Consumer involvement

Guidelines can only meet the needs of the population if they are developed with meaningful and authentic engagement with consumers

Consumer involvement

Consumers’ are people who have lived experience of a health issue. They might receive health care or advice, or otherwise use health care services. They include patients, their friends, families, carers and members of the general public. Consumers can also be people who represent the views and interests of a consumer organisation, a community or a wider constituency (Kelson, Akl et al. 2012). Representation by carers or consumer advocates is especially important for any consumer group that might have trouble getting their voices heard in their care, for instance people with dementia or mental ill-health.

The terminology used around consumer ‘involvement’ can be confusing since it is used interchangeably with related terms like ‘consultation’, ‘participation’, ‘engagement’, ‘partnership’, ‘co-production’ and ‘collaboration’. A useful way to think of consumer involvement is decision making with or by consumers, rather than ‘to’, ‘about’ or ‘for’ them (Ocloo and Matthews 2016).

Guidelines are designed to improve the health and wellbeing of consumers who have the right to be involved in any decision making on health issues that affect them. They therefore have the right be involved at all stages of guideline development. Consumers are best placed to ensure that recommendations made for them or about them are consistent with their values and preferences—this is done by sharing their lived experience with developers. For example, patients with rheumatoid arthritis might be more concerned by fatigue than pain, but pain is the primary outcome of clinical trials on this condition (Kirwan, de Wit et al. 2016). Authentic consumer involvement can also help make guidelines more readable and relevant, provide important information and insights missing from an evidence search and also help predict the acceptability of recommendations to target groups. Open and transparent involvement of consumers in a guideline’s development can also enhance its legitimacy.

Despite clear advantages and a documented impact in health and medical research (Shelef, Rand et al. 2016) consumer involvement has not been widespread in Australian guidelines (NHMRC 2014). There is a clear need for a shift in the attitude of many guideline developers and their organisations to acknowledge and value consumer contributions in guideline development. Developers should actively seek to increase the levels of consumer involvement as much as possible throughout guideline development and to strive for equal and alike participation.

Guidelines seeking NHMRC approval must involve consumers as members of the guideline development group and throughout the guideline development process. Ideally you will have more than one consumer in your guideline development group, and seek out consumers from diverse or marginalised backgrounds to make sure their voices are heard. This module outlines how you can engage with and support consumers in ways that can help them make a meaningful contribution to guideline development. Other modules that you might find useful include Engaging stakeholders, Guideline Development Group, Organisation and budgeting and Training.

What to do

1. Plan for consumer involvement

Consumer involvement needs to be planned for all stages of guideline development and with the active participation of consumers in the planning process. For example, early planning might involve an experienced consumer who has previously worked on similar guidelines—they might even be a member or Chair of the organising or steering committee. Other planning activities might involve the consumer members of your guideline development group or an external advisory group from a consumer organisation. However you choose to proceed, early consumer involvement in the planning stages will ensure that consumer needs will be considered within the project timelines and resources of your guideline (see Organisation and budgeting).

Things that you will need to plan for include:

  • when and how consumer involvement will take place
  • the recruitment of consumers for the guideline development group and other planned activities
  • the processes and policies for supporting consumer involvement
  • the training needs of consumers, developers and organisations
  • the methods for supporting consumer involvement.

Begin by defining the target populations of your guideline and decide which other groups will also be affected by its recommendations (see Considering purpose and context and Scoping the guideline). Consider how these groups can contribute to decision making at each stage of development and whether their perspectives are best captured through the participation of individual consumers or by the representatives from consumer organisations that might speak on behalf of a constituency (CHF, 2017). These consideration are discussed in more detail in Section 2 and Section 3 of this module.

Your guideline development group and/or organisation should make sure that it has policies and procedures in place to support consumer involvement. These should allow for a safe, respectful and inclusive environment that encourages the meaningful and sustainable participation of consumers in the guideline development process. Make sure everyone involved understands the importance and value of consumer contributions.

Involving consumers might have monetary, time and other resource costs such as training, sitting fees, venue hire, outreach tools and travel costs. It is important that you plan early to make the best use of available resources and ensure that the guideline budget provides for this (see Organisation and budgeting). Tools such as the Involvement Cost Calculator developed by the National Institute for Health Research INVOLVE program can give you a good idea of items to budget for when planning consumer involvement in guideline development—however, bear in mind that the costings used in this tool are not relevant to an Australian setting.

As a guideline developer, you and others from the guideline development group might need training to engage effectively with consumers, such as communication or cultural awareness training (e.g. cultural competence training for projects in Aboriginal and Torres Strait Islander health) (see also Section 8 and Training).

Your planning for the most effective ways of engaging with consumers will largely depend on their preferences about how they would like to be involved. Some approaches to consider include:

  • formal, structured activities (e.g. interviews, focus groups, consensus methods)
  • informal methods (e.g. project or advisory meetings, feedback on documents, public consultations)
  • modes of involvement (e.g. face-to-face, online, video-/teleconference, email)
  • timing of involvement (e.g. one-off, multistage, continuous).

