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Methodology paper| Volume 30, ISSUE 1, P101-109, February 2023

Ethical and feasible stakeholder engagement in guideline development

      ABSTRACT

      Background

      Stakeholder engagement impacts on the relevance and usability of guidelines. Consequently, guideline developers are advised to engage with a diverse group of stakeholders. One of the most critical and challenging phases of guideline development is determining the guideline scope, and there is currently scant guidance for how stakeholders can be engaged in feasible and ethical ways.

      Aim

      This article aims to provide practical guidance for how diverse stakeholders can be engaged to determine the scope of a guideline.

      Methods

      Supported by previous frameworks and by drawing on experiences from a research project aiming to develop a clinical practice guideline on non-pharmacological approaches for agitation in the intensive care unit, this paper describes a 7-step process for stakeholder engagement. Guideline developers need to consider the aim of their project, identify relevant stakeholders, decide on the level of engagement, plan how to engage in feasible and ethical ways, consider how to increase the trustworthiness of a project, and finally consider how to evaluate the project.

      Conclusion

      Consultation of diverse stakeholder groups is feasible, but it is essential to plan the activities and be aware of the steps to take to ensure an effective and ethical process.

      Keywords

      Summary of relevance
      Problem or Issue
      Failure to engage relevant stakeholder groups when determining the scope of clinical practice guidelines may result in inadequately addressing existing needs, thus compromising the implementation of the guideline.
      No guidance exists on how guideline developers can involve diverse international stakeholders in feasible and ethical ways.
      What is already known
      Evidence shows that often stakeholder engagement is not done, or not done well.
      What this paper adds
      This paper describes the steps guidelines developers can take to increase the likelihood of ensuring ethical and feasible stakeholder engagement.

      1. Introduction and background

      The implementation of evidence-based practice is challenging (
      • Braithwaite J.
      • Glasziou P.
      • Westbrook J.
      The three numbers you need to know about healthcare: the 60-30-10 challenge.
      ). Although guidelines are tools developed to support this process (
      • Steinberg E.
      • Greenfield S.
      • Wolman D.M.
      • Mancher M.
      • Graham R.
      Clinical practice guidelines we can trust.
      ), the lack of guideline uptake is a major concern internationally (
      • Girlanda F.
      • Fiedler I.
      • Becker T.
      • Barbui C.
      • Koesters M.
      The evidence–practice gap in specialist mental healthcare: systematic review and meta-analysis of guideline implementation studies.
      ;
      • Heneghan C.
      • Perera R.
      • Mant D.
      • Glasziou P.
      Hypertension guideline recommendations in general practice: awareness, agreement, adoption, and adherence.
      ;
      • Reinecke H.
      • Unrath M.
      • Freisinger E.
      • Bunzemeier H.
      • Meyborg M.
      • Lüders F.
      • et al.
      Peripheral arterial disease and critical limb ischaemia: still poor outcomes and lack of guideline adherence.
      ). Lack of guideline uptake can occur when end-users do not agree with recommendations (
      • Spitaels D.
      • Vankrunkelsven P.
      • Desfosses J.
      • Luyten F.
      • Verschueren S.
      • Van Assche D.
      • et al.
      Barriers for guideline adherence in knee osteoarthritis care: a qualitative study from the patients' perspective.
      ), when a guideline format is not user friendly (
      • Cahill N.E.
      • Suurdt J.
      • Ouellette-Kuntz H.
      • Heyland D.K.
      Understanding adherence to guidelines in the intensive care unit: development of a comprehensive framework.
      ), or when the recommendations are not feasible (
      • Perez X.
      • Wisnivesky J.P.
      • Lurslurchachai L.
      • Kleinman L.C.
      • Kronish I.M.
      Barriers to adherence to COPD guidelines among primary care providers.
      ). Research has explored ways to improve knowledge uptake and to develop guidelines with a form and content that more easily can be implemented (

      National Health and Medical Research Council, N. (2020). Guidelines for Guidelines. Retrieved from https://www.nhmrc.gov.au/guidelinesforguidelines/implement (Yaccess date 10th April 2022).

      ). Evidence shows stakeholder engagement can have an impact on the relevance and usability of the final guideline (
      • Armstrong M.J.
      • Mullins C.D.
      • Gronseth G.S.
      • Gagliardi A.R.
      Impact of patient involvement on clinical practice guideline development: a parallel group study.
      ), thus increasing the likelihood of successful implementation (

      Health, N. I. f., & Excellence, C. (2015). Developing NICE guidelines: the manual: National Institute for Health and Care Excellence (NICE).

      ;

      World Health Organization. (2014). WHO handbook for guideline development. Retrieved from https://apps.who.int/iris/handle/10665/145714.

      ). Within guideline development, stakeholders include those who have a legitimate interest in a guideline and/or who may affect, or be affected by it. Stakeholders may include health professionals, patients and their representatives, those financing, managing or monitoring care, employers, and manufacturers (
      • Cluzeau F.
      • Wedzicha J.A.
      • Kelson M.
      • Corn J.
      • Kunz R.
      • Walsh J.
      • et al.
      Stakeholder involvement: how to do it right: article 9 in integrating and coordinating efforts in COPD guideline development. An official ATS/ERS workshop report.
      ).
      Despite emerging evidence for engaging diverse stakeholder groups when developing practice guidelines, often this is not done or not done well (
      • Armstrong M.J.
      • Bloom J.A.
      Patient involvement in guidelines is poor five years after institute of medicine standards: review of guideline methodologies.
      ;
      • Wyatt K.D.
      • Stuart L.M.
      • Brito J.P.
      • Leon B.C.
      • Domecq J.P.
      • Prutsky G.J.
      • et al.
      Out of context: clinical practice guidelines and patients with multiple chronic conditions: a systematic review.
      ). Facilitating ethical and feasible stakeholder engagement can be challenging, and many attempts of engagement have been criticised for being ineffective or tokenistic in nature (
      • Ocloo J.
      • Matthews R.
      From tokenism to empowerment: progressing patient and public involvement in healthcare improvement.
      ). Tokenistic engagement means that projects present a false appearance of inclusiveness. Tokenistic engagement occurs when stakeholders are not holding real influence, when their input is underestimated and not taken seriously, and when stakeholders are not allowed to contribute in ways that are meaningful and respectful to them (
      • Romsland G.I.
      • Milosavljevic K.L.
      • Andreassen T.A.
      Facilitating non-tokenistic user involvement in research.
      ).
      Determining a meaningful and feasible guideline scope
      A guideline's scope sets out what it will and will not cover (NICE, 2015).
      is considered one of the most essential and challenging phases of guideline development (

