Guideline development group

This draft module is currently open for public consultation. You are encouraged to make a submission through the online public consultation portal available at consultations.nhmrc.gov.au. Consultation closes on Wednesday 6 February 2019 at 5:00pm AEDT.

Guideline development group

The composition of a guideline development group will influence the recommendations it makes.

The size and composition of your guideline development group will depend on several factors such as the scope and complexity of the guideline, the time frame in which it is being developed and your budget. Well-drafted terms of reference will help members to understand what is expected of them. They also describe how the group will conduct its business and communicate with each other (Kunz, Fretheim et al. 2012). Effective chairing of meetings, choosing the right consensus development method and training of members can also enhance the development process.

This module provides information about the form and function of the guideline development group. This includes the selection of a Chair, group composition and function and the roles and responsibilities of members. It also discusses the practical issues of working together to develop a guideline. It does not cover the management of the guideline development process (see Organisation and budgeting). Other modules related to the guideline development group include Identifying and managing conflicts of interest, Training and Consumer involvement.

What to do

1. Select the Chair

Your group should be chaired by someone with demonstrated leadership capabilities who can listen to what members are saying and guide discussions without controlling them (Rosenfeld, Shiffman et al. 2013). In the context of a guideline development group, the Chair should have the ability to manage meetings effectively, negotiate with group members and resolve conflict (see Section 3, Table 1). Importantly, they should actively encourage and support the participation of all members of the group and make sure all voices are heard, particularly those of consumers.

The Chair does not need to be a content expert but they should have experience in evidence-based guideline development (IOM 2011), or experience in developing public and/or environmental health advice. If your Chair is a content expert, it is important that they remain impartial during discussions and should be free from conflicts of interest (see Identifying and managing conflicts of interest).

The role of the Chair begins before guideline development commences and they should be recruited early to assist in the initial project planning stages and to help select other members of the group (see Organisation and budgeting). Recruiting a Chair will depend on your organisation’s procedures, such as using an internal reference group or a steering committee. Government agencies embarking on guideline development will also have relevant legislation and Codes to comply with (e.g. Australian Government Public Governance, Performance and Accountability Act 2013, Remuneration Tribunal determinations etc.).

Although a single chair is usually chosen, two co-chairs might be more appropriate for your guideline. For example, some guideline groups may have methodological and content co-chairs. In those instances where there is a single chair, an assistant Chair may also be required should the Chair be unable to attend a meeting or otherwise fulfil their duties (Rosenfeld, Shiffman et al. 2013).

2. Determine the structure and complexity of the group

The key to a good guideline development group is to have the right mix of expertise and views relevant to the particular needs of the guideline. This would include content experts (e.g. researchers), methodologists or guideline experts, end-users (e.g. health workers) and consumers (e.g. patients or carers). There are also significant benefits in having a systematic reviewer or someone with expertise in the methods to review evidence and develop guidelines within the group—however, care must be taken to prevent the introduction of bias into any group decision making or the systematic review process (IOM 2011).

Depending on the needs of the guideline you might consider including additional experts such as economists or those with a role in implementing any final public/environmental health guideline. You should also aim to include more than one consumer in your group as the views of different consumers will not be accurately represented by just one person (see Consumer involvement). Public health guidelines often benefit from having a representative from the relevant community group. If the issue is particularly contentious, this member may be appointed as an observer in the interests of being inclusive and transparent in developing advice or guidelines.

You should aim to balance wide representation with group cohesiveness and efficiency. Your group should consist of 8–12 members (WHO 2003). Smaller groups may introduce bias or not have the full expertise required. These risks can be reduced through diverse membership and effective chairing of meetings (Rosenfeld, Shiffman et al. 2013). Larger groups may reduce the effectiveness of group processes (Shekelle, Woolf et al. 1999; IOM 2011). Evidence suggests that problems can arise when there are more than 15 members (Kunz, Fretheim et al. 2012). If larger groups are unavoidable, this issue can sometimes be counterbalanced by breaking the group into subgroups tasked with specific elements of the guideline’s development. The recruitment of a manager or secretariat can also help to coordinate members.

Group membership should not only reflect diversity (e.g. geographical, gender balance), but also include populations where the health condition is more prevalent (WHO 2014). For example, guidelines on osteoporosis should involve a greater proportion of consumers who are elderly. All guideline groups should try and include at least one Indigenous representative; however, this is not always possible (see Indigenous engagement module). In some instances Indigenous representation is not required. For example, the incidence of cystic fibrosis is less common in Australian Aboriginal and Torres Strait Islander and New Zealand Maori people, so consumer representation on a guideline development group of these peoples may not be a priority.

