Browsing by Author "Scheiman, James M."

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    Association Between Preadmission Acid Suppressive Medication Exposure and Severity of Illness in Patients Hospitalized With COVID-19
    (Elsevier, 2021) Elmunzer, B. Joseph; Wolf, Bethany J.; Scheiman, James M.; Tierney, William M.; Taylor, Jason R.; North American Alliance for the Study of Digestive Manifestations of COVID-19; Community and Global Health, Richard M. Fairbanks School of Public Health
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    Digestive Manifestations in Patients Hospitalized With Coronavirus Disease 2019
    (Elsevier, 2020-10-01) Elmunzer, B. Joseph; Spitzer, Rebecca L.; Foster, Lydia D.; Merchant, Ambreen A.; Howard, Eric F.; Patel, Vaishali A.; West, Mary K.; Qayed, Emad; Nustas, Rosemary; Zakaria, Ali; Piper, Marc S.; Taylor, Jason R.; Jaza, Lujain; Forbes, Nauzer; Chau, Millie; Lara, Luis F.; Papachristou, Georgios I.; Volk, Michael L.; Hilson, Liam G.; Zhou, Selena; Kushnir, Vladimir M.; Lenyo, Alexandria M.; McLeod, Caroline G.; Amin, Sunil; Kuftinec, Gabriela N.; Yadav, Dhiraj; Fox, Charlie; Kolb, Jennifer M.; Pawa, Swati; Pawa, Rishi; Canakis, Andrew; Huang, Christopher; Jamil, Laith H.; Aneese, Andrew M.; Glamour, Benita K.; Smith, Zachary L.; Hanley, Katherine A.; Wood, Jordan; Patel, Harsh K.; Shah, Janak N.; Agarunov, Emil; Sethi, Amrita; Fogel, Evan L.; McNulty, Gail; Haseeb, Abdul; Trieu, Judy A.; Dixon, Rebekah E.; Yang, Jeong Yun; Mendelsohn, Robin B.; Calo, Delia; Aroniadis, Olga C.; LaComb, Joseph F.; Scheiman, James M.; Sauer, Bryan G.; Dang, Duyen T.; Piraka, Cyrus R.; Shah, Eric D.; Pohl, Heiko; Tierney, William M.; Mitchell, Stephanie; Condon, Ashwinee; Lenhart, Adrienne; Dua, Kulwinder S.; Kanagala, Vikram S.; Kamal, Ayesha; Singh, Vikesh K.; Pinto-Sanchez, Maria Ines; Hutchinson, Joy M.; Kwon, Richard S.; Korsnes, Sheryl J.; Singh, Harminder; Solati, Zahra; Willingham, Field F.; Yachimski, Patrick S.; Conwell, Darwin L.; Mosier, Evan; Azab, Mohamed; Patel, Anish; Buxbaum, James; Wani, Sachin; Chak, Amitabh; Hosmer, Amy E.; Keswani, Rajesh N.; DiMaio, Christopher J.; Bronze, Michael S.; Muthusamy, Raman; Canto, Marcia I.; Gjeorgjievski, V. Mihajlo; Imam, Zaid; Odish, Fadi; Edhi, Ahmed I.; Orosey, Molly; Tiwari, Abhinav; Patwardhan, Soumil; Brown, Nicholas G.; Patel, Anish A.; Ordiah, Collins O.; Sloan, Ian P.; Cruz, Lilian; Koza, Casey L.; Okafor, Uchechi; Hollander, Thomas; Furey, Nancy; Reykhart, Olga; Zbib, Natalia H.; Damianos, John A.; Esteban, James; Hajidiacos, Nick; Saul, Melissa; Mays, Melanie; Anderson, Gulsum; Wood, Kelley; Mathews, Laura; Diakova, Galina; Caisse, Molly; Wakefield, Lauren; Nitchie, Haley; Waljee, Akbar K.; Tang, Weijing; Zhang, Yueyang; Zhu, Ji; Deshpande, Amar R.; Rockey, Don C.; Alford, Teldon B.; Durkalski, Valerie; Medicine, School of Medicine
    Background & Aims The prevalence and significance of digestive manifestations in coronavirus disease 2019 (COVID-19) remain uncertain. We aimed to assess the prevalence, spectrum, severity, and significance of digestive manifestations in patients hospitalized with COVID-19. Methods Consecutive patients hospitalized with COVID-19 were identified across a geographically diverse alliance of medical centers in North America. Data pertaining to baseline characteristics, symptomatology, laboratory assessment, imaging, and endoscopic findings from the time of symptom onset until discharge or death were abstracted manually from electronic health records to characterize the prevalence, spectrum, and severity of digestive manifestations. Regression analyses were performed to evaluate the association between digestive manifestations and severe outcomes related to COVID-19. Results A total of 1992 patients across 36 centers met eligibility criteria and were included. Overall, 53% of patients experienced at least 1 gastrointestinal symptom at any time during their illness, most commonly diarrhea (34%), nausea (27%), vomiting (16%), and abdominal pain (11%). In 74% of cases, gastrointestinal symptoms were judged to be mild. In total, 35% of patients developed an abnormal alanine aminotransferase or total bilirubin level; these were increased to less than 5 times the upper limit of normal in 77% of cases. After adjusting for potential confounders, the presence of gastrointestinal symptoms at any time (odds ratio, 0.93; 95% CI, 0.76–1.15) or liver test abnormalities on admission (odds ratio, 1.31; 95% CI, 0.80–2.12) were not associated independently with mechanical ventilation or death. Conclusions Among patients hospitalized with COVID-19, gastrointestinal symptoms and liver test abnormalities were common, but the majority were mild and their presence was not associated with a more severe clinical course.
