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Physiologic Transition During Delayed Cord Clamping With Assisted Ventilation in Preterm Infants
Fang, Jennifer L. , Petroni, Gina R. , Law, Brenda Hiu Yan , Gorman, Terri, Leone, Tina A. , Thomas, Sumesh , Niermeyer, Susan, Kattwinkel, John, Duda, Gina M, Petroni, Gina R. , Varhegyi, Nikole, Thielen, Monika, Chisholm, Christian A., Liedl, Lavonne M., Amsbaugh, Amy, Niermeyer, Susan, Barry, John-S, Lamprecht, Amy, Berlinski, Carolyn S, Johnson, Jacque-Lynne F, Irvine, Leigh , Ciorogariu-Ivan, Anna-Maria, Byrne, Bobbi J., Underwood, Mark A. , Poulain, Francis R., Pesavento, Rosa R, Fray, Caroline , Athaide, Melba, Kane, Andrea F., Carlo, Waldemar A., Bulas, Dorothy , Fairchild, Karen D. , Strand, Marya L. , Warren, Jamie B. , Niermeyer, Susan, Niermeyer, Susan, Barry, James A, Rincon, Monica P. , Josephsen, Justin , Hawkins, Melissa, Ciorogariu‐Ivan, Anna‐Maria, Travers, Colm P. , Carlo, Waldemar A. , Kline‐Fath, Beth M. , Epelman, Mónica

JAMA Network Open | November 24, 2025 | Volume: 8 | Issue: 11 | Pages: e2545258

10.1001/jamanetworkopen.2025.45258 | PMID 41284295 Get It

Importance Assisted ventilation during delayed cord clamping (DCC) may improve the physiologic transition of extremely preterm infants immediately after birth. Objective To determine whether assisted ventilation during 120 seconds of DCC was associated with reduced higher-level resuscitative interventions (intubation, chest compressions, or epinephrine administration) compared with DCC for 30 to 60 seconds followed by resuscitation. Design, Setting, and Participants This was a secondary analysis of the VentFirst randomized clinical trial that was conducted from September 2, 2016, through February 21, 2023, at 12 centers in the US and Canada. Infants born at 23 weeks 0 days’ to 28 weeks 6 days’ gestational age (GA) were included. Intervention Infants randomized to the intervention received either positive-pressure ventilation or continuous positive airway pressure from 30 to 120 seconds after birth, followed by umbilical cord clamping. Those randomized to control received 30 to 60 seconds of DCC followed by assisted ventilation. Main Outcomes and Measures The main outcome was the odds of higher-level resuscitative interventions in the delivery room (DR). Intention-to-treat analyses within 2 a priori cohorts (infants breathing well and not breathing well 30 seconds after birth) used the Cochran-Mantel-Haenszel method to estimate the odds ratios (ORs) of intervention vs control. Results All 570 infants enrolled in the trial were included. Infants had a median (IQR) GA of 26.6 (25.2-27.9) weeks and 273 (47.9%) were female. A total of 271 infants (47.5%) were assessed as not breathing well 30 seconds after birth (150 intervention and 121 control), and 299 (52.5%) were assessed as breathing well 30 seconds after birth (128 intervention and 171 control). In the not-breathing-well cohort, 146 infants (53.9%) were intubated in the DR, 4 received chest compressions (2 intervention and 2 control), and 1 received epinephrine (control). Intubation was less frequent in the intervention group (71 infants [47.3%] vs 75 infants [62.0%]; OR, 0.52; 95% CI, 0.30-0.89). When adjusted by GA strata at randomization, infants in the 26 to 28 weeks’ GA stratum who were in the intervention group were less likely to be intubated in the DR (18 of 79 infants [22.8%] vs 29 of 60 infants [48.3%]; OR, 0.32; 95% CI, 0.15-0.65). However, there was no difference in intubation rates for infants in the 23 to 25 weeks’ GA stratum (53 of 71 infants [74.7%] vs 46 of 61 infants [75.4%]; OR, 0.96; 95% CI, 0.44-2.12). Among infants breathing well at 30 seconds, 74 (24.7%) were intubated in the DR, and none received compressions or epinephrine. Intubation rates were similar between intervention and control in the breathing-well cohort. Conclusions and Relevance While the VentFirst trial did not find a difference in death or intraventricular hemorrhage, this secondary analysis found that assisted ventilation during DCC was associated with less intubation in the DR, primarily among infants born at 26 to 28 weeks’ gestation who were not breathing well 30 seconds after birth. Additional studies are needed before implementing assisted ventilation during DCC in clinical practice. Trial Registration ClinicalTrials.gov Identifier: NCT02742454
SANE Practice Integrated Competency Evaluation (SPICE): A Forensic Nurse Role Development and Performance Tool
Hoffman, Sarah J. , Dillon, Tara J., Jackson, Melissa A. , Pomegranate, Meira, Kolar, Susan, Frerich, Ellen A., Porta, Carolyn M. , Dillon, Tara

Journal of Forensic Nursing | November 11, 2025 | Volume: 22 | Issue: 2 | Pages: E128-E133

