This study was done to assess knowledge and perception of surgical informed consent and associated factors among adult post-surgical patients in Gondar University Comprehensive and Specialized Hospital, Northwest Ethiopia. Knowing gap of knowledge and perception about surgical informed consent and then identifying those factors that affect will have its own contribution to strength decision making ability of the patient in surgical informed consent regarding their surgical procedure.
In this study, we demonstrated that 36.1% (95% CI (30.8, 41.4) of post-surgical patients had good knowledge about surgical informed consent. This finding was higher than the study done in Cairo University Hospital, Egypt where 27.3% of surgical patients were knowledgeable about surgical informed consent(17). This variation might be differences in educational status of the study participants that unlike this study majority of participants (61%) in the above study were illiterate. Our finding was also different from the study done in Rwanda by Mbonera F. et.al(15) such that eighty-three percent (83%) had low knowledge, 12% had moderate and only 5% had high level of knowledge towards informed consent in surgical procedures. The possible explanation for this difference might be the difference in study setting and sample size (147) difference. This result was lower than study’s done in Nigeria by Sulaiman A. et al(2), where knowledge of patients about surgical informed consent in Nigeria was high (97.5%). The reason behind these difference might be difference in study setting, population difference and majority of the respondents (89.4%) had formal education in the above study.
Findings of this result was also different from the studies done in Croatia, by Vucemilo L. et al(20) and England studied by Akkad A. et al(13), in which half of study population were knowledgeable about surgical informed consent. The reason for this difference might be sample size (3329) and all study participants were literate in Vucemilo’s study, sociodemographic variation might also be a possible explanation for this difference with studies at England; in India by Singh A. et al(14) where the overall understanding was poor in 17%, unsatisfactory in 33%, satisfactory in 32%, and good in 18% of the patients. This difference might be as a result of differences in sociodemographic characteristics (educational status 20% illiterate) as compared to our study setting) and or variation in sample size (n=582). On the other hand, the findings of this study regarding knowledge of patients about surgical informed consent was higher than the study done in south Africa by Kalala T. et al(6) such that the general knowledge of patients about components of a valid informed consent was only 8%. Time might be the possible explanation for these difference as it was studied in 2008 and sample size (98)
During evaluation of perception of patients towards surgical informed consent, about half of post-surgical patients, 48.68% (95% CI (47.7, 54.6)), had good perception about surgical informed consent. this result is different from the study in Rwanda by Mbonera F. et al(15)., where 23% had low perception, 50% moderate and 31% of them had high level of perception towards informed consent in surgical procedures. The possible explanation for this difference might be differences in sociodemographic factors, the models they used (ordinal logistic) and sample size difference (147). On the other hand, this was different from the study reported by Sulaiman. Et al(2) in Nigerian Obstetric patients in which there was documented as high perception of patients about surgical informed consent in Amino kano teaching Hospital. The difference might be sampling technique difference which was non-probability type of purposive sampling. Unlike this study, most of the study participants (89.4%) were educated and this might also be another thing that makes perception difference in two study areas. On the other hand, the result of this finding was consistent with studies done in Egypt, by Ahmed S. et al(32), and England by Akkad A. et al(13). Stated that patients in their study areas had a great deal of poor perceptions regarding informed consent in surgical procedures.
Regarding perception of patients towards surgical informed consent, the result of this study showed that about more than half, 59.6% (95% CI= (59.4, 66.3), of post-surgical patients perceived as consent form did not made them aware of the risk of the operation during consent process. When we compare this result with other studies, it was consistent with finds by Ahmed S. et al in Egypt(32) where 62.66% of them did not be informed risk of their operation; different from studies in Nigeria by Atanda O.et al.(18)(21.3%) and in England by Akkad A. et al.(13)(12%) of them were perceived as risk of their operation couldn’t be informed during informed consent process. This implies that patients are not well informed about their operation before surgery in the study area.
Findings of this result reported that the residence of study participants was significantly associated with knowledge of surgical patients about surgical informed consent. Based on this, the odds of having good knowledge towards surgical informed consent in urban patients were 1.52 [95%CI (1.03, 3.10); p=0.016] times more likely than urban residents. This is in line with a study conducted in Nigeria by Ezeome E. et al(27), confirmed that patients came from urban areas had good knowledge about surgical informed consent and in practicing consent in surgery than rural. But this result is different from the study done in Saudi Arabia in Sohag University by EL-Nasser A. et al(11) such that living in urban or rural had no any significance (p=0.136) in patient’s preoperative satisfaction and knowledge of patients regarding surgical informed consent. This difference might be sample size difference (199) and study time (2011).
