Patient and Public Involvement and Engagement (PPIE) in research is defined as research being carried out ‘with’ or ‘by’ members of the public rather than ‘to’, ‘about’ or ‘for’ them. It recognises that patients, families, and communities bring valuable lived experiences that can make research more meaningful, ethical, and relevant to real-world needs. Involving patients and the public strengthens the quality, acceptability, and impact of health research. It ensures that research questions reflect community priorities, study designs are culturally appropriate, and findings are shared in ways that people can understand and use.

According to the National Institute for Health and Care Research, PPIE can be understood across three levels: participation, engagement, & involvement, with each representing a higher level of public contribution and influence.

1. Participation is the foundational level of PPIE, where patients or members of the public are study participants. This has historically been the most common form of interaction between researchers and the public.
2. Engagement refers to the sharing of information about research with the public. It is often a one-way process, where researchers communicate what they are doing and what they have found. Examples include using infographics or videos to share study results, or holding community meetings to discuss findings.
3. Involvement represents the highest level of PPIE, where patients and community members work in partnership with researchers throughout the research process, from setting priorities and designing studies to analysing results and sharing outcomes. Involvement fosters collaboration, ownership, and trust.

Benefits of PPIE

• Enhanced Research Quality: Patients and the public offer valuable insights into what matters most to them, improving the relevance, feasibility and acceptability of a study.
• Improved Recruitment and Retention: Patients and the public are best placed to identify the most effective and acceptable recruitment strategies and ensure study materials are clear and accessible. They can also provide advice on how to keep participants motivated to remain in a study.
• Ethical Research Conduct: Involving patients and the public aligns with the principle of “nothing about us without us” and helps ensure adherence to ethical standards. Patient input also helps with gaining ethical approvals.
• Increased Awareness & Impact: Engaging with patients and the public raises awareness and acceptance of the research, supporting participant feedback and helps translate findings into practice.
• Success with Funding Applications: Funding agencies are increasingly requiring the involvement of patients and the public in study design and conduct due to the multiple benefits of PPIE on research quality and efficiency. Studies that incorporate the patient voice in design are more likely to succeed in gaining funding.

Types of Involvement

Members of the community and experienced PPIE coordinators can support all aspects of study design, conduct and dissemination. Maximal benefit is achieved when patient and public partners are included early in the process. A key way to enable effective involvement is to establish and maintain a PPIE group of members and coordinators that can:

• Advise on research priorities to help identify the most relevant health topics, populations & interventions to study from the perspectives of patients and the public.
• Advise on the design of study protocols to make it more feasible, acceptable and relevant to the patients and the public. This can include advice on participant selection, intervention protocols and outcome measures.
• Contribute to the ethical review of studies to ensure that the proposed research is acceptable to patients and the public before formal institutional ethics review.
• Safeguard patient and participant rights to ensure no harm is done during research.
• Support the development of study materials such as participant information sheets, informed consent forms and recruitment leaflets, posters and social media content.
• Support the conduct and implementation of studies by improving the recruitment strategy, informed consent processes, administration of interventions, data collection and follow-up.
• Participate in data analysis to ensure the patient perspective is incorporated in the interpretation of the results of the study.
• Support the dissemination of results to the public by providing advice and feedback on dissemination strategies and materials (e.g. posters, infographics, video, articles, presentations, workshops, public events).

National PPIE Network

The National PPIE Network brings together PPIE groups from across Pakistan with an aim to strengthen the culture of meaningful involvement in health research. One key function of the network is to support the development of new PPIE initiatives. Support is offered in multiple ways, with this toolkit being one of them. It is a starting point and source of guidance for individuals and institutions interested in starting their PPIE initiative or group. However, the network also offers additional support, mentoring and opportunities for professional development:

• Annual National PPIE Summit that brings together partners from across the country for in-person collaboration, knowledge exchange, and shared learning.
• Regular webinars, workshops, and training sessions to build capacity in patient and public engagement.
• Online platform to enable collaboration, access to a resource repository, and exchange of best practices.
• Guidance on evaluation of PPIE initiatives to ensure continuous improvement and accountability.
• Advice from experienced PPIE practitioners to assist with all aspects of engagement work.
• Advocacy by drafting policy and creating governance frameworks to promote a high standard of practice.
• Translation of educational and dissemination materials to enhance reach to all communities in Pakistan.
• Dissemination of research findings through public events, media engagement, and community partnerships.

