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Assessment of Patient Education Delivered at Time of Hospital Discharge

Trivedi, Shreya P; Corderman, Sara; Berlinberg, Elyse; Schoenthaler, Antoinette; Horwitz, Leora I
IMPORTANCE:Patient education at time of hospital discharge is critical for smooth transitions of care; however, empirical data regarding discharge communication are limited. OBJECTIVE:To describe whether key communication domains (medication changes, follow-up appointments, disease self-management, red flags, question solicitation, and teach-back) were addressed at the bedside on the day of hospital discharge, by whom, and for how long. DESIGN, SETTING, AND PARTICIPANTS:This quality improvement study was conducted from September 2018 through October 2019 at inpatient medicine floors in 2 urban, tertiary-care teaching hospitals and purposefully sampled patients designated as "discharge before noon." Data analysis was performed from September 2018 to May 2020. EXPOSURES:A trained bedside observer documented all content and duration of staff communication with a single enrolled patient from 7 am until discharge. MAIN OUTCOMES AND MEASURES:Presence of the key communication domains, role of team members, and amount of time spent at the bedside. RESULTS:Discharge days for 33 patients were observed. Patients had a mean (SD) age of 63 (18) years; 14 (42%) identified as White, 15 (45%) were female, and 6 (18%) had a preferred language of Spanish. Thirty patients were discharged with at least 1 medication change. Of these patients, 8 (27%) received no verbal instruction on the change, while 16 of 30 (53%) were informed but not told the purpose of the changes. About half of the patients (15 of 31, 48%) were not told the reason for follow-up appointments, and 18 of 33 (55%) were not given instructions on posthospital disease self-management. Most patients (27 of 33, 81%) did not receive guidance on red-flag signs. While over half of the patients (19 of 33, 58%) were asked if they had any questions, only 1 patient was asked to teach back his understanding of the discharge plan. Median (IQR) total time spent with patients on the day of discharge by interns, senior residents, attending physicians, and nurses was 4.0 (0.75-6.0), 1.0 (0-2.0), 3.0 (0.5-7.0), and 22.5 (15.5-30.0) minutes, respectively. Most of the time was spent discussing logistics rather than discharge education. CONCLUSIONS AND RELEVANCE:In this quality improvement study, patients infrequently received discharge education in key communication domains, potentially leaving gaps in patient knowledge. Interventions to improve the hospital discharge process should address the content, method of delivery, and transparency among team members regarding patient education.
PMID: 36939674
ISSN: 2168-6114
CID: 5502462

Cluster-Randomized Trial Comparing Ambulatory Decision Support Tools to Improve Heart Failure Care

Mukhopadhyay, Amrita; Reynolds, Harmony R; Phillips, Lawrence M; Nagler, Arielle R; King, William C; Szerencsy, Adam; Saxena, Archana; Aminian, Rod; Klapheke, Nathan; Horwitz, Leora I; Katz, Stuart D; Blecker, Saul
BACKGROUND:Mineralocorticoid receptor antagonists (MRA) are under-prescribed for patients with heart failure with reduced ejection fraction (HFrEF). OBJECTIVE:To compare effectiveness of two automated, electronic health record (EHR)-embedded tools vs. usual care on MRA prescribing in eligible patients with HFrEF. METHODS:BETTER CARE-HF (Building Electronic Tools To Enhance and Reinforce CArdiovascular REcommendations for Heart Failure) was a three-arm, pragmatic, cluster-randomized trial comparing the effectiveness of an alert during individual patient encounters vs. a message about multiple patients between encounters vs. usual care on MRA prescribing. We included adult patients with HFrEF, no active MRA prescription, no contraindication to MRA, and an outpatient cardiologist in a large health system. Patients were cluster-randomized by cardiologist (60 per arm). RESULTS:The study included 2,211 patients (alert: 755, message: 812, usual care [control]: 644), with average age 72.2 years, average EF 33%, who were predominantly male (71.4%) and White (68.9%). New MRA prescribing occurred in 29.6% of patients in the alert arm, 15.6% in the message arm, and 11.7% in the control arm. The alert more than doubled MRA prescribing compared to control (RR: 2.53, 95% CI: 1.77-3.62, p<0.0001), and improved MRA prescribing compared to the message (RR: 1.67, 95% CI: 1.21-2.29, p=0.002). The number of patients with alert needed to result in an additional MRA prescription was 5.6. CONCLUSIONS:An automated, patient-specific, EHR-embedded alert increased MRA prescribing compared to both a message and usual care. Our findings highlight the potential for EHR-embedded tools to substantially increase prescription of life-saving therapies for HFrEF. (NCT05275920).
PMID: 36882134
ISSN: 1558-3597
CID: 5430312

