Written evidence from Sir Donald Irvine
CBE (REV 07)
1. INTRODUCTION
I was the President of the GMC responsible for the
introduction of revalidation policy in 1998, and earlier chairman
of the GMC Standards Committee which initiated the development
of the GMC's Good Medical Practice.
Today, in partial retirement, I chair the Board of
Picker Institute Europe, a UK charity which assesses and publishes
patients' experience of health care; I am a board member of Picker
Institute Inc in the USA; I chair the Ethics Committee of Dr Foster
Intelligence; I am a Vice-President of the Patients' Association
and President of Age UK Northumberland; and I am an Honorary Professor
in the Department of Medicine and Health in the University of
Durham. I am also a patient myself.
This experience gives me a fair insight into patients'
expectations of doctors and their performance.
2. SUMMARY
- The most critical question today is whether the
GMC, medical profession and government have the will to make revalidation
work effectively for patients, without further delay.
- The GMC should tell the public, in plain language,
what standards of everyday practice they should expect from their
doctors.
- Greater clarity is needed on the standards thresholds
to be used for revalidation and in the underpinning fitness to
practise procedures.
- The place for an assessment of knowledge within
the context of continuing professional development should be reconsidered.
- The GMC should require published clinical outcomes
data for revalidation in all specialties where this is feasible.
- The GMC's plans for assessing patient experience
are insufficient, and should be reconsidered from first principles.
- Non mainstream doctors who cannot supply evidence
of performance of sufficient quality for revalidation should take
an examination.
- The potentially important relationship between
revalidation and commissioning should be explored and developed.
- The GMC should be held to account by Parliament
in future through public hearings held by the Health Select Committee.
3. CONTEXT
In considering progress with revalidation, there
is important historical context which is relevant and needs to
be restated here so that we can be clear why we are where we are
today. For the last half century and more the British medical
profession has enjoyed a generally good reputation with the public.
This reputation, based on the conscientious practice of a majority
of doctors, has tended to obscure the fact that over a long period
of time the profession, perversely, has been prepared to tolerate
mediocre or very poor practice from a minority of its members.
The reasons include self-interest expressed are through a misplaced
sense of collegiality (i.e. we must all stick together), and the
lingering survival of early 20th century ideas of professional
autonomy which still lead some doctors to think that, once "qualified",
they have virtually unfettered discretion as to the standards
of practice they will choose to follow subsequently.
4. Over the last 30 years or so successive governments
have attempted to deal with this problem by making the profession
more accountable for the performance of its doctors, mainly through
contract of employment measures in the NHS. None have been successful
- hence the continuing problem. Revalidation, actually an initiative
by the GMC itself following the failures in paediatric cardiac
surgery at Bristol Royal Infirmary, was designed to provide a
nationwide solution through the use of the ultimate power of licensure
on a continuing basis. Revalidation thus replaces reactive professional
regulation with a proactive system in which doctors become personally
responsible for demonstrating regularly that they continue to
be fit to practise in their chosen field.
5. Not surprisingly, the GMC has encountered
a strong rearguard action from within the rank and file of the
profession designed to try and make sure that the process of revalidation
would be as benign, undemanding and unchallenging as possible.
The challengers have demanded, for example, that appraisal should
be essentially formative and developmental - a "cosy chat"-
never robust and summative; direct, objective evidence of competence
and performance should be avoided where possible; and the public
should be excluded from individual revalidation decisions.
6. The challenge nearly succeeded when, in 2001,
the GMC, under strong pressure from the BMA and others, was persuaded
to water down its originally reasonably robust proposals to an
annual appraisal unsupported by direct evidence of performance.
"Five satisfactory appraisals equals revalidation" is
how the press described it. The government of the day, by its
inaction, seemed to agree, and protests from some within the profession
(myself included) fell on deaf ears. It was Dame Janet Smith,
in her Shipman Inquiry, who brought matters to a head by showing
that the GMC's latest proposal had been weakened to a point where
it would not comply with the new legal requirement for revalidation,
namely, that revalidation should be "an evaluation of a doctor's
fitness to practise"(1). Dame Janet's analysis caused the
government and the GMC to revert to the original evidence-based
approach by means of another review completed by the Chief Medical
Officer of England in 2005(2).
7. The price of this period of appeasement has
been a huge delay in implementing this potentially significant
contribution to patient safety. Compounding this, organised medicine
is still - with some notable exceptions - reluctant energetically
to develop and use methods suitable for assessing established
doctors' performance and the outcomes of medical care. Thus, the
critical question today is whether the GMC, the medical profession
and the government have the will, singly and together, to give
the public and patients the assurance they expect of good practice
from all doctors practising in the UK in future.
8. ESTABLISHING
REVALIDATION
Against this background, I offer the following comments
on the way the GMC proposes to establish revalidation. Since I
support the direction of travel and the general approach they
should be taken as suggestions for improvement to current methods.
