Clinical practice guidelines before the law: sword or shield?

Janet E Pelly, Liza Newby, Fiona Tito, Sally Redman and Amanda M Adrian

Clinical practice guidelines are designed to improve patient care by promoting best practice. But what is the status of clinical practice guidelines in law?

MJA 1998; 169: 330-333
For editorial comment, see Dwyer
Subsequently cited in Maddern, Surgery and evidence-based medicine, MJA 1998; 169: 348-349.
 

Introduction - Questions and answers - Where to next? - Acknowledgements - References - Authors' details
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Introduction	The purpose of clinical practice guidelines (CPGs) is to achieve better health outcomes by improving the practice of health professionals and by better informing consumers about management options.1 There is good evidence that CPGs can improve patient management. A review of 59 studies2 which evaluated the effect of CPGs on clinical care detected significant improvement in the process of care in all but four of the studies. Nine of 11 trials that assessed the outcome of care reported significant improvements.2 Despite the widespread recognition of CPGs' potential value in improving care, their legal status has been unclear and of growing concern to some health professionals. For example, the National Health and Medical Research Council National Breast Cancer Centre (NBCC) surveyed a representative sample of 150 surgeons to determine their views on the NHMRC Clinical Practice Guidelines for the Management of Early Breast Cancer;3 37% felt that the guidelines would increase their exposure to medicolegal problems, while 41% felt that CPGs would protect clinicians from legal problems.4 It is perhaps not surprising that there is a lack of clarity about how CPGs may be used in a legal arena. In particular, there is confusion about whether doctors will be more, or less, vulnerable to a successful lawsuit if they follow guidelines or depart from guidelines for sound clinical reasons. Will the guidelines be a shield, enabling doctors to show that they were not negligent because they followed the CPGs? Or will they be a sword, enabling a plaintiff's lawyers to establish negligence in court when they show that the doctor's treatment of the patient departed from the CPGs? How will the courts deal with the fact that proper clinical management of individual patients cannot always be achieved by strict adherence to guidelines? Because of the time lag before malpractice cases come to court, litigation currently before court often relates to incidents which occurred several years before CPG use became widespread. To date, CPGs have rarely, if ever, been used as evidence in medical litigation, and there is virtually no judicial comment on their legal status. There is little information available, even from the United States. In one of the few studies that looked at how guidelines are used in the US legal system,5 259 randomly selected insurance company malpractice claims were reviewed and 960 medical malpractice attorneys were surveyed. Clinical guidelines were important or used as evidence in only 6% of surveyed cases and, significantly, were used by both plaintiff and defendant. However, this study related to claims which were opened in 1990-1991, a period when rigorously developed, evidence-based guidelines were not common.5 Interestingly, CPGs did appear to play a role in the decision to settle; 27% of attorneys reported that the existence of guidelines in respect of a particular disease or condition had influenced their decision to settle, and 26% of plaintiffs' attorneys reported that guidelines were influential at least once in the previous year in a decision not to take a case.5 Against this background, and because of concerns by some clinicians about the adoption of the NHMRC's early breast cancer guidelines, the NBCC commissioned a research paper in June 1997 on the medicolegal implications of CPGs. A forum was then convened to address several issues relating to the law and CPGs (Box 1).
Where do guidelines fit in the legal process?	The commissioned research paper6 explored the Australian and international experience and concluded that: Clinical practice guidelines neither hinder nor encourage litigation directly -- they are simply likely to be considered another form of expert evidence; or evidence of practice in a court case. In considering CPGs as "just another form of expert evidence", the authors of the paper noted that the evidentiary value of guidelines depends on their purpose, development, ratification, dissemination, use, and whether they are current. For example, in the United Kingdom, judges do not automatically equate established guidelines with reasonable and proper medical practice. Questioning (in court) may address the scope of the guideline, how it was developed and adopted, the mandatory force of its recommendations, the existence of known exceptions to its application, and whether any school of medical thought rejects it and adopts a different approach to treatment.7 The same rules would apply in Australia and the United States. In Australia, the NHMRC has established a nationally credible and effective process for the development, ratification and endorsement of CPGs, and in October 1995 published Guidelines for the development and implementation of clinical practice guidelines,1 which is currently being updated. Endorsement by a recognised expert body such as the NHMRC may add weight to the evidentiary value of guidelines, as can formal evaluations which establish the clinical efficacy of the guideline.Where CPGs are accepted as good evidence of appropriate practice, it can be more difficult for a doctor whose actions and decisions are not consistent with the CPG's recommendation to defend a case simply on the basis of customary local practice.6 Recommendation of the forum: see points 1, 2, and 3 (Box 2).
