The Challenge
The implementation of Patient Blood Management is hampered by barriers mostly related to the difficulty of changing traditional “physician’s attitudes” towards transfusion(40) and “transfusion behavior”.(41–43) Even hard-hitting crises such as the HIV-pandemic in the 1970s and 1980s with tens of thousands infected from contaminated donor blood, the huge death toll, billions of dollars in financial losses from lawsuits and compensations and criminal charges (44) only had a transient impact on changing long standing transfusion practice(45). What was called at the time “transfusion alternative strategies” showed compelling results and could have been helpful to reduce overall blood utilization with similar outcomes, (46–49), but went largely unnoticed (4). Instead, the focus remained solely on improving blood product safety through introducing donor blood testing methods with unprecedented cost per quality adjusted life year (QALY) between 4.7 and 11.2 million US-$, representing 94-224 times the then commonly accepted threshold in public health decision making (50,000 US-$/QALY) (50,51). Meanwhile, and despite rapidly accumulating clinical evidence for adverse transfusion and favorable Patient Blood Management outcomes (52), numerous Patient Blood Management guidelines (22,28–36), WHO endorsement (23) and call for Patient Blood Management (24), and several national policy recommendations, the global implementation of Patient Blood Management is still alarmingly slow. Huge inter-center and inter-country transfusion variability indicates, that blood utilization is rather driven by culture and behavior than evidence (42,43,53–55).
An essential challenge in replacing this long-standing, well-organized, product-centered culture by a patient-centered treatment model is that most diverse stakeholders need to communicate, collaborate and overcome the complexity of the Patient Blood Management implementation process. This starts with their specific contribution to the systemic implementation as exemplified in Table 5 and presented in more detail in the additional online material (Additional File 2).
Using the Implementation Matrix to Develop Patient Blood Management Strategies
Unless translated into the daily routine and organizational culture, evidence is of limited value (56). To bridge the gap and effectuate the necessary culture change, it is essential to understand the drivers and barriers for Patient Blood Management as well as the stakeholders’ roles and responsibilities. The Patient Blood Management-implementation matrix, as derived from the interviews, guides Patient Blood Management implementors in systematically identifying effective measures for Patient Blood Management implementation depending on the economic and healthcare context in their country. These measures will be discussed in more detail along six implementation levels.
Government Level
The focus of Patient Blood Management is to improve patient outcomes by managing and preserving the patient’s hematopoietic system in surgical and medical settings. Corollaries of Patient Blood Management are decreased demand for blood products and significant reduction in average length of hospital stay. In Western Australia, hospital stays were reduced by almost 70,000 days over 5 years (20). Suchlike improvement enhances capacity of care and consequently, patient access, and resource utilization. Reduced morbidity, mortality, and improved patient safety related to Patient Blood Management are likely to increase life-expectancy, health-related quality of life, and national productivity. Massive savings due to Patient Blood Management allow for better allocation of scarce resources, thus increasing productivity of the healthcare sector. The multiple-win advantage of Patient Blood Management (57) support national healthcare priorities such as better equity, access, and affordability. This should motivate national policy makers to sharpen the national policies by prioritizing Patient Blood Management.
A national Patient Blood Management policy, as suggested by some of the implementors, needs to address the broad scope of Patient Blood Management with a bundle of measures as described earlier(58). Introducing Patient Blood Management through local Patient Blood Management pilot programs can happen more rapidly than a full national policy and program, and may serve as a prototype proving feasibility, success, and effectiveness in the local context.
Structural changes on government level usually require long time. One implementor stated “it takes more than seven years to introduce a policy in our country”. Creating a sense of urgency through multiple stimuli can help to overcome the inertness for introducing a new medical model perceived as being complex(15).
Healthcare Provider Level
Patient Blood Management offers the rare opportunity to improve patient outcomes while reducing resource utilization and cost (20,59,60). The HCP related measures reported by the implementors start with the identification of local champions and allies from clinical and non-clinical departments but also encompass establishing multi-disciplinary teams including IT and administration, Patient Blood Management committees, program coordinators and other dedicated staff, and securing of funding, reinforcing the recommendations by previous experts (25,58).
