Content validation of an algorithm for the assessment, management and monitoring of drug-induced qtc prolongation in the psychiatric population

Abstract

Background: QTc interval (QTcI) prolongation leads to serious complications, making it a concern for clinicians. Assessing the risk of QTcI prolongation in the psychiatric population is important because they are exposed to multiple medications known to increase the risk of life-threatening arrhythmias. Aim: The study aims to validate the content of an algorithm for the assessment, management and monitoring of drug-induced QTc prolongation in the psychiatric population. Methodology: Qualitative semi-structured interviews of cardiologists, to gather information regarding their approach in assessing the risk of drug-induced QTc prolongation at the time of prescribing. After the interview, an orientation to the algorithm was provided with a link to a cross-sectional, anonymous survey. The online survey included quantitative and qualitative components to gather feedback on the relevance and appropriateness of each step in the algorithm. Results: Interview responses were incorporated into 4 themes. Responses indicated a lack of a unified protocol when assessing QTcI prolongation, which supports the need of an algorithm that includes a verified risk scoring tool. Quantitative survey results showed a mean score ranging from 3.08 to 3.67 out of 4 for the appropriateness of the algorithm’s steps, 3.08 to 3.58 for the safety and 3.17 to 3.75 for the reliability of references used. Additional analysis using the modified kappa and I-CVI statistical measures indicate high validity of contents and high degree of agreement between raters. As per the open-ended questions, cardiologists supported the implementation of the algorithm; however, they recommended simplification of the steps as they appear to be cumbersome. Conclusion: The results demonstrate that the implementation of the algorithm after minor alterations can prove to be useful as a tool for the risk assessment of QTc prolongation. Further validation of the algorithm with mental health pharmacists and clinicians will be conducted as a separate phase of the study.