Our dream is to build a connected and sustainable PPIE network across Pakistan that supports meaningful collaboration between researchers and the communities they serve.

Establishment of a successful PPIE initiative takes careful planning and execution. Figure 1 provides an overview of the process our team followed to establish a PPIE group and the list below highlights the importance of each step in the overall success of an initiative. The remainder of this toolkit gives detailed guidance for each step.

1. Identify Site Team: Having a person dedicated to PPIE is crucial in order to progress and coordinate the initiative, while a senior lead is needed to navigate institutional processes and gain buy-in from leadership.
2. Coordinator Training: The dedicated people have to be equipped with the knowledge and skills to effectively lead a PPIE initiative, including an understanding of international standards on public engagement, ethics of working with vulnerable individuals as well as skills in communication and group facilitation.
3. Project Plan: Clear aims and objectives serve as a guiding light for the initiative, enabling the team to plan the work, communicate with potential members and partners, and evaluate progress as well as impact.
4. Recruitment & Engagement: Generating awareness and gaining support for the initiative from a broad range of partners not only helps with recruitment, but also encourages collaboration and promotes impact in the long-term. Effective onboarding of PPIE members sets the tone for a collaborative working relationship.
5. Inaugural Group Meeting: Co-creation of a Terms of Reference with PPIE members promotes ownership and engagement with the PPIE initiative, and sets the ground rules for the group moving forward.
6. First Task: Completing a task that is ‘low-hanging fruit’ early provides evidence of potential impact of the initiative and is important for motivation and retention of both PPIE coordinators and members.

Patient and public involvement and engagement is not a simple add-on to usual research practice. Rather, it requires staff equipped with content expertise and the right set of skills. At a minimum, we recommend that the initiative has a dedicated PPIE coordinator and a senior lead. The senior lead is needed for oversight, support with navigating institutional approvals and funding requirements, and convincing senior leadership and doctors to support PPIE. The coordinator should allocate approximately 50% of their working week to PPIE activities, particularly at the start of the initiative where significant time is spent on creating a project plan, establishing processes, recruiting members and engaging with various partners. An example job description for a PPIE coordinator can be found in Appendix A.

Ideally, your PPIE initiative is managed by a diverse team with different backgrounds and responsibilities. As an example, our PPIE initiative at Ziauddin University started with three coordinators and a senior lead, with a fourth marketing coordinator joining 18 months later (Table 1). Having a team of individuals working towards a common goal was key to our success, as we were able to motivate and support each other and benefit from our distinct expertise and ideas. However, one of the coordinators was working on the initiative voluntarily without pay for the first 18 months and another could only dedicate 10 hours per month to the project. Our team was able to grow and provide adequate compensation to all coordinators due to the success of the initiative, which took time and effort. This may not be feasible in all situations. The national PPIE network led by Ziauddin University is able to support new PPIE initiatives with advice, templates and training, which should lessen the burden on individual teams.

Once the team has been identified, an important next step is training. We strongly recommend that all individuals involved in the PPIE initiative complete the free online course ‘An Introduction and Practical Guide to Community Engagement and Involvement in Global Health Research’ created by the National Institute for Health and Care Research (NIHR) and the Mesh Community Engagement Network. A key skill to develop for PPIE is small group facilitation. Further training and reading can be found on the Mesh website and in Appendix B.

