A Prospective Cohort Study Evaluating PAN-PROMISE, a Patient-reported Outcome Measure to Detect Post-ERCP Morbidity
The Cotton Consensus (CC) criteria for post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) may not capture post-ERCP morbidity. PAN-PROMISE, a patient-reported outcome measure (PROM), was developed to quantify acute pancreatitis-related morbidity. This study aims to determi...
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Veröffentlicht in: | Clinical gastroenterology and hepatology 2023-05, Vol.21 (5), p.1233-1242.e14 |
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creator | Thiruvengadam, Nikhil R. Kouanda, Abdul Kalluri, Anita Schaubel, Douglas Saumoy, Monica Forde, Kimberly Song, Jun Faggen, Alec Davis, Brenton G. Onwugaje, Kenechukwu Chudy Cote, Gregory Arain, Mustafa A. Kochman, Michael L. |
description | The Cotton Consensus (CC) criteria for post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) may not capture post-ERCP morbidity. PAN-PROMISE, a patient-reported outcome measure (PROM), was developed to quantify acute pancreatitis-related morbidity. This study aims to determine the value of PAN-PROMISE in independently defining ERCP-related morbidity.
We conducted a prospective cohort study of patients undergoing ERCP at 2 academic centers from September 2021 to August 2022. We administered PAN-PROMISE and assessed quality of life and work productivity at baseline, 48 to 72 hours, 7 days, and 30 days following ERCP. PEP was defined by a 3-physician committee using the CC criteria. We defined high morbidity following ERCP (elevated PROM) by an increase of PAN-PROMISE score of >7 at 7 days post-procedure. The McNemar test assessed discordance between PEP and elevated-PROM.
A total of 679 patients were enrolled. Choledocholithiasis (30%) and malignant biliary obstruction (29%) were the main indications for ERCP. Thirty-two patients (4.7%) developed PEP. One hundred forty-seven patients (21.6%) had an elevated PROM, whereas only 20 of them (13.4%) had PEP by the CC criteria (P < .001 for discordance). An elevated PROM strongly correlated with lower physical quality of life and increased direct and indirect health care costs ($80 and $25 per point increase in PAN-PROMISE, respectively). Patients with pancreatic cancer (odds ratio, 4.52; 95% confidence interval, 1.68–10.74) and primary sclerosing cholangitis (odds ratio, 1.79; 95% confidence interval, 1.29–2.45) had the highest odds of elevated PROM.
A substantial number of patients experience significant morbidity after ERCP despite not developing PEP or other adverse events. Future studies are needed to characterize better the reasons behind this increase in symptoms and potential interventions to reduce the symptom burden post-ERCP. ClinicalTrials.gov number, NCT05310409.
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doi_str_mv | 10.1016/j.cgh.2022.08.034 |
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We conducted a prospective cohort study of patients undergoing ERCP at 2 academic centers from September 2021 to August 2022. We administered PAN-PROMISE and assessed quality of life and work productivity at baseline, 48 to 72 hours, 7 days, and 30 days following ERCP. PEP was defined by a 3-physician committee using the CC criteria. We defined high morbidity following ERCP (elevated PROM) by an increase of PAN-PROMISE score of >7 at 7 days post-procedure. The McNemar test assessed discordance between PEP and elevated-PROM.
A total of 679 patients were enrolled. Choledocholithiasis (30%) and malignant biliary obstruction (29%) were the main indications for ERCP. Thirty-two patients (4.7%) developed PEP. One hundred forty-seven patients (21.6%) had an elevated PROM, whereas only 20 of them (13.4%) had PEP by the CC criteria (P < .001 for discordance). An elevated PROM strongly correlated with lower physical quality of life and increased direct and indirect health care costs ($80 and $25 per point increase in PAN-PROMISE, respectively). Patients with pancreatic cancer (odds ratio, 4.52; 95% confidence interval, 1.68–10.74) and primary sclerosing cholangitis (odds ratio, 1.79; 95% confidence interval, 1.29–2.45) had the highest odds of elevated PROM.
A substantial number of patients experience significant morbidity after ERCP despite not developing PEP or other adverse events. Future studies are needed to characterize better the reasons behind this increase in symptoms and potential interventions to reduce the symptom burden post-ERCP. ClinicalTrials.gov number, NCT05310409.
