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The Research Process

Part of deciding if you are ready to engage a patient partner on your clinical trial/research team depends on identifying who, what, where, when, and how to engage a patient partner. Review steps in the research process/lifecycle and consider where you feel your priorities are for engaging a patient partner in your study. 

Engaging Patients as Partners

CIHR has general principles relevant to engaging patients as partners in research. These include:

Mutual Respect. Patients bring their lived experience and insights to the Neglecting their potential contributions can negate important aspects of health. Patient partners also come from a variety of cultural backgrounds and may have different expectations about appropriate ways of interacting. This may be highlighted by the patient’s sense they lack the appropriate vocabulary. Key qualities to engaging patients on clinical trial/research teams include: being a good listener; communicating in lay, non-technical terms; being non-judgmental; using personal experiences constructively for; working collaboratively, and being interested in expanding one’s knowledge and skills.

Co-Build. Patient partners should shape the clinical trial/research project that is intended to benefit them. They should be involved from the start to identify problems and gaps, set priorities for research and work together to create and implement solutions.

Support. Investigators and patient partners should have shared commitments and a willingness to help others achieve a common goal. Patients need to be appropriately supported. This means creating safe environments that allow for honest interactions, cultural competence, training, and education. This also includes financial compensation to recognize the expertise and contributions of patient partners.

Engagement. Patient engagement in research brings different patient perspectives. Patient partners need to be recognized as people who bring their lives and their experiences related to their health and healthcare to the research team. The values of candour, honesty and promise-keeping must be upheld.

Resources

Depending on the role of the patient it may be appropriate to engage more than one patient partner. Multiple patient voices provide a sense of diversity and commonality of lived experiences. More than one patient partner also helps to ensure balance so that the patient does not feel over-burdened or over-whelmed. Multiple patient partners also offer opportunity for mutual support among patient partners. Specific roles to consider can include:

  • Identifying and Prioritizing. Engage patient partners early in the project. Encourage patient partners to share what they consider priorities for research based on their lived experience, including input into the formulation of the research question. Ensure budget is adequate to compensate and reimburse participants.
  • Input into the Design of the Clinical Trial/Research. This could include defining strategies for participant recruitment and informing study inclusion criteria.
  • Development of the Grant Proposal. Develop the research questions, relevant outcomes, and defining characteristics of study participants. Discuss authorship possibilities with patient partners at the outset of the Consider a governance structure that includes patient partners. Explain the funding application process to patient partners.
  • Preparation for Execution of the Study. This may include assisting to develop and review recruitment posters, places to recruit, and strategies to meet enrolment targets.
  • Data Collection. Patient partners can assist with interviews and surveys and consideration must be given to extra training to ensure accurate documentation, avoidance of bias, and accurate storage of information.
  • Analyzing and Interpreting Data. Patient partners can assist with theme development, interpretation of data from a patient partner perspective, noting that all data need to be anonymized and extra training may be required. Patient partners must be recognized appropriately in presentations and publications.
  • Dissemination. This includes identifying organizations/public forums for knowledge exchange and translation, co-authoring manuscripts/newsletters, jointly presenting findings at scientific meetings, assisting with dissemination in informal patient networks, informing policy and practice.
  • Implementation. Patient partners should consider representation on the Data Safety Monitoring Board (DSMB).
  • Monitoring and Evaluation. This includes providing oversight of the clinical trial/research project and ensuring quality assurance (e.g., increases likelihood that results will be implemented). Also consider how the impact of patient engagement will be evaluated and reported.
Reference

If you are conducting a clinical trial, or another type of research study, it may be possible to recruit patient partners through our partner organizations:

  • Use open and fair approaches to recruit a range of people (i.e., under-represented groups) including those who use health and care service, caregivers and communities.
  • Ensure safety of all patient partners prior to commencing research.
  • The intended outcomes for involvement should be agreed and recorded at the start in order that they can be monitored and evaluated.
  • The policy, process, and budget for the payment of fees and expenses needs to be clarified in advance of involvement.
  • Consult how patient partners want to be rewarded and acknowledged.
  • Clarify roles and responsibilities of researchers and patient partners.
  • Provide contact information to patient partners.
  • Involve patient partners as early as possible.
  • Remain flexible and attempt to involve patient partner(s) in as many parts of the research as possible.
  • Investigators and the patient partner(s) should show mutual respect for each other’s roles and perspectives.
  • Investigators and the patient partner(s) should have access to the support and training necessary to enable them to involve and be involved. Ensure to budget for this extra training.
  • Investigators should provide accessible information and show clarity and openness around the aims and scope for involvement in the research.
  • Clarity and transparency from the start in all communications.
  • Jargon should be avoided, clear and repeated explanations of terms and acronyms used should be given.
  • Offer training and support to all patient partners and members of the investigative team.
  • Organize and administer meetings to provide all information related to the research project in a timely manner.
  • Build and maintain relationships by minimizing power differentials where possible.

Patient partners need to be adequately informed of all factors prior to making an informed decision. They need to be provided with enough time to review the information, participate in the discussion, provided an opportunity to ask questions, and be equally involved in all research team decisions.

Most decisions are made by:

  • Expert
  • Leader
  • Team votes and the one that gets more than half wins
  • Consensus. All members must agree with the decision.
Researcher and Patient Partner Surveys

Researcher and Patient Partner surveys will assist researchers to evaluate the patient partner and researcher partnership experience. There are three tools for the researcher and three tools for the patient partner, each delivered at the start of the clinical trial/research project, mid-way through the trial/project, and then at the end of the trial/project.

