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Is there a difference between the readabilities of Iinformed consent forms used for elective and emergency procedures in Turkey?

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Is There a Difference Between

the Readabilities of Informed Consent

Forms Used for Elective and Emergency

Procedures in Turkey?

Mehmet Giray So¨nmez

1

, Leyla O

¨ ztu¨rk So¨nmez, MD, PhD

2,3

,

Betu¨l Kozanhan

4

, and Zerrin Defne Du¨ndar

2

Abstract

Background: Informed consent is an important aspect of ethical medical practice. In legal terms, making an intervention without informed consent may mean negligence or malpractice and may lead to legal action, maltreatment, and even attack against the doctor. This study aims to evaluate the readability of informed consent forms (ICFs) used for elective (urology and general surgery) and emergency procedures (emergency medicine and intensive care) by comparing through readability formulas. Methods: Elective and emergency ICFs were accessed through the web sites of national health care associations. A total of 387 consent forms were evaluated and the same forms were included only once. A total of 35 consent forms were evaluated for emergency procedures, while a total of 55 consent forms were evaluated for elective procedures. Ates¸man and Bezirci-Yılmaz formulas defined for determining the readability level of Turkish texts and Gunning fog and Flesch Kincaid formulas measuring the general readability level were used for calculating the readability level of consent forms.

Results: Even though elective ICFs are more readable compared to those of emergency procedures according to Bezirci-Yılmaz formulas, this was statistically insignificant (P¼ .54). The readability of elective consent forms was found to be at a significantly more difficult level to read compared to Ates¸man, Gunning fog, and Flesch Kincaid formulas (P¼ .002, P < .001, P < .001, respectively).

Conclusion: Even though the procedure is emergency or elective, a difficult readability level may cause problems for the doctor in legal phases. Readable and understandable consent forms should be available to be able to explain morbidity and mortality and improve prognosis. Education level of our country should also be considered while preparing these consent forms.

Keywords

emergency, informed consent forms, intensive care, readability, understandability

Background

Health literacy is defined as “the capacity of individuals to take, process and understand the basic health information and services required to be able to make decisions on health” and is the best predictor of the health condition of an individual. Low health literacy skills may negatively influence the comprehen-sion of the patients and their decicomprehen-sion phase.1,2In a recent study it was reported that 64.6% of the public had inadequate health literacy in Turkey.2

In general, low health literacy is associated with difficulty in understanding the medical procedures. Low health literacy influences patients’ health in several ways, such as a decreased use of preventive services and a poor understanding of illness and medication adherence. Also, a low health literacy will impede grasping the highly complex technical information pre-sented in the informed consent documents.1-3

Informed consent means the authorization given to the health professional for the diagnosis or treatment interventions planned with the patient’s consent. Informed consent forms

1

Department of Urology, Meram Medical Faculty, Necmettin Erbakan Uni-versity, Konya, Turkey

2Department of Emergency Medicine, Meram Medical Faculty, Necmettin

Erbakan University, Konya, Turkey

3Department of Physiology, Selcuklu Medical School, Selcuk University, Konya,

Turkey

4Department of Anesthesiology and Reanimation, University of Health

Sci-ences, Konya Training and Research Hospital, Konya, Turkey

Submitted 15-Jun-2019; accepted 11-Jul-2019 Corresponding Author:

Mehmet Giray So¨nmez, Department of Urology, Meram Medical Faculty, Necmettin Erbakan University, Konya 42080, Turkey.

Email: drgiraysonmez@gmail.com

& Regulatory Science 1-5

ªThe Author(s) 2019 Article reuse guidelines: sagepub.com/journals-permissions DOI: 10.1177/2168479019871040 tirs.sagepub.com

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(ICFs) are used to help the patients during the treatment phase by explaining the indications, advantages, and possible risks of medical procedures.3,4It was shown that these texts may be effective in solving the problems in treatment phase with sev-eral advantages such as providing patient-doctor communica-tion and making the accordance of the patient to treatment easier. Also, the fact that health insurance costs and malprac-tice cases have seen an increasing trend makes it especially important for the doctors and nurses to enhance the readability and comprehensibility of ICFs.

