6 Advice and commentary
In addition to the evidence in the assessment report, the committee considers advice and commentary in formulating its recommendations on procedures.
6.1 Opinions of experts
NICE seeks the opinion of as many experts as are deemed appropriate for the procedure. Experts 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 scope. The number of questionnaires that are returned to NICE also depends on professional organisations nominating their members, and the number of individual experts 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. Experts 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.
NICE approaches the relevant professional organisations for the names of experts for each procedure, and gets the opinions of these identified experts if possible. NICE also makes use of previously approved experts, if necessary, to maintain timeliness.
Occasionally, NICE may not be able to find experts with sufficient knowledge of the procedure to give advice. This is most likely to occur with very new procedures. If 2 experts 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 experts with any knowledge may suggest that the procedure is not currently being used. Rarely, it may be appropriate to proceed with a single expert, 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.
Expert advice is usually provided using a questionnaire. Questionnaires completed by experts are copied to the professional body that nominated them. The completed questionnaires are published on NICE's website at the same time as the assessment report, when the consultation period for the draft guidance starts.
A clinician who has notified NICE about a procedure cannot normally act as an expert 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, experts are required to declare their interests in line with NICE's policy on declaring and managing interests for NICE advisory committees. Experts' interests are available to the chair and the committee alongside the questionnaires.
An expert may be asked to provide more detailed assistance to the programme. This includes, but is not restricted to, attending committee meetings (either virtually 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 experts is sought on the following issues, which are mainly encompassed in the questionnaire:
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possible controversy between specialties over the procedure
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whether they consider the procedure to be established, a minor variation on current practice, novel or the first in a new class of procedure
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interventions that could be considered as comparators
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potential adverse events associated with the procedure (including theoretical and anecdotal adverse events)
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uncertainties or concerns about the efficacy or safety of the procedure
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suggested efficacy and safety outcomes for audit
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training or facilities needed to do the procedure safely
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current research or registers
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current and likely future impact of the procedure on the NHS.
6.2 Evidence from companies
Request for information
Details on requests for information are in section 1.3 of the NICE HealthTech programme manual.
Company attendance at the committee meeting
Details on the participation of company representatives at the committee meeting are in sections 1.3.5 and 1.3.6 of NICE health technology evaluations: the manual.
6.3 Contributions from patient commentators
NICE's people and communities team 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 scope. Patient commentary is not sought if the committee chair, the NICE team and the people and communities team 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:
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no commentary sought by NICE, and reasons why
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commentary sought but no replies received
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commentary received that was/was not in agreement with evidence (fewer than 10 received)
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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 there are 10 or more responses, 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:
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living with the condition
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comparing life before and after the procedure
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side effects of the procedure
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experience of disease progression with and without the procedure
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outcomes that patients value most from the procedure
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the difference the procedure may make to:
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the physical wellbeing of patients (symptoms, pain, mobility, disability)
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lifestyles and the choices that matter to patients and carers (impact on daily activities, work, hobbies, social life, relationships)
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the psychological health of patients and carers (for example, mood, anxiety, distress)
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the balance between quality of life and length of life (if appropriate)
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the various treatment choices that matter to patients and carers
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experience of having the procedure.