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Published in final edited form as: J Aging Stud. 2023 May 20;65:101139. doi: 10.1016/j.jaging.2023.101139

Applying Person-centered Research Ethics in the Design of Dementia-Specific Measures

Sheila L Molony 1, Sam Fazio 2, Ricci Sanchez 3, Joe Montminy 4, Maureen Rulison 5, Rev Dennis McGuire 6, Richard Feinn 7, Sangchoon Jeon 8, Rachel Montesano 9, Lorna Prophater 10, Kimberly VanHaitsma 11, Sheryl Zimmerman 12
PMCID: PMC10259161  NIHMSID: NIHMS1902921  PMID: 37268373

There is an emerging call for new strengths-based measures to guide research, care, and support for persons living with Alzheimer’s disease and related dementia (Gaugler et al., 2019; Stoner, Orrell, Long, Csipke, & Spector, 2017). An estimated 6.5 million Americans aged 65 and older are living with Alzheimer’s disease, mild cognitive impairment, or other dementia types (Alzheimer’s Association, 2022). In addition to focusing on global quality of life, many non-pharmacological interventions for persons living with dementia are evaluated using measures of cognition, function, agitation, depression, neuropsychiatric symptoms, and caregiver burden (Abraha et al, 2017; Lopez-Ortiz et al., 2021; Sun et al., 2022). In recent years, scholars and advocates have called for an expanded repertoire of measures to document the outcomes of person-centered care, and the opportunities for living well with dementia (JPND Working Group, 2015). One way to accomplish this work is to involve persons living with dementia as collaborators and coresearchers (Morbey et al., 2019; Swarbrick et. al., 2019). This work is part of a larger project entitled “Holistic Evaluation to Advance Research in Dementia (HEARD).” The goal of the HEARD project is to develop new positive psychosocial outcome measures that may be used in early to moderate stages of Alzheimer’s disease and related dementia. The study was firmly grounded in the principles of person-centeredness highlighted in the most recent Dementia Care Practice Recommendations (Fazio et al., 2018) and the collaborative work facilitated by LINC-AD (https://alz.org/linc-ad/overview.asp). The study used Human Centered Design (HCD) to develop new measures and included persons living with dementia and care partners as both co-designers and key informants. While design thinking and HCD began in the technology and business sphere to develop new consumer-oriented products, they have been successfully combined to achieve humanistic goals and social change, (Hoover, 2022; Roumani, 2020). While HCD has been used to co-design products with persons living with dementia, it is not typically used to create research or clinical measures (Rodgers, 2021). A recent systematic review of HCD in the development of new technologies identified only 7 out of 49 studies where persons living with dementia were included as co-designers throughout the development process, rather than merely as informants in a single phase of the study. The design process is complementary to the more traditional process used to develop patient reported outcome measures (PROMs). Rather than beginning with an a priori construct such as “health-related quality of life,” and/or adapting existing questionnaires, HCD uses grassroots data collection methods including observation, interviews, empathy immersion and analogous experiences to glean insights that may not have been previously explicit (Brown, 2008). HCD prioritizes risk taking mindsets and “failing fast and often” to generate unique solutions. HEARD trialed the use of this person-centered, non-traditional process and included persons living with dementia and care partners in each step of the design process, from inspiration to ideation and implementation (IDEO, 2015). This resulted in the design and iterative testing of two prototypes (one process measure and one outcome measure) for further iterative testing (a key step in the HCD process). A core component of HCD is the cultivation of deep empathy for the population whose needs are being addressed. HCD is therefore both person-centered and relationship-based, requiring a sensitivity to the role of person-centered ethics. Person-centered ethics goes beyond d traditional principles of autonomy, beneficence, non-maleficence, and justice, and explores the moral aspects of social processes (Doody & Noonan, 2016, Cascio & Racine, 2018). This paper will provide an overview of person-centered ethics, a brief summary of the methods used in the current project, and a discussion of how person-centered ethical principles were applied to the process of HCD with a team that included persons living with dementia and care partners.

Methods

The method of HCD included an infrastructure-building component (creating the design team, framing the design challenge, creating the parameters for evaluation), a working design component, (using focus groups and other sources to build empathy and inspire ideation and design), and an implementation component (refining and retesting measure prototypes, field testing new measures). Table 1 outlines each phase in the design process.

