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
Hauptverfasser: 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.
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container_end_page 1242.e14
container_issue 5
container_start_page 1233
container_title Clinical gastroenterology and hepatology
container_volume 21
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. ▪
doi_str_mv 10.1016/j.cgh.2022.08.034
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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 &gt;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 &lt; .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. 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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. 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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 &lt; .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. 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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 &gt;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 &lt; .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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