Guidelines for Guidelines

Once you have decided on a guideline topic you need to define the purpose and scope of the guideline to create a practical framework for the development process (NICE 2014). Defining the scope is done by outlining what the guideline will and will not include. The main boundaries to establish when scoping your guideline are:

• what your guideline will and won’t cover (the area of health practice, policy or public/environmental health issue that the guideline addresses)
• who your guideline is meant for and why (including end users of the guideline and populations covered by the recommendations)
• which specific actions and interventions are the focus of your guideline.

As well as defining these key issues, scoping the guideline also helps you plan the development process. For example, the preliminary scoping exercise usually yields the questions that will govern the systematic reviews. It can also help clarify what resources will be required to complete the guideline. An important part of the scoping process is the preliminary evidence search, which will identify any existing guidelines to determine if the guideline is necessary and feasible (see Section 4). Finally, once the guideline development group has finalised the scope of the guideline the scope can be made publicly accessible, not only for transparency but because it can enhance the coordination of guideline development resources and minimise duplication of work.

You should note that the sequence of events described in this module is intended only as a guide and the actual order of events will depend on your situation and what works best for you. In addition, earlier steps may need to be revisited if results from the scoping search or stakeholder consultation require reappraisal of target populations or desired health outcomes. Other modules that you might find useful at this stage include Organisation and budgeting, Considering purpose and context, Adapt, adopt or start from scratch, Consumer involvement, Engaging stakeholders and Forming the questions.

What to do

1. Plan the scoping process

Having a plan in place for scoping will help you keep track of what you need to consider and what you should record and report for transparency. You should plan for each of the steps in this module. You should make decisions about:

• who will be involved in the scoping process
• what scoping activities are needed and when (e.g. guideline development group meetings, literature searches, consultations)
• how will guideline topics be prioritised and decided upon
• how the available resources will be allocated to complete the guideline
• who decides on the final scope
• the processes and circumstances for modifying the scope in the future.

2. Decide who will be involved and when

It is up to developers to decide who will scope the guideline. Some well-resourced organisations set up steering or organising committees to conduct preliminary work like guideline planning (including setting priority topics and drafting a scope) and recruiting members for the guideline development group (WHO 2014) (see Project planning module). Other organisations might scope a guideline in-house with or without members of the development group (such as the chair) before taking the draft to the broader group for approval (NICE 2014). As with the guideline development group, the balance between the contributions of these groups is important to develop a guideline scope that is useful, current, focused, feasible to implement and unbiased.

Some of the key people you should include in your scoping team are:

• the chair of your guideline development group
• someone with methodological expertise (such as conducting systematic reviews)
• a topic expert
• consumers or consumer representatives.

As there is a fair amount of work involved, a smaller working group can more easily coordinate efforts to prepare a draft scoping document and lead any other scoping activities. This preliminary work can then be taken to the guideline development group for discussion and decision making. Tasks of the working group may include:

• drafting discussion papers introducing the purpose and context of the guideline
• suggesting priority topics, issues, target populations and end users
• scoping existing recommendations from other well-conducted guidelines
• scoping the literature for existing systematic reviews
• drafting a scoping document.

Whatever approach you decide to take, the guideline development group must reach consensus and decide on the final scope of the guideline. The first meeting of the group is a good opportunity to do this. The reasoning behind all scoping decisions made by the group must be documented in the guideline. Decisions must also take into account input from stakeholders (see Engaging stakeholders) to ensure that the populations and key issues covered by the guideline are relevant and appropriate. You may also need to adjust the composition of your guideline development group depending on issues raised during the scoping process.

Consumer input during the scoping stage of guideline development is particularly important to identify important questions and obtain consumer preferences for health outcomes (see Consumer involvement). The consumers or consumer representatives on the guideline development group can provide this perspective; however, you can also consider obtaining input from consumers in other ways. For example, NICE guidelines recommend in some cases setting up scoping workshops with key stakeholders or consumers, or releasing the draft scope document for public consultation. You should also consider consulting with other stakeholders during the scoping process as they can provide useful input into the scoping activities (see Engaging stakeholders).

