Informed consent research at a tertiary hospital: How impactful is competency in simpler versus standard consent forms for intravitreal injection therapy?

Hamidu Hamisi Gobeka 1 * , Yiğit Şenol 2, Saadet Alijanli 1, Mustafa Doğan 1, İbrahim Ethem Ay 1
More Detail
1 Department of Ophthalmology, Faculty of Medicine, Afyonkarahisar Health Sciences University, Afyonkarahisar, Turkey
2 Department of Public Health, Faculty of Medicine, Afyonkarahisar Health Sciences University, Afyonkarahisar, Turkey
* Corresponding Author
J CLIN MED KAZ, Volume 20, Issue 1, pp. 18-23. https://doi.org/10.23950/jcmk/12897
OPEN ACCESS 1071 Views 661 Downloads
Download Full Text (PDF)

ABSTRACT

Aim: To compare the impact of competency in intravitreal injection therapy (IVIT)-related simpler versus standard consent forms (CFs).
Material and methods: Four hundred patients scheduled for IVIT in a tertiary hospital were enrolled between April 1, 2022 and June 30, 2022. These patients were eligible for the study if they had their first IVIT in one eye; those scheduled for IVIT in the other eye were not. Data, including age, gender, educational level, whether the patient was admitted alone or with a companion, and prior IVIT status were collected. A trained clinic secretary first gave the patients the commonly used standard CFs, followed by simpler CFs.
Results: The mean age was 66.10±9.90 years. 93.80% had previously received IVIT. 53.80% of the patients consented on their own. While 98.00% consented without reading standard CFs, 56.00% consented after reading simpler CFs (p<0.001). The need for IVIT-related extra information and the desire against having IVIT were significantly higher in simpler than standard CFs (p<0.001). 5.00% of those who approved IVIT without reading both forms were illiterate, and 29.20% had vision issues. The probability of simpler CF reading increased by 4.653 and 7.510 times in high school and university graduates, respectively, relative to primary school graduates.
Conclusion: Simpler CFs had a much higher reading rate, which was linked to a higher rate of patients opting against IVIT. In medical fields like ophthalmology, where many procedures and research are performed, ethically approved informed consent requires consideration of patients' education and prior treatment experience.
Keywords: Consent forms, educational level, ethics, intravitreal injection therapy, readability

CITATION

Gobeka HH, Şenol Y, Alijanli S, Doğan M, Ay İE. Informed consent research at a tertiary hospital: How impactful is competency in simpler versus standard consent forms for intravitreal injection therapy?. J CLIN MED KAZ. 2023;20(1):18-23. https://doi.org/10.23950/jcmk/12897

