Select Committee on Health Written Evidence


Evidence submitted by Lifeblood: The Thrombosis Charity (NICE 35)

EXECUTIVE SUMMARY

  Lifeblood: the thrombosis charity is pleased to respond to the House of Commons Select Committee Inquiry into NICE. As the Medical Director of Lifeblood and a practicing consultant physician, I consult regularly with colleagues from other disciplines and charities on matters of patient care and health policy.

  We all agree that there is a definite need for an authority such as the NICE to exist, to produce evidence-based guidelines for healthcare professionals. However, we are well aware of the increasing number of challenges to NICE decisions, not just with regards to technology appraisals, but also with regards to the formulation and implementation of clinical guidelines.

  In particular, we have become increasingly concerned by the process used by NICE to draw up clinical recommendations and can point to occasions where these have been fundamentally flawed as a result of a misinterpretation of the evidence-base.

  We feel strongly that the processes NICE uses in setting clinical recommendations could be substantially improved, leading to additional benefits for patients and the health service at large.

  In addition, as a small charity we find it increasingly difficult to respond on behalf of patients to consultations, assessments and draft guidelines from the three different authorities in England, Scotland and Wales, which all have different protocols and guidelines for identical conditions. This compounds the ability of many stakeholders and medical professionals to effectively feed into guideline development and to then share best practice which would ultimately benefit patients in the long term.

  Positive systematic changes need to be addressed by NICE as a matter of urgency to stem the slide in confidence of both the public and the medical professions.

1.  INTRODUCTION TO LIFEBLOOD

  1.1 Thrombosis has been—and remains—a major cause of death in the United Kingdom, yet astonishingly this fact is not widely known. Most people have little or no understanding about the causes and effects of thrombosis, and how it can be prevented. Within the medical field, many see thrombosis as a peripheral area.

  1.2 Lifeblood: The Thrombosis Charity was founded in February 2002. Although small in size, Lifeblood is the leading thrombosis charity group in the UK, increasing awareness and commissioning research. Our ambition is to improve the understanding of its causes, the impact on sufferers and the treatments available.

2.   WHY NICE'S DECISIONS ARE INCREASINGLY BEING CHALLENGED

  2.1 As a practicing Consultant Physician and Medical Director of a small charity with a strong interest in thrombosis I converse regularly with colleagues about the work of NICE—since the clinical guidance and recommendations published by the institute have an impact on the work of medical professionals on a daily basis.

  2.2 Lifeblood firmly believes that in the absence of any alternative, there is a definite need for an authority such as NICE to exist to produce evidence-based guidelines, enabling healthcare professionals to work within minimal acceptable standards for care across the NHS.

  2.3 However, in recent years Lifeblood have become acutely aware of the increasing prevalence of high profile challenges to decisions made by NICE. Most of these concern NICE's technology appraisals and the issues surrounding patient eligibility for cancer and central nervous condition medicines. This does not help instil public and professional confidence in the process.

3.   NICE'S EVALUATION PROCESS

  3.1 Whilst any proposal that seeks to strengthen guidelines should be welcomed, recent examples have suggested that the way in which NICE formulates its recommendations can lead to flawed, capricious decisions. These are a result of a misinterpretation of the evidence-base that the expert committee uses to reach its conclusions.

  3.2 The focus of this submission outlines our deep concern about the process by which NICE recommendations go against internationally accepted evidence based best practice.

Clinical Guidelines

  3.3 An example of our concerns is the recent draft clinical practice guideline on "The prevention of pulmonary embolism in high risk surgical patients".[92] This is an area where excellent international guidelines already exist, the gold standard being the American College of Chest Physicians (ACCP) guidelines. It is interesting to note that all the international guidelines are written by experts in the field and they all recommend the same practice.

  3.4 NICE reviewed the same scientific data as all the other guidelines including ACCP but came up with a very different set of conclusions, resulting in very different recommendations. This has resulted in a huge amount of work by advisory organisation, to comment on the proposals, in the hope of changing the guidelines. Surely it would be better to attain correct guidelines in the first place, so that time could be usefully used elsewhere? We believe the inconsistency between NICE and the ACCP guidelines occurred for several reasons.

