Assessment of the Factors Influencing the Patient's Comprehension of the Informed Consent to Interventional Pain Procedures.

Abstract

Background: Informed consent is the first step of every medical procedure and is considered a standard of care for patients undergoing medical interventions. Our study seeks to evaluate patients' understanding of the procedure they consented to and the factors affecting the degree of understanding.

Methods: In this cross-sectional study, we used an anonymous postprocedural questionnaire to assess our patients' understanding of the procedure being performed and their level of satisfaction. It was conducted between June 2021 and January 2022 on every consenting patient who declined English interpreter services and was undergoing a first elective lumbar epidural steroid injection.

Results: The mean age of 201 subjects was 57.3 (23-90) years, with a race distribution of Black (44.3%), White (31.8%), and other races (23.9%). 15.9% of our subjects worked in the medical field. Older age and patients identified as Black and other races had a positive correlation with the propensity to predict a poor understanding of consent. This study failed to demonstrate any difference in understanding of informed consent content between the different subgroups when stratified by assigned sex at birth, level of education, and profession. Patients' expectation from the treatment was classified as desperate (will take any help they can) in 78 patients (38.8%), feeling hopeful (expecting partial improvement in their symptoms) in 52 patients (25.9%), and being optimistic (will obtain full recovery from this injection) in 71 patients (35.3%). 192 patients (95.5%) were very satisfied with the consent process. Seven patients (3.5%) stated that they wanted more information, and 2 patients (1.0%) did not understand the explanation. 180 patients (89.6%) were satisfied with the overall experience, while 21 patients (10.4%) were not. The Wilks test (likelihood-ratio test) resulted in a p value of 0.023 and was deemed statistically significant for a relationship between understanding of consent and the satisfaction of the patient from the procedure.

Conclusions: Although patients carry a variable expectation of procedures, most patients in our pain clinic have a high level of satisfaction despite having a poor understanding of the procedure provided via informed consent. Although our patients' level of objective comprehension is low, those with a better understanding of the procedure tend to have a more satisfactory experience.