ORLANDO – An integrated care model that includes a hematologist, a specialized hematology nurse, a physical therapist, a social worker, and 24/7 access to a specialized coagulation laboratory is recommended in a new hemophilia care guideline jointly developed by the National Hemophilia Foundation and McMaster University in Hamilton, Ontario.
The guideline has been formally accepted for inclusion in the National Guideline Clearinghouse (NGC), the National Hemophilia Foundation announced at its annual meeting, held immediately before the World Hemophilia Foundation World Congress here.
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“The integrated care model, as is utilized within the U.S. federally funded network of hemophilia treatment centers (HTCs), should be advocated for optimal care of persons with hemophilia,” wrote guideline coauthors Steven W. Pipe, MD, from the University of Michigan School of Medicine in Ann Arbor, and Craig M. Kessler, MD, from Georgetown University in Washington, in an introduction to the guideline, published in the journal Hemophilia.
Developed according to evidence-based principles, the guideline is hoped to “promote harmonization of care delivery and reduce practice variations within the U.S. HTC network. This guideline will inform the HTC network how best to prioritize additional ‘high-value’ research to fill data gaps or strengthen the evidence base as outlined in the manuscript,” they added.
The guideline authors recognized three basic models of care in use in the United States:
The integrated care, comprehensive care, or HTC model, which generally assumes that all aspects of care will be delivered in a specialized center.
Specialist-based care, under which a hematologist may or may not have training in the management of patients with hemophilia, is provided in a hospital or medical office, but not in a specialized center.
Non-specialist care, delivered in an emergency department or primary care practitioners office.
“We believe that the ‘No Care’ model, theoretically indicating complete absence of care, does not currently operate in the U.S. Yet, this is likely the de facto model of care for many individuals with hemophilia who do not have access to care due to profound resource constraints, particularly in developing countries or underserved minorities,” the authors wrote.
The guideline’s main recommendation – that the integrated-care model is preferable to the non-integrated care model – is conditional, with moderate certainty in the evidence.
For persons with hemophilia with inhibitors to clotting factors, however, the integrated-care model recommendation is considered to be strong, with moderate certainty.
The guideline development panel found that there were significant gaps in evidence for the benefits of integrated care for specific populations such as older patients and populations with poor access to care, and called for additional studies to clarify these questions.
Additionally, the panelists call for study into which specific interventions or aspects of care should be included in the integrated model, and for more in-depth studies into the effects on patient-important outcomes.
“This collaborative project constitutes an important milestone on a critical component of evidence-based guideline methodology,” Alfonso Iorio, MD, PhD, from the Department of Clinical Epidemiology and Biostatistics at McMaster University, said in a press statement. “It demonstrates how a patient advocacy organization can promote and support a guideline process, in the true spirit of patient involvement in research and care process, without compromising a rigorous and transparent conflict of interest management process.”
The guidelines were funded by the National Hemophilia Foundation. Several guideline panelists reported financial relationships with companies that make clotting factors and other products for persons with hemophilia.