How will guidelines be considered as evidence?	Some clinicians are concerned that courts will treat CPGs as inflexible rules of conduct, and thus reduce the scope for individual clinical judgement in particular cases. However, the result of any litigation will depend on the evidence brought before a court. The patient who is suing a doctor must prove negligence on the part of the doctor. Where a clinician has not followed a CPG, there is no automatic assumption of negligence. A clinician could show that the guideline was not relevant in a particular case. Alternatively, he or she could show that the treatment actually provided was supported by other good evidence, or that the guideline was sufficiently flexible to include the chosen treatment. Equally, following a guideline may not automatically prevent a doctor from being sued successfully for negligence. It will depend on all the evidence before the court. The authors of the research paper argue that, were CPGs not available, similar information could be adduced from the scientific information used to develop guidelines. However, there is little doubt that the meta-analysis and distillation of this often enormous volume of scientific evidence, as achieved in a rigorous guideline development process, make the research and clinical practice more understandable to a court, just as it does to an individual consumer or clinician.Therefore, guidelines can aid the legal process by presenting a clear summary of available evidence, rather than leaving the courts with the responsibility of distilling this information from expert testimony. Recommendation of the forum: see point 4 (Box 2).
Will a doctor be medicolegally protected if he or she practises within the guidelines?	CPGs are not designed to be prescriptive rules, but, rather, to provide guidance. They provide leeway for clinical judgement concerning the circumstances of the patient, the preferences of the patient and a range of other factors. This flexibility is explicitly stated in the introduction to the NHMRC's early breast cancer guidelines. Following them to the letter would not be possible or desirable; as such, words like "must" or "should" are not appropriate, and are not used in these guidelines. With appropriate ratification and credible standing in the health community, guidelines may well represent the agreed professional "standard of care", but the courts are the final arbiters of this standard, and retain the right to base judgments on information other than that in the guidelines.
What will happen if a doctor practises outside of the guidelines?	The content of CPGs pertain to the "usual" case, as CPGs are based primarily on evidence from randomised trials, which, because of inclusion and exclusion criteria and controlled clinical environments, produce an average result for the conditions studied. However, there may be many reasons for a clinician to provide care to an individual that departs from the guidelines' recommendations. The clinician may be aware of evidence other than that included in the guidelines, appraise the evidence differently to the guideline developers, be managing a person whose situation is different from that within the guidelines, or be treating a person who selects management outside of the guidelines. For example, the NHMRC's early breast cancer guidelines recommend that radiation therapy be offered after breast-conserving surgery. However, women who are carriers of a mutant ataxia telangiectasia (AT) gene have an extreme sensitivity to ionising radiation and can sustain severe normal tissue damage.8 In the rare case where a woman's AT status is known, radiation therapy would be best avoided. The paper concludes that:5 It is likely that departure from the practices advised in a guideline would be subject to the same test as any other departure from a generally accepted standard of care. Departure from practices recommended in guidelines because of ignorance of the guidelines would seem more likely to expose a doctor to risk of litigation, if a patient is damaged by a breach of the guidelines. Conscious departure from guidelines because of specific circumstances in a particular patient may be much easier to defend as consistent with an appropriate standard of care. If a clinician practises outside the guidelines, it is important to ensure that this is well documented and that appropriate strategies have been implemented. Recommendation of the forum: see point 5 (Box 2).
