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TBCRC 057: An online survey about anxiety and willingness to participate in breast cancer clinical trials during the COVID-19 pandemic.
Mead‐Harvey, Carolyn , Frank, Elizabeth , Melisko, Michelle , Salamone, Jeannine M., Pollastro, Terri, Spears, Patricia A. , Smith, Karen L. , Mazza, Gina L , Shinn, Eileen H. , Eaton, Cyd K. , Wolff, Antonio C. , Rocque, Gabrielle B.

Journal of Clinical Oncology | June 6, 2022 | Volume: 40 | Issue: 16_suppl | Pages: 1564-1564

10.1200/jco.2022.40.16_suppl.1564 Get It

1564 Background: Enrollment in clinical trials has declined during the COVID-19 pandemic. Simultaneously, breast cancer patients have reported heightened anxiety. We assessed whether breast cancer patients’ anxiety about the pandemic affects their willingness to participate in trials. Methods: English or Spanish-speaking US residents with breast cancer were eligible to complete the online REDCap survey 8/6/21 – 9/30/21. Respondents rated their anxiety about the pandemic on an 11-point scale from 0 (no anxiety) to 10 (worst anxiety possible). Anxiety scores were categorized as no/mild (0-3), moderate (4-6) or severe (7-10). Knowledge about trials was assessed with 11 true/false items and attitudes toward trials with the Attitudes Toward Cancer Trials Scales - Cancer Treatment Subscale (ATCTS-CTS). Respondents rated their willingness to participate in a breast cancer clinical trial before and during the pandemic on 5-point scales from 0 (not at all willing) to 4 (definitely willing). Trial participants were considered “definitely willing.” Change in willingness to participate in trials during the pandemic compared to prior was defined as a binary outcome, "less willing" vs "no less willing." Means were compared via t-test and mean difference was tested via paired t-test. Multivariable logistic regression was used to model the association of anxiety and other factors with being less willing to participate in trials during compared to prior to the pandemic. Results: Among 385 respondents, median age was 52 (range 25-85), 271 (70%) were non-Hispanic White and 202 (53%) had metastatic disease. 154 (40%) received care at academic centers and 37 (10%) were current trial participants. Most rated their anxiety as moderate (43%) or severe (38%). Mean willingness to participate in a trial was lower during compared to prior to the pandemic (2.97 vs 3.10; p < 0.0001). Fifty (13%) respondents were less willing to participate in a trial during the pandemic compared to prior. After controlling for covariates, those with severe anxiety had 5.07 times odds of being less willing to participate during the pandemic compared to prior than those with no/mild anxiety (p = 0.01). For every 1-point increase in ATCTS-CTS score (indicating better attitude toward trials) there was a 3% decrease in the odds of being less willing to participate during the pandemic (p = 0.006). For every 1-point increase in the clinical trials knowledge score (indicating more knowledge) there was a 15% decrease in the odds of being less willing to participate during the pandemic (p = 0.02). Conclusions: Pandemic-related anxiety is common in breast cancer patients and is associated with being less willing to participate in trials during the pandemic compared to prior. Education about trials, including safety modifications implemented during the pandemic, may mitigate anxiety and improve willingness to participate.
Ciltacabtagene Autoleucel, an Anti–B-cell Maturation Antigen Chimeric Antigen Receptor T-Cell Therapy, for Relapsed/Refractory Multiple Myeloma: CARTITUDE-1 2-Year Follow-Up
Martin, Thomas G. , Usmani, Saad Z. , Berdeja, Jesús G. , Agha, Mounzer , Cohen, Adam D. , Hari, Parameswaran , Avigan, David , Deol, Abhinav , Htut, Myo , Lesokhin, Alexander M. , Munshi, Nikhil C. , O’Donnell, Elizabeth , Stewart, A. Keith , Schecter, Jordan M. , Goldberg, Jenna D., Jackson, Carolyn C. , Yeh, Tzu‐Min, Banerjee, Arnob , Allred, Alicia J., Zudaire, Enrique, Deraedt, William , Olyslager, Yunsi, Zhou, Changwei, Pacaud, Lida , Lin, Yi , Jakubowiak, Andrzej , Lin, Yi , Jagannath, Sundar , Lesokhin, Alexander M , Cohen, Adam D , Hari, Parameswaran , Berdeja, Jesús G , Usmani, Saad , Goldberg, Jenna D., Madduri, Deepu , Jakubowiak, Andrzej , Jagannath, Sundar

