An Evaluation of the Efficacy of a Supplemental Computer-based Tutorial to Enhance the Informed Consent Process for Cataract Surgery: an Exploratory Randomized Clinical Study

Overview

Journal BMC Ophthalmol

Publisher Biomed Central

Specialty Ophthalmology

Date 2022 Nov 11

PMID 36368980

Authors

Marlies Ullrich

Oliver Findl

Katharina Kefer

Birgit Doller

Ralph Varsits

Julius Hienert

Nino Hirnschall

Affiliations

Soon will be listed here.

Abstract

Background: To assess whether informing patients with a computer-based tutorial in addition to standard informed consent influences the patient's attitude towards surgery and increases patient's knowledge.

Methods: In this prospective, exploratory, randomized clinical study, patients scheduled for their first eye cataract surgery were randomly allocated to two groups, receiving standard face-to-face informed consent (control group) or additionally using an interactive computer-based tool (CatInfo) containing an audiovisual presentation about cataract and its treatment (study group). Cataract-related knowledge and decisional confidence (decisional conflict scale (DCS)) were assessed as well as one-month postoperatively decisional regret (decision regret scale (DRS)) and willingness to exchange face-to-face discussion time for the use of such a tool.

Results: The study comprised 134 patients, 64 patients in the study group and 70 in the control group. Patients in the study group answered more questions correctly, 16.3 ± 2.0 (median 16.5, 11.0-19.0) versus 15.5 ± 1.9 (median 16.0, 8.0-19.0; p = 0.01). Patients showed a high decisional confidence with a study group mean DCS score of 92.4 ± 9.8 (median 96.9, 65.6-100) and control group score of 91.6 ± 10.9 (median 95.3, 43.3-100; p = 0.52). Mean DRS score in the study group was 2.5 ± 8.0 (median 0, 0-40) and 4.3 ± 12.5 (median 0, 0-75) in the control group (p = 0.14). Of study group patients 23 (67.6%) were willing to trade time, on average 158 ± 180 s (median 120 s, 45-900). Satisfaction with the tool was high with a mean of 9.1 ± 1.3 out of 10 (median 9.7, 5.0-10).

Conclusions: Cataract-related knowledge was generally good, with slightly higher scores in the study group. In both groups, decisional confidence was high and regret after surgery was low. A tendency towards slightly higher decisional confidence and lower regret was found in the study group, although these differences were not statistically significant. Additional use of an interactive computer-based tool may prove useful in the informed consent process in a high-volume cataract outpatient setting.

Trial Registration: ClinicalTrials.gov, NCT04975126. Retrospectively registered - July 23, 2021.

References

Shukla A, Daly M, Legutko P . Informed consent for cataract surgery: patient understanding of verbal, written, and videotaped information. J Cataract Refract Surg. 2011; 38(1):80-4. DOI: 10.1016/j.jcrs.2011.07.030. View

Ali N . A decade of clinical negligence in ophthalmology. BMC Ophthalmol. 2007; 7:20. PMC: 2225389. DOI: 10.1186/1471-2415-7-20. View

OConnor A . Validation of a decisional conflict scale. Med Decis Making. 1995; 15(1):25-30. DOI: 10.1177/0272989X9501500105. View

Brezis M, Israel S, Weinstein-Birenshtock A, Pogoda P, Sharon A, Tauber R . Quality of informed consent for invasive procedures. Int J Qual Health Care. 2008; 20(5):352-7. DOI: 10.1093/intqhc/mzn025. View

Vo T, Ngai P, Tao J . A randomized trial of multimedia-facilitated informed consent for cataract surgery. Clin Ophthalmol. 2018; 12:1427-1432. PMC: 6089606. DOI: 10.2147/OPTH.S150670. View

Deyo R, Cherkin D, Weinstein J, Howe J, Ciol M, Mulley Jr A . Involving patients in clinical decisions: impact of an interactive video program on use of back surgery. Med Care. 2000; 38(9):959-69. DOI: 10.1097/00005650-200009000-00009. View

Edmunds M, Barry R, Denniston A . Readability assessment of online ophthalmic patient information. JAMA Ophthalmol. 2013; 131(12):1610-6. DOI: 10.1001/jamaophthalmol.2013.5521. View

Degner L, Sloan J . Decision making during serious illness: what role do patients really want to play?. J Clin Epidemiol. 1992; 45(9):941-50. DOI: 10.1016/0895-4356(92)90110-9. View

Bhan A, Dave D, Vernon S, Bhan K, Bhargava J, Goodwin H . Risk management strategies following analysis of cataract negligence claims. Eye (Lond). 2004; 19(3):264-8. DOI: 10.1038/sj.eye.6701493. View

10.

Huang G, Fang C, Agarwal N, Bhagat N, Eloy J, Langer P . Assessment of online patient education materials from major ophthalmologic associations. JAMA Ophthalmol. 2015; 133(4):449-54. DOI: 10.1001/jamaophthalmol.2014.6104. View

11.

Degner L, Sloan J, Venkatesh P . The Control Preferences Scale. Can J Nurs Res. 1998; 29(3):21-43. View

12.

Kiss C, Richter-Mueksch S, Stifter E, Diendorfer-Radner G, Velikay-Parel M, Radner W . Informed consent and decision making by cataract patients. Arch Ophthalmol. 2004; 122(1):94-8. DOI: 10.1001/archopht.122.1.94. View

13.

Zhang M, Haq Z, Braithwaite E, Simon N, Riaz K . A randomized, controlled trial of video supplementation on the cataract surgery informed consent process. Graefes Arch Clin Exp Ophthalmol. 2019; 257(8):1719-1728. PMC: 7846231. DOI: 10.1007/s00417-019-04372-5. View

14.

Tipotsch-Maca S, Varsits R, Ginzel C, Vecsei-Marlovits P . Effect of a multimedia-assisted informed consent procedure on the information gain, satisfaction, and anxiety of cataract surgery patients. J Cataract Refract Surg. 2016; 42(1):110-6. DOI: 10.1016/j.jcrs.2015.08.019. View

15.

Kraushar M, Turner M . Medical malpractice litigation in ophthalmology: the New Jersey experience. Ophthalmic Surg. 1986; 17(10):671-4. View

16.

Brehaut J, OConnor A, Wood T, Hack T, Siminoff L, Gordon E . Validation of a decision regret scale. Med Decis Making. 2003; 23(4):281-92. DOI: 10.1177/0272989X03256005. View

17.

Tomkins C . Over 120 years of defending ophthalmologists. Br J Ophthalmol. 2006; 90(9):1084-5. PMC: 1857366. DOI: 10.1136/bjo.2006.097311. View

18.

Newman-Casey P, Ravilla S, Haripriya A, Palanichamy V, Pillai M, Balakrishnan V . The Effect of Counseling on Cataract Patient Knowledge, Decisional Conflict, and Satisfaction. Ophthalmic Epidemiol. 2015; 22(6):387-93. PMC: 4774860. DOI: 10.3109/09286586.2015.1066016. View

19.

Zhang Y, Ruan X, Tang H, Yang W, Xian Z, Lu M . Video-Assisted Informed Consent for Cataract Surgery: A Randomized Controlled Trial. J Ophthalmol. 2017; 2017:9593631. PMC: 5278206. DOI: 10.1155/2017/9593631. View

20.

Heim N, Faron A, Fuchs J, Martini M, Reich R, Loffler K . [Comprehensibility of online-based patient education material in ophthalmology]. Ophthalmologe. 2016; 114(5):450-456. DOI: 10.1007/s00347-016-0367-9. View