You will need to be flexible and adapt to consumer needs for any approach you choose to take, especially if they live remotely or have ongoing health challenges (see Section 7).

In addition to your plans for consumer involvement, you may find it useful to refer to a literature review of consumer values and preferences on the guideline topic (Yu, Enkh-Amgalan et al. 2017), or even conduct your own. For example, Kelson et al. (2012) used an existing systematic review of consumer experiences of breathlessness (Gysels, Bausewein et al. 2007) to help them develop a guideline for chronic obstructive pulmonary disease, while Selva et al. (2017) have developed a search strategy for retrieving studies on consumer preferences. This can be particularly useful for when the guideline development group or expert committee is discussing harms and benefits, values and preferences and equity issues in the balance of consequences stage of the GRADE process (see Evidence to decision).

Finally, you should make sure that decisions about how and when consumers are engaged with are clearly documented in the final guideline. The AGREE II tool (2013) is typically used for guideline appraisal (see Adopt, adapt or start from scratch). It can also be used as a framework to guide you on what consumer involvement information will be required and how it should be reported in the final guideline (see Section 9). This will enable you to plan ahead and ensure you meet best practice reporting requirements to improve the quality of your guideline.

2. Consider the goals of consumer involvement at each stage of development

There are many ways for consumers to participate in guideline development (e.g. refer to Table 3 in Section 4 in Engaging stakeholders). While there is little empirical evidence for the most effective engagement approach (Nilsen, Myrhaug et al. 2006), there is a large body of published literature discussing different methods from the perspectives of guideline developers. Decisions about how and when to engage consumers should come back to achieving the goals of each stage of development. Table 1 outlines some of these goals and provides examples of how they might be achieved through different methods of consumer involvement.

You need to be explicit about your goals for consumer involvement as clarity around this will help you engage the right people and the right people choose you. It will also clarify consumer roles and expectations for each level of engagement, the reasons for involvement and how by working together you can achieve your shared purpose.

Table 1: Examples of consumer involvement in guideline development

Stage of guideline development

Goal of consumer involvement

Examples

Scoping the guideline

To ensure the guideline meets the needs of consumers by focusing on topics that are most important to them

  • SIGN and NICE invite consumers and other stakeholders to make online submissions to help identify gaps in health research or advice and use this information to prioritise new topics for guideline development.
  • During development of Kidney Health Australia’s Caring for Australians with Renal Impairment (CARI) guidelines, patients and carers (but not members of the guideline development group) attended three peer-facilitated workshops to discuss their views on tests and treatments for chronic kidney disease. These perspectives were presented to the guideline development group to inform the prioritisation of guideline topics and outcomes (Tong, Lopez-Vargas et al. 2012).

Planning the evidence review

To prioritise the outcomes that are most important to consumers and to refine the research questions

  • The GRADE approach allows for explicit consideration of patient values and preferences in decision making during the prioritisation of outcomes (GRADE, 2013).
  • NHMRC invited members of the Australian community to submit published studies to be part of an evidence evaluation on the health effects of water fluoridation (available on the NHMRC Public Consultations website).
  • As part of their Improving Medication Safety in Seniors project, the University of Western Australia and the Telethon Kids Institute ran community fora to discuss the proposed research questions. As a result two new issues were identified and incorporated into the project: the use of brand names rather than active ingredients on prescription medicine packaging; and the potential danger of non-specific dosing information on prescription medicines (e.g. ‘take as directed by doctor’) (McKenzie and Alpers 2015).

Conducting the evidence review

To find and incorporate evidence on consumer values and preferences

  • Developers of a guideline on chronic obstructive pulmonary disease utilised an existing systematic review of consumer experiences of breathlessness (Gysels, Bausewein et al. 2007) to assist them in understanding how this symptom affects consumers (Kelson, Akl et al. 2012).
  • In order to adopt, adapt and develop clinical practice guidelines for the Ministry of Health for the Kingdom of Saudi Arabia, international collaborators undertook systematic reviews of patient values and preferences on a range of topics and incorporated their findings into their GRADE EtD frameworks (Zhang, Coello et al. 2017).

Reviewing draft recommendations

To ensure the feasibility and acceptability of guideline recommendations, particularly where they reflect consumer values and preferences

  • Guidelines developed by SIGN undergo consumer review as part of its peer review process; the final draft of each guideline is reviewed by at least two lay people to obtain comments from the consumer perspective. These comments are compiled in a report that is discussed by the guideline development group. Each point is addressed and the resulting change to the guideline (or if no change is made, the reason for this) is recorded. The names of all reviewers, including consumer reviewers are published in the guideline and their comments and declarations of interest forms are made available from SIGN on request (SIGN, 2015).
  • Before they are completed, guidelines developed and approved by NHMRC are externally reviewed by invitation (see Independent review) and through public consultation (see Public consultation), which allows expert consumers and the general public to comment on the feasibility of the draft recommendations.

