Process and methods

6 Guidance Development Group

A Guidance Development Group (GDG) is established for each good practice guidance (GPG). The GDG is the primary source of expertise that determines the content of the GPG as defined within the scope of the project.

The chair, vice chair and members of each GDG may be drawn from the NHS, healthcare professionals, key stakeholders (including the pharmaceutical industry), social care, patients and carers, and academia. Members do not usually represent their organisation(s) and are selected for their knowledge and experience. All members of the GDG have equal status, reflecting the relevance and importance of their different expertise and experience.

The GDG considers the NICE project team's initial review of the existing evidence, confirming (or challenging) the appropriateness for inclusion in the GPG. It identifies potential additional evidence sources and, when needed, calls for expert oral and written testimony. The GDG also determines the validity and application of such evidence with the NICE project team.

All GDG members are committed to developing the GPG according to the processes set out in this methods guide and to work within NICE's equality scheme. They are expected to attend all GDG meetings (usually 5).

Members of the GDG are not permitted to submit comments as stakeholders during the consultation on the draft guidance (see section 13). If a GDG member is involved with a registered stakeholder organisation, they should not submit comments during the consultation on behalf of that organisation – someone else in the organisation should submit the comments.

6.1 Forming the Guidance Development Group

The chair, vice chair and members of the GDG are appointed for the duration of a particular piece of guidance development. Discussion about GDG membership takes place at the scoping workshop (see section 4.5.1).

6.1.1 The composition of the Guidance Development Group

The composition of each GDG is described in the project plan that is prepared by the NICE project team after the scoping workshop. This plan is agreed by the project lead and signed off by the Programme Director. Each GDG usually consists of 15–25 people, excluding the NICE project team.

The GDG has 5 key constituents:

  • the chair

  • the vice chair

  • members from health, social care and other professions (both specialists in the topic and generalists)

  • public, patient and/or carer representatives ('lay members')

  • NICE project team members.

Membership of the GDG is multidisciplinary and the exact composition of the GDG is tailored to the topic covered by the GPG. It should reflect the range of stakeholders and groups whose professional activities or care will be covered by the GPG, and should include at least 2 lay members. Members of the GDG should have sufficient expertise and credibility to command the respect of people within their field.

The GDG may also be supported by expert advisers (see section 5.5).

As far as possible, the GDG will have an appropriate balance with regard to the principles of NICE's equality scheme.

Ideally, GDG members are drawn from different parts of England and Wales, but this is influenced by the expertise available and does not exclude anyone from any other home country.

New members are not usually added to the GDG once the first GDG meeting has taken place, because this may disturb the group dynamic. After appointment, if a GDG member is unable to fulfil their duties (for example, because of illness), the project team may consider recruiting to replace that person. If additional expertise is needed, the GDG may co-opt (see section 6.1.5) an 'expert adviser' on the group or invite them to attend a specific portion of a meeting.

Vacancies for GDG positions are posted on the NICE website. Other means are also used to alert people to GDG vacancies, including sending email alerts to target groups from the NICE medicines and prescribing email alert system and using local networks.

6.1.2 Recruiting the Guidance Development Group chair and vice chair

Recruitment for the positions of chair and vice chair for each GDG follows NICE's policy Appointments to guidance producing bodies advisory to NICE (November 2006).

Applicants are required to submit a curriculum vitae (CV; including names and contact details of 2 referees), a completed declaration of interests form, a completed equality monitoring form and a statement explaining how they meet the criteria laid out in the person specification. The chair and vice chair are appointed after interview by the selection panel, which should include the Centre for Clinical Practice Director (or delegate) and a non-executive director of NICE.

6.1.3 Recruiting Guidance Development Group members from health, social care and other professions

Recruitment of members for each GDG follows NICE's policy Appointments to guidance producing bodies advisory to NICE (November 2006).

Health and social care (and other professions where relevant) professional members of the GDG are recruited shortly after scoping. They should represent the perspective(s) of health and social care professionals (and other professionals where relevant) involved in the care of people affected by the guidance topic.

The members are professionals with appropriate knowledge and skills; detailed research expertise is not necessary.

A GDG has, on average, between 11 and 21 health and social care professional members (excluding chair, vice chair and lay members), the list of professions represented is agreed as part of the project plan.

The roles and responsibilities of the health and social care (and other professions) professional members of the GDG are shown in box 6.1.

