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\begin{document}

\title{Intra-operative use of biological products -- Are we aware of their
derivatives?}



\author[1]{Navdeep Bhamra}%
\author[1]{Karan Jolly}%
\author[1]{Adnan Darr}%
\author[2]{Duncan  Bowyer}%
\author[3]{Shahzada Ahmed}%
\affil[1]{Royal Wolverhampton Hospitals NHS Trust}%
\affil[2]{Shrewsbury and Telford Hospital NHS Trust}%
\affil[3]{University Hospitals Birmingham NHS Foundation Trust}%


\vspace{-1em}



  
  \date{May 24, 2024}


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\selectlanguage{english}
\begin{abstract}
Introduction: Global medical advances within healthcare have
subsequently led to the widespread introduction of biological products
such as grafts, haemostats, and sealants. Although these products have
been used for many decades, this subject is frequently not discussed
during the consent process and remains an area of contention. Methods: A
nationwide confidential online survey was distributed to UK-based junior
registrars (ST3-5), senior registrars (ST6-8), post-CCT fellows,
specialist associates/staff grade doctors and consultants working in
general/vascular surgery, neurosurgery, otolaryngology, oral \&
maxillofacial surgery and plastic surgery. Results: Data was collected
from a total of 308 survey respondents. Biological derivatives were
correctly identified in surgical products by only 25\% of survey
respondents, only 19\% stated that they regularly consent for use of
these products. Our results demonstrate that most participants in this
study do not routinely consent (81\%) to the intra-operative use of
biological materials. An overwhelming 74\% of participants agreed that
further education on the intra-operative use of biological materials
would be valuable. Discussion: This study highlights deficiencies in
knowledge that results in potential ethical compromise of the consenting
process for surgical procedures. A solution to this would be for
clinicians to increase their awareness via educational platforms 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: 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.%
\end{abstract}%



\sloppy


\emph{Intra-operative use of biological products -- are we aware of
their derivatives?}

\textbf{Dr Navdeep Bhamra -- MBChB, Department of Otolaryngology, The
Royal Wolverhampton NHS Trust, UK. \emph{--}} \emph{study conception and
design, analysis and interpretation, data collection, writing and
critical revision of article.}

navdeepbhamra@gmail.com

\textbf{Mr. Karan Jolly -- MBChB, FRCS (ORL-HNS), Department of
Otolaryngology, The Royal Wolverhampton NHS Trust, UK. \emph{--}}
\emph{study conception and design, analysis and interpretation, data
collection, writing of article.}

kjolly@nhs.net

\textbf{Mr. Adnan Darr -- BSc (Hons), MSc, MBChB, FRCS (ORL-HNS),
Department of Otolaryngology, The Royal Wolverhampton NHS Trust,
UK.\emph{--}} \emph{study conception and design, analysis and
interpretation, data collection, critical revision of article.}

adnan.darr@nhs.net

\textbf{Mr. Duncan J Bowyer -- MBChB, FRCS (ORL-HNS), Department of
Otolaryngology, Shrewsbury and Telford Hospital NHS Trust, UK.\emph{--}}
\emph{study conception and critical revision of article.}

duncan.bowyer@sath.nhs.uk

\textbf{Mr. Shahzada K Ahmed -- BSc (Hons) DLO MBChB, FRCS (ORL-HNS),
PhD, Department of Otolaryngology, University Hospitals Birmingham NHS
Trust, UK.} \emph{-- study conception and critical revision of article.}

shahz.ahmed@nhs.net

All authors have read and approved the paper.

\emph{Corresponding author:}

Dr Navdeep Bhamra - The Royal Wolverhampton NHS Trust, UK, WV10 0QP --
navdeepbhamra@gmail.com.

Dr Navdeep Bhamra assumes full responsibility for the integrity of the
content of this paper.

No conflicts of interest or funding to be declared.

No ethical approval was required for this study.

\textbf{Abstract}

\textbf{INTRODUCTION} Global medical advances within healthcare have
subsequently led to the widespread introduction of biological products
such as grafts, haemostats, and sealants. Although these products have
been used for many decades, this subject is frequently not discussed
during the consent process and remains an area of contention.

\textbf{METHODS}

A nationwide confidential online survey was distributed to UK-based
junior registrars (ST3-5), senior registrars (ST6-8), post-CCT fellows,
specialist associates/staff grade doctors and consultants working in
general/vascular surgery, neurosurgery, otolaryngology, oral \&
maxillofacial surgery and plastic surgery.