REFERENCES

  • Joffe S, Cook EF, Cleary PD, Clark JW, Weeks JC. Quality of informed consent: a new measure of understanding among research subjects. J Natl Cancer Inst. 2001;93(2):139-147. https://doi.org/10.1093/jnci/93.2.139
  • Sreenivasan G. Does informed consent to research require comprehension? Lancet. 2003;362(9400):2016-2018. https://doi.org/10.1016/S0140-6736(03)15025-8
  • International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Integrated addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2). Current Step 4 version. Available from: www.ich.org/products/guidelines/efficacy/article/efficacy-guidelines.html Date last updated: November 9, 2016. Date last accessed: March 22, 2018.
  • Hall DE, Prochazka AV, Fink AS. Informed consent for clinical treatment. CMAJ. 2012;184(5):533-540. https://doi.org/10.1503/cmaj.112120
  • Joffe S, Cook EF, Cleary PD, Clark JW, Weeks JC. Quality of informed consent in cancer clinical trials: a cross-sectional survey. Lancet. 2001;358(9295):1772-1777. https://doi.org/10.1016/S0140-6736(01)06805-2
  • Ay IE, Doğan M. An Evaluation of the Comprehensibility Levels of Ophthalmology Surgical Consent Forms. Cureus. 2021;13(7):e16639. https://doi.org/10.7759/cureus.16639
  • Mandava A, Pace C, Campbell B, Emanuel E, Grady C. The quality of informed consent: mapping the landscape. A review of empirical data from developing and developed countries. J Med Ethics. 2012;38(6):356-365. https://doi.org/10.1136/medethics-2011-100178
  • Bothun LS, Feeder SE, Poland GA. Readability of Participant Informed Consent Forms and Informational Documents: From Phase 3 COVID-19 Vaccine Clinical Trials in the United States. Mayo Clin Proc. 2021;96(8):2095-2101. https://doi.org/10.1016/j.mayocp.2021.05.025
  • Mathenge W. Age-related macular degeneration. Community Eye Health. 2014;27(87):49-50.
  • Song P, Xu Y, Zha M, Zhang Y, Rudan I. Global epidemiology of retinal vein occlusion: a systematic review and meta-analysis of prevalence, incidence, and risk factors. J Glob Health. 2019;9(1):010427. https://doi.org/10.7189/jogh.09.010427
  • International Diabetes Federation. Diabetes atlas. 6th ed. [Last accessed on 2017 Mar 20]. Available from: https://www.idf.org/e-library/epidemiology./diabetes-atlas/19-atlas-6th-edition.html.
  • Wong WL, Su X, Li X, Cheung CM, Klein R, Cheng CY, et al. Global prevalence of age-related macular degeneration and disease burden projection for 2020 and 2040: a systematic review and meta-analysis. Lancet Glob Health. 2014;2(2):e106-116. https://doi.org/10.1016/S2214-109X(13)70145-1
  • Pascolini D, Mariotti SP. Global estimates of visual impairment: 2010. Br J Ophthalmol. 2012;96(5):614-8. https://doi.org/10.1136/bjophthalmol-2011-300539
  • Maca SM, Abela-Formanek C, Kiss CG, Sacu SG, Benesch T, Barisani-Asenbauer T. Intravitreal triamcinolone for persistent cystoid macular oedema in eyes with quiescent uveitis. Clin Exp Ophthalmol. 2009;37(4):389-396. https://doi.org/10.1111/j.1442-9071.2009.02033.x
  • Orski M, Gawęcki M. Current Management Options in Irvine-Gass Syndrome: A Systemized Review. J Clin Med. 2021;10(19):4375. https://doi.org/10.3390/jcm10194375
  • Moustafa GA, Moschos MM. Intravitreal aflibercept (Eylea) injection for cystoid macular edema secondary to retinitis pigmentosa - a first case report and short review of the literature. BMC Ophthalmol. 2015;15:44. https://doi.org/10.1186/s12886-015-0033-z
  • Bezirci B, Yılmaz AE. Metinlerin okunabilirliğinin ölçülmesi üzerine bir yazılım kütüphanesi ve Türkçe için yeni bir okunabilirlik ölçütü (A software library for assessing text readability and a new readability criterion for Turkish). DEÜ Fen ve Mühendislik Derg. 2010;12(3):49–62.
  • Ateşman E. Türkçede okunabilirliğin ölçülmesi (Measuring readability in Turkish). Dil Derg. 1997;58:71–74.
  • Beauchamp TL, Childress JF. Principles of Biomedical Ethics, Third Edition. New York: Oxford University Press, 1989:1–470.
  • del Carmen MG, Joffe S. Informed consent for medical treatment and research: a review. Oncologist. 2005;10(8):636-641. https://doi.org/10.1634/theoncologist.10-8-636
  • Faden RR, Beauchamp TL. A History and Theory of Informed Consent. New York: Oxford University Press, 1986:1–392
  • Anderson OA, Wearne IM. Informed consent for elective surgery--what is best practice? J R Soc Med. 2007;100(2):97-100. https://doi.org/10.1177/014107680710000226
  • Emanuel EJ, Joffe S. Ethics in oncology. In: Bast RC, Kufe DW, Pollock RE et al., eds. Cancer Medicine, Fifth Edition. Hamilton: B.C. Decker, Inc., 2000:1145–1163
  • Meisel A, Roth LH, Lidz CW. Toward a model of the legal doctrine of informed consent. Am J Psychiatry. 1977;134(3):285-289. https://doi.org/10.1176/ajp.134.3.285
  • Vo TA, Ngai P, Tao JP. A randomized trial of multimedia-facilitated informed consent for cataract surgery. Clin Ophthalmol. 2018;12:1427-1432. https://doi.org/10.2147/OPTH.S150670
  • Enders C, Ryszka J, Lang GE, Strametz R, Lang GK, Werner JU. Intravitreale Injektionen – welche Informationen aus dem Aufklärungsgespräch bleiben Patienten im Gedächtnis? [Patient's Knowledge after Informed Consent for Intravitreal Injections]. Klin Monbl Augenheilkd. 2021;238(6):721-726. German. https://doi.org/10.1055/a-0886-6507
  • Hadden KB, Prince LY, Moore TD, James LP, Holland JR, Trudeau CR. Improving readability of informed consents for research at an academic medical institution. J Clin Transl Sci. 2017;1(6):361-365. https://doi.org/10.1017/cts.2017.312
  • Morrow G, Gootnick J, Schmale A. A simple technique for increasing cancer patients knowledge of informed consent to treatment. Cancer. 1978;42(2):793-799. https://doi.org/10.1002/1097-0142(197808)42:2<793::aid-cncr2820420252>3.0.co;2-c
  • Berg JW, Appelbaum PS, Lidz CW and Parker LS: Informed Consent: Legal Theory and Clinical Practice. 2nd Edition, Fair Lawn, NJ, Oxford University Press. 2001:1–340. https://doi.org/10.1093/oso/9780195126778.003.0017