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Telemedicine is effective and safe for clinical management of patients with headache disorders: An American Headache Society position statement

Arca, Karissa N; Bazarsky, Allyson B; Yuan, Derek Y; Villanueva, Raissa; Friedman, Deborah I; Charles, Andrew; ,
OBJECTIVES/BACKGROUND/OBJECTIVE:This study was undertaken to review the published literature and provide a position statement from the American Headache Society regarding the safety, efficacy, and impact on access to care of telemedicine for the clinical management of patients with headache disorders. Access to specialized care in headache medicine is severely limited in the United States and worldwide. Telemedicine has been used as an approach to care delivery in headache medicine for more than a decade, with accelerated adoption during the COVID-19 pandemic. There is now uncertainty regarding the extent to which telemedicine will be accepted by health systems and reimbursed by payers moving forward. The purpose of this position statement is to summarize evidence and clinical experience supporting the utility of telemedicine in headache medicine. METHODS:Evidence regarding the safety and efficacy of telemedicine, and patient and clinician satisfaction with the use of telemedicine for headache specialty care, was gathered from a variety of sources, including PubMed, Google Scholar, and ClinicalTrials.gov. The results and conclusions based upon these results were reviewed and discussed by the authors and the Board of Directors of the American Headache Society to confirm consistency with clinical experience and to achieve consensus. RESULTS:Several randomized clinical trials and observational studies have been performed to compare telemedicine with in-person visits in the management of patients with headache disorders. These studies showed consistently that telemedicine is noninferior to in-person care based upon multiple outcome measures, including disability measures, patient satisfaction, and clinician satisfaction. In addition, these studies found that telemedicine rarely leads to a missed diagnosis of secondary headache or mismanagement of primary headache. Telemedicine has substantial advantages for patients, including improved access to care and reduced costs associated with obtaining care. Studies evaluating health care utilization indicate no significant differences between patients evaluated and treated virtually versus in person. Obvious limitations of telemedicine include the inability to perform an in-person physical exam or to perform injections. For a substantial number of patients, however, these limitations are outweighed by its advantages. The experience with telemedicine reported in the literature is consistent with the experience of the Board of Directors of the American Headache Society, who endorse its use for patients when feasible and appropriate. CONCLUSION/CONCLUSIONS:Telemedicine has significantly advanced the care of patients with headache disorders. Its further development and deployment should be supported and reimbursed.
PMID: 41098085
ISSN: 1526-4610
CID: 5955022

Extracellular Vesicles From Chylomicron-Treated Endothelial Cells Drive Macrophage Inflammation

Tilp, Anna; Nasias, Dimitris; Carley, Andrew L; Park, Min Young; Mooring, Ashley; Tirumalasetty, Munichandra Babu; Abumrad, Nada A; Wang, Yang; Miao, Qing Robert; Lewandowski, E Douglas; Alemán, José O; Goldberg, Ira J; Cabodevilla, Ainara G
BACKGROUND/UNASSIGNED:Movement of circulating lipids into tissues and arteries requires transfer across the endothelial cell (EC) barrier. This process allows the heart to obtain fatty acids, its chief source of energy, and apoB-containing lipoproteins to cross the arterial endothelial barrier, leading to cholesterol accumulation in the subendothelial space. Multiple studies have established elevated postprandial TRLs (triglyceride-rich lipoproteins) as an independent risk factor for cardiovascular disease. We explored how chylomicrons affect ECs and transfer their fatty acids across the EC barrier. METHODS/UNASSIGNED:C]oleate, we studied the uptake and release of this labeled by ECs. RESULTS/UNASSIGNED:]C labeled chylomicron triglycerides exited ECs primarily in phospholipids. EVs from chylomicron-treated versus untreated ECs were larger, more abundant, and contained specific microRNAs. Treatment of macrophages and naive ECs with media from chylomicron-treated ECs increased expression of inflammatory genes. CONCLUSIONS/UNASSIGNED:EC chylomicron metabolism produces EVs that increase macrophage inflammation and create LDs. Media containing these EVs also increases EC inflammation, illustrating an autocrine inflammatory process. Fatty acids within chylomicron triglycerides are converted to phospholipids within EVs. Thus, EC uptake of chylomicrons constitutes an important pathway for vascular inflammation and tissue lipid acquisition.
PMID: 41099102
ISSN: 1524-4636
CID: 5955042

Measurement of 11-Oxo-Androgens, A Novel Biomarker, in Females with Clinical Signs of Premature Adrenarche