Using Rapid Randomized Trials to Improve Health Care Systems

Horwitz, Leora I; Krelle, Holly A
Rapid randomized controlled trials have been surprisingly rare in health care quality improvement (QI) and systems interventions. Applying clinical trials methodology QI work brings two distinct fields together, applying the robustness of randomized controlled trials (RCTs) to the practical, operational learnings of the well-established QI field. Rapid trials also add a third element-speed-that enables health care systems to rapidly test multiple variations of an intervention in much the same way that A/B testing is done in the technology sector. When performed well, these rapid trials free researchers and health care systems from the requirement to be correct the first time (because it is low cost and quick to try something else) while offering a standard of evidence often absent in QI. Here we outline the historical underpinnings of this approach, provide guidance about how best to implement it, and describe lessons learned from running more than 20 randomized projects in the NYU Langone Health system. Expected final online publication date for the Annual Review of Public Health, Volume 44 is April 2023. Please see http://www.annualreviews.org/page/journal/pubdates for revised estimates.
PMID: 36400154
ISSN: 1545-2093
CID: 5385022

Design and pilot implementation for the BETTER CARE-HF trial: A pragmatic cluster-randomized controlled trial comparing two targeted approaches to ambulatory clinical decision support for cardiologists

Mukhopadhyay, Amrita; Reynolds, Harmony R; Xia, Yuhe; Phillips, Lawrence M; Aminian, Rod; Diah, Ruth-Ann; Nagler, Arielle R; Szerencsy, Adam; Saxena, Archana; Horwitz, Leora I; Katz, Stuart D; Blecker, Saul
BACKGROUND:Beart failure with reduced ejection fraction (HFrEF) is a leading cause of morbidity and mortality. However, shortfalls in prescribing of proven therapies, particularly mineralocorticoid receptor antagonist (MRA) therapy, account for several thousand preventable deaths per year nationwide. Electronic clinical decision support (CDS) is a potential low-cost and scalable solution to improve prescribing of therapies. However, the optimal timing and format of CDS tools is unknown. METHODS AND RESULTS/RESULTS:We developed two targeted CDS tools to inform cardiologists of gaps in MRA therapy for patients with HFrEF and without contraindication to MRA therapy: (1) an alert that notifies cardiologists at the time of patient visit, and (2) an automated electronic message that allows for review between visits. We designed these tools using an established CDS framework and findings from semistructured interviews with cardiologists. We then pilot tested both CDS tools (n = 596 patients) and further enhanced them based on additional semistructured interviews (n = 11 cardiologists). The message was modified to reduce the number of patients listed, include future visits, and list date of next visit. The alert was modified to improve noticeability, reduce extraneous information on guidelines, and include key information on contraindications. CONCLUSIONS:The BETTER CARE-HF (Building Electronic Tools to Enhance and Reinforce CArdiovascular REcommendations for Heart Failure) trial aims to compare the effectiveness of the alert vs. the automated message vs. usual care on the primary outcome of MRA prescribing. To our knowledge, no study has directly compared the efficacy of these two different types of electronic CDS interventions. If effective, our findings can be rapidly disseminated to improve morbidity and mortality for patients with HFrEF, and can also inform the development of future CDS interventions for other disease states. (Trial registration: Clinicaltrials.gov NCT05275920).
PMID: 36640860
ISSN: 1097-6744
CID: 5403312