Regardless of whom you choose to involve and how, early input from expected end users will make sure that your guideline is relevant and focused on the health topic of importance.

3. Consider the purpose and context

The purpose of your guideline will inform the scope of your guideline. This is discussed in greater detail elsewhere (see Considering purpose and context) as it can be a challenging process for complex guidelines such as those encountered in public and environmental health scenarios.

Defining the purpose involves thinking about the big picture and what you are trying to achieve within the current landscape. Some of the things you will need to consider are:

• the objectives of the guideline
• the rationale or reasons for why the guideline is needed
• who the guideline is for.

You might find it helpful to brainstorm the priority topics, key issues and target populations. You will also need to consider the context in which your guideline is being developed (NICE 2014). Contextual issues you can consider include:

• the burden of disease
• socioeconomic, demographic and cultural issues
• other health impacts
• political sensitivities
• ethical considerations
• media activity
• the current regulatory and policy environment (existing legislation, policies, programs)
• any potential policy or program implications as a result of your recommendations
• current research activity
• how care is currently delivered and who is responsible
• the cost of care
• workforce issues and variance in service organisation
• end user experiences (especially consumer experiences) and safety concerns.

Once you’ve looked at the overall picture, it is important to narrow it down and concentrate on interventions or policies where change is desired, areas where equity issues might be a factor or areas where there is controversy and clear guidance is needed. Formal priority setting is an important process that should be transparent, systematic and carried out according to the governance processes you have put in place during your planning stages (see Section 2 and the Project planning module). This will result in clearer definitions of target conditions or interventions, target populations and intended end users of the guideline for your final scope (see Section 6). These definitions will also be used to develop research questions for your evidence synthesis (see the Forming the questions module).

The G-I-N McMaster Guideline Development Checklist recommends prioritising topics according to specific criteria such as high prevalence and burden of disease, avoidable mortality and morbidity, high cost, emerging diseases or emerging care options, variation in clinical practice and rapidly changing evidence. Input from key stakeholders (particularly consumers) can help inform the prioritisation of these topics. For example, the developers of the International evidence-based guideline for the assessment and management of Polycystic Ovary Syndrome (PCOS) 2018 surveyed over 1800 consumers to help with various scoping activities such as priority setting of outcomes. Results from the scoping search or considerations of equity can also help you prioritise topics.

4. Scope the evidence

A preliminary search of the literature will identify existing guidelines or systematic reviews relevant to the guideline topic (Armstrong, Hall et al. 2011; JBI 2015). This scoping search is a useful way to identify gaps or overlaps in current guidance that can justify the need for a guideline. It also serves to inform any upcoming systematic reviews by defining the scope of the proposed review and the associated costs (see the Project planning module).

Information on guidelines and existing systematic reviews can be found in open access databases (e.g. PROSPERO, Australian Clinical Practice Guidelines portal, G-I-N international guideline library, Cochrane Library). You should also consider mapping any existing or prospective Australian guidelines to reduce duplication of effort (see the Clinical Practice Guidelines in Development Register).

In addition to looking through peer-reviewed literature, you can search government websites and publications, organisational reports and other sources of ‘grey’ literature to find information on:

• current policy and legislation
• economic evaluations
• information on current practice and any variations
• differences between populations/equity considerations
• statistics describing epidemiology and current practice
• information on the experiences, values and preferences of consumers.

Information from non-academic sources such as these will be useful to understand the current landscape around your desired health outcome. It can be used to further flesh out the context of your guideline and identify any important considerations or sensitivities. For example, identifying variations in practice or policy during the scoping search will help you develop questions for the evidence evaluation (see Forming the questions) — you will then need to dig deeper into the evidence to verify what works and what doesn’t work in case previously unconsidered options exist.

The guideline development group should consider the results of the scoping search and provide feedback. You can also consider publishing the scoping search in a relevant journal to contribute to the body of evidence in guideline development, although this will depend on your available time and resources.

