What does NICE do

NICE's responsibilities are extensive, and the way in which they organise their work programme is rather complicated. 

Its duties fall into three main areas:

Clinical guidelines

NICE develops guidelines for the provision of care to patients with particular diseases, syndromes, or injuries.  For example, it is currently looking at subjects such as: breast cancer, post-traumatic stress disorder, epilepsy, and head injury.  NICE's job is to review all the available evidence about the way in which care is - or could be - provided in these patient groups, and to lay down guidelines for future NHS practice.

In conducting its reviews, NICE makes use of bodies it has founded called NCCs: National Collaborating Centres.  NCCs bring together representatives from various professional bodies and patients' groups, to form an expert panel.  There are currently 7 NCCs, which deal with acute care, cancer, chronic conditions, mental health, nursing and supportive care, primary care, and women's and children's health, respectively.  The development of each set of guidelines is overseen by one or other of these NCCs.

In the guideline development process, NCCs are required to seek the input of "stakeholders" at several stages.  There are four types of stakeholder: "patient/carer stakeholders" (such as patient support groups and charities); "professional stakeholders" (such as the Royal Colleges, and other healthcare providers' organisations); "commercial stakeholders" (such as pharmaceutical companies whose products are used in the clinical area in question); and "NHS stakeholders" (this is always a number of NHS Trusts that are selected to represent the interests of all the NHS organisations that will eventually have to implement the guidelines).  The Department of Health is also allowed to contribute to any stakeholder consultations.

The process through which the relevant evidence is analysed and the guidelines drawn up is quite complicated but, essentially, it is a four-stage process:

• The NCC, in consultation with stakeholders, draws up the precise scope of the investigation.  Although NICE will have been provided with a general indication of the topic it is being asked to analyse, it needs to come up with a specific definition of its inquiry.  For example, the Department of Health told NICE to investigate "the early management of head injury", but it was up to the NCC to decide that it wanted to produce guidelines on "Imaging practice and involvement of the neurosurgical department".
• The NCC then forms a Guideline Development Group (GDG), to review the evidence, and produce a draft of its findings.  Each GDG is made up differently, but each must include medical experts in the area under review, patients/carers with experience of the service, and "methodologists" (researchers, analysts, statisticians, etc., whose job it is to find and present evidence for the Group to consider).  The GDG will meet on several occasions, to discuss the issues and available evidence, and will then draft 3 separate versions of its recommendations: a full version (containing a full description of what has been considered, who has considered it, and how it has been considered, as well as detailed analysis and recommendations); a summarised version (containing recommendations and advice on how they should be implemented); and a patient version (containing a simplified version of the advice, in a form that the layperson can easily understand).
• The GDG's draft reports are circulated to stakeholders and to NICE, who are given an opportunity to make comments.  Once this consultation period is over, final reports are produced by the NCC, building on the draft versions provided by the GDG, and taking on board any comments form the consultation that the NCC believes are applicable.
• The final reports are published.  They are made available on NICE's website (www.nice.org.uk), and press releases ensure that the media is aware of the new guidance.  The reports are also circulated throughout the NHS: a copy is posted to each Trust, which it is expected to disseminate the information throughout its organisation.  There are other ways in which NICE's advice enters practice (for example, there is a central computer database - "PRODIGY" - that helps GPs to make prescriptions when they have identified a diagnosis; if new NICE guidelines have an effect on a particular area in this database, then it will be updated, so that GPs get the most current advice available).

You can find out more about NICE's Clinical Guidelines protocols on their website.

Technology appraisals

Technology appraisals are not dissimilar to the consideration of clinical guidelines, but they start from the opposite point: instead of asking what the best kind of treatment is for a given condition, they ask whether a given treatment is appropriate for any conditions. The name "technology" may be a bit misleading: the things that NICE refers to as technologies can include medicines, devices, techniques, and procedures. From this perspective, anything from an aspirin to an x-ray to a hernia operation can be a technology and, as such, can be reviewed under the technology appraisals procedure.