In addition to training and reading, we also suggest that individuals involved in PPIE join a community of practice dedicated to engagement. Our team members have found it very helpful to be a part of a group of peers that are passionate about PPIE. Such a community offers motivation, advice and peer-to-peer support as well as opportunities for professional development, including webinars and events. One such community of practice is the national PPIE network led by Ziauddin University for those based in Pakistan. The Mesh Community Engagement Network is available to all globally: https://mesh.tghn.org/

The success of any research initiative lies in having clear aims and objectives along with a detailed method and feasible timeline documented in a protocol or project plan. A PPIE initiative is no different. Careful planning and creation of a PPIE project plan sets your team up for success. The plan can also be used to apply for funding and approvals, explain the initiative to potential collaborators, and as a basis for a budget, manuscript and evaluation. A worksheet to come up with a Project Plan, with examples, can be found in Appendix C as an example.

Essential components of a project plan include:

• Title: A clear and succinct title outlining the focus of the initiative.
• Aim: An overarching purpose of the project outlining the action and desired outcome.
• Objectives: The specific, measurable, achievable, relevant and time-bound steps needed to achieve the aim.
• Team: The individuals contributing to the project and their responsibilities.
• Planned work: Detailed methods and planned activities to accomplish each objective.
• Expected outcomes: Outcomes and tangible outputs if the aim and objectives are achieved.
• Timeline: Important milestones and timeframe in which tasks are completed.

Top tips

• Tokenism: Avoiding tokenism, the symbolic inclusion of patients, is essential to avoid wasting the time and effort of patients. A key way to avoid tokenism is to plan for PPIE input where changes are realistic. Asking a PPIE group to review documents that will never be used or to provide feedback on a research project with a finalised protocol is pointless. The objectives and activities should focus on where your team has influence. For example, you will be able to change the consent form for a study led by your senior lead, whereas it is less likely you’ll be able to change the consent form template of the national ethics board.
• Solutions: Another way to avoid tokenism and ensure effective engagement is to identify problems that could be solved by PPIE. Our group chose to focus on improving the consent processes for trials because of feedback from study coordinators and families that the trial information was not clear or communicated in a patient-centred manner. Input from a PPIE was a clear solution to this problem.

• Low-hanging fruit: Early achievements are important to demonstrate value to PPIE members, leadership and collaborators, and will serve as motivation for coordinators. Thus, the first activity should be a straightforward task with a clear output. For example, reviewing and improving a patient-facing information sheet.

• Flexibility: The project plan will likely change over time. In fact, it is important that the plan is flexible enough to be guided by the priorities of your patient members. In the beginning, your members will benefit from having clear tasks to ease them into the work. Later, your objectives should be co-created with the patient members to ensure ownership and relevance. For example, when working on improving consent for trials, members could first review existing forms and later decide the format and content of new consent materials.

• Feedback: Once drafted, it is worthwhile getting critical feedback from others. The group at Ziauddin University would be happy to review any PPIE project plans.

Establishment of a PPIE initiative may require consideration of finances, ethics and contracts dependent on institutional requirements, collaborations and funding arrangements. While these are primarily guided by project and context-specific considerations, below are some key points when planning a PPIE initiative.

Budget

Effective and meaningful patient and public involvement and engagement requires finances for personnel, compensation and reimbursement of patient and public partners (Chapter 5), marketing and outreach (Chapters 6-7), meetings (Chapter 8), activities of the PPIE initiative (Chapter 9) and evaluation (Chapter 10). Ideally, each research project and grant application should have a budget for PPIE, as obtaining separate funding for PPIE is challenging – See the funding page on Mesh for potential sources. Coming up with a budget requires clarity on your project plan, proposed activities and local costs. A budget worksheet can be found in Appendix D.

Ethics

No consensus exists nationally or internationally about the necessity of obtaining ethics approval for the establishment of a PPIE group consisting of patients, their families and the public, and each jurisdiction approaches the issue differently. Some argue that the involvement of patients in any activity requires the oversight of an ethics committee, while others maintain that involvement in PPIE groups is fundamentally different to being a research subject and thus does not fall under the remit of institutional review boards. Our recommended approach is to obtain written confirmation from the committee that no ethics is required or an exemption from ethics has been granted for the establishment of the PPIE group. This practical approach ensures that your team has a document to share in case a funder, journal editor, collaborator, senior leader or any other party feels ethics approval is needed. Appendix E provides further guidance and a worksheet for an ethics exemption application for the establishment of a PPIE group.

