Personalized 3D-Printed Model for Informed Consent for Stage I Lung Cancer: A Randomized Pilot Trial.

We conducted a preliminary evaluation of the usefulness of personalized 3D-printed models for improving patient comprehension in informed consent for surgical resection of stage I lung cancer. From January through March 2018, we enrolled a total of 20 adult patients who were suspected to have stage I lung cancer on a preoperative multidetector chest computed tomography and decided to undergo elective surgical resection. The patients were randomly assigned to 3D printing and control arms. Informed consent was obtained before surgery with or without a half-life-size patient-specific 3D-printed model depending on the assigned arm. The patients evaluated the quality of the informed consent process in a 5-point scale using a questionnaire regarding patient knowledge, benefit, risk, alternative treatments, and satisfaction. The patient knowledge score was significantly higher in the 3D-printing group than in the control group (13.6 ± 1.5 vs 11.8 ± 1.6; P = 0.02), while the total score and the scores of the other 4 categories did not significantly differ between the groups: total score, 61.3 ± 7.8 vs 55.4 ± 7.3 (P = 0.12); benefit, 13.1 ± 0.9 vs 11.6 ± 2.1 (P = 0.10); risk, 11.3 ± 2.1 vs 11.7 ± 1.7 (P = 0.73); alternative treatment, 10.3 ± 3.1 vs 9.0 ± 2.7 (P = 0.40); and satisfaction, 13.0 ± 2.2 vs 11.3 ± 2.5 (P = 0.10). Personalized 3D printing was technically implementable and had the potential to improve patient comprehension in informed consent for surgical resection in patients suspected of having stage I lung cancer.

RCT Entities:   Population Interventions Outcomes