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Journal of Orthodontics
Abstract
Objective: To evaluate the readability of orthodontic treatment informed consent forms (ICFs).
Design: A cross-sectional observational investigation.
Methods: An online search strategy was adopted to identify ICFs for orthodontic treatment. The text of each form that
satisfied inclusion criteria was modified to a standardised protocol. The readability was evaluated using three validated
instruments. GraphPad Software (GraphPad Software Inc., La Jolla, CA, USA) was used for statistical analyses.
Results: A total of 59 ICFs were evaluated. The majority were available on the websites of orthodontists (66.1%) and
general dentists (27.1%). The scores recorded from the three instruments indicated that the content of 93.2%–98.3% of
ICFs was difficult to read. A strong correlation was observed between the Simple Measure of Gobbledegook (SMOG)
and the Flesch Kincaid Grade level (FKGL) instruments (r = 0.9782; P < 0.0001). The mean SMOG score for all assessed
forms was 11.19 (95% confidence interval [CI] 10.85−11.54). The ICFs authored by the manufacturers of orthodontic
appliances provided by clinicians recorded a mean Flesch Reading (FRE) score of 40.14 (95% CI 33.91−46.37) out of a
maximum 100. An analysis of the SMOG scores indicated that the content of ICFs authored by national orthodontic
societies was more difficult to read than those written by all other authors (P=0.01; 95% CI −1.6 to −0.2)
Conclusion: The readability of the ICFs was too difficult for a significant number of the population. Many patients
will be unable to validly consent to treatment based solely on reading of the content of the evaluated ICFs. A greater
effort is required to improve the readability of ICFs to help ensure patient autonomy regarding orthodontic treatment
decision-making and management.
Keywords
informed consent, orthodontic treatment, health literacy, readability
Date received: 13 April 2021; revised: 7 June 2021; accepted: 29 June 2021
Table 1. Tools used to evaluate ICF readability scores. A P value < 0.05 indicated statistical significance.
Readability tool Formula
Statistical analyses were performed through GraphPad
Prism 9.0 (GraphPad Software Inc., La Jolla, CA, USA).
SMOG Index 1.043 × √ (C × (30/S)) + 3.1291
Figure 1. Website type and country of origin (n = 59). AUS, Australia; CAN, Canada; GDP, general dental practitioner; UK,
United Kingdom; US, United States.
4 Journal of Orthodontics
Readability test
CI, confidence interval; FKGL, Flesch-Kincaid Grade Level; FRE, Flesch Reading Ease; ICF, informed consent form; NOS, National Orthodontic
Society; OAM, orthodontic appliance manufacturer; SD, standard deviation; SMOG, Simple Measure of Gobbledegook; UA, unspecified author.
Figure 2. Reading difficulty as per USDHSS criteria (n = 59 per readability tool). FKGL, Flesch-Kincaid Grade Level; FRE, Flesch
Reading Ease; SMOG, Simple Measure of Gobbledegook.
compared with that written by all other authors (P = 0.01; The ICFs contained within US websites, however, were
95% CI −1.6 to −0.2). There was no difference in the ease of significantly more difficult to read compared with those
readability between those ICFs authored by NOSs and those located in UK websites (P = 0.0185; 95% CI = 0.1852
authored by OAMs (P = 0.69; 95% CI = –2.1 to 1.7). to 1.817).
Meade and Dreyer 5
Readability test
CI, confidence interval; GDP, general dental practitioner; ICF, informed consent form; FKGL, Flesch-Kincaid Grade Level; FRE, Flesch Reading Ease;
SD, standard deviation; SMOG, Simple Measure of Gobbledegook.
To provide context to the results determined by the pre- to those used generally in orthodontic practice. Nevertheless,
sent survey, the mean FRE and FKGL readability scores of it would be reasonable to expect that the ICFs provided by
articles in a range of British broadsheet newspapers article the NOSs and OAMs to be used widely among orthodontic
were found to be 42.35 and 11.76, respectively, in a 2010 treatment providers.
study (Williamson and Martin, 2010). In contrast, the same Improving patient comprehension and health literacy
investigation found that articles in a range of tabloid news- through addressing the readability of ICFs will aid the ame-
papers were easier to read (mean FRE = 58; mean FKGL lioration of patient outcomes. The orthodontic profession
= 9.9). In addition, the mean FRE, FKGL and SMOG needs to take the lead in providing ‘easier to read’ ortho-
scores of the penultimate draft of the presented academic dontic treatment ICFs as well as guiding clinicians and
article were 41.1, 9.7 and 8.5, respectively. manufacturers of orthodontic appliances on how best to
The mean overall FRE score of 41.73 is significantly deliver more readable ICFs. Whether clinicians should be
lower than the recommended minimum score of 70 recom- using ICFs from OAMs, which risk providing biased infor-
mended for written health information (Perni et al., 2018). mation, must be part of any conversation regarding patient
This indicates the level of readability required by a student consent. Correspondingly, simpler terms, less technical
attending university is required to understand most ICFs. It ‘jargon’ and shorter sentences will improve readability
compares with mean FRE scores of 29.1−68.9 observed in (Graham et al., 2015). In the future, quantitative and quali-
‘general dental’, ‘invasive medical procedure’ and ‘ortho- tative research will be required to enable the development
paedic procedure’ ICFs (Eltori et al., 2015; Glick et al., of consent forms that provide high-quality information that
2010; Sivanadarajah et al., 2017). is tailored for the patient, yet is easy to read.
The SMOG and FKGL scores were closely correlated in
the present survey. The mean SMOG score of 11.85 for
NOS ICFs exceeds the recommended grade 6 advocated by
Conclusion
USDHSS guidelines and ‘gold standards’ adopted in simi- Readability is a core element of health literacy and is essen-
lar surveys. This equates to a UK school age of almost 17 tial to ensure that ICFs are understood as intended. The
years (Fitzsimmons et al., 2010). It compares with SMOG readability of the ICFs evaluated in the present study was
scores of 14.1−14.5 for ICFs related to radiation therapy, determined to be too difficult to understand for a significant
general dental and urological procedures (Glick et al., number of the population. Many patients will be unable to
2010; Graham et al., 2015; Perni et al., 2018). validly consent to treatment based solely on reading of the
The British Orthodontic Society does not provide a ‘pro- content of the ICF. A greater effort is required to improve
forma’ ICF. It, nevertheless, provides guidance regarding the readability of ICFs to help ensure patient autonomy
the inclusion of content pertaining to treatment options, regarding orthodontic treatment decision-making and
treatment details, benefits and risks (British Orthodontic management.
Society, 2015). It also emphasises that valid consent com-
prises an ongoing communication process and is not just a Declaration of Conflicting Interests
signed ICF. The judgement of a recent UK court case con- The author(s) declared no potential conflicts of interest with
cluded that valid consent must stress information that is of respect to the research, authorship, and/or publication of this
particular relevance to the individual patient (Montgomery article.
vs Lanarkshire, 2015). This may mean that ICF templates
should be designed with ‘space’ to provide patient-specific Funding
information. However, a well-designed ICF containing rel- The author(s) received no financial support for the research,
evant high-quality information is of little value if the infor- authorship, and/or publication of this article.
mation is difficult to read.
The limitations of this investigation must be acknowl- ORCID iD
edged. The study did not assess the visual presentation and Maurice J Meade https://orcid.org/0000-0001-5688-1079
graphic layouts of the ICFs which can further influence
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