Researching COVID to enhance recovery (RECOVER) pregnancy study: Rationale, objectives and design

Metz, Torri D; Clifton, Rebecca G; Gallagher, Richard; Gross, Rachel S; Horwitz, Leora I; Jacoby, Vanessa L; Martin-Herz, Susanne P; Peralta-Carcelen, Myriam; Reeder, Harrison T; Beamon, Carmen J; Chan, James; Chang, A Ann; Costantine, Maged M; Fitzgerald, Megan L; Foulkes, Andrea S; Gibson, Kelly S; Güthe, Nick; Habli, Mounira; Hackney, David N; Hoffman, Matthew K; Hoffman, M Camille; Hughes, Brenna L; Katz, Stuart D; Laleau, Victoria; Mallett, Gail; Mendez-Figueroa, Hector; Monzon, Vanessa; Palatnik, Anna; Palomares, Kristy T S; Parry, Samuel; Pettker, Christian M; Plunkett, Beth A; Poppas, Athena; Reddy, Uma M; Rouse, Dwight J; Saade, George R; Sandoval, Grecio J; Schlater, Shannon M; Sciurba, Frank C; Simhan, Hyagriv N; Skupski, Daniel W; Sowles, Amber; Thaweethai, Tanayott; Thomas, Gelise L; Thorp, John M; Tita, Alan T; Weiner, Steven J; Weigand, Samantha; Yee, Lynn M; Flaherman, Valerie J; ,
IMPORTANCE/OBJECTIVE:Pregnancy induces unique physiologic changes to the immune response and hormonal changes leading to plausible differences in the risk of developing post-acute sequelae of SARS-CoV-2 (PASC), or Long COVID. Exposure to SARS-CoV-2 during pregnancy may also have long-term ramifications for exposed offspring, and it is critical to evaluate the health outcomes of exposed children. The National Institutes of Health (NIH) Researching COVID to Enhance Recovery (RECOVER) Multi-site Observational Study of PASC aims to evaluate the long-term sequelae of SARS-CoV-2 infection in various populations. RECOVER-Pregnancy was designed specifically to address long-term outcomes in maternal-child dyads. METHODS:RECOVER-Pregnancy cohort is a combined prospective and retrospective cohort that proposes to enroll 2,300 individuals with a pregnancy during the COVID-19 pandemic and their offspring exposed and unexposed in utero, including single and multiple gestations. Enrollment will occur both in person at 27 sites through the Eunice Kennedy Shriver National Institutes of Health Maternal-Fetal Medicine Units Network and remotely through national recruitment by the study team at the University of California San Francisco (UCSF). Adults with and without SARS-CoV-2 infection during pregnancy are eligible for enrollment in the pregnancy cohort and will follow the protocol for RECOVER-Adult including validated screening tools, laboratory analyses and symptom questionnaires followed by more in-depth phenotyping of PASC on a subset of the overall cohort. Offspring exposed and unexposed in utero to SARS-CoV-2 maternal infection will undergo screening tests for neurodevelopment and other health outcomes at 12, 18, 24, 36 and 48 months of age. Blood specimens will be collected at 24 months of age for SARS-CoV-2 antibody testing, storage and anticipated later analyses proposed by RECOVER and other investigators. DISCUSSION/CONCLUSIONS:RECOVER-Pregnancy will address whether having SARS-CoV-2 during pregnancy modifies the risk factors, prevalence, and phenotype of PASC. The pregnancy cohort will also establish whether there are increased risks of adverse long-term outcomes among children exposed in utero. CLINICAL TRIALS.GOV IDENTIFIER/BACKGROUND:Clinical Trial Registration: http://www.clinicaltrials.gov. Unique identifier: NCT05172011.
PMCID:10734909
PMID: 38128008
ISSN: 1932-6203
CID: 5612082

