RESUMO
BACKGROUND: No patient-reported instrument assesses patient-specific information needs, treatment goals, and Personal Meaningful Gain (PMG, a novel construct evaluating individualized, clinically relevant improvement). This study reports the development of the Patient-Specific Needs Evaluation (PSN) and examines its discriminative validity (i.e., its ability to distinguish satisfied from dissatisfied patients) and test-retest reliability in patients with hand or wrist conditions. METHODS: A mixed-methods approach was used to develop and validate the PSN, following COSMIN guidelines, including pilot testing, a survey (pilot: n=223, final PSN: n=275), cognitive debriefing (n=16), expert input, and validation. Discriminative validity was assessed by comparing the satisfaction level of patients who did or did not achieve their PMG (n=1,985) and test-retest reliability using absolute agreement, Cohen's kappa, and ICCs (n=102). We used a sample of 2,860 patients to describe responses to the final PSN. RESULTS: The PSN has only five questions (completion time ±3 minutes) and is freely accessible online. The items and response options were considered understandable by 90-92% and complete by 84-89% of the end-users. The PSN had excellent discriminative validity (Cramer's V: 0.48, p<0.001) and moderate to high test-retest reliability (Kappa: 0.46-0.68, ICCs: 0.53-0.73). CONCLUSIONS: The PSN is a freely available patient-centered decision-support tool that helps clinicians tailor their consultations to the patient's individual needs and goals. It contains the PMG, a novel construct evaluating individualized, clinically relevant treatment outcomes. The PSN may function as a conversation starter, facilitate expectation management, and aid shared decision-making. The PSN is implementation-ready and can be readily adapted to other patient populations. LEVEL OF EVIDENCE: I.
