Guideline development process

Introduction


NICE clinical guidelines are systematically-developed recommendations on how healthcare and other professionals should care for people with specific conditions. The recommendations are based on the best available evidence.

Bpacnz make changes of a contextual nature to clinical guidelines, overseen by NICE and guided by a Guideline Review and Contextualisation Group (GRCG), before these guidelines are published. The process bpacnz undertakes is based on the ADAPTE approach. New Zealand’s unique variances, compared to the United Kingdom, are taken into account during the guideline contextualisation process. These variances include (but are not limited to) our reduced population, ethnic and cultural differences, health sector differences (including funding and governance), economic constraints and access to care.

There are three main phases in the ADAPTE approach:

Set-up Phase: Outlines the necessary tasks to be completed prior to beginning the adaption process ( such as identifying necessary skills and resources).

Adaptation Phase: Assists the process of selecting a topic to identifying specific health questions; searching for and retrieving guidelines; assessing the consistency of the evidence and the guideline quality, currency, content, and applicability; decision making around adaption; and preparing the draft adapted guideline.

Final Phase: Guides the user through the process of obtaining feedback on the document from stakeholders impacted by the guideline, consulting with the developers of source guidelines used in the adaption process, establishing a process for the review and updating of the adapted guideline, and creating a final document.

Bpacnz guidelines make evidence-based recommendations on a wide range of topics, from preventing and managing specific conditions, improving health, and managing medicines in different settings, to providing social care and support to adults and children, safe staffing, and planning broader services and interventions to improve the health of communities. They aim to promote individualised care and integrated care (for example, by covering transitions between children's and adult services and between health and social care).

How bpacnz guidelines are developed


Initial setup

The guideline topic is agreed in consultation with the bpacnz board and/or the Clinical Advisory Group to ensure guidance is feasible. Contextualisation of any guideline must also be agreed with NICE. This is to ensure the evidence base for that guideline is up to date and robust for contextualisation.

Resources required for the contextualisation are decided upon by the bpacnz project team, and the schedule of tasks is agreed with NICE. Recruitment of the Guideline Review and Contextualisation Group (GRCG) begins (see The Guideline Review and Contextualisation Group), in which bpacnz makes contact with the Chair of the GRCG, who will be an eminent professional with expertise in the guideline topic. The initial schedule for contextualisation is drafted following discussions with the Chair. Bpacnz then work with the Chair to identify a cross-functional and multi-disciplinary group of colleagues to form the GRCG. Where possible these members will bring experience of different areas of the sector, different cultural and ethnic backgrounds as well as regional expertise.

Membership of the GRCG is usually between five to seven members. This is due, in part, to the close relationships held between experienced health professionals working within specialties/across conditions, and the contextualisation process itself, where bpacnz solely makes changes of a contextual nature to NICE guidance rather than begins complete guideline development altogether.

Confirming the scope

The scope sets out what a guideline will and will not cover. Contextualising the NICE clinical guideline scope is the first step in bpacnz contextualising a NICE guideline. This scope is used to create a framework for the contextualisation work and guides the GRCG in their work.

Purpose of the scope

The scope sets boundaries that ensure contextualisation work stays within defined constraints.

  • defines the population(s) and setting(s) that will and will not be covered
  • describes what the guideline will consider
  • identifies the key issues and lists the key questions that will be considered
  • describes any economic perspective(s) to be used

Developing the scope

An initial scoping exercise is conducted by the Guideline Review and Contextualisation Chair to ensure the evidence base of the guideline is appropriate for contextualisation, with topic-specific expertise being provided by other members if required.

The draft scope is prepared by the Guideline Review and Contextualisation Group for review by NICE. Following feedback the scope is revised, and a final version is sent to NICE for contextualisation work to begin.

Review questions

The GRCG will consider contextual changes in line with questions based around the PICO (population, intervention, comparison and outcome) framework. The PICO framework divides each question into 4 components: the population (the population being studied), the interventions (what is being done), the comparators (other main treatment options) and the outcomes (measures of how effective the interventions are).