Table 1:

Steps in Human Centered Design Process

1. Identify key roles for design team
2. Recruit design team members
3. Plan meetings - finalize the setting, context, and schedule
4. Acquire necessary expertise
5. Finalize the setting, context, and schedule for design meetings
6. Introduce design team members and set the stage for successful collaboration
7. Train the design team
8. Initiate the human-centered design process

  1. Inspiration

  2. Ideation

  3. Implementation
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Identifying and Recruiting Design Team

HCD is an approach to problem-solving grounded in the belief that the people who face problems every day are the ones who hold the key to their answer. The core team of designers would therefore need to represent potential end-users of the new psychosocial measures. The new measures would be completed by persons living with dementia and care partners, administered by researchers, and psychometrically evaluated by biostatisticians. Therefore, representatives from each of these groups were considered users of the desired end product and were invited to participate in the core design team, known as the HEARD Steering Council. The terms “design team” and “Steering Council” are used interchangeably in this paper. Design team members also had contact with social networks of people living with dementia and/or brought unique perspectives related to their life experience and professional roles. In addition to the primary investigator (PI) and Co-PI, the team included two individuals living with early stage Alzheimer’s disease, two care partners of individuals in middle stages of Alzheimer’s disease or mixed dementia, two researchers skilled in researching interventions to improve dementia related quality of life, and two biostatisticians with expertise in instrument development or psychometric evaluation. Three of the professionals serving on the design team also had personal experience as caregivers for persons living with dementia.

Individuals living with dementia and care partners were recruited from the community of individuals who had either participated in the Alzheimer’s Association® National Early-Stage Advisory Group (ESAG) or were alumni of the group. “Early-Stage” refers to people, irrespective of age, who are diagnosed with Alzheimer’s disease or related disorders and are in the beginning stage of their disease. One care partner was known to the PI from an earlier collaboration and was recruited from outside of the ESAG group. One member cared for his wife, whose disease progressed to a more advanced stage over the course of the HEARD project.

Planning and Preparing for Collaboration

The Steering Council guided all phases of the instrument design process including defining and refining the aims of the design challenge, creating an interview guide for focus groups, and analyzing the resulting data. The Steering Council met online approximately twice per month for two 90-minute sessions. Typically, the first session would include discussion and the second session would focus on decision making, design, and planning next steps. Early meetings were devoted to relationship-building and HCD training.

Instrument Design, Development and Testing

The design team first decided upon the evaluation criteria for prioritization and evaluation of new measures. The measures needed to be meaningful to persons with lived experience, useful to care and service providers hoping to improve care, sensitive to change (improvement), and psychometrically sound. The measures also needed to be sensitive to incremental improvements in psychosocial wellbeing.The methods used included qualitative data collection with ESAG members and dementia support/advocacy groups to inform item development and to gather feedback about question response options and formats. The design team used discussion, brainstorming and consensus building to prioritize the concepts to be measured. The team developed a plan for prototyping, testing, and revising draft measures, and evaluated feedback from experts (including additional ESAG members living with dementia) on face validity and content validity. This process resulted in two novel measures for pilot testing, the Living Well with Dementia Inventory, and the Quality of Day Scale. Details regarding the instrument development process are described in a separate paper (Author, 2022). The process was grounded in person-centered ethics.

Personhood and Person-centered Ethics

Person-centered ethics relies on philosophical and conceptual foundations of personhood. Kitwood and Bredin (1992) view personhood as being inherently social, defined by a human being’s relation to others. This includes having a valued status in the social world and being worthy of respect. The quality of the social environment has a direct impact on the wellbeing of the person living with dementia. Kitwood went on to write that one universal ethical principle would be to always look for possible meaning in the behaviors and speech of someone with dementia, even if they first appeared to be indecipherable (Kitwood, 1998). Person-centered care attends to human needs for comfort, attachment, inclusion, occupation, and identity (Kitwood, 1997).