10.1097/jfn.0000000000000585 | PMID 41217373 Get It

Background Despite the widespread adoption of established and emerging forensic training and education modalities, there is limited evidence supporting effective ways in which to systematically evaluate their adoption into forensic nursing practice. To address this, our team developed the Sexual Assault Nurse Examiner (SANE) Practice Integrated Competency Evaluation (SPICE) as an innovative tool to support self-reflection, goal setting, and an evaluation of role development. Aim To establish expert consensus on the content and capacity of SPICE to evaluate role development across essential forensic nurse competencies, responsibilities, and clinical practice expectations. Method We utilized a modified Delphi method to establish expert consensus. Results We engaged forensic experts in multiple rounds of review. A deductive, rapid thematic analysis synthesized qualitative discussion. Survey-based results were summarized descriptively. Discussion The expert consensus approach we describe here highlights the potential and promising utility of SPICE to evaluate, guide, and enhance SANE role performance and ongoing professional development.
NCOG-27. Neuro-oncology anywhere: A fully decentralized clinical trial evaluating cognitive assessments and interventions for patients who received intracranial radiation therapy
Neth, Bryan J. , Galloway, Taylor , Hughes, Heather , Caron, Samantha, Batty, N., Alden, Eva , Kizilbash, Sani H. , Breen, William G. , Lehrer, Eric J. , Campian, Jian , Uhm, Joon H. , Ruff, Michael W. , Burns, Stacy D’Andre Terry, Haddad, Tufia C. , Flickinger, Lynn M. , Chan, Katrina, Mead‐Harvey, Carolyn , Geyer, Susan, Chan, Katrina , Neth, Byran J. , Kizilbash, Sani H , Sener, Uğur , Stricker, Nikki H. , Burns, Stacy D’Andre Terry

Neuro-Oncology | November 11, 2025 | Volume: 27 | Issue: Supplement_5 | Pages: v327-v327

10.1093/neuonc/noaf201.1294 Get It

Abstract BACKGROUND Cognitive symptoms are common among cancer patients treated with intracranial radiation but inadequately assessed and suboptimally treated, owing in part to the time-consuming and resource-intensive nature of formal neuropsychological testing. Through remote administration of brief cognitive assessments and symptom-directed interventions, decentralization uniquely addresses this problem. METHODS In this single-site phase 2 fully decentralized clinical trial (NCT06377696), patients treated with radiation therapy (RT) for primary or metastatic brain tumors undergo cognitive evaluations with the application, Mayo Test Drive, and the Short Test of Mental Status (STMS; via telehealth or in person), at baseline and every three months for one year. Participants are provided wearable devices for health promotion. Half the participants are randomized to metformin to evaluate this agent’s efficacy in treating RT-related cognitive symptoms. Target enrollment is 100 participants. RESULTS Seventy-three patients (median age 45.5, 46% female) with brain tumors who received RT were enrolled May 2024 to May 2025. In this unplanned interim analysis, we evaluated the impact of decentralization on study participation. Thirty-six participants (49%) reported a primary residence greater than 150 miles from our institution. Seven patients were consented remotely, the remainder in person. Of 380 study-related visits (201 STMS, 179 treatment toxicity checks) 216 (57%) were completed by telehealth. Thirty-two of 336 (9.5%) study-related lab draws were completed at locations outside our institution. Wearable device data was continuously collected, with median 3022 steps tracked per patient per day on study. 190/250 (76%) quality-of-life surveys sent digitally were completed to date. CONCLUSION Decentralization implemented as part of this clinical trial enabled participation despite significant distance from our institution and facilitated study-related assessments through digital solutions, eliminating the need for travel. Our findings demonstrate the feasibility of conducting a fully decentralized supportive care trial in neuro-oncology, which can increase participation and accelerate evaluation of novel therapeutics.
INNV-26. Neuro-oncology anywhere (NOA) 242: Interim results from a pragmatic clinical trial evaluating telehealth versus in-person evaluations for individuals with glioma undergoing oral chemotherapy
Galloway, Taylor , Schultz, Sydney , Hughes, Heather, Steinmetz, Sue, Tauer, William, Mason, Charles W. , Huebert, Carey, Walt, Charles Van Der , Uhm, Joon H. , Campian, Jian , Kizilbash, Sani H. , Neth, Bryan J. , Ruff, Michael W. , Karbhari, Nishika , Breen, William G. , Lehrer, Eric J. , Kottschade, Becky, Mead‐Harvey, Carolyn , Geyer, Susan, Haddad, Tufia C. , Neth, Byran J. , Kizilbash, Sani H , Karbhari, Nishika , Sener, Uğur , Hughes, Heather, Mason, Charles, Walt, Charles Van Der , Burns, Terry C.

Neuro-Oncology | November 11, 2025 | Volume: 27 | Issue: Supplement_5 | Pages: v230-v230

