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. 2017 Nov;99(8):645-649.
doi: 10.1308/rcsann.2017.0188. Epub 2017 Oct 19.

Informed consent and the readability of the written consent form

N Sivanadarajah  1 , I El-Daly  2 , G Mamarelis  3 , M Z Sohail  3 , P Bates  2
Affiliations

Informed consent and the readability of the written consent form

N Sivanadarajah et al. Ann R Coll Surg Engl. 2017 Nov.

Abstract

Introduction The aim of this study was to objectively ascertain the level of readability of standardised consent forms for orthopaedic procedures. Methods Standardised consent forms (both in summary and detailed formats) endorsed by the British Orthopaedic Association (BOA) were retrieved from orthoconsent.com and assessed for readability. This involved using an online tool to calculate the validated Flesch reading ease score (FRES). This was compared with the FRES for the National Health Service (NHS) Consent Form 1. Data were analysed and interpreted according to the FRES grading table. Results The FRES for Consent Form 1 was 55.6, relating to the literacy expected of an A level student. The mean FRES for the BOA summary consent forms (n=27) was 63.6 (95% confidence interval [CI]: 61.2-66.0) while for the detailed consent forms (n=32), it was 68.9 (95% CI: 67.7-70.0). All BOA detailed forms scored >60, correlating to the literacy expected of a 13-15-year-old. The detailed forms had a higher FRES than the summary forms (p<0.001). Conclusions This study demonstrates that the BOA endorsed standardised consent forms are much easier to read and understand than the NHS Consent Form 1, with the detailed BOA forms being the easiest to read. Despite this, owing to varying literacy levels, a significant proportion of patients may struggle to give informed consent based on the written information provided to them.

Keywords: Ethics; Informed consent; Orthopaedics; Readability.

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Figures

Figure 1
Figure 1
Flesch reading ease score formula
Figure 2
Figure 2
Flesch reading ease scores for Consent Form 1 as well as standardised summary and detailed consent forms
See this image and copyright information in PMC

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