Perihan Elif EKMEKÇİ, Alp Burak EKMEKÇİ, Ozgür KARAKAS, Ahmet KULDUK, BERNA ARDA

Evaluation of the informed consent procedure for total knee arthroplasty patients in Turkey

Objective: The purpose of this research is to evaluate the ethical aspects of informed consent process oftotal knee arthroplasty (TKA) patients in Turkey.Methods: The study included 50 patients undergoing TKA in Gazi Mustafa Kemal State Hospital Orthopedics Clinic. A face to face survey was conducted to determine the ethical appropriateness of the maincomponents of informed consent process such as; disclosure of material information about the diseaseand alternative treatment options, understanding the disclosed information, comprehending the writtenconsent form and voluntariness in deciding.Results: The survey revealed that all TKA patients signed informed consent form, 80% of the participants

___

Beauchamp TL, Childress JF. Principles of Biomedical Ethics. 5th ed. New York: Oxford University Press; 2001:57e103.

American Association of Orthopedic Surgeons. Code of Ethics and Profession- alism for Orthopedic Surgeons. http://www.aaos.org/about/papers/ethics/code. asp eris¸im 08.04.15. Upadhyay A, York S, Macaulay W, McGrory B, Robbennolt J, Bal BS. Medical malpractice in hip and knee arthroplasty. J Arthroplast. 2007;22(6 suppl 2):2e7.

Johnson MR, Singh JA, Stewart T, Gioe TJ. Patient understanding and satisfac- tion in informed consent for total knee arthroplasty: a randomized study. Arthritis Care Res (Hoboken). 2011;63:1048e1054.

Beresford-Cleary N, Halliday J, Biant L, Breusch S. Consent process for elective total hip and knee arthroplasty. J Orthop Surg. 2011;19:274e278.

Aydın ER, S¸enses EUROM, Akpınar A, Ersoy N. Ortopedide Aydınlatılmıs¸ Onama Ait Etik Sorunlar: Kocaeli'den Bir EUROrnek Turkiye Klinikleri. J Med Sci. 2011;31: e463.

A galar F, Çakmakçı M, Yorgancı K, ErgEURor G, Sayek _I. Hasta memnuniyeti- aydınlatma ve aydınlatılmıs¸ onam sorunu. Toplum Hekim Bülteni. 1996:11e12.

David M. Clarke autonomy, rationality and the wish to die. J Med Ethics. ;25:457e462. El-Wakeel H, Taylor GJ, Tate JJ. What do patients really want to know in an informed consent procedure? A questionnaire-based survey of patients in the bath area. U. K. J Med Ethics. 2006;32:612e616.

Newton-Howes PA, Bedford ND, Dobbs BR, et al. Informed consent: what do patients want to know? N. Z. Med J. 1998;111:340e342.

Aunan E. Writing information and consent prior to orthopedic surgery. Tidsskr Nor Laegeforen. 2003;25;123:2594e2596.

Vohra HA, Ledsham J, Vohra H, Patel RL. Issues concerning consent in patients undergoing cardiac surgery-the need for patient-directed improvements: a UK perspective. Cardiovasc Surg. 2003;11:64e69.

Feldman-Stewart D, Chammas S, Hayter C, Pater J, Mackillop WJ. An empirical approach to informed consent in ovarian cancer. J Clin Epidemiol. 1996;49: e1269.

Braddock C, Hudak PL, Feldman JJ, Bereknyei S, Frankel RM, Levinson W. Sur- gery is certainly one good option: quality and time-efŞciency of informed decision-making in surgery. J Bone Jt Surg Am. 2008;90:1830e1838.

Atrey A, Leslie I, Carvell J, et al. Standardised consent forms on the website of the British Orthopaedic Association. J Bone Jt Surg Br. 2008;90-B:422e423.

Bhattacharyya T, Yeon H, Harris MB. The medical-legal aspects of informed consent in orthopaedic surgery. J Bone Jt Surg Am. 2005;87:2395e2400.

Hassan M. Informed consent and the lawdan English legal perspective. Dig Dis. ;26:23e27. Egri M, Celbis O, Karaca M, Ozdemir B, Kok AN. The informed consent status for surgery patients in eastern Turkey: a cross-sectional study. Indian J Med Ethics. ;5:26e28. Department of Health. Good Practice in Consent Implementation Guide: Consent to Examination or Treatment. London: Department of Health Publications; 2001. http://www.health.wa.gov.au/mhareview/resources/documents/UK_DOH_ implementation_guide.pdf. Accessed 01.04.15.

Holt W. Informed Consent: A Process, Not a Piece of Paper. American Academy of Orthopaedic managing5.asp. eris¸im 08.04.15. Degerliyurt K, Gunsolley JC, Laskin DM. Informed consent: what do patients really want to know? J Oral Maxillofac Surg. 2010;68:1849e1852.

Ittenbach RF, Senft EC, Huang G, Corsmo JJ, Sieber JE. Readability and under- standing of informed consent among participants with low incomes: a pre- liminary report. J Empir Res Hum Res Ethics. 2015;10:444e448.

Miller MJ, Abrams MA, Earles B, Phillips K, McCleeary EM. Improving patient-provider communication for patients having surgery: patient per- ceptions of a revised health literacy-based consent process. J Patient Saf. ;7:30e38. Kusec S, Oreskovi c S, Skegro M, Korolija D, Busi c Z, Horzi c M. Improving comprehensionofinformedconsent.PatientEducCouns.2006;60: e300.

Bollschweiler E, Apitzsch J, Obliers R, et al. Improving informed consent of surgical patients using a multimedia-based program? Results of a prospective randomized multicenter study of patients before cholecystectomy. Ann Surg. ;248:205e211.