Informed consent patient information sheets used in the study
| Title of trial | Readability* | Extracts from scientific information |
|---|---|---|
| *Calculated by averaging Flesch–Kincaid, SMOG, FOG and Fry test scores for each information sheet. | ||
| A: A study of Siglogasone in patients with type II diabetes not previously treated with oral medication | Low (that is, easiest to read): | A randomised, double-blind study |
| US school grade level 10 Readability age 15 years | Randomised: Sometimes because we do not know which way of treating patients is best, we need to make comparisons … A computer that has no information about the individual selects the groups—that is, by chance. | |
| Double blind: Neither you nor your doctor will know in which treatment group you are (although if your doctor needs to find out he/she can do so). This is to limit the potential for bias throughout the study. | ||
| B: A study in patients with type II diabetes comparing Taglipogasone with placebo when added to existing therapy | Medium: US school grade level 12 Readability age 17 years | During the study, in addition to your regular antidiabetic medication, you receive either the active study drug (Taglipogasone) or a dummy substance (placebo). This looks like the real thing but it contains no active drug. Whether you receive the active or inactive drug will be decided by a computer, which has no information about you (that is, decided by chance). There is an equal chance of receiving either the study drug or the placebo. |
| C: A Phase II, double-blind,placebo-controlled, randomised,two-period crossover, short term safety and efficacy study of repeat oral doses of WeN 1976 in patients with diabetic neuropathy | High: US school grade level 12 Readability age 17 years | The study medication you will receive could be either the active medication, containing the new drug WeN 1976, or a placebo (dummy tablet), which will be a substance that looks identical to the active medication but will not contain the new drug. Every patient will at some time during the study receive WeN 1976 and placebo and the order in which you receive either WeN 1976 or placebo will be decided at random (rather like tossing a coin). This is called a double-blind study, which means that during the study neither you nor your doctor will know which treatment you are receiving. However, in case of an emergency, your doctor can find out what treatment you are receiving very easily. |