10.1093/neuonc/noaf201.0915 Get It

Abstract BACKGROUND Access to in-person evaluations is challenging for patients with glioma due to disease-related disability and distance from specialized neuro-oncology centers. Telehealth is an alternative to in-person evaluations, but acceptability of and therapy compliance with this model has not been prospectively evaluated. METHODS In this single-arm non-randomized pragmatic clinical trial, we compared patient satisfaction with telehealth and in-person assessments among patients with glioma undergoing chemotherapy with temozolomide. Participants acted as their own controls, alternating between telehealth and in-person visits. Patient satisfaction with care delivered was evaluated by Press-Ganey surveys with Likert response scales (1-5, 1=very poor, 5=very good). A digital pill diary (DPD) was implemented to track chemotherapy compliance. RESULTS We accrued 30 patients (median age 59, 38% female) between October 2024 and May 2025. Half of the patients (n=15) reported a primary residence greater than 150 miles from our institution. Surveys from 25 participants were reviewed, with 17/25 completing one or more surveys following an in-person visit, and 21/25 completing one or more surveys following a telehealth visit. Overall average Press-Ganey scores were similar between the two visit modalities with high scores (telehealth=4.8; in-person=4.7). Median scores for specific modalities were similarly highly rated: likelihood of recommending practice to others (telehealth=5.0; in-person=5.0), concern the care provider showed (telehealth=5.0, in-person=4.7), provider’s discussion of treatment options (telehealth=5.0, in-person=5.0), provider effort to include patients in decision-making (telehealth=5.0, in-person=5.0). DPDs used to monitor treatment compliance indicated adherence to all prescribed doses of temozolomide in 75/79 cycles; the other 4 (of 79) treatment cycles were halted per provider instructions. CONCLUSION This interim assessment demonstrates feasibility of treating patients with similar patient satisfaction of care delivered between telehealth and in-person visits. The DPD was effective in tracking chemotherapy administration. Additional results including visit type preference and acute care utilization data are maturing.
Evaluation of Interventions for Cognitive Symptoms in Long COVID
Koltai, Deborah, Laskowitz, Daniel T. , Wisnivesky, Juan P., Federman, Alex D. , Silverstein, Adam M. , Lokhnygina, Yuliya, Haddad, Michelle M., Mahncke, Henry W. , Vleet, Tom Van, Huang, Rong , Cox, Wendy C., Terry, Diana, Karwowski, Jeannie, McCray, Netia, Lin, Jenny , Singh, Upinder , Geng, Linda N. , Reece, Rebecca , Moy, James N., Arvanitakis, Zoe , Parthasarathy, Sairam , Patterson, Thomas F., Gupta, Aditi , Parsonnet, Jeffrey, Kiriakopoulos, Elaine T. , Mullington, Janet , Jolley, Sarah E. , Shah, Nirav S. , Morimoto, Sarah Shizuko , Lee‐Iannotti, Joyce , Isache, Carmen, Frontera, Jennifer , O’Steen, Ashley, James, Melissa, Harper, Barrie, Zimmerman, Kanecia O. , Lawler, Andrew , Johnson, Brandon M. , Pitsch, Chloe E. , Feuerriegel, Elen , McKeehan, Jeffrey, Molden, Joie, Reid, Kayleigh M., Dowling, Sarah , Wodushek, Thomas, Canton, Diara, Turut, Dilara, Sheppard, Ethan , Scott‐Sutherland, Jennifer, Shaughnessy, Lynn, Beck, Michelle L. , Heisey, Sabrina, Katragadda, Vaishanvi, Yusuff, Amidat, Perlack, Amy, Merisme, Christie, Krause, David, Schulte, Duncan, Dupre, Fabiola, Sanchez, Gina A. Montealegre , Asupoto, Olanike, Simmons, Quinneil, Schroeder, Ryan W. , Timlin, Shannon, Devis, Ycar, Carter, Della, Caceres, Leomaris Caba, Rodríguez, Miguel Grande, Alvarez, Zariya , Yakubov, Amin , Engelson, Celia, Reyes, Michael, Youkhana, Alvin, Jennings, Cheryl , Naquiallah, Dina, Behun, Dylan , Stephen, Ellen, Timm, Emily , Bilimoria, Farrah, Li, Grace , Stricker, Thomas, Michelle, Kang, Minnie, Suarez, Rebeca Tojo, Carmona, Tania, Ramírez, Ana, Kadubek, Grace, Baker, Aileen, Romo-Serna, Andrea, Predki, Barbara, Leman, Cindy, Panhans, Cristina, Roth, Genevieve E., Rudraraju, Gowrisree , Miller, Hannah , DeLisa, Julie A., Williams, Kat, Woodson, Kimberly S., Jennette, Kyle J. , Villanueva, Laura, Norwick, Maria, Martínez, M. T., Rowley, Matt, Carrithers, Michael D. , Pliskin, Neil H. , Pérez, Nicolás , Durkin, Nicole M., Maniar, Nikita, Beety, Rachel, Daspgupta, Raktima, Ramchandran, Ramaswamy, Jaramillo, R., Hasek, Sharon, Macías, S Aguirre, Schuh, Tina , Ialacci, Sarah, Bailey, Christopher , Labbato, Danielle, Hautmann, Amanda , Smith, Beth, Nath, Dia, Meyer, Jessica , DiFrancesco, Kathryn, Pettinato, Kimberly, Curtis, Lynette, Daher, Joviane , Koberssy, Ziad , Mavar, Caleb, Andrefsky, John, Merheb, Alexander, Hernandez, Carla, Baissary, Jhony , Atieh, Ornina , Pereira, Carol, Carpenter, Deborah, Raynor, Jennifer , Brunton, Kristine, Podgoreanu, Andreea, Bunch, P. C., O’Brien, Sean M. , Dickey, Sheila, McNulty, Steven E., Gajjar, Varsha, Neale, Alec C. , Cohen, Cari, Geary, Elizabeth, Campanella, Franco, Anderson, Kirsten, Prestige, Laura, Guidotti-Breting, Leslie, Biewer, Megan, Morton, Melissa , Mathenia, Nicholas, Adeyemi, Oluwadamilola A. , Hengst, Samanike, Ning, Wei , Vanderloo, Adam, Caplan, Amanda, Chen, July, Acree, Mary Ellen , Nakhate, Mukund, Dan, Zaw Nu, Pk, Switzer, Aryal, Shambhu , Sanchez, Jessica, Sims, Luke, Ferdinand, Rebecca , Mammadova, Mehriban, Grimes, Carolyn Z. , Vidales, Elizabeth, Pham, Hau , Nielsen, Laura, Keller, Maryjane, Uruba, Syeda, Hernandez, Maria, Patel, Bela , Umana-Sanchez, Virginia, Pak, Chong, Gainer, Jeffery, BURR, R, Trapuzzano, Ashleigh, Celso, Brian G. , Bienkowski, Grace, Bowman, Jennifer, Verdecia, Jorge , Zerwekh, Kathryn, Serrano, Liliana , Marotz, Meghan, Propp, Piper, Sarig, Yonatan , Murphy, Annie, Comfort, Brandon, Torres, Iri, Klein, Jeffrey A. , Walker, John, Moore, John J., Tempest-Browning, Lisa, Arain, Mudassar, Kemp, Pamela, Sullivan, Samantha, Way, Sonja, Chevalier, Jessica, Sykes, Carly, Kruck, Carrie L., Sackett, L. W., Bang, Claire, Hynes, Mary, Gallagher, Torrey L., Childers-Kakos, Margaret, Zia, Ahmad, South, AP, Oravets, Anne, Ferreyra, Carolyn, Glaze, Chad, Villanueva, Daphne-Dominique , Blystone, Erica, Pritchard, Jane, Alyward, Laura, Cooper, Melissa, Chidester, Michelle, Alderson, R. Matt , Clark, Renee D., Hodder, Sally , Sarwari, Arif R, Juskowich, Joy, Welch, Shelly, Civil, Alyssa, Bendl, Ashley, Dicker, Elisa, Hanson, Hannah, Viola, Heather, Morinigo, Janice, Pantaleon, Karisma, Marcon, Kathryn, Stone, Kimberly, Stewart, Kiwan, Evo-Ortega, Lorraine, McVeety, Megan, Guliyeva, Sabina , Watson, Eric , Pehel, Shayna, Ko, Tim, Caropolo, Leah, Kocas, H. Deniz , O’Donnell, Andrew, Saperia, Corey , Thai, Daniel, Pathak, Divya , Keller, Jennifer M. , Olszewski, Kelly, Clinton, Kimberly, Cherian, Kirsten , Dutton, L M, Elepano, Ma, Mohapatra, Sukanya , Chen, Ting , Wroolie, Tonita, Leang, Zenita, Shashidhar, Sumana, Nguyen, T L, Ravisankar, Ashwath, Weiden, Brycie, Bolliger, Dawn, Glesne, Heather, Dixon, Jennifer , Chebrolu, Praneeth, Gazali, Zarine, Hurst, Whitney, Fry, Avery, Murthy, Ganesh, Grischo, Garrett, Erickson, Heidi L. , Gomez, Isaias, Copeland, Jacquelynn, Galaz, Judy, Autry, Lynn, DiLise-Russo, Marjorie, Marshell, Nikki, Borwege, Sabine, Vadovicky, Sheila, Marsh, Stephanie, Hartley, William, Murtagh, Linda, Kennedy, Anna, Meltzer-Christensen, Annie, Stringham, Caitlyn, Gaskin, Ella, Judd, Melissa, Côté, Sarah , Mahasenan, Shreya, Bjorklund, Todd, Farner, Cheryl E., Taylor, Barbara S. , Soileau, Bridgette, Cote, Cyrena , Hromas, Gabrielle A., Scholler, Irma, Longoria, Lisa, Heard, Patricia, Jones, Johnnie, Tragus, Robin , Harris, Maya, Pinones, Alexis, Anderson, Alyssa , Hastings, Gabrielyd, Courtright, jessica, Jayakumar, Madhumita, Fischer, M, Solis, Pamela, Harteloo, Alex, Elias-Warren, Anna, Nguyen, Daniel , McDonald, Dylan , Rau, Holly , Mernaugh, Jean, Pagulayan, Kathleen F. , Watanabe, Kino, Huden, Kristen, Peabody, Laurel, Mei, Tiffany, Ogunwuyi, Catherine, Cobbina, Esther, Sankar, Ian, Nguyen, Lisa , Fromm, N., Arnold, R. Douglas, Ogu, Stephanie, Yuan, Ying , Ibrahim, Homam , Szum, Izabella, Patel, Jignesh, Sultan, Sonia, Jazayeri, Yasmin, Anderson, Betty Lise, Muñoz, Isabel , Rhys, Logan, Vane, Ryan, Kim, Jessica , Diaz, Leticia M., Yee, Nathan, Gruhn, Robert, Browngoetz, Sarah, Johnson, Elisha, Chand, Arista , Bottrill, Kenneth , Henderson, Kymberly, Johnson, DeArmond, Richard C., Hughes, Trina, Silverstein, A , Silverstein, Adam P , Frontera, Jennifer , Geng, Linda N. , Knopman, David S. , Becker, Jacqueline , Charvet, Leigh , Pilloni, Giuseppina , Huang, Rong, Cox, Wendy, Karwowski, Jeannie, McComsey, Grace A. , Chu, Helen Y. , Ostrosky‐Zeichner, Luis , Fong, Tamara G. , Killgore, William D. S. , Dwyer, Brigid C. , Stringer, William W. , Krishnan, Jerry A , James, Melissa, Johnson, Brandon, Erlandson, Kristine M. , Dowling, Sarah, Hauser, Kristine , Doyle, Michael, Beck, Michelle, Tran, Anh, Altaras, Caroline , Sanchez, Gina, Krengel, Maxine , Ly, Monica T. , Asupoto, Olanike, Schroeder, Ryan, Rodriguez, Miguel, González, David Andrés , Torres, Jimena, García, Maria Luisa , Carrera, Laura, Rutherford, Melissa, Perez, Nicolas, Jaramillo, Ruthie, Smith, Beth, Walkup, Kevin, Scott, Sarah , Mavar, Caleb B., Carpenter, Deborah, Bunch, Pyper, Brown, Richard, Escobar, Carolina, Campanella, Franco, Mathenia, Nicholas, Glickman, Michael S. , Sims, Luke A., Pham, Hoai Phuang, Lopez, John, Hernandez, Maria, Lin, Matthew Junda , Gainer, Jeffery, Brown, Gina , Klein, Jeffrey, Reed, Jessica, Walker, John, Sackett, Lisa, Kaden, Sarah J. , Childers-Kakos, Margaret G, South, Amy, Blystone, Erica, Cooper, Melissa, Alderson, Rachael, Clark, Renee, Bardes, James M. , Hanson, Hannah, Loizos, Maria , Caropolo, Leah J., Fernandez, Luis, Keller, Jennifer, Lin, Rebecca, Brown, Daniel, Dixon, Jennifer, James, Michelle, Kala, Mrinalini , Smith, Ryan S. , Mahasenan, Shreya, Johnson, Hillary, Anderson, Alyssa, Hernandez, Jessica, Sullivan, Michael, Nguyen, Helen , Logue, Jennifer, Mei, Tiffany, Arnold, Rowan, Szum, Izabella , Hatlen, Timothy J. , Anderson, Betty, Munoz, Isabel, Wright, Matthew, Diaz, Leticia, DeCato, Thomas W. , Ortiz, Ernesto, Hildebrand, Lindsey L. , DeArmond, Richard