▪</description><identifier>ISSN: 1542-3565</identifier><identifier>EISSN: 1542-7714</identifier><identifier>DOI: 10.1016/j.cgh.2022.08.034</identifier><identifier>PMID: 36075501</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Acute Disease ; Cholangiopancreatography, Endoscopic Retrograde - adverse effects ; Cholangiopancreatography, Endoscopic Retrograde - methods ; Cotton Consensus Criteria ; Humans ; Morbidity ; PAN-PROMISE ; Pancreatitis - diagnosis ; Pancreatitis - epidemiology ; Pancreatitis - etiology ; Patient Reported Outcome Measures ; Patient-reported Outcome Measure ; Post-ERCP Morbidity ; Post-ERCP Pancreatitis ; Prospective Studies ; Quality of Life ; Retrospective Studies ; Risk Factors</subject><ispartof>Clinical gastroenterology and hepatology, 2023-05, Vol.21 (5), p.1233-1242.e14</ispartof><rights>2023 AGA Institute</rights><rights>Copyright © 2023 AGA Institute. Published by Elsevier Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c353t-1b8df24088a14b030ec1e84bf413ae4c89d322fdec34db187b066663916a1a283</citedby><cites>FETCH-LOGICAL-c353t-1b8df24088a14b030ec1e84bf413ae4c89d322fdec34db187b066663916a1a283</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.cgh.2022.08.034$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,780,784,3550,27924,27925,45995</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/36075501$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Thiruvengadam, Nikhil R.</creatorcontrib><creatorcontrib>Kouanda, Abdul</creatorcontrib><creatorcontrib>Kalluri, Anita</creatorcontrib><creatorcontrib>Schaubel, Douglas</creatorcontrib><creatorcontrib>Saumoy, Monica</creatorcontrib><creatorcontrib>Forde, Kimberly</creatorcontrib><creatorcontrib>Song, Jun</creatorcontrib><creatorcontrib>Faggen, Alec</creatorcontrib><creatorcontrib>Davis, Brenton G.</creatorcontrib><creatorcontrib>Onwugaje, Kenechukwu Chudy</creatorcontrib><creatorcontrib>Cote, Gregory</creatorcontrib><creatorcontrib>Arain, Mustafa A.</creatorcontrib><creatorcontrib>Kochman, Michael L.</creatorcontrib><title>A Prospective Cohort Study Evaluating PAN-PROMISE, a Patient-reported Outcome Measure to Detect Post-ERCP Morbidity</title><title>Clinical gastroenterology and hepatology</title><addtitle>Clin Gastroenterol Hepatol</addtitle><description>The Cotton Consensus (CC) criteria for post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) may not capture post-ERCP morbidity. PAN-PROMISE, a patient-reported outcome measure (PROM), was developed to quantify acute pancreatitis-related morbidity. This study aims to determine the value of PAN-PROMISE in independently defining ERCP-related morbidity.
We conducted a prospective cohort study of patients undergoing ERCP at 2 academic centers from September 2021 to August 2022. We administered PAN-PROMISE and assessed quality of life and work productivity at baseline, 48 to 72 hours, 7 days, and 30 days following ERCP. PEP was defined by a 3-physician committee using the CC criteria. We defined high morbidity following ERCP (elevated PROM) by an increase of PAN-PROMISE score of >7 at 7 days post-procedure. The McNemar test assessed discordance between PEP and elevated-PROM.
A total of 679 patients were enrolled. Choledocholithiasis (30%) and malignant biliary obstruction (29%) were the main indications for ERCP. Thirty-two patients (4.7%) developed PEP. One hundred forty-seven patients (21.6%) had an elevated PROM, whereas only 20 of them (13.4%) had PEP by the CC criteria (P < .001 for discordance). An elevated PROM strongly correlated with lower physical quality of life and increased direct and indirect health care costs ($80 and $25 per point increase in PAN-PROMISE, respectively). Patients with pancreatic cancer (odds ratio, 4.52; 95% confidence interval, 1.68–10.74) and primary sclerosing cholangitis (odds ratio, 1.79; 95% confidence interval, 1.29–2.45) had the highest odds of elevated PROM.
A substantial number of patients experience significant morbidity after ERCP despite not developing PEP or other adverse events. Future studies are needed to characterize better the reasons behind this increase in symptoms and potential interventions to reduce the symptom burden post-ERCP. ClinicalTrials.gov number, NCT05310409.