Introducing Patient Blood Management practically via piloting accompanied by internal capability building through training and gaining practical experience, also is aligned with published approaches to change (61,62). Developing Patient Blood Management standard operating procedures helps tailoring the general guidance to the local context, and electronic transfusion decision support systems can effectively reduce transfusion rate and index in the daily routine(63,64) and serve as a ‘nudging’ mechanism. ’Nudging’ denotes “non-regulatory and non-monetary interventions for changing behavior that steer people in a particular direction while preserving their freedom of choice”(65,66). This includes automated or targeted reminders, individual performance reviews based on local data collection and analysis, or Patient Blood Management dashboards as reported elsewhere(67).
Training and Education Level
In all surveyed countries, except for Western Australia, Patient Blood Management is currently not included in the undergraduate curriculum of medical students. Like Patient Blood Management preceptorships, educational and training activities for Patient Blood Management, including accredited CME, are organized for post-graduates, often initiated by the implementors and local Patient Blood Management champions, and mostly industry sponsored. To accelerate the national uptake of Patient Blood Management and for enabling sustainability, implementors should liaise with the leadership of academia and medical schools to firmly integrate Patient Blood Management into the undergraduate education in alignment with the federal MoH and Ministry of Education, where applicable.
To avoid asymmetry of information and conflicting behaviors within the hospital, training, and communication on Patient Blood Management needs to include the entire clinical staff including nurses, pharmacists, and others influencing decisions related to managing patients’ blood.
Research Level
Patient Blood Management offers a broad spectrum of new experimental, clinical, epidemiological, and health-economic research opportunities, as evidenced by the growing number of research publications. Benchmarking and reporting of Patient Blood Management key performance indicators are contributing valuable insights concerning clinical and economic outcomes related to Patient Blood Management. Further research will help to improve Patient Blood Management techniques and was also highlighted by international thought leaders (35,58,67,68).
Funder Level
Public funders may benefit from Patient Blood Management through reduced average length of hospital stay and lower resource consumption, resulting in cost containment and better resource use. Private funders may expect higher profitability, in particular with diagnosis related groups (DRG) or value-based reimbursement systems (e.g., accountable care): in DRGs with high anemia prevalence and potentially high blood loss such as obstetrics, cardiovascular surgery or oncology, the total cost per episode of care have shown to decrease over time, thus leading to reduced tariffs (69). For Germany, overall yearly cost-savings with elective surgery were calculated to be €1,029 million - almost 1.58% of the total national hospital budget(70).
Even in fee-for-service settings, funders may benefit from Patient Blood Management: currently, they might reimburse hospitals for the number of transfusions administered, while patients pay for their anemia treatment out-of-pocket. Where transparent, implementors in the interviews reported increasing cost of blood components (per unit) due to increasing measures for quality and safety testing. Once funders stop to incentivize transfusion and begin incentivizing (pre-operative) anemia management as an essential part of Patient Blood Management, they foster better outcomes, fewer complications, and shorter hospital stays, thus reducing the overall reimbursement cost per episode of care. This principle holds even true in healthcare systems where allogeneic blood products are covered by national funds and are considered ‘free’, because the cost of quality assurance and administering these blood products is a multifold of their actual acquisition cost and therefore represents a substantial cost volume for the hospital and consequently for the funder (71,72).
Given the documented savings potential with Patient Blood Management (20,70,73–76), it should be a priority for implementors to inform, educate and engage funders on this important issue. Following the example of the German health insurance BARMER (69), insurers might even help underpinning the Patient Blood Management value using their own data to demonstrate savings with improved outcomes.
Patient Level
According to the implementors, Patient Blood Management and its benefits are largely unknown to patients, despite being the ‘big winners’ from Patient Blood Management with significantly improved clinical outcomes, safety, and reduced average length of hospital stay. Patients usually seek medical treatment based on a proper diagnosis and expect ‘their problem to be fixed’ with safe and effective medical or surgical interventions. Unless being informed by their treating physician or alerted by credible public information, they would not know that Patient Blood Management improves their chances for earlier discharge from hospital and reduces their risk for hospital acquired infection or even mortality. Patient advocates could contribute by creating Patient Blood Management awareness, but also by educating, and defending patients’ rights. Collaborating and likewise, supporting national campaigns to emphasize safety and the beneficial outcomes of Patient Blood Management, could foster shared clinical decision making and informed consent. Some implementors also saw the potential for patient advocates to approach funders to incentivize and support Patient Blood Management.
