Select Committee on Health First Report


5  Implementation

248. If NHS organisations do not take up its recommendations, NICE's work is pointless. The implementation of guidance is therefore a major challenge to NICE and the Department of Health.

249. NICE produces several different types of guidance which are implemented in different ways:

  • Technology appraisals (both single and multiple), which PCTs are under a legal obligation to implement within three months. They are a core standard assessed by the Healthcare Commission [a core standard is an area NHS organisations must implement];
  • Clinical guidelines, which organisations are expected to work towards adopting. They are considered developmental standards by the Healthcare Commission [a developmental standard is an area organisations must take steps towards implementing];
  • Public health guidance, which organisations should work towards adopting. This is also a developmental standard.

Who is responsible for implementation?

THE DEPARTMENT OF HEALTH AND NHS ORGANISATIONS

250. While NICE has a role to play in implementation, in that it must issue guidance that it is possible to follow, that is affordable and that is acceptable to clinicians, it is not its job to ensure that organisations take its advice. It is up to the Department of Health and individual NHS organisations to ensure implementation of guidance. The Department is obliged to make adequate funding available for the implementation of technology appraisals and other types of guidance. Departmental officials argued that PCTs and other purchasers should be able to afford to adopt NICE guidance because of the large increases in NHS resources that have occurred in the past few years.[236]

251. The Department, through SHAs, has also to provide management support for local organisations to help them implement NICE guidance. Dr Felicity Harvey told us:

there is a role for the Strategic Health Authorities in understanding where their Primary Care Trusts are in terms of taking a view as to how they implement this guidance.[237]

252. The implementation of positive technology appraisals (ie. appraisals of products that NICE recommends for use in the NHS) on medicines and public health guidance is chiefly the responsibility of PCTs. The implementation of clinical guidelines and appraisals of interventional procedures is likely fall within the remits of both primary and secondary care organisations. Local organisations are required to make funding available for positive technology appraisals almost immediately and should work towards funding other types of guidance. Witnesses indicated that implementing NICE guidance involved more than just allocating resources, however. Dame Gill Morgan stated:

To say it is just £1.2 billion [ie. the cost to the NHS of the products recommended by NICE technology appraisals] I think underplays the complexity of the decisions that have to be made at local level.[238]

NICE

253. Since the publication of the Health Committee's first report on NICE, the Institute has made considerable efforts to improve the implementation of guidance. It has published a guide, How to Implement NICE Guidance, and has issued costing templates to help PCTs plan for the expense associated with guidance. Professor Rawlins stated that pilot studies of commissioning guides were underway:

We have started to develop commissioning guides to accompany our clinical guidelines. This is advice to commissioners on what service provisions they should be contracting for with their providers. As a pilot we have developed five or six and we plan to do more next year. In principle, we would like resources…to expand that role.[239]

254. The implementation directorate at NICE has created a database on the uptake of positive technology appraisals to help commissioners. Of the 89 appraisals that had been published by November 2006, 47 had at least one study on uptake (either commissioned by NICE or in external literature) documented within the database.

255. Mr Dillon told the Committee that regional 'implementation consultants' were now working with the NHS at a local level to improve the adoption of NICE guidance:

Take a look at Birmingham City Hospital, where I was recently, and their approach to introducing technology appraisals, for example. We are seeding that good practice through those implementation consultants around the NHS. [240]

256. Furthermore, NICE has tried to improve training for clinicians, and future clinicians, in the use of evidence-based guidance. Mr Dillon stated:

we decided to talk to those who design the curricula for medical undergraduates and other health professional education, because we believe it is important that those who are in the early stages of the training understand the benefits and the limitations of evidence-based guidance; not that they learn by rote the guidance that NICE has produced but that they are in a position, when they come out and start practising, to look at it as part of the support that is available to them.[241]

To what extent is NICE guidance implemented

257. We received mixed evidence about the implementation of NICE guidance. The Department told us that uptake of NICE guidance was increasing. A review carried out by the Healthcare Commission in 2005/2006 showed that 84.6% of organisations reported full compliance and only 4.6% did not meet this standard. A more recent pilot study showed that 90% of trusts reported "good, excellent or fair implementation" of clinical guidelines and 88% reported a similar result for public health guidance.[242] Officials also cited a report on the 'Review of NHS Usage of Cancer Drugs Approved by NICE' in 2006.[243] It:

…showed significant progress in reducing variation in access to NICE approved cancer drugs across the country in the past two years. The report concluded that there has been a 47% increase in use of key cancer drugs since the last assessment in 2004, and that geographic variation in the use of these drugs has decreased.

