Describe your topic.

AT Therapy in Children

Describe why this topic is important.

Thromboembolism (TE) in pediatric patients is rare and makes management studies a challenge, resulting in limited direct evidence. In children, 50% of all drugs used are unlicensed or off-label, reflecting the paucity of specific trials in children. Thus, most recommendations are based on extrapolation from adults. There is evidence that such extrapolation may, in many circumstances, be inappropriate. Fortunately, recent regulatory initiatives have resulted in the development of specific pediatric investigational plans for select novel anticoagulants. Although these studies will take years to complete, they will provide excellent data on the safety and efficacy of currently used anticoagulants in children as well as an understanding of the newer drugs. At the same time, additional research is required to understand the basic pharmacokinetics and pharmacodynamics of commonly prescribed antithrombotic drugs in children because significant differences exist in antithrombotic activity and impact on monitoring tests in children compared with adults. The use of antithrombotic drugs in pediatric patients differs from adults in the following ways: 1) the epidemiology of TE in pediatric patients differs from that seen in adults; 2) the hemostatic system is a dynamic, evolving entity that likely affects not only the frequency and natural history of TEs in children but also the response to therapeutic agents; 3) the distribution, binding, and clearance of antithrombotic drugs are age dependent; 4) the frequency and type of intercurrent illnesses and concurrent medications vary with age; 5) the need for general anesthesia to perform many diagnostic studies in pediatric patients has an impact on the ability to investigate and monitor TEs and, hence, the confidence one can have in therapeutic decisions; 6) limited vascular access reduces the ability to effectively deliver some antithrombotic therapies and can influence the choice of antithrombotic agent; 7) specific pediatric formulations of antithrombotic drugs are not available, making accurate, reproducible dosing difficult; 8) dietary differences make the use of oral VKAs particularly difficult, which is especially true in neonates because breast milk and infant formulas have very different vitamin K levels; and 9) compliance issues are vastly different, for example, in small infants who cannot understand the need for therapy, adolescents who intellectually comprehend but emotionally are unable to cooperate, and children who experience the effects of inadequate parenting.

Tell us why you are suggesting this topic.

Antithrombotic Therapy in Neonates and Children has been the focus of 9 editions of evidence-based guidelines developed by the American College of Chest Physicians (CHEST), the last of which was published in 2012 and accepted by the National Guideline Clearinghouse. CHEST aims to update its guidelines every 5 years per the National Academy of Medicine (formerly IOM) and AHRQ standards, but due to increased demand for guidelines, has fallen short on this objective. Development of an evidence review on at least some, if not all, of the PICO’s described above would serve as the source document to facilitate the update of these guidelines.

Target Date.

 

Describe what you are doing currently and what you are hoping will change because of a new evidence report.

As described above, evidence reports form the basis of all CHEST clinical practice guidelines. If this topic is selected for an AHRQ evidence report, the results of that report will directly inform an update of the guideline on Antithrombotic Therapy in Neonates and Children. The original selection of this topic was due to professional demand based on inconsistent or lack of clear guidance based on current evidence. CHEST guidelines have been touted as a useful tool to assist in clinical decision-making, resulting in improved concordance between practice and the larger body of published evidence. In order to meet the National Academy of Medicine (formerly IOM) standards, it is imperative that an updated evidence report be developed to update the guidelines.

How will you or your group use the information from a new evidence report?

As described above, the evidence report will be directly used to inform the update of evidence-based guidelines on this topic.

How would you or your group plan to disseminate information from the report? Who would you plan to disseminate it to?

The report will be disseminated in the following ways: 1) communications to CHEST membership (nearly 19,000 healthcare providers) via electronic (ie eNews Alerts), print (ie CHEST Physician Newsletter), and social media. There will also be opportunities to inform providers about the report through our eLearning and Live Learning platforms, including our Annual Conference. Finally, the report will be referenced as the source document for the subsequent update of the guideline, furthering dissemination of the report as well as use of its contents in clinical practice.

Do you know of organizations that could use an evidence report to change clinical practice? Are you a part of, or have you been in contact with, any organizations that might implement the research findings of an evidence report?

CHEST serves as the primary organization that will directly use this evidence report to update our clinical practice guideline on Antithrombotic Therapy in Neonates and Children. Such guidelines have the opportunity to change clinical practice by improving clinical decisions in concordance with current evidence. Other organizations that would also benefit from this evidence report include: the American Thoracic Society, the American Society of Hematology, and the American Association of Pediatrics.

Information About You: (optional)

Provide a description of your role or perspective.

The American College of Chest Physicians (CHEST) is a professional society

If you are you making a suggestion on behalf of an organization, please state the name of the organization.

The American College of Chest Physicians (CHEST)

Please tell us how you heard about the Effective Health Care Program.

CHEST has collaborated with AHRQ in the past on evidence reviews, most recently the VTE Prophylaxis in Orthopedic Surgery Update

 

We are suggesting the following PICO questions pertaining to Antithrombotic Therapy in Neonates and Children.