The Pharmaceutical Journal
Vol 268 No 7196 p624-625
4 May 2002

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Health Services Research and Pharmacy Practice summary

Inadequate patient leaflets fail the EU user test

Three widely used patient information leaflets — for the "morning after pill" Levonelle and a branded (Adalat) and generic (Norton) nifedipine preparation — have failed a European Union-recommended user test. In the test, which is widely used in Australia, 20 potential users of a medicine are given a PIL and asked to find and explain 15 pieces of information. The testers must be people who could use the medicine concerned, but never have. The gold standard is a leaflet where 16 out of 20 people can find and explain all the points.

Mary Woodland and colleagues (University of Leeds) carried out the Levonelle test in 20 women waiting to see their GP. The women were the right age group for emergency hormonal contraception, but had not used it, and were not necessarily seeing the GP about it. Items they were asked to find included "how does the medicine work?" and "will it prevent all pregnancies?". The two nifedipine leaflets were tested in pharmacy customers aged over 65 years who were not taking nifedipine, but were on other medication. The items they were asked to find included "what side effects are common after starting nifedipine?".

"None of the leaflets came close to the target," Ms Woodland told the meeting on April 11. With the Levonelle leaflet, only three items were found and explained by at least 16 people. With the Adalat PIL, nine items were found by at least 16 people. The Norton leaflet did best, with 13 items found by at least 16 testers. Two people found and explained all 15 points.

In the test, people scored a mark for finding each point, and up to two marks for explaining it. The Norton leaflet scored significantly higher than the Bayer one for both finding and explaining, and users took less time to complete the test.

Ms Woodland said this could be linked to differences in layout: "The Norton leaflet used bullet points and colour. It looked nicer."

There was evidence of an education effect with all three leaflets: people with qualifications did better, and faster, than people without. This and inter-rater differences were possible sources of bias, and needed further work.

"Both projects show the inadequacy of information provided to patients," Ms Woodland concluded. "User testing of PILs is more than just a good idea."