Communication and relationships are central to person-centered ethics, which combines the principles of relational ethics, everyday ethics, and person-centered care (Cascio & Racine, 2018). Relational ethics focuses on mutual trust and engagement and posits that ethical decisions and actions are made within the context of a concrete relationship between two or more people that incorporates mutual trust and engagement (Pollard, 2015). Relational ethics also incorporates an understanding of how the environment influences relationships, including the role of power structures (Moore, Engel & Prentice, 2014). Everyday ethics recognizes the plurality of occurrences in day-to-day life that pose moral conflicts between individual values and the social structures that provide services and supports, particularly in long-term care settings (Kemp, Craft & Burgess, 2022; Powers, 2005; Kane & Kaplan, 1990). Person-centered care (PCC) prioritizes the needs, values and expressed desires of each person in all decision making. Person-centered care is also holistic and inclusive of family, significant others, and context (American Association of Colleges of Nursing, n.d.). PCC is holistic, individualized, respectful, and empowering (Morgan & Yoder, 2012). These attributes and approaches were synthesized and led to principles of person-centered ethics which include: (1) Respect for holistic personhood; (2) Empowerment in decision making (3) Focus on researcher-participant relationships, (4) Acknowledgement of (everyday) lived world; and (5) Individualization. This framework was later expanded using findings from the literature to translate ethics into practice (Silva, Cascio & Racine, 2020). Each of these principles was applied to the HEARD study. Examples of this application are included in Table 2 and described below.

Table 2:

Translation of Ethical Principles into HEARD Project

Person-centered Ethical Guidepost Example of Translation to HEARD Project
1. Respect for holistic personhood

  • Including persons diagnosed with dementia as equal members of the research/design team

  • Including care partners as equal members of the research/design team

  • Using multiple methods (interview, observation, analogous experiences) to gain empathy into the lived experience of cognitive impairment

  • Using communication techniques tailored to individual needs and preferences (e.g., videoconferencing, 1:1 calls via telephone or zoom)

  • Checking in periodically with all members of the team and being open to critique or disagreement to enrich discussion

  • Encouraging feedback about any changes needed in the pace of the work, the methods being used and the clarity of the terminology
2. Empowerment in decision-making and participation

  • Recognizing the participant’s agency to provide informed consent Presenting information about the study in an accessible format Using communication techniques to enable ongoing consent Allowing participants to leave at any point

  • As a general rule, encouraging persons living with lived experience (diagnosis or care partner) to speak first, before researchers or others on the team

  • Explaining the process to be used at the beginning of each meeting and defining terms first, before engaging in the design process Using a white board to enable nonjudgmental brainstorming and using multi-voting methods to facilitate equal participation in decision-making
3. Focus on researcher participant relationships

  • Maintaining relationships with gatekeepers (e.g., trusted members of existing networks/groups such as the Alzheimer’s Association Early Stage Advisory Group or the Black Dementia Minds group)

  • Spending time at the beginning of the design work to develop relationships with all team members (e.g., used informal sharing to enhance interpersonal knowledge outside of formal roles)

  • Providing training for all Steering Council members during first meeting in dementia friendly language and methods of empowerment

  • Expressing concern for participants’ wellbeing and offering 1:1 check-in calls before or after meetings

  • Being mindful of language used in all communication

  • Avoiding stigmatizing terms

  • Using active listening skills, welcoming, conversational tone, and positive engagement during all focus group meetings
4. Acknowledgement of the lived world

  • Striking a balance between sending timely e-mail reminders and not overwhelming participants with too many e-mails

  • Including care partner support to optimize participant engagement

  • Sending written materials in advance of scheduled meetings to allow enough time for all team members to review and prepare

  • Rescheduling meetings when necessary to accommodate unanticipated events
5. Individualization

  • Hosting meetings during times of day that team members felt they could optimally participate (e.g., mornings or early afternoons)

  • Adjusting meeting schedules to accommodate participants’ preferences and needs

  • Maintaining flexibility and openness to all methods to optimize participation and success in all phases of the work
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Application of Person-Centered Ethics to HEARD Project