Journal of Clinical Oncology | June 4, 2022 | Volume: 41 | Issue: 6 | Pages: 1265-1274

10.1200/jco.22.00842 | PMID 35658469 Get It

PURPOSE CARTITUDE-1, a phase Ib/II study evaluating the safety and efficacy of ciltacabtagene autoleucel (cilta-cel) in heavily pretreated patients with relapsed/refractory multiple myeloma, yielded early, deep, and durable responses at 12 months. Here, we present updated results 2 years after last patient in (median follow-up [MFU] approximately 28 months), including analyses of high-risk patient subgroups. METHODS Eligible patients had relapsed/refractory multiple myeloma, had received ≥ 3 prior lines of therapy or were double refractory to a proteasome inhibitor and immunomodulatory drug and had received prior proteasome inhibitor, immunomodulatory drug, and anti-CD38 therapy. Patients received a single cilta-cel infusion 5-7 days after lymphodepletion. Responses were assessed by an independent review committee. RESULTS At a MFU of 27.7 months (N = 97), the overall response rate was 97.9% (95% CI, 92.7 to 99.7); 82.5% (95% CI, 73.4 to 89.4) of patients achieved a stringent complete response. Median duration of response was not estimable. Median progression-free survival (PFS) and overall survival (OS) were not reached; 27-month PFS and OS rates were 54.9% (95% CI, 44.0 to 64.6) and 70.4% (95% CI, 60.1 to 78.6), respectively. Overall response rates were high across all subgroups (95.1%-100%). Duration of response, PFS, and/or OS were shorter in patients with high-risk cytogenetics, International Staging System stage III, high tumor burden, or plasmacytomas. The safety profile was manageable with no new cilta-cel–related cytokine release syndrome and one new case of parkinsonism (day 914 after cilta-cel) since the last report. CONCLUSION At approximately 28 months MFU, patients treated with cilta-cel maintained deep and durable responses, observed in both standard and high-risk subgroups. The risk/benefit profile of cilta-cel remained favorable with longer follow-up.
Social Media, Digital Health Literacy, and Digital Ethics in the Light of Health Equity
Gabarrón, Elia , Miron‐Shatz, Talya , Petersen, Carolyn , Petersen, Carolyn , Rivera-Romero, Octavio , Denecke, Kerstin

Yearbook of Medical Informatics | June 2, 2022 | Volume: 31 | Issue: 01 | Pages: 082-087