9. A benchmark for patients
Good Medical Practice is excellent and should be
used as the foundation for revalidation. However, it is written
primarily for doctors. The GMC and the Royal Colleges need to
tell the public and patients, in plain language, what standards
of everyday practice they should use as the benchmarks against
which to judge their own experiences with their own doctors. People
do not have this information at present. It needs to be immediately
accessible to every patient and every patient's carer in the land.
It would help patients to make fully informed choices of doctor.
It would strengthen the leverage patients could bring to bear
in securing improvement. And it would help to underpin revalidation
decisions.
10. Clarity on the bar for standards
The GMC needs to tell the profession and the public
what threshold of practice it intends to use for revalidation.
Is it to be optimal practice, which is the best that can be achieved
under normal practising conditions? That seems to be what patients
instinctively expect. Or is it to be something less than that,
a minimum standard, and if so how minimal is the minimum? The
question applies to decisions made in the course of the revalidation
procedures themselves, but equally to the GMC's fitness to practise
procedures. These latter procedures are the backstop for revalidation;
they will be the means by which the GMC finally decides, in cases
of doubt, whether a doctor can continue to have an unrestricted
license to practise.
11. The question was explored in 2004 by Dame
Janet Smith, at the time of her Shipman Inquiry (3).The nub of
the argument, set out in paras 26.98, 26.180 and 26.181 of her
report, is that the "remarkably low" standard above
which doctors will be revalidated does not square with the claim
that revalidation gives an assurance that the doctor is "up
to date and fit to practise. Today it would appear that some GMC
panels are still giving doctors the benefit of the doubt, signing
off some doctors as fit to practise when colleagues who have referred
them, or who have done preliminary investigations, or who have
attempted remediation, still have serious concerns.
12. This matter must be clarified urgently and
resolved, once and for all, for if the foundation for continuing
licensure is shown to be unsound the whole revalidation exercise
becomes pointless in terms of protecting patients. If nothing
else, The Health Select Committee could assist all concerned by
helping the GMC and the profession to get to an answer which is
right for patients as soon as possible. It all boils down to how
determined the GMC, the medical profession and the government
- all three - are prepared to be in making sure that the public
are properly protected from the insufficiently competent doctor.
13. The assessment of knowledge
In the development of revalidation few things have
been more contentious than the question of whether doctors' knowledge
should be tested. For patients, the matter seems straightforward
- in the 2005 government survey on revalidation the public put
being up to date at the top of their priority list, with outcomes
second (4). It would be difficult for doctors to be able to claim
to be up to date without being able to show that they know what
they are supposed to know and therefore that they know what they
are doing. It is a self-evident truth that modern medicine is
heavily dependent on knowledge coupled with higher order problem
solving skills. The medical profession in the USA has acknowledged
this by making a knowledge test the only mandatory part of their
national Maintenance of Certification (ie revalidation) procedures
(eg 5, 6). And it is almost certain to apply when relicensure
becomes operational.
14. However, in the UK the profession is divided.
On the one hand the BMA has said that as a matter of "principle"
knowledge testing should form no part of revalidation (7). This
sits rather oddly given that the profession is proud of the excellent
assessment instruments which it uses rigorously and systematically
in the training which leads to basic qualification in medicine
and subsequently in the preparations for specialist or general
practice. On the other hand there is the approach being taken
by the Society of Cardiothoracic Surgeons of Great Britain and
Ireland (8). Even though they are the only specialty to record
and publish their powerful clinical outcomes on a continuous basis,
they have in addition decided strongly to recommend to their members
that they should complete an on-line SESATS formative assessment
of knowledge and problem solving skills every five years, as part
of their continuous professional development. Indeed they plan
to offer this assessment without charge as part of their service
to members.
15. My own view is that our cardiac surgeons
(and the Americans) are right on the need to assess and demonstrate
essential knowledge as one element of the evidence for revalidation.
This is especially true in those subjects where it will be very
difficult to develop valid measure of outcome - general practice,
and geriatric and psychiatric medicine are examples - and where
checking knowledge and skills would be an economical and effective
alternative. I hope that the Select Committee will commend the
stance of the UK cardiac surgeons, and ask the GMC to explain
why other parts of the profession should not do something similar.
I am sure the public would appreciate the degree of added objectivity
and rigour such an approach would bring, at minimal cost to the
doctor and no cost to the taxpayer.
16. Clinical outcomes
Well developed clinical outcomes are an excellent
indicator of clinical performance and, wherever possible, must
become the central part of the evidence for revalidation. I have
referred earlier to the data produced by the UK cardiac surgeons
to illustrate the point. Their evidence of clinical success, reported
day by day by individual surgeons, is very impressive. It contributes
to quality in its own right and will be their basic evidence for
revalidation. I am struck by the impact that their imperative
for quality data has had on forcing improvement in the quality
of clinical governance and patient care. Their motivator was Bristol.
Now, revalidation must become the motivator needed to generalize
from their experience across the broader spectrum of medicine.
We have no other instrument with comparable reach and the potential
power to change practising culture. Therefore, I would urge the
GMC to be ambitious and far-sighted, to raise its game, to require
outcome data for revalidation from other specialties - especially
others in surgery - to drive quality in the NHS. The time is propitious
because of the declared commitment of The Coalition government
to give priority to clinical outcomes. This is the way of the
future.
