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Quality improvement of a community-engaged authorship system: lessons learned from the RECOVER initiative
Esquenazi-Karonika, Shari; Mathews, Patenne D; Wood, Marion J; Mudumbi, Praveen M; Linton, Janelle; Briscoe, Jasmine; Seibert, Elle; Coombs, K; Laynor, Gregory; Katz, Stuart D; Chung, Alicia
BACKGROUND:Inclusion of patients, caregivers, and community members in scientific research should be essential for patient-centered care. Patients’ lived experiences can propose new areas of focus that may not have previously been considered, ensure that potentially sensitive topics are addressed thoughtfully, contribute to the interpretation of findings, and identify future directions of research. Further, their inclusion in the drafting of manuscripts can ensure that research findings are translatable to real-world practice. To achieve this goal, the Researching COVID to Enhance Recovery (RECOVER) consortium developed a Representative Authorship system for development of scientific manuscripts that report RECOVER data. This paper describes a Quality Improvement (QI) project that was conducted to identify system strengths and improvement opportunities. METHODS:An online QI survey was distributed to RECOVER’s Representative Authors about a year into the implementation of the Representative Authorship System. The survey focused on several key aspects, including the clarity regarding the authorship process, training opportunities, the matching process, communication within writing groups, and the perceived impact of the representative engagement on the quality and applicability of research. The survey also explored participants’ satisfaction with compensation, support, and involvement in the system, as well as areas for improvement. RESULTS:The survey was sent to 49 representative authors with 17 respondents (35%). Most respondents reported positive experiences, highlighting the effective matching to manuscripts based on their expertise and the perceived positive impact of their involvement on research outcomes. Additionally, participants felt that including diverse voices enhanced the relevance of research for clinical practice. Several areas for improvement were identified, including communication challenges within writing groups, the utility of manuscript orientation calls, and the fairness of compensation. Respondents also indicated a need for more training opportunities and logistical support. CONCLUSIONS:RECOVER’s Representative Authorship system is effective in fostering collaboration and improving the inclusivity of scientific research. The survey findings indicate that there are logistical changes around communication, training, and compensation that could enhance the experience for all collaborators. Based on these findings, we plan to implement changes to improve awareness, understanding, and collaboration. Additional work is needed to solicit feedback from investigators and administrative staff to obtain a more holistic understanding of the system. SUPPLEMENTARY INFORMATION:The online version contains supplementary material available at 10.1186/s12913-025-12914-3.
PMCID:12225380
PMID: 40611083
ISSN: 1472-6963
CID: 5888422
Implementing Precision Medicine for Dilated Cardiomyopathy: Insights From the DCM Consortium
Jordan, Elizabeth; Ni, Hanyu; Parker, Patricia; Kinnamon, Daniel D; Owens, Anjali; Lowes, Brian; Shenoy, Chetan; Martin, Cindy M; Judge, Daniel P; Fishbein, Daniel P; Stoller, Douglas; Minami, Elina; Kransdorf, Evan P; Smart, Frank; Haas, Garrie J; Huggins, Gordon S; Ewald, Gregory A; Diamond, Jamie; Wilcox, Jane E; Jimenez, Javier; Wang, Jessica; Tallaj, Jose; Drazner, Mark H; Hofmeyer, Mark; Wheeler, Matthew T; Wever Pinzon, Omar; Shah, Palak; Gottlieb, Stephen S; Katz, Stuart; Shore, Supriya; Tang, W H Wilson; Hershberger, Ray E; ,
PMID: 40528765
ISSN: 2574-8300
CID: 5870922
Characterizing Long COVID Symptoms During Early Childhood
Gross, Rachel S.; Thaweethai, Tanayott; Salisbury, Amy L.; Kleinman, Lawrence C.; Mohandas, Sindhu; Rhee, Kyung E.; Snowden, Jessica N.; Tantisira, Kelan G.; Warburton, David; Wood, John C.; Kinser, Patricia A.; Milner, Joshua D.; Rosenzweig, Erika B.; Irby, Katherine; Flaherman, Valerie J.; Karlson, Elizabeth W.; Chibnik, Lori B.; Pant, Deepti B.; Krishnamoorthy, Aparna; Gallagher, Richard; Lamendola-Essel, Michelle F.; Hasson, Denise C.; Katz, Stuart D.; Yin, Shonna; Dreyer, Benard P.; Blancero, Frank; Carmilani, Megan; Coombs, K.; Fitzgerald, Megan L.; Letts, Rebecca J.; Peddie, Aimee K.; Foulkes, Andrea S.; Stockwell, Melissa S.; RECOVER Pediatrics Group Authors; RECOVER Pediatrics Consortium