  3.5 The Independent Guideline Development Group assembled to review the data and provide guidance to the statisticians performing the systematic review consists of non-experts in the area. In addition, the Chairman is not required to be an expert in the field. Although this is laudable—excluding those with a possible conflict of interests—it also may result in a Guideline Development Group that lacks a detailed understanding of the scientific data they are reviewing. The risk is that this "lay" committee is unable to recognise the quality of the studies being reviewed, and therefore does apportion the appropriate weights to superior and inferior studies. Furthermore, experts are consulted to give evidence to the committee, however there are no predefined rules as to what NICE considers constitutes "an expert". There does not seem to be an independent review mechanism objectively scanning CVs to determine eligibility. Thus many worthy or suitably qualified individuals are not considered.

  3.6 In addition, whilst the selection of the NICE Guideline Development Group is undertaken by the National Collaboration Centre in conjunction with NICE, often the selection of group members has a lot to do with the preferences of the Chairman of the Guideline Development Group and the number of nominations received by the sifting group in topic selection, rather than objective criteria for expertise. There is also a tendency to encompass all relevant stakeholders rather than the range of clinical scientific opinions in the field. As a result, relevant dissenting views are not consulted during the guideline development process. This often leads to an unfortunate tendency towards "group think" and subsequent surprise when the final guidelines are not greeted positively:

    —  We propose that the National Collaboration Centre revises the criteria it uses to recruit for membership of guideline development groups to ensure experts in the clinical area should be included in the Independent Guideline Development Group, on the proviso they declare all their conflicts of interest. Only those with substantial interests (eg 10% of gross salary or grant income £100,000 from interested parties) should not be invited to contribute to the guideline process. We also suggest that NICE uses a simple but formal assessment tool to determine expertise—perhaps evidence of substantial clinical publications in the area being reviewed.

  3.7 We also believe there can be divergence due to issues with data gathering. In some instances the overly-prescriptive formulaic approaches to data gathering lead to many worthwhile, though imperfect, large studies being ignored, while very small randomised trials are considered useful—despite the latter having significant limitations in terms of statistical power. There is also a tendency to use mixed meta-analysis—lumping together a large number of studies that experts in the field would argue were completely different. Similar experiences have affected colleagues involved in draft guidelines in the fields of hypertension and hyperlipidaemia, which also needed dramatic revision at a late stage before final publication. Recently, concerns have been raised about the post-myocardial infarction guideline process for similar reasons.

    —  We propose that NICE should revise the criteria used to gather data and minimise the use of mixed meta-analysis that can on occasion lead to misleading conclusions as a result of a misinterpretation of the evidence-base.

4.   COMPARISON WITH THE WORK OF THE SCOTTISH INTERCOLLEGIATE GUIDELINES NETWORK (SIGN)

  4.1 As NICE decisions only apply to the NHS in England and Wales it can be confusing for a small charity such as ours when having to deal with each of the relevant authorities' different protocols and guidelines for identical conditions. The Cooksey Review and Office of Fair Trading have proposed a UK-wide Health Technology Appraisal organisation:

    —  Development of a single body to assess technologies and clinical guidelines throughout the UK could also encourage wider sharing of best practice and might ultimately result in better levels of patient care. A single UK body would also reduce workload for small patient groups which have limited resources to make submissions and respond to consultations.

5.   SUMMARY OF RECOMMENDATIONS

  We propose that the National Collaboration Centre revises the criteria it uses to recruit for membership of guideline development groups to ensure experts in the clinical area should be included in the Independent Guideline Development Group, on the proviso they declare all their conflicts of interest. Only those with substantial interests (eg >10% of gross salary or grant income >£100,000 from interested parties) should not be invited to contribute to the guideline process. We also suggest that NICE uses a simple but formal assessment tool to determine expertise—perhaps evidence of substantial clinical publications in the area being reviewed.

  We propose that NICE should revise the criteria used to gather data and minimise the use of mixed meta-analysis that can on occasion lead to misleading conclusions as a result of a misinterpretation of the evidence-base.

  Development of a single body to assess technologies and clinical guidelines throughout the UK could also encourage wider sharing of best practice and might ultimately result in better levels of patient care. A single UK body would also reduce workload for small patient groups which have limited resources to make submissions and respond to consultations.

6.  CONCLUSION

  6.1 NICE is in a unique position to develop a coherent set of guidelines that could potentially save many more thousands of lives each year. We believe that the processes NICE currently use could be substantially improved, leading to significant additional benefits for both patients and the health service and improved confidence in the system.

Dr Beverley Hunt

Medical Director

Lifeblood: The Thrombosis Charity

March 2007






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