Researcher Surveys (initial, mid-, and end-project surveys)

There are three researcher surveys designed to understand the researcher experience in the patient and researcher partnership. The first survey is designed to be delivered early in the partnership, the second to be delivered mid-way through the partnership, and the end-project survey is to be delivered in the KT component of the research.

Patient Partner Surveys (initial, mid-, and end-project surveys)

In addition, there are three patient partner surveys designed to understand the patient partner experience in the patient and researcher partnership. The first survey is designed to be delivered early in the partnership, the second to be delivered mid-way through the partnership, and the end-project survey is to be delivered in the KT component of the research.

Patient Engagement Quality Guidance Tool

The Patient Engagement Quality Guidance Tool can be used to help you to plan, develop, and assess the quality of your patient engagement activities. 

Seven quality criteria describe the core values of good patient engagement practice and should be considered (in this order) when you have finished your clinical trial/study 

  • Shared purpose
  • Respect and accessibility
  • Representativeness of stakeholders
  • Roles and responsibilities
  • Capacity and capability for engagement
  • Transparency in communication and documentation
  • Continuity and sustainability

It can also be used for a gap analysis to identify what worked well and what could be improved as you plan your next clinical trial/study. Access the assessment template here: Assessing an ongoing or completed clinical trial/study.

The Patient Engagement Quality Guidance Tool can be used to help you to plan, develop, and assess the quality of your patient engagement activities. In the planning phases of your project the tool can be used to inspire and guide your patient engagement activities.

You can use the tool to communicate the benefits of engaging patients in your clinical trial/research project (as in a grant proposal).

Investigators who focus on different types of research (e.g., biomedical, clinical, etc.) will find the quality criteria helpful in planning patient engagement activities (e.g., biomedical researchers can engage a representative number of patient partners [men, women] who have a shared purpose, responsibilities on advisory or governance committees, and who communicate and collaborate respectfully and with transparency).

Seven quality criteria describe the core values of good patient engagement practice and should be considered (in this order) when you have finished your clinical trial/study:

  • Shared purpose
  • Respect and accessibility
  • Representativeness of stakeholders
  • Roles and responsibilities
  • Capacity and capability for engagement
  • Transparency in communication and documentation
  • Continuity and sustainability

The Patient Engagement Quality Guidance Tool can also be used as an assessment tool when you have finished your clinical trial/research project. It can also be used for a gap analysis to identify what worked well and what could be improved as you plan your next clinical trial/research project.

Two templates are provided within the Patient Engagement Quality Guidance Tool document:

The Patient Expertise in Research Collaboration (PERC) at McMaster University also has tools to assist in engaging patients as partners in research. Their Building Patient Engagement in Research: A Guide for Research Teams provides information, resources, and methods to support partnerships between researchers and patients to conduct research focused on needs, preferences and priorities for the patient’s health and health care.

Other resources include: 

Reference

Those experiencing health concerns and problems are those closest to detect them and suggest how to deal with them (1, 2). Patient-Reported Outcomes (PRO) are patient’s self-report about their health condition such as functional status, symptoms, and well-being (3). PRO aims to represent the patient’s own interpretation of their condition without interpretation from health care providers or anyone else (3), and evidence suggests that the use of the patient reported outcome measures (PROMs) and patient reported experience measures (PREMs) to monitor the effectiveness of health care services and interventions are essential to capture relevant health outcomes from the patient’s perspective (4-6). Although mortality and health care utilization are common outcome measures in clinical trials, they fail to capture other important aspects of the lives of people. The use of PROMs, in combination with these concepts, provides a fuller picture of the effects of the treatment on patients’ lives (7).

The use of PROMs has been limited in routine practice in Canada (4, 8), however, PROM data are increasingly being used in clinical trials and other research settings (5). Multiple instruments are now available for common health problems, and some have been validated in the Canadian population (8). PROMs are designed to measure either ‘general’ health status (i.e., generic PROMs) or health status relating to a specific condition (i.e., condition-specific PROMs (2, 8).

Generic instruments

Measure broad aspects of health and are not tailored to a specific patient population (2).

  • Have potential to capture the influence of co-morbidity on health, including unexpected positive or negative effects of an intervention.
  • Are applicable for comparisons between treatments for different patient groups and with the general population.
  • Potentially less responsive to clinically important changes in health (9).
Disease/condition-specific instruments
  • Tailored to the symptoms and impact on function of a specific condition (2).
  • Are responsive to clinically important changes in health that result from interventions.
  • Limited ability to make comparison across disease specialties (2, 6), which limits the application in economic evaluation and the restricted focus may prevent them from detecting side effects or unexpected effects of treatment.

It is important to note that: 1) PROMs are not always designed and selected with patient input to ensure that they measure what matters most to patients, 2) measurement properties, patient acceptability and burden, cultural validity, and interpretation guidelines are not always considered, and 3) inconsistency in PROMs used within and across disease specialties make comparisons difficult (5).

To address the inconsistency in inclusion of PROMs in clinical trials, the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) statement was published in 2013 (10) to improve the completeness of trial protocols. In 2018, the SPIRIT-PRO Group provided an extension to the guidelines with recommendations for the PRO content of clinical trial protocols (7). The key PRO-specific issues at each stage in the trial protocol process are summarized in the following table.