ORIGINAL:0017675
ISSN: 2168-6203
CID: 5853942
Antecedent Flu-Like Illness and Onset of Idiopathic Dilated Cardiomyopathy: The DCM Precision Medicine Study
Ni, Hanyu; Cao, Jinwen; Kinnamon, Daniel D; Jordan, Elizabeth; Haas, Garrie J; Hofmeyer, Mark; Kransdorf, Evan P; Diamond, Jamie; Owens, Anjali; Lowes, Brian; Stoller, Douglas; Tang, W H Wilson; Drazner, Mark H; Shah, Palak; Wilcox, Jane E; Katz, Stuart D; Jimenez, Javier; Shore, Supriya; Judge, Daniel P; Mead, Jonathan O; Cowan, Jason; Parker, Patricia K; Huggins, Gordon S; Hershberger, Ray E
BACKGROUND/UNASSIGNED:Previous studies have speculated that a viral infection may act as a trigger in the development of idiopathic dilated cardiomyopathy (DCM) among individuals genetically at risk. This study aims to describe the frequency of patients with DCM who reported experiencing symptoms of flu-like illness before their DCM diagnosis and to examine if this experience modified the association between genetics and DCM. METHODS/UNASSIGNED:We analyzed data from the family-based cross-sectional DCM Study conducted between 2016 and 2021. Self-reported symptoms of flu-like illness proximal to DCM diagnosis were obtained from patient interviews. Exome sequencing identified rare variants (pathogenic, likely pathogenic, or variant of uncertain significance) in DCM genes. In a case-only design, logistic mixed models were used to examine if flu-like illness modified the effect of these rare variants on DCM risk. Firth logistic regression was used to examine if flu-like illness modified the effect of each of 13 400 141 common autosomal variants (minor allele frequency ≥1%) on DCM risk. RESULTS/UNASSIGNED:) was identified by case-only genome-wide association study. CONCLUSIONS/UNASSIGNED:Approximately one-third of patients with DCM experienced flu-like illness symptoms before DCM diagnosis. We did not find evidence that a flu-like illness modified the effect of rare variants on DCM risk; however, our genome-wide association study analysis suggested that flu-like illness may modify the effect of a common variant on DCM risk. REGISTRATION/UNASSIGNED:URL: https://www.clinicaltrials.gov; Unique identifier: NCT03037632.
PMCID:12094084
PMID: 40392911
ISSN: 1941-3297
CID: 5853022
Alcohol Exposure Among Patients With Dilated Cardiomyopathy and Their First-Degree Relatives: The DCM Precision Medicine Study
Jimenez, Javier; Ni, Hanyu; Katz, Stuart D; Haas, Garrie J; Cao, Jinwen; Rubens, Muni; Chaparro, Sandra; Saxena, Anshul; Hofmeyer, Mark; Kransdorf, Evan; Ewald, Gregory A; Morris, Alanna A; Owens, Anjali; Lowes, Brian; Stoller, Douglas; Tang, W H Wilson; Shah, Palak; Wilcox, Jane E; Smart, Frank; Wang, Jessica; Gottlieb, Stephen S; Judge, Daniel P; Mead, Jonathan O; Hurst, Natalie; Parker, Patricia K; Huggins, Gordon S; Jordan, Elizabeth; Kinnamon, Daniel D; Hershberger, Ray E; ,
BACKGROUND/UNASSIGNED:Whether prolonged and excessive alcohol consumption contributes to dilated cardiomyopathy (DCM) remains uncertain. This study aimed to describe the prevalence of alcohol use in patients with DCM and their first-degree relatives (FDRs) and determine if cumulative alcohol exposure associates with DCM/partial DCM or modifies the association of DCM with DCM-relevant rare variants. METHODS/UNASSIGNED:All probands had DCM; FDRs were classified as with or without DCM or partial DCM. Alcohol exposure was measured with the Alcohol Use Disorder Identification Test-Consumption questionnaire and years of drinking. Rare variants in 36 DCM genes were classified as pathogenic, likely pathogenic, or variants of uncertain significance (pathogenic, likely pathogenic, variant of uncertain significance). Generalized linear mixed models were used to assess the association of DCM/partial DCM with alcohol use among FDRs. RESULTS/UNASSIGNED:=0.55). CONCLUSIONS/UNASSIGNED:Alcohol use was frequent among probands and FDRs. This study did not provide evidence supporting an association of cumulative alcohol exposure with DCM/partial DCM or a modifying effect of alcohol use on the association of DCM with DCM-relevant rare variants. REGISTRATION/UNASSIGNED:URL: https://www.clinicaltrials.gov; Unique identifier: NCT03037632.
