The informed consent: a study of the efficacy of informed consents and the associated role of language barriers.

BACKGROUND: Obtaining informed consent before performing invasive procedures and operations has become a standard practice at all medical institutions in the United States. All agree that patients should be both conscious of and in agreement with their medical care. Though patients routinely sign consent forms with numerous risks and complications detailed, there are only a limited amount of reports that study if these patients have a thorough understanding of those risks and complications. Confounding the issue of the efficacy of informed consents is the growing population of patients who do not speak English. To obtain objective data on the efficacy of informed consents and the role of language barriers we looked at how well patients who consented to have a laparoscopic cholecystectomy understood the complications associated with this procedure.
METHODS: We conducted a randomized prospective study of all patients seen in the General Surgery Resident Outpatient Clinic who presented for an elective cholecystectomy. Fifty patients agreed to participate in our study. Participants were split into two groups. In the first group (the control group) surgical benefits, risks and complications were explained in the usual fashion. In the second group, after hearing the standard explanation of surgical risks, complications and benefits, patients watched a PowerPoint presentation with illustrations on laparoscopic cholecystectomy. Patients from both groups then took a ten question assessment based on the presentations that they encountered. Spanish speaking patients were addressed with an interpreter and given a Spanish PowerPoint presentation with a Spanish assessment. The patients' age, education level, income, and birth country were also studied.
RESULTS: Fifty-two percent of the patients in the study were born outside of the United States. All of the non-US born patients were Hispanic and their primary language was Spanish. The average age of the studied patients was 38. Sixty-eight percent of the patients reported an education level no higher than high school. The majority of the studied patients noted an income of less than $40,000. Differences were seen between patient native to the US and those born outside the United States. US born patients had an 80% correct response rate versus non-US born patients who had only a 63% correct response. Differences were seen between US born patient and non-US born patients concerning the topics of the severity of a common bile duct injury, gastrointestinal changes after cholecystectomy and the safety concerning conversion from laparoscopic to open cholecystectomy. No difference was appreciated in the PowerPoint group versus the non-PowerPoint group.
CONCLUSION: The addition of a PowerPoint presentation did not increase understanding of the risks and benefits associated with a laparoscopic cholecystectomy. This study did however highlight the problem of obtaining consent from foreign born patients. Patients who were not US natives showed a decreased understanding of the surgical procedure and the severity of the complications in both the control group and the PowerPoint group. Better methods of educating foreign patients should be investigated to truly obtain informed consents from this patient population.

RCT Entities:   Population Interventions Outcomes