Some PPIE activities may require ethics approval depending on the nature of the activity. It is always best to liaise with your institutional review board in case of uncertainty. The recommendation above pertains only to the establishment of a PPIE group to advise or collaborate with researchers.

Contracts

Depending on your funding arrangements and collaborations, you may need to have contracts or memorandums of understanding to facilitate your PPIE initiative. For example, our group at Ziauddin University uses a Memorandum of Understanding (MoU, Appendix F) to formalise collaborations with other institutions, who we support with their PPIE activities. In cases where our PPIE initiative provides funding to compensate patient and public partners at other institutions, for example, a Research Collaboration Agreement (RCA, Appendix G) is used. The main difference between the two documents is that an RCA usually requires the involvement of a legal and finance team while the MoU is simply signed by senior leadership.

A clear policy on honorariums and reimbursement of expenses for patient, family and public members has to be in place before asking them to be involved in your PPIE initiative. A written policy provides transparency and sets clear expectations for potential members. An example policy, created based on guidance from the National Institute of Health and Care Research (NIHR) and feedback from our patient and public partners, can be found in Appendix H.

Honoraria

Honorarium payments are made to acknowledge the time and contributions made by patient, family and public members to the PPIE initiative. Members’ lived expertise, skills and time should be compensated, similarly to how researchers are paid for their work on a research project.

Payment can be made based on the time spent preparing and attending PPIE-related activities or based on the nature of the task or activity. The payment rate is based on your judgment, local practices and, ideally, input from your patient members as there are currently no nationally recommended payment rates in Pakistan. Our group uses a rate of 1000 PKR/hour for both online and in-person activities based on our experience and feedback from members.

Expenses

Patient, family and public members should not incur any out-of-pocket expenses in order to contribute to the PPIE initiative. Travel to PPIE activities, meals and refreshments during meetings, as well as accommodation and subsistence for out-of-town visits should be reimbursed. Additional expenses should also be considered depending on the circumstances of the members. For example, childcare costs should be covered for parents of young children while costs incurred by a family member for arranging a carer for an elderly relative while they attend a meeting should be reimbursed. Accessibility needs of members should also be considered.

Payments

The policy should outline how to claim expenses, when to expect honoraria and reimbursements, and how funds are received (i.e. cash, cheque, transfer). Our group advocates for making the payment process as easy as possible for members. For example, instead of requiring receipts or other proof of payment for local travel, we provide all members a flat rate that is sufficient to reasonably cover return travel in a 10km radius. Electronic bank transfers are also preferred by our members, as this avoids the need to physically go to a bank to deposit cheques.

Alternative methods of payment or recognition, such as vouchers or gift cards, are commonly used in high-income countries. Our group has decided not to use these methods due to the absence of appropriate vendors and based on advice of members, who prefer to decide for themselves how to use their honoraria (e.g. donations).

Taxation

Receipt of honoraria may have tax implications for the recipients. It is best to liaise with your institutional legal and finance teams about the appropriate tax procedures for making payments to members and advice to give to members in case they have any additional tax responsibilities.

Patient & Public Involvement & Engagement initiatives involve, by their very nature, public-facing communication. Recruitment for PPIE members is likely to include printed and digital advertising materials distributed in-person and on social media. Raising awareness of a disease, intervention or research study as part of the PPIE initiative requires determining key messages, creating educational content and driving engagement with the content using various channels. The trustworthiness of messages from the PPIE initiative will be shaped by your public image and brand. While PPIE initiatives certainly do not aim to sell a product for profit, much can be learned from the field of marketing to deliver your messages to an intended audience, recruit members and identify collaborating partners.