10.1055/s-0042-1742503 | PMID 35654433 Get It

Objective: Social media is used in the context of healthcare, for example in interventions for promoting health. Since social media are easily accessible they have potential to promote health equity. This paper studies relevant factors impacting on health equity considered in social media interventions. Methods: We searched for literature to identify potential relevant factors impacting on health equity considered in social media interventions. We included studies that reported examples of health interventions using social media, focused on health equity, and analyzed health equity factors of social media. We identified Information about health equity factors and targeted groups. Results: We found 17 relevant articles. Factors impacting on health equity reported in the included papers were extracted and grouped into three categories: digital health literacy, digital ethics, and acceptability. Conclusions: Literature shows that it is likely that digital technologies will increase health inequities associated with increased age, lower level of educational attainment, and lower socio-economic status. To address this challenge development of social media interventions should consider participatory design principles, visualization, and theories of social sciences.
Utility of Biomarkers for Sepsis-Associated Acute Kidney Injury Staging
Molinari, Luca , Smith, A.J. Conrad , Landsittel, Douglas , Singbartl, Kai , Yealy, Donald M., Kellum, John A. , Investigators, ProCESS and ProGReSS-AKI, Keener, Christopher, Lucko, Nicole, Pike, Francis, Yende, Sachin , Gimbel, Elizabeth, Landis, Kyle, Stapleton, Diana K., Weissfeld, Lisa A., Willochell, Michael, Wofford, Kourtney A., Watts, Hannah , Venkat, Arvind , Hou, Peter C. , Massaro, Anthony F., Parmar, Siddharth , Brewer, Kori L. , Delbridge, Theodore R. , Mainhart, Allison, Miner, James R. , Allen, Todd L., Grissom, Colin K. , Swadron, Stuart P., Carlson, Richard, LoVecchio, Frank , Parry, Blair A. , Ellender, Timothy J., Sama, Andrew E., Fine, Jonathan , Nafeei, Soheil, Wojnar, Margaret, Pearl, Ronald G. , Wilber, Scott T., Sinert, Richard , Orban, David J., Ufberg, Jacob W. , Albertson, Timothy, Panacek, Edward A., Parekh, Sohan, Gunn, Scott R. , Rittenberger, Jon S., Wadas, Richard J. , Edwards, Andrew R., Holmes, T., Weinert, Craig , Harris, Estelle S. , Self, Wesley H. , Dubinski, Diane, Phillips, Carolyn, Migues, Ronald M., Singbartl, Kai , Kellum, John A , Rio‐Pertuz, Gaspar Del , Palevsky, Paul M. , Chawla, Lakhmir S. , Huang, David T. , Angus, Derek C. , Investigators, ProCESS and ProGReSS-AKI, Barnato, Amber E. , Eaton, Tammy L. , Kulstad, Erik Benjamin , Limkakeng, Alexander T. , Conrad, Steven A. , Bajwa, Ednan K. , Filbin, Michael R. , Terndrup, Thomas E. , Wilson, Jason W. , Kelly, Matthew, Wang, Henry E. , McCurdy, Michael T. , Phillips, Carolyn A

JAMA Network Open | May 18, 2022 | Volume: 5 | Issue: 5 | Pages: e2212709

10.1001/jamanetworkopen.2022.12709 | PMID 35583867 Get It

Abstract 9544: Physical Activity in Individuals With Hypertrophic Cardiomyopathy: Baseline Data From the Prospective "Lifestyle and Exercise in Hcm" (live-hcm) Study
Lampert, Rachel , Ackerman, Michael J. , Marino, Bradley S. , Burg, Matthew M. , Ainsworth, Barbara E. , Balaji, Seshadri , Czosek, Richard J. , Bos, Martijn, Choudhury, Lubna , Etheridge, Susan P. , Ware, James S, Maron, Martin S. , Eidem, Benjamin W., Saarel, Elizabeth V. , Maron, Barry J. , Cannom, David S. , Briske, Kaylie A., Simone, Laura, Barth, Cheryl , Concannon, Maryann, Day, Sharlene M. , Salberg, Lisa , Tome, Maite , Ho, Carolyn Y. , James, Cynthia A. , Emery, Michael S. , Cooper, Robert , Geske, Jeffrey B. , Lal, Ashwin K. , Ware, James S. , Dubin, Anne M. , Gray, Belinda , Molossi, Silvana M , Saberi, Sara , Jacoby, Daniel Louis , Harmon, Kimberly G. , Hall, Kevin D. , Olshansky, Brian , Link, Mark S. , Law, Ian H. , Estes, N.A. Mark , Li, Fangyong

Circulation | April 28, 2022 | Volume: 144 | Issue: Suppl_1 | Pages: No page available