Box 6.1 Key roles of health and social care (and other professions) professional members of the Guidance Development Group

GDG members from health and social care professions (and other professionals where relevant) are expected to:

  • agree the terms of reference for the GDG and abide by them

  • agree the draft GPG structure including review questions, based on the key issues in the scope

  • contribute constructively to meetings and have good communication and team-working skills; this should include a commitment to the needs of patients and carers

  • use their background knowledge and experience of the GPG topic to provide guidance to the NICE project team

  • author and advise on the draft of the GPG in liaison with the NICE project team

  • read all relevant documentation and make constructive comments and proposals at (and between) GDG meetings

  • with other members of the GDG, develop recommendations based on the evidence reviews, or on consensus when evidence is poor or lacking

  • advise on how to identify good practice in areas where research evidence is absent, weak or equivocal

  • with other members of the GDG, consider implementation issues arising from recommendations, feed back to the NICE implementation team and assist with developing identified implementation support tools (see section 15)

  • with other members of the GDG, agree the minutes of GDG meetings.

Vacancies for health, social care and other professional GDG members are advertised on the NICE website. NICE informs registered stakeholder organisations about the advertisement via email. In addition, other means are used to alert people to GDG vacancies, including sending an email alert to relevant groups signed up to receive NICE medicines and prescribing email alerts and using local networks.

Applicants are required to submit a CV (including names and contact details of 2 referees), a completed declaration of interests form, an equality monitoring form and a statement explaining how they meet the criteria laid out in the person specification. Members are selected by the NICE project team in agreement with the programme director. They are not usually asked to attend an interview.

6.1.4 Recruiting lay members

Patients, carers and other members of the public can apply to become GDG members by responding to advertisements posted on the NICE website. NICE's Public Involvement Programme contacts all registered patient and carer stakeholder organisations to alert them to these advertisements. However, a person does not need to be a member of a registered stakeholder organisation to apply. The process includes:

  • People who want to reply to the advertisement can download an application pack from the NICE website, which includes a 'job description' and a person specification to help them decide whether they have the experience and skills to make an effective contribution to the GDG. This pack can be sent by post on request.

  • Applicants are asked to complete an application form describing how their skills and experience meet the specified requirements. They must also complete a declaration of interests form and an equality monitoring form.

  • Applications are sent to the Public Involvement Programme, which can also offer advice and support during the application process, both to patient and carer organisations and to individual applicants.

  • The Public Involvement Programme forwards all applications to the NICE project team. The NICE project team selects lay members according to the criteria in the job description and person specification. Applicants are not usually interviewed.

6.1.5 Non-Guidance Development Group members attending Guidance Development Group meetings

People who are not members of the GDG may also attend GDG meetings, as either expert advisers or observers. They may be health or social care or other professionals, patients or carers, other experts, or NICE staff. They are expected to follow the code of conduct of the GDG and to sign the confidentiality agreement form (see section 6.3).

6.1.5.1 Expert advisers and presenters of oral evidence

If the GDG does not have sufficient knowledge or expertise to make recommendations in a particular area, it may call on presenters of oral evidence (see section 8.9) and/or 'expert advisers'. Stakeholders and/or relevant organisations or individuals with a significant role or interest in the GPG topic being developed may be invited to present oral evidence.

To support the GDG to make decisions, external expert advisers can be appointed to provide additional evidence from their specific expertise. The advisers can also include people with a patient and carer perspective. Expert advisers attend a GDG meeting because of their knowledge in a particular area. It is therefore important that they sit within the group and enter fully into any discussion. However, they are not full members of the GDG; they do not have voting rights, and they should not be involved in the final decisions or influence the wording of recommendations. They are required to submit a declaration of interests form before attending the GDG meeting (see section 6.3).

6.1.5.2 Observers

An observer at a GDG meeting may be asked to sit apart from the group, and should enter into discussions only if invited to do so by the GDG chair. Observers at GDG meetings may include members of NICE staff (for example, the lead editor and the implementation lead). Observers who are not members of NICE staff are required to sign a declaration of interests form, and need prior permission of the group to attend.

6.2 Induction to the Guidance Development Group

As part of the first GDG meeting, the NICE project team conducts a brief induction for all GDG members. This includes an overview of the development process and timelines and relevant NICE policies and procedures. The project team ensures that the group has the project team's contact details for ongoing support. Additional support is available for lay members from NICE's Public Involvement Programme.

6.3 Governance

6.3.1 Terms of reference for the Guidance Development Group

The NICE project team produces a draft terms of reference for the GDG that is discussed and agreed at the first GDG meeting. All members of the GDG must agree to terms of reference and abide by them. The NICE project team will use a standard GDG 'terms of reference' template.

6.3.2 Code of conduct and declaration of interests

On appointment, all GDG members are asked to sign a declaration of interests form and a confidentiality form stating that they agree not to disclose any of the draft GPG recommendations before the public consultation begins. This is to ensure that recommendations in the public domain have been agreed by all members of the GDG. NICE has a code of practice for declaring or dealing with conflicts of interest (October 2008).

All people who see documents or who are party to discussions relating to GPG before public consultation are required to sign the declaration of interests and confidentiality agreement forms before becoming involved.

