Background
Methods
Patients
Demographic and clinical variables
PRO instruments
Gastrointestinal Symptom Rating Scale (GSRS)
Quality of Life in Reflux and Dyspepsia questionnaire (QOLRAD)
36-item Short-Form Health Survey (SF-36)
Hospital Anxiety and Depression scale (HAD)
Psychometric evaluation of the GSRS and the QOLRAD
Reliability
Construct validity
Statistical methods
Results
Demographic and clinical characteristics
Variables | South Africa | Germany | Hungary | Italy | Poland | Spain |
---|---|---|---|---|---|---|
Number of patients | ||||||
visit 1 | 111 | 141 | 136 | 175 | 135 | 155 |
visit 2 | 54 | 54 | 82 | 101 | 78 | 72 |
Mean age (years), (SD) | 42.2 (11.8) | 43.8 (14.9) | 45.1 (14.2) | 45.8 (15.4) | 45.0 (14.0) | 48.3 (15.9) |
Female | 68.5 | 68.8 | 72.1 | 61.1 | 66.7 | 67.7 |
Caucasian | 11 | 98 | 100 | 100 | 100 | 100 |
Married | 59.5 | 61.7 | 69.1 | 69.7 | 65.9 | 69.0 |
Full-time employed | 41.4 | 61.0 | 64.0 | 48.6 | 52.6 | 43.9 |
Duration of current episode of dyspepsia symptoms > 1 month | 71.2 | 53.2 | 72.8 | 58.3 | 65.1 | 72.3 |
Duration of disease > 5 years | 26.1 | 41.8 | 24.3 | 19.4 | 40.0 | 49.7 |
Severity of symptoms last 7 days at least moderate | 95.5 | 89.3 | 73.5 | 75.4 | 77.8 | 69.7 |
Symptoms on at least 5 days in previous week | 64.9 | 61.0 | 47.1 | 28.6 | 62.2 | 48.4 |
No comorbidity | 59.4 | 80.8 | 69.8 | 84.0 | 73.3 | 31.6 |
Concomitant medication | ||||||
No current medication | 33.3 | 71.6 | 37.5 | 58.3 | 39.2 | 33.5 |
Proton pump inhibitors | 21.6 | 15.6 | 25.7 | 6.8 | 27.4 | 20.6 |
Predominant dyspepsia symptom | ||||||
Abdominal pain | 70.3 | 50.4 | 58.8 | 38.3 | 47.4 | 20.6 |
Abdominal discomfort | 29.7 | 46.1 | 30.1 | 58.3 | 51.9 | 79.4 |
Previous peptic ulcer and/or ulcerative reflux esophagitis | 14.4 | 4.3 | 6.6 | 9.1 | 8.1 | 5.2 |
Emotional problems, past 5 years | 33.3 | 2.8 | 5.1 | 8.0 | 13.3 | 38.7 |
Psychometric evaluation
Reliability
Translation | ||||||
---|---|---|---|---|---|---|
Questionnaire and domain
|
Afrikaans
|
German
|
Hungarian
|
Italian
|
Polish
|
Spanish
|
GSRS
| (N = 108) | (N = 132) | (N = 124) | (N = 165) | (N = 134) | (N = 154) |
Reflux | 0.61 | 0.72 | 0.73 | 0.84 | 0.49 | 0.67 |
Abdominal pain | 0.60 | 0.43 | 0.59 | 0.65 | 0.49 | 0.45 |
Indigestion | 0.76 | 0.79 | 0.74 | 0.74 | 0.73 | 0.78 |
Diarrhoea | 0.75 | 0.84 | 0.79 | 0.72 | 0.78 | 0.82 |
Constipation | 0.82 | 0.81 | 0.79 | 0.76 | 0.87 | 0.75 |
QOLRAD
| (N = 108) | (N = 123) | (N = 124) | (N = 174) | (N = 134) | (N = 154) |
Emotional distress | 0.91 | 0.94 | 0.94 | 0.93 | 0.92 | 0.95 |
Food/drink problems | 0.83 | 0.90 | 0.90 | 0.88 | 0.86 | 0.91 |
Physical/social functioning | 0.84 | 0.90 | 0.89 | 0.89 | 0.86 | 0.91 |
Sleep disturbance | 0.88 | 0.89 | 0.94 | 0.89 | 0.91 | 0.93 |
Vitality | 0.79 | 0.90 | 0.87 | 0.80 | 0.87 | 0.89 |
Questionnaire and domain | Translation | |||||
---|---|---|---|---|---|---|
Afrikaans
|
German
|
Hungarian
| Italian* |
Polish
|
Spanish
| |
GSRS
| (N = 108) | (N = 132) | (N = 124) | (N = 165) | (N = 134) | (N = 154) |
Reflux | 0.37 | 0.66 | 0.59 | N/A | 0.61 | 0.48 |