JAMA Neurology | November 10, 2025 | Volume: 83 | Issue: 1 | Pages: 49

10.1001/jamaneurol.2025.4415 | PMID 41212544 Get It

Importance Treatment for cognitive dysfunction due to postacute sequelae of long COVID (ie, symptoms of fatigue, malaise, weakness, confusion that persist beyond 12 weeks after an initial COVID infection) remains a significant unmet need. Objective To test evidence-based rehabilitation strategies for improving cognitive symptoms in persons with long COVID. Design, Setting, and Participants This was a 5-arm, multicenter, randomized clinical trial of 3 remotely delivered interventions conducted between August 17, 2023, and June 10, 2024. The study took place at 22 trial sites and included the screening of individuals with cognitive long COVID. Interventions Participants were randomized to 1 of 5 arms: adaptive computerized cognitive training (BrainHQ [Posit Science]), cognitive-behavioral rehabilitation involving both group and individual counseling sessions (PASC-Cognitive Recovery [PASC-CoRE]) paired with BrainHQ, and transcranial direct current stimulation (tDCS) paired with BrainHQ. Two comparator arms were included as follows: unstructured computer puzzles and games (active comparator) and sham tDCS paired with BrainHQ. The interventions occurred 5 times per week over 10 weeks. Main Outcomes and Measures Cognitive and behavioral in-person assessments were performed at baseline, midintervention, at the end of intervention, and 3 months after the end of the intervention. The primary outcome measure was the modified Everyday Cognition Scale 2 (ECog2) completed at the end of the intervention compared to the baseline visit based on participant self-report looking back over the prior 7 days. Results A total of 378 individuals were screened, from which there were 328 participants (median [IQR] age, 48.0 [37.0-58.0] years; 241 female [73.5%]; race: 15 Asian [4.6%], 47 Black [14.3%], and 235 White [71.6%]; ethnicity: 52 Hispanic [15.9%]). None of the 3 active interventions demonstrated benefits on the modified ECog2 in the intention-to-treat population by the end of the intervention period. The adjusted differences in mean change were 0.0 (95% CI, −0.2 to 0.2) for BrainHQ vs active comparator, 0.1 (95% CI, −0.1 to 0.3) for PASC-CoRE + BrainHQ vs active comparator, 0.0 (95% CI, −0.2 to 0.2) for tDCS-active + BrainHQ vs tDCS-sham + BrainHQ, and 0.1 (95% CI, −0.1 to 0.3) for PASC-CoRE + BrainHQ vs BrainHQ alone. Secondary participant-reported outcomes and neuropsychological tests showed no differential benefits for any treatment arm. All 5 arms demonstrated some improvements over time on the modified ECog2 and on secondary outcomes. There were no serious adverse events attributable to the interventions. Conclusions and Relevance This phase 2 randomized clinical trial failed to demonstrate differential benefits for online cognitive training, a structured cognitive rehabilitation program, and tDCS for cognitive long COVID. Trial Registration ClinicalTrials.gov Identifier: NCT05965739 .
Shape analysis of the amygdala, hippocampus and thalamus in former American football players
John, Omar , Wickham, Alana, Jung, Leonard , Mirmajlesi, Anya S, Stearns, J. W. , Breedlove, Katherine M. , Billah, Tashrif , Pasternak, Ofer , Chamaria, Arushi , Bernick, Charles , Balcer, Laura J. , Rushmore, R. Jarrett , Alosco, Michael L. , Lin, Alexander , Cummings, Jeffrey L., Reiman, Eric M. , Arciniega, Hector , Su, Yi, Chen, Kewei, Protas, Hillary, Boker, Connie, Alosco, Michael L, Au, Rhoda, Cantu, Robert C, Farrer, Lindsay, Helm, Robert, Katz, Douglas I, Kowall, Neil, Mez, Jesse, Mercier, Gustavo, Otis, James, Weller, Jason, Simkin, Irene, Andino, Alondra, Conneely, Shannon, Diamond, Courtney, Fagle, Tessa, Haller, Olivia, Hunt, Tennyson, Gullotti, Nicole, Mariani, Megan, Mayville, Brian, McLaughlin, Kathleen , Nanna, Mary, Platt, Taylor, Rice, Fiona, Sestak, Madison, Annis, Douglas S. , Dixon, Diane, Finney, Carolyn, Gallagher, Kerrin, Hartlage, Kaitlin , Martin, Brett, Palmisano, Joseph , Pine, Brittany, Fitzsimmons, Jennifer, Pasternak, Ofer, Arcinieago, Hector, Coello, Eduardo , Coleman, Michael J. , Jung, Leonhard, Liao, Huijun, Loy, Maria, Rizzoni, Elizabeth, Schultz, Vivian , Silva, Annelise, Vessey, Brynn, Banks, Sarah J. , Ritter, Aaron, Cruz, Raelynn de la, Durant, Jan, Golceker, Morgan, Harmon, Nicolette, Kaylegian, Kaeson, Long, Rachelle, Nance, Christin, Sandoval, Priscilla, Serrano, Andrew, Falk, Bryce W., Duffy, Amy, Howard, Marci, Montague, Michelle , Osgood, Thomas, Babcock, Debra, Marmar, Charles R. , Hasanaj, Lisena, Serrano, Liliana , Al-Kharafi, Alhassan, George, Allan , Martin, Sammie, Runge, William, Peskind, Elaine R. , Colasurdo, Elizabeth A. , Marcus, Daniel S., Gurney, Jenny , Greenwald, Richard M., Johnson, Keith A, Jung, Leonard B , Stearns, Jared , Breedlove, Katherine , Tripodis, Yorghos , Adler, C H , Alosco, Michael L , Koerte, Inga K , Arciniega, Hector , Kim, Nicholas , Daneshvar, Daniel H. , Coleman, Michael , Tripodis, Yorghos , Adler, Charles H. , Stern, Robert A. , Shenton, Martha E. , Bouix, Sylvain , Su, Yi, Chen, Kewei, Alosco, Michael L., Au, Rhoda, Cantu, Robert C. , Mez, Jesse, Weller, Jason , Simkin, Irene, Fagle, Tessa, Pulukuri, Surya Vamsi , McClean, Michael D , Annis, Douglas, Chaisson, Christine E. , Finney, Carolyn, Lü, Jun , Ojo, Emmanuel, Ramachandran, Janani , Bonke, Elena M. , Wiegand, Tim L. T. , Miller, Jason Rafe , Sabbagh, Marwan Noel , II, Robert W. Turner , Marek, Kenneth , Dodick, David W. , Geda, Yonas E. , Wethe, Jennifer V. , Falk, Bryce, Montague, Michelle, Bellgowan, Patrick S.F. , Barr, William , Goldberg, Judith D. , Wısnıewskı, Thomas , Kirov, Ivan I. , Lui, Yvonne W. , George, Allan, Riley, Edward P. , Cummings, Jeffrey L. , Johnson, Keith A.

