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Abstract Background Critical stakeholder-identified gaps in current health research engagement strategies include the exclusion of voices traditionally less heard and a lack of consideration for the role of trauma in lived experience. Previous work has advocated for a trauma-informed, intersectional, and critical reflexive approach to patient and public involvement in health research. The Valuing All Voices Framework embodies these theoretical concepts through four key components: trust, self-awareness, empathy, and relationship building. The goal of this framework is to provide the context for research teams to conduct patient engagement through the use of a social justice and health equity lens, to improve safety and inclusivity in health research. The aim of this study was to revise the proposed Valuing All Voices Framework with members of groups whose voices are traditionally less heard in health research. Methods A qualitative descriptive approach was used to conduct a thematic analysis of participant input on the proposed framework. Methods were co-developed with a patient co-researcher and community organizations. Results Group and individual interviews were held with 18 participants identifying as Inuit; refugee, immigrant, and/or newcomer; and/or as a person with lived experience of a mental health condition. Participants supported the proposed framework and underlying theory. Participant definitions of framework components included characterizations, behaviours, feelings, motivations, and ways to put components into action during engagement. Emphasis was placed on the need for a holistic approach to engagement; focusing on open and honest communication; building trusting relationships that extend beyond the research process; and capacity development for both researchers and patient partners. Participants suggested changes that incorporated some of their definitions; simplified and contextualized proposed component definitions; added a component of “education and communication”; and added a ‘how to’ section for each component. The framework was revised according to participant suggestions and validated through member checking. Conclusions The revised Valuing All Voices Framework provides guidance for teams looking to employ trauma-informed approaches, intersectional analysis, and critical reflexive practice in the co-development of meaningful, inclusive, and safe engagement strategies. Plain English Summary Patient engagement in health research continues to exclude many people who face challenges in accessing healthcare, including (but not limited to) First Nations, Inuit, and Metis people; immigrants, refugees, and newcomers; and people with lived experience of a mental health condition. We proposed a new guide to help researchers engage with patients and members of the public in research decision-making in a meaningful, inclusive, and safe way. We called this the Valuing All Voices Framework, and met with people who identify as members of some of these groups to help define the key parts of the framework (trust; self-awareness; empathy; and relationship building), to tell us what they liked and disliked about the proposed framework, and what needed to be changed. Input from participants was used to change the framework, including clarifying definitions of the key parts, adding another key part called “education and communication”, and providing action items so teams can put these key parts into practice.

Background: The re-conceptualization of patients' and caregivers' roles in research from study participants to co-researchers ("patient partners") has led to growing pains within and outside the research community, such as how to effectively engage patients in research and as part of interdisciplinary teams. To support the growth of more successful research partnerships by developing a shared understanding of how patient partners conceptualize and contribute to their role, this study aimed to explore patient partners' motivations for engagement and understanding of their role., Methods: We conducted semi-structured interviews with participants (n = 13) of an online survey of activities and impacts of patient engagement in Strategy for Patient-Oriented Research projects. Eligibility criteria included being a patient partner that indicated interest in interview participation upon survey completion, the ability to read/write in English and provide informed consent. Data were analyzed thematically using an inductive, codebook thematic analysis., Results: Illuminating the lived/living patient and caregiver experience was central to how most patient partners conceptualized the role in terms of its definition, purpose, value, and responsibilities. Participants also identified four additional categories of motivations for becoming a patient partner and contributions that patient partners make to research that build upon and are in addition to sharing their lived/living experiences. Lastly, participants highlighted important connotations of the term patient partner, including temporal and context-specific considerations for the term "patient" and what "partner" may imply about the nature of the research relationship., Conclusions: At the onset of partnership, academic researchers and patient partners must create the space necessary to discuss and understand each other's underlying motivations for partnering and their perspectives on the purpose, value, and responsibilities of the patient partner role. These early conversations should help unearth what research partners hope to get out of and feel that they are able to contribute to engaging, and in such contribute to the development of reciprocal relationships that work towards shared and valued goals. Trial registration Not applicable., (© 2023. The Author(s).)

