Introduction
What is professional practice and how does it differ between patient facing versus laboratory based clinical scientists? Is there in fact a difference? Professional practice is one of the 5 domains of good scientific practice which define the standards and values all healthcare professionals should strive towards. Additionally, professional practice can be further divided into professional practice, probity, working with colleagues and training and developing others. As can be imagined all clinical scientists, whether in a patient facing role or not, will need to embody each of these to be an effective healthcare scientist.
Histocompatibility and Immunogenetics (H&I) is the branch of Clinical Science involved in HLA typing and screening for solid organ and haematopoietic stem cell transplants (Histocompatibility) and the genetics of major histocompatibility complex associated disease (immunogenetics). Clinical scientists within this field have limited patient interactions yet must still embody professional practice. Each of the following statements will examine aspects of professional practice and how they impact on the role of clinical scientists within H&I.
‘Clinical scientists lead the way in innovation’
The central tenet of professional practice, and the very core of the NHS constitution, is to make the patient your first consideration. While this includes concepts such as exercising duty of care and keeping scientific skills relevant and up-to-date, it also encompasses scientific innovation for the betterment of patient care whether by improving diagnostic tools or developing newer, better treatments. With the NHS being the single biggest integrated healthcare system worldwide with a history of innovation, a staff who are in a unique position to identify the most prominent clinical need plus a patient population willing to become involved in clinical research (1) one could conclude that clinical scientists are in the perfect position to provide leadership in scientific innovation.
One area where H&I clinical scientists have the opportunity for leadership is through immunogenetics and the implementation of personalised medicine. Personalised medicine is based on the ability to predict how an individual patient with react to a specific therapy, or the likelihood of determining who is at risk of developing certain diseases. Current treatment options are based on a ‘one-sized fits all’ approach where a diagnosis is made based on clinical presentation, and the same first line treatment is given to every patient diagnosed with the condition. This results in a therapeutic efficiency of 30-60% (2). Immunogenetics can be utilised to determine a patients’ underlying characterisation, inform a tailored treatment which could increase therapeutic efficiency and even reduce the occurrence of side-effects. One example of how immunogenetics and personalised medicine has improved patient outcome is in the treatment of HIV. Abacavir is a drug routinely used to treat HIV/AIDS that can have an adverse hypersensitivity in some patients (3). The adverse response to abacavir was shown to only occur in patients with the HLA-B57*01 allele (4). So consistent was this observation that it is now policy to test HIV patients for the presence of HLA-B27 prior to embarking on abacavir treatment (5). The role of immunogenetics in determining patient therapy is still emerging yet promises to play an essential role in delivering excellent patient outcomes.
The NHS chief executive wrote in 2011 that the ambition for the NHS was to show a commitment to innovation which would be demonstrated by supporting research and adoption of the most innovative ideas, products and services into clinical practice (6). However, does the NHS have the funding to carry out innovative clinical research? Per a health research analysis published in 2015 there are 4 major sectors involved in health-relevant research – Business, University, Public Sector and Private non-profit. From the public sector research budget for 2014 (£1.9bn), only 15.3% was spent in R&D in the public sector (7). Of this 15.3%, less than 1% (£16.4m) was spent on renal research (7). This funding also includes funding for urogenital research and is distributed through a variety of research streams including disease aetiology, prevention, treatment and disease management. These numbers show a disproportionate distribution when comparing the burden of renal disease to the level of funding (7).
Within the UK there is also a geographic inequality in funding to consider. As of 2014 London received 32% of all health care funding with Scotland, Wales and Northern Ireland sharing 16.1% between them. Oxford and Cambridge also receive less funding combined than London (22.8%) (7). In addition to funding, there is also the issue of staff availability to carry out research. With the number of people on the transplant waiting list increasing on a yearly basis, clinical scientists in H&I are facing an ever-increasing workload that may negatively impact on their ability to perform innovative research. To ensure that innovation continues in H&I may therefore require clinical scientists to show leadership by developing constructive collaborations with Business or Academic groups to combine the knowledge of what is needed with the capability to provide the time and funding to carry out the research.