3. Define the roles and functions of the group

All members are required to review the guideline’s scope and questions, prioritise outcomes and help to develop recommendations (WHO 2014). Each member will have additional roles depending on their background and skill set. For example, a systematic reviewer may be responsible for either developing a systematic review or identifying and adapting an existing review. They may also be required to help other members of the group understand the evidence. Table 1 highlights some key responsibilities of guideline development group members.

Table 1: Key responsibilities of development group members (adapted from NICE 2014)

Group member

Key responsibilities

All members

  • Agree on the scope, questions and P[I/E]CO
  • Contribute constructively to meetings, including approving the minutes
  • Declare all relevant interests so that conflicts of interest can be identified and managed
  • Develop actionable recommendations based on reviews of evidence
  • Identify potential implementation issues and propose steps to overcome them
  • Assess the acceptability and feasibility of the recommendations
  • Weigh the potential risks and benefits of treatment
  • Make decisions on what information should be included
  • Consider and deliberate on public consultation submissions

Chair

  • Contribute to the drafting of terms of reference and formation of the guideline development group
  • Facilitate group processes and promote balanced participation of group members
  • Support effective consumer involvement
  • Manage conflicts of interest during meetings
  • Ensure that the group stays focused and task oriented
  • Delegate work and co-ordinate output of the group

Content experts

  • Apply their knowledge to improving the identification of relevant evidence
  • Advise on how to identify best practice in areas for which limited evidence is available
  • Identify, critically appraise and synthesise evidence into a format useful for developing recommendations*
  • Assist the group in understanding the evidence and evidence-to-decision process*

Consumers

  • Consider to what extent published evidence reflects outcome measures that consumers consider important.
  • Ensure that questions and recommendations address consumer issues and concerns
  • Ensure that the guideline is worded appropriately

Methodological experts

  • Identify, critically appraise and synthesise evidence into a format useful for developing recommendations
  • Assist the group in understanding the evidence and evidence-to-decision process
  • Maintain comprehensive records

* This is often considered a core task of content experts, particularly in the absence of a methodological expert (SIGN 2015)

After the guideline has been published, members should be encouraged to promote it. Not only are they knowledgeable of the topic but they also command respect in their field and are well placed to champion its use.

4. Develop the Terms of Reference

Terms of reference define the purpose of the group and outline the working arrangements among members. They should include expectations around meeting attendance, communication and standards of behaviour at meetings. They will also detail processes such as the schedule and format of meetings, managing conflicts of interest and confidentiality (Table 2).

Table 2: Key considerations when developing guideline group terms of reference

Terms

Description

Responsibilities and expectations of group members

  • Participate in group discussions
  • Understand the evidence on which the guideline is based
  • Understand and adhere to agreed methods of communication and methods of document generation and review
  • Adhere to a code of conduct

General tasks assigned to members

  • Read and comment on documents between meetings
  • Participate in the drafting of recommendations
  • Comment on the draft guideline prior to publication

Schedule and format of planned meetings

  • Frequency of meetings
  • Location of meetings and whether they will be conducted face-to-face or via other media (e.g. teleconference, videoconference)
  • Development and distribution of agenda and minutes
  • Actioning of tasks assigned during the meeting
  • Minimum attendance, quorum size, ability for members to send a proxy

Conflicts of interest

  • Disclosure of all relevant interests upon acceptance into the group so that conflicts of interest can be identified and managed
  • Inform the Chair of any new interests at the beginning of each meeting
  • Outline strategies to deal with conflicts of interest, e.g. excluding conflicted members from contributing to formulating recommendations involving a particular topic for which they are conflicted (see Identifying and managing conflicts of interest)

Confidentiality of information

  • Prohibition from revealing proprietary or confidential information to individuals outside of the group
  • Members are not to use information gained during the development process for purposes other than fulfilment of work within the group (Stroke Foundation 2017)

 

5. Establish the guideline development group

The organisation who initiated the guideline development process (or were commissioned to do so, e.g. the steering committee or primary developer) is responsible for recruiting members. Each group consists of a diverse range of stakeholders. This diversity means that there is no single place where they can be sourced.

There are various channels where members can be sought. Consumers can be identified by seeking expressions of interest in consumer information portals (e.g. healthdirect) or through relevant support groups and consumer organisations (see Consumer involvement). Content experts can often be located by contacting specialist societies or colleges. Methodologists can be found by contacting health technology assessment agencies or organisations that conduct systematic reviews (e.g. Cochrane).

