Practice Patterns of Informed Consent Before Contrast Dye Administration in Spine Radiology: A Cross-Sectional Study

Background: Contrast media are frequently used in spine radiology for improving the quality of images obtained by means of magnetic resonance imaging (MRI and computed tomographyCT scans. However, contrast media can cause allergic reactions, nephrotoxicity and, more rarely, other systemic complications. For this reason, administration of contrast media requires prior informed consent which must be provided in accordance with the ethical principles of medical practice and with the relevant legal requirements. In clinical practice, however, there is considerable variability in the way in which informed consent is obtained and recorded. the objective is to assess practice patterns of informed consent before contrast dye administration in spine radiology and to assess compliance with established standards. Material and Methods: A hospital-based cross-sectional study was conducted to include 312 patients of spine imaging using contrast dye. The data were obtained by using a structured questionnaire and by auditing the patients’ medical records. The variables studied were type of consent, information given to the patient, patients’ understanding and documentation. The data thus obtained were analyzed using descriptive and inferential statistics. Results: Among the patients studied, 58.3% of them received a written consent for the administration of contrast dye. However, 41.7% of them were given consent verbally. Furthermore, 46.8% of patients stated that they were completely informed of the risks and alternatives of the use of contrast dye for their spinal images. Documentation of pre-contrast assessment of renal function was found in 72.1% of cases. The presence of institutional protocols was significantly associated with the quality of consent (p value < 0.05). Conclusion: Large numbers of patients undergoing contrast-enhanced spine imaging are not receiving adequate informed consent. Efforts to standardize the processes of obtaining and documenting informed consent, as well as improving patient education, are required to address these issues and improve the safety of patients.

Keywords: Spine radiology, contrast media, informed consent, MRI, patient safety, cross-sectional study.