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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
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 t...
Autores principales: | , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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BioMed Central
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9650904/ https://www.ncbi.nlm.nih.gov/pubmed/36368980 http://dx.doi.org/10.1186/s12886-022-02652-z |
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author | Ullrich, Marlies Findl, Oliver Kefer, Katharina Döller, Birgit Varsits, Ralph Hienert, Julius Hirnschall, Nino |
author_facet | Ullrich, Marlies Findl, Oliver Kefer, Katharina Döller, Birgit Varsits, Ralph Hienert, Julius Hirnschall, Nino |
author_sort | Ullrich, Marlies |
collection | PubMed |
description | 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. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12886-022-02652-z. |
format | Online Article Text |
id | pubmed-9650904 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-96509042022-11-15 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 Ullrich, Marlies Findl, Oliver Kefer, Katharina Döller, Birgit Varsits, Ralph Hienert, Julius Hirnschall, Nino BMC Ophthalmol Research 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. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12886-022-02652-z. BioMed Central 2022-11-11 /pmc/articles/PMC9650904/ /pubmed/36368980 http://dx.doi.org/10.1186/s12886-022-02652-z Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Research Ullrich, Marlies Findl, Oliver Kefer, Katharina Döller, Birgit Varsits, Ralph Hienert, Julius Hirnschall, Nino 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 |
title | 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 |
title_full | 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 |
title_fullStr | 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 |
title_full_unstemmed | 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 |
title_short | 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 |
title_sort | evaluation of the efficacy of a supplemental computer-based tutorial to enhance the informed consent process for cataract surgery: an exploratory randomized clinical study |
topic | Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9650904/ https://www.ncbi.nlm.nih.gov/pubmed/36368980 http://dx.doi.org/10.1186/s12886-022-02652-z |
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