Exploring patient and caregiver perceptions of the meaning of the patient partner role: a qualitative study.

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.

Developing a shared understanding and respect for each other's motivations, experiences, and expectations is an important step toward successful academic researcher-patient partnerships. Therefore, this study aimed to explore patient partners' motivations for engagement and understanding of their role. We met this aim by interviewing 13 English-speaking individuals with lived/living experience of being patient partners on Strategy for Patient-Oriented Research projects. These individuals were identified through our database of previous study participants interested in future research opportunities. We analyzed the information gathered through interviews by identifying themes that arose among sets of interview questions. Our findings revealed that illuminating (i.e., sharing and drawing attention to) the lived/living patient and caregiver experience was central to how most participants defined the patient partner role and its purpose, value, and responsibilities. We also identified four other categories of motivations for becoming a patient partner and contributions that patient partners make to research other than sharing their lived/living experiences. Finally, interviews highlighted different types of meanings that could be attached to the title of "patient partner." Based on our findings, we suggest that it is very important that academic researchers and patient partners take the time to discuss and understand each other's underlying motivations for partnering and their thoughts 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 can contribute to engaging and, through this, help establish two-way relationships focused on shared and valued goals.

Activities and impacts of patient engagement in CIHR SPOR funded research: a cross-sectional survey of academic researcher and patient partner experiences.

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.

The Canadian Institutes of Health Research developed the Strategy for Patient-Oriented Research (SPOR) to help increase capacity for patient engagement in research. However, little is known about the ways in which Canadian patient co-researchers (i.e., patient partners) are being engaged in research and the perceived impacts of engagement. Therefore, this study aimed to describe engagement activities and perceived impacts of SPOR-funded projects. To do so, we carried out an online survey of academic researchers and patient partners engaging in projects funded through 13 SPOR funding calls. We analysed the collected data using thematic analysis, which focuses on finding themes among data. Sixty-six of 511 academic researchers and 20 of 28 patient partners contacted completed the survey and were included in analyses. We found 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. We also found that 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. The findings of this study can be used to inform ongoing and future research, including empowering patient partners to be more informed and actively shape how they may contribute to research processes.

Scoping review of models and frameworks of patient engagement in health services research.

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.

Adaptive randomised controlled non-inferiority multicentre trial (the Ketodex Trial) on intranasal dexmedetomidine plus ketamine for procedural sedation in children: study protocol.

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.

Study protocol for two complementary trials of non-steroidal or opioid analgesia use for children aged 6 to 17 years with musculoskeletal injuries (the No OUCH study).

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.

Innovative approaches to investigator-initiated, multicentre paediatric clinical trials in Canada.

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.

Models and frameworks of patient engagement in health services research: a scoping review protocol.

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.