Intended for healthcare professionals

Education And Debate

Clinical guidelines—the hidden costs

BMJ 1999; 318 doi: https://doi.org/10.1136/bmj.318.7180.391 (Published 06 February 1999) Cite this as: BMJ 1999;318:391
  1. Alan Haycox, senior research fellow (AHAY{at}liv.ac.uk),
  2. Adrian Bagust, senior research fellow,
  3. Tom Walley, director
  1. Prescribing Research Group, Pharmacology and Therapeutics, University of Liverpool, Liverpool L69 3GF
  1. Correspondence to: Dr Haycox
  • Accepted 6 April 1998

The publication of guidelines for statin treatment in the United Kingdom attracted criticism, particularly that no attempt had been made to assess the implications for resources associated with the guidelines. 1 2 The need to evaluate cost and clinical effectiveness in real terms before the widespread use of a treatment is frequently acknowledged.3 Unfortunately, these issues are rarely addressed in clinical guidelines, and there is little evidence that cost effectiveness in practice is considered in drawing up guidelines. 4 5

Surprisingly little consideration has been given to the role of guidelines in a healthcare system in which resources are constrained. 6 7 Cholesterol lowering drugs epitomise the problems that affect clinical guidelines in many areas. We consider here some unintended consequences from the development of guidelines (whether regulatory or … supposedly … advisory) that arise for those funding health care, doctors, and patients.

Summary points

Implementation of evidence based guidelines may limit doctors' discretion and the autonomy of local commissioners

Guidelines allow narrow interest groups to impose their priorities on the health service

Implications for resources and the real effects of proposals must be evaluated thoroughly if guidelines are to be of value

Failure to do this may distort decision making in health care; this, in turn, can lead to unbalanced structures that do not serve the best interests of patients

Nature and role of guidelines

All clinical guidelines aim to promote “best practices” that improve the outcomes of treatment.8 This rests on two assumptions—firstly, that outcomes identified in clinical trials are reproducible in normal practice and, secondly, that rapid and universal adoption of an effective treatment leads to optimal treatment for the whole population. Guidelines place most weight on evidence generated in randomised controlled trials. Unfortunately, real life clinical practice, where resources are more restricted, patient compliance less reliable, and treatment cannot be limited to a narrow patient group, does not provide such a controlled environment. Consequently, the anticipated benefits are rarely fully realised in an everyday setting,9 and true therapeutic effectiveness is established only through the accumulation of practical clinical experience. 10 11

The cost of haste

Guidelines may allow the introduction of new treatments to be fast tracked, thus bypassing traditional processes of adoption. However, the time “gained” is not without a cost. This period previously allowed treatment to be refined and true effectiveness to be evaluated. Costly new treatments may gain widespread acceptance through over hasty use of guidelines, when in practice their results may be poorer than expected.

Figure1

Incentive regions for the introduction of new treatment. (The nature of the incentives is given in the table)


Embedded Image

Modelling cost and outcome

Optimal decision making about treatments requires doctors to balance incremental changes in patient outcomes with incremental changes in cost (compared to current treatment). The six distinct combinations of cost and outcome that may be presented by a new treatment are illustrated in the figure. In region A, the new treatment has been proved to worsen the outcome appreciably, in region B it improves the outcome and reduces the cost of treatment, while in region E it improves the outcome but increases the cost. In regions C, D, and F, the impact of the new treatment in practice is still uncertain. In regions A and B the interests of doctors and health commissioners will coincide. In regions C and D, given the uncertainty over the impact of treatment, the most powerful opinion will tend to dominate. In practice, most conflict arises in region E, where improved outcome is achieved only at increased cost. Here strong clinical support exists for a treatment that may shift priorities away from less fashionable but more cost effective treatments. The natures of the incentive operating in each case are outlined in the table.

Effects of new treatment and incentive structures compared with current treatment related to the regions in the figure

View this table:

Interested parties

The role of guidelines is complex, inevitably reflecting the contrasting agendas of various interested parties—professional groups and clinical enthusiasts are keen to extend their influence, pharmaceutical suppliers to capture and exploit market share, while local and national authorities seek to promote public health while restraining public expenditure. It is naive to suppose that any formulating committee will be immune from these concerns, and we must therefore take into account the source of a guideline when interpreting its broader implications for the health service.

