Legal implications of clinical practice guidelines

Clinical practice guidelines may be used as evidence, but this should not distract doctors from their advantages.

MJA 1998; 169: 292-293

Clinical practice guidelines are systematically developed statements to assist practitioner and patient decisions about appropriate healthcare for specific clinical circumstances.1 Formulated by the United States Institute of Medicine, this definition was used by the National Health and Medical Research Council (NHMRC) in its work on clinical practice guidelines. In 1995, the NHMRC published guidelines for the development and implementation of clinical practice guidelines.2 It described a worldwide focus on guidelines ". . . prompted by concern about unjustifiable variations in clinical practice for the same condition, the increased availability of new treatments and technology and uncertainty as to the effectiveness of many interventions in improving people's health and a desire to make the best use of available health resources".2 The NHMRC emphasised the need for clinical practice guidelines to be based on the best available evidence. Relevant to this need are principles of evidence-based medicine, which entail the explicit and judicious use of current best evidence in making decisions about the care of individual patients. The practice of evidence-based medicine means integrating individual clinical expertise with the best available external clinical evidence from systematic research.3 Since 1995, the NHMRC has published nine clinical practice guidelines: on early breast cancer, coronary heart disease, depression in young people, prevention of stroke, uncomplicated lower urinary tract symptoms in men, unstable angina, preterm birth, diabetic retinopathy, and acute pain management.4 Clinical practice guidelines are not intended to replace clinical judgement, nor can they. They are not prescriptive, but serve to guide practitioners in making relevant clinical interventions. Used correctly, they can assist more informed and meaningful patient participation in treatment decisions. They can enhance and maintain professional standards and quality assurance programs. By reducing unnecessary variations in practice they may encourage cost-effective healthcare. Despite these potential benefits, some doctors are uncertain about the legal implications of clinical practice guidelines. One study found that Australian general practitioners did not regard legal implications as very important to their decision to follow guidelines.5 In another survey, 32% of clinicians were unsure whether guidelines on managing early breast cancer would be used to sue doctors and 45% agreed or strongly agreed that they would.6 In a survey of surgeons' opinions about the NHMRC clinical practice guidelines for the management of early breast cancer (published in this issue of the Journal), 41% of surgeons felt that guidelines would protect clinicians from legal implications, whereas 37% believed clinicians would be exposed to increased medicolegal problems by using them.7 The risk of legal liability is not unimportant, but for medical practitioners to approach clinical practice guidelines from a defensive perspective may well deny them and their patients the opportunity to achieve optimal health outcomes, an objective of paramount importance to the medical profession. The law imposes on a medical practitioner a duty to exercise reasonable care and skill in the provision of professional advice and treatment. This duty is a single, comprehensive one covering all the ways in which a doctor is called upon to exercise his or her skill and judgement. It extends to the examination, diagnosis and treatment of a patient, the provision of information and the processes of obtaining the patient's consent to treatment.8 The word reasonable is important. As a former Chief Justice of the High Court of Australia observed: "It is easy to overlook the all-important emphasis placed upon the word 'reasonable' in the statement of the duty. Perfection or the use of increased knowledge or experience embraced in hindsight after the event should form no part of the components of what is reasonable in all the circumstances."9 The standard of reasonable care and skill required is that of the ordinary skilled practitioner exercising and professing to have the capabilities required in the particular field of medical practice under consideration.8 In ascertaining what, in a particular case, constitutes reasonable care and ordinary skill in the relevant medical discipline, a court will usually receive evidence of the practice of medical practitioners and the state of medical knowledge at the relevant time. This evidence is usually given as expert opinion from medical witnesses and is of considerable significance when there are allegations of negligence in diagnosis or treatment. However, evidence of professional practice cannot dictate to a court the standard of care applicable to the clinical facts before it. The court will determine the standard demanded by the law in the practice of medicine (or, indeed, in the practice of any other profession). Clinical practice guidelines might be introduced into evidence before a court either by a plaintiff or by a defendant doctor. If so, it is likely that they would be included within the evidence of an expert medical witness given in the usual way. Soundly based clinical practice guidelines may well serve to make medical expert opinion more reliable and acceptable to a court,10 but are unlikely to alter the usual evidentiary processes in litigation. In considering the probative value of any clinical practice guidelines in evidence before it, a court would need to be satisfied, by appropriate evidence of their manner of formulation, of the quality and reliability of the medical/scientific evidence upon which they are based as well as their currency, acceptance and use by the profession. In an appropriate case, a medical witness called to give expert opinion evidence on behalf of a plaintiff might refer to clinical practice guidelines, offering the opinion that the defendant doctor had wrongly departed from the guidelines in the treatment of the patient. It would be open to a defendant doctor to counter this with evidence that the guidelines were not available at the time, outdated or not relevantly endorsed, or that clinical factors justified departure from the guidelines in the exercise of professional judgement, or that the treatment given did in fact comply with the guidelines. Given their purpose and evidence-based foundation, it is unlikely that clinical practice guidelines will promote litigation. Arguably, they may well reduce it by reducing any uncertainty about what constitutes reasonable medical practice. The legal implications of clinical practice guidelines were considered recently at a forum convened by the New South Wales Department of Health, together with the NHMRC National Breast Cancer Centre and United Medical Protection Ltd. A summary of the recommendations arising from the forum and the basis for their formulation are reported in this issue of the Journal.11 When properly understood, clinical practice guidelines will be appreciated for the significant beneficial purposes for which they are designed. In considering acceptance and use of clinical practice guidelines, the medical profession should not be distracted by speculation about legal implications. Nevertheless, as it appears that patients have become more litigious and doctors more vulnerable to allegations that they have failed their patients,12 clinical practice guidelines may become an important part of clinical risk management. Ultimately, care may well come to be regarded as less than reasonable should clinical practice guidelines be available but not followed, unless this can be justified on appropriate clinical grounds. Peter Dwyer Barrister 11th Floor, St James Hall 169 Phillip Street, Sydney, NSW Field MJ, Lohr KN. Clinical practice guidelines: directions for a new program. Washington, DC: Institute of Medicine. National Academy Press, 1990. National Health and Medical Research Council. Guidelines for the development and implementation of clinical practice guidelines. Canberra: NHMRC, 1995. Sackett DL, Richardson WS, Rosenberg WR, Haynes RB. Evidence-based medicine: how to practice and teach EBM. New York: Churchill Livingstone, 1997: 2. Smallwood RA, Lapsley HM. Clinical practice guidelines: to what end? Med J Aust 1997; 166: 592-595. Gupta L, Ward J, Hayward RSA. Clinical practice guidelines in general practice: a national survey of recall, attitudes and impact. Med J Aust 1997; 166: 69-72. Ward JE, Boyages J, Gupta L. Local impact of the NHMRC early breast cancer guidelines: where to from here? Med J Aust 1997; 167: 362-365. Carrick S, Benevista 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. Rogers v Whitaker (High Court of Australia) 175 CLR 479. Per Barwick CJ in Maloney v Commissioner for Railways (NSW) [1978] 52 ALJR 292 at 292. Tjiong RTT. Reforming the law on expert evidence. Med J Aust 1998; 168: 53-54. Pelly JE, Newby L, Tito F, et al. Clinical practice guidelines before the law: sword or shield? Med J Aust 1998; 169: 330-333. Tomkins C. Recent trends in litigation worldwide -- the implications for Australia. J Med Defence Union July 1998: 2-4.