BACKGROUND AND AIMS: Determining clinically meaningful change of patient-reported outcome measures is important for evaluating effectiveness of treatments for gastrointestinal (GI) diseases. This study evaluates responsiveness of the Patient Assessment of Gastrointestinal Disorders-Symptom Severity Index (PAGI-SYM) in gastroesophageal reflux disease (GERD) and dyspepsia. METHODS: The PAGI-SYM was based on a review of the published literature and interviews with patients and clinicians. Items were developed to be linguistically and culturally appropriate for multicountry studies. The PAGI-SYM includes 6 subscales: heartburn/regurgitation, fullness/early satiety, nausea/vomiting, bloating, upper abdominal pain, and lower abdominal pain. Subjects with GERD (n = 810) or dyspepsia (n = 767) participated in this multicountry, observational study. All subjects completed the PAGI-SYM, a global symptom relief questionnaire, and a measure of patient-rated change in GI-related symptoms, the Overall Treatment Effect (OTE) scale. Responsiveness was evaluated at 8 weeks by comparing groups by disease, symptom relief, and OTE (improved, stable, and worsened). RESULTS: Subjects reporting symptom relief reported significantly lower (better) PAGI-SYM scores than those reporting no symptom relief ( P < 0.0001 to P < 0.0005). Subjects with improvements in overall GI symptoms exhibited significant decreases in PAGI-SYM subscale scores compared with those who remained the same or worsened (all P values < 0.0001). Effect sizes ranged from 0.21-1.28, and standard errors of measurement ranged from 0.29-0.63, depending on subscale and disease sample. CONCLUSIONS: The PAGI-SYM is a brief symptom severity instrument that measures common GI symptoms. Results suggest that the PAGI-SYM is responsive and sensitive to change in clinical status in subjects with GERD or dyspepsia.
BACKGROUND AND AIMS: Determining clinically meaningful change of patient-reported outcome measures is important for evaluating effectiveness of treatments for gastrointestinal (GI) diseases. This study evaluates responsiveness of the Patient Assessment of Gastrointestinal Disorders-Symptom Severity Index (PAGI-SYM) in gastroesophageal reflux disease (GERD) and dyspepsia. METHODS: The PAGI-SYM was based on a review of the published literature and interviews with patients and clinicians. Items were developed to be linguistically and culturally appropriate for multicountry studies. The PAGI-SYM includes 6 subscales: heartburn/regurgitation, fullness/early satiety, nausea/vomiting, bloating, upper abdominal pain, and lower abdominal pain. Subjects with GERD (n = 810) or dyspepsia (n = 767) participated in this multicountry, observational study. All subjects completed the PAGI-SYM, a global symptom relief questionnaire, and a measure of patient-rated change in GI-related symptoms, the Overall Treatment Effect (OTE) scale. Responsiveness was evaluated at 8 weeks by comparing groups by disease, symptom relief, and OTE (improved, stable, and worsened). RESULTS: Subjects reporting symptom relief reported significantly lower (better) PAGI-SYM scores than those reporting no symptom relief ( P < 0.0001 to P < 0.0005). Subjects with improvements in overall GI symptoms exhibited significant decreases in PAGI-SYM subscale scores compared with those who remained the same or worsened (all P values < 0.0001). Effect sizes ranged from 0.21-1.28, and standard errors of measurement ranged from 0.29-0.63, depending on subscale and disease sample. CONCLUSIONS: The PAGI-SYM is a brief symptom severity instrument that measures common GI symptoms. Results suggest that the PAGI-SYM is responsive and sensitive to change in clinical status in subjects with GERD or dyspepsia.
Authors: Pankaj J Pasricha; Katherine P Yates; Linda Nguyen; John Clarke; Thomas L Abell; Gianrico Farrugia; William L Hasler; Kenneth L Koch; William J Snape; Richard W McCallum; Irene Sarosiek; James Tonascia; Laura A Miriel; Linda Lee; Frank Hamilton; Henry P Parkman Journal: Gastroenterology Date: 2015-08-21 Impact factor: 22.682
Authors: Puja Khanna; Nikhil Agarwal; Dinesh Khanna; Ron D Hays; Lin Chang; Roger Bolus; Gil Melmed; Cynthia B Whitman; Robert M Kaplan; Rikke Ogawa; Bradley Snyder; Brennan Mr Spiegel Journal: Am J Gastroenterol Date: 2013-12-17 Impact factor: 10.864
Authors: William L Hasler; Laura A Wilson; Henry P Parkman; Linda Nguyen; Thomas L Abell; Kenneth L Koch; Pankaj J Pasricha; William J Snape; Gianrico Farrugia; Linda Lee; James Tonascia; Aynur Unalp-Arida; Frank Hamilton Journal: Am J Gastroenterol Date: 2011-04-12 Impact factor: 10.864
Authors: U Khayyam; P Sachdeva; J Gomez; Z Ramzan; M S Smith; A H Maurer; R S Fisher; H P Parkman Journal: Neurogastroenterol Motil Date: 2010-01-18 Impact factor: 3.598
Authors: Christina Brock; Birgitte Brock; Anne Grave Pedersen; Asbjørn Mohr Drewes; Niels Jessen; Adam D Farmer Journal: World J Diabetes Date: 2016-08-25
Authors: Nora B Zschau; Jane M Andrews; Richard H Holloway; Mark N Schoeman; Kylie Lange; William Ce Tam; Gerald J Holtmann Journal: World J Gastroenterol Date: 2013-04-28 Impact factor: 5.742