Journal of Thrombosis and Haemostasis, 13: 155–159

DOI: 10.1111/jth.12763


Recommendations for the development of a dedicated pediatric anticoagulation service: communication from the SSC of the ISTH F. NEWALL,*†‡§¶ S. JONES,*§¶ M. BAUMAN,** A. BRUCE,** M. P. MASSICOTTE** and P. MONAGLE,*§¶ FOR THE SUBCOMMITTEE ON PERINATAL AND PAEDIATRIC HAEMOSTASIS *Clinical Haematology Department, Royal Children’s Hospital; †Nursing Research Department, Royal Children’s Hospital, Parkville; ‡Department of Nursing, The University of Melbourne; §Department of Paediatrics, The University of Melbourne; ¶Haematology Research Group, Murdoch Childrens Research Institute, Melbourne, Victoria, Australia; and **Pediatrics Department, Stollery Children’s Hospital, University of Alberta,Edmonton, AB, Canada

To cite this article: Newall F, Jones S, Bauman M, Bruce A, Massicotte MP, Monagle P, for the Subcommittee on Perinatal and Paediatric Haemostasis. Recommendations for the development of a dedicated pediatric anticoagulation service: communication from the SSC of the ISTH. J Thromb Haemost 2015; 13: 155–9.

acknowledge that the absence of robust evidence limits the strength of these recommendations. The number of children receiving treatment with anticoagulants for thromboembolic complications has risen over the last decade [1]. Children’s physiologic response to anticoagulants is inherently different from that of adults [2–6]. The complexity of anticoagulation management in the acute setting has led to the development of dedicated anticoagulation services within many major pediatric centers [7–13]. Clinical outcome data demonstrate that dedicated pediatric anticoagulation services provide enhanced care, as measured by efficacy (achievement of therapeutic range) and safety (incidence of adverse events) [11,13–16]. Evidence-based guidelines, such as the American College of Chest Physicians Anti-thrombotic and Thrombolytic Therapy Evidence, advocate the management of children with thromboembolism by experienced pediatric hematologists, where possible [3]. Data detailing clinical outcomes for children requiring anticoagulation not managed by a dedicated anticoagulation service are limited to case reports or retrospective cohort studies [16–18]. The recommendations presented in this article draw on the available evidence to support the development of pediatric anticoagulation services at tertiary centers, but we

Correspondence: Fiona Newall, Nursing Research Department, Royal Children’s Hospital, Flemington Road, Parkville 3052, Victoria, Australia. Tel.: +61 3 9345 5762; fax: +61 3 9345 5606. E-mail: [email protected] Received 30 March 2014 Manuscript handled by: S. Eichinger Final decision: F. R. Rosendaal, 9 October 2014 © 2014 International Society on Thrombosis and Haemostasis

Recommendations and discussion Service scope

The establishment of a dedicated pediatric anticoagulation service requires institutional clarity regarding the scope of the service, which ought to reflect the clinical specialities of the institution, the expertise of available staff, and the ability of the team to service the needs of the patient population. Key considerations include whether the service is for inpatients, outpatients, or restricted clinical specialities, and whether referral to the service by other clinicians is mandatory or optional. Given that the majority of pediatric patients requiring anticoagulant therapy have a primary cardiac condition [13], the relationship between the anticoagulation service and cardiology departments within major pediatrics hospitals needs to be clearly articulated and documented. For example, agreement must be secured regarding which department decides upon the target International Normalized Ratio (INR), the timing of commencement or discontinuation of therapy, or the requirement for periprocedural bridging. The available staff support may determine the scope of the service; however, where possible, it is recommended that the service provide 24 h access to a clinician. The provision of a scheduled anticoagulant outpatient clinic supports optimal management, by facilitating anticoagulation education for patients and families [10,19–21], assessing the suitability of monitoring plans, and developing an effective relationship between patients and the managing team [22]. No robust evidence supports specific recommendations regarding the optimal frequency

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of outpatient review, the duration of clinic appointments, or the contribution of face-to-face vs. information technology-supported (SMS, email, and telephone) engagement. The recognized challenges of maintaining children within their target therapeutic range supports the notion that two-way communication is probably ideal to support shared decision-making. Although there is evidence to suggest that self-management of oral anticoagulation can achieve safe and effective outcomes [23], further studies are required to confirm this within larger populations. Data management

The unpredictability of pediatric dose requirements for anticoagulant therapies often necessitates frequent monitoring. A data management system is central to a coordinated and consistent management approach. Options for data management include computerized dosing systems (such as DAWN; 4S, Milnthorpe, UK), a dosing nomogram, or a database. Two pediatric cohort studies reported increased efficacy of vitamin K antagonist (VKA) management with a computerized dosing program as compared with manual dosing, with improvements in target INR range achievement [24,25]. Neither study was conducted in centers with a dedicated anticoagulation service, and the method used to determine target range achievement varied between the studies [24,25]. Pediatric dosing nomograms for VKA therapy and low molecular weight heparin (LMWH) have been published, and safety and efficacy have been successfully demonstrated [7,9,26– 28]. Many anticoagulation services also achieve satisfactory anticoagulant control with individualized dosing regimens, supported by a database of previous results and known patient-related factors [12–14,16]. Personalized dosing requires a foundation of efficient data management and adequate staffing. Although dosing strategies may differ, individual patient records, including patient demographics and relevant medical history, are a feature of all of them. Superiority of one strategy over another cannot be determined from the available evidence. Implementation of evidence-based guidelines for anticoagulant management

Standardized anticoagulation management should be informed by evidence-based clinical practice guidelines (CPGs) [29]. In addition, institutional guidelines are needed to address local requirements. Although data to support recommendations for anticoagulation therapy in children are limited, CPGs synthesize the available data and provide a clinical decision-making resource [3,30]. Furthermore, they enhance consistency of approach. Institutional CPGs have been developed to support the clinical practice of pediatric anticoagulation services; however, evidence of their impact on patient outcomes is limited [30,31].

