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

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.

Keywords: Audio-visual tutorial; Cataract surgery; Informed consent; Patient education.

Conflict of interest statement

The authors declare that they have no competing interests.

© 2022. The Author(s).

Figures

Fig. 1

Degner control preferences scale: Panel A – favorite role of the patient: A—most active patient role, C—collaborative decision, E—most passive patient role, n = 82; Panel B – ordinal scale: 1—the most active role in the decision; 11—most passive role; only transitive permutations counted, n = 53 (CPS = control preferences scale)

Fig. 2

Knowledge on cataract and cataract surgery at the pre-assessment visit measured by correctly answered MCQs; maximum score 19 points (dashed line), n = 134 (MCQ = multiple-choice question)

Fig. 3

Decisional conflict scale; results shown here as decisional confidence, 0—lowest decisional confidence, 100—highest decisional confidence, n = 131 (DCS = Decisional conflict scale)

Fig. 4

Trade-off times in categories of one minute; 32.4% were not willing to trade time (trade-off time 0 s), 67.6% were willing to trade time, one patient was willing to trade 15 min (not shown in bar chart), n = 34