      World Health Organization. (2014). WHO handbook for guideline development. Retrieved from https://apps.who.int/iris/handle/10665/145714.

      ). This paper aims to provide guidance on how diverse stakeholder groups can be engaged to determine the scope of clinical practice guidelines. The guidance will be supported by existing frameworks and a clinical example.

      2. Philosophical foundation and theoretical lens

      Pragmatism formed the philosophical foundation for this paper. Pragmatism was chosen as it is outcome orientated and focuses on solving practical problems in the real world (
      • Creswell J.W.
      • Clark V.L.P.
      Designing and conducting mixed methods research.
      ;
      • Kaushik V.
      • Walsh C.A.
      Pragmatism as a research paradigm and its implications for social work research.
      ). According to pragmatism, researchers can and should use multiple methods and sources of knowledge to solve a problem (
      • Creswell J.W.
      Research design: qualitative, quantitative, and mixed methods approaches.
      ;
      • Kaushik V.
      • Walsh C.A.
      Pragmatism as a research paradigm and its implications for social work research.
      ).
      The integrated knowledge translation (IKT) framework was chosen to guide the guideline development process. IKT is "a model of collaborative research, where researchers work with knowledge users who identify a problem and have the authority to implement the research recommendations" (
      • Kothari A.
      • McCutcheon C.
      • Graham I.D.
      Defining integrated knowledge translation and moving forward: a response to recent commentaries.
      , p. 299). IKT aligns well with pragmatism (
      • Nowell L.
      Pragmatism and integrated knowledge translation: exploring the compatabilities and tensions.
      ), and is a promising framework to increase knowledge uptake (
      • Straus S.
      • Tetroe J.
      • Graham I.D.
      Knowledge translation in health care: moving from evidence to practice.
      ). Traditionally those who produced knowledge and those who used the knowledge were seen as two separate groups, where knowledge got transferred from production in the first group to implementation in the last (
      • Landry R.
      • Amara N.
      • Pablos-Mendes A.
      • Shademani R.
      • Gold I.
      The knowledge-value chain: a conceptual framework for knowledge translation in health.
      ). IKT aims to bridge these two groups early in the research process with the purpose of making research relevant and useful to its end-users (
      • Kothari A.
      • Wathen C.N.
      A critical second look at integrated knowledge translation.
      ). In IKT, researchers and knowledge users work together in all stages of a research project to solve complex real word problems (
      • Kothari A.
      • Wathen C.N.
      A critical second look at integrated knowledge translation.
      ). IKT share many similarities with models such as Engaged Scholarship
      Engaged scholarship: Participative research process expanding the capabilities of scholars to gather perspectives of key stakeholders.
      , Participatory Research
      Participatory research: Address community issues in collaborative consultation with people with lived experiences.
      and Co-production
      Co-production/co-creation: Active involvement of consumers in the knowledge production process.
      (
      • Kothari A.
      • Wathen C.N.
      A critical second look at integrated knowledge translation.
      ). But in contrast to these models with backgrounds in social science, social justice and education, IKT originates from health research and focuses on increasing knowledge use to improve patient care (
      • Kothari A.
      • Wathen C.N.
      Integrated knowledge translation: digging deeper, moving forward.
      ;
      • Nguyen T.
      • Graham I.D.
      • Mrklas K.J.
      • Bowen S.
      • Cargo M.
      • Estabrooks C.A.
      • et al.
      How does integrated knowledge translation (IKT) compare to other collaborative research approaches to generating and translating knowledge? Learning from experts in the field.
      ). IKT brings together researchers and stakeholders such as health care providers and policymakers (
      • Kothari A.
      • Wathen C.N.
      A critical second look at integrated knowledge translation.
      ). However, IKT scholars have started exploring the opportunities to engage patients and the public in their research (D.
      • Banner D.
      • Bains M.
      • Carroll S.
      • Kandola D.K.
      • Rolfe D.E.
      • Wong C.
      • et al.
      Patient and public engagement in integrated knowledge translation research: are we there yet?.
      ; D. J.
      • Banner D.J.
      • Graham I.D.
      • Bains M.
      • Carroll S.
      • Aaron S.
      • Healey J.
      • et al.
      Ready to go: Using an integrated knowledge translation approach to support the development of a funding application to explore patient engagement in Canadian circulatory and respiratory diseases research.
      ).
      To our knowledge, no papers have described the step-by-step process for how all relevant stakeholders, including patients and their families, can be engaged in IKT research. To ensure feasible and ethical engagement with a broad group of stakeholders, this study was guided by patient and public engagement experts, including the International Association for Public Participation (

      IAP2. iap2 International Association for Public Participation. Retrieved from https://www.iap2.org/mpage/Home (access date 24th Nov 2021).

      ) and the UK's National Institute for Health Research community engagement program INVOLVE (

      INVOLVE. (2015). Public involvement in research: Values and principles framework. Eastleigh: INVOLVE Retrieved from https://www.invo.org.uk/wp-content/uploads/2017/08/Values-Principles-framework-Jan2016.pdf (21 Nov 2021).