These questions are considered to aid contextualisation and drafting of a contextualised version of the NICE clinical guideline. Review questions which guided the development of the NICE clinical guideline are available in the full version of the guideline (where the evidence reviews are presented). For the bpacnz contextualised guideline these questions can be found in the scope document, but are not included in the published guidance, due to their use in guiding contextualisation.

Contextualisation and Consultation

Once a finalised scope is confirmed, the GRCG develops contextualised recommendations based on these agreed parameters. New Zealand specific variances (compared to the United Kingdom) must be considered by the GRCG, such as the reduced population, ethnic and cultural differences, health sector differences (including funding and governance), economic constraints and access to care.

To improve patient outcomes, the behaviours we promote in our guidelines need to be; evidence based (are our recommendations based on the best available evidence?), patient centred (are they likely to improve outcomes for patients?), context-sensitive (are they relevant to the context of care in NZ?) and cost-effective (are the recommendations cost-effective?).

These issues are central to ensuring the guideline is relevant for use in the New Zealand health sector. The multi-disciplinary make up of the GRCG is to ensure that broad ranging views and input can be gained when contextual changes are considered.

Drafting the contextualised guideline

The Chair and members of the GRCG are each assigned areas of the guideline to focus on, using the scope document as a guide on contextual issues which are to be addressed. For each section the member assesses the initial guideline content and reviews recommendations to determine any contextual changes to be made, and any recommendations which hold true for the New Zealand health sector, as in the United Kingdom.

Agreeing changes

The GRCG meet to review the draft contextual changes, and a full document review is conducted to agree contextual changes. Any potential areas where the group may need to expand on the original NICE clinical guideline are also called out by the GRCG during this process. If a guideline area requires further information the GRCG make revisions based on New Zealand specific evidence using a literature review.

The drafted guideline, and any relevant New Zealand evidence, must be provided to NICE for review before a guideline is made available for Consultation. The minutes from each Guideline Review and Contextualisation Group meeting are made available on the bpacnz website.

Consultation

The draft guideline then undergoes a consultation period, where stakeholders can review and provide feedback on any potential changes or comments. An initial group of stakeholders are identified by the GRCG, and these are usually organisations with an interest in the particular guideline topic or people whose practice or care is directly affected by the guideline. Where possible the GRCG will aim to identify stakeholders who bring a varied regional, cultural, ethnic and health sector view to the guideline Consultation process.

Consultation with stakeholders is a crucial part of contextualising a guideline. Comments from stakeholders help make sure a contextualised guideline is accurate and relevant to the people who will be using it and to people using services. Initial stakeholders to engage are identified by the GRCG and advanced notification may be made to these groups/individuals where appropriate.

Stakeholders are organisations or individuals who have been identified during the development process of a contextualisation. The stakeholders identified by the Guideline Review and Contextualisation Group will include national bodies or health professionals who work within the scope of the guideline topic. Such stakeholders may include:

  • national organisations for people who use health and social care services, their families and carers, and the public
  • local consumer organisations and local organisations that have no national group to participate on their behalf
  • national organisations that represent health and social care practitioners and other relevant professionals whose practice may be affected by the guideline, or who can influence uptake of the guideline recommendations
  • District Health Boards (DHBs) or local health organisations, for examples Primary Health Organisations (PHOs)
  • private, voluntary sector and other independent providers of care or services
  • professional bodies that represent medicine, device or equipment manufacturers
  • industries relevant to public health
  • organisations that fund or carry out research
  • Government departments and national statutory agencies

The draft guideline is made publically available on the bpacnz website, and interested parties can register their interest prior to the Consultation period. The Consultation is another means for bpacnz to gain a broad range of views and opinions on the contextual changes to the guideline.

