A0185 - Quality Indicator Development for the Approach to Ineffective Esophageal Motility: A Modified Delphi Study

Sunday, October 23, 2022

5:00 PM – 7:00 PM ET

Location: Crown Ballroom

Presenting Author(s)

AK

Afrin N. Kamal, MD, MS

Clinical Assistant Professor of Medicine
Stanford University
Redwood City, CA

Afrin N. Kamal, MD, MS¹, Priya Kathpalia, MD², David A. Leiman, MD³, Albert Bredenoord, MD, PhD⁴, John O. Clarke, MD¹, C. Prakash Gyawali, MD, MRCP⁵, David A. Katzka, MD⁶, Adriana Lazarescu, MD⁷, John Pandolfino, MD⁸, Roberto Penagini, MD⁹, Sabine Roman, MD¹⁰, Edoardo Savarino, MD, PhD¹¹, Marcelo F. Vela, MD¹², Fouad Otaki, MD¹³
¹Stanford University, Redwood City, CA; ²University of California, San Francisco, San Francisco, CA; ³Duke University School of Medicine, Durham, NC; ⁴Amsterdam University Medical Center, Amsterdam, Utrecht, Netherlands; ⁵Washington University in St. Louis, St. Louis, MO; ⁶Columbia University, New York, NY; ⁷University of Alberta, Edmonton, AB, Canada; ⁸Northwestern University, Chicago, IL; ⁹University of Milan, Milan, Lombardia, Italy; ¹⁰Lyon Est Medical School, Lyon, Auvergne, France; ¹¹University of Padua, Padua, Veneto, Italy; ¹²Mayo Clinic, Scottsdale, AZ; ¹³Oregon Health & Science University, Portland, OR

Introduction: Ineffective esophageal motility (IEM) is identified in up to 30% of patients undergoing esophageal high resolution manometry (HRM) based on the Chicago Classification version 4.0. The clinical significance of this pattern is not established and management remains challenging due to a limited framework guiding gastroenterologists when IEM is identified.

Aim: To establish quality indicators for approaching IEM when identified on esophageal HRM.

Methods: Using RAND/University of California, Los Angeles (UCLA) 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 three-round iterative process. Highly valid quality indicators reached scores with ≥80% agreement in the 7-9 range (on a 9-point Likert scale) across all four categories.

Results: There were 10 experts in the management of esophageal diseases invited to participate and all (100%) rated 12 proposed quality indicator statements. In round one, 7 (58.3%) quality indicators were rated with mixed agreement (< 80% agreement across all four categories). Statements were modified based on panel suggestion, modified further following round two’s virtual discussion, and in round three voting identified 2 highly valid quality indicators, 4 moderately valid, and 1 invalid. In total, 2 (16.7%) quality indicators reached high validity. The panel agreed on the concept of determining if IEM is clinically relevant to the patient’s presentation and managing GERD rather than the IEM pattern (Table 1). The panel disagreed in all four domains on the use of promotility agents (e.g., prucalopride, metoclopramide) in IEM, and had mixed agreement that IEM with contraction reserve on pre-operative HRM can be viewed similar to a manometric pattern without IEM specific to anti-reflux surgery, probably reflecting the lack of solid scientific evidence on this pattern.

Discussion: Using a robust methodology, two IEM quality indicators were identified. These quality indicators can track performance when physicians identify this manometric pattern on HRM with the goal of ultimately improving patient outcomes. 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.

	Proportion Agreement (%) with high validity
Statements	Importance	Scientific Acceptability	Usability	Feasibility
IF a high resolution esophageal manometry reveals >70% ineffective swallow sequences then the manometric pattern is consistent with IEM	60	60	90	100
IF a high resolution esophageal manometry reveals >= 50%	50	60	90	100
IF a patient’s high resolution esophageal manometry reveals IEM, THEN a member of the care team should assess if the manometric pattern is clinically relevant.	90	80	80	100
IF a patient’s high resolution esophageal manometry reveals IEM, THEN a member of the care team should communicate the clinical relevance of this manometric pattern to the patient.	80	70	60	90
IF a patient has gastroesophageal reflux disease (GERD) and a manometric pattern of IEM, THEN control of GERD is the main approach to patient management.	90	80	90	100
IF a patient with a manometric pattern of IEM and contractile reserve on pre-operative high resolution esophageal manometry is being considered for anti-reflux surgery, THEN surgical management should not differ from a patient without IEM.	40	50	60	60
IF a patient with a manometric pattern of IEM and absent contractile reserve on pre-operative high resolution esophageal manometry is being considered for anti-reflux surgery, THEN the care team should discuss the increased risks of post-operative dysphagia.	70	60	60	80

Table: Proportion of Expert Agreement on Proposed Quality Indicators: Round #2

Disclosures:

Afrin Kamal indicated no relevant financial relationships.