Brain Communications | November 6, 2025 | Volume: 7 | Issue: 6 | Pages: No page available

10.1093/braincomms/fcaf440 | PMID 41277896 Get It

Abstract Repetitive head impacts are common in contact and collision sports and are linked to structural brain changes and an elevated risk of neurodegenerative diseases such as Chronic Traumatic Encephalopathy. Identifying early in vivo structural markers remains challenging. Although diagnosis currently requires post-mortem confirmation, clinical symptoms, including cognitive impairment and behavioural changes, are reflected in the diagnosis of Traumatic Encephalopathy Syndrome. These symptoms align with dysfunction in key brain regions—amygdala, hippocampus and thalamus—which support memory, emotion and behaviour and commonly show tau pathology in Chronic Traumatic Encephalopathy. This study uses shape analysis to examine structural differences in these regions between former American football players and unexposed asymptomatic controls and evaluates the influence of age, head impact exposure and clinical diagnosis on brain structure. We analyzed brain morphology in former American football players (n = 163) and unexposed, asymptomatic controls (n = 53). Structural segmentation was performed with FreeSurfer 7.1, and the shape analysis pipeline was used to generate subregional reconstructions. Vertex-level morphometry, based on the logarithm of the Jacobian determinant and radial distance, quantified local surface area dilation and thickness. Group differences were examined with covariate-adjusted linear regression models contrasting football players and controls, as well as participants with and without a Traumatic Encephalopathy Syndrome diagnosis. Partial correlations examined the influence of age, age of first football exposure and cumulative head impact index metrics, including frequency, linear acceleration and rotational force. Models were adjusted accordingly for age, body mass index, education, race, imaging site, apolipoprotein ϵ4 status and total intracranial volume. Former football players exhibited bilateral surface area contractions in the hippocampus and amygdala, along with reduced amygdala thickness, compared to controls. Older age was associated with widespread surface contractions and thinning across all regions, except for preserved thickness in the left hippocampus. An earlier age of first exposure to football correlated with surface contractions in the thalamus and left hippocampus. Greater cumulative linear acceleration was linked to bilateral hippocampal surface contractions and reduced thickness in the left thalamus, while greater rotational force exposure was associated with hippocampal thinning. No significant structural differences were found between players with and without a diagnosis of Traumatic Encephalopathy Syndrome. These findings extend volume-based research by revealing localized alterations in surface area dilation and thickness and emphasize the roles of age and repetitive head impact exposure in long-term brain changes.
Assessing Critical Care Delivery Using National-Level ICU Registry Data
Kasotakis, George , Kuriyama, Akira , Smalls, Norma, Connor, Kathryn , Miller, Andrew G , Bittner, Edward A. , Temsah, Mohamad-Hani, Siddiqui, Shahla , Biswas, Saptarshi , Slain, Katherine , Akuamoah-Boateng, Kwame , Sakhuja, Ankit , Boomer, Laura A., Setliff, Erika L., Neyra, Javier A. , Rincon, Teresa , Bose, Somnath , Barwise, Amelia , Group, the Society of Critical Care Medicine (SCCM) U.S. ICU Registry Working, Barwise, Amelia K , Dempsey, Timothy , Jaehne, Anja Kathrin , Temsah, Mohamad‐Hani , Bell, Carolyn M. , Khanna, Ashish K. , Owusu, Kent A. , Alexander, Peta , Dugar, Siddharth , Cantrell, Sarah E. , Shein, Steven L. , Group, the Society of Critical Care Medicine (SCCM) U.S. ICU Registry Working