Abdominal pain | 0.55 | 0.36 | 0.57 | N/A | 0.45 | 0.62 |
Indigestion | 0.46 | 0.61 | 0.75 | N/A | 0.71 | 0.75 |
Diarrhoea | 0.56 | 0.67 | 0.70 | N/A | 0.63 | 0.38 |
Constipation | 0.71 | 0.60 | 0.72 | N/A | 0.72 | 0.72 |
QOLRAD
| (N = 108) | (N = 123) | (N = 124) | (N = 174) | (N = 134) | (N = 154) |
Emotional distress | 0.51 | 0.75 | 0.70 | N/A | 0.56 | 0.65 |
Food/drink problems | 0.51 | 0.62 | 0.79 | N/A | 0.62 | 0.75 |
Physical/social functioning | 0.53 | 0.73 | 0.74 | N/A | 0.68 | 0.69 |
Sleep disturbance | 0.62 | 0.73 | 0.82 | N/A | 0.61 | 0.66 |
Vitality | 0.46 | 0.71 | 0.74 | N/A | 0.41 | 0.66 |
Construct validity
Correlation of the GSRS with the QOLRAD
Correlation of the GSRS with the SF-36
Questionnaire and domain | SF-36 domain and correlation coefficient | |||||
---|---|---|---|---|---|---|
Afrikaans*
|
German
|
Hungarian
|
Italian
|
Polish
|
Spanish
| |
GSRS
| ||||||
Reflux | -- | GH (0.32), PF (0.30) | BP (0.35), GH (0.41), MH (0.38), PF (0.46), RP (0.30), SF (0.34), V (0.39) | -- | -- | BP (0.35) |
Abdominal pain | BP (0.45), PF (0.33) | BP (0.40), MH (0.45), PF (0.34), RE (0.36), RP (0.43), SF (0.31), V (0.40) | BP (0.54), GH (0.32), MH (0.45), PF (0.43), RE (0.30), RP (0.46), SF (0.50), V (0.52) | BP (0.43), MH (0.36), RE (0.36), SF (0.37) | BP (0.36), RP (0.35) | BP (0.37), MH (0.40), RE (0.34), SF (0.35), V (0.34) |
Indigestion | BP (0.39), PF (0.34) | GH (0.35), RE (0.31), V (0.30) | BP (0.53), GH (0.35), MH (0.42), PF (0.43), RE (0.30), RP (0.42), SF (0.47), V (0.44) | MH (0.30), RE (0.31), SF (0.33), | -- | BP (0.39), GH (0.32), MH (0.32), V (0.31) |
Diarrhoea | -- | GH (0.37), MH (0.35), PF (0.31), RE (0.30), SF (0.43) | GH (0.31), SF (0.37) | PF (0.30) | -- | GH (0.31), MH (0.37), SF (0.30) |
Constipation | BP (0.34) | SF (0.35) | BP (0.40), GH (0.41), MH (0.34), PF (0.46), RP (0.38), SF (0.40), V (0.33) | PF (0.39) | -- | BP (0.30) |
QOLRAD
| ||||||
Emotional distress | BP (0.50), MH (0.35), RE (0.35), RP (0.43), SF (0.36), V (0.39) | BP (0.41), GH (0.40), MH (0.68), PF (0.48), RE (0.42), RP (0.60), SF (0.61), V (0.60) | BP (0.68), GH (0.59), MH (0.65), PF (0.52), RE (0.47), RP (0.55), SF (0.58), V (0.68) | BP (0.45), GH (0.49), MH (0.59), PF (0.36), RE (0.49), RP (0.47), SF (0.56), V (0.56) | BP (0.42), GH (0.36), MH (0.47), PF (0.34), RE (0.30), RP (0.37), SF (0.49), V (0.44) | BP (0.47), GH (0.43), MH (0.55), PF (0.33), RE (0.39), RP (0.42), SF (0.51), V (0.44) |
Sleep disturbance | BP (0.39), GH (0.31), MH (0.35), RE (0.31), RP (0.41), SF (0.38), V (0.49) | BP (0.43), GH (0.30), MH (0.44), PF (0.48), RE (0.42), RP (0.60), SF (0.61), V (0.60) | BP (0.63), GH (0.56), MH (0.51), PF (0.64), RE (0.51), RP (0.64), SF (0.49), V (0.59) | BP (0.46), GH (0.48), MH (0.46), PF (0.37), RE (0.47), RP (0.43), SF (0.51), V (0.50) | BP (0.43), MH (0.33), PF (0.32), RE (0.30), RP (0.41), SF (0.38), V (0.36) | BP (0.39), GH (0.34), MH (0.50), PF (0.37), RE (0.33), RP (0.44), SF (0.44), V (0.47) |