Obtaining an informed consent for medical procedures is an essential step before all medical procedures. However, insuffi-cient understanding of this informed consent process and thereby the medical intervention may lead to significant legal and ethical consequences.3-5

In cases of certain life-threatening situations in the emer-gency and reanimation departments, relatives of patients tend to give immediate approval to the procedure for the necessary intervention. Therefore, they may approve the transaction with-out fully reading the ICFs.

However, in elective procedures, the patient or the patient’s relatives may want to have more detailed informa-tion about the process. Therefore, they may want to evaluate the ICFs in more detail.

In this sense, although the ICFs of emergency and elective procedures differ from each other, the consent forms in both cases should be easy to read.

Assessment of the readability level of the ICFs may give an idea about the understandability of the forms. Presenting some quantitative data on texts, readability provides information on whether the text is easily understandable by the reader at a certain level through the characteristics of the syllables, words, and sentences in that language.6,7

There are many formulas developed for readability analy-sis. Ates¸man and Bezirci-Yılmaz formulas were defined to analyze the readability level of Turkish texts.8,9Gunning fog and Flesh Kincaid are the most common used readability for-mulas.10,11As the average reading level of adults in USA is of eighth-grade, the National Institutes of Health (NIH) and the American Medical Association (AMA) suggest that the read-ability of patient materials should be of sixth-grade or lower reading level.12-14

The aim of this study was to evaluate the readability of ICFs used for elective (urology and general surgery) and emergency procedures (emergency medicine and intensive care) by com-paring the forms using readability formulas.

Methods

Elective and emergency ICFs were accessed through the web sites of national medical associations and local institutions in Turkey (http://www.uroturk.org.tr/, http://www.urolojikcerrahi dernegi.org/, https://www.turkcer.org.tr/, http://www.atuder. org.tr/, https://www.tatd.org.tr/, http://meramtip.com.tr/kalite/ onamlar.html). All of these ICFs were prepared by the relevant

medical associations and used routinely in the hospitals for preprocedure approval. In the ICFs, parts including personal information (such as name, address, etc.) were removed to avoid the possible changes in the number of words, syllables, and the level of readability, before the analyses. A total of 35 consent forms were evaluated for emergency procedures (emergency medicine and intensive care) while a total of 55 consent forms were evaluated for elective procedures (urology and general surgery).

Information text available in these ICFs was copied and transferred to Microsoft Word (Microsoft, Redmond, WA) pro-gram and was calculated manually with Microsoft Excel (Microsoft, Redmond, WA) program. The Ates¸man and Bezirci-Yılmaz formula8,9was used for determining the read-ability level of Turkish texts, and Gunning fog and Flesch Kincaid10,11 formulas for measuring the general readability level were used for calculating the readability level of ICFs.

Ates¸man Readability Formula

8

It is a formula based on the number of words and length of the sentence. The readability score is formulated as 198.825 – 40.175 (total syllables/total words) – 2.610  (total words/ total sentences). According to the Ates¸man formula, the read-ability of a text is considered easier when it comes closer to 100 and harder when it comes closer to 0.

Bezirci-Yılmaz Readability Formula

9

It was developed in 2010 by Bezirci and Yılmaz and is based on the sentence lengths and syllable number in words, characteris-tics in different formulas and statistical characterischaracteris-tics of Turkish language. Being developed with the C programming language with the main feature of platform independency, the software library is expected to serve as a resource for the upcoming researches in this topic; meanwhile, the proposed readability metric is expected to find wide application areas for prediction of the readability levels of Turkish texts. According to this for-mula, the readability of a text becomes harder with an increase in the number of longer sentences and the number of syllables. The Bezirci-Yılmaz formula is shown below.

ffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffi AWNðS3  0:84Þ þ ðS4  1:5Þ þ ðS5  3:5Þ þ ðS6  6:26:25Þ r

Average word number (AWN)

S3: Number of words with an average of 3 syllables S4: Number of words with an average of 4 syllables S5: Number of words with an average of 5 syllables S6: Number of words with an average of 6 or more syllables This formula explains which class level a text represents according to the education system in Turkey:

for classes 1-8¼ elementary school; for classes 9-12¼ high school; for classes 12-16¼ undergraduate, for classes >16¼ post-academic.

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Flesch-Kincaid Formula

10

In the Flesch-Kincaid formula, the length of the words and sentences is determined.