Critical Care Medicine | October 27, 2025 | Volume: 53 | Issue: 12 | Pages: e2674-e2685

10.1097/ccm.0000000000006886 | PMID 41139471 Get It

Objective: The specialty of critical care in the United States currently lacks a single, broad, unified database. We conducted a scoping review of existing established national ICU databases, describing national and international patterns of critical care delivery. Data Sources: A systematic literature search was undertaken using MEDLINE, Embase, and Web of Science search engines. Study Selection: Projects describing national critical care delivery (including any subspecialty) published in any language were included. Titles, abstracts, and full-text manuscripts were reviewed in duplicate for inclusion. Data Extraction: National database characteristics were collected, including the number and subspecialty of ICUs, the inaugural year, data entry methodology, the number of episodes of care included, and captured clinical data elements. Data Synthesis: Of 24,003 abstracts screened, 185 manuscripts were eligible for inclusion. Thirty countries were identified as having established national ICU registries: Argentina, Australia/New Zealand, Austria, Belgium, Brazil, Canada, Denmark, Ecuador, Finland, Germany, Iceland, India, Ireland, Italy, Japan, Kenya, Malaysia, Mexico, Nepal, Netherlands, Norway, Pakistan, Paraguay, Spain, Sri Lanka, Sweden, Switzerland, United Kingdom, United States and Uruguay. Data entry commonly incorporates a combination of automated data abstraction from electronic healthcare systems and manual data entry, followed by independent validation. Frequently recorded variables include patient demographics; admission vital signs and laboratory data; comorbidities; admission source and diagnoses; ICU diagnoses, treatments, and complications; illness severity scores; and clinically relevant outcomes including discharge disposition, functional status, lengths of stay, and mortality. Conclusions: Insights and experience gained from the study of mature national ICU registries may be used to guide an equivalent U.S. multidisciplinary program aimed at benchmarking, needs assessment, quality improvement, and research facilitation
Methods for implementing and reporting the Patient‐Reported Outcomes version of the Common Terminology Criteria for Adverse Events to measure patient‐reported adverse events in cancer clinical trials
Dueck, Amylou C. , Thanarajasingam, Gita , Rogak, Lauren , Mazza, Gina L. , Langlais, Blake, Ginos, Brenda, Mead‐Harvey, Carolyn , Lee, Minji K. , Deal, Allison M., Meek, Eric A., Basch, Ethan , Dueck, A. C. , Langlais, Blake T., Ginos, Brenda F, Yee, Claire I., Basch, Ethan , Mazza, Gina L , Noble, Brie N. , Yee, Claire

Cancer | October 22, 2025 | Volume: 131 | Issue: S2 | Pages: No page available

10.1002/cncr.35951 | PMID 41123546 Get It

Abstract The Patient‐Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO‐CTCAE) was developed by the US National Cancer Institute to allow patients to directly report their side effects, enhancing the accuracy and patient‐centeredness of cancer clinical trial adverse event reporting. Clinician‐based reporting often misses the full range of patient symptoms, resulting in underreporting of side effects. The selection of adverse events for patient reporting must be defined in advance and consistently applied across all study arms. Investigators can use core symptom sets, including diarrhea, fatigue, and nausea, alongside tailored items specific to the treatments being studied. PRO‐CTCAE has demonstrated similar scores across electronic, paper‐based, and automated telephone administration methods. PRO‐CTCAE administration typically occurs before start of treatment and regularly throughout treatment, with the administration frequency tailored to the expected trajectory of side effects. Ensuring high survey completion rates is essential for PRO‐CTCAE success. Standard reporting can include tabular reporting of the proportion of patients with any (score ≥1) and high (score ≥3) levels of symptoms at the individual item level. A baseline‐adjustment approach should be applied to account for symptoms before start of treatment to isolate treatment‐emergent adverse events. The distribution of PRO‐CTCAE scores at each time point can be visualized using stacked bar charts. PRO‐CTCAE integration into cancer clinical trials is crucial for capturing a comprehensive range of treatment‐related symptomatic adverse events and improving the evaluation of therapy tolerability. Ongoing research continues to refine its implementation, supported by regulatory guidance.
Association between housing instability and frailty among people with HIV
Fahey, Carolyn A. , Drumright, Lydia N. , Fredericksen, Rob J. , Yendewa, George A. , Karris, Maile , Mixson, L. Sarah , Agil, Deana , Burkholder, Greer , Bamford, Laura , Fleming, Julia, Hahn, Andrew W. , Austad, Steven N. , Cachay, Edward R. , Kitahata, Mari M. , Saag, Michael S, Crane, Heidi M. , Whitney, Bridget M. , Cachay, Edward, Drumright, Lydia N , Ruderman, Stephanie A. , Napravnik, Sonia , Webel, Allison R. , Mayer, Kenneth Hugh , Fleming, Julia, Kritchevsky, Stephen B. , Delaney, Joseph A. , Saag, Michael S.

