Trial reportBMC ophthalmology2022
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.
Trial report in BMC ophthalmology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04975126 (Computer-based Tutorial as Supportive Means to Enhance Quality and Efficiency of the Informed Consent Process for Cataract Surgery), which is not on this map. Not yet cited in PubMed.
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The trial behind it
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Computer-based Tutorial as Supportive Means to Enhance Quality and Efficiency of the Informed Consent Process for Cataract Surgery: an Exploratory Study
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Authors and funding
7 authors.
Funding
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Abstract
backgroundTo 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.
methodsIn 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.
resultsThe 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).
conclusionsCataract-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 registrationClinicalTrials.gov, NCT04975126. Retrospectively registered - July 23, 2021.
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