26 Sep

Persistent upper gastrointestinal symptoms despite proton pump inhibitor therapy: Psychometric validity (Part 4)

Responsiveness and discriminant validity

The PASS results showed that 42 (30%) and 35 (33%) patients in the English- and French-speaking groups, respectively, were ‘PASS test responders’ on a per protocol analysis; ie, they had complete resolution of their symptoms (PASS test score 0) at the end of treatment.

Most of the effect sizes for individual domains of the three validated scales GSRS, RDQ and QoLRAD were moderate-to-good for PASS test responders in both the English- and French-speaking groups (Table 2) and responders’ effect sizes were, on average, two to three times higher than the effect sizes for the PASS test nonresponders.

The first PASS question provided the greatest observed response reduction (-1.25 and -1.68 for English and French, respectively), with other questions providing responses in the range of 0.45 to 0.85 (data not shown), comparable to the individual domain responses for all three validated scales. Despite the small number of subjects in some response classes, greater improvement was observed in those PASS test responders who had also reported a larger overall treatment effect (Figure 4).

TABLE 2 Effect sizes for Proton pump inhibitor Acid Suppression Symptom (PASS) test responders (PASS score = 0) and pAsS test nonresponders (PASS score > 0) for the Gastrointestinal Symptom Rating Scale (GSRS), Quality of Life in Reflux and Dyspepsia (QoLRAD) and Reflux Disease Questionnaire (RDQ) by domain after four weeks of treatment

SCALE,Domain English French
Nonresponders  Responders Nonresponders Responders
Diarrhea -0.17 -0.68 -0.27 -0.44
Indigestion -0.45 -0.96 -0.69 -1.20
Constipation -0.26 -0.55 -0.21 -0.71
Abdominal pain -0.43 -1.04 -0.61 -1.14
Reflux -0.61 -1.20 -0.70 -1.38
Emotional distress 0.50 0.92 0.51 1.31
Sleep disturbance 0.49 0.93 0.47 1.27
Food or drinking problem 0.69 1.29 0.62 1.53
Physical or social 0.35 0.68 0.35 1.15
Vitality 0.55 1.08 0.48 1.45
Heartburn -0.49 -1.00 -0.46 -1.21
Regurgitation -0.53 -0.95 -0.38 -1.12
Epigastric pain -0.41 -0.95 -0.53 -1.29
GERD -0.56 -1.04 -0.49 -1.34

Mean change in total score

Figure 4) Mean change in Proton pump inhibitor Acid Suppression Symptom (PASS) total score (line indicates SD) for PASS test responders and nonresponders, stratified by degree of change in overall treatment effect (n in each column) after four weeks of treatment at visit 3 for both English- (upper panel) and French-speaking (lower panel) patients
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