Gabriel, Liana; Mejia-Corletto, Jorge; Blinov, Beatriz; Akerman, Meredith; Frank, Jacklyn; Saenger, Paul
BACKGROUND/UNASSIGNED:Endocrine findings in premature adrenarche have been characterized by elevated DHEAS levels in the past. METHODS/UNASSIGNED:We reviewed 44 female patients, aged 4 to 8 years, with premature adrenarche who were seen at our center between 2019 and 2023. Data were collected on the traditional androgens (DHEA and DHEAS) and novel 11-oxo-androgens. 11-oxo-androgens, DHEAS, and DHEA levels were measured using Liquid chromatography/tandem mass spectrometry (LC/MS-MS) assays in commercial laboratories (Lab Corp). RESULTS/UNASSIGNED:The majority, 89% of patients from the youngest group (4-5year olds), presented with apocrine odor as the only symptom of premature adrenarche. We have demonstrated that DHEA and DHEAS levels were within the normal range in many girls with premature adrenarche, whereas 11-oxo-androgens, particularly 11-hydroxyandrostenedione and 11β-hydroxytestosterone, were elevated. Out of those with normal DHEAS, 75 % had elevated 11-hydroxyandrostenedione, and 77.8% of those patients with normal DHEA had the same elevated oxo-adrogen. Additionally, advanced bone age greater than 1 year compared to chronological age was positively associated with 11-ketotestosterone (Spearman correlation coefficient = 0.32, 95% CI: 0.01-0.57, p=0.0429) and 11β-hydroxy testosterone (Spearman correlation coefficient=0.32, 95% CI: 0.01-0.58, p=0.0395). CONCLUSION/UNASSIGNED:We propose that 11-oxoandrogens are a more sensitive steroid to be measured in premature adrenarche.
PMID: 41090402
ISSN: 1308-5735
CID: 5954762

A Phase II Exploratory Trial Evaluating CT-based Mid-Treatment Nodal Response to Select for De-escalated chemoradiation therapy in the definitive management of p16+ Oropharyngeal Cancer

Kim, Joseph K; Tam, Moses; Kim, S Gene; Solomon, Eddy; Hill, Colin; Karp, Jerome M; Hung, Christie; Oh, Cheongeun; Concert, Catherine; Rybstein, Marissa; Li, Zujun; Zan, Elcin; Goldberg, Judith D; Hochman, Tsivia; Jacobson, Adam; Duvvuri, Umamaheswar; Persky, Michael; Persky, Mark; Harrison, Louis; Hu, Kenneth
PURPOSE/OBJECTIVE:This prospective, non-randomized phase II single-arm pilot trial aimed to explore favorable mid-treatment nodal response (FMNR) through CT imaging to guide de-escalated chemoradiation therapy (CRT) in patients with favorable risk, node-positive HPV-associated oropharyngeal cancer (OPC). MATERIALS AND METHODS/METHODS:. At week 4, CT imaging evaluated nodal response: ≥40% reduction warranted de-escalation to 60 Gy, while <40% reduction continued standard CRT. Primary endpoint was 2-year PFS from initiation of dose de-escalated CRT. Tissue tumor modified viral (TTMV) HPV DNA samples and DW-MRI were collected at baseline and week 4. MDADI questionnaires were collected at baseline, 1, 3, 6, 12, and 24 months. RESULTS:Of 39 patients, 26 had FMNR and underwent de-escalated treatment. 13 pts had slow mid-treatment nodal shrinkage and received standard dose. At a median follow-up of 47.4 months, the 2-year PFS was 92.1% (95% CI: 0.72-0.98) for the deescalated dose group and 92.3% for the standard dose patients (95% CI: 0.57-0.99), p=0.96. With a median survival follow up of 48.9 months (range: 16.7-77.8 months), there were no deaths or distant failures. FMNR was associated with rapid TTMV HPV DNA clearance, reduced TTMV HPV DNA flare, lower baseline and week 4 MRI diffusivity, and higher baseline and week 4 MRI diffusional kurtosis. No differences in acute or late maximum grade 3-4 toxicity by patient were noted. MDADI composite scores showed minimal clinical important difference (MCID) in the de-escalated group at 1-month post-treatment while the standard group had MCID up to 1-year post-treatment. No patients required feeding tube placement. CONCLUSIONS:De-escalated CRT using CT-based mid-treatment nodal response in favorable risk, node-positive HPV-associated OPC achieved excellent 2-year PFS and OS rates and represents a potential approach in better selecting patients for treatment de-escalation.
PMID: 41101558
ISSN: 1879-355x
CID: 5954192