Researching COVID to Enhance Recovery (RECOVER) adult study protocol: Rationale, objectives, and design

Horwitz, Leora I; Thaweethai, Tanayott; Brosnahan, Shari B; Cicek, Mine S; Fitzgerald, Megan L; Goldman, Jason D; Hess, Rachel; Hodder, S L; Jacoby, Vanessa L; Jordan, Michael R; Krishnan, Jerry A; Laiyemo, Adeyinka O; Metz, Torri D; Nichols, Lauren; Patzer, Rachel E; Sekar, Anisha; Singer, Nora G; Stiles, Lauren E; Taylor, Barbara S; Ahmed, Shifa; Algren, Heather A; Anglin, Khamal; Aponte-Soto, Lisa; Ashktorab, Hassan; Bassett, Ingrid V; Bedi, Brahmchetna; Bhadelia, Nahid; Bime, Christian; Bind, Marie-Abele C; Black, Lora J; Blomkalns, Andra L; Brim, Hassan; Castro, Mario; Chan, James; Charney, Alexander W; Chen, Benjamin K; Chen, Li Qing; Chen, Peter; Chestek, David; Chibnik, Lori B; Chow, Dominic C; Chu, Helen Y; Clifton, Rebecca G; Collins, Shelby; Costantine, Maged M; Cribbs, Sushma K; Deeks, Steven G; Dickinson, John D; Donohue, Sarah E; Durstenfeld, Matthew S; Emery, Ivette F; Erlandson, Kristine M; Facelli, Julio C; Farah-Abraham, Rachael; Finn, Aloke V; Fischer, Melinda S; Flaherman, Valerie J; Fleurimont, Judes; Fonseca, Vivian; Gallagher, Emily J; Gander, Jennifer C; Gennaro, Maria Laura; Gibson, Kelly S; Go, Minjoung; Goodman, Steven N; Granger, Joey P; Greenway, Frank L; Hafner, John W; Han, Jenny E; Harkins, Michelle S; Hauser, Kristine S P; Heath, James R; Hernandez, Carla R; Ho, On; Hoffman, Matthew K; Hoover, Susan E; Horowitz, Carol R; Hsu, Harvey; Hsue, Priscilla Y; Hughes, Brenna L; Jagannathan, Prasanna; James, Judith A; John, Janice; Jolley, Sarah; Judd, S E; Juskowich, Joy J; Kanjilal, Diane G; Karlson, Elizabeth W; Katz, Stuart D; Kelly, J Daniel; Kelly, Sara W; Kim, Arthur Y; Kirwan, John P; Knox, Kenneth S; Kumar, Andre; Lamendola-Essel, Michelle F; Lanca, Margaret; Lee-Lannotti, Joyce K; Lefebvre, R Craig; Levy, Bruce D; Lin, Janet Y; Logarbo, Brian P; Logue, Jennifer K; Longo, Michele T; Luciano, Carlos A; Lutrick, Karen; Malakooti, Shahdi K; Mallett, Gail; Maranga, Gabrielle; Marathe, Jai G; Marconi, Vincent C; Marshall, Gailen D; Martin, Christopher F; Martin, Jeffrey N; May, Heidi T; McComsey, Grace A; McDonald, Dylan; Mendez-Figueroa, Hector; Miele, Lucio; Mittleman, Murray A; Mohandas, Sindhu; Mouchati, Christian; Mullington, Janet M; Nadkarni, Girish N; Nahin, Erica R; Neuman, Robert B; Newman, Lisa T; Nguyen, Amber; Nikolich, Janko Z; Ofotokun, Igho; Ogbogu, Princess U; Palatnik, Anna; Palomares, Kristy T S; Parimon, Tanyalak; Parry, Samuel; Parthasarathy, Sairam; Patterson, Thomas F; Pearman, Ann; Peluso, Michael J; Pemu, Priscilla; Pettker, Christian M; Plunkett, Beth A; Pogreba-Brown, Kristen; Poppas, Athena; Porterfield, J Zachary; Quigley, John G; Quinn, Davin K; Raissy, Hengameh; Rebello, Candida J; Reddy, Uma M; Reece, Rebecca; Reeder, Harrison T; Rischard, Franz P; Rosas, Johana M; Rosen, Clifford J; Rouphael, Nadine G; Rouse, Dwight J; Ruff, Adam M; Saint Jean, Christina; Sandoval, Grecio J; Santana, Jorge L; Schlater, Shannon M; Sciurba, Frank