Administrative Information

Describe the PRO-specific research question and rationale for PRO assessment and summarize PRO findings in relevant studies.

State specific PRO objectives or hypotheses (including relevant PRO concepts/domains).

Methods: Participants, Interventions, and Outcomes

Specify any PRO-specific eligibility criteria (e.g., language/reading requirements).

Specify the PRO concepts/domains used to evaluate the intervention (e.g., overall health related quality of life, specific domain, specific symptom) and, for each one, the analysis metric and the principal time point or period of interest.

Include a schedule of PRO assessments, providing a rationale for the time points, and the required sample size related to the PRO outcome. 

Methods: Data Collection, Management, and Analysis

Justify the PRO instrument to be used and describe domains, number of items, recall period, instrument scaling and scoring. Evidence of PRO instrument measurement properties, interpretation guidelines, and patient acceptability and burden should be provided or cited in the population of interest.

Include a data collection plan, the mode of administration (e.g., paper, telephone, electronic, other) and setting (e.g., clinic, home, other).

Specify whether more than one language version will be used and describe how the translated versions have been developed.

When the trial context requires a proxy-reported outcome, state and justify the use of a proxy respondent including evidence of the proxy assessment validity.

Specify PRO data collection and management strategies for minimizing missing data.

State PRO analysis methods and how missing data will be described and outline the methods for handling missing items or entire assessments.

Methods: Monitoring

State whether or not PRO data will be monitored during the study to inform the clinical care of individual trial participants and, describe how this will be managed in a standardized way. Describe how this process will be explained to participants (e.g., in information sheet and consent form).

Resources
References
  • Chalmers I. Confronting therapeutic ignorance. Bmj. 2008;337:a841.
  • Black N. Patient reported outcome measures could help transform healthcare. Bmj. 2013;346:f167.
  • US Food and Drug Administration. Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance. Health and Quality of Life Outcomes. 2006;4:1-20.
  • Kluetz PG, O’Connor DJ, Soltys K. Incorporating the patient experience into regulatory decision making in the USA, Europe, and Canada. The Lancet Oncology. 2018;19(5):e267-e74.
  • Calvert M, Kyte D, Price G, Valderas JM, Hjollund NH. Maximising the impact of patient reported outcome assessment for patients and society. BMJ. 2019;364:k5267.
  • Wiering B, de Boer D, Delnoij D. Patient involvement in the development of patient‐reported outcome measures: a scoping review. Health Expectations. 2017;20(1):11-23.
  • Calvert M, Kyte D, Mercieca-Bebber R, Slade A, Chan A-W, King MT, et al. Guidelines for inclusion of patient-reported outcomes in clinical trial protocols: the SPIRIT-PRO extension. Jama. 2018;319(5):483-94.
  • Bryan S, Broesch J, Dalzell K, Davis J, Dawes M, Doyle-Waters MM, et al. What are the most effective ways to measure patient health outcomes of primary health care integration through PROM (Patient Reported Outcome Measurement) instruments. Vancouver: Centre for Clinical Epidemiology & Evaluation. 2013.
  • Devlin NJ, Appleby J. Getting the most out of PROMs. Putting health outcomes at the heart of NHS decision-making London: The King’s Fund. 2010.
  • Chan A-W, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Annals of internal medicine. 2013;158(3):200-7.

Sex (biological factors) and gender (socio-cultural factors) are distinct concepts that need to be considered when designing clinical trials and patient-oriented research.

  • Sex is based on biological attributes of humans and animals, including physical features, chromosomes, gene expression, hormones, and anatomy (1).
  • Gender refers to socially- constructed roles, behaviours, expressions, and identities of girls, women, boys, men and gender-diverse people (1).

Sex and gender influence people’s health and wellbeing in distinct yet interrelated ways (2, 3). Sex-specific differences between men and women due to sex chromosome or sex hormones may contribute to variations seen in development of certain diseases, the safety and efficacy of drugs and medical devices (2). Sex-based analysis allows researchers to determine if there are any sex differences in the response to treatment and can provide insight into the scientific basis for individual therapy differences and provide future directions for research (4). Historically, gender related differences have received limited attention compared with the sex-specific differences between men and women; however, there is a spectrum of gender identities and expressions defining how individuals identify themselves and express their gender (3). There is no reason to doubt that gender is equally relevant for people’s health (5, 6), and there is a continuous need to encourage researcher to explicitly apply sex and gender consideration to clinical trial research.

Already in 2010, the Canadian Institute of Health Research (CIHR) implemented a policy mandating sex and gender reporting in federally funded studies, acknowledging that both biology (sex) and society (gender) influence outcome in health research (7, 8). 