Background: Knowledge about the specific engagement activities pursued and associated impacts of patient engagement in research in Canada remains nascent. This study aimed to describe engagement activities and perceived impacts of projects funded by the Strategy for Patient-Oriented Research (SPOR)., Methods: This was a cross-sectional online survey of academic researchers and patient partners engaging in projects funded through 13 SPOR funding calls (2014-2019). Patient engagement activities and impacts were measured using a self-developed survey. Thematic analysis was used to describe engagement activities and impacts., Results: 66 of 511 academic researchers and 20 of 28 patient partners contacted completed the survey and were included in analyses. Respondents reported that patient partners were engaged in seven types of activities across the research cycle: (a) sharing experiences/giving advice, (b) identifying the research focus/methods, (c) developing/revising aspects of the project, (d) conducting research activities, (e) study participation, (f) presenting on behalf of the project, and (g) other grant development or knowledge translation activities. Engagement was associated with six different types of impacts related to knowledge, outputs, or directions being (a) created, (b) moulded, (c) confirmed, or (d) chosen/prioritized, (e) perceived success of the research, and (f) minimal/negative impacts on the research., Conclusions: This study presents information on different ways that patient partners were engaged in SPOR-funded research and the potential impacts of these activities. This knowledge base is imperative to the future of patient engagement in research, including the planning and evaluation of future studies that engage patients as active shapers of research., (© 2022. The Author(s).)

Objective: To count and describe the elements that overlap (ie, present in two or more) and diverge between models and frameworks of patient engagement in health services research. Our specific research question was 'what are the elements that underlie models and frameworks of patient engagement in health services research?', Design: Scoping review., Data Sources: On 6-7 July 2021, we searched six electronic databases (ie, CINAHL, Cochrane Database of Systematic Reviews, Joanna Briggs Institute Evidence Based Practice Database, MEDLINE, PsycINFO and Scopus) and Google Scholar for published literature, and ProQuest Dissertations & Theses, Conference Proceedings Citation Index, Google, and key agencies' websites for unpublished (ie, grey) literature, with no date restrictions. These searches were supplemented by snowball sampling., Eligibility Criteria: We included published and unpublished literature that presented (a) models or frameworks (b) of patient engagement (c) in health services research. We excluded articles unavailable as full text or not written in English., Data Extraction and Synthesis: Two independent reviewers extracted data from included articles using an a priori developed standardised form. Data were synthesised using both quantitative (ie, counts) and qualitative (ie, mapping) analyses., Results: We identified a total of 8069 articles and ultimately included 14 models and frameworks in the review. These models and frameworks were comprised of 18 overlapping and 57 diverging elements, that were organised into six conceptual categories (ie, principles, foundational components, contexts, actions, levels and outcomes) and spanned intrapersonal, interpersonal, process, environmental, and health systems and outcomes domains., Conclusions: There is little overlap between the elements that comprise existing models and frameworks of patient engagement in health services research. Those seeking to apply these models and frameworks should consider the 'fit' of each element, by conceptual category and domain, within the context of their study., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Up to 40% of orthopaedic injuries in children require a closed reduction, almost always necessitating procedural sedation. Intravenous ketamine is the most commonly used sedative agent. However, intravenous insertion is painful and can be technically difficult in children. We hypothesise that a combination of intranasal dexmedetomidine plus intranasal ketamine (Ketodex) will be non-inferior to intravenous ketamine for effective sedation in children undergoing a closed reduction., Methods and Analysis: This is a six-centre, four-arm, adaptive, randomised, blinded, controlled, non-inferiority trial. We will include children 4-17 years with a simple upper limb fracture or dislocation that requires sedation for a closed reduction. Participants will be randomised to receive either intranasal Ketodex (one of three dexmedetomidine and ketamine combinations) or intravenous ketamine. The primary outcome is adequate sedation as measured using the Paediatric Sedation State Scale. Secondary outcomes include length of stay, time to wakening and adverse effects. The results of both per protocol and intention-to-treat analyses will be reported for the primary outcome. All inferential analyses will be undertaken using a response-adaptive Bayesian design. Logistic regression will be used to model the dose-response relationship for the combinations of intranasal Ketodex. Using the Average Length Criterion for Bayesian sample size estimation, a survey-informed non-inferiority margin of 17.8% and priors from historical data, a sample size of 410 participants will be required. Simulations estimate a type II error rate of 0.08 and a type I error rate of 0.047., Ethics and Dissemination: Ethics approval was obtained from Clinical Trials Ontario for London Health Sciences Centre and McMaster Research Ethics Board. Other sites have yet to receive approval from their institutions. Informed consent will be obtained from guardians of all participants in addition to assent from