      ).

      3. Steps for stakeholder engagement

      Successful stakeholder engagement largely depends on thoughtful planning. To help future guideline developers, we propose seven critical steps for stakeholder engagement. These steps include clarifying the aim, identifying stakeholders and where to find them, considering if Human Research Ethics Committee (HREC) review is required, planning how to engage, ensuring the project's trustworthiness and integrity, and evaluating the project.

      4. A clinical example

      The seven steps are illustrated by examples of how we engaged Danish and Australian stakeholders to identify a guideline's scope. The guideline aimed to describe the non-pharmacological management of agitation in the intensive care unit (ICU). Non-pharmacological management is critical to avoid the harmful effects seen from an overuse of sedatives and antipsychotic drugs (Devlin et al., 2018).

      5. Step 1: Clarify the aim of engagement

      Guideline developers must articulate a well-defined aim for stakeholder engagement and justify why it is needed (
      • Andrews D.
      • Fong G.
      • Hackam D.
      • Li L.
      • Lynam M.
      • Mathews M.
      • Strauss S.
      Guide to knowledge translation planning at CIHR: Integrated and end–of–grant approaches.
      ). By clarifying the aim, clear boundaries and limitations can be set and appropriate methods chosen. The aim will depend on the stage of guideline development. For example, will stakeholders help select a topic, scope the guideline, identify and synthesise the evidence, develop recommendations and/or disseminate and implement the recommendations? Our project aimed to engage stakeholders to advise on the appropriate scope of a clinical practice guideline. A mixed-methods systematic review indicated the need for a guideline (
      • Adams A.M.N.
      • Chamberlain D.
      • Grønkjær M.
      • Thorup C.B.
      • Conroy T.
      Caring for patients displaying agitated behaviours in the intensive care unit–a mixed-methods systematic review.
      ), and systematic searches suggested that no guidelines existed on the topic. The aim of our stakeholder consultation was not to address a research gap.

      6. Step 2: Identify all relevant stakeholders

      When identifying relevant stakeholders, it is beneficial to ask the following questions. Who will be directly and indirectly affected by the guideline? Who would want to be involved? Are there any organisations representing the condition that is the focus of the guideline? For example, the UK's National Institute for Health Care Excellence (NICE) invites organisations, representatives of service users and registered stakeholders with specific knowledge of or experience with a condition to comment on the scope of their guidelines. In our project, relevant organisations or representatives of service users did not exist, and therefore we invited previous patients and their families with personal experiences of agitation in the ICU. We also invited ICU clinicians and researchers.
      It is also necessary to consider how many stakeholders to engage. Most commonly, the aim of a scoping project is not to make generalisations, and therefore a large number of stakeholders is not necessary. However, guideline developers should have an inclusive approach and ideally seek a range of perspectives from individuals with diverse backgrounds (

      National Health and Medical Research Council, N. (2020). Guidelines for Guidelines. Retrieved from https://www.nhmrc.gov.au/guidelinesforguidelines/implement (Yaccess date 10th April 2022).

      ). We knew that non-pharmacological practices to reduce and manage agitation in ICU varied between countries and within countries. Therefore, we mapped out a variety of stakeholders groups from the different geographical locations. We eventually included around 50 stakeholders, which was manageable while also providing comprehensive information from various people.

      7. Step 3: Consider how to find stakeholders

      It is essential to consider how to find stakeholders. The Guidelines International Network (GIN) Public working group, a broad group of researchers, health professionals and consumers, suggests using either open or targeted invitations or a combination of these (

      Cowl, J., Armstrong, M. J., Schaefer, C., & Fielding, J. (2021). GIN public Toolkit, Chapter 1 Consultation. Retrieved from https://g-i-n.net/get-involved/resources/#toolkit (access date June 2021).

      ). Open invitation means publicly publishing a draft guideline scope and asking anyone to provide feedback. The advantage of this method is that anyone can be involved, and since stakeholders are unknown to the guideline development group, they are unlikely to feel pressured to agree with the group, thus reducing bias. The risk is that nobody provides feedback because nobody feels responsible, or too many provide feedback leaving guideline developers overwhelmed with responses (

      Cowl, J., Armstrong, M. J., Schaefer, C., & Fielding, J. (2021). GIN public Toolkit, Chapter 1 Consultation. Retrieved from https://g-i-n.net/get-involved/resources/#toolkit (access date June 2021).

      ). Targeted invitations mean sending out invitations directly to relevant stakeholders. This method can be more effective as it takes less time to find stakeholders, and if they are trained, they will know exactly what is required from them. The disadvantage is that important voices may be lost (

      Cowl, J., Armstrong, M. J., Schaefer, C., & Fielding, J. (2021). GIN public Toolkit, Chapter 1 Consultation. Retrieved from https://g-i-n.net/get-involved/resources/#toolkit (access date June 2021).

      ). We used both open and targeted invitations. We contacted researchers directly while also reaching out broadly through professional and patient organisations. These organisations then reached out to their members via emails and newsletters.
      We struggled to find previous patients and their family members. The engagement of lay people in projects involving diverse international stakeholder groups has shown to be challenging (
      • Ingoe H.M.
      • Eardley W.
      • Rangan A.
      • Hewitt C.
      • McDaid C.
      An international multi-stakeholder delphi consensus exercise to develop a core outcomes set (COS) for surgical fixation of rib fractures.
      ).
      • Ocloo J.
      • Matthews R.
      From tokenism to empowerment: progressing patient and public involvement in healthcare improvement.
      warn that stakeholders can struggle with a lack of confidence and feel they do not have much to contribute. In our project, this was illustrated by one stakeholder who contacted us writing, "I am just an ordinary person with some experiences in this area," and then, unfortunately, withdrew from the project. We believe that meeting individuals and describing the study personally increases stakeholders' trust in the study and their self-confidence, thus encouraging participation. Unfortunately, due to COVID restrictions, we did not have access to post ICU patient support groups which hindered this level of personal contact.

