Assessment of empathy by simulated patients: Adaptation and validation of a new instrument

Background: Medical doctors' empathy is vital in their interaction with patients, impacting on patient trust and health outcomes. The Consultation and Relational Empathy (CARE) scale helps assess healthcare professionals' empathy but there is a reasonable doubt about its validity when directly implemented in simulation contexts. This study adapts and validates a version of the CARE scale for simulated patients (Sp-SIMCARE), filling a gap in empathy assessment within medical training simulations. Methods: The contextual adaptation of the CARE scale for simulated patients followed a four-phase process: 1) preparation of a preliminary adaptation proposal; 2) drafting the first version; 3) piloting the initial version with simulated patients; and 4) refining the final Sp-SIMCARE version. A panel of five experts collaborated with five simulated patients to ensure clarity, relevance, and language equivalence. The validation was conducted using typical primary care scenarios. Simulated patients assessed the performance of undergraduate medical students in four primary patient roles: acute, chronic, with high functional component, and with a hostile attitude. Psychometric parameters that were evaluated included convergent validity (assessed by simulated patients using a global score), acceptability and face validity, homogeneity, and internal reliability. Results: The adaptation process resulted in a clear, relevant, and comprehensible scale, ensuring uniform understanding among users. Validation involved 95 students in 270 encounters with eight simulated patients. The final version showed convergent validity (Spearman's rho=0.730, p<0.001), acceptability and face validity (1.96% "Does not apply"/missing values), homogeneity (item-total correlations 0.705-0.865) and reliability (Cronbach's alpha=0.960). Conclusions: The Sp-SIMCARE scale appears to be a valid and reliable tool for simulated patients to assess empathy in future doctors during their training from a multidimensional perspective.