Development of a novel patient-oriented tool to assess achalasia symptoms and response to treatment (I-PASS, International Patient-oriented tool for Achalasia Symptom Score)

: Achalasia treatment outcomes are often assessed using the Eckardt score, which has not been formally validated and is not designed as a patient-reported outcome (PRO) tool. To address this unmet clinical need, a group of healthcare providers developed the International Patient-oriented tool for Achalasia Symptom Score (I-PASS), which aims to record both symptom severity and frequency in a patient-oriented manner. Using the RAND/ University of California, Los Angeles, Appropriateness Methodology, a 16-member international, multidisciplinary panel identified key symptomatic domains through three Delphi rounds. Dysphagia, regurgitation (daytime and nocturnal), and chest pain were selected as primary domains, with weight loss included as an additional factor. Severity and frequency scoring were agreed upon, resulting in a maximum composite score of 53. The pretreatment I-PASS was pilot-tested in 118 treatment-naïve achalasia patients in the UK and Italy. Comprehension, completion time, acceptability, and correlation with the standard Eckardt score were assessed. All the patients completed the I-PASS. Most (96.5%) reported full comprehension, the median completion time was 10 minutes, and 98% expressed willingness to complete it again. The median I-PASS score was 29 (IQR 20-36), compared with a median Eckardt score of 7 (IQR 5-9). A strong correlation was observed between I-PASS and Eckardt (ρ = 0.68, P < 0.0001). Regression analysis confirmed that each one-point increase in Eckardt corresponded to a 3.1-point increase in I-PASS. The I-PASS questionnaire is feasible, well accepted, and provides a more comprehensive assessment of achalasia symptoms than the Eckardt score. Future studies will evaluate its reliability, responsiveness, and validity as a standardized PRO instrument.