Readability¼ (0.39  sentence length) þ (1.18  word length) – 15.59

World length¼ syllable number/word number Sentence length¼ word number/sentence number. Syllable number is divided to the word number for the word length and word number is divided into sentence number for sentence length. The text is evaluated as easy when the syllable number of each word is closer to 1 and as difficult when the syllable number rises up to 10. The same operation is valid for the sentence. The text is evaluated as easy when the word number decreases to 1 and as difficult when it is more than 10.

Gunning Fog Index Formula

11

There are 2 important aspects in Gunning’s formula. These are words containing 3 or more syllables and the average number of words used in sentences.

Fog Index¼ 0.4  (word rate with 3 syllables þ average number of words).

Word rate with 3 syllables¼ (number of words with 3 or more syllables / remaining number of words) 100.

Average number of words ¼ word number/sentence number.

It is an easy text if the result is between 8 and 10 and a difficult text above 11.

The readability levels of the readability formulas used in the study are available in Table 1.

Statistical Analysis

SPSS 20.0 (Chicago, IL, USA) program was used for statistical evaluation. The readability levels of emergency and nonemer-gency urologic ICFs were compared using independent T test and Mann-Whitney U. P values <.05 value were regarded as significant for all examinations.

Results

Readability of elective ICFs was found to be at a significantly more difficult level to read compared to Ates¸man, Gunning fog, and Flesch-Kincaid formulas (P ¼ .002, P < .001, and P < .001, respectively). Even though elective ICFs are more readable compared to those of emergency ICFs according to Bezirci-Yılmaz formulas, this was statistically insignificant (P¼ .54). It was measured that the sentence, word, syllable, letter, and multisyllable numbers were significantly high in elective ICFs (P < .001).

Even though there is a difference among them, the read-ability levels of the ICFs of both groups were detected at aver-age difficulty level according to the Ates¸man formula, very difficult according to the Flesch-Kincaid formula, difficult

according to the Gunning fog formula, and at high school level according to Bezirci-Yılmaz.

The readability scores of the groups are shown in Table 2.

Discussion

ICFs are forms prepared to inform the patient before any sur-gical operation or intervention. It is one of the standpoints of

Table 1. Readability Levels of the Readability Formulas Used in the Study.

Ates¸man scores Readability level

90-100 Very easy

70-89 Easy

50-69 Average difficulty

30-49 Difficult

1-29 Very difficult

Bezirci-Yılmaz scores Readability level according to

education level

1-8 Elementary school

9-12 High school

12-16 Bachelor’s degree

>16 Academic

Gunning fog index score Readability level

8-10 Easy

>11 Difficult

Flesch Kincaid grade level Numeric level

of the text Readability level 5 90-100 Very easy 6 80-90 Easy 7 70-80 Quite easy 8-9 60-70 Standard 10-11 50-60 Rather difficult 13-16 30-50 Difficult

Adults 0-30 Very difficult

Table 2. Numeric and Statistical Values on Elective and Emergency Informed Consent Forms.

Parameters (mean + SD) Elective ICFs (n¼ 55) Emergency ICFs (n¼ 35) P Sentence number 107.1 + 33.5 70.3 + 18.4 <.001 Word number 947 + 231 707 + 207 <.001 Letter number 6545 + 1644 4620 + 1435 <.001 Character number 8057 + 1985 5767 + 1734 <.001 Syllables number 2845 + 720 1993 + 619 <.001

Words with an average syllablenumber of 4 and above 325 + 91 195 + 79 <.001 Flesch Kincaid 23.3 + 1.3 21.6 + 2.42 <.001 Gunning fog 17.2 + 1.3 14.9 + 1.8 <.001 Ates¸man 54.8 + 5.7 59.4 + 7.88 .002 Bezirci-Yılmaz 9.84 + 1.58 10.01 + 1.16 .54

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the patient and doctor. According to the studies, patients can keep nearly 20% of the verbal information in their minds prob-ably due to worry, pain, fear of unknown, time restrictions, and lack of medical information. But this ratio rises up to 50% when used together with written material. Thus, getting informed consent forms signed before a medical intervention is extremely important.7 However, in several studies, it was concluded that there was a relation between education and understanding levels in general.12-15 Stating the target educa-tion level of a text provides a certain degree of informaeduca-tion on its understandability. Consent forms for emergency or elective interventions should be understandable by the patient popula-tion at every educapopula-tion level. In our study, the readability of elective and emergency ICFs were found to be of average difficulty level according to the Ates¸man formula, very diffi-cult according to the Flesch-Kincaid formula, diffidiffi-cult accord-ing to the Gunnaccord-ing fog formula, and of high school level according to Bezirci-Yılmaz.

