The quality of informed consent from nurses’ and hospitalized patients’ points of view in Iran: A cross-sectional study

Informed consent constitutes a fundamental aspect of patient rights. How informed consent is procured significantly influences patient satisfaction during the treatment and care continuum and contributes to decreased mortality associated with high-risk medical interventions. The primary objective of this study is to assess the quality of informed consent from the perspectives of both nurses and hospitalized patients within the educational medical centers of Ardabil, Iran. This research employs a cross-sectional design involving a sample of 420 individuals drawn from the target population, comprising 210 patients and 210 nurses. Stratified random sampling was utilized for participant selection, with data collection occurring between February and July 2024. The instrument for data gathering consisted of a two-part questionnaire; the first section captured demographic information of both patients and nurses, while the second section focused on evaluating the quality of informed consent as perceived by nurses and patients. Data analysis was performed using inferential statistical methods, including independent t-test, one-sample t-test, the Chi-square test, and analysis of variance (ANOVA) test. The mean informed consent quality score was higher in nurses compared to patients (107.44 [standard deviation [SD]=14.85] vs. 103.84 [SD=17.53], P<0.05). Results of the one-sample t-test indicated that the quality of obtained informed consent from patients and nurses' viewpoints was lower than the expected amount in information provision, understanding the information, voluntary participation, signing the consent form, and the interaction between the patient and the doctor. At the same time, the score assigned to decision-making competence was higher than the expected amount. The general quality of obtaining informed consent was unfavorable from nurses’ and patients’ points of view. It is recommended that the process of obtaining informed consent be modified and that transparency and capacity in all the stages of obtaining informed consent be improved.