‘Clinical scientists must consider the ethical implication of altruistic kidney donation’
As of April 2016, 6476 patients were active on the organ transplant list in the UK; of these 5275 were awaiting kidney transplants (8). In 2015-2016 3071 kidney transplants were carried out (8). Assuming a similar number of transplants occur in 2016-2017 that provides a shortfall of 2204 kidneys. While the number of donors (both deceased and living) are increasing, thus improving organ procurement, alternate methods of transplantation are required to make up the shortfall. It must also be borne in mind that there is currently a steady increase in the diagnoses of Type 2 diabetes mellitus (9), which will provide a steady increase in the number of patients who require kidney transplantations in the future.
In addition to the described shortfall in the number of kidneys available for transplantation, the financial impact of chronic kidney disease (CKD) also indicates that new solutions for transplantation are required. A study by Kerr et.al. from 2012 examined the financial impact of CKD on the NHS (10). The authors found that in 2009-2010 the estimated cost of CKD to the NHS was £1.45billion, or 1.3% of the NHS budget; this is a significant proportion of the NHS budget for relatively few patients. With the average time from placement on the transplant list to organ transplantation currently being 30 months (14 months-43 months) (8,11) a large proportion of this spending is on dialysis and patient maintenance. Dependent upon which method of dialysis a patient is placed on while awaiting transplantation the annual cost can range from £18,986 to £24,602 (12). This annual cost doesn’t take into consideration patient transport costs or patient maintenance. With transplantation giving both an increased life-span compared with dialysis, and being more cost-effective alternative methods to increase the available donor organ pool are required.
Although the numbers of deceased donors are increasing yearly (8,11), there are still around 40% of families who refuse to consent to the use of such organs despite the potential donor being on the organ donor register (11). Add in the fact that patient outcomes are improved with live donation and the focus then becomes increasing the pool of living donors (13). To achieve this one option that may become a focus for clinical scientists in H&I is that of altruistic donation and the shared kidney scheme. Altruistic donation occurs when a person donates to an unknown
recipient. The shared kidney scheme, also known as paired donation, involves a minimum of two incompatible recipient-donor pairs who swap incompatible donors (13). Paired donation can involve a chain of transplants where each recipient incompatible donor donates to the next recipient. Often these chains begin with an altruistic donor, known as a domino-paired donation. There are ethical and legal considerations for altruistic donations. Clinical scientists have a duty under the profession practice standards and values to consider these ethical and legal pitfalls, not only for the recipient but also on behalf of the altruistic donor.
A review by Fortins (2013) described 4 primary ethical issues (14). These ethical issues were 1) risk:benefit ratio, 2) informed consent, 3) anonymity and 4) organ equivalency. The risk:benefit ratio is in favour of the recipient as they receive a kidney from a living donor while the donor undergoes a non-medically required surgery. Informed consent can be defined as a formal agreement that a patient signs to give permission for medical intervention (in this situation surgery) after achieving an understanding of what is involved. In the case of altruistic donation informed consent must be received from the donor prior to any testing being carried out by the laboratory. Anonymity is suggested to be essential to prevent psychological pressure being placed on the altruistic donor from the recipient or their families. With a domino-paired donation there is no guarantee that donors will have the same physical characteristics (age, immunological compatibility) so is it ethical to allow a shared donation to occur if everyone isn’t receiving the same quality of organ?
From a clinical scientist viewpoint, the most pressing ethical concern is that of informed consent. As HLA testing is done at a genetic level there is a risk of secondary findings e.g. genetic susceptibility to disease. Prior to any testing occurring clinical scientists must ensure that the altruistic donor has been given all required information required for informed consent.
‘Effective communication in multidisciplinary teams saves lives’
The aspect of professional practice covered by the above statement is working with colleagues, and specifically working efficiently as a member of a multidisciplinary team. The Department of Health has suggested that multidisciplinary team meetings are the core model for managing chronic diseases such as chronic kidney disease (CKD). The uptake in multidisciplinary team meetings within the NHS have coincided with an increase in medical specialism, increasing complexity in medical knowledge and a push to involve patients in their own treatment (15). The use of multidisciplinary team meetings may provide patients with an improved outcome due to effective decision making. A significant advantage of multidisciplinary teams is the prevention of preferential partnering occurring (16). Preferential partnering in health care situations generally occur when decisions regarding patient care are taken by one set of professionals (e.g. surgical team) with no input from other care professionals involved in patient care.
