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• W2035442761 abstract "Capillary point-of-care (POC) International Normalized Ratio (INR) measurement within the home is a feasible method of INR testing and is associated with non-inferior warfarin/INR control when compared with traditional approaches 1, 2. Owing to the lack of studies providing evidence for guidance in POC INR Home Testing (PIHT), consensus recommendations have been developed for use in the pediatric community. Vitamin K antagonist therapy which includes all coumarin preparations (VKA-C) is monitored using the prothrombin time expressed as an INR, and conventional management consists of attending a laboratory for venipuncture. The POC INR meter requires a minimal blood sample, produces an immediate INR result and can be performed at the patients' convenience thereby eliminating the need for laboratory attendance 3, 4. Laboratory attendance interrupts school and parent professional engagement potentially impacting adherence 5. The convenience of PIHT facilitates more frequent INR testing which is necessary in children on VKA-C as a result of additional special challenges compared with adults 4. The level of evidence in POC INR monitoring pediatric trials is weak owing to the methodological limitations inherent in most study designs employed. The incidence of major clinical complications is the best method for quality assessment but requires large patient numbers and is not feasible in pediatrics 1. Minor complications are complex to evaluate and often not reported. Time in target therapeutic range (TTR) is commonly used as a surrogate measure for safety and efficacy of VKA-C therapy 6; however, varied statistical methodologies are employed in pediatrics studies which may not be interchangeable. Children's reported laboratory TTR is approximately 50% 4; however, previous studies have demonstrated that PIHT results in better control (TTR 60–84%) 1. Currently, vitamin K antagonists will probably remain the most common oral anticoagulant used in children. Although novel oral anticoagulants are being tested in adults, pharmacokinetic studies in pediatrics are still in their infancy and necessary to guide pediatric dosing. PIHT testing can be performed accurately, has been demonstrated to be non-inferior to laboratory monitoring and is associated with patient preference 7, 8, and possibly improved the health-related quality of life 1, 9 This position paper recommends that PIHT be considered for children prescribed long-term VKA-C therapy (>3 months) such as children with prothrombotic conditions or in children with acquired or congenital heart disease requiring thromboprophylaxis. PIHT programs have been conducted within dedicated pediatric anticoagulant clinics. Studies evaluating PIHT are largely cohort studies with only one randomized control trial (RCT) and are reviewed by Christensen et al. 1. Further limitations to study design include sample size and the low number of warfarin patient-years reported. Two models exist, patient self-testing and patient self-management, described below. Successful implementation of a PIHT program can be achieved through a clearly articulated plan incorporating quality assurance, education and training, maintenance and evaluation processes. A strategic approach to program development ensures that all requisite elements for success are considered and accommodated. There is no minimum number of patients required to initiate PIHT INR monitoring. PIHT can be established for one patient if the recommendations in this manuscript are adhered to. Educational information can be acquired from the manufacturers or other pediatric centers. Characteristics that preclude PIHT have not been identified in a systematic way in either adults or children. Until these characteristics are identified the health care provider and family should agree on the feasibility of this method of management. Time in target therapeutic range is demonstrated to increase in children using PIHT 1. Therefore, children attending the laboratory with low TTR would be eligible and benefit from PIHT. Pediatric PIHT programs should provide access to participants for queries at pre-specified times and 24-h availability for exceptional INR results, and in case of emergencies. PIHT of VKA-C therapy in children affords considerable advantages, including ease of blood collection, immediacy of results, patient preference for PIHT and non-inferior if not better warfarin control. Given the current level of evidence for PIHT, well-designed studies are required to further evaluate PIHT-associated quality of life and long-term VKA-C control in patients performing PIHT 1. The authors state that they have no conflict of interest." @default.
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• W2035442761 date "2013-02-01" @default.
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• W2035442761 title "Recommendations for point‐of‐care home International Normalized Ratio testing in children on vitamin K antagonist therapy" @default.
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• W2035442761 doi "https://doi.org/10.1111/jth.12089" @default.
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