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ABOP, the automatic patient information leaflet optimizer: evaluation of a tool in development
Maarten Charles J Franck1, Veerle Foulon, Leona Van Vaerenbergh
1Department for Translation and Interpretation, Artesis University College Antwerp, Antwerp, Belgium.
The semi-automated leaflet optimizer (ABOP) significantly improved readability for the oxazepam patient information leaflet (PIL). ABOP largely prepares PILs for readability testing, potentially reducing costs and time.
Area of Science:
- Pharmaceutical Sciences
- Health Communication
- Medical Information Design
Background:
- Patient information leaflets (PILs) are crucial for medication adherence and safety.
- Ensuring PIL readability is a regulatory requirement (EC guideline).
- Current PILs may present challenges in information traceability and comprehension.
Purpose of the Study:
- To assess the impact of the semi-automated leaflet optimizer (ABOP) on PIL readability.
- To evaluate the effect of ABOP revisions on information traceability and comprehension.
- To determine if ABOP can optimize PIL quality and reduce testing burdens.
Main Methods:
- Developed a semi-automated leaflet optimizer (ABOP) for Dutch PILs.
- Revised two PILs (oxazepam and tetracycline) using ABOP.
- Tested original and ABOP-revised PILs for readability according to EC guidelines.
Main Results:
- The ABOP-revised oxazepam PIL showed significantly improved readability (p<.0001).
- The ABOP-revised tetracycline PIL showed improved readability, though not statistically significant.
- Terminology improvements most impacted information retrieval and comprehension; instructions/warnings did not.
- ABOP revisions improved, but did not fully ensure, compliance with EC requirements.
Conclusions:
- ABOP effectively prepares PILs for readability testing, addressing many text quality issues.
- Utilizing ABOP as a revision tool can enhance PIL quality.
- ABOP may lead to reduced readability testing time and associated costs.
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