Interventional procedures programme manual

'Standard' arrangements

For a procedure to be recommended for use with standard arrangements (previously called normal arrangements) for clinical governance, consent and audit, the evidence should be adequate in the following respects.

'Special' arrangements

A special arrangements recommendation states that clinicians using the procedure must inform the clinical governance lead in their trust, tell the patient about the uncertainties regarding the safety and efficacy of the procedure and collect further data by means of audit or research. The Committee recommends these arrangements when using a procedure because there are significant uncertainties in the evidence on efficacy or safety, or an inadequate quantity of evidence. The Committee may also consider the balance of risks and benefits of the procedure is such that special arrangements should be in place. This recommendation is often made when the procedure is considered to be emerging practice in the NHS.

When the Committee recommends special arrangements and audit is needed, and there is no data collection facility in place, NICE prepares an audit tool containing audit criteria for use with the procedure, drawing on advice from specialist advisers and Committee members. NICE publishes the audit tool with the guidance.

Audit tools are designed to help individual units: the Committee would always favour publication of outcomes, ideally on a collaborative basis. Recommendations sometimes make reference to publication of audit findings, specifically when no suitable register is available. NICE may liaise with professional organisations to explore possibilities for data collection.

'Research only'

Sometimes the Committee recommends that the procedure should be carried out only in the context of formal research studies approved by a research ethics committee. This recommendation is normally made when at least 1 of the following is the case:

In guidance that recommends research only, the Committee's research recommendations state the areas of uncertainty that the research should address, and sometimes refer to outcomes or other details that should be addressed in studies. The NICE Science Policy and Research team monitors all published NICE guidance and extracts these research recommendations. They are added to the NICE research recommendation database and made publicly available on the NICE website. This database is monitored by research funders such as the National Institute for Health Research (NIHR). For example, the NIHR National Evaluation, Trials and Studies Coordinating Centre (NETSCC) actively reviews all NICE research recommendations and considers for funding those that are within the remit of the programmes that they manage.

'Do not use'

When the evidence suggests that a procedure has no efficacy or poses unacceptable safety risks, the Committee recommends that it should not be used.

Clinical teams and specialised units

The Committee sometimes recommends that a procedure should only be done by a specific type of clinical team or unit. Recommendations of this kind are usually based on the views of specialist advisers or comments received during consultation, and take into account the following considerations:

Recommendations may stipulate that specific team members are considered essential. They may state that the team 'should include' particular specialists, but recognise that the make‑up of an appropriate team may vary between units. Recommendations sometimes refer to supporting services needed to deal with potential problems arising from a procedure.

It is not within the remit of the interventional procedures programme to make recommendations on the number of procedures (or similar procedures) that should be carried out regularly, or should have been done previously by a clinician or unit, even though this is sometimes suggested during consultation. It is the role of commissioners of health services to set these types of standards for the hospitals that provide their services. It is recognised that some units will be starting to use a procedure de novo, and that they may not initially be able to do the procedure in substantial numbers. The important issues to be considered are access to appropriate training and thorough audit within a clinical governance framework, both during and after the introduction phase of the procedure.

Training

It is expected, without being stated in the guidance, that consultants should be adequately trained to do procedures within their specialty. Similarly, it is expected that consultants involved in the delivery of a diagnostic or therapeutic intervention that involves radiation exposure are accredited in its use. Special knowledge and training may also be needed to use certain devices, including those that deliver energy such as laser, radiofrequency or ultrasound. Therefore, specific recommendations about training are made only when particular training issues have been raised by specialist advisers, comments from consultation or publications. Most often these issues relate to difficult technical challenges that may necessitate an above normal level of training, expertise or experience for a specialist in the relevant discipline.

Consultants are, by definition, fully trained in their own specialty. The term 'training', as used in the Committee recommendations, is intended to encapsulate all ways of acquiring knowledge and skills from others, such as mentoring and supervising, for the procedure in question.

When possible, the Committee seeks to identify procedures that need an enhanced level of training or experience and to reflect this in the recommendations. Specifying the kind of training needed is not possible unless published standards exist, or there are training courses that have been recognised and supported by the appropriate professional organisations. Training or standards that are already provided by professional organisations are referenced in the guidance. If specialist advisers advise the Committee that specific training is essential, and if no published standards exist, then NICE may approach professional organisations with a request to publish standards that can be referred to in the guidance.

For some procedures, specialist training for members of the operating theatre team, other than the clinician doing the procedure, may also be needed and this is specified in the guidance.

Other information

Other information may be included in the guidance, for example, on whether evidence suggests that certain patient subgroups may derive a greater or lesser benefit, or be at a greater or lesser risk, from a procedure and about regulatory issues, such as off‑label use of pharmaceutical products. These issues are normally addressed in the 'committee comments' or the 'further information' section of the guidance.

Clinical studies

If an appropriate research study is in progress or is nearing the stage of recruitment, a recommendation may be made for clinicians to enter patients into that study. This involves the Committee judging that the study is viable and that its main outcomes are relevant to the guidance. In these circumstances, a recommendation to enter patients into the study is considered likely to benefit recruitment and to lead to more rapid data collection. The Committee considers whether the trial is open to recruitment of patients by clinicians who are not already involved. The consultation document refers to the trial by name.

The situation is more difficult when the Committee considers that additional formal clinical research would be of value but there are no ongoing studies into which clinicians might be recommended to enter patients. This is a common situation. The practical and procedural obstacles and resource needs for setting up new clinical research projects are considerable, and the delay between deciding to address a research question and starting to recruit patients may be lengthy. In these circumstances, the Committee may comment on the desirability of further evidence on the procedure, referring to the outcomes for which improved evidence would enable NICE to update the guidance.

Registers

When the data on the efficacy or safety of a procedure are inadequate in quantity or quality, the Committee may recommend that data be collected on all patients having the procedure. The aims are:

A recommendation for data collection through a register may specify sending data to:

Before an established register is recommended, the programme team confirms that the standards in table 2 are met, using the criteria outlined.

Patient Reported Outcome Measure (PROMS) data are used if collected through a national register that meets the standards in table 2.

Table 2 Register standards and criteria for recommending a register in Interventional Procedures guidance

In some cases, NICE commissions an External Assessment Centre to establish a national register to collect observational data on procedures for which the Committee has identified a need for further evidence. This usually relates to the long‑term safety and efficacy of a procedure.