Efficiency, equity, and NICE clinical guidelines

Clinical guidelines need a broader view than just the clinical

The stated purpose of clinical guidelines from the United Kingdom's National Institute for Clinical Excellence (NICE) is to “help healthcare professionals and patients make the right decisions about healthcare in specific clinical circumstances.”1 However, what constitutes “the right decisions” depends on your point of view. For individual patients the right decision is that which maximises their wellbeing, and this is properly the concern of the clinician. Yet in resource constrained healthcare systems this will not always coincide with the right decisions for patients in general or society as a whole, thereby leading to some understandable tensions. NICE is a national policy making body whose responsibility is clearly broader than the individual patient.2 This wider viewpoint is reflected in NICE's technology appraisals by the central role afforded to cost effectiveness. We argue that the methods currently used by the NICE clinical guideline programme confuse these two viewpoints.

Cost effectiveness analysis allows decision makers to improve efficiency by spending the limited healthcare budget on those activities that generate the greatest health benefits per pound spent.3 Such efficiency considerations are a key part of NICE technology appraisals, and NICE's remit demands that the same principles of assessing societal wellbeing should apply to clinical guidelines work.

Clinical guidelines themselves are not a new concept,4 5 but the NICE clinical guideline programme is different. Rarely have clinical guidelines been intended to operate at a national level, incorporate both clinical and cost effectiveness, and provide instructions that are mandatory within the NHS (though, unlike technology appraisals, there is no requirement for funding to be provided).1 6 Currently, development of guidelines is commissioned by NICE from development teams via several national collaborating centres that are largely based at the royal colleges. These teams produce evidence reviews that are presented and considered by guideline development groups, who then produce the guideline recommendations based on the best available evidence.

Guideline development groups consist substantially of senior clinicians with special interest in the disease area.7 Undoubtedly the understanding of clinical evidence is enhanced by the inclusion of such experts, but the incentives for members of these groups to recommend cost effective practices may clash with their feelings of responsibility to patients and fellow professionals within this disease area. Each development group has to include only one member, a health economist, whose role is to promote the social viewpoint. The health economists are often relatively junior, new to the disease area, and struggling with a lack of economic evidence. For cost effectiveness to underpin NICE guidelines in these circumstances is particularly challenging.

Recommendations made within a clinical guideline are graded according to the strength of the evidence on which they are based. The highest grades are afforded to recommendations based on meta-analysis of randomised controlled trials and the lowest grade to recommendations based on expert opinion, including the view of the development group. This classification also has the effect of reducing the impact of cost effectiveness considerations: health economic evidence is often sparse in established clinical areas and, where it does exist, is of variable quality. Rarely is economic evidence based entirely on clinical trials: most economic analyses require additional data sources or assumptions. Members of the guideline development group, who may wish to downplay economic evidence, can use the grading system to this end by claiming that clinical evidence is of a higher grade. Qualitative evaluation has identified exactly this tendency in the Netherlands.8

We applaud the efforts of NICE and the guideline development groups to consider cost effectiveness. However, the absence of evidence on the cost effectiveness of guideline recommendations is not an adequate rationale for issuing guidelines as though they had no implications for resources. One solution might be for NICE to delineate clearly the individual viewpoints of patients and society and allocate expertise to tasks that are appropriate in the light of this distinction. In this scenario, collaborating centres would be commissioned to produce wholly clinical guidelines, at arm's length from NICE. This work would provide a crucially important foundation for subsequent cost effectiveness assessment undertaken by specialist academic units. Clinical guidelines that carry the NICE stamp of approval—and its associated weight in the NHS—should be produced by guideline appraisal committees, analogous to NICE technology appraisal committees, based on consideration of the best available evidence on clinical and cost effectiveness. A membership that includes expertise in a broad range of clinical specialties, health economics, public health, and statistics, together with representatives of NHS organisations, can be expected to make better recommendations that truly reflect the societal viewpoint that NICE must reflect.

Such an approach would promote consistency between the appraisal and guidelines functions of NICE, make the basis for recommendations transparent, and avoid accusations that NICE guidelines are wish lists created by panels of clinical experts that threaten the efficient and equitable use of scarce NHS resources.9