Our team has benefited hugely from having a marketing strategy and clarity on our brand (Appendix I). Our online and social media presence has led to new partnerships and invitations to speak at events. The visibility of our initiative has provided us with legitimacy. Our branding, including a color scheme, slogans and key sentiments, make it very easy to come up with advertising materials, graphics, events and presentations. Articulating a primary marketing goal and activities ensured we have been able to evaluate and demonstrate progress. Consistent monitoring of our marketing efforts has enabled us to report our reach and impact to funders and senior leadership.

How can a PPIE initiative develop a marketing strategy? Our group has created a worksheet (Appendix J) that can be used by anyone to think through their goals, activities and branding. Below are some key things our group thought through when we built our strategy and approach:

• Logo (Figure 2): One of the first tasks we undertook was to design a logo to use as part of our recognisable brand identity in all our public-facing materials. The design depicts our PPIE initiative as a connection between people while maintaining focus on individuals, with the colour scheme aligned with our institution.
• Website (https://zu.edu.pk/ccrg/ppie): Concurrently to creating a logo, we also ensured to have an online presence with the creation of a website. The site serves as a repository of our activities, a source for additional information and signals legitimacy as an active entity.
• Primary Goal: During the early parts of our initiative, our marketing activities were sporadic and often an afterthought. While our marketing activities achieved success, the unstructured approach made it feel resource-intense and somewhat pointless. Setting a primary goal clarified the purpose of our marketing activities, focused our efforts, reduced our workload and helped us set processes to support the activities.
• Process: Due to limited resources, we have kept our marketing activities simple and embedded in day-to-day processes. While we would like to create more interesting audiovisual content or establish presence on new platforms (e.g. Bluesky), we focus on content that is easy for us to produce (simple graphics) and platforms where our institution is active.
• Voice: Our group considered what our public voice should sound like, whether authoritative, professional, casual, knowledgeable, revolutionary or something else. Establishing our desired voice as ‘positive, excited, inquisitive and collaborative’ has meant that every time we create materials, social media posts, events and presentations, we check that we channel these desired characteristics.

All PPIE initiatives require the recruitment of some patient and public members. Effective recruitment requires a clear objective and appropriate recruitment activities. See Appendix K for an example recruitment strategy.

Recruitment Objectives & Desired Members

Your recruitment objective should specify the number and characteristics of desired members, and be directly informed by your initiative’s purpose. For example, if you aim to improve care for heart disease patients, you will likely recruit those directly affected, such as survivors of heart attacks and carers looking after people with heart failure. Other interested groups to recruit include those working for heart disease charities e, first responders or psychologists dealing with the emotional consequences of chronic illness. Finally, including people with existing ties to communities (e.g. community organisers) and useful skills (e.g. communication specialists) could be beneficial.

• Size: No guidance exists about the optimal size for PPIE groups. In our experience, it is good to aim for a group of 8-10 people in order to include a range of perspectives but be small enough to encourage meaningful engagement. To account for dropouts, a target of 12-14 is recommended for a group of 8-10 people.
• Balance: Including individuals with lived experience of the topics of your focus is key, but so is the inclusion of other perspectives. In our experience, it is worthwhile to have a 60:40 split in your group between those directly affected (e.g. patients, carers, staff) and others, such as community leaders and charity workers.
• Arts: We strongly recommend having someone in your group with a background in art, media or storytelling to help your initiative have wider impact and reach intended audiences through effective communication.
• Diversity: A group of 10 individuals will never be able to represent the diversity of any population. However, it is possible to purposefully maximise diversity of perspectives. For example, our group made sure we had members who supported, felt neutral and opposed research, and had diversity in language, socio-economic background, religion and geographical location. Additionally, your close public working partners are just the start – Your activities down the line can involve surveys and further engagement with a wider population.

