The General Medical Council's most recent advice to the medical profession, in its 1998 statement Maintaining Good Medical Practice, is that 'clinical teams will normally use recommended clinical guidelines'.1 But important questions have not been addressed by the GMC:
- Guidelines recommended by whom?
- On the basis of what sort of appraisal?
- Using which particular criteria?
Despite concerns about their variable quality, the Government wants to see more clinical guidelines developed to promote better practice, and to help ensure consistency of healthcare quality across the NHS.
To this end, it has established the National Institute for Clinical Excellence to take the lead in developing and disseminating cost-effective guidelines.2
A variety of general legal questions arise, which this series of four articles will address, including:
- Are guidelines to be viewed as advisory or mandatory?
- What sorts of regulatory functions do guidelines serve?
- Have the courts accorded guidelines any particular credence?
- Do guidelines allow sufficient room for clinical discretion?
UK courts have sometimes taken note of guidelines,3 called for their development and adoption,4 overruled prestigious guidelines,5 and ruled on whether adherence to, or deviation from, specific guidelines was reasonable in particular circumstances.68
These articles will address concerns about the legal implications of guideline use frequently voiced by health-care professionals, such as:
- Whether doctors who deviate from guidelines place themselves at increased risk of being found liable in negligence
- Whether compliance with guidelines can protect healthcare workers from liability
- What legal responsibility developers and issuers of guidelines may have if their guidance is found to be faulty.
The NHS Executive has observed that clinical guidelines may take the form of:
' anything from a set of prescriptive rules (with sanctions for non-compliance), to a voluntary code for self-regulation.'
It believes that the term 'guideline' should be understood as referring to:
' a variety of documents produced to meet different needs. Some guidelines have more to do with the agreed protocols of interaction between health service organisations than direct relevance to decisions by clinicians about therapeutic management.' 9
This offers a broader view of guidelines than does the oft-repeated definition developed by the US Institute of Medicine (IoM), which states that clinical guidelines are:
' systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances.'
Clear, formal and systematic methods of development are now required to ensure that guideline recommendations are as evidence-based as possible.11
But the IoM definition does not really provide sufficient grounds to distinguish clinical guidelines from other statements of guidance and recommendation. Nor does it help us to understand why, for example, different systematically developed guidelines, covering the same treatment areas, may vary significantly in the strategies and treatment thresholds they recommend.12
The Evidence-Based Medicine Working Group provides greater understanding of the nature of clinical guidelines. In its view, guidelines:
'Like overviews, gather, appraise and combine evidence. Guidelines, however, go beyond most overviews in attempting to address all the issues relevant to a clinical decision and all the values that might sway a clinical recommendation.
'Like decision analysis, guidelines refine clinical questions and balance trade-offs. Guidelines differ from decision analysis in relying more on qualitative reasoning and in emphasising a particular clinical context.
'Guidelines make explicit recommendations, often on behalf of health organisations, with a definite intent to influence what clinicians do.
'These suggestions about what should be done go beyond a simple presentation of evidence, costs, or decision models. They reflect value judgements about the relative importance of various health and economic outcomes in specific clinical situations.
'As a result, they should be required to pass unique tests about how matters of opinion, in addition to matters of science, are handled.' 13
The Evidence-Based Medicine Working Group clearly perceives the potential regulatory effect of guidelines upon medical practice; it also acknowledges the role that human values play in the social organisation of health care and in the construction and operation of guidelines. The Group emphasises that:
'The clinical problems for which practice guidelines are most needed often involve complex trade-offs between competing benefits, harms and costs, usually under conditions of uncertainty.
'Even in the presence of strong evidence from randomised clinical trials, the effect size of an intervention may be marginal or the intervention may be associated with costs, discomforts, or impracticalities that lead to disagreement or ambivalence among guideline developers about what to recommend'. 14
This discussion helps to clarify why the recommendations of clinical guidelines addressing the same medical condition may differ.
However, in the context of court proceedings, guidelines tend to share the same potential legal significance; in advising doctors to practise in one way rather than another, according to a particular clinical standard rather than another, they offer the courts examples of more or less agreed standards of clinical care, with which the clinical practice under scrutiny can be compared.15
The next article in this series will outline the nature of medical negligence in the UK, and the role that clinical guidelines may play in such actions.
- General Medical Council. Maintaining Good Medical Practice. London: GMC, 1998.
- Secretary of State for Health. The New NHS. Cm 3807. London: HMSO, 1997.
- In re A and others (minors) (child abuse: guidelines). 1991 1 Weekly Law Reports 1026-32.
- Re F (Mental patient: sterilisation). 1989 2 All England Reports 545.
- Re W (A minor). 1992 3 Weekly Law Reports 758-82.
- Loveday v Renton and Wellcome Foundation Ltd (QBD) 1990 1 Medical Law Reports 117-204.
- Early v Newham Health Authority. 1994 5 Medical Law Reports 215-17.
- Re W (A minor) 1992 3 Weekly Law Reports 758-82.
- National Health Service Executive. Clinical Guidelines. Using Clinical Guidelines to Improve Patient Care within the NHS. London: Department of Health, 1996: 9.
- Field M, Lohr K. Clinical Practice Guidelines. Directions for a New Program. Washington: Institute of Medicine, 1990: 8-14.
- Royal College of General Practitioners. The Development and Implementation of Clinical Guidelines. London: Royal College of General Practitioners, 1995.
- Fahey TP, Peters TJ. What constitutes controlled hypertension? Patient-based comparison of hypertension guidelines. Br Med J 1996: 313: 93-6.
- Hayward RSA, Wilson MC, Tunis SR, Bass EB, Guyatt G. For the Evidence-Based Medicine Working Group. Users' guides to the medical literature. J Am Med Assoc 1995; 274: 570-4.
- Hayward RSA, Wilson MC, Tunis SR, Bass EB, Guyatt G. Users' guide to medical literature. J Am Med Assoc 1995; 274: 573.
- Hurwitz B. Clinical guidelines: proliferation and medico-legal significance. Q Health Care 1994; 3: 37-44.