Multidisciplinary staffing

A multidisciplinary approach to anticoagulation management is recommended to ensure that patients and families receive comprehensive care and support. This is especially pertinent to the increasing numbers of children requiring lifelong anticoagulation. Various service models, represented by hematologists, advanced practice nurses, and pharmacists, have been reported. No service model has demonstrated superiority over any other model; however, a common theme is the importance of dedicated staff who are knowledgeable in the field. The ideal training or credentialing of staff working within a pediatric anticoagulation service has not been explored. The sharing of responsibilities between medical and nursing staff enhances communication to the patient about anticoagulation therapy dosing, monitoring, and administration [13]. The shared expertise of nursing, medical and allied health professional can facilitate the patients’ and families’ learning about anticoagulation, and ultimately contribute to improved safety and efficacy of treatment [32]. This has been demonstrated in pediatric cohort studies utilizing structured education programs [10,12,13,33]. Regular team meetings for discussion of specific patient management strategies and outcomes provide a platform to reduce variation in practice and promote adherence to guidelines. In addition, the availability of web-based resources for clinical staff regarding anticoagulant management and education is probably beneficial, but has yet to be evaluated. Although they have not been reported in the literature specifically with respect to pediatric anticoagulant management, specific mortality and morbidity meetings provide a mechanism with which to review the clinical management leading up to a poor patient outcome [34]. Educational materials and process

The development of education and training materials is a key responsibility of an anticoagulation service [10,12]. These materials contribute to the standardization of processes and treatment, and support the implementation of evidence-based guidelines [10,21,33,35]. The provision of educational materials to patients and families within a structured education regime supports the stability of anticoagulation therapy [10,12,15]. Effective education strategies ought to be individualized, and appropriate to developmental age, gender, underlying condition, and indication for anticoagulant therapy [19,35]. Reliance on ward nursing staff to educate patients regarding warfarin therapy may not be ideal, given reported knowledge deficits of nurses working within clinical areas where anticoagulants are commonly used [36]. This also highlight the role of the anticoagulation service in providing education to clinical staff across the institution. Targeted didactic education can © 2014 International Society on Thrombosis and Haemostasis

SSC Recommendations for Pediatric Anticoagulation Clinics 157

be supported by web-based resources and clinical guidelines. Clinical hematology services need to have formalized processes supporting the induction of staff who are new to their teams. Mechanisms to assess knowledge and competency assessment are recommended; however, the strength of this recommendation is based solely on clinical experience.

Addendum F. Newall is responsible for leading the literature review, drafting the first version of the paper, and coordinating review and editing by coauthors. S. Jones, M. Bauman, A. Bruce, M. P. Massicotte, and P. Monagle contributed to the literature review and editing of each draft created.

Interdisciplinary partnership

Disclosure of Conflict of Interests

The requirement for anticoagulation therapy is often secondary to a child’s underlying illness. Hence, communication with the child’s primary treating team regarding the anticoagulation therapy is a core responsibility of an anticoagulation service. There is little discussion of this in the literature. Strategies for communication with other treating teams are needed to produce anticoagulation management plans around procedures to support safe and standardized care. The evidence to support bridging of anticoagulation therapy around procedures remains scarce [27]. In children with cancer, for example, LMWH is often instead of VKAs, owing to the need for frequent procedures with the latter [3,37,38]. Certainly, the increased risks associated with surgical, dental or investigative procedures for children on anticoagulation therapy necessitate a formalized approach [35].

M. P. Massicotte served on the International Steering Committee for Rivaroxaban study (Einstein Junior) for Bayer GmBh, outside the submitted work. The other authors state that they have no conflict of interest.

Service evaluation

Prospective evaluation of the service’s outcomes supports the securing of ongoing service funding, program development, and targeted research. Preliminary evaluation may focus on outcomes achieved by specific patient populations, management techniques, or safety and efficacy outcomes [7–9,11–13,27,39–42]. As the service develops and expertise increases, targeted research and quality improvement projects may focus on service expansion, laboratory research, and program development [10,23,26,30,43–51]. Recently, attention has been directed towards the impact of anticoagulant therapies upon quality of life for children and families [43,47,52]. This field of research is timely, given that most children with an indication for anticoagulant therapies require indefinite or lifelong anticoagulation. Conclusion In establishing a dedicated pediatric anticoagulant service, the aim is to improve patient care through coordinated, evidence-based delivery of excellent clinical care. This position paper recommends that achievement of this aim is contingent upon clarity of service scope, appropriate staffing and development, sufficient infrastructure, commitment to the importance of educational resource development, and a comprehensive plan for service evaluation. © 2014 International Society on Thrombosis and Haemostasis

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Recommendations for the development of a dedicated pediatric anticoagulation service: communication from the SSC of the ISTH.

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