However, one implementor apprehended that entering the public domain too early might carry the risk of creating demand before physicians would be sufficiently familiar with Patient Blood Management and its benefit. Another implementor cautioned, that too much information on transfusion risks may negatively impact on the willingness to donate blood. Improving patient outcomes and using donated blood more effectively should always remain the priority objective of Patient Blood Management. Involvement of patients or patient advocates should happen thoroughly and be planned within the country culture and context. However, the aim to involve patients more in their own care(77), the strive for ‘Person-centered healthcare’(78), and the priority of increased patient safety(79–81) conforms to physicians’ obligations towards educating and informing patients about all risks and benefits of available treatment options. Medico-legal experts increasingly caution that widespread disregard of transfusion associated risks for adverse outcomes may result in litigation against those physicians and specialists (82). Informing the public and the patients in collaboration with patient advocacy groups can be a powerful element of the Patient Blood Management implementation strategy. Engaging the public and patients will not only result in more demand for Patient Blood Management as best practice but also improve patient satisfaction and foster participatory medicine.
Guided Implementation
In some of the countries described in this survey, Patient Blood Management was implemented simultaneously from bottom-up (e.g., from a department level or hospital/clinical level) and top-down (driven by policy and/or hospital administrative leadership) (see Table 2) with large variation in the closeness of the interaction between policy and operational levels. In other countries, implementation still progresses just through the bottom-up pathway, predominantly initiated, and led by individuals or small groups with different clinical background or innovation managers. To effectively coordinate and execute a statewide or even national implementation project across six diverse but interdependent layers requires governance, a pivotal element for bundling the power, control, bureaucracy, organization and legislative initiative(20,26,83). The example of Western Australia (20,83) and the EU Guide for Health Authorities (26) suggest that National Patient Blood Management Steering Committees, preferably under the authority of the MoH, should oversee subcommittees to coordinate planning and provisioning of Patient Blood Management resources, structural requirements, and national and international Patient Blood Management research efforts. Transitional tasks forces were proposed to develop national Patient Blood Management reimbursement schemes and managing Patient Blood Management transition costs (i.e. costs to manage the ‘paradigm shift’). National Patient Blood Management Steering Committees accompanied by a Patient Blood Management Guidelines Standard Committee and a Patient Blood Management Data Collection, Benchmarking and Analytics Committee could facilitate broad and homogeneous adoption.
The experiences and expectations of the implementors confirmed how important the implementation into the local healthcare and cultural context and alignment with the local / national healthcare priorities and funding situation is. Implementation success depends on good change processes; pushback from the old transfusion paradigm due to ignorance and conflicting incentives needs to be overcome, and the Patient Blood Management paradigm must be anchored in the healthcare delivery culture.
Kotter’s model for managing change embraces eight essential accelerators: establishing a sense of urgency, creating a guiding coalition, developing a change vision, communicating the vision for buy-in, empowering broad-based action, generating short-term wins, never letting up, and incorporating changes into the culture(84,85). Concurrent action, well adapted to the local context, across all eight change accelerators while rapidly building a network of change agents should maximize its adoption and impact(85).
Adaptation to the local context depends on the access to the key stakeholders and influencers within the own healthcare environment. Implementors need to identify the stakeholders in implementing Patient Blood Management and understand what motivates each of them to support, engage, or contribute(25–27).
The full implementation matrix (Additional File 2) may serve as a guidance in planning, even if starting with a small pilot. In creating the own path with clear aims, the user should, on each level, assess what works (best) in the local context, when, and which stakeholders should be involved (following Realist Evaluation approach(86)).
Limitations
The following limitations should be considered for this research. The selected countries cannot be fully representative for all countries and healthcare systems across the world. However, they were from five continents and represented healthcare systems of high or lower income, and the interviewees were professionals leading and/or promoting Patient Blood Management in the healthcare sector of their respective environment. The impact of the various implementation measures across six levels could not be determined. Once Patient Blood Management will be established in more countries and healthcare systems, certain key performance indicators might be linked to specific measures and rated, thus showing their relative importance.