Readability is a concept that can be objectively measured, revealing the degree of difficulty in reading any text. Read-ability levels of ICFs were measured in different countries for different medical branches before. ICFs used in public hospi-tals were analyzed globally in Spain and it was shown that 62.4% had somewhat difficult, 23.4% had normal, and 13.4% had very difficult readability.16ICF readability values among the branches were compared in another study, and it was reported that urology ICFs were at “very and somewhat difficult” intervals.17 Boztas¸ et al evaluated the ICFs used before anesthesia in Turkey and reported that these had low to very low readability levels.6

In a study conducted in USA, it was reported that ICFs for invasive operations were written at an average of 15th-grade level (ie, third year of college).18Gargoum and Keeffe evaluated the information forms used for endoscopic interventions in Ire-land and reported that only 62% of the forms were easy to read and that 57% were at the reading level for 13-15-year-olds.19

According to national data of Turkey at 2010, the average education level of the population age over 15 was reported as 7.18 years and the average education level of only females over 15 years of age is reported as 6.33 years.20Also, it was reported that two-thirds of the population in Turkey has an inadequate level of health literacy.2Even though the education level of the individual is high, it may cause misunderstanding for an indi-vidual not used to medical literature. Crepeau et al found the understanding and recalling of the patients for surgical consent form to be unexpectedly low.15Thus, consent forms should not contain medical terms as much as possible.4,6Therefore, the ease of readability of ICFs, regardless of the department, will increase the intelligibility of the procedure to be applied.

In this study, it was concluded that the ICFs of elective pro-cedures were more difficult to read compared to the emergency ICFs. We think that this condition is due to longer words and sentences since the operation to be performed in elective surgical intervention ICFs are explained in more detail. But it was found that both elective and emergency ICFs had low readability

levels—that of high school education. This condition is in line with studies conducted in different specialties in many countries. Therefore, generally it is necessary to discuss what is needed to make ICFs more readable and understandable.

Some suggestions for an adequate understanding of ICFs by the readers are limiting medical words, using language at a reading level suitable for the target audience, containing a proper and readable text style and containing visual presenta-tion as much as possible. Generally, the first few lines are very important for the readability of the text because these have a critical importance for the reader to continue reading the con-sent form. Use of interesting samples and stories for the reader, forming a logical structure with important points at the begin-ning of each paragraph and ordinary use of the language, are other general suggestions.21 In previous studies, it was also reported that, marking the text, using diagrams and supporting with videos makes the medical text more understandable and may be remembered later.3,22Readability of ICFs made easier and enriched by visual information such as videos and dia-grams would increase ratios for understanding the procedure and remembering its possible risks. In addition to an easier operative phase for both the patient and the doctor, easily understandable ICFs would also simplify the management of conditions that may occur due to the possible postintervention complications.

Limitations

In this study, the use of the ICFs of only emergency (emer-gency medicine and intensive care) and elective (urology and general surgery), the evaluation of a small number of consent forms, and the use of 4 readability formulas could be counted as our limitations. Therefore, we believe that studies that evaluate using different readability formulas and include many different departments will contribute to the literature.

Conclusion

In this study, readability ratios of both elective and emergency ICFs were detected low and required an education level of high school or above. Even though a medical intervention is emergency or elective, a low readability level may cause problems for the doctors and nurses in legal aspects. Readable and understandable consent forms should be available to be able to explain morbidity and mortality and improve prog-nosis. Education level and the local environment should be considered while preparing these ICFs. We think that atten-tion should be paid to this subject which is both medically and legally binding for the doctors, and verbal and visual support should be provided for informing the patients in addition to consent forms. Associations and health institutions active in this field should cooperate to be able to develop new forms in line with the suggested strategies for the revision of the patient consent forms.

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Authors’ Note

Presentation: Abstract of this article was presented at 12th European Emergency Medicine Congress, in Glasgow, United Kingdom.

Ethical Statement

This study was conducted in accordance with the principles of the Helsinki World Health Organization Declaration. In this study, it was not necessary to obtain informed consent form and ethics committee approval as human participants were absent and only the readability level of the written texts was evaluated.