▪</description><subject>Acute Disease</subject><subject>Cholangiopancreatography, Endoscopic Retrograde - adverse effects</subject><subject>Cholangiopancreatography, Endoscopic Retrograde - methods</subject><subject>Cotton Consensus Criteria</subject><subject>Humans</subject><subject>Morbidity</subject><subject>PAN-PROMISE</subject><subject>Pancreatitis - diagnosis</subject><subject>Pancreatitis - epidemiology</subject><subject>Pancreatitis - etiology</subject><subject>Patient Reported Outcome Measures</subject><subject>Patient-reported Outcome Measure</subject><subject>Post-ERCP Morbidity</subject><subject>Post-ERCP Pancreatitis</subject><subject>Prospective Studies</subject><subject>Quality of Life</subject><subject>Retrospective Studies</subject><subject>Risk Factors</subject><issn>1542-3565</issn><issn>1542-7714</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kE1PGzEQhq0KVL76A7hUPnLobv21u456itLwIRGyAnq2vPYsOEriYHsj5d9jlMCxc5nR6JlXmgehS0pKSmj9e1Gal9eSEcZKIkvCxTd0SivBiqah4ugw86quTtBZjAtC2EiMmu_ohNekqSpCT1Ec4zb4uAGT3BbwxL_6kPBTGuwOT7d6Oejk1i-4HT8U7eN8dvc0_YU1bvMW1qkIsMk4WDwfkvErwDPQcQiAk8d_IeVQ3PqYiunjpMUzHzpnXdpdoONeLyP8OPRz9O96-jy5Le7nN3eT8X1heMVTQTtpeyaIlJqKjnAChoIUXS8o1yCMHFnOWG_BcGE7KpuO1Ln4iNaaaib5Obra526CfxsgJrVy0cByqdfgh6hYQ5kUTS1YRukeNVlGDNCrTXArHXaKEvXhWi1Udq0-XCsiVXadb34e4oduBfbr4lNuBv7sAchPbh0EFU3WZsC6kNUo691_4t8BeZaN8A</recordid><startdate>202305</startdate><enddate>202305</enddate><creator>Thiruvengadam, Nikhil R.</creator><creator>Kouanda, Abdul</creator><creator>Kalluri, Anita</creator><creator>Schaubel, Douglas</creator><creator>Saumoy, Monica</creator><creator>Forde, Kimberly</creator><creator>Song, Jun</creator><creator>Faggen, Alec</creator><creator>Davis, Brenton G.</creator><creator>Onwugaje, Kenechukwu Chudy</creator><creator>Cote, Gregory</creator><creator>Arain, Mustafa A.</creator><creator>Kochman, Michael L.</creator><general>Elsevier Inc</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>202305</creationdate><title>A Prospective Cohort Study Evaluating PAN-PROMISE, a Patient-reported Outcome Measure to Detect Post-ERCP Morbidity</title><author>Thiruvengadam, Nikhil R. ; Kouanda, Abdul ; Kalluri, Anita ; Schaubel, Douglas ; Saumoy, Monica ; Forde, Kimberly ; Song, Jun ; Faggen, Alec ; Davis, Brenton G. ; Onwugaje, Kenechukwu Chudy ; Cote, Gregory ; Arain, Mustafa A. ; Kochman, Michael L.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c353t-1b8df24088a14b030ec1e84bf413ae4c89d322fdec34db187b066663916a1a283</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Acute Disease</topic><topic>Cholangiopancreatography, Endoscopic Retrograde - adverse effects</topic><topic>Cholangiopancreatography, Endoscopic Retrograde - methods</topic><topic>Cotton Consensus Criteria</topic><topic>Humans</topic><topic>Morbidity</topic><topic>PAN-PROMISE</topic><topic>Pancreatitis - diagnosis</topic><topic>Pancreatitis - epidemiology</topic><topic>Pancreatitis - etiology</topic><topic>Patient Reported Outcome Measures</topic><topic>Patient-reported Outcome Measure</topic><topic>Post-ERCP Morbidity</topic><topic>Post-ERCP Pancreatitis</topic><topic>Prospective Studies</topic><topic>Quality of Life</topic><topic>Retrospective Studies</topic><topic>Risk Factors</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Thiruvengadam, Nikhil R.</creatorcontrib><creatorcontrib>Kouanda, Abdul</creatorcontrib><creatorcontrib>Kalluri, Anita</creatorcontrib><creatorcontrib>Schaubel, Douglas</creatorcontrib><creatorcontrib>Saumoy, Monica</creatorcontrib><creatorcontrib>Forde, Kimberly</creatorcontrib><creatorcontrib>Song, Jun</creatorcontrib><creatorcontrib>Faggen, Alec</creatorcontrib><creatorcontrib>Davis, Brenton G.</creatorcontrib><creatorcontrib>Onwugaje, Kenechukwu Chudy</creatorcontrib><creatorcontrib>Cote, Gregory</creatorcontrib><creatorcontrib>Arain, Mustafa A.