C; Selvaggi, Caitlin; Seshadri, Sudha; Sesso, Howard D; Shah, Dimpy P; Shemesh, Eyal; Sherif, Zaki A; Shinnick, Daniel J; Simhan, Hyagriv N; Singh, Upinder; Sowles, Amber; Subbian, Vignesh; Sun, Jun; Suthar, Mehul S; Teunis, Larissa J; Thorp, John M; Ticotsky, Amberly; Tita, Alan T N; Tragus, Robin; Tuttle, Katherine R; Urdaneta, Alfredo E; Utz, P J; VanWagoner, Timothy M; Vasey, Andrew; Vernon, Suzanne D; Vidal, Crystal; Walker, Tiffany; Ward, Honorine D; Warren, David E; Weeks, Ryan M; Weiner, Steven J; Weyer, Jordan C; Wheeler, Jennifer L; Whiteheart, Sidney W; Wiley, Zanthia; Williams, Natasha J; Wisnivesky, Juan P; Wood, John C; Yee, Lynn M; Young, Natalie M; Zisis, Sokratis N; Foulkes, Andrea S
IMPORTANCE/OBJECTIVE:SARS-CoV-2 infection can result in ongoing, relapsing, or new symptoms or other health effects after the acute phase of infection; termed post-acute sequelae of SARS-CoV-2 infection (PASC), or long COVID. The characteristics, prevalence, trajectory and mechanisms of PASC are ill-defined. The objectives of the Researching COVID to Enhance Recovery (RECOVER) Multi-site Observational Study of PASC in Adults (RECOVER-Adult) are to: (1) characterize PASC prevalence; (2) characterize the symptoms, organ dysfunction, natural history, and distinct phenotypes of PASC; (3) identify demographic, social and clinical risk factors for PASC onset and recovery; and (4) define the biological mechanisms underlying PASC pathogenesis. METHODS:RECOVER-Adult is a combined prospective/retrospective cohort currently planned to enroll 14,880 adults aged ≥18 years. Eligible participants either must meet WHO criteria for suspected, probable, or confirmed infection; or must have evidence of no prior infection. Recruitment occurs at 86 sites in 33 U.S. states, Washington, DC and Puerto Rico, via facility- and community-based outreach. Participants complete quarterly questionnaires about symptoms, social determinants, vaccination status, and interim SARS-CoV-2 infections. In addition, participants contribute biospecimens and undergo physical and laboratory examinations at approximately 0, 90 and 180 days from infection or negative test date, and yearly thereafter. Some participants undergo additional testing based on specific criteria or random sampling. Patient representatives provide input on all study processes. The primary study outcome is onset of PASC, measured by signs and symptoms. A paradigm for identifying PASC cases will be defined and updated using supervised and unsupervised learning approaches with cross-validation. Logistic regression and proportional hazards regression will be conducted to investigate associations between risk factors, onset, and resolution of PASC symptoms. DISCUSSION/CONCLUSIONS:RECOVER-Adult is the first national, prospective, longitudinal cohort of PASC among US adults. Results of this study are intended to inform public health, spur clinical trials, and expand treatment options. REGISTRATION/BACKGROUND:NCT05172024.
PMID: 37352211
ISSN: 1932-6203
CID: 5538502

