Patient and public involvement and engagement with underserved communities in dementia research: Reporting on a partnership to co-design a website for postdiagnostic dementia support.

INTRODUCTION: Despite the advancements in Patient and Public Involvement and Engagement (PPIE), the voices of traditionally underserved groups are still poorly reflected in dementia research. This study aimed to report on a PPIE partnership between academics and members of the public from underserved communities to co-design Forward with Dementia-Social Care, a resource and information website supporting people receiving a dementia diagnosis. METHODS: The PPIE partnership was set up in four stages: 1-identifying communities that have been under-represented from PPIE in dementia research; 2-recruiting PPIE partners from these communities; 3-supporting PPIE partners to become confident to undertake their research roles and 4-undertaking research co-design activities in an equitable fashion. RESULTS: To address under-representation from PPIE in dementia research we recruited seven PPIE partners from Black, Asian and other minority ethnic groups; lesbian, gay, bisexual, transgender, queer+ communities; remote/rural area; religious minorities and partners living with rare forms of dementia. The partners met regularly throughout the project to oversee new sections for the study website, refine existing content and promote the website within their communities. CONCLUSION: Strategies can be used to successfully recruit and involve PPIE partners from underserved communities in co-design activities. These include networking with community leaders, developing terms of reference, setting out 'rules of engagement', and investing adequate resources and time for accessible and equitable involvement. These efforts facilitate the co-design of research outputs that reflect the diversity and complexity of UK contemporary society. PATIENT OR PUBLIC CONTRIBUTION: This study received support from seven members of the public with lived experience of dementia from communities that have been traditionally underserved in dementia research. These seven members of the public undertook the role of partners in the study. They all equally contributed to the study design, recruitment of participants, development and revision of topic guides for the interviews and development of the website. Three of these partners were also co-authors of this paper. On top of the activities shared with the other partners, they contributed to write independently of the academic team the section in this paper titled 'Partners' experiences, benefits and challenges of the partnership'. Further, they provided input in other sections of the paper on a par with the other (academic) co-authors.

Patient engagement in health implementation research: A logic model.

INTRODUCTION: Growing evidence supports patient engagement (PE) in health implementation research to improve the quality, relevance and uptake of research. However, more guidance is needed to plan and operationalize PE before and throughout the research process. The aim of the study was to develop a logic model illustrating the causal links between context, resources, activities, outcomes and impact of PE in an implementation research programme. METHODS: The Patient Engagement in Health Implementation Research Logic Model (hereafter the Logic Model) was developed using a descriptive qualitative design with a participatory approach, in the context of the PriCARE programme. This programme aims to implement and evaluate case management for individuals who frequently use healthcare services in primary care clinics across five Canadian provinces. Participant observation of team meetings was performed by all team members involved in the programme and in-depth interviews were conducted by two external research assistants with team members (n = 22). A deductive thematic analysis using components of logic models as coding categories was conducted. Data were pooled in the first version of the Logic Model, which was refined in research team meetings with patient partners. The final version was validated by all team members. RESULTS: The Logic Model highlights the importance of integrating PE into the project before its commencement, with appropriate support in terms of funding and time allocation. The governance structure and leadership of both principal investigators and patient partners have significant effects on PE activities and outcomes. As an empirical and standardized illustration that facilitates a shared understanding, the Logic Model provides guidance for maximizing the impact of patient partnership in various contexts for research, patients, providers and health care. CONCLUSION: The Logic Model will help academic researchers, decision makers and patient partners plan, operationalize, and assess PE in implementation research for optimal outcomes. PATIENT OR PUBLIC CONTRIBUTION: Patient partners from the PriCARE research programme contributed to developing the research objectives and designing, developing and validating data collection tools, producing data, developing and validating the Logic Model and reviewing the manuscript.

Facing new challenges to informed consent processes in the context of translational research: the case in CARPEM consortium.

BACKGROUND: In the context of translational research, researchers have increasingly been using biological samples and data in fundamental research phases. To explore informed consent practices, we conducted a retrospective study on informed consent documents that were used for CARPEM's translational research programs. This review focused on detailing their form, their informational content, and the adequacy of these documents with the international ethical principles and participants' rights. METHODS: Informed consent forms (ICFs) were collected from CARPEM investigators. A content analysis focused on information related to biological samples and data treatment (context of sampling and collect, aims, reuse, consent renewal), including the type of consent. An automatic assessment of the readability of the ICFs were performed with the IT program "Flesch Score". RESULTS: 29 ICFs from 25 of 49 studies were analyzed after selection criteria were applied. Three types of consent were identified: 11 broad consents, six specific consents, and two opt-out consents. The Flesch Scores showed that most of the documents were too complex to be fully understood by most of the potential research participants. Most of the biological samples were collected during the healthcare routine, but the information content about secondary use of biological samples varied between ICFs. All documents mentioned personal data treatment but information about their reuse was not standardized in the ICFs. CONCLUSIONS: Our review of current IC procedures of CARPEM showed that practices could be improved considering new translational research methods. "Old fashion written ICFs" should be adapted to the translational research approach, to better respect individual rights and international research ethics principles. In this context, theoretically, a digital tool allowing dynamic information and consent of participants, through an electronic interactive platform may be a good way to promote more active participation in research. Nevertheless, its feasibility in the complex environment of biological samples and data research remains to prove. The way of a combination of a broad consent followed by dynamic information may be alternatively tested.