DISCUSSION:
The use of biological products in medicine has become routine but remains controversial and the subject of debate.5Patients wish to know the derivative of any biological products that may be used, which itself raises the issue of informed consent prior to their use.1 Due to a patient’s ethical, religious or personal beliefs the use of these biological products without consent is morally flawed. Clinicians tend to underestimate the impact and importance of religion in their patients’ lives and the implications of this upon their care.11Sulmasy DP. The healer’s calling: a spirituality for physicians and other health care professionals. New York: Paulist Press; 1997 Ignoring the impact of religion on a patient’s decision is likely to lead to a breakdown in the trust between clinician and patient.22Silvestri GA, Knittig S, Zoller JS, Nietert PJ. Importance of faith on medical decisions regarding cancer care. J Clin Oncol 2003; 21:1379–1382.
Whilst religion remains a major influence on the objection of the medicinal use of biological products, there has been an increase in people who self-identify as vegan and also object to the use of animal derived products. In a 2018 Ipsos Mori study commissioned byThe Vegan Society , the number of vegans in the United Kingdom had increased from 0.25% of the population to 1.16% in 2018, which equates to approximately 600,000 adults.33The Vegan Society. Food and You Surveyhttps://www.vegansociety.com/my-account/the-vegan/issue-3-2018/survey (Accessed 01/04/2020) This number may have increased further given the recent publicity and awareness-raising campaigns promoting veganism and vegetarianism. Of the biological products we have included within this survey, only one product (Surgicel ) is plant-based, with the remainder including a human or animal derivative. This can restrict treatment options in those who specifically object to the use of products of human or animal origin, potentially altering surgical outcomes. Alongside this, we must not overlook that objection to the use of biological products need not be driven by religious or dietary motives but more a matter of personal ethical and moral principles.
This study has demonstrated that there is a lack of awareness amongst surgeons of biological products and their derivatives, implying that patients are also often unaware and thus may not be consented for their use. This lack of awareness can be appropriately addressed by educating clinicians, which can be delivered efficiently through educational platforms such as e-learning modules. This notion is supported by 74% of our cohort who agreed that further education was required in this subject area (Table 5).
The design of this study may have given rise to a degree of participant bias, as respondents may have been more likely to complete the survey if they had sufficient knowledge within the field. A greater geographic spread, as well as numbers in specialties other than general surgery/ vascular surgery and otolaryngology may have highlighted specific deficits in knowledge.
Our results demonstrate that most participants in this study do not routinely consent (81%) to the intra-operative use of biological materials (Table 5). The authors hope that this study highlights deficiencies in knowledge that results in potential compromise of the consenting process for surgical procedures. A simple solution to this would be for clinicians to increase their awareness in this area and to incorporate an additional statement on the consent form which addresses the potential intraoperative use of biological products and what their derivatives may be.
CONCLUSION: Although the intra-operative use of biological materials has become routine, the consent process does not reflect this. Patients wish to know which products may be used during their procedure; however, this is not being routinely discussed pre-operatively. This may partly be due to a lack of awareness amongst surgeons of the contents of these products, highlighting a need for increased education. The authors recommend that the use of biological products should be added to a surgical consent, allowing surgeons to have an open and transparent discussion, whilst upholding their duty to ensure that their clinical practice is patient centred. Modernising the current consent process to reflect the development and use of surgical biological products will help to ensure improved patient satisfaction, fewer future legal implications as well as a better surgeon-patient relationship.
No further acknowledgements.