Professor Richards confirmed that patchiness in implementation had reduced for some treatments. He told us of the "unacceptable variation between cancer networks" that existed in 2004. The Department asked SHAs to develop action plans to tackle the problem. He stated that this approach was successful:

We repeated the study in 2006, after an 18 month gap, and what we saw were two things that mattered. First of all, there was a major increase in the uptake of drugs. The average increase in uptake was 47% so a huge increase in an 18 month period. Equally importantly the variation between networks had decreased for each and every drug.[244]

258. On the other hand, there is evidence that the rate of uptake of guidance may be considerably lower than the Department has estimated. Research by the Audit Commission revealed that NICE guidance was not implemented systematically throughout the NHS and only 25% of PCTs assessed by the Commission could verify that implementation of NICE technology appraisals took place within three months.[245]

259. Witnesses told us that implementation was patchy. The Ethical Medicines Industry Group spoke for many others, stating:

In spite of considerable efforts by NICE to dedicate resource to working with the NHS and other stakeholders to improve implementation of its guidance, implementation remains slow and patchy, denying patients access to medicines that have been found to be clinically and cost effective.[246]

260. The ADPH told us that PCTs in their response to the Healthcare Commission may "fudge" the true position of implementation of NICE guidance. Dr Crayford stated:

a lot of NICE guidance is relatively complex, and simply there are not the measurement tools available in the NHS to ascertain whether or not NICE guidance or guidelines are being implemented to the Nth degree. The honest truth is probably that we do not know, to a very precise measure, to what extent NICE guidance is being implemented.[247]

261. Nevertheless, overall there appear to be fewer problems with the implementation of technology appraisals. Although the Audit Commission found that there were particular difficulties in implementing guidance for high-cost drugs,[248] many witnesses indicated that guidelines on products evaluated as part of STAs or MTAs were implemented fairly swiftly overall.[249] Implementation of technology assessments within three months was clearly a challenge for the health service,[250] but this requirement meant more uniform access to products and services.[251]

262. The implementation of clinical guidelines, however, appears to be more variable. A study conducted in 2004 showed that, for four conditions, only 40 per cent of patients received care that reflected the best practice as described in NICE guidelines.[252] While the situation may have improved since then, the evidence we received revealed much dissatisfaction about implementation of guidelines. Help the Aged told us that clinical guidelines were "poorly implemented".[253] Dr Tom Marshall, from the University of Birmingham pointed out that the implementation of guidelines was dependent on the decisions of individual GPs.[254] Beat, the eating disorders charity, told us of the ambivalence of GPs towards implementing the guideline on eating disorders, which was published in January 2004, adding:

Given the vital role of GPs in diagnosing and providing access to secondary and specialist care—this ambivalence and sense of burden that NICE guidance places does need to be addressed with some priority.[255]

Diabetes UK also referred to the "difficulties" of implementing NICE clinical guidelines. The patient group stated:

There are inherent difficulties with the position of NICE as their recommendations are neither mandatory but neither are they insignificant in their weight.

263. Take-up is often slow.[256] Best practice is not spread evenly across the country.[257] Variance in rates of guidance implementation has led to criticism of PCTs that do not fund certain treatments and of NICE and the Department for not ensuring that guidance is followed. We discuss these issues below.

What are the barriers to implementation

264. Witnesses indicated that there were a number of significant barriers to the implementation of guidance. According to NICE, inadequate resources, the lack of a clear organisational process and disagreement with the recommendations were the main barriers to implementation of clinical guidelines. Here we discuss the organisational difficulties and clinical attitudes which have led to the variable implementation of NICE guidance.

ORGANISATIONAL DIFFICULTIES

Lack of resources

265. Lack of funding is widely seen as the principal reason for the limited implementation of guidance. The Audit Commission assessed the extent to which PCTs made funding available for the implementation of guidance. The Commission found that 85% of survey respondents said that funds for implementing technology appraisals were insufficient. Lack of money or access to necessary resources was cited as one of the main barriers to implementation among NHS bodies. The Audit Commission also reported that recent financial pressures meant that some trusts lacked the capacity to manage change and that better financial management was needed to improve implementation of NICE guidance.[258]

266. Many witnesses agreed that a lack of resources was responsible for the uneven implementation of NICE guidance in England.[259] The ADPH stated that for this reason the implementation of public health guidance affecting primary care services was particularly likely to be slow:

