Personalizing treatment for multiple actinic keratoses with the validation of a patient decision aid

Actinic keratoses (AKs) are the most common skin lesions with potential for progression to skin cancer, with conversion rates to squamous cell carcinoma ranging from 0.1% to 20%.1-3 As predicting which AKs will progress is not currently possible, treatment of all lesions is advised. European guidelines recommend a shared decision-making process that considers body site, lesion count and patient characteristics such as age and immune status.4 Our research group previously developed a patient decision aid (PDA) for managing multiple AKs, aligned with the International Patient Decision Aid Standards (IPDAS) (Figure 1).5 This randomized controlled trial aimed to assess the impact of the PDA on informed decision-making. Thirty-three patients (26 male, 7 female; mean age 75.1, SD = 8.4) with multiple AKs were enrolled from departmental skin cancer clinics (November 2023–March 2024). Eligible patients were randomly assigned via block randomization6 to standard verbal counselling (VC group; n = 15) or the PDA plus VC (PDA group; n = 18). Participants completed the validated Decisional Conflict Scale7 (DCS), 9-item Shared Decision-Making Queestionnaire8 (SDM-Q-9), a patient satisfaction questionnaire9 and an adapted knowledge assessment.10 There were no significant age differences between groups (p = 0.64, CI: −0.85 to 0.52). Educational attainment, measured using the National Framework of Qualifications, was higher in the PDA group (M = 6.53, SD = 2.17) compared to the VC group (M = 4.82, SD = 2.20), t(30) = 2.20, p = 0.04, d = 0.78, 95% CI: 0.05–1.50. Health literacy (BRIEF Health Literacy Screening Tool) was also higher in the PDA group (M = 17.11, SD = 3.10) compared to the VC group (M = 14.93, SD = 3.43), although this was not significant (p = 0.07, 95% CI: −0.04 to 1.37). Patients in the PDA group had significantly lower decisional conflict across all subscales (Table 1). The mean total DCS score was 3 (SD = 4) in the PDA group versus 22 (SD = 15) in the VC group, yielding a statistically significant mean difference of −19.2, p < 0.001, with a large effect size (d = −1.83, 95% CI: −2.64 to −0.99). Among subscales, the largest effect was observed in the “Informed” domain (MD = −37.7, p < 0.001, d =−1.63, 95% CI: −2.41 to −0.82), while the smallest effect was found in the ‘Support’ domain (MD = −13.6, p = 0.005, d = −1.07, 95% CI: −1.79 to −0.32). The PDA group also reported significantly higher involvement in decision-making, as measured by the SDMQ-9, both in raw (M = 44 vs. 35) and transformed scores (M = 98 vs. 78), with mean differences of 9 and 20 points, respectively (both ps < 0.001). Satisfaction scores were significantly higher in the PDA group (M = 36, SD = 3) than in the VC group (M = 28, SD = 6, p < 0.001, d = 1.80, 95% CI: 0.97–2.61). While both groups demonstrated strong knowledge scores, the between-group difference was not statistically significant (MD = +0.5, p = 0.15, d = 0.51, 95% CI: −0.19 to 1.21), which may reflect the high educational level of this cohort. This study validates a PDA for the treatment of multiple AKs by demonstrating it improves the decision-making process, decision quality and patient satisfaction with care. The randomized controlled design and use of validated outcome measures strengthen its methodological quality and support the robustness of the findings. However, the small sample size and baseline differences in education and health literacy limit generalizability. As European treatment guidelines do not outline specific strategies to implement personalized care for AKs, this validated PDA aids clinicians in making personalized treatment decisions for patients. The study was completed in partial fulfilment of a doctorate of medicine funded by a research grant from The City of Dublin Skin and Cancer Hospital Charity. The funders were not involved in the study design, data collection, data analysis or manuscript preparation. None to declare. This study was approved by St Vincent's Healthcare Group Research Ethics Committee (RS22-046). The conduct, design and reporting of this study followed the CONSORT guidelines for randomized clinical trials. The patients in this manuscript have given written and informed consent to publication of their case details. The data that support the findings of this study are available from the corresponding author upon reasonable request.