\textbf{RESULTS}

Data was collected from a total of 308 survey respondents. Biological
derivatives were correctly identified in surgical products by only 25\%
of survey respondents, only 19\% stated that they regularly consent for
use of these products. Our results demonstrate that most participants in
this study do not routinely consent (81\%) to the intra-operative use of
biological materials. An overwhelming 74\% of participants agreed that
further education on the intra-operative use of biological materials
would be valuable.

\textbf{DISCUSSION}

This study highlights deficiencies in knowledge that results in
potential compromise of the consenting process for surgical procedures.
A solution to this would be for clinicians to increase their awareness
via educational platforms 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.

\textbf{CONCLUSION}

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.

\textbf{MeSH Keywords: Biological products, consent, education,
surgery.}

\textbf{What is known about this topic:}

Global medical advances within healthcare have subsequently led to the
widespread introduction of biological products such as grafts,
haemostats, and sealants. Although these products have been used for
many decades, this subject is frequently not discussed during the
consent process and remains an area of contention.

A recent study demonstrated that in 534 patient respondents, 44\% wanted
to be informed if biological products were to be used and 17\% objected
to their use.

\textbf{What does this article add?}

As demonstrated by our observational study, 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.

\textbf{INTRODUCTION:} Global medical advances within the field of
healthcare have subsequently led to the widespread introduction of
biological products. Medication, dressings, implants and tissue grafts
derived from human or animal material have become part of routine
practice.11Jolly, K., Darr, A., Aslanidou, A., Bowyer, D., \& Ahmed, S.
(2019). \emph{The intra-operative use of biological products: A
multi-centre regional patient perspective of a potential consenting
conundrum. Clinical Otolaryngology.} doi:10.1111/coa.13367 Although
these products have been used by doctors for many decades, this subject
is frequently not discussed during the consent process and remains a
controversial topic.22Enoch, S., Shaaban, H., Dunn, KW. (2005).
\emph{Informed consent should be obtained from patients to use products
(skin substitutes) and dressings containing biological material. Journal
of Medical Ethics, 31(1), 2--6.}
doi:10.1136/jme.2003.005272~\textsuperscript{,}33Eriksson, A.,
Burcharth, J. \& Rosenberg, J. Animal derived products may conflict with
religious patients' beliefs.~\emph{BMC Med Ethics} ~\textbf{14,~} 48
(2013). https://doi.org/10.1186/1472-6939-14-48 The majority of
biological materials used intra-operatively in modern surgery contain
porcine or bovine derivatives, the most common of which is
gelatin.\textsuperscript{1} Gelatin is found in collagen extracted from
dermal and skeletal structures of cows (bovine) and pigs (porcine). The
use of gelatin has been evaluated by different faith groups, however
general consensus remains a contentious issue.\textsuperscript{3}

Broadly speaking biological materials can be divided into three main
categories based upon their primary use: grafts, haemostats, and
sealants (Table 1). The evolution of new surgical techniques has been
facilitated by the development of a range of materials used as grafts
and sealants to repair defects and promote wound healing, as well as
haemostats to stop bleeding and reduce infection. Consideration is
required with their use to ensure that it does not conflict with the
patient's ethical, personal, or religious beliefs. It has been
documented that Buddhists, Christians (including of Jehovah's witnesses)
and Jews accept the use of dressings, implants or medication which are
of animal or human origin.\textsuperscript{3} Amongst other faiths,
Hindus and Sikhs do not permit the use of any products derived from
bovine material\textsuperscript{3,}44Sattar, S. P., Ahmed, M. S.,
Majeed, F., \& Petty, F. (2004). \emph{Inert Medication Ingredients
Causing Nonadherence Due to Religious Beliefs. Annals of
Pharmacotherapy, 38(4), 621--624.} doi:10.1345/aph.1d324~, and Muslims
object to the use of porcine-derived materials. However, in general,
most faiths agree that in an emergency life-threatening situation the
use of any product biological or otherwise is permitted.55Easterbrook,
C. (2008). \emph{Porcine and Bovine Surgical Products. Archives of
Surgery, 143(4), 366.}doi:10.1001/archsurg.143.4.366 The major exception
to this is in the Jehovah's witness community where it is strictly
forbidden to receive primary human blood components (red blood cells,
plasma, platelets)\textsuperscript{1}, however the use of human-derived
mesh is unclear.66Dixon JL, Smalley MG. Jehova's Witnesses: the
surgical/ethical challenge. JAMA 1981;246:2471--2472. A recent study
demonstrated that in 534 patient respondents, 44\% wanted to be informed
if biological products were to be used and 17\% objected to their use.
The reason for objection was multifactorial and often not motivated by
religious beliefs.\textsuperscript{1}

