Effect of a patient decision aid on shared decision making in patients with differentiated thyroid cancer: a randomized controlled trial

BACKGROUND: : Over the last decades optimal treatment for patients with differentiated thyroid cancer (DTC) is debated. Two treatment decisions for patients who could benefit from more individualized approaches and shared decision making (SDM), are the extent of surgery decision in patients with low-risk DTC, and the decision to start or delay the treatment with Tyrosine Kinase Inhibitors (TKIs) in patients with advanced DTC. Our aim is to examine the effect of a Patient Decision Aid (PtDA) on observed SDM, while physicians were trained in SDM. METHODS: In this multicenter RCT (2020-2024), all physicians (n = 26) received a 5-hour SDM training. Patients (n = 86) with DTC were randomized to receive a PtDA or care as usual. The primary outcome was the observed SDM as rated by blinding observers with the observing patient involvement in decision making (OPTION5) scale from audio-recorded consultations. Secondary outcomes included well-being measures, information-related measures, and decision-related measures. RESULTS: Mean OPTION5 scores were 52 (range 0-100) for the PtDA and 54 (range 0-100) for the usual care group. The PtDA did not improve observed SDM, nor the secondary outcomes. Results of the Beta testing (n = 33) showed that the PtDA was readable (n = 30) and helpful for decision making (n = 28). All patients recommended using the PtDA. CONCLUSION: In this RCT, with high baseline SDM quality provided by trained physicians, PtDAs did not further improve SDM quality. Nevertheless, since all patients recommended the PtDA, future studies should establish the potential benefit of PtDAs, particularly as SDM training is usually not provided. TRIAL REGISTRATION: ClinicalTrials.gov NCT03905369.