The impact of COVID-19 monoclonal antibodies on clinical outcomes: A retrospective cohort study

Nagler, Arielle R; Horwitz, Leora I; Jones, Simon; Petrilli, Christopher M; Iturrate, Eduardo; Lighter, Jennifer L; Phillips, Michael; Bosworth, Brian P; Polsky, Bruce; Volpicelli, Frank M; Dapkins, Isaac; Viswanathan, Anand; François, Fritz; Kalkut, Gary
DISCLAIMER/CONCLUSIONS:In an effort to expedite the publication of articles, AJHP is posting manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time. PURPOSE/OBJECTIVE:Despite progress in the treatment of coronavirus disease 2019 (COVID-19), including the development of monoclonal antibodies (mAbs), more clinical data to support the use of mAbs in outpatients with COVID-19 is needed. This study is designed to determine the impact of bamlanivimab, bamlanivimab/etesevimab, or casirivimab/imdevimab on clinical outcomes within 30 days of COVID-19 diagnosis. METHODS:A retrospective cohort study was conducted at a single academic medical center with 3 campuses in Manhattan, Brooklyn, and Long Island, NY. Patients 12 years of age or older who tested positive for COVID-19 or were treated with a COVID-19-specific therapy, including COVID-19 mAb therapies, at the study site between November 24, 2020, and May 15, 2021, were included. The primary outcomes included rates of emergency department (ED) visit, inpatient admission, intensive care unit (ICU) admission, or death within 30 days from the date of COVID-19 diagnosis. RESULTS:A total of 1,344 mAb-treated patients were propensity matched to 1,344 patients with COVID-19 patients who were not treated with mAb therapy. Within 30 days of diagnosis, among the patients who received mAb therapy, 101 (7.5%) presented to the ED and 79 (5.9%) were admitted. Among the patients who did not receive mAb therapy, 165 (12.3%) presented to the ED and 156 (11.6%) were admitted (relative risk [RR], 0.61 [95% CI, 0.50-0.75] and 0.51 [95% CI, 0.40-0.64], respectively). Four mAb patients (0.3%) and 2.64 control patients (0.2%) were admitted to the ICU (RR, 01.51; 95% CI, 0.45-5.09). Six mAb-treated patients (0.4%) and 3.37 controls (0.3%) died and/or were admitted to hospice (RR, 1.61; 95% CI, 0.54-4.83). mAb therapy in ambulatory patients with COVID-19 decreases the risk of ED presentation and hospital admission within 30 days of diagnosis.
PMCID:9619808
PMID: 36242772
ISSN: 1535-2900
CID: 5361302

The reduction in non-COVID-19 hospitalizations during the pandemic: Problematic or beneficial? [Editorial]

Blecker, Saul B; Horwitz, Leora I
PMID: 36213943
ISSN: 1553-5606
CID: 5351882

Effects of Real-time Prescription Benefit Recommendations on Patient Out-of-Pocket Costs: A Cluster Randomized Clinical Trial