participants. Study data will be submitted for publication regardless of results., Trial Registration Number: NCT0419525., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Critical stakeholder-identified gaps in current health research engagement strategies include the exclusion of voices traditionally less heard and a lack of consideration for the role of trauma in lived experience. Previous work has advocated for a trauma-informed, intersectional, and critical reflexive approach to patient and public involvement in health research. The Valuing All Voices Framework embodies these theoretical concepts through four key components: trust, self-awareness, empathy, and relationship building. The goal of this framework is to provide the context for research teams to conduct patient engagement through the use of a social justice and health equity lens, to improve safety and inclusivity in health research. The aim of this study was to revise the proposed Valuing All Voices Framework with members of groups whose voices are traditionally less heard in health research., Methods: A qualitative descriptive approach was used to conduct a thematic analysis of participant input on the proposed framework. Methods were co-developed with a patient co-researcher and community organizations., Results: Group and individual interviews were held with 18 participants identifying as Inuit; refugee, immigrant, and/or newcomer; and/or as a person with lived experience of a mental health condition. Participants supported the proposed framework and underlying theory. Participant definitions of framework components included characterizations, behaviours, feelings, motivations, and ways to put components into action during engagement. Emphasis was placed on the need for a holistic approach to engagement; focusing on open and honest communication; building trusting relationships that extend beyond the research process; and capacity development for both researchers and patient partners. Participants suggested changes that incorporated some of their definitions; simplified and contextualized proposed component definitions; added a component of "education and communication"; and added a 'how to' section for each component. The framework was revised according to participant suggestions and validated through member checking., Conclusions: The revised Valuing All Voices Framework provides guidance for teams looking to employ trauma-informed approaches, intersectional analysis, and critical reflexive practice in the co-development of meaningful, inclusive, and safe engagement strategies., Plain English Summary: Patient engagement in health research continues to exclude many people who face challenges in accessing healthcare, including (but not limited to) First Nations, Inuit, and Metis people; immigrants, refugees, and newcomers; and people with lived experience of a mental health condition. We proposed a new guide to help researchers engage with patients and members of the public in research decision-making in a meaningful, inclusive, and safe way. We called this the Valuing All Voices Framework , and met with people who identify as members of some of these groups to help define the key parts of the framework (trust; self-awareness; empathy; and relationship building), to tell us what they liked and disliked about the proposed framework, and what needed to be changed. Input from participants was used to change the framework, including clarifying definitions of the key parts, adding another key part called "education and communication", and providing action items so teams can put these key parts into practice., Competing Interests: Competing interestsThe authors declare that they have no competing interests., (© The Author(s) 2020.)

Introduction: Musculoskeletal (MSK) injuries are a frequent cause for emergency department (ED) visits in children. MSK injuries are associated with moderate-to-severe pain in most children, yet recent research confirms that the management of children's pain in the ED remains inadequate. Clinicians are seeking better oral analgesic options for MSK injury pain with demonstrated efficacy and an excellent safety profile. This study aims to determine the efficacy and safety of adding oral acetaminophen or oral hydromorphone to oral ibuprofen and interpret this information within the context of parent/caregiver preference., Methods and Analysis: Using a novel preference-informed complementary trial design, two simultaneous trials are being conducted. Parents/caregivers of children presenting to the ED with acute limb injury will be approached and they will decide which trial they wish to participate in: an opioid-inclusive trial or a non-opioid trial. Both trials will follow randomised, double-blind, placebo-controlled, superiority-trial methodology and will enrol a minimum of 536 children across six Canadian paediatric EDs. Children will be eligible if they are 6 to 17 years of age and if they present to the ED with an acute limb injury and a self-reported verbal Numerical Rating Scale pain score ≥5. The primary objective is to determine the effectiveness of oral ibuprofen+oral hydromorphone versus oral ibuprofen+oral acetaminophen versus oral ibuprofen alone. Recruitment was launched in April 2019., Ethics and Dissemination: This study has been approved by the Health Research Ethics Board (University of Alberta), and by appropriate ethics boards at all recruiting centres. Informed consent will be obtained from parents/guardians of all participants, in conjunction with assent from the participants themselves. Study data will be submitted for publication regardless of results. This study is funded through a Canadian Institutes of Health Research grant., Trial Registration Number: NCT03767933, first registered on 07 December 2018., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Data from clinical trials are needed to guide the safe and effective use of