PMID: 40151927
ISSN: 2574-8300
CID: 5817272
Concurrent Validity of a Physical Activity Vital Sign Used in an Adult Preventive Cardiology Clinic
McCarthy, Margaret; Fletcher, Jason; Melkus, Gail; Vorderstrasse, Allison; Chehade, Mireille; Katz, Stuart
BACKGROUND:In clinical settings, counseling patients on physical activity starts by assessing patients' current physical activity levels. Self-report measures of PA are generally easy to administer; however, they may be too long to be convenient and are known to correlate poorly with objective measures of physical activity. OBJECTIVE:To assess the concurrent validity of a self-report three-question physical activity vital sign with objective Fitbit step counts and the distance walked during a 6-min walk test. METHODS:This pilot study tested a best practice advisory embedded in the Epic electronic health record, which was designed to prompt providers in a preventive cardiology clinic to counsel patients reporting low levels of physical activity . Patients were invited to participate in the remote patient monitoring phase to assess the change in their physical activity by wearing a Fitbit for 12 weeks and completing a 6-min walk test at baseline and 12 weeks. This analysis used the cross-sectional data collected in this phase. Pearson correlations were conducted between self-reported physical activity, Fitbit step counts, and the distance walked during the 6-min walk-a measure associated with current physical activity levels. Kappa coefficients were calculated to assess agreement between the self-reported physical activity and step counts. RESULTS:Participants who enrolled in the Fitbit monitoring were approximately 50% female, with the majority identified as White non-Hispanic adults. Their most common cardiovascular risk factor was hypertension. The self-reported physical activity vital signs were significantly associated with step counts at baseline and 12 weeks but were not associated with the distance during the 6-min walk test. However, the distance walked was significantly associated with step counts at baseline and 12 weeks. The Kappa results demonstrate a poor level of agreement between two categories (meeting or not meeting current physical activity guidelines) of self-report physical activity vitals and the objective Fitbit step counts. DISCUSSION/CONCLUSIONS:There were moderate correlations between the self-reported physical activity vital signs and the Fitbit step counts, but there was lack of agreement when they were categorized. Further validation of this physical activity vital sign is warranted.
PMID: 40088421
ISSN: 1538-9847
CID: 5812782
2024 Update of the RECOVER-Adult Long COVID Research Index
Geng, Linda N; Erlandson, Kristine M; Hornig, Mady; Letts, Rebecca; Selvaggi, Caitlin; Ashktorab, Hassan; Atieh, Ornina; Bartram, Logan; Brim, Hassan; Brosnahan, Shari B; Brown, Jeanette; Castro, Mario; Charney, Alexander; Chen, Peter; Deeks, Steven G; Erdmann, Nathaniel; Flaherman, Valerie J; Ghamloush, Maher A; Goepfert, Paul; Goldman, Jason D; Han, Jenny E; Hess, Rachel; Hirshberg, Ellie; Hoover, Susan E; Katz, Stuart D; Kelly, J Daniel; Klein, Jonathan D; Krishnan, Jerry A; Lee-Iannotti, Joyce; Levitan, Emily B; Marconi, Vincent C; Metz, Torri D; Modes, Matthew E; Nikolich, Janko Ž; Novak, Richard M; Ofotokun, Igho; Okumura, Megumi J; Parthasarathy, Sairam; Patterson, Thomas F; Peluso, Michael J; Poppas, Athena; Quintero Cardona, Orlando; Scott, Jake; Shellito, Judd; Sherif, Zaki A; Singer, Nora G; Taylor, Barbara S; Thaweethai, Tanayott; Verduzco-Gutierrez, Monica; Wisnivesky, Juan; McComsey, Grace A; Horwitz, Leora I; Foulkes, Andrea S; ,
