Effect of Informed Consent on the Rate of Complaints in Patients Undergoing Spinal Surgery

Obtaining informed consent is necessary for non-emergent interventions. Interventions that promote informed consent are effective for both patients and the medical staff. The current study was conducted to study the effects of improving informed consent and obtaining presumption of innocence on compliants against doctors after elective lumbar disk surgery in Tajrish hospital.

Methods and Materials:

In the present experimental study,  a total of 1000 patients, admitted for elective lumbar disk surgery in Tajrish hospital, were selected using simple random sampling and according to the including criteria. Then, the participants were divided in two groups: the control group received a consent form with brief information including the diagnosis, the proposed treatment, alternative treatments, and their risks and benefits, and the risks and benefits of declining treatment. The intervention group received a more detailed information form, including more details about the risks of treatment, unwilling harm to the patients through system failures, and predictable human error. The patient’s consent and innocence forms were obtained from the latter, too. Next, the the two groups were followed for over two years after surgery and the complaints against doctors were compared by analyzing the data in SPSS, version 21, running Exactly Fisher test. 

There was no significant difference between the patients' sex and age and the number of complaints (p<0.012) nor was any significant difference between the site of surgery and complaints (p<0.1). Yet, complinats agianst doctors in the first group was %8 compared with the 1% complaints in the second groups, which shows a statistically significant difference. 

Obtaining a more complete informed consent form as well as presumption of innocence results in lower complaints against the physicians.