Informed Consent for Lumbar Fusion Aided by Tablet-PC: A Prospective, Randomized, Controlled, and Blinded Comparison
Authors: Schleicher Philipp , Scholz Matti , Kandziora Frank 
Published: April 2016

Introduction

With increasing work load and medicolegal obligations for documentation, an increased efficiency of recurrent tasks, like the informed consent of a surgical patient, is essential. The better the preoperative knowledge about the procedure, the higher the satisfaction will be. The complexity of today's surgical procedures is continuously increasing. These procedures are therefore difficult to explain to the patient during the informed consent process. Tablet-PCs are a widespread medium, which make it possible to present multimedia content at the point-of-care. So these devices are ideal for aiding the explanation of complex procedures. The aim of this study was to investigate, whether an informed consent aided by a multimedia app on the tablet-PC could increase the process efficiency and if this app was able to influence the patients' satisfaction in spinal surgery.

Material and Methods

We conducted a prospective, randomized, blinded pilot trial. Elective spine surgery patients, which were scheduled for either mono- or bisegmental TPLIF surgery, were randomized to one of the two groups “TABLET” (study group) or “PAPER” (control group). Patients in the control group received a standard informed consent process based on a conventional premanufactured paper form (Thieme compliance, Thieme GmbH, Stuttgart) and an individual interview with a spinal surgeon. In the TABLET group, a special multimedia informed consent app (iSpine Operations; AnatomateApps, Australia), was additionally demonstrated to the patients. This included a computer animation of goals and technique of the TLIF procedure as well as information on therapeutic alternatives and possible complications. The further consent process was identical to that of the control group (paper form and interview). The interviewing surgeon was blinded to the group allocation, to prevent an intentional influence on the interview duration. Primary endpoint was the duration of the interview (min). Secondary endpoints were the number of questions, which remained after the interview, patients' satisfaction with the informed consent process in total and with the interview itself.

Results

We could include 40 Patients (23 female, 17 male) with an average age of 62 (27–79) years in this study. The median duration of the interview was 18 minutes (IQR 13–22 minute). The difference between the groups was statistically significant: TABLET 15 (11–20) minutes, PAPER 20 (14–25) minutes, p = 0,041 (Mann-Whitney-U). Patient satisfaction with the informed consent process in total was high (VAS: 9,75/10) and was nearly identical in both groups PAPER (VAS: 9,75/10) and TABLET (9,75/10; p = 0,9). The satisfaction with the doctor's interview itself was 9.5/10 in the PAPER group and 10/10 in the TABLET group ( p = 0,74). The mean number of remaining questions was 3.1 in the PAPER group and 1.4 in the TABLET group ( p = 0,16).

Conclusion

These data show, that by the aid of a special animated app the efficiency of the informed consent process for mono- and bisegmental TPLIF surgery can be enhanced, even if the interviewing surgeon is blinded to the use of this aid.