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    Digestive Manifestations in Patients Hospitalized With Coronavirus Disease 2019
    (Elsevier, 2021-07) Elmunzer, B. Joseph; Spitzer, Rebecca L.; Foster, Lydia D.; Merchant, Ambreen A.; Howard, Eric F.; Patel, Vaishali A.; West, Mary K.; Qayed, Emad; Nustas, Rosemary; Zakaria, Ali; Piper, Marc S.; Taylor, Jason R.; Jaza, Lujain; Forbes, Nauzer; Chau, Millie; Lara, Luis F.; Papachristou, Georgios I.; Volk, Michael L.; Hilson, Liam G.; Zhou, Selena; Kushnir, Vladimir M.; Lenyo, Alexandria M.; McLeod, Caroline G.; Amin, Sunil; Kuftinec, Gabriela N.; Yadav, Dhiraj; Fox, Charlie; Kolb, Jennifer M.; Pawa, Swati; Pawa, Rishi; Canakis, Andrew; Huang, Christopher; Jamil, Laith H.; Aneese, Andrew M.; Glamour, Benita K.; Smith, Zachary L.; Hanley, Katherine A.; Wood, Jordan; Patel, Harsh K.; Shah, Janak N.; Agarunov, Emil; Sethi, Amrita; Fogel, Evan L.; McNulty, Gail; Haseeb, Abdul; Trieu, Judy A.; Dixon, Rebekah E.; Yang, Jeong Yun; Mendelsohn, Robin B.; Calo, Delia; Aroniadis, Olga C.; LaComb, Joseph F.; Scheiman, James M.; Sauer, Bryan G.; Dang, Duyen T.; Piraka, Cyrus R.; Shah, Eric D.; Pohl, Heiko; Tierney, William M.; Mitchell, Stephanie; Condon, Ashwinee; Lenhart, Adrienne; Dua, Kulwinder S.; Kanagala, Vikram S.; Kamal, Ayesha; Singh, Vikesh K.; Pinto-Sanchez, Maria Ines; Hutchinson, Joy M.; Kwon, Richard S.; Korsnes, Sheryl J.; Singh, Harminder; Solati, Zahra; Willingham, Field F.; Yachimski, Patrick S.; Conwell, Darwin L.; Mosier, Evan; Azab, Mohamed; Patel, Anish; Buxbaum, James; Wani, Sachin; Chak, Amitabh; Hosmer, Amy E.; Keswani, Rajesh N.; DiMaio, Christopher J.; Bronze, Michael S.; Muthusamy, Raman; Canto, Marcia I.; Gjeorgjievski, V. Mihajlo; Imam, Zaid; Odish, Fadi; Edhi, Ahmed I.; Orosey, Molly; Tiwari, Abhinav; Patwardhan, Soumil; Brown, Nicholas G.; Patel, Anish A.; Ordiah, Collins O.; Sloan, Ian P.; Cruz, Lilian; Koza, Casey L.; Okafor, Uchechi; Hollander, Thomas; Furey, Nancy; Reykhart, Olga; Zbib, Natalia H.; Damianos, John A.; Esteban, James; Hajidiacos, Nick; Saul, Melissa; Mays, Melanie; Anderson, Gulsum; Wood, Kelley; Mathews, Laura; Diakova, Galina; Caisse, Molly; Wakefield, Lauren; Nitchie, Haley; Waljee, Akbar K.; Tang, Weijing; Zhang, Yueyang; Zhu, Ji; Deshpande, Amar R.; Rockey, Don C.; Alford, Teldon B.; Durkalski, Valerie; North American Alliance for the Study of Digestive Manifestations of COVID-19; Medicine, School of Medicine
    BACKGROUND & AIMS: The prevalence and significance of digestive manifestations in coronavirus disease 2019 (COVID-19) remain uncertain. We aimed to assess the prevalence, spectrum, severity, and significance of digestive manifestations in patients hospitalized with COVID-19. METHODS: Consecutive patients hospitalized with COVID-19 were identified across a geographically diverse alliance of medical centers in North America. Data pertaining to baseline characteristics, symptomatology, laboratory assessment, imaging, and endoscopic findings from the time of symptom onset until discharge or death were abstracted manually from electronic health records to characterize the prevalence, spectrum, and severity of digestive manifestations. Regression analyses were performed to evaluate the association between digestive manifestations and severe outcomes related to COVID-19. RESULTS: A total of 1992 patients across 36 centers met eligibility criteria and were included. Overall, 53% of patients experienced at least 1 gastrointestinal symptom at any time during their illness, most commonly diarrhea (34%), nausea (27%), vomiting (16%), and abdominal pain (11%). In 74% of cases, gastrointestinal symptoms were judged to be mild. In total, 35% of patients developed an abnormal alanine aminotransferase or total bilirubin level; these were increased to less than 5 times the upper limit of normal in 77% of cases. After adjusting for potential confounders, the presence of gastrointestinal symptoms at any time (odds ratio, 0.93; 95% CI, 0.76-1.15) or liver test abnormalities on admission (odds ratio, 1.31; 95% CI, 0.80-2.12) were not associated independently with mechanical ventilation or death. CONCLUSIONS: Among patients hospitalized with COVID-19, gastrointestinal symptoms and liver test abnormalities were common, but the majority were mild and their presence was not associated with a more severe clinical course.
