Informed Consent for Surgical Procedures; Are Ethics Observed? A Cross-Sectional Study at Tertiary Teaching Hospitals, Among Doctors and Elective Post - Operative Patients

Abstract

Background: Consent can simply be defined as permission for something to happen or agreement to do something. Important aspect of consent is that a patient voluntarily takes part in the treatment or participation in research. Informed consent can be defined as willingly and revocable agreement by a mentally competent person to participate in a therapeutic procedure or research study, based on adequate understanding of its nature, intention and implication. In surgical consent the process involves but is not limited to disclosing to the person the nature of diagnosis, risks and benefits of the procedure, alternative treatments with risks and benefits and lastly the risks and benefits of not receiving or undergoing a treatment or procedure and this should be explained in the language a patient can understand. Aim/Objective: To evaluate the informed consent process at tertiary teaching hospitals. Methodology: The study design was a cross-sectional analytical study, involving elective post-operative patients and doctors at JKCI, MOI and MNH between July 2020 and December 2020. The sample size was estimated to be 307 for patients and 123 for doctors, distributed in all three hospitals depending on the number of surgeries performed weekly. Data was collected through a structured questionnaire. Data was entered in Excel and cleaned. Statistical analysis was performed using R. Data is presented as proportions for categorical variables. The means and standard deviations is used to summarize continuous variables while categorical data is expressed as frequencies with their corresponding percentages. Statistical association between independent variable (age, sex, level of education, working experience, time spent acquiring consent and the study outcome (ethics observation) will be done using cross tabulation. Chi-square test will be used to compare proportions. P value of <0.05 is considered statistical significant. Results, Patients: The study enrolled 280 patients from three hospitals, Jakaya Kikwete Cardiac Institute, Muhimbili Orthopaedic institute and Muhimbili National hospital; the distribution is 10.7%, 35.7% and 53.6% respectively. Men were (54.6%) and female (45.7%). Minimum age of the patient seen was 18 years, with a mean of 44.5 years, and maximum age of 85 years. 95.7% had formal education and only 4.3% were illiterate. 76.1% were not adequately informed while only 23.9% (67) were informed. An association between level of education of patients and how informed are the patients when getting consent was calculated by chi square with p value <0.05 Doctors 68 doctors filled the questionnaires in total; 63.2% from Muhimbili National hospital 17% Muhimbili Orthopaedic Institute and 11.8% Jakaya Kikwete Cardiac Institute. Mean age was 33.8 years, minimum 26 years and maximum 45 years. 16.17% doctors had one degree,70.59% either masters or resident students in surgical specialties and 13.24% super specialists. Work experience was categorized into less than 5 years, 42.6%, between 5 and 10 years 41.2% and above 10 years 16.2%. 44.1% had no adequate knowledge on informed consent, while 55.9% had adequate about informed consent process. An association was established between level of knowledge on Informed consent and level of education of doctor as well as work experience. Conclusion and recommendation: This study concludes that patients are not informed even though there is a signed form for informed consent. Also doctors knowledge is still low on informed consent. There is an association between the level of education of a patient and how informed they can be. Work experience and level of education of doctors influences the level of knowledge on informed consent. It recommends the use of guideline and capacity building programs to improve services. Patient education on rights is also important to help improve the services.