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

O'Sullivan, Lydia
; 
Sukumar, Prasanth
; 
Crowley, Rachel
; 
McAuliffe, Eilish
; 
Doran, Peter
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Author
O'Sullivan, Lydia
 Sukumar, Prasanth
 Crowley, Rachel
 McAuliffe, Eilish
 Doran, Peter
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Other Contributors
Departments
School of Medicine & School of Nursing, Midwifery and Health Systems, University College Dublin, Dublin, Ireland lydia.osullivan@ucd.ie.
Date
2020-09-03
Date Submitted
Keywords
Clinical trials
medical education & training
MEDICAL ETHICS
medical law
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Readability and understandability of clinical research patient information leaflets and consent forms in Ireland and the UK a retrospective quantitative analysis.pdf
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URI
https://hdl.handle.net/10147/631437
Abstract
A total of 176 PILs were collected, of which 154 were evaluable. None of the PILs/ICFs had the mean reading age of <12 years recommended by the American Medical Association. 7.1% of PILs/ICFs were evaluated as 'Plain English', 40.3%: 'Fairly Difficult', 51.3%: 'Difficult' and 1.3%: 'Very Difficult'. No PILs/ICFs achieved a CCI >90. Only two documents complied with all six best practice literacy metrics.
Language
en
Citation
ISSN
eISSN
2044-6055
ISBN
DOI
10.1136/bmjopen-2020-037994
PMID
32883734
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