Standards for Regulation

Stephen Tyreman, Thinking about guidelines:

Following on from the stimulating and highly relevant discussion about guidelines, I want to raise the point that there is a political dimension to the guidelines question that can’t be ignored if the CauseHealth project is to have practical relevance. I recognise that the previous discussion was around clinical guidelines such as those produced by NICE, but these cannot be divorced from the broader issue of guidelines as they concern professional regulation.

I’m currently working with Prof Bill Fulford and the General Osteopathic Council (GOsC) in the UK to review the rôle of professional regulation in the profession. The GOsC became aware some time ago that the perception of regulation by the profession was at best defensive—‘How do I ensure I stay out of trouble?’—and at worst hostile and mistrustful—‘What do ‘they’ know about healthcare and why should I change my behaviour because of bad practice in other professions?’. The question that Tim Walker, the Chief Exec. of the GOsC, is asking is how does a regulating body better support its members in doing the right or the best thing, rather than appearing to stand there to catch people out when they make mistakes? How do we avoid what has been termed, ‘the iron cage of regulation’?

This is an issue that was also raised last year by the Professional Standards Authority (PSA) who are the body responsible to government for overseeing the regulators. They recognise that something is wrong and needs a different approach, what they perceive as ‘the right touch’. They recognise that health and social care today is complex and entails practices that are not met by the current regulatory framework.

What has been happening is that when something bad or serious/harmful occurs such as Mid-Staffordshire, Shipman, Bristol and so on, which rightly causes public and political anger/concern, the response has been to bring in a new set of regulations/guidelines to counter it, to ensure it never happens again. An attempted simple solution to a complex problem. (Brexit and Trump are perfect examples of this.) Of course, it is not just in healthcare this occurs, it is the reflex response to any dramatic catastrophe, e.g. gun laws following the Dunblane massacre. The problem is that there are often unforeseen consequences from tinkering with complex situations, plus, these events are often specific to single or atypical situations that ordinary practitioners find difficult to relate to their experience or to see the relevance of for dealing with common everyday events.

The result is an increasing gap between grass-roots practitioners concerned to do a good job in providing effective treatment to patients who are individual and often complex, and the regulator who is seen as an outsider bringing in extraneous, unhelpful elements to situations they are perceived as knowing little about.

In a report commissioned by the GOsC in 2015 into practitioners’ perceptions of regulation it was found that 22% were concerned that their practice didn’t meet the Osteopathic Practice Standards (OPS). Unless nearly a quarter of the profession are consciously providing poor quality care, something is going wrong when what practitioners do, and what they see as required by the regulator, fail to coincide. It’s perhaps similar to the situation where students focus their learning on what is required by the examinations rather than what is intrinsic to the subject itself.

Where Bill Fulford and I have been involved is in looking to bring his Values Based Practice (VBP) approach to balance the narrow and Draconian effect that EBM has brought into clinical decision making. VBP explicitly recognises that even the most technical decisions involve not just ‘best evidence’, but also values and these values belong to patients, practitioners and many others involved in the clinical situation. The important thing about values is that they are often disputed and controversial; different people may hold conflicting views that are not so much disagreement on ‘the facts’ but about priorities, what is important and what matters to them in their life. Patients may value parts of the therapeutic relationship differently from their practitioner and both may assume the other thinks like they do.

VBP is being given further support by the recent Montgomery judgement in which ‘doing the right thing’ for a patient is not just following the guidelines or taking account of risks as a percentage, but taking into account ‘what matters’ to the patient what his/her values are. This involves a different kind of decision-making and can’t be achieved by reading out all the risks, or ticking a box that says we’ve told the patient the implications of the procedure being recommended. It involves asking how this treatment might impact on the patient’s life and what matters to them. This requires a proper dialogue. What the regulators realise they are up against in supporting this is that practitioners will not be able to follow a safe procedure—an algorithm or guideline—that will guarantee they do the right thing; they must make a judgment weighing up a range of fact and value-based criteria, which of course is what David Sackett originally intended EBM to be. The response from some practitioners is to say, ‘we haven’t got time to do all this deep and meaningful discussion stuff, just tell me what the right thing to do is.’ Or, ‘what if I make the wrong decision? I don’t want to get into trouble.’

What I understand the CauseHealth project to be about (and I am provocatively oversimplifying it) is recognising that practitioners, health educators, regulators and particularly governments, have been living in a world of delusion where it was assumed that patients come with distinct problems for which there are single, albeit complicated, answers and therefore right and wrong ways of acting on the part of the practitioner. This is in contrast to the reality, which is that patients are people who cannot be divorced from their complex, multifactorial lives; more significantly their illnesses cannot be divorced from them either. Responding to this entails a completely different set of decision-making skills—ontological rather than epistemological judgments—and I don’t think the professions are ready for this and neither do they want it.

A key point is that governments don’t want it either. They want and expect the regulators to deliver, clear unambiguous standards that can be judged to be right or wrong and if wrong be met with appropriate disciplinary action. The regulator is doing a good job if lots of its members are found out and struck off! If not, they are obviously being too lenient. Being hard, it is assumed, will weed out poor performance and through the survival of the survivors, standards will improve. The real outcome, as the GOsC report showed, is that practice becomes defensive and narrow; practitioners seek to stay out of trouble and keep quiet about their failures and concerns.

The real world of clinical practice is complex and multifactorial; it involves choices and decisions that are not so much epistemological decisions of what is wrong and conforming to what the guidelines say, but professional, value-based judgements that meet the needs—biological, social and psychological—of patients. Dispositionalism is clearly a move in that direction, but it entails a completely different way of thinking and decision-making from the ways clinicians have been taught. Our task in CauseHealth, as I see it, is not only to provide a clear theoretical/philosophical foundation for understanding health problems and their genesis, but to point to practical ways in which it can be taught across healthcare educational programmes that meet the clinical needs of practitioners, PLUS be formulated in a way that appeals to regulators and governments in their quite proper desire to ensure safe and effective practice.

Regulators are recognising that making practice safe and effective for the public is not just about policing bad practice, but about supporting their members in identifying good (and therefore value-laden) practice and good care.

It is therefore important that in our discussions we ensure that our feet remain firmly planted in the agendas of the regulators not just those of academics and clinicians.

Stephen Tyreman PhD, MA, DO