medicines in children. Clinical trials are challenging to design and implement in all populations, and children present additional considerations. Several regions including the UK, USA and Europe have established clinical trial infrastructure to capitalise on expertise and promote clinical trials enrolling children. Our objective is to describe the partnerships and operational considerations for the development of paediatric clinical trials infrastructure in Canada. We describe the design and conduct of four emergency room paediatric trials, with four separate sponsors, across four provinces in parallel. Operations discussed include multisite contract development, centralised risk-based data monitoring, ethical review and patient engagement. We conclude with lessons learnt, additional challenges and potential solutions to facilitate drug development for children in Canada., Competing Interests: Competing interests: The Innovation in Paediatric Clinical Trials (iPCT) project is funded by an Innovative Clinical Trials Multi-year Grant from the Canadian Institutes of Health Research, as part of the Strategy for Patient-Oriented Research and in partnership with the Alberta Children’s Hospital Research Institute, Centre Hospitalier Universitaire Sainte-Justine, Children’s Hospital Research Institute of Manitoba, Children’s Hospital of Eastern Ontario Research Institute, Hospital for Sick Children Research Institute, Research Manitoba, University of Western Ontario and Women & Children’s Health Research Institute. The authors have no conflicts of interest to disclose., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Plain English Summary: Patient engagement in research is an emerging approach that involves active and meaningful collaboration between researchers and patients throughout all phases of a project, including planning, data collection and analysis, and sharing of findings. To better understand the core features (elements) that underlie patient engagement, it is useful to have a look at models and frameworks that guide its conduct. Therefore, this manuscript aims to present a protocol for a scoping review of models and frameworks of patient engagement in health services research. Methods: Our protocol design is based on an established framework for conducting scoping reviews. We will identify relevant models and frameworks through systematic searches of electronic databases, websites, reference lists of included articles, and correspondence with colleagues and experts. We will include published and unpublished articles that present models and frameworks of patient engagement in health services research and exclude those not in English or unavailable as full texts. Two reviewers will independently review abstracts and full texts of identified articles for inclusion and extract relevant data; a third reviewer will resolve discrepancies. Our primary objective is to count and describe elements of patient engagement that overlap (present in 2 or more) and diverge among included models and frameworks. Discussion: We hope this review will raise awareness of existing models and frameworks of patient engagement in health services research. Further, by identifying elements that overlap and diverge between models and frameworks, this review will contribute to a clearer understanding of what patient engagement in research is and/or could be ., Abstract: Background: Patients can bring an expert voice to healthcare research through their lived experience of receiving healthcare services. Patient engagement in research is an emerging approach that challenges researchers to acknowledge and utilize this expertise through meaningful and active collaboration with patients throughout the research process. In order to facilitate a clearer understanding of the core elements that underlie patient engagement, it is useful to examine existing models and frameworks that guide its conduct. Therefore, the aim of this manuscript is to present a protocol for a scoping review of models and frameworks of patient engagement in health services research. Methods: Drawing on Arksey and O'Malley's and Levac et al.'s framework for scoping reviews, we designed our protocol to identify relevant a) published articles through systematic searches of 7 electronic databases and snowball sampling and b) unpublished articles through systematic searches of databases and websites and snowball sampling. We will include published and unpublished models and frameworks of patient engagement in health services research and exclude those not in English or unavailable as full texts. Two reviewers will independently screen the abstracts and full texts of identified articles for inclusion and extract relevant data; a third reviewer will resolve disagreements. We will conduct a descriptive analysis of the characteristics (i.e., elements underlying patient engagement and those related to the study authors, publication, and model/framework) of included articles and a narrative analysis of the data concerning elements of the model or framework. Our primary objective is to count and describe elements of patient engagement that overlap (present in ≥ 2) and diverge (present in < 2) among identified models and frameworks. Discussion: Through identification of elements that overlap and diverge between existing models and frameworks, this review will provide a starting point for the critical reflection on our collective understanding of what patient engagement in health services research is and/or could be . Ultimately, we hope that the findings of this review raise awareness of existing models and frameworks and shed light on some of the complexity of conducting patient engaged research through identification of key elements that shape this approach., Competing Interests: Not applicable.Not applicable.The authors declare that they have no competing interests.Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.