6.3.3 Social value judgements and equality scheme

Before the GDG starts its work, all GDG members are sent an electronic copy of NICE's most recent report on social value judgements: Social value judgements: principles for the development of NICE guidance (2nd edition; 2008) (paper copies are provided on request). The NICE project team also makes sure that GDG members are aware of NICE's equality scheme and action plan.

6.3.4 Dealing with enquiries on Guidance Development Group work

If GDG members are asked by external parties – including stakeholders or their professional organisation – to provide information about the work of the GDG, they should first discuss the request with the NICE project team. They should also declare this at the next GDG. Any media-related enquires should be directed immediately to NICE's Enquiry-handling team via nice@nice.org.uk and the NICE project team should also be informed.

6.4 Running the Guidance Development Group

Running the GDG is the responsibility of the NICE project team, in consultation with the chair. Core responsibilities for all meetings include:

  • setting meeting dates (which is done well in advance)

  • planning agenda items

  • sending out papers

  • keeping records of all meetings

  • ensuring that all GDG members have a copy of the current interim methods guide for developing GPG.

Notes are taken at each meeting by the NICE project team, which include:

  • where the meeting took place

  • who attended

  • apologies for absence

  • any changes to declarations of interest of those in attendance, including actions and decisions made about any conflict of interest

  • a list of the subjects discussed

  • a summary of the discussion that took place with any actions or decisions

  • date, time and venue of next meeting.

Each set of notes is approved by the GDG at the following meeting, and signed off by the GDG chair and the NICE project team.

6.4.1 General principles

Because the GDG is multidisciplinary, its members bring with them different beliefs, values and experience. All these perspectives should be valued and respected. Each GDG member should have an equal opportunity to contribute to the guidance development process. It is the role of the NICE project team to ensure terminology used by GDG members is understood by all and clarified if needed. The chair should ensure that there is sufficient discussion to allow different beliefs, values and experiences to be considered, while keeping the group focused on the GPG scope and the timescale of the project.

6.4.2 Quorum

The quorum of the GDG is 50% of appointed members. No business relating to the formulation of GPG recommendations may be conducted unless the meeting is quorate. If a member is excluded because of a conflict of interest and this causes membership to fall below the quorum, no business may be transacted.

Expert advisers (see section 5.5) are not appointed members of the GDG and do not count towards the quorum.

6.4.3 Guidance Development Group meetings

There are usually 5 GDG meetings that are scheduled in advance and form part of the project plan. Most are 1‑day meetings, but some may take place over 2 days. Some meetings may be rescheduled to meet the needs of the GDG.

Box 6.2 provides an overview of the purpose of each GDG meeting.

Box 6.2 Guidance Development Group meetings

Purpose

GDG meeting 1

  • Provide an overview of the GPG development process and introduce the role of the GDG

  • Provide an overview of the project timeline

  • Introduce the NICE policies relevant to GDG members

  • Gain agreement of the GDG terms of reference

  • Present and review the literature search

  • Discuss the Gap analysis (see section 8.8) including a discussion on methods to address gaps and a discussion of the proposed draft review questions (see section 7)

GDG meeting 2

  • Discuss the progress made on the development of the guidance wording and on the additional evidence received since GDG meeting 1

  • If necessary, the GDG should agree organisations that will be called to give oral evidence at GDG meeting 3

GDG meeting 3

  • Discuss the progress made on the development of the guidance wording

  • If needed, include an oral evidence session led by the chair. After an oral evidence session, the GDG discusses the evidence presented and how this feeds into the development of the GPG

GDG meeting 4

  • Discuss the final wording of the draft GPG for consultation including recommendations

  • Approve and confirm final draft recommendations prior to consultation

GDG meeting 5

  • Discuss the comments received during consultation and any amendments needed to the GPG

  • Agree the final wording of the recommendations

6.5 Making group decisions and reaching consensus

6.5.1 Reaching agreement

GDG members need to make collective decisions throughout the development of the GPG. These include agreeing review questions (section 7), interpreting the evidence (section 9) and developing GPG recommendations (section 12). There are many different approaches to making group decisions, and there is no blueprint about which approach should be used in which circumstances. Also, because GDGs function in different ways to reflect their individual membership, it is difficult to be prescriptive about the approach that should be used.

In most cases, the GDG reaches decisions through a process of informal consensus. The role of the chair is to ensure that each person on the GDG is able to present their views, that assumptions can be debated and that the discussions are open and constructive. The GDG chair needs to allow sufficient time for all members to express their views without feeling intimidated or threatened, and should check that all members of the group agree to endorse any recommendations. If the group cannot come to consensus in a particular area, this is reflected in the wording of the recommendation. Any areas of uncertainty are acknowledged by the GDG.

Some GDGs may choose to use more formal voting procedures for certain decisions, but it is beyond the scope of this guide to offer guidance on when these should be used, or which of the many variants might be used.