10.1161/circ.144.suppl_1.9544 Get It

Introduction: Safety of vigorous exercise for individuals with appropriately-treated HCM remains debated. Physical activity practices in this population have not been described. The objective of this report is to describe physical activity pattern in HCM patients. Long term follow up which is ongoing will determine safety of vigorous exercise. Methods: The NIH-funded LIVE-HCM study prospectively enrolled individuals age 8-60 years with clinically overt HCM or patients with a positive genetic test for sarcomeric HCM. Participants (or parents, for children) answered surveys describing activity patterns. Vigorous exercise was defined as > 6 METS for > 60 hours per year. Clinical and demographic data were derived from medical record review. Results: Among 1798 participants, 745 (41%) reported exercising vigorously, including 296 competitive athletes, with 59 at high-school or college varsity level, 770 (43%) were exercising at moderate, and 283 (16%) at low levels. Of those working, 6% described jobs more active than walking, including 16 in protective services, and 11 in sports/coaching. Clinical/demographic data including imaging characteristics and treatments, are shown in Table, and were mostly similar amongst the exercise-groups. Conclusions: Many patients with HCM are engaged in vigorous exercise including competitive athletics. Prospective follow-up of this cohort is ongoing. Comparison of arrhythmic outcomes outcomes in vigorous exercisers vs moderate/low level exercisers will help determine the safety of exercise in HCM patients.
Selecting venues for AMIA events and conferences: guiding ethical principles
Lehmann, Christoph U. , Hollis, Kate Fultz , Petersen, Carolyn , DeMuro, Paul R. , Subbian, Vignesh , Koppel, Ross , Solomonides, Anthony , Pan, Eric, Fultz Hollis, Kate , Solomonides, Anthony E , Pan, Eric C , Goodman, Kenneth W , Koppel, Ross , Lehmann, Christoph U , Petersen, Carolyn , Subbian, Vignesh , Berner, Eta S. , Adler‐Milstein, Julia , Goodman, Kenneth W.

Journal of the American Medical Informatics Association | April 28, 2022 | Volume: 29 | Issue: 8 | Pages: 1319-1322

10.1093/jamia/ocac073 | PMID 35579334 Get It

Abstract A discussion and debate on the American Medical Informatics Association’s (AMIA) Ethical, Legal, and Social Issues (ELSI) Working Group listserv in 2021 raised important issues related to a forthcoming conference in Texas. Texas had recently enacted a restrictive abortion law and restricted voting rights. Several AMIA members advocated for a boycott of the state and the scheduled conference. The discussion led the AMIA Board of Directors to request that the organization’s Ethics Committee provide general guidance for principle-based venue selection. This document recommends overarching principles for the venue selection for future AMIA events and conferences. Discussions by the AMIA Board, the Ethics Committee, and the ELSI Working Group informed these recommendations, and this document on guiding principles was approved by the AMIA Board of Directors in April 2022.
NCCN Guidelines® Insights: Hodgkin Lymphoma, Version 2.2022
Hoppe, Richard T. , Advani, Ranjana H. , Ambinder, Richard F. , Armand, Philippe , Bello, Celeste, Benitez, Cecil M. , Chen, Weina , Dabaja, Bouthaina S. , Daly, Megan E. , Hansen, Neil, Herrera, Alex F. , Hochberg, Ephraim P. , Johnston, Patrick B. , Kaminski, Mark , Kenkre, Vaishalee P. , Lynch, Ryan C. , Maddocks, Kami J. , Metzger, Monika L. , Morgan, David , Mulroney, Carolyn , Pullarkat, Sheeja T. , Rabinovitch, Rachel , Rosenspire, Karen C., Seropian, Stuart , Tao, Randa , Torka, Pallawi , Yang, Joanna C. , Burns, Jennifer L. , Campbell, Mallory, Sundar, Hema, Advani, Ranjana H , Hoppe, Richard T , Ambinder, Richard F , Tao, Randa , Ai, Weiyun Z. , Gordon, Leo I. , Kelsey, Chris R. , Khan, Nadia , McConathy, Jonathan , Winter, Jane N. , Yahalom, Joachim

Journal of the National Comprehensive Cancer Network | April 7, 2022 | Volume: 20 | Issue: 4 | Pages: 322-334