Develop consumer or companion resources

To ensure the quality, readability, acceptability and use of resources developed to accompany the guideline

Planning implementation of the guideline

To let consumer knowledge and experience assist planning for the dissemination and implementation of the guideline, including identifying opportunities to promote it

  • NICE engages with consumers through its Public Involvement Programme, using a range of methods to assist with the implementation of new guidelines. E.g. it consults with consumers about local barriers to uptake and with consumer organisations about the best way to disseminate advice.
  • NHMRC engages with state and territory policy areas with responsibilities for ongoing oversight and monitoring of the use of guidelines when developing resources for consumers, such as the question-and-answer resource for NHMRC’s Public Statement on Water Fluoridation.

3. Decide what type of consumer expertise is needed

Once you are clear about your goals for consumer involvement you will need to decide what kind of consumer expertise is needed. Consumer expertise often comes from lived experience, and their views will be informed by:

  • their values
  • their experiences of the health care system and related services
  • their motives
  • their environmental, cultural and socioeconomic backgrounds.

Individual consumers can offer valuable expertise from lived experience. However, the views of a single consumer should not be considered representative of an entire constituency. In that sense consumer viewpoints are analogous to those of clinicians, researchers or policy makers, who would not be expected to represent the views of all members of their profession. Rather than aiming specifically to obtain a diverse range of views, you should select consumers based on the perspectives they can offer and on their capacity to make a meaningful contribution to decision making when supported to do so (see Section 8).

If it is difficult for you to find consumer perspectives on specific issues, it can be helpful to seek the help of consumer organisations. Representatives from groups with strong consumer networks can provide insights into consumer perspectives while facilitating ongoing dialogue between developers and consumer groups or communities. Some individuals can also bring specific skills and experience that enable them to represent the views of others—this can be important when there are many consumer perspectives to take into account. Table 2 outlines possible perspectives provided by consumers depending on their experience or role (adapted from Kelson, Akl et al. 2012; Greenhalgh 2017).

Table 2: Different consumer perspectives (adapted from Kelson, Akl et al. 2012; Greenhalgh 2017)

Type of consumer

Perspective

Patients

People who seek or receive health care. They have lived experience of a condition or state of health and are familiar with health service delivery issues.

Carers

Those who help others to look after themselves and access services. They can offer expertise in what it means to care for someone, in health service delivery issues and in the wider impact of illness on a family. They might also be able to articulate the values and preferences of patients who are unable to speak for themselves (such as infants) and may have values that differ from those of patients (e.g. around end of life care). Family members and friends may provide related experiences, particularly from an unpaid carer perspective.

Clients

People engaging with social services. They might be familiar with service delivery issues in areas such as welfare and community support services, or allied health services.

Consumer representatives

People nominated by a consumer organisation who bring a consumer perspective of their own, or that of others. In the case that they are appointed to represent an organisation, they may report back or otherwise be accountable to it. The term ‘consumer advocate’ is sometimes used to describe a similar role, including for those representing a particularly vulnerable person or group (e.g. mobility or communication issues, underserved communities). Can also include consumer representatives from hospital or other health care organisation committees (e.g. quality or safety committees).

Consumer organisations

Organisations that research and campaign on behalf of consumers on a range of issues including consumer rights. They may also be familiar with health and related social service delivery issues.

Community members

People who share a common interest or background (e.g. cultural, social, political, health, economic), or a particular public health or environmental exposure (e.g. an area of water contamination) but do not necessarily have a geographic association.

General public

All people in a defined country or geographical region. Their perspectives may differ from those of patients since they may not have experience related to the health topic. They may have a broader perspective of the health topic and its relation to health and social services.

Not all consumers can contribute to each stage of development so when you plan consider both the perspectives of different consumers as well as their capacity to contribute. You should be flexible and adapt your planned activities to suit consumers throughout the engagement process (see Section 7 and Section 8).

When selecting consumers for guideline development consider the broader social circumstances related to your guideline topic. For example, you might need to engage with consumers who have insight as people living with disability, or who come from culturally and linguistically diverse backgrounds, are who are of a particular gender, sexual orientation, or age group, who come from a particular geographic location or rurality, or have additional health challenges, or a combination of these. Consider and document what type of consumer perspectives would be most appropriate and relevant for your guideline at each stage of development.

4. Decide on appropriate levels of engagement

Consider the degree to which consumers should be engaged at each stage of guideline development so that they can make a meaningful contribution to decision making. A strong rationale for any decisions should be provided to avoid tokenism, and ideally consumers will be involved in making these decisions with you.

It can be useful to view consumer engagement as a continuum, sometimes described as a ‘ladder of participation’ where lower degrees of involvement can risk tokenistic involvement and higher degrees can provide consumers with full decision making authority (Arnstein 1969). A more recent example is illustrated in Figure 1—this presents a tiered framework for consumer involvement in cancer research (see the Cancer Australia website) that can be applicable to guideline development.

