Training and capacity development in patient-oriented research: Ontario SPOR SUPPORT Unit (OSSU) initiatives.

BACKGROUND: In Canada, the Canadian Institutes of Health Research launched the Strategy for Patient-Oriented Research (SPOR) in 2011. The strategy defines 'patient-oriented research' as a continuum of research that engages patients as partners, focuses on patient priorities, and leads to improved patient outcomes. The overarching term 'patient' is inclusive of individuals with personal experience of a health issue as well as informal caregivers including family and friends. The vision for the strategy is improved patient experiences and outcomes through the integration of patient-oriented research findings into practice, policy, and health system improvement. Building capacity in patient-oriented research among all relevant stakeholders, namely patients, practitioners, organizational leaders, policymakers, researchers, and research funders is a core element of the strategy. MAIN BODY: The objective of this paper is to describe capacity building initiatives in patient-oriented research led by the Ontario SPOR SUPPORT Unit in Ontario, Canada over the period 2014-2020. CONCLUSION: The Ontario SPOR SUPPORT Unit Working Group in Training and Capacity Development has led numerous capacity building initiatives: developed a Capacity Building Compendium (accessed greater than 45,000 times); hosted Masterclasses that have trained hundreds of stakeholders (patients, practitioners, organizational leaders, policymakers, researchers, and trainees) in the conduct and use of patient-oriented research; funded the development of online curricula on patient-oriented research that have reached thousands of stakeholders; developed a patient engagement resource center that has been accessed by tens of thousands of stakeholders; identified core competencies for research teams and research environments to ensure authentic and meaningful patient partnerships in health research; and shared these resources and learnings with stakeholders across Canada, North America, and internationally.

In 2011, Canada developed a Strategy for Patient-Oriented Research. The aim of the strategy was to ensure that patients were included as equal partners in research, with the goal to improve the patient experience and enhance health outcomes using research findings to influence clinical care, policy, and health system improvement. Building capacity in patient-oriented research is a core element of the strategy. Since 2014, the Ontario SPOR SUPPORT Unit has led numerous initiatives to build capacity in patient-oriented research. Successes include a Capacity Building Compendium (a catalogue of resources that has been accessed greater than 45,000 times); courses on how to do and how to use patient-oriented research that have trained hundreds of patients, practitioners, organizational leaders, policymakers, and researchers; created online patient-oriented research materials; developed a patient engagement resource center; identified what is required to ensure authentic and meaningful patient partnerships in research; and shared these resources and learnings widely.

Offloading devices for neuropathic foot ulcers in adult persons with type 1 or type 2 diabetes: a rapid review with meta-analysis and trial sequential analysis of randomized controlled trials.

INTRODUCTION: Healing time for neuropathic planter foot ulcers (NPFUs) in persons with diabetes may be reduced through use of non-removable fiberglass total contact casting (F-TCC) compared with removable cast walkers (RCWs), although the evidence base is still growing. RESEARCH DESIGN AND METHODS: We conducted a rapid review and systematically searched for, and critically assessed, randomized controlled trials (RCTs) that compared the efficacy of F-TCC versus RCW, focusing on the time to ulcer healing in adult persons (18+ years) with NPFUs and type 1 or type 2 diabetes. We meta-analysed the mean differences and associated 95% CIs using an inverse variance, random-effects model. We also conducted a trial sequential analysis (TSA) to assess if the available evidence is up to the required information size for a robust conclusion. We assessed and quantified statistical heterogeneity between the included studies using the I2 statistic. RESULTS: Out of 102 retrieved citations, five RCTs met the eligibility criteria. Participants' inclusion in relation to stage of ulcer was highly variable as was peripheral neuropathy complicating comparisons. F-TCC appeared to present a shorter ulcer healing time (-5.42 days, 95% CI -9.66 days to -1.17 days; I2 9.9%; 5 RCTs; 169 participants) compared with RCW. This finding was supported by the TSA. CONCLUSIONS: There is limited evidence from RCTs to suggest that F-TCC has a shorter ulcer healing time compared with RCW among adults with diabetic NPFUs. Properly designed and conducted RCTs are still required for a stronger evidence base.

Evaluation of the partners in research course: a patient and researcher co-created course to build capacity in patient-oriented research.