17. Patient experience
I think that the GMC's current plans are insufficient.
A single small survey of patient experience every five years will
contribute little if anything to the picture of a doctor's performance
capable of being assessed through evidence of experience.
18. I agree with comment being submitted by the
Picker Institute Europe that this strand of evidence needs to
be rethought from first principles. With the deferred date for
implementation introduced by the government there is an opportunity
to do just that. This is a fast developing aspect of healthcare
where new instruments and technologies have the potential to bring
more sophistication to assessment than is envisaged in the GMC's
current plans.
19. Non mainstream doctors
I fully appreciate the difficulty some doctors in
this category will have in being able to produce evidence of performance
of an acceptable quality. Since, inevitable, relatively little
is known about the capability of many of these doctors, I believe
they should be revalidated early in the introductory cycle. Think
of the locum Dr Ubani - I suggest that his basic clinical deficiencies
would have been detected, and loss of life prevented, if he had
been properly assessed for revalidation before being allowed to
practise here. So I think the GMC should grasp the nettle, and
ask these doctors to complete a five yearly assessment. This was
first mooted as an obvious solution some years ago now. Many of
them might be quite relieved to have uncertainty removed. The
start-up assessment instrument could be PLAB, which is up and
running, and successful.
20. Commissioning
If commissioning is to be successful, commissioners
will want to seek evidence that the medical practitioners from
whom they will purchase care will, amongst other things, be capable
of providing personal medical care of a good standard. Successful
revalidation should be the indicator of that standard. By the
same token, patients will want to know that general practitioners
commissioning care on their behalf are themselves in good clinical
standing, and therefore to be trusted by them with commissioning
decisions. In this context, everything points to the importance
of establishing revalidation from the outset as a reliable indicator
of clinical quality and modern professionalism, and therefore
as an important component of commissioning.
21. The GMC's accountability to Parliament
Lastly, I mention accountability because I believe
that the current method of holding the GMC to account by Parliament
is insufficient, and should therefore be reconsidered.
22. The GMC, as the medical licensing authority,
carries the ultimate responsibility for the effectiveness of the
professional regulatory system. Parliament gave it the power to
license doctors, to hold the specialist and general practice registers,
and to have overall supervision of all stages of medical education.
Only the GMC can say who shall practise medicine in the UK and
who shall not. Ultimately only the GMC can say what "goodness"
and "poorness" mean, in terms of doctors' competence
and performance. Therefore, the public is utterly dependant on
the integrity of licensure and specialist certification.
23. To ensure its continuing effectiveness, the
GMC needs to be held to account for its management of medical
regulation and medical education. It needs the discipline and
indeed the support that can flow from public accountability, a
fact the GMC itself recognized and sought when in 2006 it responded
to the CMO's report on revalidation. Subsequently, the government
strengthened the reporting requirements from the GMC to the Privy
Council and specified that copies of these reports should be laid
before each House of Parliament.
24. This mechanism is insufficient and lacking
in transparency. For these reasons I wish to revive a proposal
I first put forward in 2001(9). Parliament should establish a
Select Committee mechanism for conducting a regular review of
the GMC, rather like US Congressional Hearings, designed to hold
it to account for the integrity and good performance of all regulatory
functions for which it is ultimately responsible. The Committee,
armed with thorough analysis of its performance prepared a by
an independent organisation like the National Audit Office, would
question the chairman and chief executive of the GMC, in front
of the television cameras, about the Council's stewardship of
medical regulation and medical education. Ideally, there would
be a transparent mechanism for letting the public ask questions
also. Dame Janet Smith's methods of assessing the GMC's performance
in the Shipman Inquiry give an excellent insight into how such
reviews could be made to work well. They would give the public
the chance to judge for itself whether the medical profession
continues to meet expectations.
25. REFERENCES
1. The Shipman Inquiry. Safeguarding patients:
lessons from the past, proposals for the future.London: Stationery
Office, 2004, see pages 1023-1176.
2. Donaldson L. Good doctors: safer patients.
A report by the Chief Medical Officer for England. London: Department
of Health, 2006.
3. The Shipman Inquiry, see pages 1057, 1083-85.
4. Mori Social Research Institute on behalf of
the Department of Health. Attitudes to medical regulation and
the revalidation of doctors. Research amongst doctors and the
general public. London: Department of Health, 2005.
5. Choudhry NK, Fletcher RH, Soumerai SB.Systematic
review: the relationship between clinical experience and quality
of care. Ann Intern Med.2005; 142:260-273.
6. Holmboe ES, Lipner R, Greiner A. Assessing
quality of care: knowledge matters.JAMA 2008; 299:338-340.
7. British Medical Association. Statement of
principles on revalidation 2010. Access at:
www.bma.org.uk/revalidation.
8. The Society for Cardiothoracic Surgery in
Great Britain and Ireland. Modern medical professionalism 2010.
In preparation.
9. Irvine DH. The doctor's tale: professionalism
and public trust. Oxford: Radcliffe Medical Press, 2003.
October 2010
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