The consumer involvement model matches consumer capability with different levels of engagement, and makes suggestions about the activities an organisation can use to facilitate engagement at each level. This model should not suggest that engagement must always occur at the highest level of the continuum, but can be used to reflect on how the degree of engagement will help developers and consumers both achieve their respective goals at each stage of guideline development. Another useful tool is the International Association of Public Participation (IAP2) public participation spectrum—this suggests the appropriate level of commitment expected from developers when involving consumers.

Figure 1: Consumer involvement model (reproduced with permission from Cancer Australia)  

Regardless of how else consumers might participate, it is vital that they are involved as valued members of the guideline development group. This is the core opportunity for them to contribute to decision making at all stages of guideline development, including scoping the guideline, forming questions, assessing evidence, writing recommendations and responding to community feedback. Ideally the development group should include more than one consumer so that a range of perspectives is incorporated and to ensure consumers do not feel outnumbered by other members (Armstrong, Mullins et al. 2017). Recruitment of consumers to the development committee is discussed in Section 5 below and in the Guideline Development Group module.

Note that while it is important to conduct public consultation on draft guidelines and recommendations (discussed further in Public consultation) it is not a substitute for more direct consumer involvement during the development process.

EXAMPLE: The International evidence-based guideline for the assessment and management of polycystic ovary syndrome 2018 adopted the IAP2 framework for community and consumer engagement.

Women with PCOS and consumer representatives actively contributed in all phases of guideline development, including:

  • informing needs, gaps, priorities and scope from an international survey of over 1600 consumer respondents
  • providing feedback at critical points in guideline development through an international consumer advisory panel (e.g. priority setting, forming questions and draft recommendations)
  • embedding consumer perspectives within the GRADE decision-making process as members of all guideline development groups
  • disseminating the draft guideline for public consultation through peak consumer groups
  • co-designing the implementation, translation and dissemination program through a translation advisory consumer group.

5. Identify and recruit consumers

Many developers have previously found it difficult to identify and recruit consumers. There are now many online resources and networks available to make this easier, including social media.

Useful channels for approaching consumers include:

In addition, the team involved in searching and selecting consumers for the guideline needs to include other consumers in this process as they can use their networks and experience to help you find the people you need. These might be the consumer members of your guideline development group, members of external consumer advisory groups or experienced consumers who have previously worked on similar guidelines. You can also seek individuals from consumer groups who will have had contact with many other people with the condition rather than just bringing their own expertise—often these individuals will have also have been trained and are more experienced in bringing a consumer perspective.

As mentioned earlier in Section 1, it is important to have multiple consumer voices around the table, and this can be done by recruiting multiple consumers with diverse perspectives. You should also aim address equity issues by proactively and creatively seeking and involving consumers from disadvantaged groups who might be affected by your guideline—this includes groups that are typically hard to reach (e.g. the homeless, people with drug dependencies or mental illness) (see Equity). This will ensure that the voices of these groups are heard during your guideline’s development and you can take steps to address any inequities in health that might come about from your guideline recommendations (O’Mara-Eves, Brunton et al. 2013; Cyril, Smith et al. 2015).

You will need to ensure that the way in which you approach consumers is appropriate, respectful and sensitive to their needs, particularly with vulnerable groups such as young people with mental illness (James 2007). You should also recognise and acknowledge the diversity between populations—some approaches and mechanisms for engagement that work for one group might not work for another and you might need to adapt and be flexible. For example, the Gayaa Dhuwi (Proud Spirit) Declaration recommends acknowledging the cultural and historical differences between Aboriginal and Torres Strait Islander peoples with locally developed, specific strategies.

Consumers should be selected based on the goals of each stage of guideline development, focusing on their potential to meaningfully participate in the decision-making process. Begin by drafting a statement of requirement which outlines the consumer skills and knowledge you are seeking. As well as specifying the type of consumer (e.g. carers of patients with a particular health condition), you can consider other attributes that might be important such as being a confident communicator or having experience participating in meetings. Consider any additional requirements in the case of consumer representatives, such as having the backing of a consumer organisation or condition group.

The statement of requirement can inform the guideline development group’s messaging when seeking consumers, such as through community networks, social media and other advertising. It will also be useful when contacting relevant professional societies, condition groups and consumer organisations.

It is important to be transparent when planning the degree and methods of consumer involvement for different groups. Decisions about the recruitment of consumers should be well-documented and refer to clearly specified requirements based on the goals of each stage of development.   

More information about the recruitment and role of consumers on the guideline development group is provided elsewhere (see Guideline Development Group)

6. Establish expectations

You should explain your expectations of consumers at each stage of development, and be clear about the expected time commitment, reimbursement and administrative support that will be available. Consumers can also expect certain obligations from you in return, such as an induction to your guideline or professional development that will help them make meaningful contributions. Most importantly, consumers should expect to be considered a valued member of the guideline development team and to have their views respectfully listened to and taken into account.