For guidance affecting primary care, there is a tension between promoting implementation and guarding against overspend of budgets, especially on prescribing. The net effect in most PCTs is half-hearted endorsement of NICE guidelines, with agreement that it is the right direction of travel, but little active encouragement and especially where new resources are required.[260]

267. While Professor Mike Richards denied that PCTs refused to fund medicines, he admitted that a lack of resources had played a role in the failure to implement cancer guidelines in the past:

It is not …that the PCTs were not funding the drugs. There had been some problem about PCTs not necessarily funding enough of the other costs, like the costs of the nurses and pharmacists because obviously you need more of those to deliver the drugs. There was a problem at a local level with forward planning.[261]

NHS organisations' ability to implement guidance

268. A point made by a number of witnesses was that NHS organisations differed greatly in their capacity to deliver services. Dr Felicity Harvey of the Department of Health told us:

the difficulty you do have with a clinical guideline is that you have delivery at different positions in different parts of the country.[262]

Mr Dillon agreed. He told us that it was "inevitable" that some areas of the health service would take longer to implement recommendations than others for this reason:

For any disease or condition one part of the NHS might, for all sorts of reasons…be much closer to broad concordance with our recommendations when we publish a piece of guidance than in other parts of the NHS, which has not made that investment and has a much longer road to travel in implementing our recommendations.[263]

269. The Minister told us that it was "a challenge" to implement NICE guidance, and clinical guidelines in particular, because PCTs were in different positions at the start of the process. She added that the Department was still learning about the best ways to encourage guidance uptake:

The very nature of the [clinical] guidelines…can be very challenging because it depends where the PCTs themselves are in their experience…there is still quite a lot for us to learn about how we engage and roll those out[264]

She highlighted the need to balance "local priorities and national direction" but acknowledged the need to "to speed up to a standard that is across the whole country". [265]

270. Those responsible for commissioning services were also blamed for poor implementation. David Anderson from the Faculty of Old Age Psychiatry at the Royal College of Psychiatrists claimed that sometimes PCTs did not implement NICE technology appraisals because those responsible were not aware of them.[266] The Royal College of Nursing also blamed individual commissioners, and the non-obligatory status of clinical guidelines for their limited implementation:

The main element of difficulty is the apparent intransigence of some commissioners to respond positively to clinical guideline recommendations, as these do not have the same mandatory weight as technology appraisals.[267]

THE ATTITUDE OF CLINICIANS

271. Witnesses also told us that the slow uptake of treatments approved by NICE was sometimes due to the approaches of individual clinicians. The Audit Commission stated that lack of time, lack of knowledge about guidance and resistance to change among clinicians were important contributors to poor implementation.[268]

272. Clinicians sometimes think that NICE's guidance is inadequate. This is particularly likely when there are conflicting guidelines. This was the case for venous thromboembolism, where conflicting NICE guidance and Department of Health guidelines were published at roughly the same time.

273. There are obviously circumstances when clinicians have legitimate grounds for ignoring or rejecting NICE guidance. The publication of new evidence after NICE has published its guidance can undermine the validity of that guidance. There may also be specific cases in which NICE guidance is inappropriate due to the characteristics of the patient. As Professor Rawlins stated, "guidelines are guidelines; they cannot cover 100% of patient interactions".[269]

274. Professor Michael Schlander, from the Institute for Innovation and Valuation in Health Care in Germany, stated that guidance may be "more likely to be adopted when there is strong professional support…guidance needs to be clear and reflect the clinical context". The Royal College of Nursing told us:

To some extent, implementation of NICE guidance often depends on whether the clinicians want to use it…[270]

275. NICE officials and the Department of Health agreed that "clinical engagement" was needed to ensure the effective uptake of NICE guidance.

How to improve implementation

276. While the uptake of some guidance seems to be improving, there is more that could be done. The recommendations we made earlier in the report to improve the evidence base for NICE's assessments, for re-examination of the cost-per-QALY threshold and for better use of experts should lead to improvements in implementation.

277. In addition, we received evidence recommending the following changes, particularly in relation to clinical guidelines:

BETTER PLANNING AND SANCTIONS

278. PCT managers have limited time and resources. NICE clinical guidelines may recommend significant changes to areas of service delivery. The NHS Confederation argued that the Department could help PCTs improve their implementation of clinical guidelines by offering more advice on prioritisation and planning:

Departmental expectations of implementation for NICE products needs to consider how organisations such as a NHS trust and its PCT partner(s) can prioritise which guidelines and within individual guidelines which recommendations to implement first and where business planning is required to progress new or additional resource.[271]

279. AstraZeneca argued that inspection by the Healthcare Commission should be combined with "joined-up financial incentives/penalties for lack of implementation".[272] The ABPI also told us that there were few sanctions that could be taken when NHS organisations failed to take up guidance. It suggested that the lack of sanctions contributed to the problem of poor implementation.[273]

280. Others agreed that SHA managers had few powers to improve implementation at present.[274] Dr Harvey told us that when PCTs do not take up NICE guidance…:

This is where we would expect the Strategic Health Authorities to be taking management action.[275]

It was not made clear exactly what this management action would involve, however. Indeed, it is perhaps more likely that SHAs would take action to reduce cases of overspending than encourage PCTs to spend more money on implementing NICE guidance.