Bpacnz encourages dissemination of the draft guideline amongst groups and individuals with an interest in the topic. Any of these groups or individuals may then register as stakeholders in order to express their views during the consultation process. Bpacnz will consider comments on the draft scope and guideline from individuals, although we do not have the resources to respond to these comments individually.

Consultation feedback is collated, and a thematic analysis performed to determine any areas of the guideline which may need further revision. This involves the identification of key themes from the feedback by bpacnz project staff. All stakeholders providing input will receive a response from bpacnz to acknowledge receipt, and further clarification may be sought in certain circumstances (i.e. if the GRCG requires further information, or a specific reference, to aid contextualisation). Stakeholder feedback, and key themes, are reviewed by the GRCG and guide any further contextualisation work. Feedback from the consultation is also provided to NICE for their records and oversight.

How to comment on the draft guideline

The draft version of the guideline is put on the bpacnz website for consultation, and stakeholders can register interest at any stage prior to the Consultation period. The stakeholders identified by the GRCG are advised when the draft is available for commenting, and how to submit comments. Bpacnz seeks stakeholder views on the contextual changes and relevant issues during the Consultation, but it is important to note that bpacnz does not change the evidence base agreed in the original NICE guidance.

Consultation period

The drafted guideline is made available for stakeholders to review and provide feedback over a four week period. Feedback is collated by bpacnz and made available to the GRCG during the consultation period, as well as following the closing of the Consultation window.

Validation

Following Consultation, the guideline goes through a validation process to ensure any contextual changes that have been proposed by stakeholders have a sound evidence base. This involves both internal review by the bpacnz clinical advisory group, the Guideline Review and Contextualisation Group, and externally by NICE.

The GRCG makes any contextual changes or amendments to the guideline document following consultation feedback. Following the thematic analysis, the GRCG review all feedback and group agreement is sought on the changes to be made. An evidence review is conducted by the GRCG if required. Any change proposed by a stakeholder that is not agreed by the GRCG is given justification which is forwarded to the stakeholder by the bpacnz project team.

NICE are provided with an updated version of the guideline, which has contextual changes highlighted. This is reviewed at NICE along with the Consultation feedback. Any revisions are suggested by NICE, and the GRCG review these to agree on a final version to be put forward for sign off activities.

Sign off

After Validation, the GRCG seeks agreement from NICE that the guideline is fit for use. Sign off meetings are held and any final amendments agreed upon.

The guideline is to then be made freely available on the bpacnz website. Identified stakeholders may also be sent a copy where requested.

The Guideline Review and Contextualisation Group


Convening an effective Guideline Review and Contextualisation Group (GRCG) is one of the most important stages in contextualising a bpacnz guideline. The GRCG considers the initial NICE guideline evidence for relevance to cover New Zealand specific issues and nuances. They review and agree the scope for contextualisation work, contextualise the recommendations based on the agreed scope, and oversee the validation and sign off processes for the guideline before it is published.

While the NICE clinical guideline evidence base is not changed in the contextualisation process, the GRCG must make an initial review this to guide any contextual differences, particularly in relation to the availability of services or products in New Zealand and to identify if any comparative cultural and ethnic health studies will need to be sourced as part of the contextualisation process.

Forming the GRCG

The Chair and members of the GRCG are appointed for the duration of a particular guideline's contextualisation. The Chair is appointed before the guideline scoping stage and is involved with initial scoping.

The composition of the GRCG

The GDG has four key roles:

  • the Chair
  • members from healthcare professions, and from other professions where relevant
  • clinical lead(s)
  • a project manager

The GRCG Chair

To work well, a GRCG needs an effective Chair. The GRCG Chair is a member of the initial scoping process and should therefore be recruited before work starts on the scope.

The Chair guides the GRCG in terms of task (developing the contextualised guideline) and helps the group to work collaboratively, ensuring a balanced contribution from all members (see Making group decisions and reaching consensus). The Chair works with the Project Manager to guide the GRCG in terms of process.