10.6004/jnccn.2022.0021 | PMID 35390768 Get It

Hodgkin lymphoma (HL) is an uncommon malignancy of B-cell origin. Classical HL (cHL) and nodular lymphocyte–predominant HL are the 2 main types of HL. The cure rates for HL have increased so markedly with the advent of modern treatment options that overriding treatment considerations often relate to long-term toxicity. These NCCN Guidelines Insights discuss the recent updates to the NCCN Guidelines for HL focusing on (1) radiation therapy dose constraints in the management of patients with HL, and (2) the management of advanced-stage and relapsed or refractory cHL.
Abstract 318: Caregiver Experiences with Decision Making in Destination Therapy Left Ventricular Assist Devices: A Qualitative Study
Jones, Jacqueline , Nowels, Carolyn T., McIlvennan, Colleen Kelley , Allen, Larry A. , Lindenfeld, JoAnn , Swetz, Keith M. , Matlock, Daniel D.

Circulation: Cardiovascular Quality and Outcomes | March 20, 2022 | Volume: 7 | Issue: suppl_1 | Pages: No page available

10.1161/circoutcomes.7.suppl_1.318 Get It

BACKGROUND: Destination therapy left ventricular assist device (DT LVAD) is increasingly offered to patients with end-stage heart failure who are ineligible for heart transplantation. Implanting centers often require the identification of a dedicated caregiver prior to DT LVAD implantation; however, the caregiver experience surrounding this difficult decision is relatively unexplored. METHODS: Between October 2012 and July 2013, we conducted semi-structured, in-depth interviews of caregivers to understand their experiences with decision making for loved ones considering and living with DT LVADs. Data were analyzed using a mixed inductive and deductive approach. RESULTS: We interviewed 17 caregivers: 16 caregivers of patients who had received a DT LVAD and 1 caregiver of a patient who had declined a DT LVAD. At the time of the caregiver interview, 10 DT LVAD patients were living and 7 were deceased. The majority were women (n=16) of whom 12 were either spouses or widows of the patients. Median age of caregivers was 65 (range 35-79). Twelve caregivers reported spending more than 8 hours per week caring for their loved one, and 14 attended regular medical appointments. Throughout the interviews, caregivers reported that DT LVAD was a complex decision making process with many inherent tensions. The themes identified are broadly interpreted under three domains: 1) the stark decision context with tension between hopes and realities, “when we first started out¼we had hopes of a transplant¼but once the lung function was done, and the kidneys ¼there was pretty much nothing. There was no hope other than the LVAD”; 2) the challenging decision process and the tension between wanting their loved ones to live, “I said ‘Well, I'll tell you what. I didn't marry you to be a young widow” and wanting to respect their loved ones’ wishes, “My thoughts were this was his life and it was his choice”; and 3) the downstream decision outcome and the tension between gratitude, “I'm just thankful to have my dad here¼” and a feeling of burden, “I've never felt caregiver was my gift¼I tend to feel like I'm being imposed upon at times.” CONCLUSIONS: Despite the promise of significantly improved survival for some patients, DT LVAD has major implications for caregives as well as patients. Decision making surrounding DT LVAD requires education of both the patient and caregiver of potential stresses. Additionally, decision-making surrounding DT LVAD should seek to incorporate decision support for patients and caregivers. This should include a focus on caregiver burden and the tensions that caregivers may experience.
Abstract 18767: Race-related Disparities in Ventricular-arterial Coupling in Elderly Individuals: The Atherosclerosis Risk in Communities Study
Fernandes-Silva, Miguel Morita , Claggett, Brian , Solomon, Scott D. , Shah, Amil M. , Hegde, Sheila M. , Gonçalves, Alexandra , Cheng, Susan , Nadruz, Wilson , Lam, Carolyn S.P. , Borlaug, Barry A. , Solomon, Scott David

Circulation | March 19, 2022 | Volume: 132 | Issue: suppl_3 | Pages: No page available

