Quality Indicator Development for the Approach to Ineffective Esophageal Motility: A Modified Delphi Study

Afrin N. Kamal; Priya Kathpalia; David A. Leiman; Albert J. Bredenoord; John O. Clarke; C. Prakash Gyawali; David A. Katzka; Adriana Lazarescu; John E. Pandolfino; Roberto Penagini; Sabine Roman; Edoardo Savarino; Marcelo F. Vela; Fouad Otaki

doi:10.1097/MCG.0000000000001963

Quality Indicator Development for the Approach to Ineffective Esophageal Motility: A Modified Delphi Study

Afrin N. Kamal, Priya Kathpalia, David A. Leiman, Albert J. Bredenoord, John O. Clarke, C. Prakash Gyawali, David A. Katzka, Adriana Lazarescu, John E. Pandolfino, Roberto Penagini, Sabine Roman, Edoardo Savarino, Marcelo F. Vela, Fouad Otaki^*

^*Corresponding author for this work

Medicine, Gastroenterology Division

Research output: Contribution to journal › Article › peer-review

2 Scopus citations

Abstract

Goals: Develop quality indicators for ineffective esophageal motility (IEM). Background: IEM is identified in up to 20% of patients undergoing esophageal high-resolution manometry (HRM) based on the Chicago Classification. The clinical significance of this pattern is not established and management remains challenging. Study: Using RAND/University of California, Los Angeles Appropriateness Methods, we employed a modified-Delphi approach for quality indicator statement development. Quality indicators were proposed based on prior literature. Experts independently and blindly scored proposed quality statements on importance, scientific acceptability, usability, and feasibility in a 3-round iterative process. Results: All 10 of the invited esophageal experts in the management of esophageal diseases invited to participate rated 12 proposed quality indicator statements. In round 1, 7 quality indicators were rated with mixed agreement, on the majority of categories. Statements were modified based on panel suggestion, modified further following round 2's virtual discussion, and in round 3 voting identified 2 quality indicators with comprehensive agreement, 4 with partial agreement, and 1 without any agreement. The panel agreed on the concept of determining if IEM is clinically relevant to the patient's presentation and managing gastroesophageal reflux disease rather than the IEM pattern; they disagreed in all 4 domains on the use of promotility agents in IEM; and had mixed agreement on the value of a finding of IEM during anti-reflux surgical planning. Conclusion: Using a robust methodology, 2 IEM quality indicators were identified. These quality indicators can track performance when physicians identify this manometric pattern on HRM. This study further highlights the challenges met with IEM and the need for additional research to better understand the clinical importance of this manometric pattern.

Original language	English (US)
Pages (from-to)	975-980
Number of pages	6
Journal	Journal of Clinical Gastroenterology
Volume	58
Issue number	10
DOIs	https://doi.org/10.1097/MCG.0000000000001963
State	Published - Jan 15 2024

Funding

D.L. is a consultant for Allakos Pharmaceuticals and Astra Zeneca. He received research grants from Takeda Pharmaceuticals. He serves on the Advisory Board of Sanofi. A.J.B. received research funding from Nutria, Norgine, Dr Falk Pharma, Thelial, and SST and received speaker and/or consulting fees from Laborie, Medtronic, Dr Falk Pharma, Alimentiv, Sanofi/Regeneron, and AstraZeneca. J.C. is a consultant for Alnylam, Castle biosciences, Isothrive, Medtronic, Phathom, Pfizer, Regeron, and Sanofi, key opinion leader advisory panels for Alnylam, Castle, Isothrive, Phathom, grant reviewer for Pfizer and data safety monitoring board for Regeneron, Sanofi. C.P.G. received consulting and/or speaker fees from Medtronic, Ironwood, Takeda, Johnson&Johnson, Dexcel Pharma, and Ardelyx. E.S. has served as a speaker for Abbvie, AGPharma, Alfasigma, EG Stada Group, Fresenius Kabi, Grifols, Janssen, Innovamedica, Malesci, Pfizer, Reckitt Benckiser, Sandoz, SILA, Sofar, Takeda, Unifarco. He has served as a consultant for Alfasigma, Amgen, Biogen, Bristol-Myers Squibb, Celltrion, Diadema Farmaceutici, Falk, Fresenius Kabi, Janssen, Merck & Co, Reckitt Benckiser, Regeneron, Sanofi, Shire, SILA, Sofar, Synformulas GmbH, Takeda, Unifarco. He received research support from Reckitt Benckiser, SILA, Sofar, and Unifarco. D.K. is a consultant for Takeda and Celgene. J.P. received consulting and/or speaking fees from Sandhill Scientific/Diversatek, Takeda, Astra Zeneca, Medtronic, Torax, and Ironwood. R.P. received consulting and/or speaker fees from Alfasigma, Reckitt Benckiser, and Sofar. S.R. received consulting fees from Dr Falk Pharma and Sanofi and research support from Medtronic and Diversatek Healthcare. M.V. is a consultant for Medtronic. The remaining authors declare that they have nothing to disclose.