The Sex and Gender Equity in Research (SAGER) guidelines (3) contributes with a comprehensive procedure for applying assessment and the use of sex- and gender-based analysis into clinical trial research design. Highlighting the importance of reporting sex and gender information in study design, data analyses, results, and interpretation of findings. Emphasis is being placed on:

  • Appropriate use of the terms sex and gender. Collect information on sex assigned at birth: male or female; also collect information on preferred gender identity: woman, man, gender-fluid, non-binary, two-spirited, or prefer not to answer.
  • Consider collecting other demographic information that may help to describe gender such as highest education level, employment status, primary earner in house, range of personal income, average number of hours per week doing housework, primary person responsible for housework or childcare, and stress level. Examples of gender-related variables | BMJ.
  • The research should be designed and conducted in a way that can reveal sex-related differences (e.g., adequately powered).
  • Where research participants also can be differentiated by gender (shaped by social and cultural circumstances), the research should be designed and conducted in a way that can reveal gender-related differences.
Gender Variables

Methods for prospectively and retrospectively incorporating gender-related variables in clinical research was presented at CIHR’s Institute for Gender and Health Meet the Methods Series

Which dimension(s) of gender are relevant?
  • Gender identity: How an individual self-identifies, including how they behave, express their gender, and are perceived by other people.
  • Gender relations: How individuals interact with and are treated by other people based on their perceived and/or expressed gender identity.
  • Gender roles: Social expectations and norms typically associated with a given gender.
  • Institutionalized gender: The way power, resources, and opportunities are distributed in society based on gender.
Which gender-related variables are relevant?
  • Gender identity: Stress, personality traits, anxiety and depression, self-reported gender identity (e.g., woman, man, non-binary).
  • Gender relations: Marital or relationship status, social support (e.g., ENRICHD Social Support InventoryFootnote3), family or local network (i.e., social capital), experiences of gender-based violence, experience with healthcare providers (e.g., use of gender inclusive language).
  • Gender roles: Household responsibilities, family caregiver or parental responsibilities, occupation or employment status, primary earner status, gender of healthcare providers.
  • Institutionalized gender: Wage gap, education level, retirement eligibilities, gender inequality (e.g., Gender Inequality IndexFootnote4*).

*Note that this instrument uses only a binary definition of sex.

Source: GOING-FWD

Approaches to analyzing gender-related variables
  • Developing a gender score (composite measure of gender).
  • Investigate gender as a main effect.
  • Explore gender as an interaction term.
  • Utilize a mediation analysis to assess gender.

To improve relevance and facilitate future meta-analysis on treatment effects, the Office of Research on Women’s Health, NIH, and Institute of Gender and Health, CIHR, have proposed a two-step approach for reporting demographic characteristics of study participants and outcomes by sex and gender whereby both sex assigned at birth, and current gender identity, are presented in the demographic table in manuscripts (8).

Sex and gender science is rapidly evolving as more evidence is created across different populations. The critiques of sex and gender measurement focuses on the questions researchers ask, which tend to categorize each as binary and static. A proposed Gender/Sex 3×3 approach measures and categorized gender/sex beyond binaries. Dimensions of a 3×3 grid include the gender trajectory (i.e., the relationship between sex assigned at birth and identities and experiences described as cisgender, transgender, or allogender) and binary relation (i.e., binary, nonbinary and allobinary). More information can be found at van Anders lab

The Gender Outcomes INternational Group: to Further Well-being Development (GOING-FWD) aims to consolidate sex and gender-related determinants of health and well-being knowledge in chronic diseases (cardiovascular disease, metabolic disease, chronic kidney disease and neurological disease) and apply/disseminate this knowledge using technological innovations across cohorts/countries. GOING-FWD will construct innovative ways to disseminate the application of gender measurement towards personalized approaches to chronic disease prevention, diagnosis, and treatment and will be another good resource for information.

The Women’s Xchange also has a robust library collection of information on integrating sex and gender into health research, including clinical trial research. Resource Library at The Women’s Xchange.

Resources
References
  • Coen S, Banister E, editors. What a difference sex and gender make: a gender, sex and health research casebook. Ottawa, Canada: Canadian Institutes of Health Research; 2012.
  • Institute of Medicine (IOM). Sex‐specific Reporting of Scientific Research: A Workshop Summary. Washington, DC: The National Academies Press; 2012.
  • Heidari S, Babor TF, De Castro P, Tort S, Curno M. Sex and Gender Equity in Research: rationale for the SAGER guidelines and recommended use. Research Integrity and Peer Review. 2016;1(1):1.
  • Welch, V., Doull, M., Yoganathan, M., Jull, J., Boscoe, M., Coen, S. E., … & Puil, L. Reporting of sex and gender in randomized controlled trials in Canada: a cross-sectional methods study. Research Integrity and Peer Review, 2017: 2(1), 15.
  • Reisner SL, Poteat T, Keatley J, Cabral M, Mothopeng T, Dunham E, et al. Global health burden and needs of transgender populations: a review. The Lancet. 2016;388(10042):412-36.
  • Polderman TJ, Kreukels BP, Irwig MS, Beach L, Chan Y-M, Derks EM, et al. The Biological Contributions to Gender Identity and Gender Diversity: Bringing Data to the Table. Behavior genetics. 2018;48(2):1-14.
  • Tannenbaum C, Clow B, Haworth-Brockman M, Voss P. Sex and gender considerations in Canadian clinical practice guidelines: a systematic review. CMAJ open. 2017;5(1):E66.
  • Clayton JA, Tannenbaum C. Reporting Sex, Gender, or Both in Clinical Research? Reporting Sex, Gender, or Both in Clinical ResearchReporting Sex, Gender, or Both in Clinical Research. JAMA. 2016;316(18):1863-4.

