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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.
Identifying a gap in research and making decisions about what will be studied, how it will be studied, and who will be involved.
The grant proposal is developed and submitted to a funding organization for their consideration to fund.
This includes ethics submission, individual site training for multi-site clinical trials, hiring study personnel.
Participants are recruited and data are collected qualitatively (e.g., focus groups) or quantitatively (e.g., surveys, physiologic measures).
Results are analyzed and interpreted.
Research results are shared beyond the research team (e.g., publication, public forums, conference presentation, infographics, chats on X).
Translating and utilizing the research findings (e.g., approval for pharmaceutical agents).
Continuing to monitor outcomes after the results have been implemented.
CIHR has general principles relevant to engaging patients as partners in research. These include:
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:
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:
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:
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.
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.
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.
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
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.
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:
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:
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.
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).
Measure broad aspects of health and are not tailored to a specific patient population (2).
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.
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).
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.
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.
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).
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 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:
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
*Note that this instrument uses only a binary definition of sex.
Source: GOING-FWD
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.
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 Goal | Promise To The Public | |
|---|---|---|
| Inform | To provide the public with balanced and objective information to assist them in understanding the problem, alternatives and/or solutions. | We will keep you informed. |
| Consult | To 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. |
| Involve | To 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. |
| Collaborate | To 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. |
| Empower | To 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.
| Time | Rate | Details |
|---|---|---|
| Hourly rate | $25 | For activities less than 4 hours |
| Half day rate | $100 | +/- 4-hour commitments |
| Full day rate | $200 | +/- 8-hour commitments |
| Commitment | Responsibility | Scope | Example of Activity | Suggested Compensation |
|---|---|---|---|---|
| Availability of email; willing and able to participate in a few meetings by phone or in person | Contributes advice and feedback for decision making by research team | Works within a specific clinical trial | In-person meetings will require expense reimbursement in addition to compensation | $500 to $800 per year, depending on number of meetings and other requirements |
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:
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.
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:
Ensure minutes are reviewed by Chair(s) and circulated within 2 weeks.
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:
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.
| Time | Rate | Details |
|---|---|---|
| Hourly rate | $25 | For activities less than 4 hours |
| Half day rate | $100 | +/- 4-hour commitments |
| Full day rate | $200 | +/- 8-hour commitments |
| Commitment | Responsibility | Scope | Example of Activity | Suggested Compensation |
|---|---|---|---|---|
| Availability of email; willing and able to participate in a few meetings by phone or in person | Contributes advice and feedback for decision making by research team | Works within a specific clinical trial | In-person meetings will require expense reimbursement in addition to compensation | $500 to $800 per year, depending on number of meetings and other requirements |
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).
Measure broad aspects of health and are not tailored to a specific patient population (2).
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.
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).
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.
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.
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).
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 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:
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
*Note that this instrument uses only a binary definition of sex.
Source: GOING-FWD
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.
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).
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.
Patient partners can assist to present results at public forums and scientific conferences.
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.
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.
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.
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
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.
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:
