

OBJECTIVES/OBJECTIVE:To examine the effects of PlayReadVIP, a pediatric primary care intervention promoting early relational health, on child behaviors. STUDY DESIGN/METHODS:A factorial randomized controlled trial enrolled mother-child dyads postpartum. PlayReadVIP was delivered in two phases: birth to 3 years (PlayReadVIP 0-3) and 3 to 5 years (PlayReadVIP 3-5). At enrollment, dyads were assigned to PlayReadVIP 0-3 or control. At age 3, dyads were re-randomized to PlayReadVIP 3-5 or control. Analyses included dyads with a second randomization and complete data on the mediators and child outcomes. In PlayReadVIP, dyads attended one-on-one sessions with a parent coach, in which they received child development information, learning materials, and real-time, strengths-based feedback on brief video recordings of parent-child interactions. Cognitive stimulation and harsh discipline were reported by mothers. Child behaviors were assessed using the Behavior Assessment System for Children, Second Edition. RESULTS:grade. No significant indirect effects through harsh discipline were found. CONCLUSIONS:PlayReadVIP leads to sustained but small improvements in child behaviors by enhancing maternal cognitive stimulation, emphasizing the potential of early intervention in pediatric primary care for promoting child mental health in disadvantaged populations.

BACKGROUND:Keloids are common in genetically predisposed individuals and in darker skin types, and treatment is especially challenging; the most commonly used therapeutic options return inconsistent results and often result in recurrence. Despite their prevalence and therapeutic challenges, keloids remain understudied and are often conflated with hypertrophic scars in the literature, though these conditions likely have distinct biomechanical etiologies. There remains a need for better optimization and comparison of existing treatment modalities to more effectively manage keloidal scarring. METHODS:Thirteen patients with two similar keloids or one large keloid completed four treatments of a fractionally ablative erbium YAG laser, followed by application of either triamcinolone 10 mg/mL solution to one keloid or one half of the keloid or 5-fluorouracil solution 50 mg/mL solution to the second keloid or the other half of the keloid. Photos and measurements of the keloids were taken at each visit. The Patient and Observer Scar Assessment Scale (POSAS) score was recorded by the participants and the blinded physician observer at each visit. Blinded dermatologist observers completed the Hamilton score based on the scar photographs. RESULTS:; there was not a statistically significant difference between the two (p = 0.56). Ten out of 13 patients were Fitzpatrick skin types IV-VI. There were no serious adverse events reported. CONCLUSION/CONCLUSIONS:In this pilot study of keloid patients, POSAS scores significantly improved after both laser-assisted TAC delivery and laser-assisted 5-FU delivery, with no statistically significant difference between the two treatment arms. However, there was a noted discrepancy in patient reports of post-procedural hyperpigmentation, with more patients experiencing this adverse effect within the 5-FU arm than in the TAC arm. While fractionally ablative laser-assisted drug delivery with either 5-FU or TAC is a safe and effective method to treat keloids, special attention should be paid to hyperpigmentation as a possible adverse effect in patients with darker skin tones, who are disproportionately affected by both keloids and hyperpigmentation.

IMPORTANCE/UNASSIGNED:Lung cancer screening (LCS) with low-dose computed tomography (CT) remains underused in the US, partly because of incomplete smoking history documentation in electronic health records (EHRs) and limited time for shared decision-making in primary care. OBJECTIVE/UNASSIGNED:To determine whether a patient-facing, EHR-integrated tool combined with clinician-facing clinical decision support improves the identification of LCS-eligible patients and the ordering of low-dose CT compared with clinician-facing tools alone. DESIGN, SETTING, AND PARTICIPANTS/UNASSIGNED:This pragmatic, unstratified, randomized clinical trial with parallel groups was conducted from March 29, 2024, to March 28, 2025, at primary care clinics at University of Utah Health and New York University Langone Health. Adults aged 50 to 79 years with a documented smoking history, an active patient portal account, and a primary care visit in the preceding year were included. Study 1 enrolled patients with uncertain LCS eligibility (10 to 19 pack-years, unknown pack-years, or missing quit date); study 2 enrolled patients with documented eligibility (20 or more pack-years and currently smoking or quit smoking within 15 years). INTERVENTIONS/UNASSIGNED:The control included the clinician-facing Decision Precision+ tool (preventive care reminders and a shared decision-making tool). The intervention included the Decision Precision+ tool as well as the MyLungHealth tool, which collected detailed smoking history (study 1) and delivered personalized education and risk/benefit information (studies 1 and 2) via the patient portal in English and Spanish. MAIN OUTCOMES AND MEASURES/UNASSIGNED:The primary outcomes were the proportion of patients newly identified as eligible for LCS (study 1) and low-dose CT ordering rates (study 2) over 12 months. Analyses used intention-to-treat mixed-effects logistic regression. RESULTS/UNASSIGNED:There were 31 303 randomized participants, including 26 729 in study 1 (13 144 [49.2%] female; 13 580 [50.8%] male; median [IQR] age, 62 [55-69] years) and 4574 in study 2 (2230 [48.8%] female; 2344 [51.2%] male; median [IQR] age, 63 [56-69] years). In study 1, the MyLungHealth tool increased new LCS eligibility identification (635 of 13 412 [4.7%] vs 308 of 13 317 [2.3%]; adjusted odds ratio, 2.19; 95% CI, 1.99-2.42; P < .001). In study 2, low-dose CT ordering was higher in the intervention arm (474 of 2312 [20.5%] vs 434 of 2262 [19.2%]; adjusted odds ratio, 1.16; 95% CI, 1.04-1.30; P = .008). CONCLUSIONS AND RELEVANCE/UNASSIGNED:In this randomized clinical trial, integrating a patient-centered tool into primary care EHR workflows increased the identification of patients eligible for LCS and the ordering of low-dose CTs. The relative increases in these primary outcomes were substantial, but absolute increases were more modest. Research on more intensive interventions is warranted to evaluate their ability to further improve LCS screening. TRIAL REGISTRATION/UNASSIGNED:ClinicalTrials.gov Identifier: NCT06338592.

OBJECTIVES/OBJECTIVE:To evaluate whether ultrasound-guided preoperative localization of soft tissue masses in the musculoskeletal system using a wireless radar reflector reduces operative times and reoperation rates compared to a control group referred by the same oncology team. METHODS:Retrospective review of SAVI SCOUT radar localizations performed preoperatively for soft tissue masses between 2021 and 2025. All imaging, clinical details, and operative times were evaluated. Comparison was made between the localized group and a control group matched for demographics (age and sex), comorbidities (American Society of Anesthesiologists score), location (trunk versus appendicular; subcutaneous versus deep/subfascial), histopathology (benign versus malignant), and case complexity (primary closure versus flap reconstruction). Cases were performed by the same oncological surgical team referred directly or via the multidisciplinary tumor board during the same time course. RESULTS:Twenty-four radar localized cases were compared with 24 control cases. Median case time in the SAVI SCOUT group was 52.0 minutes (interquartile range 38.0) and there was no significant difference in case times between the localized and control groups (p > .05). There were no reoperations in the localized group whereas 5 patients in the non-localized control group underwent reoperation for positive margins, though this difference fell short of statistical significance (p = .056). The most common lesions in the localized group were metastatic melanoma (12.5%) and intramuscular myxoma (8.3%), liposarcoma (8.3%), and metastatic leiomyosarcoma (8.3%). CONCLUSIONS:Preoperative localization demonstrated no substantial improvement in operative time compared to the non-localized group. However, re-resection rates were higher in the non-localized group.

OBJECTIVE:To evaluate whether the risk of long COVID among individuals infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) during pregnancy differs from that of individuals who were not pregnant at time of virus acquisition. METHODS:We conducted a multicenter observational cohort study at 79 NIH RECOVER (Researching COVID to Enhance Recovery) sites. Individuals assigned female at birth aged 18-45 years with an index (first) SARS-CoV-2 infection on or after December 1, 2021, were included. The exposure was pregnancy (any gestational age) at the time of index SARS-CoV-2 infection. The primary outcome was long COVID 6 months after index infection , defined as RECOVER-Adult Long COVID Research Index score 11 or higher based on a detailed symptom survey. To account for confounding and differential selection between participants who were pregnant and not pregnant at infection, propensity score-matching methods were used to balance the groups on variables potentially associated with both pregnancy status and long COVID. RESULTS:Overall 2,423 participants were included; 580 (23.9%) were pregnant at index SARS-CoV-2 infection. The median age at infection was 33 years (interquartile range 28-38 years), and 2,131 of participants (90.0%) with known vaccination status were vaccinated. After propensity score matching, the adjusted long COVID prevalence estimates 6 months after index infection were 10.2% (95% CI, 6.2-14.3%) among those pregnant at infection and 10.6% (95% CI, 8.8-12.4%) among those not pregnant at infection. Pregnancy was not associated with a difference in adjusted risk of long COVID (adjusted risk ratio 0.96, 95% CI, 0.63-1.48). CONCLUSION/CONCLUSIONS:Acquisition of SARS-CoV-2 during pregnancy was not associated with a differential risk of long COVID at 6 months compared with similar-aged individuals who acquired SARS-CoV-2 outside of pregnancy.