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Michael Power, Clinical Knowledge Author, Guideline Developer and Informatician Sowerby Centre for Health Informatics at Newcastle Ltd, NE41 2ES, UK.
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The GRADE system (like other systems) for ranking the strength of a recommendation applies only to recommendations that are (i) simple (in the sense of not having multiple component subrecommendations), (ii) unambiguous, and (iii) directly reflect the balancing of pros and cons and uncertainties for a recommended action. In my experience as a daily user of guidelines produced by many different organisations, many recommendations do not meet these constraints. An example of a recommendation that cannot be GRADEd is: ======================================================= If paracetamol or topical NSAIDs are insufficient at relieving pain, consider adding: – opioid analgesics (consider the risks and benefits of prescribing opioids, particularly in elderly people) – an oral NSAID/COX-2 inhibitor (see box 1) to the paracetamol. -------------------------------------------------- Box 1 Treatment with oral NSAIDs/COX-2 inhibitors – Offer a standard NSAID or a COX-2 inhibitor (but not etoricoxib 60 mg) as a first choice. – Co-prescribe with a proton pump inhibitor (choose the agent with the lowest acquisition cost). – Prescribe at the lowest effective dose for the shortest possible period of time. – Owing to potential gastrointestinal, liver and cardio-renal toxicity: o take into account individual patient risk factors, including age, when choosing the NSAID/COX-2 inhibitor and dose to be prescribed o assess and/or monitor patient risk factors o consider prescribing an alternative analgesic if the patient is already taking low-dose aspirin for another condition. From the NICE guideline on Osteoarthritis [1] ======================================================= This recommendation cannot be meaningfully GRADEd. For example, it contains: (i) An incomplete list of options — additional options would be to add a topical NSAID to paracetamol, or paracetamol to a topical NSAID. (ii) Several sub-recommendations at several levels. (iii) Several hedges — “consider adding”; “consider the risks and benefits”; and in box 1: “take into account individual patient risk factors, including age”, “consider prescribing an alternative analgesic”. Hedging is a form of grading, and thus it does not make sense to grade it. (iv) Unclear advice, e.g. “ Prescribe at the lowest effective dose for the shortest possible period of time”. But, no advice is given on how to find out what the “lowest effective dose” or “shortest possible time” is. The GRADE system should, either include a caveat for guideline authors and users explaining which recommendations are not suitable for GRADEing. Or, preferably, the GRADE guidance should change the word “recommendation” to “conclusion”, and explain that the ranking of the conclusion refers to the weighing up of all the pros and cons (benefits, harms, costs, values, practicalities) and their uncertainties. To ensure that the basis for guideline recommendations is transparent, guideline authors need a structured checklist analogous to the CONSORT [2] (and similar) checklists for research reports. This gap is not met by the AGREE guideline assessment instrument [3]. REFERENCES [1] NICE guideline on Osteoarthritis: www.nice.org.uk/nicemedia/pdf/CG59NICEguideline.pdf [2] CONSORT statement: www.consort-statement.org [3] AGREE guideline assessment instrument: www.agreecollaboration.org Competing interests: None declared |
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