Researchers and clinicians will have established links to other experts in their field. These individuals can be invited to the group; however, steps must be taken to ensure diversity of membership. For example, you do not want your group to contain too many content experts at the expense of consumers or methodologists.

All members should be appointed based on merit. You should consider developing a ‘statement of requirement’ to outline the skills, knowledge and expertise you seek (G-I-N 2015). This both helps to inform candidates of the desired attributes and is useful as a tool to screen and select applicants. Consider inviting unsuccessful applicants to contribute via other channels such as independent review or as part of a focus group.

6. Support effective functioning of the guideline development group

Guideline development groups may encounter problems such as being unable to reach consensus, gaps in content or methodological knowledge and unproductive meetings. Differing viewpoints can also lead to conflict and communication breakdown which can stall the process. There are several ways to improve group participation and reduce conflict.

Training

Many members of the group will be unfamiliar with the methods used to develop guideline recommendations. Consider offering training to these individuals to help them understand the process and improve participation (Fretheim, Schunemann et al. 2006).

Although training will primarily involve consumers and non-experts it may also benefit expert members of the group. For example, facilitator training may be useful for the Chair and content experts may benefit from GRADE training. Cultural awareness training may also be important when developing your guideline (see Training).

Consensus development methods

Consensus development methods are ways in which members of the group can practise shared decision making. You should describe anticipated methods of consensus development at the start of the process. This should include information about whether the group will adhere to a particular decision rule (e.g. whether full consensus is required or if the majority is sufficient) (Kea and Sun 2015).

Consensus development methods can be either explicit or implicit. Explicit methods include the Delphi method and the Nominal Group Technique (NGT). Implicit methods include ‘informal consensus’ and ‘consensus development conference’ techniques (Fretheim, Schunemann et al. 2006). Efforts should be made to avoid visible voting methods as these can make it less likely for members to change their mind. There are many sources of information regarding consensus development methods (Black, Murphy et al. 1999; Fretheim, Schunemann et al. 2006).

Stakeholder and expert consultation

Not everyone who is interested in the guideline topic can be included within the group. Experts who express an interest can be included as independent reviewers (see Independent review) or as members of focus groups (see Engaging stakeholders and Consumer involvement). You may also consider inviting experts to participate in group meetings as external consultants. Additionally, group meetings may be held at different stages of the development process, providing stakeholders with the opportunity to share their opinions. For each of these contributions it is important to remember that these individuals have no authority over the decision-making process.

Conflict resolution

Guideline development includes a variety of individuals with different opinions and viewpoints. While debate and discussion are encouraged within the group there may be instances where conflict can arise among members. This can derail the guideline development process if not identified quickly and managed appropriately. The Chair has an important role in managing disagreements within the group (Fretheim, Schunemann et al. 2006)—they should remain neutral and give all viewpoints equal consideration. It is important that a record is kept of the disagreement and how it was resolved.

Holding effective meetings

Constructive meetings are essential to efficiently developing guidelines. It is the Chair’s responsibility to ensure that all members are provided with clear information about how the meeting will be run. Consider the following:

  • Has an agenda been developed and distributed?
  • What materials need to be sent to members prior to the meeting?
  • Will the group draft recommendations before the meeting and then discuss them, or draft them during the meeting?
  • What are the specific objectives of the meeting? What decisions and outputs are expected following the meeting?
  • Have all members declared any relevant interests at the start of the meeting?
  • How will any conflicts of interest be managed in the meeting?
  • Who will record the meetings deliberations?
  • How will actionable items be allocated and followed up?

For example, the objective of a meeting may be to discuss evidence-to-decision tables and draft recommendations. Relevant materials should be distributed before the meeting and what is required from each member during this process outlined. The Chair is responsible for ensuring that the agenda is adhered to and that discussions stay on topic. They should also try to keep members focused and ensure that distractions are kept to a minimum (e.g. the use of mobile phones).

Consider member’s needs

Members of the guideline development group can be supported in a number of other ways that can enhance their experience and improve their positive engagement in group processes. The use of software and online shared folders can provide members with easy access to real-time working documents and agenda papers. You should also aim to provide flexible arrangements for members to participate in meetings (e.g. through digital platforms or video-/teleconferencing) if they cannot attend face-to-face meetings due to location or other requirements. Pay particular attention to the needs of the consumer members of the guideline development group when scheduling and organising meetings, as they may have ongoing health conditions that will impact their ability to engage (see Consumer involvement).