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    Rectal Indomethacin Dose Escalation (RIDE) for Prevention of Post-ERCP Pancreatitis in High-Risk Patients: a Randomized Trial
    (Elsevier, 2020-02) Fogel, Evan L.; Lehman, Glen A.; Tarnasky, Paul; Cote, Gregory A.; Schmidt, Suzette E.; Waljee, Akbar K.; Higgins, Peter D. R.; Watkins, James L.; Sherman, Stuart; Kwon, Richard S. Y.; Elta, Grace H.; Easler, Jeffrey J.; Pleskow, Douglas K.; Scheiman, James M.; El Hajj, Ihab I.; Guda, Nalini M.; Gromski, Mark A.; McHenry, Lee, Jr.; Arol, Seena; Korsnes, Sheryl; Suarez, Alejandro L.; Spitzer, Rebecca; Miller, Marilyn; Hofbauer, Maria; Elmunzer, Badih Joseph; Medicine, School of Medicine
    Background Although rectal indometacin 100 mg is effective in reducing the frequency and severity of pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP) in high-risk patients, the optimal dose is unknown, and pancreatitis incidence remains high. The aim of this study was to compare the efficacy of two dose regimens of rectal indometacin on the frequency and severity of pancreatitis after ERCP in high-risk patients. Methods In this randomised, double-blind, comparative effectiveness trial, we enrolled patients from six tertiary medical centres in the USA. Eligible patients were those at high risk for the development of pancreatitis after ERCP. We randomly assigned eligible patients (1:1) immediately after ERCP to receive either two 50 mg indometacin suppositories and a placebo suppository (standard-dose group) or three 50 mg indometacin suppositories (high-dose group). 4 h after the procedure, patients assigned to the high-dose group received an additional 50 mg indometacin suppository, whereas patients in the standard-dose group received an additional placebo suppository. The randomisation schedule, stratified according to study centre and with no other restrictions, was computer generated by an investigator who was uninvolved in the clinical care of any participants, distributed to the sites, and kept by personnel not directly involved with the study. These same personnel were responsible for packaging the drug and placebo in opaque envelopes. Patients, study personnel, and treating physicians were masked to study group assignment. The primary outcome of the study was the development of pancreatitis after ERCP. Analyses were done on an intention-to-treat basis. This trial is registered with ClinicalTrials.gov, number NCT01912716, and enrolment is complete. Findings Between July 9, 2013, and March 22, 2018, 1037 eligible patients were enrolled and randomly assigned to receive either standard-dose (n=515) or high-dose indometacin (n=522). Pancreatitis after ERCP occurred in 141 (14%) of 1037 patients—76 (15%) of 515 patients in the standard-dose indometacin group and 65 (12%) of 522 patients in the high-dose indometacin group (risk ratio [RR] 1·19, 95% CI 0·87–1·61; p=0·32). We observed 19 adverse events that were potentially attributable to study drug. Clinically significant bleeding occurred in 14 (1%) of 1037 patients—six (1%) of 515 patients in the standard-dose indometacin group and eight (2%) of 522 patients in the high-dose indometacin group (p=0·79). Three (1%) of 522 patients in the high-dose indometacin group developed acute kidney injury versus none in the standard-dose group (p=0·25). A non-ST elevation myocardial infarction occurred in the standard-dose indometacin group 2 days after ERCP. A transient ischaemic attack occurred in the high-dose indometacin group 5 days after ERCP. All 19 adverse events, in addition to the 141 patients who developed pancreatitis after ERCP, were considered serious as all required admission to hospital. We observed no allergic reactions or deaths at 30 day follow-up. Interpretation Dose escalation to rectal indometacin 200 mg did not confer any advantage compared with the standard 100 mg regimen, with pancreatitis incidence remaining high in high-risk patients. Current practice should continue unchanged. Further research should consider the pharmacokinetics of non-steroidal anti-inflammatory drugs to determine the optimal timing of their administration to prevent pancreatitis after ERCP.