Consumers on the guideline development group should share the same benefits as other members and should be offered sitting fees for participating in working group meetings where possible. They should not be expected to pay for out-of-pocket expenses or forego paid work to attend meetings or relevant training without recompense (Table 3).

Table 3: Expectations of developers and consumers

Responsibilities of the guideline development group

  • Be clear about expectations, including remuneration—include these in the terms of reference.
  • Develop an induction or orientation package, including information that might help with interpreting technical data (e.g. the SIGN handbook for patient and carer representatives).
  • Promote an inclusive meeting culture—balance contributions on technical issues regarding the guideline topic with those that address public and consumer issues.
  • Clearly outline the types of documents consumers can expect to receive (confidentiality agreements, agenda papers, attachments, etc.) and ensure any technical matters are understood.
  • Give consideration to the scheduling, timing, length and location of meetings to ensure that the health needs and family/caring commitments of consumers are taken into account.
  • Give consideration to personal circumstances that may restrict attendance or availability.
  • Support effective consumer involvement
  • Provide feedback to consumers about how their input has been used in the guideline.

Responsibilities of consumers

  • Understand the commitment involved and feel comfortable in approaching the organisation for any further information required.
  • Adhere to conflict of interest disclosure requirements and declare interests when relevant.
  • Become familiar with discussion topics and working group documents before attending meetings.
  • Be aware of who the other members of the development group are.
  • Report back from and to the sponsoring consumer organisation as appropriate (if applicable) while respecting confidentiality requirements.
  • Be willing to undertake relevant professional development (if applicable).

7. Ensure effective communication with consumers

Effective communication between developers and consumers can sometimes be challenging. The use of medical terminology or technical jargon can be a barrier to involvement and you can counter this by ensuring that the language used to communicate with consumers (e.g. in emails, reports and presentations) is presented in a readable way and adapted to the appropriate level of technical knowledge. This will depend on the level of consumer involvement and their prior scientific knowledge. In addition, all information for consumers should be scannable, accessible and presented in plain language (e.g. see the Australian government writing style guide). Infographics can also be a useful way to present technical content wherever feasible or relevant—this is an effective way of communicating guideline content for all guideline users, not just consumers. Consider consulting with consumers and your organisation’s communications team to make sure technical information is presented in a suitable way. Consumer input is also important when writing lay summaries and considering dissemination strategies (see Dissemination).

Use inclusive language and be mindful and respectful of consumers when using medical terminology. For example, describing expectant mothers as ‘patients’ might incorrectly imply illness or disease. Similarly, it is insensitive and stigmatising to define patients by their illness; refer to ‘people with schizophrenia’ instead of ‘schizophrenics’ and to ‘people with diabetes’ instead of ‘diabetics.’ Consult with consumers early to determine the correct terminology.

You should also ask consumers which form of communication they prefer, particularly when they have ongoing health challenges that might restrict their ability to engage. The method and frequency of communications needs to be provided in an appropriate, accessible and convenient way. This is particularly important when preparing for meetings—some simple considerations can go a long way to helping consumers provide meaningful input into discussions. An example of practical ways to provide consumer support and ensure effective communication and participation is shown in Table 4. Remember that face-to-face meetings, while the best option for group decision-making, may not always be convenient for some consumers (e.g. consumers living in remote areas). In these instances, you will need to provide options for attending meetings remotely (e.g. digital meeting platforms, videoconferencing, webinar services, teleconferences).

Table 4: Examples of ways developers and organisations can support consumers in meetings*

Consumer needs

How consumers can be supported for meaningful involvement

Blind or visual impairment

 

  • Ask if they would like someone to meet them before the meeting
  • Provide an orientation session at the venue before the meeting
  • Help to get drinks, food and WC
  • Arrange to buddy up with team member to communicate his ideas during break-out sessions
  • Reserve front seating
  • Send agenda papers and handouts (PDFs, slides, documents) in advance electronically and with large print if required (at least 18 point font)

Complex communication needs (CCN)

  • Provide papers in advance, including lists of specific vocabulary that can be included on the attendee’s Augmentative and Alternative Communication (AAC) system
  • Ask if a communication support person will be attending, if they have difficulty understanding written or spoken language and what specific strategies would be most helpful for them (e.g. how would they like to indicate that they would like to contribute something)
  • Ask the Chair to manage the meeting such that the person with CCN has the opportunity and time to contribute or prepare responses
  • Provide support for the physical management of relevant materials i.e. turning pages of documents
  • Provide written notes from the meeting
  • Be mindful of the person’s fatigue levels – communication using speech and/or an aided AAC system may be very tiring for a person with communication difficulties