Recruitment Activities

Activities to recruit members depend largely on your desired members (e.g. if you want school-aged children, you would engage with your local school), but below are some broad considerations:

• Build on trust: Recruit people through trusted individuals and established organisations, groups and networks, who already have established relationships with a community. For example, physicians, charities and local leaders. Getting their endorsement will enable you to reach people you couldn’t otherwise.
• Engage widely: At the beginning, take all opportunities to meet people, network, hold events and engage. Most of it won’t amount to anything, but collectively these efforts promote awareness.
• Snowball: Ask your team members, new connections and identified partners to assist with recruitment through their personal contacts and by posting in their alumni and professional WhatsApp groups.
• Public events: Holding a workshop or interactive public event allows people to get practically involved and learn more about your work, which may inspire some to volunteer to become PPIE members.
• Persist: Recruitment for PPIE is hard. It took us 6 months to get 10 members. But it is worth it. Persist.

Selection Criteria

Prior to selecting individuals to your initiative, it is good to consider how you will assess their suitability for inclusion. While there is no need for strict eligibility criteria, it is useful to consider characteristics that could indicate people’s ability to effectively participate in your initiative. For us, the most important attributes were motivation, confidence and ability to voice opinions. We also viewed prior experience of working with communities in some capacity as a desirable quality. However, we did not feel that prior research engagement experience, English language skills or education were qualities that our PPIE members needed to possess.

It is also important to consider factors that would indicate that an individual is not a good fit for the initiative. Primary focus on compensation, lack of curiosity about the project, and an inability to articulate a clear motivation for joining all point to someone who may not be committed to engagement. During interactions with potential members, we also noted that many listened to our pitch out of respect towards us or the person who referred them. These ‘Yes Men’, as our public partners call them, would not be able to critically contribute. Finally, any individual with disproportionate impact on group dynamics may need to be excluded. For example, our group decided not to recruit religious leaders due to concerns that other members would not feel comfortable disagreeing with them.

Selection & Onboarding Process

Our group follows a three-step process to vet & onboard members following expressions of interest. Having multiple interactions with potential members helps confirm they are appropriate for the initiative and establishes the foundations of a good collaborative relationship between the coordinator(s) and new members.

• Vetting: An informal phone discussion with one of the coordinators is used to understand motivations for joining the PPIE group, confirm that individuals can commit the time required for the initiative and establish whether they are prepared to provide honest feedback during meetings. If the potential member and coordinator jointly feel that inclusion is appropriate, a time is arranged to meet in-person.
• Confirmation: An hour-long in-person meeting is used to complete the ‘My Involvement Profile’ (Appendix L) on a laptop together with two coordinators in order to facilitate a two-way exchange about expectations and needs. The profile asks about experiences, skills, interests and motivations, allowing coordinators and members to get to know each other more intimately. The exploration also helps identify the unique perspectives a member brings to the initiative and ways they may be able to contribute.
• Onboarding: Prior to attending the first meeting, the new member will be asked to review and sign the Terms of Reference for the group. The Terms of Reference outlines the aims and activities of the group, as well as the responsibilities and code of conduct of members.

Further Training & Orientation

Additional training may be needed depending on the nature of your PPIE initiative. Our approach is to teach members whatever is necessary for them to effectively engage with the task at hand. For example, explaining the core concepts of informed consent prior to reviewing consent materials for a study. We treat our members as experts in lived experience, who do not need to become experts in research, ethics or medicine in order to contribute meaningfully. A further consideration is relationship-building within a group. If someone new joins, it is worthwhile thinking about how they will integrate and what you can do to promote cohesion (e.g. organise social activities.)

The First Meeting

The first meeting represents an important step in building a team from the diverse set of patient and public partners selected for the initiative. As with building any team, it is important to ensure individuals agree on a shared goal and values, determine the most effective ways of working together, and achieve clarity about roles and responsibilities. Our recommendation is to use the first meeting with your PPIE partners to collaboratively come up with a ‘Terms of Reference’ (template in Appendix M) outlining the mission, aim, activities and governance of the group, ways of working, and roles and responsibilities of individuals, including a code of conduct. The key is to co-create the ‘Terms of Reference’, not to draft it for review by the members, as the act of deciding collaboratively promotes ownership and commitment. A suggested outline for a first meeting can be found in Appendix N). Other things to keep in mind:

• Authority: Any actual or perceived asymmetric power relations will hinder effective engagement and need to be proactively managed. In our case, our coordinators were doctors yet never used their titles with the PPIE members in order to prevent the perception of a hierarchy. The coordinators insisted on not having a right to vote as it was important that decisions were made by members. Coordinators ensured everyone was able to speak in meetings, with dominant voices moderated and quieter ones encouraged.
• Language: The primary spoken language should suit members’ needs, not coordinators, and efforts should be taken to promote equal opportunity for all members to contribute regardless of language skills.
• Environment: Ideally, meetings should take place in a neutral place where all members feel comfortable, rather than where it is convenient for coordinators to meet (e.g. research office, hospital).
• Confidentiality: To promote honest and critical input, meetings should be held in private settings and it should be clear that nothing that is shared will leave the group.
• Team-building: Fostering positive social relationships is important for effective teamwork, which can be achieved by incorporating small acts, like icebreakers and joint lunch, at each meeting.

The First Task

A key lesson we have learned is that early wins are vitally important for morale, retention and sustainability. Our recommendation is to choose your first collective task to be ‘low-hanging fruit’ – A task that can be completed easily and quickly with tangible impact. Successful completion of a task should be emphatically celebrated. It will demonstrate value to leadership and give everyone motivation to keep going with an initiative that can often feel theoretical, intangible and aspirational. First tasks could include creating a study lay summary (written, graphic, video), reviewing a consent form or public-facing material, or sharing the findings of a study (social media, video). Of course, creating, ratifying and publishing a ‘Terms of Reference’ on a website is also a type of ‘low-hanging fruit.’

Activities & Sustainability

Subsequent activities depend on your project plan. Similarly to research, having clear goals and methods informed by evidence are key to success. One thing to consider is whether your group will accept requests from others, in which case a procedure for handling requests may be beneficial (see Appendix O). Sustaining involvement is challenging, but can be promoted by regular communication and activities, acknowledging contributions and providing members opportunities that matter to them. However, personal circumstances and interests change over time. Loss of members is thus to be expected. Recruitment and addition of new members can, however, inject new energy and enthusiasm to your PPIE initiative, thus promoting engagement and sustainability.

Evaluation is one way to systematically assess an initiative to establish impact and improve practice using evidence-based insights. Results from an evaluation of a PPIE initiative will assist with reporting to leadership, funders and collaborators as well as improving how activities are conducted, while evaluating the impact of PPIE activities will advance the practice and science of engagement. Both types are amenable to publication in scientific journals.

Evaluating PPIE initiatives & activities

An evaluation of your PPIE initiative should be built-in from the start in order to enable you to collect necessary information throughout your project. Planning an evaluation in the midst of your activities or at the end is cumbersome and you’ll likely find you have forgotten half the things you have done. The evaluation can be informal, with a simple report on progress towards objectives, or more formal and comprehensive with multiple evaluation activities (see an example protocol). This depends on your ultimate goal, whether that is to compile a report, identify lessons learned, assess impact or conduct an evaluation study with comparable findings. Some considerations:

• Timing: Consider whether to perform an evaluation periodically, in the middle or at the end, and what an evaluation will involve at each stage. Our group has opted to evaluate our initiative annually.
• Records: Our recommendation is to keep records of activities and impact throughout the lifecycle of your project, as it is easier to capture this during rather than at the end of your project. Our group has developed a Master Log (Appendix P) where relevant activities can be recorded and data later used for evaluation, for example, the number of meetings, attendance rates, and reach of social media posts and events.
• Methods: Evaluations can employ many different methods depending on the goals of the evaluation, such as surveys, interviews, focus groups, written reflections, document analysis and quantification of outcomes.
• Participants: You may be interested in the experiences and perspectives of PPIE members or coordinators, but could also consider exploring perceptions of senior management or other collaborators whose work may have been influenced by the PPIE initiative (e.g. investigator of a study that was reviewed by the PPIE group).
• Evaluators: Ideally, the evaluation should be co-led and co-written with your patient and public partners.

