Development and preliminary evaluation of the KIDCLOT PAC QL©: A new health-related quality of life measure for pediatric long-term anticoagulation therapy

Long term anticoagulation (LTA) is hypothesized to induce treatment dissatisfaction influence quality of life (QOL). QOL is measured by a tool developed specific to the patient condition. Pediatric QOL inventory for children on LTA should assess constructs salient for this population. Identification and evaluation of QOL constructs, critical to improve care, and is accepted as the "gold-standard" measurement for patient-centered outcomes in clinical research.ObjectivesTo develop and preliminarily validate a pediatric QOL inventory for children/families receiving LTA. Secondary objective was to determine how anticoagulation disrupts children's life.MethodsStage 1: Item/theme generation through focus groups and existing inventories, Stage 2: Item reduction, inventory generation and content validity. Stage 3: Inventory refinement, implementation and reliability testing. Responses were evaluated for variability, internal consistency, and scale structure. Item reduction was based on response rate, item variability, and clinical utility.ResultsTwo inventories, KIDCLOT-PAC-Child -Tween QL© and KIDCLOT-PAC Parent-proxy-QL © were developed. Content and face validity was assessed by experts, parents, and patients. Internal consistency determined by Cronbach's α was good for parent-proxy(0.82) and child(0.89). Pearson correlation was acceptable with > 0.5 for test-retest reliability (parent inventory).ConclusionsKIDCLOT-PAC-QL© is the first preliminarily validated inventory to assess QOL in anticoagulated children. The inventory identifies barriers in care and areas for improvement in order to modify care to provide the "best" management (improved QOL associated with safety and efficacy) for children requiring LTA.