5. Consider other issues

Your questions should not be purely driven by what is in the literature. There are a number of other issues that can impact the scope of your guideline — some examples of these are outlined below. Considering these issues can help reduce the risk of introducing bias into your guideline, and will ensure that your questions will always be derived around an explicit health need that is relevant to your guideline’s end users.

Equity

You must consider and assess any social, legal or ethical requirements that may impact guideline development. In particular, identifying equity issues early on can help define the scope of the guideline and ensure that these issues will be addressed (NICE 2014).

For instance, you will need to consider:

• if there is any risk of discrimination arising from the guideline
• if adjustments can be made to the recommendations to avoid putting any group of people covered by the scope at a substantial disadvantage
• if any equity issues should be included in the guideline and why or why not.

For example, Australian guideline developers must consider Aboriginal and Torres Strait Islander equity issues when scoping their guideline (see Procedures and requirements) as there is a documented gap in health status, outcomes and access to services for these people. Any decisions to include or exclude any disadvantaged populations from the scope of your guidelines must be outlined in the guideline itself, including the reasoning behind them.

Multimorbidities

It is common for people to have more than one health condition and to be receiving multiple health interventions. These may interact with each other and it is important to consider whether the guideline will specifically address the need to vary care according to the presence of other diseases and interventions. This will be covered in more detail in the Multimorbidity module.

Updating

It is also worth considering any updating requirements of your guideline. With the emergence of ‘living guidelines’ individual recommendations may be updated as new evidence becomes available. The original scoping document is often used to inform new systematic reviews for guideline updates, and so any discussions on future updates should be captured in the scoping stage (Synnot, Turner et al. 2017). This may include identifying topics or areas of research that will become outdated rapidly, or outlining decisions on how frequently new evidence may be sought and screened for incorporation into a guideline. It will also be useful to search trial registries to identify current clinical trials that may impact your recommendations in the near future. These can then be flagged to feed into any updating processes.

Implementation

Although it is not your role as a developer to implement your guidelines, you can consider strategies to make your guideline more implementable as you scope your guideline. This will allow you to identify any possible issues early on during the scoping stage so that you can make sure they are addressed during development.

6. Draft the scope

Your guideline scope is a statement that captures all the above considerations in clear, concise language. It outlines what is included and what is excluded from the guideline. This is often a short paragraph included at the start of the final guideline, although the scoping of target populations, justification for the guideline and analysis of other factors such as equity might also become separate sections that you might like to include in the final guideline as well. Alternatively, some organisations such as NICE produce a scoping document that is published on their website.

A scoping document may also include:

• a brief description of the guideline topic (e.g. a description of the condition or disease, health or social care services, organisation of services, areas of public health practice or environmental health issues)
• a brief overview of the context (current policy and practice)
• a summary of why the guideline is needed and where it will add value.

The scope should make it clear what the guideline development group will be covering in its work. The title of the guideline (also used for a draft scoping document) should accurately reflect the content of the scope.

The scope can include drafting key questions that need to be answered (see the Forming the questions module). These questions will be used to guide the evidence synthesis. Depending on how the work of the guideline development group is planned it may be appropriate at this stage to develop detailed questions using the population, intervention/exposure, comparison, outcome (PI/ECO) format). Alternatively, it may be appropriate to draft key questions that will be developed in detail once the full group is established and meeting for the first time. Examples of health issues and possible key questions that can be asked are given in Table 1.

7. Consult on the draft scope

It is critical to get feedback on your draft scope to make sure it addresses outcomes that are important to end users and reflects their values and preferences. You can put this scoping document out for public consultation, or you can hold focus groups or workshops to discuss the scope (see the NICE guidelines manual) so you can make sure you address end user needs.

8. Review, revise and prioritise

After you have taken all issues and stakeholder feedback into consideration it is worthwhile taking a step back to review the scope. Ask yourself:

• Can the guideline be developed within a reasonable timeframe?
• Are there sufficient financial and human resources to complete the guideline?
• Can some lower priority topics, questions and recommendations be removed?
• Do you need to readjust the composition of the guideline development group to address any equity issues identified in the scoping process?

