Readability and understandability of clinical research patient information leaflets and consent forms in Ireland and the UK: a retrospective quantitative analysis.

ABSTRACT:

Objectives

The first aim of this study was to quantify the difficulty level of clinical research Patient Information Leaflets/Informed Consent Forms (PILs/ICFs) using validated and widely used readability criteria which provide a broad assessment of written communication. The second aim was to compare these findings with best practice guidelines.

Design

Retrospective, quantitative analysis of clinical research PILs/ICFs provided by academic institutions, pharmaceutical companies and investigators.

Setting

PILs/ICFs which had received Research Ethics Committee approval in the last 5 years were collected from Ireland and the UK.

Intervention

Not applicable.

Main outcome measures

PILs/ICFs were evaluated against seven validated readability criteria (Flesch

SUBMITTER: O'Sullivan L 

PROVIDER: S-EPMC7473620 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature