Blood and blood products are valuable resources and are crucial to treatment, patient management and overall health outcomes. However, these valuable resources are dependent upon proper management as well as generous donors. To ensure adequate supply and appropriate management of blood and blood products to patients, the National Blood Authority (NBA) developed a series of Patient Blood Management (PBM) Guidelines, that were published between 2011 and 2016. The PBM Guidelines are written specifically for clinicians and consist of six modules that address transfusion strategies and the use of alternatives to transfusion in various aspects of care, including critical care, medical care and perioperative care.
Module 1 of the PBM Guidelines provides clinical guidance for patients with critical bleeding. For the purpose of these Guidelines, critical bleeding is considered life-threatening and therefore patients are likely to require massive transfusion. Uncontrolled bleeding, or major haemorrhage, is associated with considerable mortality and morbidity in trauma and maternity settings. Globally, trauma is one of the leading causes of death and disability. In Australia, approximately 8% of deaths are due to trauma.
The NBA engaged HTANALYSTS to conduct a series of systematic reviews to inform an update of Module 1 and to transition the Guidelines to an online platform. This is to ensure the ‘living’ guidelines remain current and are guided by the best available evidence. As part of this review, a Clinical/Consumer Reference Group (CRG) was established, and rigorous comprehensive processes are performed to ensure the guidelines are objective and reflect best practices for the Australian healthcare setting.
To identify all available evidence relevant to Module 1, HTANALYSTS conducted several robust systematic reviews using a structured methodology based on that described in the Cochrane Handbook for Systematic Reviews and relevant sections in the Joanna Briggs Institute Reviewer’s manual. This approach was chosen to ensure the best available evidence was independently evaluated.
HTANALYSTS proposed four fundamental steps, in line with the rigorous standard held by the NHMRC Guidelines for Guidelines. First, HTANALYSTS prepared a detailed protocol, transparently prespecifying the intended processes involved in the review, including the search strategy and methods, inclusion and exclusion criteria, types of studies and data collection and analysis. Module 1 consisted of nine research questions. The pre-specified population, interventions, comparisons and outcomes applicable to each question and agreed on by the CRG were the foundations on which the systematic review was developed.
HTANALYSTS meticulously evaluated all studies identified across several databases, extracting data from studies meeting the inclusion criteria. A hierarchical approach was applied to the review, whereby systematic reviews and meta-analyses of randomised controlled trials (RCTs) were assessed and updated where possible. In the absence of systematic review evidence, HTANALYSTS sought additional evidence from other quantitative study designs, including experimental studies, prospective and retrospective cohort studies and interrupted time-series. Studies with no comparator group were not included.
This approach enabled HTANALYSTS to present the CRG with independent evidence for consideration. Based on guidance from the CRG, the overall quality of evidence for each outcome is recorded in summary of findings tables using the GRADE approach. GRADE provides a framework for determining the certainty of the evidence (high, moderate, low, very low) for each outcome (e.g., mortality, morbidity). This information is translated into CRG agreed recommendations (strong or weak) for or against a particular action. Recommendations are guided by an evidence-to-decision framework that considers the certainty of the evidence, in conjunction with values and preferences, resource availability, and the balance of benefits and harms.
The success and high standard of this process has seen the PBM Guidelines used in everyday practice throughout all Australian hospitals and has paved the way for other countries to develop and review patient blood management.
The rigorous systematic review provides an evidence-base in which to confidently support and guide clinicians in the management and use of patient blood and blood products. Furthermore, systematic reviews highlight gaps in evidence and knowledge bases offering opportunity for future direction and research. However, the lag time between reviewing the evidence and publishing recommendations places patients at risk, as clinicians cannot keep up with the continually evolving evidence. As new evidence is identified and clinical practice evolves, the transition of Module 1 to a living guideline platform will allow the guidelines to be continually updated using the same rigorous processes, ensuring clinicians deliver the best care to patients with critical bleeding.