      8. Step 4: Consider if your project requires a Human Research Ethics Committee (HREC) review

      Stakeholder consultation should be an integral part of all health research. The Australian
      National Health Medical Research Council
      Statement on consumer and community involvement in health and medical research.
      states consultation activities are more likely to result in ethically conducted patient-centred research. However, the concept of engagement is relatively new, and confusion exists around ethics and the risks involved for stakeholders. Scholars argue that ethics approval is not needed when patients and the public are consulted or involved in developing the processes and scope of projects as opposed to being subjects or participants of research (

      Involve. (2009). Patient and public involvement in research and research ethics committee review. Retrieved from https://www.invo.org.uk/wp-content/uploads/2011/12/INVOLVENRESfinalStatement310309.pdf (7th May 2021).

      ). Consultation in guideline development poses a very low risk of harm to stakeholders. This is because being consulted differs from participating in research where data, such as personal information and experiences, are collected, transcribed, analysed, published and stored. Therefore consultation of stakeholders rarely causes ethical concerns (

      Australian Clinical Trials Alliance. (2021). Ethics review and involvement. Retrieved from https://involvementtoolkit.clinicaltrialsalliance.org.au/toolkit/undertaking/ethics-review-and-involvement/ (access date 10th April 2022).

      ). However, regardless of the nature of their engagement in a project, ethical dilemmas can arise (
      • Pandya-Wood R.
      • Barron D.S.
      • Elliott J.
      A framework for public involvement at the design stage of NHS health and social care research: time to develop ethically conscious standards.
      ;
      • Salerno J.
      • Coleman K.J.
      • Jones F.
      • Peters E.S.
      The ethical challenges and opportunities of implementing engagement strategies in health research.
      ). Examples of this can be when stakeholders feel pressured to participate; when they provide certain answers due to their relationship with a guideline developer; when stakeholders do not fully understand their role or the aim of a project; or when guideline developers breach confidentiality. Due to these concerns, we recommend following ethical principles for stakeholder engagement (
      • Pandya-Wood R.
      • Barron D.S.
      • Elliott J.
      A framework for public involvement at the design stage of NHS health and social care research: time to develop ethically conscious standards.
      ;
      • Salerno J.
      • Coleman K.J.
      • Jones F.
      • Peters E.S.
      The ethical challenges and opportunities of implementing engagement strategies in health research.
      ), while also contacting a relevant ethics committee for advice on local requirements.

      9. Step 5: Plan how to engage

      Once the why stakeholder engagement is needed and the who stakeholders are is clear, it is time to identify how to engage stakeholders. It is crucial to make a tailored plan that will suit the project's purpose and the characteristics of the involved stakeholders. Guideline developers should work ethically and recognise the limitations of resources available. Below we describe the importance of considering the level of engagement, what questions to ask the stakeholders, the different forms of engagement, how to ensure clear and effective communication, how to maximise benefits and minimise harm, and finally, how to allocate sufficient time and resources.

      9.1 Decide on the level of engagement

      IKT projects require varying levels of engagement at various times (
      • Andrews D.
      • Fong G.
      • Hackam D.
      • Li L.
      • Lynam M.
      • Mathews M.
      • Strauss S.
      Guide to knowledge translation planning at CIHR: Integrated and end–of–grant approaches.
      ). Guideline developers must be clear about the level of engagement required for their project. The IAP2 Public Participation Spectrum can help to define the exact role of the stakeholders (see levels of engagement Fig. 1)
      Fig 1
      Fig. 1IAP2 Spectrum of Public Participation (), published with approval from the IAP2 working group.
      The level of engagement ranges along a continuum from informing through to collaborating and empowering. At the lower level of engagement, stakeholders are informed but not able to influence decision-making processes. In contrast, at the higher end, the decisions are fully led by the stakeholders. Levels of engagement may depend on many factors, such as the aim of the project, the financial resources, and the timeframe. In guideline development, inform can be used to inform and raise awareness about guidelines and their updates. Consultation can be used in different phases but is commonly used to get advice on the guideline's relevance, scope or review tentative recommendations. Involvement and collaboration often refer to stakeholders who are members of the guideline development group where they can be review evidence or carry out research. Finally, empower refer to stakeholders who help implement and disseminate research.
      We decided to consult stakeholders about the guideline scope. While consultation has been criticised for being tokenistic (
      • Arnstein S.R.
      A ladder of citizen participation.
      ) and a 'tick box' exercise compared with approaches that collaborate and empower stakeholders, it can be a vital step in international guideline development, allowing a larger group of people to be heard. Consultation suited our aim, and while stakeholders were not able to make final decisions, their advice directly influenced the determination of the final scope, and they were continuously kept informed about the progress of the guideline development.

      9.2 Decide to engage diverse stakeholder groups separately or simultaneously

      Professionals and laypeople can be engaged separately or simultaneously, and there are advantages and disadvantages to both options. Separately engaged groups may facilitate the development of unique and more directly relevant questions for each group. For instance, Serrano-Aguilar et al. (
      • Serrano-Aguilar P.
      • del Mar Trujillo-Martin M.
      • de la Rosa A.P.
      • Cuellar-Pompa L.
      • Saavedra-Medina H.
      • Linertova R.
      • et al.
      Patient participation in a clinical guideline development for systemic lupus erythematosus.
      ) carried out a Delphi study to reach agreement amongst consumers on priorities for a practice guideline and Tong et al. (
      • Tong A.
      • Lopez-Vargas P.
      • Howell M.
      • Phoon R.
      • Johnson D.
      • Campbell D.
      • et al.
      Consumer involvement in topic and outcome selection in the development of clinical practice guidelines.
      ) invited 30 consumers to participate in two 3-hour workshops to select the topic and outcomes on early-stage chronic kidney disease. While such methods may be effective, they are also resource-intensive. We engaged diverse groups simultaneously to integrate several views into a project with strict time and resource restrictions.

