12 Draft recommendations

The Committee makes its draft (or provisional) recommendations on the efficacy and safety of the procedure, taking into account the overview, specialist advice, patient commentary and factors related to equalities. Draft recommendations are formulated in accordance with the NICE equalities scheme.

For each procedure, the Committee makes recommendations on conditions for the safe use of the procedure. These include details of the arrangements that should be made for consent, audit and clinical governance. Recommendations take into account efficacy and safety in both the short and the longer term. The relative importance of either short- or long‑term outcomes may vary according to the nature of the condition (for example, whether it is acute or chronic). Often, explicit statements are made about each of these 4 aspects (that is, efficacy in the short and long term, and safety in the short and long term). However, sometimes specific reference to each is implicit or unnecessary on the basis of the clinical knowledge, or because long‑term follow‑up considerations may, by their nature, be inapplicable for certain procedures and conditions.

The Committee does not have a remit to determine the place of a procedure in the pathway of care for the condition or disease in question, or to consider the cost effectiveness of procedures.

NICE has a Citizens Council to help determine its approach, and that of its Committees, to making social value judgements. The Council's views continue to influence and inform the Committee's and NICE's position on how value judgements should influence its guidance. For example, it may consider what an adequate level of safety is for a procedure, and which factors should influence that judgement.

12.1 Main types of recommendations made by the Committee

The main recommendations made by the Committee are intended to address the practical steps that clinicians should take to carry out the procedure safely in relation to their hospital's clinical governance arrangements, the patient consent process and the collection of data. The Committee may include comments in the guidance describing its judgement of the evidence, and the balance between risks and benefits, or other important factors affecting their decision.

Sometimes, it is appropriate to make 2 different recommendations in the same piece of guidance. This normally happens when, for example, there are 2 different patient groups for whom the risks and benefits of the procedure differ.

'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.

  • It should be valid, relevant and of good quality.

  • It should be available in sufficient quantities for the Committee to make a positive decision.

  • It should be sufficiently consistent in nature.

  • It should show benefits within an appropriate time of the procedure (short- or long‑term efficacy). It may not be practical to obtain long‑term efficacy evidence for some recently introduced procedures, so specific recommendations may be made about the need for more data on long‑term outcomes. When long‑term safety issues seem relevant, data on these should be adequate or the need for reporting on long‑term safety outcomes may be stipulated.

  • It should be shown that the frequency and severity of adverse effects of the procedure are similar to, or less than, those of any comparable and established procedures. In exceptional circumstances, the frequency and severity of adverse events may be greater, but this would normally only lead to a recommendation for standard arrangements if the procedure has a much greater benefit: that is, in reasonable proportion to the severity of the condition being treated and the size of clinical benefit obtained; and acceptable in the context of the natural history of the condition.

'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:

  • the procedure is still considered to be experimental in nature

  • the level of uncertainty about the efficacy or safety evidence is such that it is considered to be in the best interest of patients to recommend controlled investigation of the procedure under the scrutiny and protection of research ethics committees

  • resolution of substantial uncertainties about its efficacy or safety would be fundamental to its routine use.

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.

12.2 Additional recommendations to support effective use of procedures

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:

  • Appropriate team members and adequate facilities can be important for some procedures.

  • Specialist teams may need members to help with patient selection, counselling, doing the procedure, dealing with unexpected problems, care during recovery, adjuvant treatments and rehabilitation.

  • Some procedures can be skilfully done by clinicians of more than 1 specialty.

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.

12.3 Data collection to address uncertainty

When data on efficacy or safety are inadequate, the recommendations usually refer to the need for further evidence generation to enable NICE to review and update the guidance. The outcomes that are most needed are specified, for example, quality‑of‑life measures or long‑term outcomes. The guidance may recommend either research in formal clinical studies or routine data collection through a register. The considerations for recommending a specific type of research design are:

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:

  • to accrue evidence for future update of the guidance

  • to monitor the use and dissemination of the procedure

  • to encourage audit of outcomes.

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

  • an established register specific to the procedure

  • an established register that includes several related procedures

  • an established register that is to be modified to enable data collection on the procedure

  • a new register, created as a result of the guidance.

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

Standards

Criteria

All known procedures (all devices), without exception, are recorded in the database

Raw anonymised data available for secondary analysis and validation.

Denominator data available to assess data coverage, such as sales figures and routine health service information.

The data recorded address relevant efficacy and safety outcomes and important patient characteristics

Medicines and Healthcare products Regulatory Agency/NICE and professional representatives involved in dataset design and agree final protocol.

Data include details of modifications or evolution of procedure/device and numbers done for the original indication (and respective outcomes).

Independent oversight

Independent steering group responsible for design, data monitoring and analysis.

Register recorded on national database of registers.

Explicit intent to publish results whatever the outcome.

Process for data collection, storage and analysis independent of any particular company or any commercial interest.

The Register must comply with the data protection principles laid out in the UK Data Protection Act 1998 and any other relevant legislation

Data is:

  • used fairly and lawfully

  • used for limited, specifically stated purposes

  • used in a way that is adequate, relevant and not excessive

  • accurate

  • kept for no longer than is absolutely necessary

  • handled according to people's data protection rights

  • kept safe and secure

  • not transferred outside the European Economic Area without adequate protection.

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.

12.4 The interventional procedure consultation document

When the Committee has made draft recommendations, NICE issues a public consultation document. This sets out:

  • the recommendations that NICE proposes to issue

  • a brief description of the procedure, the indications for which it is normally used and current treatments for the condition

  • a summary of the main efficacy and safety outcomes that were available in the published literature and which the Committee considered as part of the evidence about the procedure

  • a summary of the opinions of specialist advisers on the efficacy and safety of the procedure

  • any additional efficacy and safety issues raised by patient commentators

  • other information of importance, such as details of any Medicines and Healthcare products Regulatory Agency safety notices, registers and other research in progress

  • any other comments or observations from the Committee about the procedure and the evidence presented.