"Innovation is the lifeblood of a perpetual movement in advancements"
Medicine cannot advance without the introduction of Innovation into clinical techniques
and practices and hence it is vital for progress in surgery. A key question “springs out” at
first instance: what is surgical innovation? A challenge to the definition of this concept is the
lack of consensus among surgeons on how they would distinguish innovation from
variations introduced in the clinical practice.
Identifying an innovation is essential to the collection of evidence recommended by the
IDEAL model. It is acknowledged in the literature that there are several key features of
surgical innovation that distinguishes it from incremental variations: newness or novelty;
degree of change; level of risk; impact; and requirement of formal processes. Nevertheless,
there is the need for a uniform and / or accepted definition of surgical innovation that will
assist surgeons to identify, manage and develop better therapies and thus increase patient
safety.
Surgical innovations comprise new techniques, modified strategies, or innovative
instruments1. Unlike the clear policies regulating pharmacological interventions and medical
devices, there is no established framework for the introduction and evaluation of a new
surgical therapy. Currently, the overall number of randomised controlled trials (RCT) and
systematic reviews in surgical innovation remains small in comparison with the number of
studies evaluating drug treatments1. Although challenging, the adequate assessment of
each new technology by the surgical community, the evaluation of surgical competence,
audit and provision of transparent informed consent should be part of the ethical evaluation
of untested, innovative surgery2. Solutions tailored to research and a framework to capture
evidence on which to base surgical practice are essential. Without an adequate evidence
base, healthcare practitioners cannot determine whether and innovation technique is the
most safe and effective method of treating a patient. To overcome such challenge and
improve the evidence base for surgery, the IDEAL framework describes five stages of
development and evaluation for surgical and interventional innovations: idea, development,
exploration, assessment and long-term study1.
Since the early 1990s, evidence-based healthcare has become a cornerstone in policies to
identify both effective and cost-effective practices, which has become central to rationing
decisions in the National Health Service (NHS). The basic economic problem is that
resources of healthcare provision are scarce but competing demands on them are infinite
hence to ensure efficient allocation in healthcare, it is required that benefits of an
intervention outweigh their opportunity cost. The National Institute for Health and Care
Excellence (NICE) attempts to address this problem by introducing guidance on what
treatment should be provided by the NHS, which in turn represents an approach to
introducing economic considerations into these decisions3. In June 2013, NICE was given
new Terms of Reference to implement value based assessment further by introducing a
broader definition of value (“blue print”) 4 with the purpose to allocate resources efficiently
and maximise public health.
Aiming to get a perspective and views from a leading key opinion leader and highly
recognised health professional, I interviewed Mr Aristotle Protopapas, Cardiothoracic
Surgeon, and invited him to comment on the following issues and therefore contributed to
this article by sharing his experience and knowledge and as it follows:
1) Provision of surgery and rationalisation towards surgical innovation
“There is only one philosophy to rationalise and appraise surgical innovation: the impact of
innovation on quality improvement. This means improved outcomes: in plain words, less
deaths, less complications, better quality of life. The key challenge is how we measure these
and how we compare outcomes. This is why we should apply cost effectiveness and cost
utility analyses5 to rationalise surgical innovation.”
2) The impact the regulatory framework and policies have on the quality of care (the
choices doctors and specialists face when confronted with cost containing
measures and the care that should be provided).
“As resources are finite, a rationalisation of spending is necessary at all levels: global,
international organisations, national organisations, healthcare networks, hospitals, health
practices and so on. Regardless of the social framework that governs healthcare spending, the
evidence-base medicine is a pre-requisite and in order to supply the best care, best treatment
and available funds these determining factors need be considered5. As you state and I agree
in principle, Healthcare systems are re-designing care from the patients’ perspective in order
to deliver high quality at low-cost. The goal of evidence-based medicine is to integrate clinical
expertise with the patients’ preferences using the best available evidence6.”
3) Regulation is a pre-requisite, what is the impact on innovation uptake?