      9.3 Consider what questions to ask the stakeholders

      A proposed guideline scope, built on the existing literature, should be developed before consultation commences. Guideline developers can then seek input on the proposed questions for the guideline to address, the population, including potential subgroups, end-users, setting, interventions, and meaningful outcomes (

      Cowl, J., Armstrong, M. J., Schaefer, C., & Fielding, J. (2021). GIN public Toolkit, Chapter 1 Consultation. Retrieved from https://g-i-n.net/get-involved/resources/#toolkit (access date June 2021).

      ). We also found it helpful to also ask stakeholders about the predicted barriers to guideline implementation.
      Regrettably, we did not ask stakeholders to rank outcomes and interventions. Such information is essential for conducting relevant systematic reviews that will inform the guideline recommendations, and therefore, we recommend future guideline developers do this during the scoping phase.

      9.4 Offer different forms of consultation

      Consultation can take different forms and can occur online or face-to-face, through workshops, meetings, open online discussions, or submission of written feedback. Traditional research methods such as surveys, interviews and focus groups may also be appropriate if the aim of a project is not to get input on a proposed scoping document but to answer a specific research question (
      • Del Campo P.D.
      • Gracia J.
      • Blasco J.
      • Andradas E.
      A strategy for patient involvement in clinical practice guidelines: methodological approaches.
      ;
      • Tong A.
      • Lopez-Vargas P.
      • Howell M.
      • Phoon R.
      • Johnson D.
      • Campbell D.
      • et al.
      Consumer involvement in topic and outcome selection in the development of clinical practice guidelines.
      ). For example, research questions could be 'what are the lived experiences of patient agitation in ICU?' or 'what are the views of agitation management in ICU?'.
      To maximise opportunities for stakeholder input, we offered three different modes of online engagement, including workshops, one-on-one meetings and the opportunity to provide written feedback. There are several advantages of online patient engagement (
      • Grant S.
      • Hazlewood G.S.
      • Peay H.L.
      • Lucas A.
      • Coulter I.
      • Fink A.
      • et al.
      Practical considerations for using online methods to engage patients in guideline development.
      ). Overall, the modes allowed us to hear the voices of multiple people at their convenience, regardless of time, geographical location, educational levels, income and ethnic backgrounds. Providing a diversity of methods for input and feedback also offered environments where stakeholders could feel safe and comfortable speaking up. We believe that by providing these modes, our strategy was as inclusive and flexible as possible. We have summarised the perceived advantages and disadvantages of each method in Table 2.
      Although there are several advantages of online consultation, there are also disadvantages. These include not being able to ensure stakeholders fully understand the tasks required from them (
      • Grant S.
      • Hazlewood G.S.
      • Peay H.L.
      • Lucas A.
      • Coulter I.
      • Fink A.
      • et al.
      Practical considerations for using online methods to engage patients in guideline development.
      ) and not being able to reach homeless people, people with mental or chronic illnesses, people from lower socioeconomic backgrounds without a computer and Internet connection, and those with poor reading or communication skills. These people may have a greater need for health care than the wider population (
      • Ocloo J.
      • Matthews R.
      From tokenism to empowerment: progressing patient and public involvement in healthcare improvement.
      ). Reaching these groups would have been valuable and potentially uncovered equity issues. However, this would have required meeting people face-to-face rather than online, which was not possible in our project due to the geographical distance between stakeholders. We suggest guideline developers are aware of the limitations of online engagement and consider if and how barriers can be mitigated.

      9.5 Ensure clear and effective communication

      While collaboration across borders has become increasingly popular, it can be challenging to ensure clear and effective communication with people speaking different languages (
      • Dusdal J.
      • Powell J.J.
      Benefits, motivations, and challenges of international collaborative research: A sociology of science case study.
      ). Translation of documents and other material can be a lengthy process and researchers, therefore, often restrict themselves to their native language (

      Alkhaffaf, B., Blazeby, J. M., Metryka, A., Glenny, A.-M., Adeyeye, A., Costa, P. M., et al. (2021). Methods for conducting international Delphi surveys to optimise global participation in Core Outcome Set development: a case study in gastric cancer informed by a comprehensive literature review.

      ;
      • Berk L.
      • Jorm A.F.
      • Kelly C.M.
      • Dodd S.
      • Berk M.
      Development of guidelines for caregivers of people with bipolar disorder: a Delphi expert consensus study.
      ). We believe this can become a significant limitation of a project and can lead to important voices being lost. We advise guideline developers working with multinational groups to accurately translate all recruitment material and conduct meetings in stakeholders' native language.
      It is essential that stakeholders are fully informed before agreeing to be involved (
      • Andrews D.
      • Fong G.
      • Hackam D.
      • Li L.
      • Lynam M.
      • Mathews M.
      • Strauss S.
      Guide to knowledge translation planning at CIHR: Integrated and end–of–grant approaches.
      ; ;
      • Wright D.
      • Foster C.
      • Amir Z.
      • Elliott J.
      • Wilson R.
      Critical appraisal guidelines for assessing the quality and impact of user involvement in research.
      ). When stakeholders do not feel clear about what is expected from them, this can hinder engagement (
      • Ocloo J.
      • Matthews R.
      From tokenism to empowerment: progressing patient and public involvement in healthcare improvement.
      ). We developed a bilingual online platform for people with different literacy competencies to ensure all stakeholders were fully informed. The platform offered several videos and text describing the purpose of the guideline development and how stakeholders could be involved. We developed participant information sheets describing the project's purpose and expectations to stakeholders. We advised stakeholders that participation was voluntary and that they could withdraw at any time without consequences. We pilot tested all material on individuals from Denmark and Australia, including health professionals, a participatory disability researcher, “lay” people and members of minority groups. We highly recommend testing all material, as this process encouraged us to make several changes. For instance, we realised that two different information sheets were necessary to accommodate different audiences. We developed an easy read and a standard version, and participants could choose which version they preferred. In the easy read version, we were conscious about using plain inclusive language without medical terminology and jargon and infographics when possible. The standard version contained more detailed background information without infographics.