Evaluating impact

The evidence on the impact of PPIE on the design, conduct and reach of research is limited, with even fewer studies attempting to measure the impact of PPIE on clinical outcomes. Part of the reason for this is that the impact of PPIE on research or clinical outcomes is indirect with multiple confounders and the desired impact of PPIE is not easily measured (e.g. more patient-centred research processes). However, often engagement practitioners fail to think about evaluation and measurement of impact. Progress can be made by: i) dedicating time to think through a theory of change for how the PPIE initiative and activities is expected to lead to specific changes; and ii) designing high-quality studies to understand the impact of PPIE initiatives. Some research ideas include:

• Study within a trial comparing participant understanding of trial-related information between consent materials and procedures created by researchers to those co-created with patient and public partners.
• Comparison of recruitment rates before and after the implementation of changes to recruitment methods and materials recommended by patient and public partners.
• A narrative case study on the evolution of a clinical trial from a research question to the recruitment of the first participant outlining changes made based on patient and public partner input.

Patient and Public Involvement and Engagement (PPIE) is an essential, exciting and evolving practice in health research. Pakistan is leading the way in promoting high-quality PPIE with the creation of a national network and establishment of multiple initiatives up and down the country. This toolkit has synthesised the trials, tribulations and successes of a few PPIE pioneers into a practical guide that aims to ease the journey for others taking on the noble task of meaningfully engaging and involving patients, families and communities in research. We conclude this toolkit with general advice that does not fit neatly into the specific tasks outlined in each of the chapters.

• Joy: First and foremost, remember to enjoy PPIE work! Meeting new people and building meaningful relationships is fulfilling. Running workshops is enjoyable and successful events provide a sense of success. One of our proudest moments was when our public event was featured in the national news. Creative work associated with PPIE, whether social media marketing, video creation or developing infographics, can be deeply satisfying and stimulates different parts of your brain. Finally, seeing tangible impact on patient and public partners, and amplifying their voices provides purpose and pride.
• Power: Ultimately, PPIE work comes down to power. Engagement activities aim to shift the balance of power so that research is not just the domain of researchers, but co-created and co-led with those that research intends to serve; the public. Clinicians and investigators are used to being the ‘experts’ making all the decisions. Within PPIE, lived experience is recognised as a form of expertise. Patients are experts in living with a condition, families are experts in caring for their loved ones and members of a community are experts in how life works in a specific culture or society. All these forms of expertise can improve the design and conduct of research studies, if those with power (researchers, clinicians) are willing to share the power. This is not easy nor does it happen naturally, but requires reflection and a real change in how things are done.
• Uncertainty: The novelty of PPIE is exciting but brings with it a great deal of uncertainty. Lack of established processes or practices mean that you may have to create things from scratch, even in areas that are out of your comfort zone. For example, we had to create entirely new processes for the finance and marketing departments in order to make direct electronic payments to public partners and accept subscriptions to our newsletter. Giving up control and being led by patient and public members also means that you may have to change plans unexpectedly. Amidst all this uncertainty, flexibility and adaptability is key. Be willing to change your assumptions, ways of working and plans, and accept that not everything will go to plan.
• Time & Effort: It is hard to do PPIE. Engagement in health research is relatively novel and challenges how things are usually done. Establishing meaningful relationships and building trust with patients, families and public members does not happen overnight, but requires time and persistence. Involvement and engagement activities, such as co-design, marketing and knowledge translation, all require the development of new skills and knowledge. Impact is often intangible and takes longer to achieve as you are involving more people in the process. Thus, PPIE work takes dedication, time, patience and persistence. Do not expect immediate results or be disheartened if things don’t work. The national network is always there if you need support or advice!

Our sincere hope is that the information, guidance and tools contained on these pages are helpful, and we remain available to support all those that share our vision. Do not hesitate to get in touch with us a [email protected]. Our group wishes you all the success in your efforts to promote the patient voice.

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