TY - JOUR
T1 - Responsiveness and interpretation of a symptom severity index specific to upper gastrointestinal disorders
AU - Revicki, Dennis A.
AU - Rentz, Anne M.
AU - Tack, Jan
AU - Stanghellini, Vincenzo
AU - Talley, Nicholas J.
AU - Kahrilas, Peter
AU - De La Loge, Christine
AU - Trudeau, Elyse
AU - Dubois, Dominique
PY - 2004/9
Y1 - 2004/9
N2 - Background & 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.
AB - Background & 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.
KW - ANCOVA
KW - GERD
KW - GI
KW - OTE
KW - Overall Treatment Effect
KW - PAGI-SYM
KW - Patient Assessment of Gastrointestinal Disorders-Symptom Severity Index
KW - SEM
KW - analysis of covariance
KW - gastroesophageal reflux disease
KW - gastrointestinal
KW - standard error of measurement
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U2 - 10.1016/S1542-3565(04)00348-9
DO - 10.1016/S1542-3565(04)00348-9
M3 - Article
C2 - 15354277
AN - SCOPUS:4444268123
VL - 2
SP - 769
EP - 777
JO - Clinical Gastroenterology and Hepatology
JF - Clinical Gastroenterology and Hepatology
SN - 1542-3565
IS - 9
ER -