Do consumer guides satisfy the criteria of informed consent?	Australian law recognises the individual's fundamental right of self-determination,9 unless there is an overriding public policy issue to the contrary. Part of this is the right to have access to proper information on which to base decisions. Consumer versions of guidelines assist people by providing them with information about the choices available in their treatment. Just as a signed consent form is only considered to be one piece of evidence of consent, simply handing a patient a booklet about a particular condition or procedure is unlikely to be accepted as sufficient evidence of disclosure of risk by a doctor. There would also need to be evidence that the patient had had an opportunity to ask the doctor questions, as well as adequate opportunity to read and understand the material contained in the booklet. Recommendation of the forum: see point 6 (Box 2).
Are guideline developers liable?	Concerns have been raised that CPG developers such as the Australian Cancer Network, NBCC and NHMRC could be held liable if patient harm occurs as a result of a doctor following the guidelines. The NHMRC's Guidelines for the development and implementation of clinical practice guidelines addresses this issue:1 Normally a general publication, even where negligently collated, does not give rise to liability because the author does not owe a duty of care to the general public at large, although the guideline issuer could be held liable if a relevant close relationship can be established between them and the person who suffers a loss. If guidelines purport to be a definitive statement of the correct or appropriate procedure there would be a greater risk of liability than where the guidelines are expressly stated to be provided as a general guide subject to the medical practitioner's expert judgement in each case. As already outlined, guideline developers need to be able to demonstrate that the information in the guidelines has been properly developed and ratified. Additionally, the guidelines should clearly state that they are not a definitive statement, and note the date of development to make clear that the information is correct only to that date. Recommendation of the forum: see point 7 (Box 2).
Where to next?	The commissioned research paper and the forum agreed that changes should not be sought to the current legal status of guidelines. Rather, attention should be given to satisfying the criteria relating to appropriate development, ratification, evaluation and updating. If this is done, the likelihood of their acceptance within the current legal framework is enhanced. The general view at the forum was against legislating to define the status of guidelines within the legal framework. Rather, evidence-based guidelines should be used to inform the standard of care in courts of law. The forum recommended that a continuing legal education program be established to promote a better understanding in the legal profession of the role, development and use of CPGs among the legal profession. Recommendation of the forum: see point 8 (Box 2).
Acknowledgements	The authors would like to acknowledge the valuable contribution of The Hon. Justice Margaret Beazley of the NSW Court of Appeal to this paper.
References	1. National Health and Medical Research Council. Guidelines for the development and implementation of clinical practice guidelines. Canberra: NHMRC, 1995. 2. Grimshaw J, Russell I. Effect of clinical guidelines on medical practice: a systematic review of rigorous evaluations. Lancet 1993; 342: 1317-1321. 3. National Health and Medical Research Council. Clinical practice guidelines for the management of early breast cancer. Canberra: NHMRC, 1995. 4. Carrick SE, Bonevski B, Redman S, et al. Surgeons' opinions about the NHMRC clinical practice guidelines for the management of early breast cancer. Med J Aust 1998; 169: 300-305. 5. Hyams A, Brandenburg B, Lipsitz S, et al. Practice guidelines and malpractice legislation: a two way street. Ann Intern Med 1995; 122: 450-455. 6. Tito F, Newby L. Medico-legal implications of clinical practice guidelines. Sydney: NHMRC National Breast Cancer Centre, 1998. 7. Hurwitz B. Clinical guidelines and the law. BMJ 1995; 311: 1517-1518. 8. Appleby JM, Barber JB, Levine E, et al. Absence of mutations in the ATM gene in breast cancer patients with severe responses to radiotherapy. Br J Cancer 1997; 76: 1546-1549. 9. Review of professional indemnity arrangements for health care professionals [Tito F, chairman], Final Report. Compensation and professional indemnity in health care. Canberra: Commonwealth Department of Human Services and Health, 1995.
Authors' details	NHMRC National Breast Cancer Centre, Sydney, NSW Janet E Pelly, MA, Communications Manager. Liza Newby, LLB, MA, FAIM, former Health Services Commissioner, Victoria. Sally Redman, BA(Hons), PhD, Director. Enduring Solutions Pty Ltd, Waniassa, ACT. Fiona Tito, BA(Hons), LLB, Executive Director. NSW Department of Health, Sydney, NSW. Amanda M Adrian, RN, LLB, BA, Director, Private Health Care Branch.
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