BACKGROUND: In the past decade, patient-oriented research (POR) has been at the forefront of healthcare research in Canada because it has the potential to make research more meaningful and relevant to patient needs. Despite this growing emphasis on and expectation to conduct POR, there is limited guidance about how to apply POR in practice. To address this capacity building need, the Knowledge Translation (KT) Program and patient partners co-designed, delivered, and evaluated Partners in Research (PiR), a 2-month online course for patients and researchers to collectively learn how to conduct and engage in POR. METHODS: PiR was delivered to 4 cohorts of patients and researchers between 2017 and 2018. For each cohort, we evaluated the impact of the course on participants' knowledge, self-efficacy, intentions, and use of POR using surveys at 3 time points: baseline, post-course and 6-months post-course. We also monitored the process of course design and delivery by assessing implementation quality of the PiR course. Participants were asked to rate their satisfaction with course format, course materials, quality of delivery and their level of engagement via a 7-point Likert scale in the post-course survey. RESULTS: A total of 151 participants enrolled in the PiR course throughout the 4 cohorts. Of these, 49 patients and 33 researchers (n = 82 participants) consented to participate in the course evaluation. Process and outcome evaluations collected over a 9-month period indicated that participation in the PiR course increased knowledge of POR concepts for patients (p < .001) and for researchers (p < .001) from pre-course to post-course timepoints. Likewise, self-efficacy to engage in POR increased from baseline to post-course for both patients (p < .001) and researchers (p < .001). Moreover, participants reported high levels of satisfaction with content, delivery and interactive components of the course. CONCLUSIONS: The PiR course increased capacity in POR for both researchers and patients. This work enhances our understanding of how to design useful and engaging education opportunities to increase patient and researcher capacity in POR.

Patient-oriented research (POR) is the meaningful inclusion of patients as active contributing partners in research. In meaningful POR, patients are engaged and valued as contributory members of the research team throughout the research process, from developing research questions, participating in research activities, to sharing new research findings. In Canada, POR is recognized as an important component of research and many healthcare institutions aim to engage patients in their work. However, there is little guidance on how patients and researchers can effectively participate as equal partners in research activities. To address the need for POR education opportunities, we launched Partners in Research (PiR), a 2­month online course for patients and researchers to learn how to conduct and engage in POR. This paper describes the design, delivery, and evaluation of the PiR course, with a focus on the following objectives: (1) To assess the impact of the PiR course on participant knowledge, confidence, intentions and use of POR (2) To determine the quality of course design and delivery and its ability to achieve learning objectives (3) To identify factors that limit and facilitate participation in POR The findings from the evaluation show that the PiR course was effective in increasing knowledge of, and confidence in POR concepts. In addition, the course was well-received, with participants reporting a high level of engagement in course content and activities. Overall, this work supports our understanding of how to design useful and engaging opportunities to increase patient and researcher capacity in POR.

Projected impact of biosimilar substitution policies on drug use and costs in Ontario, Canada: a cross-sectional time series analysis.

BACKGROUND: Several Canadian provinces have introduced reimbursement policies mandating substitution of innovator biologics with lower-cost biosimilars. We estimated the number of patients affected and cost implications if such policy changes were to be implemented in Ontario, Canada. METHODS: We conducted a cross-sectional time series analysis of Ontarians dispensed publicly funded biologics indicated for inflammatory diseases (rheumatic conditions, inflammatory bowel disease: infliximab, etanercept, adalimumab) between January 2018 and December 2019, and forecasted trends to Dec. 31, 2020. The primary source of data was pharmacy claims data for all biologics reimbursed by the public drug program. We modelled the number of patients affected and government expenditures (in nominal Canadian dollars) of several biosimilar policy options, including mandatory nonmedical biosimilar substitution, substitution in new users, introduction of a biosimilar for adalimumab, and price negotiations. In a secondary analysis, we included insulin glargine. RESULTS: In 2018, 14 089 individuals were prescribed a publicly funded biologic for inflammatory diseases. A mandatory nonmedical biosimilar substitution would potentially have affected 7209 patients and saved $238.6 million from 2018 to 2020. A new-user substitution would have affected 757 patients and saved $34.2 million. If an adalimumab biosimilar were to become available, 12 928 patients would be affected by a mandatory nonmedical substitution and the 3-year savings would increase to $645.9 million (all biosimilars priced at 25% of innovator biologics). Finally, an expanded nonmedical substitution policy including insulin glargine would affect 115 895 patients and save $288.7 million (not including adalimumab). INTERPRETATION: Policies designed to curb rising costs of biologics can have substantially different effects on patients and government expenditures. Such analyses warrant careful consideration of the balance between cost savings and effects on patients.