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of NICE guidance ‘There is as yet no published information on the implementation by the NHS of NICE’s guidance, so we cannot assess success against this yardstick. Sharp criticism indicates that NICE’s honeymoon period is long over and that there is, or will be, resistance to implementation of pieces of guidance that are particularly expensive or clinically unpersuasive.’ Referring to disagreements between some of the rapid review centres (contracted to NICE to perform technology assessments) and NICE, the authors suggest that the wider criteria used by NICE in terms of its appraisals means that its threshold for approval will always be lower. One message from all of this is that the scepticism may be reflected at PCT level among both directors of public health and pharmaceutical advisers — so there may be a need for NHS influencers to prepare for this where their products have been appraised. NICE
conference 2003 — a focus on implementation So opening the conference, Professor Mike Rawlins outlined a renewed focus on the implementation of NICE guidance and that the Institute was working closely with both government and the NHS in order to identify best practice in implementation. Implementation is now recognised as a key challenge for the NHS and professor Rawlins outlined how he thought that NICE could contribute to successful implementation. He suggested that the topics for appraisal and guidelines must be relevant to clinical practice; that the processes involved in developing NICE guidance must be robust and command broad confidence (a bit iffy here); that the guidance must be clear and unambiguous; that the guidance must be implementable and that it must be appropriately disseminated to those who need it and in a manner which is accessible at the time they need it. Just picking up on a few of Professor Rawlins’ comments in these areas: On topic selection — he was not sure that this was optimal as yet and that NICE had not really managed to engage the wider NHS in proposing topics nor had the NHS been forthcoming in suggesting topics for disinvestment. On clarity — he said that this was an ‘awkward’ area in that on the one hand guidance must be comprehensive and yet on the other hand it must be accessible during the hurly-burly of surgeries, clinics and ward rounds. Probably, he said, they had so far erred on the side of comprehensiveness so new simpler formats are now being produced. On ‘implementability’ — he said that this depended on the availability of appropriate financial and human resources, as well as the necessary infrastructure. He gave examples of benefits of local health communities getting together such as the NICE ‘college’ in Bristol. On dissemination — NICE is to change the way it disseminates guidance to meets the needs of each key audience. Said Professor Rawlins: ‘Only if our guidance is implemented — and makes a real difference to patients — can we really claim to be successful. We will be doing everything we can to support the NHS in this key task, by producing answers that matter, in concise and accessible formats with practical advice on impact and implementation'. He also said that NICE does need to know whether its guidance is being adopted into routine clinical care, and if not, why not? He reiterated that the real challenge now facing NICE, and the NHS, is what can ‘we’ do to ensure that NICE guidance was being fully implemented. The conference closed with Lord Norman Warner, the health minister responsible for NICE, making the following comments: ‘With over four year’s experience of NICE, we need to examine how effective we are at implementing NICE guidance and I want to pose a number of questions. Have we been realistic about the speed at which NICE guidance can be implemented? Have we got the processes right whereby the NHS receives ‘implementation-ready’ guidance from NICE? Do we understand enough about what health bodies and clinicians do with the guidance when it arrives at the local level? How clear are the accountabilities for ensuring that action is taken on NICE guidance. Where does NICE guidance fit into national standards for the NHS to be produced under the Health and Social Care Act?’ NHS influencers will now find a separate part of NICE’s website devoted to implementation. Gillian Leng has been appointed as NICE implementation systems director. Her detailed plans should be available in the early part of 2005. October 2004 saw York University’s Professor Trevor Sheldon publish the results of a NICE-sponsored study into the implementation of its guidance, mostly in the acute setting — this in a special BMJ evidence-based medicine (EBM) theme issue. The results confirm earlier studies published in 2004 from the national cancer director Professor Mike Richards (otherwise known as the cancer tsar) about the variability of NICE technology appraisal guidance implementation. The uptake of 12 pieces of NICE guidance was found to be patchy. In this study, the authors used time series analysis, case note review, surveys and interviews, to conduct a national study of the institute's early recommendations and found that prescribing (eg, some taxanes) was particularly amenable to change. There was little evidence, however, that NICE had influenced the use of surgical procedures or medical devices. The main outcome measures used in the study were rates of prescribing and use of procedures and medical devices relative to evidence based guidance. The authors concluded that implementation would be improved if the guidance was clear and based on an understanding of clinical practice, if the evidence was strong, if adequate funding was available, and if the guidance was supported and disseminated by professional bodies. 'Trusts’, they added, ‘should institute strong supportive internal systems for handling guidance and gathering data on implementation'. See ‘What's the evidence that NICE guidance has been implemented? Results from a national evaluation using time series analysis, audit of patients' notes and interviews’ See also www.yhec.co.uk. Both the study and NICE itself are critiqued in the same issue by Nick Freemantle’s ‘Is NICE delivering the goods?’. Increasing numbers of countries are now considering cost effectiveness in decisions about which drugs to make available for prescription. In another BMJ review article Rod Taylor and Mike Drummond examined the international development of so-called fourth hurdle policies, analysed their effect, and identified some of the future challenges and likely directions. They comment that:
A ‘should read’ — see ‘Inclusion of cost effectiveness in licensing requirements of new drugs: the fourth hurdle’.
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