Screened but Still Struggling: Challenges in Delivering Financial Assistance After Positive Financial Toxicity Screens

Budhu, Joshua A; Tin, Amy L; Steele, Melanie; Doyle, Stephanie; Gany, Francesca; Elshiekh, Cleopatra; Caramore, Amy; Sokolowski, Stefania; Vega, Lana; Sharma, Bayley; Blinder, Victoria; Aviki, Emeline Mariam; Vickers, Andrew J; Chino, Fumiko; Thom, Bridgette
PURPOSE/OBJECTIVE:Financial toxicity can negatively affect treatment adherence, quality of life, and survival in patients with cancer. Although screening for financial toxicity is increasingly implemented across oncology practices and cancer centers, less is known about challenges in delivering timely interventions after a positive screen. We evaluated outcomes and barriers in a systematic financial toxicity screening and referral program at a large comprehensive cancer center. METHODS:From March 2023 to December 2024, patients in breast, gynecologic, GI, and thoracic oncology clinics at Memorial Sloan Kettering Cancer Center completed an electronic survey assessing health-related social risks and the 12-item Comprehensive Score for Financial Toxicity (COST). A positive screen was defined as COST <16, unmet essential need, or new loan/borrowing for treatment. Patients screening positive and requesting assistance were referred to Patient Financial Services (PFS) for follow-up. Outcomes included proportions with documented outreach, receipt of any intervention, intervention types, and barriers. RESULTS:A total of 83,978 patients were eligible; of whom 50,949 (61%) completed screening. Of 9,724 positive screens, 8,004 (82%) requested follow-up, and 6,987 referrals were placed. PFS attempted follow-up in 3,383 patients (of the 6,987 = 48%), with documented interventions in 1,510 of 3,383 (45%). Counseling on financial resources (983/3,383 = 29%) was most common, followed by insurance-related counseling (402/3,383 = 12%) and formal program referrals (823/3,383 = 24%). Among patients referred to assistance programs, this was most often to the institutional Financial Assistance Program (438/796 = 55%) or social work (318/796 = 40%). The most frequent barrier was the inability to contact patients (1,464/3,383 = 43%). CONCLUSION/CONCLUSIONS:Routine financial toxicity screening was implemented at scale and connected many patients to meaningful financial support. However, 81% of those who screened positive did not receive an intervention, underscoring the need for expanded infrastructure and policy reforms to address financial toxicity in cancer care.
PMID: 41074759
ISSN: 2688-1535
CID: 5952522

Relative Donor Site Morbidity and Complication Rates of Gracilis Myocutaneous and Muscle Flaps in Reconstructive Surgery

Sobba, Walter D; Thai, Sydney; Barrera, Janos A; Montgomery, Samuel R; Agrawal, Nikhil; Levine, Jamie P; Hacquebord, Jacques Henri
BACKGROUND:The gracilis flap is a versatile muscle flap that can be utilized as a muscle only or myocutaneous flap for soft tissue coverage, as well as for reconstruction of facial animation or extremity function. Few studies have compared donor site complications of free and pedicled gracilis flaps, including the effect of skin paddle harvest on donor site morbidity. METHODS:We performed a retrospective review of patients who underwent a free or pedicled gracilis flap at our institution from 2013-2023. Gracilis flaps were categorized as: pedicled gracilis muscle flaps used for vaginectomy in gender reaffirming surgery, free gracilis muscle flaps, and free gracilis myocutaneous flaps. Outcome variables were duration of drain placement and complications including seroma, hematoma, infection, dehiscence, and persistent numbness. RESULTS:We identified 128 gracilis flaps including 19 free myocutaneous flaps, 35 free muscle flaps, and 74 pedicled muscle flaps. Free myocutaneous flaps required longer drain placement as compared to free muscle flaps or pedicled flaps (13.6 vs 8.4 vs 7.4 days, respectively, p=0.002). Free myocutaneous flaps displayed a higher complication rate (36.8%) as compared to pedicled muscle flaps (10.8%), or free muscle flaps (11.4%, p=0.020). After adjusting for age, BMI, and ASA status, free myocutaneous flaps demonstrated higher odds of major donor site complication as compared to pedicled muscle flaps (OR 1.23, p<0.001), while free muscle flaps were not associated with increased odds of major complication (OR 1.08, p=0.117). Of the documented complications, the most common were surgical site infection (36.8%), hematoma (21.1%) and seroma (21.1%). CONCLUSION/CONCLUSIONS:The inclusion of a skin paddle during gracilis flap harvest is associated with increased duration of drain placement and donor site complications including surgical site infection, hematoma, and seroma. These factors should be carefully considered in the context of patients' reconstructive needs and other risk factors.
PMID: 41072485
ISSN: 1098-8947
CID: 5952452

