From: Clinical drug trials in general practice: how well are external validity issues reported?
Exclusion criteria in total of 23 trials | Baseline data of included patients. Mean (CI) | Data from other population/GP studies for comparison | |||
---|---|---|---|---|---|
Exclusion criteria | Scotlanda | Belgiumb | Norwayc | ||
Age | 58.2 years (56.3–60.1) | 66.3 | 58 | 62.4 | |
< 18 | 19 | ||||
< 21 | 1 | ||||
< 40 | 1 | ||||
< 65 | 1 | ||||
No lower limit reported | 1 | ||||
> 70–79 | 10 | ||||
> 80 | 5 | ||||
No upper limit reported | 8 | ||||
Gender | 54.2% male (52.4–56.0) | 54.3 | 51.9 | 49.9 | |
Females | 0 | ||||
Pregnancy | 3 | ||||
Lack of contraception use | 3 | ||||
Breastfeeding | 1 | ||||
HbA1c | 8.1% (7.85–8.35) | 7.4 | 7.1 | 7.7 | |
< 6 | 1 | ||||
< 6.5 | 4 | ||||
< 7 | 8 | ||||
< 7.5 | 5 | ||||
No lower limit reported | 5 | ||||
> 9 | 2 | ||||
> 10–10.9 | 11 | ||||
> 11 | 4 | ||||
> 12 | 2 | ||||
No upper limit reported | 4 | ||||
BMI | 30.6 kg/m2 (30.1–31.1) | 31.4 | 31 | 29.7 | |
< 18 | 1 | ||||
< 22–23 | 4 | ||||
> 35 | 3 | ||||
> 40–45 | 6 | ||||
No BMI exclusion criteria reported | 14 | ||||
Medical comorbidities | 7 trials reported participants’ comorbidity | ||||
Coronary heart disease | 14 | ||||
Heart failure | 9 | ||||
Stroke | 4 | ||||
Renal dysfunction | 17 | ||||
Liver dysfunction | 14 | ||||
Other type of diabetes | 13 | ||||
Previous or suspected drug intolerance | 3 | ||||
Other disease | 7 | ||||
Medication related | 5 trials reported participants’ co-medication | ||||
Concurrent medication | 8 | ||||
Race/ethnicity | 0 | 19 trials reported participants’ race/ethnicity |