Owing to the routine use of biological products in surgical practice and
patient's stated desire to be informed if this is to be the case, it is
essential that this forms part of the consent process. Anecdotally the
authors found that the use of these products are not routinely being
discussed pre-operatively with patients in the United Kingdom (UK); we
believe that may partially be due to a lack of knowledge of the
constituents of biological materials by the clinician.

We sought to investigate on a national scale what proportion of surgeons
from a range of specialties routinely consent for the intra-operative
use of biological materials, whilst assessing awareness of these
products and their derivatives. We hope this study will strengthen and
support our belief that informed consent for the use of biological
products intra-operatively should be added to the standard consent form
template for all surgery.

\textbf{METHOD:}

A nationwide confidential online survey (Table 2) was distributed to
UK-based junior registrars (ST3-5), senior registrars (ST6-8), post-CCT
fellows, specialist associates/staff grade doctors and consultants
working in general/vascular surgery, neurosurgery, otolaryngology, oral
\& maxillofacial surgery and plastic surgery. Dissemination platforms
included social media and local and national trust based internal mail.
Demographic data including the participant's grade, region of employment
and parent speciality were collected, all respondents remaining
anonymous. The survey was tailored to each speciality, with specific
questions about materials that reflected commonly used products in their
surgical practice. Each participant was given the name of three
biological materials which would be used in their speciality and asked
to correctly identify the derivative. These questions equally
represented the three categories of biological material we have
previously outlined (grafts, haemostats, and sealants). Each participant
was also asked whether they currently routinely consent for the use of
biological material intra-operatively and if they felt that further
education in this area would be of value for clinicians.

The survey was created online and distributed via a weblink using social
media and email correspondence. Data was analysed using Microsoft Excel.
This weblink survey was live for 4 months from November 2019 to February
2020.

\textbf{RESULTS:} Data was collected from a total of 308 survey
respondents.

Of the respondents, 34\% were consultants (n=105), 29\% senior
registrars and post-CCT fellows (n=88), 25\% junior registrars (n=77)
and 12\% specialist associates/staff grades (n=38). The largest
proportion of responses were obtained within the West Midlands deanery
(n=71, 23\%) and then by London deaneries (n=46, 15\%). The breakdown
for the responses collected in other deaneries are summarised below
(Table 3).

General and vascular surgery was the most represented speciality (n=120,
39\%), followed by otolaryngology (n=109, 35\%), neurosurgery (n=34,
11\%), plastic surgery (n=24, 8\%) and lastly oral \& maxillofacial
surgery (n=21, 7\%), (Table 4).

Biological derivatives were correctly identified in surgical products by
only 25\% of survey respondents. Within this, 80 survey respondents
identified the correct biological derivative for grafts (26\%), 62 for
haemostats (20\%) and 85 for sealants (28\%). The correct response rate
for all the materials by speciality is summarised in table 4. Our
results demonstrate a poor awareness about the constituents of the
products surgeons commonly use across all specialties.

There was no observed significance in correct response rate between the
grade of surgeon. Overall, all grades demonstrated poor knowledge in
this area (Table 4).

Of the total 308 survey participants, 19\% stated that they regularly
consent for use of these products. Analysing the individual surgical
specialties included in this survey, otolaryngologists most commonly
consent routinely for the use of biological materials during surgery
(23\%), with oral and maxillofacial surgeons most infrequently (10\%).
An overwhelming 74\% of participants agreed that further education on
the intra-operative use of biological materials would be valuable (Table
5).

\textbf{DISCUSSION:}

The use of biological products in medicine has become routine but
remains controversial and the subject of
debate.\textsuperscript{5}Patients 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.\textsuperscript{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 \emph{Ipsos Mori} study commissioned
by\emph{The 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. \emph{Food
and You
Survey}https://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 (\emph{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.

\textbf{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.

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