Comic-based consenting on patient-reported experience and outcome measures for transfemoral aortic valve implantation

Abstract Background The impact of an improved patient informed consent (IC) before transcatheter aortic valve implantation (TAVI) on patient-reported experience and outcome measures (PREMs and PROMs) as well as on clinical outcomes remains unclear. Purpose To investigate patient satisfaction, PREMs, PROMs and clinical outcomes in patients receiving additional illustrative graphic-based IC (comic group) compared to conventional IC (control group) for TAVI at two tertiary care centers as part of a randomised controlled trial ("TAVI-COMIC study"). Methods Adult patients undergoing elective TAVI were enrolled. Patient satisfaction and PREMs were assessed after providing IC, PROMs at 90 days after TAVI and clinical safety outcomes within 7 days after TAVI (Figure). Results Only 48 (32%) of all patients read the official usual patient information sheet. Of 299 patients undergoing TAVI, comic-based IC was performed in 152 (51%) patients. Patient satisfaction was significantly higher (29 [23-32] vs 25 [22-30] of a maximum of 32 points in the validated Client Satisfaction Questionnaire [CSQ], p<0.001) and anxiety was lower (34 [25-51] vs 39 [29-55], p<0.001 in the validated Spielberger State-Trait-Anxiety Inventory [STAI]) in the comic group. 92 (61%) patients in the comic group felt "relaxed" prior to the procedure compared to only 44 (30%) patients receiving conventional IC (p<0.001). 91 (60%) were "very satisfied" with the delivered patient IC compared to 28 (19%) patients in the control group (p<0.001). PROMs at 90 days were assessed in a subgroup of 198 (66% of total cohort) patients: The comic group had similar PROMs as the control group (e.g. general health condition, walking ability and rate of dizziness, syncope, helplessness, depression, dyspnea or angina). Clinical outcomes, such as bleeding, pneumonia, stroke, delirium, or TAVI unit and hospital length of stay, were similar in both groups. Conclusion Use of an alternative IC approach, such as medical graphic narratives, might significantly improve patient satisfaction and PREMs, while facilitating similar PROMs and procedural safety as conventional treatment strategies.