Development of the Preferred Components for Co-Design in Research Guideline and Checklist: Protocol for a Scoping Review and a Modified Delphi Process.

BACKGROUND: There is increasing evidence that co-design can lead to more engaging, acceptable, relevant, feasible, and even effective interventions. However, no guidance is provided on the specific designs and associated methods or methodologies involved in the process. We propose the development of the Preferred Components for Co-design in Research (PRECISE) guideline to enhance the consistency, transparency, and quality of reporting co-design studies used to develop complex health interventions. OBJECTIVE: The aim is to develop the first iteration of the PRECISE guideline. The purpose of the PRECISE guideline is to improve the consistency, transparency, and quality of reporting on studies that use co-design to develop complex health interventions. METHODS: The aim will be achieved by addressing the following objectives: to review and synthesize the literature on the models, theories, and frameworks used in the co-design of complex health interventions to identify their common elements (components, values or principles, associated methods and methodologies, and outcomes); and by using the results of the scoping review, prioritize the co-design components, values or principles, associated methods and methodologies, and outcomes to be included in the PRECISE guideline. RESULTS: The project has been funded by the Canadian Institutes of Health Research. CONCLUSIONS: The collective results of this project will lead to a ready-to-implement PRECISE guideline that outlines a minimum set of items to include when reporting the co-design of complex health interventions. The PRECISE guideline will improve the consistency, transparency, and quality of reports of studies. Additionally, it will include guidance on how to enact or enable the values or principles of co-design for meaningful and collaborative solutions (interventions). PRECISE might also be used by peer reviewers and editors to improve the review of manuscripts involving co-design. Ultimately, the PRECISE guideline will facilitate more efficient use of new results about complex health intervention development and bring better returns on research investments. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/50463.

Considerations for the design of overdose education and naloxone distribution interventions: results of a multi-stakeholder workshop.

INTRODUCTION: Opioid overdose epidemic is a public health crisis that is impacting communities around the world. Overdose education and naloxone distribution programs equip and train lay people to respond in the event of an overdose. We aimed to understand factors to consider for the design of naloxone distribution programs in point-of-care settings from the point of view of community stakeholders. METHODS: We hosted a multi-stakeholder co-design workshop to elicit suggestions for a naloxone distribution program. We recruited people with lived experience of opioid overdose, community representatives, and other stakeholders from family practice, emergency medicine, addictions medicine, and public health to participate in a full-day facilitated co-design discussion wherein large and small group discussions were audio-recorded, transcribed and analysed using thematic approaches. RESULTS: A total of twenty-four participants participated in the multi-stakeholder workshop from five stakeholder groups including geographic and setting diversity. Collaborative dialogue and shared storytelling revealed seven considerations for the design of naloxone distribution programs specific to training needs and the provision of naloxone, these are: recognizing overdose, how much naloxone, impact of stigma, legal risk of responding, position as conventional first aid, friends and family as responders, support to call 911. CONCLUSION: To create an naloxone distribution program in emergency departments, family practice and substance use treatment services, stigma is a central design consideration for training and naloxone kits. Design choices that reference the iconography, type, and form of materials associated with first aid have the potential to satisfy the need to de-stigmatize overdose response.

Designing a Sensory Kit to Improve the Environment for Children with Autism Spectrum Disorder in the Pediatric Emergency Department.

Children with autism spectrum disorder (ASD) have more frequent use of healthcare services, including visits to the emergency department (ED). Medical care for children with ASD can be adversely affected by the highly stimulating environment of the ED. In this study, we gained insights from stakeholders with lived experience (parents of children with ASD, children with ASD, and ED healthcare providers) to create and implement a sensory equipment kit. The kit was evaluated and iteratively improved based on observations of children using the sensory equipment, satisfaction surveys from their parents, and interviews with healthcare providers in the ED. Findings from this study can be used to guide other EDs in creating their own ASD sensory kit.

Design details for overdose education and take-home naloxone kits: Codesign with family medicine, emergency department, addictions medicine and community.