NHMRC requirements

Guidelines approved by NHMRC must meet all requirements outlined in the Procedures and requirements for meeting the NHMRC standard. The following requirements are specific to the Guideline Development Group module:

  • A.3 A multidisciplinary group that includes end-users, relevant disciplines and clinical experts is convened to develop the purposes, scope and content of the guideline, and the process and criteria for selecting members are described.
  • A.4 Consumers participate in the guideline development, and the processes employed to recruit, involve and support consumer participants are described.
  • A.5 A complete list of all the people involved in the guideline development process is provided, including the following information for each person: name, profession or discipline, organisational affiliation and role in the guideline development process.
  • A.6 Potential competing interests are identified, managed and documented, and a competing interest declaration is completed by each member of the guideline development group.
  • A.4.1 The guideline development process includes participation by representatives of Aboriginal and Torres Strait Islander peoples and culturally and linguistically diverse communities (as appropriate to the clinical need and context), and the processes employed to recruit, involve and support these participants are described.

NHMRC Standards

The following Standards apply to the Guideline Development Group module:

2. To be transparent guidelines will make publicly available:

  2.1. The details of the processes and procedures used to develop the guideline

  2.3. The declarations of interest of members of the guideline development group and information on how any conflicts of interest were managed.

3. The guideline development group will:

  3.1. Be composed of an appropriate mix of expertise and experience, including relevant end users

  3.2. Have clearly defined, documented processes for reaching consensus.

4. To identify and manage conflicts of interest guideline developers will:

  4.1. Require all interests of all guideline development group members to be declared.

Useful resources

National Institute of Health and Care Excellence (NICE) – The guidelines manual – Decision making committees

World Health Organisation – WHO Handbook for Guideline Development – 2nd Edition (3.2 The guideline development group, p.24)

Institute of Medicine – Clinical Practice Guidelines We Can Trust (Guideline development group composition and group process, p.83)

References

Black, N., Murphy, M., et al. (1999). Consensus development methods: a review of best practice in creating clinical guidelines. Journal of health services research & policy 4(4): 236-248.

Eccles, M. P., Grimshaw, J. M., et al. (2012). Developing clinical practice guidelines: target audiences, identifying topics for guidelines, guideline group composition and functioning and conflicts of interest. Implementation science : IS 7: 60.

Fretheim, A., Schunemann, H. J., et al. (2006). Improving the use of research evidence in guideline development: 5. Group processes. Health research policy and systems / BioMed Central 4: 17.

G-I-N. (2015). Guidelines International Network Public Toolkit. from www.g-i-n.net/document-store/working-groups-documents/g-i-n-public/toolkit/toolkit-2015.

Institute of Medicine (IOM) (2011). Clinical Practice Guidelines We Can Trust. Guidelines We Can Trust. M. M. Graham R, Miller Wolman D, et al. Washington, DC, The National Academies Press.

Kea, B. and Sun, B. C. (2015). Consensus development for healthcare professionals. Internal and emergency medicine 10(3): 373-383.

Kunz, R., Fretheim, A., et al. (2012). Guideline group composition and group processes: article 3 in Integrating and coordinating efforts in COPD guideline development. An official ATS/ERS workshop report. Proceedings of the American Thoracic Society 9(5): 229-233.

NICE (2014). Developing NICE guidelines: the manual. Manchester, UK, National Institute for Health and Care Excellence.

Rosenfeld, R. M., Shiffman, R. N., et al. (2013). Clinical practice guideline development manual, Third Edition: a quality-driven approach for translating evidence into action. Otolaryngology - Head and Neck Surgery 148(1 Suppl): S1-S55.

Shekelle, P. G., Woolf, S. H., et al. (1999). Clinical guidelines: developing guidelines. British Medical Journal 318(7183): 593-596.

SIGN (2015). SIGN 50: a guideline developer’s handbook.

Stroke Foundation (2017). Clinical Guidelines for Stroke Management. Melbourne, Australia.

WHO (2003). Guidelines for WHO Guidelines. Global Programme on Evidence for Health Policy. Geneva, Switzerland.

World Health Organisation (WHO) (2014). WHO Handbook for guideline development, World Health Organisation.

 

Acknowledgements

NHMRC would like to acknowledge and thank Professor Lisa Bero from the Charles Perkins Centre at the University of Sydney for her contribution to this module as editor.

 

Version 3.0. Last updated 23/11/2018.

Suggested citation: NHMRC. Guidelines for Guidelines: Guideline Development Group. https://nhmrc.gov.au/guidelinesforguidelines/plan/guideline-development-group. Last published 23/11/2018.

ISBN: 978-1-86496-024-2