Chronic fatigue syndrome 

  • Ask if they have any needs about pacing and rests during the meeting

Deaf or hearing impairment

  • Arrange for audio transcription if possible
  • Send copies of agenda papers well in advance so they can make their own arrangements

Multiple and chemical sensitivities

  • Arrange to check if accommodations/venues have been recently painted or have new carpet
  • Request information about dietary requirements

Cultural (e.g. migrant communities, Aboriginal or Torres Strait Islander peoples)

  • Open the meeting with an Acknowledgment of country
  • Ask if they have any cultural needs before the meeting
  • Check if there are any language needs (e.g. need for an interpreter)

Language

  • Provide papers in advance
  • Ask if they will require a translator service
  • Check if they have understood

Social

  • Ask if they will be comfortable in meeting room
  • Check if they would prefer video conferencing/teleconference
  • Let them know beforehand who will also be attending the meeting

Cognitive impairment

 

 

  • Ask if space needs to be reserved for a carer
  • Send copies of agenda papers well in advance – check if they want to have a chat about the content prior to the meeting and arrange main topic points in bullet list
  • Ask the chair to keep discussion on track
  • Ask for advice about any other requirements that may affect concentration (e.g. lighting, timing of meeting, duration)

*please note that this table provides some examples and is not intended to be exhaustive

8. Support effective consumer involvement

Consumers participate in guideline development for different reasons, but many are likely to be motivated by an altruistic desire to give something back from their personal or community experience to improve the quality of life of others. However, in contrast to other stakeholders, they often face barriers that can hinder effective involvement. Because of this it is important for you to put inclusive processes in place during guideline development to ensure that they can participate to their fullest potential. Some simple things you can do in preparing for meetings and inclusive working environments within your organisation have been outlined earlier in Section 1 and in Table 4.

It is important to remember that you can provide a safe working environment for consumer involvement by adopting inclusive processes within your organisation or workplace to ensure that everyone, including consumers, feels comfortable and safe to share their experiences and opinions and are treated with respect. Central to this is the role of the Chair, who is responsible for making consumers feeling included and for making sure that their voices are heard in discussions. It is a responsibility of the entire group to make sure that consumers are treated equally and as valued members of the group.

You can also enhance consumer involvement by offering learning and development opportunities that can improve health literacy. Consumers might not be knowledgeable about all areas of discussion in a meeting but their input will be more effective if they understand the health issue of interest. Well-informed and experienced consumers are more likely to interact with guideline developers than those who are less informed or less familiar with the medical terminology or jargon that is used (Schunemann, Fretheim et al. 2006).

Participation in the guideline development group requires an understanding of the evidence and consumers may need some additional training to learn the scientific basis of evidence and how it is evaluated. However, even without technical expertise consumers can consider and comment on the implications of recommendations and whether they might lead to practical benefits for others.

Consumers can also be supported by participating in mentor programs and connecting with relevant consumer or community organisations. Providing professional development opportunities and encouraging the use of support systems such as those listed in Table 5 can help make consumers’ involvement more effective and enjoyable. As their expertise and advocacy skills develop, consumers will not only be able to participate at a higher level on the continuum of engagement (see Figure 1 in Section 4), but could also become highly sought after as a valued provider of consumer perspectives and advice in guideline development.

Table 5: Examples of methods for consumer learning and development

Induction or orientation sessions

These should be required for all consumers to provide information on topics such as:

  • the context and purpose of the guideline
  • the nature of the organisation developing the guideline (e.g. Teach yourself Cochrane)
  • the scope of the guideline
  • the guideline development group
  • the role of the consumer
  • current health policies or sensitivities related to the guideline.

Technical training*

This might be required for more in-depth involvement in guideline development, such as being on the guideline development group.

Training may be required for consumers to:

Other professional development*

For consumers:

For developers:

  • consumer engagement
  • science communication
  • facilitation of meetings
  • cultural awareness/competence training.

E.g. ‘masterclasses’ at Better Together or courses at www.ceh.org.au

Guideline development team contact

A designated consumer contact can help to answer questions about guideline development as they arise, such as:

  • providing information about upcoming meetings
  • fielding technical questions in a more informal setting.

They can also receive consumer and community feedback and facilitate ongoing dialogue between the development team and consumers.

Mentoring

Mentor relationships with experienced consumers or health professionals can provide independent and ongoing support and advice.

Connections to networks and alliances

Consumers who are connected to networks and alliances can receive:
  • emotional and peer support
  • resources (such as interpreter services)
  • training (e.g. consumer involvement)
  • opportunities to meet other consumers and develop their abilities to represent the voice of others and to debrief
  • advocacy.

E.g. the Cochrane Consumer Network provides online resources such as training and support groups for consumers interested in systematic reviews.

* Please note that costs may be associated with some of these courses.

