Informed consent and the readability of the written consent form

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.

An assessment of the treatment information contained within the websites of direct‐to‐consumer orthodontic aligner providers

“…This was less than the minimum score of 70 that has been recommended to ensure optimal comprehension of presented written information. 25 Text that is difficult to read might result in a barrier in understanding the presented material. It risks enhancing deficiencies of the material by readers misinterpreting and misunderstanding the information being read.…”

“…This underlines the importance of not relying only on written information when obtaining consent. 25 Direct interaction and communication between the clinician and patient is at the heart of valid consent, particularly for those patients with deficient literary skills, visual impairment and limited English. 6,26 The present investigation contains limitations encountered in similar cross-sectional studies.…”

“…11,12 FRE scores greater than 70 have been described as acceptable (Table 3). 11,12,25 The text from each website, up to a limit of 3000 words, was copied and pasted into a Word document [Microsoft Office, Version 16.26]. The text was verified against the website and edited to ensure only complete sentences were evaluated in the online readability calculator (http://www.readabilityformulas.com).…”

The Role of Advanced Technology Product Animations on Informing Patients with Gonarthrosis Preoperatively

“…Also, the lack of informed consent of the individuals before the medical procedure or the failure to obtain it appropriately causes essential ethical and legal problems in clinical practice (9). The conventional informed consent is generally in the form of insufficient written texts (10,11). Studies show that patients do not understand the main elements of the consent in their informed consent performed with written or verbal information (10,(12)(13)(14)(15).…”

Medicolegal Aspects of Craniofacial Trauma

“…Several US organizations have pushed for the readability of health care materials to be no higher than that of the sixthgrade level, or what is expected of an 11-year-old child. 8 While concerns regarding the readability of the informed consent are legitimate, ultimately the two-way conversation remains the cornerstone of the informed consent process.…”