Beyond diagnostic test performance: two content-validated questionnaires assessing patient and clinician satisfaction with diagnostic tests

Utilization of diagnostic tests depends not only on diagnostic accuracy but also on clinicians’ and patients’ perceptions of the diagnostic test, including ease-of-use and rapidity of results. However, there has been little focus on validated measures for diagnostic test satisfaction in the literature. Satisfaction data can provide valuable information for decision-makers evaluating whether to approve, reimburse, or implement new diagnostic tests. This study describes the development and content validation of one patient-reported outcome instrument and one clinician instrument designed to evaluate satisfaction and preferences for diagnostic tests for acute medical events. The instruments were developed using concept elicitation interviews (20 patients; 20 clinicians), clinical expert input, and cognitive debriefing interviews (10 patients; 10 clinicians). Patients (who had undergone a diagnostic test for an acute medical event within 3 months prior) and clinicians (≥2 years of experience performing diagnostic tests; 5+ tests per month) were recruited from the United States, United Kingdom, and Canada. Cognitive debriefing interviews were conducted, with evidence-based revisions made to the instruments between rounds. Study findings supported the content validity of the instruments and suitability for intended use. Specifically, concept elicitation interviews revealed factors impacting patient and clinician satisfaction with diagnostic tests, informing development of the Patient Satisfaction with Diagnostic Test Questionnaire (PSDT-Q) and Clinician Satisfaction with Diagnostic Test Questionnaire (CSDT-Q). Evidence-based revisions from cognitive debriefing interviews included wording updates, response option alterations, and inclusion of additional items to facilitate conceptual comprehensiveness. The content-validated PSDT-Q comprised four sections (20 items) assessing satisfaction with the diagnostic test process, satisfaction with sample/measurement collection, emotional well-being during the diagnostic test process, and preference between two diagnostic tests (optional module). The content-validated CSDT-Q comprised three sections (12 items) assessing satisfaction, confidence, and preference for the diagnostic test under study versus standard care. The PSDT-Q and CSDT-Q are the first content-validated instruments to measure patient and clinician satisfaction with diagnostic tests. Ongoing clinical research will assess the psychometric properties of these instruments. Integrating evidence-based measurement tools like these into clinical studies and health technology evaluations can help ensure that the preferences of those directly impacted by diagnostic innovations are represented in decision-making.