ASSESSMENT OF THE READABILITY OF INFORMED CONSENT FORMS USED IN AN ORAL AND MAXILLOFACIAL SURGERY CLINIC

Year 2025, Volume: 11 Issue: 1, 32 - 40, 27.03.2025

Ömer Ekici , Farbod Mahfozi

https://doi.org/10.21306/dishekimligi.1600348

Abstract

Aim
Informed consent documents should be written in a manner that is easy to read and understand. This study aims to evaluate the readability of informed consent documents utilized before surgical procedures in the department of oral and maxillofacial surgery at a university in Türkiye.
Methods
This study analyzed twenty consent forms used in a university's maxillofacial surgery clinic. The number of sentences, words, syllables, words per sentence, syllables per word, and the frequency of medical terms were calculated for each form. The readability levels of the consent forms were evaluated using the Ateşman formula.
Results
The mean number of words in the consent forms was 11.8, the mean number of syllables was 2.9, and the proportion of medical terms was 3.38. Based on the Ateşman readability formula, the readability scores of the consent documents used in surgery ranged from 37.1 to 68.8. Among the 20 consent forms analyzed, six were deemed 'difficult' in readability, while 14 were rated as 'moderate difficulty'.
Conclusion
Based on study findings, informed consent forms used in oral and maxillofacial surgery are difficult to read and generally require a high school or higher level of education. Given Türkiye's average education level and health literacy rate, it is recommended that consent forms used in oral and maxillofacial surgery be revised to enhance readability.
Keywords
Ateşman readability formula, Informed consent form, Oral and maxillofacial surgery, Readability.

Keywords

Ateşman readability formula, Informed consent form, Oral and maxillofacial surgery, Readability.

Ethical Statement

This research received approval from the Clinical Research Ethics Committee of Afyonkarahisar Health Sciences University (approval date: December 1, 2023; approval number: 2023/499) and was carried out in line with the principles stated in the Helsinki Declaration

Supporting Institution

No financial support was obtained for the completion of this study.

TÜRKİYE'DE BİR ÜNİVERSİTENİN ORAL VE MAKSİLLOFASİYAL CERRAHİ KLİNİĞİNDE KULLANILAN BİLGİLENDİRİLMİŞ ONAM FORMLARININ OKUNABİLİRLİĞİNİN DEĞERLENDİRİLMESİ

Abstract

Amaç
Tıbbi tanı ve tedavi öncesinde hastaları bilgilendirmek ve onamlarını almak için kullanılan aydınlatılmış onam formlarının okunması ve anlaşılması kolay olmalıdır. Bu araştırma, Türkiye'deki bir üniversitenin ağız, diş ve çene cerrahisi bölümünde cerrahi müdahalelerden önce kullanılan bilgilendirilmiş onam belgelerinin okunabilirliğini değerlendirmeyi amaçlamaktadır. Yöntem
Bu çalışmada, bir üniversitenin çene cerrahisi kliniğinde kullanılan yirmi onam formu analiz edildi. Her formun cümle, kelime, hece, cümle başına kelime, kelime başına hece ve tıbbi terim sayısı hesaplandı. Onam formlarının okunabilirlik düzeyleri Ateşman formülü kullanılarak değerlendirildi.
Bulgular
Onam formlarındaki ortalama kelime sayısı 11,8, ortalama hece sayısı 2,9 ve tıbbi terim oranı %3,38 olarak belirlendi. Ateşman okunabilirlik formülüne göre, onam belgelerinin okunabilirlik puanı 37.1 ile 68.8 arasında değişmiş ve 20 onam formundan 6 onam belgesinin okunabilirliği "zor" seviyesinde, 14 onam formunun okunabilirliği ise "orta zorluk" seviyesinde bulunmuştur.
Sonuç
Çalışma bulgularına göre, ağız ve çene yüz cerrahisinde kullanılan bilgilendirilmiş onam formlarının okunması zor olup genellikle lise veya daha yüksek eğitim seviyesi gerektirmektedir. Türkiye'nin ortalama eğitim seviyesi ve sağlık okuryazarlığı oranı göz önüne alındığında, oral ve maksillofasiyal cerrahide kullanılan onam formlarının okunabilirliğini artırmak için revize edilmesi önerilir.
Anahtar Kelimeler
Ateşman okunabilirlik formülü, Bilgilendirilmiş onam formu, Ağız ve çene cerrahisi, Okunabilirlik.