The Chair may be a specialist in the guideline topic, but this is not essential because specialist knowledge can be provided by other GRCG members.

Making group decisions and reaching consensus

GRCG members need to make collective decisions throughout the contextualisation of a clinical guideline. These include interpreting the evidence and developing guideline recommendations. In most cases, the GRCG reaches decisions through a process of informal consensus.

The role of the Chair is to ensure that each individual on the GRCG is able to present their views, that assumptions can be debated and that the discussions are open and constructive.

Quorum

If there is no clear consensus, the decision will be taken to a vote – chair has casting vote if required.

The quorum of a GRCG is 50% of the total potential membership and no agreement can be made unless the quorum is reached.

Conflicts of interest

All GRCG members are asked to declare any conflicts of interest at the initial group meeting and then all subsequent meetings. Any conflicts identified by GRCG members are held by bpacnz within a Conflict of Interest register and are made available on the bpacnz guidelines website for each guideline.

Appendix: The New Zealand Health System


Ministry of Health, District Health Boards and local governance

An overview of the New Zealand health system and the funding for the New Zealand health sector can be found on the Ministry of Health website.

An outline of the New Zealand primary care sector funding and services can also be found on the Ministry of Health website. New Zealand has a number of specific health strategies, including an overall National Health Strategy. In New Zealand, ranking patients for elective publicly funded surgical procedures uses Clinical Priority Access Criteria (CPAC).These criteria are based on a combination of:

  • Impact on life
  • Effectiveness of the procedure in improving impact on life.
  • Risk of complications /adverse effects of the surgical procedures.

The threshold CPAC score for surgery varies between DHBs throughout New Zealand.

All consumers of health and disability services within New Zealand have rights under the Health and Disability Commissioner Act 1994 which are contained within the Code of Health and Disability Services Consumers’ Rights. These include the right to informed consent.

Cultural and ethnic differences

New Zealand has a diverse population. In particular Māori and Pacific Island populations have their own unique cultures, and with it varied health care requirements.

The major ethnic groups in New Zealand are*:

  • European (74%)
  • Māori (15%)
  • Asian (12%)
  • Pacific Island peoples (7%)

*based on figures from the 2013 New Zealand census

The New Zealand government (through the Ministry of Health) has a special relationship with Māori based on Te Tiriti o Waitangi (the Treaty of Waitangi), the principles of which can be found here. The Ministry of Health also has a Māori Health Strategy and Pathways to Pacific Health to recognise specific health needs across different ethnicities.

Epidemiology

The Code of Health and Disability Services Consumers’ Rights within New Zealand specifies that care must be culturally appropriate (including, but not limited to, rights 1-3). New Zealand professional bodies have developed their own codes of practice including, but not limited to, doctors, nurses and physiotherapy.

Health professional regulation

Within New Zealand there is a Health Practitioners Competence Assurance Act 2003 (the Act) which provides a framework for the regulation of health practitioners in order to protect the public where there is a risk of harm from professional practice.

The Act sets out requirements for health practitioners to work within a scope of practice defined by the relevant regulatory authority, administered by the Ministry of Health.

Medicines and devices (registration, regulation and funding)

The use of medicines within New Zealand is regulated by the Medicines Act 1981. This is administered by the regulatory authority Medsafe.

The marketing authority for medicines in New Zealand is contained in the Medsafe approved data sheets. However, medicine prescribing is permissive under the Act so that practitioners may prescribe or obtain other, non-Medsafe approved medications for use provided they adhere to Sections 25 and 29 of the Act.

Funding

Public funding for pharmaceuticals in New Zealand is administered by PHARMAC. Community pharmaceuticals are funded under a fixed budget, the Community Pharmaceutical Schedule, and medicines on the schedule are available without charge for patients (other than prescription charges). PHARMAC has taken over hospital pharmaceutical management, and administers a schedule for this, but this is not yet under a fixed budget. PHARMAC has also been given responsibility for devices, and is developing a funding model for these.