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.