      9.6 Maximise benefits and minimise harm

      Guideline developers should ensure maximum benefits for stakeholders and minimal harm (
      • Salerno J.
      • Coleman K.J.
      • Jones F.
      • Peters E.S.
      The ethical challenges and opportunities of implementing engagement strategies in health research.
      ). It may be appropriate to reimburse stakeholders for their participation, as limited resources, for example, caring responsibilities, time, money for transport, limited Internet access etc. can hinder participation (
      • Ocloo J.
      • Matthews R.
      From tokenism to empowerment: progressing patient and public involvement in healthcare improvement.
      ). We required participants to have access to a computer with an Internet connection and spend a significant amount of time (more than one hour) reading and answering several questions. Since reimbursing consumers in consultation projects aligns with the principles of patient and public involvement (
      • Hayes H.
      • Buckland S.
      • Tarpey M.
      Briefing notes for researchers: public involvement in NHS, public health and social care research.
      [updated 2021]), we decided to provide a small reimbursement (AU$30 voucher) for all participants. However, we advise offering incentives carefully, in particular when there is a risk that a large group of stakeholders will register their interest. Guideline developers can state that only a limited number of stakeholders will receive a voucher on a 'first come, first served' basis to avoid exceeding budget limits. Guideline developers can also decide only to reimburse certain stakeholder groups such as patients and family members. We experienced that health professionals participated during their working hours, were able to claim hours spent on the project as professional development hours and found a few health professionals described feeling uncomfortable receiving reimbursements. Considering the differences in resource access and reciprocity, we believe guideline developers should prioritise reimbursement of patients and family members over healthcare professionals.
      Stakeholders must be able to provide advice without feeling any undue burden (
      • Salerno J.
      • Coleman K.J.
      • Jones F.
      • Peters E.S.
      The ethical challenges and opportunities of implementing engagement strategies in health research.
      ), and guideline developers must work sensitively to avoid or minimise potentially emotionally upsetting situations (
      • Pandya-Wood R.
      • Barron D.S.
      • Elliott J.
      A framework for public involvement at the design stage of NHS health and social care research: time to develop ethically conscious standards.
      ). In our project, we knew that thinking back to their time in the ICU could be uncomfortable for some stakeholders. To moderate this, we carefully developed questions that focused on the purpose of the project (see Table 1). We did not ask in-depth questions such as ‘what do you feel about it?’ or ‘how was your emotional reaction to that?’ We anticipated that focusing on the specific questions would minimise the risk of participants finding the involvement emotionally burdening. Although stakeholders are unlikely to become distressed during a meeting, we had a backup plan in case it would happen. Participants were always able to contact the principal investigator for a debrief, and we had a list of free online counsellors available, as suggested by the literature (
      • Pandya-Wood R.
      • Barron D.S.
      • Elliott J.
      A framework for public involvement at the design stage of NHS health and social care research: time to develop ethically conscious standards.
      ;
      • Wright D.
      • Foster C.
      • Amir Z.
      • Elliott J.
      • Wilson R.
      Critical appraisal guidelines for assessing the quality and impact of user involvement in research.
      ).
      Table 1Examples of questions for stakeholders.
      Examples of questions
      Is the guideline needed? Please explain your answer.
      Do you think there are other aspects the guideline should cover? Please explain your answer.
      Who will find the guideline useful?
      What strategies do you think work for (insert group impacted by the guideline)?
      What kind of results are you hoping for?
      Do you predict any difficulties when trying to use the guideline?
      Table 2The perceived advantages and disadvantages of different engagement methods.
      MethodAdvantagesDisadvantagesAdvice
      Written feedbackEnable busy shift workers to participate Convenient for both stakeholders and guideline developers. Allows a larger number of people to be engaged.While some responses were lengthy and detailed with references and explanations, others were brief. Answers from stakeholders may be unclear.We recommend receiving written feedback before running the workshops and one-on-one meetings. This sequential approach can provide an opportunity to seek clarification on some written feedback.
      One-on-one meetingsCan be carried out at a negotiated time that suits stakeholders. Offers more speaking time, thus an opportunity to provide more detailed feedback.Can be time-consuming for guideline developers. Require guideline developers to be available outside regular working hours when including stakeholders from other time zones.Provide questions in advance and encourage stakeholders to come prepared. On average, meetings took between 20 and 40 minutes. This method can be valuable for groups that are challenging to reach. For instance, we experienced that patients and family members preferred this option.
      Workshops Workshops are different from focus groups. Focus groups are helpful research methods to reach an in-depth understanding of a phenomenon (
      • Gawlik K.
      Focus group interviews.
      ). In contrast, the aim of workshops is not to develop new knowledge. A workshop is: "a meeting of people to discuss and perform practical work in a subject or activity" ("Cambridge Dictionary," 1995-2021). Workshops are often used when consulting stakeholders in research projects (
      • Gutman T.
      • Tong A.
      • Howell M.
      • Dansie K.
      • Hawley C.M.
      • Craig J.C.
      • Murphy L.
      Principles and strategies for involving patients in research in chronic kidney disease: report from national workshops.
      ,
      • Honey-Rosés J.
      • Canessa M.
      • Daitch S.
      • Gomes B.
      • García J.M.-B.
      • Xavier A.
      • Zapata O.
      Comparing Structured and Unstructured Facilitation Approaches in Consultation Workshops: A Field Experiment.
      ,
      • Northway R.
      • Hurley K.
      • O’Connor C.
      • Thomas H.
      • Howarth J.
      • Langley E.
      • Bale S.
      Deciding what to research: an overview of a participatory workshop.
      ,
      • Rapport F.
      • Doel M.
      • Hutchings H.
      • Jones A.
      • Culley L.
      • Wright S.
      Consultation workshops with patients and professionals: developing a template of patient-centred professionalism in community nursing.
      .
      Allows for discussion of the proposed guideline scope with other stakeholders We experienced passionate and enthusiastic stakeholders who asked both us and each other questions.Power imbalances can occur. Time-consuming for stakeholders.To promote comfortable group dynamics and avoid power imbalances, group stakeholders with similar backgrounds. A total of 6–8 individuals in each group allow all stakeholders to answer all questions. 2.5–3-hour workshops provide enough time to hear everybody’s advice and opinions on all questions. We recommend having two facilitators in each workshop, one being an experienced facilitator.Provide questions in advance and encourage stakeholders to come prepared. Have a clear agenda for the workshop and set ground rules, including showing respect and maintaining confidentiality.
      To align with principles of respect in public involvement, stakeholders must also feel appreciated and respected (