IMPORTANCE/UNASSIGNED:Classification of persons with long COVID (LC) or post-COVID-19 condition must encompass the complexity and heterogeneity of the condition. Iterative refinement of the classification index for research is needed to incorporate newly available data as the field rapidly evolves. OBJECTIVE/UNASSIGNED:To update the 2023 research index for adults with LC using additional participant data from the Researching COVID to Enhance Recovery (RECOVER-Adult) study and an expanded symptom list based on input from patient communities. DESIGN, SETTING, AND PARTICIPANTS/UNASSIGNED:Prospective, observational cohort study including adults 18 years or older with or without known prior SARS-CoV-2 infection who were enrolled at 83 sites in the US and Puerto Rico. Included participants had at least 1 study visit taking place 4.5 months after first SARS-CoV-2 infection or later, and not within 30 days of a reinfection. The study visits took place between October 2021 and March 2024. EXPOSURE/UNASSIGNED:SARS-CoV-2 infection. MAIN OUTCOMES AND MEASURES/UNASSIGNED:Presence of LC and participant-reported symptoms. RESULTS/UNASSIGNED:A total of 13 647 participants (11 743 with known SARS-CoV-2 infection and 1904 without known prior SARS-CoV-2 infection; median age, 45 years [IQR, 34-69 years]; and 73% were female) were included. Using the least absolute shrinkage and selection operator analysis regression approach from the 2023 model, symptoms contributing to the updated 2024 index included postexertional malaise, fatigue, brain fog, dizziness, palpitations, change in smell or taste, thirst, chronic cough, chest pain, shortness of breath, and sleep apnea. For the 2024 LC research index, the optimal threshold to identify participants with highly symptomatic LC was a score of 11 or greater. The 2024 index classified 20% of participants with known prior SARS-CoV-2 infection and 4% of those without known prior SARS-CoV-2 infection as having likely LC (vs 21% and 5%, respectively, using the 2023 index) and 39% of participants with known prior SARS-CoV-2 infection as having possible LC, which is a new category for the 2024 model. Cluster analysis identified 5 LC subtypes that tracked quality-of-life measures. CONCLUSIONS AND RELEVANCE/UNASSIGNED:The 2024 LC research index for adults builds on the 2023 index with additional data and symptoms to help researchers classify symptomatic LC and its symptom subtypes. Continued future refinement of the index will be needed as the understanding of LC evolves.
PMID: 39693079
ISSN: 1538-3598
CID: 5764512
Assessment of Revascularization Preferences with Best-Worst Scaling Among Patients with Ischemic Heart Disease
Mukhopadhyay, Amrita; Dickson, Victoria Vaughan; Langford, Aisha; Spertus, John A; Bangalore, Sripal; Zhang, Yan; Tarpey, Thaddeus; Hochman, Judith; Katz, Stuart D
PMID: 39423941
ISSN: 1532-8414
CID: 5718902
Cardiologist Perceptions on Automated Alerts and Messages To Improve Heart Failure Care
Maidman, Samuel D; Blecker, Saul; Reynolds, Harmony R; Phillips, Lawrence M; Paul, Margaret M; Nagler, Arielle R; Szerencsy, Adam; Saxena, Archana; Horwitz, Leora I; Katz, Stuart D; Mukhopadhyay, Amrita
Electronic health record (EHR)-embedded tools are known to improve prescribing of guideline-directed medical therapy (GDMT) for patients with heart failure. However, physicians may perceive EHR tools to be unhelpful, and may be therefore hesitant to implement these in their practice. We surveyed cardiologists about two effective EHR-tools to improve heart failure care, and they perceived the EHR tools to be easy to use, helpful, and improve the overall management of their patients with heart failure.
