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Having evidence from a high-level study such as a randomised controlled trial does not immediately mean that a good clinical recommendation will result. Suppose we had one well-conducted randomised controlled trial on which to base our recommendations: if the effects of the intervention were small and the outcome measures were surrogates, rather than clinical outcomes, the evidence would be relatively unhelpful.
In assessing the likely ratio of benefit to harm it is often helpful to produce a simple ‘balance sheet’ in an attempt to estimate, for a ‘typical’ group of patients, the number of subjects who will experience benefit or harm. All of the known beneficial and harmful effects of the treatment should be included in the balance sheet. In order to assess the applicability of the guideline advice to other groups of patients, an attempt should be made to create a new balance sheet with revised estimates of the number of beneficial and harmful effects.
For instance, if an effective preventive treatment (such as treatment to lower cholesterol or the use of warfarin for non-rheumatic atrial fibrillation) is being applied to a population at low risk of the outcome of interest, the estimated number of benefits may not exceed the estimated number of harms by a satisfactory margin. The guideline development group must make a judgment about how wide this margin should be in order to justify a recommendation for treatment.
Other factors warranting consideration when making recommendations are the cost-effectiveness of the interventions, the financial implications for the health budget of full implementation of the recommendations, and any inequity that may arise if only certain sections of the community can afford to pay for the interventions recommended.
2.4 A multidisciplinary approach that includes consumers
If guidelines are to be relevant, those who are expected to use them or to benefit from their use should play a part in their conception and development.
The involvement of a range of specialist and generalist clinicians, allied health professionals, experts in methodology (such as epidemiologists and health economists), and consumers will improve the quality and continuity of care and increase the likelihood of the guidelines’ adoption. These groups can make significant contributions to the identification of relevant outcomes, values, target audiences and guideline formats for different users. They can also play a critical role in identifying potential obstacles to guideline implementation and in the formulation of implementation strategies.
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