At first glance, the technology appraisal procedure appears quite similar to the clinical guidelines process.  However, it is slightly different at each stage:

• All investigations are overseen by NICE's Technology Appraisal Committee (TAC), a standing committee of NICE that currently comprises 39 members, of whom only 2 are laypersons.  Instead of "stakeholders", the TAC refers to "consultees".  Such people include the manufacturer(s) of any technology under consideration, as well as relevant patient organisations and professional bodies.  As with the clinical guidelines process, the first step is to define the "scope" of the appraisal in detail, in discussion with the consultees.
• The next step is for the technology in question to be assessed.  The TAC commissions a report from a Technology Assessment Review (TAR) team.  This is very often administered by a specialist NHS research body called the National Coordinating Centre for Health Technology Assessment (NCCHTA - www.ncchta.org).  The TAR report will review and summarise the available evidence relating to the technology in question.  Consultees are invited to make written submissions, for the TAR team to consider.  There will also be one meeting at which consultees and NICE representatives can discuss issues with the TAR team in person.
• When the TAR team has produced its report, consultees have an opportunity to produce further submissions, commenting on the TAR team's findings.  All this paperwork is then considered by the TAC, which meets in conjunction with representatives nominated by patient and professional bodies.  When the Committee has held its discussion, a preliminary version of their views is published on the Internet.  The Committee then reconvenes, after a consultation period of 4 weeks and, having considered any views it has received in the consultation period, finalises its report.
• There is then an appeal stage, at which time the consultees can object to the TAC's findings.  Once this process is observed, the final guidance document will be published.  This happens in exactly the same way as step (iv) of the clinical guidelines process (see above).

You can find out more about NICE's Technology Appraisals protocols on their website.

New interventional procedures

The last area in which NICE issues guidance relates to the use of what it refers to as "new interventional procedures".  NICE defines an interventional procedure as one that "involves an incision, a puncture, [or] entry into a body cavity [including by] electromagnetic or acoustic energy".  Thus, although most of the procedures that come under this heading will be operations of some kind, the definition also applies to certain other tests and treatments.

Whenever a doctor is considering an interventional procedure that has yet to be commonly introduced to the NHS, he or she has to consult NICE's Interventional Procedures Advisory Committee (IPAC).  If NICE has already issued guidance on the procedure, the doctor is obliged to study and follow that guidance.  If NICE is in the process of investigating the procedure, the doctor should "express an interest".  In the event that the procedure has not been considered by NICE at all, the doctor must notify IPAC that he or she is thinking of using the procedure, and seek their guidance.

IPAC's investigation of a new interventional procedure is a process with either one or two steps:

• Firstly, NICE produces an "Overview" of the procedure, consisting of an outline of the nature and purpose of the procedure, a summary of published literature, and the opinions of at least three Specialist Advisors whom it has consulted.  Specialist Advisors are expert clinicians who have been nominated or approved by professional bodies whose members are involved in the use of interventional procedures.  The Overview is accompanied by IPAC's "Provisional recommendations" on the procedure.  These will particularly focus on the apparent safety and effectiveness of the procedure.  Advice regarding the experience, training and facilities needed by clinicians undertaking the procedure may also be the subject of provisional recommendations.  IPAC may choose to recommend that the procedure is reviewed by the Technology Appraisals Committee (see above).
• If it thinks it is necessary, IPAC can then refer the procedure on to an independent Review Body.  At the same time, IPAC produces a consultation document that is published on the NICE website for a 4-week consultation period.  The Review Body will be made up of a consortium of three universities and a teaching hospital NHS Trust.  It produces a "systematic review" of all available evidence on the procedure and, if appropriate, organises data collection in collaboration with the relevant specialist societies, Royal Colleges or other professional organisations. When it has completed this process, the Review Body prepares an "evaluation report".  IPAC considers this evaluation report along with submissions from key "stakeholders" (patient/carer organisations, professional bodies, manufacturers, etc.).  They then produce an updated consultation document.  The second consultation document is published on the NICE website, again for a 4-week consultation period.  Finally, IPAC reviews the second consultation document in the light of comments received during the consultation process, and produces a final document containing recommendations for the procedure.  NICE then publishes the formal guidance in the same way it circulates its other guidelines (see above).

Doctors who are keen to undertake new interventional procedures before NICE's appraisal has been completed are permitted to do so, but only if they inform the Chief Executive of their Trust or hospital of their intention.  They must also make absolutely certain that the patients/carers involved understand that the procedure is new, and that it is not certain how safe and/or effective it is.

You can find out more about NICE's Interventional Procedures protocols on their website.

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