@article{ba2efadf6b0f4f42baa2449b44d65e00,
title = "Clinical role of ambulatory reflux monitoring in PPI non-responders: recommendation statements",
abstract = "Background: Optimal ambulatory reflux monitoring methodology in symptomatic reflux patients continues to be debated. Aims: To utilise published literature and expert opinion to develop recommendation statements addressing use of ambulatory reflux monitoring in clinical practice. Methods: The RAND Appropriateness Method (RAM) was utilised among 17 experts with discussion, revision and two rounds of ranking of recommendation statements. Ambulatory reflux monitoring protocol, methodology and thresholds ranked as appropriate by ≥80% of panellists met the criteria for appropriateness. Results: Prolonged (96-h recommended) wireless pH monitoring off proton pump inhibitor (PPI) was identified as the appropriate diagnostic tool to assess the need for acid suppression in patients with unproven gastro-oesophageal reflux disease (GERD) and persisting typical reflux symptoms despite once-daily PPI. Acid exposure time (AET) <4.0% on all days of monitoring with negative reflux-symptom association excludes GERD and does not support ongoing PPI treatment. Conversely, AET >6.0% across ≥2 days is conclusive evidence for GERD and supports treatment for GERD, while AET >10% across ≥2 days identifies severe acid burden that supports escalation of anti-reflux treatment. In previously proven GERD, impedance-pH monitoring on PPI is helpful in defining refractory GERD and mechanisms of continued symptoms; the presence of <40 reflux events, AET <2.0% and a negative reflux-symptom association does not support escalation of anti-reflux treatment. In contrast, AET > 4.0% and positive reflux-symptom association support escalation of anti-reflux treatment, including use of invasive therapeutics. Conclusions: Statements meeting appropriateness for average clinical care have been identified when utilising reflux monitoring in patients with typical reflux symptoms and PPI non-response.",
author = "Rena Yadlapati and Gawron, {Andrew J.} and Gyawali, {C. Prakash} and Joan Chen and John Clarke and Ronnie Fass and Anand Jain and Kristle Lynch and Abraham Khan and Katz, {Philip O.} and Katzka, {David A.} and Joel Richter and Felice Schnoll-Sussman and Spechler, {Stuart J.} and Vaezi, {Michael F.} and Marcelo Vela and Pandolfino, {John E.}",
note = "Funding Information: RY is supported by NIH R01 DK092217‐04 (PI: Pandolfino); RY is supported by NIH K23 DK125266 (PI: Yadlapati). Funding Information: We would like to sincerely acknowledge Dr Donald O. Castell, a pioneer in the field of GERD with numerous contributions to reflux testing that laid the foundations for the recommendations put forth in this document. Dr Castell accepted the invitation to participate in this study prior to his passing. Declaration of personal interests: RY: Consultant: Medtronic, Phathom Pharmaceuticals: RJS Mediagnostix, Stat DataLink. CPG: Consultant: Medtronic, Diversatek, Ironwood, Iso-Thrive, Quintiles, Takeda, Johnson&Johnson. JC: Consulting agreement—Phathom Pharmaceuticals. John Clarke: Consultant: Alnylam, Isothrive, Medtronic, Phathom Pharmaceuticals, Pfizer, Regeneron, Sanofi. RF: Advisor—Takeda, Medtronic, Phathom Pharmaceuticals, Neurogastrx, GERDCar, Celexio, Evoke Pharma Speaker—Astrazeneca, Takeda, GI Supply, Eisai, Johnson & Johnson. KL: Consultant Medtronic, Takeda, LUCID. AK: Consultant: Medtronic. POK: Consultant: Phathom Pharma, Takeda. DAK: Consulting for Takeda, Celgene and Regeneron. JR: Consultant for Medtronic. FSS: Consultant: Ethicon, Interpace, Medtronic. SJS: Consultant for Phathom Pharmaceuticals, Takeda Pharmaceuticals, Ironwood Pharmaceuticals, Interpace Diagnostics, Castle Biosciences, and ISOThrive. MFV: Ironwood, Phathom, ISOthrive, Sanofi, Bayer, Medtronic, Diversatek. Legal-consultation in litigations relating to acid suppressive therapy; Patent on Mucosal Integrity testing. MV: Medtronic—Consultant, Diversatek—Research Support. JEP: Consultant: Medtronic, Diversatek, Ethicon/Torax, Endogastric solutions, Takeda, Astra Zeneca, Phathom, Neurogastrx, Ironwood. AJG, AJ: None. Publisher Copyright: {\textcopyright} 2022 John Wiley & Sons Ltd.",
year = "2022",
month = oct,
doi = "10.1111/apt.17180",
language = "English",
volume = "56",
pages = "1274--1283",
journal = "Alimentary Pharmacology and Therapeutics",
issn = "0269-2813",
number = "8",
}