      INVOLVE. (2015). Public involvement in research: Values and principles framework. Eastleigh: INVOLVE Retrieved from https://www.invo.org.uk/wp-content/uploads/2017/08/Values-Principles-framework-Jan2016.pdf (21 Nov 2021).

      ;
      • Pandya-Wood R.
      • Barron D.S.
      • Elliott J.
      A framework for public involvement at the design stage of NHS health and social care research: time to develop ethically conscious standards.
      ). Researchers and guideline developers are encouraged to promise stakeholders feedback on how their participation influenced decision-making (“). Therefore, all stakeholders in our project received a summary of our findings, a description of how their feedback contributed to the final scoping document, and rationales for why some feedback was not incorporated. We also asked stakeholders if they would like to be publically acknowledged for their participation in future publications.
      Guideline developers must be conscious of how they handle personal and sensitive information (
      • Pandya-Wood R.
      • Barron D.S.
      • Elliott J.
      A framework for public involvement at the design stage of NHS health and social care research: time to develop ethically conscious standards.
      ). For instance, recording meetings and conversations may be preferable since notetaking can interrupt the flow of discussions. However, the reasons for recording must be clear and permissions obtained. Unless the aim is to carry out research, it is not necessary to transcribe recordings word by word, and personal information, such as names and institutions, should not be written down. All recordings must be destroyed promptly after notetaking, as storing such data involves risks for the stakeholders and may require ethics approval. Due to the nature of workshops, it is not possible to guarantee confidentiality. However, participants can be advised to leave their video off and leave out their real names if they prefer. They must also be reminded to respect the privacy of fellow stakeholders and not repeat sensitive information outside the workshop.

      9.7 Allocate sufficient time and resources

      It is important to allocate sufficient time and resources for an IKT project (
      • Andrews D.
      • Fong G.
      • Hackam D.
      • Li L.
      • Lynam M.
      • Mathews M.
      • Strauss S.
      Guide to knowledge translation planning at CIHR: Integrated and end–of–grant approaches.
      ). Guideline developers need to allocate money for reimbursements. They also need to allocate time to develop materials and for stakeholders to read through the material and think about it before giving feedback. Insufficient time may result in inadequate feedback and stress for stakeholders (
      • Pandya-Wood R.
      • Barron D.S.
      • Elliott J.
      A framework for public involvement at the design stage of NHS health and social care research: time to develop ethically conscious standards.
      ). We gave stakeholders between two to three weeks to review the scoping documents, with additional time available to any participant who requested it.

      10. Step 6: Consider how you will increase the trustworthiness and integrity of your project

      Using rigorous research methods may not be necessary for engagement activities (
      • Doria N.
      • Condran B.
      • Boulos L.
      • Maillet D.G.C.
      • Dowling L.
      • Levy A.
      Sharpening the focus: differentiating between focus groups for patient engagement vs. qualitative research.
      ), but can increase the quality and integrity of a study. We experienced that dealing with data from multiple stakeholders from different countries required a systematic approach. We used the software program Nvivo () to organise the notes from the meetings. These notes were then analysed using content analysis. Content analysis is a research method that is suitable when combining different types of data. It is a method that is particularly suited when dealing with descriptive, focused and narrow questions that do not require deep and complex interpretation (
      • Liamputtong P.
      Qualitative research methods.
      ). To ensure transparency, guideline developers are also encouraged to feed back the results to stakeholders with a description of how the final decisions were made. To support the integrity of our project, all stakeholders were encouraged to declare any conflicts of interest, such as financial or other interests that could potentially influence considerations on the topic. If significant conflicts of interests were found, stakeholders would be asked to withdraw from the project. This was important since potential conflicts of interest of guideline developers can damage people's trust and confidence in the guidelines (

      National Health and Medical Research Council, N. (2020). Guidelines for Guidelines. Retrieved from https://www.nhmrc.gov.au/guidelinesforguidelines/implement (Yaccess date 10th April 2022).

      ).

      11. Step 7: Evaluating the project and assessing the impact of engagement

      While stakeholder input is essential to the development of quality guidelines, few studies demonstrate the impact of engagement. Such evaluation is essential to support future engagement projects and secure funding (
      • Andrews D.
      • Fong G.
      • Hackam D.
      • Li L.
      • Lynam M.
      • Mathews M.
      • Strauss S.
      Guide to knowledge translation planning at CIHR: Integrated and end–of–grant approaches.
      ). Evaluating the impact of engagement is also important to stakeholders who want to know if their contribution made a difference (

      Hardavella, G., Bjerg, A., Saad, N., Jacinto, T., & Powell, P. (2015). Doing science: how to optimise patient and public involvement in your research.