It is important to realise that scoping your guideline can end up being a reiterative process. It might be necessary to go back and re-evaluate your core objectives based on issues you have discovered during a scoping search or from consumer feedback. It might even require repeated consultation with stakeholders, and mechanisms should be in place to allow for this. It is important to remain flexible during the scoping stage and spend whatever time you need on this process in order to get it right. Becoming prescriptive too early and forging ahead without proper reflection may create problems later on in guideline development, such as having to commission another expensive systematic review. However, bear in mind that by the time you have finished your scoping activities the scope of your guideline must be finalised so that guideline work can proceed. This will ensure that the boundaries for your evidence search can be set — this will avoid ‘scope creep’. It will also enable you to set and manage the expectations of your commissioning or sponsoring body, the guideline development group and key stakeholders.

9. Publish the scope

Once the scoping exercise is complete a description of the process and the clearly defined scope should be made available to the public either on your organisation’s website or a central website such as the NHMRC Clinical Practice Guidelines in Development Register. This will enable policy-makers and other developers to better co-ordinate guideline development activities in Australia. Once the guideline has been published, the scope can be described in a brief statement at the beginning of the published guideline, although some organisations (e.g. NICE) publish a more comprehensive scoping report alongside the guideline.

NHMRC requirements

Guidelines approved by NHMRC must meet all requirements outlined in the Procedures and requirements for meeting the NHMRC standard. The following requirements apply to the Scoping the guideline 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 member are described.
• B.1 The purpose of the guideline is stated, including the clinical questions (see Requirement C.1), issue or problems the guideline addresses.
• B.2 The health care setting to which the recommendations apply is described, including the health system level (e.g. primary care, acute care) and clinical stage (e.g. whether the guideline covers prevention, screening, assessment, treatment, rehabilitation or monitoring).
• B.3. The intended end users of the guideline are clearly defined, and any relevant exceptions are identified.
• B.4 The population to which the guideline recommendations will apply is defined (e.g. children, adolescents, adults or older adults) and population subgroups for which specific information is required are identified and described.
• B.5 Issues relevant to Aboriginal and Torres Strait Islander peoples (such as particular risks, treatment considerations or sociocultural considerations) are identified and described.   
• B.5.1 (desirable) Issues relevant to special-needs groups such as culturally and linguistically diverse communities or groups with low socioeconomic status (e.g. particular risks, treatment considerations or sociocultural considerations) are identified and described.

NHMRC Standards

The following standards apply to the Scoping the guideline module:

1. To be relevant and useful for decision making guidelines will:

1.1. Address a health issue of importance

1.2. Clearly state the purpose of the guideline and the context in which it will be applied.

 

5. To be focused on health and related outcomes guidelines will:

5.1. Be developed around explicitly defined clinical or public health questions

5.2. Address outcomes that are relevant to the guideline's expected end users

5.3. Clearly define the outcomes considered to be important to the person/s who will be affected by the decision, and prioritise these outcomes.

Useful resources

Developing NICE guidelines: the manual – the scope

World Health Organisation (WHO) - Handbook for Guideline Development

G-I-N McMaster Guideline Development Checklist 2. Priority setting

References

Armstrong, R., Hall, B. J., et al. (2011). Cochrane Update: 'Scoping the scope' of a Cochrane review. Journal of Public Health 33(1): 147-150.

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

Synnot, A., Turner, T., et al. (2017). Cochrane Living Systematic Reviews - Interim guidance for pilots (Version 0.3, 21 April 2017).

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

Acknowledgements

NHMRC would like to acknowledge and thank Doctor Phil Alderson from the National Institute of Health and Care Excellence (NICE) for his contributions to this module as editor.

Version 4.0. Last updated 23/11/2018.

Suggested citation: NHMRC. Guidelines for Guidelines: Scoping the guideline. https://nhmrc.gov.au/guidelinesforguidelines/plan/scoping-guideline. Last published 23/11/2018.