Declaration of Conflicting Interests

No potential conflicts were declared.

Funding

No financial support of the research, authorship, and/or publication of this article was declared.

ORCID iD

Mehmet Giray So¨nmez https://orcid.org/0000-0003-4615-7348

References

1. Meneguin S, Aparecido Ayres J. Perception of the informed con-sent form by participants in clinical trials. Invest Educ Enferm. 2014;32(1):97-102.

2. Tanrıo¨ver MD, Yıldırım HH, Ready FND, C¸ akır B, Akalın HE. Turkey Health Literacy Survey. http://www.sagliksen.org.tr/cdn/ uploads/gallery/pdf/8dcec50aa18c21cdaf86a2b33001a409.pdf. Published December 2014

3. Borello A, Ferrarese A, Passera R, et al. Use of a simplified consent form to facilitate patient understanding of informed con-sent for laparoscopic cholecystectomy. Open Med (Wars). 2016; 11(1):564-573.

4. Boztas¸ N, O¨ zbilgin S¸, O¨c¸men E, et al. Evaluating the readability of informed consent forms available before anaesthesia: a com-parative study. Turk J Anaesthesiol Reanim. 2014;42:140-144. 5. Ates¸man E. Measuring readability in Turkish. AU To¨mer

Lan-guage J 1997;58:171-174.

6. Bezirci B, Yılmaz AE. A software library for measurement of readability of texts and a new readability metric for Turkish. DEU FMD. 2010;12(3):49-62.

7. Flesch R. A new readability yardstick. J Appl Psychol. 1948; 32(3):221-233.

8. Gunning R. The Technique of Clear Writing. New York, NY: McGraw-Hill International Book Co; 1952.

9. Sanghvi S, Cherla DV, Shukla PA, Eloy JA. Readability assess-ment of internet-based patient education materials related to facial fractures. Laryngoscope. 2012;122(9):1943-1948.

10. Eltorai AE, Sharma P, Wang J, Daniels AH. Most American academy of orthopaedic surgeons’ online patient education mate-rial exceeds average patient reading level. Clin Orthop Relat Res. 2015;473(4):1181-1186.

11. Eltorai AE, Han A, Truntzer J, Daniels AH. Readability of patient education materials on the American Orthopaedic Society for Sports Medicine website. Phys Sports Med. 2014;42(4):125-130. 12. Eltorai AE, Ghanian S, Adams CA Jr, Born CT, Daniels AH. Readability of patient education materials on the American asso-ciation for surgery of trauma website. Arch Trauma Res. 2014; 3(2):e18161.

13. Crepeau AE, McKinney BI, Fox-Ryvicker M, Castelli J, Penna J, Wang ED. Prospective evaluation of patient comprehension of informed consent. J Bone Joint Surg Am. 2011;93(19):e114(1-7). 14. Mariscal-Crespo MI, Coronado-Va´zquez MV, Ramirez-Dura´n MV. Global analysis of the readability of the informed consent forms used in public hospitals of Spain [in Spanish]. Rev Calid Asist. 2017;32(4):200-208.

15. San Norberto EM, Go´mez-Alonso D, Trigueros JM, Quiroga J, Gualis J, Vaquero C. Readability of surgical informed consent in Spain [in Spanish]. Cir Esp. 2014;92(3):201-207.

16. Eltorai AE, Naqvi SS, Ghanian S, et al. Readability of invasive procedure consent forms. Clin Transl Sci. 2015;8(6):830-833. 17. Gargoum FS, O’Keeffe ST. Readability and content of patient

information leaflets for endoscopic procedures. Ir J Med Sci. 2014;183(3):429-432.

18. Barro R, Lee JW. Educational attainment dataset. http://www.bar rolee.com/. Published 2011.

19. Pruthi A, Nielsen ME, Raynor MC, Woods ME, Wallen EM, Smith AB. Readability of American online patient education materials in urologic oncology: a need for simple communication. Urology. 2015;85(2):351-356.

20. Shukla AN, Daly MK, Legutko P. Informed consent for cataract surgery: patient understanding of verbal, written, and videotaped information. J Cataract Refract Surg. 2012;38(1):80-84.

Şekil

Table 2. Numeric and Statistical Values on Elective and Emergency Informed Consent Forms.

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