Keywords

esophageal diseases
evidence practice gaps
gastroesopahgeal reflux
gastrointestinal motility
quality indicators

ASJC Scopus subject areas

Gastroenterology

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10.1097/MCG.0000000000001963

Cite this

Kamal, A. N., Kathpalia, P., Leiman, D. A., Bredenoord, A. J., Clarke, J. O., Gyawali, C. P., Katzka, D. A., Lazarescu, A., Pandolfino, J. E., Penagini, R., Roman, S., Savarino, E., Vela, M. F., & Otaki, F. (2024). Quality Indicator Development for the Approach to Ineffective Esophageal Motility: A Modified Delphi Study. Journal of Clinical Gastroenterology, 58(10), 975-980. https://doi.org/10.1097/MCG.0000000000001963

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title = "Quality Indicator Development for the Approach to Ineffective Esophageal Motility: A Modified Delphi Study",

abstract = "Goals: Develop quality indicators for ineffective esophageal motility (IEM). Background: IEM is identified in up to 20% of patients undergoing esophageal high-resolution manometry (HRM) based on the Chicago Classification. The clinical significance of this pattern is not established and management remains challenging. Study: Using RAND/University of California, Los Angeles Appropriateness Methods, we employed a modified-Delphi approach for quality indicator statement development. Quality indicators were proposed based on prior literature. Experts independently and blindly scored proposed quality statements on importance, scientific acceptability, usability, and feasibility in a 3-round iterative process. Results: All 10 of the invited esophageal experts in the management of esophageal diseases invited to participate rated 12 proposed quality indicator statements. In round 1, 7 quality indicators were rated with mixed agreement, on the majority of categories. Statements were modified based on panel suggestion, modified further following round 2's virtual discussion, and in round 3 voting identified 2 quality indicators with comprehensive agreement, 4 with partial agreement, and 1 without any agreement. The panel agreed on the concept of determining if IEM is clinically relevant to the patient's presentation and managing gastroesophageal reflux disease rather than the IEM pattern; they disagreed in all 4 domains on the use of promotility agents in IEM; and had mixed agreement on the value of a finding of IEM during anti-reflux surgical planning. Conclusion: Using a robust methodology, 2 IEM quality indicators were identified. These quality indicators can track performance when physicians identify this manometric pattern on HRM. This study further highlights the challenges met with IEM and the need for additional research to better understand the clinical importance of this manometric pattern.",

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author = "Kamal, {Afrin N.} and Priya Kathpalia and Leiman, {David A.} and Bredenoord, {Albert J.} and Clarke, {John O.} and Gyawali, {C. Prakash} and Katzka, {David A.} and Adriana Lazarescu and Pandolfino, {John E.} and Roberto Penagini and Sabine Roman and Edoardo Savarino and Vela, {Marcelo F.} and Fouad Otaki",

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Kamal, AN, Kathpalia, P, Leiman, DA, Bredenoord, AJ, Clarke, JO, Gyawali, CP, Katzka, DA, Lazarescu, A, Pandolfino, JE, Penagini, R, Roman, S, Savarino, E, Vela, MF & Otaki, F 2024, 'Quality Indicator Development for the Approach to Ineffective Esophageal Motility: A Modified Delphi Study', Journal of Clinical Gastroenterology, vol. 58, no. 10, pp. 975-980. https://doi.org/10.1097/MCG.0000000000001963

TY - JOUR

T1 - Quality Indicator Development for the Approach to Ineffective Esophageal Motility

T2 - A Modified Delphi Study

AU - Kamal, Afrin N.