AIDS | October 7, 2025 | Volume: 40 | Issue: 1 | Pages: 90-99

10.1097/qad.0000000000004370 | PMID 41056002 Get It

Background: Housing instability and HIV are both associated with early onset of aging-related health conditions, including frailty. However, little is known about the relationship between housing and frailty among people with HIV. Methods: We analyzed data on adults in HIV care collected during routine clinical visits at 6 sites within the US Centers for AIDS Research Network of Integrated Clinical Systems (CNICS) between 2019 and 2024. We measured frailty using a previously validated approach, defined as having at least three of four components (fatigue, weight loss, immobility, inactivity) vs. less than three components. Housing status was based on self-perceived living situation in the past month (“Stable,” “Unstable,” “Homeless,” or “Don’t know”). We estimated the association between most recent housing status and frailty with prevalence ratios from relative risk regression adjusted for sociobehavioral and clinical characteristics. Results: Among 6961 people with HIV (84% men, 16% women) with a median age of 52 years (IQR: 40–60), 11% ( n = 760) were frail and 9% ( n = 625) were unstably housed (5% unstable, 3% homeless, 1% do not know). Compared to individuals with stable housing, the prevalence of frailty more than doubled among those experiencing unstable housing [prevalence ratio = 2.41, 95% confidence interval (95% CI): 1.95–2.97] or homelessness (prevalence ratio = 2.05, 95% CI: 1.56–2.69). Stratified analyses indicated stronger associations among younger vs. older individuals and among those virally suppressed vs. unsuppressed. Conclusion: Housing instability and frailty were both prevalent and strongly associated among adults in HIV care, including within younger and virally suppressed subgroups. These findings highlight the importance of social determinants of health for clinical outcomes among all people with HIV.
Blood Pressure, Safety and Clinical Efficacy of Vericiguat in Chronic Heart Failure with Reduced Ejection Fraction: Insights from the VICTOR Trial
Mentz, Robert J. , McMullan, Ciaran J. , Wojdyla, Daniel , Anstrom, Kevin J. , Barash, Irina , Bonaca, Marc P. , Borentain, Maria, Corda, Stefano , Gates, Davis, Lam, Carolyn, Lewis, Eldrin F. , O'Connor, Christopher M., Reddy, Yogesh N.V. , Rosano, Giuseppe M.C., Saldarriaga, Clara , Senni, Michele, Teixeira, Pedro Pinto , Udelson, James E. , Urbinati, Alessia , Vlajnic, Vanja , Xing, Aiwen, Zannad, Faiez, Group, for the VICTOR Study, Nishimura, Rick , Mentz, Robert J , Butler, Javed , Ezekowitz, Justin A. , Lam, Carolyn S.P. , Lindenfeld, JoAnn , O’Connor, Christopher M. , Ponikowski, Piotr , Senni, Michele , Voors, Adriaan A. , Zannad, Faı̈ez , Group, for the VICTOR Study

European Journal of Heart Failure | September 29, 2025 | Volume: 27 | Issue: 12 | Pages: 2825-2836

10.1002/ejhf.70033 | PMID 41020754 Get It

Abstract Aims The efficacy and safety of vericiguat in patients with chronic heart failure with reduced ejection fraction (HFrEF) on contemporary heart failure (HF) therapies and without recent worsening was investigated in the VICTOR trial, yet some subgroups may be more susceptible to symptomatic hypotension. Methods and results Among VICTOR trial participants that received at least one dose of study drug or placebo, we describe the systolic blood pressure (SBP) trajectories over time (mean change from baseline), symptomatic hypotension events and efficacy of vericiguat in potentially vulnerable patient subgroups: lower baseline blood pressure (SBP ≤110 mmHg), older patients (>75 years) and those taking angiotensin receptor–neprilysin inhibitors (ARNI) or sodium–glucose co-transporter 2 inhibitors (SGLT2i) at baseline. The efficacy outcomes of cardiovascular death and HF hospitalization and cardiovascular death alone across baseline SBP were examined using Cox proportional hazards models. Overall SBP trajectories showed a small initial decline from baseline in vericiguat-treated patients compared with placebo (placebo-corrected differences of −1.17 [−1.84, −0.50], p = 0.0007) that was relatively stable throughout follow-up. This trajectory was similar in those >75 years (vs. younger) as well as those receiving ARNI or SGLT2i (as compared with those not receiving these) or those with SBP ≤110 mmHg at baseline (compared with >110 mmHg). Symptomatic hypotension occurred in 11.3% of vericiguat-treated patients compared with 9.2% of placebo-treated patients with an adjusted hazard ratio of 1.24 (95% confidence interval 1.06–1.46), which was similar across age, SBP, SGLT2i and ARNI groups (all interaction p >0.05). The treatment effect of vericiguat compared with placebo on the efficacy outcomes was similar across the spectrum of baseline SBP (both interaction p >0.15). Conclusions Vericiguat showed a slight adjusted decrease in SBP and resulted in more symptomatic hypotension compared with placebo but was overall well-tolerated in a broad population with HFrEF on contemporary therapy even among those predisposed to hypotension. Treatment effects on efficacy outcomes were consistent regardless of baseline SBP.