“When the great innovation appears, it will almost certainly be in muddled, incomplete and confusing form....For any speculation which does not at first glance look crazy, there is no hope”
Healthcare by its very nature is complex. It comprises of not just one single integrated system, but consists of a large number of interrelated systems.¹  Risk²  is inherent in the system. As a result of its complexity, it is also prone to errors due to concatenation of multiple small failures.³  Given the fore-going, it is unsurprising that a patient care pathway can be complex as regards the nature of care delivered and in the number of organisations that contribute to the care.⁴  In parallel to this is the mounting cost of healthcare, emergence of post approval hurdle-pricing reimbursement and health technology assessments-that are more stringent.

Risk in general lacks precision both in definition and the impact it presents. There appears to be an inverse relationship between the tolerance of risk in a given society and its level of affluence. However, most affluent society seeks change in the delivery of service. This is to make for faster, efficient and effective delivery of quality services taking advantage of new technologies. The paradox is that change is front-loaded with uncertainty and it is inherently risky. In the National Health Service-as in many public organisations in developed societies that are involved in healthcare-change is influenced by the public choice theory⁵  and market theory principles.⁶  The government is increasingly relying on effective partnership to deliver on broad outcome measures⁷  which is the nature of Public Service Agreement (PSA). Of note, it recognises that good risk management is integral to delivery of successful partnership.⁸  Collaboration, co-invention and partnership have now become the buzz words in the pharmaceutical industries as part of effort to optimise on their research and development undertakings, reduce redundant capacity and adoption of Darwinian approach to portfolio management.

The development of risk assessment and management is largely due to trends in the wider society, technological advances in health care, and the paradigm shift from paternalism to autonomy, consumerism, and clinical negligence litigation.⁹  Further, in post-Vioxx world, the regulatory environment in the industry has become more challenging resulting in robust risk management and label restrictions. The political and economic trends and impacts on risk assessment and management are now more ubiquitous; and conflate and complicate the perception of risks.

Given this background, wholesale or partial significant changes in healthcare or a significant change in direction must be done circumspectly whilst factoring in inter alia: the complexity of the sector, risk management and resource reallocation among the various competing influences. According to Le Chatelier’s principle¹⁰  which can be roughly stated as:

“Any change in status quo within a closed system will result in an opposing reaction in the responding system.”

At this stage in this discourse, it may be pertinent to look at the practical applications of change particularly with respect to research in healthcare as recently advocated by some healthcare leaders.

In December 2012, Lucien Engelen, director Raboud REshape and Innovation Centre at Raboud University Njimegen Medical Centre communicated his ‘Big Ideas 2013:The ideas include a launch of an initiative where patients together with their family and informal carers will come up with research-ideas and patients will also try to raise the money for chosen research ideas.’ According to Mr Engelen, ‘This will start a new movement.”

Mr Engelen’s qualities as a visionary leader (his innovation centre is the second largest Academic Medical Centre in the Netherlands) and indeed enthusiasm are never in doubt. Neither is his honest intention to make healthcare truly participatory with patient at the very heart of service delivery. In principle participatory healthcare is laudable, given that patients come into such partnership/relationship better informed and able to negotiate better and take active part in management of their health.

However, it may be of some concern when ‘Big Ideas’ are bandied around with a complete disconnect between fundamental research and applied research. His idea of research needless to say is informed by the wisdom of the crowd and successes in other fields-art and culture, new technology etc. Healthcare is unique in more ways than one and attempts to extrapolate from other unrelated sector may have the unintended consequences that have far reaching implications.

Bold initiatives and innovation are laudable in all human efforts and endeavours, be it healthcare, other sectors, etc. The problem with the big ideas in research as advanced by Mr Englene is that it is emotive--and I dare say--has a whiff of personal imprimatur in his attempt to vivify research. Further, big ideas by its very nature, generally have at stake self-beliefs, ego and personal ambitions, etc; “outcomes”¹¹ (as it is said torture data long enough it will confess to anything) become everything. The new game will be the end justifies the means and as a result ‘Lance Armstronging’¹² investigative studies will not be off the radar of the “researchers,” given that the vocal minority backing the effort will be banking on immediate positive outcomes. This cannot by any stretch of definition be called a scientific quest for truth. Call it by any other name--by all means-but not research. Research in healthcare is complex and is beset with vicissitudes of life. Serendipity is integral to any serious research effort and certainly it has changed lives. Part of the reasons why pharmaceutical industries have not had as many successes as previously--apart from the fact that previous research efforts have picked the low hanging fruits--is the ‘sanitised’ funding that leaves little room for serendipity. I am pleased to note that The Dean of the University where Mr Englene is based, Paul Smits, although he likes the idea--it brings science into the living room’--however cautioned that care ought to be exercised that the big ideas are not pursued at the expense of fundamental research.

We have to accept that certain endeavours are more difficult than others, no matter how much other disciplines may attempt to borrow from science or even language up what they do to imbricate scientific investigations. The output will be at best a pseudoscientific pretender. Einstein’s wise words are instructive: “Everything should be made as simple as possible, but not simpler.”

By Dr Anayo Unachukwu

The author anayou@gmail.com is a medical doctor; he was a consultant psychiatrist at Ansel Clinic Nottingham, UK. He is currently into research and publication while researching for a book on chronic pain. He is interested in medico-legal matters and social inequality and their effect on health and public understanding of medical research. He has a Masters of Law Degree (LLM). His author’s URL http://ssrn.com/author=1182210 for some of his medico-legal papers.

End notes

¹.Ellie Scrivens, Quality, Risk And Control in Health Care. Open University Press 2005. p. 8
² HM Treasure. The Orange Book Management of Risk-Principle and Concepts (October 2004).
³ Ibid.
⁴ Sheila Peskett, “The challenges of commissioning healthcare: a discussion paper,” Int J Health Plann Mgmt 2009; 24: 95-112.
⁵ This take the view that publicly provided services are prone to be less efficient, less productive and less focused on their customers than privately provided services.
⁶ Competition amongst providers will drive up quality, innovation and productivity whilst containing costs.
⁷ This applies not only in the  health sector and other public sectors.
⁸ HM TREASURY. Managing risks with delivery partners. Office of Government Commerce (OCG).
⁹ Department of Health Making Amends: A Consultation Paper Setting out proposals for Reforming the Approach to Clinical Negligence in the NHS (2003); the cost of compensating patients jumped 400 per cent in the course of the 1970s and 750 per cent in the 1990s.
¹⁰This principle is native to chemistry and  in its original form states that in a closed system-a chemical system-if it experiences a change in concentration, temperature, volume or pressure, the new equilibrium is achieved to counteract the imposed change.
¹¹ Who is measuring; always bear in mind Hawthorn’s effect
¹² One is not talking about being dishonest to achieve a success, but going to an inordinate extraordinary length to see that success is ensured without counting the cost in the long term.