How informed is informed consent?—Evaluating the quality of informed consent among surgical patients in a tertiary care hospital in Nepal

by Sunil Basukala, Oshan Shrestha, Niranjan Thapa, Sagun Karki, Ayushma Pandit, Bikash Bikram Thapa, Anup Thapa

Informed consent-taking is a part of clinical practice that has ethical and legal aspects attached to it. This protects the autonomy of the patients by providing complete information regarding the rationale, modality, potential risks, benefits, and alternatives of the planned procedure to the patients. This enables the patients to make the right decision for themselves and their care. This study aims to find out if the informed consent-taking process has ensured the active participation of the patients or the next of kin in the decision-making.

This is a prospective cross-sectional study conducted in a military healthcare institution among patients undergoing major surgical procedures from July 2022 to October 2022. Ethical clearance was obtained before the commencement of this study. A structured questionnaire was prepared, and the collected data was refined in Excel and imported into SPSS for analysis.

A total of 350 individuals of mean age 47.95 ± 16.057 years were part of this study. The majority of the respondents were married, literate, and family by beneficiary category. All of the respondents received and signed the consent form. About 77% of the respondents read it completely, and 95.4% of them reported that it was understandable. The majority of the patients did not know who was going to perform the surgery, the alternatives to the planned treatment, the benefits of the surgery, or the outcome of non-treatment. On the patient satisfaction scale, 16.28% of the participants agreed that they were satisfied with the informed consent-taking process.

Deficiencies in the informed consent-taking process were the lack of dissemination of adequate information on the nature, duration, pros and cons, post-operative state, and alternative of the planned procedure. A well-structured format of the consent form that is specific to a particular procedure should be adopted, and various alternatives to it must be disseminated to the patient or the next of kin to improve the quality of the informed consent-taking process.