The International Association for Public Participation (IAP2) defines various levels of public/patient participation/engagement depending on goals, timelines, and available resources (IAP2 Federation). Patients can engage as partners in five various capacities, from the lowest level of inform (i.e., investigator/researcher makes decisions and informs the patient of trial progress) to the highest level of empower (e.g., patients make the final decision in trial progress and the investigator/researcher implement what the patient decides). It is likely that most patient engagement in clinical trial research will not involve these extremes but will include consultation, involvement, and collaboration with patient partners. However, the farther right you are on the IAP2 spectrum, the more empowered patient partners will be to influence decisions regarding the clinical trial/research project. Note: SPOR is seeking to move the level of engagement to collaborate.

Patient partners can engage in each and every step of the research process/lifecycle associated with each clinical trial/research project. The level or spectrum of engagement, defined earlier using the IAP2 criteria, is a very useful tool for defining Patient Partner Roles and Responsibilities within a clinical trial/research team.

Public Participation GoalPromise To The Public
InformTo provide the public with balanced and objective information to assist them in understanding the problem, alternatives and/or solutions.We will keep you informed.
ConsultTo obtain public feedback on analysis, alternatives and/or decision.We will keep you informed, listen to and acknowledge concerns and aspirations, and provide feedback on how public input influenced the decision.
InvolveTo work directly with the public throughout the process to ensure that public concerns and aspirations are consistently understood and considered.We will work with you to ensure that your concerns and aspirations are directly reflected in the alternatives developed and provide feedback on how public input influenced the decision.
CollaborateTo partner with the public in each aspect of the decision including the development of alternatives and the identification of the preferred solution.We will look to you for advice and innovation in formulating solutions and incorporate your advice and recommendations into the decisions to the maximum extent possible.
EmpowerTo place final decision-making in the hands of the public.We will implement what you decide.

Research proposals should include a plan and related budget for fairly compensating patient partners. The amount and details of reimbursement/compensation should reflect the circumstances of the patient partner engagement. Budgets for patient partners should be distinguished from budgets generated for research project participants.

Possible costs for compensating patient partners may related to costs for developing relationships between the patient partner(s), the PI(s), and other team members. This will likely involve time for meetings and time for training/orientation. There may also be costs related to study methods, such as writing the lay abstract, recruitment, writing lay summaries, etc. Travel and accommodation costs need to be covered. If patient partners are co-presenters at conferences, then their conference registration needs to be covered. Time for preparation and attendance at team meetings will need to be covered. To ensure the benefits of engaging patient partners in your clinical trial/research project are attained, careful consideration to budget line items is absolutely necessary.

Reimbursement
  • Expense payment is the cost of doing business when patients are partners on a team
  • Expenses include transportation, supplies, meals, conference registration, etc.
Compensation
  • Compensation does not always mean payment of money, although it is important for equity
  • Compensation can be a mix of monetary and non-monetary (e.g., charity donations) – depending on what your patient partner may wish and what is realistic for your institution/organization
  • Compensation should reflect the level of expertise, commitment, responsibility, type of work, and the degree of participation contemplated
  • One-on-one discussion on compensation should occur at the start of the project
  • Rate structures are based on unit of time or level of engagement
  • All income is subject to relevant tax laws and regulations. In Ontario, compensation above $500 is generally taxable income
Rate Structure based on Unit of Time
TimeRateDetails
Hourly rate$25For activities less than 4 hours
Half day rate$100+/- 4-hour commitments
Full day rate$200+/- 8-hour commitments
Rate Structure based on Level of Engagement
CommitmentResponsibilityScopeExample of ActivitySuggested Compensation
Availability of email; willing and able to participate in a few meetings by phone or in personContributes advice and feedback for decision making by research teamWorks within a specific clinical trialIn-person meetings will require expense reimbursement in addition to compensation$500 to $800 per year, depending on number of meetings and other requirements
Resources

The patient-family advisors and The Saskatchewan Centre for Patient-Oriented Research (SCPOR) developed PORLET 2.0 (Patient-Oriented Level of Engagement Tool). PORLET 2.0 provides a standard set of criteria for determining the level of Patient Partner engagement in a clinical trial/research project. The PORLET 2.0 is an excellent writing guide for investigators and patients writing patient-oriented grant proposals. PORLET 2.0 integrates the IAP2 criteria (inform, consult, involve, collaborate, and empower) and utilizes five (5) criteria for scoring: patients as partners, patient-identified priorities, outcomes important to patients, aims to integrate knowledge into practice, and team is multidisciplinary. Each criterion is rated on a scale from 1 (lowest) to 5 (highest) with the lowest possible PORLET 2.0 total score of 5 and the highest possible PORLET total score of 25. Please note this is an English-only tool.

The patient-family advisors and The Saskatchewan Centre for Patient-Oriented Research (SCPOR) also developed the Indigenous Research Level of Engagement Tool (IRLET). This measures the degree to which a clinical trial/research project meets patient-oriented research criteria in the context of Indigenous communities. The criteria used for evaluation in this tool includes partnership (Indigenous stakeholders), knowledge to practice, strengths-based approach, and Indigenous knowledges/ways of knowing. IRLET is intended to be used in conjunction with PORLET 2.0. Investigators undertaking research in collaboration with Indigenous communities are also encouraged to review the section on Consideration of Indigenous Perspectives (p. 6) in the Ethics Guidance for Developing Partnerships with Patients and Researchers.