Emerging and Pandemic Pathogens: Lessons Learned From a Clinical Research Network

Atmar, Robert L; Abate, Getahun; Deming, Meagan E; George, Sarah L; Fleming, Andrew; Frey, Sharon E; Lyke, Kirsten E; Stephens, David S; Del Rio, Carlos; El Sahly, Hana M
Pathogens infecting humans continue to emerge or reemerge to cause outbreaks and widespread disease. The National Institute of Allergy and Infectious Diseases has funded Vaccine Treatment and Evaluation Units (VTEUs) for more than 50 years. VTEUs perform clinical studies to assess the safety and immunogenicity of candidate vaccines and other interventions to mitigate the impact of emerging and ongoing infectious diseases. Here, we review clinical studies conducted in the VTEUs since 2000 that have addressed emerging pathogens and other infectious agents with pandemic potential or of bioterrorism concern. The studies conducted range from phase 1 to phase 3 clinical trials, and they have included vaccines, therapeutics, and epidemiological studies. The results of the trials have guided national and often international recommendations for treatment and prevention of many of the evaluated pathogens, culminating in coronavirus disease 2019 studies that began within three months of severe acute respiratory syndrome coronavirus 2 identification. The VTEU network continues to be a critical public health resource for addressing emerging pathogens and expediting the development of safe and effective vaccines and treatments to protect at-risk populations.
PMCID:12513351
PMID: 41071737
ISSN: 1537-6591
CID: 5952402

"Does Academic Quarter or Operative Day of the Week Affect Flap Success?"

Sobba, Walter D; Jacobi, Sophia; Barrera, Janos A; Gursky, Alexis K; Wyatt, Hailey Paige; Levine, Jamie P; Agrawal, Nikhil; Hacquebord, Jacques Henri
BACKGROUND:The "July Effect" refers to the potential increase in adverse outcomes associated with the annual turnover of medical trainees, though its impact on surgical fields remains uncertain. Additionally, few studies have examined whether the operative day of the week and subsequent flap monitoring during the weekend affect time to reoperation or flap salvage. This study investigated whether academic quarter and operative day influence reoperation rates, flap salvage, or flap failure in microvascular free flap procedures. METHODS:A retrospective review was conducted on 769 free flaps performed between June 2011 and November 2023. Multivariate analyses adjusted for patient demographics, comorbidities, flap type, and recipient region. Flaps were categorized by academic quarter and operative day, excluding weekends due to limited sample size. Primary outcomes included reoperation rates for vascular compromise, time to reoperation, and flap salvage. RESULTS:No significant differences in reoperation rates for vascular compromise were observed across academic quarters. While procedure duration trended longer in the first three quarters compared to the fourth, these differences were not statistically significant. Additionally, operative day did not impact reoperation rates, flap salvage, or time to reoperation. Flaps were predominantly indicated for head and neck reconstruction (74.4%) and had an overall flap loss rate of 3.0%. CONCLUSION/CONCLUSIONS:We found no evidence of a "July Effect" in microvascular surgery or that operative day affects free flap outcomes. Institutional factors, such as structured flap monitoring, attending oversight, and advanced practice provider support, likely mitigate risks associated with trainee turnover and shift-based staffing fluctuations.
PMID: 41067266
ISSN: 1098-8947
CID: 5952212