9. Report consumer involvement

Consumer input into guideline development should be reported in the guideline itself to ensure that your guidelines are transparent and can be evaluated by others at a later stage. Some guidelines outline in detail where consumers were involved in decision making. For example, the NHMRC Borderline Personality Disorder guideline noted in the technical report:

The consumer and carer representative attended all committee meetings and were involved in the development of the clinical questions and recommendations. They also participated in discussions that informed the development of the narrative to ensure that the consumer and carer perspective was accurately reflected.

There are a number of tools you can use to ensure that you meet reporting requirements. As mentioned earlier in Section 1, the AGREE II tool (2013) is useful as a framework for guideline development and has a specific domain related to stakeholder involvement—including consumers. By applying this framework, you can have a better idea of what kind of information is assessed in appraisal tools and ensure that you meet best practice reporting criteria.

In addition, the GRIPP2 tool (Staniszewska, Brett et al. 2017) provides checklists for reporting patient and public involvement in health and social care research that also applies to guideline development. Consider using these checklists to ensure you have captured all aspects of consumer involvement in your guideline.

10. Acknowledge consumer contributions

Consumer contributions should always be acknowledged. Where changes to your guideline have been made as a result of consumer advice, this should be recorded and fed back to consumer organisations to demonstrate that consumer involvement is making a difference (adapted from ACSQHC, 2012). Consider acknowledging consumer contributions in other ways, such as encouraging consumers to present at conferences and events, or to co-author journal articles. This will also help in the dissemination and promotion of your guideline to community and consumer organisations (see Dissemination).

After your guideline has been completed, give consumers the opportunity to provide confidential feedback about their overall experience and consider the impact of their involvement to identify areas for future improvement. There are also a number of tools that can be adapted to evaluate the processes and methods used for consumer involvement throughout guideline development (e.g. the Patient and Public Engagement Toolkit; Oliver, Rees et al. 2008).

You may also decide to contribute to the body of knowledge about consumer engagement by publishing the results of impact studies, particularly if any innovative strategies were used during guideline development. For example, Payne, D'Antoine et al. (2011) found that consumer and community involvement had significant influence on the success of project outputs and outcomes in the Alcohol and Pregnancy Project undertaken in Western Australia.

You must ensure that you have captured an authentic consumer perspective and that the multiple voices and lived experiences of people and communities affected by the guideline are heard. Failure to listen will severely compromise the effectiveness of your guideline and will neither adequately address consumer needs nor produce the desired health outcomes.

NHMRC requirements

Guidelines approved by NHMRC must meet all requirements as outlined in the Procedures and requirements for meeting the NHMRC standard. The following requirements are relevant to consumer involvement:

  • A.4 Consumers participate in the guideline development, and the processes employed to recruit, involve and support consumer participants are described.
  • A.4.1 (desirable) 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 Consumer involvement module:

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

  1.1. Address a health issue of importance.

3. The guideline development group will:

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

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.

6. To be evidence informed guidelines will:

  6.2. Consider the body of evidence for each outcome (including the quality of that evidence) and other factors that influence the process of making recommendations including benefits and harms, values and preferences, resource use and acceptability.

Useful resources

AGREE II for practice guideline development—see Domain 2: Stakeholder Involvement

Australian Commission on Safety and Quality in Healthcare

Cancer Australia Consumer Involvement Toolkit

COMET outcomes

Cochrane Consumers and Communication Group

Cochrane Consumer Network

Consumer Health Forum

Framework for the engagement of people with a lived experience in program implementation and research (Suomi, Freeman et al. 2017)—see Appendix 2 for examples of consumer involvement

GRIPP2 reporting checklists

Guidelines International Network Public toolkit

Health Issues Centre – Recruiting consumers

International Association for Public Participation (IAP2) website

James Lind Alliance website

National Institute for Health and Care Excellence (NICE) Public Involvement program

National Institute for Health Research INVOLVE program

Scottish Intercollegiate Guidelines Network (SIGN) patient involvement website

South Australia Health consumer and community engagement resources

WA Consumer and Community Health Research Network

References

Appraisal of Guidelines for Research and Evaluation (AGREE) Trust (2013). AGREE II Instrument Users Manual.

Armstrong, M. J., Mullins, C. D., et al. (2017). Recommendations for patient engagement in guideline development panels: A qualitative focus group study of guideline-naïve patients. PloS one 12(3): e0174329.

Arnstein, S. R. (1969). A ladder of citizen participation. Journal of the American Institute of Planners 35(4): 216-224.

Australian Commission on Safety and Quality in Health Care (ACSQHC) (2012). Safety and Quality Improvement Guide Standard 2: Partnering with Consumers.

Consumers Health Forum of Australia (CHF). (2017). Representation. from https://chf.org.au/representation.

Cyril, S., Smith, B. J., et al. (2015). Exploring the role of community engagement in improving the health of disadvantaged populations: a systematic review. Global health action 8: 29842-29842.

GRADE Working Group (2013). GRADE Handbook. Handbook for grading the quality of evidence and the strength of recommendations using the GRADE approach. H. Schünemann, J. Brożek, G. Guyatt and A. Oxman.

