Roehrl, S. and Dendl, L. M. and Scharf, G. and Zeman, F. and Stroszczynski, C. and Schreyer, A. G. (2015) Informed Consent in Contrast-Enhanced CT: Understanding of Risks and Identification of Possible Prognostic Factors. ROFO-FORTSCHRITTE AUF DEM GEBIET DER RONTGENSTRAHLEN UND DER BILDGEBENDEN VERFAHREN, 187 (11). pp. 973-979. ISSN 1438-9029, 1438-9010
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Purpose: Aim of our study was to assess understanding of risks associated with intravascular application of contrast media in patients undergoing CT examination. We wanted to evaluate epidemiologic and socio-economic prognostic factors for a higher understanding of risks. Additionally, we evaluated a possible correlation between an extensive, outcome-oriented oral informed consent and better understanding of risks. Materials and Methods: 120 patients distributed in 2 study arms participated in this prospective study. In study arm I, the treating physician was not informed that his patients participated in a study whereas the physician in study arm II knew about the survey. After the informed consent we performed a standardized, semi-structured interview to enquire the 3 most frequent risks of intravascular application of contrast agents (anaphylactoid reactions, nephropathy and thyrotoxic crisis) and epidemiologic data. The understanding of the risks was evaluated using a 6 point scale. Results: Patients scored 3.73 points in study arm I and 4.93 points in arm II on average. The statistical difference between both study arms was highly significant (p < 0.001). In a combined logistic regression analysis, only "higher education" (p = 0.001) and participation in study armII (p = 0.001) showed a significant connection to a better understanding of risks. Conclusion: Patients profit from an outcome-oriented and individualized informed consent. Due to the significant correlation between educational level and understanding of risks, informed consent should be adjusted to the educational status of the individual patient, e.g. by using didactic aids or individualized information sheets.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | PARTICIPANTS; AWARENESS; informed consent; understanding of risks; contrast agent |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Röntgendiagnostik Medicine > Zentren des Universitätsklinikums Regensburg > Zentrum für Klinische Studien |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 07 May 2019 13:20 |
| Last Modified: | 07 May 2019 13:20 |
| URI: | https://pred.uni-regensburg.de/id/eprint/4550 |
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