“Regulation is a pre-requisite for any organised activity and policies are applied under the
umbrella of healthcare regulators. The successful regulation in surgery has to prove
improved outcomes, and such proof relies on robust measurement of those outcomes.”
“This impact on the adoption of surgical innovation is currently difficult to quantify. I am not
aware of an appropriate model that is used currently. It appears a Herculean task to
quantify such.”
4) What is the level of innovation uptake in the UK comparing to other EU countries
and USA?
“A meaningful comparison at this point would require data that I do not have to make a
comment on this issue. An accurate reply would require a model and study designed and
applied successfully to the healthcare economies of this country, Europe and the US.”
5) Are doctors (HC professionals) using the most innovative forms of care being
delivered to patients?
“Surgeons are specifically guided by a non-exhaustive list with a number of parameters:
empirical knowledge (where experience is valuable), clinical and laboratory evidence, clinical
guidelines established by the National Institute for Health and Care Excellence (NICE) in the
UK and the US Food and Drug Administration (FDA), professional societies, network policies
and of course direct contact with the industry through the web, educational activities,
advertisement or other.
There will always be colleagues who will innovate earlier than others, and the decision
pathways are complex and under scientific investigation. As we discussed, there is no magic
bullet in surgery and there should exist the controlled application of surgical innovation and
quality control measures such as: surgical audits (a cycle of monitoring the effect of a
change), outcomes recording and acting upon promptly, an enlightened yet robust surgical
regulation.”
6) Paying for outcomes rather than surgical activities
“This translates as outcome-based commissioning and appears to increasingly affect the
National Health Service (NHS) in Great Britain. I understand commissioning of surgical
provision at national, regional or local NHS level as the process of planning and purchasing
surgery for the patients through the Clinical Commissioning Groups. These are primary care
(general practice) teams.”
7) Paying for value rather than reimbursing surgical costs
“This is the same principle as paying for outcomes rather than activities and relies on
accurate coding and recording of performance.”
Final remarks:
In the modern surgical practice, progress has been captured from advances in anatomy,
physiology, pathology and anaesthetics to recent synergies embedded in technological
innovation.
Novel advancements happen by challenging the status quo, developing and testing new
ideas and principles that leads to the discovery of novel techniques and practice.
Innovation in surgery delivers benefits to patients as well as to the economy, the efficiency
of healthcare providers and other stakeholders at the national level, and to the global
society.
The overall process of innovation (i.e. from idea & development to implementation) is
challenging and its successful adoption depends on diffusion factors, which in turn have
interdependencies between evidence generation and assessment to financial resources,
professional training and infrastructure. Therefore, exploring patterns of innovation
development, diffusion and uptake will help and hinder the future of surgical innovation.
I am very thankful to Mr Aristotle Protopapas for kindly accepting the invitation to
contribute to this article!
REFERENCES:
[1] Diener, M. IDEAL Framework for Surgical Innovation. BMJ 2013; 346 : 3012.
[2] Veronique KM, Tan. An Approach to the Ethical Evaluation of Innovation Surgical
Procedures. Ann Acad Med Singapore 2011; 40 pp 26-29.
[3] Walker, S et al, The Role of Nice Technological Appraisal in NHS Rationing. British
Medical Bulletin 2007, 81 and 82 pp 51-64.
[4] ABPI. Understanding the 2014 Pharmaceutical Price Regulation Scheme.
[5] Ashrafian A, Sevdalis N, Athanasiou T. Evidence-based Surgery. In: Athanasiou T, Debas
H, Darzi A (Eds.) Key Topics in Surgical Research and Methodology. Berlin Heidelberg:
Springer-Verlag 2010 pp 9-27.
[6] Varghese TK, Farjah F, Flum DR. Decision Making: The Surgeon’s Perspective. In:
Ferguson MK (Ed.) Difficult Decisions in Thoracic Surgery: An Evidence-Based Approach.
Second Edition. London: Springer 2011 pp 45-61.