Priya Kathpalia indicated no relevant financial relationships.

David Leiman: Allakos – Advisory Committee/Board Member, Consultant, Grant/Research Support. Arena Pharmaceuticals – Site PI. Celgene – Site PI. Medtronic – Consultant. Phathom – Site PI. Revolo Biotherapeutics – Site PI. Takeda – Grant/Research Support.

Albert Bredenoord: Arena Pharmaceuticals – Consultant. AstraZeneca – Consultant. Bayer – Stock Options. Calypso Biotech – Consultant. Dr Falk – Consultant. EsoCap – Consultant. Gossamer Bio – Consultant. Laborie – Consultant. Medtronic – Consultant. Nutricia – Stock Options. RB Pharma – Consultant. Regeneron Pharmaceuticals, Inc. – Consultant. Robarts Clinical Trials – Consultant. SST – Grant/Research Support. SST – Stock Options.

John Clarke: Alnylam – Advisory Committee/Board Member. Castle Biosciences – Advisory Committee/Board Member. Isothrive – Advisory Committee/Board Member. Medtronic – Advisory Committee/Board Member. Regeneron – Advisory Committee/Board Member. Sanofi – Advisory Committee/Board Member.

C. Prakash Gyawali: Ardelyx – Advisor or Review Panel Member. Dexcel Pharma – Consultant. Diversatek – Consultant. Ironwood – Consultant. Johnson & Johnson – Speakers Bureau. Medtronic – Consultant. Takeda – Speakers Bureau.

David Katzka: celgene – Consultant. Takeda – Consultant.

Adriana Lazarescu: Bausch Health – Advisor or Review Panel Member, Speakers Bureau. Knight – Advisor or Review Panel Member.

John Pandolfino: EndoGastric Solutions – Consultant, Speakers Bureau. Ethicon- J&J – Consultant, Speakers Bureau. Ironwood – Consultant, Grant/Research Support. Medtronic – Advisor or Review Panel Member, Consultant, Grant/Research Support, Intellectual Property/Patents, Royalties, Speakers Bureau. Neurogastrx – Consultant. Phathom – Consultant. Takeda – Consultant, Speakers Bureau.

Roberto Penagini indicated no relevant financial relationships.

Sabine Roman: Dr Falk Pharma – Consultant. Medtronic – Grant/Research Support. Sanofi – Consultant.

Edoardo Savarino: AbbVie – Speakers Bureau. AG Pharma – Speakers Bureau. Alfasigma – Consultant, Speakers Bureau. Amgen – Consultant. Biogen – Consultant. Bristol Myers Squibb – Consultant. Celltrion – Consultant. Diadema Farmaceutici – Consultant. EG Stada Group – Speakers Bureau. Falk – Consultant. Fresenius Kabi – Consultant, Speakers Bureau. Grifols – Speakers Bureau. Innovamedica – Speakers Bureau. Janssen – Consultant, Speakers Bureau. Malesci – Speakers Bureau. Merck – Consultant. Pfizer – Speakers Bureau. Reckitt Benckiser – Consultant, Grant/Research Support, Speakers Bureau. Regeneron – Consultant. Sandoz – Speakers Bureau. Sanofi – Consultant. Shire – Consultant. SILA – Consultant, Grant/Research Support, Speakers Bureau. Sofar – Consultant, Grant/Research Support, Speakers Bureau. Synformulas GmbH – Consultant. Takeda – Consultant, Speakers Bureau. Unifarco – Consultant, Grant/Research Support, Speakers Bureau.

Marcelo Vela: Medtronic – Consultant.

Fouad Otaki indicated no relevant financial relationships.