Patients’ comprehension. Comparing Enhanced versus Conventional informed consent forms for surgical procedures among patients undergoing elective surgeries

Abstract

Background Comprehension is an essential element in truly informed consent and well-informed patients are proactive and compliant. Poor comprehension among patients after offering consent is a global problem with African countries noted with worse situation. Several interventions have been designed and proved to improve patients’ comprehension but applicability depend on social-cultural settings. This study assessed the impact of locally designed enhanced informed consent form for surgical procedures on patients’ compression who underwent electives surgeries at Muhimbili national hospital, Tanzania. Method A hospital-based, randomized, double blinded, interventional study. The study population was patients admitted for elective surgical procedures. 212 participants randomly assigned into two groups; Interventional and Control groups. The interventional group used the Enhanced informed consent form while the control group used the Conventional informed consent form. Enhanced informed consent form is a locally designed form with a conversation checklist intended to properly guide clinician on the consenting process. Interviewer-administered questionnaire was used to assess the level of comprehension in both groups post-surgery. Patients’ comprehension described using proportion and computed for differences using Chi square with P-value set at 0.05. Results No statistically significant differences in patient demographics were observed between groups. A significantly greater proportion of patients demonstrated a good comprehension in the enhanced informed consent form group while none had good comprehension in the conventional informed consent form group (71.7% Vs 0%, P < 0.001).Conclusion Enhanced informed consent form for surgical procedures is a locally designed, cost effective and user-friendly intervention that imparts more comprehension to patients than Conventional informed consent form for surgical procedures.