10.1161/circ.132.suppl_3.18767 Get It

Introduction: The incidence of heart failure (HF) is higher in black than in white Americans, but the causes are unclear. We proposed that ethnic differences in ventricular-arterial interaction may contribute to this differential HF risk. Methods: We studied measures of arterial elastance (Ea) and left ventricle (LV) end-systolic elastance (Ees) in 5767 community-based elderly participants (76±5 years, 41% male, 22% black) who underwent echocardiography in the Atherosclerosis Risk in Community (ARIC) Study. Results: Black participants were more frequently women (66 vs 57%) and had a higher prevalence of obesity (46 vs 31%), hypertension (94 vs 80%), and diabetes mellitus (47 vs 34%). Adjusting for these baseline differences, the prevalence of LV hypertrophy was similar, but Ea, Ees and Ea/Ees ratio were higher in blacks than whites, particularly in black women (Figure). Ea was positively associated with LV mass index and E/e’ ratio in blacks, but not in whites (p for interaction < 0.001). Conclusion: These community-based data demonstrate that ventricular-arterial stiffening is greater in black than white Americans, coupled with more ventricular remodeling and dysfunction. The heightened afterload dependence in blacks suggests greater potential for risk reduction with anti-hypertensive therapy.
Abstract 582: Overexpression of Mnsod Reduces Aortic Valve Calcification Through Repression of Pro-osteogenic Signaling
Roos, Carolyn M, Hagler, Michael A , Versoza, Grace C, Thalji, Nassir M , Richardson, Arlan , Z, Bin, Miller, Jordan D.

Arteriosclerosis, Thrombosis, and Vascular Biology | March 19, 2022 | Volume: 35 | Issue: suppl_1 | Pages: No page available

10.1161/atvb.35.suppl_1.582 Get It

Increased BMP signaling and markers of osteogenic differentiation are strongly associated with regions of valvular calcification in aortic valves from humans with end-stage calcific aortic valve stenosis. While oxidative stress is also markedly elevated in these regions, it is unknown whether increasing antioxidant capacity can reduce pro-osteogenic signaling and valvular calcification. Therefore, we hypothesized that overexpression of manganese superoxide dismutase (MnSOD) can reduce pro-osteogenic signaling in the aortic valves from hypercholesterolemic mice, ultimately resulting in reduced valvular calcification and improved valvular function. We used Ldlr -/- /ApoB 100/100 (LA) mice that were wild-type for MnSOD (LA-MnSOD 0/0 ) or overexpressing MnSOD (LA-MnSOD Tg/0 ) and fed a western diet (TD88137) for six months. We first measured mRNA levels of the BMP ligands BMP2 and BMP4 (qRT-PCR), both of which were unchanged between LA-MnSOD 0/0 and LA-MNSOD Tg/0 mice. While there was a small but significant increase in Runx2 mRNA levels in LA-MnSOD Tg/0 mice compared to wild-type littermates (1.22±0.09, 1.0±0.09, qRT-PCR, p < 0.05.) gene expression levels of late stage osteoblast marker Sp7 were reduced by approximately 50% in LA-MnSOD Tg/0 compared to wild-type littermates (0.53±0.15, 1.0±0.24, qRT-PCR, p < 0.05). Sp7 protein levels (immunohistochemistry) were also significantly reduced in LA-MnSOD Tg/0 compared to wild-type littermates (164.5±12.3 RFU vs 259.6±10.4 RFU, p < 0.05). Critically, aortic valve calcification (Alizarin Red) was also significantly reduced in LA-MnSOD Tg/0 mice compared to their LA-MnSOD 0/0 littermates. Functionally, aortic valve cusp separation distance (high resolution echocardiography) was slightly improved in LA-MnSOD Tg/0 mice compared to LA-MnSOD 0/0 mice (0.98±0.04 mm vs 0.91±0.03 mm, p = n.s.). Collectively, these data suggest that increasing mitochondrial antioxidant capacity can reduce pro-osteogenic signaling and attenuate aortic valve calcification, and may be a potential therapeutic target to slow the progression of valvular calcification and dysfunction in patients with calcific aortic valve stenosis.