Assessing informed consent in surgical patients at Queen Elizabeth Central Hospital in Blantyre, Malawi: a cross-sectional study

Abstract

Introduction
Informed consent is critical to medical practice, and a clearly outlined process that results in signing the consent form may improve the validity of the given consent. There is a paucity of studies in Malawi that have assessed the informed consent process in surgical patients.
Aim: To assess the informed consent process for patients undergoing surgery at QECH in Malawi.
Methods
A cross-sectional quantitative descriptive study was conducted among postoperative patients in the adult surgical wards at QECH through face-to-face interviews. The calculated sample size was 235. A consecutive sampling technique was used. Those below 18 years and those who didn’t or couldn’t consent were excluded. Data was entered and analyzed in Microsoft Excel 2016 and IBM SPSS 25.0. The level of significance was considered as P<0.05.
Results
A total of 222 patients were interviewed. The age range was 21 to 75 years, with a median of 38.5. Two hundred and twelve (95%) patients signed a consent form before surgery, and 21 (9%) knew the content of the form. Most patients, 100 (47%) had a primary school education, and 156 (70%) could read and write. Those with secondary or tertiary education were more likely to want to ask a question given the opportunity (OR 2.82, p= 0.0012), but there was no significant difference in the likelihood of being given time to ask questions between the two groups who had primary and no formal education vs those who had secondary and tertiary education (OR 1.4, p=0.3367)
Conclusion
This study highlights the necessity of employing effective communication strategies during the consent process for surgical procedures and the need to tailor the consent form to the patient’s education level.