Desai, Sunita M; Chen, Alan Z; Wang, Jiejie; Chung, Wei-Yi; Stadelman, Jay; Mahoney, Chris; Szerencsy, Adam; Anzisi, Lisa; Mehrotra, Ateev; Horwitz, Leora I
Importance/UNASSIGNED:Rising drug costs contribute to medication nonadherence and adverse health outcomes. Real-time prescription benefit (RTPB) systems present prescribers with patient-specific out-of-pocket cost estimates and recommend lower-cost, clinically appropriate alternatives at the point of prescribing. Objective/UNASSIGNED:To investigate whether RTPB recommendations lead to reduced patient out-of-pocket costs for medications. Design, Setting, and Participants/UNASSIGNED:In this cluster randomized trial, medical practices in a large, urban academic health system were randomly assigned to RTPB recommendations from January 13 to July 31, 2021. Participants were adult patients receiving outpatient prescriptions during the study period. The analysis was limited to prescriptions for which RTPB could recommend an available alternative. Electronic health record data were used to analyze the intervention's effects on prescribing. Data analyses were performed from August 20, 2021, to June 8, 2022. Interventions/UNASSIGNED:When a prescription was initiated in the electronic health record, the RTPB system recommended available lower-cost, clinically appropriate alternatives for a different medication, length of prescription, and/or choice of pharmacy. The prescriber could select either the initiated order or one of the recommended options. Main Outcomes and Measures/UNASSIGNED:Patient out-of-pocket cost for a prescription. Secondary outcomes were whether a mail-order prescription and a 90-day supply were ordered. Results/UNASSIGNED:Of 867 757 outpatient prescriptions at randomized practices, 36 419 (4.2%) met the inclusion criteria of having an available alternative. Out-of-pocket costs were $39.90 for a 30-day supply in the intervention group and $67.80 for a 30-day supply in the control group. The intervention led to an adjusted 11.2%; (95% CI, -15.7% to -6.4%) reduction in out-of-pocket costs. Mail-order pharmacy use was 9.6% and 7.6% in the intervention and control groups, respectively (adjusted 1.9 percentage point increase; 95% CI, 0.9 to 3.0). Rates of 90-day supply were not different. In high-cost drug classes, the intervention reduced out-of-pocket costs by 38.9%; 95% CI, -47.6% to -28.7%. Conclusions and Relevance/UNASSIGNED:This cluster randomized clinical trial showed that RTPB recommendations led to lower patient out-of-pocket costs, with the largest savings occurring for high-cost medications. However, RTPB recommendations were made for only a small percentage of prescriptions. Trial Registration/UNASSIGNED:ClinicalTrials.gov Identifier: NCT04940988; American Economic Association Registry: AEARCTR-0006909.
PMID: 36094537
ISSN: 2168-6114
CID: 5332742

Sex differences in the prognostic value of troponin and D-dimer in COVID-19 illness

Mukhopadhyay, Amrita; Talmor, Nina; Xia, Yuhe; Berger, Jeffrey S; Iturrate, Eduardo; Adhikari, Samrachana; Pulgarin, Claudia; Quinones-Camacho, Adriana; Yuriditsky, Eugene; Horowitz, James; Jung, Albert S; Massera, Daniele; Keller, Norma M; Fishman, Glenn I; Horwitz, Leora; Troxel, Andrea B; Hochman, Judith S; Reynolds, Harmony R
BACKGROUND:Male sex, elevated troponin levels, and elevated D-dimer levels are associated with more complicated COVID-19 illness and greater mortality; however, while there are known sex differences in the prognostic value of troponin and D-dimer in other disease states, it is unknown whether they exist in the setting of COVID-19. OBJECTIVE:We assessed whether sex modified the relationship between troponin, D-dimer, and severe COVID-19 illness (defined as mechanical ventilation, ICU admission or transfer, discharge to hospice, or death). METHODS:We conducted a retrospective cohort study of patients hospitalized with COVID-19 at a large, academic health system. We used multivariable regression to assess associations between sex, troponin, D-dimer, and severe COVID-19 illness, adjusting for demographic, clinical, and laboratory covariates. To test whether sex modified the relationship between severe COVID-19 illness and troponin or D-dimer, models with interaction terms were utilized. RESULTS:Among 4,574 patients hospitalized with COVID-19, male sex was associated with higher levels of troponin and greater odds of severe COVID-19 illness, but lower levels of initial D-dimer when compared with female sex. While sex did not modify the relationship between troponin level and severe COVID-19 illness, peak D-dimer level was more strongly associated with severe COVID-19 illness in male patients compared to female patients (males: OR=2.91, 95%CI=2.63-2.34, p<0.001; females: OR=2.31, 95%CI=2.04-2.63, p<0.001; p-interaction=0.005). CONCLUSION/CONCLUSIONS:Sex did not modify the association between troponin level and severe COVID-19 illness, but did modify the association between peak D-dimer and severe COVID-19 illness, suggesting greater prognostic value for D-dimer in males with COVID-19.
PMCID:9597518
PMID: 36334466
ISSN: 1527-3288
CID: 5358922