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    Rectal Indomethacin Dose Escalation (RIDE) for Prevention of Post-ERCP Pancreatitis in High-Risk Patients: a Randomized Trial
    (Elsevier, 2020) Fogel, Evan L.; Lehman, Glen A.; Tarnasky, Paul; Cote, Gregory A.; Schmidt, Suzette E.; Waljee, Akbar K.; Higgins, Peter D. R.; Watkins, James L.; Sherman, Stuart; Kwon, Richard S. Y.; Elta, Grace H.; Easler, Jeffrey J.; Pleskow, Douglas K.; Scheiman, James M.; El Hajj, Ihab I.; Guda, Nalini M.; Gromski, Mark A.; McHenry, Lee, Jr.; Arol, Seena; Korsnes, Sheryl; Suarez, Alejandro L.; Spitzer, Rebecca; Miller, Marilyn; Hofbauer, Maria; Elmunzer, B. Joseph; US Cooperative for Outcomes Research in Endoscopy (USCORE); Medicine, School of Medicine
    Background: Although rectal indometacin 100 mg is effective in reducing the frequency and severity of pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP) in high-risk patients, the optimal dose is unknown, and pancreatitis incidence remains high. The aim of this study was to compare the efficacy of two dose regimens of rectal indometacin on the frequency and severity of pancreatitis after ERCP in high-risk patients. Methods: In this randomised, double-blind, comparative effectiveness trial, we enrolled patients from six tertiary medical centres in the USA. Eligible patients were those at high risk for the development of pancreatitis after ERCP. We randomly assigned eligible patients (1:1) immediately after ERCP to receive either two 50 mg indometacin suppositories and a placebo suppository (standard-dose group) or three 50 mg indometacin suppositories (high-dose group). 4 h after the procedure, patients assigned to the high-dose group received an additional 50 mg indometacin suppository, whereas patients in the standard-dose group received an additional placebo suppository. The randomisation schedule, stratified according to study centre and with no other restrictions, was computer generated by an investigator who was uninvolved in the clinical care of any participants, distributed to the sites, and kept by personnel not directly involved with the study. These same personnel were responsible for packaging the drug and placebo in opaque envelopes. Patients, study personnel, and treating physicians were masked to study group assignment. The primary outcome of the study was the development of pancreatitis after ERCP. Analyses were done on an intention-to-treat basis. This trial is registered with ClinicalTrials.gov, number NCT01912716, and enrolment is complete. Findings: Between July 9, 2013, and March 22, 2018, 1037 eligible patients were enrolled and randomly assigned to receive either standard-dose (n=515) or high-dose indometacin (n=522). Pancreatitis after ERCP occurred in 141 (14%) of 1037 patients-76 (15%) of 515 patients in the standard-dose indometacin group and 65 (12%) of 522 patients in the high-dose indometacin group (risk ratio [RR] 1·19, 95% CI 0·87-1·61; p=0·32). We observed 19 adverse events that were potentially attributable to study drug. Clinically significant bleeding occurred in 14 (1%) of 1037 patients-six (1%) of 515 patients in the standard-dose indometacin group and eight (2%) of 522 patients in the high-dose indometacin group (p=0·79). Three (1%) of 522 patients in the high-dose indometacin group developed acute kidney injury versus none in the standard-dose group (p=0·25). A non-ST elevation myocardial infarction occurred in the standard-dose indometacin group 2 days after ERCP. A transient ischaemic attack occurred in the high-dose indometacin group 5 days after ERCP. All 19 adverse events, in addition to the 141 patients who developed pancreatitis after ERCP, were considered serious as all required admission to hospital. We observed no allergic reactions or deaths at 30 day follow-up. Interpretation: Dose escalation to rectal indometacin 200 mg did not confer any advantage compared with the standard 100 mg regimen, with pancreatitis incidence remaining high in high-risk patients. Current practice should continue unchanged. Further research should consider the pharmacokinetics of non-steroidal anti-inflammatory drugs to determine the optimal timing of their administration to prevent pancreatitis after ERCP.