Holistic Personhood

Including neurodivergent people as equal partners in research is becoming more common (Nicolaidis, 2015; Clare et. al., 2014). Including persons affected by the condition under study demonstrates respect for holistic personhood. In the HEARD project, persons with lived experience of dementia were included as equal partners in the design team. All Steering Council members were valued for their expertise, received the same compensation in recognition of their work, and were encouraged to provide feedback about not only the content of the work, but also the pace and structure of the meetings themselves. A research assistant was assigned the task of monitoring group process and to assess body language for signs of fatigue, frustration, or desire to speak. Group members were frequently reminded that disagreement was supported and encouraged in the design process, and all input was affirmed and respected. The entire HCD process affirms holistic personhood by encouraging the use of multiple methods to gain empathy into the lived experience of cognitive impairment. Individual needs and contexts were honored by using communication techniques that were tailored to individual schedules, pace, and preferences. These included group and individual or smaller group videoconferencing and 1:1 meetings or phone calls.

Empowerment

Empowerment was fostered by recognizing, valuing, and supporting autonomy, abilities, and strengths. An environmental scan was conducted to identify key resources and best practices related to inclusion of persons living with dementia in research (LePore, Shuman, Wiener & Gould, 2017; DEEP, 2016), and the PI attended a 2-day training entitled “Empowering Partnerships,” offered by LiveWell and the Dementia Peer Coalition, as part of a Patient Centered Outcomes Research Institute (PCORI) initiative. The project included a useful toolkit that informed the HEARD project. (https://livewell.org/empoweringpartners-toolkit/) This preparation provided helpful skills for the author to create a positive, empowering milieu throughout the project.

Individuals living with dementia were intentionally invited as single participants in the Steering Council, rather than as a member of a care partner dyad, to assure that their voices were heard equally in the design process. Similarly, care partners of persons living with mild to moderate dementia were invited to participate as individuals, rather than including both members of the care dyad. This was intended to enable care partners to speak more freely about their own viewpoints and needs. One of the Steering Council members with dementia did receive support from a care partner to optimize participation in the group. The care partner typically worked offscreen, assisting with technology, organizing meeting materials, facilitating preparation for the meeting, and offering any assistance or cueing requested by the person living with dementia during the meeting. The implications of research participation for care partners and dyads warrants additional consideration during the ethics review process.

Respect for autonomy began with recognizing the person with dementia’s agency and ability to provide consent. To assure that memory was not the sole determinant of participation, team members were reminded about the ability to leave the project at any point and were always given information in advance of meetings about what the next steps in the project would require. Information was presented in an accessible format and all terms and concepts were defined first, prior to engaging in the design process. Individuals with lived experience of dementia were given the opportunity to speak first, before others on the team. Ample time was allotted for reflection and response.

One team member challenged the group to consider how conceptualizing dementia as a disability, rather than a disease, would lead to more empowering approaches, and might inspire prioritizing the commonalities among individuals living with or without dementia, rather than the differences. An “aha” moment occurred when focus group members talked about the context of the research being just as important as the research questions themselves. Individuals with dementia and care partners expressed the desire to develop trusting relationships with the researcher prior to engaging in the data collection process. They also want the researcher to explain why they are asking the questions, how the information will be used, and how the results will benefit the respondent or others with the condition. When participating in research studies, persons with dementia also want options to have some control over the context of data collection, preferably participating during the time of day when they are sharpest, and in an environment that is comfortable, supportive, and mitigates stress to the extent possible. The HEARD Steering Council was also sensitized to the importance of asking phrasing research questions in a manner that does not require intact short-term memory in order to respond.

Relationship

Communication, mutual trust, mutual respect, and cooperation are essential for all successful group work. In the current project, some members of the team had more experience communicating with persons with dementia than others. During the first team meeting, staff members from the Alzheimer’s Association provided training on principles for success during inclusive meetings, including focusing on preparation, communication and staying connected. The original plan was to host some in-person meetings to facilitate creative design and relationship building. For persons living with dementia and care partners, the burdens of travel and staying in an unfamiliar environment needed to be weighed against the potential benefits in forming stronger relationships and fostering new insights during break-room conversations or informal chats. The COVID-19 pandemic intervened and resulted in an exclusively online, internet-facilitated design process. The design team members were all familiar with the Zoom virtual meeting platform and used it successfully throughout the project.