Keywords

Ateşman okunabilirlik formülü, Bilgilendirilmiş onam formu, Ağız ve çene cerrahisi, Okunabilirlik.

References

• 1. Ebem E, Tutar MS, Yıldız M, Canıtez A, Kara Ö, Kozanhan B. İntravenöz ve İntramüsküler Enjeksiyon Bilgilendirilmiş Onam Formlarının Okunabilirlik Açısından Değerlendirilmesi. Anadolu Klin. 2019;24:132-136.
• 2. Cheung E, Goodyear G, Yoong W. Medicolegal update on consent: ‘The Montgomery Ruling.’ The Obstetrician & Gynaecologist. 2016;18(3):171-172.
• 3. Dyke R, St-John E, Shah H, et al. Comparing shared decision making using a paper and digital consent process. A multi-site, single centre study in a trauma and orthopaedic department. Surgeon. 2023;21(4):235- 241.
• 4. Wiertz S, Boldt J. Ethical, Legal, and Practical Concerns Surrounding the Implemention of New Forms of Consent for Health Data Research: Qualitative Interview Study. J Med Internet Res. 2024;26:e52180.
• 5. St John ER, Scott AJ, Irvine TE, Pakzad F, Leff DR, Layer GT. Completion of hand-written surgical consent forms is frequently suboptimal and could be improved by using electronically generated, procedure-specific forms. Surgeon. 2017;15(4):190-195.
• 6. Cohen E, Byrom B, Becher A, Jörntén-Karlsson M, Mackenzie AK. Comparative Effectiveness of eConsent: Systematic Review. J Med Internet Res. 2023;25:e43883.
• 7. Aksu M. Tıp Bilişimi Hukuku. In: Tıp Bilişimi. Istanbul University Press; 2021.
• 8. Boztaş N, Özbilgin Ş, Öçmen E, et al. Evaluating the Readibility of Informed Consent Forms Available Before Anaesthesia: A Comparative Study. Turk J Anaesthesiol Reanim. 2014;42(3):140-4.
• 9. Gunning R. The Technique of Clear Writing. McGraw-Hill, New York, USA;1952.
• 10. Flesch R. A new readability yardstick. J Appl Psychol. 1948;32(3):221-233.
• 11. Ateşman E. Measuring readability in Turkish. A.U. Tömer Language J. 1997;58:171–4.
• 12. Sönmez MG, Kozanhan B, Özkent MS, et al. Evaluation of the readability of informed consent forms used in urology: Is there a difference between open, endoscopic, and laparoscopic surgery? Turk J Surg. 2018;34(4):295-299.
• 13. Karaarslan B, Karaarslan EŞ, Çelik S, Ertaş E, Çelik N. Evaluation of malpractice cases in dentistry which was discussed in high health council during 2001-2007. Turkiye Klinikleri J Dental Sci. 2010;16:142-148.
• 14. Pape T. Legal and ethical considerations of informed consent. AORN J. 1997;65(6):1122-1127.
• 15. Hasta Hakları Yönetmeliği. Resmi Gazete, 1998. Accessed October 8, 2023. https://www.mevzuat.gov.tr/mevzuat?MevzuatNo=48 47&MevzuatTur=7&MevzuatTertip=5
• 16. Reynard J, Reynolds J, Stevenson P. Practical Patient Safety.; 2009.
• 17. Sanghvi S, Cherla D V., Shukla PA, Eloy JA. Readability assessment of internet-based patient education materials related to facial fractures. Laryngoscope. 2012;122(9):1943-1948.
• 18. Kollia B, Basch CH, Kamowski-Shakibai MT, Tsiamtsiouris J, Garcia P. Testing the Readability of Online Content on Autism Spectrum Disorders. Adv Neurodev Disord. 2019;3(1):85-90.
• 19. Bezirci B, Yılmaz AE. A software library for measurement of readability of texts and a new readability metric for Turkish. Dokuz Eylül Üniversitesi Mühendislik Fakültesi Fen ve Mühendislik Dergisi. 2010;12(3):49–62.
• 20. Paasche-Orlow MK, Taylor HA, Brancati FL. Readability Standards for Informed-Consent Forms as Compared with Actual Readability. The new England J. 2003;348.
• 21. Walsh TM, Volsko TA. Readability Assessment of Internet-Based Consumer Health Information. Respir Care. 2008;53(10):51-63.
• 22. Eltorai AEM, Naqvi SS, Ghanian S, et al. Readability of Invasive Procedure Consent Forms. Clin Transl Sci. 2015;8(6):830-833.