Greenhalgh, T. (2017). How to Implement Evidence-Based Healthcare, John Wiley & Sons.

Gysels, M., Bausewein, C., et al. (2007). Experiences of breathlessness: a systematic review of the qualitative literature. Palliative & Supportive Care 5(3): 281-302.

James, A. M. (2007). Principles of youth participation in mental health services. Medical Journal of Australia 187(7 Suppl): S57.

Kelson, M., Akl, E. A., et al. (2012). Integrating values and consumer involvement in guidelines with the patient at the center: article 8 in Integrating and coordinating efforts in COPD guideline development. An official ATS/ERS workshop report. Proceedings of the American Thoracic Society 9(5): 262-268.

Kirwan, J. R., de Wit, M. P. T., et al. (2016). Commentary: Patients as Partners: Building on the Experience of Outcome Measures in Rheumatology. Arthritis & Rheumatology 68(6): 1334-1336.

McKenzie, A. and Alpers, K. (2015). Consumer and Community Participation Program Report on Activities 1998-2014, The University of Western Australia School of Population Health and Telethon Kids Institute.

National Health and Medical Research Council (NHMRC) (2011). Procedures and requirements for meeting the 2011 NHMRC Standard for Clinical Practice Guidelines.

National Health and Medical Research Council (NHMRC) (2014). Australian Clinical Practice Guidelines 2014 Annual Report.

Nilsen, E. S., Myrhaug, H. T., et al. (2006). Methods of consumer involvement in developing healthcare policy and research, clinical practice guidelines and patient information material. The Cochrane Database of Systematic Reviews(3): CD004563.

O’Mara-Eves, A., Brunton, G., et al. (2013). Community engagement to reduce inequalities in health: a systematic review, meta-analysis and economic analysis. https://www.ncbi.nlm.nih.gov/books/NBK262817, NIHR Journals Library (Public Health Research, No. 1.4).

Ocloo, J. and Matthews, R. (2016). From tokenism to empowerment: progressing patient and public involvement in healthcare improvement. BMJ Quality & Safety 25(8): 626-632.

Oliver, S. R., Rees, R. W., et al. (2008). A multidimensional conceptual framework for analysing public involvement in health services research. Health expectations : an international journal of public participation in health care and health policy 11(1): 72-84.

Payne, J. M., D'Antoine, H. A., et al. (2011). Collaborating with consumer and community representatives in health and medical research in Australia: results from an evaluation. Health Research Policy and Systems 9: 18.

Schunemann, H. J., Fretheim, A., et al. (2006). Improving the use of research evidence in guideline development: 10. Integrating values and consumer involvement. BioMed Central: Health Research Policy and Systems 4: 22.

Scottish Intercollegiate Guidelines Network (SIGN) (2015). SIGN 50: a guideline developer’s handbook.

Scottish Intercollegiate Guidelines Network (SIGN) (2015). SIGN 100: a handbook for patient and carer representatives.

Selva, A., Sola, I., et al. (2017). Development and use of a content search strategy for retrieving studies on patients' views and preferences. Health and Quality of Life Outcomes 15(1): 126.

Shelef, D. Q., Rand, C., et al. (2016). Using stakeholder engagement to develop a patient-centered pediatric asthma intervention. Journal of Allergy and Clinical Immunology 138(6): 1512-1517.

Staniszewska, S., Brett, J., et al. (2017). GRIPP2 reporting checklists: tools to improve reporting of patient and public involvement in research. British Medical Journal 358: j3453.

Suomi, A., Freeman, B., et al. (2017). Framework for the engagement of people with a lived experience in program implementation and research - Review and report prepared for the LifeSpan suicide prevention project, Australian National University.

Tong, A., Lopez-Vargas, P., et al. (2012). Consumer involvement in topic and outcome selection in the development of clinical practice guidelines. Health Expectations 15(4): 410-423.

Yu, T., Enkh-Amgalan, N., et al. (2017). Methods to perform systematic reviews of patient preferences: a literature survey. BMC medical research methodology 17(1): 166.

Zhang, Y., Coello, P. A., et al. (2017). Using patient values and preferences to inform the importance of health outcomes in practice guideline development following the GRADE approach. Health and Quality of Life Outcomes 15(1): 52.

Acknowledgements

NHMRC would like to acknowledge and thank Professor Jonathan Craig from Flinders University for his contribution to the development of this module as editor. We would also like to acknowledge and thank members of the James Lind Alliance and the NHMRC Community and Consumer Advisory Group for their feedback on the draft module, as well as the many individuals and organisations that provided comments during public consultation.

 

Version 4.0. Last updated 23/11/2018,

Suggested citation: NHMRC. Guidelines for Guidelines: Consumer involvement. https://nhmrc.gov.au/guidlinesforguidelines/plan/consumer-involvement. Last updated 23/11/2018.

ISBN: 978-1-86496-024-2