Ethics Guidance for Developing Partnerships with Patients and Researchers – CIHR

Meaningful engagement of patients on clinical trials/study teams requires that information flows easily among team members, and that patient partners feel included in decision making. Communication is also important to keep patient partners meaningfully engaged from proposal development through to funding, ethics review, field work (data collection), analysis, and knowledge translation and exchange. It is important to identify the preferred methods of communication and involvement of patient partners. While some patient partners may function online, others may not use email or social media. The option of receiving communication through the postal mail or talking on the telephone should always be offered. 

Tips for inclusive communication include:

  • Communication should be clear, concise, and easy to understand.
  • Always include the person’s name, phone number, and postal address in contact details.
  • Offer to provide communication through the postal mail.
  • When providing communication, give people the option of requesting larger font or other accessible formats (e.g., Easy Read).
  • Always check patient partner requirements, such as hearing loops, level access to meeting rooms, timing of caring responsibilities and/or travel limitations.
Forms

Effective investigator/researcher and patient partner ‘partnerships’ acknowledge the unique and valued scientific knowledge from investigators/researchers and the unique and valued practical knowledge from patient partners. This is accomplished by sharing values, acknowledging expertise, and accepting mutual accountability and interdependence for the clinical trial/study design and conduct. 

Therefore, within a clinical trial/study team it is important to create a climate where all members feel valued and accept accountability to contribute to the overall goal of the clinical trial/research project. Co-building rests on the acknowledged complementarity of expertise from the investigator/researcher and the patient partner(s).

Tuckman (1965) defines a model of team development based on two assumptions: 1) a common goal, and 2) quality of team member relationships (e.g., trust, managing conflict). All teams transition through four stages: forming, storming, norming and performing.

Successful teams need to spend time to become a team before they can become effective (e.g., forming). This includes accepting the unique contributions from each team member, deciding on a common goal, clarifying accountabilities/reimbursements and compensations, and acknowledging the role of the leader. Discussing and learning about the lived experiences of each patient partner will help them feel a valued member of the clinical trials/study team. It might be helpful at this stage to also discuss roles and responsibilities of team members, including patient partner roles and responsibilities.

Storming serves to figure out what each team member wants. Every team member contributes and understands and accepts diverging perspectives. It is normal for teams to storm. Spending time in the forming stage will help to minimize time spent in the storming stage.

Norming serves to set the rules for working together; meeting ground rules are established, opportunities for equal contributions are formulated, and strategies for providing constructive feedback/making decisions are confirmed.

Teams that achieve effective and satisfying results (e.g., recruitment and retention targets) are performing. Small team set-backs will not affect team member motivation. During this stage it is important to recognize the individual contributions of each team member.

References
  • CIHR SPOR Foundations in Patient-Oriented Research, Module 3: Building Partnerships and Consolidating Teams (Module 3 Lead Nicolas Fernandez and Alexandre Berkesse).
Planning a Meeting
  • Consider meeting patient partners in their own environment (e.g., in their organization or group).
  • Consider venues that are on neutral ground (e.g., hospitals may be associated with difficult experiences).
  • Choose locations that are easily accessible for patient partners, including parking and public transportation.
  • Consider starting late morning or early afternoon to allow adequate travel time.
  • Ask for special dietary requirements.
  • Develop an agenda and circulate at least one week before the meeting.
Conducting the Meeting
  • Follow appropriate communication strategies.
  • Provide name badges in large clear font and ensure. introductions at the start of the meeting.
  • Follow the Ground Rules.
  • Use clear language and explain jargon and acronyms.
  • Plan for frequent breaks and refreshments.
  • Consider large and small group activities to foster equal. contributions among team members.
Meeting Ground Rules
  • Listen/read to understand, not to react
  • Speak directly to the issue
  • Argue constructively
  • Respect other people’s opinions
  • Recognize and value the expertise and experience that other members bring to the discussion
  • Seek and maintain a solutions-based approach
  • Use given name, no titles (i.e., avoid Dr., Prof., Mr., Mrs.)
After the Meeting

Ensure minutes are reviewed by Chair(s) and circulated within 2 weeks.

Research proposals should include a plan and related budget for fairly compensating patient partners. The amount and details of reimbursement/compensation should reflect the circumstances of the patient partner engagement. Budgets for patient partners should be distinguished from budgets generated for research project participants.

Possible costs for compensating patient partners may related to costs for developing relationships between the patient partner(s), the PI(s), and other team members. This will likely involve time for meetings and time for training/orientation. There may also be costs related to study methods, such as writing the lay abstract, recruitment, writing lay summaries, etc. Travel and accommodation costs need to be covered. If patient partners are co-presenters at conferences, then their conference registration needs to be covered. Time for preparation and attendance at team meetings will need to be covered. To ensure the benefits of engaging patient partners in your clinical trial/research project are attained, careful consideration to budget line items is absolutely necessary.

