[Analysis of documented informed consent forms for computed tomography : Completeness and data quality in four clinics]

Abstract

Background: Before performing a medical procedure, such as a computed tomography, an obligatory informed consent of the patient and its detailed documentation is necessary.

Methods: A total of 1424 informed consent forms for contrast-enhanced computed tomography from four clinics with different healthcare levels were analyzed. Informed consent forms were evaluated related to completeness, legibility and quality.

Results: In all, 1110 (77.9%) informed consent forms were sufficiently completed, 267 patients (18.8%) answered the form incompletely and 47 patients (3.3%) returned it without answering a question. Handwritten comments were found in 1391 (97.7%) cases. Thereof, 1329 (93.3%) were graded as detailed comments and 62 (4.4%) as less detailed comments. These comments were well legible in 675 (47.4%) cases, 558 (39.2%) informed consents showed limited legibility and in 158 (11.1%) more than 50% of the comments were unreadable. Signatures were complete in 1374 (96.5%) informed consent forms.

Conclusion: The results show a better quality and documentation of informed consent forms for computed tomography obtained by radiology residents compared to radiological specialists. Compared to the radiologists, the non-radiologists performed significantly worse. The establishment of videos and use of digital informed consent forms could provide a possible solution.

Keywords: Documentation; Handwritten comments; Legibility; Patient briefing; Signature.