Process and methods

10 Advice and commentary

In addition to the evidence in the overview, the Committee considers advice and commentary in formulating its recommendations on procedures.

10.1 Opinions of specialist advisers

NICE seeks the opinion of as many specialist advisers as are deemed appropriate for the procedure. Advisers are requested from specialties involved in the procedure (sometimes more than 1 specialty) and also, when relevant, from specialties involved in the selection, referral and care of patients having the procedure. The appropriate number of professional organisations depends on the number identified in the brief. The number of questionnaires that are returned to NICE also depends on professional organisations nominating their members, and the number of individual advisers returning their questionnaire to NICE within the required timescale before it is considered by the Committee. New procedures often have potential benefits and, importantly, risks that are not yet fully described in the scientific literature. Specialist advisers provide insight into these aspects, sometimes supported by accounts of their clinical experience. They have an essential role in the process of assessing novel interventional procedures; their knowledge and opinion provides supplementary evidence that may be absent from the scientific literature. A list of all current specialist advisers is on NICE's website.

NICE approaches the relevant professional organisations for the names of specialist advisers for each procedure, and gets the opinions of these identified advisers if possible. NICE also makes use of previously approved advisers, if necessary, to maintain timeliness.

Occasionally, NICE may not be able to find specialist advisers with sufficient knowledge of the procedure to give advice. This is most likely to occur with very new procedures. If 2 specialist advisers cannot be found from those approved in the relevant specialty or specialties, NICE will normally delay developing guidance on the procedure until sufficient advice is available. The absence of advisers with any knowledge may suggest that the procedure is not currently being used. Rarely, it may be appropriate to proceed with a single specialist adviser, at the discretion of the Committee Chair and by agreement with the Programme Director, provided the Chair considers that sufficient advice is available to the Committee for it to make a sound decision.

Specialist advice is usually provided via a questionnaire. Questionnaires completed by specialist advisers are copied to the professional body that nominated them. The completed questionnaires are published on NICE's website at the same time as the overview, when the consultation period for the draft guidance starts.

A clinician who has notified NICE about a procedure cannot normally act as a specialist adviser for that procedure. However, there may be times when a notifier's expertise in, or specialised knowledge of, the procedure means that it is appropriate to ask for their advice.

For each procedure, specialist advisers are required to declare their interests in line with NICE's policy on conflicts of interest. Specialist advisers' interests are available to the Chair and the Committee alongside the questionnaires.

A specialist adviser may be asked to provide more detailed assistance to the programme. This includes, but is not restricted to, attending Committee meetings (either by telephone or in person), commenting on an audit tool for the procedure (if NICE is producing one), commenting on the suitability of registers for compiling further data on the procedure and commenting on the lay version of the guidance. The opinion of specialist advisers is sought on the following issues, which are mainly encompassed in the questionnaire:

  • possible controversy between specialties over the procedure

  • whether they consider the procedure to be established, a minor variation on current practice, novel or the first in a new class of procedure

  • interventions that could be considered as comparators

  • potential adverse events associated with the procedure (including theoretical and anecdotal adverse events)

  • uncertainties or concerns about the efficacy or safety of the procedure

  • suggested efficacy and safety outcomes for audit

  • training or facilities needed to do the procedure safely

  • current research or registers

  • current and likely future impact of the procedure on the NHS.

10.2 Evidence from companies

Structured information request

While preparing the brief, a search is done for companies producing devices that may be used to do the procedure. Because there is no standard way of finding this information, NICE cannot do a comprehensive search. When NICE is aware that a branded device or devices are used in a procedure, it makes a structured information request to the companies involved at the beginning of the assessment of the procedure. This is normally done at the time NICE is preparing the brief for the procedure.

The structured information request covers limited factual information on:

  • settings and locations in which the product is being used for the indication or purpose in the assessment

  • evidence relevant to the assessment including unpublished trials, trials in progress, registers and post‑marketing data

  • dates on which trials and other evidence are expected to become available.

Companies are not obliged to make this information available to NICE, and are not penalised if they do not do so. However, it helps the quality and timeliness of NICE's assessment of the procedure if they send any available information to NICE. NICE evaluates the evidence on the procedure, rather than any particular device(s) involved. Companies do not need to make a formal submission to NICE.

Company attendance at the Committee meeting

NICE invites companies that it has identified in the procedure brief, and that it has approached to request information, to attend the meetings at which the Committee makes its draft recommendations and considers public consultation comments. The Committee may ask the company factual questions about their product, in the context of the procedure being assessed. Companies speak only when invited to do so, and are not invited to make a presentation on their product at the Committee meeting. Companies are present during part 1 of the committee discussions (see section 15).

10.3 Contributions from patient commentators

NICE's public involvement programme (PIP) seeks information about the impact of both the condition and the procedure on patients or their carers before the Committee meeting. Patient commentators can provide insight into outcomes not fully described in the scientific literature, such as quality of life. Their views are obtained by means of a questionnaire.

NICE tries to ensure that patient opinions are obtained by questionnaire for as many procedures as possible. However, because it relies on clinicians agreeing to send questionnaires to patients on its behalf, delays in this process or lack of response from patient commentators may mean that the questionnaires are not always available to NICE. To maintain timeliness, NICE does not delay guidance development if patient questionnaires are not available for a procedure. If patient questionnaires are not available to the Committee when it produces its draft recommendations but become available during the consultation period, the Committee considers the questionnaires when making its final recommendations.

The names of patient commentators are personal data under the Data Protection Act 1998 and are not released into the public domain. However, an anonymised copy of information supplied by patients about their experience of the procedure is available on request.

Occasionally, the programme is notified about procedures for which it may be inappropriate or impossible to obtain commentary from patient commentators (for example, an intraoperative diagnostic procedure that a patient may be unaware has been used during their treatment). The suitability of a topic for gaining patient commentary is discussed as part of developing each brief. Patient commentary is not sought if the Committee Chair, the programme team and the PIP all agree it would not be appropriate.

For all procedures, a statement is made in the guidance to indicate what NICE did to obtain patient commentary, and with what results. This is normally covered by 1 of the following categories:

  • no commentary sought by NICE, and reasons why

  • commentary sought but no replies received

  • commentary received that was/was not in agreement with evidence (fewer than 10 received)

  • commentary received that was/was not in agreement with evidence (10 or more received) and a summary was prepared.

NICE is aware that patients with experience of specific procedures have a unique insight that may be of value to the Committee in formulating its recommendations. NICE is committed to taking this into account when assessing procedures.

Patient commentators' responses

Patient commentators' responses to the questionnaires, which have been anonymised, are presented to the Committee to help it formulate recommendations. When responses number 10 or more, a summary is prepared for the Committee.

How patient commentary is used

Commentary on patients' experiences of the procedure is considered by the Committee when it formulates its recommendations, particularly when issues are raised that are not reported in the published literature. Descriptions of the benefits or harms of procedures that may only be identified by patients are of interest, particularly those relating to quality of life, for example:

  • living with the condition

  • comparing life before and after the procedure

  • side effects of the procedure

  • experience of disease progression with and without the procedure

  • outcomes that patients value most from the procedure

  • the difference the procedure may make to:

    • the physical wellbeing of patients (symptoms, pain, mobility, disability)

    • lifestyles and the choices that matter to patients and carers (impact on daily activities, work, hobbies, social life, relationships)

    • the psychological health of patients and carers (for example, mood, anxiety, distress)

    • the balance between quality of life and length of life (if appropriate)

    • the various treatment choices that matter to patients and carers.

  • experience of having the procedure.