On the day prior to the first meeting, a written question was sent for an ice breaker activity. Participants were asked, “If I came to visit you in your home, what is one thing that would you want to show me as we took a tour and why?” The intent of this activity was to begin the process of relationship building and to help team members to know one another as individuals rather than people associated with a role or diagnosis. This icebreaker was somewhat unique. It established this group as different from traditional groups and painted a visual picture that for some members was more long-lasting than the spoken word. For example, one person with dementia shared a picture of the side of his home that had personalized artwork etched in the side, and another participant spoke proudly of a floating dock that her partner had recently built. These responses engendered true interest in one another as individuals and highlighted the value of holistic personhood. All team meetings were recorded, and if a group member was ill or unable to attend, a one-on-one phone call was offered and a link to the recording was shared. E-mail and telephone contact information was shared, and participants were encouraged to provide any additional feedback before or after the meeting. The co-facilitator took notes, welcomed individuals to the meeting, and monitored group process to focus on inclusion and communication. All participant contributions were integrated into the conversation, whether offered by chat or live conversation.

An important ethical consideration was the avoidance of power differentials between persons living with dementia, researchers, and statisticians. During each meeting, the facilitator would first explain the process that would be used during the meeting, define unfamiliar terms (e.g., “psychosocial”, “quantitative vs. qualitative methods,” “reliability and validity”) and then lead the group in the design process. A balancing act was required to share information that some researchers on the team had been thinking about for years (e.g., quality of domains, adaptation vs. coping, process vs. outcome measures) but that might be new information for other members of the group. Researchers sometimes needed to “hold back” from sharing, resisting the urge to educate or provide data from the research literature. This was addressed by encouraging multiple forms of sharing for all group members, including pre and post-meeting emails, phone calls or zoom calls (with researchers and persons living with dementia).

When the group was striving to achieve consensus on the important concepts to be captured by any new research measure, an online white board was used enable nonjudgmental brainstorming and multi-voting methods facilitated equal participation in consensus decision-making. The pace of the meetings was modulated to allow adequate time for information processing.

Acknowledgement of the Lived World

The timing of team meetings was important. Some individuals with dementia have times of day when they experience optimal cognitive clarity, and other times when it is more difficult to process information or expend mental energy. The individuals living with dementia were committed advocates, often volunteering their time and energy to multiple projects and interviews. It was important to balance their time investment with opportunities to restore energy levels. The researchers and academics on the team also needed to schedule around competing commitments and scheduling uncertainties. Scheduling mutually convenient meeting times for researchers, academics, persons with dementia and care partners, was one of the most challenging aspects of the project. In order to find mutually convenient days/times, schedules were often set up months in advance, and rescheduled as needed. Calendar invites were sent out at several weeks before scheduled meetings and included the start time for each participating time zone. A reminder and copy of the agenda were sent the day prior to the meeting. Team members were asked if there were others who should be copied on these messages (e.g., assistants or care partners).

Members living with dementia were forthright in sharing any self-perceived declines in cognitive function or processing speed, whether short-term (i.e., “having a challenging morning”) or part of a more persistent cognitive downturn. The team used methods before, during and after each meeting to facilitate ongoing comfort and participation. All members were given opportunities for pre-meeting contacts. During the meeting, reflection and feedback were used to assure that the individual’s intent was heard and interpreted correctly. Smaller breakout sessions were scheduled to enable persons living with dementia to collaborate and support each other and build off of each other’s comments and experiences. Additional calls or meetings were offered after each larger group meeting and a check-in was done to assess whether team members felt that the group process should be modified in any way to create a more positive milieu.

Individualization

Communication strategies included using dementia-friendly and person-first language in all materials. PowerPoint slides were evaluated for logical progression, concise, clear language, and appropriate inclusion of context. Graphics or pictures were used judiciously. Single column, large font type was used, and bold text, titles and bullet points were used to present information in meaningful sections. At least two members of the team reviewed each slide presentation prior to distribution. Slides were sent 1–2 weeks prior to the meeting to give adequate time for review and preparation. During the online meetings, a chat box was available to enable communication, but it sometimes served as a distraction for persons living with dementia. Facilitators therefore encouraged alternate strategies such as hand-raising and writing down thoughts on a notebook to capture all input. After-meeting thoughts were welcomed and collected by e-mail.

