Validation of the PAGI-SYM and PAGI-QOL among healing and maintenance of erosive esophagitis clinical trial participants.
OBJECTIVE
Valid instruments are needed to assess important patient-reported outcomes (PROs) in erosive esophagitis (EE).


METHODS
Data from 4,092 patients in clinical trials to determine efficacy of dexlansoprazole MR to heal EE and maintain healed EE were used to assess the psychometric properties of the Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life (PAGI-QOL) and the PAGI-Symptoms Severity Index (PAGI-SYM). A daily diary, gastroesophageal reflux disease (GERD) Symptoms Investigator Assessment and endoscopy results were also used in this study.


RESULTS
PAGI-QOL and PAGI-SYM subscales and total score internal consistency reliability estimates for both studies were acceptable (Cronbach's alpha coefficient = 0.81-0.97). Most subscale and total scores yielded moderate-to-strong correlations with other measures reflecting signs and symptoms of EE. Some subscales were able to detect differences >1 standard error of measurement (SEM) in change scores among patients with improved heartburn frequency compared to those with stable/worsening heartburn frequency in the healing study. Those with relapsed EE demonstrated differences >1 SEM in some PAGI-QOL and PAGI-SYM subscale or total scores compared to patients who maintained their healing status.


CONCLUSIONS
The findings of this study support the consideration of the PAGI-QOL and PAGI-SYM in future clinical trials and in the general EE population.
Wyrwich
Kathleen W
KW
United BioSource Corporation, Bethesda, MD 20814, USA. kathy.wyrwich@unitedbiosource.com
Mody
Reema
R
Larsen
Lois M
LM
Lee
Misun
M
Harnam
Neesha
N
Revicki
Dennis A
DA
D053799:2-Pyridinylmethylsulfinylbenzimidazoles / Q000494:pharmacology / Q000627:therapeutic use*; D000223:Adaptation, Psychological; D000704:Analysis of Variance; D000897:Anti-Ulcer Agents / Q000494:pharmacology / Q000627:therapeutic use*; D064748:Dexlansoprazole; D015930:Diet Records; D004942:Esophagitis, Peptic / Q000188:drug therapy*; D005260:Female; D006304:Health Status; D006801:Humans; D064747:Lansoprazole; D008297:Male; D008499:Medical Records; D008875:Middle Aged; D054328:Proton Pump Inhibitors / Q000494:pharmacology / Q000627:therapeutic use*; D011594:Psychometrics; D011788:Quality of Life; D015203:Reproducibility of Results; D012720:Severity of Illness Index; D013223:Statistics as Topic; D018709:Statistics, Nonparametric; D011795:Surveys and Questionnaires
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000897:Anti-Ulcer Agents; D054328:Proton Pump Inhibitors; D064747:Lansoprazole; D064748:Dexlansoprazole