AU - Kathpalia, Priya

AU - Leiman, David A.

AU - Bredenoord, Albert J.

AU - Clarke, John O.

AU - Gyawali, C. Prakash

AU - Katzka, David A.

AU - Lazarescu, Adriana

AU - Pandolfino, John E.

AU - Penagini, Roberto

AU - Roman, Sabine

AU - Savarino, Edoardo

AU - Vela, Marcelo F.

AU - Otaki, Fouad

PY - 2024/1/15

Y1 - 2024/1/15

N2 - Goals: Develop quality indicators for ineffective esophageal motility (IEM). Background: IEM is identified in up to 20% of patients undergoing esophageal high-resolution manometry (HRM) based on the Chicago Classification. The clinical significance of this pattern is not established and management remains challenging. Study: Using RAND/University of California, Los Angeles Appropriateness Methods, we employed a modified-Delphi approach for quality indicator statement development. Quality indicators were proposed based on prior literature. Experts independently and blindly scored proposed quality statements on importance, scientific acceptability, usability, and feasibility in a 3-round iterative process. Results: All 10 of the invited esophageal experts in the management of esophageal diseases invited to participate rated 12 proposed quality indicator statements. In round 1, 7 quality indicators were rated with mixed agreement, on the majority of categories. Statements were modified based on panel suggestion, modified further following round 2's virtual discussion, and in round 3 voting identified 2 quality indicators with comprehensive agreement, 4 with partial agreement, and 1 without any agreement. The panel agreed on the concept of determining if IEM is clinically relevant to the patient's presentation and managing gastroesophageal reflux disease rather than the IEM pattern; they disagreed in all 4 domains on the use of promotility agents in IEM; and had mixed agreement on the value of a finding of IEM during anti-reflux surgical planning. Conclusion: Using a robust methodology, 2 IEM quality indicators were identified. These quality indicators can track performance when physicians identify this manometric pattern on HRM. This study further highlights the challenges met with IEM and the need for additional research to better understand the clinical importance of this manometric pattern.

AB - Goals: Develop quality indicators for ineffective esophageal motility (IEM). Background: IEM is identified in up to 20% of patients undergoing esophageal high-resolution manometry (HRM) based on the Chicago Classification. The clinical significance of this pattern is not established and management remains challenging. Study: Using RAND/University of California, Los Angeles Appropriateness Methods, we employed a modified-Delphi approach for quality indicator statement development. Quality indicators were proposed based on prior literature. Experts independently and blindly scored proposed quality statements on importance, scientific acceptability, usability, and feasibility in a 3-round iterative process. Results: All 10 of the invited esophageal experts in the management of esophageal diseases invited to participate rated 12 proposed quality indicator statements. In round 1, 7 quality indicators were rated with mixed agreement, on the majority of categories. Statements were modified based on panel suggestion, modified further following round 2's virtual discussion, and in round 3 voting identified 2 quality indicators with comprehensive agreement, 4 with partial agreement, and 1 without any agreement. The panel agreed on the concept of determining if IEM is clinically relevant to the patient's presentation and managing gastroesophageal reflux disease rather than the IEM pattern; they disagreed in all 4 domains on the use of promotility agents in IEM; and had mixed agreement on the value of a finding of IEM during anti-reflux surgical planning. Conclusion: Using a robust methodology, 2 IEM quality indicators were identified. These quality indicators can track performance when physicians identify this manometric pattern on HRM. This study further highlights the challenges met with IEM and the need for additional research to better understand the clinical importance of this manometric pattern.

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KW - evidence practice gaps

KW - gastroesopahgeal reflux

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Quality Indicator Development for the Approach to Ineffective Esophageal Motility: A Modified Delphi Study

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