Written Informed Consent-Translating into Plain Language. A Pilot Study.

Background: Informed consent is important in clinical practice, as a person's written consent is required prior to many medical interventions. Many informed consent forms fail to communicate simply and clearly. The aim of our study was to create an easy-to-understand form.

Methods: Our assessment of a Polish-language plastic surgery informed consent form used the Polish-language comprehension analysis program (jasnopis.pl, SWPS University) to assess the readability of texts written for people of various education levels; and this enabled us to modify the form by shortening sentences and simplifying words. The form was re-assessed with the same software and subsequently given to 160 adult volunteers to assess the revised form's degree of difficulty or readability.

Results: The first software analysis found the language was suitable for people with a university degree or higher education, and after revision and re-assessment became suitable for persons with 4-6 years of primary school education and above. Most study participants also assessed the form as completely comprehensible.

Conclusions: There are significant benefits possible for patients and practitioners by improving the comprehensibility of written informed consent forms.