</creatorcontrib><creatorcontrib>Kochman, Michael L.</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Clinical gastroenterology and hepatology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Thiruvengadam, Nikhil R.</au><au>Kouanda, Abdul</au><au>Kalluri, Anita</au><au>Schaubel, Douglas</au><au>Saumoy, Monica</au><au>Forde, Kimberly</au><au>Song, Jun</au><au>Faggen, Alec</au><au>Davis, Brenton G.</au><au>Onwugaje, Kenechukwu Chudy</au><au>Cote, Gregory</au><au>Arain, Mustafa A.</au><au>Kochman, Michael L.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A Prospective Cohort Study Evaluating PAN-PROMISE, a Patient-reported Outcome Measure to Detect Post-ERCP Morbidity</atitle><jtitle>Clinical gastroenterology and hepatology</jtitle><addtitle>Clin Gastroenterol Hepatol</addtitle><date>2023-05</date><risdate>2023</risdate><volume>21</volume><issue>5</issue><spage>1233</spage><epage>1242.e14</epage><pages>1233-1242.e14</pages><issn>1542-3565</issn><eissn>1542-7714</eissn><abstract>The Cotton Consensus (CC) criteria for post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) may not capture post-ERCP morbidity. PAN-PROMISE, a patient-reported outcome measure (PROM), was developed to quantify acute pancreatitis-related morbidity. This study aims to determine the value of PAN-PROMISE in independently defining ERCP-related morbidity.
We conducted a prospective cohort study of patients undergoing ERCP at 2 academic centers from September 2021 to August 2022. We administered PAN-PROMISE and assessed quality of life and work productivity at baseline, 48 to 72 hours, 7 days, and 30 days following ERCP. PEP was defined by a 3-physician committee using the CC criteria. We defined high morbidity following ERCP (elevated PROM) by an increase of PAN-PROMISE score of >7 at 7 days post-procedure. The McNemar test assessed discordance between PEP and elevated-PROM.
A total of 679 patients were enrolled. Choledocholithiasis (30%) and malignant biliary obstruction (29%) were the main indications for ERCP. Thirty-two patients (4.7%) developed PEP. One hundred forty-seven patients (21.6%) had an elevated PROM, whereas only 20 of them (13.4%) had PEP by the CC criteria (P < .001 for discordance). An elevated PROM strongly correlated with lower physical quality of life and increased direct and indirect health care costs ($80 and $25 per point increase in PAN-PROMISE, respectively). Patients with pancreatic cancer (odds ratio, 4.52; 95% confidence interval, 1.68–10.74) and primary sclerosing cholangitis (odds ratio, 1.79; 95% confidence interval, 1.29–2.45) had the highest odds of elevated PROM.
A substantial number of patients experience significant morbidity after ERCP despite not developing PEP or other adverse events. Future studies are needed to characterize better the reasons behind this increase in symptoms and potential interventions to reduce the symptom burden post-ERCP. ClinicalTrials.gov number, NCT05310409.
▪</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>36075501</pmid><doi>10.1016/j.cgh.2022.08.034</doi></addata></record> |
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subjects | Acute Disease Cholangiopancreatography, Endoscopic Retrograde - adverse effects Cholangiopancreatography, Endoscopic Retrograde - methods Cotton Consensus Criteria Humans Morbidity PAN-PROMISE Pancreatitis - diagnosis Pancreatitis - epidemiology Pancreatitis - etiology Patient Reported Outcome Measures Patient-reported Outcome Measure Post-ERCP Morbidity Post-ERCP Pancreatitis Prospective Studies Quality of Life Retrospective Studies Risk Factors |
title | A Prospective Cohort Study Evaluating PAN-PROMISE, a Patient-reported Outcome Measure to Detect Post-ERCP Morbidity |
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