Experts in HCD often use games, drawing, and other creative exercises to unleash creativity and tap the inventive parts of imagination during the design process. In many traditional brainstorming activities, a short time limit is recommended to stimulate rapid ideation under pressure. Acknowledging the lived world of persons with dementia, these techniques were modified for the current project. A drawing exercise was used to spark innovative thinking, but a generous time frame was allowed, followed by a refreshing break. In one brainstorming exercise, smaller breakout rooms were used to enable persons with dementia, care partners, statisticians, and researchers to pair up and synergistically build off of the ideas of a team member with common experiences.

One team member living with dementia candidly expressed that having the shared zoom screen with nine people interacting and sharing ideas was sometimes overwhelming. Having more frequent smaller subgroup meetings and using breakout rooms was a recommended strategy.

Outcomes

The initial goal of the design team was to design new strengths-based psychosocial research measures. The HCD process resulted in the development of two pilot measures that will be subject to further testing including one process measure called the Living Well with Dementia Inventory (LWWDI), and one new outcome measure called the Quality of Day Scale (QODS). The LWWDI includes strategies and approaches that individuals with early stage dementia use to maintain and enhance wellbeing while adapting to challenges posed by day to day life with dementia. The QODS acknowledges the dynamic nature of the ups and downs of daily life with dementia, and a short temporal frame to assess wellbeing. Next steps include psychometric testing and piloting for acceptability and feasibility. Future work will include recommendations for assessment of wellbeing in individuals with more advanced disease.

Discussion

While principles of person-centered ethics provided a harmonious basis for the HCD process, some ethical issues arose during the HEARD study that have not received a great deal of attention in the literature. The first was the issue of discussing disease progression and the usefulness of self-report measures to persons with moderate and/or later-stage Alzheimer’s disease. The group considered alternate measurement methods once the disease had progressed to a point where language or abstraction became more impaired. The design team considered the need for observational measures and care partner proxies for individuals with more advanced phases of dementia. While the design team members with early stage disease were fully aware of potential trajectories and outcomes, this was not necessarily in the foreground of their awareness on a daily basis. Participation in the HEARD project may have highlighted this idea and raised fears about the future. This issue was discussed in a transparent manner with the team members living with dementia. Team members stated that they understood that this concern would be part of the current project and recommended that researchers continue to provide frequent check-ins prior to each work session, to give permission to engage or disengage with the process at any time.

The second ethical issue that arose was the feeling on the part of some team members who did not have dementia that they “owed something back” to the individuals with dementia and care partners, who were sharing intimate experiences and feelings during the meetings. This type of reciprocity was not part of the formal role of the team members but should be considered as an important aspect of relational ethics. This type of imbalance warrants further consideration in this project and similar studies.

A third ethical issue that warrants increased attention is the need to include under-represented groups in the research process. Older non-Hispanic Blacks and Hispanic Americans are disproportionally more likely to have Alzheimer’s disease or other dementia than older Whites (Alzheimer’s Association, 2022). Gaining feedback from multiple audiences and experts with lived experience acknowledges diversity of perspectives and broadens the possibilities for inclusivity. Black and African American people living with dementia who were members of pre-existing support and advocacy groups participated in the HEARD focus groups and provided additional feedback early in the design process. Researchers with experience working with diverse populations vis-à-vis race, ethnicity, gender identity and sexual orientation, were also included as members of an external advisory board. It will be important to continue to include individuals from underrepresented groups during the pilot testing and psychometric evaluation of the new measures. Individuals from non-majority communities may not use the term “dementia” to describe their experience and/or may encounter greater stigma than other groups. This may reduce participation in research and challenge equity in measure development and testing. Community outreach and education, face-to- face discussions, remote access and partnership with trusted professionals, groups or local organizations are strategies that have been successful in other studies (Esiaka et al., 2022).

Another core ethical principle involves balancing benefits with burdens. Leaving participants with a positive sense of contribution is part of person-centered research (Murphy, Jordan, Hunter, Cooney & Casey, 2015). Throughout the HEARD project, participants expressed the rewards associated with participation, including their ability to contribute to science, and enhance the development of the new research instruments. Participants frequently expressed gratitude for the opportunity to be involved in the project, and to further the longer term goals of person-centered care and research. In return for their participation, they hoped that any aggregate results would be shared. This request was honored not only to ensure equipoise, but also as a check to assure that conclusions resonated with their lived experience.