INTRODUCTION: Overdose education and naloxone distribution (OEND) programmes equip and train people who are likely to witness an opioid overdose to respond with effective first aid interventions. Despite OEND expansion across North America, overdose rates are increasing, raising questions about how to improve OEND programmes. We conducted an iterative series of codesign stakeholder workshops to develop a prototype for take-home naloxone (THN)-kit (i.e., two doses of intranasal naloxone and training on how to administer it). METHODS: We recruited people who use opioids, frontline healthcare providers and public health representatives to participate in codesign workshops covering questions related to THN-kit prototypes, training on how to use it, and implementation, including refinement of design artefacts using personas and journey maps. Completed over 9 months, the workshops were audio-recorded and transcribed with visible results of the workshops (i.e., sticky notes, sketches) archived. We used thematic analyses of these materials to identify design requirements for THN-kits and training. RESULTS: We facilitated 13 codesign workshops to identify and address gaps in existing opioid overdose education training and THN-kits and emphasize timely response and stigma in future THN-kit design. Using an iterative process, we created 15 prototypes, 3 candidate prototypes and a final prototype THN-kit from the synthesis of the codesign workshops. CONCLUSION: The final prototype is available for a variety of implementation and evaluation processes. The THN-kit offers an integrated solution combining ultra-brief training animation and physical packaging of nasal naloxone to be distributed in family practice clinics, emergency departments, addiction medicine clinics and community settings. PATIENT OR PUBLIC CONTRIBUTION: The codesign process was deliberately structured to involve community members (the public), with multiple opportunities for public contribution. In addition, patient/public participation was a principle for the management and structuring of the research team.

Supporting community overdose response planning in Ontario, Canada: Findings from a situational assessment.

BACKGROUND: Many communities across North America are coming together to develop comprehensive plans to address and respond to the escalating overdose crisis, largely driven by an increasingly toxic unregulated drug supply. As there is a need to build capacity for successful implementation, the objective of our mixed methods study was to identify the current planning and implementation practices, needs, and priority areas of support for community overdose response plans in Ontario, Canada. METHODS: We used a situational assessment methodology to collect data on current planning and implementation practices, needs, and challenges related to community overdose response plans in Ontario, consisting of three components. Between November 2019 to February 2020, we conducted ten semi-structured key informant interviews, three focus groups with 25 participants, and administered an online survey (N = 66). Purposeful sampling was used to identify professionals involved in coordinating, supporting, or partnering on community overdose response plans in jurisdictions with relevant information for Ontario including other Canadian provinces and American states. Key informants included evaluators, representatives involved in centralised supports, as well as coordinators and partners on community overdose response plans. Focus group participants were coordinators or leads of community overdose response plans in Ontario. RESULTS: Sixty-six professionals participated in the study. The current planning and implementation practices of community overdose response plans varied in Ontario. Our analysis generated four overarching areas for needs and support for the planning and implementation of community overdose response plans: 1) data and information; 2) evidence and practice; 3) implementation/operational factors; and 4) partnership, engagement, and collaboration. Addressing stigma and equity within planning and implementation of community overdose response plans was a cross-cutting theme that included meaningful engagement of people with living and lived expertise and meeting the service needs of different populations and communities. CONCLUSIONS: Through exploring the needs and related supports for community overdose response plans in Ontario, we have identified key priority areas for building local capacity building to address overdose-related harms. Ongoing development and refinement, community partnership, and evaluation of our project will highlight the influence of our supports to advance the capacity, motivation, and opportunities of community overdose response plans.

The Time Moving exhibit: Exploring perceptions of time in end-of-life experiences.

BACKGROUND: Conversations about end of life rarely take place beyond healthcare spaces and in advance of imminent death. As the Canadian ageing population increases and new policies and options emerge for end-of-life choices, there will be an increasing need for supports for decision-making on end of life. Time Moving was a participatory art exhibit created to engage participants in reflections on end-of-life experiences and the ways in which their perception of time fluctuated within these moments. DESIGN: A participatory and constructivist approach informed decisions on exhibit design and analysis. The Time Moving exhibit was installed in a downtown university hall for 10 days during the 2019 annual DesignTO festival, open to all members of the public. The exhibit was used as the primary method of data collection. There were three prompts informed by concepts from prior work on time perception. Participants were invited to respond by drawing, writing or constructing. OUTCOME: There were over 120 contributions of participants over the duration of the Time Moving exhibit. These contributions revealed new insights related to temporal perception and end-of-life experiences. Participants shared their perception of time during end-of-life experiences in a variety of ways, revealing a diversity of perceptions of time beyond calendar and clock time, including time experienced as a spiral. CONCLUSIONS: The insights on time perception highlight opportunities for approaching dialogue on end of life and in grief support, and for exhibit as a mechanism for research and education. PATIENT OR PUBLIC CONTRIBUTION: As a public exhibit, over 120 people contributed ideas, personal stories, drawings and other creative outputs to the exhibit. An estimated 250 people visited the exhibit.