281. The Minister told us that more could be done to manage the organisations that are slow at taking up guidance:

I would need to consider and discuss with my officials whether there is an enhanced role that the strategic health authorities might be able to play in addressing the timeframe problem that you are identifying.[276]

IMPROVED MEASUREMENT OF PROGRESS

282. While some witnesses stressed that inspection by the Healthcare Commission and inclusion of NICE guidance in its core and developmental standards represented a "very powerful tool"[277], others thought that more could be done. AstraZeneca claimed that the implementation of NICE guidance was not a priority for the Healthcare Commission. Professor Richards stressed the need to assess and record progress:

The way in which we can make progress… is through measurement, through audit.[278]

283. Dr Fiona Adshead, Deputy Chief Medical Officer, agreed. She added that using different ways of assessing the impact of guidance was important.[279]

284. It was argued that self-assessment by PCTs of their implementation of NICE guidance was not adequate.[280] The Healthcare Commission should conduct more in-depth inspections of this element of practice. The charity Help the Aged told us that this was particularly important for clinical guidelines, as they had "no real monitoring or performance by SHAs or the Healthcare Commission".[281] The Medical Technology Group stated that measuring implementation:

…does not appear to be a sufficiently high priority for the Healthcare Commission.[282]

CLINICAL ENGAGEMENT

285. As we discussed above, ensuring strong support for guidance among healthcare professionals would improve levels of implementation. Better use of appropriate experts in the appraisal of treatments and development of clinical guidelines, as recommended earlier, should increase the sense of 'ownership' among clinicians. This in turn should improve levels of implementation.

A ROLE FOR THE ROYAL COLLEGES AND OTHER PROFESSIONAL ORGANISATIONS

286. Greater involvement of the Royal Colleges and other professional organisations in encouraging implementation could also increase the uptake of NICE guidance. The Multiple Sclerosis (MS) Society drew the Committee's attention to an audit of the NICE guideline for MS which was carried out by the Royal College of Physicians in association with the MS Trust to encourage the uptake of its recommendations.

287. Dr Llewellyn told us that professional organisations could play a role in improving implementation of NICE guidance on the uptake of new technologies as well as disinvestment from old approaches:

I do think there is something about…nationally encouraging colleges, as part of their remit of looking at professional standards, et cetera, to look at NICE, to look at the implementation, but also to look at the implementation of disinvestment decisions.[283]

288. In addition, the approval of trusts as training organisations (eg. teaching hospitals) could be linked to uptake of guidance.

CLARITY OF GUIDANCE STATUS

289. It appears that patients and the public are sometimes not aware that only approved technology appraisals are mandatory and that the NHS is not under any obligation to implement other types of guidance within a specific timeframe. This is partly because of the terminology used by NICE: the term 'guidance' is commonly employed for all types of advice given by the Institute, and does not differentiate between that which is obligatory and that which is not.

290. This has led to confusion about the status of the different types of guidance issued by NICE, and elevated expectations among patients of the type of treatment that they will receive. For example, in vitro fertilisation (IVF) is the subject of a clinical guideline. NICE recommended that PCTs should provide three cycles of IVF to eligible patients. Many patients therefore believe that the NICE guideline means that they should have access to three cycles of IVF through the NHS.[284] However, PCTs are not obliged to fund this number of cycles and many do not. Access to such treatment therefore varies widely across the country. The National Infertility Awareness Campaign told us of the disappointment faced by many couples as a result:

It is incredibly frustrating for the one in seven couples affected by difficulties in conceiving that more than three years after the publication of the NICE fertility guideline, huge inequalities in access to NHS funded treatment continue to exist. This is not what patients were promised and many feel let down.[285]

Members suggested that clearer terminology could mitigate this problem.