The ethical issues arising in the current study shared similarities and differences with studies completed using Community-Based Participatory Action (CBPR). HCD shares many of the values and processes used in CBPR. Both methods involve co-creation, stakeholder engagement in all stages, flexibility, iteration, and mutual knowledge exchange (Chen, Leos, Kowitt & Moracco, 2020). HCD has a shorter timeline with rapid cycles of prototyping with goal of building and implementing a solution that can be widely used and disseminated. CBPR focuses on longer-term capacity building within a particular community, grounded in local insights within a specific community milieu. A literature review synthesizing ethical issues in 57 CBPR studies identified ethical issues that were similar and divergent from those discussed in this paper (Mikesell et al., 2013). Components of ethical CBPR research and the HCD process used in the current study include community collaboration (involvement, mutuality, trust, transparency, and authenticity). Having a focus on strengths, community significance, relevance, and community benefit, are principles relevant to both CBPR and HCD. CBPR ethical principles that were not central to the HEARD project but considered to be integral to CBPR, include community initiation, social action orientation, community capacity building, and joint ownership of data (Mikesell et al., 2013). Shared leadership of the design team was not a formal part of the HEARD study, but group meetings did enable each team member to initiate, direct or focus the discussion. Two of the tensions mentioned in the CBPR literature were equally relevant to the current study, namely addressing power differentials and lack of clarity regarding who should represent or speak for the broader community.

HCD is an approach to problem-solving that places human experience at the forefront. It involves understanding the needs, behaviors, and preferences of the people who will be using a product, service, or system, and designing solutions that meet those needs in an empathetic and effective way. In the context of healthcare, HCD can be used to develop patient-reported outcome measures (PROMs) by involving patients in the research process from the beginning. Traditional research processes used to create PROMs often rely on standardized questionnaires or surveys developed by researchers. These measures may not reflect the full range of experiences and outcomes that are meaningful to persons living with dementia. This paper proposes a framework for integrating HCD and traditional health services research methods. Drawing on the strengths of both methods can offset their individual limitations and facilitate the design of innovative, acceptable, and pragmatic strategies to deliver and evaluate person-centered dementia care.

Conclusion

The ability to deeply empathize with the lived experience of the individual is a key element of person-centered care. As the foundation for humanistic practice, person-centered care is supported by person-centered research. Proactive consideration of ethical issues and ongoing development of person-centered research ethics will provide guidance for researchers to design studies honoring humanistic praxis. Additional research, reflection and discussion are needed to explore areas of ethical challenge specific to the dynamic nature of cognitive impairment, the diversity of diagnoses and experiences within the populations affected, and the ways in which ethical principles are translated into the field during research and practice.

We thank all the individuals living with cognitive impairment and all care partners who participated in our focus groups for candidly sharing their experiences and enriching our project. We are grateful to the members of the Early Stage Advisory Group who offered constructive critique and recommendations throughout the design process. We thank Kerry Lanigan and Monica Moreno, who assisted with recruitment of Steering Council and Focus Group members, assisted with gathering demographic data, scheduling, and providing training in dementia friendly language and approaches.

Highlights.

  • Person-centered research ethics combine principles of person-centered care, relational ethics, and everyday ethics

  • Human-centered design (HCD) is built on a foundation of empathy that is consistent with person-centered research ethics

  • Human centered design was used to design and develop new positive psychosocial measures for persons with dementia

  • Including persons living with dementia as co-researchers and designers highlights the importance of person-centered approaches and raises new questions for ethical exploration

  • Combining HCD with community-based participatory action (CBPR) approaches may yield advances in public health if ethical principles can be conscientiously applied

Funding Sources:

The project was entitled Holistic Evaluation to Advance Research in Dementia (HEARD) and was supported by the National Institute on Aging of the National Institutes of Health (Award Number R21AG070481). Dr. Zimmerman and Dr. Fazio’s effort was additionally supported by Award Number R24 AG065185. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Footnotes

Declaration of Interest:

None

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