Alternative Means of Informed Consent in Cardiology: Strategies and Effectiveness in a Group of Italian Patients
Abstract
:1. Introduction
1.1. Informed Consent in Medicine
1.2. Limits in the Implementation of Traditional Informed Consent and Current Alternatives
1.3. Informed Consent in Cardiology
2. Objectives
- To verify patients’ objective understandings of the information received by comparing the results of questionnaires given to the two groups—one whose members were given a traditional paper-based informed consent (control group) and one whose members were given a video-based informed consent (experimental group);
- To analyse the sample’s perceptions of their own subjective understandings of the information contained in the informed consent they received, verifying the presence of any differences between the experimental and the control group;
- To verify the perception of usefulness of the two different kinds of informed consent by the participants in both groups;
- To analyse the variables of anxiety, stress and depression in the two groups to assess whether video-based informed consent, since it presents information in a more direct and explicit way, has a different impact on patients’ psychological experiences than traditional paper-based consent.
3. Materials and Methods
3.1. Participants
3.2. Data Collection and Analysis
4. Results
5. Discussion
6. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Measure | EG | CG | Test t | Mann–Whitney Test | ||||||
---|---|---|---|---|---|---|---|---|---|---|
M | SD | Med | M | SD | Med | t (38) | p-Value | U | p-Value | |
Questionnaire total score | 6.85 | 0.37 | 7.00 | 4.85 | 1.14 | 4.50 | 7.49 | <0.001 | 29 | <0.001 |
Comprehension score | 4.60 | 0.60 | 5.00 | 3.25 | 1.41 | 4.00 | 3.94 | <0.001 | 83 | 0.001 |
Usefulness score | 4.90 | 0.31 | 5.00 | 3.55 | 0.83 | 4.00 | 6.85 | <0.001 | 31 | <0.001 |
Measure | EG | CG | Test t | Mann–Whitney Test | ||||||
---|---|---|---|---|---|---|---|---|---|---|
M | SD | Med | M | SD | Med | t (38) | p-Value | U | p-Value | |
dass_depression | 6.40 | 5.62 | 6.00 | 7.25 | 5.55 | 7.00 | −0.48 | 0.633 | 181 | 0.606 |
dass_anxiety | 9.00 | 4.32 | 9.50 | 9.65 | 5.00 | 10.00 | −0.44 | 0.662 | 183 | 0.635 |
dass_stress | 12.10 | 5.39 | 12.00 | 10.50 | 5.99 | 11.50 | 0.89 | 0.380 | 167 | 0.371 |
dass_total | 27.50 | 13.10 | 28.50 | 27.40 | 14.43 | 28.00 | 0.02 | 0.982 | 197 | 0.935 |
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Testoni, I.; Ronconi, L.; Lampis, F.; Iacona, E.; Zammarrelli, J.; Pompele, S.; Valle, R.; Boscolo, G.; De Leo, D. Alternative Means of Informed Consent in Cardiology: Strategies and Effectiveness in a Group of Italian Patients. Behav. Sci. 2023, 13, 430. https://doi.org/10.3390/bs13050430
Testoni I, Ronconi L, Lampis F, Iacona E, Zammarrelli J, Pompele S, Valle R, Boscolo G, De Leo D. Alternative Means of Informed Consent in Cardiology: Strategies and Effectiveness in a Group of Italian Patients. Behavioral Sciences. 2023; 13(5):430. https://doi.org/10.3390/bs13050430
Chicago/Turabian StyleTestoni, Ines, Lucia Ronconi, Francesca Lampis, Erika Iacona, Josephine Zammarrelli, Sara Pompele, Roberto Valle, Gabriele Boscolo, and Diego De Leo. 2023. "Alternative Means of Informed Consent in Cardiology: Strategies and Effectiveness in a Group of Italian Patients" Behavioral Sciences 13, no. 5: 430. https://doi.org/10.3390/bs13050430
APA StyleTestoni, I., Ronconi, L., Lampis, F., Iacona, E., Zammarrelli, J., Pompele, S., Valle, R., Boscolo, G., & De Leo, D. (2023). Alternative Means of Informed Consent in Cardiology: Strategies and Effectiveness in a Group of Italian Patients. Behavioral Sciences, 13(5), 430. https://doi.org/10.3390/bs13050430