Clinical guidelines

An ambitious national strategy

The NHS Executive has published its approach to the development, appraisal, and application of clinical guidelines.1 In principle, guidelines are attractive because of the potential of standardising clinical practice around an appropriate norm. Concerns about them include the amount of time and effort required to produce and update really good guidelines, the variable quality of existing guidelines, and the danger of inadvertently suppressing innovative or patient centred care by imposing an imperfect external standard.2 3 Many of these concerns have been addressed by the NHS Executive in its document, which conveys throughout a non-directive, “light touch” approach to the effectiveness initiative.

Clinical guidelines are defined as “systematically developed statements which assist clinicians and patients in making decisions about appropriate treatment for specific conditions,” a definition which is likely to be widely accepted. The authors advise against using the term “protocol” and reinforce the distinction between nationally and locally developed clinical guidelines. The status of guidelines as guidance, rather than instructions or commands, is reinforced. They are seen as aids to, not substitutes for, clinical judgment.

Although anyone can, in theory, develop guidelines, the NHS Executive believes that the task of developing national guidelines is specifically the responsibility of the professional royal colleges. This approach might be considered an optimistic one since it remains to be seen whether the colleges have the resources to produce an adequate series of guidelines that consider the views of non-members—including patients and other disciplines. There are many obstacles, both practical and political, to the development of truly multidisciplinary, patient focused guidelines.

The NHS Executive intends to commend for use only those guidelines that complement other centrally commissioned work, focusing their energy and resources on a few key initiatives. The Clinical Outcomes Group, a multidisciplinary group set up by the executive, will be responsible for endorsing suitable guidelines that the executive can then safely promote for use in the NHS. The outcomes group will classify guidelines according to the quality of evidence on which they are based. Only those based on randomised controlled trials will be recommended for use in contracts. The danger is that areas which are not a current priority, and therefore already relatively neglected in terms of funding and research attention, will be further disadvantaged because guidelines relevant to them will not be endorsed. The insistence on evidence from randomised controlled trials, although in many ways commendable, could cause further bias. Some clinical areas—for example, rehabilitation and learning disability—do not lend themselves easily to this research design.4 5

Responsibilities are clearly set out for the professional royal colleges (development of guidelines), the Clinical Outcomes Group (endorsement), and the NHS Executive (commending endorsed guidelines to the service), but certain other responsibilities remain vague. For example, it is not clear who will appraise guidelines (on behalf of the Clinical Outcomes Group) independently of the professions and the NHS Executive, or who will be responsible for ensuring that guidelines are implemented locally across all relevant disciplines. The potential conflict between local and national guidelines is not explored, yet this may be one of the most difficult problems. There is a paradox in that local ownership is often held to be related to use while national guidelines are seen to be more firmly based on empirical research. In fact, the evidence that national guidelines are more difficult to implement is not robust.6 Further research on the mechanisms governing the implementation of guidelines is required to clarify this whole area.

With the possible exception of the Clinical Outcomes Group, no new organisations have been set up, or are planned, to push guidelines into practice. This approach relies heavily on traditional responsibilities and differs greatly from that adopted in the United States and in Scotland, where the development, implementation, and monitoring of guidelines is overseen by custom built organisations.

Monitoring is also a weak area of the strategy. The Clinical Standards Advisory Group has a role in this, and has already studied the use of guidelines in elective surgery7 and strokes, but it investigates only about two clinical areas each year. At least one of the national research and development programmes lists guideline evaluation as one of its top priorities. Surely this objective should be generalised to other areas?

The NHS Executive is committed to the development and adoption of high quality national guidelines as the most tangible means of improving the clinical effectiveness of care in the NHS. This could be seen as a move away from supporting an alternative approach to the same problem—namely, local clinical audit. However, guidelines and recommended pathways of care can provide the ideal structure for effective audit. The executive's plan is likely to be broadly supported but needs a clear plan for evaluation to ensure that guidelines do after all promote clinical effectiveness across the full spectrum of professional practice.