The National Hemophilia Foundation (NHF), under the guidance of its Medical and Scientific Advisory Council (MASAC), is undertaking a multi-year project to develop evidence-based clinical practice guidelines (CPGs) in hemophilia. Considering the many changes in the healthcare environment, including the increased emphasis on evidenced-based care and the regional variability in clinical practice, NHF determined that the first guideline would focus on evaluating different care models for hemophilia management, including the comprehensive care model of the hemophilia treatment centers (HTCs). The goal of this guideline will be to support patient-centered clinical decision-making and optimize hemophilia care for each patient.
NHF and MASAC have long been engaged in advancing the standard of clinical care and issuing treatment recommendations for all bleeding disorders. In 2012, the NHF held a strategic summit to assess the US health care environment and develop a plan to assure that individuals with hemophilia and other bleeding disorders have access to high quality care. One of the key recommendations of the summit was for NHF to initiate the development of evidence-based clinical practice guidelines that would be eligible for inclusion in the US Department of Health and Human Services' National Guidelines Clearinghouse (NGC). Inclusion in the clearinghouse will reflect a rigorous methodological standard and is will be advantageous to acceptance by insurers.
For this project, NHF is partnering with McMaster University, which has an international reputation for its work in CPG development. The McMaster team has provided methodological support in defining the composition of the guideline panel, managed conflict of interest, and will conduct the key elements of guideline development - literature search and review, evidence profiling, and grading the evidence. Drs. Holger Schunemann and Alfonso Iorio of the Department of Clinical Epidemiology and Biostatics at McMaster University will be serving as co-principal investigators for the project.
In accordance with criteria established by the National Guideline Clearinghouse, NHF and McMaster have built a diverse guideline panel with appropriate expertise and experience from within and outside the hemophilia community. Each panel member has gone through a thorough conflict of interest and subject matter expertise review appropriate for their role on the panel. In addition to representatives from McMaster, the panel includes: health care professionals from the field of hematology and other specialties; patients and caregivers; those with broad public health backgrounds; and methodologic experts. Consistent with NGC practice, to avoid the risk of undue influence and maintain panel independence, the panel membership is not disclosed at this early stage in the process. The guideline report will disclose panel composition, and contain a full review of the selection process, as well as each member's conflicts of interest and selection criteria.
The first guideline panel meeting was held on June 21, 2014, during the annual International Society on Thrombosis and Haemostasis (ISTH) meeting in Milwaukee, WI. At this meeting the panel members reviewed the scope of the guideline and the questions that will be addressed by the guidelines. In preparation for the meeting the McMaster team prepared a background document on hemophilia and types of care models, along with information on the guideline development process.
In preparation for the first panel meeting, the McMaster team sent brief surveys to HTC Directors and other providers in the US and globally as well as patients, to get their input on how to frame the key questions for the guidelines. Further input on the guideline at key points in the process will be sought from the community.
Over the next nine to ten months the McMaster team will complete a systematic review of the literature and an assessment of the quality of the evidence. A final meeting of the Guideline Panel will be held in May of 2015. At this meeting, the panel will be asked to review evidence summaries and analyze the balance of benefits and harms, the values and preferences that inform the recommendations. Based on these factors, the panel will decide on whether to make strong or weak recommendations for or against proposed interventions. NHF anticipates completion of the guideline project on models of hemophilia care by the end of 2015 and will update the community periodically throughout the process.
Read the NHF-McMaster Guideline: Care Models for Hemophilia Management here.