Despite enthusiasm for multidisciplinary team and the potential for a better patient outcome, not everyone agrees that multidisciplinary team are the best model. One potential bases for disagreement with the benefits of multidisciplinary team meetings is the potential for biases to occur which are not in the patients best interest (17). Mazzaferro et.al. described the possible biases as excessive empiricism or rationalism, considering risk of an adverse event occurring over the potential benefit of a specific treatment and the risk of clinicians choosing self-indulgent treatment options for fear of losing control (17).
Clinical scientists in H&I are involved in several multidisciplinary team meetings to ensure the effectiveness of the laboratory’s processes particularly pre- and post-transplant. The multidisciplinary team meetings outlined here are specific for solid organ, particularly kidney, transplants. One of the most important multidisciplinary team meetings that H&I clinical scientists attend is the Antibody Incompatible Transplantation (AIT) meeting. The previous statement looked at the rise of altruistic donors and the kidney sharing scheme. However, some patients are so sensitised that it is highly unlikely that a potential match will be easily identified through normal routes. Between 2012-2015 patients with a calculated reaction frequency of >95% who were also highly sensitised had a transplant rate of 17%, compared with 40% for those less sensitised. In such cases, it may be suggested that these patients consider an AIT.
While there are treatments available that may reduce the risks from an AIT it may be more in the patients’ best interest to consider putting them into the shared kidney scheme discussed above, particularly if they have an unmatched living donor. Therefore, the AIT multidisciplinary team must discuss the options available for each sensitised patient. The British Society of Transplantation guidelines for AIT recommend that sensitised patients have two runs through the shared kidney scheme after which AIT should be discussed with the patient (18). It is imperative that the patient fully understands the risk that such a transplant entails, over and above the risks of transplantation itself. It is essential that all members of the AIT multidisciplinary team are aware of the status of each high-risk patient.
There are two other multidisciplinary team meetings for solid organ transplant where H&I clinical scientists are involved. First is the pre-transplant multidisciplinary team known as the listing meeting. The main aim of this multidisciplinary team is to ensure that as a transplant unit consistent care is delivered, and that all members of the clinical team agree about whether a patient is suitable for listing on the organ donation waiting list. From the clinical scientists’ viewpoint, this multidisciplinary team ensures that the laboratory has knowledge of all patients being considered for transplant, and that all required tests have been carried out. The pre-listing multidisciplinary team meeting also ensures that H&I clinical scientists are made aware of any sensitising event that may require a patient be re-tested such as pregnancy or blood transfusion as per the BSHI guidelines (19). Post-transplantation there is the Solid Organ Transplant multidisciplinary team meeting. During this meeting, all post-transplant patients are discussed. For clinical scientists, this meeting is essential for ensuring post-transplant monitoring. Post-transplant monitoring is essential in cases where graft rejection is suspected (19). Early intervention with a potential rejection can save the transplant if treatment is begun as soon as symptoms are detected (20).
While the merits of multidisciplinary team meetings may be debated for other medical specialisms, within H&I they are essential for ensuring decisions are made in the best interests of the patients, decisions that may save the lives of transplant patients.
Conclusion
Laboratory based clinical scientists best serve patients by ensuring all laboratory tests are carried out to the highest standard and by providing leadership to developing new technologies and therapies that will allow to improve patient outcomes. With restrictions in NHS funding reducing the ability of clinical scientists to perform innovative clinical research, clinical scientists in H&I may have a role in championing of altruistic donations and the advent of personalised medicine. While the merits of multidisciplinary team meetings are debated in other disciplines, within H&I they are invaluable for providing the best care and treatment options for transplantation patients.
To answer the question posed in the Introduction – no there is no difference in professional practice between patient facing and non-patie
nt facing clinical scientists. Irrespective of specialism all clinical scientists should aim to follow the tenets of professional practice and abide by the pillars of the NHS constitution. If a clinical scientist were ever to lose sight of why professional practice is so important all they need to do is consider one question – how would you want someone who was involved in the care of one of their loved ones to act?