• 23. Sönmez MG, Taşkapu HH, Sönmez LÖ et al. Türkiye’de Elektif Üroloji ve Acil Tıp Prosedürleri için Kullanılan Bilgilendirilmiş Onam Formlarının Okunabilirlikleri Arasında Fark Var mı? Genel Tıp Derg. 2020;30:151-156.
• 24. García-Álvarez JM, García-Sánchez A. Readability and Comprehension of Anesthesia Informed Consent Forms in a Spanish County Hospital: An Observational Study. Nursing reports (Pavia, Italy). 2024;14(2):1338- 1352.
• 25. Dural İE. Are Consent Forms Used in Cardiology Clinics Easy to Read? Turk Kardiyol Dern Ars. 2022;50(8):590-594.
• 26. Friedman DB, Hoffman-Goetz L. A systematic review of readability and comprehension instruments used for print and web-based cancer information. Health Educ Behav. 2006;33(3):352-373.
• 27. TUIK, Ulusal Eğitim İstatistikleri 2023. Accessed July 10, 2024. https://data.tuik.gov.tr/Bulten/Index?p=Ulusal-EgitimIstatistikleri-2023-53444.
• 28. Davis TC, Michielutte R, Askov EN, Williams M V., Weiss BD. Practical assessment of adult literacy in health care. Health Educ Behav. 1998;25(5):613-624.
• 29. Şahin N, Öztürk A, Özkan Y, Demirhan Erdemir A. What do patients recall from informed consent given before orthopedic surgery? Acta Orthop Traumatol Turc. 2010;44(6):469-475.
• 30. Finnie RKC, Felder TM, Linder SK, Mullen PD. Beyond reading level: a systematic review of the suitability of cancer education print and Web-based materials. J Cancer Educ. 2010;25(4):497-505.
• 31. Özdemir S, Akça H. Health Literacy in Turkey. Med J SDU. 2021; 28: 535-536.
• 32. Borello A, Ferrarese A, Passera R, et al. Use of a simplified consent form to facilitate patient understanding of informed consent for laparoscopic cholecystectomy. Open Med (Wars). 2016;11(1):564- 573.
• 33. Shukla AN, Daly MK, Legutko P. Informed consent for cataract surgery: patient understanding of verbal, written, and videotaped information. J Cataract Refract Surg. 2011;38(1):80-84.
• 34. Owen D, Aresti N, Mulligan A, Kosuge D. Customizable pre-printed consent forms: a solution in light of the Montgomery ruling. Br J Hosp Med (Lond). 2018;79(2):97-101.
• 35. St John ER, Bakri AC, Johanson E, et al. Assessment of the introduction of semi-digital consent into surgical practice. Br J Surg. 2021;108(4):342-345.
• 36. Bethune A, Davila-Foyo M, Valli M, Da Costa L. e-Consent: approaching surgical consent with mobile technology. Canadian Journal of Surgery. 2018;61(5):339.
• 37. Reeves JJ, Mekeel KL, Waterman RS, et al. Association of Electronic Surgical Consent Forms With Entry Error Rates. JAMA Surg. 2020;155(8):777-778.
• 38. De Sutter E, Zaçe D, Boccia S, et al. Implementation of Electronic Informed Consent in Biomedical Research and Stakeholders’ Perspectives: Systematic Review. J Med Internet Res. 2020;22(10):46-9.
• 39. Ellis LB, Barcroft J, St John E, Loughran D, Kyrgiou M, Phelps D. Digital consent in gynecology: an evaluation of patient experience. Arch Gynecol Obstet. 2024;309(2):611-619.
• 40. Chen C, Lee PI, Pain KJ, Delgado D, Cole CL, Campion TR Jr. Replacing Paper Informed Consent with Electronic Informed Consent for Research in Academic Medical Centers: A Scoping Review. AMIA Jt Summits Transl Sci Proc. 2020;2020:80-88.
• 41. Houten R, Hussain MI, Martin AP, et al. Digital Versus Paper-Based Consent from the UK NHS Perspective: A Micro-costing Analysis. Pharmacoecon Open. 2024;9(1):27-39.
• 42. Baser B, Gulnar B, Tuhan Kutlu E. Comparison of conventionally and digitally completed patient consentanamnesis forms in terms of surface contamination. Technol Health Care. 2023;31(5):1737-1746.
• 43. St John ER, Bakri AC, Johanson E, et al. Assessment of the introduction of semi-digital consent into surgical practice. Br J Surg. 2021;108(4):342-345.