PMID: 39423991
ISSN: 1097-6744
CID: 5718912
Post-Acute Sequelae of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) After Infection During Pregnancy
Metz, Torri D; Reeder, Harrison T; Clifton, Rebecca G; Flaherman, Valerie; Aragon, Leyna V; Baucom, Leah Castro; Beamon, Carmen J; Braverman, Alexis; Brown, Jeanette; Cao, Tingyi; Chang, Ann; Costantine, Maged M; Dionne, Jodie A; Gibson, Kelly S; Gross, Rachel S; Guerreros, Estefania; Habli, Mounira; Hadlock, Jennifer; Han, Jenny; Hess, Rachel; Hillier, Leah; Hoffman, M Camille; Hoffman, Matthew K; Hughes, Brenna L; Jia, Xiaolin; Kale, Minal; Katz, Stuart D; Laleau, Victoria; Mallett, Gail; Mehari, Alem; Mendez-Figueroa, Hector; McComsey, Grace A; Monteiro, Jonathan; Monzon, Vanessa; Okumura, Megumi J; Pant, Deepti; Pacheco, Luis D; Palatnik, Anna; Palomares, Kristy T S; Parry, Samuel; Pettker, Christian M; Plunkett, Beth A; Poppas, Athena; Ramsey, Patrick; Reddy, Uma M; Rouse, Dwight J; Saade, George R; Sandoval, Grecio J; Sciurba, Frank; Simhan, Hyagriv N; Skupski, Daniel W; Sowles, Amber; Thorp, John M; Tita, Alan T N; Wiegand, Samantha; Weiner, Steven J; Yee, Lynn M; Horwitz, Leora I; Foulkes, Andrea S; Jacoby, Vanessa; ,
OBJECTIVE:To estimate the prevalence of post-acute sequelae of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection (PASC) after infection with SARS-CoV-2 during pregnancy and to characterize associated risk factors. METHODS:In a multicenter cohort study (NIH RECOVER [Researching COVID to Enhance Recovery]-Pregnancy Cohort), individuals who were pregnant during their first SARS-CoV-2 infection were enrolled across the United States from December 2021 to September 2023, either within 30 days of their infection or at differential time points thereafter. The primary outcome was PASC , defined as score of 12 or higher based on symptoms and severity as previously published by the NIH RECOVER-Adult Cohort, at the first study visit at least 6 months after the participant's first SARS-CoV-2 infection. Risk factors for PASC were evaluated, including sociodemographic characteristics, clinical characteristics before SARS-CoV-2 infection (baseline comorbidities, trimester of infection, vaccination status), and acute infection severity (classified by need for oxygen therapy). Multivariable logistic regression models were fitted to estimate associations between these characteristics and presence of PASC. RESULTS:Of the 1,502 participants, 61.1% had their first SARS-CoV-2 infection on or after December 1, 2021 (ie, during Omicron variant dominance); 51.4% were fully vaccinated before infection; and 182 (12.1%) were enrolled within 30 days of their acute infection. The prevalence of PASC was 9.3% (95% CI, 7.9-10.9%) measured at a median of 10.3 months (interquartile range 6.1-21.5) after first infection. The most common symptoms among individuals with PASC were postexertional malaise (77.7%), fatigue (76.3%), and gastrointestinal symptoms (61.2%). In a multivariable model, the proportion PASC positive with vs without history of obesity (14.9% vs 7.5%, adjusted odds ratio [aOR] 1.65, 95% CI, 1.12-2.43), depression or anxiety disorder (14.4% vs 6.1%, aOR 2.64, 95% CI, 1.79-3.88) before first infection, economic hardship (self-reported difficulty covering expenses) (12.5% vs 6.9%, aOR 1.57, 95% CI, 1.05-2.34), and treatment with oxygen during acute SARS-CoV-2 infection (18.1% vs 8.7%, aOR 1.86, 95% CI, 1.00-3.44) were associated with increased prevalence of PASC. CONCLUSION/CONCLUSIONS:The prevalence of PASC at a median time of 10.3 months after SARS-CoV-2 infection during pregnancy was 9.3% in the NIH RECOVER-Pregnancy Cohort. The predominant symptoms were postexertional malaise, fatigue, and gastrointestinal symptoms. Several socioeconomic and clinical characteristics were associated with PASC after infection during pregnancy. CLINICAL TRIAL REGISTRATION/BACKGROUND:ClinicalTrials.gov , NCT05172024.
PMCID:11326967
PMID: 38991216
ISSN: 1873-233x
CID: 5699102