      ). Several tools exist to evaluate the impact of engagement (

      Boivin, A., & Abelson, J. Evaluation Toolkit. Retrieved from https://ceppp.ca/en/collaborations/evaluation-toolkit/#div3 |all|1. (access date 10th April 2022).

      ), yet, much evidence in this area has been criticised as being weak and anecdotal (
      • Russell J.
      • Fudge N.
      • Greenhalgh T.
      The impact of public involvement in health research: what are we measuring? Why are we measuring it? Should we stop measuring it?.
      ). Due to resource issues, we did not assess the impact of our project. However, we recommend that future guideline developers use robust methods to evaluate their project and recognise that robust assessment must be planned early on as it is time-consuming and may require ethical approval.

      12. Discussion

      By critically reflecting on stakeholder engagement, this paper offers a seven-step framework for how to plan and operationalise feasible and ethical stakeholder engagement (see Table 3) when determining a guideline scope. Since we engaged our stakeholders in 2021, some principles for IKT engagement in spinal cord injury research have been developed. (
      • Hoekstra F.
      • Trigo F.
      • Sibley K.M.
      • Graham I.D.
      • Kennefick M.
      • Mrklas K.J.
      • et al.
      Systematic overviews of partnership principles and strategies identified from health research about spinal cord injury and related health conditions: a scoping review.
      ;

      The University of British Columbia. IKT guiding principles. Retrieved from https://ikt.ok.ubc.ca/ (10th April 2022).

      ). When mapping the IKT principles to our 7-step process, we notice that our project reflects seven of the eight principles. Principle two states, "partners share in decision making." We consulted stakeholders, and therefore they did not hold the power to make final decisions on what should be included in our guidelines. However, we believe that each level of engagement in the IAP2 spectrum of public participation is equally beneficial at different stages of a research project. With more than 50 international stakeholders involved in the early stage of guideline development, shared decision making was not feasible. To allow stakeholders more influence on the final scope, consensus methods may be useful (
      • French S.D.
      • Nielsen M.
      • Hall L.
      • Nicolson P.J.
      • van Tulder M.
      • Bennell K.L.
      • et al.
      Essential key messages about diagnosis, imaging, and self-care for people with low back pain: a modified Delphi study of consumer and expert opinions.
      ;
      • McMillan S.S.
      • King M.
      • Tully M.P.
      How to use the nominal group and Delphi techniques.
      ), although they require considerably more time and resources (
      • Trevelyan E.G.
      • Robinson N.
      Delphi methodology in health research: how to do it?.
      ).
      Table 3Steps for stakeholder engagement.
      StepsTasks
      1Clarify the purpose of engagement.
      2Identify all relevant stakeholders.
      3Consider how to find stakeholders.
      4Consider if your project requires a Human Research Ethics Committee (HREC) review.
      5Plan how to engage:
      • Decide on the level of engagement.
      • Decide to engage stakeholder groups separately or simultaneously.
      • Consider what questions to ask the stakeholders.
      • Offer different forms of engagement.
      • Ensure clear and effective communication.
      • Maximise benefits and minimise harm.
      • Allocate sufficient time and resources.
      6Consider how you will increase trustworthiness and integrity.
      7Evaluating the project and assessing the impact of engagement.
      While we did not have the resources required to accurately measure the impact of the engagement process, it was clear that the engagement significantly impacted the development of the guideline. To provide one example, stakeholders believed that the guidelines should be for the multidisciplinary team, not just for nurses, as was initially proposed. They stated that developing recommendations only for nurses would hinder implementation and complicate multidisciplinary collaboration. This finding changed the draft scope, the design of further guideline development and most likely the implementability of the guidelines. We also experienced that stakeholder consultation resulted in outcomes that we had not expected. These included important networking with stakeholders and between stakeholders, which could positively influence later stages of guideline development and implementation.

      13. Conclusion

      There is no consensus on best practices for consulting diverse stakeholder groups simultaneously in a knowledge translation project. This paper describes a starting point for guideline developers through a practical example and existing frameworks. While getting advice from stakeholders may seem straightforward, developing well-founded guideline scopes in ethical ways requires several considerations.
      In our study, we experienced that the consultation of international stakeholders greatly impacted the final guideline scope and highlighted areas that the research team had not considered. Overall, we believe the process made a significant contribution to the development of an effective and implementable guideline. Consultation requires additional resources in terms of time and finances. Still, it is feasible even for novice guideline developers, and unlike other types of engagement projects, we believe this can be done without additional training of researchers and stakeholders. Ethical engagement is feasible, valuable and should be incorporated into the development of all clinical practice guideline projects.

      Authorship contribution statement

      Anne Mette Adams: Conceptualisation, Methodology, Investigation, Writing – original draft, Writing – review & editing, Diane Chamberlain: Conceptualisation, Writing – review & editing, Mette Grønkjær: Writing – review & editing, Charlotte Brun Thorup: Investigation, Writing – review & editing, Tiffany Conroy: Conceptualisation, Methodology, Investigation, Writing – review & editing, Supervision.
      All authors have given final approval of the final version of the manuscript to be published, agree to be accountable for all aspects of the work and acknowledge that those who are entitled to authorship are listed as authors.

      Funding

      The primary investigator received a seeding grant from the Australian College of Critical Care Nurses in 2020 and is currently receiving an Australian Government Research Training Program Stipend Scholarship.

      Ethical statement

      The project that formed the basis of this manuscript was exempted from ethics review. This decision was based on advice from the Flinders University Ethics committee, as the stakeholders were acting as specialist advisors in the planning and designing of a guideline scope, thus not directly participating in research.

      Conflict of interest

      None.

      Acknowledgements

      We would like to thank all the stakeholders who were involved in the project that formed the basis of this paper.

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