Reimbursement
  • Expense payment is the cost of doing business when patients are partners on a team
  • Expenses include transportation, supplies, meals, conference registration, etc.
Compensation
  • Compensation does not always mean payment of money, although it is important for equity
  • Compensation can be a mix of monetary and non-monetary (e.g., charity donations) – depending on what your patient partner may wish and what is realistic for your institution/organization
  • Compensation should reflect the level of expertise, commitment, responsibility, type of work, and the degree of participation contemplated
  • One-on-one discussion on compensation should occur at the start of the project
  • Rate structures are based on unit of time or level of engagement
  • All income is subject to relevant tax laws and regulations. In Ontario, compensation above $500 is generally taxable income
Rate Structure based on Unit of Time
TimeRateDetails
Hourly rate$25For activities less than 4 hours
Half day rate$100+/- 4-hour commitments
Full day rate$200+/- 8-hour commitments
Rate Structure based on Level of Engagement
CommitmentResponsibilityScopeExample of ActivitySuggested Compensation
Availability of email; willing and able to participate in a few meetings by phone or in personContributes advice and feedback for decision making by research teamWorks within a specific clinical trialIn-person meetings will require expense reimbursement in addition to compensation$500 to $800 per year, depending on number of meetings and other requirements
Resources
  • Document and record patient partner involvement in your research.
  • Outcomes should be available to the public.
  • Staff should show a commitment to act on involvement and make changes to decisions and policies.
  • There should be accountability to communities and groups that are affected, and involvement should be assessed with feedback provided to those involved.
  • Recognize and show appreciation for the contribution of patient partners if they wish to be acknowledged publicly (some patient partners will not want this – it should be their decision).

Lay summaries can broaden the impact of your work. The Declaration of Helsinki states that ‘all medical research subjects would be given the option of being informed about the general outcome and results of the study’. Some clinical trial regulations also state that a summary of clinical trial results should be provided in a format that is understandable by a lay audience within one year after trial completion. CTO has developed specific guidance and templates for these types of clinical trial summaries (for adults and youth and their caregivers).

  • Keep in mind that the summary is meant for the general public.
  • Use succinct, short sentences and write in plain language, use two syllable words or less (i.e., write at a grade 6 – 7 reading level).
  • Avoid jargon and explain if you need to keep it in.
  • Use the first person and an active voice ‘we completed’ rather than ‘it was completed’.
  • Use positive or generative sentences.
  • Avoid length and simplicity, include patient partners in writing/review.
  • Translate summaries as needed.
  • Use visuals to assist with understanding, and to make the summary more appealing.
  • Use tables and figures to present results.
  • Always include a disclaimer stating the results of a particular trial do not convey the full medical picture and that patients should always consult their physicians before changing any ongoing therapies.
Ten essential aspects of a lay summary
  1. Clinical trial identification (including the title of the trial, protocol number, and other identifiers).
  2. Name and contact of sponsor.
  3. General information about the clinical trial (including where and when the trial was conducted, main objectives of the trial, and reasons for conducting the trial).
  4. Subjects (number, age, sex/gender, inclusion and exclusion criteria).
  5. Intervention details.
  6. Describe any adverse events (if any).
  7. Overall results of the clinical trial.
  8. Comments on the outcomes of the clinical trial (including patient partner interpretations).
  9. Implications and next steps.
  10. Where additional trial information can be found.
Resources

Patient partners can be involved in any or all steps in publishing a manuscript. It will be important to review common terms (e.g., open access, peer review, impact factor) with patient partners at the outset of publication discussions.

There is very little guidance on authorship for patient partners within the purview of POR and the International Committee of Medical Journal Editors (ICJME). A recent publication entitled Guidance on authorship with and acknowledgement of patient partners in patient-oriented research provides guidance for patient partners and investigators on the publishing process. It is helpful for investigators to explain the process to patient partners who may be unfamiliar with writing and submitting a manuscript. Common publishing terms/definitions and publishing process/timelines are outlines in this guidance document; these may be beneficial for patient partners. Guidance is also offered to researchers in determining whether contributors should be considered for authorship

A useful 4-minute video also describes publishing a manuscript with patient partners:

Guidance on authorship versus acknowledgment is also provided for investigators.

Two versions of GRIPP (Guidance for Reporting Involvement of Patients and the Public) checklists are available for writing about patient engagement in clinical trials (GRIPP2-short form [SF] and the GRIPP2-long-form [LF]). Both can be found on the EQUATOR Network: GRIPP2 reporting checklists: tools to improve reporting of patient and public involvement in research.

References

Patient partners can assist to present results at public forums and scientific conferences.

Researcher & Patient Partner Surveys

Researcher and Patient Partner surveys will assist researchers to evaluate the patient partner and researcher partnership experience. There are three tools for the researcher and three tools for the patient partner, each delivered at the start of the clinical trial/research project, mid-way through the trial/project, and then at the end of the trial/project.

Researcher Surveys (initial, mid-, and end-project surveys)

There are three researcher surveys designed to understand the researcher experience in the patient and researcher partnership. The first survey is designed to be delivered early in the partnership, the second to be delivered mid-way through the partnership, and the end-project survey is to be delivered in the KT component of the research.

Patient Partner Surveys (initial, mid-, and end-project surveys)

In addition, there are three patient partner surveys designed to understand the patient partner experience in the patient and researcher partnership. The first survey is designed to be delivered early in the partnership, the second to be delivered mid-way through the partnership, and the end-project survey is to be delivered in the KT component of the research.

Public and Patient Engagement Evaluation Tool (PPEET)

Three questionnaires comprise the PPEET: the participant questionnaire, the project questionnaire, and the organization questionnaire.

The purpose of the participant questionnaire is to obtain feedback on key features of the patient engagement experience. Two versions are available: a) one-time engagement questionnaire, and b) on-going/long-term engagement questionnaire.

The purpose of the project questionnaire is to assess the planning, implementation, and impact of the patient engagement component of specific projects.

The purpose of the organization questionnaire is to assess how patient engagement is being utilized within organizations.

