Interventional procedures

What is an interventional procedure?

An interventional procedure is one that involves making a cut through the skin, using instruments to enter the body (e.g. endoscopes) or equipment which uses energy sources (e.g. ultrasound or electromagnetic radiation) to diagnose or treat patients.

What does NICE's Interventional Procedures programme do?

The programme looks at whether particular procedures used for treating a patient or diagnosing an illness are safe enough and work well enough for wider use in the NHS.

Based on this, NICE publishes guidance on whether or not doctors should consider specific interventional procedures to treat or diagnose their patients.

This type of NICE guidance does not consider how much the procedures would cost the NHS, or whether the NHS should allocate funding for them. These decisions are made at a local NHS level and usually on a case-by-case basis.

This means that if NICE has issued guidance recommending any given interventional procedure, the NHS is not obliged to provide it. There is no legal requirement to comply with the recommendations NICE makes, although it is considered best clinical practice for the NHS to do so.

The guidance does not name or relate to the specific devices that may be used: it evaluates the procedure, not the technology.

Why does NICE publish this type of guidance?

Unlike medicines, there is no licensing system in the UK for operations or other interventional procedures. This means that it can be difficult for healthcare professionals to be fully informed about the possible risks and benefits of procedures that are emerging within UK clinical practice.

The guidance both encourages doctors to consider newer procedures that they may not have otherwise used, as well as protects patients by advising on the risks and benefits of their use.

The guidance means that innovative procedures that could provide significant health benefits can be incorporated into clinical practice in a responsible way.

Which settings does NICE publish this guidance for?

NICE publishes its interventional procedures guidance for NHS healthcare settings in England, Northern Ireland, Scotland and Wales.

Does NICE investigate all interventional procedures?

No. NICE typically investigates procedures that are not well established in clinical practice; for example, if they are being performed as part of trials, or if they are not widely performed in the UK. However, NICE can also look at more established procedures if there are any uncertainties about their safety or efficacy.

Interventional procedures also have to be notified to NICE. This means healthcare professionals or other members of the public ask NICE to consider publishing guidance on a procedure.

Furthermore, for NICE to be able to publish guidance on a particular interventional procedure, there has to be evidence that it is being used in the UK, or is intended to be used within a foreseeable timescale.

Who develops this type of guidance for NICE?

NICE's interventional procedures guidance is developed by an independent committee made up of 25 members, who have a range of expertise. The committee includes doctors who perform interventional procedures, people who are familiar with the issues that affect patients, as well as experts in regulation. For further information, please visit the interventional procedures webpage.

What sorts of recommendations does NICE make?

There is no such thing as an interventional procedure that is entirely free from risk; NICE has to balance the extent of these risks and any uncertainties, against the benefits and what is already known.

It is not simply a case of recommending "for" or "against" the use of interventional procedures in the NHS.There are four types of recommendations that NICE can make regarding whether the NHS should consider offering certain interventional procedures. These are:

1. Use with normal arrangements for clinical governance, consent and audit

This is the most positive recommendation that NICE can make for an interventional procedure. It means that there is enough evidence to show that the procedure works well enough and is safe enough for doctors to consider it as an option for their patients, providing that they follow their hospital's existing policies around getting permission to perform operations and monitoring the results afterwards.

The recommendation does not mean that all patients who have the condition or symptom in question "should" or "must" be offered the procedure - this is decided at a local NHS level and usually on a case-by-case basis between the doctor and patient.

2. Use with special arrangements for clinical governance, consent and audit

NICE makes this recommendation if there are any uncertainties about the safety and/or efficacy of the procedure following the review of the published research; for example, if there is only evidence of a procedure's short term clinical benefits. NICE would also make this recommendation if there are known risks of serious harm which will need to be carefully explained to the patient beforehand.

This recommendation puts a greater emphasis on the need for informed consent - both from the patient (and carer, if necessary) and from senior medics (usually the hospital's medical director) - and encourages healthcare professionals to closely monitor how their patients are doing afterwards and to facilitate further research (e.g. by submitting data to a national register).

3. Use only in research

This recommendation means that NICE believes that the procedure should be carried out only in the context of formal research studies, as approved by a research ethics committee.

NICE would make this recommendation if the procedure is still considered to be experimental or because any uncertainties have to be resolved before more positive guidance regarding its use can be developed.

4. Do not use

NICE makes this recommendation if the evidence suggests that the procedure does not work very well, and/or if there are unacceptable safety risks. Out of the 400 pieces of interventional procedures guidance published as of June 2011, only 6 of these have not been recommended for use.

How long does it take to publish Interventional Procedures guidance?

On average, it takes around 37 weeks for NICE to publish final guidance for the NHS on an interventional procedure. This is from when the scope is finalised (i.e. when NICE formally agrees to investigate the procedure) and includes the time in which specialist advisers research the procedure, as well as the period during which patients, doctors and other relevant third parties have the opportunity to comment on the draft recommendations.

For further information, read Section 2.3 of the Process Guide.

What should I do if I am a patient and wish to receive a procedure that NICE has published IP guidance on?

Firstly, it's important to bear in mind that NICE IP guidance doesn't mean that a hospital must provide the procedure. NICE publishes its guidance so that healthcare professionals and patients can make informed decisions about their treatment options. If NICE advises that a procedure should be offered under the hospital's "normal" or "special" arrangements for clinical governance, audit and consent, this does not necessarily mean that it will be suitable for all patients with the condition in question. Patients should discuss their treatment options with their examining doctor.

NICE publishes a version of its guidance specifically for patients and other members of the public, which details what NICE has recommended and why, as well as questions that they may wish to ask their doctor before they make their decision. These documents are called "Understanding NICE guidance" and can be found on the various guidance pages of the website.

For further information, please visit: www.nice.org.uk/IP or call the NICE press office on 0845 003 7782 (NHS and public enquiries to 0845 003 7781).