Food/drink problems | BP (0.32), GH (0.31), V (0.41) | BP (0.46), GH (0.31), MH (0.50), PF (0.50), RE (0.42), RP (0.60), SF (0.45), V (0.48) | BP (0.62), GH (0.40), MH (0.44), PF (0.49), RE (0.43), RP (0.58), SF (0.49), V (0.49) | BP (0.59), GH (0.50), MH (0.46), RE (0.45), RP (0.46), SF (0.52), V (0.51) | BP (0.40), GH (0.31), MH (0.37), PF (0.33), RE (0.33), RP (0.40), SF (0.41), V (0.32) | BP (0.38), MH (0.37), RE (0.37), RP (0.35), SF (0.39), V (0.33) |
Physical/social functioning | BP (0.44), MH (0.39), PF (0.32), RE (0.44), RP (0.47), SF (0.48), V (0.39) | BP (0.49), GH (0.38), MH (0.56), PF (0.62), RE (0.43), RP (0.69), SF (0.64), V (0.52) | BP (0.76), GH (0.52), MH (0.61), PF (0.66), RE (0.54), RP (0.73), SF (0.69), V (0.68) | BP (0.58), GH (0.49), MH (0.51), PF (0.45), RE (0.56), RP (0.60), SF (0.69), V (0.56) | BP (0.45), GH (0.46), MH (0.50), PF (0.46), RE (0.40), RP (0.53), SF (0.55), V (0.42) | BP (0.46), GH (0.45), MH (0.48), PF (0.49), RE (0.35), RP (0.55), SF (0.61), V (0.46) |
Vitality | BP (0.46), MH (0.32), RE (0.31), RP (0.35), SF (0.34), V (0.36) | BP (0.50), GH (0.31), MH (0.59), PF (0.46), RE (0.47), RP (0.66), SF (0.49), V (0.63) | BP (0.72), GH (0.55), MH (0.63), PF (0.60), RE (0.51), RP (0.65), SF (0.60), V (0.71) | BP (0.54), GH (0.47), MH (0.50), PF (0.33), RE (0.52), RP (0.49), SF (0.53), V (0.59) | BP (0.41), GH (0.35), MH (0.44), PF (0.27), RE (0.26), RP (0.40), SF (0.50), V (0.44) | BP (0.43), GH (0.39), MH (0.52), PF (0.36), RE (0.38), RP (0.44), SF (0.51) |
Correlation of the QOLRAD with the SF-36
Correlation of the GSRS with the HAD
Questionnaire and domain | Translation | |||||
---|---|---|---|---|---|---|
Afrikaans* |
German
|
Hungarian
|
Italian
|
Polish
|
Spanish
| |
GSRS
| (N = 108) | (N = 132) | (N = 124) | (N = 165) | (N = 134) | (N = 154) |
Reflux | N/A | A: 0.29, | A: 0.44, | A: 0.16 | A: 0.22 | A: 0.15 |
D: 0.14 | D: 0.44 | D: 0.01 | D: 0.04 | D: 0.17 | ||
Abdominal pain | N/A | A: 0.48, | A: 0.38, | A: 0.29 | A: 0.15 | A: 0.35 |
D: 0.18 | D: 0.38 | D: 0.18 | D: 0.03 | D: 0.28 | ||
Indigestion | N/A | A: 0.44, | A: 0.38, | A: 0.27 | A: 0.09 | A: 0.33 |
D: 0.14 | D: 0.36 | D: 0.15 | D: 0.13 | D: 0.25 | ||
Diarrhoea | N/A | A: 0.35, | A: 0.26, | A: 0.10 | A: 0.24 | A: 0.31 |
D: 0.21 | D: 0.19 | D: -0.01 | D: 0.21 | D: 0.26 | ||
Constipation | N/A | A: 0.32, | A: 0.39, | A: 0.25 | A: -0.00 | A: 0.25 |
D: 0.07 | D: 0.48 | D: 0.11 | D: -0.01 | D: 0.16 | ||
QOLRAD
| (N = 108) | (N = 123) | (N = 124) | (N = 174) | (N = 134) | (N = 154) |
Emotional distress | N/A | A: 0.49, | A: 0.67, | A: 0.67 | A: 0.40 | A: 0.41 |
D: 0.36 | D: 0.57 | D: 0.49 | D: 0.34 | D: 0.44 | ||
Food/drink problems | N/A | A: 0.35, | A: 0.48, | A: 0.51 | A: 0.35 | A: 0.30 |
D: 0.18 | D: 0.47 | D: 0.47 | D: 0.27 | D: 0.28 | ||
Physical/social functioning | N/A | A: 0.36, | A: 0.60, | A: 0.64 | A: 0.43 | A: 0.37 |
D: 0.28 | D: 0.64 | D: 0.53 | D: 0.38 | D: 0.48 | ||
Sleep disturbance | N/A | A: 0.29, | A: 0.59, | A: 0.53 | A: 0.29 | A: 0.39 |
D: 0.14 | D: 0.59 | D: 0.41 | D: 0.27 | D: 0.36 | ||
Vitality | N/A | A: 0.41, | A: 0.64, | A: 0.59 | A: 0.30 | A: 0.43 |
D: 0.32 | D: 0.61 | D: 0.46 | D: 0.30 | D: 0.42 |