The Public and Patient Engagement Evaluation Tool has been licensed under a Creative Commons Attribution-Non-commercial-Share Alike 4.0 International License. © 2018, Julia Abelson and the PPEET Research-Practice Collaborative. McMaster University. All rights reserved.

Patient-Oriented Level of Engagement Tool (PORLET)

The patient-family advisors and The Saskatchewan Centre for Patient-Oriented Research (SCPOR) developed PORLET 2.0 (Patient-Oriented Level of Engagement Tool). PORLET 2.0 provides a standard set of criteria for determining the level of Patient Partner engagement in a clinical trial/research project.  The PORLET 2.0 is an excellent writing guide for investigators and patients writing patient-oriented grant proposals. PORLET 2.0 integrates the IAP2 criteria (inform, consult, involve, collaborate, and empower) and utilizes five (5) criteria for scoring: patients as partners, patient-identified priorities, outcomes important to patients, aims to integrate knowledge into practice, and team is multidisciplinary. Each criterion is rated on a scale from 1 (lowest) to 5 (highest) with the lowest possible PORLET 2.0 total score of 5 and the highest possible PORLET total score of 25. Please note this is an English-only tool. 

The patient-family advisors and The Saskatchewan Centre for Patient-Oriented Research (SCPOR) also developed the Indigenous Research Level of Engagement Tool (IRLET). This measures the degree to which a clinical trial/research project meets patient-oriented research criteria in the context of Indigenous communities. The criteria used for evaluation in this tool includes partnership (Indigenous stakeholders), knowledge to practice, strengths-based approach, and Indigenous knowledges/ways of knowing. IRLET is intended to be used in conjunction with PORLET 2.0. Investigators undertaking research in collaboration with Indigenous communities are also encouraged to review the section on Consideration of Indigenous Perspectives (p. 6)  in the Ethics Guidance for Developing Partnerships with Patients and Researchers.

Patient Engagement Quality Guidance Tool

The Patient Engagement Quality Guidance Tool can be used to help you to plan, develop, and assess the quality of your patient engagement activities. In the planning phases of your project the tool can be used to inspire and guide your patient engagement activities.

You can use the tool to communicate the benefits of engaging patients in your clinical trial/research project (as in a grant proposal).

Investigators who focus on different types of research (e.g., biomedical, clinical, etc.) will find the quality criteria helpful in planning patient engagement activities (e.g., biomedical researchers can engage a representative number of patient partners [men, women] who have a shared purpose, responsibilities on advisory or governance committees, and who communicate and collaborate respectfully and with transparency).

Seven quality criteria describe the core values of good patient engagement practice and should be considered (in this order) when you have finished your clinical trial/study:

  • Shared purpose
  • Respect and accessibility
  • Representativeness of stakeholders
  • Roles and responsibilities
  • Capacity and capability for engagement
  • Transparency in communication and documentation
  • Continuity and sustainability

The Patient Engagement Quality Guidance Tool can also be used as an assessment tool when you have finished your clinical trial/research project. It can also be used for a gap analysis to identify what worked well and what could be improved as you plan your next clinical trial/research project.

Two templates are provided within the Patient Engagement Quality Guidance Tool document:

There are a variety of tools used to measure patient and public engagement in research. These include Ways of Engaging – Engagement Activity Tool (WE-ENACT), the Patient Engagement in Research Scale (PEIRS), to name a few. A list of evaluation tools can be found here: Patient and Public Engagement Evaluation Tools

Reference
  • Engaging patients as partners in clinical trial/research teams means that research is focused on what matters most to patients. This might mean that clinical trial/research teams have made changes to research questions, processes, and trial design to improve study participants’ experiences in the trial/research project. These changes may enhance participant recruitment, retention, and trial completion (i.e., improved quality of the clinical trial/research project). Moreover, patient partners can inform to whom and how the research results are disseminated. This may enhance consumer trust in the information received and a better understanding of research results.
  • Suggested indicators, methods, and tools for determining the impact of patient engagement in a clinical trial/research project may include:
  • Improved recruitment and retention
  • Increased diversity of trial participants (e.g., access to hard-to-reach populations)
  • Faster trial completion due to enhanced recruitment
  • Increased number and type of patient reported outcomes (PROS)
  • Better participant experience in trial (e.g., reduced number of missed visits)
  • Enhanced reading level of research documents/instruments (e.g., information sheets, consent forms, recruitment materials, lay summaries)
  • Improved dissemination to the public through forums, social media, etc.
  • PCORI Ways of Engaging – Engagement ACtivity Tool (WE-ENACT) – Patients and Stakeholders 3.0 Item Pool
References

Clinical trials/research projects will vary in scope, length, number of investigators/patient partners, etc. There is no specific ‘recipe’ for engaging patients on investigative teams. It is a give and take and room for negotiation must be anticipated. There are many things that can stress patient partner and investigator relationships, including team communication and function. It is important to establish a point person for patient partner(s), someone they can go to with questions or concerns. Concerns can usually be resolved quickly by informal discussion. Suggestions to assist if things go wrong with patient partnership(s) include:

  • Acknowledge early that there is an issue or a problem.
  • Listen carefully to concerns of affected members.
  • Allow space for reflection and informed decision.
  • Refer back to patient partnership materials that may include ground rules for meetings, privacy/confidentiality agreements, terms of reference, etc.
  • Agree on action items and timelines for resolution.
  • Ensure adequate support of affected members.