October 23, 2014 — Blog Post
Blood: The Gift You May Not Need
“To the giver, the gift is quickly replaced by the body. There is no permanent loss. To the receiver, the gift may be everything: life itself.”
(Richard Titmuss. The Gift Relationship)
Would the FDA approve transfusion if it entered the market today?
Blood transfusion is the most commonly performed medical procedure in the U.S. with recent figures reporting an estimated 5 million transfusion recipients (Whitaker & Hinkins, 2011). Despite transfusion’s common place in medical practice, current evidence supporting its effectiveness is limited; evidence to support a reduction in mortality and morbidity in transfusion recipients is not well documented (Pape et al, 2009). While an individual with anemia feels the benefit of a blood transfusion almost immediately, there are both short and long-term risks of transfusion. Indeed, a paradox exists between anemia and transfusion, as both have been associated with organ injury and increased morbidity and mortality as extensively described by Shander et al (2011)’s excellent and extensive article. In addition, evidence among patients who commonly refuse blood, such as Jehovah’s Witnesses, and in trials with restrictive transfusion policies, have found outcomes for such patients to be comparable to those of transfused patients.
Overuse of blood
The rate of blood (red cell units) transfused in the U.S.is 48.8/1,000 people, much higher than in Canada or Europe (Hoffman, 2011). In the U.S., as in other countries, the donor pool that provides blood is shrinking and the number of donations is on a downward trend. Only 4.6% of the US population aged 15 – 64 donated blood according to the most recent health and Human Services (HHS) report (Whitaker & Hinkins, 2011). However, decreases in demand, due mainly to better blood management, have enabled us to maintain an adequate supply. Despite this, 10.3% of hospitals in the U.S. have reported at least one day in which non-surgical blood could not be provided.
With the blood supply in such a delicate balance it is important that blood is transfused appropriately. Yet, decisions to transfuse that cannot be justified by guidelines range from 4% to 66% of all cases (Hasley et al 1994; Hebert et al, 1997). In addition, when the decision to transfuse does adhere to guidelines, recipients may receive more blood than they actually need – they are over-transfused. In a previous study, we found over-transfusion occurred in 19% of blood recipients in Northern Ireland (Barr et al, 2011a), with others reporting rates ranging from 24% to 75%. Mixed evidence supporting guidelines may be a significant contributor to such wide variations in appropriate use of blood.
To transfuse or not transfuse? Patient preferences are what matters.
Historically, a hemoglobin level below 10g/dL was viewed as a ‘transfusion trigger’. However, more recent guidelines, such as those from the AABB (Carson et al, 2012), recommend transfusion when hemoglobin falls below 7g/dL – 8g/dL for stable patients. Others suggest lower hemoglobin levels are safe and that the most important factor in deciding whether a transfusion should be considered is whether the patient is symptomatic of anemia (Williams, 2013). In practice, a zone of uncertainty exists between 6 – 10g/dL where factors other than hemoglobin, including patient age, existing co-morbidity, patient’s symptoms and blood loss, play a significant role in guiding the decision.
When such equipoise exists in decision making, the patient’s preferences should guide the decision. Despite this, patients are rarely included in the transfusion decision-making process. In my own research (Barr et al, 2011a), reviewing medical records for over 2000 unique transfusion episodes, only a handful of patients were documented as being included in the transfusion decision making process. In addition, existing informed consent is not adequate with reading levels of consent materials beyond the recommended 7th grade level (Abrams & Earles, 2007). In efforts to address concerns of overuse and potential risks of transfusion, strategies including restrictive hemoglobin levels, perioperative optimization of hemoglobin level, cell salvage and pharmacological interventions have all been considered (Barr, 2011b). Is it now time to unlock the potential of the patient?Engaging patients by improving health literacy
Transfusion decision making is preference sensitive and new approaches are being developed to share the decision with the patient. Central to this are efforts to improve health literacy, which, in its broadest sense, includes a patient’s ability to understand, access and use health-related tools and services. The CDC has highlighted the importance of health literacy in improving blood safety and centers in the U.S. have initiated efforts to improve health literacy around transfusion. For example, at Iowa Health System, a health literacy team has been established to create more reader-friendly and understandable written consent documents, including for blood transfusion (Abrams and Earls, 2007). The new consent forms use:
- Plain language
- Simple words
- Short sentences
- Clear headings
- Generous white space
- 12-14 point serif fonts
- Use of bold text, 1.5 line spacing
- Space for teach back in the patient’s own words
Efforts have also commenced in Europe, where the WHO’s regional office has released a report highlighting the development of tools to support health literacy in transfusion to empower patients, which they believe can improve both the quality of practice and patient safety (Virone & Tarasenko, 2011).
