Assessing the Process of Written Informed Consent for Surgical Procedures among Inpatients: A Cross-sectional Study from a Tertiary Care Teaching Hospital in Southern India
Correspondence Address :
Dr. Imaad Mohammed Ismail,
Professor, Department of Community Medicine, Yenepoya Medical College, Deralakatte, Mangaluru-575018, Karnataka, India.
E-mail: imaad82@yahoo.com
Introduction: Informed Consent (IC) is a decision-making process wherein patients are provided with all necessary information regarding treatment to make an uncoerced, educated choice. There are gaps in the implementation of the IC process that need to be identified and addressed.
Aim: To estimate the proportion of patients/surrogates who read, understood, and signed the IC form before undergoing surgical procedures; to identify the different healthcare team members involved in explaining the IC form; to evaluate the extent to which different components of the IC form were explained to patients/surrogates; and to determine the influence of the IC form on surgical decision-making, and the overall satisfaction with the IC process.
Materials and Methods: This cross-sectional study was conducted at a tertiary care hospital in the Dakshina Kannada District of Southern India from April 2020 to March 2021. It included 100 adult patients admitted to the postsurgical wards of general surgery, orthopaedics, obstetrics and gynaecology, otorhinolaryngology, and ophthalmology. Ethical clearance was obtained from the Institutional Ethics Committee. The parameters studied included socio-demographic variables, administration of the IC form, details on the person explaining the IC form along with its content, and the influence of the IC form on decision-making, as well as overall satisfaction with the IC process. Data were collected using a predesigned questionnaire and analysed using descriptive statistics in Statistical Package for the Social Sciences (SPSS) version 27.0. Categorical variables were presented as frequencies and proportions, whereas continuous variables were presented as means and standard deviations.
Results: All participants received the IC form; however, only 21% read, understood, and signed it. The explanation of the IC form was given to 59% of the patients, with only 15% of these explanations provided by the treating surgeon. The components of the IC form, such as the surgical procedure and its benefits, were explained to the majority of the patients; however, the risks of the surgical procedure and alternative options were explained to only 53% and 7% of patients, respectively. The IC form had a minor influence on surgical decision-making for 61% of patients, and 43% expressed satisfaction with the IC process.
Conclusion: The study revealed that the implementation of IC was inadequate. Surgeons should provide and explain the IC form well in advance, allowing time for patients to read, understand, and clarify their doubts. Hospital Ethics Committees need to enforce strict adherence to IC guidelines to ensure informed decision-making.b
Autonomy, Consent forms, Evaluation, Health communication, Medical ethics, Patient rights, Surgical consent
DOI: 10.7860/JCDR/2024/74608.20219
Date of Submission: Jul 30, 2024
Date of Peer Review: Aug 23, 2024
Date of Acceptance: Sep 25, 2024
Date of Publishing: Oct 01, 2024
AUTHOR DECLARATION:
• Financial or Other Competing Interests: None
• Was Ethics Committee Approval obtained for this study? Yes
• Was informed consent obtained from the subjects involved in the study? Yes
• For any images presented appropriate consent has been obtained from the subjects. NA
PLAGIARISM CHECKING METHODS:
• Plagiarism X-checker: Jul 31, 2024
• Manual Googling: Aug 26, 2024
• iThenticate Software: Sep 24, 2024 (9%)
ETYMOLOGY: Author Origin
EMENDATIONS: 7
- Emerging Sources Citation Index (Web of Science, thomsonreuters)
- Index Copernicus ICV 2017: 134.54
- Academic Search Complete Database
- Directory of Open Access Journals (DOAJ)
- Embase
- EBSCOhost
- Google Scholar
- HINARI Access to Research in Health Programme
- Indian Science Abstracts (ISA)
- Journal seek Database
- Popline (reproductive health literature)
- www.omnimedicalsearch.com