Regarding the educational status of patients, the study confirmed that there was a significant association between knowledge of adult surgical patients regarding informed consent and educational level of the participants. As educational level of participants increased, so does their knowledge about surgical informed consent. Patients with an educational level of college and above were four times [AOR=4.25;95%CI (1.06,5.10); p=0.042] more likely knowledgeable than illiterate patients. (Table 5)
This is supported by findings in: - Nigeria by Sulaiman A. et al.(2) and by Agu K et al.(4) stated that educated patients are conscious of their rights and are more likely to understand consent process in surgical procedures than non-educated; in Rwanda by Mbonera F. et al(15) it was confirmed that level of education influences significantly the knowledge of patients towards informed consent for surgical procedures; in south Africa by Minnies D. et al(33) and in Melendo M. et al(24) stated as the more educated a patient, the more likely s/he was to link informed consent to the understanding of procedures during a consent process.
On the other hand, this finding was different from studies done:- in India by Rajesh A. et al.(9) and America by Fink A.et al(26) reported as looking at the values the level of understanding is not different between those who had a primary level of education and those who did not had formal education, but it was significantly better in those who had higher education. The justification for this difference might be sample size (555). A study in Saudi Arabia ,by EL-Nasser,(11) showed that education was not a predictor variable for knowledge of patients towards SIC. The possible explanation might be difference in educational status of study participants such that 62.8% of patients were illiterate in Saudi, while 45.7% in this study
This study also confirmed that there is a significant association between knowledge and past surgical history of patients. Based on this result, patients having past surgical history were nearly two times [AOR=2.2; 95%CI (1.39, 6.42); p=0.005] more likely to have good knowledge than those who didn’t have. The reason behind might be due to preoperative health education in their previous surgery. This result was different from study by Kalala Tshimanga(6), in south Africa where past surgical history of study participants showed no added advantage over those without it related to patients’ knowledge about informed consent. The difference might be difference in time (2008), sociodemographic factor, and difference in sample size (1768), surgical patients might not have had preoperative health education regarding informed consent.
Our study also tried to identify those factors which affects perception of patients about surgical informed consent. According to this study, the odds of having good perception towards surgical informed consent in urban patients were 2.07 [AOR=2.07;95%CI (1.06,4.04); p=0.033] times more likely than surgical patients from rural setting. This might be because of most of the time educated populations were living in urban areas in other words patients with a high educational level had relatively good perception about informed consent in surgical procedures.
Findings in this result also reported that educational status of the study participants was significantly associated with perception of patients regarding surgical informed consent. But, it was confirmed that there was no perception difference between patients with educational status of primary school, preparatory and illiterate patients. Based on this finding, those patients with educational level of college and above were nearly nine times [AOR=8.9; 95%CI (8.25, 9.82); p=0.000] more likely having good perception than illiterate participants. This finding was similar in studies done in Rwanda by Mbonera F. et al(15) and in south Africa by Kalala Tshimanga(6) where formal education had positive association with better perception of informed consent.
The type of surgery was still another factor that affects patients’ perception towards surgical informed consent. Based on these finding, the odds of having good perception about surgical informed consent in orthopedic patients was decreased by 91% [AOR=0.09; 95% CI (0.03, 0.32); p=0.000] than ophthalmologic surgical patients. It might be due to difference in preoperative health education. This finding was consistent with study done in Nigeria by Sulaiman A. et al(2) Stated that there was a statistically significant association between type of surgery and patients’ perception about surgical informed consent (p=0.006). On the other hand the above finding was different from studies done in:-Jerusalem, Israel by Brezis M. et al.(21) ; Rwanda by Mbonera F. eta al(15) stated as there was no perception difference between different surgical disciplines of the patient. The justification for this difference might be sample size (147 for Mbonera et al.’s study), time (2008 for Brezis et. al).
The result of this finding still reported that there was a significant association between HCW profession from whom the patient had taken informed consent process and patients’ perception regarding SIC (surgical informed consent). Based on this finding, the odds of having good perception about SIC in patients who had taken SIC process from intern practitioner were decreased by 55% [AOR=0.45;95%CI (0.26,0.96); p=0.024] than patients received from physicians. This is supported by studies done in Croatia by Vucemilo L.et al(22). and in Saudi Arabia by Abolfotohu M. et al(23), stated as higher quality was predicted when the physician was the one who explained the informed consent. This implies that perception of patients about surgical informed consent should increase as consent process was explained by physicians.
The strength of this study was since there were no similar studies so far in our country, therefore this study shows index of knowledge and perception of patients towards surgical informed consent in our context, and being a base line for future researchers. The study was also tried to include study participants in all surgery disciplines and as it was conducted at tertiary care Hospital, so diversity of patients was obtained.
Our study has the following limitations: Lack of triangulation (data source and methodological triangulation might provide the investigator with better insight towards knowledge of patients towards surgical informed consent among adult surgical patients if there were qualitative data); the study was conducted in a single referral hospital and Institution based study, not generalizable for the community as whole.