Problems with guidelines

Curtailing discretion— A new guideline presents the doctor with an explicit threshold for treatment, where he or she previously relied upon professional discretion drawn from accumulated experience. In an increasingly litigious environment, the doctor may opt for safety first, perceiving the guideline as a minimum level of treatment to be given. Introducing a guideline will therefore “ratchet up” the volume of treatment prescribed, overriding professional discretion and available evidence.

Constraining local flexibility— A guideline issued by a national body or professional institute may hamper local attempts to tailor solutions to local needs and resources. Though health authorities may publish local advice, this will inevitably be heavily influenced by national guidelines and carries less weight.

Pre-empting resources— Professional and special interest groups promote guidelines to increase the resources devoted to a subgroup of the population. It is disingenuous to present these initiatives in isolation, given that each pound spent on a new treatment for one group of patients must be at the expense of another unsuspecting group. Consider, for example, the £8 million annual cost of statins in one health authority cited by Freemantle et al.2 The inexorable growth in demand throughout the healthcare system represents the tyranny of the possible over the affordable, and the publication of uncosted clinical guidelines only reinforces this growth dynamic. One example of the danger of introducing clinical guidelines without previous evaluation of their implications for resources is provided in the box.

Case study in dyspepsia

Guidelines based on national recommendations were developed for the management of dyspepsia in a health district.12 New patients aged over 45 years who had symptoms of dyspepsia were to be referred automatically to a consultant. Previous work showed that the prevalence of dyspepsia in the community was about 38%, and that about 25% of these patients visited their general practitioner. This suggested that in any year over 13 000 people aged over 45 in the health district would be likely to see their family doctor because of dyspeptic symptoms. (Though not all of these patients will present with new disease, evidence shows that the rate of general practitioner consultation for dyspeptic symptoms is over 50% higher in this age group than in the general population.14) Conservative estimates showed that applying these guidelines would require a threefold increase in the number of endoscopies funded by the health district. This could have been achieved only by diverting substantial resources from other services. As a consequence, the recommendations were generally—and quite rationally—ignored.

Vested interests— Lipid lowering drugs highlight a common conflict between the development priorities of a resource constrained health service and the narrow interests of clinical and commercial innovators. Guidelines are an ideal vehicle for gaining rapid market dissemination, particularly if they avoid mention of cost altogether.

Developing better guidelines

What value does disseminating clinical guidelines have for the health service? There is a case to be made for stemming the flood of advisory documents and pursuing instead improved professional continuing education and audit based on outcomes. Where guidance is mandatory, the least dangerous form merely cautions against new treatments with limited cost effectiveness and existing treatments that no longer provide adequate value for money.

Any guidelines must start from a patient perspective while encompassing the needs of the whole community. Thus, in diabetes, benefit from reducing lipid concentrations must be compared with other methods of benefiting diabetic patients. The only secure basis for guidelines is a comprehensive assessment of all consequences (direct and indirect) of a new treatment. This requires analysis of the lifetime healthcare experience of the affected group of patients together with any “knock on” consequences for other patient groups. Such an approach requires that the entry of new treatments into the healthcare system should be managed.3 While this may delay access to beneficial innovations, it would ensure that both the costs and consequences of new treatments are fully explored before they become widely available.

Guidelines generate systematic and paternalistic pressure for the many to conform to the views of the few. They replaces the gradual and time honoured process by which non-specialists learn from experience with an attempt to force the pace of disseminating “good practice,” measured by narrow criteria. The unquestioning pursuit of clinical guidelines without regard to the added problems and pressures they may engender poses dangers for us all, representing as it does the exercise of power without responsibility.

Acknowledgments

Contributors Each author contributed fully at all stages in the development of the core ideas. The final draft was prepared by AH, who is also the guarantor.

Conflict of interest None.

Funding: None.

References

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