In addition to these efforts, we are collaborating with a team from the UK to finalize an Option Grid, www.optiongrid.org, for red cell transfusion decision making. Option Girds are one page point of care decision support tools (POCET) explaining risks and benefits of treatment options while eliciting patients’ preferences. These tools can act as a scaffolding to the doctor-patient conversation, presenting the evidence in a clear and understandable way to patients and clinicians. We plan to test the impact of this tool in the upcoming months and would be happy to collaborate with interested partners in doing so.
Engaging patients in a process of shared decision making, using high-quality, accessible tools has the potential to improve safety and quality while reducing overuse of blood, and at the same time can protect against under-transfusion if the pendulum of practice swings too far to one side. Including patients in all aspects of their care is a central tenet of modern medicine and, as stated by the AMA (2007), “patient understanding is the first patient right… this right is not one that physicians confer, but one they assist patients in exercising freely.”
Abrams and Earles. Developing an Informed Consent Process With Patient Understanding in Mind. NC Med J September/October 2007, Volume 68, Number 5
American Medical Association Foundation and American Medical Association. Health Literacy and Patient Safety: Help Patients Understand. Reducing the Risk by Designing a Safer, Shame-free Health Care Environment. American Medical Association Foundation and American Medical Association; 2007.
Barr PJ, Donnelly M, Cardwell CR, Parker M, Morris K, Bailie KE. The appropriateness of red blood cell use and the extent of overtransfusion: right decision? Right amount? Transfusion 2011;51:1684-94.
Barr PJ, Bailie KEM. Transfusion thresholds in FOCUS. N Engl J Med. 2011. 365;26: 2532 – 2533
Carson JL, Grossman BJ, Kleinman S. On behalf of the Clinical Transfusion Medicine Committee of the AABB. Red blood cell transfusion: a clinical practice guidelines from the AABB. Ann Intern Med. 2012; 157(1): 49 – 58
Centers for disease and Control. Blood Safety. Department of Health and Human Services. http://www.cdc.gov/ncbddd/blooddisorders/documents/bbv_pnv_c0_1159_blood_safety_r1mtr.pdf
Hasley PB, Lave JR, Kapoor WN. The necessary and the unnecessary transfusion: a critical review of reported appropriateness rates and criteria for red cell transfusions. Transfusion 1994;34:110-5.
Hebert PC, Schweitzer I, Calder L, Blajchman M, Giulivi A. Review of the clinical practice literature on allogeneic red blood cell transfusion. CMAJ 1997;156:S9-26.
Hoffman A. Economics of Blood Transfusion. Presentation to the HHS Advisory Committee for Blood Safety and Availability. June 2011. http://nih.granicus.com/ViewPublisher.php?view_id=22
Pape A, Stein P, Horn O, Habler O. Clinical evidence of blood transfusion effectiveness. Blood Transfusion 2009. 7(4): 250 – 258
Shander A, Javidroozi M, Ozawa S, Hare GMT. What is really dangerous: anaemia or transfusion? Br J Anaesth 2011. 107(Suppl 1): i41- i59
Titmuss RT. The Gift Relationship: From Human Blood to Social Policy. London: Allen and Unwin, 1970.
Virone MG, Tarasenko N. WHO Europe. Patient Safety and Rights Developing tools to support consumer health literacy Reporters. August 2011. http://www.euro.who.int/__data/assets/pdf_file/0018/133128/e94739.pdf
Whitaker BI & Hinkins S. The 2011 National blood Collection and Utilization Survey Report. The United States Department of Health and Human Services. Bethesda, MD. http://www.hhs.gov/ash/bloodsafety/2011-nbcus.pdf
Williams S. Against the flow: what’s behind the decline in blood transfusions? Stanford Medicine. Spring 2013. http://sm.stanford.edu/archive/stanmed/2013spring/article5.html