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1999
Dr Don Sheldon
Practice guidelines are being introduced throughout medicine, but expectations about their impact on the profession depend on whether one is a clinician, Patient, payer, administrator, or politician.
Their proponents hope that guidelines will enhance the knowledge, attitudes, and behaviour of practitioners and that they will optimise health outcomes, lower costs, and clarify malpractice decisions. However scientific evidence of these effects is limited.
There are also concerns that guidelines could actually impact adversely on patient care. Clinicians worry that guidelines will promote "cookbook -medicine", decreasing both their autonomy and income, and increasing medico-legal liability. A particular concern relates to the expansion of enforcement programs that require clinicians to follow guidelines or face financial or other penalties. Guidelines can rarely define optimal care with certainty, due, to poor science, imperfect analytic processes, and differences in patients. Recommendations are often worded in highly specific language that achieves clarity at the expense of scientific validity. Rigid enforcement of such guidelines could harm patients, interfere with the individualisation of care, increase costs and promote unfair judgements against clinicians who deviate from them for good reasons.
Well-meaning clinicians may see evidence-based practice guidelines as fundamental to their learning and essential to the maintenance of their practice standards. But the responsible clinician understands that the guidelines of today will almost certainly be superseded in the future. He appreciates the generality of guidelines and knows that all patients are individuals and treatment protocols may need to be modified from case to case. He is aware that 'best practice" for duodenal ulcer thirty years ago was Polya gastrectomy. He is aware that guidelines are an important professional discipline, but that unless they are constantly updated they may become inappropriate or even dangerous. He or she knows that guidelines are a snapshot of a continuously-changing surgical knowledge base. Such a clinician may be somewhat bemused and not at all reassured to read in the conclusion of Guidelines for the Development and Implementation of Clinical Practice Guidelines that "the Guidelines should clearly state that they are not a definitive statement of the correct procedure, but rather are provided as a general guide to be followed only subject to the medical practitioner's judgement in each individual case".
However, other authorities have different agenda for the use of guidelines, including lowering health care expenditures and insurance premiums and reducing the federal government deficit. There are very real fears that "best practice" guidelines will become "cheapest practice" guidelines and, ultimately, "enforceable practice" guidelines.
We are all aware that the great body of knowledge our predecessors have 'bequeathed to this generation of clinicians represents the collective intellectual property of many brilliant and dedicated men and women. We in turn have a duty to nurture this knowledge, to expand this knowledge and to ensure it is promulgated appropriately and responsibly. It should not be bartered for personal or commercial gain, or political favour. It should not be allowed to be bastardised by unscrupulous opportunists and charlatans. Clinical practice - guidelines are, and should remain, the property of the profession. Best practice protocols can already be found in text books by leading authorities, and in journal reviews and articles. Controversies surrounding treatments could be debated, and announcements of new knowledge made available, at seminars at the R.A.C.S. ASC.
My concerns are focused on the development and promulgation of "official guidelines". To reassure us of the validity of these guidelines we are referred to the text "Guidelines for the Development of Guidelines" which contains explanations on the status of the quality of evidence ratings. Note that: "Opinions of respected authorities, based on clinical experience, descriptive studies or reports of expert committees" rates last out of four grades of evidence quality (and yet that is not how we practice).
Steven Woolf in Arch of Interval Medium (vol 152 May 1992) states "Rules of evidence are emphasised over expert opinion in making recommendations".
Recently, another set of guidelines has been given an endorsement by the Council of this College, even though I doubt many councillors ever read them.
Practising surgeons find these guidelines helpful in determining treatment recommendations in some of their complex and controversial areas. They do not, however, regard them as immutable, permanent or necessarily correct. They are the best we have until the next set of guidelines debunks them. In practice we place more weight on the opinion of an esteemed colleague than we do on reports by expert committees. However these publications are not restricted in their distributions. They are produced by expert committees with the stamp of approval from health rministers and Royal Colleges. I have heard a head of the Commonwealth health department ridicule the proposition that an individual surgeon would use his personal judgement in the management of a patient, if this deviated from recommedations in "The Lancet" which was apparently perceived by that economist as holy writ.
I note already that experts in public health are conducting surveys on compliance by practising Surgeons with guidelines for the management of early breast cancer, the overt implications being that non-compliance represents sub-optimal care.
I have no doubt that in a court of law, failure to comply with such guidelines would be indefensible, despite the disclaimers in the guidelines and the reassurance of legal advisers.
Patients and their relatives and journalists will assume the guidelines to be beyond reproach. Health department economists will use the material to determine which procedures will attract a Medicare rebate. Guidelines will be seen as commandments with absolute veracity and will be ultimately enforceable.
Surgical knowledge should not be kept secret. However great care and responsibility needs to be exercised before the collective intellectual property of our profession is made available to those. who would use that information improperly or who might make inappropriate interpretation of the material. There is a great potential good in the pursuit of clinical practice guidelines. There is also great potential mischief.
If medical knowledge is to become a commodity, tutors may be less enthusiastic to discharge their Hippocratic obligations and disseminate their hard-earned knowledge - the profession’s intellectual property - free of charge, whilst ‘practice guidelines experts' accept government contracts and consultancies to health funds etc.
Professional knowledge may well become concealed. Professional secrets might only be divulged, to close colleges and business associates. The very basis of Hippocratic ethics and practice will cease.
Will there be payment for distilling the collective knowledge and experience of the professional and providing it to government, health funds etc? If guidelines become a commercial commodity will royalties be paid to the researchers? Will clinicians and researchers withhold valuable discoveries unless they are paid, or patents granted?
Clinical practice guidelines are an integral component of continuing medical education. Clinicians know they are only guidelines and accept their limitations. However once they receive official sanction by Colleges and governments they may assume the status of absolute gold standard in the perceptions of patients, the public, economists, journalists, administrators and lawyers. Great care needs to be observed to prevent incorrect interpretation or mischievous misuse of guidelines. They are the intellectual property of the profession and should only be used to improve the care of our patients.
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