Corrigendum to "Mixed methods feasibility study for the surviving opioid overdose with naloxone education and resuscitation (SOONER) trial" [Resuscitation Plus 6 (2021) 100131].

[This corrects the article DOI: 10.1016/j.resplu.2021.100131.].

Mixed methods feasibility study for the surviving opioid overdose with naloxone education and resuscitation (SOONER) trial.

AIM: We plan to conduct a randomised clinical trial among people likely to witness opioid overdose to compare the educational effectiveness of point-of-care naloxone distribution with best-available care, by observing participants' resuscitation skills in a simulated overdose. This mixed methods feasibility study aims to assess the effectiveness of recruitment and retention strategies and acceptability of study procedures. METHODS: We implemented candidate-driven recruitment strategies with verbal consent and destigmatizing study materials in a family practice, emergency department, and addictions service. People ≥16 years of age who are likely to witness overdose were randomized to point-of-care naloxone distribution or referral to an existing program. We evaluated participant skills as a responder to a simulated overdose 3-14 days post-recruitment. Retention strategies included flexible scheduling, reminders, cash compensation and refreshments. The primary outcome was recruitment and retention feasibility, defined as the ability to recruit 28 eligible participants in 28 days, with <50% attrition at the outcome simulation. Acceptability of study procedures and motivations for participation were assessed in a semi-structured interview. RESULTS: We enrolled 30 participants over 24 days, and retained 21 participants (70%, 95%CI 56.7-100). The most common motivation for participation was a desire to serve the community or loved ones in distress. Participants reported that study procedures were acceptable and that the outcome simulation provided a supportive and affirming environment. CONCLUSION: The planned trial is ready for implementation. Recruitment and retention is feasible and study processes are acceptable for people who are likely to witness overdose. (Registration: NCT03821649).

Protocol for a mixed-methods feasibility study for the surviving opioid overdose with naloxone education and resuscitation (SOONER) randomised control trial.

INTRODUCTION: The surviving opioid overdose with naloxone education and resuscitation (SOONER) project uses co-design and trial methods to develop and evaluate a point-of-care overdose education and naloxone distribution (OEND) tool. We plan to conduct a randomised controlled trial to assess the effectiveness of our OEND tool in comparison with best available standard of care by observing participants' performance as a responder to a simulated overdose. Recruiting and retaining people at risk of or likely to witness opioid overdose raises scientific, logistical and bioethical challenges. A feasibility study is needed to establish the effectiveness of recruitment and retention strategies and acceptability of study procedures prior to launching the full trial. METHODS AND ANALYSIS: Strategies to enhance recruitment include candidate-driven recruitment, verbal informed consent, and attractive, destigmatising materials. Adults at risk of or likely to witness opioid overdose will be recruited through an urban emergency department, inpatient and ambulatory addiction medicine service, and outpatient family practice settings. Participants randomised to the intervention arm will receive our OEND intervention; those in the control arm will be referred to existing OEND programme. Retention procedures include participant reminders, flexible scheduling, cash and comfort compensation, and strategies to maintain a consistent relationship between individual study staff and participants. Within 2 weeks following recruitment, participants will engage as a responder to a manikin-simulated overdose, and complete overdose knowledge and attitudes questionnaires. The primary outcome is recruitment and retention feasibility, defined as the recruitment of 28 participants within 28 days of recruitment and <50% attrition at the overdose simulation. Staff and participant feedback will also be collected and considered. ETHICS AND DISSEMINATION: The study has been reviewed by ethics boards at St. Michael's Hospital, Toronto Public Health and the University of Toronto. Dissemination will occur through peer-reviewed publication and presentations. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov registry (NCT03821649).