Final Report > Chapter 25: Competent Healthcare Professionals > The systems for assuring competence > Acquiring and developing new skills to an appropriate level of competence

Acquiring and developing new skills to an appropriate level of competence

65 We turn now to an issue which was a central feature of the Bristol story: how is a healthcare professional to acquire competence in a new clinical activity so as to enhance skills while at the same time safeguarding the interests of patients? Given its prominence in the Bristol story we concentrate on surgery. What we say, however, is not limited to surgery, but applies to any circumstance in which the healthcare professional proposes to carry out a clinical procedure with which he is unfamiliar and which, by its nature, exposes the patient to a risk of significant harm. [27] The issue we refer to is sometimes characterised as the problem of `the learning curve'. The implication of this expression is that, as regards carrying out new procedures, competence is acquired gradually: that there is an upward gradient of success, with, and this is crucial, an implicit assumption that failure initially is inevitable and, by that token, justifiable. The common example is the surgeon attempting a new procedure, but this issue applies equally to any doctor or nurse who embarks on a new procedure, wherever it is performed on the patient (hospital, GP practice or other clinic). There are, in fact, at least three different sets of circumstances which require consideration:

• the procedure is known and already carried out in the trust, but the particular healthcare professional is performing it for the first time;
• the procedure is known, but is being done for the first time in the trust; and
• the procedure is being done for the first time anywhere.

66 From a patient's point of view, there is a paradox. Innovations are desirable and should be introduced, but they should be tried out on someone else first! Three guiding principles may offer a way around the paradox. The first is the need for supervision; the second is the need for openness and honesty with the patient; the third is the need for an agreed and established system within the hospital for managing innovation.

Supervision

67 If a procedure has already been carried out in the trust, it is both possible and, indeed, essential, that the surgeon carrying out the procedure for the first time should be suitably trained and be directly supervised by colleagues who have the necessary competence and proficiency, until the relevant degree of expertise has been acquired; that is, the patient is not exposed to a risk greater than the norm. [28] If the procedure is one which has not previously been performed in the trust, the surgeon carrying it out must have obtained appropriate training in a place where expertise in the procedure is established. He must further ensure that, initially, he is supervised within his own trust by someone who has the necessary expertise. This is the process which Sir Barry Jackson, President of the Royal College of Surgeons of England, described in Phase One as mentoring. We see a further role for the Royal College of Surgeons. It already has a unit for the training of surgeons. With appropriate assistance from the NHS, this unit should be developed to provide training in new technologies and procedures. It should also explore the question of whether there is an age beyond which surgeons, specifically in areas such as paediatric cardiac surgery, should not attempt new procedures or even should not continue in a particular field of surgery.

68 If a procedure is being carried out for the first time anywhere, a distinction should be drawn between undertaking a variation of an existing procedure and carrying out a genuinely new innovation. Of course, these are not polar opposites: any particular procedure may lie somewhere along a spectrum. In our view, when any new and hitherto untried invasive clinical procedure is attempted, the surgeon concerned should inform the trust's or the local research ethics committee. [29] The committee, the composition of which may need to be re-formed so as to consider such matters, will need to be satisfied that the surgeon has undertaken all necessary preparation (for instance, through the use of simulation). The committee will then decide where, along the spectrum of innovation, the proposed procedure lies, and on what matters it needs to be satisfied. It may be objected that this approach is unnecessarily burdensome and will hamper innovation. We make two observations. Healthcare professionals intending to introduce innovations in other areas of diagnosis or drug treatment are expected and expect to seek the approval of the local research ethics committee before embarking on what is, in effect, an experiment. [30] We see no reason why new surgical treatments should be treated differently. Secondly, there is intrinsic value in the act of making an application to the local research ethics committee. The applicant (the surgeon in our case) will have to set down the arguments and reasons for proceeding. This will cause reflection on a wide range of matters, not least the interests of patients, before embarking on any innovation. We accept that surgeons, undoubtedly, already go through a process of reflection. Some surgeons may object that, to go a step further and present a proposal to the local research ethics committee, is unwieldy and bureaucratic. However, to the patient it is a desirable, indeed necessary, safeguard. [31] The lesson of Bristol is that when it comes to innovation it may not always be enough to leave the decision to the professional. Some system of reflection and accountability is essential.

Openness

69 A further safeguard for patients is the requirement that the surgeon be open and honest with them, or, in the case of children, with their parents. Patients are entitled to know what experience the surgeon has, how experimental or innovative a procedure is, and that this may be the first occasion on which the surgeon has carried out the procedure. This knowledge is essential if patients' consent to treatment is to be valid. Conversely, not to inform patients about a matter of such significance in terms of their healthcare is a violation of their rights. Furthermore, it is not open to surgeons to say that they would not be able to innovate if the patient always had to agree. This is to put the surgeon's desire to innovate above the patient's right to choose. It also fails to acknowledge the willingness of patients to participate actively in the development of medical care, provided their interests are respected.

Managing innovation

70 Trusts should have a system in place to manage innovation. Such as system should recognise the need for training and ensure that it is made available; it should ensure the involvement of the research ethics committee and see that local protocols reflect the need for openness and real consent from the patient. Clearly, there must be someone within the trust whose task it is to see that a system is in place and it is observed. This responsibility should rest ultimately with the chief executive, since, in our view, it is part of the statutory responsibility for quality of care.

Footnotes

[27] There is a difference between a planned departure from current surgical practice, and doing something which could not be planned but is a response to a situation which arises. The latter is not included within our definition of innovation. We are concerned instead with the circumstances in which the doctor decides in advance to innovate

[28] For an example of `a surgical teaching initiative' which `had a major effect on ... outcomes' see Lehander Martling A et al. `Effect of a surgical training programme on outcome of rectal cancer in the County of Stockholm'. `Lancet', 2000; 356: 94-6

[29] It may be that only complex procedures should attract this requirement. This is a matter properly for consultation

[30] We acknowledge that a considerable amount of standard practice is on one level experimental since its efficacy has not been demonstrated, but we do not see this as a reason for dispensing with the need to demonstrate efficacy and competence in new procedures. See Chalmers I, Lindley R. `Double Standards on Informed Consent to Treatment', which appears in `Informed consent in medical research: respecting patients' rights in research and practice'. Tobias J. (Ed). London: BMJ Books, 2000

[31] See de Leval M. `Lessons from the arterial-switch operation.' `Lancet'. Vol 357, 9 June 2001. Professor de Leval writes that the `dilemma of scientific progress and clinical application of new treatments must be addressed by society at large.'