Fracture-Dislocation of the Proximal Humerus: A Marker of Poor Outcome

Adams, Jack C; Rivero, Steven; Stevens, Nicole; Ganta, Abhishek; Zuckerman, Joseph D; Egol, Kenneth A
PURPOSE/OBJECTIVE:The purpose of this study was to evaluate the effect that associated glenohumeral dislocations have on outcomes following surgical treatment of proximal humerus fractures. METHODS:This IRB-approved study reports on 301 patients, who underwent operative treatment for proximal humerus fractures at an academic medical center from January 2006 to January 2023. Fractures were classified according to the Neer system. Patients were separated into two cohorts based on whether a glenohumeral dislocation was present at the time of initial injury. Outcomes measured included the Disabilities of the Arm, Shoulder, and Hand (DASH) score, shoulder range of motion (forward elevation, external rotation, internal rotation), readmission rates, complications, hardware removal, and need for revision surgery. Independent samples t-tests and chi-squared analysis were used for continuous and categorical variables, respectively. A binary logistic regression was performed to analyze the influence of these factors on complication rate. RESULTS:230 patients sustained an isolated fracture (PHF) and 71 sustained a fracture-dislocation (FD). Significant differences were observed between the FD and PHF groups in all measured outcomes. The FD group had a poorer DASH score (24.38 ± 19.09 vs 10.54 ± 13.67; P < 0.001) and reduced range of shoulder motion in forward elevation (114° ± 40° vs 162° ± 19°; P < 0.001), external rotation (40° ± 19° vs 66° ± 19°; P < 0.001), and internal rotation (57° ± 26° vs 82° ± 21°; P < 0.001). Readmission rates were higher in the FD group (0.28 ± 0.85 vs 0.05 ± 0.28; P < 0.001). The FD cohort also had a higher rate of complications (25.35% vs 6.52%; P < 0.001), need for removal of hardware (14.08% vs 3.04%; P = 0.002), and overall revision surgery (11.27% vs 1.30%; P < 0.001). The FD cohort demonstrated a greater incidence of AVN (12.68% vs 4.35%; P = 0.012). No significant difference was observed regarding rates of fracture healing and recurrent dislocation. Multivariate analysis in the form of binary logistic regression indicated that fracture-dislocation significantly increased the complication risk (OR = 3.310, 95% CI = 1.42-7.70; P = 0.005). CONCLUSION/CONCLUSIONS:Proximal humerus fracture-dislocations are associated with worse functional outcomes and higher complication rates compared to those without dislocations. These findings highlight the potential need for specialized treatment strategies to mitigate the impact of dislocation on recovery.
PMID: 41076057
ISSN: 1532-6500
CID: 5952602

Antihypertensive Treatment in the Postpartum Care of Preeclampsia: A Hemodynamic-Based Approach

Ogamba-Alphonso, Ifeoma; Miller, Erin; Brown-Thomas, Tudi-Max; Katehis, Ioanna; Gitlin, Saige; Maldonado, Delphina; Fernandez De Salvo, Gabriella; Asfour, Tony; Ginsberg, Izzy; Gunabalan, Silpaa; Rajan, Anand; Shah, Keya; Kapoor, Mehak; Gubernikoff, George; Kinzler, Wendy; Chavez, Martin; Heo, Hye; Rekawek, Patricia
Labetalol and nifedipine are first-line antihypertensives for hypertensive disorders of pregnancy. However, there is limited research comparing their effectiveness based on hemodynamic profiles seen in preeclampsia, such as high cardiac output (CO) and high systemic vascular resistance (SVR). This study assesses whether concordance of antihypertensive treatment with the hemodynamic status on echocardiogram reduces time to achieve target postpartum blood pressure (BP) before discharge.This retrospective cohort study included patients with preeclampsia with severe features who received a postpartum echocardiography, excluding patients with cardiac etiology. Antihypertensive choices were provider-dependent. The CO and SVR were calculated retrospectively from the echocardiogram in collaboration with cardiology. Concordance was defined as patients with high CO (>6 L/min) started on labetalol and high SVR (>1,200 dynes·sec·cm5) started on nifedipine; opposite pairings were discordant. The primary outcome was time to achieve target BP, defined as the period from the start of antihypertensive therapy to when no titration was needed to sustain BPs of less than 140/90 mm Hg. Chi-square and Fisher's tests were used for categorical variables, and Mann-Whitney U test for continuous variables.Of 298 patients, 155 (52%) received concordant therapy and 143 (48%) discordant. Of the cohort, 229 (76.8%) had high SVR and 69 (23.2%) had high CO. Median time to target BP was not significantly different (concordant: 32 hours [interquartile range, IQR: 0-61], discordant: 41 hours [IQR: 4-75], p = 0.13). The concordant group needed fewer titrations to achieve target BP (1 [IQR: 0-2] vs. 2 [IQR: 1-3]; p = 0.008) and were less likely to be discharged home on multiple antihypertensive medications compared with the discordant group (28.9 vs. 42.7%, p = 0.014). Maternal demographics were similar between groups.While time to target BP did not differ, concordance of antihypertensive therapy to postpartum hemodynamics in patients with severe preeclampsia reduced medication adjustments and increased the likelihood of discharge on a single-agent regimen. · Echocardiography can be used to assess maternal hemodynamics.. · Aligning BP meds to hemodynamics cuts the need for a second agent.. · Aligning BP meds to hemodynamics reduces dose adjustments..
PMID: 41061763
ISSN: 1098-8785
CID: 5951962