MANDATING ELEMENTS OF CLINICAL GUIDELINES

291. There was widespread dissatisfaction with the limited implementation of some clinical guidelines. Some witnesses thought that there were elements of certain clinical guidelines that were equally, or more, important than the topics assessed as technology appraisals.[286] It would be impossible for all organisations to implement all the recommendations contained within a clinical guideline. As Mr Dillon stated:

it is difficult to [implement clinical guidelines over a period of time] because a guideline might contain 30 or 40 recommendations and could involve for individual parts of the NHS very significant changes.[287]

292. Nonetheless, it seems illogical that technology appraisals must be implemented while eminently sensible elements of clinical guidelines are not obligatory. An example of what might be done relates to the guidelines on VTE. The risk assessment for all hospital patients for VTE which is included in the NICE guidelines on the subject, could be mandatory whereas other aspects of the guidelines could remain as guidelines. Questioned about this subject, the Minister told us that it was "a reasonable proposition"[288] that sections of clinical guidelines should be mandatory.

Recommendations

293. Despite both the efforts of NICE and other organisations to improve implementation and inspections by the Healthcare Commission to determine levels of implementation, NHS bodies respond to NICE guidance at different rates.[289] This means that new technologies are not available to all patients and the highest standards are not used throughout the NHS.

294. There need to be additional measures to improve the implementation of clinical guidelines. There should be more help for PCTs to implement guidelines. We recommend that the Department ensure that PCTs are aware of the assistance that is available and develop other ways of helping PCTs to plan and prioritise clinical guidelines.

295. Better measurement of guidance implementation is also needed. Self-assessment is not enough. We recommend that the Healthcare Commission conduct more in-depth inspections of this element of practice.

296. Improvements to the system of evaluating medicines and greater involvement of experts in the technology appraisal and guideline development processes should also result in guidance that is more acceptable to clinicians.

297. We also recommend greater involvement of Royal Colleges and other professional organisations in ensuring implementation. For instance, the approval of trusts as training organisations could be linked to uptake of guidance. Elements of clinical guidelines, particularly those covered by technology appraisals, such as risk assessment of VTE patients, should be mandatory.

298. To combat public confusion over the status of technology appraisals and other types of guidance, we recommend:-

  • Recommendations made following technology appraisals should be referred to as 'NICE directives'; and
  • Everything else should be referred to as guidelines or guidance.

299. Greater involvement of PCTs in NICE assessments and a re-examination of the NICE cost per QALY threshold, which we recommend above, would produce guidance which NHS organisations find more affordable.


236   Mr Simon Reeve, policy lead for NICE at DoH, stated: 'In terms of your question about affordability, if you have £1.2 billion cumulative pressure (ie. the cost of implementing NICE guidance) and in the same period the cash flow within funding has been over £40 billion, that pressure accounts for about 3% of the growth (Q 19) Back

237   Q 739 Back

238   Q 309 Back

239   Q 640 Back

240   Q 132. There are now five implementation consultants in post, covering the East of England, the North, the West, the South West, and London & South East Back

241   Q 132 Back

242   Q 659 Back

243   Department of Health, September 2006. Usage of cancer drugs approved by NICE Back

244   Q 40 Back

245   Audit Commission, September 2005. Managing the implementation of NICE guidance Back

246   Ev 103 Back

247   Q 328 Back

248   Audit Commission, September 2005. Managing the implementation of NICE guidance Back

249   Q 328 Back

250   Q 319 Back

251   Q 730 Back

252   Hanies et al. Bulletin of the WHO 2004; 82: 724-732  Back

253   Ev 112 Back

254   Ev 268 Back

255   Ev 54 Back

256   Ev 46, 171 Back

257   Ev 46, 68, 182 Back

258   Audit Commission, September 2005. Managing the implementation of NICE guidance Back

259   Ev 43, 52 Back

260   NICE 111 Back

261   Q 40 Back

262   Q 755 Back

263   Q 652 Back

264   Q 753 Back

265   Q 754 Back

266   Q 274 Back

267   Ev 204 Back

268   Audit Commission, September 2005. Managing the implementation of NICE guidance Back

269   Q 653 Back

270   Ev 204 Back

271   Ev 181 Back

272   Ev 53 Back

273   Ev 47 Back

274   Q 326 Back

275   Q 55 Back

276   Q 757 Back

277   Q 326 Back

278   Q 44 Back

279   Q 46 Back

280   Ev 43, 66 Back

281   Ev 112 Back

282   Ev 150 Back

283   Q 351 Back

284   Ev 172 Back

285   Ev 174 Back

286   Ev 176, Q 592 Back

287   Q 653 Back

288   Q 761 Back

289   See IVF example above Back


 
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